Interventions to improve water quality and supply, sanitation and hygiene practices, and their effects on the nutritional status of children.

PubMed

Dangour, Alan D; Watson, Louise; Cumming, Oliver; Boisson, Sophie; Che, Yan; Velleman, Yael; Cavill, Sue; Allen, Elizabeth; Uauy, Ricardo

2013-08-01

Water, sanitation and hygiene (WASH) interventions are frequently implemented to reduce infectious diseases, and may be linked to improved nutrition outcomes in children. To evaluate the effect of interventions to improve water quality and supply (adequate quantity to maintain hygiene practices), provide adequate sanitation and promote handwashing with soap, on the nutritional status of children under the age of 18 years and to identify current research gaps. We searched 10 English-language (including MEDLINE and CENTRAL) and three Chinese-language databases for published studies in June 2012. We searched grey literature databases, conference proceedings and websites, reviewed reference lists and contacted experts and authors. Randomised (including cluster-randomised), quasi-randomised and non-randomised controlled trials, controlled cohort or cross-sectional studies and historically controlled studies, comparing WASH interventions among children aged under 18 years. Two review authors independently sought and extracted data on childhood anthropometry, biochemical measures of micronutrient status, and adherence, attrition and costs either from published reports or through contact with study investigators. We calculated mean difference (MD) with 95% confidence intervals (CI). We conducted study-level and individual-level meta-analyses to estimate pooled measures of effect for randomised controlled trials only. Fourteen studies (five cluster-randomised controlled trials and nine non-randomised studies with comparison groups) from 10 low- and middle-income countries including 22,241 children at baseline and nutrition outcome data for 9,469 children provided relevant information. Study duration ranged from 6 to 60 months and all studies included children under five years of age at the time of the intervention. Studies included WASH interventions either singly or in combination. Measures of child anthropometry were collected in all 14 studies, and nine studies reported at least one of the following anthropometric indices: weight-for-height, weight-for-age or height-for-age. None of the included studies were of high methodological quality as none of the studies masked the nature of the intervention from participants.Weight-for-age, weight-for-height and height-for-age z-scores were available for five cluster-randomised controlled trials with a duration of between 9 and 12 months. Meta-analysis including 4,627 children identified no evidence of an effect of WASH interventions on weight-for-age z-score (MD 0.05; 95% CI -0.01 to 0.12). Meta-analysis including 4,622 children identified no evidence of an effect of WASH interventions on weight-for-height z-score (MD 0.02; 95% CI -0.07 to 0.11). Meta-analysis including 4,627 children identified a borderline statistically significant effect of WASH interventions on height-for-age z-score (MD 0.08; 95% CI 0.00 to 0.16). These findings were supported by individual participant data analysis including information on 5,375 to 5,386 children from five cluster-randomised controlled trials.No study reported adverse events. Adherence to study interventions was reported in only two studies (both cluster-randomised controlled trials) and ranged from low (< 35%) to high (> 90%). Study attrition was reported in seven studies and ranged from 4% to 16.5%. Intervention cost was reported in one study in which the total cost of the WASH interventions was USD 15/inhabitant. None of the studies reported differential impacts relevant to equity issues such as gender, socioeconomic status and religion. The available evidence from meta-analysis of data from cluster-randomised controlled trials with an intervention period of 9-12 months is suggestive of a small benefit of WASH interventions (specifically solar disinfection of water, provision of soap, and improvement of water quality) on length growth in children under five years of age. The duration of the intervention studies was relatively short and none of the included studies is of high methodological quality. Very few studies provided information on intervention adherence, attrition and costs. There are several ongoing trials in low-income country settings that may provide robust evidence to inform these findings.

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus.

PubMed

Nobels, Frank; Debacker, Noëmi; Brotons, Carlos; Elisaf, Moses; Hermans, Michel P; Michel, Georges; Muls, Erik

2011-09-22

To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Recruitment was completed in December 2008 with 3994 evaluable patients. This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. NCT00681850.

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

PubMed Central

2011-01-01

Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial.

PubMed

Nkhoma, Kennedy; Seymour, Jane; Arthur, Antony

2013-07-13

Many HIV/AIDS patients experience pain often due to advanced HIV/AIDS infection and side effects of treatment. In sub-Saharan Africa, pain management for people with HIV/AIDS is suboptimal. With survival extended as a direct consequence of improved access to antiretroviral therapy, the prevalence of HIV/AIDS related pain is increasing. As most care is provided at home, the management of pain requires patient and family involvement. Pain education is an important aspect in the management of pain in HIV/AIDS patients. Studies of the effectiveness of pain education interventions for people with HIV/AIDS have been conducted almost exclusively in western countries. A randomised controlled trial is being conducted at the HIV and palliative care clinics of two public hospitals in Malawi. To be eligible, patient participants must have a diagnosis of HIV/AIDS (stage III or IV). Carer participants must be the individual most involved in the patient's unpaid care. Eligible participants are randomised to either: (1) a 30-minute face-to-face educational intervention covering pain assessment and management, augmented by a leaflet and follow-up telephone call at two weeks; or (2) usual care. Those allocated to the usual care group receive the educational intervention after follow-up assessments have been conducted (wait-list control group). The primary outcome is pain severity measured by the Brief Pain Inventory. Secondary outcomes are pain interference, patient knowledge of pain management, patient quality of life, carer knowledge of pain management, caregiver motivation and carer quality of life. Follow-up assessments are conducted eight weeks after randomisation by palliative care nurses blind to allocation. This randomised controlled trial conducted in sub-Saharan Africa among people living with HIV/AIDS and their carers will assess whether a pain education intervention is effective in reducing pain and improving pain management, quality of life and carer motivation. Current Controlled Trials ISRCTN72861423.

Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work).

PubMed

Hunter, Myra S; Hardy, Claire; Norton, Sam; Griffiths, Amanda

2016-10-01

Hot flushes and night sweats (HFNS) - the main symptoms of the menopause transition - can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility. One hundred menopausal working women, aged 45-60 years, experiencing bothersome HFNS for two months will be recruited from several (2-10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention. This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms. Clin.Gov NCT02623374. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Development of a practical approach to expert elicitation for randomised controlled trials with missing health outcomes: Application to the IMPROVE trial

PubMed Central

Mason, Alexina J; Gomes, Manuel; Grieve, Richard; Ulug, Pinar; Powell, Janet T; Carpenter, James

2017-01-01

Background/aims: The analyses of randomised controlled trials with missing data typically assume that, after conditioning on the observed data, the probability of missing data does not depend on the patient’s outcome, and so the data are ‘missing at random’ . This assumption is usually implausible, for example, because patients in relatively poor health may be more likely to drop out. Methodological guidelines recommend that trials require sensitivity analysis, which is best informed by elicited expert opinion, to assess whether conclusions are robust to alternative assumptions about the missing data. A major barrier to implementing these methods in practice is the lack of relevant practical tools for eliciting expert opinion. We develop a new practical tool for eliciting expert opinion and demonstrate its use for randomised controlled trials with missing data. Methods: We develop and illustrate our approach for eliciting expert opinion with the IMPROVE trial (ISRCTN 48334791), an ongoing multi-centre randomised controlled trial which compares an emergency endovascular strategy versus open repair for patients with ruptured abdominal aortic aneurysm. In the IMPROVE trial at 3 months post-randomisation, 21% of surviving patients did not complete health-related quality of life questionnaires (assessed by EQ-5D-3L). We address this problem by developing a web-based tool that provides a practical approach for eliciting expert opinion about quality of life differences between patients with missing versus complete data. We show how this expert opinion can define informative priors within a fully Bayesian framework to perform sensitivity analyses that allow the missing data to depend upon unobserved patient characteristics. Results: A total of 26 experts, of 46 asked to participate, completed the elicitation exercise. The elicited quality of life scores were lower on average for the patients with missing versus complete data, but there was considerable uncertainty in these elicited values. The missing at random analysis found that patients randomised to the emergency endovascular strategy versus open repair had higher average (95% credible interval) quality of life scores of 0.062 (−0.005 to 0.130). Our sensitivity analysis that used the elicited expert information as pooled priors found that the gain in average quality of life for the emergency endovascular strategy versus open repair was 0.076 (−0.054 to 0.198). Conclusion: We provide and exemplify a practical tool for eliciting the expert opinion required by recommended approaches to the sensitivity analyses of randomised controlled trials. We show how this approach allows the trial analysis to fully recognise the uncertainty that arises from making alternative, plausible assumptions about the reasons for missing data. This tool can be widely used in the design, analysis and interpretation of future trials, and to facilitate this, materials are available for download. PMID:28675302

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study.

PubMed

Radcliffe, Michael J; Lewith, George T; Turner, Richard G; Prescott, Philip; Church, Martin K; Holgate, Stephen T

2003-08-02

To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy. Double blind randomised placebo controlled parallel group study. Hospital in Hampshire. 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo. Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of beta glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution. Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season. The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred. Enzyme potentiated desensitisation showed no treatment effect in this study.

The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial.

PubMed

Boden, Ianthe; Browning, Laura; Skinner, Elizabeth H; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K; Denehy, Linda

2015-12-15

Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and physiotherapy, measures many known confounders, and includes a post-discharge follow-up of complication rates, functional capacity, and health-related quality of life. This trial is currently recruiting. Australian New Zealand Clinical Trials Registry number: ACTRN12613000664741 , 19 June 2013.

Can Healthcare Assistant Training (CHAT) improve the relational care of older people? Study protocol for a pilot cluster randomised controlled trial.

PubMed

Arthur, Antony; Maben, Jill; Wharrad, Heather; Aldus, Clare; Sarre, Sophie; Schneider, Justine; Nicholson, Caroline; Barton, Garry; Cox, Karen; Clark, Allan

2015-12-09

People aged 75 years and over account for 1 in 4 of all hospital admissions. There has been increasing recognition of problems in the care of older people, particularly in hospitals. Evidence suggests that older people judge the care they receive in terms of kindness, empathy, compassion, respectful communication and being seen as a person not just a patient. These are aspects of care to which we refer when we use the term 'relational care'. Healthcare assistants deliver an increasing proportion of direct care to older people, yet their training needs are often overlooked. This study will determine the acceptability and feasibility of a cluster randomised controlled trial of 'Older People's Shoes' a 2-day training intervention for healthcare assistants caring for older people in hospital. Within this pilot, 2-arm, parallel, cluster randomised controlled trial, healthcare assistants within acute hospital wards are randomised to either the 2-day training intervention or training as usual. Registered nurses deliver 'Older People's Shoes' over 2 days, approximately 1 week apart. It contains three components: experiential learning about ageing, exploration of older people's stories, and customer care. Outcomes will be measured at the level of patient (experience of emotional care and quality of life during their hospital stay), healthcare assistant (empathy and attitudes towards older people), and ward (quality of staff/patient interaction). Semi-structured interviews of a purposive sample of healthcare assistants receiving the intervention, and all trainers delivering the intervention, will be undertaken to gain insights into the experiences of both the intervention and the trial, and its perceived impact on practice. Few training interventions for care staff have been rigorously tested using randomised designs. This study will establish the viability of a definitive cluster randomised controlled trial of a new training intervention to improve the relational care proided by healthcare assistants working with older people in hospital. The study was registered as an International Standard Randomised Controlled Trial ( ISRCTN10385799 ) on 29 December 2014.

Incentive spirometry combined with expiratory positive airway pressure improves asthma control and quality of life in asthma: a randomised controlled trial.

PubMed

Rondinel, Tatiana Zacarias; Corrêa, Isadora Faraco; Hoscheidt, Luíza Machado; Bueno, Mirelle Hugo; Da Silva, Luciano Muller Corrêa; Reppold, Caroline Tozzi; Dal Lago, Pedro

2015-03-01

The use of the incentive spirometer (IS) and expiratory positive airway pressure (EPAP) provides several benefits in patients with respiratory disorders. However, the effects of the use of these devices coupled (IS + EPAP) are still unknown in asthmatic patients. The aim of this study was to evaluate the effect of IS associated with EPAP on exercise tolerance (six-minute walk test - 6MWT), lung function (by spirometry), asthma control (Asthma Control Questionnaire - ACQ) and quality of life (Asthma Quality of Life Questionnaire - AQLQ) in patients with severe asthma. Patients were randomised into two groups: IS + EPAP (n = 8) and control (n = 6). The IS + EPAP group performed breathing exercises at home, twice daily for 20 min, over a period of 5 weeks. There was no significant difference in spirometric variables and in the distance walked in the 6MWT in both groups. However, the IS + EPAP group showed an improvement in asthma control (p = 0.002) and quality of life (p = 0.02). These findings demonstrate that the IS + EPAP protocol, when performed at home, provides an improvement in asthma control and quality of life for patients with severe asthma when evaluated by ACQ and AQLQ, respectively.

Hyperbaric oxygen therapy for Bell's palsy.

PubMed

Holland, N Julian; Bernstein, Jonathan M; Hamilton, John W

2012-02-15

Bell's palsy is an idiopathic, acute unilateral facial weakness that evolves rapidly and is maximal within two days. Moderate ear discomfort, sensitivity to sound and reduced tearing may occur. To assess the effects of hyperbaric oxygen therapy on recovery of facial function in adults with moderate to severe Bell's palsy. We searched the Cochrane Neuromuscular Disease Group Specialized Register (January 2012), CENTRAL (2011, Issue 4), MEDLINE (January 1966 to January 2012), EMBASE (January 1980 to January 2012), CINAHL (1937 to January 2012), AMED (1985 to January 2012), LILACS (January 1982 to January 2012). In addition we made a systematic search for relevant controlled trials in specific hyperbaric literature sources. Randomised controlled trials or quasi-randomised controlled trials of adults (over 16 years of age) undergoing hyperbaric oxygen therapy for moderate to severe Bell's palsy. We considered studies to be of sufficient quality for inclusion in the review only if there was blinding in the assessment of the facial palsy grade. We planned to include studies of HBOT used as adjuvant therapy, or in addition to routine medical therapy (including corticosteroids or antivirals, or both). Both treatment and control groups were to receive the same baseline therapy. HBOT had to be delivered at concentrations greater than or equal to 1.2 ATA in a hyperbaric oxygen chamber as a series of dives of 30 to 120 minutes. Two reviewers independently assessed eligibility and study quality and extracted data. We contacted study authors for additional information. Our searches found no randomised controlled trials or quasi-randomised controlled trials that met the eligibility criteria for this review.There is very low quality evidence from one randomised trial involving 79 participants with acute Bell's palsy, but this study was excluded as the outcome assessor was not blinded to treatment allocation and thus did not meet pre-defined eligibility criteria. The trial compared 42 people who received hyperbaric oxygen therapy (2.8 atmospheres for 60 minutes twice daily, five days per week until the facial palsy resolved; maximum 30 'dives') and placebo tablets with 37 people who received placebo hyperbaric oxygen therapy (achieving only a normal partial pressure of oxygen) and prednisone (40 mg twice daily, reducing over eight days). Facial function recovered in more participants treated with hyperbaric oxygen therapy than with prednisone (hyperbaric oxygen therapy, 40/42 (95%); prednisone, 28/37 (76%); risk ratio 1.26, 95% CI 1.04 to 1.53). There were no reported major complications and all participants completed the trial. Very low quality evidence from one trial suggests that hyperbaric oxygen therapy may be an effective treatment for moderate to severe Bell's palsy, but this study was excluded as the outcome assessor was not blinded to treatment allocation. Further randomised controlled trials are needed.

Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

PubMed Central

Cui, Xiao-Ping; Lin, Min; Mu, Jun-Shan; Ye, Jian-Xin; He, Wen-Qing; Fu, Mao-Lin; Li, Hua; Fang, Jia-Yang; Shen, Feng-Feng; Lin, Hang

2016-01-01

Introduction Whether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS. Methods and analysis A randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modified Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL). Ethics and dissemination The study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS. Trial registration number NCT02689037 PMID:27852711

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

PubMed

McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings. Clinicaltrials.gov Identifier: NCT02791048.

Study protocol: a randomised placebo-controlled clinical trial to study the effect of vitamin D supplementation on glycaemic control in type 2 Diabetes Mellitus SUNNY trial.

PubMed

Krul-Poel, Yvonne H M; van Wijland, Hans; Stam, Frank; ten Boekel, Edwin; Lips, Paul; Simsek, Suat

2014-07-17

Besides the classical role of vitamin D on calcium and bone homeostasis, vitamin D deficiency has recently been identified as a contributing factor in the onset of insulin resistance in type 2 diabetes mellitus. However, it is uncertain whether vitamin D deficiency and poor glycaemic control are causally interrelated or that they constitute two independent features of type 2 diabetes mellitus. There are limited clinical trials carried out which measured the effect of vitamin D supplementation on glycaemic control.The objective of this study is to investigate the effect of vitamin D supplementation on glycaemic control and quality of life in patients with type 2 diabetes mellitus. In a randomised double-blind placebo-controlled trial conducted in five general practices in the Netherlands three hundred patients with type 2 diabetes mellitus treated with lifestyle advises or metformin or sulphonylurea-derivatives are randomised to receive either placebo or 50,000 IU Vitamin D3 at monthly intervals. The primary outcome measure is the change in glycated haemoglobin level between baseline and six months. Secondary outcome measures include blood pressure, anthropometric parameters, lipid profile, insulin resistance, quality of life, advanced glycation end products and safety profiles. Quality of life will be measured by The Short Form (SF-36) Health Survey questionnaire. Advanced glycation end products are measured by an AGE-reader. This trial will be the first study exploring the effect of vitamin D supplementation on both glycaemic control and quality of life in patients with type 2 diabetes mellitus. Our findings will contribute to the knowledge of the relationship between vitamin D status and insulin resistance in patients with type 2 diabetes mellitus. The Netherlands trial register: NTR3154.

Quality of life improves in patients with chronic heart failure and Cheyne-Stokes respiration treated with adaptive servo-ventilation in a nurse-led heart failure clinic.

PubMed

Olseng, Margareth W; Olsen, Brita F; Hetland, Arild; Fagermoen, May S; Jacobsen, Morten

2017-05-01

The aim of this study was to investigate if quality of life improved in chronic heart failure patients with Cheyne-Stokes respiration treated with adaptive servo-ventilation in nurse-led heart failure clinic. Cheyne-Stokes respiration is associated with decreased quality of life in patients with chronic heart failure. Adaptive servo-ventilation is introduced to treat this sleep-disordered breathing. Randomised, controlled design. Fifty-one patients (ranging from 53-84 years), New York Heart Association III-IV and/or left ventricular ejection fraction ≤40% and Cheyne-Stokes respiration were randomised to an intervention group who received adaptive servo-ventilation or a control group. Minnesota Living with Heart Failure Questionnaire was used to assess quality of life at randomisation and after three months. Both groups were followed in the nurse-led heart failure clinic. Adaptive servo ventilation improved quality of life-scores both in a per protocol analysis and in an intention to treat analysis. Twenty-one patients dropped out of the study, nine in the control and 12 in the intervention group. Use of adaptive servo-ventilation improved quality of life in chronic heart failure patients with Cheyne-Stokes respiration. However, the drop-out rate was high. Chronic heart failure patients come regularly to the nurse-led heart failure clinic. The heart failure nurses' competency has to include knowledge of equipment to provide support and continuity of care to the patients. © 2016 John Wiley & Sons Ltd.

Comparing clinical quality indicators for asthma management in children with outcome measures used in randomised controlled trials: a protocol.

PubMed

Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B; Coiera, Enrico

2015-09-08

Clinical quality indicators are necessary to monitor the performance of healthcare services. The development of indicators should, wherever possible, be based on research evidence to minimise the risk of bias which may be introduced during their development, because of logistic, ethical or financial constraints alone. The development of automated methods to identify the evidence base for candidate indicators should improve the process of indicator development. The objective of this study is to explore the relationship between clinical quality indicators for asthma management in children with outcome and process measurements extracted from randomised controlled clinical trial reports. National-level indicators for asthma management in children will be extracted from the National Quality Measures Clearinghouse (NQMC) database and the National Institute for Health and Care Excellence (NICE) quality standards. Outcome measures will be extracted from published English language randomised controlled trial (RCT) reports for asthma management in children aged below 12 years. The two sets of measures will be compared to assess any overlap. The study will provide insights into the relationship between clinical quality indicators and measurements in RCTs. This study will also yield a list of measurements used in RCTs for asthma management in children, and will find RCT evidence for indicators used in practice. Ethical approval is not necessary because this study will not include patient data. Findings will be disseminated through peer-reviewed publications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Safe household water treatment and storage using ceramic drip filters: a randomised controlled trial in Bolivia.

PubMed

Clasen, T; Brown, J; Suntura, O; Collin, S

2004-01-01

A randomised controlled field trial was conducted to evaluate the effectiveness of ceramic drip filters to improve the microbiological quality of drinking water in a low-income community in rural Bolivia. In four rounds of water sampling over five months, 100% of the samples were free of thermotolerant (faecal) coliforms (TTC) compared to an arithmetic mean TTC count of 1517, 406, 167 and 245 among control households which continued to use their customary sources of drinking water. The filter systems produced water that consistently met WHO drinking-water standards despite levels of turbidity that presented a challenge to other low-cost POU treatment methods. The filter systems also demonstrated an ability to maintain the high quality of the treated water against subsequent re-contamination in the home.

Effect of paper quality on the response rate to a postal survey: A randomised controlled trial. [ISRCTN32032031

PubMed Central

Clark, T Justin; Khan, Khalid S; Gupta, Janesh K

2001-01-01

Background Response rates to surveys are declining and this threatens the validity and generalisability of their findings. We wanted to determine whether paper quality influences the response rate to postal surveys Methods A postal questionnaire was sent to all members of the British Society of Gynaecological Endoscopy (BSGE). Recipients were randomised to receiving the questionnaire printed on standard quality paper or high quality paper. Results The response rate for the recipients of high quality paper was 43/195 (22%) and 57/194 (29%) for standard quality paper (relative rate of response 0.75, 95% CI 0.33–1.05, p = 0.1 Conclusion The use of high quality paper did not increase response rates to a questionnaire survey of gynaecologists affiliated to an endoscopic society. PMID:11782286

Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre?

PubMed

Wilcock, Andrew; Manderson, CathAnn; Weller, Rebecca; Walker, George; Carr, Diane; Carey, Anne-Marie; Broadhurst, Debbie; Mew, June; Ernst, Edzard

2004-05-01

A randomised controlled pilot study was carried out to examine the effects of adjunctive aromatherapy massage on mood, quality of life and physical symptoms in patients with cancer attending a specialist unit. Participants were randomised to conventional day care alone or day care plus weekly aromatherapy massage using a standardised blend of oils for four weeks. At baseline and at weekly intervals, patients rated their mood, quality of life and the intensity and bother of two symptoms most important to them. Forty-six patients were recruited to the study. Due to a large number of withdrawals, only 11 of 23 (48%) patients in the aromatherapy group and 18 of 23 (78%) in the control group completed all four weeks. Mood, physical symptoms and quality of life improved in both groups. There was no statistically significant difference between groups in any of the outcome measures. Despite a lack of measurable benefit, all patients were satisfied with the aromatherapy and wished to continue. Whilst this pilot study has shown that a randomised controlled trial of complementary therapy is feasible, it has also identified several areas that would require further consideration when designing future studies, e.g., the recruitment and retention of appropriate numbers of patients and the outcome measures used.

A prospective randomised controlled trial of nutritional supplementation in malnourished elderly in the community: clinical and health economic outcomes.

PubMed

Edington, J; Barnes, R; Bryan, F; Dupree, E; Frost, G; Hickson, M; Lancaster, J; Mongia, S; Smith, J; Torrance, A; West, R; Pang, F; Coles, S J

2004-04-01

Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs. Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals' services and social services were measured throughout the study. Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24. In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early.

Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies.

PubMed

Li, Ling; Li, Sheyu; Deng, Ke; Liu, Jiali; Vandvik, Per Olav; Zhao, Pujing; Zhang, Longhao; Shen, Jiantong; Bala, Malgorzata M; Sohani, Zahra N; Wong, Evelyn; Busse, Jason W; Ebrahim, Shanil; Malaga, German; Rios, Lorena P; Wang, Yingqiang; Chen, Qunfei; Guyatt, Gordon H; Sun, Xin

2016-02-17

To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. Systematic review and meta-analysis of randomised and observational studies. Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. Eligible studies included 43 trials (n=68,775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1,777,358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15,701 v 33/12,591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18,554 v 552/18,474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

PubMed Central

Salisbury, Chris; Francis, Caia; Rogers, Chris; Parry, Kate; Thomas, Huw; Chadwick, Stephanie; Turton, Pat

2002-01-01

AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes. PMID:12528584

Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice

PubMed Central

Mathers, Nigel; Ng, Chirk Jenn; Campbell, Michael Joseph; Colwell, Brigitte; Brown, Ian; Bradley, Alastair

2012-01-01

Objective To determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT). Design A cluster RCT. Setting 49 general practices in UK randomised into intervention (n=25) and control (n=24). Participants General practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. Exclusion criteria: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and analysis. Intervention Brief training of clinicians and use of PDA with patients in single consultation. Primary outcomes Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c). Secondary outcomes Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications. Results Intervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of ‘hypo’, ‘weight gain’, ‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups. Conclusions Use of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice. ISRCTN Trials Register Number 14842077. PMID:23129571

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

PubMed

Cullington, Helen; Kitterick, Padraig; Weal, Mark; Margol-Gromada, Magdalena

2018-04-20

Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. University of Southampton Auditory Implant Service: provider of National Health Service care. 60 adults who had used cochlear implants for at least 6 months. Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. ISRCTN14644286. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial

PubMed Central

Kitterick, Padraig; Weal, Mark; Margol-Gromada, Magdalena

2018-01-01

Introduction Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. Objectives To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. Design Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. Setting University of Southampton Auditory Implant Service: provider of National Health Service care. Participants 60 adults who had used cochlear implants for at least 6 months. Interventions Control group (n=30) followed usual care pathway. Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). Main outcome measures Primary: change in patient activation; measured using the Patient Activation Measure. Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. Results One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. Conclusions Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. Trial registration number ISRCTN14644286. PMID:29678970

Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

PubMed

Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

2016-03-07

A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.

Pain reduction after total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy among women with dysmenorrhoea: a randomised controlled trial.

PubMed

Berner, E; Qvigstad, E; Myrvold, A K; Lieng, M

2015-07-01

To evaluate the effectiveness of total laparoscopic hysterectomy compared with laparoscopic supracervical hysterectomy for alleviating dysmenorrhoea. Randomised blinded controlled trial. Norwegian university teaching hospital. Sixty-two women with dysmenorrhoea. Participants randomised to either total laparoscopic hysterectomy (n = 31) or laparoscopic supracervical hysterectomy (n = 31). The primary outcome measure, measured 12 months after intervention, was reduction of cyclic pelvic pain (visual analogue scale, 0-10). Secondary outcome measures included patient satisfaction (visual analogue scale, 0-10) and quality of life (Short Form 36, 0-100). The groups were comparable at baseline. There was no difference in self-reported dysmenorrhoea at 12 months (mean 0.8 [SD 1.6] versus 0.8 [SD 2.0], P = 0.94). There was no difference in patient satisfaction (mean 9.3 [SD 1.5] versus 9.1 [SD 1.2], P = 0.66) or quality of life (mean 81.6 [SD 17.8] versus 80.2 [SD 18.0], P = 0.69). Improvement in dysmenorrhoea and quality of life as well as patient satisfaction were comparable in the medium term when comparing total laparoscopic hysterectomy with laparoscopic supracervical hysterectomy. © 2015 Royal College of Obstetricians and Gynaecologists.

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study

PubMed Central

Radcliffe, Michael J; Lewith, George T; Turner, Richard G; Prescott, Philip; Church, Martin K; Holgate, Stephen T

2003-01-01

Objective To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy. Design Double blind randomised placebo controlled parallel group study. Setting Hospital in Hampshire. Participants 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo. Interventions Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of β glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution. Main outcome measures Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season. Results The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred. Conclusions Enzyme potentiated desensitisation showed no treatment effect in this study. PMID:12896934

Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

PubMed

van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

2016-07-26

Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

Online parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: study protocol for a randomised controlled trial.

PubMed

Wakefield, Claire E; Sansom-Daly, Ursula M; McGill, Brittany C; McCarthy, Maria; Girgis, Afaf; Grootenhuis, Martha; Barton, Belinda; Patterson, Pandora; Osborn, Michael; Lowe, Cherie; Anazodo, Antoinette; Miles, Gordon; Cohn, Richard J

2015-04-11

Due to advances in multimodal therapies, most children survive cancer. In addition to the stresses of diagnosis and treatment, many families are now navigating the challenges of survivorship. Without sufficient support, the ongoing distress that parents experience after their child's cancer treatment can negatively impact the quality of life and psychological wellbeing of all family members. The 'Cascade' (Cope, Adapt, Survive: Life after C AncEr) study is a three-arm randomised controlled trial to evaluate the feasibility and efficacy of a new intervention to improve the quality of life of parents of young cancer survivors. Cascade will be compared to a peer-support group control and a 6-month waitlist control. Parents (n = 120) whose child (under 16 years of age) has completed cancer treatment in the past 1 to 12 months will be recruited from hospitals across Australia. Those randomised to receive Cascade will participate in four, weekly, 90-minute online group sessions led live by a psychologist. Cascade involves peer discussion on cognitive-behavioural coping skills, including behavioural activation, thought challenging, mindfulness and acceptance, communication and assertiveness skills training, problem-solving and goal-setting. Participants randomised to peer support will receive four, weekly, 90-minute, live, sessions of non-directive peer support. Participants will complete measures at baseline, directly post-intervention, one month post-intervention, and 6 months post-intervention. The primary outcome will be parents' quality of life. Secondary outcomes include parent depression, anxiety, parenting self-agency, and the quality of life of children in the family. The child cancer survivor and all siblings aged 7 to 15 years will be invited to complete self-report quality of life measures covering physical, emotional, social and school-related domains. This article reviews the empirical rationale for group-based, online cognitive-behavioural therapy in parents of children who have recently finished cancer treatment. The potential challenges of delivering skills-based programs online are highlighted. Cascade's videoconferencing technology has the potential to address the geographic and psychological isolation of families after cancer treatment. Teaching parents coping skills as they resume their normal lives after their child's cancer may see long-term benefits for the quality of life of the family as a whole. ACTRN12613000270718 (registered 6 March 2013).

A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial.

PubMed

Bjerk, Maria; Brovold, Therese; Skelton, Dawn A; Bergland, Astrid

2017-08-14

Falls and fall-related injuries in older adults are associated with great burdens, both for the individuals, the health care system and the society. Previous research has shown evidence for the efficiency of exercise as falls prevention. An understudied group are older adults receiving home help services, and the effect of a falls prevention programme on health-related quality of life is unclear. The primary aim of this randomised controlled trial is to examine the effect of a falls prevention programme on quality of life, physical function and falls efficacy in older adults receiving home help services. A secondary aim is to explore the mediating factors between falls prevention and health-related quality of life. The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or older, receiving home help services, who are able to walk with or without walking aids, who have experienced at least one fall during the last 12 months and who have a Mini Mental State Examination of 23 or above. The intervention group receives a programme, based on the Otago Exercise Programme, lasting 12 weeks including home visits and motivational telephone calls. The control group receives usual care. The primary outcome is health-related quality of life (SF-36). Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, nutritional status and falls efficacy. All measurements are performed at baseline, following intervention at 3 months and at 6 months' follow-up. Sample size, based on the primary outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% drop out. Participants are recruited from six municipalities in Norway. This trial will generate new knowledge on the effects of an exercise falls prevention programme among older fallers receiving home help services. This knowledge will be useful for clinicians, for health managers in the primary health care service and for policy makers. ClinicalTrials.gov . NCT02374307 . First registration, 16/02/2015.

GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

PubMed Central

2014-01-01

Background Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT. Methods/design A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation. Discussion This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD. Trial registration German Clinical Trial Registration (DRKS): DRKS00005025 PMID:24476555

Quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice - systematic review.

PubMed

Heinmüller, Stefan; Schneider, Antonius; Linde, Klaus

2016-04-23

Academic infrastructures and networks for clinical research in primary care receive little funding in Germany. We aimed to provide an overview of the quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice. We searched Scopus (last search done in April 2015), publication lists of institutes and references of included articles. We included randomised trials published between January 2000 and December 2014 with a first or last author affiliated with a German university department of general practice or family medicine. Risk of bias was assessed with the Cochrane tool, and study findings were quantified using standardised mean differences (SMDs). Thirty-three trials met the inclusion criteria. Seventeen were cluster-randomised trials, with a majority investigating interventions aimed at improving processes compared with usual care. Sample sizes varied between 6 and 606 clusters and 168 and 7807 participants. The most frequent methodological problem was risk of selection bias due to recruitment of individuals after randomisation of clusters. Effects of interventions over usual care were mostly small (SMD <0.3). Sixteen trials randomising individual participants addressed a variety of treatment and educational interventions. Sample sizes varied between 20 and 1620 participants. The methodological quality of the trials was highly variable. Again, effects of experimental interventions over controls were mostly small. Despite limited funding, German university institutes of general practice or family medicine are increasingly performing randomised trials. Cluster-randomised trials on practice improvement are a focus, but problems with allocation concealment are frequent.

Acupuncture for Bell's palsy.

PubMed

Chen, Ning; Zhou, Muke; He, Li; Zhou, Dong; Li, N

2010-08-04

Bell's palsy or idiopathic facial palsy is an acute facial paralysis due to inflammation of the facial nerve. A number of studies published in China have suggested acupuncture is beneficial for facial palsy. The objective of this review was to examine the efficacy of acupuncture in hastening recovery and reducing long-term morbidity from Bell's palsy. We updated the searches of the Cochrane Neuromuscular Disease Group Trials Specialized Register (24 May 2010), The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010), MEDLINE (January 1966 to May 2010), EMBASE (January 1980 to May 2010), AMED (January 1985 to May 2010), LILACS (from January 1982 to May 2010) and the Chinese Biomedical Retrieval System (January 1978 to May 2010) for randomised controlled trials using 'Bell's palsy' and its synonyms, 'idiopathic facial paralysis' or 'facial palsy' as well as search terms including 'acupuncture'. Chinese journals in which we thought we might find randomised controlled trials relevant to our study were handsearched. We reviewed the bibliographies of the randomised trials and contacted the authors and known experts in the field to identify additional published or unpublished data. We included all randomised controlled trials involving acupuncture by needle insertion in the treatment of Bell's palsy irrespective of any language restrictions. Two review authors identified potential articles from the literature search, extracted data and assessed quality of each trial independently. All disagreements were resolved by discussion between the review authors. The literature search and handsearching identified 49 potentially relevant articles. Of these, six RCTs were included involving 537 participants with Bell's palsy. Two more possible trials were identified in the update than the previous version of this systematic review, but both were excluded because they were not real RCTs. Of the six included trials, five used acupuncture while the other one used acupuncture combined with drugs. No trial reported on the outcomes specified for this review. Harmful side effects were not reported in any of the trials. Poor quality caused by flaws in study design or reporting (including uncertain method of randomisation, allocation concealment and blinding) and clinical differences between trials prevented reliable conclusions about the efficacy of acupuncture. The quality of the included trials was inadequate to allow any conclusion about the efficacy of acupuncture. More research with high quality trials is needed.

A cluster-randomised quality improvement study to improve two inpatient stroke quality indicators.

PubMed

Williams, Linda; Daggett, Virginia; Slaven, James E; Yu, Zhangsheng; Sager, Danielle; Myers, Jennifer; Plue, Laurie; Woodward-Hagg, Heather; Damush, Teresa M

2016-04-01

Quality indicator collection and feedback improves stroke care. We sought to determine whether quality improvement training plus indicator feedback was more effective than indicator feedback alone in improving inpatient stroke indicators. We conducted a cluster-randomised quality improvement trial, randomising hospitals to quality improvement training plus indicator feedback versus indicator feedback alone to improve deep vein thrombosis (DVT) prophylaxis and dysphagia screening. Intervention sites received collaborative-based quality improvement training, external facilitation and indicator feedback. Control sites received only indicator feedback. We compared indicators pre-implementation (pre-I) to active implementation (active-I) and post-implementation (post-I) periods. We constructed mixed-effect logistic models of the two indicators with a random intercept for hospital effect, adjusting for patient, time, intervention and hospital variables. Patients at intervention sites (1147 admissions), had similar race, gender and National Institutes of Health Stroke Scale scores to control sites (1017 admissions). DVT prophylaxis improved more in intervention sites during active-I period (ratio of ORs 4.90, p<0.001), but did not differ in post-I period. Dysphagia screening improved similarly in both groups during active-I, but control sites improved more in post-I period (ratio of ORs 0.67, p=0.04). In logistic models, the intervention was independently positively associated with DVT performance during active-I period, and negatively associated with dysphagia performance post-I period. Quality improvement training was associated with early DVT improvement, but the effect was not sustained over time and was not seen with dysphagia screening. External quality improvement programmes may quickly boost performance but their effect may vary by indicator and may not sustain over time. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.

PubMed

Karanth, Laxminarayan; Barua, Ankur; Kanagasabai, Sachchithanantham; Nair, Sreekumar

2015-09-09

Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated.This is an update of a Cochrane review first published in 2013. To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 18 June 2015. Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible. No trials matching the selection criteria were eligible for inclusion. No trials matching the selection criteria were eligible for inclusion. The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders.

PubMed

Karanth, Laxminarayan; Barua, Ankur; Kanagasabai, Sachchithanantham; Nair, N S

2013-04-30

Congenital bleeding disorders can cause obstetric haemorrhage during pregnancy, labour and following delivery. Desmopressin acetate is found to be an effective drug which can reduce the risk of haemorrhage and can also stop bleeding in certain congenital bleeding disorders. Its use in pregnancy has been controversial. Hence beneficial and adverse effects of desmopressin acetate in these groups of pregnant women should be evaluated. To determine the efficacy of desmopressin acetate in preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coaguopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant and abstract books of conferences proceedings. We also searched for any randomised controlled trials in a registry of ongoing trials and the reference lists of relevant articles and reviews.Date of most recent search: 28 February 2013. Randomised and quasi-randomised controlled trials investigating the efficacy of desmopressin acetate versus tranexamic acid or factor VIII or rFactor VII or fresh frozen plasma in preventing and treating congenital bleeding disorders during pregnancy were eligible. No trials matching the selection criteria were eligible for inclusion. No trials matching the selection criteria were eligible for inclusion. The review did not identify any randomised controlled trials investigating the relative effectiveness of desmopressin acetate for bleeding during pregnancy in women with congenital bleeding disorders. In the absence of high quality evidence, clinicians need to use their clinical judgement and lower level evidence (e.g. from observational trials) to decide whether or not to treat women with congenital bleeding disorders with desmopressin acetate.Given the ethical considerations, future randomised controlled trials are unlikely. However, other high quality controlled studies (such as risk allocation designs, sequential design, parallel cohort design) to investigate the risks and benefits of using desmopressin acetate in this population are needed.

A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery.

PubMed

Awad, Sherif; Varadhan, Krishna K; Ljungqvist, Olle; Lobo, Dileep N

2013-02-01

Whilst preoperative carbohydrate treatment (PCT) results in beneficial physiological effects, the effects on postoperative clinical outcomes remain unclear and were studied in this meta-analysis. Prospective studies that randomised adult non-diabetic patients to either PCT (≥50 g oral carbohydrates 2-4 h pre-anaesthesia) or control (fasted/placebo) were included. The primary outcome was length of hospital stay. Secondary outcomes included development of postoperative insulin resistance, complications, nausea and vomiting. Methodological quality was assessed using GRADEpro® software. Twenty-one randomised studies of 1685 patients (733 PCT: 952 control) were included. No overall difference in length of stay was noted for analysis of all studies or subgroups of patients undergoing surgery with an expected hospital stay ≤2 days or orthopaedic procedures. However, patients undergoing major abdominal surgery following PCT had reduced length of stay [mean difference, 95% confidence interval: -1.08 (-1.87 to -0.29); I² = 60%, p = 0.007]. PCT reduced postoperative insulin resistance with no effects on in-hospital complications over control (risk ratio, 95% confidence interval, 0.88 (0.50-1.53), I² = 41%; p = 0.640). There was significant heterogeneity amongst studies and, therefore, quality of evidence was low to moderate. PCT may be associated with reduced length of stay in patients undergoing major abdominal surgery, however, the included studies were of low to moderate quality. Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

How completely are physiotherapy interventions described in reports of randomised trials?

PubMed

Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

A systematic review of randomised controlled trials evaluating the effect of mother/baby skin-to-skin care on successful breast feeding.

PubMed

Carfoot, Sue; Williamson, Paula R; Dickson, Rumona

2003-06-01

to examine the effects of early skin-to-skin contact between mother and baby on the initiation and duration of breast feeding. electronic databases--the Cochrane Library, MEDLINE,CINAHL and EMBASE. References of studies were examined to identify additional trials and contact was made with researchers in the field. Study selection criteria: randomised or quasi-randomised controlled trials in any language in which skin-to-skin contact between mothers and their healthy full-term newborn babies was compared to routine contact. Primary outcomes were success of first breast feed and duration of breast feeding. Secondary outcomes included, baby temperature and behaviour. STUDY-QUALITY ASSESSMENT: validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Application of inclusion criteria, validity assessment and data extraction were carried out independently by two reviewers with a third reviewer to resolve differences. seven randomised controlled trials were identified. Five studies assessed duration of breast feeding with mixed results. None of the studies assessed the success of the first breast-feeding experience. Study quality was variable with methods of randomisation and blinding of assessment unclear in four of the five studies providing relevant results. the findings of this systematic review fail to support the current initiatives to implement changes in clinical practice to include skin-to-skin contact. Methodological flaws within the included studies prohibit firm conclusions being reached with regard to the effect of skin-to-skin contact on the duration of breast feeding, timing of first breast feed or baby physiological factors. The review highlights the need for further primary research to assess the effect of skin-to-skin contact on the breast-feeding experience.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

PubMed

Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effect of training and lifting equipment for preventing back pain in lifting and handling: systematic review

PubMed Central

2008-01-01

Objectives To determine whether advice and training on working techniques and lifting equipment prevent back pain in jobs that involve heavy lifting. Data sources Medline, Embase, CENTRAL, Cochrane Back Group’s specialised register, CINAHL, Nioshtic, CISdoc, Science Citation Index, and PsychLIT were searched up to September-November 2005. Review methods The primary search focused on randomised controlled trials and the secondary search on cohort studies with a concurrent control group. Interventions aimed to modify techniques for lifting and handling heavy objects or patients and including measurements for back pain, consequent disability, or sick leave as the main outcome were considered for the review. Two authors independently assessed eligibility of the studies and methodological quality of those included. For data synthesis, we summarised the results of studies comparing similar interventions. We used odds ratios and effect sizes to combine the results in a meta-analysis. Finally, we compared the conclusions of the primary and secondary analyses. Results Six randomised trials and five cohort studies met the inclusion criteria. Two randomised trials and all cohort studies were labelled as high quality. Eight studies looked at lifting and moving patients, and three studies were conducted among baggage handlers or postal workers. Those in control groups received no intervention or minimal training, physical exercise, or use of back belts. None of the comparisons in randomised trials (17 720 participants) yielded significant differences. In the secondary analysis, none of the cohort studies (772 participants) had significant results, which supports the results of the randomised trials. Conclusions There is no evidence to support use of advice or training in working techniques with or without lifting equipment for preventing back pain or consequent disability. The findings challenge current widespread practice of advising workers on correct lifting technique. PMID:18244957

Randomised controlled trial of the effectiveness of using foot reflexology to improve quality of sleep amongst Taiwanese postpartum women.

PubMed

Li, Chia-Yen; Chen, Su-Chiu; Li, Chung-Yi; Gau, Meei-Ling; Huang, Chiu-Mieh

2011-04-01

to examine the effectiveness of using foot reflexology to improve sleep quality in postpartum women. randomised controlled trial, conducted at two postpartum centres in northern Taiwan. 65 postpartum women reporting poor quality of sleep were recruited from July 2007 to December 2007. participants were assigned randomly to either an intervention or a control group. Participants in both groups received the same care except for reflexology therapy. The intervention group received a single 30-minute foot reflexology session at the same time each evening for five consecutive days. Sessions were administered by a certified nurse reflexologist. MEASURES AND FINDINGS: the outcome measure was the Pittsburgh sleep quality index (PSQI), and this was performed at baseline and post test. Mean PQSI scores for both groups declined over time between baseline and post test. Using a generalised estimation equation to control several confounding variables, the changes in mean PSQI were found to be significantly lower in the intervention group (β=-2.24, standard error=0.38, p<0.001) than in the control group. an intervention involving foot reflexology in the postnatal period significantly improved the quality of sleep. midwives should evaluate maternal sleep quality and design early intervention programmes to improve quality of sleep in order to increase maternal biopsychosocial well-being. Midwives interested in complementary therapies should be encouraged to obtain training in reflexology and to apply it in clinical settings if it is allowed. Copyright © 2009 Elsevier Ltd. All rights reserved.

Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

PubMed Central

Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

2014-01-01

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

Fostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: study protocol for a cluster randomised controlled trial.

PubMed

Melhuish, Edward; Howard, Steven J; Siraj, Iram; Neilsen-Hewett, Cathrine; Kingston, Denise; de Rosnay, Marc; Duursma, Elisabeth; Luu, Betty

2016-12-19

A substantial research base documents the benefits of attendance at high-quality early childhood education and care (ECEC) for positive behavioural and learning outcomes. Research has also found that the quality of many young children's experiences and opportunities in ECEC depends on the skills, dispositions and understandings of the early childhood adult educators. Increasingly, research has shown that the quality of children's interactions with educators and their peers, more than any other programme feature, influence what children learn and how they feel about learning. Hence, we sought to investigate the extent to which evidence-based professional development (PD) - focussed on promoting sustained shared thinking through quality interactions - could improve the quality of ECEC and, as a consequence, child outcomes. The Fostering Effective Early Learning (FEEL) study is a cluster randomised controlled trial for evaluating the benefits of a professional development (PD) programme for early childhood educators, compared with no extra PD. Ninety long-day care and preschool centres in New South Wales, Australia, will be selected to ensure representation across National Quality Standards (NQS) ratings, location, centre type and socioeconomic areas. Participating centres will be randomly allocated to one of two groups, stratified by centre type and NQS rating: (1) an intervention group (45 centres) receiving a PD intervention or (2) a control group (45 centres) that continues engaging in typical classroom practice. Randomisation to these groups will occur after the collection of baseline environmental quality ratings. Primary outcomes, at the child level, will be two measures of language development: verbal comprehension and expressive vocabulary. Secondary outcomes at the child level will be measures of early numeracy, social development and self-regulation. Secondary outcomes at the ECEC room level will be measures of environmental quality derived from full-day observations. In all cases, data collectors will be blinded to group allocation. This is the first randomised controlled trial of a new approach to PD, which is focussed on activities previously found to be influential in children's early language, numeracy, social and self-regulatory development. Results should inform practitioners, policy-makers and families of the value of specific professional development for early childhood educators. Australian New Zealand Clinical Trials Registry (ACTRN) identifier ACTRN12616000536460 . Registered on 27 April 2016. This trial was retrospectively registered, given the first participant (centre) had been enrolled at the time of registration.

School-based programmes for preventing smoking.

PubMed

Thomas, R

2002-01-01

Smoking rates in adolescents are rising. Helping young people to avoid starting smoking is a widely endorsed goal of public health, but there is uncertainty about how to do this. Schools provide a route for communicating with a large proportion of young people, and school-based programmes for smoking prevention have been widely developed and evaluated. To review all randomised controlled trials of behavioural interventions in schools to prevent children (aged 5 to12) and adolescents (aged 13 to18) starting smoking. We searched The Cochrane Controlled Trials and Tobacco Review group registers, MEDLINE, EMBASE, Psyclnfo, ERIC, CINAHL, Health Star, Dissertation Abstracts and studies identified in the bibliographies of articles. Individual MEDLINE searches were made for 133 authors who had undertaken randomised controlled trials in this area. Types of studies: those in which individual students, classes, schools, or school districts were randomised to the intervention or control groups and followed for at least six months. Children (aged 5 to12) or adolescents (aged 13 to18) in school settings. Types of interventions: Classroom programmes or curricula, including those with associated family and community interventions, intended to deter use of tobacco. We included programmes or curricula that provided information, those that used social influences approaches, those that taught generic social competence, and those that included interventions beyond the school into the community. We included programmes with a drug or alcohol focus if outcomes for tobacco use were reported. Types of outcome measures: Prevalence of non-smoking at follow-up among those not smoking at baseline. We did not require biochemical validation of self-reported tobacco use for study inclusion. We assessed whether identified citations were randomised controlled trials. We assessed the quality of design and execution, and abstracted outcome data. Because of the marked heterogeneity of design and outcomes, we did not perform a meta-analysis. We synthesised the data using narrative systematic review. We grouped studies by intervention method (information; social competence; social influences; combined social influences/social competence and multi-modal programmes). Within each category, we placed them into three groups according to validity using quality criteria for reported study design. Of the 76 randomised controlled trials identified, we classified 16 as category one (most valid). There were no category one studies of information giving alone. There were fifteen category one studies of social influences interventions. Of these, eight showed some positive effect of intervention on smoking prevalence, and seven failed to detect an effect on smoking prevalence. The largest and most rigorous study, the Hutchinson Smoking Prevention Project, found no long-term effect of an intensive 8-year programme on smoking behaviour. There was a lack of high quality evidence about the effectiveness of combinations of social influences and social competence approaches. There was limited evidence about the effectiveness of multi-modal approaches including community initiatives. There is no rigorous test of the effects of information giving about smoking. There are well-conducted randomised controlled trials to test the effects of social influences interventions: in half of the group of best quality studies those in the intervention group smoke less than those in the control, but many studies showed no effect of the intervention. There is a lack of high-quality evidence about the effectiveness of combinations of social influences and social competence interventions, and of multi-modal programmes that include community interventions.

Effects of the carrier frequency of interferential current on pain modulation in patients with chronic nonspecific low back pain: a protocol of a randomised controlled trial.

PubMed

Corrêa, Juliana Barbosa; Costa, Leonardo Oliveira Pena; de Oliveira, Naiane Teixeira Bastos; Sluka, Kathleen A; Liebano, Richard Eloin

2013-06-27

Low back pain is an important public health problem that is associated with poor quality of life and disability. Among the electrophysical treatments, interferential current (IFC) has not been studied in patients with low back pain in a high-quality randomised controlled trial examining not only pain, but pain mechanisms and function. A three-arm randomised controlled trial with patient and assessor blinded to the group allocation. One hundred fifty patients with chronic, nonspecific low back pain from outpatient physical therapy clinics in Brazil. The patients will be randomly allocated into 3 groups (IFC 1 kHz, IFC 4 kHz or Placebo IFC). The interferential current will be applied three days per week (30 minutes per session) over four weeks. Pain intensity. The pressure pain threshold, global impression of recovery, disability, function, conditioned pain modulation and temporal summation of pain, discomfort caused by the current. All outcomes will be measured at 4 weeks and 4 months after randomisation. The between-group differences will be calculated by using linear mixed models and Tukey's post-hoc tests. The use of a placebo group and double-blinding assessor and patients strengthen this study. The present study is the first to compare different IFC carrier frequencies in patients with chronic low back pain. Brazilian Registry of Clinical Trials: http://RBR-8n4hg2.

Methodological quality of randomised controlled trials in burns care. A systematic review.

PubMed

Danilla, Stefan; Wasiak, Jason; Searle, Susana; Arriagada, Cristian; Pedreros, Cesar; Cleland, Heather; Spinks, Anneliese

2009-11-01

To evaluate the methodological quality of published randomised controlled trials (RCTs) in burn care treatment and management. Using a predetermined search strategy we searched Ovid MEDLINE (1950 to January 2008) database to identify all English RCTs related to burn care. Full text studies identified were reviewed for key demographic and methodological characteristics. Methodological trial quality was assessed using the Jadad scale. A total of 257 studies involving 14,535 patients met the inclusion criteria. The median Jadad score was 2 (out of a best possible score of 5). Information was given in the introduction and discussion sections of most RCTs, although insufficient detail was provided on randomisation, allocation concealment, and blinding. The number of RCTs increased between 1950 and 2008 (Spearman's rho=0.6129, P<0.001), although the reporting quality did not improve over the same time period (P=0.1896) and was better in RCTs with larger sample sizes (median Jadad score, 4 vs. 2 points, P<0.0001). Methodological quality did not correlate with journal impact factor (P=0.2371). The reporting standards of RCTs are highly variable and less than optimal in most cases. The advent of evidence-based medicine heralds a new approach to burns care and systematic steps are needed to improve the quality of RCTs in this field. Identifying and reviewing the existing number of RCTs not only highlights the need for burn clinicians to conduct more trials, but may also encourage burn health clinicians to consider the importance of conducting trials that follow appropriate, evidence-based standards.

Interventions for promoting smoke alarm ownership and function.

PubMed

DiGuiseppi, C; Higgins, J P

2001-01-01

Residential fires caused at least 67 deaths and 2,500 non-fatal injuries to children aged 0-16 in the United Kingdom in 1998. Smoke alarm ownership is associated with a reduced risk of residential fire death. We evaluated interventions to promote residential smoke alarms, to assess their effect on smoke alarm ownership, smoke alarm function, fires and burns and other fire-related injuries. We searched the Cochrane Controlled Trials Register, Cochrane Injuries Group database, MEDLINE, EMBASE, PsycLIT, CINAHL, ERIC, Dissertation Abstracts, International Bibliography of Social Sciences, ISTP, FIREDOC and LRC. Conference proceedings, published case studies, and bibliographies were systematically searched, and investigators and relevant organisations were contacted, to identify trials. Randomised, quasi-randomised or nonrandomised controlled trials completed or published after 1969 evaluating an intervention to promote residential smoke alarms. Two reviewers independently extracted data and assessed trial quality. We identified 26 trials, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR=1.26; 95% CI: 0.87 to 1.82) or having a functional alarm (OR=1.19; 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR=1.96; 1.03 to 3.72) and function (OR=1.72; 0.78 to 3.80). Results were sensitive to trial quality, however, and effects on fire-related injuries were not reported. In two non randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire-related injuries. Media and community education showed little benefit in non randomised trials. Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give-away programmes apparently reduce fire-related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give-away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

2015-12-24

Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial. NCT01847534 (First registered 5 February 2013, last updated 14 October 2015).

Gut-directed hypnotherapy for irritable bowel syndrome: piloting a primary care-based randomised controlled trial

PubMed Central

Roberts, Lesley; Wilson, Sue; Singh, Sukhdev; Roalfe, Andrea; Greenfield, Sheila

2006-01-01

Background In western populations irritable bowel syndrome (IBS) affects between 10% and 30% of the population and has a significant effect on quality of life. It generates a substantial workload in both primary and secondary care and has significant cost implications. Gut-directed hypnotherapy has been demonstrated to alleviate symptoms and improve quality of life but has not been assessed outside of secondary and tertiary referral centres. Aim To assess the effectiveness of gut-directed hypnotherapy as a complementary therapy in the management of IBS. Design of study Randomised controlled trial. Setting Primary care patients aged 18–65 years inclusive, with a diagnosis of IBS of greater than 6 weeks' duration and having failed conventional management, located in South Staffordshire and North Birmingham, UK. Method Intervention patients received five sessions of hypnotherapy in addition to their usual management. Control patients received usual management alone. Data regarding symptoms and quality of life were collected at baseline and again 3, 6, and 12 months post-randomisation. Results Both groups demonstrated a significant improvement in all symptom dimensions and quality of life over 12 months. At 3 months the intervention group had significantly greater improvements in pain, diarrhoea and overall symptom scores (P<0.05). No significant differences between groups in quality of life were identified. No differences were maintained over time. Intervention patients, however, were significantly less likely to require medication, and the majority described an improvement in their condition. Conclusions Gut-directed hypnotherapy benefits patients via symptom reduction and reduced medication usage, although the lack of significant difference between groups beyond 3 months prohibits its general introduction without additional evidence. A large trial incorporating robust economic analysis is, therefore, urgently recommended. PMID:16464325

Effect of a 16-week Bikram yoga program on perceived stress, self-efficacy and health-related quality of life in stressed and sedentary adults: A randomised controlled trial.

PubMed

Hewett, Zoe L; Pumpa, Kate L; Smith, Caroline A; Fahey, Paul P; Cheema, Birinder S

2018-04-01

The purpose of this study was to investigate the effect of 16 weeks of Bikram yoga on perceived stress, self-efficacy and health related quality of life (HRQoL) in sedentary, stressed adults. 16 week, parallel-arm, randomised controlled trial with flexible dosing. Physically inactive, stressed adults (37.2±10.8 years) were randomised to Bikram yoga (three to five classes per week) or control (no treatment) group for 16 weeks. Outcome measures, collected via self-report, included perceived stress, general self-efficacy, and HRQoL. Outcomes were assessed at baseline, midpoint and completion. Individuals were randomised to the experimental (n=29) or control group (n=34). Average attendance in the experimental group was 27±18 classes. Repeated measure analyses of variance (intention-to-treat) demonstrated significantly improved perceived stress (p=0.003, partial η 2 =0.109), general self-efficacy (p=0.034, partial η 2 =0.056), and the general health (p=0.034, partial η 2 =0.058) and energy/fatigue (p=0.019, partial η 2 =0.066) domains of HRQoL in the experimental group versus the control group. Attendance was significantly associated with reductions in perceived stress, and an increase in several domains of HRQoL. 16 weeks of Bikram yoga significantly improved perceived stress, general self-efficacy and HRQoL in sedentary, stressed adults. Future research should consider ways to optimise adherence, and should investigate effects of Bikram yoga intervention in other populations at risk for stress-related illness. Australia New Zealand Clinical Trials Registry ACTRN12616000867493. Registered 04 July 2016. URL: http://www.anzctr.org.au/ACTRN12616000867493.aspx. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

PubMed

Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

2013-10-25

A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Australian New Zealand Clinical Trials Registry (ACTRN12611001070921).

Randomised controlled trial of expressive writing and quality of life in men and women treated for colon or rectal cancer.

PubMed

Lepore, Stephen J; Revenson, Tracey A; Roberts, Katherine J; Pranikoff, Julie R; Davey, Adam

2015-01-01

This randomised trial tested (i) whether a home-based expressive writing (EW) intervention improves quality of life in patients with colorectal cancer (CRC) and (ii) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings. Patients treated for CRC were randomised to an EW (n = 101) or control writing (CW; n = 92) group. Assessments were completed at 1 month pre- and post-intervention. Sex and perceived social constraints on disclosure were evaluated as moderators. Primary outcomes were depressive symptoms, sleep problems and quality of life indicators. Eighty-one per cent of participants completed all writing assignments. Consistent with hypotheses, relative to the CW group, participants in the EW group expressed more negative emotion in writing and rated their writings as more meaningful, personal and emotionally revealing. There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes. Although EW is feasible to use with persons who have CRC, it was not effective as a stand-alone psychotherapeutic intervention. Neither was it more effective for men nor for people who felt they could not freely disclose cancer-related concerns and feelings.

Improving the wellbeing of staff who work in palliative care settings: A systematic review of psychosocial interventions.

PubMed

Hill, Rebecca C; Dempster, Martin; Donnelly, Michael; McCorry, Noleen K

2016-10-01

Staff in palliative care settings perform emotionally demanding roles which may lead to psychological distress including stress and burnout. Therefore, interventions have been designed to address these occupational risks. To investigate quantitative studies exploring the effectiveness of psychosocial interventions that attempt to improve psychological wellbeing of palliative care staff. A systematic review was conducted according to methodological guidance from UK Centre for Reviews and Dissemination. A search strategy was developed based on the initial scans of palliative care studies. Potentially eligible research articles were identified by searching the following databases: CINAHL, MEDLINE (Ovid), PsycINFO and Web of Science. Two reviewers independently screened studies against pre-set eligibility criteria. To assess quality, both researchers separately assessed the remaining studies using the Quality Assessment Tool for Quantitative Studies. A total of 1786 potentially eligible articles were identified - nine remained following screening and quality assessment. Study types included two randomised controlled trials, two non-randomised controlled trial designs, four one-group pre-post evaluations and one process evaluation. Studies took place in the United States and Canada (5), Europe (3) and Hong Kong (1). Interventions comprised a mixture of relaxation, education, support and cognitive training and targeted stress, fatigue, burnout, depression and satisfaction. The randomised controlled trial evaluations did not improve psychological wellbeing of palliative care staff. Only two of the quasi-experimental studies appeared to show improved staff wellbeing although these studies were methodologically weak. There is an urgent need to address the lack of intervention development work and high-quality research in this area. © The Author(s) 2016.

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

PubMed Central

Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

2016-01-01

Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN80067039. PMID:28186943

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.

PubMed

Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

2016-11-10

To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Epilepsy clinics in 1 English National Health Service (NHS) Trust. Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. ISRCTN80067039. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Interventions for waterpipe tobacco smoking prevention and cessation: a systematic review

PubMed Central

Jawad, Mohammed; Jawad, Sena; Waziry, Reem K.; Ballout, Rami A.; Akl, Elie A.

2016-01-01

Waterpipe tobacco smoking is growing in popularity despite adverse health effects among users. We systematically reviewed the literature, searching MEDLINE, EMBASE and Web of Science, for interventions targeting prevention and cessation of waterpipe tobacco smoking. We assessed the evidence quality using the Cochrane (randomised studies), GRADE (non-randomised studies) and CASP (qualitative studies) frameworks. Data were synthesised narratively due to heterogeneity. We included four individual-level, five group-level, and six legislative interventions. Of five randomised controlled studies, two showed significantly higher quit rates in intervention groups (bupropion/behavioural support versus placebo in Pakistan; 6 month abstinence relative risk (RR): 2.3, 95% CI 1.4–3.8); group behavioural support versus no intervention in Egypt, 12 month abstinence RR 3.3, 95% CI 1.4–8.9). Non-randomised studies showed mixed results for cessation, behavioural, and knowledge outcomes. One high quality modelling study from Lebanon calculated that a 10% increase in waterpipe tobacco taxation would reduce waterpipe tobacco demand by 14.5% (price elasticity of demand −1.45). In conclusion, there is a lack of evidence of effectiveness for most waterpipe interventions. While few show promising results, higher quality interventions are needed. Meanwhile, tobacco policies should place waterpipe on par with cigarettes. PMID:27167891

Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.

PubMed

Jin, Feng; Li, Xiao-Qian; Tan, Wen-Fei; Ma, Hong; Lu, Huang-Wei

2015-12-10

Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with midline incision. Preoperative RSB has been shown to be effective, but it has not been compared with postoperative RSB. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively. This study is a prospective, randomised, controlled (randomised, parallel group, concealed allocation), single-blinded trial. All patients undergoing transabdominal gynaecological surgery will be randomised 1:1 to the treatment intervention with general anaesthesia as an adjunct to preoperative or postoperative RSB. The objective of the trial is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively (n = 32) versus postoperatively (n = 32). All of the patients, irrespective of group allocation, will receive patient-controlled intravenous analgesia (PCIA) with oxycodone. The primary objective is to compare the interval between leaving the post-anaesthesia care unit and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative versus postoperative RSB. The secondary objectives will be to compare (1) cumulative oxycodone consumption at 24 hours after surgery; (2) postoperative sleep quality, as measured using a BIS-Vista monitor during the first night after surgery; and (3) cytokine levels (interleukin-1, interleukin-6, tumour necrosis factor-α and interferon-γ) during surgery and at 24 and 48 hours postoperatively. Clinical experience has suggested that RSB is a very effective postoperative analgesic technique, and we will answer the following questions with this trial. Do preoperative block and postoperative block have the same duration of analgesic effects? Can postoperative block extend the analgesic time? The results of this study could have actual clinical applications that could help to reduce postoperative pain and shorten hospital stays. Current Controlled Trials NCT02477098 15 June 2015.

Effect on peer review of telling reviewers that their signed reviews might be posted on the web: randomised controlled trial.

PubMed

van Rooyen, Susan; Delamothe, Tony; Evans, Stephen J W

2010-11-16

To see whether telling peer reviewers that their signed reviews of original research papers might be posted on the BMJ's website would affect the quality of their reviews. Randomised controlled trial. A large international general medical journal based in the United Kingdom. 541 authors, 471 peer reviewers, and 12 editors. Consecutive eligible papers were randomised either to have the reviewer's signed report made available on the BMJ's website alongside the published paper (intervention group) or to have the report made available only to the author-the BMJ's normal procedure (control group). The intervention was the act of revealing to reviewers-after they had agreed to review but before they undertook their review-that their signed report might appear on the website. The main outcome measure was the quality of the reviews, as independently rated on a scale of 1 to 5 using a validated instrument by two editors and the corresponding author. Authors and editors were blind to the intervention group. Authors rated review quality before the fate of their paper had been decided. Additional outcomes were the time taken to complete the review and the reviewer's recommendation regarding publication. 558 manuscripts were randomised, and 471 manuscripts remained after exclusions. Of the 1039 reviewers approached to take part in the study, 568 (55%) declined. Two editors' evaluations of the quality of the peer review were obtained for all 471 manuscripts, with the corresponding author's evaluation obtained for 453. There was no significant difference in review quality between the intervention and control groups (mean difference for editors 0.04, 95% CI -0.09 to 0.17; for authors 0.06, 95% CI -0.09 to 0.20). Any possible difference in favour of the control group was well below the level regarded as editorially significant. Reviewers in the intervention group took significantly longer to review (mean difference 25 minutes, 95% CI 3.0 to 47.0 minutes). Telling peer reviewers that their signed reviews might be available in the public domain on the BMJ's website had no important effect on review quality. Although the possibility of posting reviews online was associated with a high refusal rate among potential peer reviewers and an increase in the amount of time taken to write a review, we believe that the ethical arguments in favour of open peer review more than outweigh these disadvantages.

Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial.

PubMed

Sambrook, A M; Elders, A; Cooper, K G

2014-05-01

To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). Follow up of a prospective, double-blind randomised controlled trial at 5 years. A teaching hospital in the UK. A total of 320 women eligible for and requesting endometrial ablation. Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation. © 2014 Royal College of Obstetricians and Gynaecologists.

Physical therapy for Bell s palsy (idiopathic facial paralysis).

PubMed

Teixeira, Lázaro Juliano; Soares, Bernardo Garcia de Oliveira; Vieira, Vanessa Pedrosa; Prado, Gilmar F

2008-07-16

Bell's palsy (idiopathic facial paralysis) is commonly treated by physical therapy services with various therapeutic strategies and devices. There are many questions about their efficacy and effectiveness. To evaluate the efficacy of physical therapies on the outcome of Bell's palsy. We searched the Cochrane Neuromuscular Disease Group Trials Register (February 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2007), MEDLINE (January 1966 to February 2008), EMBASE (January 1980 to February 2008), LILACS (January 1982 to February 2008), PEDro (from 1929 to February 2008), and CINAHL (January 1982 to February 2008). We selected randomised or quasi-randomised controlled trials involving any physical therapy. We included participants of any age with a diagnosis of Bell's palsy and all degrees of severity. The outcome measures were: incomplete recovery six months after randomisation, motor synkinesis, crocodile tears or facial spasm six months after onset, incomplete recovery after one year and adverse effects attributable to the intervention. Titles and abstracts identified from the register were scrutinized. The assessment of methodological quality took into account secure method of randomisation, allocation concealment, observer blinding, patient blinding, differences at baseline of the experimental groups, and completeness of follow-up. Data were extracted using a specially constructed data extraction form. Separate subgroup analyses of participants with more and less severe disability were undertaken. The search identified 45 potentially relevant articles. Six studies met the inclusion criteria. Three trials studied the efficacy of electrostimulation (294 participants) and three exercises (253 participants). Neither treatment produced significantly more improvement than the control treatment or no treatment. There was limited evidence that improvement began earlier in the exercise group. There is no evidence of significant benefit or harm from any physical therapy for idiopathic facial paralysis. The possibility that facial exercise reduces time to recover and sequelae needs confirming with good quality randomised controlled trials.

A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma (RESPECT-MESO): study protocol for a randomised controlled trial.

PubMed

Gunatilake, Samal; Brims, Fraser J H; Fogg, Carole; Lawrie, Iain; Maskell, Nick; Forbes, Karen; Rahman, Najib; Morris, Steve; Ogollah, Reuben; Gerry, Stephen; Peake, Mick; Darlison, Liz; Chauhan, Anoop J

2014-09-19

Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos. The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing. Median survival is 8 to 12 months, and most patients have symptoms at diagnosis. The fittest patients may be offered chemotherapy with palliative intent. For patients not fit for systemic anticancer treatment, best supportive care remains the mainstay of management. A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12 weeks after diagnosis. While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis, oncology and palliative care services in the United Kingdom, and many other countries, vary considerably compared to the United States. The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma. This multicentre study is an non-blinded, randomised controlled, parallel group trial. A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4 weekly regular early specialist symptom control care, or standard care. The primary outcome is health related quality of life for patients at 12 weeks. Secondary outcomes include health related quality of life for patients at 24 weeks, carer health related quality of life at 12 and 24 weeks, patient and carer mood at 12 and 24 weeks, overall survival and analysis of healthcare utilisation and cost. Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness. This study aims to investigate whether early, regular specialist care input can result in significant health related quality of life gains for patients with mesothelioma and if this change in treatment model is cost-effective. The results will be widely applicable to many institutions and patients both in the United Kingdom and internationally. Current controlled trials ISRCTN18955704. Date ISRCTN assigned: 31 January 2014.

A repeated short educational intervention improves asthma control and quality of life.

PubMed

Plaza, Vicente; Peiró, Meritxell; Torrejón, Montserrat; Fletcher, Monica; López-Viña, Antolín; Ignacio, José María; Quintano, José Antonio; Bardagí, Santiago; Gich, Ignasi

2015-11-01

We assessed the effectiveness of an asthma educational programme based on a repeated short intervention (AEP-RSI) to improve asthma control (symptom control and future risk) and quality of life. A total of 230 adults with mild-to-moderate persistent uncontrolled asthma participated in a 1-year cluster randomised controlled multicentre study. The AEP-RSI was given in four face-to-face sessions at 3-month intervals, and included administration of a written personalised action plan and training on inhaler technique. Centres were randomised to the AEP-RSI (intervention) group or usual clinical practice group. Specialised centres using a standard educational programme were the gold standard group. A significant improvement in the Asthma Control Test score was observed in all three groups (p<0.001), but improvements were higher in the intervention and gold standard groups than in the usual clinical practice group (p=0.042), which also showed fewer exacerbations (mean±sd; 1.20±2.02 and 0.56±1.5 versus 2.04±2.72, respectively) and greater increases in the Mini Asthma Quality of Life Questionnaire scores (0.95±1.04 and 0.89±0.84 versus 0.52±0.97, respectively). The AEP-RSI was effective in improving asthma symptom control, future risk and quality of life. Copyright ©ERS 2015.

Is reflexology an effective intervention? A systematic review of randomised controlled trials.

PubMed

Ernst, Edzard

2009-09-07

To evaluate the evidence for and against the effectiveness of reflexology for treating any medical condition. Six electronic databases were searched from their inception to February 2009 to identify all relevant randomised controlled trials (RCTs). No language restrictions were applied. RCTs of reflexology delivered by trained reflexologists to patients with specific medical conditions. Condition studied, study design and controls, primary outcome measures, follow-up, and main results were extracted. 18 RCTs met all the inclusion criteria. The studies examined a range of conditions: anovulation, asthma, back pain, dementia, diabetes, cancer, foot oedema in pregnancy, headache, irritable bowel syndrome, menopause, multiple sclerosis, the postoperative state and premenstrual syndrome. There were > 1 studies for asthma, the postoperative state, cancer palliation and multiple sclerosis. Five RCTs yielded positive results. Methodological quality was evaluated using the Jadad scale. The methodological quality was often poor, and sample sizes were generally low. Most higher-quality trials did not generate positive findings. The best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.

The impact of an empowering Internet-based Breast Cancer Patient Pathway program on breast cancer patients' clinical outcomes: a randomised controlled trial.

PubMed

Ryhänen, Anne M; Rankinen, Sirkku; Siekkinen, Mervi; Saarinen, Maiju; Korvenranta, Heikki; Leino-Kilpi, Helena

2013-04-01

To evaluate the effect of the Breast Cancer Patient Pathway program on breast cancer patient's empowerment process. The results of earlier studies indicate that the use of tailored Internet-based patient education programs increased patient's knowledge level; however, other outcome measures differed. This randomised control trial studied the effect of the Internet-based patient educational program on breast cancer patients' empowerment. In this study, we measured the quality of life, anxiety and managing with treatment-related side effects as the outcomes of breast cancer patients' empowering process. Breast cancer patients who were Internet users in one Finnish university hospital during 2008-2010 were randomised to the control group (n=43) and the intervention group (n=47). Baseline data were collected first in the hospital and the following data seven times during the treatment process, the last time one year after breast cancer diagnosis. There were no statistically significant differences in the quality of life, anxiety or side effects of treatment between the groups. The amount of treatment-related side effects was connected to both physical and psychological well-being. In this study, the Breast Cancer Patient Pathway program did not decrease anxiety level or treatment-related side effects among breast cancer patients or improve subscales of quality of life when compared with controls. There is a need to relieve the side effects caused by patients' care with the help of patient education. Internet-based patient education programs need more focus when developing new patient education methods. © 2013 Blackwell Publishing Ltd.

Implementing guidelines in nursing homes: a systematic review.

PubMed

Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte; Lund, Hans

2016-07-25

Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects of interventions to improve the implementation of guidelines in nursing homes. A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted-time-series studies. The EPOC risk of bias tool was used to evaluate the risk of bias in the included studies. The overall quality of the evidence was rated using GRADE. Five cluster-randomised controlled trials met the inclusion criteria, evaluating a total of six different multifaceted implementation strategies. One study reported a small statistically significant effect on professional practice, and two studies demonstrated small to moderate statistically significant effects on patient outcome. The overall quality of the evidence for all comparisons was low or very low using GRADE. Little is known about how to improve the implementation of guidelines in nursing homes, and the evidence to support or discourage particular interventions is inconclusive. More implementation research is needed to ensure high quality of care in nursing homes. PROSPERO 2014: CRD42014007664.

Effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure: a randomised controlled trial.

PubMed

Wang, Tzu-Chieh; Huang, Jin-Long; Ho, Wen-Chao; Chiou, Ai-Fu

2016-04-01

Fatigue is a common symptom in patients with heart failure that is easy to ignore. In addition, fatigue may affect patients' physical function and psychosocial conditions that can impair their quality of life. An effective nursing care programme is required to alleviate patients' fatigue and improve their quality of life. To investigate the effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure. A randomised controlled trial design was used. Ninety-two patients with heart failure were randomly assigned to an intervention group (n=47) or a control group (n=45). The patients in the intervention group participated in 12 weeks of a supportive educational nursing care programme including fatigue assessment, education, coaching self-care and evaluation. The intervention was conducted by a cardiac nurse during four face-to-face interviews and three follow-up telephone interviews. Fatigue and quality of life were assessed at the baseline and 4 weeks, 8 weeks and 12 weeks after enrollment in both groups. The participants in the intervention group exhibited a significant decrease in the level of fatigue after 12 weeks, whereas those in the control group exhibited no significant changes. Compared with the control group, the intervention group exhibited a significantly greater decrease in the level of fatigue and significantly greater improvement in quality of life after 12 weeks of intervention. The supportive educational nursing care programme was recommended to alleviate fatigue and improve quality of life in patients with heart failure. © The European Society of Cardiology 2015.

Structure and content components of self-management interventions that improve health-related quality of life in people with inflammatory bowel disease: a systematic review, meta-analysis and meta-regression.

PubMed

Tu, Wenjing; Xu, Guihua; Du, Shizheng

2015-10-01

The purpose of this review was to identify and categorise the components of the content and structure of effective self-management interventions for patients with inflammatory bowel disease. Inflammatory bowel diseases are chronic gastrointestinal disorders impacting health-related quality of life. Although the efficacy of self-management interventions has been demonstrated in previous studies, the most effective components of the content and structure of these interventions remain unknown. A systematic review, meta-analysis and meta-regression of randomised controlled trials was used. A systematic search of six electronic databases, including Pubmed, Embase, Cochrane central register of controlled trials, Web of Science, Cumulative Index of Nursing and Allied Health Literature and Chinese Biomedical Literature Database, was conducted. Content analysis was used to categorise the components of the content and structure of effective self-management interventions for inflammatory bowel disease. Clinically important and statistically significant beneficial effects on health-related quality of life were explored, by comparing the association between effect sizes and various components of self-management interventions such as the presence or absence of specific content and different delivery methods. Fifteen randomised controlled trials were included in this review. Distance or remote self-management interventions demonstrated a larger effect size. However, there is no evidence for a positive effect associated with specific content component of self-management interventions in adult patients with inflammatory bowel disease in general. The results showed that self-management interventions have positive effects on health-related quality of life in patients with inflammatory bowel disease, and distance or remote self-management programmes had better outcomes than other types of interventions. This review provides useful information to clinician and researchers when determining components of effective self-management programmes for patients with inflammatory bowel disease. More high-quality randomised controlled trials are needed to test the results. © 2015 John Wiley & Sons Ltd.

So you want to conduct a randomised trial? Learnings from a 'failed' feasibility study of a Crisis Resource Management prompt during simulated paediatric resuscitation.

PubMed

Teis, Rachel; Allen, Jyai; Lee, Nigel; Kildea, Sue

2017-02-01

No study has tested a Crisis Resource Management prompt on resuscitation performance. We conducted a feasibility, unblinded, parallel-group, randomised controlled trial at one Australian paediatric hospital (June-September 2014). Eligible participants were any doctor, nurse, or nurse manager who would normally be involved in a Medical Emergency Team simulation. The unit of block randomisation was one of six scenarios (3 control:3 intervention) with or without a verbal prompt. The primary outcomes tested the feasibility and utility of the intervention and data collection tools. The secondary outcomes measured resuscitation quality and team performance. Data were analysed from six resuscitation scenarios (n=49 participants); three control groups (n=25) and three intervention groups (n=24). The ability to measure all data items on the data collection tools was hindered by problems with the recording devices both in the mannequins and the video camera. For a pilot study, greater training for the prompt role and pre-briefing participants about assessment of their cardio-pulmonary resuscitation quality should be undertaken. Data could be analysed in real time with independent video analysis to validate findings. Two cameras would strengthen reliability of the methods. Copyright © 2016 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

Effectiveness and cost-effectiveness of community singing on mental health-related quality of life of older people: randomised controlled trial.

PubMed

Coulton, Simon; Clift, Stephen; Skingley, Ann; Rodriguez, John

2015-09-01

As the population ages, older people account for a greater proportion of the health and social care budget. Whereas some research has been conducted on the use of music therapy for specific clinical populations, little rigorous research has been conducted looking at the value of community singing on the mental health-related quality of life of older people. To evaluate the effectiveness and cost-effectiveness of community group singing for a population of older people in England. A pilot pragmatic individual randomised controlled trial comparing group singing with usual activities in those aged 60 years or more. A total of 258 participants were recruited across five centres in East Kent. At 6 months post-randomisation, significant differences were observed in terms of mental health-related quality of life measured using the SF12 (mean difference = 2.35; 95% CI = 0.06-4.76) in favour of group singing. In addition, the intervention was found to be marginally more cost-effective than usual activities. At 3 months, significant differences were observed for the mental health components of quality of life (mean difference = 4.77; 2.53-7.01), anxiety (mean difference = -1.78; -2.5 to -1.06) and depression (mean difference = -1.52; -2.13 to -0.92). Community group singing appears to have a significant effect on mental health-related quality of life, anxiety and depression, and it may be a useful intervention to maintain and enhance the mental health of older people. © The Royal College of Psychiatrists 2015.

Telehealthcare for chronic obstructive pulmonary disease: Cochrane Review and meta-analysis

PubMed Central

McLean, Susannah; Nurmatov, Ulugbek; Liu, Joseph LY; Pagliari, Claudia; Car, Josip; Sheikh, Aziz

2012-01-01

Background Chronic obstructive pulmonary disease (COPD) is common. Telehealthcare, involving personalised health care over a distance, is seen as having the potential to improve care for people with COPD. Aim To systematically review the effectiveness of telehealthcare interventions in COPD to improve clinical and process outcomes. Design and setting Cochrane Systematic Review of randomised controlled trials. Methods The study involved searching the Cochrane Airways Group Register of Trials, which is derived from the Cochrane Central Register of Controlled Trials, MEDLINE®, embase™, and CINAHL®, as well as searching registers of ongoing and unpublished trials. Randomised controlled trials comparing a telehealthcare intervention with a control intervention in people with a clinical diagnosis of COPD were identified. The main outcomes of interest were quality of life and risk of emergency department visit, hospitalisation, and death. Two authors independently selected trials for inclusion and extracted data. Study quality was assessed using the Cochrane Collaboration’s risk of bias method. Meta-analysis was undertaken using fixed effect and/or random effects modelling. Results Ten randomised controlled trials were included. Telehealthcare did not improve COPD quality of life: mean difference –6.57 (95% confidence interval [CI] = –13.62 to 0.48). However, there was a significant reduction in the odds ratios (ORs) of emergency department attendance (OR = 0.27; 95% CI = 0.11 to 0.66) and hospitalisation (OR = 0.46; 95% CI = 0.33 to 0.65). There was a non-significant change in the OR of death (OR = 1.05; 95% CI = 0.63 to 1.75). Conclusion In COPD, telehealthcare interventions can significantly reduce the risk of emergency department attendance and hospitalisation, but has little effect on the risk of death. PMID:23211177

Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial.

PubMed

Rasmussen, Rune Skovgaard; Østergaard, Ann; Kjær, Pia; Skerris, Anja; Skou, Christina; Christoffersen, Jane; Seest, Line Skou; Poulsen, Mai Bang; Rønholt, Finn; Overgaard, Karsten

2016-03-01

To evaluate if home-based rehabilitation of inpatients improved outcome compared to standard care. Interventional, randomised, safety/efficacy open-label trial. University hospital stroke unit in collaboration with three municipalities. Seventy-one eligible stroke patients (41 women) with focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation. Thirty-eight patients were randomised to home-based rehabilitation during hospitalization and for up to four weeks after discharge to replace part of usual treatment and rehabilitation services. Thirty-three control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients. Ninety days post-stroke the modified Rankin Scale score was the primary endpoint. Other outcome measures were the modified Barthel-100 Index, Motor Assessment Scale, CT-50 Cognitive Test, EuroQol-5D, Body Mass Index and treatment-associated economy. Thirty-one intervention and 30 control patients completed the study. Patients in the intervention group achieved better modified Rankin Scale score (Intervention median = 2, IQR = 2-3; Control median = 3, IQR = 2-4; P=0.04). EuroQol-5D quality of life median scores were improved in intervention patients (Intervention median = 0.77, IQR = 0.66-0.79; Control median = 0.66, IQR = 0.56 - 0.72; P=0.03). The total amount of home-based training in minutes highly correlated with mRS, Barthel, Motor Assessment Scale and EuroQol-5D™ scores (P-values ranging from P<0.00001 to P=0.01). Economical estimations of intervention costs were lower than total costs of standard treatment. Early home-based rehabilitation reduced disability and increased quality of life. Compared to standard care, home-based stroke rehabilitation was more cost-effective. © The Author(s) 2015.

Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.

PubMed

Lamb, S E; Pepper, J; Lall, R; Jørstad-Stein, E C; Clark, M D; Hill, L; Fereday-Smith, J

2009-09-14

The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. ISRCTN 16772662.

Interventions for treating acute bleeding episodes in people with acquired hemophilia A.

PubMed

Zeng, Yan; Zhou, Ruiqing; Duan, Xin; Long, Dan; Yang, Songtao

2014-08-28

Acquired hemophilia A is a rare bleeding disorder caused by autoantibodies to coagulation factor VIII (FVIII). In most cases, bleeding episodes are spontaneous and severe at presentation. The optimal hemostatic therapy is controversial. To determine the efficacy of hemostatic therapies for acute bleeds in people with acquired hemophilia A; and to compare different forms of therapy for these bleeds. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 4) and MEDLINE (Ovid) (1948 to 30 April 2014). We searched the conference proceedings of the: American Society of Hematology; European Hematology Association; International Society on Thrombosis and Haemostasis (ISTH); and the European Association for Haemophilia and Allied Disorders (EAHAD) (from 2000 to 30 April 2014). In addition to this we searched clinical trials registers. All randomised controlled trials and quasi-randomised trials of hemostatic therapies for people with acquired hemophilia A, with no restrictions on gender, age or ethnicity. No trials matching the selection criteria were eligible for inclusion. No trials matching the selection criteria were eligible for inclusion. No randomised clinical trials of hemostatic therapies for acquired hemophilia A were found. Thus, we are not able to draw any conclusions or make any recommendations on the optimal hemostatic therapies for acquired hemophilia A based on the highest quality of evidence. GIven that carrying out randomized controlled trials in this field is a complex task, the authors suggest that, while planning randomised controlled trials in which patients can be enrolled, clinicians treating the disease continue to base their choices on alternative, lower quality sources of evidence, which hopefully, in the future, will also be appraised and incorporated in a Cochrane Review.

Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial.

PubMed

Vickerstaff, Victoria; Ambler, Gareth; Bunce, Catey; Xing, Wen; Gazzard, Gus

2015-11-11

The LiGHT trial (Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial) is a multicentre randomised controlled trial of two treatment pathways for patients who are newly diagnosed with open-angle glaucoma (OAG) and ocular hypertension (OHT). The main hypothesis for the trial is that lowering intraocular pressure (IOP) with selective laser trabeculoplasty (SLT) as the primary treatment ('Laser-1st') leads to a better health-related quality of life than for those started on IOP-lowering drops as their primary treatment ('Medicine-1st') and that this is associated with reduced costs and improved tolerability of treatment. This paper describes the statistical analysis plan for the study. The LiGHT trial is an unmasked, multi-centre randomised controlled trial. A total of 718 patients (359 per arm) are being randomised to two groups: medicine-first or laser-first treatment. Outcomes are recorded at baseline and at 6-month intervals up to 36 months. The primary outcome measure is health-related quality of life (HRQL) at 36 months measured using the EQ-5D-5L. The main secondary outcome is the Glaucoma Utility Index. We plan to analyse the patient outcome data according to the group to which the patient was originally assigned. Methods of statistical analysis are described, including the handling of missing data, the covariates used in the adjusted analyses and the planned sensitivity analyses. The trial was registered with the ISRCTN register on 23/07/2012, number ISRCTN32038223 .

Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial.

PubMed

Morgan, Gemma S; Haase, Anne M; Campbell, Rona; Ben-Shlomo, Yoav

2015-03-13

As people live longer, their risk of disability increases. Disability affects quality of life and increases health and social care costs. Preventing or delaying disability is therefore an important objective, and identifying an effective intervention could improve the lives of many older people. Observational and interventional evidence suggests that physical activity may reduce the risk of age-related disability, as assessed by physical performance measures. However it is unclear what approach is the most cost-effective intervention in changing long-term physical activity behaviour in older adults. A new theory-driven behavioural intervention has been developed, with the aim of increasing physical activity in the everyday lives of older adults at risk of disability. This pilot study tests the feasibility and acceptability of delivering this intervention to older adults. A randomised controlled trial (RCT) design will be used in the pilot study. Sixty patients aged 65 years and older will be recruited from primary care practices. Patients will be eligible to participate if they are inactive, not disabled at baseline, are at risk of developing disability in the future (Short Physical Performance Battery score <10/12), and have no contraindications to physical activity. Following baseline measures, participants will be randomised in a 2:1 ratio to the intervention or to a control arm and all participants will be followed-up after 6 months. Those randomised to the intervention arm will receive sessions with a trained Physical Activity Facilitator, delivering an intervention based on self-determination theory. Control participants receive a booklet on healthy ageing. The main outcomes of interest are recruitment, adherence, retention and acceptability. Data will also be collected on: self-report and accelerometer-recorded physical activity; physical performance; depression; wellbeing; cognitive function; social support; quality of life, healthcare use, and attitudes to physical activity. A mixed-methods process evaluation will run alongside the RCT. The intervention, if effective, has the potential to reduce disability and improve quality of life in older adults. Before proceeding to a full-scale trial a pilot trial is necessary to ensure intervention feasibility and acceptability, and that the intervention shows evidence of promise. Current Controlled Trials ISRCTN80470273 . Registered 25 October 2013.

The 'Cancer Home-Life Intervention': A randomised controlled trial evaluating the efficacy of an occupational therapy-based intervention in people with advanced cancer.

PubMed

Pilegaard, Marc Sampedro; la Cour, Karen; Gregersen Oestergaard, Lisa; Johnsen, Anna Thit; Lindahl-Jacobsen, Line; Højris, Inger; Brandt, Åse

2018-04-01

People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the 'Cancer Home-Life Intervention'. To evaluate the efficacy of the 'Cancer Home Life-Intervention' compared with usual care with regard to patients' performance of, and participation in, everyday activities, and their health-related quality of life. A randomised controlled trial ( ClinicalTrials.gov NCT02356627). The 'Cancer Home-Life Intervention' is a brief, tailored, occupational therapy-based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. A total of 242 participants were randomised either to the intervention group ( n = 121) or the control group ( n = 121). No effect was found on the primary outcome (between-group mean change: -0.04 logits (95% confidence interval: -0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. In most cases, the 'Cancer Home-Life Intervention' was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants' everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing.

[A randomised clinical trial to evaluate the effectiveness of an educational intervention developed for adult asthmatics in a primary care centre].

PubMed

Cano Fuentes, Gloria; Dastis Bendala, Carmen; Morales Barroso, Isabel; Manzanares Torné, M Luisa; Fernández Gregorio, Andrés; Martín Romana, Leticia

2014-03-01

To assess the effect of an educational intervention on asthma control and quality of life. A randomised clinical trial of patients with asthma, with an intervention group (IG) and a control (GC). Asthma control and quality of life was measured in both groups at baseline and every three months for one a year. Blinding was only possible in the collection and analysis of data. Two urban Primary Care Health Centres A total of 163 patients aged 18 to 55 years were included: 84 were assigned to the IG and 79 to the CG. The follow-up was completed by 104 patients (GI: 55 and GC 49). Three educational sessions in small interactive groups. The first session was at the beginning of spring, the second 15 days later, and the third 6 months later, to recall the knowledge. Asthma control level and quality of life using ACT(Asthma Control Test) and the AQLQ (Asthma Quality of life Questionnaire). In the third month, statistically significant differences were detected in the percentage of patients with good control [(P=.0002), 75% in the GI, and 48.5% in the GC, Relative Risk (RR)=1.6 [1.2 to 2.1], Number Needed to Treat (NNT)=3.8 [2.4 to 9.4], and an improvement in levels of quality of life from baseline (P=.005), RR=2.3 [1.3 to 4.1], NNT: 4.3 [2.6 to 12.4]. No differences were detected in the remaining sessions. These interventions are effective in improving the control and quality of life in short-term, which can guide us in choosing the best time to do it. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Assessment of the quality of harms reporting in non-randomised studies and randomised controlled studies of topiramate for the treatment of epilepsy using CONSORT criteria.

PubMed

Carmichael, Katie; Nolan, Sarah J; Weston, Jennifer; Tudur Smith, Catrin; Marson, Anthony G

2015-08-01

Treatment decisions should be informed by high quality evidence of both the potential benefit and harms of treatment alternatives. Randomised controlled trials (RCTs) provide the best evidence regarding benefits; however information relating to serious, rare and long-term harms is usually available only from non-randomised studies (NRSs). The aim of this study was to use a checklist based on the CONSORT (Consolidating Standards for Reporting Trials) extension for harms recommendations to assess the quality of reporting of harms data in both NRSs and RCTs of antiepileptic drugs, using studies of topiramate as an example. Seventy-eight studies were included from an online search of seven databases. Harms data was extracted from each study using a 25-point checklist. The mean number of items met was 11.5 (SD 2.96) per study. Commercially funded studies met on average 12.7 items and non-commercially funded studies met 10.08 (p value < 0.001). RCTs met on average 13.0 items and NRSs met 10.8 (p = 0.001). Multi-centre studies and commercially funded studies met significantly more items than single centre and non-commercially funded studies respectively. There was no significant difference in the mean number of items met by studies that had included adult vs. child participants, or studies published pre- vs. post-CONSORT extension for harms in 2004. Reporting of harms is significantly better in RCTs than in NRSs of TPM, but is suboptimal overall and has not improved since the publication of CONSORT extension for harms in 2004. There is a need to improve the reporting of harms in order to better inform treatment decisions. Copyright © 2015 Elsevier B.V. All rights reserved.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction).

PubMed

Bidad, Natalie; MacDonald, Lindsay; Winters, Zoë E; Edwards, Sarah J L; Emson, Marie; Griffin, Clare L; Bliss, Judith; Horne, Rob

2016-09-02

Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives. The trial was the 'Quality of Life after Mastectomy and Breast Reconstruction' (QUEST) trial. Thirty-nine women participated in qualitative interviews 1 month post-surgery. Twenty-seven women (10 trial decliners and 17 acceptors) who spontaneously mentioned 'altruism' were selected for thematic analysis. Verbatim transcripts were coded independently by two researchers. Participants' motivations to accept or decline randomisation were cross-referenced with their understanding of the QUEST trials and the process of randomisation. The seven emerging themes were: (1) altruism expressed by acceptors and decliners; (2) overriding personal needs in decliners; (3) pure altruism in acceptors; (4) 'hypothetical altruism' amongst acceptors; (5) weak altruism amongst acceptors; (6) conditional altruism amongst acceptors; and (7) sense of duty to participate. Poor understanding of the trial rationale and its implications was also evident. Altruism was a motivating factor for participation in the QUEST randomised controlled trials where the main outcomes comprised quality of life and allocated treatments comprised established surgical procedures. Women's decisions were influenced by their understanding of the trial. Both acceptors and decliners of the trial expressed 'altruism', but most acceptors lacked an obvious treatment preference, hoped for personal benefits regarding a treatment allocation, or did not articulate complete understanding of the trial. QUEST A, ISRCTN38846532 ; Date assigned 6 January 2010. QUEST B, ISRCTN92581226 ; Date assigned 6 January 2010.

Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial

PubMed Central

Clayton, Josephine; Butow, Phyllis N; Silvester, William; Detering, Karen; Hall, Jane; Kiely, Belinda E; Cebon, Jonathon; Clarke, Stephen; Bell, Melanie L; Stockler, Martin; Beale, Phillip; Tattersall, Martin H N

2016-01-01

Introduction There is limited evidence documenting the effectiveness of Advance Care Planning (ACP) in cancer care. The present randomised trial is designed to evaluate whether the administration of formal ACP improves compliance with patients' end-of-life (EOL) wishes and patient and family satisfaction with care. Methods and analysis A randomised control trial in eight oncology centres across New South Wales and Victoria, Australia, is designed to assess the efficacy of a formal ACP intervention for patients with cancer. Patients with incurable cancer and an expected survival of 3–12 months, plus a nominated family member or friend will be randomised to receive either standard care or standard care plus a formal ACP intervention. The project sample size is 210 patient–family/friend dyads. The primary outcome measure is family/friend-reported: (1) discussion with the patient about their EOL wishes and (2) perception that the patient's EOL wishes were met. Secondary outcome measures include: documentation of and compliance with patient preferences for medical intervention at the EOL; the family/friend's perception of the quality of the patient's EOL care; the impact of death on surviving family; patient–family and patient–healthcare provider communication about EOL care; patient and family/friend satisfaction with care; quality of life of patient and family/friend subsequent to trial entry, the patient's strength of preferences for quality of life and length of life; the costs of care subsequent to trial entry and place of death. Ethics and dissemination Ethical approval was received from the Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064). Study results will be submitted for publication in peer-reviewed journals and presented at national and international conferences. Trial registration number Pre-results; ACTRN12613001288718. PMID:27909034

A feasibility randomised controlled trial of pre-operative occupational therapy to optimise recovery for patients undergoing primary total hip replacement for osteoarthritis (PROOF-THR).

PubMed

Jepson, Paul; Sands, Gina; Beswick, Andrew D; Davis, Edward T; Blom, Ashley W; Sackley, Catherine M

2016-02-01

To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement. Single blinded feasibility randomised controlled trial, with data collection prior to the intervention, and at 4, 12, and 26 weeks following surgery. Recruitment from two NHS orthopaedic outpatient centres in the West Midlands, UK. Patients awaiting primary total hip replacement due to osteoarthritis were recruited. Following pre-operative assessment, patients were individually randomised to intervention or control by a computer-generated block randomisation algorithm stratified by age and centre. The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations, assessed home safety, and provided appropriate adaptive equipment. The control group received treatment as usual. The study assessed the feasibility of recruitment procedures, delivery of the intervention, appropriateness of outcome measures and data collection methods. Health related quality of life and resource use were recorded at 4, 12 and 26 weeks. Forty-four participants were recruited, 21 were randomised to the occupational therapy intervention and 23 to usual care. Analysis of 26 week data included 18 participants in the intervention group and 21 in the control. The intervention was delivered successfully with no withdrawals or crossovers; 5/44 were lost to follow-up with further missing data for participation and resource use. The feasibility study provided the information required to conduct a definitive trial. Burden of assessment would need to be addressed. A total of 219 patients would be required in an efficacy trial. © The Author(s) 2015.

RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial

PubMed Central

Jopson, Laura; Newton, Julia L; Palmer, Jeremy; Floudas, Achilleas; Isaacs, John; Qian, Jessica; Wilkinson, Jennifer; Trenell, Mike; Blamire, Andrew; Howel, Denise; Jones, David E

2015-01-01

Introduction Primary biliary cirrhosis (PBC) is an autoimmune liver disease with approximately 50% of patients experiencing fatigue. This can be a particularly debilitating symptom, affecting quality of life and resulting in social isolation. Fatigue is highlighted by patients as a priority for research and patient support groups were involved in designing this trial. This is the first randomised controlled trial to investigate a treatment for fatigue in PBC. The trial protocol is innovative as it utilises novel magnetic resonance spectroscopy (MRS) techniques as an outcome measure. The protocol will be valuable to research groups planning clinical trials targeting fatigue in PBC and also transferrable to other conditions associated with fatigue. Methods and analysis RITPBC is a Medical Research Council (MRC) and National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (EME)-funded project. It is a phase II, single-centre, randomised controlled, double-blinded trial comparing rituximab with placebo in fatigued PBC patients. 78 patients with PBC and moderate to severe fatigue will be randomised to receive two infusions of rituximab or placebo. The study aims to assess whether rituximab improves fatigue in patients with PBC, the safety, and tolerability of rituximab in PBC and the sustainability of any beneficial actions. The primary outcome will be an improvement in fatigue domain score of the PBC-40, a disease-specific quality of life measure, evaluated at 12-week assessment. Secondary outcome measures include novel MRS techniques assessing muscle bioenergetic function, physical activity, anaerobic threshold and symptom, and quality of life measures. The trial started recruiting in October 2012 and recruitment is ongoing. Ethics and dissemination The trial has ethical approval from the NRES Committee North East, has Clinical Trial Authorisation from MHRA and local R&D approval. Trial results will be communicated to participants, presented at national and international meetings and published in peer-reviewed journals. Trial registration number ISRCTN03978701. PMID:26297361

The EQ-5D-5L is a valid approach to measure health related quality of life in patients undergoing bariatric surgery.

PubMed

Fermont, Jilles M; Blazeby, Jane M; Rogers, Chris A; Wordsworth, Sarah

2017-01-01

Bariatric surgery is considered an effective treatment for individuals with severe and complex obesity. Besides reducing weight and improving obesity related comorbidities such as diabetes, bariatric surgery could improve patients' health-related quality of life. However, the frequently used instrument to measure quality of life, the EQ-5D has not been validated for use in bariatric surgery, which is a major limitation to its use in this clinical context. Our study undertook a psychometric validation of the 5 level EQ-5D (EQ-5D-5L) using clinical trial data to measure health-related quality of life in patients with severe and complex obesity undergoing bariatric surgery. Health-related quality of life was assessed at baseline (before randomisation) and six months later in 189 patients in a randomised controlled trial of bariatric surgery. Patients completed two generic health-related quality of life instruments, the EQ-5D-5L and SF-12, which were used together for the validation using data from all patients in the trial as the trial is ongoing. Psychometric analyses included construct and criterion validity and responsiveness to change. Of the 189 validation patients, 141 (75%) were female, the median age was 49 years old (range 23-70 years) and body mass index ranged from 33-70 kg/m2. For construct validity, there were significant improvements in the distribution of responses in all EQ-5D dimensions between baseline and 6 months after randomisation. For criterion validity, the highest degree of correlation was between the EQ-5D pain/discomfort and SF-12 bodily pain domain. For responsiveness the EQ-5D and SF-12 showed statistically significant improvements in health-related quality of life between baseline and 6 months after randomisation. The EQ-5D-5L is a valid generic measure for measuring health-related quality of life in bariatric surgery patients.

An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

PubMed

Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

2013-05-29

Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1): Trial protocol

PubMed Central

2011-01-01

Background This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats) in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested: Compared to usual care, group cognitive behavioural therapy will: 1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation. 2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation. Methods/Design Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT) sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes. Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires) are collected six to eight weeks later and follow-up measures (questionnaires and a use of medical services measure) at six months post-randomisation. Discussion MENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals. Trial Registration Current Controlled Trials ISRCTN13771934 PMID:21281461

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial.

PubMed

Rodgers, Helen; Shaw, Lisa; Bosomworth, Helen; Aird, Lydia; Alvarado, Natasha; Andole, Sreeman; Cohen, David L; Dawson, Jesse; Eyre, Janet; Finch, Tracy; Ford, Gary A; Hislop, Jennifer; Hogg, Steven; Howel, Denise; Hughes, Niall; Krebs, Hermano Igo; Price, Christopher; Rochester, Lynn; Stamp, Elaine; Ternent, Laura; Turner, Duncan; Vale, Luke; Warburton, Elizabeth; van Wijck, Frederike; Wilkes, Scott

2017-07-20

Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. NHS stroke services. adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points. The results from this trial will determine whether robot-assisted training improves upper limb function post stroke. ISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013.

Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea.

PubMed

Szajewska, H; Kołodziej, M

2015-10-01

Antibiotic-associated diarrhoea is a common complication of antibiotic use, but it can be prevented with administration of probiotics. To update our 2005 meta-analysis on the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in children and adults. The Cochrane Library, MEDLINE, and EMBASE databases were searched up until May 2015, with no language restrictions, for randomised controlled trials; additional references were obtained from reviewed articles. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines. Twenty-one randomised controlled trials (4780 participants), among which 16 were new trials, met the inclusion criteria for this updated systematic review. Administration of S. boulardii compared with placebo or no treatment reduced the risk of antibiotic-associated diarrhoea (as defined by the study investigators) in patients treated with antibiotics from 18.7% to 8.5% (risk ratio, RR: 0.47; 95% CI: 0.38-0.57, number needed to treat, NNT: 10; 95% CI: 9-13). In children, S. boulardii reduced the risk from 20.9% to 8.8% (6 randomised controlled trials, n=1653, RR: 0.43, 95% CI: 0.3-0.6); in adults, from 17.4% to 8.2% (15 randomised controlled trials, n=3114, RR: 0.49, 95% CI: 0.38-0.63). Moreover, S. boulardii reduced the risk of Clostridium difficile-associated diarrhoea; however, this reduction was significant only in children (2 randomised controlled trials, n = 579, RR: 0.25; 95% CI: 0.08-0.73) and not in adults (9 randomised controlled trials, n = 1441, RR: 0.8, 95% CI: 0.47-1.34). This meta-analysis confirms that S. boulardii is effective in reducing the risk of antibiotic-associated diarrhoea in children and adults. © 2015 John Wiley & Sons Ltd.

The Hawthorne Effect: a randomised, controlled trial

PubMed Central

McCarney, Rob; Warner, James; Iliffe, Steve; van Haselen, Robbert; Griffin, Mark; Fisher, Peter

2007-01-01

Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD). Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group), and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048 PMID:17608932

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial

PubMed Central

Vahedian-Azimi, Amir; Hajiesmaieli, Mohammadreza; Kangasniemi, Mari; Alhani, Fatemah; Jelvehmoghaddam, Hosseinali; Fathi, Mohammad; Farzanegan, Behrooz; Ardehali, Seyed H; Hatamian, Sevak; Gahremani, Mehdi; Mosavinasab, Seyed M M; Rostami, Zohreh; Madani, Seyed J; Izadi, Morteza

2016-01-01

Objective To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI). Methods We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and postintervention for a total of 9 assessments. Quality of life, perceived stress, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively. Results 70 patients were randomised. Baseline characteristics were similar. Ejection fraction was significantly higher in the intervention group at measurements 2 (p=0.01) and 3 (p=0.001). Exercise tolerance measured as walking distance was significantly improved in the intervention group throughout the study. The quality of life results in the FCEM group showed significant improvement both within the group over time (p<0.0001) and when compared with control (p<0.0001). Similarly, the perceived stress and state anxiety results showed significant improvement both within the FCEM group over time (p<0.0001) and when compared with control (p<0.0001). No significant difference was found either within or between groups for trait anxiety. Conclusions The family-centred empowerment model may be an effective hybrid cardiac rehabilitation method for improving the physical and mental health of patients post-MI; however, further study is needed to validate these findings. Clinical Trials.gov identifier NCT02402582. Trial registration number NCT02402582. PMID:27110376

A systematic review of physical therapy interventions for patients with anorexia and bulemia nervosa.

PubMed

Vancampfort, Davy; Vanderlinden, Johan; De Hert, Marc; Soundy, Andrew; Adámkova, Milena; Skjaerven, Liv Helvik; Catalán-Matamoros, Daniel; Lundvik Gyllensten, Amanda; Gómez-Conesa, Antonia; Probst, Michel

2014-01-01

The purpose of this systematic review was to summarise the evidence from randomised controlled trials examining the effectiveness of physical therapy compared with care as usual or a wait-list condition on eating pathology and on physiological and psychological parameters in patients with anorexia and bulimia nervosa. EMBASE, PsycINFO, PubMed, Cumulative Index to Nursing and Allied Health Literature, Physiotherapy Evidence Database and The Cochrane Library were searched from their inception until February, 2013. Articles were eligible if they utilised a randomised controlled trial design, compared physical therapy with a placebo condition, control intervention, or standard care and included patients with anorexia and bulimia nervosa. The methodological quality was assessed with the Jadad scale. Eight randomised controlled trials involving 213 patients (age range: 16-36 years) met all selection criteria. Three of the 8 included studies were of strong methodological quality (Jadad score≥3). Major methodological weaknesses were attrition and selection bias. The main results demonstrate that aerobic and resistance training result in significantly increased muscle strength, body mass index and body fat percentage in anorexia patients. In addition, aerobic exercise, yoga, massage and basic body awareness therapy significantly lowered scores of eating pathology and depressive symptoms in both anorexia and bulimia nervosa patients. No adverse effects were reported. The paucity and heterogeneity of available studies limits overall conclusions and highlights the need for further research. Implications for Rehabilitation Supervised physical therapy might increase weight in anorexia nervosa patients. Aerobic exercise, massage, basic body awareness therapy and yoga might reduce eating pathology in patients with anorexia and bulimia nervosa. Aerobic exercise, yoga and basic body awareness therapy might improve mental and physical quality of life in patients with an eating disorder.

Effectiveness of a nurse-supported self-management programme for dual sensory impaired older adults in long-term care: a cluster randomised controlled trial

PubMed Central

Roets-Merken, Lieve M; Zuidema, Sytse U; Vernooij-Dassen, Myrra J F J; Teerenstra, Steven; Hermsen, Pieter G J M; Kempen, Gertrudis I J M; Graff, Maud J L

2018-01-01

Objective To evaluate the effectiveness of a nurse-supported self-management programme to improve social participation of dual sensory impaired older adults in long-term care homes. Design Cluster randomised controlled trial. Setting Thirty long-term care homes across the Netherlands. Participants Long-term care homes were randomised into intervention clusters (n=17) and control clusters (n=13), involving 89 dual sensory impaired older adults and 56 licensed practical nurses. Intervention Nurse-supported self-management programme. Measurements Effectiveness was evaluated by the primary outcome social participation using a participation scale adapted for visually impaired older adults distinguishing four domains: instrumental activities of daily living, social-cultural activities, high-physical-demand and low-physical-demand leisure activities. A questionnaire assessing hearing-related participation problems was added as supportive outcome. Secondary outcomes were autonomy, control, mood and quality of life and nurses’ job satisfaction. For effectiveness analyses, linear mixed models were used. Sampling and intervention quality were analysed using descriptive statistics. Results Self-management did not affect all four domains of social participation; however. the domain ‘instrumental activities of daily living’ had a significant effect in favour of the intervention group (P=0.04; 95% CI 0.12 to 8.5). Sampling and intervention quality was adequate. Conclusions A nurse-supported self-management programme was effective in empowering the dual sensory impaired older adults to address the domain ‘instrumental activities of daily living’, but no differences were found in addressing the other three participation domains. Self-management showed to be beneficial for managing practical problems, but not for those problems requiring behavioural adaptations of other persons. Trial registration number NCT01217502; Results. PMID:29371264

Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review

PubMed Central

Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen HM

2017-01-01

Background: Three-dimensional printing provides an exciting opportunity to customise upper-limb prostheses. Objective: This review summarises the research that assesses the efficacy and effectiveness of three-dimensional printed upper-limb prostheses. Study design: Systematic review. Methods: PubMed, Web of Science and OVID were systematically searched for studies that reported human trials of three-dimensional printed upper-limb prostheses. The studies matching the language, peer-review and relevance criteria were ranked by level of evidence and critically appraised using the Downs and Black Quality Index. Results: After removing duplicates, 321 records were identified. Eight papers met the inclusion criteria. No studies used controls; five were case studies and three were small case-series studies. All studies showed promising results, but none demonstrated external validity, avoidance of bias or statistically significant improvements over conventional prostheses. The studies demonstrated proof-of-concept rather than assessing efficacy, and the devices were designed to prioritise reduction of manufacturing costs, not customisability for comfort and function. Conclusion: The potential of three-dimensional printing for individual customisation has yet to be fully realised, and the efficacy and effectiveness to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on quality of life remain unknown. Clinical relevance Initial studies suggest that three-dimensional printing shows promise for customising low-cost upper-limb prosthetics. However, the efficacy and effectiveness of these devices have yet to be rigorously assessed. Until randomised controlled trials with follow-up are performed, the comfort, functionality, durability and long-term effects on patient quality of life remain unknown. PMID:28649911

Baclofen for alcohol withdrawal.

PubMed

Liu, Jia; Wang, Lu-Ning

2017-08-20

Baclofen shows potential for rapidly reducing symptoms of severe alcohol withdrawal syndrome (AWS) in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane Review published in 2015, Issue 4. To assess the efficacy and safety of baclofen for people with AWS. We updated our searches of the following databases to March 2017: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, PubMed, Embase, and CINAHL. We also searched registers of ongoing trials. We handsearched the references quoted in the identified trials, and sought information from researchers, pharmaceutical companies, and relevant trial authors about unpublished or uncompleted trials. We placed no restrictions on language. We included all randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for people with AWS. We excluded uncontrolled, non-randomised, or quasi-randomised trials. We included both parallel group and cross-over studies. We used standard methodological procedures expected by Cochrane. We included three RCTs with 141 randomised participants. We did not perform meta-analyses due to the different control interventions. For the comparison of baclofen and placebo (1 study, 31 participants), there was no significant difference in Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores (very low quality evidence). For the comparison of baclofen and diazepam (1 study, 37 participants), there was no significant difference in CIWA-Ar scores (very low quality evidence), adverse events (risk difference (RD) 0.00, 95% confidence interval (CI) -0.10 to 0.10; very low quality evidence), dropouts (RD 0.00, 95% CI -0.10 to 0.10; very low quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.10 to 0.10; very low quality evidence). For the comparison of baclofen and chlordiazepoxide (1 study, 60 participants), there was no significant difference in CIWA-Ar scores (mean difference (MD) 1.00, 95% CI 0.70 to 1.30; very low quality evidence), global improvement (MD 0.10, 95% CI -0.03 to 0.23; very low quality evidence), adverse events (RD 2.50, 95% CI 0.88 to 7.10; very low quality of evidence), dropouts (RD 0.00, 95% CI -0.06 to 0.06; very low quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.06 to 0.06; very low quality evidence). No conclusions can be drawn about the efficacy and safety of baclofen for the management of alcohol withdrawal because we found insufficient and very low quality evidence.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

PubMed Central

2013-01-01

Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. Discussion The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12611001070921) PMID:24160714

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

PubMed Central

2010-01-01

Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). Discussion This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. Trial Registration Current controlled trial ISRCTN54009836 PMID:20398349

General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial.

PubMed

Purwar, B; Ismail, K M; Turner, N; Farrell, A; Verzune, M; Annappa, M; Smith, I; El-Gizawy, Zeiad; Cooper, J C

2015-08-01

Spinal anaesthesia (SA) and general anaesthesia (GA) are widely used techniques for vaginal surgery for pelvic floor disorders with inconclusive evidence of the superiority of either. We conducted a randomised controlled trial (RCT) to assess the feasibility of a full scale RCT aiming to examine the effect of anaesthetic mode for vaginal surgery on operative, patient reported and length of hospital stay (LOHS) outcomes. Patients undergoing vaginal surgery, recruited through a urogynaecology service in a University teaching hospital, were randomised to receive either GA or SA. Patients were followed up for 12 weeks postoperatively. Pain was measured on a visual analogue scale; nausea was assessed with a four-point verbal rating scale. Patient's subjective perception of treatment outcome, quality of life (QoL) and functional outcomes were assessed using the International Consultation on Incontinence Modular Questionnaire (ICIQ) on vaginal symptoms and the SF-36 questionnaire. Sixty women were randomised, 29 to GA and 31 to SA. The groups were similar in terms of age and type of vaginal surgery performed. No statistically significant differences were noted between the groups with regard to pain, nausea, quality of life (QoL), functional outcomes as well as length of stay in the postoperative recovery room, use of analgesia postoperatively and LOHS. This study has demonstrated that a full RCT is feasible and should focus on the length of hospital stay in a subgroup of patients undergoing vaginal surgery where SA may help to facilitate enhanced recovery or day surgery.

Supervised pelvic floor muscle training versus attention-control massage treatment in patients with faecal incontinence: Statistical analysis plan for a randomised controlled trial.

PubMed

Ussing, Anja; Dahn, Inge; Due, Ulla; Sørensen, Michael; Petersen, Janne; Bandholm, Thomas

2017-12-01

Faecal incontinence affects approximately 8-9% of the adult population. The condition is surrounded by taboo; it can have a devastating impact on quality of life and lead to major limitations in daily life. Pelvic floor muscle training in combination with information and fibre supplements is recommended as first-line treatment for faecal incontinence. Despite this, the effect of pelvic floor muscle training for faecal incontinence is unclear. No previous trials have investigated the efficacy of supervised pelvic floor muscle training in combination with conservative treatment and compared this to an attention-control massage treatment including conservative treatment. The aim of this trial is to investigate if 16 weeks of supervised pelvic floor muscle training in combination with conservative treatment is superior to attention-control massage treatment and conservative treatment in patients with faecal incontinence. Randomised, controlled, superiority trial with two parallel arms. 100 participants with faecal incontinence will be randomised to either (1) individually supervised pelvic floor muscle training and conservative treatment or (2) attention-control massage treatment and conservative treatment. The primary outcome is participants' rating of symptom changes after 16 weeks of treatment using the Patient Global Impression of Improvement Scale. Secondary outcomes are the Vaizey Incontinence Score, the Fecal Incontinence Severity Index, the Fecal Incontinence Quality of Life Scale, a 14-day bowel diary, anorectal manometry and rectal capacity measurements. Follow-up assessment at 36 months will be conducted. This paper describes and discusses the rationale, the methods and in particular the statistical analysis plan of this trial.

Personalised telehealth intervention for chronic disease management: A pilot randomised controlled trial.

PubMed

Bohingamu Mudiyanselage, Shalika; Stevens, Jo; Watts, Jennifer J; Toscano, Julian; Kotowicz, Mark A; Steinfort, Christopher L; Bell, Jennifer; Byrnes, Janette; Bruce, Stephanie; Carter, Sarah; Hunter, Claire; Barrand, Chris; Hayles, Robyn

2018-01-01

Introduction The aim of this study was to assess the impact of home-based telehealth monitoring on health outcomes, quality of life and costs over 12 months for patients with diabetes and/or chronic obstructive pulmonary disease (COPD) who were identified as being at high risk of readmission to hospital. Methods This pilot study was a randomised controlled trial combined with an economic analysis to examine the outcomes of standard care versus home-based telehealth for people with diabetes and/or COPD who were at risk of hospital readmission within one year. The primary outcomes were (i) hospital admission and length of stay (LOS); and (ii) health-related quality of life (HRQOL); and the secondary outcomes were (i) health-related clinical outcomes; (ii) anxiety and depression scores; and (iii) health literacy. The costs of the intervention and hospitalisations were included. Results A total of 86 and 85 participants were randomised to the intervention and control groups respectively. The difference between groups in hospital LOS was -3.89 (95% confidence interval (CI): -9.40, 1.62) days, and for HRQOL, 0.09 (95% CI: 0.05, 0.14) in favour of the telehealth monitoring group. There was a saving of AUD$6553 (95% CI: -12145, -961) in the cost of hospitalisation over 12 months, which offset the increased cost of tele-monitoring. The intervention group showed an improvement in anxiety, depression and health literacy at 12 months, and in the diabetes group, a reduction in microalbuminuria. Discussion The telehealth monitoring intervention improved patient's health outcomes and quality of life at no additional cost.

The 30-year experience-A meta-analysis of randomised and high-quality non-randomised studies of hyperthermic intraperitoneal chemotherapy in the treatment of gastric cancer.

PubMed

Desiderio, Jacopo; Chao, Joseph; Melstrom, Laleh; Warner, Susanne; Tozzi, Federico; Fong, Yuman; Parisi, Amilcare; Woo, Yanghee

2017-07-01

Hyperthermic intraperitoneal chemotherapy (HIPEC) has been used within various multimodality strategies for the prevention and treatment of gastric cancer peritoneal carcinomatosis. To systematically evaluate the role of HIPEC in gastric cancer and clarify its effectiveness at different stages of peritoneal disease progression. Medline and Embase databases between January 1, 1985 and June 1, 2016. Randomised control trials and high-quality non-randomised control trials selected on a validated tool (methodological index for non-randomised studies) comparing HIPEC and standard oncological management for the treatment of advanced stage gastric cancer with and without peritoneal carcinomatosis were considered. A random-effects network meta-analysis. The primary outcomes were overall survival and disease recurrence. Secondary outcomes were overall complications, type of complications, and sites of recurrence. A total of 11 RCTs and 21 non-randomised control trials (2520 patients) were included. For patients without the presence of peritoneal carcinomatosis (PC), the overall survival rates between the HIPEC and control groups at 3 or 5 years resulted in favour of the HIPEC group (risk ratio [RR] = 0.82, P = 0.01). No difference in the 3-year overall survival (RR = 0.99, P = 0.85) in but a prolonged median survival of 4 months in favour of the HIPEC group (WMD = 4.04, P < 0.001) was seen in patients with PC. HIPEC was associated with significantly higher risk of complications for both patients with PC (RR = 2.15, P < 0.01) and without (RR = 2.17, P < 0.01). This increased risk in the HIPEC group was related to systemic drugs toxicity. Anastomotic leakage rates were found to be similar between groups. Our study demonstrates a survival advantage of the use of HIPEC as a prophylactic strategy and suggests that patients whose disease burden is limited to positive cytology and limited nodal involvement may benefit the most from HIPEC. For patients with extensive carcinomatosis, the completeness of cytoreductive surgery is a critical prognostic factor for survival. Future RCTs should better define patient selection criteria. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating an extended rehabilitation service for stroke patients (EXTRAS): study protocol for a randomised controlled trial.

PubMed

Rodgers, Helen; Shaw, Lisa; Cant, Robin; Drummond, Avril; Ford, Gary A; Forster, Anne; Hills, Katie; Howel, Denise; Laverty, Anne-Marie; McKevitt, Christopher; McMeekin, Peter; Price, Christopher

2015-05-05

Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models. We describe the protocol for a multicentre randomised controlled trial which is evaluating an extended stroke rehabilitation service. The extended service commences when routine 'organised stroke care' (stroke unit and early supported discharge (ESD)) ends. This study is a multicentre randomised controlled trial with health economic and process evaluations. It is set within NHS stroke services which provide ESD. Participants are adults who have experienced a new stroke (and carer if appropriate), discharged from hospital under the care of an ESD team. The intervention group receives an extended stroke rehabilitation service provided for 18 months following completion of ESD. The extended rehabilitation service involves regular contact with a senior ESD team member who leads and coordinates further rehabilitation. Contact is usually by telephone. The control group receives usual stroke care post-ESD. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice. Randomisation is via a central independent web-based service. The primary outcome is extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post-randomisation. Secondary outcomes (at 12 and 24 months post-randomisation) are health status, quality of life, mood and experience of services for patients, and quality of life, experience of services and carer stress for carers. Resource use and adverse events are also collected. Outcomes are undertaken by a blinded assessor. Implementation and delivery of the extended stroke rehabilitation service will also be described. Semi-structured interviews will be conducted with a subsample of participants and staff to gain insight into perceptions and experiences of rehabilitation services delivered or received. Allowing for 25% attrition, 510 participants are needed to provide 90% power to detect a difference in mean Nottingham Extended Activities of Daily Living Scale score of 6 with a 5% significance level. The provision of longer term support for stroke survivors is currently limited. The results from this trial will inform future stroke service planning and configuration. This trial was registered with ISRCTN (identifier: ISRCTN45203373 ) on 9 August 2012.

Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial

PubMed Central

Hunter, Amanda; Shah, Anoop; Assi, Valentina; Lewis, Stephanie; Mangion, Kenneth; Berry, Colin; Boon, Nicholas A; Clark, Elizabeth; Flather, Marcus; Forbes, John; McLean, Scott; Roditi, Giles; van Beek, Edwin JR; Timmis, Adam D; Newby, David E

2017-01-01

Background In patients with suspected angina pectoris, CT coronary angiography (CTCA) clarifies the diagnosis, directs appropriate investigations and therapies, and reduces clinical events. The effect on patient symptoms is currently unknown. Methods In a prospective open-label parallel group multicentre randomised controlled trial, 4146 patients with suspected angina due to coronary heart disease were randomised 1:1 to receive standard care or standard care plus CTCA. Symptoms and quality of life were assessed over 6 months using the Seattle Angina Questionnaire and Short Form 12. Results Baseline scores indicated mild physical limitation (74±0.4), moderate angina stability (44±0.4), modest angina frequency (68±0.4), excellent treatment satisfaction (92±0.2) and moderate impairment of quality of life (55±0.3). Compared with standard care alone, CTCA was associated with less marked improvements in physical limitation (difference −1.74 (95% CIs, −3.34 to −0.14), p=0.0329), angina frequency (difference −1.55 (−2.85 to −0.25), p=0.0198) and quality of life (difference −3.48 (−4.95 to −2.01), p<0.0001) at 6 months. For patients undergoing CTCA, improvements in symptoms were greatest in those diagnosed with normal coronary arteries or who had their preventative therapy discontinued, and least in those with moderate non-obstructive disease or had a new prescription of preventative therapy (p<0.001 for all). Conclusions While improving diagnosis, treatment and outcome, CTCA is associated with a small attenuation of the improvements in symptoms and quality of life due to the detection of moderate non-obstructive coronary artery disease. Trial registration number: NCT01149590. PMID:28246175

Conclusions for mammography screening after 25-year follow-up of the Canadian National Breast Cancer Screening Study (CNBSS).

PubMed

Heywang-Köbrunner, S H; Schreer, I; Hacker, A; Noftz, M R; Katalinic, A

2016-02-01

Twenty-five-year follow-up data of the Canadian National Breast Cancer Screening Study (CNBSS) indicated no mortality reduction. What conclusions should be drawn? After conducting a systematic literature search and narrative analysis, we wish to recapitulate important details of this study, which may have been neglected: Sixty-eight percent of all included cancers were palpable, a situation that does not allow testing the value of early detection. Randomisation was performed at the sites after palpation, while blinding was not guaranteed. In the first round, this "randomisation" assigned 19/24 late stage cancers to the mammography group and only five to the control group, supporting the suspicion of severe errors in the randomisation process. The responsible physicist rated mammography quality as "far below state of the art of that time". Radiological advisors resigned during the study due to unacceptable image quality, training, and medical quality assurance. Each described problem may strongly influence the results between study and control groups. Twenty-five years of follow-up cannot heal these fundamental problems. This study is inappropriate for evidence-based conclusions. The technology and quality assurance of the diagnostic chain is shown to be contrary to today's screening programmes, and the results of the CNBSS are not applicable to them. • The evidence base of the Canadian study (CNBSS) has to be questioned.• Severe flaws in the randomization process and test methods occurred. • Problems were criticized during and after conclusion of the trial by experts.• The results are not applicable to quality-assured screening programs. • The evidence base of this study must be re-analyzed.

Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy.

PubMed

Gurusamy, Kurinchi Selvan; Nagendran, Myura; Guerrini, Gian Piero; Toon, Clare D; Zinnuroglu, Murat; Davidson, Brian R

2014-03-13

While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery and overnight stay laparoscopic cholecystectomy. The safety and effectiveness of intraperitoneal local anaesthetic instillation in people undergoing laparoscopic cholecystectomy is unknown. To assess the benefits and harms of intraperitoneal instillation of local anaesthetic agents in people undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded to March 2013 to identify randomised clinical trials of relevance to this review. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic intraperitoneal instillation versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy for the review with regards to benefits while we considered quasi-randomised studies and non-randomised studies for treatment-related harms. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We included 58 trials, of which 48 trials with 2849 participants randomised to intraperitoneal local anaesthetic instillation (1558 participants) versus control (1291 participants) contributed data to one or more of the outcomes. All the trials except one trial with 30 participants were at high risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Various intraperitoneal local anaesthetic agents were used but bupivacaine in the liquid form was the most common local anaesthetic used. There were considerable differences in the methods of local anaesthetic instillation including the location (subdiaphragmatic, gallbladder bed, or both locations) and timing (before or after the removal of gallbladder) between the trials. There was no mortality in either group in the eight trials that reported mortality (0/236 (0%) in local anaesthetic instillation versus 0/210 (0%) in control group; very low quality evidence). One participant experienced the outcome of serious morbidity (eight trials; 446 participants; 1/236 (0.4%) in local anaesthetic instillation group versus 0/210 (0%) in the control group; RR 3.00; 95% CI 0.13 to 67.06; very low quality evidence). Although the remaining trials did not report the overall morbidity, three trials (190 participants) reported that there were no intra-operative complications. Twenty trials reported that there were no serious adverse events in any of the 715 participants who received local anaesthetic instillation. None of the trials reported participant quality of life, return to normal activity, or return to work.The effect of local anaesthetic instillation on the proportion of participants discharged as day surgery between the two groups was imprecise and compatible with benefit and no difference of intervention (three trials; 242 participants; 89/160 (adjusted proportion 61.0%) in local anaesthetic instillation group versus 40/82 (48.8%) in control group; RR 1.25; 95% CI 0.99 to 1.58; very low quality evidence). The MD in length of hospital stay was 0.04 days (95% CI -0.23 to 0.32; five trials; 335 participants; low quality evidence). The pain scores as measured by the visual analogue scale (VAS) were significantly lower in the local anaesthetic instillation group than the control group at four to eight hours (32 trials; 2020 participants; MD -0.99 cm; 95% CI -1.10 to -0.88 on a VAS scale of 0 to 10 cm; very low quality evidence) and at nine to 24 hours (29 trials; 1787 participants; MD -0.53 cm; 95% CI -0.62 to -0.44; very low quality evidence). Various subgroup analyses and meta-regressions to investigate the influence of the different local anaesthetic agents, different methods of local anaesthetic instillation, and different controls on the effectiveness of local anaesthetic intraperitoneal instillation were inconsistent. Serious adverse events were rare in studies evaluating local anaesthetic intraperitoneal instillation (very low quality evidence). There is very low quality evidence that it reduces pain in low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. However, the clinical importance of this reduction in pain is unknown and likely to be small. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.

Advance care planning--a multi-centre cluster randomised clinical trial: the research protocol of the ACTION study.

PubMed

Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley; Preston, Nancy J; Jabbarian, Lea J; Christensen, Caroline Arnfeldt; de Brito, Maja; Bulli, Francesco; Caswell, Glenys; Červ, Branka; van Delden, Johannes; Deliens, Luc; Gorini, Giuseppe; Groenvold, Mogens; Houttekier, Dirk; Ingravallo, Francesca; Kars, Marijke C; Lunder, Urška; Miccinesi, Guido; Mimić, Alenka; Paci, Eugenio; Payne, Sheila; Polinder, Suzanne; Pollock, Kristian; Seymour, Jane; Simonič, Anja; Johnsen, Anna Thit; Verkissen, Mariëtte N; de Vries, Esther; Wilcock, Andrew; Zwakman, Marieke; van der Heide Pl, Agnes

2016-04-08

Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control, and improve their quality of life. We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised. In the intervention sites, patients will be offered interviews with a trained facilitator. In the control sites, patients will receive care as usual. In total, 1360 patients will be included. All participating patients will be asked to complete questionnaires at inclusion, and again after 2.5 and 4.5 months. If a patient dies within a year after inclusion, a relative will be asked to complete a questionnaire on end-of-life care. Use of medical care will be assessed by checking medical files. The primary endpoint is patients' quality of life at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. International Standard Randomised Controlled Trial Number: ISRCTN63110516. Date of registration: 10/3/2014.

Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

PubMed Central

Lamb, SE; Pepper, J; Lall, R; Jørstad-Stein, EC; Clark, MD; Hill, L; Fereday-Smith, J

2009-01-01

Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00)). Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662 PMID:19751517

The effect of rhythmic-cued motor imagery on walking, fatigue and quality of life in people with multiple sclerosis: A randomised controlled trial.

PubMed

Seebacher, Barbara; Kuisma, Raija; Glynn, Angela; Berger, Thomas

2017-02-01

Motor imagery and rhythmic auditory stimulation are physiotherapy strategies for walking rehabilitation. To investigate the effect of motor imagery combined with rhythmic cueing on walking, fatigue and quality of life (QoL) in people with multiple sclerosis (MS). Individuals with MS and Expanded Disability Status Scale scores of 1.5-4.5 were randomised into one of three groups: 17 minutes of motor imagery, six times per week, for 4 weeks, with music (A) or metronome cues (B), both with verbal cueing, and (C) controls. Primary outcomes were walking speed (Timed 25-Foot Walk) and distance (6-Minute Walk Test). Secondary outcomes were walking perception (Multiple Sclerosis Walking Scale-12), fatigue (Modified Fatigue Impact Scale) and QoL (Short Form-36 Health Survey, Multiple Sclerosis Impact Scale-29, Euroquol-5D-3L Questionnaire). Of the 112 participants randomised, 101 completed the study. Compared to controls, both interventions significantly improved walking speed, distance and perception. Significant improvements in cognitive but not psychosocial fatigue were seen in the intervention groups, and physical fatigue improved only in the music-based group. Both interventions improved QoL; however, music-cued motor imagery was superior at improving health-related QoL. Rhythmic-cued motor imagery improves walking, fatigue and QoL in people with MS, with music-cued motor imagery being more effective.

A review of the evidence for dietary interventions in preventing or slowing the progression of age-related macular degeneration.

PubMed

Evans, Jennifer R; Lawrenson, John G

2014-07-01

To summarise the results of recent Cochrane systematic reviews that have investigated whether nutritional supplements prevent or slow the progression of age-related macular degeneration (AMD). There is no good evidence from randomised controlled trials that the general population should be taking antioxidant vitamin supplements to reduce their risk of developing AMD later on in life. By contrast, there is moderate quality evidence that people with AMD may experience a delay in progression by taking specific antioxidant vitamin and mineral supplements. This finding is drawn from one large randomised controlled trial conducted in the USA in a relatively well-nourished population. Although observational studies have shown that the consumption of dietary omega 3 long chain polyunsaturated fatty acids may reduce the risk of progression to advanced AMD, two recently published randomised controlled trials failed to show any benefit of omega 3 supplements on AMD progression. There is no high quality experimental evidence that nutritional supplementation is beneficial for the primary prevention of AMD. However, people with AMD may benefit from supplementation with antioxidant vitamins. There is currently no evidence to support increasing levels of omega 3 long chain polyunsaturated fatty acids in the diet for the explicit purpose of preventing or slowing the progression of AMD. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

Streamlining cardiovascular clinical trials to improve efficiency and generalisability.

PubMed

Zannad, Faiez; Pfeffer, Marc A; Bhatt, Deepak L; Bonds, Denise E; Borer, Jeffrey S; Calvo-Rojas, Gonzalo; Fiore, Louis; Lund, Lars H; Madigan, David; Maggioni, Aldo Pietro; Meyers, Catherine M; Rosenberg, Yves; Simon, Tabassome; Stough, Wendy Gattis; Zalewski, Andrew; Zariffa, Nevine; Temple, Robert

2017-08-01

Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Physical interventions to interrupt or reduce the spread of respiratory viruses: systematic review

PubMed Central

2008-01-01

Objective To systematically review evidence for the effectiveness of physical interventions to interrupt or reduce the spread of respiratory viruses. Data extraction Search strategy of the Cochrane Library, Medline, OldMedline, Embase, and CINAHL, without language restriction, for any intervention to prevent transmission of respiratory viruses (isolation, quarantine, social distancing, barriers, personal protection, and hygiene). Study designs were randomised trials, cohort studies, case-control studies, and controlled before and after studies. Data synthesis Of 2300 titles scanned 138 full papers were retrieved, including 49 papers of 51 studies. Study quality was poor for the three randomised controlled trials and most of the cluster randomised controlled trials; the observational studies were of mixed quality. Heterogeneity precluded meta-analysis of most data except that from six case-control studies. The highest quality cluster randomised trials suggest that the spread of respiratory viruses into the community can be prevented by intervening with hygienic measures aimed at younger children. Meta-analysis of six case-control studies suggests that physical measures are highly effective in preventing the spread of SARS: handwashing more than 10 times daily (odds ratio 0.45, 95% confidence interval 0.36 to 0.57; number needed to treat=4, 95% confidence interval 3.65 to 5.52); wearing masks (0.32, 0.25 to 0.40; NNT=6, 4.54 to 8.03); wearing N95 masks (0.09, 0.03 to 0.30; NNT=3, 2.37 to 4.06); wearing gloves (0.43, 0.29 to 0.65; NNT=5, 4.15 to 15.41); wearing gowns (0.23, 0.14 to 0.37; NNT=5, 3.37 to 7.12); and handwashing, masks, gloves, and gowns combined (0.09, 0.02 to 0.35; NNT=3, 2.66 to 4.97). The incremental effect of adding virucidals or antiseptics to normal handwashing to decrease the spread of respiratory disease remains uncertain. The lack of proper evaluation of global measures such as screening at entry ports and social distancing prevent firm conclusions being drawn. Conclusion Routine long term implementation of some physical measures to interrupt or reduce the spread of respiratory viruses might be difficult but many simple and low cost interventions could be useful in reducing the spread. PMID:18042961

How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China.

PubMed

Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

2015-01-01

While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. The integrated care system needs collaborative work from different levels of caregivers. So it is extremely important to consider the supplier cooperative behaviour. In this trial, we introduced payment system to help the delivery system integration through providing financial incentives to motivate people to play their roles. Also, the multidisciplinary team, the multi-institutional pathway and system global budget and pay-for-performance payment system could afford as a solution.

A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented. Discussion This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012. Trial registration ISRCTN58683841 PMID:22721452

A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial.

PubMed

Kemp, Joanne L; Moore, Kate; Fransen, Marlene; Russell, Trevor G; Crossley, Kay M

2015-01-27

Early-onset hip osteoarthritis is commonly seen in people undergoing hip arthroscopy and is associated with increased pain, reduced ability to participate in physical activity, reduced quality of life and reduced range of motion and muscle strength. Despite this, the efficacy of non-surgical interventions such as exercise therapies remains unknown. The primary aim is to establish the feasibility of a phase III randomised controlled trial investigating a targeted physiotherapy intervention for people with early-onset hip osteoarthritis. The secondary aims are to determine the size of treatment effects of a physiotherapy intervention, targeted to improve hip joint range and hip-related symptoms in early-onset hip osteoarthritis following hip arthroscopy, compared to a health-education control. This protocol describes a randomised, assessor- and participant-blind, controlled clinical trial. We will include 20 participants who are (i) aged between 18 and 50 years; (ii) have undergone hip arthroscopy during the past six to 12 months; (iii) have early-onset hip osteoarthritis (defined as chondrolabral pathology) at the time of hip arthroscopy; and (iv) experience hip-related pain during activities. Primary outcome will be the feasibility of a phase III clinical trial. Secondary outcomes will be (i) perceived global change score; (ii) hip-related symptoms (measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) pain subscale, activity subscale, and sport and recreation subscale); (iii) hip quality of life (measured using the HOOS quality of life subscale and International Hip Outcome tool; (iv) hip muscle strength and (v) hip range of motion. The physiotherapy intervention is semi-standardised, including joint and soft tissue mobilisation and stretching, hip and trunk muscle retraining and functional and activity-specific retraining and education. The control intervention encompasses individualised health education, with the same frequency and duration as the intervention. The trial primary end-point is the conclusion of the 12-week intervention, and follow-up measures will be collected at the 12-week post-baseline assessment. The findings of this study will provide guidance regarding the feasibility of a full-scale phase III randomised controlled trial, prior to its undertaking. The trial protocol was registered with the Australian Clinical Trials Registry (number: 12614000426684 ) on 17 April 2014.

How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

PubMed Central

Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

2015-01-01

Background While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. Conclusion The integrated care system needs collaborative work from different levels of caregivers. So it is extremely important to consider the supplier cooperative behaviour. In this trial, we introduced payment system to help the delivery system integration through providing financial incentives to motivate people to play their roles. Also, the multidisciplinary team, the multi-institutional pathway and system global budget and pay-for-performance payment system could afford as a solution. PMID:26034466

Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy.

PubMed

Loizides, Sofronis; Gurusamy, Kurinchi Selvan; Nagendran, Myura; Rossi, Michele; Guerrini, Gian Piero; Davidson, Brian R

2014-03-12

While laparoscopic cholecystectomy is generally considered to be less painful than open surgery, pain is one of the important reasons for delayed discharge after day surgery resulting in overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of local anaesthetic wound infiltration in people undergoing laparoscopic cholecystectomy is not known. To assess the benefits and harms of local anaesthetic wound infiltration in patients undergoing laparoscopic cholecystectomy and to identify the best method of local anaesthetic wound infiltration with regards to the type of local anaesthetic, dosage, and time of administration of the local anaesthetic. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify studies of relevance to this review. We included randomised clinical trials for benefit and quasi-randomised and comparative non-randomised studies for treatment-related harms. Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing local anaesthetic wound infiltration versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy, trials comparing different local anaesthetic agents for local anaesthetic wound infiltration, and trials comparing the different times of local anaesthetic wound infiltration were considered for the review. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects meta-analysis models using RevMan. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence interval (CI). Twenty-six trials fulfilled the inclusion criteria of the review. All the 26 trials except one trial of 30 participants were at high risk of bias. Nineteen of the trials with 1263 randomised participants provided data for this review. Ten of the 19 trials compared local anaesthetic wound infiltration versus inactive control. One of the 19 trials compared local anaesthetic wound infiltration with two inactive controls, normal saline and no intervention. Two of the 19 trials had four arms comparing local anaesthetic wound infiltration with inactive controls in the presence and absence of co-interventions to decrease pain after laparoscopic cholecystectomy. Four of the 19 trials had three or more arms that could be included for the comparison of local anaesthetic wound infiltration versus inactive control and different methods of local anaesthetic wound infiltration. The remaining two trials compared different methods of local anaesthetic wound infiltration.Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Seventeen trials randomised a total of 1095 participants to local anaesthetic wound infiltration (587 participants) versus no local anaesthetic wound infiltration (508 participants). Various anaesthetic agents were used but bupivacaine was the commonest local anaesthetic used. There was no mortality in either group in the seven trials that reported mortality (0/280 (0%) in local anaesthetic infiltration group versus 0/259 (0%) in control group). The effect of local anaesthetic on the proportion of people who developed serious adverse events was imprecise and compatible with increase or no difference in serious adverse events (seven trials; 539 participants; 2/280 (0.8%) in local anaesthetic group versus 1/259 (0.4%) in control; RR 2.00; 95% CI 0.19 to 21.59; very low quality evidence). None of the serious adverse events were related to local anaesthetic wound infiltration. None of the trials reported patient quality of life. The proportion of participants who were discharged as day surgery patients was higher in the local anaesthetic infiltration group than in the no local anaesthetic infiltration group (one trial; 97 participants; 33/50 (66.0%) in the local anaesthetic group versus 20/47 (42.6%) in the control group; RR 1.55; 95% CI 1.05 to 2.28; very low quality evidence). The effect of local anaesthetic on the length of hospital stay was compatible with a decrease, increase, or no difference in the length of hospital stay between the two groups (four trials; 327 participants; MD -0.26 days; 95% CI -0.67 to 0.16; very low quality evidence). The pain scores as measured by the visual analogue scale (0 to 10 cm) were lower in the local anaesthetic infiltration group than the control group at 4 to 8 hours (13 trials; 806 participants; MD -1.33 cm on the VAS; 95% CI -1.54 to -1.12; very low quality evidence) and 9 to 24 hours (12 trials; 756 participants; MD -0.36 cm on the VAS; 95% CI -0.53 to -0.20; very low quality evidence). The effect of local anaesthetic on the time taken to return to normal activity between the two groups was imprecise and compatible with a decrease, increase, or no difference in the time taken to return to normal activity (two trials; 195 participants; MD 0.14 days; 95% CI -0.59 to 0.87; very low quality evidence). None of the trials reported on return to work.Four trials randomised a total of 149 participants to local anaesthetic wound infiltration prior to skin incision (74 participants) versus local anaesthetic wound infiltration at the end of surgery (75 participants). Two trials randomised a total of 176 participants to four different local anaesthetics (bupivacaine, levobupivacaine, ropivacaine, neosaxitoxin). Although there were differences between the groups in some outcomes the changes were not consistent. There was no evidence to support the preference of one local anaesthetic over another or to prefer administration of local anaesthetic at a specific time compared with another. Serious adverse events were rare in studies evaluating local anaesthetic wound infiltration (very low quality evidence). There is very low quality evidence that infiltration reduces pain in low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. However, the clinical importance of this reduction in pain is likely to be small. Further randomised clinical trials at low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.

A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

PubMed

Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

2014-11-11

Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and, more importantly, patients can make informed choices. Current Controlled Trials ISRCTN80061723 (assigned 8 March 2010).

Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill.

PubMed

Thomas, Kirsty; Wright, Stephen E; Watson, Gillian; Baker, Catherine; Stafford, Victoria; Wade, Clare; Chadwick, Thomas J; Mansfield, Leigh; Wilkinson, Jennifer; Shen, Jing; Deverill, Mark; Bonner, Stephen; Hugill, Keith; Howard, Philip; Henderson, Andrea; Roy, Alistair; Furneval, Julie; Baudouin, Simon V

2015-05-25

Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised controlled trials to determine the most effective rehabilitation strategy for critically ill patients at risk of critical illness-associated physical morbidity. In response to this, we will conduct a randomised controlled trial, comparing physiotherapy aimed at early and intensive patient mobilisation with routine care. We hypothesise that this intervention will improve physical outcomes and the mental health and functional well-being of survivors of critical illness. 308 adult patients who have received more than 48 h of non-invasive or invasive ventilation in Critical Care will be recruited to a patient-randomised, parallel group, controlled trial, comparing two intensities of physiotherapy. Participants will be randomised to receive either standard or intensive physiotherapy for the duration of their Critical Care admission. Outcomes will be recorded on Critical Care discharge, at 3 and 6 months following initial recruitment to the study. The primary outcome measure is physical health at 6 months, as measured by the SF-36 Physical Component Summary. Secondary outcomes include assessment of mental health, activities of daily living, delirium and ventilator-free days. We will also include a health economic analysis. The trial has ethical approval from Newcastle and North Tyneside 2 Research Ethics Committee (11/NE/0206). There is a Trial Oversight Committee including an independent chair. The results of the study will be submitted for publication in peer-reviewed journals and presented at national and international scientific meetings. ISRCTN20436833. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.

PubMed

Ma, Jun; Strub, Peg; Lv, Nan; Xiao, Lan; Camargo, Carlos A; Buist, A Sonia; Lavori, Philip W; Wilson, Sandra R; Nadeau, Kari C; Rosas, Lisa G

2016-01-01

Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores <6 out of 9) to a 6-month DASH behavioural intervention (n=46) or usual-care control (n=44). Intention-to-treat analyses used repeated-measures mixed models.Participants were middle-aged, 67% female and multiethnic. Compared with controls, intervention participants improved on DASH scores (mean change (95% CI) 0.6 (0, 1.1) versus -0.3 (-0.8, 0.2); difference 0.8 (0.2, 1.5)) and the primary outcome, Asthma Control Questionnaire scores (-0.2 (-0.5, 0) versus 0 (-0.3, 0.3); difference -0.2 (-0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (-0.1, 1.0), emotions 0.4 (-0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant.The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted. Copyright ©ERS 2016.

Sleep positioning systems for children with cerebral palsy.

PubMed

Blake, Sharon F; Logan, Stuart; Humphreys, Ginny; Matthews, Justin; Rogers, Morwenna; Thompson-Coon, Joanna; Wyatt, Katrina; Morris, Christopher

2015-01-01

Sleep positioning systems can be prescribed for children with cerebral palsy to help reduce or prevent hip migration, provide comfort to ease pain and/or improve sleep. As sleep disturbance is common in children with developmental disabilities, with impact on their carers' sleep, and as sleep positioning systems can be expensive, guidance is needed to support decisions as to their use. To determine whether commercially-available sleep positioning systems, compared with usual care, reduce or prevent hip migration in children with cerebral palsy. Any negative effect of sleep positioning systems on hip migration will be considered within this objective.Secondary objectives were to determine the effect of sleep positioning systems on: (1) number or frequency of hip problems; (2) sleep patterns and quality; (3) quality of life of the child and family; (4) pain; and (5) physical functioning. We also sought to identify any adverse effects from using sleep positioning systems. In December 2014, we searched CENTRAL, Ovid MEDLINE, Embase, and 13 other databases. We also searched two trials registers. We applied no restrictions on date of publication, language, publication status or study design. We checked references and contacted manufacturers and authors for potentially relevant literature, and searched the internet using Google. We included all randomised controlled trials (RCTs) evaluating whole body sleep positioning systems for children and adolescents (up to 18 years of age) with cerebral palsy. Two review authors independently screened reports retrieved from the search against pre-determined inclusion criteria and assessed the quality of eligible studies.Members of the public (parent carers of children with neurodisability) contributed to this review by suggesting the topic, refining the research objectives, interpreting the findings, and reviewing the plain language summary. We did not identify any randomised controlled trials that evaluated the effectiveness of sleep positioning systems on hip migration.We did find two randomised cross-over trials that met the inclusion criteria in respect of secondary objectives relating to sleep quality and pain. Neither study reported any important difference between sleeping in sleep positioning systems and not for sleep patterns or sleep quality (two studies, 21 children, very low quality evidence) and pain (one study, 11 children, very low quality evidence). These were small studies with established users of sleep positioning systems and were judged to have high risk of bias.We found no eligible trials that explored the other secondary objectives (number or frequency of hip problems, quality of life of the child and family, physical functioning, and adverse effects). We found no randomised trials that evaluated the effectiveness of sleep positioning systems to reduce or prevent hip migration in children with cerebral palsy. Nor did we find any randomised trials that evaluated the effect of sleep positioning systems on the number or frequency of hip problems, quality of life of the child and family or on physical functioning.Limited data from two randomised trials, which evaluated the effectiveness of sleep positioning systems on sleep quality and pain for children with cerebral palsy, showed no significant differences in these aspects of health when children were using and not using a sleep positioning system.In order to inform clinical decision-making and the prescription of sleep positioning systems, more rigorous research is needed to determine effectiveness, cost-effectiveness, and the likelihood of adverse effects.

Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

PubMed

Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

2017-05-26

A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

Interventions in the workplace to support breastfeeding for women in employment.

PubMed

Abdulwadud, Omar A; Snow, Mary Elizabeth

2012-10-17

In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and fellow employees, they might give up breastfeeding when they return to work. As a result, the duration and exclusivity of breastfeeding to the recommended age of the babies would be affected.Workplace environment can play a positive role to promote breastfeeding. For women going back to work, various types of workplace support interventions are available and this should not be ignored by employers. Notably, promoting breastfeeding in a workplace may have benefits for the women, the baby and also the employer. To assess the effectiveness of workplace interventions to support and promote breastfeeding among women returning to paid work after the birth of their children, and its impact on process outcomes pertinent to employees and employers. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (2 August 2012). Two authors independently assessed all identified studies for randomised controlled trials and quasi-randomised controlled trials that compared workplace interventions with no intervention or two or more workplace interventions against each other. Two authors planned to evaluate the methodological quality of the eligible trials and extract data. There were no randomised controlled trials or quasi-randomised controlled trials identified. No trials have evaluated the effectiveness of workplace interventions in promoting breastfeeding among women returning to paid work after the birth of their child. The impact of such intervention on process outcomes is also unknown. Randomised controlled trials are required to establish the benefits of various types of workplace interventions to support, encourage and promote breastfeeding among working mothers.

A randomised controlled trial of benefit finding in caregivers: The Building Resources in Caregivers Study Protocol

PubMed Central

Brand, Charles; O’Connell, Brenda H

2015-01-01

Caregivers may engage in benefit finding, that is, an increase in perceived positive growth, as a cognitive strategy for coping with stress. The Building Resources in Caregivers study will compare effects of a brief benefit finding writing intervention with a control intervention. Caregivers of people with mental and physical disabilities will be randomised into either a benefit-writing group or a neutral writing group. Caregivers will complete measures relating to themselves and care-recipients (e.g. sociodemographics and illness type) and psychometric measures of benefit finding, distress and quality of life at three time points. Additionally, qualitative commentary on participation experiences will be gathered. PMID:28070362

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

The effect of educational intervention on intercultural communication: results of a randomised controlled trial.

PubMed

Harmsen, Hans; Bernsen, Roos; Meeuwesen, Ludwien; Thomas, Siep; Dorrenboom, Govert; Pinto, David; Bruijnzeels, Marc

2005-05-01

Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. General practice in Rotterdam. Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.

Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j PMID:23298183

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

PubMed

Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

2016-09-08

One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation. Demonstrating the efficacy of vault and uterine prolapse surgeries is relevant not only to patients and clinicians but also to health care providers, both in the UK and globally. Current controlled trials ISRCTN86784244 (assigned 19 October 2012), and the first subject was randomly assigned on 1 May 2013.

The effects of a team-based continuous quality improvement intervention on the management of primary care: a randomised controlled trial

PubMed Central

Engels, Yvonne; van den Hombergh, Pieter; Mokkink, Henk; van den Hoogen, Henk; van den Bosch, Wil; Grol, Richard

2006-01-01

Aim To study the effects of a team-based model for continuous quality improvement (CQI) on primary care practice management. Design of study Randomised controlled trial. Setting Twenty-six intervention and 23 control primary care practices in the Netherlands. Method Practices interested in taking part in the CQI project were, after assessment of their practice organisation, randomly assigned to the intervention or control groups. During a total of five meetings, a facilitator helped the teams in the intervention group select suitable topics for quality improvement and follow a structured approach to achieve improvement objectives. Checklists completed by an outreach visitor, questionnaires for the GPs, staff and patients were used to assemble data on the number and quality of improvement activities undertaken and on practice management prior to the start of the intervention and 1 year later. Results Pre-test and post-test data were compared for the 26 intervention and 23 control practices. A significant intervention effect was found for the number of improvement objectives actually defined (93 versus 54, P<0.001) and successfully completed (80 versus 69% of the projects, P<0.001). The intervention group also improved on more aspects of practice management, as measured by our practice visit method, than the control group but none of these differences proved statistically significant. Conclusion The intervention exerted a significant effect on the number and quality of improvement projects undertaken and self-defined objectives met. Failure of the effects of the intervention on the other dimensions of practice management to achieve significance may be due to the topics selected for some of the improvement projects being only partly covered by the assessment instrument. PMID:17007709

Ethical considerations in placebo-controlled randomised clinical trials.

PubMed

Kaufman, Kenneth R

2015-06-01

Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al 's article 'Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials' and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent. None. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Do maternal pushing techniques during labour affect obstetric or neonatal outcomes?

PubMed

Barasinski, C; Lemery, D; Vendittelli, F

2016-10-01

To assess, through a literature review, the maternal and neonatal morbidity associated with the type of pushing used during the second stage of labour. We searched the Cochrane Library and the Medline database for randomised controlled trials from 1980 to 2015, using the following keywords: "delivery", "birth", "birthing", "bearing down, coached, uncoached, pushing", "second and stage and labour", "randomised controlled trials" and "meta-analysis". Seven randomised controlled trials were found. Interventions varied between the studies. In the intervention groups, open-glottis pushing was spontaneous or coached. The groups did not differ for perineal injuries, episiotomies or type of birth. Impact on pelvic floor structure varied between the studies. Only one study found a better 5-minute Apgar score and a better umbilical artery pH in the "open glottis" group. The low methodological quality of the studies and the differences between the protocols do not justify a recommendation of a particular pushing technique. Further studies appear necessary to study outcomes with each of these techniques. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand.

PubMed

Wilder-Smith, Annelies; Byass, Peter; Olanratmanee, Phanthip; Maskhao, Pongsri; Sringernyuang, Luechai; Logan, James G; Lindsay, Steve W; Banks, Sarah; Gubler, Duane; Louis, Valérie R; Tozan, Yesim; Kittayapong, Pattamaporn

2012-11-15

There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. clinicaltrial.gov. NCT01563640.

Vitex agnus-castus extracts for female reproductive disorders: a systematic review of clinical trials.

PubMed

van Die, M Diana; Burger, Henry G; Teede, Helena J; Bone, Kerry M

2013-05-01

Vitex agnus-castus L. (chaste tree; chasteberry) is a popular herbal treatment, predominantly used for a range of female reproductive conditions in Anglo-American and European practice. The objective of this systematic review was to evaluate the evidence for the efficacy and safety of Vitex extracts from randomised, controlled trials investigating women's health.Eight databases were searched using Latin and common names for Vitex and phytotherapeutic preparations of the herb as a sole agent, together with filters for randomised, controlled trials or clinical trials. Methodological quality was assessed according to the Cochrane risk of bias and Jadad scales, as well as the proposed elaboration of CONSORT for reporting trials on herbal interventions.Thirteen randomised, controlled trials were identified and twelve are included in this review, of which eight investigated premenstrual syndrome, two premenstrual dysphoric disorder, and two latent hyperprolactinaemia. For premenstrual syndrome, seven of eight trials found Vitex extracts to be superior to placebo (5 of 6 studies), pyridoxine (1), and magnesium oxide (1). In premenstrual dysphoric disorder, one study reported Vitex to be equivalent to fluoxetine, while in the other, fluoxetine outperformed Vitex. In latent hyperprolactinaemia, one trial reported it to be superior to placebo for reducing TRH-stimulated prolactin secretion, normalising a shortened luteal phase, increasing mid-luteal progesterone and 17β-oestradiol levels, while the other found Vitex comparable to bromocriptine for reducing serum prolactin levels and ameliorating cyclic mastalgia. Adverse events with Vitex were mild and generally infrequent. The methodological quality of the included studies varied, but was generally moderate-to-high. Limitations include small sample sizes in some studies, heterogeneity of conditions being treated, and a range of reference treatments.Despite some methodological limitations, the results from randomised, controlled trials to date suggest benefits for Vitex extracts in the treatment of premenstrual syndrome, premenstrual dysphoric disorder and latent hyperprolactinaemia. Further research is recommended, and greater transparency in reporting for future trials. Georg Thieme Verlag KG Stuttgart · New York.

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.

PubMed

Thornell, Anders; Angenete, Eva; Gonzales, Elisabeth; Heath, Jane; Jess, Per; Läckberg, Zoltan; Ovesen, Henrik; Rosenberg, Jacob; Skullman, Stefan; Haglind, Eva

2011-08-01

Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40). HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.

Randomised crossover trial of telemonitoring in chronic respiratory patients (TeleCRAFT trial)

PubMed Central

Chatwin, M; Hawkins, G; Panicchia, L; Woods, A; Hanak, A; Lucas, R; Baker, E; Ramhamdany, E; Mann, B; Riley, J; Cowie, M R; Simonds, A K

2016-01-01

Objective To assess the impact of home telemonitoring on health service use and quality of life in patients with severe chronic lung disease. Design Randomised crossover trial with 6 months of standard best practice clinical care (control group) and 6 months with the addition of telemonitoring. Participants 68 patients with chronic lung disease (38 with COPD; 30 with chronic respiratory failure due to other causes), who had a hospital admission for an exacerbation within 6 months of randomisation and either used long-term oxygen therapy or had an arterial oxygen saturation (SpO2) of <90% on air during the previous admission. Individuals received telemonitoring (second-generation system) via broadband link to a hospital-based care team. Outcome measures Primary outcome measure was time to first hospital admission for an acute exacerbation. Secondary outcome measures were hospital admissions, general practitioner (GP) consultations and home visits by nurses, quality of life measured by EuroQol-5D and hospital anxiety and depression (HAD) scale, and self-efficacy score (Stanford). Results Median (IQR) number of days to first admission showed no difference between the two groups—77 (114) telemonitoring, 77.5 (61) control (p=0.189). Hospital admission rate at 6 months increased (0.63 telemonitoring vs 0.32 control p=0.026). Home visits increased during telemonitoring; GP consultations were unchanged. Self-efficacy fell, while HAD depression score improved marginally during telemonitoring. Conclusions Telemonitoring added to standard care did not alter time to next acute hospital admission, increased hospital admissions and home visits overall, and did not improve quality of life in chronic respiratory patients. Trial registration number NCT02180919 (ClinicalTrials.gov). PMID:26962013

Improving Quality of the Child Care Environment through a Consultancy Programme for Centre Directors

ERIC Educational Resources Information Center

Helmerhorst, Katrien O. W.; Fukkink, Ruben G.; Riksen-Walraven, J. Marianne A.; Gevers Deynoot-Schaub, Mirjam J. J. M.; Tavecchio, Louis W. C.

2017-01-01

This study examined the effects of a newly developed on-site consultancy programme to improve global quality of the child care environment in non-parental child care centres for 0- to 4-year-old children as measured with the ITERS-R/ECERS-R. Using a randomised controlled trial with a pretest, posttest, and follow-up test, we compared 35…

Improving Diabetes care through Examining, Advising, and prescribing (IDEA): protocol for a theory-based cluster randomised controlled trial of a multiple behaviour change intervention aimed at primary healthcare professionals

PubMed Central

2014-01-01

Background New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type 2 diabetes, likely requiring them to change multiple different clinical behaviours. The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing, advising, and examining consistent with high-quality diabetes care. Aim To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type 2 diabetes. Design/methods We will conduct a two-armed cluster randomised controlled trial in 44 general practices in the North East of England to evaluate a theory-based behaviour change intervention. We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type 2 diabetes: prescribing for hypertension; prescribing for glycaemic control; providing physical activity advice; providing nutrition advice; providing on-going education; and ensuring that feet have been examined. The primary outcome will be the proportion of patients appropriately prescribed and examined (using anonymised computer records), and advised (using anonymous patient surveys) at 12 months. We will use behaviour change techniques targeting motivational, volitional, and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type 2 diabetes care. We will also investigate whether the intervention was delivered as designed (fidelity) by coding audiotaped workshops and interventionist delivery reports, and operated as hypothesised (process evaluation) by analysing responses to theory-based postal questionnaires. In addition, we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation, and a post-trial economic analysis to estimate the costs of the intervention and cost of service use. Discussion Consistent with UK Medical Research Council guidance and building on previous development research, this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care. Trial registration ISRCTN66498413. PMID:24886606

Have CONSORT guidelines improved the quality of reporting of randomised controlled trials published in public health dentistry journals?

PubMed

Savithra, Prakash; Nagesh, Lakshminarayan Shetty

2013-01-01

To assess a) whether the quality of reporting of randomised controlled trials (RCTs) has improved since the formulation of the Consolidated Standards of Reporting Trials (CONSORT) statement and b) whether there is any difference in reporting of RCTs between the selected public health dentistry journals. A hand search of the journals of public health dentistry was performed and four journals were identified for the study. They were Community Dentistry and Oral Epidemiology (CDOE), Community Dental Health (CDH), Journal of Public Health Dentistry (JPHD) and Oral Health and Preventive Dentistry (OHPD). A total of 114 RCTs published between 1990 and 2009 were selected. CONSORT guidelines were applied to each selected article in order to assess and determine any improvement since the publication of CONSORT guidelines. The chi-square test was employed to determine any statistical significant difference in quality of reporting of RCTs before and after the publication of the CONSORT guidelines. A comparison was also done to determine any statistically significant difference in quality of reporting of RCTs between the selected journals. Title, abstract, discussion and conclusion sections of the selected articles showed adherence to the CONSORT guidelines, whereas the compliance was poor with respect to the methodology section. The quality of reporting of RCTs is generally poor in public health dentistry journals. Overall, the quality of reporting has not substantially improved since the publication of CONSORT guidelines.

Effectiveness and cost-effectiveness of admissions to women's crisis houses compared with traditional psychiatric wards: pilot patient-preference randomised controlled trial.

PubMed

Howard, L; Flach, C; Leese, M; Byford, S; Killaspy, H; Cole, L; Lawlor, C; Betts, J; Sharac, J; Cutting, P; McNicholas, S; Johnson, S

2010-08-01

Women's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards. To examine the effectiveness and cost-effectiveness of women's crisis houses by first examining the feasibility of a pilot patient-preference randomised controlled trial (PP-RCT) design (ISRCTN20804014). We used a PP-RCT study design to investigate women presenting in crisis needing informal admission. The four study arms were the patient preference arms of women's crisis house or hospital admission, and randomised arms of women's crisis house or hospital admission. Forty-one women entered the randomised arms of the trial (crisis house n = 19, wards n = 22) and 61 entered the patient-preference arms (crisis house n = 37, ward n = 24). There was no significant difference in outcomes (symptoms, functioning, perceived coercion, stigma, unmet needs or quality of life) or costs for any of the groups (randomised or preference arms), but women who obtained their preferred intervention were more satisfied with treatment. Although the sample sizes were too small to allow definite conclusions, the results suggest that when services are able to provide interventions preferred by patients, those patients are more likely to be satisfied with treatment. This pilot study provides some evidence that women's crisis houses are as effective as traditional psychiatric wards, and may be more cost-effective.

A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong.

PubMed

Tiwari, A; Leung, W C; Leung, T W; Humphreys, J; Parker, B; Ho, P C

2005-09-01

To evaluate the effectiveness of an empowerment intervention in reducing intimate partner violence (IPV) and improving health status. Randomised controlled trial. Antenatal clinic in a public hospital in Hong Kong. One hundred and ten Chinese pregnant women with a history of abuse by their intimate partners. Women were randomised to the experimental or control group. Experimental group women received empowerment training specially designed for Chinese abused pregnant women while the control group women received standard care for abused women. Data were collected at study entry and six weeks postnatal. IPV [on the Conflict Tactics Scale (CTS)], health-related quality of life (SF-36) and postnatal depression [Edinburgh Postnatal Depression Scale (EPDS)]. Following the training, the experimental group had significantly higher physical functioning and had significantly improved role limitation due to physical problems and emotional problems. They also reported less psychological (but not sexual) abuse, minor (but not severe) physical violence and had significantly lower postnatal depression scores. However, they reported more bodily pain. An empowerment intervention specially designed for Chinese abused pregnant women was effective in reducing IPV and improving the health status of the women.

Planned hospital birth versus planned home birth

PubMed Central

Olsen, Ole; Clausen, Jette A

2014-01-01

Background Observational studies of increasingly better quality and in different settings suggest that planned home birth in many places can be as safe as planned hospital birth and with less intervention and fewer complications. This is an update of a Cochrane review first published in 1998. Objectives To assess the effects of planned hospital birth compared with planned home birth in selected low-risk women, assisted by an experienced midwife with collaborative medical back up in case transfer should be necessary. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 March 2012) and contacted editors and authors involved with possible trials. Selection criteria Randomised controlled trials comparing planned hospital birth with planned home birth in low-risk women as described in the objectives. Data collection and analysis The two review authors as independently as possible assessed trial quality and extracted data. We contacted study authors for additional information. Main results Two trials met the inclusion criteria but only one trial involving 11 women provided some outcome data and was included. The evidence from this trial was of moderate quality and too small to allow conclusions to be drawn. Authors’ conclusions There is no strong evidence from randomised trials to favour either planned hospital birth or planned home birth for low-risk pregnant women. However, the trials show that women living in areas where they are not well informed about home birth may welcome ethically well-designed trials that would ensure an informed choice. As the quality of evidence in favour of home birth from observational studies seems to be steadily increasing, it might be as important to prepare a regularly updated systematic review including observational studies as described in the Cochrane Handbook for Systematic Reviews of Interventions as to attempt to set up new randomised controlled trials. PMID:22972043

Effects of a hospital-based education programme on self-care behaviour, care dependency and quality of life in patients with heart failure--a randomised controlled trial.

PubMed

Köberich, Stefan; Lohrmann, Christa; Mittag, Oskar; Dassen, Theo

2015-06-01

To evaluate the effects of a nurse-led, hospital-based heart failure specific education session with a three-month telephone follow-up on self-care behaviour, care dependency and quality of life for patients with chronic heart failure. Patient education in patients with heart failure is able to promote heart failure-specific self-care, to reduce mortality, morbidity and rehospitalisation rates and to enhance quality of life, especially if heart failure education is embedded in a multidisciplinary approach. Evidence of the effect of a nurse-led self-care education, quality of life and care dependency in addition to standard medical treatment in Germany is lacking. Nonblinded, prospective, single-centre, randomised controlled trial. Sixty-four patients were allocated either to the intervention group or to the control group. Patients in the intervention group received education about heart failure self-care with a consecutive telephone follow-up over three months in addition to standard medical treatment. Patients in the control group received standard medical treatment only. Data of 110 patients (58 in the intervention group and 52 in the control group) with a mean age of 62 years and mean left ventricular ejection fraction of 28·2% could be analysed. Self-care education had a significant influence on overall heart failure self-care but not on quality of life and care dependency. A single education session with a consecutive telephone follow-up is able to improve overall self-care behaviours but not quality of life. Care dependency was not influenced by the education session. The easy to implement and short educational intervention has a positive effect on self-care behaviour for patients with heart failure. However, there was no effect on quality of life and care dependency. To improve quality of life and to influence care dependency, different measures have to be applied. © 2015 John Wiley & Sons Ltd.

Providing activity for people with dementia in care homes: a cluster randomised controlled trial.

PubMed

Wenborn, Jennifer; Challis, David; Head, Jenny; Miranda-Castillo, Claudia; Popham, Carolyn; Thakur, Ruchi; Illes, Jacqueline; Orrell, Martin

2013-12-01

Activity levels remain low in care homes, but activity engagement can enhance residents' quality of life. This study aimed to assess an occupational therapy programme designed to enable care home staff to increase activity provision. A cluster randomised controlled trial with blinded assessment of outcome was conducted. A total of 210 residents with dementia in 16 care homes were recruited. Intervention homes received the programme, and control homes were provided usual care. Primary outcome is quality of life; secondary measures are dependency, challenging behaviour, depression, anxiety, severity of dementia and number and type of medication. Quality of life decreased overall with statistically significant change in staff ratings (p < 0.001). At follow-up, staff-rated quality of life was slightly lower in the intervention group (mean difference in staff ratings = -1.91, 95% CI -3.39 to -0.43, p = 0.01). There were no significant differences between the two groups for self-rated quality of life or secondary outcomes. The results may be related to the following: wide variability in how the intervention was implemented, such as low staff attendance at the education and coaching sessions, and patchy provision of additional activities to residents; or the residents' severity of dementia or the choice of outcome measures. Future studies need to pay more attention to process measures such as implementation and fidelity strategies, and outcome measures that better capture the focus of the intervention such as level of engagement and activity. Copyright © 2013 John Wiley & Sons, Ltd.

Momordica charantia for type 2 diabetes mellitus.

PubMed

Ooi, Cheow Peng; Yassin, Zaitun; Hamid, Tengku-Aizan

2012-08-15

Momordica charantia (bitter gourd) is not only a nutritious vegetable but it is also used in traditional medical practices to treat type 2 diabetes mellitus. Experimental studies with animals and humans suggested that the vegetable has a possible role in glycaemic control. To assess the effects of mormodica charantia for type 2 diabetes mellitus. Several electronic databases were searched, among these were The Cochrane Library (Issue 1, 2012), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to February 2012), combined with handsearches. No language restriction was used. We included randomised controlled trials (RCTs) that compared momordica charantia with placebo or a control intervention, with or without pharmacological or non-pharmacological interventions. Two authors independently extracted data. Risk of bias of the trials was evaluated using the parameters of randomisation, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias. A meta-analysis was not performed given the quality of data and the variability of preparations of momordica charantia used in the interventions (no similar preparation was tested twice). Four randomised controlled trials with up to three months duration and investigating 479 participants met the inclusion criteria. Risk of bias of these trials (only two studies were published as a full peer-reviewed publication) was generally high. Two RCTs compared the effects of preparations from different parts of the momordica charantia plant with placebo on glycaemic control in type 2 diabetes mellitus. There was no statistically significant difference in the glycaemic control with momordica charantia preparations compared to placebo. When momordica charantia was compared to metformin or glibenclamide, there was also no significant change in reliable parameters of glycaemic control. No serious adverse effects were reported in any trial. No trial investigated death from any cause, morbidity, health-related quality of life or costs. There is insufficient evidence on the effects of momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.

Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial.

PubMed

Vervoort, Ajmw; van der Voet, L F; Hehenkamp, Wjk; Thurkow, A L; van Kesteren, Pjm; Quartero, H; Kuchenbecker, W; Bongers, M; Geomini, P; de Vleeschouwer, Lhm; van Hooff, Mha; van Vliet, H; Veersema, S; Renes, W B; Oude Rengerink, K; Zwolsman, S E; Brölmann, Ham; Mol, Bwj; Huirne, Jaf

2018-02-01

To compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Multicentre randomised controlled trial. Eleven hospitals collaborating in a consortium for women's health research in the Netherlands. Women reporting postmenstrual spotting after a caesarean section who had a niche with a residual myometrium of ≥3 mm, measured during sonohysterography. Women were randomly allocated to hysteroscopic niche resection or expectant management for 6 months. The primary outcome was the number of days of postmenstrual spotting 6 months after randomisation. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, surgical parameters, quality of life, women's satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, except for niche measurements, also at 6 months after randomisation. We randomised 52 women to hysteroscopic niche resection and 51 women to expectant management. The median number of days of postmenstrual spotting at baseline was 8 days in both groups. At 6 months after randomisation, the median number of days of postmenstrual spotting was 4 days (interquartile range, IQR 2-7 days) in the intervention group and 7 days (IQR 3-10 days) in the control group (P = 0.04); on a scale of 0-10, discomfort as a result of spotting had a median score of 2 (IQR 0-7) in the intervention group, compared with 7 (IQR 0-8) in the control group (P = 0.02). In women with a niche with a residual myometrium of ≥3 mm, hysteroscopic niche resection reduced postmenstrual spotting and spotting-related discomfort. A hysteroscopic niche resection is an effective treatment to reduce niche-related spotting. © 2017 The Authors. BJOG An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.

Exercise for depression in care home residents: a randomised controlled trial with cost-effectiveness analysis (OPERA).

PubMed

Underwood, M; Lamb, S E; Eldridge, S; Sheehan, B; Slowther, A; Spencer, A; Thorogood, M; Atherton, N; Bremner, S A; Devine, A; Diaz-Ordaz, K; Ellard, D R; Potter, R; Spanjers, K; Taylor, S J C

2013-05-01

Many older people living in care homes (long term residential care or nursing homes) are depressed. Exercise is a promising non-drug intervention for preventing and treating depression in this population. To evaluate the impact of a 'whole-home' intervention, consisting of training for residential and nursing home staff backed up with a twice-weekly, physiotherapist-led exercise class on depressive symptoms in care home residents. A cluster randomised controlled trial with a cost-effectiveness analysis to compare (1) the prevalence of depression in intervention homes with that in control homes in all residents contributing data 12 months after homes were randomised (cross-sectional analysis); (2) the number of depressive symptoms at 6 months between intervention and control homes in residents who were depressed at pre-randomisation baseline assessment (depressed cohort comparison); and (3) the number of depressive symptoms at 12 months between intervention and control homes in all residents who were present at pre-randomisation baseline assessment (cohort comparison). Seventy-eight care homes in Coventry and Warwickshire and north-east London. Care home residents aged ≥ 65 years. Control intervention: Depression awareness training programme for care home staff. Active intervention: A 'whole-home' exercise intervention, consisting of training for care home staff backed up with a twice-weekly, physiotherapist-led exercise group. Geriatric Depression Scale-15, proxy European Quality of Life-5 Dimensions (EQ-5D), cost-effectiveness from an National Health Service perspective, peripheral fractures and death. We recruited a total of 1054 participants. Cross-sectional analysis: We obtained 595 Geriatric Depression Scale-15 scores and 724 proxy EQ-5D scores. For the cohort analyses we obtained 765 baseline Geriatric Depression Scale-15 scores and 776 proxy EQ-5D scores. Of the 781 who we assessed prior to randomisation, 765 provided a Geriatric Depression Scale-15 score. Of these 374 (49%) were depressed and constitute our depressed cohort. Resource-use and quality-adjusted life-year data, based on proxy EQ-5D, were available for 798 residents recruited prior to randomisation. We delivered 3191 group exercise sessions with 31,705 person attendances and an average group size of 10 (5.3 study participants and 4.6 non-study participants). On average, our participants attended around half of the possible sessions. No serious adverse events occurred during the group exercise sessions. In the cross-sectional analysis the odds for being depressed were 0.76 [95% confidence interval (CI) 0.53 to 1.09] lower in the intervention group at 12 months. The point estimates for benefit for both the cohort analysis (0.13, 95% CI -0.33 to 0.60) and depressed cohort (0.22, 95% CI -0.52 to 0.95) favoured the control intervention. There was no evidence of differences in fracture rates or mortality (odds ratio 1.07, 95% CI 0.79 to 1.48) between the two groups. There was no evidence of differences in the other outcomes between the two groups. Economic analysis: The additional National Health Service cost of the OPERA intervention was £374 per participant (95% CI -£655 to £1404); the mean difference in quality-adjusted life-year was -0.0014 (95% CI -0.0728 to 0.0699). The active intervention was thus dominated by the control intervention, which was more effective and less costly. The results do not support the use of a whole-home physical activity and moderate-intensity exercise programme to reduce depression in care home residents. Current Controlled Trials ISRCTN43769277. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 18. See the Health Technology Assessment programme website for further project information.

Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial.

PubMed

Yates, Rachel; Edwards, Katie; King, John; Luzon, Olga; Evangeli, Michael; Stark, Daniel; McFarlane, Fiona; Heyman, Isobel; İnce, Başak; Kodric, Jana; Murphy, Tara

2016-05-01

Quality of life of children with Tourette Syndrome (TS) is impacted greatly by its symptoms and their social consequences. Habit Reversal Training (HRT) is effective but has not, until now, been empirically evaluated in groups. This randomised controlled trial evaluated feasibility and preliminary efficacy of eight HRT group sessions compared to eight Education group sessions. Thirty-three children aged 9-13 years with TS or Chronic Tic Disorder took part. Outcomes evaluated were tic severity and quality of life (QoL). Tic severity improvements were found in both groups. Motor tic severity (Yale Global Tic Severity Scale) showed greatest improvements in the HRT group. Both groups showed a strong tendency toward improvements in patient reported QoL. In conclusion, group-based treatments for TS are feasible and exposure to other children with tics did not increase tic expression. HRT led to greater reductions in tic severity than Education. Implications, such as cost-effectiveness of treatment delivery, are discussed. Copyright © 2016. Published by Elsevier Ltd.

The ‘Cancer Home-Life Intervention’: A randomised controlled trial evaluating the efficacy of an occupational therapy–based intervention in people with advanced cancer

PubMed Central

la Cour, Karen; Gregersen Oestergaard, Lisa; Johnsen, Anna Thit; Lindahl-Jacobsen, Line; Højris, Inger; Brandt, Åse

2018-01-01

Background: People with advanced cancer face difficulties with their everyday activities at home that may reduce their health-related quality of life. To address these difficulties, we developed the ‘Cancer Home-Life Intervention’. Aim: To evaluate the efficacy of the ‘Cancer Home Life-Intervention’ compared with usual care with regard to patients’ performance of, and participation in, everyday activities, and their health-related quality of life. Design and intervention: A randomised controlled trial (ClinicalTrials.gov NCT02356627). The ‘Cancer Home-Life Intervention’ is a brief, tailored, occupational therapy–based and adaptive programme for people with advanced cancer targeting the performance of their prioritised everyday activities. Setting/participants: Home-living adults diagnosed with advanced cancer experiencing functional limitations were recruited from two Danish hospitals. They were assessed at baseline, and at 6 and 12 weeks of follow-up. The primary outcome was activities of daily living motor ability. Secondary outcomes were activities of daily living process ability, difficulty performing prioritised everyday activities, participation restrictions and health-related quality of life. Results: A total of 242 participants were randomised either to the intervention group (n = 121) or the control group (n = 121). No effect was found on the primary outcome (between-group mean change: −0.04 logits (95% confidence interval: −0.23 to 0.15); p = 0.69). Nor was any effect on the secondary outcomes observed. Conclusion: In most cases, the ‘Cancer Home-Life Intervention’ was delivered through only one home visit and one follow-up telephone contact, which not was effective in maintaining or improving participants’ everyday activities and health-related quality of life. Future research should pay even more attention to intervention development and feasibility testing. PMID:29299957

Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

PubMed

Jull, Andrew; Aye, Phyu Sin

2015-06-01

To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively). Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Inspiratory muscle training to enhance recovery from mechanical ventilation: a randomised trial.

PubMed

Bissett, Bernie M; Leditschke, I Anne; Neeman, Teresa; Boots, Robert; Paratz, Jennifer

2016-09-01

In patients who have been mechanically ventilated, inspiratory muscles remain weak and fatigable following ventilatory weaning, which may contribute to dyspnoea and limited functional recovery. Inspiratory muscle training may improve inspiratory muscle strength and endurance following weaning, potentially improving dyspnoea and quality of life in this patient group. We conducted a randomised trial with assessor-blinding and intention-to-treat analysis. Following 48 hours of successful weaning, 70 participants (mechanically ventilated ≥7 days) were randomised to receive inspiratory muscle training once daily 5 days/week for 2 weeks in addition to usual care, or usual care (control). Primary endpoints were inspiratory muscle strength and fatigue resistance index (FRI) 2 weeks following enrolment. Secondary endpoints included dyspnoea, physical function and quality of life, post-intensive care length of stay and in-hospital mortality. 34 participants were randomly allocated to the training group and 36 to control. The training group demonstrated greater improvements in inspiratory strength (training: 17%, control: 6%, mean difference: 11%, p=0.02). There were no statistically significant differences in FRI (0.03 vs 0.02, p=0.81), physical function (0.25 vs 0.25, p=0.97) or dyspnoea (-0.5 vs 0.2, p=0.22). Improvement in quality of life was greater in the training group (14% vs 2%, mean difference 12%, p=0.03). In-hospital mortality was higher in the training group (4 vs 0, 12% vs 0%, p=0.051). Inspiratory muscle training following successful weaning increases inspiratory muscle strength and quality of life, but we cannot confidently rule out an associated increased risk of in-hospital mortality. ACTRN12610001089022, results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Herbal medicines for advanced colorectal cancer.

PubMed

Guo, Zhongning; Jia, Xiaoqiang; Liu, Jian Ping; Liao, Juan; Yang, Yufei

2012-05-16

Herbal medicine has been widely used in patients with advanced colorectal cancer in China, but its efficacy has not been confirmed. To evaluate the beneficial effect and safety on Chinese herbal medicine therapy for advanced stage colorectal cancer, and it's influence on the patients' quality of life. The following electronic databases were searched: BIOSIS Previews, Cochrane Controlled Trials Register, Medline EMBASE, Biological Abstracts, until Aug. 2011. Manual searching was performed on 16 types of Chinese journals which started from their respective first publication dates, as well as unpublished conference proceedings. No language restriction was applied. Randomized or quasi-randomised controlled trials on the treatment of advanced stage colorectal cancer by herbal medicines or herbal medicines combined with chemotherapy, regardless of blinding. The data were extracted independently by two reviewers. Methodological quality of the included in trials was assessed according to the following parameters: randomisation, allocation concealment, double blinding, and drop-out rates. A total of 20 randomised controlled trials with 1304 participants were identified. All the 20 trials compared the use of herbal medicines with chemotherapy and chemotherapy alone in the treatment of advanced stage colorectal cancers.Compared with chemotherapy alone, the use of Quxie capsule combined with chemotherapy could decrease mortality rate (RR 0.17, 95% CI 0.03 to 0.97); the use of Jianpi Jiedu formula, Xiaozheng formula and Yiqi Huoxue herbal medicine combined with chemotherapy respectively could improve 1-year survival rate significantly; the use of Xiaozheng Formula in conjunction with chemotherapy could improve 3-year survival rate. There were 10 herbal medicines showing benefit in improving quality of life. Herbal medicines did not show additional benefit in response rate or stability rate. No trials reported serious adverse effect from herbal medicine. Some herbal medicines combined chemotherapy compared with chemotherapy alone showed more beneficial effects in improving 1-year, 3-year survival and quality of life.

Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

PubMed Central

2011-01-01

Background Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. Methods/design In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. Conclusion The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. Trial Registration Number Netherlands Trial Register (NTR): NTR2579 PMID:21410949

Fidelity considerations in translational research: Eating As Treatment - a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy.

PubMed

Beck, Alison Kate; Baker, Amanda; Britton, Ben; Wratten, Chris; Bauer, Judith; Wolfenden, Luke; Carter, Gregory

2015-10-15

The confidence with which researchers can comment on intervention efficacy relies on evaluation and consideration of intervention fidelity. Accordingly, there have been calls to increase the transparency with which fidelity methodology is reported. Despite this, consideration and/or reporting of fidelity methods remains poor. We seek to address this gap by describing the methodology for promoting and facilitating the evaluation of intervention fidelity in The EAT (Eating As Treatment) project: a multi-site stepped wedge randomised controlled trial of a dietitian delivered behaviour change counselling intervention to improve nutrition (primary outcome) in head and neck cancer patients undergoing radiotherapy. In accordance with recommendations from the National Institutes of Health Behaviour Change Consortium Treatment Fidelity Workgroup, we sought to maximise fidelity in this stepped wedge randomised controlled trial via strategies implemented from study design through to provider training, intervention delivery and receipt. As the EAT intervention is designed to be incorporated into standard dietetic consultations, we also address unique challenges for translational research. We offer a strong model for improving the quality of translational findings via real world application of National Institutes of Health Behaviour Change Consortium recommendations. Greater transparency in the reporting of behaviour change research is an important step in improving the progress and quality of behaviour change research. ACTRN12613000320752 (Date of registration 21 March 2013).

A cluster randomised controlled trial of a staff-training intervention in residential units for people with long-term mental illness in Portugal: the PromQual trial.

PubMed

Cardoso, Graça; Papoila, Ana; Tomé, Gina; Killaspy, Helen; King, Michael; Caldas-de-Almeida, José Miguel

2017-11-01

This study aimed to assess the efficacy of a staff-training intervention to improve service users' engagement in activities and quality of care, by means of a cluster randomised controlled trial. All residential units with at least 12-h a day staff support (n = 23) were invited to participate. Quality of care was assessed with the Quality Indicator for Rehabilitative Care (QuIRC) filled online by the unit's manager. Half the units (n = 12) were randomly assigned to continue providing treatment as usual, and half (n = 11) received a staff-training intervention that focused on skills for engaging service users in activities, with trainers working alongside staff to embed this learning in the service. The primary outcome was service users' level of activity (measured with the Time Use Diary), reassessed at 4 and 8 months. Secondary outcomes were the quality of care provided (QuIRC), and service users' quality of life (Manchester Short Assessment of Quality of Life) reassessed at 8 months. Generalized linear mixed effect models were used to assess the difference in outcomes between units in the two trial arms. The trial was registered with Current Controlled Trials (Ref NCT02366117). Knowledge acquired by the staff during the initial workshops increased significantly (p ≤ 0.01). However, the intervention and comparison units did not differ significantly in primary and secondary outcomes at either follow-up. The intervention increased the level of knowledge of staff without leading to an improvement in service users' engagement in activities, quality of life, or quality of care in the units.

A caregiver educational program improves quality of life and burden for cancer patients and their caregivers: a randomised clinical trial.

PubMed

Belgacem, Bénédicte; Auclair, Candy; Fedor, Marie-Christine; Brugnon, David; Blanquet, Marie; Tournilhac, Olivier; Gerbaud, Laurent

2013-12-01

The French setting, including laws and guidelines, advocates greater involvement of informal caregivers in the care of cancer patients to protect the caregivers from depression, distress, and a decrease in their quality of life. This study aimed to assess the efficacy of a caregiver educational programme by measuring two outcomes: patients' and caregivers' quality of life and caregivers' burden. A multicentre randomised controlled trial was performed in six oncology wards in French hospitals. Eligible patients had a cancer, a main caregiver, allowed their caregivers' involvement, and received an inclusion agreement by a doctor/psychologist dyad. The experimental group participated in an educational programme performed by nurses to improve their skills in meal support, nursing care, welfare care, or symptom management. The SF36 and the Zarit burden scales were used to measure quality of life and caregivers' burden at the beginning and at the end of the study. 67 patients were randomised and 33 were included in the experimental group. Evolution scores, which measured the difference between baseline and final scores, showed an improvement in patients' and caregivers' quality of life and an alleviated burden for experimental group caregivers. An educational programme for caregivers encourages the involvement of patients, informal caregivers and health-care providers in a triangular relationship which enhances the quality of life of patients and caregivers alike and decreases caregivers' burden. Care organisation should therefore be rethought as a triangular relationship between patients, caregivers and health-care providers, with nurses as the mainstay. Copyright © 2013 Elsevier Ltd. All rights reserved.

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

PubMed

Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J

2017-01-01

Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.

Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial)

PubMed Central

Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E.; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E.; McIntosh, Caroline; Menz, Hylton B.; Redmond, Anthony C.; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith

2017-01-01

Background Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Design Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. Results In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. Conclusion There was a small reduction in falls. The intervention may be cost-effective. Trial Registration ISRCTN ISRCTN68240461 PMID:28107372

Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study).

PubMed

Skou, Soren T; Roos, Ewa M; Laursen, Mogens B; Rathleff, Michael S; Arendt-Nielsen, Lars; Simonsen, Ole H; Rasmussen, Sten

2012-05-09

There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain. The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0-100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)(4) defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength. This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA. Clinicaltrials.gov reference: NCT01410409.

Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study)

PubMed Central

2012-01-01

Background There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain. Methods/Design The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0–100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)4 defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength. Discussion This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA. Trial registration Clinicaltrials.gov reference: NCT01410409 PMID:22571284

RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial.

PubMed

Jopson, Laura; Newton, Julia L; Palmer, Jeremy; Floudas, Achilleas; Isaacs, John; Qian, Jessica; Wilkinson, Jennifer; Trenell, Mike; Blamire, Andrew; Howel, Denise; Jones, David E

2015-08-20

Primary biliary cirrhosis (PBC) is an autoimmune liver disease with approximately 50% of patients experiencing fatigue. This can be a particularly debilitating symptom, affecting quality of life and resulting in social isolation. Fatigue is highlighted by patients as a priority for research and patient support groups were involved in designing this trial. This is the first randomised controlled trial to investigate a treatment for fatigue in PBC. The trial protocol is innovative as it utilises novel magnetic resonance spectroscopy (MRS) techniques as an outcome measure. The protocol will be valuable to research groups planning clinical trials targeting fatigue in PBC and also transferrable to other conditions associated with fatigue. RITPBC is a Medical Research Council (MRC) and National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (EME)-funded project. It is a phase II, single-centre, randomised controlled, double-blinded trial comparing rituximab with placebo in fatigued PBC patients. 78 patients with PBC and moderate to severe fatigue will be randomised to receive two infusions of rituximab or placebo. The study aims to assess whether rituximab improves fatigue in patients with PBC, the safety, and tolerability of rituximab in PBC and the sustainability of any beneficial actions. The primary outcome will be an improvement in fatigue domain score of the PBC-40, a disease-specific quality of life measure, evaluated at 12-week assessment. Secondary outcome measures include novel MRS techniques assessing muscle bioenergetic function, physical activity, anaerobic threshold and symptom, and quality of life measures. The trial started recruiting in October 2012 and recruitment is ongoing. The trial has ethical approval from the NRES Committee North East, has Clinical Trial Authorisation from MHRA and local R&D approval. Trial results will be communicated to participants, presented at national and international meetings and published in peer-reviewed journals. ISRCTN03978701. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial.

PubMed

Muth, Christiane; Uhlmann, Lorenz; Haefeli, Walter E; Rochon, Justine; van den Akker, Marjan; Perera, Rafael; Güthlin, Corina; Beyer, Martin; Oswald, Frank; Valderas, Jose Maria; Knottnerus, J André; Gerlach, Ferdinand M; Harder, Sebastian

2018-02-24

Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice. Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation. 72 general practices in Hesse, Germany. 505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study. Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care. The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months' follow-up: quality of life, functioning, medication adherence, and so on. At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence). The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement. ISRCTN99526053. NCT01171339; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma

PubMed Central

Ma, Jun; Strub, Peg; Lv, Nan; Xiao, Lan; Camargo, Carlos A.; Buist, A. Sonia; Lavori, Philip W.; Wilson, Sandra R.; Nadeau, Kari C.; Rosas, Lisa G.

2016-01-01

Rigorous research on the benefit of healthy eating patterns for asthma control is lacking. We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores <6 out of 9) to a 6-month DASH behavioural intervention (n=46) or usual-care control (n=44). Intention-to-treat analyses used repeated-measures mixed models. Participants were middle-aged, 67% female and multiethnic. Compared with controls, intervention participants improved on DASH scores (mean change (95% CI) 0.6 (0, 1.1) versus −0.3 (−0.8, 0.2); difference 0.8 (0.2, 1.5)) and the primary outcome, Asthma Control Questionnaire scores (−0.2 (−0.5, 0) versus 0 (−0.3, 0.3); difference −0.2 (−0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (−0.1, 1.0), emotions 0.4 (−0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant. The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted. PMID:26493792

Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial.

PubMed

Johnson, Stephanie; Clayton, Josephine; Butow, Phyllis N; Silvester, William; Detering, Karen; Hall, Jane; Kiely, Belinda E; Cebon, Jonathon; Clarke, Stephen; Bell, Melanie L; Stockler, Martin; Beale, Phillip; Tattersall, Martin H N

2016-12-01

There is limited evidence documenting the effectiveness of Advance Care Planning (ACP) in cancer care. The present randomised trial is designed to evaluate whether the administration of formal ACP improves compliance with patients' end-of-life (EOL) wishes and patient and family satisfaction with care. A randomised control trial in eight oncology centres across New South Wales and Victoria, Australia, is designed to assess the efficacy of a formal ACP intervention for patients with cancer. Patients with incurable cancer and an expected survival of 3-12 months, plus a nominated family member or friend will be randomised to receive either standard care or standard care plus a formal ACP intervention. The project sample size is 210 patient-family/friend dyads. The primary outcome measure is family/friend-reported: (1) discussion with the patient about their EOL wishes and (2) perception that the patient's EOL wishes were met. Secondary outcome measures include: documentation of and compliance with patient preferences for medical intervention at the EOL; the family/friend's perception of the quality of the patient's EOL care; the impact of death on surviving family; patient-family and patient-healthcare provider communication about EOL care; patient and family/friend satisfaction with care; quality of life of patient and family/friend subsequent to trial entry, the patient's strength of preferences for quality of life and length of life; the costs of care subsequent to trial entry and place of death. Ethical approval was received from the Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064). Study results will be submitted for publication in peer-reviewed journals and presented at national and international conferences. Pre-results; ACTRN12613001288718. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

PubMed Central

2011-01-01

Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery. Trial registration Current Controlled Trials ISRCTN82127540 PMID:21854596

Specialist teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality.

PubMed

Chang, Alvin S M; Berry, Andrew; Jones, Lisa J; Sivasangari, Subramaniam

2015-10-28

Maternal antenatal transfers provide better neonatal outcomes. However, there will inevitably be some infants who require acute transport to a neonatal intensive care unit (NICU). Because of this, many institutions develop services to provide neonatal transport by specially trained health personnel. However, few studies report on relevant clinical outcomes in infants requiring transport to NICU. To determine the effects of specialist transport teams compared with non-specialist transport teams on the risk of neonatal mortality and morbidity among high-risk newborn infants requiring transport to neonatal intensive care. We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), MEDLINE (1966 to 31 July 2015), EMBASE (1980 to 31 July 2015), CINAHL (1982 to 31 July 2015), conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. randomised, quasi-randomised or cluster randomised controlled trials. neonates requiring transport to a neonatal intensive care unit. transport by a specialist team compared to a non-specialist team. any of the following outcomes - death; adverse events during transport leading to respiratory compromise; and condition on admission to the neonatal intensive care unit. The methodological quality of the trials was assessed using the information provided in the studies and by personal communication with the author. Data on relevant outcomes were extracted and the effect size estimated and reported as risk ratio (RR), risk difference (RD), number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH) and mean difference (MD) for continuous outcomes. Data from cluster randomised trials were not combined for analysis. One trial met the inclusion criteria of this review but was considered ineligible owing to serious bias in the reporting of the results. There is no reliable evidence from randomised trials to support or refute the effects of specialist neonatal transport teams for neonatal retrieval on infant morbidity and mortality. Cluster randomised trial study designs may be best suited to provide us with answers on effectiveness and clinical outcomes.

Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial

PubMed Central

Fourcade, Lola; Boutron, Isabelle; Moher, David; Ronceray, Lucie; Baron, Gabriel; Ravaud, Philippe

2007-01-01

Objective: The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT). Design: Paired randomised controlled trial. Participants: Clinicians and systematic reviewers. Interventions: We developed an Internet-based computer learning system (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist. Randomised participants received either a specific Web-based training with the ICLS (intervention group) or no specific training. Outcome measures: The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT. Results: Between April and June 2006, 78 participants were randomly assigned to receive training with the ICLS (39) or no training (39). Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT. The mean paired difference and corresponding 95% confidence interval was 0.5 (−5.1 to 6.1). The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item. Combining both groups, the rate of correct answers was high or items related to allocation sequence (79.5%), description of the intervention (82.0%), blinding of patients (79.5%), and follow-up schedule (83.3%). The rate of correct answers was low for items related to allocation concealment (46.1%), co-interventions (30.3%), blinding of outcome assessors (53.8%), specific measures to avoid ascertainment bias (28.6%), and intention-to-treat analysis (60.2%). Conclusions: Although we showed no difference in effect between the intervention and control groups, our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct. PMID:17479163

An electronic medical record-based intervention to improve quality of care for gastro-esophageal reflux disease (GERD) and atypical presentations of GERD.

PubMed

Player, Marty S; Gill, James M; Mainous, Arch G; Everett, Charles J; Koopman, Richelle J; Diamond, James J; Lieberman, Michael I; Chen, Ying Xia

2010-01-01

Gastro-esophageal reflux disease (GERD) is common in primary care but is often underdiagnosed and untreated. GERD can also present with atypical symptoms like chronic cough and asthma, and physicians may be unaware of this presentation. We aimed to implement and evaluate an intervention to improve diagnosis and treatment for GERD and atypical GERD in primary care. This was a randomised controlled trial in primary care office practice using a national network of US practices (the Medical Quality Improvement Consortium - MQIC) that share the same electronic medical record (EMR). Thirteen offices with 53 providers were randomised to the intervention of EMR-based prompts and education, and 14 offices with 66 providers were randomised to the control group totalling over 67 000 patients and examining outcomes of GERD diagnosis and appropriate treatment. Among patients who did not have GERD at baseline, new diagnoses of GERD increased significantly in the intervention group (3.1%) versus the control group (2.3%) (P<0.01). This remained significant after controlling for clustering with an odds of diagnosis of 1.33 (95% CI 1.13-1.56) for the intervention group. For patients with atypical symptoms, those in the intervention group had both higher odds of being diagnosed with GERD (OR 2.02, 95% CI 1.41-2.88) and of being treated for GERD (OR 1.40, 95% CI 1.08-1.83) than those in the control group. GERD diagnosis and treatment in primary care, particularly among patients with atypical symptoms, can be improved through the use of an EMR-based tool incorporating decision support and education. However, significant room for improvement exists in use of appropriate treatment.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-02-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial.

PubMed

Falloon, Karen; Elley, C Raina; Fernando, Antonio; Lee, Arier C; Arroll, Bruce

2015-08-01

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I. To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia. Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand. Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined 'insomnia remission' treatment response was calculated. Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference -2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects. SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice. © British Journal of General Practice 2015.

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

PubMed

Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

2018-01-01

To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-06-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Optimising the changing role of the community pharmacist: a randomised trial of the impact of audit and feedback

PubMed Central

Winslade, Nancy; Eguale, Tewodros; Tamblyn, Robyn

2016-01-01

Objective To evaluate the impact of comparative performance feedback to community pharmacists on provision of professional services and the quality of patients’ medication use. Design Randomised, controlled, single-blind trial. Setting All 1833 community pharmacies in the Quebec province, Canada. Participants 1814 pharmacies not opting out and with more than 5 dispensings of the target medications during the 6-month baseline were randomised by a 2×2 factorial design to feedback first for hypertension adherence (907 control, 907 intervention) followed by randomisation for asthma adherence (791 control, 807 intervention). 1422 of 1814 pharmacies had complete information available during the follow-up for hypertension intervention (706 intervention, 716 control), and 1301 of 1598 had the follow-up information for asthma (657 intervention, 644 control). Intervention Using provincial billing data to measure performance, mailed comparative feedback reported the pharmacy-level percentage of dispensings to patients non-adherent to antihypertensive medications or overusing asthma rescue inhalers. Primary and secondary outcome measures The number of hypertension/asthma services billed per pharmacy and percentage of dispensings to non-adherent patients over the 12 months post intervention. Results Feedback on the asthma measure led to increased provision of asthma services (control 0.2, intervention 0.4, RR 1.58, 95% CI 1.02 to 2.46). However, this did not translate into reductions in patients’ overuse of rescue inhalers (control 45.5%, intervention 44.6%, RR 0.99, 95% CI 0.98 to 1.01). For non-adherence to antihypertensive medications, feedback resulted in no difference in either provision of hypertension services (control 0.7, intervention 0.8, RR 1.25, 95% CI 0.86 to 1.82) or antihypertensive treatment adherence (control 27.9%, intervention 28.0%, RR 1.0, 95% CI 0.99 to 1.00). Baseline performance did not influence results, and there was no evidence of a cumulative effect with repeated feedback. Conclusions Comparative pharmacy performance feedback increased the provision of asthma pharmacists’ services but did not improve the performance on medication-use measures. Billing data can be used to evaluate the impact of billable services rendered by pharmacists on the quality of patients’ medication use. PMID:27207626

A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

PubMed Central

Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

2012-01-01

Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland. PMID:22761291

Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy.

PubMed

Gurusamy, Kurinchi Selvan; Vaughan, Jessica; Toon, Clare D; Davidson, Brian R

2014-03-28

While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown. To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal (WHO ICTRP) to March 2013 to identify randomised clinical trials of relevance to this review. We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review. Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We included 25 trials with 2505 participants randomised to the different pharmacological agents and inactive controls. All the trials were at unclear risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Participants were allowed to take additional analgesics as required in 24 of the trials. The pharmacological interventions in all the included trials were aimed at preventing pain after laparoscopic cholecystectomy. There were considerable differences in the pharmacological agents used and the methods of administration. The estimated effects of the intervention on the proportion of participants who were discharged as day-surgery, the length of hospital stay, or the time taken to return to work were imprecise in all the comparisons in which these outcomes were reported (very low quality evidence). There was no mortality in any of the groups in the two trials that reported mortality (183 participants, very low quality evidence). Differences in serious morbidity outcomes between the groups were imprecise across all the comparisons (very low quality evidence). None of the trials reported patient quality of life or time taken to return to normal activity. The pain at 4 to 8 hours was generally reduced by about 1 to 2 cm on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). The pain at 9 to 24 hours was generally reduced by about 0.5 cm (a modest reduction) on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). There is evidence of very low quality that different pharmacological agents including non-steroidal anti-inflammatory drugs, opioid analgesics, and anticonvulsant analgesics reduce pain scores in people at low anaesthetic risk undergoing elective laparoscopic cholecystectomy. However, the decision to use these drugs has to weigh the clinically small reduction in pain against uncertain evidence of serious adverse events associated with many of these agents. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.

The effect of educational intervention on intercultural communication: results of a randomised controlled trial

PubMed Central

Harmsen, Hans; Bernsen, Roos; Meeuwesen, Ludwien; Thomas, Siep; Dorrenboom, Govert; Pinto, David; Bruijnzeels, Marc

2005-01-01

Background Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. Aims To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. Design of study A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. Setting General practice in Rotterdam. Method Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the ‘Western’ and ‘non-Western’ patients, and for patients with different cultural backgrounds separately. Results An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with ‘non-Western’ patients. Conclusions A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between ‘Western’ and ‘non-Western’ patients. PMID:15904552

Results of a multicentre randomised controlled trial of statistical process control charts and structured diagnostic tools to reduce ward-acquired meticillin-resistant Staphylococcus aureus: the CHART Project.

PubMed

Curran, E; Harper, P; Loveday, H; Gilmour, H; Jones, S; Benneyan, J; Hood, J; Pratt, R

2008-10-01

Statistical process control (SPC) charts have previously been advocated for infection control quality improvement. To determine their effectiveness, a multicentre randomised controlled trial was undertaken to explore whether monthly SPC feedback from infection control nurses (ICNs) to healthcare workers of ward-acquired meticillin-resistant Staphylococcus aureus (WA-MRSA) colonisation or infection rates would produce any reductions in incidence. Seventy-five wards in 24 hospitals in the UK were randomised into three arms: (1) wards receiving SPC chart feedback; (2) wards receiving SPC chart feedback in conjunction with structured diagnostic tools; and (3) control wards receiving neither type of feedback. Twenty-five months of pre-intervention WA-MRSA data were compared with 24 months of post-intervention data. Statistically significant and sustained decreases in WA-MRSA rates were identified in all three arms (P<0.001; P=0.015; P<0.001). The mean percentage reduction was 32.3% for wards receiving SPC feedback, 19.6% for wards receiving SPC and diagnostic feedback, and 23.1% for control wards, but with no significant difference between the control and intervention arms (P=0.23). There were significantly more post-intervention 'out-of-control' episodes (P=0.021) in the control arm (averages of 0.60, 0.28, and 0.28 for Control, SPC and SPC+Tools wards, respectively). Participants identified SPC charts as an effective communication tool and valuable for disseminating WA-MRSA data.

Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

PubMed Central

Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

2007-01-01

Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

Epilation for Minor Trachomatous Trichiasis: Four-Year Results of a Randomised Controlled Trial

PubMed Central

Habtamu, Esmael; Rajak, Saul N.; Tadesse, Zerihun; Wondie, Tariku; Zerihun, Mulat; Guadie, Birhan; Gebre, Teshome; Kello, Amir Bedri; Callahan, Kelly; Mabey, David C. W.; Khaw, Peng T.; Gilbert, Clare E.; Weiss, Helen A.; Emerson, Paul M.; Burton, Matthew J.

2015-01-01

Background Trachomatous trichiasis (TT) needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye) in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye) in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity. Methodology/ Principal Findings 1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5%) were re-examined: 572 (88%) and 579 (89%) from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33%) of the epilation arm had received surgery, while 383 (67%) declined surgery and had continued epilating (“epilation-only”). Among the epilation-only group, 207 (54.1%) fully controlled their TT, 166 (43.3%) had minor TT and 10 (2.6%) had major TT (>5 lashes). There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years. Conclusions/ Significance Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment. PMID:25768796

Effectiveness of a nurse-supported self-management programme for dual sensory impaired older adults in long-term care: a cluster randomised controlled trial.

PubMed

Roets-Merken, Lieve M; Zuidema, Sytse U; Vernooij-Dassen, Myrra J F J; Teerenstra, Steven; Hermsen, Pieter G J M; Kempen, Gertrudis I J M; Graff, Maud J L

2018-01-24

To evaluate the effectiveness of a nurse-supported self-management programme to improve social participation of dual sensory impaired older adults in long-term care homes. Cluster randomised controlled trial. Thirty long-term care homes across the Netherlands. Long-term care homes were randomised into intervention clusters (n=17) and control clusters (n=13), involving 89 dual sensory impaired older adults and 56 licensed practical nurses. Nurse-supported self-management programme. Effectiveness was evaluated by the primary outcome social participation using a participation scale adapted for visually impaired older adults distinguishing four domains: instrumental activities of daily living, social-cultural activities, high-physical-demand and low-physical-demand leisure activities. A questionnaire assessing hearing-related participation problems was added as supportive outcome. Secondary outcomes were autonomy, control, mood and quality of life and nurses' job satisfaction. For effectiveness analyses, linear mixed models were used. Sampling and intervention quality were analysed using descriptive statistics. Self-management did not affect all four domains of social participation; however. the domain 'instrumental activities of daily living' had a significant effect in favour of the intervention group (P=0.04; 95% CI 0.12 to 8.5). Sampling and intervention quality was adequate. A nurse-supported self-management programme was effective in empowering the dual sensory impaired older adults to address the domain 'instrumental activities of daily living', but no differences were found in addressing the other three participation domains. Self-management showed to be beneficial for managing practical problems, but not for those problems requiring behavioural adaptations of other persons. NCT01217502; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Treatment for postpolio syndrome.

PubMed

Koopman, Fieke Sophia; Beelen, Anita; Gilhus, Nils Erik; de Visser, Marianne; Nollet, Frans

2015-05-18

Postpolio syndrome (PPS) may affect survivors of paralytic poliomyelitis and is characterised by a complex of neuromuscular symptoms leading to a decline in physical functioning. The effectiveness of pharmacological treatment and rehabilitation management in PPS is not yet established. This is an update of a review first published in 2011. To systematically review the evidence from randomised and quasi-randomised controlled trials for the effect of any pharmacological or non-pharmacological treatment for PPS compared to placebo, usual care or no treatment.  We searched the following databases on 21 July 2014: Cochrane Neuromuscular Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO and CINAHL Plus. We also checked reference lists of all relevant articles, searched the Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment (HTA) Database and trial registers and contacted investigators known to be involved in research in this area. Randomised and quasi-randomised trials of any form of pharmacological or non-pharmacological treatment for people with PPS. The primary outcome was self perceived activity limitations and secondary outcomes were muscle strength, muscle endurance, fatigue, pain and adverse events. We used standard methodological procedures expected by The Cochrane Collaboration. We included 10 pharmacological (modafinil, intravenous immunoglobulin (IVIg), pyridostigmine, lamotrigine, amantadine, prednisone) and three non-pharmacological (muscle strengthening, rehabilitation in a warm climate (that is temperature ± 25°C, dry and sunny) and a cold climate (that is temperature ± 0°C, rainy or snowy), static magnetic fields) studies with a total of 675 participants with PPS in this review. None of the included studies were completely free from any risk of bias, the most prevalent risk of bias being lack of blinding.There was moderate- and low-quality evidence that IVIg has no beneficial effect on activity limitations in the short term and long term, respectively, and inconsistency in the evidence for effectiveness on muscle strength. IVIg caused minor adverse events in a substantial proportion of the participants. Results of one trial provided very low-quality evidence that lamotrigine might be effective in reducing pain and fatigue, resulting in fewer activity limitations without generating adverse events. Data from two single trials suggested that muscle strengthening of thumb muscles (very low-quality evidence) and static magnetic fields (moderate-quality evidence) are safe and beneficial for improving muscle strength and pain, respectively, with unknown effects on activity limitations. Finally, there was evidence varying from very low quality to high quality that modafinil, pyridostigmine, amantadine, prednisone and rehabilitation in a warm or cold climate are not beneficial in PPS. Due to insufficient good-quality data and lack of randomised studies, it was impossible to draw definite conclusions about the effectiveness of interventions for PPS. Results indicated that IVIg, lamotrigine, muscle strengthening exercises and static magnetic fields may be beneficial but need further investigation to clarify whether any real and meaningful effect exists.

Effect of multivitamin and multimineral supplements on morbidity from infections in older people (MAVIS trial): pragmatic, randomised, double blind, placebo controlled trial.

PubMed

Avenell, Alison; Campbell, Marion K; Cook, Jonathan A; Hannaford, Philip C; Kilonzo, Mary M; McNeill, Geraldine; Milne, Anne C; Ramsay, Craig R; Seymour, D Gwyn; Stephen, Audrey I; Vale, Luke D

2005-08-06

To examine whether supplementation with multivitamins and multiminerals influences self reported days of infection, use of health services, and quality of life in people aged 65 or over. Randomised, placebo controlled trial, with blinding of participants, outcome assessors, and investigators. Communities associated with six general practices in Grampian, Scotland. 910 men and women aged 65 or over who did not take vitamins or minerals. Daily multivitamin and multimineral supplementation or placebo for one year. Primary outcomes were contacts with primary care for infections, self reported days of infection, and quality of life. Secondary outcomes included antibiotic prescriptions, hospital admissions, adverse events, and compliance. Supplementation did not significantly affect contacts with primary care and days of infection per person (incidence rate ratio 0.96, 95% confidence interval 0.78 to 1.19 and 1.07, 0.90 to 1.27). Quality of life was not affected by supplementation. No statistically significant findings were found for secondary outcomes or subgroups. Routine multivitamin and multimineral supplementation of older people living at home does not affect self reported infection related morbidity. ISRCTN: 66376460.

Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

PubMed Central

2012-01-01

Background A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. Methods/Design This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, “ReCaPTure LiFe” will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15–25 years who have completed cancer treatment in the past 1–6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. Discussion This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. Trial Registration ACTRN12610000717055 PMID:22862906

Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: a multicenter randomised controlled trial of Recapture Life-AYA.

PubMed

Sansom-Daly, Ursula M; Wakefield, Claire E; Bryant, Richard A; Butow, Phyllis; Sawyer, Susan; Patterson, Pandora; Anazodo, Antoinette; Thompson, Kate; Cohn, Richard J

2012-08-03

A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, "ReCaPTure LiFe" will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15-25 years who have completed cancer treatment in the past 1-6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. ACTRN12610000717055.

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

PubMed

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom use. Finally, one trial showed that collection of sexual health information using mobile technology was acceptable. The findings suggest interventions delivered by SMS interventions can increase uptake of sexual health services and STI testing. High quality trials of interventions using standardised objective measures and employing a wider range of behavioural change techniques are needed to assess if interventions delivered by mobile phone can alter safer sex behaviours carried out between couples and reduce STIs.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

PubMed

Harrison, Eleanor F; Haines, Rachel H; Cowdell, Fiona; Sach, Tracey H; Dean, Taraneh; Pollock, Ian; Burrows, Nigel P; Buckley, Hannah; Batchelor, Jonathan; Williams, Hywel C; Lawton, Sandra; Brown, Sara J; Bradshaw, Lucy E; Ahmed, Amina; Montgomery, Alan A; Mitchell, Eleanor J; Thomas, Kim S

2015-09-02

Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series. Current Controlled Trials ISRCTN77261365 (registered 11 November 2013).

Ad libitum or demand/semi-demand feeding versus scheduled interval feeding for preterm infants.

PubMed

McCormick, Felicia M; Tosh, Karen; McGuire, William

2010-02-17

Scheduled interval feeding of prescribed enteral volumes is current standard practice for preterm infants. However, feeding preterm infants in response to their hunger and satiation cues (ad libitum or demand/semi demand) rather than at scheduled intervals might help in the establishment of independent oral feeding, increase nutrient intake and growth rates, and allow earlier hospital discharge. To assess the effect of a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding prescribed volumes at scheduled intervals on growth rates and the time to hospital discharge. We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2009), MEDLINE (1966 to Oct 2009), EMBASE (1980 to Oct 2009), CINAHL (1982 to Oct 2009), conference proceedings, and previous reviews. Randomised or quasi-randomised controlled trials (including cluster randomised trials) that compared a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding at scheduled intervals. We used the standard methods of the Cochrane Neonatal Review Group with separate evaluation of trial quality and data extraction by two review authors. We found eight randomised controlled trials that compared ad libitum or demand/semi-demand regimens with scheduled interval regimes in preterm infants in the transition phase from intragastric tube to oral feeding. The trials were generally small and of variable methodological quality. The duration of the intervention and the duration of data collection and follow-up in most of the trials was not likely to have allowed detection of measurable effects on growth. Three trials reported that feeding preterm infants using an ad libitum or demand/semi-demand feeding regimen allowed earlier discharge from hospital (by about two to four days) but other trials did not confirm this finding. Limited evidence exists that feeding preterm infants with ad libitum or demand/semi-demand regimens allows earlier attainment of full oral feeding and earlier hospital discharge. This finding should be interpreted cautiously because of methodological weaknesses in the included trials. A large randomised controlled trial is needed to confirm this finding and to determine if ad libitum of demand/semi-demand feeding of preterm infants affects other clinically important outcomes.

Novel Noxipoint Therapy versus Conventional Physical Therapy for Chronic Neck and Shoulder Pain: Multicentre Randomised Controlled Trials

PubMed Central

Koo, Charles C.; Lin, Ray S.; Wang, Tyng-Guey; Tsauo, Jau-Yih; Yang, Pan-Chyr; Yen, Chen-Tung; Biswal, Sandip

2015-01-01

As chronic pain affects 115 million people and costs $600B annually in the US alone, effective noninvasive nonpharmacological remedies are desirable. The purpose of this study was to determine the efficacy and the generalisability of Noxipoint therapy (NT), a novel electrotherapy characterised by site-specific stimulation, intensity-and-submodality-specific settings and a immobilization period, for chronic neck and shoulder pain. Ninety-seven heavily pretreated severe chronic neck/shoulder pain patients were recruited; 34 and 44 patients were randomly allocated to different treatment arms in two patient-and-assessor-blinded, randomised controlled studies. The participants received NT or conventional physical therapy including transcutaneous electrical nerve stimulation (PT-TENS) for three to six 90-minute sessions. In Study One, NT improved chronic pain (−89.6%, Brief Pain Inventory, p < 0.0001, 95% confidence interval), function (+77.4%, range of motion) and quality of life (+88.1%) at follow-up (from 4 weeks to 5 months), whereas PT-TENS resulted in no significant changes in these parameters. Study Two demonstrated similar advantages of NT over PT-TENS and the generalisability of NT. NT-like treatments in a randomised rat study showed a similar reduction in chronic hypersensitivity (−81%, p < 0.01) compared with sham treatments. NT substantially reduces chronic neck and shoulder pain, restores function, and improves quality of life in a sustained manner. PMID:26552835

The Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality.

PubMed

Hammond, Naomi E; Bellomo, Rinaldo; Gallagher, Martin; Gattas, David; Glass, Parisa; Mackle, Diane; Micallef, Sharon; Myburgh, John; Saxena, Manoj; Taylor, Colman; Young, Paul; Finfer, Simon

2017-09-01

0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects. To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline. We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation. The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months. The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.

A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue.

PubMed

Moss-Morris, Rona; McCrone, Paul; Yardley, Lucy; van Kessel, Kirsten; Wills, Gary; Dennison, Laura

2012-06-01

The majority of people affected by Multiple Sclerosis (paMS) experience severe and disabling fatigue. A recent randomised controlled trial (RCT) showed that cognitive behaviour therapy with a clinical psychologist was an effective treatment for MS fatigue. An Internet-based version of this intervention, MS Invigor8, was developed for the current study using agile design and input from paMS. MS Invigor8 includes eight tailored, interactive sessions. The aim was to test the feasibility and potential efficacy and cost-effectiveness of the programme in a pilot RCT. 40 patients were randomised to MS Invigor8 (n=23) or standard care (n=17). The MS Invigor8 group accessed sessions over 8-10 weeks and received up to three 30-60min telephone support sessions. Participants completed online standardised questionnaires assessing fatigue, mood, quality of life and service use at baseline and 10 weeks follow-up. Large between group treatment effects were found for the primary outcomes of fatigue severity (d=1.19) and impact (d=1.02). The MS Invigor8 group also reported significantly greater improvements in anxiety, depression and quality-adjusted life years. These data suggest that Internet-based CBT may be a clinically and cost-effective treatment for MS fatigue. A larger RCT with longer term follow-up is warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

What is the quality of reporting on guideline, protocol or algorithm implementation in adult trauma centres? Protocol for a systematic review.

PubMed

Gotlib Conn, Lesley; Nathens, Avery B; Perrier, Laure; Haas, Barbara; Watamaniuk, Aaron; Daniel Pereira, Diego; Zwaiman, Ashley; da Luz, Luis Teodoro

2018-05-09

Quality improvement (QI) is mandatory in trauma centres but there is no prescription for doing successful QI. Considerable variation in implementation strategies and inconsistent use of evidence-based protocols therefore exist across centres. The quality of reporting on these strategies may limit the transferability of successful initiatives across centres. This systematic review will assess the quality of reporting on guideline, protocol or algorithm implementation within a trauma centre in terms of the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). We will search for English language articles published after 2010 in EMBASE, MEDLINE, CINAHL electronic databases and the Cochrane Central Register of Controlled Trials. The database search will be supplemented by searching trial registries and grey literature online. Included studies will evaluate the effectiveness of guideline implementation in terms of change in clinical practice or improvement in patient outcomes. The primary outcome will be a global score reporting the proportion of studies respecting at least 80% of the SQUIRE 2.0 criteria and will be obtained based on the 18-items identified in the SQUIRE 2.0 guidelines. Secondary outcome will be the risk of bias assessed with the Risk Of Bias In Non-randomised Studies- of Interventions tool for observational cohort studies and with the Cochrane Collaboration tool for randomised controlled trials. Meta-analyses will be conducted in randomised controlled trials to estimate the effectiveness of guideline implementation if studies are not heterogeneous. If meta-analyses are conducted, we will combine studies according to the risk of bias (low, moderate or high/unclear) in subgroup analyses. All study titles, abstracts and full-text screening will be completed independently and in duplicate by the review team members. Data extraction and risk of bias assessment will also be done independently and in duplicate. Results will be disseminated through scientific publication and conferences. CRD42018084273. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Early closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial

PubMed Central

Correa-Marinez, Adiela; Angenete, Eva; Skullmann, Stefan; Haglind, Eva; Rosenberg, Jacob

2011-01-01

Objective The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal). Background Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7–9% and minor complications varying from 4–5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality. Design and methods Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0–12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation). Discussion The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637. PMID:22021780

Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.

PubMed

Rambaldi, A; Jacobs, B P; Gluud, C

2007-10-17

Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases. To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C). The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (July 2007). Manufacturers and researchers in the field were contacted. Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality. Eighteen randomised clinical trials assessed milk thistle in 1088 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 28.6% of the trials reported high methodological quality characteristics. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50). Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.

A Comparison of Randomised Controlled Trials in Health and Education

ERIC Educational Resources Information Center

Torgerson, Carole J.; Torgerson, David J.; Birks, Yvonne F.; Porthouse, Jill

2005-01-01

Health care and educational trials face similar methodological challenges. Methodological reviews of health care trials have shown that a significant proportion have methodological flaws. Whether or not educational trials have a similar proportion of poor-quality trials is unknown. The authors undertook a methodological comparison between health…

[Physical therapy of frozen shoulder: literature review].

PubMed

Alvado, A; Pélissier, J; Bénaim, C; Petiot, S; Hérisson, C

2001-03-01

To determine the efficacy of physical treatments in adhesive capsulitis of the shoulder by a systematic review of literature, attempting to perform a meta-analysis from randomised clinical trials. A systematic literature search was conducted to retrieve all randomised controlled trials of physical therapy such as physiotherapy and manipulation, but also arthrographic distension, mobilisation under general anaesthesia or nerve block, arthroscopic distension or arthrolysis, and intra-articular corticoid injections. The main outcome for meta-analysis was the restoration of range of movement between the sixth week and the third month. Only 16 articles could be selected, and only three about capsular distension were included in a meta-analysis because of the heterogeneity of the criteria assessing the functional results and of the poor methodological value of most of the articles. Some open studies stressed the value of daily manipulations and physiotherapy, intra-articular corticosteroid injections, but their quality was poor or limited. Nothing was written about antalgic drugs to facilitate joint mobilisation, and the use of a thoraco-brachial abduction device between exercises was only quoted. The most refractory cases might need more aggressive interventions: arthrographic distension with local anaesthesia and steroid injection; mobilisation under general or local anaesthesia, specially interscalene brachial plexus block; arthroscopic release. But there was no randomised controlled study comparing these three techniques and it seemed impossible to come to any conclusion about the superiority of one of them. The meta-analysis showed yet that capsular distension with intra-articular corticoid injections was better than corticoid injections alone. This demonstrated the need of a consensus about the criteria of assessment, the time of evaluation, before assessing by randomised clinical trials of good quality their therapeutic value.

Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy.

PubMed

Al-Aqeel, Sinaa; Gershuni, Olga; Al-Sabhan, Jawza; Hiligsmann, Mickael

2017-02-03

Poor adherence to antiepileptic medication is associated with increased mortality, morbidity and healthcare costs. In this review, we focus on interventions designed and tested in randomised controlled trials and quasi-randomised controlled trials to assist people with adherence to antiepileptic medication. This is an updated version of the original Cochrane review published in the Cochrane Library, Issue 1, 2010. To determine the effectiveness of interventions aimed at improving adherence to antiepileptic medication in adults and children with epilepsy. For the latest update, on 4 February 2016 we searched the Cochrane Epilepsy Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO), MEDLINE (Ovid 1946 to 4 February 2016), CINAHL Plus (EBSCOhost 1937 to 4 February 2016), PsycINFO (EBSCOhost 1887 to 4 February 2016), ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform. We also searched the reference lists of relevant articles. Randomised and quasi-randomised controlled trials of adherence-enhancing interventions aimed at people with a clinical diagnosis of epilepsy (as defined in individual studies), of any age and treated with antiepileptic drugs in a primary care, outpatient or other community setting. All review authors independently assessed lists of potentially relevant citations and abstracts. At least two review authors independently extracted data and performed quality assessment of each study according to the Cochrane tool for assessing risk of bias. We graded the level of evidence for each outcome according to the GRADE working group scale.The studies differed widely according to the type of intervention and measures of adherence; therefore combining data was not appropriate. We included 12 studies reporting data on 1642 participants (intervention = 833, control = 809). Eight studies targeted adults with epilepsy, one study included participants of all ages, one study included participants older than two years, one study targeted caregivers of children with epilepsy, and one study targeted families of children with epilepsy. We identified six ongoing trials. Follow-up time was generally short in most trials, ranging from one to 12 months. The trials examined three main types of interventions: educational interventions, behavioural interventions and mixed interventions. All studies compared treatment versus usual care or 'no intervention', except for two studies. Due to heterogeneity between studies in terms of interventions, methods used to measure adherence and the way the studies were reported, we did not pool the results and these findings were inappropriate to be included in a meta-analysis. Education and counselling of participants with epilepsy resulted in mixed success (moderate-quality evidence). Behavioural interventions such as use of intensive reminders provided more favourable effects on adherence (moderate-quality evidence). The effect on adherence to antiepileptic drugs described by studies of mixed interventions showed improved adherence in the intervention groups compared to the control groups (high-quality evidence). Behavioural interventions such as intensive reminders and the use of mixed interventions demonstrate some positive results; however, we need more reliable evidence on their efficacy, derived from carefully-designed randomised controlled trials before we can draw a firm conclusion. Since the last version of this review, none of the new relevant studies have provided additional information that would lead to significant changes in our conclusions. This current update includes 12 studies, of which six came from the latest searches.

Photodynamic therapy for recurrent respiratory papillomatosis.

PubMed

Lieder, Anja; Khan, Muhammad K; Lippert, Burkard M

2014-06-05

Recurrent respiratory papillomatosis (RRP) is a benign condition of the mucosa of the upper aerodigestive tract. It is characterised by recurrent papillomatous lesions and is associated with human papillomavirus (HPV). Frequent recurrence and rapid papilloma growth are common and in part responsible for the onset of potentially life-threatening symptoms. Most patients afflicted by the condition will require repeated surgical treatments to maintain their airway, and these may result in scarring and voice problems. Photodynamic therapy introduces a light-sensitising agent, which is administered either orally or by injection. This substance (called a photo-sensitiser) is selectively retained in hyperplastic and neoplastic tissue, including papilloma. It is then activated by light of a specific wavelength and may be used as a sole or adjuvant treatment for RRP. To assess the effects of photodynamic therapy in the management of recurrent respiratory papillomatosis (RRP) in children and adults. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 27 January 2014. Randomised controlled trials utilising photodynamic therapy as sole or adjuvant therapy in participants of any age with proven RRP versus control intervention. Primary outcome measures were symptom improvement (respiratory distress/dyspnoea and voice quality), quality of life improvement and recurrence-free interval. Secondary outcomes included reduction in the frequency of surgical intervention, reduction in disease volume and adverse effects of treatment.   We used the standard methodological procedures expected by The Cochrane Collaboration. Meta-analysis was not possible and results are presented descriptively. We included one trial with a total of 23 participants. This study was at high risk of bias. None of our primary outcomes and only one of our secondary outcomes (reduction in volume of disease, assessed endoscopically) was measured in the study. There was no significant difference between the groups (very low-quality evidence). Adverse effects reported included airway swelling requiring intubation in a child with severe RRP a few hours after photodynamic therapy. There is insufficient evidence from high-quality randomised controlled trials to determine whether photodynamic therapy alters the course of disease or provides an added benefit to surgery in patients with recurrent respiratory papillomatosis. Multicentre randomised controlled trials with appropriate sample sizes and long-term follow-up are required to evaluate whether photodynamic therapy is of benefit. Outcomes such as improvement in symptoms (respiratory function and voice quality) and quality of life should be measured in future trials.

A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions

PubMed Central

Farmer, Sybil; Pandyan, Anand; Chockalingam, Nachiappan

2018-01-01

Background Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world’s population need a prosthesis or orthosis. Objective The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions. Methods Literature searches, completed in September 2015, were carried out in fourteen databases between years 1995 and 2015. The search results were independently screened by two reviewers. For the purpose of this manuscript, only randomized controlled trials which examined interventions using orthotic or prosthetic devices were selected for data extraction and synthesis. Results A total of 342 randomised controlled trials were identified (319 English language and 23 non-English language). Only 4 of these randomised controlled trials examined prosthetic interventions and the rest examined orthotic interventions. These orthotic interventions were categorised based on the medical conditions/injuries of the participants. From these studies, this review focused on the medical condition/injuries with the highest number of randomised controlled trials (osteoarthritis, fracture, stroke, carpal tunnel syndrome, plantar fasciitis, anterior cruciate ligament, diabetic foot, rheumatoid and juvenile idiopathic arthritis, ankle sprain, cerebral palsy, lateral epicondylitis and low back pain). The included articles were assessed for risk of bias using the Cochrane Risk of Bias tool. Details of the clinical population examined, the type of orthotic/prosthetic intervention, the comparator/s and the outcome measures were extracted. Effect sizes and odds ratios were calculated for all outcome measures, where possible. Conclusions At present, for prosthetic and orthotic interventions, the scientific literature does not provide sufficient high quality research to allow strong conclusions on their effectiveness and cost-effectiveness. PMID:29538382

A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial

PubMed Central

Deeks, Jonathan J; Griffith, Michael; Lip, Gregory YH; Mehta, Samir; Slinn, Gemma; Stanbury, Mary; Steeds, Richard P; Townend, Jonathan N

2017-01-01

Background and objective Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article, we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. Design and intervention The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a prospective, randomised, open-label, blinded end point design comparing initial rate control with digoxin or bisoprolol. This will be the first head-to-head randomised trial of digoxin and beta-blockers in AF. Participants Recruited patients will be aged ≥60 years with permanent AF and symptoms of breathlessness (equivalent to New York Heart Association class II or above), with few exclusion criteria to maximise generalisability to routine clinical practice. Outcome measures The primary outcome is patient-reported quality of life, with secondary outcomes including echocardiographic ventricular function, exercise capacity and biomarkers of cellular and clinical response. Follow-up will occur at 6 and 12 months, with feasibility components to inform the design of a future trial powered to detect a difference in hospital admission. The RATE-AF trial will underpin an integrated approach to management including biomarkers, functions and symptoms that will guide future research into optimal, personalised rate control in patients with AF. Ethics and dissemination East Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications. Trial registration Clinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results. PMID:28729311

A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial.

PubMed

Kotecha, Dipak; Calvert, Melanie; Deeks, Jonathan J; Griffith, Michael; Kirchhof, Paulus; Lip, Gregory Yh; Mehta, Samir; Slinn, Gemma; Stanbury, Mary; Steeds, Richard P; Townend, Jonathan N

2017-07-20

Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article , we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity. Such a trial should concentrate on the long-term effects of treatment in the largest proportion of patients with AF, those with symptomatic permanent AF, with the aim of improving patient well-being. The RAte control Therapy Evaluation in permanent Atrial Fibrillation (RATE-AF) trial will enrol 160 participants with a prospective, randomised, open-label, blinded end point design comparing initial rate control with digoxin or bisoprolol. This will be the first head-to-head randomised trial of digoxin and beta-blockers in AF. Recruited patients will be aged ≥60 years with permanent AF and symptoms of breathlessness (equivalent to New York Heart Association class II or above), with few exclusion criteria to maximise generalisability to routine clinical practice. The primary outcome is patient-reported quality of life, with secondary outcomes including echocardiographic ventricular function, exercise capacity and biomarkers of cellular and clinical response. Follow-up will occur at 6 and 12 months, with feasibility components to inform the design of a future trial powered to detect a difference in hospital admission. The RATE-AF trial will underpin an integrated approach to management including biomarkers, functions and symptoms that will guide future research into optimal, personalised rate control in patients with AF. East Midlands-Derby Research Ethics Committee (16/EM/0178); peer-reviewed publications. Clinicaltrials.gov: NCT02391337; ISRCTN: 95259705. Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The influence of quality criteria on parents' evaluation of medical web-pages: an Italian randomised trial.

PubMed

Currò, Vincenzo; Buonuomo, Paola Sabrina; Zambiano, Annaluce; Vituzzi, Andrea; Onesimo, Roberta; D'Atri, Alessandro

2007-01-01

The aim of this study is to verify the usefulness for parents of a web evaluation framework composed of ten quality criteria to improve their ability to assess the quality level of medical web sites. We conducted a randomised controlled trial that included two groups of parents who independently evaluated five paediatric web sites by filling out two distinct questionnaires: group A with the evaluation framework, group B without it. 40 volunteers were recruited from parents referring to the General Paediatrics Out-patients Department who satisfied the following eligibility criteria: Internet users, at least 1 child under 12 months old, no professional skill in Internet and medicine. The survey was taken between February 2, 2000 and March 22, 2000. Parents evaluated each web site and assigned a score, compared with a gold standard created by a group of experts. Suggesting evaluation criteria to parents seem useful for an improvement of their ability to evaluate web sites.

A randomised trial of peer review: the UK National Chronic Obstructive Pulmonary Disease Resources and Outcomes Project.

PubMed

Roberts, C M; Stone, R A; Buckingham, R J; Pursey, N A; Harrison, B D W; Lowe, D; Potter, J M

2010-06-01

Peer review has been widely employed within the NHS to facilitate health quality improvement but has not been rigorously evaluated. This article reports the largest randomised trial of peer review ever conducted in the UK. The peer review intervention was a reciprocal supportive exercise that included clinicians, hospital management, commissioners and patients which focused on the quality of the provision of four specific evidence-based aspects of chronic obstructive pulmonary disease care. Follow up at 12 months demonstrated few quantitative differences in the number or quality of services offered in the two groups. Qualitative data in contrast suggested many benefits of peer review in most but not all intervention units and some control teams. Findings suggest peer review in this format is a positive experience for most participants but is ineffective in some situations. Its longer term benefits and cost effectiveness require further study. The generic findings of this study have potential implications for the application of peer review throughout the NHS.

TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

PubMed

Watson, Gillian; O'Hara, James; Carding, Paul; Lecouturier, Jan; Stocken, Deborah; Fouweather, Tony; Wilson, Janet

2016-04-01

Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction. TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time. ISRCTN38578686 . Registered 17 April 2014.

The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand

PubMed Central

2012-01-01

Background There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. Methods A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7–18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Discussion Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. Trial registration clinicaltrial.gov. Registration number: NCT01563640 PMID:23153360

Lee Silverman Voice Treatment versus standard speech and language therapy versus control in Parkinson's disease: a pilot randomised controlled trial (PD COMM pilot).

PubMed

Sackley, Catherine M; Smith, Christina H; Rick, Caroline E; Brady, Marian C; Ives, Natalie; Patel, Smitaa; Woolley, Rebecca; Dowling, Francis; Patel, Ramilla; Roberts, Helen; Jowett, Sue; Wheatley, Keith; Kelly, Debbie; Sands, Gina; Clarke, Carl E

2018-01-01

Speech-related problems are common in Parkinson's disease (PD), but there is little evidence for the effectiveness of standard speech and language therapy (SLT) or Lee Silverman Voice Treatment (LSVT LOUD®). The PD COMM pilot was a three-arm, assessor-blinded, randomised controlled trial (RCT) of LSVT LOUD®, SLT and no intervention (1:1:1 ratio) to assess the feasibility and to inform the design of a full-scale RCT. Non-demented patients with idiopathic PD and speech problems and no SLT for speech problems in the past 2 years were eligible. LSVT LOUD® is a standardised regime (16 sessions over 4 weeks). SLT comprised individualised content per local practice (typically weekly sessions for 6-8 weeks). Outcomes included recruitment and retention, treatment adherence, and data completeness. Outcome data collected at baseline, 3, 6, and 12 months included patient-reported voice and quality of life measures, resource use, and assessor-rated speech recordings. Eighty-nine patients were randomised with 90% in the therapy groups and 100% in the control group completing the trial. The response rate for Voice Handicap Index (VHI) in each arm was ≥ 90% at all time-points. VHI was highly correlated with the other speech-related outcome measures. There was a trend to improvement in VHI with LSVT LOUD® (difference at 3 months compared with control: - 12.5 points; 95% CI - 26.2, 1.2) and SLT (difference at 3 months compared with control: - 9.8 points; 95% CI - 23.2, 3.7) which needs to be confirmed in an adequately powered trial. Randomisation to a three-arm trial of speech therapy including a no intervention control is feasible and acceptable. Compliance with both interventions was good. VHI and other patient-reported outcomes were relevant measures and provided data to inform the sample size for a substantive trial. International Standard Randomised Controlled Trial Number Register: ISRCTN75223808. registered 22 March 2012.

Does an intensive self-management structured education course improve outcomes for children and young people with type 1 diabetes? The Kids In Control OF Food (KICk-OFF) cluster-randomised controlled trial protocol

PubMed Central

Price, Katherine J; Wales, Jerry; Eiser, Christine; Knowles, Julie; Heller, Simon; Freeman, Jenny; Brennan, Alan; McPherson, Amy; Wellington, Jerry

2013-01-01

Introduction The Kids In Control OF Food (KICk-OFF) is a cluster-randomised controlled trial, which aims to determine the efficacy of a 5 day structured education course for 11-year-olds to 16-year-olds with type 1 diabetes (T1DM) when compared with standard care, and its cost effectiveness. Less than 15% of children and young people with T1DM in the UK meet the recommended glycaemic target. Self-management education programmes for adults with T1DM improve clinical and psychological outcomes, but none have been evaluated in the paediatric population. KICk-OFF is a 5-day structured education course for 11-year-olds to 16- year-olds with T1DM. It was developed with input from young people, parents, teachers and educationalists. Methods and analysis 36 paediatric diabetes centres across the UK randomised into intervention and control arms. Up to 560 participants were recruited prior to centre randomisation. KICk-OFF courses are delivered in the intervention centres, with standard care continued in the control arm. Primary outcomes are change in glycaemic control (HbA1c) and quality of life between baseline and 6 months postintervention, and the incidence of severe hypoglycaemia. Sustained change in self-management behaviour is assessed by follow-up at 12 and 24 months. Health economic analysis will be undertaken. Data will be reported according to the CONSORT statement for cluster-randomised clinical trials. All analyses will be by intention-to-treat with a two-sided p value of <0.05 being regarded as statistically significant. The study commenced in 2008. Data collection from participants is ongoing and the study will be completed in 2013. Ethics The study has been approved by the Sheffield Research Ethics Committee. Dissemination Results will be reported in peer reviewed journals and conferences. Trial registration Current Controlled Trials ISRCTN37042683. PMID:23355675

Physical therapy for Bell's palsy (idiopathic facial paralysis).

PubMed

Teixeira, Lázaro J; Valbuza, Juliana S; Prado, Gilmar F

2011-12-07

Bell's palsy (idiopathic facial paralysis) is commonly treated by various physical therapy strategies and devices, but there are many questions about their efficacy. To evaluate physical therapies for Bell's palsy (idiopathic facial palsy). We searched the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2011), MEDLINE (January 1966 to February 2011), EMBASE (January 1946 to February 2011), LILACS (January 1982 to February 2011), PEDro (from 1929 to February 2011), and CINAHL (January 1982 to February 2011). We included searches in clinical trials register databases until February 2011. We selected randomised or quasi-randomised controlled trials involving any physical therapy. We included participants of any age with a diagnosis of Bell's palsy and all degrees of severity. The outcome measures were: incomplete recovery six months after randomisation, motor synkinesis, crocodile tears or facial spasm six months after onset, incomplete recovery after one year and adverse effects attributable to the intervention. Two authors independently scrutinised titles and abstracts identified from the search results. Two authors independently carried out risk of bias assessments, which , took into account secure methods of randomisation, allocation concealment, observer blinding, patient blinding, incomplete outcome data, selective outcome reporting and other bias. Two authors independently extracted data using a specially constructed data extraction form. We undertook separate subgroup analyses of participants with more and less severe disability. For this update to the original review, the search identified 65 potentially relevant articles. Twelve studies met the inclusion criteria (872 participants). Four trials studied the efficacy of electrical stimulation (313 participants), three trials studied exercises (199 participants), and five studies compared or combined some form of physical therapy with acupuncture (360 participants). For most outcomes we were unable to perform meta-analysis because the interventions and outcomes were not comparable.For the primary outcome of incomplete recovery after six months, electrostimulation produced no benefit over placebo (moderate quality evidence from one study with 86 participants). Low quality comparisons of electrostimulation with prednisolone (an active treatment)(149 participants), or the addition of electrostimulation to hot packs, massage and facial exercises (22 participants), reported no significant differences. Similarly a meta-analysis from two studies, one of three months and the other of six months duration, (142 participants) found no statistically significant difference in synkinesis, a complication of Bell's palsy, between participants receiving electrostimulation and controls. A single low quality study (56 participants), which reported at three months, found worse functional recovery with electrostimulation (mean difference (MD) 12.00 points (scale of 0 to 100) 95% confidence interval (CI) 1.26 to 22.74).Two trials of facial exercises, both at high risk of bias, found no difference in incomplete recovery at six months when exercises were compared to waiting list controls or conventional therapy. There is evidence from a single small study (34 participants) of moderate quality that exercises are beneficial on measures of facial disability to people with chronic facial palsy when compared with controls (MD 20.40 points (scale of 0 to 100), 95% CI 8.76 to 32.04) and from another single low quality study with 145 people with acute cases treated for three months where significantly fewer participants developed facial motor synkinesis after exercise (risk ratio 0.24, 95% CI 0.08 to 0.69). The same study showed statistically significant reduction in time for complete recovery, mainly in more severe cases (47 participants, MD -2.10 weeks, 95% CI -3.15 to -1.05) but this was not a prespecified outcome in this meta analysis.Acupuncture studies did not provide useful data as all were short and at high risk of bias. None of the studies included adverse events as an outcome. There is no high quality evidence to support significant benefit or harm from any physical therapy for idiopathic facial paralysis. There is low quality evidence that tailored facial exercises can help to improve facial function, mainly for people with moderate paralysis and chronic cases. There is low quality evidence that facial exercise reduces sequelae in acute cases. The suggested effects of tailored facial exercises need to be confirmed with good quality randomised controlled trials.

Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

PubMed

Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

2016-09-01

Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p<.001). However, anxiety and depression scores in the intervention group remained unchanged after 12 weeks of the supportive nursing care programme (p>.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, p<.001), daytime sleepiness (β=-4.23, p<.001), anxiety (β=-1.94, p<.001), and depression (β=-3.05, p<.001) after 12 weeks of the intervention. This study confirmed that a supportive nursing care programme could effectively improve sleep quality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes.

PubMed

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Australian and New Zealand Clinical Trials Registry ACTRN12609000973213.

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

PubMed Central

2010-01-01

Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services. Clinical trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 PMID:21073703

Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

PubMed Central

Bennell, Kim; Bowles, Kelly-Ann; Payne, Craig; Cicuttini, Flavia; Osborne, Richard; Harris, Anthony; Hinman, Rana

2007-01-01

Background Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. Trial registration ACTR12605000503628; NCT00415259. PMID:17892539

A cluster randomised controlled trial and process evaluation of a training programme for mental health professionals to enhance user involvement in care planning in service users with severe mental health issues (EQUIP): study protocol for a randomised controlled trial.

PubMed

Bower, Peter; Roberts, Chris; O'Leary, Neil; Callaghan, Patrick; Bee, Penny; Fraser, Claire; Gibbons, Chris; Olleveant, Nicola; Rogers, Anne; Davies, Linda; Drake, Richard; Sanders, Caroline; Meade, Oonagh; Grundy, Andrew; Walker, Lauren; Cree, Lindsey; Berzins, Kathryn; Brooks, Helen; Beatty, Susan; Cahoon, Patrick; Rolfe, Anita; Lovell, Karina

2015-08-13

Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their own care, there is substantial empirical evidence that the majority of users are not fully involved in the care planning process. Our aim is to evaluate the effectiveness and cost-effectiveness of training for mental health professionals in improving user involvement with the care planning processes. This is a cluster randomised controlled trial of community mental health teams in NHS Trusts in England allocated either to a training intervention to improve user and carer involvement in care planning or control (no training and care planning as usual). We will evaluate the effectiveness of the training intervention using a mixed design, including a 'cluster cohort' sample, a 'cluster cross-sectional' sample and process evaluation. Service users will be recruited from the caseloads of care co-ordinators. The primary outcome will be change in self-reported involvement in care planning as measured by the validated Health Care Climate Questionnaire. Secondary outcomes include involvement in care planning, satisfaction with services, medication side-effects, recovery and hope, mental health symptoms, alliance/engagement, well-being and quality of life. Cost- effectiveness will also be measured. A process evaluation informed by implementation theory will be undertaken to assess the extent to which the training was implemented and to gauge sustainability beyond the time-frame of the trial. It is hoped that the trial will generate data to inform mental health care policy and practice on care planning. ISRCTN16488358 (14 May 2014).

The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial.

PubMed

Thomsen, Tanja; Aadahl, Mette; Beyer, Nina; Hetland, Merete Lund; Løppenthin, Katrine; Midtgaard, Julie; Christensen, Robin; Østergaard, Mikkel; Jennum, Poul Jørgen; Esbensen, Bente Appel

2017-09-01

The aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA). In this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist-hip ratio. 75 patients were allocated to each group. Mean reduction in daily sitting time was -1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference -2.20 (95% CI -2.72 to -1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention. An individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels. NCT01969604; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

PubMed

Grant, A M; Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

2013-04-18

To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Initial recruitment in 21 UK hospitals. Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. Current Controlled Trials ISRCTN15517081.

Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

PubMed Central

2013-01-01

Background Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. Methods/design In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. Discussion If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion. Trial registration Current Controlled Trials ISRCTN21027481 PMID:23710796

Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease.

PubMed

Radunovic, Aleksandar; Annane, Djillali; Rafiq, Muhammad K; Mustfa, Naveed

2013-03-28

Amyotrophic lateral sclerosis, also known as motor neuron disease, is a fatal neurodegenerative disease. Neuromuscular respiratory failure is the commonest cause of death, usually within two to five years of the disease onset. Supporting respiratory function with mechanical ventilation may improve survival and quality of life. This is the first update of a review first published in 2009. The primary objective of the review is to examine the efficacy of mechanical ventilation (tracheostomy and non-invasive ventilation) in improving survival in ALS. The secondary objectives are to examine the effect of mechanical ventilation on functional measures of disease progression and quality of life in people with ALS; and assess adverse events related to the intervention. We searched The Cochrane Neuromuscular Disease Group Specialized Register (1 May 2012), CENTRAL (2012, Issue 4), MEDLINE (January 1966 to April 2012), EMBASE (January 1980 to April 2012), CINAHL Plus (January 1937 to April 2012), and AMED (January 1985 to April 2012). We also searched for ongoing studies on ClinicalTrials.gov. Randomised and quasi-randomised controlled trials involving non-invasive or tracheostomy assisted ventilation in participants with a clinical diagnosis of amyotrophic lateral sclerosis, independent of the reported outcomes. We planned to include comparisons with no intervention or the best standard care. For the original review, four authors independently selected studies for assessment and two authors reviewed searches for this update. All authors extracted data independently from the full text of selected studies and assessed the risk of bias in studies that met the inclusion criteria. We attempted to obtain missing data where possible. We planned to collect adverse event data from included studies. For the original Cochrane review, the review authors identified and included two randomised controlled trials involving 54 participants with ALS receiving non-invasive ventilation. There were no new randomised or quasi-randomised controlled trials at this first update.Incomplete data were published for one study and we contacted the trial authors who were not able to provide the missing data. Therefore, the results of the review were based on a single study of 41 participants that compared non-invasive ventilation with standard care. It was a well conducted study with low risk of bias.The study showed that the overall median survival was significantly different between the group treated with non-invasive ventilation and the standard care group. The median survival in the non-invasive ventilation group was 48 days longer (219 days compared to 171 days for the standard care group (estimated 95% CI 12 to 91 days, P = 0.0062)). This survival benefit was accompanied by an enhanced quality of life. On subgroup analysis, the survival and quality of life benefit was much more in the subgroup with normal to moderately impaired bulbar function (20 participants); median survival was 205 days longer (216 days in NIV group versus 11 days in the standard care group, P = 0.0059). Non-invasive ventilation did not prolong survival in participants with poor bulbar function (21 participants), although it showed significant improvement in the mean symptoms domain of the Sleep Apnoea Quality of Life Index but not in the Short Form-36 Health Survey Mental Component Summary score. Neither trial reported clinical data on intervention related adverse effects. Evidence from a single randomised trial of non-invasive ventilation in 41 participants suggests that it significantly prolongs survival and improves or maintains quality of life in people with ALS. Survival and some measures of quality of life were significantly improved in the subgroup of people with better bulbar function, but not in those with severe bulbar impairment. Future studies should examine the health economics of NIV and factors influencing access to NIV. We need to understand the factors, personal and socioeconomic, that determine access to NIV.

Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel ‘RCT within-a-cohort’ study design

PubMed Central

Sihvonen, Raine; Paavola, Mika; Malmivaara, Antti; Järvinen, Teppo L N

2013-01-01

Introduction Arthroscopic partial meniscectomy (APM) to treat degenerative meniscus injury is the most common orthopaedic procedure. However, valid evidence of the efficacy of APM is lacking. Controlling for the placebo effect of any medical intervention is important, but seems particularly pertinent for the assessment of APM, as the symptoms commonly attributed to a degenerative meniscal injury (medial joint line symptoms and perceived disability) are subjective and display considerable fluctuation, and accordingly difficult to gauge objectively. Methods and analysis A multicentre, parallel randomised, placebo surgery controlled trial is being carried out to assess the efficacy of APM for patients from 35 to 65 years of age with a degenerative meniscus injury. Patients with degenerative medial meniscus tear and medial joint line symptoms, without clinical or radiographic osteoarthritis of the index knee, were enrolled and then randomly assigned (1 : 1) to either APM or diagnostic arthroscopy (placebo surgery). Patients are followed up for 12 months. According to the prior power calculation, 140 patients were randomised. The two randomised patient groups will be compared at 12 months with intention-to-treat analysis. To safeguard against bias, patients, healthcare providers, data collectors, data analysts, outcome adjudicators and the researchers interpreting the findings will be blind to the patients’ interventions (APM/placebo). Primary outcomes are Lysholm knee score (a generic knee instrument), knee pain (using a numerical rating scale), and WOMET score (a disease-specific, health-related quality of life index). The secondary outcome is 15D (a generic quality of life instrument). Further, in one of the five centres recruiting patients for the randomised controlled trial (RCT), all patients scheduled for knee arthroscopy due to a degenerative meniscus injury are prospectively followed up using the same protocol as in the RCT to provide an external validation cohort. In this article, we present and discuss our study design, focusing particularly on the internal and external validity of our trial and the ethics of carrying out a placebo surgery controlled trial. Ethics and dissemination The protocol has been approved by the institutional review board of the Pirkanmaa Hospital District and the trial has been duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. Trial registration ClinicalTrials.gov, number NCT00549172. PMID:23474796

Cancer-related fatigue management: evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study.

PubMed

Bourmaud, A; Anota, A; Moncharmont, C; Tinquaut, F; Oriol, M; Trillet-Lenoir, V; Bajard, A; Parnalland, S; Rotonda, C; Bonnetain, F; Pérol, D; Chauvin, F

2017-03-28

To assess the efficacy of a patient educational program built according to guidelines that aims at reducing cancer-related fatigue (CRF). Randomised controlled trial, multicentre, comparing a patient education program, vs the standard of care. Patients were adult cancer outpatients with any tumour site. The primary outcome was fatigue severity assessed with a visual analogical scale (VAS), between the day of randomisation and week 7. Secondary outcomes were fatigue assessed with other scales, health-related quality of life, anxiety and depression. The time to fatigue severity deterioration was assessed. Analyses were performed in a modified intent-to-treat way, that is, including all patients with at least one baseline and 1 week 7 score. A total of 212 patients were included. Fatigue severity assessment was made on 79 patients in the experimental group and 65 in the control group. Between randomisation and week 7, the fatigue (VAS) improved by 0.96 (2.85) points in the experimental group vs 1.63 (2.63) points in the control group (P=0.15). No differences with the secondary outcomes were highlighted between two groups. No other factors were found to be associated with fatigue severity deterioration. Despite rigorous methodology, this study failed to highlight the program efficacy in fatigue reduction for cancer patients. Other assessment tools should be developed to measure the effect of the program on CRF and behaviour. The implementation of the program should also be explored in order to identify its mechanisms and longer-term impact.

Evaluation of a complex intervention to improve activities of daily living of disabled cancer patients: protocol for a randomised controlled study and feasibility of recruitment and intervention

PubMed Central

2014-01-01

Background Many cancer patients have problems performing activities of daily living (ADL). A randomised controlled trial was designed to examine the effects of an ADL intervention in addition to standard treatment and care in a hospital setting. The objective of this article was to present the study and to analyse the feasibility of the recruitment process and the intervention. Methods Adult disabled cancer patients at Næstved Hospital in Denmark were enrolled between 1 March 2010 and 30 June 2011 and randomised into an ADL intervention or to a control group. The intervention was performed by occupational therapists. The feasibility of the recruitment was analysed with regard to success in achieving the estimated number of participants and identification of barriers, and feasibility of the intervention was based on calculations of patient attendance and patient acceptability. The primary outcome of the randomised controlled trial was patients’ health-related quality of life 2 and 8 weeks after baseline. Results A total of 118 disabled cancer patients were enrolled in the study over a time span of 16 months. Very few meetings between occupational therapist and patient were cancelled. Time spent on the intervention varied considerably, but for the majority of patients, time consumption was between 1–3 hours. Conclusions Despite difficulties with recruitment, participation was considered feasible and the intervention was accepted among patients. Missing data in the follow-up period were mostly due to death among participants. Very few participants declined to complete questionnaires during follow-up. PMID:24779438

Cancer-related fatigue management: evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study

PubMed Central

Bourmaud, A; Anota, A; Moncharmont, C; Tinquaut, F; Oriol, M; Trillet-Lenoir, V; Bajard, A; Parnalland, S; Rotonda, C; Bonnetain, F; Pérol, D; Chauvin, F

2017-01-01

Background: To assess the efficacy of a patient educational program built according to guidelines that aims at reducing cancer-related fatigue (CRF). Methods: Randomised controlled trial, multicentre, comparing a patient education program, vs the standard of care. Patients were adult cancer outpatients with any tumour site. The primary outcome was fatigue severity assessed with a visual analogical scale (VAS), between the day of randomisation and week 7. Secondary outcomes were fatigue assessed with other scales, health-related quality of life, anxiety and depression. The time to fatigue severity deterioration was assessed. Analyses were performed in a modified intent-to-treat way, that is, including all patients with at least one baseline and 1 week 7 score. Results: A total of 212 patients were included. Fatigue severity assessment was made on 79 patients in the experimental group and 65 in the control group. Between randomisation and week 7, the fatigue (VAS) improved by 0.96 (2.85) points in the experimental group vs 1.63 (2.63) points in the control group (P=0.15). No differences with the secondary outcomes were highlighted between two groups. No other factors were found to be associated with fatigue severity deterioration. Conclusions: Despite rigorous methodology, this study failed to highlight the program efficacy in fatigue reduction for cancer patients. Other assessment tools should be developed to measure the effect of the program on CRF and behaviour. The implementation of the program should also be explored in order to identify its mechanisms and longer-term impact. PMID:28196066

SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375].

PubMed

McCahon, Deborah; Fitzmaurice, David A; Murray, Ellen T; Fuller, Christopher J; Hobbs, Richard F D; Allan, Teresa F; Raftery, James P

2003-09-18

Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

Effect of Treatment Delay, Stroke Type, and Thrombolysis on the Effect of Glyceryl Trinitrate, a Nitric Oxide Donor, on Outcome after Acute Stroke: A Systematic Review and Meta-Analysis of Individual Patient from Randomised Trials.

PubMed

Bath, Philip M; Woodhouse, Lisa; Krishnan, Kailash; Anderson, Craig; Berge, Eivind; Ford, Gary A; Robinson, Thompson G; Saver, Jeffrey L; Sprigg, Nikola; Wardlaw, Joanna M; In Acute Stroke Collaboration Basc, Blood Pressure

2016-01-01

Background. Nitric oxide (NO) donors are a candidate treatment for acute stroke and two trials have suggested that they might improve outcome if administered within 4-6 hours of stroke onset. We assessed the safety and efficacy of NO donors using individual patient data (IPD) from completed trials. Methods. Randomised controlled trials of NO donors in patients with acute or subacute stroke were identified and IPD sought from the trialists. The effect of NO donor versus control on functional outcome was assessed using the modified Rankin scale (mRS) and death, by time to randomisation. Secondary outcomes included measures of disability, mood, and quality of life. Results. Five trials (4,197 participants) were identified, all involving glyceryl trinitrate (GTN). Compared with control, GTN lowered blood pressure by 7.4/3.3 mmHg. At day 90, GTN did not alter any clinical measures. However, in 312 patients randomised within 6 hours of stroke onset, GTN was associated with beneficial shifts in the mRS (odds ratio (OR) 0.52, 95% confidence interval (CI) 0.34-0.78) and reduced death (OR 0.32, 95% CI 0.14-0.78). Conclusions. NO donors do not alter outcome in patients with recent stroke. However, when administered within 6 hours, NO donors might improve outcomes in both ischaemic and haemorrhagic stroke.

Information provision for people with multiple sclerosis.

PubMed

Köpke, Sascha; Solari, Alessandra; Khan, Fary; Heesen, Christoph; Giordano, Andrea

2014-04-21

People with multiple sclerosis (MS) are confronted with a number of important uncertainties concerning many aspects of the disease. Among others, these include diagnosis, prognosis, disease course, disease-modifying therapies, symptomatic therapies and non-pharmacological interventions. It has been shown that people with MS demand adequate information to be able to actively participate in medical decision making and to self-manage their disease. On the other hand, it has been found that patients' disease-related knowledge is poor. Therefore, guidelines have recommended clear and concise high-quality information at all stages of the disease. Several studies have outlined communication and information deficits in the care of people with MS and, accordingly, a number of information and decision support programmes have been published. To evaluate the effectiveness of information provision interventions for people with MS that aim to promote informed choice and improve patient-relevant outcomes. We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Specialised Register which contains trials from CENTRAL (The Cochrane Library 2013, Issue 6), MEDLINE, EMBASE, CINAHL, LILACS, PEDro and clinical trials registries (12 June 2013) as well as other sources. In addition, we searched PsycINFO, trial registries, and reference lists of identified articles. We also contacted trialists. Randomised controlled trials, cluster randomised controlled trials and quasi-randomised trials comparing information provision for people with MS or suspected MS (intervention groups) with usual care or other types of information provision (control groups) were eligible. Two review authors independently assessed the retrieved articles for relevance and methodological quality, and extracted data. Critical appraisal of studies addressed the risk of selection bias, performance bias, attrition bias and detection bias. We contacted authors of relevant studies for additional information. Ten randomised controlled trials involving a total of 1314 participants met the inclusion criteria and were analysed. The interventions addressed a variety of topics using different approaches for information provision in different settings. Topics included disease-modifying therapy, relapse management, self-care strategies, fatigue management, family planning and general health promotion. The interventions contained decision aids, educational programmes, self-care interventions and personal interviews with physicians. All interventions were complex interventions using more than one active component, but the number and extent of the intervention components differed markedly between studies. The studies had a variable risk of bias. We did not perform meta-analyses due to marked clinical heterogeneity. All four studies assessing MS-related knowledge (524 participants; moderate-quality evidence) detected significant differences between groups as a result of the interventions indicating that information provision may successfully increase participants' knowledge. There were mixed results from four studies reporting effects on decision making (836 participants; low-quality evidence) and from five studies assessing quality of life (605 participants; low-quality evidence). There were no adverse events in the six studies reporting on adverse events. Information provision for people with MS seems to increase disease-related knowledge, with less clear results on decision making and quality of life. There seem to be no negative side effects from informing patients about their disease. Interpretation of study results remains challenging due to the marked heterogeneity of the interventions and outcome measures.

The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials.

PubMed

Archer, S; Buxton, S; Sheffield, D

2015-01-01

This systematic review examined the effectiveness of creative psychological interventions (CPIs) for adult cancer patients. In particular, the findings of randomised controlled trials of art, drama, dance/movement and music therapies on psychological outcomes were examined. The review yielded 10 original studies analysing data from a total of 488 patients. Data extraction and quality assessment were conducted by two independent reviewers. Four of the papers focused on the use of art therapy, three studies used music therapy, one paper utilised dance therapy, one study used dance/movement therapy and the remaining paper used creative arts therapies, which was a combination of different art-based therapy approaches. Eight papers focused solely on breast cancer patients, and the remaining studies included mixed cancer sites/stages. The studies reported improvements in anxiety and depression, quality of life, coping, stress, anger and mood. However, few physical benefits of CPIs were reported; there was no significant impact of a CPI on physical aspects of quality of life, vigour-activity or fatigue-inertia or physical functioning. One study was assessed as high quality, seven studies were assessed as satisfactory and two studies were assessed to be of poorer quality. There is initial evidence that CPIs benefit adult cancer patients with respect to anxiety and depression, quality of life, coping, stress, anger and mood; there was no evidence to suggest that any one type of CPI was especially beneficial. However, more and better quality research needs to be conducted, particularly in the areas of drama and dance/movement therapies. Copyright © 2014 John Wiley & Sons, Ltd.

PREvention STudy On preventing or reducing disability from musculoskeletal complaints in music school students (PRESTO): protocol of a randomised controlled trial.

PubMed

Baadjou, Vera A E; Verbunt, Jeanine A M C F; Eijsden-Besseling, Marjon D F van; Samama-Polak, Ans L W; Bie, Rob A D E; Smeets, Rob J E M

2014-12-01

Up to 87% of professional musicians develop work-related complaints of the musculoskeletal system during their careers. Music school students are at specific risk for developing musculoskeletal complaints and disabilities. This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders. Secondary objectives are evaluation of cost-effectiveness and feasibility. Healthy, first or second year students (n=150) will be asked to participate in a multicentre, single-blinded, parallel-group randomised controlled trial. Students randomised to the intervention group (n=75) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy, while incorporating aspects from behavioural change theories. A control group (n=75) will participate in a program that stimulates a healthy physical activity level using a pedometer, which conforms to international recommendations. No long-term effects are expected from this control intervention. Total follow-up duration is two years. The primary outcome measure is disability (Disabilities of Arm, Shoulder and Hand questionnaire). The secondary outcome measures are pain, quality of life and changes in health behaviour. Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements. Furthermore, cost-effectiveness, cost-utility and feasibility will be analysed. It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised controlled trial.

PubMed

Ardalan, Zaid Sm; Vasudevan, Abhinav; Hew, Simon; Schulberg, Julien; Lontos, Steve

2015-12-14

To evaluate the effect of Star Wars music (SWM) compared with endoscopist-selected popular music (PM) on quality outcomes in colonoscopy. A single-centre, prospective, randomised controlled trial conducted in an endoscopy suite within a quaternary-centre gastroenterology unit, Melbourne, Australia. The primary outcome measures were procedure time, polyp detection rate (PDR) and adenoma detection rate (ADR). The secondary outcome measure was adenomas per colonoscopy (APC). 103 colonoscopies were analysed: 58 in the SWM group and 45 in the PM group. Bowel preparation was assessed as good or excellent in 57% of the SWM group compared with 69% of the PM group (P < 0.01). The PDR was significantly higher in the SWM group than in the PM group (60% v 35%; P = 0.006). Similarly, the ADR was significantly higher in the SWM group than in the PM group (48% v 27%; P = 0.01). The APC in the SWM group was 84% compared with 35% in the PM group (P = 0.01). SWM compared with PM improves key quality outcomes in colonoscopy, despite poorer bowel preparation.

Reporting and Methodological Quality of Randomised Controlled Trials in Vascular and Endovascular Surgery.

PubMed

Hajibandeh, S; Hajibandeh, S; Antoniou, G A; Green, P A; Maden, M; Torella, F

2015-11-01

Randomised controlled trials (RCTs) are subject to bias if they lack methodological quality. Moreover, optimal and transparent reporting of RCT findings aids their critical appraisal and interpretation. The aim of this study was to ascertain whether the methodological and reporting quality of RCTs in vascular and endovascular surgery is improving. The most recent 75 and oldest 75 RCTs published in leading journals over a 10-year period (2003-2012) were identified. The reporting quality and methodological quality data of the old and new RCTs were extracted and compared. The former was analysed using the Consolidated Standards of Reporting Trials (CONSORT) statement, the latter with the Scottish Intercollegiate Guidelines Network (SIGN) checklist. Reporting quality measured by CONSORT was better in the new studies than in the old studies (0.68 [95% CI, 0.66-0.7] vs. 0.60 [95% CI, 0.58-0.62], p < .001); however, both new and old studies had similar methodological quality measured by SIGN (0.9 [IQR 0.1] vs. .09 [IQR: 0.2], p = .787). Unlike clinical items, the methodological items of the CONSORT statement were not well reported in old and new RCTs. More trials in the new group were endovascular related (33.33% vs. 17.33%, p = .038) and industry sponsored (28% vs. 6.67%, p = .001). Despite some progress, there remains room for improvement in the reporting quality of RCTs in vascular and endovascular surgery. The methodological quality of recent RCTs is similar to that of trials performed >10 years ago. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making

PubMed Central

Whale, Katie; Fish, Daniel; Fayers, Peter; Cafaro, Valentina; Pusic, Andrea; Blazeby, Jane M.; Efficace, Fabio

2016-01-01

Purpose Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. Methods A systematic review from January 2004–February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research—patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. Results Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. Conclusions Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings. PMID:25910987

Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus.

PubMed

Hemmingsen, Bianca; Sonne, David P; Metzendorf, Maria-Inti; Richter, Bernd

2017-05-10

The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues are able to prevent or delay T2DM and its associated complications in people at risk for the development of T2DM is unknown. To assess the effects of DPP-4 inhibitors and GLP-1 analogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these. We searched the Cochrane Central Register of Controlled Trials; MEDLINE; PubMed; Embase; ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform; and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was January 2017. We included randomised controlled trials (RCTs) with a duration of 12 weeks or more comparing DPP-4 inhibitors and GLP-1 analogues with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with impaired fasting glucose, impaired glucose tolerance, moderately elevated HbA1c or combinations of these. Two review authors read all abstracts and full-text articles and records, assessed quality and extracted outcome data independently. One review author extracted data which were checked by a second review author. We resolved discrepancies by consensus or the involvement of a third review author. For meta-analyses, we planned to use a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence using the GRADE instrument. We included seven completed RCTs; about 98 participants were randomised to a DPP-4 inhibitor as monotherapy and 1620 participants were randomised to a GLP-1 analogue as monotherapy. Two trials investigated a DPP-4 inhibitor and five trials investigated a GLP-1 analogue. A total of 924 participants with data on allocation to control groups were randomised to a comparator group; 889 participants were randomised to placebo and 33 participants to metformin monotherapy. One RCT of liraglutide contributed 85% of all participants. The duration of the intervention varied from 12 weeks to 160 weeks. We judged none of the included trials at low risk of bias for all 'Risk of bias' domains and did not perform meta-analyses because there were not enough trials.One trial comparing the DPP-4 inhibitor vildagliptin with placebo reported no deaths (very low-quality evidence). The incidence of T2DM by means of WHO diagnostic criteria in this trial was 3/90 participants randomised to vildagliptin versus 1/89 participants randomised to placebo (very low-quality evidence). Also, 1/90 participants on vildagliptin versus 2/89 participants on placebo experienced a serious adverse event (very low-quality evidence). One out of 90 participants experienced congestive heart failure in the vildagliptin group versus none in the placebo group (very low-quality evidence). There were no data on non-fatal myocardial infarction, stroke, health-related quality of life or socioeconomic effects reported.All-cause and cardiovascular mortality following treatment with GLP-1 analogues were rarely reported; one trial of exenatide reported that no participant died. Another trial of liraglutide 3.0 mg showed that 2/1501 in the liraglutide group versus 2/747 in the placebo group died after 160 weeks of treatment (very low-quality evidence).The incidence of T2DM following treatment with liraglutide 3.0 mg compared to placebo after 160 weeks was 26/1472 (1.8%) participants randomised to liraglutide versus 46/738 (6.2%) participants randomised to placebo (very low-quality evidence). The trial established the risk for (diagnosis of) T2DM as HbA1c 5.7% to 6.4% (6.5% or greater), fasting plasma glucose 5.6 mmol/L or greater to 6.9 mmol/L or less (7.0 mmol/L or greater) or two-hour post-load plasma glucose 7.8 mmol/L or greater to 11.0 mmol/L (11.1 mmol/L). Altogether, 70/1472 (66%) participants regressed from intermediate hyperglycaemia to normoglycaemia compared with 268/738 (36%) participants in the placebo group. The incidence of T2DM after the 12-week off-treatment extension period (i.e. after 172 weeks) showed that five additional participants were diagnosed T2DM in the liraglutide group, compared with one participant in the placebo group. After 12-week treatment cessation, 740/1472 (50%) participants in the liraglutide group compared with 263/738 (36%) participants in the placebo group had normoglycaemia.One trial used exenatide and 2/17 participants randomised to exenatide versus 1/16 participants randomised to placebo developed T2DM (very low-quality evidence). This trial did not provide a definition of T2DM. One trial reported serious adverse events in 230/1524 (15.1%) participants in the liraglutide 3.0 mg arm versus 96/755 (12.7%) participants in the placebo arm (very low quality evidence). There were no serious adverse events in the trial using exenatide. Non-fatal myocardial infarction was reported in 1/1524 participants in the liraglutide arm and in 0/55 participants in the placebo arm at 172 weeks (very low-quality evidence). One trial reported congestive heart failure in 1/1524 participants in the liraglutide arm and in 1/755 participants in the placebo arm (very low-quality evidence). Participants receiving liraglutide compared with placebo had a small mean improvement in the physical component of the 36-item Short Form scale showing a difference of 0.87 points (95% CI 0.17 to 1.58; P = 0.02; 1 trial; 1791 participants; very low-quality evidence). No trial evaluating GLP-1-analogues reported data on stroke, microvascular complications or socioeconomic effects. There is no firm evidence that DPP-4 inhibitors or GLP-1 analogues compared mainly with placebo substantially influence the risk of T2DM and especially its associated complications in people at increased risk for the development of T2DM. Most trials did not investigate patient-important outcomes.

Evaluation of the effectiveness of manual chest physiotherapy techniques on quality of life at six months post exacerbation of COPD (MATREX): a randomised controlled equivalence trial

PubMed Central

2012-01-01

Background Manual chest physiotherapy (MCP) techniques involving chest percussion, vibration, and shaking have long been used in the treatment of respiratory conditions. However, methodological limitations in existing research have led to a state of clinical equipoise with respect to this treatment. Thus, for patients hospitalised with an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), clinical preference tends to dictate whether MCP is given to assist with sputum clearance. We standardised the delivery of MCP and assessed its effectiveness on disease-specific quality of life. Methods In this randomised, controlled trial powered for equivalence, 526 patients hospitalised with acute COPD exacerbation were enrolled from four centres in the UK. Patients were allocated to receive MCP plus advice on airway clearance or advice on chest clearance alone. The primary outcome was a COPD specific quality of life measure, the Saint Georges Respiratory Questionnaire (SGRQ) at six months post randomisation. Analyses were by intention to treat (ITT). This study was registered, ISRCTN13825248. Results All patients were included in the analyses, of which 372 (71%) provided evaluable data for the primary outcome. An effect size of 0·3 standard deviations in SGRQ score was specified as the threshold for superiority. The ITT analyses showed no significant difference in SGRQ for patients who did, or did not receive MCP (95% CI −0·14 to 0·19). Conclusions These data do not lend support to the routine use of MCP in the management of acute exacerbation of COPD. However, this does not mean that MCP is of no therapeutic value to COPD patients in specific circumstances. PMID:22748085

Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol

PubMed Central

2009-01-01

Background A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Methods and design Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) or the Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors associated with successful implementation. Discussion The trial will evaluate the impact of screening and brief alcohol intervention in routine probation work and therefore its findings will be highly relevant to probation teams and thus the criminal justice system in the UK. Ethical approval was given by Northern & Yorkshire REC Trial Registration number ISRCTN 19160244 PMID:19922618

Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol.

PubMed

Newbury-Birch, Dorothy; Bland, Martin; Cassidy, Paul; Coulton, Simon; Deluca, Paolo; Drummond, Colin; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; Kaner, Eileen; Myles, Judy; Oyefeso, Adenekan; Parrott, Steve; Perryman, Katherine; Phillips, Tom; Shenker, Don; Shepherd, Jonathan

2009-11-18

A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) or the Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors associated with successful implementation. The trial will evaluate the impact of screening and brief alcohol intervention in routine probation work and therefore its findings will be highly relevant to probation teams and thus the criminal justice system in the UK.Ethical approval was given by Northern & Yorkshire REC. ISRCTN 19160244.

Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial.

PubMed

Hester, Katy L M; Newton, Julia; Rapley, Tim; De Soyza, Anthony

2016-04-23

There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. Previous work shows that patients and their families want more information, which could potentially improve their understanding and self-management. Using interviews and focus groups, we have co-developed a novel patient and carer information resource, aiming to meet their identified needs. The aims and objectives are: 1. To assess the potential impact of the information resource 2. To evaluate and refine the intervention 3. To establish the feasibility of carrying out a multi-centre randomised controlled trial to determine its effect on understanding, self-management and health outcomes This is a feasibility study, with a single-centre, randomised controlled trial design, comparing use of a novel patient information resource to usual care in bronchiectasis. Additionally, patients and carers will be invited to focus groups to discuss their views on both the intervention itself and the trial process. The study duration for each participant will be 3 months from the study entry date. A total of 70 patients will be recruited to the study, and a minimum of 30 will be randomised to each arm. Ten participants (and their carers if applicable) will be invited to attend focus groups on completion of the study visits. Participants will be adults with bronchiectasis diagnosed as per national bronchiectasis guidelines. Once consented, participants will be randomised to the intervention or control arm using random permuted blocks to ensure treatment group numbers are evenly balanced. Randomisation will be web-based. Those randomised to the intervention will receive the information resource (website and booklet) and instructions on its use. Outcome measures (resource satisfaction, resource use and alternative information seeking, quality of life questionnaires, unscheduled healthcare visits, exacerbation frequency, bronchiectasis knowledge questionnaire and lung function tests) will be recorded at baseline, 2 weeks and 3 months. All outcome measures will be used in assessing feasibility and acceptability of a future definitive trial. Feasibility outcomes include recruitment, retention and study scale form completion rates. Focus groups will strengthen qualitative data for resource refinement and to identify participant views on the trial process, which will also inform feasibility assessments. Questionnaires will also be used to evaluate and refine the resource. ISRCTN84229105.

Corticosteroids for Bell's palsy (idiopathic facial paralysis).

PubMed

Madhok, Vishnu B; Gagyor, Ildiko; Daly, Fergus; Somasundara, Dhruvashree; Sullivan, Michael; Gammie, Fiona; Sullivan, Frank

2016-07-18

Inflammation and oedema of the facial nerve are implicated in causing Bell's palsy. Corticosteroids have a potent anti-inflammatory action that should minimise nerve damage. This is an update of a review first published in 2002 and last updated in 2010. To determine the effectiveness and safety of corticosteroid therapy in people with Bell's palsy. On 4 March 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. We reviewed the bibliographies of the randomised trials and contacted known experts in the field to identify additional published or unpublished trials. We also searched clinical trials registries for ongoing trials. Randomised trials and quasi-randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group receiving no therapy considered effective for this condition, unless the same therapy was given in a similar way to the experimental group. We used standard Cochrane methodology. The main outcome of interest was incomplete recovery of facial motor function (i.e. residual facial weakness). Secondary outcomes were cosmetically disabling persistent sequelae, development of motor synkinesis or autonomic dysfunction (i.e. hemifacial spasm, crocodile tears) and adverse effects of corticosteroid therapy manifested during follow-up. We identified seven trials, with 895 evaluable participants for this review. All provided data suitable for the primary outcome meta-analysis. One of the trials was new since the last version of this Cochrane systematic review. Risk of bias in the older, smaller studies included some unclear- or high-risk assessments, whereas we deemed the larger studies at low risk of bias. Overall, 79/452 (17%) participants allocated to corticosteroids had incomplete recovery of facial motor function six months or more after randomisation; significantly fewer than the 125/447 (28%) in the control group (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.50 to 0.80, seven trials, n = 895). The number of people who need to be treated with corticosteroids to avoid one incomplete recovery was 10 (95% CI 6 to 20). The reduction in the proportion of participants with cosmetically disabling sequelae six months after randomisation was very similar in the corticosteroid and placebo groups (RR 0.96, 95% CI 0.40 to 2.29, two trials, n = 75, low-quality evidence). However, there was a significant reduction in motor synkinesis during follow-up in participants receiving corticosteroids (RR 0.64, 95% CI 0.45 to 0.91, three trials, n = 485, moderate-quality evidence). Three studies explicitly recorded the absence of adverse effects attributable to corticosteroids. One trial reported that three participants receiving prednisolone had temporary sleep disturbances and two trials gave a detailed account of adverse effects occurring in 93 participants, all non-serious; the combined analysis of data from these three trials found no significant difference in adverse effect rates between people receiving corticosteroids and people receiving placebo (RR 1.04, 95% CI 0.71 to 1.51, n = 715). The available moderate- to high-quality evidence from randomised controlled trials showed significant benefit from treating Bell's palsy with corticosteroids.

The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care

PubMed Central

de Lusignan, Simon; Gallagher, Hugh; Chan, Tom; Thomas, Nicki; van Vlymen, Jeremy; Nation, Michael; Jain, Neerja; Tahir, Aumran; du Bois, Elizabeth; Crinson, Iain; Hague, Nigel; Reid, Fiona; Harris, Kevin

2009-01-01

Background Chronic kidney disease (CKD) is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP) control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT) Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices) powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small group of practices (n = 4) will take part in an in-depth process evaluation. We will use time series data to examine the natural history of CKD in the community. Finally, we will conduct an economic evaluation based on a comparison of the cost effectiveness of each intervention. Clinical Trials Registration ISRCTN56023731. ClinicalTrials.gov identifier. PMID:19602233

The Effectiveness of Disaster Risk Communication: A Systematic Review of Intervention Studies

PubMed Central

Bradley, Declan T; McFarland, Marie; Clarke, Mike

2014-01-01

Introduction: A disaster is a serious disruption to the functioning of a community that exceeds its capacity to cope within its own resources. Risk communication in disasters aims to prevent and mitigate harm from disasters, prepare the population before a disaster, disseminate information during disasters and aid subsequent recovery. The aim of this systematic review is to identify, appraise and synthesise the findings of studies of the effects of risk communication interventions during four stages of the disaster cycle. Methods: We searched the Cochrane Central Register of Controlled Trials, Embase, MEDLINE, PsycInfo, Sociological Abstracts, Web of Science and grey literature sources for randomised trials, cluster randomised trials, controlled and uncontrolled before and after studies, interrupted time series studies and qualitative studies of any method of disaster risk communication to at-risk populations. Outcome criteria were disaster-related knowledge and behaviour, and health outcomes. Results: Searches yielded 5,224 unique articles, of which 100 were judged to be potentially relevant. Twenty-five studies met the inclusion criteria, and two additional studies were identified from other searching. The studies evaluated interventions in all four stages of the disaster cycle, included a variety of man-made, natural and infectious disease disasters, and were conducted in many disparate settings. Only one randomised trial and one cluster randomised trial were identified, with less robust designs used in the other studies. Several studies reported improvements in disaster-related knowledge and behaviour. Discussion: We identified and appraised intervention studies of disaster risk communication and present an overview of the contemporary literature. Most studies used non-randomised designs that make interpretation challenging. We do not make specific recommendations for practice but highlight the need for high-quality randomised trials and appropriately-analysed cluster randomised trials in the field of disaster risk communication where these can be conducted within an appropriate research ethics framework. PMID:25642365

Compliance, satisfaction, and quality of life of patients with colorectal cancer receiving home chemotherapy or outpatient treatment: a randomised controlled trial.

PubMed

Borras, J M; Sanchez-Hernandez, A; Navarro, M; Martinez, M; Mendez, E; Ponton, J L; Espinas, J A; Germa, J R

2001-04-07

To compare chemotherapy given at home with outpatient treatment in terms of colorectal cancer patients' safety, compliance, use of health services, quality of life, and satisfaction with treatment. Randomised controlled trial. Large teaching hospital. 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer. Treatment with fluorouracil (with or without folinic acid or levamisole) at outpatient clinic or at home. Treatment toxicity; patients' compliance with treatment, quality of life, satisfaction with care, and use of health resources. 42 patients were treated at outpatient clinic and 45 at home. The two groups were balanced in terms of age, sex, site of cancer, and disease stage. Treatment related toxicity was similar in the two groups (difference 7% (95% confidence interval -12% to 26%)), but there were more voluntary withdrawals from treatment in the outpatient group than in the home group (14% v 2%, difference 12% (1% to 24%)). There were no differences between groups in terms of quality of life scores during and after treatment. Levels of patient satisfaction were higher in the home treatment group, specifically with regard to information received and nursing care. There were no significant differences in use of health services. Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment.

Reporting quality of randomised controlled trials published in prosthodontic and implantology journals.

PubMed

Kloukos, D; Papageorgiou, S N; Doulis, I; Petridis, H; Pandis, N

2015-12-01

The purpose of this study was to examine the reporting quality of randomised controlled trials (RCTs) published in prosthodontic and implantology journals. Thirty issues of nine journals in prosthodontics and implant dentistry were searched for RCTs, covering the years 2005-2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry & Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry and Journal of Dentistry. The reporting quality was assessed using a modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations (α = 0·05). A total of 147 RCTs were identified with a mean CONSORT score of 69·4 (s.d. = 9·7). Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score (80·6, s.d. = 5·5) followed by Clinical Oral Implants Research (73·7, s.d. = 8·3). Involvement of a statistician/methodologist was significantly associated with increased CONSORT scores. Overall, the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement. This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making. © 2015 John Wiley & Sons Ltd.

Interventions for preventing unintended pregnancies among adolescents.

PubMed

Oringanje, Chioma; Meremikwu, Martin M; Eko, Hokehe; Esu, Ekpereonne; Meremikwu, Anne; Ehiri, John E

2016-02-03

Unintended pregnancy among adolescents represents an important public health challenge in high-income countries, as well as middle- and low-income countries. Numerous prevention strategies such as health education, skills-building and improving accessibility to contraceptives have been employed by countries across the world, in an effort to address this problem. However, there is uncertainty regarding the effects of these interventions, hence the need to review the evidence-base. To assess the effects of primary prevention interventions (school-based, community/home-based, clinic-based, and faith-based) on unintended pregnancies among adolescents. We searched all relevant studies regardless of language or publication status up to November 2015. We searched the Cochrane Fertility Regulation Group Specialised trial register, The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015 Issue 11), MEDLINE, EMBASE, LILACS, Social Science Citation Index and Science Citation Index, Dissertations Abstracts Online, The Gray Literature Network, HealthStar, PsycINFO, CINAHL and POPLINE and the reference lists of articles. We included both individual and cluster randomised controlled trials (RCTs) evaluating any interventions that aimed to increase knowledge and attitudes relating to risk of unintended pregnancies, promote delay in the initiation of sexual intercourse and encourage consistent use of birth control methods to reduce unintended pregnancies in adolescents aged 10 years to 19 years. Two authors independently assessed trial eligibility and risk of bias, and extracted data. Where appropriate, binary outcomes were pooled using a random-effects model with a 95% confidence interval (Cl). Where appropriate, we combined data in meta-analyses and assessed the quality of the evidence using the GRADE approach. We included 53 RCTs that enrolled 105,368 adolescents. Participants were ethnically diverse. Eighteen studies randomised individuals, 32 randomised clusters (schools (20), classrooms (6), and communities/neighbourhoods (6). Three studies were mixed (individually and cluster randomised). The length of follow up varied from three months to seven years with more than 12 months being the most common duration. Four trials were conducted in low- and middle- income countries, and all others were conducted in high-income countries. Multiple interventionsResults showed that multiple interventions (combination of educational and contraceptive-promoting interventions) lowered the risk of unintended pregnancy among adolescents significantly (RR 0.66, 95% CI 0.50 to 0.87; 4 individual RCTs, 1905 participants, moderate quality evidence. However, this reduction was not statistically significant from cluster RCTs. Evidence on the possible effects of interventions on secondary outcomes (initiation of sexual intercourse, use of birth control methods, abortion, childbirth, sexually transmitted diseases) was not conclusive.Methodological strengths included a relatively large sample size and statistical control for baseline differences, while limitations included lack of biological outcomes, possible self-report bias, analysis neglecting clustered randomisation and the use of different statistical tests in reporting outcomes. Educational interventionsEducational interventions were unlikely to significantly delay the initiation of sexual intercourse among adolescents compared to controls (RR 0.95, 95% CI 0.71 to 1.27; 2 studies, 672 participants, low quality evidence).Educational interventions significantly increased reported condom use at last sex in adolescents compared to controls who did not receive the intervention (RR 1.18, 95% CI 1.06 to 1.32; 2 studies, 1431 participants, moderate quality evidence).However, it is not clear if the educational interventions had any effect on unintended pregnancy as this was not reported by any of the included studies. Contraceptive-promoting interventionsFor adolescents who received contraceptive-promoting interventions, there was little or no difference in the risk of unintended first pregnancy compared to controls (RR 1.01, 95% CI 0.81 to 1.26; 2 studies, 3,440 participants, moderate quality evidence).The use of hormonal contraceptives was significantly higher in adolescents in the intervention group compared to those in the control group (RR 2.22, 95% CI 1.07 to 4.62; 2 studies, 3,091 participants, high quality evidence) A combination of educational and contraceptive-promoting interventions appears to reduce unintended pregnancy among adolescents.  Evidence for programme effects on biological measures is limited. The variability in study populations, interventions and outcomes of included trials, and the paucity of studies directly comparing different interventions preclude a definitive conclusion regarding which type of intervention is most effective.

Palliative pharmacological sedation for terminally ill adults.

PubMed

Beller, Elaine M; van Driel, Mieke L; McGregor, Leanne; Truong, Shani; Mitchell, Geoffrey

2015-01-02

Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain, vomiting, and psychological and physical distress. In the terminal phase of life, these symptoms may become refractory, and unable to be controlled by supportive and palliative therapies specifically targeted to these symptoms. Palliative sedation therapy is one potential solution to providing relief from these refractory symptoms. Sedation in terminally ill people is intended to provide relief from refractory symptoms that are not controlled by other methods. Sedative drugs such as benzodiazepines are titrated to achieve the desired level of sedation; the level of sedation can be easily maintained and the effect is reversible. To assess the evidence for the benefit of palliative pharmacological sedation on quality of life, survival, and specific refractory symptoms in terminally ill adults during their last few days of life. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 11), MEDLINE (1946 to November 2014), and EMBASE (1974 to December 2014), using search terms representing the sedative drug names and classes, disease stage, and study designs. We included randomised controlled trials (RCTs), quasi-RCTs, non-RCTs, and observational studies (e.g. before-and-after, interrupted-time-series) with quantitative outcomes. We excluded studies with only qualitative outcomes or that had no comparison (i.e. no control group or no within-group comparison) (e.g. single arm case series). Two review authors independently screened titles and abstracts of citations, and full text of potentially eligible studies. Two review authors independently carried out data extraction using standard data extraction forms. A third review author acted as arbiter for both stages. We carried out no meta-analyses due to insufficient data for pooling on any outcome; therefore, we reported outcomes narratively. The searches resulted in 14 included studies, involving 4167 adults, of whom 1137 received palliative sedation. More than 95% of people had cancer. No studies were randomised or quasi-randomised. All were consecutive case series, with only three having prospective data collection. Risk of bias was high, due to lack of randomisation. No studies measured quality of life or participant well-being, which was the primary outcome of the review. Five studies measured symptom control, using four different methods, so pooling was not possible. The results demonstrated that despite sedation, delirium and dyspnoea were still troublesome symptoms in these people in the last few days of life. Control of other symptoms appeared to be similar in sedated and non-sedated people. Only one study measured unintended adverse effects of sedative drugs and found no major events; however, four of 70 participants appeared to have drug-induced delirium. The study noticed no respiratory suppression. Thirteen of the 14 studies measured survival time from admission or referral to death, and all demonstrated no statistically significant difference between sedated and non-sedated groups. There was insufficient evidence about the efficacy of palliative sedation in terms of a person's quality of life or symptom control. There was evidence that palliative sedation did not hasten death, which has been a concern of physicians and families in prescribing this treatment. However, this evidence comes from low quality studies, so should be interpreted with caution. Further studies that specifically measure the efficacy and quality of life in sedated people, compared with non-sedated people, and quantify adverse effects are required.

Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial.

PubMed

Farmer, Andrew; Toms, Christy; Hardinge, Maxine; Williams, Veronika; Rutter, Heather; Tarassenko, Lionel

2014-01-08

The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations. Current controlled trials ISRCTN40367841.

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

PubMed Central

2012-01-01

Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial.

PubMed

Game, Frances; Jeffcoate, William; Tarnow, Lise; Day, Florence; Fitzsimmons, Deborah; Jacobsen, Judith

2017-10-10

Diabetic foot ulcers are a common and severe complication of diabetes mellitus. Standard treatment includes debridement, offloading, management of infection and revascularisation where appropriate, although healing times may be long. The LeucoPatch® device is used to generate an autologous platelet-rich fibrin and leucocyte wound dressing produced from the patient's own venous blood by centrifugation, but without the addition of any reagents. The final product comprises a thin, circular patch composed predominantly of fibrin together with living platelets and leucocytes. Promising results have been obtained in non-controlled studies this system, but this now needs to be tested in a randomised controlled trial (RCT). If confirmed, the LeucoPatch® may become an important new tool in the armamentarium in the management of diabetic foot ulcers which are hard-to-heal. People with diabetes and hard-to-heal ulcers of the foot will receive either pre-specified good standard care or good standard care supplemented by the application of the LeucoPatch® device. The primary outcome will be the percentage of ulcers healed within 20 weeks. Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group. Ulcers of the foot are a major source of morbidity to patients with diabetes and costs to health care economies. The study population is designed to be as inclusive as possible with the aim of maximising the external validity of any findings. The primary outcome measure is healing within 20 weeks of randomisation and the trial also includes a number of secondary outcome measures. Among these are rate of change in ulcer area as a predictor of the likelihood of eventual healing, minor and major amputation of the target limb, the incidence of infection and quality of life. International Standard Randomised Controlled Trial, ISRCTN27665670 . Registered on 5 July 2013.

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.

PubMed

Norton, Christine; Emmanuel, Anton; Stevens, Natasha; Scott, S Mark; Grossi, Ugo; Bannister, Sybil; Eldridge, Sandra; Mason, James M; Knowles, Charles H

2017-03-24

Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. A three-arm, parallel-group, multicentre randomised controlled trial. to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience. (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis. This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone. International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.

Effect and maintenance of the SLIMMER diabetes prevention lifestyle intervention in Dutch primary healthcare: a randomised controlled trial.

PubMed

Duijzer, G; Haveman-Nies, A; Jansen, S C; Beek, J Ter; van Bruggen, R; Willink, M G J; Hiddink, G J; Feskens, E J M

2017-05-08

To assess the effectiveness of the SLIMMER combined dietary and physical activity lifestyle intervention on clinical and metabolic risk factors, dietary intake, physical activity, and quality of life after 12 months, and to investigate whether effects sustained six months after the active intervention period ended. SLIMMER was a randomised controlled intervention, implemented in Dutch primary healthcare. In total, 316 subjects aged 40-70 years with increased risk of type 2 diabetes were randomly allocated to the intervention group (10-month dietary and physical activity programme) or the control group (usual healthcare). All subjects underwent an oral glucose tolerance test and physical examination, and filled in questionnaires. Identical examinations were performed at baseline and after 12 and 18 months. Primary outcome was fasting insulin. The intervention group showed significantly greater improvements in anthropometry and glucose metabolism. After 12 and 18 months, differences between intervention and control group were -2.7 kg (95% confidence interval (CI): -3.7; -1.7) and -2.5 kg (95% CI: -3.6; -1.4) for weight, and -12.1 pmol l -1 (95% CI: -19.6; -4.6) and -8.0 pmol l -1 (95% CI: -14.7; -0.53) for fasting insulin. Furthermore, dietary intake, physical activity, and quality of life improved significantly more in the intervention group than in the control group. The Dutch SLIMMER lifestyle intervention is effective in the short and long term in improving clinical and metabolic risk factors, dietary intake, physical activity, and quality of life in subjects at high risk of diabetes.

Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial

PubMed Central

Boyle, Robert J; Pedroletti, Christophe; Wickman, Magnus; Bjermer, Leif; Valovirta, Erkka; Dahl, Ronald; Von Berg, Andrea; Zetterström, Olof

2011-01-01

Objective To determine whether environmental control using nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of patients with persistent atopic asthma. Design Randomised, double-blind, placebo-controlled, parallel-group trial. Setting Nineteen European asthma clinics. Participants 312 patients aged 7–70 with inadequately controlled persistent atopic asthma. Main outcome measure Proportion of patients with an increase of ≥0.5 points in asthma quality of life score after 1 year of treatment. Results TLA devices were successfully installed in the bedrooms of 282 (90%) patients included in the primary efficacy analysis. There was a difference in treatment response rate between active (143 of 189, 76%) and placebo (56 of 92, 61%) groups, difference 14.8% (95% CI 3.1 to 26.5, p=0.02).3 In patients aged ≥12, on whom the study was powered, the difference in response rate was similar-active 106 of 143 (74%), placebo 42 of 70 (60%), difference 14.1% (0.6 to 27.7, p=0.059). There was a difference between groups in fractional exhaled nitric oxide change of −7.1 ppb (−13.6 to −0.7, p=0.03). Active treatment was associated with less increase in cat-specific IgE than placebo. There was no difference in adverse event rates between treatment groups. Conclusion Inhalant exposure reduction with TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. TLA may be a treatment option for patients with inadequately controlled persistent atopic asthma. Trial registration number Clinical Trials NCT00986323. PMID:22131290

Interventions in the alcohol server setting for preventing injuries.

PubMed

Ker, K; Chinnock, P

2006-04-19

Injuries are a significant public health burden and alcohol intoxication is recognised as a risk factor for injuries. There is increasing attention on supply-side interventions, which aim to modify the environment and context within which alcohol is supplied and consumed. To quantify the effectiveness of interventions implemented in the server setting for reducing injuries. We searched the Cochrane Injuries Group Specialised Register (September 2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2004), MEDLINE (January 1966 to September 2004), EMBASE (1980 to 2004, wk 36), other specialised databases and reference lists of articles. We also contacted experts in the field. Randomised controlled trials (RCTs) and non-randomised controlled studies (NRS) of the effectiveness of interventions administered in the server setting which attempted to modify the conditions under which alcohol is served and consumed, to facilitate sensible alcohol consumption and reduce the occurrence of alcohol-related harm. Two authors independently screened search results and assessed the full texts of potentially relevant studies for inclusion. Data were extracted and methodological quality was examined. Due to variability in the intervention types investigated, a pooled analysis was not appropriate. Twenty studies met the inclusion criteria. Overall methodological quality was poor. Five studies used an injury outcome measure; only one of these studies was randomised. The studies were grouped into broad categories according to intervention type. One NRS investigated server training and estimated a reduction of 23% in single vehicle night-time crashes in the experimental area (controlled for crashes in the control area). Another NRS examined the impact of a drink driving service, and reported a reduction in injury road crashes of 15% in the experimental area, with no change in the control; no difference was found for fatal crashes. One NRS investigating the impact of a policy intervention, reported that pre-intervention the serious assault rate in the experimental area was 52% higher than the rate in the control area. After intervention, the serious assault rate in the experimental area was 37% lower than in the control. The only RCT targeting the server setting environment with an injury outcome compared toughened glassware (experimental) to annealed glassware (control) on number of bar staff injuries; a greater number of injuries were detected in the experimental group (relative risk 1.72, 95% CI 1.15 to 2.59). A NRS investigating the impact of a intervention aiming to reduce crime experienced by drinking premises; found a lower rate of all crime in the experimental premises (rate ratio 4.6, 95% CI 1.7 to 12, P = 0.01), no difference was found for injury (rate ratio 1.1. 95% CI 0.1 to 10, P = 0.093). The effectiveness of the interventions on patron alcohol consumption is inconclusive. One randomised trial found a statistically significant reduction in observed severe aggression exhibited by patrons. There is some indication of improved server behaviour but it is difficult to predict what effect this might have on injury risk. There is no reliable evidence that interventions in the alcohol server setting are effective in reducing injury. Compliance with interventions appears to be a problem; hence mandated interventions may be more likely to show an effect. Randomised controlled trials, with adequate allocation concealment and blinding are required to improve the evidence base. Further well conducted non-randomised trials are also needed, when random allocation is not feasible.

Interventions in the alcohol server setting for preventing injuries.

PubMed

Ker, Katharine; Chinnock, Paul

2008-07-16

Injuries are a significant public health burden and alcohol intoxication is recognised as a risk factor for injuries. There is increasing attention on supply-side interventions, which aim to modify the environment and context within which alcohol is supplied and consumed. To quantify the effectiveness of interventions implemented in the server setting for reducing injuries. We searched the Cochrane Injuries Group Specialised Register (September 2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2004), MEDLINE (January 1966 to September 2004), EMBASE (1980 to 2004, wk 36), other specialised databases and reference lists of articles. We also contacted experts in the field. Randomised controlled trials (RCTs) and non-randomised controlled studies (NRS) of the effectiveness of interventions administered in the server setting which attempted to modify the conditions under which alcohol is served and consumed, to facilitate sensible alcohol consumption and reduce the occurrence of alcohol-related harm. Two authors independently screened search results and assessed the full texts of potentially relevant studies for inclusion. Data were extracted and methodological quality was examined. Due to variability in the intervention types investigated, a pooled analysis was not appropriate. Twenty studies met the inclusion criteria. Overall methodological quality was poor. Five studies used an injury outcome measure; only one of these studies was randomised. The studies were grouped into broad categories according to intervention type. One NRS investigated server training and estimated a reduction of 23% in single vehicle night-time crashes in the experimental area (controlled for crashes in the control area). Another NRS examined the impact of a drink driving service, and reported a reduction in injury road crashes of 15% in the experimental area, with no change in the control; no difference was found for fatal crashes. One NRS investigating the impact of a policy intervention, reported that pre-intervention the serious assault rate in the experimental area was 52% higher than the rate in the control area. After intervention, the serious assault rate in the experimental area was 37% lower than in the control. The only RCT targeting the server setting environment with an injury outcome compared toughened glassware (experimental) to annealed glassware (control) on number of bar staff injuries; a greater number of injuries were detected in the experimental group (relative risk 1.72, 95% CI 1.15 to 2.59). A NRS investigating the impact of a intervention aiming to reduce crime experienced by drinking premises; found a lower rate of all crime in the experimental premises (rate ratio 4.6, 95% CI 1.7 to 12, P = 0.01), no difference was found for injury (rate ratio 1.1. 95% CI 0.1 to 10, P = 0.093). The effectiveness of the interventions on patron alcohol consumption is inconclusive. One randomised trial found a statistically significant reduction in observed severe aggression exhibited by patrons. There is some indication of improved server behaviour but it is difficult to predict what effect this might have on injury risk. There is no reliable evidence that interventions in the alcohol server setting are effective in reducing injury. Compliance with interventions appears to be a problem; hence mandated interventions may be more likely to show an effect. Randomised controlled trials, with adequate allocation concealment and blinding are required to improve the evidence base. Further well conducted non-randomised trials are also needed, when random allocation is not feasible.

Spectacle wearing in children randomised to ready-made or custom spectacles, and potential cost savings to programmes: study protocol for a randomised controlled trial.

PubMed

Morjaria, Priya; Murali, Kaushik; Evans, Jennifer; Gilbert, Clare

2016-01-19

Uncorrected refractive errors are the commonest cause of visual impairment in children, with myopia being the most frequent type. Myopia usually starts around 9 years of age and progresses throughout adolescence. Hyperopia usually affects younger children, and astigmatism affects all age groups. Many children have a combination of myopia and astigmatism. To correct refractive errors, the type and degree of refractive error are measured and appropriate corrective lenses prescribed and dispensed in the spectacle frame of choice. Custom spectacles (that is, with the correction specifically required for that individual) are required if astigmatism is present, and/or the refractive error differs between eyes. Spectacles without astigmatic correction and where the refractive error is the same in both eyes are straightforward to dispense. These are known as 'ready-made' spectacles. High-quality spectacles of this type can be produced in high volume at an extremely low cost. Although spectacle correction improves visual function, a high proportion of children do not wear their spectacles for a variety of reasons. The aim of this study is to compare spectacle wear at 3-4 months amongst school children aged 11 to 15 years who have significant, simple uncorrected refractive error randomised to ready-made or custom spectacles of equivalent quality, and to evaluate cost savings to programmes. The study will take place in urban and semi-urban government schools in Bangalore, India. The hypothesis is that similar proportions of children randomised to ready-made or custom spectacles will be wearing their spectacles at 3-4 months. The trial is a randomised, non-inferiority, double masked clinical trial of children with simple uncorrected refractive errors. After screening, children will be randomised to ready-made or custom spectacles. Children will choose their preferred frame design. After 3-4 months the children will be followed up to assess spectacle wear. Ready-made spectacles have benefits for providers as well as parents and children, as a wide range of prescriptions and frame types can be taken to schools and dispensed immediately. In contrast, custom spectacles have to be individually made up in optical laboratories, and taken back to the school and given to the correct child. ISRCTN14715120 (Controlled-Trials.com) Date registered: 04 February 2015.

A case report of evaluating a large-scale health systems improvement project in an uncontrolled setting: a quality improvement initiative in KwaZulu-Natal, South Africa.

PubMed

Mate, Kedar S; Ngidi, Wilbroda Hlolisile; Reddy, Jennifer; Mphatswe, Wendy; Rollins, Nigel; Barker, Pierre

2013-11-01

New approaches are needed to evaluate quality improvement (QI) within large-scale public health efforts. This case report details challenges to large-scale QI evaluation, and proposes solutions relying on adaptive study design. We used two sequential evaluative methods to study a QI effort to improve delivery of HIV preventive care in public health facilities in three districts in KwaZulu-Natal, South Africa, over a 3-year period. We initially used a cluster randomised controlled trial (RCT) design. During the RCT study period, tensions arose between intervention implementation and evaluation design due to loss of integrity of the randomisation unit over time, pressure to implement changes across the randomisation unit boundaries, and use of administrative rather than functional structures for the randomisation. In response to this loss of design integrity, we switched to a more flexible intervention design and a mixed-methods quasiexperimental evaluation relying on both a qualitative analysis and an interrupted time series quantitative analysis. Cluster RCT designs may not be optimal for evaluating complex interventions to improve implementation in uncontrolled 'real world' settings. More flexible, context-sensitive evaluation designs offer a better balance of the need to adjust the intervention during the evaluation to meet implementation challenges while providing the data required to evaluate effectiveness. Our case study involved HIV care in a resource-limited setting, but these issues likely apply to complex improvement interventions in other settings.

Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

PubMed

Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

2012-03-19

Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our understanding of whether and how to use pet dogs to promote physical activity and/or to reduce sedentary behaviour in children and adults. The trial is intended to lead to a subsequent more definitive randomised controlled trial, and the work should inform future dog-based public health interventions such as secondary prevention interventions in children or adults. ISRCTN85939423.

Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods

PubMed Central

2012-01-01

Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our understanding of whether and how to use pet dogs to promote physical activity and/or to reduce sedentary behaviour in children and adults. The trial is intended to lead to a subsequent more definitive randomised controlled trial, and the work should inform future dog-based public health interventions such as secondary prevention interventions in children or adults. Trial registration number ISRCTN85939423 PMID:22429665

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening older women for the prevention of fractures: rationale, design and methods for the SCOOP study.

PubMed

Shepstone, L; Fordham, R; Lenaghan, E; Harvey, I; Cooper, C; Gittoes, N; Heawood, A; Peters, T J; O'Neill, T; Torgerson, D; Holland, R; Howe, A; Marshall, T; Kanis, J A; McCloskey, E

2012-10-01

SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture. Introduction Osteoporotic, or low-trauma, fractures present a considerable burden to the National Health Service and have major adverse effects on quality of life, disability and mortality for the individual. Methods Given the availability of efficacious treatments and a risk assessment tool based upon clinical risk factors and bone mineral density, a case exists to undertake a community-based controlled evaluation of screening for subjects at high risk of fracture, under the hypothesis that such a screening programme would reduce fractures in this population. Results This study is a UK seven-centre, unblinded, pragmatic, randomised controlled trial with a 5-year follow-up period. A total of 11,580 women, aged 70 to 85 years and not on prescribed bone protective therapy will be consented to the trial by post via primary care providing 90% power to detect an 18% decrease in fractures. Conclusions Participants will be randomised to either a screening arm or control. Those undergoing screening will have a 10-year fracture probability computed from baseline risk factors together with bone mineral density measured by DXA in selected subjects. Individuals above an age-dependent threshold of fracture probability will be recommended for treatment for the duration of the trial. Subjects in the control arm will receive 'usual care'. Participants will be followed up 6 months after randomisation and annually by postal questionnaires with independent checking of hospital and primary care records. The primary outcome will be the proportion of individuals sustaining fractures in each group. An economic analysis will be carried out to assess cost-effectiveness of screening. A qualitative evaluation will be conducted to examine the acceptability of the process to participants.

Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial.

PubMed

O'Dwyer, Tom; Monaghan, Ann; Moran, Jonathan; O'Shea, Finbar; Wilson, Fiona

2017-01-01

Does a 3-month behaviour change intervention targeting physical activity (PA) increase habitual physical activity in adults with ankylosing spondylitis (AS)? Does the intervention improve health-related physical fitness, AS-related features, and attitude to exercise? Are any gains maintained over a 3-month follow-up? Parallel-group, randomised, controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Forty adults with a diagnosis of AS, on stable medication, and without PA-limiting comorbidities. Over a 3-month period, the experimental group engaged in individually-tailored, semi-structured consultations aiming to motivate and support individuals in participating in PA. The control group continued with usual care. The primary outcome was PA measured by accelerometry over 1 week. Secondary outcomes included clinical questionnaires and measures of health-related physical fitness. Measures were taken at baseline, post-intervention, and after a 3-month follow-up period. Baseline characteristics were similar across groups, except age and body composition. There were statistically significant, moderate-to-large time-by-group effects in health-enhancing PA (mixed-design ANOVA for overall effect F(2, 76)=14.826, p<0.001), spinal mobility (F(2, 76)=5.691, p<0.005) and quality of life (χ 2 (2)=8.400, p<0.015) favouring the intervention group; post-intervention improvements were sustained 3 months later. No significant effects were seen in other physical fitness outcomes or on clinical questionnaires. No adverse effects were reported during the study. Health-enhancing PA, spinal mobility and quality of life were significantly improved after the intervention, and improvements were maintained at 3-month follow-up. NCT02374502. [O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F (2016) Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial.Journal of PhysiotherapyXX: XX-XX]. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Music therapy for depression.

PubMed

Maratos, A S; Gold, C; Wang, X; Crawford, M J

2008-01-23

Depression is a highly prevalent disorder associated with reduced social functioning, impaired quality of life, and increased mortality. Music therapy has been used in the treatment of a variety of mental disorders, but its impact on those with depression is unclear. To examine the efficacy of music therapy with standard care compared to standard care alone among people with depression and to compare the effects of music therapy for people with depression against other psychological or pharmacological therapies. CCDANCTR-Studies and CCDANCTR-References were searched on 7/11/2007, MEDLINE, PsycINFO, EMBASE, PsycLit, PSYindex, and other relevant sites were searched in November 2006. Reference lists of retrieved articles were hand searched, as well as specialist music and arts therapies journals. All randomised controlled trials comparing music therapy with standard care or other interventions for depression. Data on participants, interventions and outcomes were extracted and entered onto a database independently by two review authors. The methodological quality of each study was also assessed independently by two review authors. The primary outcome was reduction in symptoms of depression, based on a continuous scale. Five studies met the inclusion criteria of the review. Marked variations in the interventions offered and the populations studied meant that meta-analysis was not appropriate. Four of the five studies individually reported greater reduction in symptoms of depression among those randomised to music therapy than to those in standard care conditions. The fifth study, in which music therapy was used as an active control treatment, reported no significant change in mental state for music therapy compared with standard care. Dropout rates from music therapy conditions appeared to be low in all studies. Findings from individual randomised trials suggest that music therapy is accepted by people with depression and is associated with improvements in mood. However, the small number and low methodological quality of studies mean that it is not possible to be confident about its effectiveness. High quality trials evaluating the effects of music therapy on depression are required.

A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial.

PubMed

Battersby, Nick J; Dattani, Mit; Rao, Sheela; Cunningham, David; Tait, Diana; Adams, Richard; Moran, Brendan J; Khakoo, Shelize; Tekkis, Paris; Rasheed, Shahnawaz; Mirnezami, Alex; Quirke, Philip; West, Nicholas P; Nagtegaal, Iris; Chong, Irene; Sadanandam, Anguraj; Valeri, Nicola; Thomas, Karen; Frost, Michelle; Brown, Gina

2017-08-29

Pre-operative chemoradiotherapy (CRT) for MRI-defined, locally advanced rectal cancer is primarily intended to reduce local recurrence rates by downstaging tumours, enabling an improved likelihood of curative resection. However, in a subset of patients complete tumour regression occurs implying that no viable tumour is present within the surgical specimen. This raises the possibility that surgery may have been avoided. It is also recognised that response to CRT is a key determinant of prognosis. Recent radiological advances enable this response to be assessed pre-operatively using the MRI tumour regression grade (mrTRG). Potentially, this allows modification of the baseline MRI-derived treatment strategy. Hence, in a 'good' mrTRG responder, with little or no evidence of tumour, surgery may be deferred. Conversely, a 'poor response' identifies an adverse prognostic group which may benefit from additional pre-operative therapy. TRIGGER is a multicentre, open, interventional, randomised control feasibility study with an embedded phase III design. Patients with MRI-defined, locally advanced rectal adenocarcinoma deemed to require CRT will be eligible for recruitment. During CRT, patients will be randomised (1:2) between conventional management, according to baseline MRI, versus mrTRG-directed management. The primary endpoint of the feasibility phase is to assess the rate of patient recruitment and randomisation. Secondary endpoints include the rate of unit recruitment, acute drug toxicity, reproducibility of mrTRG reporting, surgical morbidity, pathological circumferential resection margin involvement, pathology regression grade, residual tumour cell density and surgical/specimen quality rates. The phase III trial will focus on long-term safety, regrowth rates, oncological survival analysis, quality of life and health economics analysis. The TRIGGER trial aims to determine whether patients with locally advanced rectal cancer can be recruited and subsequently randomised into a control trial that offers MRI-directed patient management according to radiological response to CRT (mrTRG). The feasibility study will inform a phase III trial design investigating stratified treatment of good and poor responders according to 3-year disease-free survival, colostomy-free survival as well as an increase in cases managed without a major resection. ClinicalTrials.gov, ID: NCT02704520 . Registered on 5 February 2016.

Rehabilitation of memory following brain injury (ReMemBrIn): study protocol for a randomised controlled trial.

PubMed

das Nair, Roshan; Lincoln, Nadina B; Ftizsimmons, Deborah; Brain, Nicola; Montgomery, Alan; Bradshaw, Lucy; Drummond, Avril; Sackley, Catherine; Newby, Gavin; Thornton, Jim; Stapleton, Sandip; Pink, Anthony

2015-01-06

Impairments of memory are commonly reported by people with traumatic brain injuries (TBI). Such deficits are persistent, debilitating, and can severely impact quality of life. Currently, many do not routinely receive follow-up appointments for residual memory problems following discharge. This is a multi-centre, randomised controlled trial investigating the clinical and cost-effectiveness of a group-based memory rehabilitation programme. Three hundred and twelve people with a traumatic brain injury will be randomised from four centres. Participants will be eligible if they had a traumatic brain injury more than 3 months prior to recruitment, have memory problems, are 18 to 69 years of age, are able to travel to one of our centres and attend group sessions, and are able to give informed consent. Participants will be randomised in clusters of 4 to 6 to the group rehabilitation intervention or to usual care. Intervention groups will receive 10 weekly sessions of a manualised memory rehabilitation programme, which has been developed in previous pilot studies. The intervention will include restitution strategies to retrain impaired memory functions and compensation strategies to enable participants to cope with their memory problems. All participants will receive a follow-up postal questionnaire and an assessment by a research assistant at 6 and 12 months post-randomisation. The primary outcome is the Everyday Memory Questionnaire at 6 months. Secondary outcomes include the Rivermead Behavioural Memory Test-3, General Health Questionnaire-30, health related quality of life, cost-effectiveness analysis determined by the EQ-5D and a service use questionnaire, individual goal attainment, European Brain Injury Questionnaire (patient and relative versions), and the Everyday Memory Questionnaire-relative version. The primary analysis will be based on intention to treat. A mixed-model regression analysis of the Everyday Memory Questionnaire at 6 months will be used to estimate the effect of the group memory rehabilitation programme. The study will hopefully provide robust evidence regarding the clinical and cost-effectiveness of a group-based memory rehabilitation intervention for civilians and military personnel following TBI. We discuss our decision-making regarding choice of outcome measures and control group, and the unique challenges to recruiting people with memory problems to trials. ISRCTN65792154; Date: 18 October 2012.

Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial.

PubMed

Bourke, Stephen C; Tomlinson, Mark; Williams, Tim L; Bullock, Robert E; Shaw, Pamela J; Gibson, G John

2006-02-01

Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial. 92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (T(i)MCS and T(i)sym) and mean improvement (microMCS and microsym) were measured. NIV improved T(i)MCS, T(i)sym, microMCS, microsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0.006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including microsym (p=0.018), but conferred no survival benefit. In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.

One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

PubMed

Strange, Simon; Whitehouse, Michael R; Beswick, Andrew D; Board, Tim; Burston, Amanda; Burston, Ben; Carroll, Fran E; Dieppe, Paul; Garfield, Kirsty; Gooberman-Hill, Rachael; Jones, Stephen; Kunutsor, Setor; Lane, Athene; Lenguerrand, Erik; MacGowan, Alasdair; Moore, Andrew; Noble, Sian; Simon, Joanne; Stockley, Ian; Taylor, Adrian H; Toms, Andrew; Webb, Jason; Whittaker, John-Paul; Wilson, Matthew; Wylde, Vikki; Blom, Ashley W

2016-02-17

Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies. Results from the INFORM trial will also benefit clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness. Current controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.

Cerebral near-infrared spectroscopy monitoring for prevention of brain injury in very preterm infants.

PubMed

Hyttel-Sorensen, Simon; Greisen, Gorm; Als-Nielsen, Bodil; Gluud, Christian

2017-09-04

Cerebral injury and long-term neurodevelopmental impairment is common in extremely preterm infants. Cerebral near-infrared spectroscopy (NIRS) enables continuous estimation of cerebral oxygenation. This diagnostic method coupled with appropriate interventions if NIRS is out of normal range (that is cerebral oxygenation within the 55% to 85% range) may offer benefits without causing more harms. Therefore, NIRS coupled with appropriate responses to abnormal findings on NIRS needs assessment in a systematic review of randomised clinical trials and quasi-randomised studies. To evaluate the benefits and harms of interventions that attempt to alter cerebral oxygenation guided by cerebral NIRS monitoring in order to prevent cerebral injury, improve neurological outcome, and increase survival in preterm infants born more than 8 weeks preterm. We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 8), MEDLINE via PubMed (1966 to 10 September 2016), Embase (1980 to 10 September 2016), and CINAHL (1982 to 10 September 2016). We also searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised clinical trials and quasi-randomised studies. Randomised clinical trials and quasi-randomised clinical studies comparing continuous cerebral NIRS monitoring for at least 24 hours versus blinded NIRS or versus no NIRS monitoring. Two review authors independently selected, assessed the quality of, and extracted data from the included trials and studies. If necessary, we contacted authors for further information. We conducted assessments of risks of bias; risks of design errors; and controlled the risks of random errors with Trial Sequential Analysis. We assessed the quality of the evidence with GRADE. One randomised clinical trial met inclusion criteria, including infants born more than 12 weeks preterm. The trial employed adequate methodologies and was assessed at low risk of bias. One hundred and sixty-six infants were randomised to start continuous cerebral NIRS monitoring less than 3 hours after birth until 72 hours after birth plus appropriate interventions if NIRS was out of normal range according to a guideline versus conventional monitoring with blinded NIRS. There was no effect of NIRS plus guideline of mortality until term-equivalent age (RR 0.50, 95% CI 0.29 to 1.00; one trial; 166 participants). There were no effects of NIRS plus guideline on intraventricular haemorrhages: all grades (RR 0.93, 95% CI 0.65 to 1.34; one trial; 166 participants); grade III/IV (RR 0.57, 95% CI 0.25 to 1.31; one trial; 166 participants); and cystic periventricular leukomalacia (which did not occur in either group). Likewise, there was no effect of NIRS plus guideline on the occurrence of a patent ductus arteriosus (RR 1.96, 95% CI 0.94 to 4.08; one trial; 166 participants); chronic lung disease (RR 1.27, 95% CI 0.94 to 1.50; one trial; 166 participants); necrotising enterocolitis (RR 0.83, 95% CI 0.33 to 1.94; one trial; 166 participants); and retinopathy of prematurity (RR 1.64, 95% CI 0.75 to 3.00; one trial; 166 participants). There were no serious adverse events in any of the intervention groups. NIRS plus guideline caused more skin marks from the NIRS sensor in the control group than in the experimental group (unadjusted RR 0.31, 95% CI 0.10 to 0.92; one trial; 166 participants). There are no data regarding neurodevelopmental outcome, renal impairment or air leaks.The quality of evidence for all comparisons discussed above was assessed as very low apart from all-cause mortality and adverse events: these were assessed as low and moderate, respectively. The validity of all comparisons is hampered by a small sample of randomised infants, risk of bias due to lack of blinding, and indirectness of outcomes. The only eligible randomised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes. The trial was, however, only powered to detect difference in cerebral oxygenation, not morbidities or mortality. Our systematic review did not reach sufficient power to prove or disprove effects on clinical outcomes. Further randomised clinical trials with low risks of bias and low risks of random errors are needed.

Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases.

PubMed

Rambaldi, A; Jacobs, B P; Iaquinto, G; Gluud, C

2005-04-18

Alcohol and hepatotoxic viruses cause the majority of liver diseases. Randomised clinical trials have assessed whether extracts of milk thistle, Silybum marianum (L) Gaertneri, have any effect in patients with alcoholic and/or hepatitis B or C virus liver diseases. To assess the beneficial and harmful effects of milk thistle or milk thistle constituents versus placebo or no intervention in patients with alcoholic liver disease and/or viral liver diseases (hepatitis B and hepatitis C). The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and full text searches were combined (December 2003). Manufacturers and researchers in the field were contacted. Only randomised clinical trials in patients with alcoholic and/or hepatitis B or C virus liver diseases (acute and chronic) were included. Interventions encompassed milk thistle at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published and no language limitations were applied. The primary outcome measure was mortality. Binary outcomes are reported as relative risks (RR) with 95% confidence interval (CI). Subgroup analyses were performed with regard to methodological quality. Thirteen randomised clinical trials assessed milk thistle in 915 patients with alcoholic and/or hepatitis B or C virus liver diseases. The methodological quality was low: only 23% of the trials reported adequate allocation concealment and only 46% were considered adequately double-blinded. Milk thistle versus placebo or no intervention had no significant effect on mortality (RR 0.78, 95% CI 0.53 to 1.15), complications of liver disease (RR 0.95, 95% CI 0.83 to 1.09), or liver histology. Liver-related mortality was significantly reduced by milk thistle in all trials (RR 0.50, 95% CI 0.29 to 0.88), but not in high-quality trials (RR 0.57, 95% CI 0.28 to 1.19). Milk thistle was not associated with a significantly increased risk of adverse events (RR 0.83, 95% CI 0.46 to 1.50). Our results question the beneficial effects of milk thistle for patients with alcoholic and/or hepatitis B or C virus liver diseases and highlight the lack of high-quality evidence to support this intervention. Adequately conducted and reported randomised clinical trials on milk thistle versus placebo are needed.

[Education for patients with fibromyalgia. A systematic review of randomised clinical trials].

PubMed

Elizagaray-Garcia, Ignacio; Muriente-Gonzalez, Jorge; Gil-Martinez, Alfonso

2016-01-16

To analyse the effectiveness of education about pain, quality of life and functionality in patients with fibromyalgia. The search for articles was carried out in electronic databases. Eligibility criteria were: controlled randomised clinical trials (RCT), published in English and Spanish, that had been conducted on patients with fibromyalgia, in which the therapeutic procedure was based on patient education. Two independent reviewers analysed the methodological quality using the PEDro scale. Five RCT were selected, of which four offered good methodological quality. In three of the studies, patient education, in combination with another intervention based on therapeutic exercise, improved the outcomes in the variables assessing pain and quality of life as compared with the same procedures performed separately. Moreover, an RCT with a high quality methodology showed that patient education activated inhibitory neural pathways capable of lowering the level of pain. The quantitative analysis yields strong-moderate evidence that patient education, in combination with other therapeutic exercise procedures, offers positive results in the variables pain, quality of life and functionality. Patient education in itself has not proved to be effective for pain, quality of life or functionality in patients with fibromyalgia. There is strong evidence, however, of the effectiveness of combining patient education with exercise and active strategies for coping with pain, quality of life and functionality in the short, medium and long term in patients with fibromyalgia.

The added value of mifepristone to non-surgical treatment regimens for uterine evacuation in case of early pregnancy failure: a systematic review of the literature.

PubMed

van den Berg, Joyce; Gordon, Bernardus B M; Snijders, Marcus P M L; Vandenbussche, Frank P H A; Coppus, Sjors F P J

2015-12-01

Early pregnancy failure (EPF) is a common complication of pregnancy. Surgical intervention carries a risk of complications and, therefore, medical treatment appears to be a safe alternative. Unfortunately, the current medical treatment with misoprostol alone has complete evacuation rates between 53% and 87%. Some reports suggest that sequential treatment with mifepristone and misoprostol leads to higher success rates than misoprostol alone. To evaluate the added value of mifepristone to current non-surgical treatment regimens in women with EPF we performed a systematic literature search. Electronic databases were searched: PubMed, Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. Clinical studies, both randomised and non-randomised trials, reporting on the added value of mifepristone to current non-surgical treatment regimens in women with EPF were included. Data of sixteen studies were extracted using a data extraction sheet (based on the Cochrane Consumers and Communication Review Group's data extraction template). The methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool. In five randomised and eleven non-randomised trials, success rates of sequential treatment with mifepristone and misoprostol in case of EPF varied between 52% and 95%. Large heterogeneity existed in treatment regimens and comparators between studies. The existing evidence is insufficient to draw firm conclusions about the added value of mifepristone to misoprostol alone. A sufficiently powered randomised, double blinded placebo-controlled trial is urgently required to test whether, in EPF, the sequential combination of mifepristone with misoprostol is superior to misoprostol only. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112.

PubMed

Muers, M F; Rudd, R M; O'Brien, M E R; Qian, W; Hodson, A; Parmar, M K B; Girling, D J

2004-02-01

The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma. Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N. During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC. The planned phase III trial is feasible.

SaFaRI: sacral nerve stimulation versus the FENIX magnetic sphincter augmentation for adult faecal incontinence: a randomised investigation.

PubMed

Williams, Annabelle E; Croft, Julie; Napp, Vicky; Corrigan, Neil; Brown, Julia M; Hulme, Claire; Brown, Steven R; Lodge, Jen; Protheroe, David; Jayne, David G

2016-02-01

Faecal incontinence is a physically, psychologically and socially disabling condition. NICE guidance (2007) recommends surgical intervention, including sacral nerve stimulation (SNS), after failed conservative therapies. The FENIX magnetic sphincter augmentation (MSA) device is a novel continence device consisting of a flexible band of interlinked titanium beads with magnetic cores that is placed around the anal canal to augment anal sphincter tone through passive attraction of the beads. Preliminary studies suggest the FENIX MSA is safe, but efficacy data is limited. Rigorous evaluation is required prior to widespread adoption. The SaFaRI trial is a National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded UK multi-site, parallel group, randomised controlled, unblinded trial that will investigate the use of the FENIX MSA, as compared to SNS, for adult faecal incontinence resistant to conservative management. Twenty sites across the UK, experienced in the treatment of faecal incontinence, will recruit 350 patients randomised equally to receive either SNS or FENIX MSA. Participants will be followed-up at 2 weeks post-surgery and at 6, 12 and 18 months post-randomisation. The primary endpoint is success, as defined by device in use and ≥50 % improvement in the Cleveland Clinic Incontinence Score (CCIS) at 18 months post-randomisation. Secondary endpoints include complications, quality of life and cost effectiveness. SaFaRI will rigorously evaluate a new technology for faecal incontinence, the FENIX™ MSA, allowing its safe and controlled introduction into current clinical practice. These results will inform the future surgical management of adult faecal incontinence.

A randomised controlled trial of intravenous zoledronic acid in malignant pleural disease: a proof of principle pilot study.

PubMed

Clive, Amelia O; Hooper, Clare E; Edey, Anthony J; Morley, Anna J; Zahan-Evans, Natalie; Hall, David; Lyburn, Iain; White, Paul; Braybrooke, Jeremy P; Sequeiros, Iara; Lyen, Stephen M; Milton, Tim; Kahan, Brennan C; Maskell, Nick A

2015-01-01

Animal studies have shown Zoledronic Acid (ZA) may diminish pleural fluid accumulation and tumour bulk in malignant pleural disease (MPD). We performed a pilot study to evaluate its effects in humans. We undertook a single centre, double-blind, placebo-controlled trial in adults with MPD. Patients were randomised (1:1) to receive 2 doses of intravenous ZA or placebo, 3 weeks apart and were followed-up for 6 weeks. The co-primary outcomes were change in Visual Analogue Scale (VAS) score measured breathlessness during trial follow-up and change in the initial area under the curve (iAUC) on thoracic Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) from randomisation to week 5. Multiple secondary endpoints were also evaluated. Between January 2010 and May 2013, 30 patients were enrolled, 24 randomised and 4 withdrew after randomisation (1 withdrew consent; 3 had a clinical decline). At baseline, the ZA group were more breathless, had more advanced disease on radiology and worse quality of life than the placebo group. There was no significant difference between the groups with regards change in breathlessness (Adjusted mean difference (AMD) 4.16 (95%CI -4.7 to 13.0)) or change in DCE-MRI iAUC (AMD -15.4 (95%CI -58.1 to 27.3). Two of nine (22%) in the ZA arm had a >10% improvement by modified RECIST (vs 0/11 who received placebo). There was no significant difference in quality of life measured by the QLQ-C30 score (global QOL: AMD -4.1 (-13.0 to 4.9)), side effects or serious adverse event rates. This is the first human study to evaluate ZA in MPD. The study is limited by small numbers and imbalanced baseline characteristics. Although no convincing treatment effect was identified, potential benefits for specific subgroups of patients cannot be excluded. This study provides important information regarding the feasibility of future trials to evaluate the effects of ZA further. UK Clinical Research Network ID 8877 ISRCTN17030426 www.isrctn.com.

The effects of pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: protocol for a randomised controlled trial.

PubMed

Lee, Annemarie L; Cecins, Nola; Hill, Catherine J; Holland, Anne E; Rautela, Linda; Stirling, Robert G; Thompson, Phillip J; McDonald, Christine F; Jenkins, Sue

2010-02-02

Non-cystic fibrosis bronchiectasis is characterised by sputum production, exercise limitation and recurrent infections. Although pulmonary rehabilitation is advocated for this patient group, its effects are unclear. The aims of this study are to determine the short and long term effects of pulmonary rehabilitation on exercise capacity, cough, quality of life and the incidence of acute pulmonary exacerbations. This randomised controlled trial aims to recruit 64 patients with bronchiectasis from three tertiary institutions. Participants will be randomly allocated to the intervention group (supervised, twice weekly exercise training with regular review of airway clearance therapy) or a control group (twice weekly telephone support). Measurements will be taken at baseline, immediately following the intervention and at six and 12 months following the intervention period by a blinded assessor. Exercise capacity will be measured using the incremental shuttle walk test and the six-minute walk test. Quality of life and health status will be measured using the Chronic Respiratory Questionnaire, Leicester Cough Questionnaire, Assessment of Quality of Life Questionnaire and the Hospital Anxiety and Depression Scale. The rate of hospitalisation will be captured as well as the incidence of acute pulmonary exacerbations using a daily symptom diary. Results from this study will help to determine the efficacy of supervised twice-weekly pulmonary rehabilitation upon exercise capacity and quality of life in patients with bronchiectasis and will contribute to clinical practice guidelines for physiotherapists in the management of this population. This study protocol is registered with ClinicalTrials.gov (NCT00885521).

Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn's disease: study protocol for a randomised controlled trial.

PubMed

Tew, Garry A; Carpenter, Roger; Seed, Michael; Anderson, Simon; Langmead, Louise; Fairhurst, Caroline; Bottoms, Lindsay

2017-01-01

Structured exercise training has been proposed as a useful adjunctive therapy for Crohn's disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone strength. However, the evidence for exercise in Crohn's disease is sparse, with only a handful of small prospective trials [1, 2], with methodological limitations, including the use of non-randomised and non-controlled study designs and small sample sizes. Here, we describe the protocol for a study that aims to assess the feasibility and acceptability of two common types of exercise training-high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-in adults with inactive or mildly active Crohn's disease (CD). This is a randomised, controlled, assessor-blinded, feasibility trial with three parallel groups. Forty-five adults with inactive or mildly active Crohn's disease will be randomly assigned 1:1:1 to HIIT, MICT or usual care control. Participants in the HIIT and MICT groups will be invited to undertake three sessions of supervised exercise each week for 12 consecutive weeks. HIIT sessions will consist of ten 1-min intervals of cycling exercise at 90% of peak power output separated by 1 min of active recovery. MICT sessions will involve 30 min of continuous cycling at 35% of peak power output. Participants will be assessed before randomisation and 13 and 26 weeks after randomisation. Feasibility outcomes include rates of recruitment, retention and adherence. Interviews with participants will explore the acceptability of the exercise programmes and study procedures. Clinical/health outcomes include cardiorespiratory fitness, body mass index, resting blood pressure, markers of disease activity (faecal calprotectin and Crohn's Disease Activity Index) and activated T cell cytokine profiles. Study questionnaires include the Inflammatory Bowel Disease Quality of Life Questionnaire, EQ-5D-5L, IBD Fatigue Scale, Hospital and Anxiety Depression Scale, and International Physical Activity Questionnaire. This study will provide useful information on the feasibility and acceptability of supervised exercise training in adults with inactive and mildly active Crohn's disease and will inform the design of a subsequent, adequately powered, multi-centre trial. The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN13021107). Date registration assigned was 02/12/2015.

A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain: The trial protocol [ISRCTN41196151].

PubMed

2003-12-08

BACKGROUND: Chronic pelvic pain is a common condition with a major impact on health-related quality of life, work productivity and health care utilisation. The cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases. In the absence of pathology there is no established treatment. The Lee-Frankenhauser sensory nerve plexuses and parasympathetic ganglia in the uterosacral ligaments carry pain from the uterus, cervix and other pelvic structures. Interruption of these nerve trunks by laparoscopic uterosacral nerve ablation (LUNA) may alleviate pain. However, the balance of benefits and risks of this intervention have not been reliably assessed. LUNA has, nevertheless, been introduced into practice, although there remains controversy regarding indications for LUNA. Hence, there is an urgent need for a randomised controlled trial to confirm, or refute, any worthwhile effectiveness. The principal hypothesis is that, in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (AFS score

Helicobacter pylori eradication therapy to prevent gastric cancer in healthy asymptomatic infected individuals: systematic review and meta-analysis of randomised controlled trials

PubMed Central

Forman, David; Hunt, Richard H; Yuan, Yuhong; Moayyedi, Paul

2014-01-01

Objectives To determine whether searching for Helicobacter pylori and treating with eradication therapy leads to a reduction in incidence of gastric cancer among healthy asymptomatic infected individuals. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Medline, Embase, and the Cochrane central register of controlled trials were searched through to December 2013. Conference proceedings between 2001 and 2013 were hand searched. A recursive search was performed with bibliographies of relevant studies. There were no language restrictions. Eligibility criteria for selecting studies Randomised controlled trials examining the effect of at least seven days of eradication therapy on subsequent occurrence of gastric cancer in adults who tested positive for Helicobacter pylori but otherwise healthy and asymptomatic were eligible. The control arm had to receive placebo or no treatment. Subjects had to be followed for ≥2 years. Main outcome measures Primary outcome, defined a priori, was the effect of eradication therapy on the subsequent occurrence of gastric cancer expressed as a relative risk of gastric cancer with 95% confidence intervals. Results The search strategy identified 1560 citations, of which six individual randomised controlled trials were eligible. Fifty one (1.6%) gastric cancers occurred among 3294 individuals who received eradication therapy versus 76 (2.4%) in 3203 control subjects (relative risk 0.66, 95% confidence interval 0.46 to 0.95), with no heterogeneity between studies (I2=0%, P=0.60). If the benefit of eradication therapy was assumed to persist lifelong the number needed to treat was as low as 15 for Chinese men and as high as 245 for US women. Conclusions These data provide limited, moderate quality evidence that searching for and eradicating H pylori reduces the incidence of gastric cancer in healthy asymptomatic infected Asian individuals, but these data cannot necessarily be extrapolated to other populations. PMID:24846275

Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomised controlled trial

PubMed Central

2007-01-01

Background At postgraduate level evidence based medicine (EBM) is currently taught through tutor based lectures. Computer based sessions fit around doctors' workloads, and standardise the quality of educational provision. There have been no randomized controlled trials comparing computer based sessions with traditional lectures at postgraduate level within medicine. Methods This was a randomised controlled trial involving six postgraduate education centres in the West Midlands, U.K. Fifty five newly qualified foundation year one doctors (U.S internship equivalent) were randomised to either computer based sessions or an equivalent lecture in EBM and systematic reviews. The change from pre to post-intervention score was measured using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). Results Both groups were similar at baseline. Participants' improvement in knowledge in the computer based group was equivalent to the lecture based group (gain in score: 2.1 [S.D = 2.0] versus 1.9 [S.D = 2.4]; ANCOVA p = 0.078). Attitudinal gains were similar in both groups. Conclusion On the basis of our findings we feel computer based teaching and learning is as effective as typical lecture based teaching sessions for educating postgraduates in EBM and systematic reviews. PMID:17659076

Extended preoperative patient education using a multimedia DVD-impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial.

PubMed

Wilhelm, D; Gillen, S; Wirnhier, H; Kranzfelder, M; Schneider, A; Schmidt, A; Friess, H; Feussner, H

2009-03-01

The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview. Multimedia productions can therefore be utilised as supporting tool. In a prospective randomised trial, we evaluated the impact of an extended education on patients undergoing cholecystectomy. For extended patient information, a professionally built DVD was used. After randomisation to either the DVD or the control group, patients were informed with or without additional presentation of the DVD. The quality of education was evaluated using a purpose-built questionnaire. One hundred fourteen patients were included in the DVD and 98 in the control group. Patient characteristics did not differ significantly despite a higher educational level in the DVD group. The score of correctly answered questions was higher in the DVD group (19.88 vs. 17.58 points, p < 0.001). As subgroup analysis revealed, particular patient characteristics additionally impacted on results. Patients should be informed the most extensively prior to any surgical procedure. Multimedia productions therefore offer a suitable instrument. In the presented study, we could prove the positive impact of an information DVD on patients knowledge. Nevertheless, multimedia tools cannot replace personal interaction and should only be used to support daily work.

A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

PubMed

Diaz-Ordaz, Karla; Froud, Robert; Sheehan, Bart; Eldridge, Sandra

2013-10-22

Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality. We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites. 73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality. Despite international attempts to improve methods in cluster randomised trials, important quality limitations remain amongst these trials in residential facilities. Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement. Funding bodies and journals should promote statistician involvement and co-authorship in addition to adherence to CONSORT guidelines.

Effect of exercise versus cognitive behavioural therapy or no intervention on anxiety, depression, fitness and quality of life in adults with previous methamphetamine dependency: a systematic review.

PubMed

Morris, Linzette; Stander, Jessica; Ebrahim, Wardah; Eksteen, Stephanie; Meaden, Orissa Anna; Ras, Ané; Wessels, Annemarie

2018-01-16

Methamphetamine (MA) is a highly addictive psychostimulant used by approximately 52 million people worldwide. Chronic MA abuse leads to detrimental physiological and neurological changes, as well as increases in anxiety and depression, and decreases in overall fitness and quality of life. Exercise has been reported to possibly reverse physiological and neurological damage caused by previous MA use, and to reduce anxiety and depression in this population. The aim of this systematic review was to identify, clinically appraise and synthesise the available evidence for the effectiveness of exercise, compared to cognitive behavioural therapy (CBT), standard care or no intervention, on decreasing anxiety and depression and improving fitness and quality of life in previous MA users. Seven computerised databases were searched from inception to May 2017, namely Scopus, Cochrane Library, PubMed/MEDLINE, PEDro, CINAHL, and ScienceDirect. Search terms included exercise, methamphetamine, fitness measures, depression, anxiety and quality of life. Randomised and non-randomised controlled- or clinical trials and pilot studies, published in English, were considered for inclusion. Methodological quality was critically appraised according to the PEDro scale. Heterogeneity across studies regarding control groups and assessment intervals rendered meta analyses inappropriate for this review and results were thus described narratively using text and tables. Two hundred and fifty-one titles were identified following the initial search, and 14 potentially-relevant titles were selected and the abstracts reviewed. Three studies (two randomised controlled trials and one quasi-experimental pilot) were included, with an average PEDro score of 6.66. Exercise resulted in significantly lower depression and anxiety scores versus CBT (p = 0.001). Balance also significantly improved following exercise versus standard care (p < 0.001); as did vital capacity, hand-grip and one-leg stand with eyes closed. There were significant changes in all subdivisions of the Quality of Life Scale Questionnaire (p < 0.05), except psychology (p = 0.227). Level II evidence suggests that exercise is effective in reducing anxiety and depression and improving fitness in previous MA users, and Level III-2 evidence suggests that exercise is beneficial for improving quality of life in this population. Overall recovery in previous MA dependents might be significantly enhanced by including exercise in the rehabilitation process. Further research is required to strengthen these conclusions and to inform policy and health systems effectively.

Clinical disease registries in acute myocardial infarction.

PubMed

Ashrafi, Reza; Hussain, Hussain; Brisk, Robert; Boardman, Leanne; Weston, Clive

2014-06-26

Disease registries, containing systematic records of cases, have for nearly 100 years been valuable in exploring and understanding various aspects of cardiology. This is particularly true for myocardial infarction, where such registries have provided both epidemiological and clinical information that was not readily available from randomised controlled trials in highly-selected populations. Registries, whether mandated or voluntary, prospective or retrospective in their analysis, have at their core a common study population and common data definitions. In this review we highlight how registries have diversified to offer information on epidemiology, risk modelling, quality assurance/improvement and original research-through data mining, transnational comparisons and the facilitation of enrolment in, and follow-up during registry-based randomised clinical trials.

Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care.

PubMed

Khunti, Kamlesh; Gray, Laura J; Skinner, Timothy; Carey, Marian E; Realf, Kathryn; Dallosso, Helen; Fisher, Harriet; Campbell, Michael; Heller, Simon; Davies, Melanie J

2012-04-26

To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years. Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level. 207 general practices in 13 primary care sites in the United Kingdom. 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants. A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. The primary outcome was glycated haemoglobin (HbA(1c)) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years. HbA(1c) levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference -0.02, 95% confidence interval -0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years. A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Current Controlled Trials ISRCTN17844016.

A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial.

PubMed

McAndrew, Amy; Lawn, Will; Stevens, Tobias; Porffy, Lilla; Brandner, Brigitta; Morgan, Celia J A

2017-04-04

Worldwide, alcohol abuse is a burgeoning problem. Abstinence is key to allow recovery of physical and mental health as well as quality of life, but treatment for alcohol dependence is associated with high relapse rates. Preliminary data have suggested that a combined repeated ketamine and psychological therapy programme may be effective in reducing relapse in severe alcohol use disorder. This non-commercial proof-of-concept trial is aimed at making a preliminary assessment of the effectiveness of this combined treatment in this patient group. This is a phase II, randomised, double-blind, placebo-controlled, parallel-group clinical trial taking place in two sites in the UK: the South West of England and London. Ninety-six recently detoxified alcoholics, with comorbid depressive symptoms, will be randomised to one of four treatment arms. Patients will receive either three sessions of ketamine (0.8 mg/kg administered intravenously (IV) over 40 minutes) or placebo (50 ml saline 0.9% IV over 40 minutes) plus either seven sessions of manualised psychological therapy or an alcohol education control. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. The primary endpoints are (1) relapse rates at 6 months and (2) percentage days abstinent at 6 months. Secondary endpoints include 3 and 6 month percentage days abstinence, tolerability (indicated by dropout), adverse events, depressive symptoms, craving and quality of life. This study will provide important information on a new combined psychological and pharmacological intervention aimed at reducing relapse rates in alcoholics. The findings would have broad application given the worldwide prevalence of alcoholism and its associated medical, psychological and social problems. ClinicalTrials.gov, NCT02649231 . Registered on 5 January 2016.

Glutamine supplementation to prevent morbidity and mortality in preterm infants.

PubMed

Moe-Byrne, Thirimon; Brown, Jennifer V E; McGuire, William

2016-01-12

Glutamine is a conditionally essential amino acid. Endogenous biosynthesis may be insufficient for tissue needs in states of metabolic stress. Evidence exists that glutamine supplementation improves clinical outcomes in critically ill adults. It has been suggested that glutamine supplementation may also benefit preterm infants. To determine the effects of glutamine supplementation on mortality and morbidity in preterm infants. We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 12), MEDLINE, EMBASE and Maternity and Infant Care (to December 2015), conference proceedings and previous reviews. Randomised or quasi-randomised controlled trials that compared glutamine supplementation versus no glutamine supplementation in preterm infants at any time from birth to discharge from hospital. We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two review authors. We synthesised data using a fixed-effect model and reported typical relative risk, typical risk difference and weighted mean difference. We identified 12 randomised controlled trials in which a total of 2877 preterm infants participated. Six trials assessed enteral glutamine supplementation and six trials assessed parenteral glutamine supplementation. The trials were generally of good methodological quality. Meta-analysis did not find an effect of glutamine supplementation on mortality (typical relative risk 0.97, 95% confidence interval 0.80 to 1.17; risk difference 0.00, 95% confidence interval -0.03 to 0.02) or major neonatal morbidities including the incidence of invasive infection or necrotising enterocolitis. Three trials that assessed neurodevelopmental outcomes in children aged 18 to 24 months and beyond did not find any effects. The available trial data do not provide evidence that glutamine supplementation confers important benefits for preterm infants.

Glutamine supplementation to prevent morbidity and mortality in preterm infants.

PubMed

Moe-Byrne, Thirimon; Brown, Jennifer V E; McGuire, William

2016-04-18

Glutamine is a conditionally essential amino acid. Endogenous biosynthesis may be insufficient for tissue needs in states of metabolic stress. Evidence exists that glutamine supplementation improves clinical outcomes in critically ill adults. It has been suggested that glutamine supplementation may also benefit preterm infants. To determine the effects of glutamine supplementation on mortality and morbidity in preterm infants. We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 12), MEDLINE, EMBASE and Maternity and Infant Care (to December 2015), conference proceedings and previous reviews. Randomised or quasi-randomised controlled trials that compared glutamine supplementation versus no glutamine supplementation in preterm infants at any time from birth to discharge from hospital. We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two review authors. We synthesised data using a fixed-effect model and reported typical relative risk, typical risk difference and weighted mean difference. We identified 12 randomised controlled trials in which a total of 2877 preterm infants participated. Six trials assessed enteral glutamine supplementation and six trials assessed parenteral glutamine supplementation. The trials were generally of good methodological quality. Meta-analysis did not find an effect of glutamine supplementation on mortality (typical relative risk 0.97, 95% confidence interval 0.80 to 1.17; risk difference 0.00, 95% confidence interval -0.03 to 0.02) or major neonatal morbidities including the incidence of invasive infection or necrotising enterocolitis. Three trials that assessed neurodevelopmental outcomes in children aged 18 to 24 months and beyond did not find any effects. The available trial data do not provide evidence that glutamine supplementation confers important benefits for preterm infants.

Prophylactic antibiotics for burns patients: systematic review and meta-analysis

PubMed Central

Avni, Tomer; Levcovich, Ariela; Ad-El, Dean D; Leibovici, Leonard

2010-01-01

Objective To assess the evidence for prophylactic treatment with systemic antibiotics in burns patients. Design Systematic review and meta-analysis of randomised or quasi-randomised controlled trials recruiting burns inpatients that compared antibiotic prophylaxis (systemic, non-absorbable, or topical) with placebo or no treatment. Data sources PubMed, Cochrane Library, LILACS, Embase, conference proceedings, and bibliographies. No language, date, or publication status restrictions were imposed. Review methods Two reviewers independently extracted data. The primary outcome was all cause mortality. Risk or rate ratios with 95% confidence intervals were pooled with a fixed effect model if no heterogeneity was present. Results 17 trials were included. Trials that assessed systemic antibiotic prophylaxis given for 4-14 days after admission showed a significant reduction in all cause mortality (risk ratio 0.54, 95% confidence interval 0.34 to 0.87, five trials). The corresponding number needed to treat was 8 (5 to 33), with a control event rate of 26%. Perioperative non-absorbable or topical antibiotics alone did not significantly affect mortality. There was a reduction in pneumonia with systemic prophylaxis and a reduction in wound infections with perioperative prophylaxis. Staphylococcus aureus infection or colonisation was reduced with anti-staphylococcal antibiotics. In three trials, resistance to the antibiotic used for prophylaxis significantly increased (rate ratio 2.84, 1.38 to 5.83). The overall methodological quality of the trials was poor. Conclusions Prophylaxis with systemic antibiotics has a beneficial effect in burns patients, but the methodological quality of the data is weak. As such prophylaxis is currently not recommended for patients with severe burns other than perioperatively, there is a need for randomised controlled trials to assess its use. PMID:20156911

RCT - subjective physical performance and quality of life after a 6-month programmed sports therapy (PST) in patients with haemophilia.

PubMed

Runkel, B; Von Mackensen, S; Hilberg, T

2017-01-01

Musculoskeletal bleedings lead to limitations in the locomotor system and consequently, in health-related quality of life (HRQoL) in patients with haemophilia (PwH). Sports therapy is increasingly recommended to improve their physical performance. Until today, randomised controlled studies investigating changes in physical performance in PwH are rare. This study investigates the impact of programmed sports therapy on the subjective physical performance and the HRQoL in PwH. A randomised controlled trial (RCT) was conducted with a training intervention for over 6 months. For this purpose, 64 PwH with moderate (n = 5) or severe (n = 59) haemophilia A (n = 57) or B (n = 7) were randomised into two groups - intervention (IG) or control group (CG). The HRQoL was assessed with the SF-36 questionnaire and the disease-specific Haem-A-QoL before and after the intervention. The subjective physical performance was tested by the HEP-Test-Q. After the 6-month training intervention, PwH in the IG subjectively reported significant better 'endurance' (P = 0.000) in the HEP-Test-Q compared to the CG. In the SF-36, a significant difference in the domains 'general health perceptions' (P = 0.005) and 'mental health' (P = 0.001) was detected. The haemophilia-specific HRQoL questionnaire showed a significant improvement in the dimensions 'feeling' (P = 0.049), 'work' (P = 0.046) and 'family' (P = 0.040). In the first RCT evaluating the impact of a 6-month training intervention on the subjective perception of PwH, an increase in subjective physical performance and some domains of HRQoL was demonstrated in the IG. Specific sports therapy should be included into the comprehensive treatment under supervision and monitoring by experienced staff. © 2016 John Wiley & Sons Ltd.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

PubMed

Little, Paul; Lewith, George; Webley, Fran; Evans, Maggie; Beattie, Angela; Middleton, Karen; Barnett, Jane; Ballard, Kathleen; Oxford, Frances; Smith, Peter; Yardley, Lucy; Hollinghurst, Sandra; Sharp, Debbie

2008-08-19

To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Factorial randomised trial. 64 general practices in England. 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. Roland Morris disability score (number of activities impaired by pain) and number of days in pain. Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. National Research Register N0028108728.

Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

PubMed

Little, Paul; Lewith, George; Webley, Fran; Evans, Maggie; Beattie, Angela; Middleton, Karen; Barnett, Jane; Ballard, Kathleen; Oxford, Frances; Smith, Peter; Yardley, Lucy; Hollinghurst, Sandra; Sharp, Debbie

2008-12-01

To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Factorial randomised trial. Setting 64 general practices in England. 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. Roland Morris disability score (number of activities impaired by pain) and number of days in pain. Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.

PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

PubMed

Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

2015-04-29

Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

Pharmacological prevention of post-traumatic stress disorder and acute stress disorder: a systematic review and meta-analysis.

PubMed

Sijbrandij, Marit; Kleiboer, Annet; Bisson, Jonathan I; Barbui, Corrado; Cuijpers, Pim

2015-05-01

An increasing number of studies have investigated the pharmacological prevention of post-traumatic stress disorder (PTSD) and acute stress disorder (ASD). This is the first systematic review to examine the effects of pharmacotherapies (eg, β blockers, hydrocortisone, and selective serotonin re-uptake inhibitors) given within the first month after a traumatic or aversive event to prevent PTSD or ASD compared with no pharmacotherapy or placebo control. A systematic literature search in PubMed, PsycINFO, Embase, and the Cochrane database of randomised trials was done. Studies included randomised controlled trials, controlled clinical trials, and cohort studies; their overall quality was low to moderate. We computed the pooled incidence risk ratio (IRR): the risk of incidence of PTSD or ASD in the pharmacotherapy groups relative to the incidence of PTSD or ASD in the control groups. Additionally, we computed Hedges'g effect sizes for PTSD or ASD continuous outcomes. 15 studies met inclusion criteria (1765 individuals). Pharmacotherapy was more effective in preventing PTSD or ASD than placebo or no intervention (14 studies, 1705 individuals, IRR 0·65, 95% CI 0·55-0·78; number needed to treat 11·36), although no effect was found when only randomised controlled trials were included (ten studies, 300 individuals, IRR 0·69, 95% CI 0·40-1·21). Hydrocortisone showed a large effect in reducing the risk of PTSD (five studies, 164 individuals, IRR 0·38, 95% CI 0·16-0·92). No firm evidence was found for the efficacy of all early pharmacotherapies in the prevention of PTSD or ASD, but hydrocortisone reduced the risk of developing PTSD. The small number of studies and their limited methodological quality cast uncertainty about the effects. None. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effect of preventive primary care outreach on health related quality of life among older adults at risk of functional decline: randomised controlled trial

PubMed Central

Brazil, Kevin; Hutchison, Brian; Kaczorowski, Janusz; Dalby, Dawn M; Goldsmith, Charles H; Furlong, William

2010-01-01

Objective To evaluate the impact of a provider initiated primary care outreach intervention compared with usual care among older adults at risk of functional decline. Design Randomised controlled trial. Setting Patients enrolled with 35 family physicians in five primary care networks in Hamilton, Ontario, Canada. Participants Patients were eligible if they were 75 years of age or older and were not receiving home care services. Of 3166 potentially eligible patients, 2662 (84%) completed the validated postal questionnaire used to determine risk of functional decline. Of 1724 patients who met the risk criteria, 769 (45%) agreed to participate and 719 were randomised. Intervention The 12 month intervention, provided by experienced home care nurses in 2004-6, consisted of a comprehensive initial assessment using the resident assessment instrument for home care; collaborative care planning with patients, their families, and family physicians; health promotion; and referral to community health and social support services. Main outcome measures Quality adjusted life years (QALYs), use and costs of health and social services, functional status, self rated health, and mortality. Results The mean difference in QALYs between intervention and control patients during the study period was not statistically significant (0.017, 95% confidence interval −0.022 to 0.056; P=0.388). The mean difference in overall cost of prescription drugs and services between the intervention and control groups was not statistically significant, (−$C165 (£107; €118; $162), 95% confidence interval −$C16 545 to $C16 214; P=0.984). Changes over 12 months in functional status and self rated health were not significantly different between the intervention and control groups. Ten patients died in each group. Conclusions The results of this study do not support adoption of this preventive primary care intervention for this target population of high risk older adults. Trial registration Clinical trials NCT00134836. PMID:20400483

Calcium and phosphorus supplementation of human milk for preterm infants.

PubMed

Harding, Jane E; Wilson, Jess; Brown, Julie

2017-02-26

Preterm infants are born with low skeletal stores of calcium and phosphorus. Preterm human milk provides insufficient calcium and phosphorus to meet the estimated needs of preterm infants for adequate growth. Supplementation of human milk with calcium and phosphorus may improve growth and development of preterm infants. To determine whether addition of calcium and phosphorus supplements to human milk leads to improved growth and bone metabolism of preterm infants without significant adverse effects. We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3), MEDLINE via PubMed (1966 to 14 April 2016), Embase (1980 to 14 April 2016) and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 14 April 2016). We also searched clinical trials databases (11 May 2016) and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. Randomised and quasi-randomised trials comparing supplementation of human milk with calcium and/or phosphorus versus no supplementation in hospitalised preterm infants were eligible for inclusion in this review. Two review authors (JB, JW) independently extracted data and assessed trial quality using standard methods of the Cochrane Neonatal Review Group. We reported dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the quality of evidence. This is an update of a 2001 review that identified no eligible trials. One trial including 40 infants met the inclusion criteria for this review. Using GRADE criteria, we judged the quality of the evidence as low owing to risk of bias (inadequate reporting of methods of randomisation, allocation concealment and/or blinding) and imprecision (wide confidence intervals and data from a single small trial). We found no evidence of a difference between calcium and phosphorus supplementation versus no supplementation for neonatal growth outcomes (weight, length, head circumference) at any time point reported (two, four or six weeks postnatal age). At six weeks postnatal age, supplementation with calcium/phosphorus was associated with a decrease in serum alkaline phosphatase concentration (MD -56.85 IU/L, 95% CI -101.27 to -12.43; one randomised controlled trial (RCT); n = 40 infants). Investigators provided no data on growth at 12 to 18 months, neonatal fractures, feed intolerance, breastfeeding or any of the prespecified childhood outcomes for this review (fractures, growth, neurodevelopmental outcomes). We identified one small trial including only 40 infants that compared supplementation of human milk with calcium and phosphorus versus no supplementation in hospitalised preterm infants. We judged the evidence to be of low quality and found no evidence of differences between groups for clinically important outcomes including growth and fractures. Although serum alkaline phosphatase concentration was reduced in the group receiving supplementation at six weeks postnatal age, this difference is unlikely to be of clinical significance. We conclude that evidence is insufficient to determine whether benefit or harm ensues when human milk is supplemented with calcium and/or phosphorus for the hospitalised preterm infant. We see no advantage of conducting further trials of this intervention because with the advent of multi-component human milk fortifier, supplementation of human milk with calcium and/or phosphorus alone is no longer common practice. Future trials should consider assessing effects of multi-component fortifiers with different mineral compositions on clinically important outcomes during the neonatal period and in later childhood.

Land-based versus aquatic resistance therapeutic exercises for older women with sarcopenic obesity: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Sarcopenic obesity is a health condition that combines excess adipose tissue and loss of muscle mass and strength. Sarcopenic obesity predisposes to more functional disabilities than obesity or sarcopenia alone. Progressive resistance exercises are recommended for older people as a potential treatment for sarcopenia and also for obesity. However, there is a lack of evidence indicating which programmes are best applied to older people, and no studies have investigated their effects on sarcopenic obese people. The aims of this protocol study are to investigate and compare the efficacy of land-based and aquatic resistance exercise programmes on improving muscle performance, functional capacity and quality of life of older women with sarcopenic obesity. Methods/Design This is a protocol study for a parallel randomised controlled clinical trial. Eligible participants are older women (≥65 years) with a body mass index ≥30 kg/m 2 and hand grip strength ≤21 kg force. A total sample of 36 participants will be randomly allocated to one of the intervention groups in blocks of three: land-based, aquatic or control. Each intervention group will undergo 2-week sessions of a 10-week therapeutic exercise programme for strength, power and endurance training of the lower-limb muscles. Participants in the control group will not participate in any strengthening activity for lower limbs and will receive telephone calls once a week. Baseline and final evaluation of outcomes will encompass muscle performance of the lower limbs assessed by an isokinetic dynamometer; functional tests of usual walking speed, maximal walking speed (shuttle walking test), stair speed and the Short Physical Performance Battery; and health-related quality of life (Medical Outcomes Study Short Form Questionnaire – SF-36). Data collectors will be blinded to randomisation and will not be in touch with participants during the interventions. Discussion This study is the first randomised controlled trial designed to evaluate resistance exercises in older patients with sarcopenic obesity. If our hypothesis proves correct, both intervention programmes will be effective, with the land-based exercises conferring better results in muscle performance. Trial registration Registro Brasileiro de Ensaios Clínicos: RBR-9p5q67 PMID:24041219

The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial.

PubMed

Loughney, Lisa; West, Malcolm A; Kemp, Graham J; Rossiter, Harry B; Burke, Shaunna M; Cox, Trevor; Barben, Christopher P; Mythen, Michael G; Calverley, Peter; Palmer, Daniel H; Grocott, Michael P W; Jack, Sandy

2016-01-13

The standard treatment pathway for locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery. Neoadjuvant CRT has been shown to decrease physical fitness, and this decrease is associated with increased post-operative morbidity. Exercise training can stimulate skeletal muscle adaptations such as increased mitochondrial content and improved oxygen uptake capacity, both of which are contributors to physical fitness. The aims of the EMPOWER trial are to assess the effects of neoadjuvant CRT and an in-hospital exercise training programme on physical fitness, health-related quality of life (HRQoL), and physical activity levels, as well as post-operative morbidity and cancer staging. The EMPOWER Trial is a randomised controlled trial with a planned recruitment of 46 patients with locally advanced rectal cancer and who are undergoing neoadjuvant CRT and surgery. Following completion of the neoadjuvant CRT (week 0) prior to surgery, patients are randomised to an in-hospital exercise training programme (aerobic interval training for 6 to 9 weeks) or a usual care control group (usual care and no formal exercise training). The primary endpoint is oxygen uptake at lactate threshold ([Formula: see text] at [Formula: see text]) measured using cardiopulmonary exercise testing assessed over several time points throughout the study. Secondary endpoints include HRQoL, assessed using semi-structured interviews and questionnaires, and physical activity levels assessed using activity monitors. Exploratory endpoints include post-operative morbidity, assessed using the Post-Operative Morbidity Survey (POMS), and cancer staging, assessed by using magnetic resonance tumour regression grading. The EMPOWER trial is the first randomised controlled trial comparing an in-hospital exercise training group with a usual care control group in patients with locally advanced rectal cancer. This trial will allow us to determine whether exercise training following neoadjuvant CRT can improve physical fitness and activity levels, as well as other important clinical outcome measures such as HRQoL and post-operative morbidity. These results will aid the design of a large, multi-centre trial to determine whether an increase in physical fitness improves clinically relevant post-operative outcomes. ClinicalTrials.gov NCT01914068 (received: 7 June 2013). University Hospital Southampton NHS Foundation Trust.

Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

PubMed

Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

2016-07-29

Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding. ISRCTN61788850 . Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015.

Effects of postural specific sensorimotor training in patients with chronic low back pain: study protocol for randomised controlled trial.

PubMed

McCaskey, Michael A; Schuster-Amft, Corina; Wirth, Brigitte; de Bruin, Eling D

2015-12-15

Sensorimotor training (SMT) is popularly applied as a preventive or rehabilitative exercise method in various sports and rehabilitation settings. Yet, there is only low-quality evidence on its effect on pain and function. This randomised controlled trial will investigate the effects of a theory-based SMT in rehabilitation of chronic (>3 months) non-specific low back pain (CNLBP) patients. A pilot study with a parallel, single-blinded, randomised controlled design. Twenty adult patients referred to the clinic for CNLBP treatment will be included, randomised, and allocated to one of two groups. Each group will receive 9 x 30 minutes of standard physiotherapy (PT) treatment. The experimental group will receive an added 15 minutes of SMT. For SMT, proprioceptive postural exercises are performed on a labile platform with adjustable oscillation to provoke training effects on different entry levels. The active comparator group will perform 15 minutes of added sub-effective low-intensity endurance training. Outcomes are assessed on 4 time-points by a treatment blinded tester: eligibility assessment at baseline (BL) 2-4 days prior to intervention, pre-intervention assessment (T0), post-intervention assessment (T1), and at 4 weeks follow-up (FU). At BL, an additional healthy control group (n = 20) will be assessed to allow cross-sectional comparison with symptom-free participants. The main outcomes are self-reported pain (Visual Analogue Scale) and functional status (Oswestry Disability Index). For secondary analysis, postural control variables after an externally perturbed stance on a labile platform are analysed using a video-based marker tracking system and a pressure plate (sagittal joint-angle variability and centre of pressure confidence ellipse). Proprioception is measured as relative cervical joint repositioning error during a head-rotation task. Effect sizes and mixed-model MANOVA (2 groups × 4 measurements for 5 dependent variables) will be calculated. This is the first attempt to systematically investigate effects of a theory-based sensorimotor training in patients with CNLBP. It will provide analysis of several postural segments during a dynamic task for quantitative analysis of quality and change of the task performance in relation to changes in pain and functional status. Trial registry number on cliniclatrials.gov is NCT02304120 , first registered on 17 November 2014.

Parenting acceptance and commitment therapy: a randomised controlled trial of an innovative online course for families of children with cerebral palsy.

PubMed

Whittingham, Koa; Sheffield, Jeanie; Boyd, Roslyn N

2016-10-19

Cerebral palsy (CP) impacts on the entire family in a manner that is long-term, complex and multifactorial. In addition, the quality of the parent-child relationship impacts on many and varied child outcomes, making the provision of easily accessible and evidence-based support to parents of children with CP a priority. This paper reports the protocol of a randomised controlled trial of an innovative and translatable online intervention, parenting acceptance and commitment therapy (PACT), for families of children with CP. We predict that participating in the PACT programme will be associated with improvements in the parent-child relationship, in child functioning and in adjustment and quality of life for both parent and child. We aim to recruit 66 parents of children (2-10 years old) diagnosed with CP to this study. Families will be randomly assigned to two groups: wait-list control and PACT. PACT is a parenting intervention grounded in acceptance and commitment therapy (ACT) and developed into an online course 'PARENT101 Parenting with Purpose' using the edX platform. All participants will be offered PACT before completion of the study. Assessments will take place at baseline, following completion of PACT and at 6-month follow-up (retention) and will focus on the parent-child relationship, parent and child adjustment and parent and child quality of life. Analysis will follow standard methods for randomised controlled trials using general linear models, specifically analysis of variance or analysis of covariance. Ethics approvals have been obtained through the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/15/QRCH/115) and The University of Queensland (2015001743). If efficacy is demonstrated, then the PARENT101 course has the potential to be disseminated widely in an accessible manner and at minimal cost. Further, the PACT framework may provide a blueprint for similar online courses with parents in a full range of contexts. ACTRN12616000351415; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Long-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial.

PubMed

Jennings, Paul A; Cameron, Peter; Bernard, Stephen; Walker, Tony; Jolley, Damien; Fitzgerald, Mark; Masci, Kevin

2014-10-01

Improved early pain control may affect the longer-term prevalence of persistent pain. In a previous randomised, controlled trial, we found that the administration of ketamine on hospital arrival decreased pain scores to a greater extent than morphine alone in patients with prehospital traumatic pain. In this follow-up study, we sought to determine the prevalence of persistent pain and whether there were differences in patients who received ketamine or morphine. This study was a long-term follow-up study of the prehospital, prospective, randomised, controlled, open-label study comparing ketamine with morphine in patients with trauma and a verbal pain score of >5 after 5 mg intravenous morphine. Patients were followed-up by telephone 6-12 months after enrollment, and a questionnaire including the SF-36 (V.2) health-related quality of life survey and the Verbal Numerical Rating Scale for pain was administered. A total of 97/135 (72%) patients were able to be followed-up 6-12 months after enrollment between July 2008 and July 2010. Overall, 44/97 (45%) participants reported persistent pain related to their injury, with 3/97 (3%) reporting persistent severe pain. The prevalence of persistent pain was the same between study groups (22/50 (44%) for the ketamine group vs 22/47 (46%) for the morphine group). There was no difference in the SF-36 scores between study arms. There is a high incidence of persistent pain after traumatic injury, even in patients with relatively minor severity of injury. Although decreased pain scores at hospital arrival are achieved with ketamine compared with morphine, this difference does not affect the prevalence of persistent pain or health-related quality of life 6 months after injury. Further larger studies are required to confirm this finding. Australian and New Zealand Clinical Trials Registry (ACTRN12607000441415). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial.

PubMed

Metz, Margot J; Franx, Gerdien C; Veerbeek, Marjolein A; de Beurs, Edwin; van der Feltz-Cornelis, Christina M; Beekman, Aartjan T F

2015-12-15

Shared Decision Making (SDM) is a way to empower patients when decisions are made about treatment. In order to be effective agents in this process, patients need access to information of good quality. Routine Outcome Monitoring (ROM) may provide such information and therefore may be a key element in SDM. This trial tests the effectiveness of SDM using ROM, primarily aiming to diminish decisional conflict of the patient while making decisions about treatment. The degree of decisional conflict, the primary outcome of this study, encompasses personal certainty about choosing an appropriate treatment, information about options, clarification of patient values, support from others and patients experience of an effective decision making process. Secondary outcomes of the study focus on the working alliance between patient and clinician, adherence to treatment, and clinical outcome and quality of life. This article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams participating in the ROM Quality Improvement Collaborative (QIC), which aims to implement ROM in daily clinical practice. In the intervention teams, ROM is used as a source of information during the SDM process between the patient and clinician. Control teams receive no specific SDM or ROM instructions and apply decision making as usual. Randomisation is conducted at the level of the participating teams within the mental health organisations. A total of 12 teams from 4 organisations and 364 patients participate in the study. Prior to data collection, the intervention teams are trained to use ROM during the SDM process. Data collection will be at baseline, and at 3 and 6 months after inclusion of the patient. Control teams will implement the SDM and ROM model after completion of the study. This study will provide useful information about the effectiveness of ROM within a SDM framework. Furthermore, with practical guidelines this study may contribute to the implementation of SDM using ROM in mental health care. Reporting of the results is expected from December 2016 onwards. Dutch trial register: TC5262. Trial registration date: 24th of June 2015.

Multidisciplinary transmural rehabilitation for older persons with a stroke: the design of a randomised controlled trial.

PubMed

Vluggen, Tom P M M; van Haastregt, Jolanda C M; Verbunt, Jeanine A; Keijsers, Elly J M; Schols, Jos M G A

2012-12-31

Stroke is one of the major causes of loss of independence, decreased quality of life and mortality among elderly people. About half of the elderly stroke patients discharged after rehabilitation in a nursing home still experience serious impairments in daily functioning one year post stroke, which can lead to difficulties in picking up and managing their social life. The aim of this study is to evaluate the effectiveness and feasibility of a new multidisciplinary transmural rehabilitation programme for older stroke patients. A two group multicentre randomised controlled trial is used to evaluate the effects of the rehabilitation programme. The programme consists of three care modules: 1) neurorehabilitation treatment for elderly stroke patients; 2) empowerment training for patient and informal caregiver; and 3) stroke education for patient and informal caregiver. The total programme has a duration of between two and six months, depending on the individual problems of the patient and informal caregiver. The control group receives usual care in the nursing home and after discharge. Patients aged 65 years and over are eligible for study participation when they are admitted to a geriatric rehabilitation unit in a nursing home due to a recent stroke and are expected to be able to return to their original home environment after discharge. Data are gathered by face-to-face interviews, self-administered questionnaires, focus groups and registration forms. Primary outcomes for patients are activity level after stroke, functional dependence, perceived quality of life and social participation. Outcomes for informal caregivers are perceived care burden, objective care burden, quality of life and perceived health. Outcome measures of the process evaluation are implementation fidelity, programme deliverance and the opinion of the stroke professionals, patients and informal caregivers about the programme. Outcome measures of the economic evaluation are the healthcare utilisation and associated costs. Data are collected at baseline, and after six and 12 months. The first results of the study will be expected in 2014. International Standard Randomised Controlled Trial Register Number ISRCTN62286281, The Dutch Trial Register NTR2412.

Effectiveness of a Hospital-Based Work Support Intervention for Female Cancer Patients – A Multi-Centre Randomised Controlled Trial

PubMed Central

Tamminga, Sietske J.; Verbeek, Jos H. A. M.; Bos, Monique M. E. M.; Fons, Guus; Kitzen, Jos J. E. M.; Plaisier, Peter W.; Frings-Dresen, Monique H. W.; de Boer, Angela G. E. M.

2013-01-01

Objective One key aspect of cancer survivorship is return-to-work. Unfortunately, many cancer survivors face problems upon their return-to-work. For that reason, we developed a hospital-based work support intervention aimed at enhancing return-to-work. We studied effectiveness of the intervention compared to usual care for female cancer patients in a multi-centre randomised controlled trial. Methods Breast and gynaecological cancer patients who were treated with curative intent and had paid work were randomised to the intervention group (n = 65) or control group (n = 68). The intervention involved patient education and support at the hospital and improvement of communication between treating and occupational physicians. In addition, we asked patient's occupational physician to organise a meeting with the patient and the supervisor to make a concrete gradual return-to-work plan. Outcomes at 12 months of follow-up included rate and time until return-to-work (full or partial), quality of life, work ability, work functioning, and lost productivity costs. Time until return-to-work was analyzed with Kaplan-Meier survival analysis. Results Return-to-work rates were 86% and 83% (p = 0.6) for the intervention group and control group when excluding 8 patients who died or with a life expectancy of months at follow-up. Median time from initial sick leave to partial return-to-work was 194 days (range 14–435) versus 192 days (range 82–465) (p = 0.90) with a hazard ratio of 1.03 (95% CI 0.64–1.6). Quality of life and work ability improved statistically over time but did not differ statistically between groups. Work functioning and costs did not differ statistically between groups. Conclusion The intervention was easily implemented into usual psycho-oncological care and showed high return-to-work rates. We failed to show any differences between groups on return-to-work outcomes and quality of life scores. Further research is needed to study which aspects of the intervention are useful and which elements need improvement. Trial Registration Nederlands Trial Register (NTR) 1658 PMID:23717406

A multicentre randomised controlled trial of reciprocal lung cancer peer review and supported quality improvement: results from the improving lung cancer outcomes project

PubMed Central

Russell, G K; Jimenez, S; Martin, L; Stanley, R; Peake, M D; Woolhouse, I

2014-01-01

Background: Results from the National Lung Cancer Audit demonstrate unexplained variation in outcomes. Peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams. The aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures. Methods: English lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by 12 months of supported quality improvement. The primary outcome was change in the following national audit indicators; mulitdisciplinary team discussion, histological confirmation, active treatment, surgical resection, small-cell chemotherapy and specialist nurse review. Patient experience was measured using a new lung cancer patient questionnaire in the intervention group. Results: Thirty teams (31 trusts) entered the intervention group and 29 of these submitted a total of 67 quality improvement plans. Active treatment increased in the intervention group (n=31) by 5.2% compared with 1.2% in the control group (n=48, mean difference 4.1%, 95% CI −0.1 to 8.2%, P=0.055). The remaining audit indicators improved similarly in all groups. Mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores (0.86 to 0.22, P<0.001). Conclusions: Reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience. PMID:24651386

The effect of nutritional supplementation on quality of life in people living with HIV: a randomised controlled trial.

PubMed

Tesfaye, Markos; Kaestel, Pernille; Olsen, Mette Frahm; Girma, Tsinuel; Yilma, Daniel; Abdissa, Alemseged; Ritz, Christian; Michaelsen, Kim F; Hanlon, Charlotte; Friis, Henrik

2016-06-01

To determine the effects of lipid-based nutrient supplements (LNS) on the quality of life of people living with HIV (PLHIV) during the first 3 months of antiretroviral treatment (ART) and to investigate the effects of timing of supplementation by comparing with supplementation during the subsequent 3 months. A randomised controlled trial was conducted in three ART clinics within public health facilities in Jimma, Ethiopia. Participants were PLHIV eligible to start ART with body mass index >17 kg/m(2) and given daily supplements of 200 g of LNS containing whey or soya either during the first 3 months or the subsequent months of ART. The outcome was measured in terms of total quality-of-life scores on the adapted version of the WHOQOL-HIV-BREF assessed at baseline, three and six months. Of the 282 participants, 186 (66.0%) were women. The mean age (SD) was 32.8 (±9.0) years, and the mean (SD) total quality-of-life score was 82.0 (±14.8) at baseline assessment. At 3 months, participants who received LNS showed better quality of life than those who only received ART without LNS (β = 6.2, 95% CI: 2.9: 9.6). At 6 months, there was no difference in total quality-of-life score between the early and delayed supplementation groups (β = 3.0, 95% CI: -0.4: 6.4). However, the early supplementation group showed higher scores on the social and spirituality domains than the delayed group. LNS given during the first three months of ART improves the quality of life of PLHIV. © 2016 John Wiley & Sons Ltd.

Aripiprazole for autism spectrum disorders (ASD).

PubMed

Hirsch, Lauren E; Pringsheim, Tamara

2016-06-26

Autism spectrum disorders (ASD) include autistic disorder, Asperger's disorder and pervasive developmental disorder - not otherwise specified (PDD-NOS). Antipsychotics have been used as a medication intervention for irritability related to ASD. Aripiprazole, a third-generation, atypical antipsychotic, is a relatively new drug that has a unique mechanism of action different from that of other antipsychotics. This review updates a previous Cochrane review on the safety and efficacy of aripiprazole for individuals with ASD, published in 2011 (Ching 2011). To assess the safety and efficacy of aripiprazole as medication treatment for individuals with ASD. In October 2015, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and seven other databases as well as two trial registers. We searched for records published in 1990 or later, as this was the year aripiprazole became available. Randomised controlled trials (RCTs) of aripiprazole (administered orally and at any dosage) versus placebo for treatment of individuals with a diagnosis of ASD. Two review authors independently collected, evaluated and analysed data. We performed meta-analysis for primary and secondary outcomes, when possible. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to rate the overall quality of the evidence. We included three trials in this review. Two were included in the previous published review, and the results of one, placebo-controlled discontinuation study were added to this review. Although we searched for studies across age groups, we found only studies conducted in children and youth. Included trials had low risk of bias across most domains. High risk of bias was seen in only one trial with incomplete outcome data. We judged the overall quality of the evidence for most outcomes to be moderate.Two RCTs with similar methods evaluated use of aripiprazole for a duration of eight weeks in 316 children/adolescents with ASD. Meta-analysis of study results revealed a mean improvement of -6.17 points on the Aberrant Behavior Checklist (ABC) - Irritability subscale (95% confidence intervals (CIs) -9.07 to -3.26, two studies, 308 children/adolescents, moderate-quality evidence), -7.93 points on the ABC - Hyperactivity subscale (95% CI -10.98 to -4.88, two studies, 308 children/adolescents, moderate-quality evidence) and -2.66 points on the ABC - Stereotypy subscale (95% CI -3.55 to -1.77, two studies, 308 children/adolescents, moderate-quality evidence) in children/adolescents taking aripiprazole relative to children/adolescents taking placebo. In terms of side effects, children/adolescents taking aripiprazole had a greater increase in weight, with a mean increase of 1.13 kg relative to placebo (95% CI 0.71 to 1.54, two studies, 308 children/adolescents, moderate-quality evidence), and had a higher risk ratio (RR) for sedation (RR 4.28, 95% CI 1.58 to 11.60, two studies, 313 children/adolescents, moderate-quality evidence) and tremor (RR 10.26, 95% CI 1.37 to 76.63, two studies, 313 children/adolescents, moderate-quality evidence). A randomised, placebo-controlled discontinuation study found that 35% of children/adolescents randomised to continue intervention with aripiprazole relapsed with respect to their symptoms of irritability, compared with 52% of children/adolescents randomised to placebo, for a hazard ratio of 0.57 (95% CI 0.28 to 1.12, 85 children/adolescents, low-quality evidence).All three included trials were supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Company, Ltd. (Tokyo, Japan), with editorial support provided by Ogilvy Healthworld Medical Education and Bristol-Myers Squibb. Evidence from two RCTs suggests that aripiprazole can be effective as a short-term medication intervention for some behavioural aspects of ASD in children/adolescents. After a short-term medication intervention with aripiprazole, children/adolescents showed less irritability and hyperactivity and fewer stereotypies (repetitive, purposeless actions). However, notable side effects, such as weight gain, sedation, drooling and tremor, must be considered. One long-term, placebo discontinuation study found that relapse rates did not differ between children/adolescents randomised to continue aripiprazole versus children/adolescents randomised to receive placebo, suggesting that re-evaluation of aripiprazole use after a period of stabilisation in irritability symptoms is warranted. Studies included in this review used criteria from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (APA 2000) for ASD diagnosis; however, the diagnostic criteria for ASD changed significantly with release of the fifth edition of the DSM (DSM-5) in 2013 (APA 2013).

Psychological interventions for mental health disorders in children with chronic physical illness: a systematic review.

PubMed

Bennett, Sophie; Shafran, Roz; Coughtrey, Anna; Walker, Susan; Heyman, Isobel

2015-04-01

Children with chronic physical illness are significantly more likely to develop common psychiatric symptoms than otherwise healthy children. These children therefore warrant effective integrated healthcare yet it is not established whether the known, effective, psychological treatments for symptoms of common childhood mental health disorders work in children with chronic physical illness. EMBASE, MEDLINE, PsycINFO and CINAHL databases were searched with predefined terms relating to evidence-based psychological interventions for psychiatric symptoms in children with chronic physical illness. We included all studies (randomised and non-randomised designs) investigating interventions aimed primarily at treating common psychiatric symptoms in children with a chronic physical illness in the review. Two reviewers independently assessed the relevance of abstracts identified, extracted data and undertook quality analysis. Ten studies (209 children, including 70 in control groups) met the criteria for inclusion in the review. All studies demonstrated some positive outcomes of cognitive behavioural therapy for the treatment of psychiatric symptoms in children with chronic physical illness. Only two randomised controlled trials, both investigating interventions for symptoms of depression, were found. There is preliminary evidence that cognitive behavioural therapy has positive effects in the treatment of symptoms of depression and anxiety in children with chronic physical illness. However, the current evidence base is weak and fully powered randomised controlled trials are needed to establish the efficacy of psychological treatments in this vulnerable population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Are mass-media campaigns effective in preventing drug use? A Cochrane systematic review and meta-analysis

PubMed Central

Allara, Elias; Ferri, Marica; Bo, Alessandra; Gasparrini, Antonio; Faggiano, Fabrizio

2015-01-01

Objective To determine whether there is evidence that mass-media campaigns can be effective in reducing illicit drug consumption and the intent to consume. Design Systematic review of randomised and non-randomised studies. Methods We searched four electronic databases (MEDLINE, EMBASE, ProQuest Dissertations & Theses A&I and CENTRAL) and further explored seven additional resources to obtain both published and unpublished materials. We appraised the quality of included studies using standardised tools. We carried out meta-analyses of randomised controlled trials and a pooled analysis of interrupted time-series and controlled before-and-after studies. Results We identified 19 studies comprising 184 811 participants. Pooled analyses and narrative synthesis provided mixed evidence of effectiveness. Eight interventions evaluated with randomised controlled trials leaned towards no evidence of an effect, both on drug use (standardised mean difference (SMD) −0.02; 95% CI −0.15 to 0.12) and the intention to use drugs (SMD −0.07; 95% CI −0.19 to 0.04). Four campaigns provided some evidence of beneficial effects in preventing drug use and two interventions provided evidence of iatrogenic effects. Conclusions Studies were considerably heterogeneous in type of mass-media intervention, outcome measures, underlying theory, comparison groups and design. Such factors can contribute to explaining the observed variability in results. Owing to the risk of adverse effects, caution is needed in disseminating mass-media campaigns tackling drug use. Large studies conducted with appropriate methodology are warranted to consolidate the evidence base. PMID:26338836

Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial.

PubMed

Dat, Vu Quoc; Geskus, Ronald B; Wolbers, Marcel; Loan, Huynh Thi; Yen, Lam Minh; Binh, Nguyen Thien; Chien, Le Thanh; Mai, Nguyen Thi Hoang; Phu, Nguyen Hoan; Lan, Nguyen Phu Huong; Hao, Nguyen Van; Long, Hoang Bao; Thuy, Tran Phuong; Kinh, Nguyen Van; Trung, Nguyen Vu; Phu, Vu Dinh; Cap, Nguyen Trung; Trinh, Dao Tuyet; Campbell, James; Kestelyn, Evelyne; Wertheim, Heiman F L; Wyncoll, Duncan; Thwaites, Guy Edward; van Doorn, H Rogier; Thwaites, C Louise; Nadjm, Behzad

2018-04-04

Ventilator-associated respiratory infection (VARI) comprises ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). Although their diagnostic criteria vary, together these are the most common hospital-acquired infections in intensive care units (ICUs) worldwide, responsible for a large proportion of antibiotic use within ICUs. Evidence-based strategies for the prevention of VARI in resource-limited settings are lacking. Preventing the leakage of oropharyngeal secretions into the lung using continuous endotracheal cuff pressure control is a promising strategy. The aim of this study is to investigate the efficacy of automated, continuous endotracheal cuff pressure control in preventing the development of VARI and reducing antibiotic use in ICUs in Vietnam. This is an open-label randomised controlled multicentre trial. We will enrol 600 adult patients intubated for ≤ 24 h at the time of enrolment. Eligible patients will be stratified according to admission diagnosis (180 tetanus, 420 non-tetanus) and site and will be randomised in a 1:1 ratio to receive either (1) automated, continuous control of endotracheal cuff pressure or (2) intermittent measurement and control of endotracheal cuff pressure using a manual cuff pressure meter. The primary outcome is the occurrence of VARI, defined as either VAP or VAT during the ICU admission up to a maximum of 90 days after randomisation. Patients in both groups who are at risk for VARI will receive a standardised battery of investigations if their treating physician feels a new infection has occurred, the results of which will be used by an endpoint review committee, blinded to the allocated arm and independent of patient care, to determine the primary outcome. All enrolled patients will be followed for mortality and endotracheal tube cuff-related complications at 28 days and 90 days after randomisation. Other secondary outcomes include antibiotic use; days ventilated, in ICU and in hospital; inpatient mortality; costs of antibiotics in ICU; duration of ICU stay; and duration of hospital stay. This study will provide high-quality evidence concerning the use of continuous endotracheal cuff pressure control as a method to reduce VARI, antibiotic use and hospitalisation costs and to shorten stay. ClinicalTrials.gov, NCT02966392 . Registered on November 9, 2016. Protocol version: 2.0; issue date March 3, 2017.

Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study.

PubMed

Williams, Mark A; Heine, Peter J; Williamson, Esther M; Toye, Francine; Dritsaki, Melina; Petrou, Stavros; Crossman, Richard; Lall, Ranjit; Barker, Karen L; Fairbank, Jeremy; Harding, Ian; Gardner, Adrian; Slowther, Anne-Marie; Coulson, Neil; Lamb, Sarah E

2015-07-01

The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design. Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. The randomised feasibility study recruited people aged 10-16 years with mild AIS (Cobb angle of < 50°). The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS. The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities. A UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions. A definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning. Current Controlled Trials ISRCTN90480705. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 55. See the NIHR Journals Library website for further project information.

A randomised controlled equivalence trial to determine the effectiveness and cost-utility of manual chest physiotherapy techniques in the management of exacerbations of chronic obstructive pulmonary disease (MATREX).

PubMed

Cross, J; Elender, F; Barton, G; Clark, A; Shepstone, L; Blyth, A; Bachmann, M; Harvey, I

2010-05-01

To estimate the effect, if any, of manual chest physiotherapy (MCP) administered to patients hospitalised with chronic obstructive pulmonary disease (COPD) exacerbation on both disease-specific and generic health-related quality of life. To compare the health service costs for those receiving and not receiving MCP. A pragmatic, randomised controlled trial powered for equivalence. It was not possible to blind participants, clinicians or research staff to study arm allocation during the intervention. Four UK hospitals in Norwich, Great Yarmouth, King's Lynn and Liverpool. 526 participants aged 34-91 years were recruited between November 2005 and April 2008; of these, 372 provided evaluable data for the primary outcome. All persons hospitalised with COPD exacerbation and evidence of sputum production on examination were eligible for the trial providing there were no contraindications to performing MCP. Participants were allocated to either MCP or no MCP on an intention-to-treat (ITT) basis. However, active cycle of breathing techniques (ACBT) was used in both arms. Participants allocated to the intervention were guided to perform ACBT while the physiotherapist delivered MCP. Participants allocated to the control arm received instruction on ACBT only. The primary outcome was COPD-specific quality of life, measured using the St George's Respiratory Questionnaire (SGRQ) at 6 months post randomisation. The European Quality of Life-5 Dimensions (EQ-5D) questionnaire was used to calculate the quality-adjusted life-year (QALY) gain associated with MCP compared with no MCP. Secondary physiological outcome measures were also used. Of the 526 participants, 261 were allocated to MCP and 264 to control, with 186 participants evaluable in each arm. ITT analyses indicated no significant difference at 6 months post randomisation in total SGRQ score [adjusted effect size (no MCP - MCP) 0.03 (95% confidence interval, CI -0.14 to 0.19)], SGRQ symptom score [adjusted effect size 0.04 (95% CI -0.15 to 0.23)], SGRQ activity score [adjusted effect size -0.02 (95% CI -0.20 to 0.16)] or SGRQ impact score [adjusted effect size 0.02 (95% CI -0.15 to 0.18)]. The imputed ITT and per-protocol results were similar. No significant differences were observed in any of the outcome measures or subgroup analyses. Compared with no MCP, employing MCP was associated with a slight loss in quality of life (0.001 QALY loss) but lower health service costs (cost saving of 410.79 pounds). Based on these estimates, at a cost-effectiveness threshold of lambda = 20,000 pounds per QALY, MCP would constitute a cost-effective use of resources (net benefit = 376.14 pounds). There was, however, a high level of uncertainty associated with these results and it is possible that the lower health service costs could have been due to other factors. In terms of longer-term quality of life the use of MCP did not appear to affect outcome. However, this does not mean that MCP is of no therapeutic value to patients with COPD in specific circumstances. Although the cost-effectiveness analysis suggested that its use was cost-effective, much uncertainty was associated with this finding and it would be difficult to justify providing MCP therapy on the basis of cost-effectiveness alone. Future research should include evaluation of MCP for patients with COPD producing high volumes of sputum, and an evaluation of the effectiveness of ACBT in COPD exacerbation. Current Controlled Trials ISRCTN13825248.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)

PubMed Central

Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

2013-01-01

Objectives To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Setting Initial recruitment in 21 UK hospitals. Participants Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. Intervention The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Main outcome measures Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. Results By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations—most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. Conclusions After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. Trial registration Current Controlled Trials ISRCTN15517081. PMID:23599318

The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial.

PubMed

Sönnichsen, Andreas C; Winkler, Henrike; Flamm, Maria; Panisch, Sigrid; Kowatsch, Peter; Klima, Gert; Fürthauer, Bernhard; Weitgasser, Raimund

2010-11-05

Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group. The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear. Current Controlled trials Ltd., ISRCTN27414162.

Optimal type 2 diabetes mellitus management: the randomised controlled OPTIMISE benchmarking study: baseline results from six European countries.

PubMed

Hermans, Michel P; Brotons, Carlos; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank

2013-12-01

Micro- and macrovascular complications of type 2 diabetes have an adverse impact on survival, quality of life and healthcare costs. The OPTIMISE (OPtimal Type 2 dIabetes Management Including benchmarking and Standard trEatment) trial comparing physicians' individual performances with a peer group evaluates the hypothesis that benchmarking, using assessments of change in three critical quality indicators of vascular risk: glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol (LDL-C) and systolic blood pressure (SBP), may improve quality of care in type 2 diabetes in the primary care setting. This was a randomised, controlled study of 3980 patients with type 2 diabetes. Six European countries participated in the OPTIMISE study (NCT00681850). Quality of care was assessed by the percentage of patients achieving pre-set targets for the three critical quality indicators over 12 months. Physicians were randomly assigned to receive either benchmarked or non-benchmarked feedback. All physicians received feedback on six of their patients' modifiable outcome indicators (HbA1c, fasting glycaemia, total cholesterol, high-density lipoprotein-cholesterol (HDL-C), LDL-C and triglycerides). Physicians in the benchmarking group additionally received information on levels of control achieved for the three critical quality indicators compared with colleagues. At baseline, the percentage of evaluable patients (N = 3980) achieving pre-set targets was 51.2% (HbA1c; n = 2028/3964); 34.9% (LDL-C; n = 1350/3865); 27.3% (systolic blood pressure; n = 911/3337). OPTIMISE confirms that target achievement in the primary care setting is suboptimal for all three critical quality indicators. This represents an unmet but modifiable need to revisit the mechanisms and management of improving care in type 2 diabetes. OPTIMISE will help to assess whether benchmarking is a useful clinical tool for improving outcomes in type 2 diabetes.

Hematopoietic stem cell transplantation for people with ß-thalassaemia major.

PubMed

Jagannath, Vanitha A; Fedorowicz, Zbys; Al Hajeri, Amani; Sharma, Akshay

2016-11-30

Thalassemia is an inherited autosomal recessive blood disorder, caused by mutations in globin genes or their regulatory regions. This results in a reduced rate of synthesis of one of the globin chains that make up haemoglobin. In ß-thalassaemia major there is an underproduction of ß-globin chains combined with excess of free α-globin chains. The excess free α-globin chains precipitate in red blood cells, leading to their destruction (haemolysis) and ineffective erythropoiesis. The conventional approach to treatment is based on the correction of haemoglobin status through regular blood transfusions and iron chelation therapy for iron overload. Although conventional treatment has the capacity to improve the quality of life of people with ß-thalassaemia major, allogeneic hematopoietic stem cell transplantation is the only currently available procedure which has the curative potential. This is an update of a previously published Cochrane Review. To evaluate the effectiveness and safety of different types of allogeneic hematopoietic stem cell transplantation, in people with severe transfusion-dependant ß-thalassaemia major, ß-thalassaemia intermedia or ß0/+- thalassaemia variants requiring chronic blood transfusion. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 18 August 2016. Randomised controlled trials and quasi-randomised controlled trials comparing allogeneic hematopoietic stem cell transplantation with each other or with standard therapy (regular transfusion and chelation regimen). Two review authors independently screened studies and had planned to extract data and assess risk of bias using standard Cochrane methodologies but no studies were identified for inclusion. No relevant studies were retrieved after a comprehensive search of the literature. We were unable to identify any randomised controlled trials or quasi-randomised controlled trials on the effectiveness and safety of different types of allogeneic stem cell transplantation in people with severe transfusion-dependant ß-thalassaemia major or ß0/+- thalassaemia variants requiring chronic blood transfusion. The absence of high-level evidence for the effectiveness of these interventions emphasises the need for well-designed, adequately-powered, randomised controlled clinical trials.

Hematopoietic stem cell transplantation for people with ß-thalassaemia major.

PubMed

Jagannath, Vanitha A; Fedorowicz, Zbys; Al Hajeri, Amani; Sharma, Akshay

2014-10-15

Thalassemia is an inherited blood disorder, caused by mutations in regulatory genes and transmitted as an autosomal recessive disorder, which results in a reduced rate of synthesis of one of the globin chains that make up haemoglobin. In ß-thalassaemia major there is an underproduction of ß-globin chains combined with excess of free α-globin chains. The excess free α-globin chains damage the red blood cell membranes, leading to their destruction and a phenomenon termed ineffective erythropoiesis. The conventional approach to treatment is based on the correction of haemoglobin status through regular blood transfusions and iron chelation therapy for iron overload. Although conventional treatment has the capacity to improve the quality of life of people with ß-thalassaemia major, allogeneic hematopoietic stem cell transplantation is the only currently available procedure which has the potential to definitively cure the disease. To evaluate the effectiveness and safety of different types of allogeneic hematopoietic stem cell transplantation, in people with severe transfusion-dependant ß-thalassaemia major, ß-thalassaemia intermedia or ß0/+- thalassaemia variants requiring chronic blood transfusion. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Date of the most recent search: 11 November 2013. Randomised controlled trials and quasi-randomised controlled trials comparing allogeneic hematopoietic stem cell transplantation with each other or with standard therapy (regular transfusion and chelation regimen). Two review authors independently screened studies and had planned to extract data and assess risk of bias using standard Cochrane Collaboration methodologies but no studies were identified for inclusion. No relevant studies were retrieved after a comprehensive search of the literature. We were unable to identify any randomised controlled trials or quasi-randomised controlled trials on the effectiveness and safety of different types of allogeneic stem cell transplantation in people with severe transfusion-dependant ß-thalassaemia major or ß0/+- thalassaemia variants requiring chronic blood transfusion. The absence of high-level evidence for the effectiveness of these interventions emphasises the need for well-designed, adequately-powered, randomised controlled clinical trials.

Needle aspiration versus intercostal tube drainage for pneumothorax in the newborn.

PubMed

Bruschettini, Matteo; Romantsik, Olga; Ramenghi, Luca Antonio; Zappettini, Simona; O'Donnell, Colm P F; Calevo, Maria Grazia

2016-01-11

Pneumothorax occurs more frequently in the neonatal period than at any other time of life and is associated with increased mortality and morbidity. It may be treated with either needle aspiration or insertion of a chest tube. The former consists of aspiration of air with a syringe through a needle or an angiocatheter, usually through the second or third intercostal space in the midclavicular line. The chest tube is usually placed in the anterior pleural space passing through the sixth intercostal space into the pleural opening, turned anteriorly and directed to the location of the pneumothorax, and then connected to a Heimlich valve or an underwater seal with continuous suction. To compare the efficacy and safety of needle aspiration and intercostal tube drainage in the management of neonatal pneumothorax. We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 11), MEDLINE via PubMed (1966 to 30 November 2015), EMBASE (1980 to 30 November 2015), and CINAHL (1982 to 30 November 2015). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. Randomised controlled trials, quasi-randomised controlled trials and cluster trials comparing needle aspiration (either with the needle or angiocatheter left in situ or removed immediately after aspiration) to intercostal tube drainage in newborn infants with pneumothorax. For each of the included trial, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, kind of needle and chest tube, choice of intercostal space, pressure and device for drainage) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). The primary outcomes considered in this review are mortality during the neonatal period and during hospitalisation. One randomised controlled trial (72 infants) met the inclusion criteria of this review. We found no differences in the rates of mortality (risk ratio (RR) 1.50, 95% confidence interval (CI) 0.27 to 8.45) or complications related to the procedure. After needle aspiration, the angiocatheter was left in situ (mean 27.1 hours) and not removed immediately after the aspiration. The angiocatheter was in place for a shorter duration than the intercostal tube (mean difference (MD) -11.20 hours, 95% CI -15.51 to -6.89). None of the 36 newborns treated with needle aspiration with the angiocatheter left in situ required the placement of an intercostal tube drainage. Overall, the quality of the evidence supporting this finding is low. At present there is insufficient evidence to determine the efficacy and safety of needle aspiration versus intercostal tube drainage in the management of neonatal pneumothorax. Randomised controlled trials comparing the two techniques are warranted.

Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

PubMed

Grant, A M; Boachie, C; Cotton, S C; Faria, R; Bojke, L; Epstein, D M; Ramsay, C R; Corbacho, B; Sculpher, M; Krukowski, Z H; Heading, R C; Campbell, M K

2013-06-01

Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years) after surgery, 36% (41%) in the randomised surgical group - 15% (26%) of those who had surgery - were taking proton pump inhibitor medication compared with 87% (82%) in the randomised medical group. At each year, differences in the REFLUX score significantly favoured the randomised surgical group (a third of a SD; p< 0.01 at 5 years). SF-36 and EQ-5D scores also favoured surgery, but differences attenuated over time and were generally not statistically significant at 5 years. The worse the symptoms at trial entry, the larger the benefit observed after surgery. Those randomised to medical management who subsequently had surgery had low baseline scores that markedly improved after surgery. Following fundoplication, 3% had surgical treatment for a complication and 4% had subsequent reflux-related operations - most often revision of the wrap. Dysphagia, flatulence and inability to vomit were similar in the two randomised groups. The economic analysis indicated that surgery was the more cost-effective option for this patient group. The incremental cost-effectiveness ratio for surgery in the base case was £7028 per additional QALY; these findings were robust to changes in approaches and assumptions. The probability of surgery being cost-effective at a threshold of £20,000 per additional QALY was > 0.80 for all analyses. After 5 years, laparoscopic fundoplication continues to provide better relief of GORD symptoms with associated improved health-related quality of life. Complications of surgery were uncommon. Despite being initially more costly, a surgical policy is highly likely to be cost-effective. Current Controlled Trials ISRCTN15517081. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 22. See the HTA programme website for further project information.

Quality control in the diagnosis of Trichuris trichiura and Ascaris lumbricoides using the Kato-Katz technique: experience from three randomised controlled trials.

PubMed

Speich, Benjamin; Ali, Said M; Ame, Shaali M; Albonico, Marco; Utzinger, Jürg; Keiser, Jennifer

2015-02-05

An accurate diagnosis of soil-transmitted helminthiasis is important for individual patient management, for drug efficacy evaluation and for monitoring control programmes. The Kato-Katz technique is the most widely used method detecting soil-transmitted helminth eggs in faecal samples. However, detailed analyses of quality control, including false-positive and faecal egg count (FEC) estimates, have received little attention. Over a 3-year period, within the frame of a series of randomised controlled trials conducted in Pemba, United Republic of Tanzania, 10% of randomly selected Kato-Katz thick smears were re-read for Trichuris trichiura and Ascaris lumbricoides eggs. In case of discordant result (i.e. positive versus negative) the slides were re-examined a third time. A result was assumed to be false-positive or false-negative if the result from the initial reading did not agree with the quality control as well as the third reading. We also evaluated the general agreement in FECs between the first and second reading, according to internal and World Health Organization (WHO) guidelines. From the 1,445 Kato-Katz thick smears subjected to quality control, 1,181 (81.7%) were positive for T. trichiura and 290 (20.1%) were positive for A. lumbricoides. During quality control, very low rates of false-positive results were observed; 0.35% (n = 5) for T. trichiura and 0.28% (n = 4) for A. lumbricoides. False-negative readings of Kato-Katz thick smears were obtained in 28 (1.94%) and 6 (0.42%) instances for T. trichiura and A. lumbricoides, respectively. A high frequency of discordant results in FECs was observed (i.e. 10.0-23.9% for T. trichiura, and 9.0-11.4% for A. lumbricoides). Our analyses show that the rate of false-positive diagnoses of soil-transmitted helminths is low. As the probability of false-positive results increases after examination of multiple stool samples from a single individual, the potential influence of false-positive results on epidemiological studies and anthelminthic drug efficacy studies should be determined. Existing WHO guidelines for quality control might be overambitious and might have to be revised, specifically with regard to handling disagreements in FECs.

Impact of pelvic floor muscle training on sexual function of women with urinary incontinence and a comparison of electrical stimulation versus standard treatment (IPSU trial): a randomised controlled trial.

PubMed

Jha, Swati; Walters, Stephen J; Bortolami, Oscar; Dixon, Simon; Alshreef, Abualbishr

2018-03-01

To evaluate the clinical and cost-effectiveness of electric stimulation plus standard pelvic floor muscle training compared to standard pelvic floor muscle training alone in women with urinary incontinence and sexual dysfunction. Single centre two arm parallel group randomised controlled trial conducted in a Teaching hospital in England. Participants were women presenting with urinary incontinence and sexual dysfunction. The interventions compared were electric stimulation versus standard pelvic floor muscle training. included Prolapse and Incontinence Sexual function Questionnaire (PISQ) physical function dimension at post-treatment (primary); other dimensions of PISQ, SF-36; EQ-5D, EPAQ, resource use, adverse events and cost-effectiveness (secondary outcomes). 114 women were randomised (Intervention n=57; Control group n=57). 64/114 (56%). had valid primary outcome data at follow-up (Intervention 30; Control 34). The mean PISQ-PF dimension scores at follow-up were 33.1 (SD 5.5) and 32.3 (SD 5.2) for the Intervention and Control groups respectively; with the Control group having a higher (better) score. After adjusting for baseline score, BMI, menopausal status, time from randomisation and baseline oxford scale score the mean difference was -1.0 (95% CI: -4.0 to 1.9; P=0.474). There was no differences between the groups in any of the secondary outcomes at follow-up. Within this study, the use of electrical stimulation was cost-effective with very small incremental costs and quality adjusted life years (QALYs). In women presenting with urinary incontinence in conjunction with sexual dysfunction, physiotherapy is beneficial to improve overall sexual function. However no specific form of physiotherapy is beneficial over another. Trial registration ISRCTN09586238. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Centre-based day care for children younger than five years of age in low- and middle-income countries.

PubMed

Brown, Taylor W; van Urk, Felix C; Waller, Rebecca; Mayo-Wilson, Evan

2014-09-25

Because of poverty, children and families in low- and middle-income countries often face significant impediments to health and well-being. Centre-based day care services may influence the development of children and the economic situation of parents by providing good quality early childhood care and by freeing parents to participate in the labour force. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development, health and well-being of children and families in low- and middle-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, ERIC and 16 other sources, including several World Health Organization (WHO) regional databases. We also searched two trials registers, websites of government and non-government agencies and reference lists of relevant studies. We included randomised and quasi-randomised controlled trials and prospective non-randomised studies with contemporaneous control groups and assessments both before and after intervention. We considered non-randomised controlled trials, as centre-based care in low- and middle-income countries is unlikely to be studied using randomised controlled trials (Higgins 2011). We included the following outcomes: child intellectual development, child psychosocial development, maternal and family outcomes and incidence of infectious diseases. Two review authors independently assessed risk of bias and extracted data from the single included study. Only one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review. The single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.

A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol.

PubMed

Stow, Ruth; Rushton, Alison; Ives, Natalie; Smith, Christina; Rick, Caroline

2015-01-01

Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%-42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability. Trial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20-25 g. The primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite. The complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this feasibility trial will be used to inform the development and design of a future cluster randomised controlled trial to compare food-based intervention with prescribed oral nutritional supplements (ONS) in the treatment of malnutrition within the care home population. Current Controlled Trials ISRCTN38047922.

Telemedicine with clinical decision support for critical care: a systematic review.

PubMed

Mackintosh, Nicola; Terblanche, Marius; Maharaj, Ritesh; Xyrichis, Andreas; Franklin, Karen; Keddie, Jamie; Larkins, Emily; Maslen, Anna; Skinner, James; Newman, Samuel; De Sousa Magalhaes, Joana Hiew; Sandall, Jane

2016-10-18

Telemedicine applications aim to address variance in clinical outcomes and increase access to specialist expertise. Despite widespread implementation, there is little robust evidence about cost-effectiveness, clinical benefits, and impact on quality and safety of critical care telemedicine. The primary objective was to determine the impact of critical care telemedicine (with clinical decision support available 24/7) on intensive care unit (ICU) and hospital mortality and length of stay in adults and children. The secondary objectives included staff and patient experience, costs, protocol adherence, and adverse events. Data sources included MEDLINE, EMBASE, CINAHL, Cochrane Library databases, Health Technology Assessment Database, Web of Science, OpenGrey, OpenDOAR, and the HMIC through to December 2015. Randomised controlled trials and quasi-experimental studies were eligible for inclusion. Eligible studies reported on differences between groups using the telemedicine intervention and standard care. Two review authors screened abstracts and assessed potentially eligible studies using Cochrane guidance. Two controlled before-after studies met the inclusion criteria. Both were assessed as high risk of bias. Meta-analysis was not possible as we were unable to disaggregate data between the two studies. One study used a non-randomised stepped-wedge design in seven ICUs. Hospital mortality was the primary outcome which showed a reduction from 13.6 % (CI, 11.9-15.4 %) to 11.8 % (CI, 10.9-12.8 %) during the intervention period with an adjusted odds ratio (OR) of 0.40 (95 % CI, 0.31-0.52; p = .005). The second study used a non-randomised, unblinded, pre-/post-assessment of telemedicine interventions in 56 adult ICUs. Hospital mortality (primary outcome) reduced from 11 to 10 % (adjusted hazard ratio (HR) = 0.84; CI, 0.78-0.89; p = <.001). This review highlights the poor methodological quality of most studies investigating critical care telemedicine. The results of the two included studies showed a reduction in hospital mortality in patients receiving the intervention. Further multi-site randomised controlled trials or quasi-experimental studies with accompanying process evaluations are urgently needed to determine effectiveness, implementation, and associated costs. PROSPERO CRD42014007406.

Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

PubMed

Robertson, Wendy; Fleming, Joanna; Kamal, Atiya; Hamborg, Thomas; Khan, Kamran A; Griffiths, Frances; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Simkiss, Douglas; Harrison, Elizabeth; Kim, Sung Wook; Thorogood, Margaret

2017-05-01

Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. Three National Health Service Primary Care Trusts in West Midlands, England. Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. FFH was neither effective nor cost-effective for the management of obesity compared with UC. ISRCTN45032201. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Self-reported quality of life before and after aerobic exercise training in individuals with hypertension: a randomised-controlled trial.

PubMed

Maruf, Fatai A; Akinpelu, Aderonke O; Salako, Babatunde L

2013-07-01

The Effects of Aerobic Exercise Training (AET) on self-reported Quality of Life (QoL) in people with hypertension have been previously documented. However, data on black populations, especially from Africa, seem not to be available. This study investigated the effects of AET on QoL and exercise capacity in Nigerians on treatment for essential hypertension. This randomised-controlled trial involved newly diagnosed individuals, with mild-to-moderate essential hypertension randomly assigned to antihypertensive drugs (ADs) alone (control: n = 60) and AET+ADs (exercise: n = 60) groups. The study lasted for 12 weeks. QoL was measured using the World Health Organization QoL Short Form (WHOQoL-BREF) and exercise capacity was assessed using the Rockport Fitness Walk Test pre- and post-study. Physical health, psychological health, and social relationships domains of QoL improved significantly in the exercise and control groups post-intervention. The environment domain of QoL and exercise capacity improved significantly in only the exercise group. There were larger improvements in the physical health, psychological health, and environment domains of QoL, and exercise capacity in the exercise group. Aerobic exercise improves QoL and exercise capacity in individuals with essential hypertension. © 2013 The Authors. Applied Psychology: Health and Well-Being © 2013 The International Association of Applied Psychology.

Randomised controlled trial of routine individual feedback to improve rationality and reduce numbers of test requests.

PubMed

Winkens, R A; Pop, P; Bugter-Maessen, A M; Grol, R P; Kester, A D; Beusmans, G H; Knottnerus, J A

1995-02-25

Feedback can be described as a way to provide information on doctors' performance to enable changes in future behaviour. Feedback is used with the aim of changing test-ordering behaviour. It can lead to reductions in test usage and cost savings. It is not sufficiently clear, however, whether feedback leads to more appropriate test use. Since 1985, the Diagnostic Coordinating Center Maastricht has been giving feedback on diagnostic tests as a routine health care activity to all family doctors in its region. Both quantity and quality of requests are discussed. In a randomised, controlled trial over 2.5 years, discussion of tests not included previously was added to the existing routine feedback. One group of family doctors (n = 39) received feedback on test-group A (electrocardiography, endoscopy, cervical smears, and allergy tests), the other (n = 40) on test-group B (radiographic and ultrasonographic tests). Thus, each group of doctors acted as a control group for the other. Changes in volume and rationality of requests were analysed. The number of requests decreased during the trial (p = 0.036). Request numbers decreased particularly for test-group A (p = 0.04). The proportion of requests that were non-rational decreased more in the intervention than in the control groups (p = 0.009). Rationality improved predominantly for test-group B (p = 0.043). Thus, routine feedback can change the quantity and quality of requests.

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

PubMed Central

2011-01-01

Background Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness. The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. Methods/design This is a mixed methods pragmatic multicentre feasibility pilot study with four components:- (a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial. (b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience. (c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial. (d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. Discussion The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim. Trial registration number Current Controlled Trials ISRCTN71327395 assigned 7th June 2010. PMID:21733166

Randomised controlled trial of the effects of L-ornithine on stress markers and sleep quality in healthy workers

PubMed Central

2014-01-01

Background L-ornithine is a non-essential, non-protein amino acid. Although L-ornithine is contained in various foods, the amount is usually small. Recently, studies have shown that orally administered L-ornithine reduced the stress response in animals. From these findings, we speculated that L-ornithine may play a role in the relieve of stress and improve sleep and fatigue symptoms in humans. Through a randomised, double-blind, placebo-controlled clinical study, we asked if L-ornithine could be beneficial to stress and sleep in healthy workers. Method Fifty-two apparently healthy Japanese adults who had previously felt slight stress as well as fatigue were recruited to be study participants and were randomly divided into either the L-ornithine (400 mg/day) or placebo group. They orally consumed the respective test substance every day for 8 weeks. Serum was collected for the assessment of cortisol and dehydroepiandrosterone-sulphate (DHEA-S). Perceived mood and quality of sleep were measured by the Profile of Mood States (POMS), Athens Insomnia Scale (AIS), and Ogri-Shirakawa-Azumi sleep inventory MA version (OSA-MA). Results Serum cortisol levels and the cortisol/DHEA-S ratio were significantly decreased in the L-ornithine group in comparison with the placebo group. Also, anger was reduced and perceived sleep quality was improved in the L-ornithine group. Conclusion L-ornithine supplementation has the potential to relieve stress and improve sleep quality related to fatigue, both objectively and subjectively. PMID:24889392

Mechanical CPR: Who? When? How?

PubMed

Poole, Kurtis; Couper, Keith; Smyth, Michael A; Yeung, Joyce; Perkins, Gavin D

2018-05-29

In cardiac arrest, high quality cardiopulmonary resuscitation (CPR) is a key determinant of patient survival. However, delivery of effective chest compressions is often inconsistent, subject to fatigue and practically challenging.Mechanical CPR devices provide an automated way to deliver high-quality CPR. However, large randomised controlled trials of the routine use of mechanical devices in the out-of-hospital setting have found no evidence of improved patient outcome in patients treated with mechanical CPR, compared with manual CPR. The limited data on use during in-hospital cardiac arrest provides preliminary data supporting use of mechanical devices, but this needs to be robustly tested in randomised controlled trials.In situations where high-quality manual chest compressions cannot be safely delivered, the use of a mechanical device may be a reasonable clinical approach. Examples of such situations include ambulance transportation, primary percutaneous coronary intervention, as a bridge to extracorporeal CPR and to facilitate uncontrolled organ donation after circulatory death.The precise time point during a cardiac arrest at which to deploy a mechanical device is uncertain, particularly in patients presenting in a shockable rhythm. The deployment process requires interruptions in chest compression, which may be harmful if the pause is prolonged. It is recommended that use of mechanical devices should occur only in systems where quality assurance mechanisms are in place to monitor and manage pauses associated with deployment.In summary, mechanical CPR devices may provide a useful adjunct to standard treatment in specific situations, but current evidence does not support their routine use.

Randomised controlled trial of the effects of L-ornithine on stress markers and sleep quality in healthy workers.

PubMed

Miyake, Mika; Kirisako, Takayoshi; Kokubo, Takeshi; Miura, Yutaka; Morishita, Koji; Okamura, Hisayoshi; Tsuda, Akira

2014-06-03

L-ornithine is a non-essential, non-protein amino acid. Although L-ornithine is contained in various foods, the amount is usually small.Recently, studies have shown that orally administered L-ornithine reduced the stress response in animals.From these findings, we speculated that L-ornithine may play a role in the relieve of stress and improve sleep and fatigue symptoms in humans. Through a randomised, double-blind, placebo-controlled clinical study, we asked if L-ornithine could be beneficial to stress and sleep in healthy workers. Fifty-two apparently healthy Japanese adults who had previously felt slight stress as well as fatigue were recruited to be study participants and were randomly divided into either the L-ornithine (400 mg/day) or placebo group. They orally consumed the respective test substance every day for 8 weeks. Serum was collected for the assessment of cortisol and dehydroepiandrosterone-sulphate (DHEA-S). Perceived mood and quality of sleep were measured by the Profile of Mood States (POMS), Athens Insomnia Scale (AIS), and Ogri-Shirakawa-Azumi sleep inventory MA version (OSA-MA). Serum cortisol levels and the cortisol/DHEA-S ratio were significantly decreased in the L-ornithine group in comparison with the placebo group. Also, anger was reduced and perceived sleep quality was improved in the L-ornithine group. L-ornithine supplementation has the potential to relieve stress and improve sleep quality related to fatigue, both objectively and subjectively.

Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial.

PubMed

Bladh, Lina; Ottosson, Ellinor; Karlsson, John; Klintberg, Lars; Wallerstedt, Susanna M

2011-09-01

OBJECTIVE To evaluate the effects of a clinical pharmacist service on health-related quality of life (HRQL) and prescribing of drugs. METHODS A randomised controlled study was performed in two internal medicine wards. The intervention consisted of medication reviews with feedback to the physicians, drug treatment discussion with patients at discharge and medication reports. HRQL was evaluated at inclusion and after six months by self-rated global health (1: very poor; 5: very good) and by the EuroQol 5-dimension questionnaire (EQ-5D). Prescribing of drugs was analysed regarding three established drug-specific quality indicators (intervention and control patients) and potential drug-related problems (DRPs) during in-hospital care (intervention patients). RESULTS 345 patients (61% female; median age: 82) were analysed, 204 of whom (59%) completed the six-month HRQL follow-up. A total of 87 patients (53% of the intervention patients) received all parts of the intervention. Intention-to-treat analysis revealed no significant findings for any of the HRQL measures. Per-protocol analysis revealed significantly better HRQL in the intervention group at six-month follow-up as measured by global health (mean: 3.14 (SD: 0.87) vs 2.77 (0.94), p=0.020), but not as measured by summarised EQ-5D index (0.48 (0.36) vs 0.43 (0.37), p=0.57). The number of potentially inappropriate prescribings per patient according to the quality indicators (admission vs discharge) was 0.35 (0.73) versus 0.38 (0.72), p=0.47 (control patients), and 0.39 (0.83) versus 0.26 (0.56), p=0.039 (intervention patients who received the intervention). In the intervention group, 133 relevant potential DRPs were identified in 81 patients, 55 of which (41%) were acted upon by the attending physician. CONCLUSION A clinical pharmacist service during inpatient care may improve quality of prescribing and patients' HRQL. Trial registration clinicaltrials.gov Identifier: NCT01016301.

A cost-utility analysis of nursing intervention via telephone follow-up for injured road users

PubMed Central

Franzén, Carin; Björnstig, Ulf; Brulin, Christine; Lindholm, Lars

2009-01-01

Background Traffic injuries can cause physical, psychological, and economical impairment, and affected individuals may also experience shortcomings in their post-accident care and treatment. In an earlier randomised controlled study of nursing intervention via telephone follow-up, self-ratings of health-related quality of life were generally higher in the intervention group than in the control group. Objective To evaluate the cost-effectiveness of nursing intervention via telephone follow-up by examining costs and quality-adjusted life years (QALYs). Methods A randomised controlled study was conducted between April 2003 and April 2005. Car occupants, cyclists, and pedestrians aged between 18 and 70 years and attending the Emergency Department of Umeå University Hospital in Sweden after an injury event in the traffic environment were randomly assigned to an intervention (n = 288) or control group (n = 280). The intervention group received routine care supplemented by nursing via telephone follow-up during half a year, while the control group received routine care only. Data were collected from a mail survey using the non-disease-specific health-related quality of life instrument EQ5D, and a cost-effectiveness analysis was performed including the costs of the intervention and the QALYs gained. Results Overall, the intervention group gained 2.60 QALYs (260 individuals with an average gain of 0.01 QALYs). The car occupants gained 1.54 QALYs (76 individuals, average of 0.02). Thus, the cost per QALY gained was 16 000 Swedish Crown (SEK) overall and 8 500 SEK for car occupants. Conclusion Nursing intervention by telephone follow-up after an injury event, is a cost effective method giving improved QALY to a very low cost, especially for those with minor injuries. Trial registration This trial registration number is: ISRCTN11746866. PMID:19515265

Daily iron supplementation for improving anaemia, iron status and health in menstruating women.

PubMed

Low, Michael Sze Yuan; Speedy, Joanna; Styles, Claire E; De-Regil, Luz Maria; Pasricha, Sant-Rayn

2016-04-18

Iron-deficiency anaemia is highly prevalent among non-pregnant women of reproductive age (menstruating women) worldwide, although the prevalence is highest in lower-income settings. Iron-deficiency anaemia has been associated with a range of adverse health outcomes, which restitution of iron stores using iron supplementation has been considered likely to resolve. Although there have been many trials reporting effects of iron in non-pregnant women, these trials have never been synthesised in a systematic review. To establish the evidence for effects of daily supplementation with iron on anaemia and iron status, as well as on physical, psychological and neurocognitive health, in menstruating women. In November 2015 we searched CENTRAL, Ovid MEDLINE, EMBASE, and nine other databases, as well as four digital thesis repositories. In addition, we searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and reference lists of relevant reviews. We included randomised controlled trials (RCTs) and quasi-RCTs comparing daily oral iron supplementation with or without a cointervention (folic acid or vitamin C), for at least five days per week at any dose, to control or placebo using either individual- or cluster-randomisation. Inclusion criteria were menstruating women (or women aged 12 to 50 years) reporting on predefined primary (anaemia, haemoglobin concentration, iron deficiency, iron-deficiency anaemia, all-cause mortality, adverse effects, and cognitive function) or secondary (iron status measured by iron indices, physical exercise performance, psychological health, adherence, anthropometric measures, serum/plasma zinc levels, vitamin A status, and red cell folate) outcomes. We used the standard methodological procedures of Cochrane. The search strategy identified 31,767 records; after screening, 90 full-text reports were assessed for eligibility. We included 67 trials (from 76 reports), recruiting 8506 women; the number of women included in analyses varied greatly between outcomes, with endpoint haemoglobin concentration being the outcome with the largest number of participants analysed (6861 women). Only 10 studies were considered at low overall risk of bias, with most studies presenting insufficient details about trial quality.Women receiving iron were significantly less likely to be anaemic at the end of intervention compared to women receiving control (risk ratio (RR) 0.39 (95% confidence interval (CI) 0.25 to 0.60, 10 studies, 3273 women, moderate quality evidence). Women receiving iron had a higher haemoglobin concentration at the end of intervention compared to women receiving control (mean difference (MD) 5.30, 95% CI 4.14 to 6.45, 51 studies, 6861 women, high quality evidence). Women receiving iron had a reduced risk of iron deficiency compared to women receiving control (RR 0.62, 95% CI 0.50 to 0.76, 7 studies, 1088 women, moderate quality evidence). Only one study (55 women) specifically reported iron-deficiency anaemia and no studies reported mortality. Seven trials recruiting 901 women reported on 'any side effect' and did not identify an overall increased prevalence of side effects from iron supplements (RR 2.14, 95% CI 0.94 to 4.86, low quality evidence). Five studies recruiting 521 women identified an increased prevalence of gastrointestinal side effects in women taking iron (RR 1.99, 95% CI 1.26 to 3.12, low quality evidence). Six studies recruiting 604 women identified an increased prevalence of loose stools/diarrhoea (RR 2.13, 95% CI 1.10, 4.11, high quality evidence); eight studies recruiting 1036 women identified an increased prevalence of hard stools/constipation (RR 2.07, 95% CI 1.35 to 3.17, high quality evidence). Seven studies recruiting 1190 women identified evidence of an increased prevalence of abdominal pain among women randomised to iron (RR 1.55, 95% CI 0.99 to 2.41, low quality evidence). Eight studies recruiting 1214 women did not find any evidence of an increased prevalence of nausea among women randomised to iron (RR 1.19, 95% CI 0.78 to 1.82). Evidence that iron supplementation improves cognitive performance in women is uncertain, as studies could not be meta-analysed and individual studies reported conflicting results. Iron supplementation improved maximal and submaximal exercise performance, and appears to reduce symptomatic fatigue. Although adherence could not be formally meta-analysed due to differences in reporting, there was no evident difference in adherence between women randomised to iron and control. Daily iron supplementation effectively reduces the prevalence of anaemia and iron deficiency, raises haemoglobin and iron stores, improves exercise performance and reduces symptomatic fatigue. These benefits come at the expense of increased gastrointestinal symptomatic side effects.

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)

PubMed Central

Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-01-01

Introduction Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. Methods and analysis This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). Ethics and dissemination Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. Trial registration number NCT02632500. PMID:29674365

Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA): a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269

PubMed Central

Mant, Jonathan WF; Richards, Suzanne H; Hobbs, FD Richard; Fitzmaurice, David; Lip, Gregory YH; Murray, Ellen; Banting, Miriam; Fletcher, Kate; Rahman, Joy; Allan, Teresa; Raftery, James; Bryan, Stirling

2003-01-01

Background Atrial fibrillation (AF) is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting. Study design A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire. 1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa). The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic) or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular), hospital admissions (all cause, vascular), cognition, quality of life, disability and compliance with study medication. PMID:12939169

Upper secondary school students' compliance with two Internet-based self-help programmes: a randomised controlled trial.

PubMed

Antonson, Carl; Thorsén, Frida; Sundquist, Jan; Sundquist, Kristina

2018-02-01

Psychiatric symptoms and stress are on the increase among Swedish adolescents. We aimed to study the potential effect and feasibility of two Internet-based self-help programmes, one mindfulness based (iMBI) and the other music based in a randomised controlled trial that targeted adolescents. A total of 283 upper secondary school students in two Swedish schools were randomised to either a waiting list or one of the two programmes, on their own incentive, on schooltime. General psychiatric health (Symptoms Checklist 90), sleep quality (Pittsburgh Sleep Quality Index), and perceived stress (Perceived Stress Scale) were assessed before and after the interventions. In total, 202 participants answered the questionnaires. Less than 20 logged into each intervention and only 1 performed a full intervention (iMBI). No significant differences in any of the scales were found between those who logged in and those who did not. The potential effect of Internet-based self-help programmes was not possible to examine due to low compliance rates. Adolescents seem to have a very low compliance with Internet-based self-help programmes if left to their own incentive. There were no associations between the psychiatric and stress-related symptoms at baseline and compliance in any of the intervention groups, and no evidence for differences in compliance in relation to the type of programme. Additional studies are needed to examine how compliance rates can be increased in Internet-based self-help mindfulness programmes in adolescents, as the potentially positive effects of mindfulness are partly related to compliance rates.

Cost-effectiveness of exercise as a therapy for behavioural and psychological symptoms of dementia within the EVIDEM-E randomised controlled trial.

PubMed

D'Amico, Francesco; Rehill, Amritpal; Knapp, Martin; Lowery, David; Cerga-Pashoja, Arlinda; Griffin, Mark; Iliffe, Steve; Warner, James

2016-06-01

Although available evidence is modest, exercise could be beneficial in reducing behavioural and psychological symptoms of dementia. We aim to evaluate the cost-effectiveness of a dyadic exercise regimen for individuals with dementia and their main carer as therapy for behavioural and psychological symptoms of dementia. Cost-effectiveness analysis within a two-arm, pragmatic, randomised, controlled, single-blind, parallel-group trial of a dyadic exercise regimen (individually tailored, for 20-30 min at least five times per week). The study randomised 131 community-dwelling individuals with dementia and clinically significant behavioural and psychological symptoms with a carer willing and able to participate in the exercise regimen; 52 dyads provided sufficient cost data for analyses. Mean intervention cost was £284 per dyad. For the subsample of 52 dyads, the intervention group had significantly higher mean cost from a societal perspective (mean difference £2728.60, p = 0.05), but costs were not significantly different from a health and social care perspective. The exercise intervention was more cost-effective than treatment as usual from both societal and health and social care perspectives for the measure of behavioural and psychological symptoms (Neuropsychiatric Inventory). It does not appear cost-effective in terms of cost per quality-adjusted life year gain. The exercise intervention has the potential to be seen as cost-effective when considering behavioural and psychological symptoms but did not appear cost-effective when considering quality-adjusted life year gains. Copyright © 2015 John Wiley & Sons, Ltd.

The Effects of Skill Training on Social Workers' Professional Competences in Norway: Results of a Cluster-Randomised Study

PubMed Central

Malmberg-Heimonen, Ira; Natland, Sidsel; Tøge, Anne Grete; Hansen, Helle Cathrine

2016-01-01

Using a cluster-randomised design, this study analyses the effects of a government-administered skill training programme for social workers in Norway. The training programme aims to improve social workers' professional competences by enhancing and systematising follow-up work directed towards longer-term unemployed clients in the following areas: encountering the user, system-oriented efforts and administrative work. The main tools and techniques of the programme are based on motivational interviewing and appreciative inquiry. The data comprise responses to baseline and eighteen-month follow-up questionnaires administered to all social workers (n = 99) in eighteen participating Labour and Welfare offices randomised into experimental and control groups. The findings indicate that the skill training programme positively affected the social workers' evaluations of their professional competences and quality of work supervision received. The acquisition and mastering of combinations of specific tools and techniques, a comprehensive supervision structure and the opportunity to adapt the learned skills to local conditions were important in explaining the results. PMID:27559232

Vaccine testing for emerging infections: the case for individual randomisation

PubMed Central

Eyal, Nir; Lipsitch, Marc

2017-01-01

During the 2014–2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible—and it often will be—it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise—requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants’ prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. PMID:28396558

A study of sertraline in dialysis (ASSertID): a protocol for a pilot randomised controlled trial of drug treatment for depression in patients undergoing haemodialysis.

PubMed

Friedli, Karin; Almond, Michael; Day, Clara; Chilcot, Joseph; Gane, Maria da Silva; Davenport, Andrew; Guirguis, Ayman; Fineberg, Naomi; Spencer, Benjamin; Wellsted, David; Farrington, Ken

2015-10-26

The prevalence of depression in people receiving haemodialysis is high with estimates varying between 20 and 40 %. There is little research on the effectiveness of antidepressants in dialysis patients with the few clinical trials suffering significant methodological issues. We plan to carry out a study to evaluate the feasibility of conducting a randomised controlled trial in patients on haemodialysis who have diagnosed Major Depressive Disorder. The study has two phases, a screening phase and the randomised controlled trial. Patients will be screened initially with the Beck Depression Inventory to estimate the number of patients who score 16 or above. These patients will be invited to an interview with a psychiatrist who will invite those with a diagnosis of Major Depressive Disorder to take part in the trial. Consenting patients will be randomised to either Sertraline or placebo. Patients will be followed-up for 6 months. Demographic and clinical data will be collected at screening interview, baseline interview and 2 weeks, and every month (up to 6 months) after baseline. The primary outcome is to evaluate the feasibility of conducting a randomised, double blind, placebo pilot trial in haemodialysis patients with depression. Secondary outcomes include estimation of the variability in the outcome measures for the treatment and placebo arms, which will allow for a future adequately powered definitive trial. Analysis will primarily be descriptive, including the number of patients eligible for the trial, drug exposure of Sertraline in haemodialysis patients and the patient experience of participating in this trial. There is an urgent need for this research in the dialysis population because of the dearth of good quality and adequately powered studies. Research with renal patients is particularly difficult as they often have complex medical needs. This research will therefore not only assess the outcome of anti-depressants in haemodialysis patients with depression but also the process of running a randomised controlled trial in this population. Hence, the outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the efficacy of anti-depressants in patient on haemodialysis with depression. ISRCTN registry ISRCTN06146268 and EudraCT reference: 2012-000547-27.

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

PubMed

Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

2018-02-21

Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes.

PubMed

Tieu, Joanna; Shepherd, Emily; Middleton, Philippa; Crowther, Caroline A

2017-08-24

Gestational diabetes mellitus (GDM) is associated with adverse health outcomes for mothers and their infants both perinatally and long term. Women with a history of GDM are at risk of recurrence in subsequent pregnancies and may benefit from intervention in the interconception period to improve maternal and infant health outcomes. To assess the effects of interconception care for women with a history of GDM on maternal and infant health outcomes. We searched Cochrane Pregnancy and Childbirth's Trials Register (7 April 2017) and reference lists of retrieved studies. Randomised controlled trials, including quasi-randomised controlled trials and cluster-randomised trials evaluating any protocol of interconception care with standard care or other forms of interconception care for women with a history of GDM on maternal and infant health outcomes. Two review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data and assess the risk of bias of included studies; the quality of the evidence will be assessed using the GRADE approach. No eligible published trials were identified. We identified a completed randomised controlled trial that was designed to evaluate the effects of a diet and exercise intervention compared with standard care in women with a history of GDM, however to date, it has only published results on women who were pregnant at randomisation (and not women in the interconception period). We also identified an ongoing trial, in obese women with a history of GDM planning a subsequent pregnancy, which is assessing the effects of an intensive lifestyle intervention, supported with liraglutide treatment, compared with usual care. We also identified a trial that was designed to evaluate the effects of a weight loss and exercise intervention compared with lifestyle education also in obese women with a history of GDM planning a subsequent pregnancy, however it has not yet been published. These trials will be re-considered for inclusion in the next review update. The role of interconception care for women with a history of GDM remains unclear. Randomised controlled trials are required evaluating different forms and protocols of interconception care for these women on perinatal and long-term maternal and infant health outcomes, acceptability of such interventions and cost-effectiveness.

DiPALS: Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis - a randomised controlled trial.

PubMed

McDermott, Christopher J; Bradburn, Mike J; Maguire, Chin; Cooper, Cindy L; Baird, Wendy O; Baxter, Susan K; Cohen, Judith; Cantrill, Hannah; Dixon, Simon; Ackroyd, Roger; Baudouin, Simon; Bentley, Andrew; Berrisford, Richard; Bianchi, Stephen; Bourke, Stephen C; Darlison, Roy; Ealing, John; Elliott, Mark; Fitzgerald, Patrick; Galloway, Simon; Hamdalla, Hisham; Hanemann, C Oliver; Hughes, Philip; Imam, Ibrahim; Karat, Dayalan; Leek, Roger; Maynard, Nick; Orrell, Richard W; Sarela, Abeezar; Stradling, John; Talbot, Kevin; Taylor, Lyn; Turner, Martin; Simonds, Anita K; Williams, Tim; Wedzicha, Wisia; Young, Carolyn; Shaw, Pamela J

2016-06-01

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease resulting in death, usually from respiratory failure, within 2-3 years of symptom onset. Non-invasive ventilation (NIV) is a treatment that when given to patients in respiratory failure leads to improved survival and quality of life. Diaphragm pacing (DP), using the NeuRx/4(®) diaphragm pacing system (DPS)™ (Synapse Biomedical, Oberlin, OH, USA), is a new technique that may offer additional or alternative benefits to patients with ALS who are in respiratory failure. The Diaphragm Pacing in patients with Amyotrophic Lateral Sclerosis (DiPALS) trial evaluated the effect of DP on survival over the study duration in patients with ALS with respiratory failure. The DiPALS trial was a multicentre, parallel-group, open-label, randomised controlled trial incorporating health economic analyses and a qualitative longitudinal substudy. Eligible participants had a diagnosis of ALS (ALS laboratory-supported probable, clinically probable or clinically definite according to the World Federation of Neurology revised El Escorial criteria), had been stabilised on riluzole for 30 days, were aged ≥ 18 years and were in respiratory failure. We planned to recruit 108 patients from seven UK-based specialist ALS or respiratory centres. Allocation was performed using 1 : 1 non-deterministic minimisation. Participants were randomised to either standard care (NIV alone) or standard care (NIV) plus DP using the NeuRX/4 DPS. The primary outcome was overall survival, defined as the time from randomisation to death from any cause. Secondary outcomes were patient quality of life [assessed by European Quality of Life-5 Dimensions, three levels (EQ-5D-3L), Short Form questionnaire-36 items and Sleep Apnoea Quality of Life Index questionnaire]; carer quality of life (EQ-5D-3L and Caregiver Burden Inventory); cost-utility analysis and health-care resource use; tolerability and adverse events. Acceptability and attitudes to DP were assessed in a qualitative substudy. In total, 74 participants were randomised into the trial and analysed, 37 participants to NIV plus pacing and 37 to standard care, before the Data Monitoring and Ethics Committee advised initial suspension of recruitment (December 2013) and subsequent discontinuation of pacing (on safety grounds) in all patients (June 2014). Follow-up assessments continued until the planned end of the study in December 2014. The median survival (interquartile range) was 22.5 months (lower quartile 11.8 months; upper quartile not reached) in the NIV arm and 11.0 months (6.7 to 17.0 months) in the NIV plus pacing arm, with an adjusted hazard ratio of 2.27 (95% confidence interval 1.22 to 4.25; p = 0.01). Diaphragmatic pacing should not be used as a routine treatment for patients with ALS in respiratory failure. It may be that certain population subgroups benefit from DP. We are unable to explain the mechanism behind the excess mortality in the pacing arm, something the small trial size cannot help address. Future research should investigate the mechanism by which harm or benefit occurs further. Current Controlled Trials ISRCTN53817913. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 45. See the HTA programme website for further project information. Additional funding was provided by the Motor Neurone Disease Association of England, Wales and Northern Ireland.

Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial

PubMed Central

Santaella, Danilo F; Devesa, Cesar R S; Rojo, Marcos R; Amato, Marcelo B P; Drager, Luciano F; Casali, Karina R; Montano, Nicola

2011-01-01

Objectives Since ageing is associated with a decline in pulmonary function, heart rate variability and spontaneous baroreflex, and recent studies suggest that yoga respiratory exercises may improve respiratory and cardiovascular function, we hypothesised that yoga respiratory training may improve respiratory function and cardiac autonomic modulation in healthy elderly subjects. Design 76 healthy elderly subjects were enrolled in a randomised control trial in Brazil and 29 completed the study (age 68±6 years, 34% males, body mass index 25±3 kg/m2). Subjects were randomised into a 4-month training program (2 classes/week plus home exercises) of either stretching (control, n=14) or respiratory exercises (yoga, n=15). Yoga respiratory exercises (Bhastrika) consisted of rapid forced expirations followed by inspiration through the right nostril, inspiratory apnoea with generation of intrathoracic negative pressure, and expiration through the left nostril. Pulmonary function, maximum expiratory and inspiratory pressures (PEmax and PImax, respectively), heart rate variability and blood pressure variability for spontaneous baroreflex determination were determined at baseline and after 4 months. Results Subjects in both groups had similar demographic parameters. Physiological variables did not change after 4 months in the control group. However, in the yoga group, there were significant increases in PEmax (34%, p<0.0001) and PImax (26%, p<0.0001) and a significant decrease in the low frequency component (a marker of cardiac sympathetic modulation) and low frequency/high frequency ratio (marker of sympathovagal balance) of heart rate variability (40%, p<0.001). Spontaneous baroreflex did not change, and quality of life only marginally increased in the yoga group. Conclusion Respiratory yoga training may be beneficial for the elderly healthy population by improving respiratory function and sympathovagal balance. Trial Registration CinicalTrials.gov identifier: NCT00969345; trial registry name: Effects of respiratory yoga training (Bhastrika) on heart rate variability and baroreflex, and quality of life of healthy elderly subjects. PMID:22021757

Serum uric acid levels and multiple health outcomes: umbrella review of evidence from observational studies, randomised controlled trials, and Mendelian randomisation studies.

PubMed

Li, Xue; Meng, Xiangrui; Timofeeva, Maria; Tzoulaki, Ioanna; Tsilidis, Konstantinos K; Ioannidis, John PA; Campbell, Harry; Theodoratou, Evropi

2017-06-07

Objective  To map the diverse health outcomes associated with serum uric acid (SUA) levels. Design  Umbrella review. Data sources  Medline, Embase, Cochrane Database of Systematic Reviews, and screening of citations and references. Eligibility criteria  Systematic reviews and meta-analyses of observational studies that examined associations between SUA level and health outcomes, meta-analyses of randomised controlled trials that investigated health outcomes related to SUA lowering treatment, and Mendelian randomisation studies that explored the causal associations of SUA level with health outcomes. Results  57 articles reporting 15 systematic reviews and144 meta-analyses of observational studies (76 unique outcomes), 8 articles reporting 31 meta-analyses of randomised controlled trials (20 unique outcomes), and 36 articles reporting 107 Mendelian randomisation studies (56 unique outcomes) met the eligibility criteria. Across all three study types, 136 unique health outcomes were reported. 16 unique outcomes in meta-analyses of observational studies had P<10 -6 , 8 unique outcomes in meta-analyses of randomised controlled trials had P<0.001, and 4 unique outcomes in Mendelian randomisation studies had P<0.01. Large between study heterogeneity was common (80% and 45% in meta-analyses of observational studies and of randomised controlled trials, respectively). 42 (55%) meta-analyses of observational studies and 7 (35%) meta-analyses of randomised controlled trials showed evidence of small study effects or excess significance bias. No associations from meta-analyses of observational studies were classified as convincing; five associations were classified as highly suggestive (increased risk of heart failure, hypertension, impaired fasting glucose or diabetes, chronic kidney disease, coronary heart disease mortality with high SUA levels). Only one outcome from randomised controlled trials (decreased risk of nephrolithiasis recurrence with SUA lowering treatment) had P<0.001, a 95% prediction interval excluding the null, and no large heterogeneity or bias. Only one outcome from Mendelian randomisation studies (increased risk of gout with high SUA levels) presented convincing evidence. Hypertension and chronic kidney disease showed concordant evidence in meta-analyses of observational studies, and in some (but not all) meta-analyses of randomised controlled trials with respective intermediate or surrogate outcomes, but they were not statistically significant in Mendelian randomisation studies. Conclusion  Despite a few hundred systematic reviews, meta-analyses, and Mendelian randomisation studies exploring 136 unique health outcomes, convincing evidence of a clear role of SUA level only exists for gout and nephrolithiasis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity.

PubMed

Bonet, Mercedes; Ota, Erika; Chibueze, Chioma E; Oladapo, Olufemi T

2017-11-13

Infectious morbidities contribute to considerable maternal and perinatal morbidity and mortality, including women at no apparent increased risk of infection. To reduce the incidence of infections, antibiotics are often administered to women after uncomplicated childbirth, particularly in settings where women are at higher risk of puerperal infectious morbidities. To assess whether routine administration of prophylactic antibiotics to women after normal (uncomplicated) vaginal birth, compared with placebo or no antibiotic prophylaxis, reduces postpartum maternal infectious morbidities and improves outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2017), LILACS, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (22 August 2017) and reference lists of retrieved studies. We planned to include randomised or quasi-randomised trials evaluating the use of prophylactic antibiotics versus placebo or no antibiotic prophylaxis. Trials using a cluster-randomised design would have been eligible for inclusion, but we found none.In future updates of this review, we will include studies published in abstract form only, provided sufficient information is available to assess risks of bias. We will consider excluded abstracts for inclusion once the full publication is available, or the authors provide more information.Trials using a cross-over design are not eligible for inclusion in this review. Two review authors conducted independent assessment of trials for inclusion and risks of bias. They independently extracted data and checked them for accuracy, resolving differences in assessments by discussion. They evaluated methodological quality using standard Cochrane criteria and the GRADE approach.We present the summaries as risk ratios (RRs) and mean difference (MDs) using fixed- or random-effect models. For one primary outcome we found considerable heterogeneity and interaction. We explored further using subgroup analysis to investigate the effects of the randomisation unit. All review authors discussed and interpreted the results. One randomised controlled trial (RCT) and two quasi-RCTs contributed data on 1779 women who had uncomplicated vaginal births, comparing different antibiotic regimens with placebo or no treatment. The included trials took place in the 1960s (one trial) and 1990s (two trials). The trials were conducted in France, the USA and Brazil. Antibiotics administered included: oral sulphamethoxypyridazine or chloramphenicol for three to five days, and intravenous amoxicillin and clavulanic acid in a single dose one hour after birth. We rated most of the domains for risk of bias as high risk, with the exception of reporting bias and other potential bias.The quality of evidence ranged from low to very low, based on the GRADE quality assessment, given very serious design limitations of the included studies, few events and wide confidence intervals (CIs) of effect estimates.We found a decrease in the risk of endometritis (RR 0.28, 95% CI 0.09 to 0.83, two trials, 1364 women,very low quality). However, one trial reported zero events for this outcome and we rate the evidence as very low quality. There was little or no difference between groups for the risk of urinary tract infection (RR 0.25, 95% CI 0.05 to 1.19, two trials, 1706 women,low quality), wound infection after episiotomy (reported as wound dehiscence in the included trials) (RR 0.78, 95% CI 0.31 to 1.96, two trials, 1364 women, very low quality) and length of maternal hospital stay in days (MD -0.15, 95% CI -0.31 to 0.01, one trial, 1291 women, very low quality). Cost of care in US dollar equivalent was 2½ times higher in the control group compared to the group receiving antibiotics prophylaxis (USD 3600: USD 9000, one trial, 1291 women). There were few or no differences between treated and control groups for adverse effects of antibiotics (skin rash) reported in one woman in each of the two trials (RR 3.03, 95% CI 0.32 to 28.95, two trials, 1706 women, very low quality). The incidence of severe maternal infectious morbidity, antimicrobial resistance or women's satisfaction with care were not addressed by any of the included studies. Routine administration of antibiotics may reduce the risk of endometritis after uncomplicated vaginal birth. The small number and nature of the trials limit the interpretation of the evidence for application in practice, particularly in settings where women may be at higher risk of developing endometritis. The use of antibiotics did not reduce the incidence of urinary tract infections, wound infection or the length of maternal hospital stay. Antibiotics are not a substitute for infection prevention and control measures around the time of childbirth and the postpartum period. The decision to routinely administer prophylactic antibiotics after normal vaginal births needs to be balanced by patient features, childbirth setting and provider experience, including considerations of the contribution of indiscriminate use of antibiotics to raising antimicrobial resistance. Well-designed and high-powered randomised controlled trials would help to evaluate the added value of routine antibiotic administration as a measure to prevent maternal infections after normal vaginal delivery.

Bee venom acupuncture for rheumatoid arthritis: a systematic review of randomised clinical trials.

PubMed

Lee, Ju Ah; Son, Mi Ju; Choi, Jiae; Jun, Ji Hee; Kim, Jong-In; Lee, Myeong Soo

2014-11-07

To assess the clinical evidence for bee venom acupuncture (BVA) for rheumatoid arthritis (RA). Systematic review of randomised controlled trials (RCTs). We searched 14 databases up to March 2014 without a language restriction. Patients with RA. BVA involved injecting purified, diluted BV into acupoints. We included trials on BVA used alone or in combination with a conventional therapy versus the conventional therapy alone. Morning stiffness, pain and joint swelling Erythrocyte sedimentation rate (ESR), C reactive protein (CRP), rheumatoid factor, the number of joints affected by RA and adverse effects likely related to RA. A total of 304 potentially relevant studies were identified; only one RCT met our inclusion criteria. Compared with placebo, BVA may more effectively improve joint pain, swollen joint counts, tender joint counts, ESR and CRP but was not shown to improve morning stiffness. There is low-quality evidence, based on one trial, that BVA can significantly reduce pain, morning stiffness, tender joint counts, swollen joint counts and improve the quality of life of patients with RA compared with placebo (normal saline injection) control. However, the number of trials, their quality and the total sample size were too low to draw firm conclusions. PROSPERO 2013: CRD42013005853. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Are we failing young people not in employment, education or training (NEETs)? A systematic review and meta-analysis of re-engagement interventions.

PubMed

Mawn, Lauren; Oliver, Emily J; Akhter, Nasima; Bambra, Clare L; Torgerson, Carole; Bridle, Chris; Stain, Helen J

2017-01-25

Youth comprise 40% of the world's unemployed, a status associated with adverse wellbeing and social, health, and economic costs. This systematic review and meta-analysis review synthesises the literature on the effectiveness of interventions targeting young people not in employment, education, or training (NEET). Randomised and quasi-randomised trials with a concurrent or counterfactual control group and baseline equivalence are included. Cochrane collaboration tools are used to assess quality, and a narrative synthesis was undertaken. The primary outcome is employment; secondary outcomes were health, earnings, welfare receipt, and education. Eighteen trials are included (9 experimental and 9 quasi-experimental), sample sizes range from 32 to 54,923. Interventions include social skills, vocational, or educational classroom-based training, counselling or one-to-one support, internships, placements, on-the-job or occupational training, financial incentives, case management, and individual support. Meta-analysis of three high-quality trials demonstrates a 4% (CI 0.0-0.7) difference between intervention and control groups on employment. Evidence for other outcomes lacks consistency; however, more intensive programmes increase employment and wages over the longer term. There is some evidence that intensive multi-component interventions effectively decrease unemployment amongst NEETs. The quality of current evidence is limited, leaving policy makers under-served when designing and implementing new programmes, and a vulnerable population neglected. PROSPERO CRD42014007535.

Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson's disease: a large pragmatic randomised controlled trial (PD REHAB).

PubMed

Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Zhu, Shihua; Kandiyali, Rebecca; Yao, Guiqing; Sackley, Catherine M

2016-08-01

Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson's disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson's disease. Large pragmatic randomised controlled trial. Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. Seven hundred and sixty-two patients with mild to moderate Parkinson's disease reporting limitations in activities of daily living (ADL). Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson's Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) -0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI -1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (-0.03, 95% CI -0.07 to -0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis including all time points showed no difference in NEADL total score, but PDQ-39 summary index (curves diverging at 1.6 points per annum, 95% CI 0.47 to 2.62; p = 0.005) and EQ-5D quotient (0.02, 95% CI 0.00007 to 0.03; p = 0.04) showed significant but small differences in favour of the therapy arm. Cost-effective analysis showed that therapy was associated with a slight but not significant gain in quality-adjusted life-years (0.027, 95% CI -0.010 to 0.065) at a small incremental cost (£164, 95% CI -£141 to £468), resulting in an incremental cost-effectiveness ratio of under £4000 (£3493, 95% -£169,371 to £176,358). There was no difference in adverse events or serious adverse events. NHS PT and OT did not produce immediate or long-term clinically meaningful improvements in ADL or quality of life in patients with mild to moderate Parkinson's disease. This evidence does not support the use of low-dose, patient-centred, goal-directed PT and OT in patients in the early stages of Parkinson's disease. Future research should include the development and testing of more structured and intensive PT and OT programmes in patients with all stages of Parkinson's disease. Current Controlled Trials ISRCTN17452402. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 63. See the NIHR Journals Library website for further project information. The Birmingham Clinical Trials Unit, University of Birmingham, received support from the UK Department of Health up to March 2012. Catherine Sackley was supported by a NIHR senior investigator award, Collaboration for Leadership in Applied Health Research and Care East of England and West Midlands Strategic Health Authority Clinical Academic Training award.

Non-pharmacological interventions for people with epilepsy and intellectual disabilities.

PubMed

Jackson, Cerian F; Makin, Selina M; Marson, Anthony G; Kerr, Michael

2015-09-10

Approximately 30% of patients with epilepsy remain refractory to drug treatment and continue to experience seizures whilst taking one or more antiepileptic drugs (AEDs). Several non-pharmacological interventions that may be used in conjunction with or as an alternative to AEDs are available for refractory patients. In view of the fact that seizures in people with intellectual disabilities are often complex and refractory to pharmacological interventions, it is evident that good quality randomised controlled trials (RCTs) are needed to assess the efficacy of alternatives or adjuncts to pharmacological interventions.This is an updated version of the original Cochrane review (Beavis 2007) published in The Cochrane Library (2007, Issue 4). To assess data derived from randomised controlled trials of non-pharmacological interventions for people with epilepsy and intellectual disabilities.Non-pharmacological interventions include, but are not limited to, the following.• Surgical procedures.• Specialised diets, for example, the ketogenic diet, or vitamin and folic acid supplementation.• Psychological interventions for patients or for patients and carers/parents, for example, cognitive-behavioural therapy (CBT), electroencephalographic (EEG) biofeedback and educational intervention.• Yoga.• Acupuncture.• Relaxation therapy (e.g. music therapy). For the latest update of this review, we searched the Cochrane Epilepsy Group Specialised Register (19 August 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) via CRSO (19 August 2014), MEDLINE (Ovid, 1946 to 19 August 2014) and PsycINFO (EBSCOhost, 1887 to 19 August 2014). Randomised controlled trials of non-pharmacological interventions for people with epilepsy and intellectual disabilities. Two review authors independently applied the inclusion criteria and extracted study data. One study is included in this review. When two surgical procedures were compared, results indicated that corpus callosotomy with anterior temporal lobectomy was more effective than anterior temporal lobectomy alone in improving quality of life and performance on IQ tests among people with epilepsy and intellectual disabilities. No evidence was found to support superior benefit in seizure control for either intervention. This is the only study of its kind and was rated as having an overall unclear risk of bias. The previous update (December 2010) identified one RCT in progress. The study authors have confirmed that they are aiming to publish by the end of 2015; therefore this study (Bjurulf 2008) has not been included in the current review. This review highlights the need for well-designed randomised controlled trials conducted to assess the effects of non-pharmacological interventions on seizure and behavioural outcomes in people with intellectual disabilities and epilepsy.

Integrating evidence-based teaching into to clinical practice should improve outcomes.

PubMed

Richards, Derek

2005-01-01

Sources used were Medline, Embase, the Education Resources Information Centre , Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Best Evidence, Best Evidence Medical Education and Science Citation Index, along with reference lists of known systematic reviews. Studies were chosen for inclusion if they evaluated the effects of postgraduate evidence-based medicine (EBM) or critical appraisal teaching in comparison with a control group or baseline before teaching, using a measure of participants' learning achievements or patients' health gains as outcomes. Articles were graded as either level 1 (randomised controlled trials (RCT)) or level 2 (non-randomised studies that either had a comparison with a control group), or a before and after comparison without a control group. Learning achievement was assessed separately for knowledge, critical appraisal skills, attitudes and behaviour. Because of obvious heterogeneity in the features of individual studies, their quality and assessment tools used, a meta-analysis could not be carried out. Conclusions were weighted by methodological quality. Twenty-three relevant studies were identified, comprising four RCT, seven non-RCT, and 12 before and after comparison studies. Eighteen studies (including two RCT) evaluated a standalone teaching method and five studies (including two RCT) evaluated a clinically integrated teaching method. Standalone teaching improved knowledge but not skills, attitudes or behaviour. Clinically integrated teaching improved knowledge, skills, attitudes and behaviour. Teaching of EBM should be moved from classrooms to clinical practice to achieve improvements in substantial outcomes.

Oxcarbazepine in the maintenance treatment of bipolar disorder.

PubMed

Vasudev, A; Macritchie, K; Watson, S; Geddes, J R; Young, A H

2008-01-23

Some studies have suggested that oxcarbazepine has a role in preventing episode recurrence in bipolar affective disorder. This review attempted to investigate the existing evidence from randomised controlled trials for its use in the maintenance treatment of this illness. To review the efficacy of oxcarbazepine, relative to placebo and other agents, in the prevention of affective episodes of bipolar affective disorder. The efficacy of oxcarbazepine was considered in terms of episode recurrence, general and social functioning. Adverse effects, overall acceptability to participants and mortality were also considered. CCDANCTR-Studies and CCDANCTR-References were searched on 7/11/2007. Medline, CENTRAL, EMBASE and PsycINFO were searched in March 2007. Specialist journals and conference proceedings were handsearched. Reference lists of relevant papers and major textbooks of affective disorder were checked. Authors, experts in the field and pharmaceutical companies were contacted requesting information on published or unpublished trials. Randomised controlled trials comparing oxcarbazepine with placebo or alternative agents, where the stated intent of intervention was the maintenance treatment of bipolar affective disorder were sought. Participants with bipolar disorder, male and female, of all ages, were included. Data were extracted from the original reports individually by two review authors. The methodological quality of included studies was assessed individually by two review authors. The main outcomes were the efficacy of oxcarbazepine maintenance treatment in preventing or attenuating further episodes of bipolar affective disorder (including its efficacy in rapid cycling disorder), the acceptability of oxcarbazepine treatment to participants, the prevalence of side-effects, and mortality, if any, on oxcarbazepine treatment. Where appropriate, data concerning outcome measures and adverse effects were to be extracted from the studies and analysed using Review Manager software. Two randomised controlled trials were found that met the methodological criteria for inclusion in the review. However, they did not report data with sufficient clarity to allow their confident extraction for inclusion in the meta-analysis. Findings from the two studies were presented descriptively. There is an insufficient methodologically rigorous evidence base to provide guidance on the use of oxcarbazepine in the maintenance treatment of bipolar disorder. Given the need for more efficacious therapeutic agents, there is a need for good quality randomised controlled trials examining the therapeutic potential of this and related agents in bipolar disorder.

Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial.

PubMed

Beeken, Rebecca J; Spanos, Dimitrios; Fovargue, Sally; Hunter, Rachael; Omar, Rumana; Hassiotis, Angela; King, Michael; Wardle, Jane; Croker, Helen

2013-03-12

National obesity rates have dramatically risen over the last decade. Being obese significantly reduces life expectancy, increases the risk of a range of diseases, and compromises quality of life. Costs to both the National Health Service and society are high. An increased prevalence of obesity in people with learning disabilities has been demonstrated. The consequences of obesity are particularly relevant to people with learning disabilities who are already confronted by health and social inequalities. In order to provide healthcare for all, and ensure equality of treatment for people with learning disabilities, services must be developed specifically with this population in mind. The aim of this project is to pilot the evaluation of a manualised weight management programme for overweight and obese persons with mild-moderate learning disabilities (Shape Up-LD). An individually randomised, controlled pilot trial in 60 overweight and obese (body mass index ≥ 25) adults (age ≥ 18) with mild-moderate learning disabilities and their carers will be carried out, comparing "Shape Up-LD" with usual care. The manualised Shape Up-LD intervention will involve 12 weekly sessions, which include healthy eating messages, advice on physical activity and use of behaviour change techniques to help people manage their weight. Assessments of participants will be conducted at baseline, 12 weeks and 6 months. Service users and their carers and service providers will also give their perspectives on the experience of Shape Up-LD in qualitative interviews at 12 weeks. Feasibility outcomes will include recruitment rates, loss to follow-up, compliance rates, completion rates, collection of information for a cost-effectiveness analysis and an estimation of the treatment effect on weight. The findings from this study will inform our preparation for a definitive randomised controlled trial to test the efficacy of the programme with respect to weight loss and maintenance in this population. Weight loss through Shape Up-LD could lead to improvements in health and quality of life. Costs to the National Health Service might be reduced through decreased overall service use because of improved health. The programme would also ensure a more equitable service for overweight service users with learning disabilities and fill the current gap in weight management services for this population. International Standard Randomised Controlled Trial No ISRCTN39605930.

Importance of rate control or rate regulation for improving exercise capacity and quality of life in patients with permanent atrial fibrillation and normal left ventricular function: a randomised controlled study

PubMed Central

Levy, T; Walker, S; Mason, M; Spurrell, P; Rex, S; Brant, S; Paul, V

2001-01-01

OBJECTIVE—To determine the importance of rhythm regulation or rate control in patients with permanent atrial fibrillation (AF) and normal left ventricular function.
PATIENTS AND INTERVENTIONS—Thirty six patients with a mixed fast and slow ventricular response rate to their AF were randomised to either His bundle ablation (HBA) and VVIR pacemaker (HBA group) or VVI pacemaker and atrioventricular modifying drugs (Med group). Outcomes assessed at one, three, six, and 12 months included exercise duration and quality of life.
RESULTS—Exercise duration significantly improved from baseline in both groups. There was no difference in outcome between the groups (Med +40% v HBA +20%, p = NS). The heart rate profile on exercise was similarly slowed in both groups compared to baseline. Quality of life significantly improved in both treatment arms for the modified Karolinska questionnaire (KQ) (Med +50% v HBA +50%, p = NS) and the Nottingham health profile (NHP) (Med +40% v HBA +20%, p = NS). However, for the individual symptom scores of each questionnaire more were improved in the Med group (KQ-Med 6 improved v HBA 4, NHP-Med 3 v HBA 1). Left ventricular function was equally preserved by both treatments during follow up.
CONCLUSION—In these patients control of ventricular response rate with either HBA + VVIR pacemaker or atrioventricular modifying drugs + VVI pacemaker will lead to a significant improvement in exercise duration and quality of life. Rhythm regulation by HBA did not confer additional benefit, suggesting rate control alone is necessary for the successful symptomatic treatment of these patients in permanent AF.


Keywords: ablation; atrial fibrillation; pacemaker; atrioventricular modifying drugs PMID:11156667

Improved recognition of ineffective chest compressions after a brief Crew Resource Management (CRM) training: a prospective, randomised simulation study.

PubMed

Haffner, Leopold; Mahling, Moritz; Muench, Alexander; Castan, Christoph; Schubert, Paul; Naumann, Aline; Reddersen, Silke; Herrmann-Werner, Anne; Reutershan, Jörg; Riessen, Reimer; Celebi, Nora

2017-03-03

Chest compressions are a core element of cardio-pulmonary resuscitation. Despite periodic training, real-life chest compressions have been reported to be overly shallow and/or fast, very likely affecting patient outcomes. We investigated the effect of a brief Crew Resource Management (CRM) training program on the correction rate of improperly executed chest compressions in a simulated cardiac arrest scenario. Final-year medical students (n = 57) were randomised to receive a 10-min computer-based CRM or a control training on ethics. Acting as team leaders, subjects performed resuscitation in a simulated cardiac arrest scenario before and after the training. Team members performed standardised overly shallow and fast chest compressions. We analysed how often the team leader recognised and corrected improper chest compressions, as well as communication and resuscitation quality. After the CRM training, team leaders corrected improper chest compressions (35.5%) significantly more often compared with those undergoing control training (7.7%, p = 0.03*). Consequently, four students have to be trained (number needed to treat = 3.6) for one improved chest compression scenario. Communication quality assessed by the Leader Behavior Description Questionnaire significantly increased in the intervention group by a mean of 4.5 compared with 2.0 (p = 0.01*) in the control group. A computer-based, 10-min CRM training improved the recognition of ineffective of chest compressions. Furthermore, communication quality increased. As guideline-adherent chest compressions have been linked to improved patient outcomes, our CRM training might represent a brief and affordable approach to increase chest compression quality and potentially improve patient outcomes.

Identifying models of delivery, care domains and quality indicators relevant to palliative day services: a scoping review protocol.

PubMed

O'Connor, Seán R; Dempster, Martin; McCorry, Noleen K

2017-05-16

With an ageing population and increasing numbers of people with life-limiting illness, there is a growing demand for palliative day services. There is a need to measure and demonstrate the quality of these services, but there is currently little agreement on which aspects of care should be used to do this. The aim of the scoping review will be to map the extent, range and nature of the evidence around models of delivery, care domains and existing quality indicators used to evaluate palliative day services. Electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials) will be searched for evidence using consensus development methods; randomised or quasi-randomised controlled trials; mixed methods; and prospective, longitudinal or retrospective case-control studies to develop or test quality indicators for evaluating palliative care within non-residential settings, including day hospices and community or primary care settings. At least two researchers will independently conduct all searches, study selection and data abstraction procedures. Meta-analyses and statistical methods of synthesis are not planned as part of the review. Results will be reported using numerical counts, including number of indicators in each care domain and by using qualitative approach to describe important indicator characteristics. A conceptual model will also be developed to summarise the impact of different aspects of quality in a palliative day service context. Methodological quality relating to indicator development will be assessed using the Appraisal of Indicators through Research and Evaluation (AIRE) tool. Overall strength of evidence will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. Final decisions on quality assessment will be made via consensus between review authors. Identifying, developing and implementing evidence-based quality indicators is critical to the evaluation and continued improvement of palliative care. Review findings will be used to support clinicians and policymakers make decisions on which quality indicators are most appropriate for evaluating day services at the patient and service level, and to identify areas for further research.

Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial

PubMed Central

2013-01-01

Background Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. Methods/design A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. Trial registration ISRCTN18912042 PMID:24021033

VALFORTA: a randomised trial to validate the FORTA (Fit fOR The Aged) classification.

PubMed

Wehling, Martin; Burkhardt, Heinrich; Kuhn-Thiel, Alexandra; Pazan, Farhad; Throm, Christina; Weiss, Christel; Frohnhofen, Helmut

2016-03-01

to further validate the FORTA (Fit fOR The Aged) concept, a bicentric randomised, controlled trial was run in two geriatric clinics. patients (≥65 years, ≥3 drugs or ≥60 years, ≥6 drugs) with three relevant diseases and hospitalisation for ≥5 days were randomised. In the intervention, but not the control group, a FORTA team instructed ward physicians on FORTA. FORTA is the first positive/negative listing approach labelling medications used to treat chronic illnesses in older patients from A (indispensable), B (beneficial), C (questionable) to D (avoid). The primary end point was the FORTA score: sum of medication errors classified as over-, under- and mistreatment. Consecutive patients were randomised to the intervention and control ward; outcome assessment was blinded. four hundred and nine patients (age 81.5 years, 64% female, hospitalisation 17.4 days) were included. The primary end point was significantly (P < 0.0001) more reduced in the intervention versus control groups (2.7 ± 2.25 versus 1 ± 1.8, mean ± SD, intergroup comparison of admission/discharge differences). Over- and under-treatment scores and use of A (increase) and D (decrease) drugs were significantly improved (P < 0.01). The total number of adverse drug reactions (ADRs) was significantly reduced by FORTA (P < 0.05, number needed to treat is 5). Activities of daily living and renal failure improved significantly (P < 0.05). Blood pressure remained constant in the intervention, but decreased significantly in the control group. applying FORTA to hospitalised geriatric patients leads to improvement of medication quality and may improve secondary clinical end points (e.g. ADRs). The concept is amenable to successful communication and implementation. Registration (DRKS-ID): DRKS00000531. DFG-German Research Foundation (WE 1184/15-1). © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.

PubMed

Foley, A; Halbert, J; Hewitt, T; Crotty, M

2003-12-01

To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Single blind, three arm, randomised controlled trial. 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Functional gains were achieved with both exercise programmes compared with the control group.

Does hydrotherapy improve strength and physical function in patients with osteoarthritis—a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme

PubMed Central

Foley, A; Halbert, J; Hewitt, T; Crotty, M

2003-01-01

Objective: To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Design: Single blind, three arm, randomised controlled trial. Subjects: 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Methods: Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). Results: In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Conclusion: Functional gains were achieved with both exercise programmes compared with the control group. PMID:14644853

A regular yoga intervention for staff nurse sleep quality and work stress: a randomised controlled trial.

PubMed

Fang, Ronghua; Li, Xia

2015-12-01

Although many studies have assessed the efficacy of yoga in older individuals, minimal research has focused on how nurses use yoga to improve sleep quality and to reduce work stress after work hours. We used the Pittsburgh Sleep Quality Index in Chinese and the Questionnaire on Medical Worker's Stress in Chinese to determine the impact of yoga on the quality of sleep and work stress of staff nurses employed by a general hospital in China. Disturbances in the circadian rhythm interrupt an individual's pattern of sleep. Convenient sampling method. One hundred and twenty nurses were randomised into two groups: a yoga group and a non-yoga group. The yoga group performed yoga more than two times every week for 50-60 minutes each time after work hours. The NG group did not participate in yoga. After six months, self-reported sleep quality and work stress were compared between the two groups, and then we used linear regression to confirm the independent factors related to sleep quality. Nurses in the yoga group had better sleep quality and lower work stress compared with nurses in the non-yoga group. The linear regression model indicated that nursing experience, age and yoga intervention were significantly related to sleep quality. Regular yoga can improve sleep quality and reduce work stress in staff nurses. This study provides evidence that hospital management should pay attention to nurse sleep quality and work stress, thereby taking corresponding measures to reduce work pressure and improve health outcomes. © 2015 John Wiley & Sons Ltd.

Screening for gestational diabetes mellitus based on different risk profiles and settings for improving maternal and infant health.

PubMed

Tieu, Joanna; McPhee, Andrew J; Crowther, Caroline A; Middleton, Philippa; Shepherd, Emily

2017-08-03

Gestational diabetes mellitus (GDM) is a form of diabetes that occurs in pregnancy. Although GDM usually resolves following birth, it is associated with significant morbidities for mothers and their infants in the short and long term. There is strong evidence to support treatment for GDM. However, there is uncertainty as to whether or not screening all pregnant women for GDM will improve maternal and infant health and if so, the most appropriate setting for screening. This review updates a Cochrane Review, first published in 2010, and subsequently updated in 2014. To assess the effects of screening for gestational diabetes mellitus based on different risk profiles and settings on maternal and infant outcomes. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (14 June 2017), and reference lists of retrieved studies. We included randomised and quasi-randomised trials evaluating the effects of different protocols, guidelines or programmes for screening for GDM based on different risk profiles and settings, compared with the absence of screening, or compared with other protocols, guidelines or programmes for screening. We planned to include trials published as abstracts only and cluster-randomised trials, but we did not identify any. Cross-over trials are not eligible for inclusion in this review. Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included trials. We resolved disagreements through discussion or through consulting a third reviewer. We included two trials that randomised 4523 women and their infants. Both trials were conducted in Ireland. One trial (which quasi-randomised 3742 women, and analysed 3152 women) compared universal screening versus risk factor-based screening, and one trial (which randomised 781 women, and analysed 690 women) compared primary care screening versus secondary care screening. We were not able to perform meta-analyses due to the different interventions and comparisons assessed.Overall, there was moderate to high risk of bias due to one trial being quasi-randomised, inadequate blinding, and incomplete outcome data in both trials. We used GRADEpro GDT software to assess the quality of the evidence for selected outcomes for the mother and her child. Evidence was downgraded for study design limitations and imprecision of effect estimates. Universal screening versus risk-factor screening (one trial) MotherMore women were diagnosed with GDM in the universal screening group than in the risk-factor screening group (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.12 to 3.04; participants = 3152; low-quality evidence). There were no data reported under this comparison for other maternal outcomes including hypertensive disorders of pregnancy, caesarean birth, perineal trauma, gestational weight gain, postnatal depression, and type 2 diabetes. ChildNeonatal outcomes: large-for-gestational age, perinatal mortality, mortality or morbidity composite, hypoglycaemia; and childhood/adulthood outcomes: adiposity, type 2 diabetes, and neurosensory disability, were not reported under this comparison. Primary care screening versus secondary care screening (one trial) MotherThere was no clear difference between the primary care and secondary care screening groups for GDM (RR 0.91, 95% CI 0.50 to 1.66; participants = 690; low-quality evidence), hypertension (RR 1.41, 95% CI 0.77 to 2.59; participants = 690; low-quality evidence), pre-eclampsia (RR 0.80, 95% CI 0.36 to 1.78; participants = 690;low-quality evidence), or caesarean section birth (RR 1.00, 95% CI 0.80 to 1.27; participants = 690; low-quality evidence). There were no data reported for perineal trauma, gestational weight gain, postnatal depression, or type 2 diabetes. ChildThere was no clear difference between the primary care and secondary care screening groups for large-for-gestational age (RR 1.37, 95% CI 0.96 to 1.96; participants = 690; low-quality evidence), neonatal complications: composite outcome, including: hypoglycaemia, respiratory distress, need for phototherapy, birth trauma, shoulder dystocia, five minute Apgar less than seven at one or five minutes, prematurity (RR 0.99, 95% CI 0.57 to 1.71; participants = 690; low-quality evidence), or neonatal hypoglycaemia (RR 1.10, 95% CI 0.28 to 4.38; participants = 690; very low-quality evidence). There was one perinatal death in the primary care screening group and two in the secondary care screening group (RR 1.10, 95% CI 0.10 to 12.12; participants = 690; very low-quality evidence). There were no data for neurosensory disability, or childhood/adulthood adiposity or type 2 diabetes. There are insufficient randomised controlled trial data evaluating the effects of screening for GDM based on different risk profiles and settings on maternal and infant outcomes. Low-quality evidence suggests universal screening compared with risk factor-based screening leads to more women being diagnosed with GDM. Low to very low-quality evidence suggests no clear differences between primary care and secondary care screening, for outcomes: GDM, hypertension, pre-eclampsia, caesarean birth, large-for-gestational age, neonatal complications composite, and hypoglycaemia.Further, high-quality randomised controlled trials are needed to assess the value of screening for GDM, which may compare different protocols, guidelines or programmes for screening (based on different risk profiles and settings), with the absence of screening, or with other protocols, guidelines or programmes. There is a need for future trials to be sufficiently powered to detect important differences in short- and long-term maternal and infant outcomes, such as those important outcomes pre-specified in this review. As only a proportion of women will be diagnosed with GDM in these trials, large sample sizes may be required.

Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish 'TeleCare North' cluster-randomised trial.

PubMed

Witt Udsen, Flemming; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars

2017-05-17

To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Community-based setting in the geographical area of North Denmark Region in Denmark. 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI -754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI -0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Clinicaltrials.gov, NCT01984840, 14 November 2013. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish ‘TeleCare North’ cluster-randomised trial

PubMed Central

Witt Udsen, Flemming; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars

2017-01-01

Objectives To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. Design A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Setting Community-based setting in the geographical area of North Denmark Region in Denmark. Participants 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. Interventions In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Main outcome measure Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. Results From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI −754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI −0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Conclusions Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Trial registration Clinicaltrials.gov, NCT01984840, 14 November 2013. PMID:28515193

Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial.

PubMed

Kwok, Boon Chong; Mamun, Kaysar; Chandran, Manju; Wong, Chek Hooi

2011-06-18

Falls are common in frail older adults and often result in injuries and hospitalisation. The Nintendo® Wii™ is an easily available exercise modality in the community which has been shown to improve lower limb strength and balance. However, not much is known on the effectiveness of the Nintendo® Wii™ to improve fall efficacy and reduce falls in a moderately frail older adult. Fall efficacy is the measure of fear of falling in performing various daily activities. Fear contributes to avoidance of activities and functional decline. This randomised active-control trial is a comparison between the Nintendo WiiActive programme against standard gym-based rehabilitation of the older population. Eighty subjects aged above 60, fallers and non-fallers, will be recruited from the hospital outpatient clinic. The primary outcome measure is the Modified Falls Efficacy Scale and the secondary outcome measures are self-reported falls, quadriceps strength, walking agility, dynamic balance and quality of life assessments. The study is the first randomised control trial using the Nintendo Wii as a rehabilitation modality investigating a change in fall efficacy and self-reported falls. Longitudinally, the study will investigate if the interventions can successfully reduce falls and analyse the cost-effectiveness of the programme.

ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

PubMed Central

Fletcher-Smith, Joanna C; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D

2016-01-01

Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. Trial registration number ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634. PMID:26729394

Polyunsaturated fatty acid supplementation for drug-resistant epilepsy.

PubMed

Sarmento Vasconcelos, Vivian; Macedo, Cristiane R; de Souza Pedrosa, Alexsandra; Pereira Gomes Morais, Edna; Porfírio, Gustavo J M; Torloni, Maria R

2016-08-17

An estimated 1% to 3% of all individuals will receive a diagnosis of epilepsy during their lives, which corresponds to approximately 50 million affected people worldwide. The real prevalence is possibly higher because epilepsy is underreported in developing countries. Although most will achieve adequate control of their disease though the use of medication, approximately 25% to 30% of all those with epilepsy are refractory to pharmacological treatment and will continue to have seizures despite the use of two or more agents in adequate dosages. Over the last decade, researchers have tested the use of polyunsaturated fatty acid (PUFA) supplements for the treatment of refractory epilepsy, with inconsistent results. There have also been some concerns about the use of omega-3 PUFA compounds because they reduce platelet aggregation and could, in theory, cause bleeding. To assess the effectiveness and tolerability of omega-3 polyunsaturated fatty acids (eicosapentaenoic acid-EPA and docosahexanoic acid-DHA) in the control of seizures in people with refractory epilepsy. We searched the Cochrane Epilepsy Group Specialised Register (from inception up to November 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, issue 11), MEDLINE (1948 to November 2015), EMBASE (1980 to November 2015), SCOPUS (1823 to November 2015); LILACS (Literatura Latino-Americana e do Caribe de Informação em Ciências da Saúde) (1982 to November 2015); ClinicalTrials.gov; World Health Organization (WHO) International Clinical Trials Registry Platform (November 2015). No language restrictions were imposed. We contacted study authors for additional and unpublished information and screened the reference lists of retrieved citations for potentially eligible studies not identified through the electronic search. All randomised and quasi-randomised studies using PUFAs for the treatment of drug-resistant epilepsy. Two review authors were involved in study selection, data extraction and quality assessment of the included trials. The following outcomes were assessed: seizure freedom, seizure reduction, improvement in quality of life, potential adverse effects, gastrointestinal effects, drop-out rates and changes in plasma lipid profile. Primary analyses were by intention to treat. Eight studies were identified as potentially relevant; three fulfilled the selection criteria and were included in the review. Two placebo-controlled, double blind trials involving adult participants were conducted in developed countries, while one placebo-controlled, single blind trial involving children was conducted in a developing country (Egypt). Bromfield 2008 randomised 27 American adults to receive 2.2 g/day of omega-3 PUFAs (EPA:DHA in a 3:2 ratio) or placebo. Yuen 2005 randomised 58 people in the UK to approximately 1.7 g/day omega-3 PUFAs (1g EPA and 0.7g DHA) or placebo. Reda 2015 randomised 70 Egyptian children to receive 3 ml/day of 1200 mg fish oil (providing 0.24 g DHA and 0.36 g EPA) or placebo. The three studies recruited a total of 155 subjects (85 adults and 70 children); 78 of them (43 adults and 35 children) were randomised to PUFAs and 77 (42 adults and 35 children) to placebo. All participants were followed for up to 12 weeks. Seizure freedom was reported by only one study, with a high risk of bias, involving exclusively children. The risk estimate for this outcome was significantly higher in the children receiving PUFA compared to the control group (risk ratio (RR) 20.00, 95% confidence interval (CI) 2.84 to 140.99, 1 study, 70 children). Similarly, PUFA supplementation was associated with a significant difference in the proportion of children with at least 50% reduction in seizure frequency (RR 33.00 95% CI 4.77 to 228.15, 1 study with a high risk of bias, 70 children). However, this effect was not observed when the data from two studies including adult participants were pooled (RR 0.57, 95% CI 0.19 to 1.75, I² 0%, 2 studies, 78 participants, low-quality evidence). One of our three primary outcomes (adverse effects related to bleeding) was not assessed in any of the studies included in this review. There were no significant differences between the PUFA and control groups in relation to gastrointestinal effects (RR 0.78, 95% CI 0.32 to 1.89, 2 studies, 85 participants, low-quality evidence).Supplementation with PUFA did not produce significant differences in mean frequency of seizures, quality of life or other side effects. In view of the limited number of studies and small sample sizes, there is not enough evidence to support the use of PUFA supplementation in people with refractory epilepsy. More trials are needed to assess the benefits of PUFA supplementation in the treatment of drug-resistant epilepsy.

Medicoeconomic analysis of lobectomy using thoracoscopy versus thoracotomy for lung cancer: a study protocol for a multicentre randomised controlled trial (Lungsco01)

PubMed Central

Pagès, Pierre-Benoit; Abou Hanna, Halim; Bertaux, Anne-Claire; Serge Aho, Ludwig Serge; Magdaleinat, Pierre; Baste, Jean-Marc; Filaire, Marc; de Latour, Richard; Assouad, Jalal; Tronc, François; Jayle, Christophe; Mouroux, Jérome; Thomas, Pascal-Alexandre; Falcoz, Pierre-Emmanuel; Marty-Ané, Charles-Henri; Bernard, Alain

2017-01-01

Introduction In the last decade, video-assisted thoracoscopic surgery (VATS) lobectomy for non-small cell lung cancer (NSCLC) has had a major effect on thoracic surgery. Retrospective series have reported benefits of VATS when compared with open thoracotomy in terms of postoperative pain, postoperative complications and length of hospital stay. However, no large randomised control trial has been conducted to assess the reality of the potential benefits of VATS lobectomy or its medicoeconomic impact. Methods and analysis The French National Institute of Health funded Lungsco01 to determine whether VATS for lobectomy is superior to open thoracotomy for the treatment of NSCLC in terms of economic cost to society. This trial will also include an analysis of postoperative outcomes, the length of hospital stay, the quality of life, long-term survival and locoregional recurrence. The study design is a two-arm parallel randomised controlled trial comparing VATS lobectomy with lobectomy using thoracotomy for the treatment of NSCLC. Patients will be eligible if they have proven or suspected lung cancer which could be treated by lobectomy. Patients will be randomised via an independent service. All patients will be monitored according to standard thoracic surgical practices. All patients will be evaluated at day 1, day 30, month 3, month 6, month 12 and then every year for 2 years thereafter. The recruitment target is 600 patients. Ethics and dissemination The protocol has been approved by the French National Research Ethics Committee (CPP Est I: 09/06/2015) and the French Medicines Agency (09/06/2015). Results will be presented at national and international meetings and conferences and published in peer-reviewed journals. Trial registration number NCT02502318. PMID:28619764

A randomised controlled trial of complete denture impression materials.

PubMed

Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

2014-08-01

There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, p<0.0001). There is significant evidence that dentures made from silicone impressions were preferred by patients. Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. ISRCTN 01528038. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial.

PubMed

Atkins, Salla; Ojajärvi, Ulla; Talola, Nina; Viljamaa, Mervi; Nevalainen, Jaakko; Uitti, Jukka

2017-07-26

Employment protects and fosters health. Occupational health services, particularly in Finland, have a central role in protecting employee health and preventing work ability problems. However, primary care within occupational health services is currently underused in informing preventive activities. This study was designed to assess whether the recording of work ability problems and improvement of follow-up of work-related primary care visits can reduce sickness absences and work disability pensions after 1 year. A pragmatic trial will be conducted using patient electronic registers and registers of the central pensions agency in Finland. Twenty-two occupational health centres will be randomised to intervention and control groups. Intervention units will receive training to improve recording of work ability illnesses in the primary care setting and improved follow-up procedures. The intervention impact will be assessed through examining rates of sickness absence across intervention and control clinics as well as before and after the intervention. The trial will develop knowledge of the intervention potential of primary care for preventing work disability pensions and sickness absence. The use of routine patient registers and pensions registers to assess the outcomes of a randomised controlled trial will bring forward trial methodology, particularly when using register-based data. If successful, the intervention will improve the quality of occupational health care primary care and contribute to reducing work disability. ISRCTN Registry reference number ISRCTN45728263 . Registered on 18 April 2016.

Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. Trial registration Current controlled trials ISRCTN62237498 Date registered: 5 September 2013 PMID:25016303

Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial.

PubMed

Åsberg, Signild; Hijazi, Ziad; Norrving, Bo; Terént, Andreas; Öhagen, Patrik; Oldgren, Jonas

2017-12-02

Oral anticoagulation therapy is recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation (AF). Current guidelines do not provide evidence-based recommendations on optimal time-point to start anticoagulation therapy after an acute ischemic stroke. Non-vitamin K antagonist oral anticoagulants (NOACs) may offer advantages compared to warfarin because of faster and more predictable onset of action and potentially a lower risk of intracerebral haemorrhage also in the acute phase after an ischemic stroke. The TIMING study aims to establish the efficacy and safety of early vs delayed initiation of NOACs in patients with acute ischemic stroke and AF. The TIMING study is a national, investigator-led, registry-based, multicentre, open-label, randomised controlled study. The Swedish Stroke Register is used for enrolment, randomisation and follow-up of 3000 patients, who are randomised (1:1) within 72 h from ischemic stroke onset to either early (≤ 4 days) or delayed (≥ 5-10 days) start of NOAC therapy. The primary outcome is the composite of recurrent ischemic stroke, symptomatic intracerebral haemorrhage, or all-cause mortality within 90 days after randomisation. Secondary outcomes include: individual components of the primary outcome at 90 and 365 days; major haemorrhagic events; functional outcome by the modified Rankin Scale at 90 days; and health economics. In an optional biomarker sub-study, blood samples will be collected after randomisation from approximately half of the patients for central analysis of cardiovascular biomarkers after study completion. The study is funded by the Swedish Medical Research Council. Enrolment of patients started in April 2017. The TIMING study addresses the ongoing clinical dilemma of when to start NOAC after an acute ischemic stroke in patients with AF. By the inclusion of a randomisation module within the Swedish Stroke Register, the advantages of a prospective randomised study design are combined with the strengths of a national clinical quality register in allowing simplified enrolment and follow-up of study patients. In addition, the register adds the possibility of directly assessing the external validity of the study findings. ClinicalTrials.gov, NCT02961348 . Registered on 8 November 2016.

Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial.

PubMed

Mollerup, Annette; Veien, Niels Kren; Johansen, Jeanne Duus

2012-06-12

Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual's daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named 'The Healthy Skin Clinic' or to the control group. Block-wise randomisation according to setting and gender is carried out.The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as well of potential observer bias. Inclusion criterions are wide in order to increase transferability of the results. The trial is registered in ClinicalTrials.Gov with registration number NCT01482663.

Chronic hand eczema - self-management and prognosis: a study protocol for a randomised clinical trial

PubMed Central

2012-01-01

Background Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual’s daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. Methods/design This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named ‘The Healthy Skin Clinic’ or to the control group. Block-wise randomisation according to setting and gender is carried out. The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. Discussion The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as well of potential observer bias. Inclusion criterions are wide in order to increase transferability of the results. Trial registration The trial is registered in ClinicalTrials.Gov with registration number NCT01482663. PMID:22691871

Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial.

PubMed

Stoller, Oliver; de Bruin, Eling D; Schuster-Amft, Corina; Schindelholz, Matthias; de Bie, Rob A; Hunt, Kenneth J

2013-09-22

After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke. This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (≤20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained. Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events. This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

[Does implementation of benchmarking in quality circles improve the quality of care of patients with asthma and reduce drug interaction?].

PubMed

Kaufmann-Kolle, Petra; Szecsenyi, Joachim; Broge, Björn; Haefeli, Walter Emil; Schneider, Antonius

2011-01-01

The purpose of this cluster-randomised controlled trial was to evaluate the efficacy of quality circles (QCs) working either with general data-based feedback or with an open benchmark within the field of asthma care and drug-drug interactions. Twelve QCs, involving 96 general practitioners from 85 practices, were randomised. Six QCs worked with traditional anonymous feedback and six with an open benchmark. Two QC meetings supported with feedback reports were held covering the topics "drug-drug interactions" and "asthma"; in both cases discussions were guided by a trained moderator. Outcome measures included health-related quality of life and patient satisfaction with treatment, asthma severity and number of potentially inappropriate drug combinations as well as the general practitioners' satisfaction in relation to the performance of the QC. A significant improvement in the treatment of asthma was observed in both trial arms. However, there was only a slight improvement regarding inappropriate drug combinations. There were no relevant differences between the group with open benchmark (B-QC) and traditional quality circles (T-QC). The physicians' satisfaction with the QC performance was significantly higher in the T-QCs. General practitioners seem to take a critical perspective about open benchmarking in quality circles. Caution should be used when implementing benchmarking in a quality circle as it did not improve healthcare when compared to the traditional procedure with anonymised comparisons. Copyright © 2011. Published by Elsevier GmbH.

A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial.

PubMed

Saxon, David; Ashley, Kate; Bishop-Edwards, Lindsey; Connell, Janice; Harrison, Phillippa; Ohlsen, Sally; Hardy, Gillian E; Kellett, Stephen; Mukuria, Clara; Mank, Toni; Bower, Peter; Bradburn, Mike; Brazier, John; Elliott, Robert; Gabriel, Lynne; King, Michael; Pilling, Stephen; Shaw, Sue; Waller, Glenn; Barkham, Michael

2017-03-01

NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required. PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials. This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative. Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.

WITHDRAWN: Corticosteroids for Bell's palsy (idiopathic facial paralysis).

PubMed

Salinas, Rodrigo A; Alvarez, Gonzalo; Ferreira, Joaquim

2009-04-15

Inflammation and oedema of the facial nerve are implicated in causing Bell's palsy. Corticosteroids have a potent anti-inflammatory action which should minimise nerve damage and thereby improve the outcome of patients suffering from this condition. The objective of this review was to assess the effect of steroid therapy in the recovery of patients with Bell's palsy. We searched the Cochrane Neuromuscular Disease Group register (searched November 2005) for randomised trials, as well as MEDLINE (January 1966 to November 2005), EMBASE (January 1980 to November 2005) and LILACS (January 1982 to November 2005). We contacted known experts in the field to identify additional published or unpublished trials. Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group. Two reviewers independently assessed eligibility, trial quality, and extracted the data. Four trials with a total of 179 patients were included. One trial compared cortisone acetate with placebo; one compared prednisone plus vitamins, with vitamins alone; one compared high-dose prednisone administered intravenously against saline solution, and one, not-placebo controlled, tested the efficacy of methylprednisolone. Allocation concealment was appropriate in two trials, and the data reported allowed an intention-to-treat analysis. The data included in the meta-analyses were collected from three trials with a total of 117 patients. Overall 13/59 (22%) of the patients allocated to steroid therapy had incomplete recovery of facial motor function six months after randomisation, compared with 15/58 (26%) in the control group. This reduction was not significant (relative risk 0.86, 95% confidence interval 0.47 to 1.59). The reduction in the proportion of patients with cosmetically disabling sequelae six months after randomisation was also not significant (relative risk 0.86, 95% confidence interval 0.38 to 1.98). The trial not included in the meta-analysis showed a non-significant difference in outcomes between the arms. The available evidence from randomised controlled trials does not show significant benefit from treating Bell's palsy with corticosteroids. More randomised controlled trials with a greater number of patients are needed to determine reliably whether there is real benefit (or harm) from the use of corticosteroid therapy in patients with Bell's palsy. One trial, with 551 participants, comparing prednisolone with acyclovir with both and with neither has just been published and will be included in an update of this review.

Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial

PubMed Central

Ahrabian, D; Davies, M J; Khunti, K; Yates, T; Gray, A M

2017-01-01

Objectives Prevention of type 2 diabetes mellitus (TD2M) is a priority for healthcare systems. We estimated the cost-effectiveness compared with standard care of a structured education programme (Let's Prevent) targeting lifestyle and behaviour change to prevent progression to T2DM in people with prediabetes. Design Cost-effectiveness analysis alongside randomised controlled trial. Setting 44 general practices in Leicestershire, England. Participants 880 participants with prediabetes randomised to receive either standard care or a 6-hour group structured education programme with follow-up sessions in a primary care setting. Main outcome measure Incremental cost utility from the UK National Health Service (NHS) perspective. Quality of life and resource use measured from baseline and during the 36 months follow-up using the EuroQoL EQ-5D and 15D instruments and an economic questionnaire. Outcomes measured using quality-adjusted life years (QALYs) and healthcare costs calculated in 2012–2013 prices. Results After accounting for clustering and missing data, the intervention group was found to have a net gain of 0.046 (95% CI −0.0171 to 0.109) QALYs over 3 years, adjusted for baseline utility, at an additional cost of £168 (95% CI −395 to 732) per patient compared with the standard care group. The incremental cost-effectiveness ratio is £3643/QALY with an 86% probability of being cost-effective at a willingness to pay threshold of £20 000/QALY. Conclusions The education programme had higher costs and higher quality of life compared with the standard care group. The Let's Prevent programme is very likely to be cost-effective at a willingness to pay threshold of £20 000/QALY gained. Trial registration number ISRCTN80605705. PMID:28069625

Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial.

PubMed

Leal, J; Ahrabian, D; Davies, M J; Gray, L J; Khunti, K; Yates, T; Gray, A M

2017-01-09

Prevention of type 2 diabetes mellitus (TD2M) is a priority for healthcare systems. We estimated the cost-effectiveness compared with standard care of a structured education programme (Let's Prevent) targeting lifestyle and behaviour change to prevent progression to T2DM in people with prediabetes. Cost-effectiveness analysis alongside randomised controlled trial. 44 general practices in Leicestershire, England. 880 participants with prediabetes randomised to receive either standard care or a 6-hour group structured education programme with follow-up sessions in a primary care setting. Incremental cost utility from the UK National Health Service (NHS) perspective. Quality of life and resource use measured from baseline and during the 36 months follow-up using the EuroQoL EQ-5D and 15D instruments and an economic questionnaire. Outcomes measured using quality-adjusted life years (QALYs) and healthcare costs calculated in 2012-2013 prices. After accounting for clustering and missing data, the intervention group was found to have a net gain of 0.046 (95% CI -0.0171 to 0.109) QALYs over 3 years, adjusted for baseline utility, at an additional cost of £168 (95% CI -395 to 732) per patient compared with the standard care group. The incremental cost-effectiveness ratio is £3643/QALY with an 86% probability of being cost-effective at a willingness to pay threshold of £20 000/QALY. The education programme had higher costs and higher quality of life compared with the standard care group. The Let's Prevent programme is very likely to be cost-effective at a willingness to pay threshold of £20 000/QALY gained. ISRCTN80605705. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial).

PubMed

Tanajewski, Lukasz; Franklin, Matthew; Gkountouras, Georgios; Berdunov, Vladislav; Harwood, Rowan H; Goldberg, Sarah E; Bradshaw, Lucy E; Gladman, John R F; Elliott, Rachel A

2015-01-01

One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU) was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months. To examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care. Six hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY) gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309). Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%). The total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4)). The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008). The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded. The MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation. ClinicalTrials.gov NCT01136148.

Nutritional intervention as part of functional rehabilitation in older people with reduced functional ability: a systematic review and meta-analysis of randomised controlled studies.

PubMed

Beck, A M; Dent, E; Baldwin, C

2016-12-01

Nutritional intervention is increasingly recognised as having an important role in functional rehabilitation for older people. Nonetheless, a greater understanding of the functional benefit of nutritional interventions is needed. A systematic review and meta-analysis examined randomised controlled trials (RCTs) published between 2007 and 2014 with the aim of determining whether nutritional intervention combined with rehabilitation benefited older people with reduced functional ability. Six electronic databases were searched. RCTs including people aged 65 years and older with reduced physical, social and/or cognitive function were included. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed, and gradepro computer software (http://gradepro.org) was used for the quality assessment of critical and important outcomes. Included studies considered to be clinical homogenous were combined in a meta-analysis. Of the 788 studies screened, five were identified for inclusion. Nutritional intervention given with functional rehabilitation improved energy and protein intake, although it failed to provide any improvement in final body weight, hand-grip strength or muscle strength. There was no difference between groups in the critical outcomes; balance, cognition, activities of daily living and mortality at long-term follow-up. Nutritional intervention given with functional rehabilitation was associated with an increased likelihood of both mortality (odds ratio = 1.77; 95% confidence interval = 1.13-2.76) and hospitalisation (odds ratio = 2.29; 95% confidence interval = 1.10-4.79) during the intervention. Meta-analysis of the baseline data showed that, overall, the intervention cohort had a lower body weight and cognition. This meta-analysis highlights concerns regarding the quality of the randomisation of participants at baseline. Future high-quality research is essential to establish whether older people with loss of functional abilities can benefit from nutritional intervention. © 2016 The British Dietetic Association Ltd.

Reporting quality of randomised controlled trial abstracts among high-impact general medical journals: a review and analysis

PubMed Central

Hays, Meredith; Andrews, Mary; Wilson, Ramey; Callender, David; O'Malley, Patrick G; Douglas, Kevin

2016-01-01

Objective The aim of this study was to assess adherence to the Consolidated Standards of Reporting Trials (CONSORT) for Abstracts by five high-impact general medical journals and to assess whether the quality of reporting was homogeneous across these journals. Design This is a descriptive, cross-sectional study. Setting Randomised controlled trial (RCT) abstracts in five high-impact general medical journals. Participants We used up to 100 RCT abstracts published between 2011 and 2014 from each of the following journals: The New England Journal of Medicine (NEJM), the Annals of Internal Medicine (Annals IM), The Lancet, the British Medical Journal (The BMJ) and the Journal of the American Medical Association (JAMA). Main outcome The primary outcome was per cent overall adherence to the 19-item CONSORT for Abstracts checklist. Secondary outcomes included per cent adherence in checklist subcategories and assessing homogeneity of reporting quality across the individual journals. Results Search results yielded 466 abstracts, 3 of which were later excluded as they were not RCTs. Analysis was performed on 463 abstracts (97 from NEJM, 66 from Annals IM, 100 from The Lancet, 100 from The BMJ, 100 from JAMA). Analysis of all scored items showed an overall adherence of 67% (95% CI 66% to 68%) to the CONSORT for Abstracts checklist. The Lancet had the highest overall adherence rate (78%; 95% CI 76% to 80%), whereas NEJM had the lowest (55%; 95% CI 53% to 57%). Adherence rates to 8 of the checklist items differed by >25% between journals. Conclusions Among the five highest impact general medical journals, there is variable and incomplete adherence to the CONSORT for Abstracts reporting checklist of randomised trials, with substantial differences between individual journals. Lack of adherence to the CONSORT for Abstracts reporting checklist by high-impact medical journals impedes critical appraisal of important studies. We recommend diligent assessment of adherence to reporting guidelines by authors, reviewers and editors to promote transparency and unbiased reporting of abstracts. PMID:27470506

A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life.

PubMed

Cappello, Carmelina; Tremolaterra, Fabrizio; Pascariello, Annalisa; Ciacci, Carolina; Iovino, Paola

2013-03-01

The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed. Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group. This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.

Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial.

PubMed

Ibler, Kristina Sophie; Jemec, Gregor B E; Diepgen, Thomas L; Gluud, Christian; Lindschou Hansen, Jane; Winkel, Per; Thomsen, Simon Francis; Agner, Tove

2012-12-12

To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema. Randomised, observer blinded parallel group superiority clinical trial. Three hospitals in Denmark. 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group. Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual. The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up. Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted -3.56 (95% confidence interval -4.92 to -2.14); adjusted -3.47 (-4.80 to -2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted -0.78, non-parametric test P=0.003; adjusted -0.92, -1.48 to -0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema. A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves. ClinicalTrials.gov NCT01012453.

Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism - a randomised placebo controlled Trial (TRUST).

PubMed

Stott, David J; Gussekloo, Jacobijn; Kearney, Patricia M; Rodondi, Nicolas; Westendorp, Rudi G J; Mooijaart, Simon; Kean, Sharon; Quinn, Terence J; Sattar, Naveed; Hendry, Kirsty; Du Puy, Robert; Den Elzen, Wendy P J; Poortvliet, Rosalinde K E; Smit, Jan W A; Jukema, J Wouter; Dekkers, Olaf M; Blum, Manuel; Collet, Tinh-Hai; McCarthy, Vera; Hurley, Caroline; Byrne, Stephen; Browne, John; Watt, Torquil; Bauer, Douglas; Ford, Ian

2017-02-03

Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large randomised controlled trial (RCT) of Levothyroxine treatment for SCH. Participants are community-dwelling subjects aged ≥65 years with SCH, diagnosed by elevated TSH levels (≥4.6 and ≤19.9 mU/L) on a minimum of two measures ≥ three months apart, with fT4 levels within laboratory reference range. The study is a randomised double-blind placebo-controlled parallel group trial, starting with levothyroxine 50 micrograms daily (25 micrograms in subjects <50Kg body weight or known coronary heart disease) with titration of dose in the active treatment group according to TSH level, and a mock titration in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic and instrumental activities of daily living, haemoglobin, blood pressure, weight, body mass index and waist circumference. Patients are monitored for specific adverse events of interest including incident atrial fibrillation, heart failure and bone fracture. This large multicentre RCT of levothyroxine treatment of subclinical hypothyroidism is powered to detect clinically relevant change in symptoms / quality of life and is likely to be highly influential in guiding treatment of this common condition. Clinicaltrials.gov NCT01660126 ; registered 8th June 2012.

Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials

PubMed Central

2011-01-01

Background Studies have shown that residents in nursing homes often are exposed to inappropriate medication. Particular concern has been raised about the consumption of psychoactive drugs, which are commonly prescribed for nursing home residents suffering from dementia. This review is an update of a Norwegian systematic review commissioned by the Norwegian Directorate of Health. The purpose of the review was to identify and summarise the effect of interventions aimed at reducing potentially inappropriate use or prescribing of drugs in nursing homes. Methods We searched for systematic reviews and randomised controlled trials in the Cochrane Library, MEDLINE, EMBASE, ISI Web of Knowledge, DARE and HTA, with the last update in April 2010. Two of the authors independently screened titles and abstracts for inclusion or exclusion. Data on interventions, participants, comparison intervention, and outcomes were extracted from the included studies. Risk of bias and quality of evidence were assessed using the Cochrane Risk of Bias Table and GRADE, respectively. Outcomes assessed were use of or prescribing of drugs (primary) and the health-related outcomes falls, physical limitation, hospitalisation and mortality (secondary). Results Due to heterogeneity in interventions and outcomes, we employed a narrative approach. Twenty randomised controlled trials were included from 1631 evaluated references. Ten studies tested different kinds of educational interventions while seven studies tested medication reviews by pharmacists. Only one study was found for each of the interventions geriatric care teams, early psychiatric intervening or activities for the residents combined with education of health care personnel. Several reviews were identified, but these either concerned elderly in general or did not satisfy all the requirements for systematic reviews. Conclusions Interventions using educational outreach, on-site education given alone or as part of an intervention package and pharmacist medication review may under certain circumstances reduce inappropriate drug use, but the evidence is of low quality. Due to poor quality of the evidence, no conclusions may be drawn about the effect of the other three interventions on drug use, or of either intervention on health-related outcomes. PMID:21496345

A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

PubMed Central

Cuthbertson, Brian H; Rattray, Janice; Johnston, Marie; Wildsmith, J Anthony; Wilson, Edward; Hernendez, Rodolfo; Ramsey, Craig; Hull, Alastair M; Norrie, John; Campbell, Marion

2007-01-01

Background A number of intensive care (ICU) patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge. Methods/Design This is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270) will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge. The primary outcome measure is Health-related Quality of Life (HRQoL) 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis. Discussion The provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and cost-effectiveness. The results of this study therefore will inform clinical practice and policy with regard to the appropriate development of such services aimed at improving outcomes after intensive care. Trial Registration ISRCTN24294750. PMID:17645791

Ad libitum or demand/semi-demand feeding versus scheduled interval feeding for preterm infants.

PubMed

Tosh, K; McGuire, W

2006-07-19

Feeding preterm infants in response to their hunger and satiation cues (ad libitum or demand/semi demand) rather than at scheduled intervals might help in the establishment of independent oral feeding, increase nutrient intake and growth rates, and allow earlier hospital discharge. To assess the effect of a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding prescribed volumes at scheduled intervals on growth rates and the time to hospital discharge. We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2006), MEDLINE (1966 - March 2006), EMBASE (1980 - March 2006), CINAHL (1982 - March 2006), conference proceedings, and previous reviews. Randomised or quasi-randomised controlled trials (including cluster randomised trials) that compared a policy of feeding preterm infants on an ad libitum or demand/semi-demand basis versus feeding at scheduled intervals. The standard methods of the Cochrane Neonatal Review Group with separate evaluation of trial quality and data extraction by two review authors. The primary outcomes of interest were growth rates and age at hospital discharge. We found seven randomised controlled trials that compared ad libitum or demand/semi-demand regimes with scheduled interval regimes in preterm infants in the transition phase from intragastric tube to oral feeding. The trials were generally small and of variable methodological quality. The duration of the intervention and the duration of data collection and follow up in most of the trials is not likely to have allowed detection of measurable effects on growth. The single trial that assessed growth for longer than one week found that the rate of weight gain was lower in the ad libitum fed infants [mean difference -3.30 (95% confidence interval -6.2 to -0.4) grams per kilogram per day]. Two trials reported that feeding preterm infants using an ad libitum or demand/semi-demand feeding regime allowed earlier discharge from hospital, but the other trials did not confirm this finding. We were not able to undertake meta-analyses because of differences in study design and in the way the findings were reported. There are insufficient data at present to guide clinical practice. A large randomised controlled trial is needed to determine if ad libitum of demand/semi-demand feeding of preterm infants affects clinically important outcomes. This trial should focus on infants in the transition phase from intragastric tube to oral feeding and should be of sufficient duration to assess effects on growth and time to oral feeding and hospital discharge.

Laser-assisted in-situ keratomileusis (LASIK) versus photorefractive keratectomy (PRK) for myopia.

PubMed

Shortt, Alex J; Allan, Bruce D S; Evans, Jennifer R

2013-01-31

Myopia (also known as short-sightedness or near-sightedness) is an ocular condition in which the refractive power of the eye is greater than is required, resulting in light from distant objects being focused in front of the retina instead of directly on it. The two most commonly used surgical techniques to permanently correct myopia are photorefractive keratectomy (PRK) and laser-assisted in-situ keratomileusis (LASIK). To compare the effectiveness and safety of LASIK and PRK for correction of myopia by examining post-treatment uncorrected visual acuity, refractive outcome, loss of best spectacle-corrected visual acuity, pain scores, flap complications in LASIK, subepithelial haze, adverse events, quality of life indices and higher order aberrations. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 11), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2012), EMBASE (January 1980 to November 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to November 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 November 2012. We also searched the reference lists of the studies and the Science Citation Index. We included randomised controlled trials comparing LASIK and PRK for the correction of any degree of myopia. Two authors independently assessed trial quality and extracted data. We summarised data using the odds ratio and mean difference. We combined odds ratios using a random-effects model after testing for heterogeneity. We included 13 trials (1135 participants, 1923 eyes) in this review. Nine of these trials randomised eyes to treatment, two trials randomised people to treatment and treated both eyes, and two trials randomised people to treatment and treated one eye. None of the paired trials reported an appropriate paired analysis. We considered the overall quality of evidence to be low for most outcomes because of the risk of bias in the included trials. There was evidence that LASIK gives a faster visual recovery than PRK and is a less painful technique. Results at one year after surgery were comparable: most analyses favoured LASIK but they were not statistically significant. LASIK gives a faster visual recovery and is a less painful technique than PRK. The two techniques appear to give similar outcomes one year after surgery. Further trials using contemporary techniques are required to determine whether LASIK and PRK as currently practised are equally safe. Randomising eyes to treatment is an efficient design, but only if analysed properly. In future trials, more efforts could be made to mask the assessment of outcome.

Randomised controlled trial comparing effectiveness and acceptability of an early discharge, hospital at home scheme with acute hospital care

PubMed Central

Richards, Suzanne H; Coast, Joanna; Gunnell, David J; Peters, Tim J; Pounsford, John; Darlow, Mary-Anne

1998-01-01

Objective: To compare effectiveness and acceptability of early discharge to a hospital at home scheme with that of routine discharge from acute hospital. Design: Pragmatic randomised controlled trial. Setting: Acute hospital wards and community in north of Bristol, with a catchment population of about 224 000 people. Subjects: 241 hospitalised but medically stable elderly patients who fulfilled criteria for early discharge to hospital at home scheme and who consented to participate. Interventions: Patients’ received hospital at home care or routine hospital care. Main outcome measures: Patients’ quality of life, satisfaction, and physical functioning assessed at 4 weeks and 3 months after randomisation to treatment; length of stay in hospital and in hospital at home scheme after randomisation; mortality at 3 months. Results: There were no significant differences in patient mortality, quality of life, and physical functioning between the two arms of the trial at 4 weeks or 3 months. Only one of 11 measures of patient satisfaction was significantly different: hospital at home patients perceived higher levels of involvement in decisions. Length of stay for those receiving routine hospital care was 62% (95% confidence interval 51% to 75%) of length of stay in hospital at home scheme. Conclusions: The early discharge hospital at home scheme was similar to routine hospital discharge in terms of effectiveness and acceptability. Increased length of stay associated with the scheme must be interpreted with caution because of different organisational characteristics of the services. Key messages Pressure on hospital beds, the increasing age of the population, and high costs associated with acute hospital care have fuelled the search for alternatives to inpatient hospital care There were no significant differences between early discharge to hospital at home scheme and routine hospital care in terms of patient quality of life, physical functioning, and most measures of patient satisfaction Length of stay for hospital patients was significantly shorter than that of hospital at home patients, but, owing to qualitative differences between the two interventions, this does not necessarily mean differences in effectiveness Early discharge to hospital at home provides an acceptable alternative to routine hospital care in terms of effectiveness and patient acceptability PMID:9624070

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

PubMed

Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Cost-effectiveness of aftercare services for people with severe mental disorders: an analysis parallel to a randomised controlled clinical trial in Iran.

PubMed

Moradi-Lakeh, Maziar; Yaghoubi, Mohsen; Hajebi, Ahmad; Malakouti, Seyed Kazem; Vasfi, Mohamad Ghadiri

2017-05-01

Aftercare services are not part of the usual care for people with severe mental disorders in Iran. This study was performed to assess the cost-effectiveness of aftercare services, including telephone follow-up or home visit, in addition to caregivers' education and training of social skills, for all subjects during the 20 months after hospital discharge. An economic evaluation was performed along with a registered randomised controlled trial (IRCT201009052557N2) on two groups of 60 persons recruited between 2010 and 2012. Intervention's effectiveness was measured by psychopathology and quality of life indicators. Cost-effectiveness and cost-utility were analysed from the societal and Ministry of Health (MoH) perspectives. All indicators of psychopathology, quality of life and satisfaction with services in the intervention group were significantly different from the control group. Mean intervention costs was US$674 (95% confidence interval [CI]: 572-776) per subject in the intervention group. Average total direct costs were US$1445 (95% CI: 1086-1804) and US$1640 (95% CI: 1087-2093) per subject in the intervention and control groups respectively. From the societal perspective, intervention had more effects with lower costs. The ratios for incremental cost-effectiveness was US$8399.1 (95% CI: 8178.2-8620.0) per quality-adjusted life year (QALY) gained from the MoH perspective for 20 months of follow-up. This study showed that aftercare services can create opportunities to use hospital beds more efficiently for unmet needs of people with psychiatric disorders. Indirect and intangible costs were not considered in this study, if taken into account, they are likely to further increase the efficiency of intervention. © 2017 John Wiley & Sons Ltd.

Family support for stroke: a randomised controlled trial.

PubMed

Mant, J; Carter, J; Wade, D T; Winner, S

2000-09-02

Attention is currently focused on family care of stroke survivors, but the effectiveness of support services is unclear. We did a single-blind, randomised, controlled trial to assess the impact of family support on stroke patients and their carers. Patients with acute stroke admitted to hospitals in Oxford, UK, were assigned family support or normal care within 6 weeks of stroke. After 6 months, we assessed, for carers, knowledge about stroke, Frenchay activities index, general health questionnaire-28 scores, caregiver strain index, Dartmouth co-op charts, short form 36 (SF-36), and satisfaction scores, and, for patients, knowledge about stroke and use of services, Barthel index, Rivermead mobility index, Frenchay activities index, London handicap scale, hospital anxiety and depression scales, Dartmouth co-op charts, and satisfaction. 323 patients and 267 carers were followed up. Carers in the intervention group had significantly better Frenchay activities indices (p=0.03), SF-36 scores (energy p=0.02, mental health p=0.004, pain p=0.03, physical function p=0.025, and general health perception p=0.02), quality of life on the Dartmouth co-op chart (p=0.01), and satisfaction with understanding of stroke (82 vs 71%, p=0.04) than those in the control group. Patients' knowledge about stroke, disability, handicap, quality of life, and satisfaction with services and understanding of stroke did not differ between groups. Fewer patients in the intervention group than in the control group saw a physiotherapist after discharge (44 vs 56%, p=0.04), but use of other services was similar. Family support significantly increased social activities and improved quality of life for carers, with no significant effects on patients.

Interventions for preventing or treating alcohol hangover: systematic review of randomised controlled trials

PubMed Central

Pittler, Max H; Verster, Joris C; Ernst, Edzard

2005-01-01

Objective To assess the clinical evidence on the effectiveness of any medical intervention for preventing or treating alcohol hangover. Data sources Systematic searches on Medline, Embase, Amed, Cochrane Central, the National Research Register (UK), and ClincalTrials.gov (USA); hand searches of conference proceedings and bibliographies; contact with experts and manufacturers of commercial preparations. Language of publication was not restricted. Study selection and data extraction All randomised controlled trials of any medical intervention for preventing or treating alcohol hangover were included. Trials were considered if they were placebo controlled or controlled against a comparator intervention. Titles and abstracts of identified articles were read and hard copies were obtained. The selection of studies, data extraction, and validation were done independently by two reviewers. The Jadad score was used to evaluate methodological quality. Results Fifteen potentially relevant trials were identified. Seven publications failed to meet all inclusion criteria. Eight randomised controlled trials assessing eight different interventions were reviewed. The agents tested were propranolol, tropisetron, tolfenamic acid, fructose or glucose, and the dietary supplements Borago officinalis (borage), Cynara scolymus (artichoke), Opuntia ficus-indica (prickly pear), and a yeast based preparation. All studies were double blind. Significant intergroup differences for overall symptom scores and individual symptoms were reported only for tolfenamic acid, γ linolenic acid from B officinalis, and a yeast based preparation. Conclusion No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of alcohol induced hangover is to practise abstinence or moderation. PMID:16373736

AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

PubMed

Sort, Rune; Brorson, Stig; Gögenur, Ismail; Møller, Ann Merete

2017-06-02

Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery. AnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment. The intervention is ultrasound-guided popliteal sciatic (20 mL) and saphenal nerve (8 mL) PNB with ropivacaine 7.5 mg/mL, and controls receive spinal anaesthesia (2 mL) with hyperbaric bupivacaine 5 mg/mL. Postoperatively all receive paracetamol, ibuprofen and patient-controlled intravenous morphine on demand. Morphine consumption and pain scores are registered in the first 27 hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation of anaesthesia, opioid side effects (Opioid-Related Symptom Distress Scale), quality of recovery (Danish Quality of Recovery-15 score) and pain scores and medication days 1-7 (diary). The study has been approved by the Regional Ethics Committees in the Capital Region of Denmark, the Danish Data Protection Agency and the Danish Health and Medical Authority. We will publish the results in international peer-reviewed medical journals. AnAnkle Trial is registered in the European Clinical Trials Database (EudraCT 2015-001108-76). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Does a functional activity programme improve function, quality of life, and falls for residents in long term care? Cluster randomised controlled trial

PubMed Central

Peri, Kathy; Robinson, Elizabeth; Wilkinson, Tim; von Randow, Martin; Kiata, Liz; Parsons, John; Latham, Nancy; Parsons, Matthew; Willingale, Jane; Brown, Paul; Arroll, Bruce

2008-01-01

Objective To assess the effectiveness of an activity programme in improving function, quality of life, and falls in older people in residential care. Design Cluster randomised controlled trial with one year follow-up. Setting 41 low level dependency residential care homes in New Zealand. Participants 682 people aged 65 years or over. Interventions 330 residents were offered a goal setting and individualised activities of daily living activity programme by a gerontology nurse, reinforced by usual healthcare assistants; 352 residents received social visits. Main outcome measures Function (late life function and disability instruments, elderly mobility scale, FICSIT-4 balance test, timed up and go test), quality of life (life satisfaction index, EuroQol), and falls (time to fall over 12 months). Secondary outcomes were depressive symptoms and hospital admissions. Results 473 (70%) participants completed the trial. The programme had no impact overall. However, in contrast to residents with impaired cognition (no differences between intervention and control group), those with normal cognition in the intervention group may have maintained overall function (late life function and disability instrument total function, P=0.024) and lower limb function (late life function and disability instrument basic lower extremity, P=0.015). In residents with cognitive impairment, the likelihood of depression increased in the intervention group. No other outcomes differed between groups. Conclusion A programme of functional rehabilitation had minimal impact for elderly people in residential care with normal cognition but was not beneficial for those with poor cognition. Trial registration Australian Clinical Trials Register ACTRN12605000667617. PMID:18845605

Training a Chest Compression of 6-7 cm Depth for High Quality Cardiopulmonary Resuscitation in Hospital Setting: A Randomised Controlled Trial.

PubMed

Oh, Jaehoon; Lim, Tae Ho; Cho, Youngsuk; Kang, Hyunggoo; Kim, Wonhee; Chee, Youngjoon; Song, Yeongtak; Kim, In Young; Lee, Juncheol

2016-03-01

During cardiopulmonary resuscitation (CPR), chest compression (CC) depth is influenced by the surface on which the patient is placed. We hypothesized that training healthcare providers to perform a CC depth of 6-7 cm (instead of 5-6 cm) on a manikin placed on a mattress during CPR in the hospital might improve their proper CC depth. This prospective randomised controlled study involved 66 premedical students without CPR training. The control group was trained to use a CC depth of 5-6 cm (G 5-6), while the experimental group was taught to use a CC depth of 6-7 cm (G 6-7) with a manikin on the floor. All participants performed CCs for 2 min on a manikin that was placed on a bed 1 hour and then again 4 weeks after the training without a feedback. The parameters of CC quality (depth, rate, % of accurate depth) were assessed and compared between the 2 groups. Four students were excluded due to loss to follow-up and recording errors, and data of 62 were analysed. CC depth and % of accurate depth were significantly higher among students in the G 6-7 than G 5-6 both 1 hour and 4 weeks after the training (p<0.001), whereas CC rate was not different between two groups (p>0.05). Training healthcare providers to perform a CC depth of 6-7 cm could improve quality CC depth when performing CCs on patients who are placed on a mattress during CPR in a hospital setting.

TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

PubMed

McClinton, Samuel; Cameron, Sarah; Starr, Kathryn; Thomas, Ruth; MacLennan, Graeme; McDonald, Alison; Lam, Thomas; N'Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Keeley, Frank; Burgess, Neil; Clark, Charles Terry; MacLennan, Sara; Norrie, John

2018-05-22

Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention. The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden). The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option. The TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones. Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from randomisation. Determining whether ESWL is not inferior clinically and is cost-effective compared to ureteroscopic treatment as the initial management in adults with ureteric stones who are judged to require active treatment is relevant not only to patients and clinicians but also to healthcare providers, both in the UK and globally. ISRCTN registry, ISRCTN92289221 . Registered on 21 February 2013.

Exercise for people with peripheral neuropathy.

PubMed

White, C M; Pritchard, J; Turner-Stokes, L

2004-10-18

Peripheral neuropathies are a wide range of diseases affecting the peripheral nerves. Demyelination or axonal degeneration gives rise to a variety of symptoms including reduced or altered sensation, pain, muscle weakness and fatigue. Secondary disability arises and this may result in adjustments to psychological and social function. Exercise therapy, with a view to developing strength and stamina, forms part of the treatment for people with peripheral neuropathy, particularly in the later stages of recovery from acute neuropathy and in chronic neuropathies. The primary objective was to examine the effect of exercise therapy on functional ability in the treatment of people with peripheral neuropathy. In addition, secondary outcomes of muscle strength, endurance, broader measures of health and well being, as well as unfavourable outcomes were examined. We searched the Cochrane Neuromuscular Disease Group register (July 2002 and updated February 2004) and MEDLINE (from January 1966 to June 2004), EMBASE (from January 1980 to June 2004), CINAHL (from January 1982 to July 2002) and LILACS (from January 1982 to July 2002) electronic databases. Bibliographies of all selected randomised controlled trials were checked and authors contacted to identify additional published or unpublished data. Any randomised or quasi-randomised controlled trial comparing the effect of exercise therapy with no exercise therapy or drugs or an alternative non-drug treatment on functional ability (or disability) in people with peripheral neuropathy at least eight weeks after randomisation was included. Two reviewers independently selected eligible studies, rated the methodological quality and extracted data. Only one trial fully met the inclusion criteria. An additional two trials assessed outcomes less than eight weeks after randomisation and were also included. Methodological quality was poor for several criteria in each study. Data used in the three studies could not be pooled due to heterogeneity of diagnostic groups and outcome measures. The results of the included trials failed to show any effect of strengthening and endurance exercise programmes on functional ability in people with peripheral neuropathy. However, there is some evidence that strengthening exercise programmes were moderately effective in increasing the strength of tested muscles. There is inadequate evidence to evaluate the effect of exercise on functional ability in people with peripheral neuropathy. The results suggest that progressive resisted exercise may improve muscle strength in affected muscles.

Cluster randomised trials in the medical literature: two bibliometric surveys

PubMed Central

Bland, J Martin

2004-01-01

Background Several reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting. Methods Computer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 years. Results There has been a large increase in the numbers of methodological papers and of trial reports using the term 'cluster random' in recent years, with about equal numbers of each type of paper. The British Medical Journal contained more such reports than any other journal. In this journal there was a corresponding increase over time in the number of trials where subjects were randomised in clusters. In 2003 all reports showed awareness of the need to allow for clustering in the analysis. In 1993 and before clustering was ignored in most such trials. Conclusion Cluster trials are becoming more frequent and reporting is of higher quality. Perhaps statistician pressure works. PMID:15310402

Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

PubMed Central

Slok, Annerika H M; Kotz, Daniel; van Breukelen, Gerard; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H; Kerstjens, Huib A M; van der Molen, Thys; Asijee, Guus M; Dekhuijzen, P N Richard; Holverda, Sebastiaan; Salomé, Philippe L; Goossens, Lucas M A; Twellaar, Mascha; in ‘t Veen, Johannes C C M; van Schayck, Onno C P

2016-01-01

Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results. PMID:27401361

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial.

PubMed

Vanova, Martina; Irazoki, Eider; García-Casal, J Antonio; Martínez-Abad, Fernando; Botella, Cristina; Shiells, Kate R; Franco-Martín, Manuel A

2018-02-12

Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms. In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year. The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments. Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.

Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial.

PubMed

Fernando, Luwishennadige Madhawee N; Sim, Wan Hua; Jorm, Anthony F; Rapee, Ron; Lawrence, Katherine A; Yap, Marie B H

2018-04-19

Preventive efforts targeting childhood anxiety and depression symptoms have the potential to alter the developmental trajectory of depression and anxiety disorders across the lifespan. Substantial previous research suggests that modifiable parenting factors such as parental aversiveness and over-involvement are associated with childhood anxiety, depressive and internalising symptoms, indicating that parents can play a critical role in prevention. The Parenting Resilient Kids study is a new evidence-based online parenting program designed to prevent anxiety and depression problems in primary school-aged children by reducing family-based risk factors and enhancing protective factors through increased positive interactions between parent and child. The current study is a parallel group superiority randomised controlled trial with parent-child dyads randomised to the intervention or active-control group in a 1:1 ratio. The intervention group will receive the Parenting Resilient Kids program consisting of a feedback report on parenting behaviours and up to 12 interactive online modules personalised based on responses to the parent survey. The active-control group will receive a standardised package of online educational materials about child development and wellbeing. The trial website is programmed to run a stratified random allocation sequence (based on parent gender) to determine group membership. We aim to recruit 340 parent-child dyads (170 dyads per group). We hypothesise that the intervention group will show greater improvement in parenting risk and protective factors from baseline to 3-month follow-up (primary outcome), which will in turn mediate changes in child depressive and anxiety symptoms from baseline to 12 and 24 months (co-primary outcomes). We also hypothesise that the intervention group will show greater benefits from baseline to 3-, 12- and 24-month follow-up, with regard to: child depressive and anxiety symptoms (co-primary outcomes); and child and parent health-related quality of life, and overall family functioning (secondary outcomes). This randomised controlled trial will examine the efficacy of the Parenting Resilient Kids program as a preventive intervention for anxiety and depression symptoms in primary school-aged children, as well as changes in child and parent health-related quality of life. Findings from this study will examine design features that render web-based prevention programs effective and the extent to which parents can be engaged and motivated to change through a minimally guided parenting program. Australian New Zealand Clinical Trials Registry (ANZCTR): Trial ID ACTRN12616000621415 Registered on 13 May 2016. Updated on 3 March 2017.

Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G).

PubMed

Smith, Adam B; Cocks, Kim; Parry, David; Taylor, Matthew

2014-04-01

The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs. A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist. Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust. The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.

Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials.

PubMed

Teleni, Laisa; Chan, Raymond J; Chan, Alexandre; Isenring, Elisabeth A; Vela, Ian; Inder, Warrick J; McCarthy, Alexandra L

2016-02-01

Men receiving androgen deprivation therapy (ADT) for prostate cancer (PCa) are likely to develop metabolic conditions such as diabetes, cardiovascular disease, abdominal obesity and osteoporosis. Other treatment-related side effects adversely influence quality of life (QoL) including vasomotor distress, depression, anxiety, mood swings, poor sleep quality and compromised sexual function. The objective of this study was to systematically review the nature and effects of dietary and exercise interventions on QoL, androgen deprivation symptoms and metabolic risk factors in men with PCa undergoing ADT. An electronic search of CINAHL, CENTRAL, Medline, PsychINFO and reference lists was performed to identify peer-reviewed articles published between January 2004 and December 2014 in English. Eligible study designs included randomised controlled trials (RCTs) with pre- and post-intervention data. Data extraction and assessment of methodological quality with the Cochrane approach was conducted by two independent reviewers. Seven exercise studies were identified. Exercise significantly improved QoL, but showed no effect on metabolic risk factors (weight, waist circumference, lean or fat mass, blood pressure and lipid profile). Two dietary studies were identified, both of which tested soy supplements. Soy supplementation did not improve any outcomes. No dietary counselling studies were identified. No studies evaluated androgen-deficiency symptoms (libido, erectile function, sleep quality, mood swings, depression, anxiety and bone mineral density). Evidence from RCTs indicates that exercise enhances health- and disease-specific QoL in men with PCa undergoing ADT. Further studies are required to evaluate the effect of exercise and dietary interventions on QoL, androgen deprivation symptoms and metabolic risk factors in this cohort. © 2016 Society for Endocrinology.

Herbal medicines for treating acute otitis media: A systematic review of randomised controlled trials.

PubMed

Son, Mi Ju; Kim, Young-Eun; Song, Young Il; Kim, Yun Hee

2017-12-01

This systematic review aimed to assess the clinical evidence for the widespread use of herbal medicines in treating acute otitis media. Eleven electronic databases, including MEDLINE, EMBASE, and the CENTRAL were searched, without language limitations. All randomised controlled trials involving the use of herbal medicines, alone or in combination with conventional therapies, for acute otitis media were included. We identified 4956 studies, of which seven randomised clinical trials met the inclusion criteria. The overall risk of bias of the included trials was relatively high or unclear. Treatment with Longdan-xiegan decoction or Shenling-baizhu powder, combined with antibiotics, appeared to be more effective than treatment with antibiotics alone in terms of the proportion of patients with total symptom recovery. Moreover, combination treatment of Sinupret ® and antibiotics facilitated the recovery of middle ear conditions and hearing acuity. Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of herbal medicine for acute otitis media is inconclusive due to the poor quality of trials included. Moreover, we only analysed seven trials in this review. Therefore, to properly evaluate the effectiveness of herbal medicine for acute otitis media, systematic reviews based on more rigorously designed randomized trials are warranted in the future. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The cost-effectiveness of cardiac computed tomography for patients with stable chest pain.

PubMed

Agus, A M; McKavanagh, P; Lusk, L; Verghis, R M; Walls, G M; Ball, P A; Trinick, T R; Harbinson, M T; Donnelly, P M

2016-03-01

To assess the cost-effectiveness of cardiac CT compared with exercise stress testing (EST) in improving the health-related quality of life of patients with stable chest pain. A cost-utility analysis alongside a single-centre randomised controlled trial carried out in Northern Ireland. Patients with stable chest pain were randomised to undergo either cardiac CT assessment or EST (standard care). The main outcome measure was cost per quality adjusted life year (QALY) gained at 1 year. Of the 500 patients recruited, 250 were randomised to cardiac CT and 250 were randomised to EST. Cardiac CT was the dominant strategy as it was both less costly (incremental total costs -£50.45; 95% CI -£672.26 to £571.36) and more effective (incremental QALYs 0.02; 95% CI -0.02 to 0.05) than EST. At a willingness-to-pay threshold of £20 000 per QALY the probability of cardiac CT being cost-effective was 83%. Subgroup analyses indicated that cardiac CT appears to be most cost-effective in patients with a likelihood of coronary artery disease (CAD) of <30%, followed by 30%-60% and then >60%. Cardiac CT is cost-effective compared with EST and cost-effectiveness was observed to vary with likelihood of CAD. This finding could have major implications for how patients with chest pain in the UK are assessed, however it would need to be validated in other healthcare systems. (ISRCTN52480460); results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care.

PubMed

Kai, Joe; Middleton, Lee; Daniels, Jane; Pattison, Helen; Tryposkiadis, Konstantinos; Gupta, Janesh

2016-12-01

Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. In total, 571 women aged 25-50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen-progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = -0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery. © British Journal of General Practice 2016.

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

PubMed

Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-04-19

Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

PubMed

Barnes, Thomas R E; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom K J; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

2016-04-01

Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. Adult psychiatric services, treating people with schizophrenia. Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There were no statistically significant differences between the two treatment arms over 48-week follow-up in either the health economics outcomes or costs, and no differences in the frequency or severity of adverse effects, including corrected QT interval prolongation. The trial under-recruited, partly because cardiac safety concerns about citalopram were raised, with the 62 participants recruited falling well short of the target recruitment of 358. Although this was the largest sample randomised to citalopram in a randomised controlled trial of antidepressant augmentation for negative symptoms of schizophrenia and had the longest follow-up, the power of statistical analysis to detect significant differences between the active and placebo groups was limited. Although adjunctive citalopram did not improve negative symptoms overall, there was evidence of some positive effect on avolition/amotivation, recognised as a critical barrier to psychosocial rehabilitation and achieving better social and community functional outcomes. Comprehensive assessment of side-effect burden did not identify any serious safety or tolerability issues. The addition of citalopram as a long-term prescribing strategy for the treatment of negative symptoms may merit further investigation in larger studies. Further studies of the viability of adjunctive antidepressant treatment for negative symptoms in schizophrenia should include appropriate safety monitoring and use rating scales that allow for evaluation of avolition/amotivation as a discrete negative symptom domain. Overcoming the barriers to recruiting an adequate sample size will remain a challenge. European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2009-009235-30 and Current Controlled Trials ISRCTN42305247. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 29. See the NIHR Journals Library website for further project information.

Vaccine testing for emerging infections: the case for individual randomisation.

PubMed

Eyal, Nir; Lipsitch, Marc

2017-09-01

During the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A randomised trial of the cool pad pillow topper versus standard care for sleep disturbance and hot flushes in women on endocrine therapy for breast cancer.

PubMed

Marshall-McKenna, R; Morrison, A; Stirling, L; Hutchison, C; Rice, A M; Hewitt, C; Paul, L; Rodger, M; Macpherson, I R; McCartney, E

2016-04-01

Quality of life in women receiving adjuvant endocrine therapy for breast cancer (BC) may be impaired by hot flushes and night sweats. The cool pad pillow topper (CPPT) is a commercial product, promoted to improve quality of sleep disrupted by hot flushes. This study aimed to identify if the CPPT reduces severity of sleep disturbance by minimising effects of hot flushes. This randomised phase II trial, recruited women with BC, on adjuvant endocrine therapy, experiencing hot flushes and insomnia. Participants were randomised (stratified by baseline sleep efficiency score (SES) and menopausal status) to the intervention arm (CPPT + standard care) or control arm (standard care). Participants completed Hospital Anxiety and Depression Scale and Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaires and fortnightly sleep/hot flush diaries (where responses were averaged over 2-week periods). The primary endpoint was change in average SES from -2 to 0 weeks to 2 to 4 weeks. Seventy-four pre- (68.9 %) and post-menopausal (31.1 %) women were recruited. Median age was 49.5 years. Endocrine therapies included tamoxifen (93.2 %). Median SES at weeks 2 to 4 improved in both arms but the increase on the intervention arm was almost twice that on the control arm (p = 0.024). There were significantly greater reductions in hot flushes and HADS depression in the intervention arm (p = 0.09 and p = 0.036, respectively). There were no significant differences in FACT-B or HADS anxiety. This study supports the use of the CPPT as an aid to reduce sleep disturbance and the frequency/severity of hot flushes.

Compression stockings in the management of fractures of the ankle: a randomised controlled trial.

PubMed

Sultan, M J; Zhing, T; Morris, J; Kurdy, N; McCollum, C N

2014-08-01

In this randomised controlled trial, we evaluated the role of elastic compression using ankle injury stockings (AIS) in the management of fractures of the ankle. A total of 90 patients with a mean age of 47 years (16 to 79) were treated within 72 hours of presentation with a fracture of the ankle, 31 of whom were treated operatively and 59 conservatively, were randomised to be treated either with compression by AIS plus an Aircast boot or Tubigrip plus an Aircast boot. Male to female ratio was 36:54. The primary outcome measure was the functional Olerud-Molander ankle score (OMAS). The secondary outcome measures were; the American Orthopaedic Foot and Ankle Society score (AOFAS); the Short Form (SF)-12v2 Quality of Life score; and the frequency of deep vein thrombosis (DVT). Compression using AIS reduced swelling of the ankle at all time points and improved the mean OMAS score at six months to 98 (95% confidence interval (CI) 96 to 99) compared with a mean of 67 (95% CI 62 to 73) for the Tubigrip group (p < 0.001). The mean AOFAS and SF-12v2 scores at six months were also significantly improved by compression. Of 86 patients with duplex imaging at four weeks, five (12%) of 43 in the AIS group and ten (23%) of 43 in the Tubigrip group developed a DVT (p = 0.26). Compression improved functional outcome and quality of life following fracture of the ankle. DVTs were frequent, but a larger study would be needed to confirm that compression with AISs reduces the incidence of DVT. ©2014 The British Editorial Society of Bone & Joint Surgery.

Cognitive rehabilitation and mindfulness in multiple sclerosis (REMIND-MS): a study protocol for a randomised controlled trial.

PubMed

Nauta, Ilse M; Speckens, Anne E M; Kessels, Roy P C; Geurts, Jeroen J G; de Groot, Vincent; Uitdehaag, Bernard M J; Fasotti, Luciano; de Jong, Brigit A

2017-11-21

Cognitive problems frequently occur in patients with multiple sclerosis (MS) and profoundly affect their quality of life. So far, the best cognitive treatment options for MS patients are a matter of debate. Therefore, this study aims to investigate the effectiveness of two promising non-pharmacological treatments: cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT). Furthermore, this study aims to gain additional knowledge about the aetiology of cognitive problems among MS patients, since this may help to develop and guide effective cognitive treatments. In a dual-centre, single-blind randomised controlled trial (RCT), 120 MS patients will be randomised into one of three parallel groups: CRT, MBCT or enhanced treatment as usual (ETAU). Both CRT and MBCT consist of a structured 9-week program. ETAU consists of one appointment with an MS specialist nurse. Measurements will be performed at baseline, post-intervention and 6 months after the interventions. The primary outcome measure is the level of subjective cognitive complaints. Secondary outcome measures are objective cognitive function, functional brain network measures (using magnetoencephalography), psychological symptoms, well-being, quality of life and daily life functioning. To our knowledge, this will be the first RCT that investigates the effect of MBCT on cognitive function among MS patients. In addition, studying the effect of CRT on cognitive function may provide direction to the contradictory evidence that is currently available. This study will also provide information on changes in functional brain networks in relation to cognitive function. To conclude, this study may help to understand and treat cognitive problems among MS patients. This trial was prospectively registered at the Dutch Trial Registration (number NTR6459 , registered on 31 May 2017).

A randomised controlled crossover trial of nurse practitioner versus doctor led outpatient care in a bronchiectasis clinic

PubMed Central

Sharples, L; Edmunds, J; Bilton, D; Hollingworth, W; Caine, N; Keogan, M; Exley, A

2002-01-01

Background: With the decrease in junior doctor hours, the advent of specialist registrars, and the availability of highly trained and experienced nursing personnel, the service needs of patients with chronic respiratory diseases attending routine outpatient clinics may be better provided by appropriately trained nurse practitioners. Methods: A randomised controlled crossover trial was used to compare nurse practitioner led care with doctor led care in a bronchiectasis outpatient clinic. Eighty patients were recruited and randomised to receive 1 year of nurse led care and 1 year of doctor led care in random order. Patients were followed up for 2 years to ensure patient safety and acceptability and to assess differences in lung function. Outcome measures were forced expiratory volume in 1 second (FEV1), 12 minute walk test, health related quality of life, and resource use. Results: The mean difference in FEV1 was 0.2% predicted (95% confidence interval –1.6 to 2.0%, p=0.83). There were no significant differences in the other clinical or health related quality of life measures. Nurse led care resulted in significantly increased resource use compared with doctor led care (mean difference £1497, 95% confidence interval £688 to £2674, p<0.001), a large part of which resulted from the number and duration of hospital admissions. The mean difference in resource use was greater in the first year (£2625) than in the second year (£411). Conclusions: Nurse practitioner led care for stable patients within a chronic chest clinic is safe and is as effective as doctor led care, but may use more resources. PMID:12149523

Interventions in the workplace to support breastfeeding for women in employment.

PubMed

Abdulwadud, O A; Snow, M E

2007-07-18

In recent years there has been a rise in the participation rate of women in employment. Some may become pregnant while in employment and subsequently deliver their babies. Most may decide to return early to work after giving birth for various reasons. Unless these mothers get support from their employers and fellow employees, they might give up breastfeeding when they return to work. As a result, the duration and exclusivity of breastfeeding to the recommended age of the babies would be affected. Workplace environment can play a positive role to promote breastfeeding. For women going back to work, various types of workplace support interventions are available and this should not be ignored by employers. Notably, promoting breastfeeding in a workplace may have benefits for the women, the baby and also the employer. To assess the effectiveness of workplace interventions to support and promote breastfeeding among women returning to paid work after the birth of their children, and its impact on process outcomes pertinent to employees and employers. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 2006), CINAHL (1982 to November week 1 2006), LILACS (2 August 2006), Social Services Abstracts (1979 to November 2006), Sociological Abstracts (1952 to November 2006), Australian Public Affairs Information Service (2003 to 2006), Australian Family and Society Abstracts (2003 to 2006), International Bibliography of the Social Sciences (1951 to 2006), ProQuest Social Science Journals (1994 to 2006), Middle Eastern and Central Asian Studies (1900 to 2006) and the Campbell Collaboration Register (C2-SPECTR) (November 2006). Two authors independently assessed all identified studies for randomised controlled trials and quasi-randomised controlled trials that compared workplace interventions with no intervention or two or more workplace interventions against each other. Two authors planned to evaluate the methodological quality of the eligible trials and extract data. There were no randomised controlled trials or quasi-randomised controlled trials identified. No trials have evaluated the effectiveness of workplace interventions in promoting breastfeeding among women returning to paid work after the birth of their child. The impact of such intervention on process outcomes is also unknown. Randomised controlled trials are required to establish the benefits of various types of workplace interventions to support, encourage and promote breastfeeding among working mothers.

‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

PubMed Central

2014-01-01

Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers. Trial registration ISRCTN28645428. PMID:24758530

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

PubMed

Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

2014-04-24

Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers. ISRCTN28645428.

Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.

PubMed

Sandsund, Catherine; Towers, Richard; Thomas, Karen; Tigue, Ruth; Lalji, Amyn; Fernandes, Andreia; Doyle, Natalie; Jordan, Jake; Gage, Heather; Shaw, Clare

2017-08-28

Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold. Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

PubMed

Cockayne, Sarah; Fairhurst, Caroline; Adamson, Joy; Hewitt, Catherine; Hull, Robin; Hicks, Kate; Keenan, Anne-Maree; Lamb, Sarah E; Green, Lorraine; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Rodgers, Sara; Torgerson, David J; Vernon, Wesley; Watson, Judith; Knapp, Peter; Rick, Jo; Bower, Peter; Eldridge, Sandra; Madurasinghe, Vichithranie W; Graffy, Jonathan

2017-03-28

Randomised controlled trials are generally regarded as the 'gold standard' experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77-1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71-1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65-1.31, p = 0.65)). This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. International Standard Randomised Controlled Trials Number registry, ISRCTN68240461 . Registered on 01 July 2011.

The effect of conservative treatment of urinary incontinence among older and frail older people: a systematic review.

PubMed

Stenzelius, Karin; Molander, Ulla; Odeberg, Jenny; Hammarström, Margareta; Franzen, Karin; Midlöv, Patrik; Samuelsson, Eva; Andersson, Gunnel

2015-09-01

urinary incontinence (UI) is a common symptom among older people, with a higher prevalence among frail older persons living in nursing homes. Despite consequences such as reduced health and quality of life, many older people do not seek help for their symptoms, resulting in missed opportunity for treatment. the aim of this study was to investigate the evidence and the effect of conservative treatment of UI and the quality of life among older and frail older persons. a systematic review of randomised controlled studies and prospective, non-randomised studies was conducted, evaluating interventions of conservative treatment of UI in an older population (65 years or older). A total of 23 studies fulfilled the inclusion criteria and 9 were of high or moderate quality. Fourteen studies were of low quality and were therefore excluded from the analysis. documented and effective conservative treatments are available even for older persons with UI. Pelvic muscle exercise, physical training in combination with ADL, prompted voiding and attention training, and help to toilet are important treatments. In some studies, however, the evidence of effectiveness is limited. this systematic review concludes that there are conservative treatments for UI for older and frail older persons that reduce leakage and increase quality of life. There is however a need for further high-quality studies. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial.

PubMed

Panella, M; Marchisio, S; Demarchi, M L; Manzoli, L; Di Stanislao, F

2009-10-01

Hospital treatment of heart failure (HF) frequently does not follow published guidelines, potentially contributing to HF high morbidity, mortality and economic cost. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was undertaken to determine how clinical pathways (CP) for hospital treatment of HF affected care variability, guidelines adherence, in-hospital mortality and outcomes at discharge. Methods/ Two-arm, cluster-randomised trial. Fourteen community hospitals were randomised either to the experimental arm (CP: appropriate therapeutic guidelines use, new organisation and procedures, patient education) or to the control arm (usual care). The main outcome was in-hospital mortality; secondary outcomes were length and appropriateness of the stay, rate of unscheduled readmissions, customer satisfaction, usage of diagnostic and therapeutic procedures during hospital stay and quality indicators at discharge. All outcomes were measured using validated instruments available in literature. In-hospital mortality was 5.6% in the experimental arm (n = 12); 15.4% in controls (n = 33, p = 0.001). In CP and usual care groups, the mean rates of unscheduled readmissions were 7.9% and 13.9%, respectively. Adjusting for age, smoking, New York Heart Association score, hypertension and source of referral, patients in the CP group, as compared to controls, had a significantly lower risk of in-hospital death (OR 0.18; 95% CI 0.07 to 0.46) and unscheduled readmissions (OR 0.42; 95% CI 0.20 to 0.87). No differences were found between CP and control with respect to the appropriateness of the stay, costs and patient's satisfaction. Except for electrocardiography, all recommended diagnostic procedures were used more in the CP group. Similarly, pharmaceuticals use was significantly greater in CP, with the exception of diuretics and anti-platelets agents. The introduction of a specifically tailored CP for the hospital treatment of HF was effective in reducing in-hospital mortality and unscheduled readmissions. This study adds to previous knowledge indicating that CP should be used to improve the quality of hospital treatment of HF. NCT00519038.

Association between exogenous testosterone and cardiovascular events: an overview of systematic reviews.

PubMed

Onasanya, Oluwadamilola; Iyer, Geetha; Lucas, Eleanor; Lin, Dora; Singh, Sonal; Alexander, G Caleb

2016-11-01

Given the conflicting evidence regarding the association between exogenous testosterone and cardiovascular events, we systematically assessed published systematic reviews for evidence of the association between exogenous testosterone and cardiovascular events. We searched PubMed, MEDLINE, Embase, Cochrane Collaboration Clinical Trials, ClinicalTrials.gov, and the US Food and Drug Administration website for systematic reviews of randomised controlled trials published up to July 19, 2016. Two independent reviewers screened 954 full texts from 29 335 abstracts to identify systematic reviews of randomised controlled trials in which the cardiovascular effects of exogenous testosterone on men aged 18 years or older were examined. We extracted data for study characteristics, analytic methods, and key findings, and applied the AMSTAR (A Measurement Tool to Assess Systematic Reviews) checklist to assess methodological quality of each review. Our primary outcome measure was the direction and magnitude of association between exogenous testosterone and cardiovascular events. We identified seven reviews and meta-analyses, which had substantial clinical heterogeneity, differing statistical methods, and variable methodological quality and quality of data abstraction. AMSTAR scores ranged from 3 to 9 out of 11. Six systematic reviews that each included a meta-analysis showed no significant association between exogenous testosterone and cardiovascular events, with summary estimates ranging from 1·07 to 1·82 and imprecise confidence intervals. Two of these six meta-analyses showed increased risk in subgroup analyses of oral testosterone and men aged 65 years or older during their first treatment year. One meta-analysis showed a significant association between exogenous testosterone and cardiovascular events, in men aged 18 years or older generally, with a summary estimate of 1·54 (95% CI 1·09-2·18). Our optimal information size analysis showed that any randomised controlled trial aiming to detect a true difference in cardiovascular risk between treatment groups receiving exogenous testosterone and their controls (with a two-sided p value of 0·05 and a power of 80%) would require at least 17 664 participants in each trial group. Therefore, given the challenge of adequately powering clinical trials for rare outcomes, rigorous observational studies are needed to clarify the association between testosterone-replacement therapy and major adverse cardiovascular outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management)

PubMed Central

Peters-Klimm, Frank; Müller-Tasch, Thomas; Schellberg, Dieter; Gensichen, Jochen; Muth, Christiane; Herzog, Wolfgang; Szecsenyi, Joachim

2007-01-01

Background Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness Assessment of Care questionnaire (PACIC) and NT-proBNP. In addition, comprehensive clinical data are collected about health status, comorbidity, medication and health care utilisation. Discussion As the targeted patient group is mostly cared for and treated by GPs, a comprehensive primary care-based guideline implementation including somatic, psychosomatic and organisational aspects of the delivery of care (HICMAn) is a promising intervention applying proven strategies for optimal care. Trial registration Current Controlled Trials ISRCTN30822978. PMID:17716364

Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial.

PubMed

Acton, Jennifer H; Molik, Bablin; Binns, Alison; Court, Helen; Margrain, Tom H

2016-02-24

Visual Rehabilitation Officers help people with a visual impairment maintain their independence. This intervention adopts a flexible, goal-centred approach, which may include training in mobility, use of optical and non-optical aids, and performance of activities of daily living. Although Visual Rehabilitation Officers are an integral part of the low vision service in the United Kingdom, evidence that they are effective is lacking. The purpose of this exploratory trial is to estimate the impact of a Visual Rehabilitation Officer on self-reported visual function, psychosocial and quality-of-life outcomes in individuals with low vision. In this exploratory, assessor-masked, parallel group, randomised controlled trial, participants will be allocated either to receive home visits from a Visual Rehabilitation Officer (n = 30) or to a waiting list control group (n = 30) in a 1:1 ratio. Adult volunteers with a visual impairment, who have been identified as needing rehabilitation officer input by a social worker, will take part. Those with an urgent need for a Visual Rehabilitation Officer or who have a cognitive impairment will be excluded. The primary outcome measure will be self-reported visual function (48-item Veterans Affairs Low Vision Visual Functioning Questionnaire). Secondary outcome measures will include psychological and quality-of-life metrics: the Patient Health Questionnaire (PHQ-9), the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), the Adjustment to Age-related Visual Loss Scale (AVL-12), the Standardised Health-related Quality of Life Questionnaire (EQ-5D) and the UCLA Loneliness Scale. The interviewer collecting the outcomes will be masked to the group allocations. The analysis will be undertaken on a complete case and intention-to-treat basis. Analysis of covariance (ANCOVA) will be applied to follow-up questionnaire scores, with the baseline score as a covariate. This trial is expected to provide robust effect size estimates of the intervention effect. The data will be used to design a large-scale randomised controlled trial to evaluate fully the Visual Rehabilitation Officer intervention. A rigorous evaluation of Rehabilitation Officer input is vital to direct a future low vision rehabilitation strategy and to help direct government resources. The trial was registered with ( ISRCTN44807874 ) on 9 March 2015.

HYDration and Bicarbonate to Prevent Acute Renal Injury After Endovascular Aneurysm Repair With Suprarenal Fixation: Pilot/Feasibility Randomised Controlled Study (HYDRA Pilot Trial).

PubMed

Saratzis, Athanasios; Chiocchia, Virginia; Jiffry, Ahmad; Hassanali, Neelam; Singh, Surjeet; Imray, Christopher H; Bown, Matthew J; Mahmood, Asif

2018-05-01

Up to 25% of patients undergoing elective endovascular aneurysm repair (EVAR) develop acute kidney injury (AKI), which is associated with short and long-term morbidity and mortality. There is no high quality randomised evidence regarding prevention of EVAR related AKI. A novel AKI prevention strategy for EVAR was devised, based on best evidence and an expert consensus group. This included a bolus of high dose sodium bicarbonate (NaHCO 3 ) immediately before EVAR (1 mL/kg of 8.4% NaHCO 3 ) and standardised crystalloid based hydration pre- and post-EVAR. A pilot/feasibility randomised controlled trial (RCT) was performed in two centres to assess the safety of the intervention, potential impact on AKI prevention, and feasibility of a national RCT; the primary end point was the proportion of eligible patients recruited into the study. AKI was defined using "Kidney Disease Improving Global Outcomes" and "Acute Kidney Injury Network" criteria based on National Institute for Health and Clinical Excellence AKI recommendations, using serum creatinine and hourly urine output. Fifty-eight patients (84% of those screened; median age 75 years [range 57-89 years], 10% female) were randomised to receive the standardised intravenous hydration with (intervention) or without (control) NaHCO 3 . Groups were comparable in terms of AKI risk factors; 56 of 58 participants had a device with suprarenal fixation. Overall, 33% of patients in the control arm developed AKI versus 7% in the intervention arm (as treated analysis). None of the patients receiving NaHCO 3 developed a serious intervention related adverse event; five patients did not attend their 30 day follow-up. Bolus high dose NaHCO 3 and hydration is a promising EVAR related AKI prevention method. This trial has confirmed the feasibility of delivering a definitive large RCT to confirm the efficacy of this novel intervention, in preventing EVAR related AKI. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

CRIB--the use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial (RCT) with embedded feasibility study.

PubMed

Munro, Julie; Adams, Richard; Campbell, Anna; Campbell, Sandra; Donaldson, Cam; Godwin, Jon; Haw, Sally; Kidd, Lisa; Lane, Chrissie; Leslie, Stephen J; Mason, Helen; Mutrie, Nanette; O'Carroll, Ronan; Taylor, Cara; Treweek, Shaun; Watson, Angus; Hubbard, Gill

2014-02-18

Patients with colorectal cancer report ongoing physical and psychological impairments and a high proportion of these patients are overweight, insufficiently active and high-risk drinkers, putting them at risk of poor recovery and risk of recurrence and comorbidities. A challenge is implementing sustainable and effective rehabilitation as part of routine care for this group. A two-arm pilot randomised controlled trial (RCT) with embedded feasibility study undertaken as a phased programme of work. The intervention involves an existing cardiac rehabilitation programme for cardiac patients accepting colorectal cancer patient referrals. The intervention consists of supervised exercise sessions run by a cardiac physiotherapist and information sessions. Phase 1 will involve one research site enrolling 12 patients to assess intervention and study design processes. Semistructured interviews with patients with colorectal cancer and cardiac patients and clinicians will be used to gather data on acceptability of the intervention and study procedures. Phase 2 will involve three sites enrolling 66 patients with colorectal cancer randomised to control or intervention groups. Outcome measures will be taken preintervention and postintervention, for phases 1 and 2. The primary outcome is accelerometer measured physical activity; secondary outcomes are self-report physical activity, quality of life, anxiety, depression, symptoms including fatigue. The following variables will also be examined to determine if these factors influence adherence and outcomes: self-efficacy, risk perception and treatments. Full ethical approval was granted by NRES Committees-North of Scotland (13/NS/0004; IRAS project ID: 121757) on 22 February 2013. The proposed work is novel in that it aims to test the feasibility and acceptability of using an evidence-based and theory driven existing cardiac rehabilitation service with patients with colorectal cancer. Should this model of rehabilitation prove to be clinically and cost effective we aim to conduct a randomised controlled trial of this intervention to measure effectiveness. ISRCTN63510637; UKCRN id 14092.

Cinnamon for diabetes mellitus.

PubMed

Leach, Matthew J; Kumar, Saravana

2012-09-12

Diabetes mellitus is a chronic metabolic disorder that is associated with an increased risk of cardiovascular disease, retinopathy, nephropathy, neuropathy, sexual dysfunction and periodontal disease. Improvements in glycaemic control may help to reduce the risk of these complications. Several animal studies show that cinnamon may be effective in improving glycaemic control. While these effects have been explored in humans also, findings from these studies have not yet been systematically reviewed. To evaluate the effects of cinnamon in patients with diabetes mellitus. Pertinent randomised controlled trials were identified through AARP Ageline, AMED, AMI, BioMed Central gateway, CAM on PubMed, CINAHL, Dissertations Abstracts International, EMBASE, Health Source Nursing/Academic edition, International Pharmaceutical Abstracts, MEDLINE, Natural medicines comprehensive database, The Cochrane Library and TRIP database. Clinical trial registers and the reference lists of included trials were searched also (all up to January 2012). Content experts and manufacturers of cinnamon extracts were also contacted. All randomised controlled trials comparing the effects of orally administered monopreparations of cinnamon (Cinnamomum spp.) to placebo, active medication or no treatment in persons with either type 1 or type 2 diabetes mellitus. Two review authors independently selected trials, assessed risk of bias and trial quality, and extracted data. We contacted study authors for missing information. Ten prospective, parallel-group design, randomised controlled trials, involving a total of 577 participants with type 1 and type 2 diabetes mellitus, were identified. Risk of bias was high or unclear in all but two trials, which were assessed as having moderate risk of bias. Risk of bias in some domains was high in 50% of trials. Oral monopreparations of cinnamon (predominantly Cinnamomum cassia) were administered at a mean dose of 2 g daily, for a period ranging from 4 to 16 weeks. The effect of cinnamon on fasting blood glucose level was inconclusive. No statistically significant difference in glycosylated haemoglobin A1c (HbA1c), serum insulin or postprandial glucose was found between cinnamon and control groups. There were insufficient data to pool results for insulin sensitivity. No trials reported health-related quality of life, morbidity, mortality or costs. Adverse reactions to oral cinnamon were infrequent and generally mild in nature. There is insufficient evidence to support the use of cinnamon for type 1 or type 2 diabetes mellitus. Further trials, which address the issues of allocation concealment and blinding, are now required. The inclusion of other important endpoints, such as health-related quality of life, diabetes complications and costs, is also needed.

Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol)

PubMed Central

2011-01-01

Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers) will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use) and consultation (individual public recommendations for improvement will be collected and presented to decision makers). In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27 participants (11 public representatives and 16 clinicians and managers) and our study instruments with an additional 21 participants, which demonstrated the feasibility of the intervention and generated important insights and adaptations to engage public representatives more effectively. To our knowledge, this study is the first trial of public involvement in quality-indicator prioritisation, and its results could foster more effective upstream engagement of patients and the public in clinical practice improvement. Trial registration NTR2496 (Netherlands National Trial Register, http://www.trialregister.nl). PMID:21554691

Creatine for women in pregnancy for neuroprotection of the fetus.

PubMed

Dickinson, Hayley; Bain, Emily; Wilkinson, Dominic; Middleton, Philippa; Crowther, Caroline A; Walker, David W

2014-12-19

Creatine is an amino acid derivative and, when phosphorylated (phosphocreatine), is involved in replenishing adenosine triphosphate (ATP) via the creatine kinase reaction. Cells obtain creatine from a diet rich in fish, meat, or dairy and by endogenous synthesis from the amino acids arginine, glycine, and methionine in an approximate 50:50 ratio. Animal studies have shown that creatine may provide fetal neuroprotection when given to the mother through her diet in pregnancy. It is important to assess whether maternally administered creatine in human pregnancy (at times of known, suspected, or potential fetal compromise) may offer neuroprotection to the fetus and may accordingly reduce the risk of adverse neurodevelopmental outcomes, such as cerebral palsy and associated impairments and disabilities arising from fetal brain injury. To assess the effects of creatine when used for neuroprotection of the fetus. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 November 2014). We planned to include all published, unpublished, and ongoing randomised trials and quasi-randomised trials. We planned to include studies reported as abstracts only as well as full-text manuscripts. Trials using a cross-over or cluster-randomised design were not eligible for inclusion.We planned to include trials comparing creatine given to women in pregnancy for fetal neuroprotection (regardless of the route, timing, dose, or duration of administration) with placebo, no treatment, or with an alternative agent aimed at providing fetal neuroprotection. We also planned to include comparisons of different regimens for administration of creatine. We identified no completed or ongoing randomised controlled trials. We found no randomised controlled trials for inclusion in this review. As we did not identify any randomised controlled trials for inclusion in this review, we are unable to comment on implications for practice. Although evidence from animal studies has supported a fetal neuroprotective role for creatine when administered to the mother during pregnancy, no trials assessing creatine in pregnant women for fetal neuroprotection have been published to date. If creatine is established as safe for the mother and her fetus, research efforts should first be directed towards randomised trials comparing creatine with either no intervention (ideally using a placebo), or with alternative agents aimed at providing fetal neuroprotection (including magnesium sulphate for the very preterm infant). If appropriate, these trials should then be followed by studies comparing different creatine regimens (dosage and duration of exposure). Such trials should be high quality and adequately powered to evaluate maternal and infant short and longer-term outcomes (including neurodevelopmental disabilities such as cerebral palsy), and should consider utilisation/costs of health care.

Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial.

PubMed

Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Lam, Carly S Y; Dai, Shuan; Gao, Tina Y; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie; Wadham, Angela; Thompson, Benjamin

2016-10-18

Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at baseline, 3, 6, 12 and 24 weeks post randomisation. Treatment compliance and acceptability will also be assessed along with quality of life for adult participants. The BRAVO study is the first randomised controlled trial of a home-based videogame treatment for older children and adults with amblyopia. The results will indicate whether a binocular approach to amblyopia treatment conducted at home is effective for patients aged 7 years or older. This trial was registered in Australia and New Zealand Clinical Trials Registry ( ACTRN12613001004752 ) on 10 September 2013.

Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: Design of a randomised controlled trial

PubMed Central

Crothers, Amy; Walker, Bruce; French, Simon D

2008-01-01

Background The one year prevalence of thoracic back pain has been estimated as 17% compared to 64% for neck pain and 67% for low back pain. At present only one randomised controlled trial has been performed assessing the efficacy of spinal manipulative therapy (SMT) for thoracic spine pain. In addition no high quality trials have been performed to test the efficacy and effectiveness of Graston Technique® (GT), a soft tissue massage therapy using hand-held stainless steel instruments. The objective of this trial is to determine the efficacy of SMT and GT compared to a placebo for the treatment of non specific thoracic spine pain. Methods Eighty four eligible people with non specific thoracic pain mid back pain of six weeks or more will be randomised to one of three groups, either SMT, GT, or a placebo (de-tuned ultrasound). Each group will receive up to 10 supervised treatment sessions at the Murdoch University Chiropractic student clinic over a 4-week period. Treatment outcomes will be measured at baseline, one week after their first treatment, upon completion of the 4-week intervention period and at three, six and twelve months post randomisation. Outcome measures will include the Oswestry Back Pain Disability Index and the Visual Analogue Scale (VAS). Intention to treat analysis will be utilised in the statistical analysis of any group treatment effects. Trial Registration This trial was registered with the Australia and New Zealand Clinical Trials Registry on the 7th February 2008. Trial number: ACTRN12608000070336 PMID:18959807

Total ankle replacement versus arthrodesis (TARVA): protocol for a multicentre randomised controlled trial

PubMed Central

Goldberg, Andrew J; Zaidi, Razi; Thomson, Claire; Doré, Caroline J; Cro, Suzie; Round, Jeff; Molloy, Andrew; Davies, Mark; Karski, Michael; Kim, Louise; Cooke, Paul

2016-01-01

Introduction Total ankle replacement (TAR) or ankle arthrodesis (fusion) is the main surgical treatments for end-stage ankle osteoarthritis (OA). The popularity of ankle replacement is increasing while ankle fusion rates remain static. Both treatments have efficacy but to date all studies comparing the 2 have been observational without randomisation, and there are no published guidelines as to the most appropriate management. The TAR versus arthrodesis (TARVA) trial aims to compare the clinical and cost-effectiveness of TAR against ankle arthrodesis in the treatment of end-stage ankle OA in patients aged 50–85 years. Methods and analysis TARVA is a multicentre randomised controlled trial that will randomise 328 patients aged 50–85 years with end-stage ankle arthritis. The 2 arms of the study will be TAR or ankle arthrodesis with 164 patients in each group. Up to 16 UK centres will participate. Patients will have clinical assessments and complete questionnaires before their operation and at 6, 12, 26 and 52 weeks after surgery. The primary clinical outcome of the study is a validated patient-reported outcome measure, the Manchester Oxford foot questionnaire, captured preoperatively and 12 months after surgery. Secondary outcomes include quality-of-life scores, complications, revision, reoperation and a health economic analysis. Ethics and dissemination The protocol has been approved by the National Research Ethics Service Committee (London, Bloomsbury 14/LO/0807). This manuscript is based on V.5.0 of the protocol. The trial findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT02128555. PMID:27601503

Systematic review of the use of honey as a wound dressing

PubMed Central

Moore, Owen A; Smith, Lesley A; Campbell, Fiona; Seers, Kate; McQuay, Henry J; Moore, R Andrew

2001-01-01

Objective To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. Data sources Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. Review methods Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. Results One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. Conclusion Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility. PMID:11405898

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

PubMed Central

Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

2013-01-01

Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. Trial registration ISRCTN96634935. Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services. PMID:24136634

Open urethroplasty versus endoscopic urethrotomy--clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial.

PubMed

Stephenson, Rachel; Carnell, Sonya; Johnson, Nicola; Brown, Robbie; Wilkinson, Jennifer; Mundy, Anthony; Payne, Steven; Watkin, Nick; N'Dow, James; Sinclair, Andrew; Rees, Rowland; Barclay, Stewart; Cook, Jonathan A; Goulao, Beatriz; MacLennan, Graeme; McPherson, Gladys; Jackson, Matthew; Rapley, Tim; Shen, Jing; Vale, Luke; Norrie, John; McColl, Elaine; Pickard, Robert

2015-12-30

Urethral stricture is a common cause of difficulty passing urine in men with prevalence of 0.5 %; about 62,000 men in the UK. The stricture is usually sited in the bulbar part of the urethra causing symptoms such as reduced urine flow. Initial treatment is typically by endoscopic urethrotomy but recurrence occurs in about 60% of men within 2 years. The best treatment for men with recurrent bulbar stricture is uncertain. Repeat endoscopic urethrotomy opens the narrowing but it usually scars up again within 2 years requiring repeated procedures. The alternative of open urethroplasty involves surgically reconstructing the urethra, which may need an oral mucosal graft. It is a specialist procedure with a longer recovery period but may give lower risk of recurrence. In the absence of firm evidence as to which is best, individual men have to trade off the invasiveness and possible benefit of each option. Their preference will be influenced by individual social circumstances, availability of local expertise and clinician guidance. The open urethroplasty versus endoscopic urethrotomy (OPEN) trial aims to better guide the choice of treatment for men with recurrent urethral strictures by comparing benefit over 2 years in terms of symptom control and need for further treatment. OPEN is a pragmatic, UK multicentre, randomised trial. Men with recurrent bulbar urethral strictures (at least one previous treatment) will be randomised to undergo endoscopic urethrotomy or open urethroplasty. Participants will be followed for 24 months after randomisation, measuring symptoms, flow rate, the need for re-intervention, health-related quality of life, and costs. The primary clinical outcome is the difference in symptom control over 24 months measured by the area under the curve (AUC) of a validated score. The trial has been powered at 90% with a type I error rate of 5% to detect a 0.1 difference in AUC measured on a 0-1 scale. The analysis will be based on all participants as randomised (intention-to-treat). The primary economic outcome is the incremental cost per quality-adjusted life year. A qualitative study will assess willingness to be randomised and hence ability to recruit to the trial. The OPEN Trial seeks to clarify relative benefit of the current options for surgical treatment of recurrent bulbar urethral stricture which differ in their invasiveness and resources required. Our feasibility study identified that participation would be limited by patient preference and differing recruitment styles of general and specialist urologists. We formulated and implemented effective strategies to address these issues in particular by inviting participation as close as possible to diagnosis. In addition re-calculation of sample size as recruitment progressed allowed more efficient design given the limited target population and funding constraints. Recruitment is now to target. ISRCTN98009168 Date of registration: 29 November 2012.

Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial

PubMed Central

2010-01-01

Background This randomised, single-blind controlled pilot trial aimed to determine the effectiveness of a physiotherapy program, including exercise and manual therapy, in reducing impairments and improving physical function and health-related quality of life in people with a history of painful osteoporotic vertebral fracture. Methods 20 participants were randomly allocated to an intervention (n = 11) or control (n = 9) group. The intervention group attended individual sessions with an experienced clinician once a week for 10 weeks and performed daily home exercises with adherence monitored by a self-report diary. The control group received no treatment. Blinded assessment was conducted at baseline and 11 weeks. Questionnaires assessed self-reported changes in back pain, physical function, and health-related quality of life. Objective measures of thoracic kyphosis, back and shoulder muscle endurance (Timed Loaded Standing Test), and function (Timed Up and Go test) were also taken. Results Compared with the control group, the intervention group showed significant reductions in pain during movement (mean difference (95% CI) -1.8 (-3.5 to -0.1)) and at rest (-2.0 (-3.8 to -0.2)) and significantly greater improvements in Qualeffo physical function (-4.8 (-9.2 to -0.5)) and the Timed Loaded Standing test (46.7 (16.1 to 77.3) secs). For the perceived change in back pain over the 10 weeks, 9/11 (82%) participants in the intervention group rated their pain as 'much better' compared with only 1/9 (11%) participants in the control group. Conclusion Despite the modest sample size, these results support the benefits of exercise and manual therapy in the clinical management of patients with osteoporotic vertebral fractures, but need to be confirmed in a larger sample. Trail registration NCT00638768 PMID:20163739

Effects of antithyroid drugs on radioiodine treatment: systematic review and meta-analysis of randomised controlled trials.

PubMed

Walter, Martin A; Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat

2007-03-10

To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Meta-analysis. Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively.

Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial

PubMed Central

Aga, Anna-Birgitte; Olsen, Inge Christoffer; Lillegraven, Siri; Hammer, Hilde B; Uhlig, Till; Fremstad, Hallvard; Madland, Tor Magne; Lexberg, Åse Stavland; Haukeland, Hilde; Rødevand, Erik; Høili, Christian; Stray, Hilde; Noraas, Anne; Hansen, Inger Johanne Widding; Bakland, Gunnstein; Nordberg, Lena Bugge; van der Heijde, Désirée; Kvien, Tore K

2016-01-01

Objective To determine whether a treatment strategy based on structured ultrasound assessment would lead to improved outcomes in rheumatoid arthritis, compared with a conventional strategy. Design Multicentre, open label, two arm, parallel group, randomised controlled strategy trial. Setting Ten rheumatology departments and one specialist centre in Norway, from September 2010 to September 2015. Participants 238 patients were recruited between September 2010 and April 2013, of which 230 (141 (61%) female) received the allocated intervention and were analysed for the primary outcome. The main inclusion criteria were age 18-75 years, fulfilment of the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis, disease modifying anti-rheumatic drug naivety with indication for disease modifying drug therapy, and time from first patient reported swollen joint less than two years. Patients with abnormal kidney or liver function or major comorbidities were excluded. Interventions 122 patients were randomised to an ultrasound tight control strategy targeting clinical and imaging remission, and 116 patients were randomised to a conventional tight control strategy targeting clinical remission. Patients in both arms were treated according to the same disease modifying anti-rheumatic drug escalation strategy, with 13 visits over two years. Main outcome measures The primary endpoint was the proportion of patients with a combination between 16 and 24 months of clinical remission, no swollen joints, and non-progression of radiographic joint damage. Secondary outcomes included measures of disease activity, radiographic progression, functioning, quality of life, and adverse events. All participants who attended at least one follow-up visit were included in the full analysis set. Results 26 (22%) of the 118 analysed patients in the ultrasound tight control arm and 21 (19%) of the 112 analysed patients in the clinical tight control arm reached the primary endpoint (mean difference 3.3%, 95% confidence interval −7.1% to 13.7%). Secondary endpoints (disease activity, physical function, and joint damage) were similar between the two groups. Six (5%) patients in the ultrasound tight control arm and seven (6%) patients in the conventional arm had serious adverse events. Conclusions The systematic use of ultrasound in the follow-up of patients with early rheumatoid arthritis treated according to current recommendations is not justified on the basis of the ARCTIC results. The findings highlight the need for randomised trials assessing the clinical application of medical technology. Trial registration Clinical trials NCT01205854. PMID:27530741

Brain iron chelation by deferiprone in a phase 2 randomised double-blinded placebo controlled clinical trial in Parkinson's disease.

PubMed

Martin-Bastida, Antonio; Ward, Roberta J; Newbould, Rexford; Piccini, Paola; Sharp, David; Kabba, Christina; Patel, Maneesh C; Spino, Michael; Connelly, John; Tricta, Fernando; Crichton, Robert R; Dexter, David T

2017-05-03

Parkinson's disease (PD) is associated with increased iron levels in the substantia nigra (SNc). This study evaluated whether the iron chelator, deferiprone, is well tolerated, able to chelate iron from various brain regions and improve PD symptomology. In a randomised double-blind, placebo controlled trial, 22 early onset PD patients, were administered deferiprone, 10 or 15 mg/kg BID or placebo, for 6 months. Patients were evaluated for PD severity, cognitive function, depression rating and quality of life. Iron concentrations were assessed in the substantia nigra (SNc), dentate and caudate nucleus, red nucleus, putamen and globus pallidus by T2* MRI at baseline and after 3 and 6 months of treatment. Deferiprone therapy was well tolerated and was associated with a reduced dentate and caudate nucleus iron content compared to placebo. Reductions in iron content of the SNc occurred in only 3 patients, with no changes being detected in the putamen or globus pallidus. Although 30 mg/kg deferiprone treated patients showed a trend for improvement in motor-UPDRS scores and quality of life, this did not reach significance. Cognitive function and mood were not adversely affected by deferiprone therapy. Such data supports more extensive clinical trials into the potential benefits of iron chelation in PD.

Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial.

PubMed

Artom, Micol; Czuber-Dochan, Wladyslawa; Sturt, Jackie; Norton, Christine

2017-05-11

Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system. There is a need to integrate current best evidence across different conditions, patient experience and clinical expertise in order to develop interventions for IBD-fatigue management that are feasible and effective. Modifying an existing intervention for patients with multiple sclerosis, this study aims to assess the feasibility and initial estimates of efficacy of a cognitive behavioural therapy (CBT) intervention for the management of fatigue in patients with IBD. The study will be a two-arm pilot randomised controlled trial. Patients will be recruited from one outpatient IBD clinic and randomised individually to either: Group 1 (CBT manual for the management of fatigue, one 60-min session and seven 30-min telephone/Skype sessions with a therapist over an eight-week period); or Group 2 (fatigue information sheet to use without therapist help). Self-reported IBD-fatigue (Inflammatory Bowel Disease-Fatigue Scale) and IBD-quality of life (United Kingdom Inflammatory Bowel Disease Questionnaire) and self-reported disease activity will be collected at baseline, three, six and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression explanatory variables will be collected only at three months post randomisation. Clinical and sociodemographic data will be retrieved from the patients' medical notes. A nested qualitative study will evaluate patient and therapist experience, and healthcare professionals' perceptions of the intervention. The study will provide evidence of the feasibility and initial estimates of efficacy of a CBT intervention for the management of fatigue in patients with IBD. Quantitative and qualitative findings from the study will contribute to the development and implementation of a large-scale randomised controlled trial assessing the efficacy of CBT interventions for IBD-fatigue. ISRCTN Registry, ISRCTN17917944 . Registered on 2 September 2016.

Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemia: protocol for randomised controlled home trial to evaluate the Suspend before low function

PubMed Central

Abraham, M B; Nicholas, J A; Ly, T T; Roby, H C; Paramalingam, N; Fairchild, J; King, B R; Ambler, G R; Cameron, F; Davis, E A; Jones, T W

2016-01-01

Introduction Innovations with sensor-augmented pump therapy (SAPT) to reduce hypoglycaemia in patients with type 1 diabetes are an ongoing area of research. The predictive low glucose management (PLGM) system incorporates continuous glucose sensor data into an algorithm and suspends basal insulin before the occurrence of hypoglycaemia. The system was evaluated in in-clinic studies, and has informed the parameters of a larger home trial to study its efficacy and safety in real life. Methods and analysis The aim of this report is to describe the study design and outcome measures for the trial. This is a 6-month, multicentre, randomised controlled home trial to test the PLGM system in children and adolescents with type 1 diabetes. The system is available in the Medtronic MiniMed 640G pump as the ‘Suspend before low’ feature. Following a run-in period, participants are randomised to either the control arm with SAPT alone or the intervention arm with SAPT and Suspend before low. The primary aim of this study is to evaluate the time spent hypoglycaemic (sensor glucose <3.5 mmol/L) with and without the system. The secondary aims are to determine the number of hypoglycaemic events, the time spent hyperglycaemic, and to evaluate safety with ketosis and changes in glycated haemoglobin. The study also aims to assess the changes in counter-regulatory hormone responses to hypoglycaemia evaluated by a hyperinsulinaemic hypoglycaemic clamp in a subgroup of patients with impaired awareness. Validated questionnaires are used to measure the fear of hypoglycaemia and the impact on the quality of life to assess burden of the disease. Ethics and dissemination Ethics committee permissions were gained from respective Institutional Review boards. The findings of the study will provide high quality evidence of the ability of the system in the prevention of hypoglycaemia in real life. Trial registration number ACTRN12614000510640, Pre-results. PMID:27084290

Protocol for a multicentre randomiSed controlled TRial of IntraVEnous immunoglobulin versus standard therapy for the treatment of transverse myelitis in adults and children (STRIVE)

PubMed Central

Absoud, M; Gadian, J; Hellier, J; Brex, P A; Ciccarelli, O; Giovannoni, G; Kelly, J; McCrone, P; Murphy, C; Palace, J; Pickles, A; Pike, M; Robertson, N; Jacob, A; Lim, M

2015-01-01

Introduction Transverse myelitis (TM) is an immune-mediated disorder of the spinal cord which causes motor and sensory disturbance and limited recovery in 50% of patients. Standard treatment is steroids, and patients with more severe disease appear to respond to plasma exchange (PLEX). Intravenous immunoglobulin (IVIG) has also been used as an adjunct to steroids, but evidence is lacking. We propose the first randomised control trial in adults and children, to determine the benefit of additional treatment with IVIG. Methods and analysis 170 adults and children aged over 1 year with acute first episode TM or neuromyelitis optica (with myelitis) will be recruited over a 2.5-year period and followed up for 12 months. Participants randomised to the control arm will receive standard therapy of intravenous methylprednisolone (IVMP). The intervention arm will receive the above standard therapy, plus additional IVIG. Primary outcome will be a 2-point improvement on the American Spinal Injury Association (ASIA) Impairment scale at 6 months postrandomisation by blinded assessors. Additional secondary and tertiary outcome measures will be collected: ASIA motor and sensory scales, Kurtzke expanded disability status scale, International Spinal Cord Injury (SCI) Bladder/Bowel Data Set, Client Services Receipt Index, Pediatric Quality of Life Inventory, EQ-5D, SCI Pain and SCI Quality of Life Data Sets. Biological samples will be biobanked for future studies. After 6-months' follow-up of the first 52 recruited patients futility analysis will be carried out. Health economics analysis will be performed to calculate cost-effectiveness. After 6 months’ recruitment futility analysis will be performed. Ethics and dissemination Research Ethics Committee Approval was obtained: 14/SC/1329. Current protocol: v3.0 (15/01/2015). Study findings will be published in peer-reviewed journals. Trial registration numbers This study is registered with EudraCT (REF: 2014-002335-34), Clinicaltrials.gov (REF: NCT02398994) and ISRCTN (REF: 12127581). PMID:26009577

Adherence therapy improves medication adherence and quality of life in people with Parkinson's disease: a randomised controlled trial.

PubMed

Daley, D J; Deane, K H O; Gray, R J; Clark, A B; Pfeil, M; Sabanathan, K; Worth, P F; Myint, P K

2014-08-01

Many factors are associated with medication non-adherence in Parkinson's disease (PD), including complex treatment regimens, mood disorders and impaired cognition. However, interventions to improve adherence which acknowledge such factors are lacking. A phase II randomised controlled trial was conducted investigating whether Adherence Therapy (AT) improves medication adherence and quality of life (QoL) compared with routine care (RC) in PD. Eligible PD patients and their spouse/carers were randomised to intervention (RC plus AT) or control (RC alone). Primary outcomes were change in adherence (Morisky Medication Adherence Scale) and QoL (Parkinson's Disease Questionnaire-39) from baseline to week-12 follow up. Secondary outcomes were MDS-UPDRS (part I, II, IV), Beliefs about Medication Questionnaire (BMQ), EuroQol (EQ-5D) and the Caregiving Distress Scale. Blinded data were analysed using logistic and linear regression models based on the intention-to-treat principle. Seventy-six patients and 46 spouse/carers completed the study (intervention: n = 38 patients, n = 24 spouse/carers). At week-12 AT significantly improved adherence compared with RC (OR 8.2; 95% CI: 2.8, 24.3). Numbers needed to treat (NNT) were 2.2 (CI: 1.6, 3.9). Compared with RC, AT significantly improved PDQ-39 (-9.0 CI: -12.2, -5.8), BMQ general harm (-1.0 CI: -1.9, -0.2) and MDS-UPDRS part II (-4.8 CI: -8.1, -1.4). No significant interaction was observed between the presence of a spouse/carer and the effect of AT. Adherence Therapy improved self-reported adherence and QoL in a PD sample. The small NNT suggests AT may be cost-effective. A larger pragmatic trial to test the efficacy and cost-effectiveness of AT by multiple therapists is required. © 2014 John Wiley & Sons Ltd.

Dengzhanhua preparations for acute cerebral infarction.

PubMed

Cao, Wenzhai; Liu, Weimin; Wu, Taixiang; Zhong, Dechao; Liu, Guanjian

2008-10-08

Dengzhanhua preparations are widely used in China. Many controlled trials have been undertaken to investigate the efficacy of dengzhanhua preparations in the treatment of acute cerebral infarction. To assess whether dengzhanhua preparations are effective and safe at improving outcomes in patients with acute cerebral infarction. We searched the Cochrane Stroke Group Trials Register (last searched October 2007), the Chinese Stroke Trials Register (last searched June 2006), the trials register of the Cochrane Complementary Medicine Field (last searched June 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 2 2006), MEDLINE (1966 to June 2006), EMBASE (1980 to June 2006), AMED (the Allied and Complementary Medicine Database, 1985 to June 2006), the China Biological Medicine Database (CBM-disc, 1979 to June 2006), and Chinese Knowledge Infrastructure (CNKI,1994 to October 2007). We also searched the reference lists of relevant articles. Randomised and quasi-randomised controlled clinical trials of dengzhanhua preparations regardless of duration, dosage and route of administration in patients with confirmed acute cerebral infarction. Two review authors independently applied the inclusion criteria, assessed trial quality, and extracted the data. We included nine trials, all conducted in China, involving 723 participants. The method of randomisation and concealment was poorly described. The included trials compared dengzhanhua injection plus routine therapy with routine therapy alone. Patients were enrolled up to one week after the onset of stroke. No trials reported data on the pre-specified primary or secondary outcomes. In a post-hoc comparison of dengzhanhua injection plus routine therapy versus routine therapy alone, dengzhanhua injection showed a statistically significant benefit on the outcome 'marked neurologic improvement' (relative risk 1.53; 95% confidence interval 1.36 to 1.72). No serious adverse effects were reported. Due to the generally low methodological quality and small sample size of the included trials in this systematic review, we could not draw a firm conclusion.

Acupuncture treatment for ischaemic stroke in young adults: protocol for a randomised, sham-controlled clinical trial

PubMed Central

Chen, Lifang; Fang, Jianqiao; Jin, Xiaoming; Keeler, Crystal Lynn; Gao, Hong; Fang, Zhen; Chen, Qin

2016-01-01

Introduction Stroke in young adults is not uncommon. Although the overall incidence of stroke has been recently declining, the incidence of stroke in young adults is increasing. Traditional vascular risk factors are the main cause of young ischaemic stroke. Acupuncture has been shown to benefit stroke rehabilitation and ameliorate the risk factors for stroke. The aims of this study were to determine whether acupuncture treatment will be effective in improving the activities of daily living (ADL), motor function and quality of life (QOL) in patients of young ischaemic stroke, and in preventing stroke recurrence by controlling blood pressure, lipids and body weight. Methods and analysis In this randomised, sham-controlled, participant-blinded and assessor-blinded clinical trial, 120 patients between 18 and 45 years of age with a recent (within 1 month) ischaemic stroke will be randomised for an 8-week acupuncture or sham acupuncture treatment. The primary outcome will be the Barthel Index for ADL. The secondary outcomes will include the Fugl-Meyer Assessment for motor function; the World Health Organization Quality of Life BREF (WHOQOL-BREF) for QOL; and risk factors that are measured by ambulatory blood pressure, the fasting serum lipid, body mass index and waist circumference. Incidence of adverse events and long-term mortality and recurrence rate during a 10-year and 30-year follow-up will also be investigated. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University. Protocol V.3 was approved in June 2013. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone during follow-up calls enquiring on the patient's post-study health status. Trial registration number ChiCTR-TRC- 13003317; Pre-results. PMID:26739742

Protocol for a cluster-randomised trial to determine the effects of advocacy actions on the salt content of processed foods.

PubMed

Trevena, Helen; Thow, Anne Marie; Dunford, Elizabeth; Wu, Jason H Y; Neal, Bruce

2016-01-25

Corporate decisions affecting the composition of processed foods are a potent factor shaping the nutritional quality of the food supply. The addition of large quantities of salt to foods is incompatible with Australian Dietary Guidelines and the reformulation of processed foods to have less salt is a focus of non-governmental organisations (NGOs). There is evidence that advocacy can influence corporate behaviour but there are few data to define the effects of NGOs working in the food space. The aim of this study is to quantify the effects of advocacy delivered by a local NGO on the salt content of food products produced or marketed by companies in Australia. This is a cluster-randomised controlled trial that will be done in Australia from 2013 to 2015 which includes 45 food companies. The 23 companies in the control group will receive no specific intervention whilst the 22 companies in the intervention group will receive an advocacy program based upon an established theory of change model. The primary outcome will be the mean change in sodium content (mg/100 g) of processed foods produced or marketed by intervention compared to control companies assessed at 24 months. Interim outcomes (statements of support, published nutrition policies, level of engagement, knowledge and use of technology to reduce salt, salt reduction plans, and support for national initiatives) will also be assessed and a qualitative evaluation will provide more detailed insight. This novel study will provide robust randomised evidence about the effects of advocacy on food company behaviour and the quality of the processed food supply. A finding of improved food company behaviour will highlight the potential for greater investment in advocacy whilst the opposite result will reinforce the importance of government-led initiatives for the improvement of the food supply. ClinicalTrials.gov: NCT02373423. 26/02/2015.

Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: results of an economic evaluation alongside a randomised controlled trial.

PubMed

Oostdam, Nicolette; Bosmans, Judith; Wouters, Maurice G A J; Eekhoff, Elisabeth M W; van Mechelen, Willem; van Poppel, Mireille N M

2012-07-04

The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care. A randomised controlled trial (RCT) and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62) or to standard care (n = 59). The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs) were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios. There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204). The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs. The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of GDM cannot be recommended. NTR1139.

Quality of randomised controlled trials in medical education reported between 2012 and 2013: a systematic review protocol.

PubMed

Tolsgaard, Martin G; Ku, Cheryl; Woods, Nicole N; Kulasegaram, Kulamakan Mahan; Brydges, Ryan; Ringsted, Charlotte

2014-07-30

Research in medical education has increased in volume over the past decades but concerns have been raised regarding the quality of trials conducted within this field. Randomised controlled trials (RCTs) involving educational interventions that are reported in biomedical journals have been criticised for their insufficient conceptual, theoretical framework. RCTs published in journals dedicated to medical education, on the other hand, have been questioned regarding their methodological rigour. The aim of this study is therefore to assess the quality of RCTs of educational interventions reported in 2012 and 2013 in journals dedicated to medical education compared to biomedical journals with respect to objective quality criteria. RCTs published between 1 January 2012 and 31 December 2013 in English are included. The search strategy is developed with the help of experienced librarians to search online databases for key terms. All of the identified RCTs are screened based on their titles and abstracts individually by the authors and then compared in pairs to assess agreement. Data are extracted from the included RCTs by independently scoring each RCT using a data collection form. The data collection form consists of four steps. Step 1 includes confirmation of RCT eligibility; step 2 consists of the CONSORT checklist; step 3 consists of the Medical Education Research Study Quality Instrument framework; step 4 consists of a Medical Education Extension (MEdEx) to the CONSORT checklist. The MEdEx includes the following elements: Description of scientific background, explanation of rationale, quality of research questions and hypotheses, clarity in the description of the use of the intervention and control as well as interpretation of results. This review is the first to systematically examine the quality of RCTs conducted in medical education. We plan to disseminate the results through publications and presentation at relevant conferences. Ethical approval is not sought for this review. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Oxytocin for preventing postpartum haemorrhage (PPH) in non-facility birth settings.

PubMed

Pantoja, Tomas; Abalos, Edgardo; Chapman, Evelina; Vera, Claudio; Serrano, Valentina P

2016-04-14

Postpartum haemorrhage (PPH) is the single leading cause of maternal mortality worldwide. Most of the deaths associated with PPH occur in resource-poor settings where effective methods of prevention and treatment - such as oxytocin - are not accessible because many births still occur at home, or in community settings, far from a health facility. Likewise, most of the evidence supporting oxytocin effectiveness comes from hospital settings in high-income countries, mainly because of the need of well-organised care for its administration and monitoring. Easier methods for oxytocin administration have been developed for use in resource-poor settings, but as far as we know, its effectiveness has not been assessed in a systematic review. To assess the effectiveness and safety of oxytocin provided in non-facility birth settings by any way in the third stage of labour to prevent PPH. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov (12 November 2015), and reference lists of retrieved reports. All published, unpublished or ongoing randomised or quasi-randomised controlled trials comparing the administration of oxytocin with no intervention, or usual/standard care for the management of the third stage of labour in non-facility birth settings were considered for inclusion.Quasi-randomised controlled trials and randomised controlled trials published in abstract form only were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion in this review. Two review authors independently assessed studies for eligibility, assessed risk of bias and extracted the data using an agreed data extraction form. Data were checked for accuracy. We included one cluster-randomised trial conducted in four rural districts in Ghana that randomised 28 community health officers (CHOs) (serving 2404 potentially eligible pregnant women) to the intervention group and 26 CHOs (serving 3515 potentially eligible pregnant women) to the control group. Overall, the trial had a high risk of bias. CHOs delivered the intervention in the experimental group (injection of 10 IU (international units) of oxytocin in the thigh one minute following birth using a prefilled, auto-disposable syringe). In the control group, CHOs did not provide this prophylactic injection to the women they observed. CHOs had no midwifery skills and did not in any way manage the birth. All other CHO activities (outcome measurement, data collection, and early treatment and referral when necessary) were identical across the control and oxytocin CHOs.Although only one of the nine cases of severe PPH (blood loss greater or equal to 1000 mL) occurred in the oxytocin group, the effect estimate for this outcome was very imprecise and it is uncertain whether the intervention prevents severe PPH (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.02 to 1.30; 1570 women (very low-quality evidence)). Similarly, because of the lack of cases of severe maternal morbidity (e.g. uterine rupture) and maternal deaths, it was not possible to obtain effect estimates for those outcomes (both very low-quality evidence).Oxytocin compared with the control group decreased the incidence of PPH (> 500 mL) in both our unadjusted (RR 0.48, 95% CI 0.28 to 0.81; 1569 women) and adjusted (RR 0.49, 95% CI 0.27 to 0.90; 1174 women (both low-quality evidence)) analyses. There was little or no difference between the oxytocin and control groups on the rates of transfer or referral of the mother to a healthcare facility (RR 0.72, 95% CI 0.34 to 1.56; 1586 women (low-quality evidence)), stillbirths (RR 1.27, 95% CI 0.67 to 2.40; 2006 infants (low-quality evidence)); andearly infant deaths (0 to three days) (RR 1.03, 95% CI 0.35 to 3.07; 1969 infants (low-quality evidence)). There were no cases of needle-stick injury or any other maternal major or minor adverse event or unanticipated harmful event. There were no cases of oxytocin use during labour.There were no data reported for some of this review's secondary outcomes: manual removal of placenta, maternal anaemia, neonatal death within 28 days, neonatal transfer to health facility for advanced care, breastfeeding rates. Similarly, the women's or the provider's satisfaction with the intervention was not reported. It is uncertain if oxytocin administered by CHO in non-facility settings compared with a control group reduces the incidence of severe PPH (>1000 mL), severe maternal morbidity or maternal deaths. However, the intervention probably decreases the incidence of PPH (> 500 mL).The quality of the one trial included in this review was limited because of the risk of attrition and recruitment biases related to limitations in the follow-up of pregnant women in both arms of the trials and some baseline imbalance on the size of babies at birth. Additionally, there was serious imprecision of the effect estimates for most of the primary outcomes mainly because of the size of the trial, very few or no events and CIs around both relative and absolute estimates of effect that include both appreciable benefit and appreciable harm.Although the trial presented data both for primary and secondary outcomes, it seemed to be underpowered to detect differences in the primary outcomes that are the ones more relevant for making judgments about the potential applicability of the intervention in other settings (especially severe PPH).Therefore, taking into account the extreme setting where the intervention was implemented, the limited role of the CHO in the trial and the lack of power for detecting effects on primary (relevant) outcomes, the applicability of the evidence found seems to be rather limited.Further well-executed and adequately-powered randomised controlled trials assessing the effects of using oxytocin in pre-filled injection devices or other new delivery systems (spray-dried ultrafine formulation of oxytocin) on severe PPH are urgently needed. Likewise, other important outcomes like possible adverse events and acceptability of the intervention by mothers and other community stakeholders should also be assessed.

How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes.

PubMed

Ayling, K; Brierley, S; Johnson, B; Heller, S; Eiser, C

2015-01-01

Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes. We conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression. Standard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes. We identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly. The quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.

Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

PubMed

Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

2017-03-29

Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be acceptable to participants, particularly given participants' enduring symptoms and impact upon motivation. This study will provide data to inform both development of the intervention and to assess and inform the design of a full trial. ISRCTN.com, ISRCTN18164037 . Registered on 26 September 2016.

Pharmacological interventions for sleepiness and sleep disturbances caused by shift work.

PubMed

Liira, Juha; Verbeek, Jos H; Costa, Giovanni; Driscoll, Tim R; Sallinen, Mikael; Isotalo, Leena K; Ruotsalainen, Jani H

2015-02-01

Shift work results in sleep-wake disturbances, which cause sleepiness during night shifts and reduce sleep length and quality in daytime sleep after the night shift. In its serious form it is also called shift work sleep disorder. Various pharmacological products are used to ameliorate symptoms of sleepiness or poor sleep length and quality. To evaluate the effects of pharmacological interventions to reduce sleepiness or to improve alertness at work and decrease sleep disturbances whilst of work, or both, in workers undertaking shift work. We searched CENTRAL, MEDLINE, EMBASE, PubMed and PsycINFO up to 20 September 2013 and ClinicalTrials.gov up to July 2013. We also screened reference lists of included trials and relevant reviews. We included all eligible randomised controlled trials (RCTs), including cross-over RCTs, of pharmacological products among workers who were engaged in shift work (including night shifts) in their present jobs and who may or may not have had sleep problems. Primary outcomes were sleep length and sleep quality while of work, alertness and sleepiness, or fatigue at work. Two authors independently selected studies, extracted data and assessed risk of bias in included trials. We performed meta-analyses where appropriate. We included 15 randomised placebo-controlled trials with 718 participants. Nine trials evaluated the effect of melatonin and two the effect of hypnotics for improving sleep problems. One trial assessed the effect of modafinil, two of armodafinil and one examined caffeine plus naps to decrease sleepiness or to increase alertness.

Randomised controlled trials of psychological & pharmacological treatments for body dysmorphic disorder: A systematic review.

PubMed

Phillipou, Andrea; Rossell, Susan L; Wilding, Helen E; Castle, David J

2016-11-30

Treatment for body dysmorphic disorder (BDD) often involves a combination of psychological and pharmacological interventions. However, only a small number of randomised controlled trials (RCTs) have been undertaken examining the efficacy of different therapeutic interventions. The aim of this study was to systematically review the RCTs involving psychological and pharmacological interventions for the treatment of BDD. The literature was searched to June 2015, and studies were included if they were written in English, empirical research papers published in peer-review journals, specifically assessed BDD patients, and involved a RCT assessing BDD symptoms pre- and post-intervention. Nine studies were identified: six involving psychological and three involving pharmacological interventions. Cognitive behaviour therapy, metacognitive therapy and selective serotonin reuptake inhibitors were identified as treatments with potential benefit. The small number of RCTs and the heterogeneity of findings emphasises the need for more high quality RCTs assessing both psychological and pharmacological interventions for BDD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

PubMed

Vervoort, A J M W; Van der Voet, L F; Witmer, M; Thurkow, A L; Radder, C M; van Kesteren, P J M; Quartero, H W P; Kuchenbecker, W K H; Bongers, M Y; Geomini, P M A J; de Vleeschouwer, L H M; van Hooff, M H A; van Vliet, H A A M; Veersema, S; Renes, W B; van Meurs, H S; Bosmans, J; Oude Rengerink, K; Brölmann, H A M; Mol, B W J; Huirne, J A F

2015-11-12

A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials.

PubMed

Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

2004-04-15

Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis.

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

PubMed

Dalziel, Stuart R; Furyk, Jeremy; Bonisch, Megan; Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Donath, Susan; Sharpe, Cynthia; Harvey, Simon; Davidson, Andrew; Craig, Simon; Phillips, Natalie; George, Shane; Rao, Arjun; Cheng, Nicholas; Zhang, Michael; Sinn, Kam; Kochar, Amit; Brabyn, Christine; Babl, Franz E

2017-06-22

Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer.

PubMed

Langius-Eklöf, Ann; Crafoord, Marie-Therése; Christiansen, Mats; Fjell, Maria; Sundberg, Kay

2017-07-04

Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care. The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care. Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients' involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety. June 12 2015 NCT02477137 (Prostate cancer) and June 12 2015 NCT02479607 (Breast cancer).

Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.

PubMed

Butow, Phyllis N; Bell, Melanie L; Smith, Allan B; Fardell, Joanna E; Thewes, Belinda; Turner, Jane; Gilchrist, Jemma; Beith, Jane; Girgis, Afaf; Sharpe, Louise; Shih, Sophy; Mihalopoulos, Cathrine

2013-04-23

Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR. This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and "quick relaxation" techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes. If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population. ACTRN12612000404820.

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial.

PubMed

Forster, Anne; Hartley, Suzanne; Barnard, Lorna; Ozer, Seline; Hardicre, Natasha; Crocker, Tom; Fletcher, Marie; Moreau, Lauren; Atkinson, Ross; Hulme, Claire; Holloway, Ivana; Schmitt, Laetitia; House, Allan; Hewison, Jenny; Richardson, Gillian; Farrin, Amanda

2018-06-11

Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation. A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation. This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention. ISRCTN38920246 . Registered 22 June 2016.

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

PubMed Central

Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

2004-01-01

Background Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. Methods RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. Results The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. Conclusion There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis. PMID:15086953

Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence

PubMed Central

2013-01-01

Background Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR. Methods/design This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and “quick relaxation” techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes. Discussion If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population. Trial registration Trial registration: ACTRN12612000404820 PMID:23617696

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) - standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial.

PubMed

Katijjahbe, Md Ali; Denehy, Linda; Granger, Catherine L; Royse, Alistair; Royse, Colin; Bates, Rebecca; Logie, Sarah; Clarke, Sandy; El-Ansary, Doa

2017-06-23

The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery. This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported. The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy. Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

PubMed

Thompson, Carl

2004-01-01

Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial

PubMed Central

2011-01-01

Background Falls are common in frail older adults and often result in injuries and hospitalisation. The Nintendo® Wii™ is an easily available exercise modality in the community which has been shown to improve lower limb strength and balance. However, not much is known on the effectiveness of the Nintendo® Wii™ to improve fall efficacy and reduce falls in a moderately frail older adult. Fall efficacy is the measure of fear of falling in performing various daily activities. Fear contributes to avoidance of activities and functional decline. Methods This randomised active-control trial is a comparison between the Nintendo WiiActive programme against standard gym-based rehabilitation of the older population. Eighty subjects aged above 60, fallers and non-fallers, will be recruited from the hospital outpatient clinic. The primary outcome measure is the Modified Falls Efficacy Scale and the secondary outcome measures are self-reported falls, quadriceps strength, walking agility, dynamic balance and quality of life assessments. Discussions The study is the first randomised control trial using the Nintendo Wii as a rehabilitation modality investigating a change in fall efficacy and self-reported falls. Longitudinally, the study will investigate if the interventions can successfully reduce falls and analyse the cost-effectiveness of the programme. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000576022 PMID:21682909

The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in Polio survivors: a randomised controlled trial.

PubMed

Murray, D; Hardiman, O; Campion, A; Vance, R; Horgan, F; Meldrum, D

2017-07-01

To investigate the effect of an eight-week home-based arm ergometry aerobic exercise programme on physical fitness, fatigue, activity and quality of life in Polio Survivors. An assessor blinded randomised controlled trial. Home-based exercise. Fifty-five Polio survivors randomised to exercise or control groups. Home-based arm ergometry at an intensity of 50%-70% maximum heart rate, compared with usual physiotherapy care. The Six-minute Arm Test, Fatigue Severity Scale, Physical Activity Scale for Individuals with Physical Disabilities and SF-36. Assessments were completed at baseline and at eight weeks. There was no significant difference in the primary outcome, exercising heart rate during the Six-minute Arm Test, between the groups at follow-up [97.6 (SD10.1) compared to 102.4 (SD13.7) beats per minute ( P=0.20)]. Blood pressure was significantly lower in the intervention group at follow-up [systolic blood pressure 132(18.6)mmHg compared to 144.1(14.6)mmHg ( P=0.002)]. There were no between group differences in the Fatigue Severity Scale ( P=0.25) or Physical Activity Scale for Individuals with Physical Disabilities ( P=0.49), with a small difference in SF-36 physical component score ( P=0.04). This home-based arm ergometry programme successfully facilitated aerobic exercise in Polio Survivors, but did not result in a significant change in physical fitness, measured by the Six-minute Arm Test.

The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids.

PubMed

Tiernan, Jim; Hind, Daniel; Watson, Angus; Wailoo, Allan J; Bradburn, Michael; Shephard, Neil; Biggs, Katie; Brown, Steven

2012-10-25

Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique. The aim of this study is to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic second or third degree (Grade II or Grade III) haemorrhoids. A multi-centre, parallel group randomised controlled trial. The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention. 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals. A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group. The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids. ISRCTN41394716.

Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4).

PubMed

Griffin, Xavier L; Achten, Juul; Sones, William; Cook, Jonathan; Costa, Matthew L

2018-01-26

Sliding hip screw fixation is well established in the treatment of trochanteric fractures of the hip. The X-Bolt Dynamic Hip Plating System builds on the successful design features of the sliding hip screw but differs in the nature of the fixation in the femoral head. A randomised pilot study suggested that the X-bolt Dynamic Hip Plating System might provide similar health-related quality of life while reducing the risk of revision surgery when compared with the sliding hip screw. This is the protocol for a multicentre randomised trial of sliding hip screw versus X-Bolt Dynamic Hip Plating System for patients 60 years and over treated for a trochanteric fracture of the hip. Multicentre, multisurgeon, parallel, two-arm, randomised controlled trial. Patients aged 60 years and older with a trochanteric hip fracture are potentially eligible. Participants will be randomly allocated on a 1:1 basis to either sliding hip screw or X-Bolt Dynamic Hip Plating System. Otherwise, all care will be in accordance with National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in EuroQol-5D health-related quality of life at 4 months postrandomisation. Secondary outcomes include mortality, residential status, revision surgery and radiographic measures. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. National Research Ethics Committee approved this study on 5 February 2016 (16/WM/0001). The study is sponsored by the University of Oxford and funded through an investigator initiated grant by X-Bolt Orthopaedics. A manuscript for a high-impact peer-reviewed journal will be prepared, and the results will be disseminated to patients through local mechanisms at participating centres. ISRCTN92825709. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled trial.

PubMed

Plant, Natalie; Mallitt, Kylie-Ann; Kelly, Patrick J; Usherwood, Tim; Gillespie, James; Boyages, Steven; Jan, Stephen; McNab, Justin; Essue, Beverley M; Gradidge, Kathy; Maranan, Nereus; Ralphs, David; Aspin, Clive; Leeder, Stephen

2013-05-03

Chronic illness is a significant driver of the global burden of disease and associated health care costs. People living with severe chronic illness are heavy users of acute hospital services; better coordination of their care could potentially improve health outcomes while reducing hospital use. The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients. A randomised controlled trial in 500 chronically ill patients presenting to the emergency department of a hospital in Western Sydney, Australia. Participants have three or more hospital admissions within a previous 12 month period and either aged ≥70 years; or aged ≥45 years and of Aboriginal or Torres Strait Islander descent; or aged ≥ 16 with a diagnosis of a respiratory or cardiology related illness. Patients are randomised to either the coordinated care program (Care Navigation), or to usual care. The Care Navigation program consists of dedicated nurses who conduct patient risk assessments, oversee patient nursing while in hospital, and guide development of a care plan for the management of chronic illness after being discharged from hospital. These nurses also book community appointments and liaise with general practitioners. The main outcome variables are the number of emergency department re-presentations and hospital readmissions, and quality of life during a 24 month follow-up. Secondary outcomes are length of hospital stay, mortality, time to first hospital re-admission, time to first emergency department re-presentation, patient satisfaction, adherence to prescribed medications, amount and type of in-hospital referrals made for consultations and diagnostic testing, and the number and type of community health referrals. A process evaluation and economic analysis will be conducted alongside the randomised trial. A trial of in-hospital care coordination may support recent evidence that engaging primary health services in care plans linked to multidisciplinary team support improves patient outcomes and reduces costs to the health system. This will inform local, national and international health policy. Australia New Zealand Clinical Trials Registry ACTRN12609000554268.

Aneurysmal SubArachnoid Hemorrhage—Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol

PubMed Central

English, Shane W; Fergusson, D; Chassé, M; Lauzier, F; Griesdale, D; Algird, A; Kramer, A; Tinmouth, A; Lum, C; Sinclair, J; Marshall, S; Dowlatshahi, D; Boutin, A; Pagliarello, G; McIntyre, L A

2016-01-01

Introduction Anaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months. Methods Design This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate. Ethics and dissemination The study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH. Trial registration number NCT02483351; Pre-results. PMID:27927658

Corticosteroids for Bell's palsy (idiopathic facial paralysis).

PubMed

Salinas, Rodrigo A; Alvarez, Gonzalo; Daly, Fergus; Ferreira, Joaquim

2010-03-17

Inflammation and oedema of the facial nerve are implicated in causing Bell's palsy. Corticosteroids have a potent anti-inflammatory action which should minimise nerve damage. The objective of this review was to assess the effect of corticosteroid therapy in Bell's palsy. We searched the Cochrane Neuromuscular Disease Group Trials Specialized Register (9 December 2008) for randomised trials, as well as MEDLINE (January 1966 to December 2008), EMBASE (January 1980 to December 2008) and LILACS (9 December 2008). We contacted known experts in the field to identify additional published or unpublished trials. Randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group where no therapy considered effective for this condition was administered, unless it was also given in a similar way to the experimental group. Two authors independently assessed eligibility, trial quality, and extracted the data. Eight trials with a total of 1569 participants were included. Allocation concealment was appropriate in six trials, and the data reported allowed an intention-to-treat analysis in four, while unpublished data from the fifth and sixth trials were provided by the authors. The data included in the main outcome of this meta-analysis were collected from seven trials with a total of 1507 participants. Overall 175/754 (23%) of the participants allocated to corticosteroids had incomplete recovery of facial motor function six months or more after randomisation, significantly less than 245/753 (33%) in the control group (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.61 to 0.83). There was, also, a significant reduction in motor synkinesis during follow-up in those receiving corticosteroids (RR 0.6, 95% CI 0.44 to 0.81). The reduction in the proportion of patients with cosmetically disabling sequelae six months after randomisation, however, was not significant (RR 0.97, 95% CI 0.44 to 2.15). The trial not included in the primary outcome of this meta-analysis showed a non-significant difference in outcomes between the arms. The available evidence from randomised controlled trials shows significant benefit from treating Bell's palsy with corticosteroids.

β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol

PubMed Central

Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

2016-01-01

Introduction A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. Methods and analyses This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. Ethics and dissemination The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. Trial registration number NCT02587351; Pre-results. PMID:27267111

β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol.

PubMed

Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

2016-06-07

A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. NCT02587351; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided 'Constant-care' approach.

PubMed

Elkjaer, Margarita; Shuhaibar, Mary; Burisch, Johan; Bailey, Yvonne; Scherfig, Hanne; Laugesen, Birgit; Avnstrøm, Søren; Langholz, Ebbe; O'Morain, Colm; Lynge, Elsebeth; Munkholm, Pia

2010-12-01

The natural history of ulcerative colitis requires continuous monitoring of medical treatment via frequent outpatient visits. The European health authorities' focus on e-health is increasing. Lack of easy access to inflammatory bowel disease (IBD) clinics, patients' education and understanding of the importance of early treatment at relapse is leading to poor compliance. To overcome these limitations a randomised control trial 'Constant-care' was undertaken in Denmark and Ireland. 333 patients with mild/moderate ulcerative colitis and 5-aminosalicylate acid treatment were randomised to either a web-group receiving disease specific education and self-treatment via http://www.constant-care.dk or a control group continuing the usual care for 12 months. A historical control group was included to test the comparability with the control group. We investigated: feasibility of the approach, its influence on patients' compliance, knowledge, quality of life (QoL), disease outcomes, safety and health care costs. 88% of the web patients preferred using the new approach. Adherence to 4 weeks of acute treatment was increased by 31% in Denmark and 44% in Ireland compared to the control groups. In Denmark IBD knowledge and QoL were significantly improved in web patients. Median relapse duration was 18 days (95% CI 10 to 21) in the web versus 77 days (95% CI 46 to 108) in the control group. The number of acute and routine visits to the outpatient clinic was lower in the web than in the control group, resulting in a saving of 189 euro/patient/year. No difference in the relapse frequency, hospitalisation, surgery or adverse events was observed. The historical control group was comparable with the control group. The new web-guided approach on http://www.constant-care.dk is feasible, safe and cost effective. It empowers patients with ulcerative colitis without increasing their morbidity and depression. It has yet to be shown whether this strategy can change the natural disease course of ulcerative colitis in the long term.

Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design

PubMed Central

2014-01-01

Background Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation. Methods We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks’ follow-up. Results We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms. Conclusions Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants. Trial registration number ISRCTN73725618. PMID:24746263

Early add-on treatment vs alternative monotherapy in patients with partial epilepsy.

PubMed

Semah, Franck; Thomas, Pierre; Coulbaut, Safia; Derambure, Philippe

2014-06-01

The aim of this study was to evaluate the impact of two different therapeutic strategies in patients with partial seizures who were intractable to the first prescribed antiepileptic drug (AED); alternative monotherapy vs early add-on treatment. We conducted an open, cluster-randomised, prospective, controlled trial in patients with persistent partial seizures, despite treatment with one AED, who were never administered any other AEDs. Neurologists were randomised to two strategies: in group A, an alternative monotherapy with a second AED was employed; in group B, add-on treatment with a second AED was employed. The primary outcome was the percentage of seizure-free patients during a two-month period after six months of treatment. The secondary outcomes were: (i) the percentage of patients achieving a 50% reduction in the number of seizures at six months; (ii) the quality of life based on the Quality Of Life In Epilepsy scale; and (iii) tolerability. A total of 143 neurologists were included and randomised, and 264 patients were evaluated. At six months, the primary outcome was 51% in group A and 45% in group B (p=0.34). The percentage of patients achieving a 50% reduction in the number of seizures at six months was 76% in group A and 84% in group B (p=0.53). The quality of life and the tolerability did not significantly differ between the two groups. Alternative monotherapy or early treatment initiation with another AED drug resulted in similar efficacy, and the side effects associated with monotherapy and combined therapies were similar, which suggests that individual susceptibility is more important than the number and burden of AEDs used.

The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema.

PubMed

Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane Lindschou; Gluud, Christian

2010-08-31

Hand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive strategies are needed to reduce occupational hand eczema. We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary outcome is observer-blinded assessment of disease severity and the secondary outcomes are unblinded assessments of disease severity; number of eruptions; knowledge of skin protection; skin-protective behaviour, and quality of life. The trial is registered in ClinicalTrials.Gov, NCT01012453.

Inpatient rehabilitation improves functional capacity, peripheral muscle strength and quality of life in patients with community-acquired pneumonia: a randomised trial.

PubMed

José, Anderson; Dal Corso, Simone

2016-04-01

Among people who are hospitalised for community-acquired pneumonia, does an inpatient exercise-based rehabilitation program improve functional outcomes, symptoms, quality of life and length of hospital stay more than a respiratory physiotherapy regimen? Randomised trial with concealed allocation, intention-to-treat analysis and blinding of some outcomes. Forty-nine adults hospitalised for community-acquired pneumonia. The experimental group (n=32) underwent a physical training program that included warm-up, stretching, peripheral muscle strength training and walking at a controlled speed for 15 minutes. The control group (n=17) underwent a respiratory physiotherapy regimen that included percussion, vibrocompression, respiratory exercises and free walking. The intervention regimens lasted 8 days. The primary outcome was the Glittre Activities of Daily Living test, which assesses the time taken to complete a series of functional tasks (eg, rising from a chair, walking, stairs, lifting and bending). Secondary outcomes were distance walked in the incremental shuttle walk test, peripheral muscle strength, quality of life, dyspnoea, lung function, C-reactive protein and length of hospital stay. Measures were taken 1 day before and 1 day after the intervention period. There was greater improvement in the experimental group than in the control group on the Glittre Activities of Daily Living test (mean between-group difference 39 seconds, 95% CI 20 to 59) and the incremental shuttle walk test (mean between-group difference 130 m, 95% CI 77 to 182). There were also significantly greater improvements in quality of life, dyspnoea and peripheral muscle strength in the experimental group than in the control group. There were no between-group differences in lung function, C-reactive protein or length of hospital stay. The improvement in functional outcomes after an inpatient rehabilitation program was greater than the improvement after standard respiratory physiotherapy. The exercise training program led to greater benefits in functional capacity, peripheral muscle strength, dyspnoea and quality of life. ClinicalTrials.gov, NCT02103400. Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Exercises for adolescent idiopathic scoliosis.

PubMed

Romano, Michele; Minozzi, Silvia; Bettany-Saltikov, Josette; Zaina, Fabio; Chockalingam, Nachiappan; Kotwicki, Tomasz; Maier-Hennes, Axel; Negrini, Stefano

2012-08-15

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine . While AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. The use of scoliosis-specific exercises (SSE) to reduce progression of AIS and postpone or avoid other more invasive treatments is controversial. To evaluate the efficacy of SSE in adolescent patients with AIS. The following databases (up to 30 March 2011) were searched with no language limitations: CENTRAL (The Cochrane Library 2011, issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINHAL (from January 1982), SportDiscus (from January 1975), PsycInfo (from January 1887), PEDro (from January 1929). We screened reference lists of articles and also conducted an extensive handsearch of grey literature. Randomised controlled trials and prospective cohort studies with a control group comparing exercises with no treatment, other treatment, surgery, and different types of exercises. Two review authors independently selected studies, assessed risk of bias and extracted data. Two studies (154 participants) were included. There is low quality evidence from one randomised controlled study that exercises as an adjunctive to other conservative treatments increase the efficacy of these treatments (thoracic curve reduced: mean difference (MD) 9.00, (95% confidence interval (CI) 5.47 to 12.53); lumbar curve reduced:MD 8.00, (95% CI 5.08 to 10.92)). There is very low quality evidence from a prospective controlled cohort study that scoliosis-specific exercises structured within an exercise programme can reduce brace prescription (risk ratio (RR) 0.24, (95% CI 0.06 to1.04) as compared to usual physiotherapy (many different kinds of general exercises according to the preferences of the single therapists within different facilities). There is a lack of high quality evidence to recommend the use of SSE for AIS. One very low quality study suggested that these exercises may be more effective than electrostimulation, traction and postural training to avoid scoliosis progression, but better quality research needs to be conducted before the use of SSE can be recommended in clinical practice.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

PubMed

O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

2013-03-23

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

Progressive resistance training in Parkinson's disease: a systematic review and meta-analysis

PubMed Central

Saltychev, Mikhail; Bärlund, Esa; Paltamaa, Jaana; Katajapuu, Niina; Laimi, Katri

2016-01-01

Objectives To investigate if there is evidence on effectiveness of progressive resistance training in rehabilitation of Parkinson disease. Design Systematic review and meta-analysis. Data sources: Central, Medline, Embase, Cinahl, Web of Science, Pedro until May 2014. Randomised controlled or controlled clinical trials. The methodological quality of studies was assessed according to the Cochrane Collaboration's domain-based evaluation framework. Data synthesis: random effects meta-analysis with test for heterogeneity using the I² and pooled estimate as the raw mean difference. Participants Adults with primary/idiopathic Parkinson's disease of any severity, excluding other concurrent neurological condition. Interventions Progressive resistance training defined as training consisting of a small number of repetitions until fatigue, allowing sufficient rest between exercises for recovery, and increasing the resistance as the ability to generate force improves. Comparison Progressive resistance training versus no treatment, placebo or other treatment in randomised controlled or controlled clinical trials. Primary and secondary outcome measures Any outcome. Results Of 516 records, 12 were considered relevant. Nine of them had low risk of bias. All studies were randomised controlled trials conducted on small samples with none or 1 month follow-up after the end of intervention. Of them, six were included in quantitative analysis. Pooled effect sizes of meta-analyses on fast and comfortable walking speed, the 6 min walking test, Timed Up and Go test and maximal oxygen consumption were below the level of minimal clinical significance. Conclusions There is so far no evidence on the superiority of progressive resistance training compared with other physical training to support the use of this technique in rehabilitation of Parkinson's disease. Systematic review registration number PROSPERO 2014:CRD42014009844. PMID:26743698

Thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial

PubMed Central

Stewart, Ian; Beevers, Andrea; Fraser, John F; Platts, David

2017-01-01

Objective To examine whether providing thermal clothing improved the health of patients with heart failure during winter. Design Parallel group randomised controlled trial. Setting Large public hospital in Brisbane during winter 2016. Participants 91 patients with systolic or diastolic heart failure who were over 50 years old. Intervention 47 patients were randomised to receive thermal clothes (socks, top and hat) and 44 received usual care. Patients could not be blinded to their randomised group. All patients’ data were available for the primary outcome which was collected blind to randomised group. Main outcome measures The primary outcome was the mean number of days in hospital during winter. Secondary outcomes included quality of life and sleep, and blood tests were collected for cardiovascular risk factors. Participants completed clothing diaries in midwinter which were used to estimate their overall clothing insulation using the ‘clo’. Monitors inside the participants’ homes recorded indoor temperatures throughout winter. Results The mean number of days in hospital during winter was 4.2 in the usual care group and 3.0 in the thermal clothing group (mean difference –1.2 days, 95% CI –4.8 to 2.5 days). Most participants (85%) in the thermal clothing group reported using the thermals. There was an increase in overall clothing insulation at night in the thermal clothing group (mean difference 0.13 clo, 95% CI 0.03 to 0.23). Most participants in both groups did not wear sufficient clothing (defined as a clo below 1) and regularly experienced indoor temperatures below 18°C during midwinter. Conclusions There was no clear statistical improvement in health in the thermal clothing group. Efforts to improve health during winter may need to focus on passive interventions such as home insulation rather than interventions that target behaviour change. Trial registration number ACTRN12615001023549; Results. PMID:28993390

Thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial.

PubMed

Barnett, Adrian Gerard; Stewart, Ian; Beevers, Andrea; Fraser, John F; Platts, David

2017-10-08

To examine whether providing thermal clothing improved the health of patients with heart failure during winter. Parallel group randomised controlled trial. Large public hospital in Brisbane during winter 2016. 91 patients with systolic or diastolic heart failure who were over 50 years old. 47 patients were randomised to receive thermal clothes (socks, top and hat) and 44 received usual care. Patients could not be blinded to their randomised group. All patients' data were available for the primary outcome which was collected blind to randomised group. The primary outcome was the mean number of days in hospital during winter. Secondary outcomes included quality of life and sleep, and blood tests were collected for cardiovascular risk factors. Participants completed clothing diaries in midwinter which were used to estimate their overall clothing insulation using the 'clo'. Monitors inside the participants' homes recorded indoor temperatures throughout winter. The mean number of days in hospital during winter was 4.2 in the usual care group and 3.0 in the thermal clothing group (mean difference -1.2 days, 95% CI -4.8 to 2.5 days). Most participants (85%) in the thermal clothing group reported using the thermals. There was an increase in overall clothing insulation at night in the thermal clothing group (mean difference 0.13 clo, 95% CI 0.03 to 0.23). Most participants in both groups did not wear sufficient clothing (defined as a clo below 1) and regularly experienced indoor temperatures below 18°C during midwinter. There was no clear statistical improvement in health in the thermal clothing group. Efforts to improve health during winter may need to focus on passive interventions such as home insulation rather than interventions that target behaviour change. ACTRN12615001023549; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005

PubMed Central

Davies, Mark; Hingorani, Aroon D; Hunter, Jackie

2018-01-01

Abstract Objective To investigate the distribution, design characteristics, and dissemination of clinical trials by funding organisation and medical specialty. Design Cross sectional descriptive analysis. Data sources Trial protocol information from clinicaltrials.gov, metadata of journal articles in which trial results were published (PubMed), and quality metrics of associated journals from SCImago Journal and Country Rank database. Selection criteria All 45 620 clinical trials evaluating small molecule therapeutics, biological drugs, adjuvants, and vaccines, completed after January 2006 and before July 2015, including randomised controlled trials and non-randomised studies across all clinical phases. Results Industry was more likely than non-profit funders to fund large international randomised controlled trials, although methodological differences have been decreasing with time. Among 27 835 completed efficacy trials (phase II-IV), 15 084 (54.2%) had disclosed their findings publicly. Industry was more likely than non-profit trial funders to disseminate trial results (59.3% (10 444/17 627) v 45.3% (4555/10 066)), and large drug companies had higher disclosure rates than small ones (66.7% (7681/11 508) v 45.2% (2763/6119)). Trials funded by the National Institutes of Health (NIH) were disseminated more often than those of other non-profit institutions (60.0% (1451/2417) v 40.6% (3104/7649)). Results of studies funded by large drug companies and NIH were more likely to appear on clinicaltrials.gov than were those from non-profit funders, which were published mainly as journal articles. Trials reporting the use of randomisation were more likely than non-randomised studies to be published in a journal article (6895/19 711 (34.9%) v 1408/7748 (18.2%)), and journal publication rates varied across disease areas, ranging from 42% for autoimmune diseases to 20% for oncology. Conclusions Trial design and dissemination of results vary substantially depending on the type and size of funding institution as well as the disease area under study. PMID:29875212

Libertas: rationale and study design of a multicentre, Phase II, double-blind, randomised, placebo-controlled investigation to evaluate the efficacy, safety and tolerability of locally applied NRL001 in patients with faecal incontinence.

PubMed

Siproudhis, L; Jones, D; Shing, R Ng Kwet; Walker, D; Scholefield, J H

2014-03-01

Faecal incontinence affects up to 8% of adults. Associated social isolation and subsequent depression can have devastating effects on quality of life (QoL). Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician. There have been few well-designed, placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies. Libertas, a robustly designed study will investigate the efficacy and safety of NRL001 (1R,2S-methoxamine), an α1 -adrenoceptor agonist, in the treatment of faecal incontinence. Libertas is a multicentre, Phase II, double-blind, randomised, placebo-controlled, parallel group study. Patient recruitment took place across 55 study centres in Europe. Patients suffering with faecal incontinence were randomised into four groups (approximately 110 each) to receive once daily self-administered doses of NRL001 (5, 7.5 or 10 mg or placebo in a suppository formulation) for 8 weeks. The primary objective of Libertas is to assess the impact of once daily administration of NRL001 on the severity and frequency of incontinence episodes as assessed by the Wexner score at 4 weeks, compared with placebo. Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment; safety and tolerability; evaluation of plasma pharmacokinetics; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events; dose-response relationship; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy. Overall patient satisfaction with the treatment will also be evaluated. This is the first randomised controlled study to investigate the efficacy and safety of a selective α1 -adrenoceptor agonist for the treatment of faecal incontinence. Furthermore, this is the first time the impact of NRL001 on assessments of QoL, health outcomes and patient satisfaction will be assessed. Innovative strategies were developed to meet the challenge of recruiting patients for this study, for example, media advertising, posters and mailshots as allowed by each study centre. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

ERIC Educational Resources Information Center

Torgerson, Carole J.

2009-01-01

The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…