Acromegaly treatment in Romania. How close are we to disease control?

PubMed

Niculescu, Dan Alexandru; Baciu, Ionela Florina; Capatina, Cristina; Galoiu, Simona Andreea; Gheorghiu, Monica Livia; Radian, Serban; Trifanescu, Raluca Alexandra; Caragheorgheopol, Andra; Coculescu, Mihail; Poiana, Catalina

2017-01-01

In Romania, no nationwide data for acromegaly treatment and control rate are available. Our objective was to assess the acromegaly control rate in a tertiary referral centre, which covers an important part of Romanian territory and population of patients with acromegaly. We reviewed the records of all 164 patients (49 males and 115 females; median age 55 [47, 63.5] years) with newly or previously diagnosed acromegaly, who have been assessed at least once in our tertiary referral centre between January 1, 2012 and March 31, 2016. This sample represents 13.6% of the total expected 1200 Romanian patients with acromegaly and covers 82.9% of the counties in Romania. Control of acromegaly was defined as a random serum growth hormone (GH) < 1 ng/mL and an age-normalised serum insulin-like growth factor-I (IGF-I) value. The GH and IGF-I values used for calculation of the control rate were those at the last evaluation. The same assays for GH and IGF-I measurement were used in all patients. There were 147 treated and 17 untreated patients. Of the 147 patients assessed after therapy, 137 (93.2%) had pituitary surgery, 116 (78.9%) were on medical treatment at the last evaluation, and 67 (45.5%) had radiotherapy. Seventy-one (48.3%) had a random GH < 1 ng/mL, 54 (36.7%) had a normalised, age-adjusted IGF-I, and 42 (28.6%) had both normal random serum GH and IGF-I. In Romania, acromegaly benefits from the whole spectrum of therapeutic interventions. However, the control rate remains disappointing.

CoDuSe group exercise programme improves balance and reduces falls in people with multiple sclerosis: A multi-centre, randomized, controlled pilot study.

PubMed

Carling, Anna; Forsberg, Anette; Gunnarsson, Martin; Nilsagård, Ylva

2017-09-01

Imbalance leading to falls is common in people with multiple sclerosis (PwMS). To evaluate the effects of a balance group exercise programme (CoDuSe) on balance and walking in PwMS (Expanded Disability Status Scale, 4.0-7.5). A multi-centre, randomized, controlled single-blinded pilot study with random allocation to early or late start of exercise, with the latter group serving as control group for the physical function measures. In total, 14 supervised 60-minute exercise sessions were delivered over 7 weeks. Pretest-posttest analyses were conducted for self-reported near falls and falls in the group starting late. Primary outcome was Berg Balance Scale (BBS). A total of 51 participants were initially enrolled; three were lost to follow-up. Post-intervention, the exercise group showed statistically significant improvement ( p = 0.015) in BBS and borderline significant improvement in MS Walking Scale ( p = 0.051), both with large effect sizes (3.66; -2.89). No other significant differences were found between groups. In the group starting late, numbers of falls and near falls were statistically significantly reduced after exercise compared to before ( p < 0.001; p < 0.004). This pilot study suggests that the CoDuSe exercise improved balance and reduced perceived walking limitations, compared to no exercise. The intervention reduced falls and near falls frequency.

Cluster-randomized, controlled trial of computer-based decision support for selecting long-term anti-thrombotic therapy after acute ischaemic stroke.

PubMed

Weir, C J; Lees, K R; MacWalter, R S; Muir, K W; Wallesch, C-W; McLelland, E V; Hendry, A

2003-02-01

Identifying the appropriate long-term anti-thrombotic therapy following acute ischaemic stroke is a challenging area in which computer-based decision support may provide assistance. To evaluate the influence on prescribing practice of a computer-based decision support system (CDSS) that provided patient-specific estimates of the expected ischaemic and haemorrhagic vascular event rates under each potential anti-thrombotic therapy. Cluster-randomized controlled trial. We recruited patients who presented for a first investigation of ischaemic stroke or TIA symptoms, excluding those with a poor prognosis or major contraindication to anticoagulation. After observation of routine prescribing practice (6 months) in each hospital, centres were randomized for 6 months to either control (routine practice observed) or intervention (practice observed while the CDSS provided patient-specific information). We compared, between control and intervention centres, the risk reduction (estimated by the CDSS) in ischaemic and haemorrhagic vascular events achieved by long-term anti-thrombotic therapy, and the proportions of subjects prescribed the optimal therapy identified by the CDSS. Sixteen hospitals recruited 1952 subjects. When the CDSS provided information, the mean relative risk reduction attained by prescribing increased by 2.7 percentage units (95%CI -0.3 to 5.7) and the odds ratio for the optimal therapy being prescribed was 1.32 (0.83 to 1.80). Some 55% (5/9) of clinicians believed the CDSS had influenced their prescribing. Cluster-randomized trials provide excellent frameworks for evaluating novel clinical management methods. Our CDSS was feasible to implement and acceptable to clinicians, but did not substantially influence prescribing practice for anti-thrombotic drugs after acute ischaemic stroke.

Efficacy and safety of rasagiline as an adjunct to levodopa treatment in Chinese patients with Parkinson's disease: a randomized, double-blind, parallel-controlled, multi-centre trial.

PubMed

Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang

2013-08-01

Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.

Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial.

PubMed

Winter, Michiel M; van der Bom, Teun; de Vries, Leonie C S; Balducci, Anna; Bouma, Berto J; Pieper, Petronella G; van Dijk, Arie P J; van der Plas, Mart N; Picchio, Fernando M; Mulder, Barbara J M

2012-06-01

To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic RV due to congenitally or surgically corrected transposition of the great arteries. Fifty-four adult patients with a systemic RV, were randomized using unmarked opaque envelopes to an intervention group (n = 28) with three training sessions per week for 10 consecutive weeks, and a control group (n = 26). Randomization was stratified by participating centre. At baseline, and follow-up, we determined maximal exercise capacity (V'O(2peak)), serum NT-proBNP levels, and quality of life by means of the SF-36, and the TAAQOL Congenital Heart Disease questionnaires. The final analysis was performed by linear regression, taking into account the stratified randomization. Forty-six patients were analysed (male 50%, age 32 ± 11 years, intervention group n = 24, control group n = 22). Analysis at 10 weeks showed a significant difference in V'O(2peak) (3.4 mL/kg/min, 95% CI: 0.2 to 6.7; P = 0.04) and resting systolic blood pressure (-7.6 mmHg, 95% CI: -14.0 to -1.3; P = 0.03) in favour of the exercise group. No significant changes were found in serum NT-proBNP levels or quality of life in the intervention group or in the control group nor between groups. None of the patients in the intervention group had to discontinue the training programme due to adverse events. In adult patients with a systemic RV exercise training improve exercise capacity. We recommend to revise restrictive guidelines, and to encourage patients to become physically active. ( The study was registered at http://trialregister.nl. Identifier: NTR1909.).

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project)

PubMed Central

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-01-01

Introduction When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. Methods/design STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). Ethics and dissemination The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. Trial registration number NCT02675361; pre-results. PMID:28420661

Effect of comprehensive cardiac telerehabilitation on one-year cardiovascular rehospitalization rate, medical costs and quality of life: A cost-effectiveness analysis.

PubMed

Frederix, Ines; Hansen, Dominique; Coninx, Karin; Vandervoort, Pieter; Vandijck, Dominique; Hens, Niel; Van Craenenbroeck, Emeline; Van Driessche, Niels; Dendale, Paul

2016-05-01

Notwithstanding the cardiovascular disease epidemic, current budgetary constraints do not allow for budget expansion of conventional cardiac rehabilitation programmes. Consequently, there is an increasing need for cost-effectiveness studies of alternative strategies such as telerehabilitation. The present study evaluated the cost-effectiveness of a comprehensive cardiac telerehabilitation programme. This multi-centre randomized controlled trial comprised 140 cardiac rehabilitation patients, randomized (1:1) to a 24-week telerehabilitation programme in addition to conventional cardiac rehabilitation (intervention group) or to conventional cardiac rehabilitation alone (control group). The incremental cost-effectiveness ratio was calculated based on intervention and health care costs (incremental cost), and the differential incremental quality adjusted life years (QALYs) gained. The total average cost per patient was significantly lower in the intervention group (€2156 ± €126) than in the control group (€2720 ± €276) (p = 0.01) with an overall incremental cost of €-564.40. Dividing this incremental cost by the baseline adjusted differential incremental QALYs (0.026 QALYs) yielded an incremental cost-effectiveness ratio of €-21,707/QALY. The number of days lost due to cardiovascular rehospitalizations in the intervention group (0.33 ± 0.15) was significantly lower than in the control group (0.79 ± 0.20) (p = 0.037). This paper shows the addition of cardiac telerehabilitation to conventional centre-based cardiac rehabilitation to be more effective and efficient than centre-based cardiac rehabilitation alone. These results are useful for policy makers charged with deciding how limited health care resources should best be allocated in the era of exploding need. © The European Society of Cardiology 2015.

Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol.

PubMed

Stewart, Moira; Fortin, Martin

2017-05-09

The high prevalence of multimorbidity necessitates rethinking of the health care system. The overarching goal of the Patient-Centred Innovations for Persons with Multimorbidity program is to build on existing structures and find and evaluate patient-centred innovations relevant to multimorbidity. We describe the protocol for a proposed multijurisdictional (Quebec and Ontario) concurrent triangulation mixed-methods study. In both provinces, a qualitative descriptive study will be used to explore innovations in patient-centred multimorbidity care. Two randomized controlled trials, 1 in either province, will evaluate the innovations in a wait-list-controlled design using patient-reported outcomes. An additional control group, matched on age, sex, enrolment/index date (± 3 mo) and propensity score, will be created with the use of health administrative data. Patients will be 18-80 years of age and will have 3 or more chronic conditions. The innovations will have elements of relevance to multimorbidity care, patient-centred partnerships and integration of care. The primary outcome measures will be 2 patient-reported outcomes: patient education and self-efficacy. Secondary outcomes will include patient-reported health status, quality of life, psychological distress and health behaviours, and costs of care. This protocol describes a mixed-method study in 2 jurisdictions. The studies will answer the questions of what innovations work and how they work for patients, health care professionals and policy-makers. Trial registration: ClinicalTrials.gov, no NCT02789800 (Quebec Trial), NCT02742597 (Ontario Trial). Copyright 2017, Joule Inc. or its licensors.

A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices.

PubMed

Lüthje, Lars; Vollmann, Dirk; Seegers, Joachim; Sohns, Christian; Hasenfuß, Gerd; Zabel, Markus

2015-08-01

Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of heart failure (HF) patients. This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality. Patients with standard indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 patients (77% male; 66 ± 12 years; left ventricular ejection fraction (LVEF) 32 ± 11%; ischemic cardiomyopathy 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 patients (15%) experienced ICD shocks vs. 10 patients (11%) in the control group (P = 0.512). The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). In a single-centre randomized pilot study of RM in combination with FM, no significant influence on HF-related hospitalizations, ICD shocks, or mortality was found. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

A randomized controlled trial to evaluate utilization of physical activity recommendations among patients of cardiovascular healthcare centres in Eastern Slovakia: study design and rationale of the AWATAR study.

PubMed

Zelko, Aurel; Bukova, Alena; Kolarcik, Peter; Bakalar, Peter; Majercak, Ivan; Potocnikova, Jana; Reijneveld, Sijmen A; van Dijk, Jitse P

2018-04-04

Guidelines on modifiable risk factors regarding cardiological patients are poorly implemented in clinical practice perhaps due to low health literacy. Several digital tools for improving lifestyle and behavioural intervention were developed. Our primary aim is to evaluate the effectiveness of a digital exercise prescription tool on the adherence to physical activity recommendations among patients with cardiovascular diseases. A randomized controlled trial will be realized in cooperation with Cardiovascular Health Centres in Eastern Slovakia. Patients recruited through their cardiologists, will be randomised at 1:1 ratio to the three-months' experimental condition or control condition. The experimental group will receive standard lifestyle consultation leading to individually optimized prescription of physical activity. The control group will receive standard, usual-cardio-care lifestyle counselling, also in the domain of physical activity. The digital system will be used for optimized exercise prescription. The primary outcome is a change in the patient's adherence to exercise recommendations. Data will be collected in both groups prior to consultation and after 3 months. This study protocol presents background and design of a randomized control trial to investigate the effectiveness of a digital system-provide exercise prescription tool on the adherence to physical activity recommendations. An optimized exercise prescription that better reflects patient's diagnosis, comorbidities and medication can have a significant impact on secondary prevention of cardiovascular disease. This trial can provide important evidence about the effectiveness of digital exercise guidance in everyday practice of cardiovascular healthcare. The study was registered on 1st November, 2017 and is available online at ClinicalTrials.gov (ID: NCT03329053 ).

The Effects of Different Pre-Writing Strategies on Iranian EFL Writing Achievement

ERIC Educational Resources Information Center

Mahnam, Lily; Nejadansari, Dariush

2012-01-01

This study aimed at investigating whether applying pre-writing strategies would affect the quality of L2 learners' compositions. Twenty three adult EFL students from Jahad-e-Daneshgahi English centre in Iran participated in this study. They were randomly assigned to control and experimental groups, including 11 and 12 participants in each. They…

Effects of nanotechnologies-based devices on postural control in healthy subjects.

PubMed

Malchiodi Albedi, Giovanna; Corna, Stefano; Aspesi, Valentina; Clerici, Daniela; Parisio, Cinzia; Seitanidis, Jonathan; Cau, Nicola; Brugliera, Luigia; Capodaglio, Paolo

2017-09-05

The aim of the present preliminary randomized controlled study was to ascertain whether the use of newly developed nanotechnologies-based patches can influence posture control of healthy subjects. Thirty healthy female subjects (age 39.4 years, BMI 22.74 kg/m2) were randomly assigned to two groups: one with active patches and a control group with sham patches. Two patches were applied with a tape: one on the subject's sternum and the other on the C7 apophysis. Body sway during quiet upright stance was recorded with a dynamometric platform. Each subject was tested under two visual conditions, eyes open and closed. We used a blocked stratified randomization procedure conducted by a third party. Subjects wearing the sham patches showed a significant increase of the centre of pressure sway area after 4 hours when they performed the habitual moderate-intensity work activities. In the active patch group, a decrease of the sway path was evident, providing evidence of an enhanced balance control. Our preliminary findings on healthy subjects indicate that nanotechnological devices generating ultra-low electromagnetic fields can improve posture control.

Design of the Quality of Life in Motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer.

PubMed

Braam, Katja I; van Dijk, Elisabeth M; Veening, Margreet A; Bierings, Marc B; Merks, Johannes H M; Grootenhuis, Martha A; Chinapaw, Mai J M; Sinnema, Gerben; Takken, Tim; Huisman, Jaap; Kaspers, Gertjan J L; van Dulmen-den Broeder, Eline

2010-11-11

Childhood cancer and its treatment have considerable impact on a child's physical and mental wellbeing. Especially long-term administration of chemotherapy and/or radiotherapy impairs physical fitness both during and after therapy, when children often present with muscle weakness and/or low cardiorespiratory fitness. Physical exercise can improve these two elements of physical fitness, but the positive effects of physical exercise might be further increased when a child's wellbeing is simultaneously enhanced by psychosocial training. Feeling better may increase the willingness and motivation to engage in sports activities. Therefore, this multi-centre study evaluates the short and long-term changes in physical fitness of a child with a childhood malignancy, using a combined physical exercise and psychosocial intervention program, implemented during or shortly after treatment. Also examined is whether positive effects on physical fitness reduce inactivity-related adverse health problems, improve quality of life, and are cost-effective. This multi-centre randomized controlled trial compares a combined physical and psychosocial intervention program for children with cancer, with care as usual (controls). Children with cancer (aged 8-18 years) treated with chemotherapy and/or radiotherapy, and who are no longer than 1 year post-treatment, are eligible for participation. A total of 100 children are being recruited from the paediatric oncology/haematology departments of three Dutch university medical centres. Patients are stratified according to pubertal stage (girls: age ≤10 or >10 years; boys: ≤11 or >11 years), type of malignancy (haematological or solid tumour), and moment of inclusion into the study (during or after treatment), and are randomly assigned to the intervention or control group. Childhood cancer patients undergoing long-term cancer therapy may benefit from a combined physical exercise and psychosocial intervention program since it may maintain or enhance their physical fitness and increase their quality of life. However, the feasibility, patient need, and effectiveness of such a program should be established before the program can be implemented as part of standard care. NTR1531 (The Netherlands National Trial Register).

Human Centred Design Considerations for Connected Health Devices for the Older Adult

PubMed Central

Harte, Richard P.; Glynn, Liam G.; Broderick, Barry J.; Rodriguez-Molinero, Alejandro; Baker, Paul M. A.; McGuiness, Bernadette; O’Sullivan, Leonard; Diaz, Marta; Quinlan, Leo R.; ÓLaighin, Gearóid

2014-01-01

Connected health devices are generally designed for unsupervised use, by non-healthcare professionals, facilitating independent control of the individuals own healthcare. Older adults are major users of such devices and are a population significantly increasing in size. This group presents challenges due to the wide spectrum of capabilities and attitudes towards technology. The fit between capabilities of the user and demands of the device can be optimised in a process called Human Centred Design. Here we review examples of some connected health devices chosen by random selection, assess older adult known capabilities and attitudes and finally make analytical recommendations for design approaches and design specifications. PMID:25563225

Person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood: a study protocol for a hybrid randomised controlled trial (STEPSTONES project).

PubMed

Acuña Mora, Mariela; Sparud-Lundin, Carina; Bratt, Ewa-Lena; Moons, Philip

2017-04-17

When a young person grows up, they evolve from an independent child to an empowered adult. If an individual has a chronic condition, this additional burden may hamper adequate development and independence. Transition programmes for young persons with chronic disorders aim to provide the necessary skills for self-management and participation in care. However, strong evidence on the effects of these interventions is lacking. Therefore, as part of the STEPSTONES project (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS), we propose a trial to assess the effectiveness of a structured, person-centred transition programme to empower adolescents with congenital heart disease in the transition to adulthood. STEPSTONES will use a hybrid experimental design in which a randomised controlled trial is embedded in a longitudinal, observational study. It will be conducted in 4 paediatric cardiology centres in Sweden. 2 centres will be allocated to the randomised controlled trial group, assigning patients randomly to the intervention group (n=63) or the comparison group (n=63). The other 2 centres will form the intervention-naïve control group (n=63). The primary outcome is the level of patient empowerment, as measured by the Gothenburg Young Persons Empowerment Scale (GYPES). The study has been approved by the Regional Ethical Board of Gothenburg, Sweden. Findings will be reported following the CONSORT statement and disseminated at international conferences and as published papers in peer-reviewed journals. NCT02675361; 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/.

Intensive client-centred occupational therapy in the home improves older adults' occupational performance. Results from a Danish randomized controlled trial.

PubMed

Nielsen, Tove Lise; Andersen, Niels Trolle; Petersen, Kirsten Schultz; Polatajko, Helene; Nielsen, Claus Vinther

2018-01-12

There is growing interest in enabling older adults' occupational performance. We tested whether 11 weeks of intensive client-centred occupational therapy (ICC-OT) was superior to usual practice in improving the occupational performance of home-dwelling older adults. An assessor-masked randomized controlled trial among adults 60 + with chronic health issues, who received or applied for homecare services. Recruitment took place September 2012 to April 2014. All participants received practical and personal assistance and meal delivery as needed. In addition, they were randomized to receive either a maximum 22 sessions of occupation-based ICC-OT (N = 59) or to receive usual practice with a maximum three sessions of occupational therapy (N = 60). The primary outcome was self-rated occupational performance assessed with the Canadian Occupational Performance Measure (COPM). No important adverse events occurred. ICC-OT was accepted by 46 participants (88%), usual practice by 60 (100%). After 3 months, the ICC-OT-group had improved 1.86 points on COPM performance; the Usual-Practice group had improved 0.61 points. The between-group difference was statistically significant (95% confidence interval 0.50 to 2.02), t-test: p = 0.001. ICC-OT improved older adults' occupational performance more effectively than usual practice. This result may benefit older adults and support programmatic changes.

Efficacy of a videoconferencing intervention compared with standard postnatal care at primary care health centres in Catalonia.

PubMed

Seguranyes, Gloria; Costa, Dolors; Fuentelsaz-Gallego, Carmen; Beneit, Juan Vicente; Carabantes, David; Gómez-Moreno, Carme; Palacio-Tauste, Alicia; Pauli, Angels; Abella, Montserrat

2014-06-01

to evaluate the efficacy of an intervention combining videoconferencing and telephone contact compared to standard post partum care of recent mothers attending health centres in Catalonia were recorded. multicentre, randomised parallel controlled clinical trial. 1598 post partum women with Internet access attending eight 'Attention to Sexual and Reproductive Health' (Catalan acronym ASSIR) units at Primary Health Care centres, in Catalonia (Spain). at each of the eight ASSIR units, 100 women were randomly assigned to the intervention group (IG) and 100 to the control group (CG). Women in the IG could consult midwives by videoconference or telephone and could also receive standard care. Women in the control group received standard care from midwives at their health centres or at home. number and type of visits, reasons for consultation, type of feeding at six weeks and women's satisfaction with the intervention on a scale of 1 to 5. 1401 women were studied (80.9% of the initial sample), 683 in the IG and 718 in the CG. Two hundred and seventy-six women (40.4%) used videoconferencing or telephone in the IG. The mean total visits, virtual and face-to-face, was higher in IG women than in controls (2.74 versus 1.22). IG women made fewer visits to the health centre (mean=1) than CG women (mean=1.17). Both differences were statistically significant, with p<0.001 and p=0.002 respectively. The prevalence of breast feeding was similar in the two groups (IG 64.5%, and CG 65.4%). The mean overall satisfaction of women with midwife care was very high in both groups (IG 4.77, CG 4.76). virtual care via videoconferencing is effective for post partum women. It reduces the number of health centre visits and allows mothers to consult health staff immediately and from their own home. © 2013 Elsevier Ltd. All rights reserved.

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

PubMed

Borstlap, W A A; Buskens, C J; Tytgat, K M A J; Tuynman, J B; Consten, E C J; Tolboom, R C; Heuff, G; van Geloven, N; van Wagensveld, B A; C A Wientjes, C A; Gerhards, M F; de Castro, S M M; Jansen, J; van der Ven, A W H; van der Zaag, E; Omloo, J M; van Westreenen, H L; Winter, D C; Kennelly, R P; Dijkgraaf, M G W; Tanis, P J; Bemelman, W A

2015-06-28

At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. ClincalTrials.gov: NCT02243735 .

Oral Health among Preschool Children with Autism Spectrum Disorders: A Case-Control Study

ERIC Educational Resources Information Center

Du, Rennan Y; Yiu, Cynthia K. Y.; King, Nigel M.; Wong, Virginia C. N.; McGrath, Colman P. J.

2015-01-01

Aim: To assess and compare the oral health status of preschool children with and without autism spectrum disorders. Methods: A random sample of 347 preschool children with autism spectrum disorder was recruited from 19 Special Child Care Centres in Hong Kong. An age- and gender-matched sample was recruited from mainstream preschools as the control…

Clinical comparison of two different plating methods in minimally invasive plate osteosynthesis for clavicular midshaft fractures: A randomized controlled trial.

PubMed

Sohn, Hoon-Sang; Shon, Min Soo; Lee, Kyung-Hag; Song, Si-Jung

2015-11-01

The aim of this study was to compare the clinical and radiographic outcomes between two different plating methods (superior vs. anteroinferior) in minimally invasive plate osteosynthesis (MIPO) for acute displaced clavicular shaft fractures. A prospective, randomized controlled trial was performed in a single centre. Nineteen patients were treated with superior plating and 18 with anteroinferior plating using the MIPO technique. A 3.5-mm locking reconstruction plate was bent preoperatively and applied to either the anteroinferior or superior aspect of the clavicle through two separate incisions. The operating time, time to union, the proportional length difference, complications, and functional outcome of the shoulder joint were evaluated using the Constant score and the University of California Los Angeles (UCLA) score. There was no statistically significant difference in the Constant score and UCLA score. The mean time to union was 16.8 weeks for superior plating and 17.1 weeks for anteroinferior plating (p=0.866). The average operation time was 77.2min in superior plating and 79.4min in anteroinferior plating (p=0.491). One patient in the superior plating group showed plate failure. Despite no significant difference, one patient had nonunion in the superior plating group (p>0.999). From a clinical perspective, although MIPO with anteroinferior plating provides better outcomes especially in complications without statistically significant difference, both plating methods provided satisfactory clinical and radiographic outcomes. Level I, a single-centre, prospective, randomized controlled trial. Copyright © 2015 Elsevier Ltd. All rights reserved.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

PubMed Central

Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial. PMID:21098066

Behavioural intervention to reduce resistance in those attending adult day care centres: PROCENDIAS study protocol for a randomized clinical trial.

PubMed

Rodriguez-Sánchez, Emiliano; Tamayo-Morales, Olaya; González-Sanchez, Jesús; Mora-Simón, Sara; Losada-Baltar, Andrés; Unzueta-Arce, Jaime; Patino-Alonso, María C; De Dios-Rodríguez, Elena; Gómez-Marcos, Manuel A; García-Ortiz, Luis

2018-06-01

This study evaluates the effectiveness of a behavioural intervention programme aimed at reducing the reluctance of dependent people to attend Adult Day Care Centres. We hope that reducing resistance will have a positive influence on the mental health of caregivers. Care centres offer important relief and rest services for family caregivers. Some caregivers report being affected by behavioural and psychological symptoms of dementia when they prepare dependents for the Care Centres, especially when these have dementia. Caregivers often report the need for information about how to manage the behaviour of the sick. Nurses in community healthcare units can investigate cases of patients who present resistance when attending care centres and can promote the use of interventions aimed at reducing this problem. Randomised controlled clinical trial. The reference population will be care centre users in Salamanca (Spain) to select 120 family members responsible for the preparation and transfer of the care-recipient. Each participant will be randomised to an intervention group or control group (standard care). A baseline assessment and 6 months follow-up assessment will be performed (study approved in September 2016). The intervention group will consist of 8 sessions, one per week, each lasting 90 min. Each session will be run by a psychologist trained in behaviour analysis and will be tailored to the specific behavioural problems reported by the caregivers. The results of a previously published pilot study allow us to be optimistic about the possibilities of a brief intervention. © 2018 John Wiley & Sons Ltd.

Evidence into practice: evaluating a child-centred intervention for diabetes medicine management The EPIC Project

PubMed Central

2010-01-01

Background There is a lack of high quality, child-centred and effective health information to support development of self-care practices and expertise in children with acute and long-term conditions. In type 1 diabetes, clinical guidelines indicate that high-quality, child-centred information underpins achievement of optimal glycaemic control with the aim of minimising acute readmissions and reducing the risk of complications in later life. This paper describes the development of a range of child-centred diabetes information resources and outlines the study design and protocol for a randomized controlled trial to evaluate the information resources in routine practice. The aim of the diabetes information intervention is to improve children and young people's quality of life by increasing self-efficacy in managing their type 1 diabetes. Methods/Design We used published evidence, undertook qualitative research and consulted with children, young people and key stakeholders to design and produce a range of child-centred, age-appropriate children's diabetes diaries, carbohydrate recording sheets, and assembled child-centred, age-appropriate diabetes information packs containing published information in a folder that can be personalized by children and young people with pens and stickers. Resources have been designed for children/young people 6-10; 11-15; and 16-18 years. To evaluate the information resources, we designed a pragmatic randomized controlled trial to assess the effectiveness, cost effectiveness, and implementation in routine practice of individually tailored, age-appropriate diabetes diaries and information packs for children and young people age 6-18years, compared with currently available standard practice. Children and young people will be stratified by gender, length of time since diagnosis (< 2years and > 2years) and age (6-10; 11-15; and 16-18 years). The following data will be collected at baseline, 3 and 6 months: PedsQL (generic, diabetes and parent versions), and EQ-5 D (parent and child); NHS resource use and process data (questionnaire and interview). Baseline and subsequent HbA1c measurements, blood glucose meter use, readings and insulin dose will be taken from routine test results and hand-held records when attending routine 3-4 monthly clinic visits. The primary outcome measure is diabetes self-efficacy and quality-of-life (Diabetes PedsQL). Secondary outcomes include: HbA1c, generic quality of life, routinely collected NHS/child-held data, costs, service use, acceptability and utility. Trial Registration ISRCTN17551624. PMID:20875112

[Computer-assisted education in problem-solving in neurology; a randomized educational study].

PubMed

Weverling, G J; Stam, J; ten Cate, T J; van Crevel, H

1996-02-24

To determine the effect of computer-based medical teaching (CBMT) as a supplementary method to teach clinical problem-solving during the clerkship in neurology. Randomized controlled blinded study. Academic Medical Centre, Amsterdam, the Netherlands. 103 Students were assigned at random to a group with access to CBMT and a control group. CBMT consisted of 20 computer-simulated patients with neurological diseases, and was permanently available during five weeks to students in the CBMT group. The ability to recognize and solve neurological problems was assessed with two free-response tests, scored by two blinded observers. The CBMT students scored significantly better on the test related to the CBMT cases (mean score 7.5 on a zero to 10 point scale; control group 6.2; p < 0.001). There was no significant difference on the control test not related to the problems practised with CBMT. CBMT can be an effective method for teaching clinical problem-solving, when used as a supplementary teaching facility during a clinical clerkship. The increased ability to solve problems learned by CBMT had no demonstrable effect on the performance with other neurological problems.

Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem. Methods/Design This is a single centre study conducted at Queen’s Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr−1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score). Discussion Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration. Trial registration The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011). ISRCTN: ISRCTN92946117. Registered 26 October 2012. PMID:24885267

Effectiveness of a learner-centred training programme for primary care physicians in using a patient-centred consultation style.

PubMed

Moral, R R; Alamo, M M; Jurado, M A; de Torres, L P

2001-02-01

The aim of the present study was to find out if a training programme adapted to family physicians with several years of clinical experience changes their behaviour when they deal with fibromyalgic patients in the sense of introducing the communication skills that define the 'patient-centred' approach. A randomized, and simple blind, educative study was carried out. Twenty full-time family physicians were invited to participate. They were allocated randomly to two groups: an intervention and a control group. A total of 110 patients were recruited from people attending physicians' surgeries for the first time and who complained of generalized pain that finally fulfilled criteria for generalized musculoskeletal chronic pain/fibromyalgia. This was done for an entire year. The intervention group received an 18 hour intensive course. One week after the course, all doctors carried out a video-recorded encounter with a patient who played the part of a typical fibromyalgia clinical case. The interviews were coded by an observer blind to the training status of the participants, using the GATHARES-CP questionnaire. All patients were contacted by telephone during a 1-2-month period by a different interviewer who was 'blinded' to the patient's experimental status. They were asked to respond to three questions that represent the key components of patient-centred style. The average score on the GATHARES-CP questionnaire was 11.3 +/- 0.9 and 9 +/- 2.3, for doctors from the intervention and control groups, respectively (P < 0.01). For 11 items, scores were higher in the intervention group. The patients' answers to all three questions showed statistically significant differences in a positive direction for the trained doctors. The doctors improved the use of strategies and skills for carrying out patient-centred consultations after they had received an interactive course. The doctors' behaviour appeared to have changed as much in a more experimental situation as in the actual consultations. Moreover, the gain was observed immediately after the intervention was completed, and after having run for a variable period of time up to 1 year.

Influence of a New "Call-Out Algorithm" for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial.

PubMed

Dybvik, Lisa; Skraastad, Erlend; Yeltayeva, Aigerim; Konkayev, Aidos; Musaeva, Tatiana; Zabolotskikh, Igor; Bjertnaes, Lars; Dahl, Vegard; Raeder, Johan; Kuklin, Vladimir

2017-01-01

We recently introduced the efficacy safety score (ESS) as a new "call-out algorithm" for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS). We randomized 1152 surgical patients into three groups for postoperative observation: (1) ESS group ( n = 409), (2) Verbal Numeric Rate Scale (VNRS) for pain group ( n = 417), and (3) an ordinary qualitative observation (Control) group ( n = 326). An ESS > 10 or VNRS > 4 at rest or a nurse's observation of pain or adverse reaction to analgesic treatment in the Control group served as a "call-out alarm" for an anaesthesiologist. We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7 ± 6.3 days (mean ± SD) in the ESS group versus 14.2 ± 6.2 days in the Control group ( P < 0.001). Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128.

Does implementing a development plan for user participation in a mental hospital change patients' experience? A non-randomized controlled study.

PubMed

Rise, Marit B; Steinsbekk, Aslak

2015-10-01

Governments in several countries attempt to strengthen user participation through instructing health-care organizations to implement user participation initiatives. There is, however, little knowledge on the effect on patients' experience from comprehensive plans for enhancing user participation in whole health service organizations. To investigate whether implementing a development plan intending to enhance user participation in a mental hospital had any effect on the patients' experience of user participation. A non-randomized controlled study including patients in three mental hospitals in Central Norway, one intervention hospital and two control hospitals. A development plan intended to enhance user participation was implemented in the intervention hospital as a part of a larger reorganizational process. The plan included establishment of a patient education centre and a user office, purchase of user expertise, appointment of contact professionals for next of kin and improvement of the centre's information and the professional culture. Perceptions of Care, Inpatient Treatment Alliance Scale and questions made for this study. A total of 1651 patients participated. Implementing a development plan in a mental hospital intending to enhance user participation had no significant effect on the patients' experience of user participation. The lack of effect can be due to inappropriate initiatives or challenges in implementation processes. Further research should ensure that initiatives and implementation processes are appropriate to impact the patients' experience. © 2013 John Wiley & Sons Ltd.

Patient-appropriate health literacy educational materials in ophthalmology.

PubMed

Mikhail, David; Visscher, Kari L; Chen, Nancy; Wang, Joy; Emara, Barry Y; Hutnik, Cindy M

2015-02-01

To evaluate the literacy level of patients with glaucoma in a tertiary care teaching centre compared with a rural community centre and to assess comprehension of and preference for educational material written at different reading levels. Prospective, randomized, double-blinded study. Patients with glaucoma presenting for routine examination or referral at a tertiary care academic centre in southwestern Ontario and a single general ophthalmology clinic located in a moderately sized suburban community in Ontario, Canada, were invited to participate in this study. Patients aged 19 to 90 with sufficient visual acuity to read the pamphlets were recruited. Eligible and consenting participants underwent a validated literacy study, and their literacy levels were classified as adequate, barely adequate, marginal, or inadequate. They were then randomized to receive educational pamphlets written at either a grade 5 (intervention group) or grade 10 (control group) reading level. Comprehension of and preference for the material were determined by analysis of cloze testing and a feedback questionnaire. Of 199 participants, 179 were included in the analysis. The literacy testing found that 35% of patients in the community practice and 30% in the tertiary care academic centre had "marginal" or "inadequate" literacy skills, but there was no significant difference between sites (p = 0.77). Comprehension of the educational material was higher in the intervention group versus the control group (p = 0.0057), with a mean cloze score of 57.9% in the intervention group and 48.3% in the control group. The intervention group spent significantly less time reading the pamphlets (p < 0.0001), with an average of 2.52 minutes compared with 4.51 minutes. The feedback survey indicated that patients found the pamphlet with the lower reading level easier to read (p = 0.02), which was reflected in their comments as well. In both academic and community practice settings, about 30% of patients with glaucoma have marginal or inadequate literacy skills. However, regardless of practice, all patients better comprehend, and were more receptive to, educational material written at grade 5 reading level with illustrations, regardless of initial literacy level. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Educational intervention to improve adherence to the Mediterranean diet among parents and their children aged 1-2 years. EniM clinical trial.

PubMed

Roset-Salla, Margarita; Ramon-Cabot, Joana; Salabarnada-Torras, Jordi; Pera, Guillem; Dalmau, Albert

2016-04-01

The objective of the present study was to evaluate the effectiveness of an educational programme on healthy alimentation, carried out in day-care centres and aimed at the parents of children from 1 to 2 years of age, regarding the acquisition of healthy eating habits among themselves and their children. We performed a multicentre, multidisciplinary, randomized controlled study in a community setting. The EniM study (nutritional intervention study among children from Mataró) was performed in twelve day-care centres in Mataró (Spain). Centres were randomized into a control group (CG) and an intervention group (IG). IG received four or five educational workshops on diet, CG did not have workshops. Children, not exclusively breast-fed, from 1 to 2 years of age, in the participating day-care centres and the persons responsible for their alimentation (mother or father). Thirty-five per cent of the IG did not attend the minimum of three workshops and were excluded. The CG included seventy-four children and seventy-two parents and the IG seventy-five children and sixty-seven parents. Both groups were comparable at baseline. Basal adherence to the Mediterranean diet was 56·4 % in parents (Gerber index) and 7·7 points in children (Kidmed test). At 8 months, Mediterranean diet adherence had improved in the IG by 5·8 points in the Gerber index (P=0·01) and 0·6 points in the Kidmed test (P=0·02) compared with the CG. This educational intervention performed in parents at the key period of incorporation of a 1-2-year-old child to the family table showed significant increases in adherence of the parents to the Mediterranean diet, suggesting future improvement in different indicators of health and an expected influence on the diet of their children.

QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali.

PubMed

Dumont, Alexandre; Fournier, Pierre; Fraser, William; Haddad, Slim; Traore, Mamadou; Diop, Idrissa; Gueye, Mouhamadou; Gaye, Alioune; Couturier, François; Pasquier, Jean-Charles; Beaudoin, François; Lalonde, André; Hatem, Marie; Abrahamowicz, Michal

2009-09-18

Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all participating centres. This, along with the inventory of resources and the satisfaction surveys administered to the health personnel, will allow us to measure results before, during, and after the intervention. The overall rate of maternal mortality measured in hospitals during the post-intervention period (Year 4) is the primary outcome. The evaluation will also include cost-effectiveness.

Excessive drinking--brief intervention by a primary health care nurse. A randomized controlled trial.

PubMed

Tomson, Y; Romelsjö, A; Aberg, H

1998-09-01

To evaluate the effect of a nurse-conducted intervention on excessive drinkers. Randomized, controlled trial. Vårby Health Centre, Stockholm. The intervention group visited a nurse three times during a 12-month period. The controls met once with a general practitioner (GP). Patients were recruited at a health screening on the basis of a raised gamma-glutamyl transferase (GGT). Of 2338 subjects, aged 25-54 years, 222 had a screening GGT of > or = 0.9 mukat/l. 100 were randomized to the treatment and 122 to the control group. GGT, self-reported alcohol consumption (g/week), sickness allowance and use of health care. After 2 years a reduction of GGT from 1.52 to 1.21 mukat/l (p = 0.02) had occurred in the treatment group. The controls increased their mean level of GGT from 1.75 to 2.16 mukat/l. Mean weekly alcohol consumption in the intervention group was reduced from 337 to 228 g/week (p = 0.02). The controls did not quantify their alcohol consumption initially, but reported a reduced weekly consumption at follow-up. The intervention had an impact on GGT and self-reported consumption. The controls also reported decreased consumption possibly because their appointment with the GP functioned as a very brief intervention.

[Multicenter randomized trial of amnioinfusion].

PubMed

Fraser, W; Marcoux, S; Prendiville, W; Petrou, S; Hofmeyr, J; Reinharz, D; Goulet, C; Ohlsson, A

2000-05-01

Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.

Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre

PubMed Central

Cima, Rilana; Joore, Manuela; Maes, Iris; Scheyen, Dyon; Refaie, Amr El; Baguley, David M; Vlaeyen, Johan WS; Anteunis, Lucien

2009-01-01

Background Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol. Methods/Design In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective. Discussion This is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated. Trial Registration The trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044 PMID:19210767

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial.

PubMed

Niederer, Daniel; Vogt, Lutz; Wippert, Pia-Maria; Puschmann, Anne-Katrin; Pfeifer, Ann-Christin; Schiltenwolf, Marcus; Banzer, Winfried; Mayer, Frank

2016-10-20

Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain. A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires - clinical examination - biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing. The results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain. Identification number DRKS00010129. German Clinical Trial registered on 3 March 2016.

Influence of a New “Call-Out Algorithm” for Management of Postoperative Pain and Its Side Effects on Length of Stay in Hospital: A Two-Centre Prospective Randomized Trial

PubMed Central

Dybvik, Lisa; Skraastad, Erlend; Yeltayeva, Aigerim; Konkayev, Aidos; Musaeva, Tatiana; Zabolotskikh, Igor; Dahl, Vegard; Raeder, Johan

2017-01-01

Background We recently introduced the efficacy safety score (ESS) as a new “call-out algorithm” for management of postoperative pain and side effects. In this study, we report the influence of ESS recorded hourly during the first 8 hours after surgery on the mobility degree, postoperative nonsurgical complications, and length of hospital stay (LOS). Methods We randomized 1152 surgical patients into three groups for postoperative observation: (1) ESS group (n = 409), (2) Verbal Numeric Rate Scale (VNRS) for pain group (n = 417), and (3) an ordinary qualitative observation (Control) group (n = 326). An ESS > 10 or VNRS > 4 at rest or a nurse's observation of pain or adverse reaction to analgesic treatment in the Control group served as a “call-out alarm” for an anaesthesiologist. Results We found no significant differences in the mobility degree and number of postoperative nonsurgical complications between the groups. LOS was significantly shorter with 12.7 ± 6.3 days (mean ± SD) in the ESS group versus 14.2 ± 6.2 days in the Control group (P < 0.001). Conclusion Postoperative ESS recording in combination with the possibility to call upon an anaesthesiologist when exceeding the threshold score might have contributed to the reductions of LOS in this two-centre study. This trial is registered with NCT02143128. PMID:28855800

Revisited: A Systematic Review of Therapeutic Hypothermia for Adult Patients Following Traumatic Brain Injury.

PubMed

Watson, Hannah I; Shepherd, Andrew A; Rhodes, Jonathan K J; Andrews, Peter J D

2018-06-01

Therapeutic hypothermia has been of topical interest for many years and with the publication of two international, multicenter randomized controlled trials, the evidence base now needs updating. The aim of this systematic review of randomized controlled trials is to assess the efficacy of therapeutic hypothermia in adult traumatic brain injury focusing on mortality, poor outcomes, and new pneumonia. The following databases were searched from January 1, 2011, to January 26, 2018: Cochrane Central Register of Controlled Trial, MEDLINE, PubMed, and EMBASE. Only foreign articles published in the English language were included. Only articles that were randomized controlled trials investigating adult traumatic brain injury sustained following an acute, closed head injury were included. Two authors independently assessed at each stage. Quality was assessed using the Cochrane Collaboration's tool for assessing the risk of bias. All extracted data were combined using the Mantel-Haenszel estimator for pooled risk ratio with 95% CIs. p value of less than 0.05 was considered statistically significant. All statistical analyses were conducted using RevMan 5 (Cochrane Collaboration, Version 5.3, Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Twenty-two studies with 2,346 patients are included. Randomized controlled trials with a low risk of bias show significantly more mortality in the therapeutic hypothermia group (risk ratio, 1.37; 95% CI, 1.04-1.79; p = 0.02), whereas randomized controlled trials with a high risk of bias show the opposite with a higher mortality in the control group (risk ratio, 0.70; 95% CI, 0.60-0.82; p < 0.00001). Overall, this review is in-keeping with the conclusions published by the most recent randomized controlled trials. High-quality studies show no significant difference in mortality, poor outcomes, or new pneumonia. In addition, this review shows a place for fever control in the management of traumatic brain injury.

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

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.

Patient or treatment centre? Where are efforts invested to improve cancer patients' psychosocial outcomes?

PubMed Central

Carey, ML; Clinton-McHarg, T; Sanson-Fisher, RW; Campbell, S; Douglas, HE

2011-01-01

The psychosocial outcomes of cancer patients may be influenced by individual-level, social and treatment centre predictors. This paper aimed to examine the extent to which individual, social and treatment centre variables have been examined as predictors or targets of intervention for psychosocial outcomes of cancer patients. Medline was searched to find studies in which the psychological outcomes of cancer patient were primary variables. Papers published in English between 1999 and 2009 that reported primary data relevant to psychosocial outcomes for cancer patients were included, with 20% randomly selected for further coding. Descriptive studies were coded for inclusion of individual, social or treatment centre variables. Intervention studies were coded to determine if the unit of intervention was the individual patient, social unit or treatment centre. After random sampling, 412 publications meeting the inclusion criteria were identified, 169 were descriptive and 243 interventions. Of the descriptive papers 95.0% included individual predictors, and 5.0% social predictors. None of the descriptive papers examined treatment centre variables as predictors of psychosocial outcomes. Similarly, none of the interventions evaluated the effectiveness of treatment centre interventions for improving psychosocial outcomes. Potential reasons for the overwhelming dominance of individual predictors and individual-focused interventions in psychosocial literature are discussed. PMID:20646035

A comprehensive neuropsychological mapping battery for functional magnetic resonance imaging.

PubMed

Karakas, Sirel; Baran, Zeynel; Ceylan, Arzu Ozkan; Tileylioglu, Emre; Tali, Turgut; Karakas, Hakki Muammer

2013-11-01

Existing batteries for FMRI do not precisely meet the criteria for comprehensive mapping of cognitive functions within minimum data acquisition times using standard scanners and head coils. The goal was to develop a battery of neuropsychological paradigms for FMRI that can also be used in other brain imaging techniques and behavioural research. Participants were 61 healthy, young adult volunteers (48 females and 13 males, mean age: 22.25 ± 3.39 years) from the university community. The battery included 8 paradigms for basic (visual, auditory, sensory-motor, emotional arousal) and complex (language, working memory, inhibition/interference control, learning) cognitive functions. Imaging was performed using standard functional imaging capabilities (1.5-T MR scanner, standard head coil). Structural and functional data series were analysed using Brain Voyager QX2.9 and Statistical Parametric Mapping-8. For basic processes, activation centres for individuals were within a distance of 3-11 mm of the group centres of the target regions and for complex cognitive processes, between 7 mm and 15 mm. Based on fixed-effect and random-effects analyses, the distance between the activation centres was 0-4 mm. There was spatial variability between individual cases; however, as shown by the distances between the centres found with fixed-effect and random-effects analyses, the coordinates for individual cases can be used to represent those of the group. The findings show that the neuropsychological brain mapping battery described here can be used in basic science studies that investigate the relationship of the brain to the mind and also as functional localiser in clinical studies for diagnosis, follow-up and pre-surgical mapping. © 2013.

High-intensity training enhances executive function in children in a randomized, placebo-controlled trial

PubMed Central

Moreau, David; Kirk, Ian J; Waldie, Karen E

2017-01-01

Background: Exercise-induced cognitive improvements have traditionally been observed following aerobic exercise interventions; that is, sustained sessions of moderate intensity. Here, we tested the effect of a 6 week high-intensity training (HIT) regimen on measures of cognitive control and working memory in a multicenter, randomized (1:1 allocation), placebo-controlled trial. Methods: 318 children aged 7-13 years were randomly assigned to a HIT or an active control group matched for enjoyment and motivation. In the primary analysis, we compared improvements on six cognitive tasks representing two cognitive constructs (N = 305). Secondary outcomes included genetic data and physiological measurements. Results: The 6-week HIT regimen resulted in improvements on measures of cognitive control [BFM = 3.38, g = 0.31 (0.09, 0.54)] and working memory [BFM = 5233.68, g = 0.54 (0.31, 0.77)], moderated by BDNF genotype, with met66 carriers showing larger gains post-exercise than val66 homozygotes. Conclusion: This study suggests a promising alternative to enhance cognition, via short and potent exercise regimens. Clinical Trial Registration: Protocol #015078, University of Auckland. Funding: Centre for Brain Research: David Moreau and Karen E Waldie (9133-3706255). DOI: http://dx.doi.org/10.7554/eLife.25062.001 PMID:28825973

Semmelweis's methodology from the modern stand-point: intervention studies and causal ontology.

PubMed

Persson, Johannes

2009-09-01

Semmelweis's work predates the discovery of the power of randomization in medicine by almost a century. Although Semmelweis would not have consciously used a randomized controlled trial (RCT), some features of his material-the allocation of patients to the first and second clinics-did involve what was in fact a randomization, though this was not realised at the time. This article begins by explaining why Semmelweis's methodology, nevertheless, did not amount to the use of a RCT. It then shows why it is descriptively and normatively interesting to compare what he did with the modern approach using RCTs. The argumentation centres on causal inferences and the contrast between Semmelweis's causal concept and that deployed by many advocates of RCTs. It is argued that Semmelweis's approach has implications for matters of explanation and medical practice.

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

PubMed

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

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

Effect of perioperative parecoxib sodium on postoperative pain control for transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma: a prospective randomized trial.

PubMed

Lv, Ning; Kong, Yanan; Mu, Luwen; Pan, Tao; Xie, Qiankun; Zhao, Ming

2016-10-01

Pain is one of the most common side effects of transcatheter arterial chemoembolization (TACE) treatment. This study aimed to assess the analgesic effect of parecoxib sodium for postoperative pain control in patients with inoperable hepatocellular carcinoma (HCC) undergoing TACE. This randomized placebo-controlled prospective clinical study was conducted at a single cancer centre. Patients were randomly assigned to receive parecoxib sodium (experimental group; n = 60) or 0.9 % sodium chloride (control group; n = 60) 1 h before TACE and once every 12 h for 2 days after TACE. Pain level, morphine consumption, adverse events, and quality of life were evaluated and compared between the two groups. Pain scores, percentage distribution of pain categories, and morphine consumption were significantly lower in the experimental group than in the control group (P < 0.05). Fever score comparisons revealed significantly better body temperature balance in the experimental group than in the control group (P = 0.024). Quality-of-life scores in the experimental group were significantly better than those in the control group (P < 0.05). Our results demonstrate that the perioperative administration of parecoxib significantly improved its effectiveness in the control of postoperative pain after TACE. • Perioperative administration of parecoxib is effective for control of pain after TACE. • COX-2 inhibitors provide effective and safe pain control. • Parecoxib helps improve quality-of-life after TACE for patients with inoperable hepatocellular carcinoma.

Modifying attitude and intention toward regular physical activity using protection motivation theory: a randomized controlled trial.

PubMed

Mirkarimi, Kamal; Eri, Maryam; Ghanbari, Mohammad R; Kabir, Mohammad J; Raeisi, Mojtaba; Ozouni-Davaji, Rahman B; Aryaie, Mohammad; Charkazi, Abdurrahman

2017-10-30

We were guided by the Protection Motivation Theory to test the motivational interviewing effects on attitude and intention of obese and overweight women to do regular physical activity. In a randomized controlled trial, we selected using convenience sampling 60 overweight and obese women attending health centres. The women were allocated to 2 groups of 30 receiving a standard weight-control programme or motivational interviewing. All constructs of the theory (perceived susceptibility, severity, self-efficacy and response efficacy) and all anthropometric characteristics (except body mass index) were significantly different between the groups at 3 study times. The strongest predictors of intention to do regular physical exercise were perceived response efficacy and attitude at 2- and 6-months follow-up. We showed that targeting motivational interviewing with an emphasis on Protection Motivation Theory constructs appeared to be beneficial for designing and developing appropriate intervention to improve physical activity status among women with overweight and obesity.

A new virtual-reality training module for laparoscopic surgical skills and equipment handling: can multitasking be trained? A randomized controlled trial.

PubMed

Bongers, Pim J; Diederick van Hove, P; Stassen, Laurents P S; Dankelman, Jenny; Schreuder, Henk W R

2015-01-01

During laparoscopic surgery distractions often occur and multitasking between surgery and other tasks, such as technical equipment handling, is a necessary competence. In psychological research, reduction of adverse effects of distraction is demonstrated when specifically multitasking is trained. The aim of this study was to examine whether multitasking and more specifically task-switching can be trained in a virtual-reality (VR) laparoscopic skills simulator. After randomization, the control group trained separately with an insufflator simulation module and a laparoscopic skills exercise module on a VR simulator. In the intervention group, insufflator module and VR skills exercises were combined to develop a new integrated training in which multitasking was a required competence. At random moments, problems with the insufflator appeared and forced the trainee to multitask. During several repetitions of a different multitask VR skills exercise as posttest, performance parameters (laparoscopy time, insufflator time, and errors) were measured and compared between both the groups as well with a pretest exercise to establish the learning effect. A face-validity questionnaire was filled afterward. University Medical Centre Utrecht, The Netherlands. Medical and PhD students (n = 42) from University Medical Centre Utrecht, without previous experience in laparoscopic simulation, were randomly assigned to either intervention (n = 21) or control group (n = 21). All participants performed better in the posttest exercises without distraction of the insufflator compared with the exercises in which multitasking was necessary to solve the insufflator problems. After training, the intervention group was significantly quicker in solving the insufflator problems (mean = 1.60Log(s) vs 1.70Log(s), p = 0.02). No significant differences between both the groups were seen in laparoscopy time and errors. Multitasking has negative effects on the laparoscopic performance. This study suggests an additional learning effect of training multitasking in VR laparoscopy simulation, because the trainees are able to handle a secondary task (solving insufflator problems) quicker. These results may aid the development of laparoscopy VR training programs in approximating real-life laparoscopic surgery. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

PubMed

Roulaud, M; Durand-Zaleski, I; Ingrand, P; Serrie, A; Diallo, B; Peruzzi, P; Hieu, P D; Voirin, J; Raoul, S; Page, P; Fontaine, D; Lantéri-Minet, M; Blond, S; Buisset, N; Cuny, E; Cadenne, M; Caire, F; Ranoux, D; Mertens, P; Naous, H; Simon, E; Emery, E; Gadan, B; Regis, J; Sol, J-C; Béraud, G; Debiais, F; Durand, G; Guetarni Ging, F; Prévost, A; Brandet, C; Monlezun, O; Delmotte, A; d'Houtaud, S; Bataille, B; Rigoard, P

2015-03-01

Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015. Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial.

PubMed

Siewe, Jan; Bredow, Jan; Oppermann, Johannes; Koy, Timmo; Delank, Stefan; Knoell, Peter; Eysel, Peer; Sobottke, Rolf; Zarghooni, Kourosh; Röllinghoff, Marc

2014-09-05

The 360° fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine. But it changes the biomechanics of the spine and may cause adjacent segment disease (ASD). Among the many techniques developed to avoid this complication, one appears promising. It combines a rigid fusion with a flexible pedicle screw system (hybrid instrumentation, "topping off"). However, its clinical significance is still uncertain due to the lack of conclusive data. The study is a randomized, therapy-controlled, two-centre trial conducted in a clinical setting at two university hospitals. If they meet the criteria, outpatients presenting with degenerative disc disease, facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups: a control group undergoing conventional fusion surgery (PLIF - posterior lumbar intervertebral fusion), and an intervention group undergoing fusion surgery using a new flexible pedicle screw system (PLIF + "topping off"), which was brought on the market in 2013. Follow-up examination will take place immediately after surgery, after 6 weeks and after 6, 12, 24 and 36 months. An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires (ODI - Ostwestry Disability Index, SF-36™ - Short Form Health Survey 36, COMI - Core Outcome Measure Index). In addition, clinical and radiologic ASD, sagittal balance parameters and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications (e.g. implant failure), adverse events, and serious adverse events will be monitored and documented throughout the study. New hybrid "topping off" systems might improve the outcome of lumbar spine fusion. But to date, there is a serious lack of and a great need of convincing data on safety or efficacy, including benefits and harms to the patients, of these systems. Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants. In such a case, randomized clinical trials are the best way to evaluate benefits and risks. NCT01852526.

Effect of metronidazole versus standard care on length of stay of patients admitted with severe infectious mononucleosis: a randomized controlled trial.

PubMed

Lennon, P; O'Neill, J P; Fenton, J E

2014-07-01

Metronidazole may be of use in the treatment of infectious mononucleosis (IM). Our aim is to show that metronidazole shortens hospital stay for patients with severe IM. A single-centre randomized controlled trial was undertaken in patients admitted with severe IM, who were with a similar group treated by the standard care. Patients were blinded to which treatment arm they were in. Forty-two of these patients were enrolled in the trial. The primary endpoint was the difference in length of stay. This was significantly less in the metronidazole group (3.67 days v 4.67) (p 0.032). This study demonstrates that metronidazole has a role to play in severe infectious mononucleosis. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

PubMed

Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

2017-07-01

To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Patient-controlled oral analgesia for postoperative pain management following total knee replacement.

PubMed

Kastanias, Patti; Gowans, Sue; Tumber, Paul S; Snaith, Kianda; Robinson, Sandra

2010-01-01

To investigate whether patient-controlled oral analgesia (PCOA) used by individuals receiving a total knee replacement could reduce pain, increase patient satisfaction, reduce opioid use and/or reduce opioid side effects when compared with traditional nurse (RN)-administered oral analgesia. Patients who underwent an elective total knee replacement at a quaternary care centre (Toronto Western Hospital, Toronto, Ontario) were randomly assigned to either PCOA or RN-administered short-acting oral opioids on postoperative day 2. Subjects in the RN group called the RN to receive their prescribed short-acting opioid. Subjects in the PCOA group kept a single dose of their prescribed oral opioid at their bedside and took this dose when they felt they needed it, to a maximum of one dose every 2 h. Study outcomes, collected on postoperative day 2, included pain (measured by the Brief Pain Inventory - Short Form), patient satisfaction (measured by the Pain Outcome Questionnaire Satisfaction subscale - component II), opioid use (oral morphine equivalents), opioid side effects (nausea, pruritus and/or constipation) and knee measures (maximum passive knee flexion and pain at maximum passive knee flexion, performed on the operative knee). Study outcomes were analyzed twice. First, for a subset of 73 subjects who remained in their randomly assigned group (PCOA group, n=36; RN group, n=37), randomized analyses were performed. Second, for the larger sample of 88 subjects who were categorized by their actual method of receiving oral opioids (PCOA group, n=41; RN group, n=47), as-treated analyses were performed. There were no differences in study outcomes between the PCOA and RN groups in either analysis. PCOA was not superior to RN administration on study outcomes. However, PCOA did not increase opioid use or pain. PCOA remains an important element in the patient-centred care facility.

Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol.

PubMed

Porter, Sam; Holmes, Valerie; McLaughlin, Katrina; Lynn, Fiona; Cardwell, Chris; Braiden, Hannah-Jane; Doran, Jackie; Rogan, Sheelagh

2012-10-01

This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16 years) and their parents. Eligible participants will have a working diagnosis within the ambit of international classification of disease 10 mental and behavioural disorders and will be recruited over 15 months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13 weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010. © 2012 Blackwell Publishing Ltd.

Efficacy of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) co-administered with varenicline and counselling for smoking cessation: a randomized placebo-controlled trial.

PubMed

Hoogsteder, Philippe H J; Kotz, Daniel; van Spiegel, Paul I; Viechtbauer, Wolfgang; van Schayck, Onno C P

2014-08-01

Nicotine vaccination has been proposed as a possible treatment to aid smoking cessation. First efficacy results of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) showed that only a subgroup of the top 30% antibody responders achieved higher abstinence rates than placebo. The present study examined the efficacy of adding NicVAX versus placebo to varenicline and behavioural support as an aid in smoking cessation and relapse prevention. Randomized placebo-controlled trial. Two research centres (Maastricht University Medical Centre and Slotervaart Hospital) in the Netherlands. A total of 558 smokers were assigned randomly to six injections with NicVAX (n = 278) or placebo (n = 280) both co-administered with open label varenicline and behavioural support. Outcomes were prolonged carbon monoxide-validated abstinence from weeks 9 to 52 (primary) and weeks 37 to 52 (secondary). We also performed a pre-planned subgroup analysis in the top 30% antibody responders. There was no difference in abstinence rates between NicVAX and placebo from weeks 9 to 52 [27.7 versus 30.0%, odds ratio (OR) = 0.89, 95% confidence interval (CI) = 0.62-1.29] or weeks 37 to 52 (33.8 versus 33.2%, OR = 1.03, 95% CI = 0.73-1.46). The top 30% antibody responders, compared to the placebo group, showed a non-significant tendency towards higher abstinence rates from weeks 37 to 52 (42.2 versus 33.2%, OR = 1.47, 95% CI = 0.89-2.42). The nicotine vaccine, NicVAX, does not appear to improve the chances of stopping smoking when given in addition to varenicline and behavioural support. © 2014 Society for the Study of Addiction.

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.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies

PubMed Central

2011-01-01

Background Objective: To determine the relative effectiveness of evidence-informed practice using two high compression systems: four-layer (4LB) and short-stretch bandaging (SSB) in community care of venous leg ulcers. Design and Setting: Pragmatic, multi-centre, parallel-group, open-label, randomized controlled trial conducted in 10 centres. Cognitively intact adults (≥18 years) referred for community care (home or clinic) with a venous ulceration measuring ≥0.7cm and present for ≥1 week, with an ankle brachial pressure index (ABPI) ≥0.8, without medication-controlled Diabetes Mellitus or a previous failure to improve with either system, were eligible to participate. Methods Consenting individuals were randomly allocated (computer-generated blocked randomization schedule) to receive either 4LB or SSB following an evidence-informed protocol. Primary endpoint: time-to- healing of the reference ulcer. Secondary outcomes: recurrence rates, health-related quality of life (HRQL), pain, and expenditures. Results 424 individuals were randomized (4LB n = 215; SSB n = 209) and followed until their reference ulcer was healed (or maximum 30 months). An intent-to-treat analysis was conducted on all participants. Median time to ulcer healing in the 4LB group was 62 days [95% confidence interval (CI) 51 to 73], compared with 77 days (95% CI 63 to 91) in the SSB group. The unadjusted Kaplan-Meier curves revealed the difference in the distribution of cumulative healing times was not significantly different between group (log rank χ2 = 0.001, P = 0.98) nor ulcers recurrence (4LB, 10.1%; SSB, 13.3%; p = 0.345). Multivariable Cox Proportional Hazard Modeling also showed no significant between-bandage differences in healing time after controlling for significant covariates (p = 0.77). At 3-months post-baseline there were no differences in pain (no pain: 4LB, 22.7%; SSB, 26.7%; p = 0.335), or HRQL (SF-12 Mental Component Score: 4LB, 55.1; SSB, 55.8; p = 0.615; SF-12 Physical Component Score: 4LB, 39.0; SSB, 39.6; p = 0.675). The most common adverse events experienced by both groups included infection, skin breakdown and ulcer deterioration. Conclusions The Canadian Bandaging Trial revealed that in the practice context of trained RNs using an evidence-informed protocol, the choice of bandage system (4LB and SSB) does not materially affect healing times, recurrence rates, HRQL, or pain. From a community practice perspective, this is positive news for patient-centred care allowing individual/family and practitioner choice in selecting compression technologies based on circumstances and context. Trial registration clinicaltrials.gov Identifier: NCT00202267 PMID:21995267

Prebiotic-supplemented partially hydrolysed cow's milk formula for the prevention of eczema in high-risk infants: a randomized controlled trial.

PubMed

Boyle, R J; Tang, M L-K; Chiang, W C; Chua, M C; Ismail, I; Nauta, A; Hourihane, J O B; Smith, P; Gold, M; Ziegler, J; Peake, J; Quinn, P; Rao, R; Brown, N; Rijnierse, A; Garssen, J; Warner, J O

2016-05-01

Prevention guidelines for infants at high risk of allergic disease recommend hydrolysed formula if formula is introduced before 6 months, but evidence is mixed. Adding specific oligosaccharides may improve outcomes. To evaluate whether partially hydrolysed whey formula containing oligosaccharides (0.8 g/100 ml) (pHF-OS) can prevent eczema in high-risk infants [ISRCTN65195597]. We conducted a parallel-group, multicentre, randomized double-blind controlled trial of pHF-OS vs standard cow's milk formula. Infants with a family history of allergic disease were randomized (stratified by centre/maternal allergy) to active (n = 432) or control (n = 431) formula until 6 months of age if formula was introduced before 18 weeks. Primary outcome was cumulative incidence of eczema by 12 months in infants randomized at 0-4 weeks (375 pHF-OS, 383 control). Secondary outcomes were cumulative incidence of eczema by 12 or 18 months in all infants randomized, immune markers at 6 months and adverse events. Eczema occurred by 12 months in 84/293 (28.7%) infants allocated to pHF-OS at 0-4 weeks of age, vs 93/324 (28.7%) control (OR 0.98 95% CI 0.68, 1.40; P = 0.90), and 107/347 (30.8%) pHF-OS vs 112/370 (30.3%) control in all infants randomized (OR 0.99 95% CI 0.71, 1.37; P = 0.94). pHF-OS did not change most immune markers including total/specific IgE; however, pHF-OS reduced cow's milk-specific IgG1 (P < 0.0001) and increased regulatory T-cell and plasmacytoid dendritic cell percentages. There was no group difference in adverse events. pHF-OS does not prevent eczema in the first year in high-risk infants. The immunological changes found require confirmation in a separate cohort. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A patient-centred team-coaching concept for medical rehabilitation.

PubMed

Körner, M; Becker, S; Dinius, J; Müller, C; Zimmermann, L; Rundel, M

2018-01-01

Team coaching enhances teamwork and subsequently improves patient-centredness in medical rehabilitation clinics. Even though interprofessional teamwork is regarded as a crucial factor in medical rehabilitation, to date no evaluated team-coaching approaches are available for improving interprofessional teamwork in medical rehabilitation in Germany. Based on a systematic literature search and interviews with staff, managers, and patients of rehabilitation clinics, we developed a team-coaching approach that is standardized in its process but based on the individual needs and requests of each clinic. It takes a systemic perspective and is goal-oriented and solution-focused. The approach mainly serves to provide impulses to make use of resources within the team and to support a self-directed organisational learning process. It is manualized and can, therefore, be used by professionals aiming to improve interprofessional teamwork in their clinic. A multi-centre, cluster-randomized controlled study that was conducted to evaluate the team-coaching approach showed positive results. Team organization, knowledge integration, and responsibility can be improved, and, therefore, the implementation of the patient-centred team-coaching approach in interprofessional rehabilitation teams can be recommended.

Self-rated health and type 2 diabetes risk in the European Prospective Investigation into Cancer and Nutrition-InterAct study: a case-cohort study

PubMed Central

Wennberg, Patrik; Rolandsson, Olov; van der A, Daphne L; Spijkerman, Annemieke M W; Kaaks, Rudolf; Boeing, Heiner; Feller, Silke; Bergmann, Manuela M; Langenberg, Claudia; Sharp, Stephen J; Forouhi, Nita; Riboli, Elio; Wareham, Nicholas

2013-01-01

Objectives To investigate the association between self-rated health and risk of type 2 diabetes and whether the strength of this association is consistent across five European centres. Design Population-based prospective case-cohort study. Setting Enrolment took place between 1992 and 2000 in five European centres (Bilthoven, Cambridge, Heidelberg, Potsdam and Umeå). Participants Self-rated health was assessed by a baseline questionnaire in 3399 incident type 2 diabetic case participants and a centre-stratified subcohort of 4619 individuals from the European Prospective Investigation into Cancer and Nutrition (EPIC)-InterAct study which was drawn from a total cohort of 340 234 participants in the EPIC. Primary outcome measure Prentice-weighted Cox regression was used to estimate centre-specific HRs and 95% CIs for incident type 2 diabetes controlling for age, sex, centre, education, body mass index (BMI), smoking, alcohol consumption, energy intake, physical activity and hypertension. The centre-specific HRs were pooled across centres by random effects meta-analysis. Results Low self-rated health was associated with a higher hazard of type 2 diabetes after adjusting for age and sex (pooled HR 1.67, 95% CI 1.48 to 1.88). After additional adjustment for health-related variables including BMI, the association was attenuated but remained statistically significant (pooled HR 1.29, 95% CI 1.09 to 1.53). I2 index for heterogeneity across centres was 13.3% (p=0.33). Conclusions Low self-rated health was associated with a higher risk of type 2 diabetes. The association could be only partly explained by other health-related variables, of which obesity was the strongest. We found no indication of heterogeneity in the association between self-rated health and type 2 diabetes mellitus across the European centres. PMID:23471609

The talent study: a multicentre randomized controlled trial assessing the impact of a 'tailored lifestyle self-management intervention' (talent) on weight reduction.

PubMed

Melchart, Dieter; Doerfler, Wolfgang; Eustachi, Axel; Wellenhofer-Li, Yanqing; Weidenhammer, Wolfgang

2015-01-01

Overweight is considered an important risk factor for diseases in the context of metabolic syndrome. Lifestyle modifications are the means of choice to reduce weight in persons with a Body Mass Index of 28 to 35. The study examines whether there are any differences between two intervention strategies regarding weight reduction in overweight persons. The study is a multicentre randomized controlled trial with observation duration of 12 months. Eight study centres are involved to include a minimal sample size of 150 participants. Randomization ratio is 2:1. Feasible persons are checked according to inclusion and exclusion criteria and after given informed consent are assigned randomly to one of two intervention programs: A) intervention group: comprehensive lifestyle modification program (Individual Health Management IHM) with 3 months reduction phase plus 9 months maintaining phase, B) control group: written information with advice for healthy food habits (Usual care UC). Participants of the IHM group have access to a web-based health portal and join 3 full-day and 10 two-hour training sessions during the first 3 months. During the remaining 9 months four refresh trainings will be performed. There are 3 different diet strategies (fasting, two-day diet, meal replacement) for free choice. Participants of the control group are provided with acknowledged rules for healthy food according to the German Nutrition Society (DGE). Examinations are conducted at baseline, after 3, 6, 9 and 12 months. They include body weight, waist circumference, blood pressure, laboratory findings and a bio-impedance analysis to measure body composition. Statistical analysis of the primary outcome 'change of body weight after 12 months' is based on ITT population including analysis of variance of the weight differences between month 0 and 12 with the factors 'group', 'baseline value' and 'study centre'. Secondary outcomes will be analyzed exploratively. The monitoring of the study will implement different measures to enhance compliance, avoid attrition and ensure data quality. Based on a blended learning concept and using web-based e-health tools the program promises to achieve sustainable effects in weight reduction. German Clinical Trials Register Freiburg (DRKS): DRKS00006736 (date registered 20/09/2014).

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy

PubMed Central

Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-01-01

Objective: The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. Methods: In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. Results: 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. Conclusion: UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial. PMID:27710100

A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

PubMed

Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

2016-12-01

The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σ setup ) was no less accurate than with conventional dark ink tattoos, i.e. <2.8 mm. 46 patients were randomized to receive conventional dark or UV ink tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σ setup for the UV tattoo group was <2.8 mm in the u and v directions (p = 0.001 and p = 0.009, respectively). A larger proportion of patients reported improvement in body image score in the UV tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

Centre-related variability in hospital admissions of patients with spondyloarthritis.

PubMed

Andrés, Mariano; Sivera, Francisca; Pérez-Vicente, Sabina; Carmona, Loreto; Vela, Paloma

2016-09-01

The aim of this study was to explore the variability in hospital admissions of patients with spondyloarthritis (SpA) in Spain, and the centre factors that may influence that variability. Descriptive cross-sectional study, part of the emAR II study, performed in Spain (2009-2010). Health records of patients with a diagnosis of SpA and at least one visit to the rheumatology units within the previous 2 years were reviewed. Variables related to hospital admissions, to the SpA, and to the patient and centre were collected. A multilevel logistic regression analysis of random intercept with non-random slopes was performed to assess variability between centres. From 45 centres, 1168 patients' health records were reviewed. Main SpA forms were ankylosing spondylitis (55.2 %) and psoriatic arthritis (22.2 %). A total of 248 admissions were registered for 196 patients (19.2 %, n = 1020). An adjusted variability of 17.6 % in hospitalizations between centres was noted. The following hospital-related factors showed a significant association with admissions: the total number of admissions of the centre, the existence of electronic admission, and the availability of ultrasound in rheumatology. However, these factors only explained 42.9 % of the inter-centre variability. The risk of a patient with SpA of being admitted could double (median OR 2.09), depending on the hospital where the patient was being managed. Hospital admissions of patients with SpA varied between hospitals due to centre characteristics. Further studies are needed to ascertain which specific factors may be causing the variation, as studied variables explained less than half of the variability.

Web-based physiotherapy for people moderately affected with Multiple Sclerosis; quantitative and qualitative data from a randomized, controlled pilot study.

PubMed

Paul, Lorna; Coulter, Elaine H; Miller, Linda; McFadyen, Angus; Dorfman, Joe; Mattison, Paul George G

2014-09-01

To explore the effectiveness and participant experience of web-based physiotherapy for people moderately affected with Multiple Sclerosis (MS) and to provide data to establish the sample size required for a fully powered, definitive randomized controlled study. A randomized controlled pilot study. Rehabilitation centre and participants' homes. Thirty community dwelling adults moderately affected by MS (Expanded Disability Status Scale 5-6.5). Twelve weeks of individualised web-based physiotherapy completed twice per week or usual care (control). Online exercise diaries were monitored; participants were telephoned weekly by the physiotherapist and exercise programmes altered remotely by the physiotherapist as required. The following outcomes were completed at baseline and after 12 weeks; 25 Foot Walk, Berg Balance Scale, Timed Up and Go, Multiple Sclerosis Impact Scale, Leeds MS Quality of Life Scale, MS-Related Symptom Checklist and Hospital Anxiety and Depression Scale. The intervention group also completed a website evaluation questionnaire and interviews. Participants reported that website was easy to use, convenient, and motivating and would be happy to use in the future. There was no statistically significant difference in the primary outcome measure, the timed 25ft walk in the intervention group (P=0.170), or other secondary outcome measures, except the Multiple Sclerosis Impact Scale (P=0.048). Effect sizes were generally small to moderate. People with MS were very positive about web-based physiotherapy. The results suggested that 80 participants, 40 in each group, would be sufficient for a fully powered, definitive randomized controlled trial. © The Author(s) 2014.

The influence of having the eyelids open or closed on undisturbed postural control.

PubMed

Rougier, P

2003-09-01

To assess the possible interactions between the physiological mechanisms involved in eyelid closure and stance maintenance, 20 healthy adults were required to keep their eyes open in the dark (EOd), in daylight (EO), or to close them normally (EC), respectively and in random order. The analysis was focused on elementary motions computed from the complex centre of pressure (CP) trajectories, that is to say the vertical projection of the centre of gravity (CGv) and the difference between CP and CGv (CP-CGv). The results indicate that the mean amplitudes of the CP-CGv spectra are statistically reduced in EOd when compared to the EC condition. This diminution is thought to express a decrease in the level of activity of lower limb muscles involved in stance control. Interestingly, the CNS does not really seem to gain from these reduced horizontal accelerations at the CG level since the CGv amplitudes are in turn only slightly reduced. It can thus be hypothesised that, despite the fact that visual information in the EOd condition remains unavailable, the somesthetic cues continue to play a minor role in the detection-correction process aimed at controlling undisturbed stance.

Community resource centres to improve the health of women and children in informal settlements in Mumbai: a cluster-randomised, controlled trial.

PubMed

More, Neena Shah; Das, Sushmita; Bapat, Ujwala; Alcock, Glyn; Manjrekar, Shreya; Kamble, Vikas; Sawant, Rijuta; Shende, Sushma; Daruwalla, Nayreen; Pantvaidya, Shanti; Osrin, David

2017-03-01

Around 105 million people in India will be living in informal settlements by 2017. We investigated the effects of local resource centres delivering integrated activities to improve women's and children's health in urban informal settlements. In a cluster-randomised controlled trial in 40 clusters, each containing around 600 households, 20 were randomly allocated to have a resource centre (intervention group) and 20 no centre (control group). Community organisers in the intervention centres addressed maternal and neonatal health, child health and nutrition, reproductive health, and prevention of violence against women and children through home visits, group meetings, day care, community events, service provision, and liaison. The primary endpoints were met need for family planning in women aged 15-49 years, proportion of children aged 12-23 months fully immunised, and proportion of children younger than 5 years with anthropometric wasting. Census interviews with women aged 15-49 years were done before and 2 years after the intervention was implemented. The primary intention-to-treat analysis compared cluster allocation groups after the intervention. We also analysed the per-protocol population (all women with data from both censuses) and assessed cluster-level changes. This study is registered with ISRCTN, number ISRCTN56183183, and Clinical Trials Registry of India, number CTRI/2012/09/003004. 12 614 households were allocated to the intervention and 12 239 to control. Postintervention data were available for 8271 women and 5371 children younger than 5 years in the intervention group, and 7965 women and 5180 children in the control group. Met need for family planning was greater in the intervention clusters than in the control clusters (odds ratio [OR] 1·31, 95% CI 1·11-1·53). The proportions of fully immunised children were similar in the intervention and control groups in the intention-to-treat analysis (OR 1·30, 95% CI 0·84-2·01), but were greater in the intervention group when assessed per protocol (1·73, 1·05-2·86). Childhood wasting did not differ between groups (OR 0·92, 95% CI 0·75-1·12), although improvement was seen at the cluster level in the intervention group (p=0·020). This community resource model seems feasible and replicable and may be protocolised for expansion. Wellcome Trust, CRY, Cipla. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Early food for future health: a randomized controlled trial evaluating the effect of an eHealth intervention aiming to promote healthy food habits from early childhood.

PubMed

Helle, Christine; Hillesund, Elisabet Rudjord; Omholt, Mona Linge; Øverby, Nina Cecilie

2017-09-20

Childhood overweight and obesity is a global public health challenge. Primary prevention initiatives targeting parents have been called for to encourage a positive feeding environment and healthy eating habits that may lay a good foundation for future health. At the same time, there is a need for interventions which combine accessibility and scalability with cost effectiveness. Today's parents are extensive Internet-users, but only a few randomized controlled trials have investigated the use of Internet to promote healthy eating habits in early childhood. In Early Food for Future Health we have developed and will evaluate an Internet-based tool for parents of children between 6 and 12 months, aiming to increase knowledge about infant nutrition and foster protective feeding behavior. During springtime 2016, parents of children aged between 3 and 5 months were recruited through Norwegian child health centres and announcements on Facebook. After completing the baseline questionnaire, 718 parents were individually randomized to intervention- or control group. The intervention group received monthly emails with links to an age-appropriate web-site when their child was between 6 and 12 months. The control group received ordinary care from the child health centres. The data-collection is ongoing. All participants will be followed up at ages 12 and possibly 24 and 48 months, with questionnaires relating to eating behaviour and feeding practices, food variety and diet quality. Providing guidance and counseling to parents of infants is an important task for health authorities and the public child health services. Early Food for Future health is an intervention focusing on promoting early healthy food-habits which may prevent childhood overweight and obesity. If proven to be effective, Early Food for Future Health can be used by parents and public health nurses for supplementary guidance on feeding practices and diet. This study has the potential to provide greater insight and understanding regarding early parental feeding practices, child eating behavior and the development and efficacy of Internet-based public health interventions. ISRCTN13601567 .

Evaluation of the effectiveness of robotic gait training and gait-focused physical therapy programs for children and youth with cerebral palsy: a mixed methods RCT.

PubMed

Wiart, Lesley; Rosychuk, Rhonda J; Wright, F Virginia

2016-06-02

Robot assisted gait training (RAGT) is considered to be a promising approach for improving gait-related gross motor function of children and youth with cerebral palsy. However, RAGT has yet to be empirically demonstrated to be effective. This knowledge gap is particularly salient given the strong interest in this intensive therapy, the high cost of the technology, and the requirement for specialized rehabilitation centre resources. This is a research protocol describing a prospective, multi-centre, concurrent mixed methods study comprised of a randomized controlled trial (RCT) and an interpretive descriptive qualitative design. It is a mixed methods study designed to determine the relative effectiveness of three physical therapy treatment conditions (i.e., RAGT, a functional physical therapy program conducted over-ground (fPT), and RAGT + fPT) on gait related motor skills of ambulatory children with cerebral palsy. Children with cerebral palsy aged 5-18 years who are ambulatory (Gross Motor Function Classification System Levels II and III) will be randomly allocated to one of four treatment conditions: 1) RAGT, 2) fPT, 3) RAGT and fPT combined, or 4) a maintenance therapy only control group. The qualitative component will explicate child and parent experiences with the interventions, provide insight into the values that underlie their therapy goals, and assist with interpretation of the results of the RCT. n/a. NCT02391324 Registered March 12, 2015.

Lack of efficacy of a reduced microparticle diet in a multi-centred trial of patients with active Crohn's disease.

PubMed

Lomer, Miranda C E; Grainger, Stephen L; Ede, Roland; Catterall, Adrian P; Greenfield, Simon M; Cowan, Russell E; Vicary, F Robin; Jenkins, Anthony P; Fidler, Helen; Harvey, Rory S; Ellis, Richard; McNair, Alistair; Ainley, Colin C; Thompson, Richard P H; Powell, Jonathan J

2005-03-01

Dietary microparticles, which are bacteria-sized and non-biological, found in the modern Western diet, have been implicated in both the aetiology and pathogenesis of Crohn's disease. Following on from the findings of a previous pilot study, we aimed to confirm whether a reduction in the amount of dietary microparticles facilitates induction of remission in patients with active Crohn's disease, in a single-blind, randomized, multi-centre, placebo controlled trial. Eighty-three patients with active Crohn's disease were randomly allocated in a 2 x 2 factorial design to a diet low or normal in microparticles and/or calcium for 16 weeks. All patients received a reducing dose of prednisolone for 6 weeks. Outcome measures were Crohn's disease activity index, Van Hees index, quality of life and a series of objective measures of inflammation including erythrocyte sedimentation rate, C-reactive protein, intestinal permeability and faecal calprotectin. After 16 weeks patients returned to their normal diet and were followed up for a further 36 weeks. Dietary manipulation provided no added effect to corticosteroid treatment on any of the outcome measures during the dietary trial (16 weeks) or follow-up (to 1 year); e.g., for logistic regression of Crohn's disease activity index based rates of remission (P=0.1) and clinical response (P=0.8), in normal versus low microparticle groups. Our adequately powered and carefully controlled dietary trial found no evidence that reducing microparticle intake aids remission in active Crohn's disease.

Assessment of Professional Training Programmes in International Agricultural Research Institutions: The Case of ICRAF

ERIC Educational Resources Information Center

Wanjiku, Julliet; Mairura, Franklin; Place, Frank

2010-01-01

The following survey was undertaken in 2005 to assess the effectiveness of professional training activities in international agricultural research organizations that were undertaken between 1999 and 2002 at ICRAF (International Centre for Research in Agroforestry), now World Agroforestry Centre, Nairobi. Trainees were randomly selected from…

Autism Developmental Profiles and Cooperation with Oral Health Screening

ERIC Educational Resources Information Center

Du, Rennan Y.; Yiu, Cynthia C. Y.; Wong, Virginia C. N.; McGrath, Colman P.

2015-01-01

To determine the associations between autism developmental profiles and cooperation with an oral health screening among preschool children with autism spectrum disorders (ASDs). A random sample of Special Child Care Centres registered with the Government Social Welfare Department in Hong Kong was selected (19 out of 37 Centres). All preschool…

Decreasing Inappropriate Use of Antibiotics in Primary Care in Four Countries in South America—Cluster Randomized Controlled Trial

PubMed Central

Urbiztondo, Inés; Caballero, Lidia; Suarez, Miguel Angel; Olinisky, Monica

2017-01-01

High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America. Very few interventions targeting general practitioners (GPs) to decrease inappropriate antibiotic prescribing have been investigated in this region. This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections (RTIs) attending primary care. The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media. Both are RTIs for which antibiotics have a very limited effect. A cluster randomized two-arm control trial was implemented. Healthcare centres from Bolivia, Argentina, Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were randomly allocated to either intervention or control group. During ten consecutive weeks, GPs in the intervention group received evidence-based online feedback on the management of suspected RTIs. In patients with acute bronchitis, the intervention reduced the antibiotic prescribing rate from 71.6% to 56% (control group from 61.2% to 52%). In patients with acute otitis media, the intervention reduced the antibiotic prescribing from 94.8% to 86.2% (no change in the control group). In all RTIs, the intervention reduced antibiotic prescribing rate from 37.4% to 28.1% (control group from 29% to 27.2%). Online evidence-based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America. PMID:29240687

An randomized controlled trial of Post-it® notes did not increase postal response rates in older depressed participants.

PubMed

Lewis, Helen; Keding, Ada; Bosanquet, Katharine; Gilbody, Simon; Torgerson, David

2017-02-01

Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER + and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes (P of interaction = .019). There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. © 2016 John Wiley & Sons, Ltd.

Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial.

PubMed

Bradford, Andrew; Lees, Kennedy

2000-01-01

The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4) funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up. By randomizing 2700 patients, the study will have 84% power to detect a 5.5% absolute reduction in the primary end-point. By April 2000, 86 centres were participating, with representation in Canada, USA, Europe, South America, Singapore and Australia. So far, 1206 patients have been randomised, of whom 37% were treated within 6 h. Overall 3-month mortality was 20% and the primary outcome event rate was 43%. The study is ongoing and centres worldwide are encouraged to participate.

[Shared decision-making and individualized goal setting - a pilot trial using PRISM (Pictorial Representation of Illness and Self Measure) in psychiatric inpatients].

PubMed

Büchi, S; Straub, S; Schwager, U

2010-12-01

Although there is much talk about shared decision making and individualized goal setting, there is a lack of knowledge and knowhow in their realization in daily clinical practice. There is a lack in tools for easy applicable tools to ameliorate person-centred individualized goal setting processes. In three selected psychiatric inpatients the semistructured, theory driven use of PRISM (Pictorial Representation of Illness and Self Measure) in patients with complex psychiatric problems is presented and discussed. PRISM sustains a person-centred individualized process of goal setting and treatment and reinforces the active participation of patients. The process of visualisation and synchronous documentation is validated positively by patients and clinicians. The visual goal setting requires 30 to 45 minutes. In patients with complex psychiatric illness PRISM was used successfully to ameliorate individual goal setting. Specific effects of PRISM-visualisation are actually evaluated in a randomized controlled trial.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial.

PubMed

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care.

Medical Yoga for Patients with Stress-Related Symptoms and Diagnoses in Primary Health Care: A Randomized Controlled Trial

PubMed Central

Köhn, Monica; Persson Lundholm, Ulla; Bryngelsson, Ing-Liss; Anderzén-Carlsson, Agneta; Westerdahl, Elisabeth

2013-01-01

An increasing number of patients are suffering from stress-related symptoms and diagnoses. The purpose of this study was to evaluate the medical yoga treatment in patients with stress-related symptoms and diagnoses in primary health care. A randomized controlled study was performed at a primary health care centre in Sweden from March to June, 2011. Patients were randomly allocated to a control group receiving standard care or a yoga group treated with medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care. A total of 37 men and women, mean age of 53 ± 12 years were included. General stress level (measured using Perceived Stress Scale (PSS)), burnout (Shirom-Melamed Burnout Questionnaire (SMBQ)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), insomnia severity (Insomnia Severity Index (ISI)), pain (visual analogue scale (VAS)), and overall health status (Euro Quality of Life VAS (EQ-VAS)) were measured before and after 12 weeks. Patients assigned to the Yoga group showed significantly greater improvements on measures of general stress level (P < 0.000), anxiety (P < 0.019), and overall health status (P < 0.018) compared to controls. Treatment with medical yoga is effective in reducing levels of stress and anxiety in patients with stress-related symptoms in primary health care. PMID:23533465

The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)

PubMed Central

2010-01-01

Background Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. Methods/Design This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands. The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks. Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). Discussion This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. Trial registration ClinicalTrials.gov Identifier: NCT00713843 PMID:20096136

Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

PubMed

2016-09-01

Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

PubMed

Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

2014-11-20

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities. http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study.

PubMed

Shirazi, M; Zeinaloo, A A; Parikh, S V; Sadeghi, M; Taghva, A; Arbabi, M; Kashani, A Sabouri; Alaeddini, F; Lonka, K; Wahlström, R

2008-04-01

The Prochaska model of readiness to change has been proposed to be used in educational interventions to improve medical care. To evaluate the impact on readiness to change of an educational intervention on management of depressive disorders based on a modified version of the Prochaska model in comparison with a standard programme of continuing medical education (CME). This is a randomized controlled trial within primary care practices in southern Tehran, Iran. The participants included 192 general physicians working in primary care (GPs) were recruited after random selection and randomized to intervention (96) and control (96). Intervention consisted of interactive, learner-centred educational methods in large and small group settings depending on the GPs' stages of readiness to change. Change in stage of readiness to change measured by the modified version of the Prochaska questionnaire was the The final number of participants was 78 (81%) in the intervention arm and 81 (84%) in the control arm. Significantly (P < 0.01), more GPs (57/96 = 59% versus 12/96 = 12%) in the intervention group changed to higher stages of readiness to change. The intervention effect was 46% points (P < 0.001) and 50% points (P < 0.001) in the large and small group setting, respectively. Educational formats that suit different stages of learning can support primary care doctors to reach higher stages of behavioural change in the topic of depressive disorders. Our findings have practical implications for conducting CME programmes in Iran and are possibly also applicable in other parts of the world.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

PubMed Central

2012-01-01

Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

User fee exemptions and excessive household spending for normal delivery in Burkina Faso: the need for careful implementation.

PubMed

Ben Ameur, Amal; Ridde, Valéry; Bado, Aristide R; Ingabire, Marie-Gloriose; Queuille, Ludovic

2012-11-21

In 2006, the Parliament of Burkina Faso passed a policy to reduce the direct costs of obstetric services and neonatal care in the country's health centres, aiming to lower the country's high national maternal mortality and morbidity rates. Implementation was via a "partial exemption" covering 80% of the costs. In 2008 the German NGO HELP launched a pilot project in two health districts to eliminate the remaining 20% of user fees. Regardless of any exemptions, women giving birth in Burkina Faso's health centres face additional expenses that often represent an additional barrier to accessing health services. We compared the total cost of giving birth in health centres offering partial exemption versus those with full exemption to assess the impact on additional out-of-pocket fees. A case-control study was performed to compare medical expenses. Case subjects were women who gave birth in 12 health centres located in the Dori and Sebba districts, where HELP provided full fee exemption for obstetric services and neonatal care. Controls were from six health centres in the neighbouring Djibo district where a partial fee exemption was in place. A random sample of approximately 50 women per health centre was selected for a total of 870 women. There was an implementation gap regarding the full exemption for obstetric services and neonatal care. Only 1.1% of the sample from Sebba but 17.5% of the group from Dori had excessive spending on birth related costs, indicating that women who delivered in Sebba were much less exposed to excessive medical expenses than women from Dori. Additional out-of-pocket fees in the full exemption health districts took into account household ability to pay, with poorer women generally paying less. We found that the elimination of fees for facility-based births benefits especially the poorest households. The existence of excessive spending related to direct costs of giving birth is of concern, making it urgent for the government to remove all direct fees for obstetric and neonatal care. However, the policy of completely abolishing user fees is insufficient; the implementation process must have a thorough monitoring system to reduce implementation gaps.

Effects of honey use on the management of radio/chemotherapy-induced mucositis: a meta-analysis of randomized controlled trials.

PubMed

Xu, J-L; Xia, R; Sun, Z-H; Sun, L; Min, X; Liu, C; Zhang, H; Zhu, Y-M

2016-12-01

This meta-analysis aimed to assess the prophylactic effects of honey use on the management of radio/chemotherapy-induced mucositis. PubMed, Cochrane Library, Science Direct, China National Knowledge Infrastructure (CNKI), VIP (Chinese scientific journal database), and China Biology Medicine (CBM) were searched for relevant articles without language restriction. Two reviewers searched and evaluated the related studies independently. Statistical analyses were performed using Stata 11.0, calculating the pooled risk ratio (RR) with the corresponding 95% confidence interval (CI). Begg's funnel plot was used together with Egger's test to detect publication bias. A total of seven randomized controlled trials were finally included. Quality assessment showed one article to have a low risk of bias, two to have a moderate risk, and four to have a high risk. Meta-analysis showed that, compared with blank control, honey treatment could reduce the incidence of oral mucositis after radio/chemotherapy (RR 0.35, 95% CI 0.18-0.70, P=0.003). No meta-analysis was applied for honey vs. lidocaine or honey vs. golden syrup. The sensitivity analysis showed no significant change when any one study was excluded. No obvious publication bias (honey vs. blank control) was detected. In conclusion, honey can effectively reduce the incidence of radio/chemotherapy-induced oral mucositis; however, further multi-centre randomized controlled trials are needed to support the current evidence. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm.

PubMed

Pedersen, T F; Budtz-Lilly, J; Petersen, C N; Hyldgaard, J; Schmidt, J-O; Kroijer, R; Grønholdt, M-L; Eldrup, N

2018-06-01

Remote ischaemic preconditioning (RIPC) has been suggested as a means of protecting vital organs from reperfusion injury during major vascular surgery. This study was designed to determine whether RIPC could reduce the incidence of perioperative myocardial infarction (MI) during open surgery for ruptured abdominal aortic aneurysm (AAA). Secondary aims were to see if RIPC could reduce 30-day mortality, multiple organ failure, acute intestinal ischaemia, acute kidney injury and ischaemic stroke. This randomized, non-blinded clinical trial was undertaken at three vascular surgery centres in Denmark. Patients who had open surgery for ruptured AAA were randomized to intervention with RIPC or control in a 1 : 1 ratio. Postoperative complications and deaths were registered, and ECG and blood samples were obtained daily during the hospital stay. Of 200 patients randomized, 142 (72 RIPC, 70 controls) were included. There was no difference in rates of perioperative MI between the RIPC and control groups (36 versus 43 per cent respectively), or in rates of organ failure. However, in the per-protocol analysis 30-day mortality was significantly reduced in the RIPC group (odds ratio 0·46, 95 per cent c.i. 0·22 to 0·99; P = 0·048). RIPC did not reduce the incidence of perioperative MI in patients undergoing open surgery for ruptured AAA. Registration number: NCT00883363 ( http://www.clinicaltrials.gov).

The effect of perhexiline on myocardial protection during coronary artery surgery: a two-centre, randomized, double-blind, placebo-controlled trial

PubMed Central

Drury, Nigel E.; Howell, Neil J.; Calvert, Melanie J.; Weber, Ralf J.M.; Senanayake, Eshan L.; Lewis, Michael E.; Hyde, Jonathan A.J.; Green, David H.; Mascaro, Jorge G.; Wilson, Ian C.; Graham, Timothy R.; Rooney, Stephen J.; Viant, Mark R.; Freemantle, Nick; Frenneaux, Michael P.; Pagano, Domenico

2015-01-01

OBJECTIVES Perhexiline is thought to modulate metabolism by inhibiting mitochondrial carnitine palmitoyltransferase-1, reducing fatty acid uptake and increasing carbohydrate utilization. This study assessed whether preoperative perhexiline improves markers of myocardial protection in patients undergoing coronary artery bypass graft surgery and analysed its effect on the myocardial metabolome. METHODS In a prospective, randomized, double-blind, placebo-controlled trial, patients at two centres were randomized to receive either oral perhexiline or placebo for at least 5 days prior to surgery. The primary outcome was a low cardiac output episode in the first 6 h. All pre-specified analyses were conducted according to the intention-to-treat principle with a statistical power of 90% to detect a relative risk of 0.5 and a conventional one-sided α-value of 0.025. A subset of pre-ischaemic left ventricular biopsies was analysed using mass spectrometry-based metabolomics. RESULTS Over a 3-year period, 286 patients were randomized, received the intervention and were included in the analysis. The incidence rate of a low cardiac output episode in the perhexiline arm was 36.7% (51/139) vs 34.7% (51/147) in the control arm [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.56–1.50, P = 0.74]. Perhexiline was associated with a reduction in the cardiac index at 6 h [difference in means 0.19, 95% CI 0.07–0.31, P = 0.001] and an increase in inotropic support in the first 12 h (OR 0.55, 95% CI 0.34–0.89, P = 0.015). There were no significant differences in myocardial injury with troponin-T or electrocardiogram, reoperation, renal dysfunction or length of stay. No difference in the preischaemic left ventricular metabolism was identified between groups on metabolomics analysis. CONCLUSIONS Preoperative perhexiline does not improve myocardial protection in patients undergoing coronary surgery and in fact reduced perioperative cardiac output, increasing the need for inotropic support. Perhexiline has no significant effect on the mass spectrometry-visible polar myocardial metabolome in vivo in humans, supporting the suggestion that it acts via a pathway that is independent of myocardial carnitine palmitoyltransferase inhibition and may explain the lack of clinical benefit observed following surgery. ClinicalTrials.Gov ID NCT00845364. PMID:24948413

The effect of perhexiline on myocardial protection during coronary artery surgery: a two-centre, randomized, double-blind, placebo-controlled trial.

PubMed

Drury, Nigel E; Howell, Neil J; Calvert, Melanie J; Weber, Ralf J M; Senanayake, Eshan L; Lewis, Michael E; Hyde, Jonathan A J; Green, David H; Mascaro, Jorge G; Wilson, Ian C; Graham, Timothy R; Rooney, Stephen J; Viant, Mark R; Freemantle, Nick; Frenneaux, Michael P; Pagano, Domenico

2015-03-01

Perhexiline is thought to modulate metabolism by inhibiting mitochondrial carnitine palmitoyltransferase-1, reducing fatty acid uptake and increasing carbohydrate utilization. This study assessed whether preoperative perhexiline improves markers of myocardial protection in patients undergoing coronary artery bypass graft surgery and analysed its effect on the myocardial metabolome. In a prospective, randomized, double-blind, placebo-controlled trial, patients at two centres were randomized to receive either oral perhexiline or placebo for at least 5 days prior to surgery. The primary outcome was a low cardiac output episode in the first 6 h. All pre-specified analyses were conducted according to the intention-to-treat principle with a statistical power of 90% to detect a relative risk of 0.5 and a conventional one-sided α-value of 0.025. A subset of pre-ischaemic left ventricular biopsies was analysed using mass spectrometry-based metabolomics. Over a 3-year period, 286 patients were randomized, received the intervention and were included in the analysis. The incidence rate of a low cardiac output episode in the perhexiline arm was 36.7% (51/139) vs 34.7% (51/147) in the control arm [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.56-1.50, P = 0.74]. Perhexiline was associated with a reduction in the cardiac index at 6 h [difference in means 0.19, 95% CI 0.07-0.31, P = 0.001] and an increase in inotropic support in the first 12 h (OR 0.55, 95% CI 0.34-0.89, P = 0.015). There were no significant differences in myocardial injury with troponin-T or electrocardiogram, reoperation, renal dysfunction or length of stay. No difference in the preischaemic left ventricular metabolism was identified between groups on metabolomics analysis. Preoperative perhexiline does not improve myocardial protection in patients undergoing coronary surgery and in fact reduced perioperative cardiac output, increasing the need for inotropic support. Perhexiline has no significant effect on the mass spectrometry-visible polar myocardial metabolome in vivo in humans, supporting the suggestion that it acts via a pathway that is independent of myocardial carnitine palmitoyltransferase inhibition and may explain the lack of clinical benefit observed following surgery. NCT00845364. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.

Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities.

PubMed

Harrison, Rosamund; Veronneau, Jacques; Leroux, Brian

2010-05-13

The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting randomized trials in remote settings, the importance of thorough community collaboration, and also illustrates the likelihood that some baseline variables that may be clinically important will be unevenly split in group-randomized trials when the number of groups is small. This trial is registered as ISRCTN41467632.

Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities

PubMed Central

2010-01-01

Background The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings. Methods/design Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups. Discussion In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting randomized trials in remote settings, the importance of thorough community collaboration, and also illustrates the likelihood that some baseline variables that may be clinically important will be unevenly split in group-randomized trials when the number of groups is small. Trial registration This trial is registered as ISRCTN41467632. PMID:20465831

Using an informed consent in mammography screening: a randomized trial.

PubMed

Baena-Cañada, José M; Rosado-Varela, Petra; Expósito-Álvarez, Inmaculada; González-Guerrero, Macarena; Nieto-Vera, Juan; Benítez-Rodríguez, Encarnación

2015-12-01

Spanish women do not make an informed choice regarding breast cancer screening (BCS). Our aim was to evaluate the impact of receiving information regarding real BCS benefits and risks on knowledge, attitude, decision, feelings, and worries about cancer. Randomized controlled clinical trial of 355 women aged between 45 and 67 years, 177 and 178 assigned to the intervention group (IG) and control group (CG), respectively. After breast screening, women received either Nordic Cochrane Centre information on BCS or standard information. The primary outcome (knowledge) was determined from questionnaire administered at baseline and after a month. Answers were scored from 0 to 10 and scores of 5 or more indicated that women were well informed (had "good knowledge"). Questionnaires regarding attitudes, future screening intentions, and psychosocial impact were also administered. The Chi-squared and Student's t-tests were used to compare qualitative and quantitative variables, respectively. Good knowledge was acquired by 32 (18.10%) IG women and 15 (8.40%) CG women (P = 0.008). Mean scores from first to second interview increased from 2.97 (SD 1.16) to 3.43 (SD 1.39) in the CG and from and from 2.96 (SD 1.23) to 3.95 (SD 1.78) (P = 0.002) in the IG. No differences were found in the secondary endpoints. Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information is not very efficacious, nor does it modify attitude, decision, feelings, or worries about cancer. © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Single implants in the aesthetic region preceded by local ridge augmentation; a 10-year randomized controlled trial.

PubMed

Meijndert, Caroliene M; Raghoebar, Gerry M; Meijndert, Leo; Stellingsma, Kees; Vissink, Arjan; Meijer, Henny J A

2017-04-01

The aim of this randomized controlled trial was to assess the 10-year effects of three different augmentation techniques (augmentation with chin bone, augmentation with chin bone plus a membrane and augmentation with a bone substitute plus a membrane) for implant-supported restorations in the maxillary aesthetic region regarding clinical and radiographic parameters, and patient-centred outcomes. Ninety-three patients requesting single tooth replacement and presenting with a horizontal bone deficiency were included. After augmentation, 93 implants were placed. Clinical variables, standardized radiographs and photographs and patient questionnaires were analysed to assess the impact of the various augmentation techniques 1 month (T 1 ), 12 months (T 12 ) and 120 months (T 120 ) after final crown placement. 10-years implant survival was 95.7% and did not differ between the groups neither were significant differences observed in the other treatment outcomes assessed. Peri-implant bone loss was low, viz. 0.48 ± 1.19 mm (mesial) and 0.30 ± 1.24 mm (distal) at T 120 . Loss of midbuccal marginal gingival level at T 120 was 0.32 ± 0.83 mm. Mean overall satisfaction at T 120 was 8.6 with 98.6% of the patients satisfied. Clinical, radiographic, aesthetic and patient centred outcomes were very favourable after 10 years and did not differ between the groups with different bone augmentation techniques. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Short video interventions to reduce mental health stigma: a multi-centre randomised controlled trial in nursing high schools.

PubMed

Winkler, Petr; Janoušková, Miroslava; Kožený, Jiří; Pasz, Jiří; Mladá, Karolína; Weissová, Aneta; Tušková, Eva; Evans-Lacko, Sara

2017-12-01

We aimed to assess whether short video interventions could reduce stigma among nursing students. A multi-centre, randomised controlled trial was conducted. Participating schools were randomly selected and randomly assigned to receive: (1) an informational leaflet, (2) a short video intervention or (3) a seminar involving direct contact with a service user. The Community Attitudes towards Mental Illness (CAMI) and Reported and Intended Behaviour Scale (RIBS) were selected as primary outcome measures. SPANOVA models were built and Cohen's d calculated to assess the overall effects in each of the trial arms. Compared to the baseline, effect sizes immediately after the intervention were small in the flyer arm (CAMI: d = 0.25; RIBS: d = 0.07), medium in the seminar arm (CAMI: d = 0.61; RIBS: d = 0.58), and medium in the video arm (CAMI: d = 0.49 RIBS: d = 0.26; n = 237). Effect sizes at the follow-up were vanishing in the flyer arm (CAMI: d = 0.05; RIBS: d = 0.04), medium in the seminar arm (CAMI: d = 0.43; RIBS: d = 0.26; n = 254), and small in the video arm (CAMI: d = 0.22 RIBS: d = 0.21; n = 237). Seminar had the strongest and relatively stable effect on students' attitudes and intended behaviour, but the effect of short video interventions was also considerable and stable over time. Since short effective video interventions are relatively cheap, conveniently accessible and easy to disseminate globally, we recommend them for further research and development.

Effect of urban closed circuit television on assault injury and violence detection

PubMed Central

Sivarajasingam, V; Shepherd, J; Matthews, K

2003-01-01

Objective: To evaluate the effect of closed circuit television (CCTV) surveillance on levels of assault injury and violence detection. Design: Intervention versus control study design. Setting: Five town/cities with CCTV surveillance and five, matched control centres without CCTV surveillance in England. Intervention: CCTV installation and surveillance. Methods: Assault related emergency department attendances and violent offences recorded by the police in CCTV and control centres in the four years, 1995–99, two years before and two years after CCTV installation, were compared. Results: Assault related emergency department attendances decreased in intervention centres (3% decrease, ratio 0.96; 95% confidence interval (CI) 0.93 to 0.99) and increased in control centres (11% increase, ratio 1.11; 95% CI 1.08 to 1.14). Overall, changes in emergency department assault attendance in CCTV and control centres were significantly different (t test, p<0.05). Police recorded violence increased in CCTV (11% increase, ratio 1.16; 95% CI 1.08 to 1.24) and control centres (5% increase, ratio 1.06; 95% CI 0.99 to 1.13). Overall, changes in police recording in CCTV and control centres were not significantly different (t test, p>0.05). In CCTV centres, decreases in assault related emergency department attendances and increases in police violence detection were not uniform. Conclusion: CCTV surveillance was associated with increased police detection of violence and reductions in injury or severity of injury. CCTV centre variation deserves further study. PMID:14693891

Newer classification and regression tree techniques: Bagging and Random Forests for ecological prediction

Treesearch

Anantha M. Prasad; Louis R. Iverson; Andy Liaw; Andy Liaw

2006-01-01

We evaluated four statistical models - Regression Tree Analysis (RTA), Bagging Trees (BT), Random Forests (RF), and Multivariate Adaptive Regression Splines (MARS) - for predictive vegetation mapping under current and future climate scenarios according to the Canadian Climate Centre global circulation model.

Patient-controlled oral analgesia for postoperative pain management following total knee replacement

PubMed Central

Kastanias, Patti; Gowans, Sue; Tumber, Paul S; Snaith, Kianda; Robinson, Sandra

2010-01-01

PURPOSE: To investigate whether patient-controlled oral analgesia (PCOA) used by individuals receiving a total knee replacement could reduce pain, increase patient satisfaction, reduce opioid use and/or reduce opioid side effects when compared with traditional nurse (RN)-administered oral analgesia. METHODS: Patients who underwent an elective total knee replacement at a quaternary care centre (Toronto Western Hospital, Toronto, Ontario) were randomly assigned to either PCOA or RN-administered short-acting oral opioids on postoperative day 2. Subjects in the RN group called the RN to receive their prescribed short-acting opioid. Subjects in the PCOA group kept a single dose of their prescribed oral opioid at their bedside and took this dose when they felt they needed it, to a maximum of one dose every 2 h. Study outcomes, collected on postoperative day 2, included pain (measured by the Brief Pain Inventory – Short Form), patient satisfaction (measured by the Pain Outcome Questionnaire Satisfaction sub-scale – component II), opioid use (oral morphine equivalents), opioid side effects (nausea, pruritis and/or constipation) and knee measures (maximum passive knee flexion and pain at maximum passive knee flexion, performed on the operative knee). RESULTS: Study outcomes were analyzed twice. First, for a subset of 73 subjects who remained in their randomly assigned group (PCOA group, n=36; RN group, n=37), randomized analyses were performed. Second, for the larger sample of 88 subjects who were categorized by their actual method of receiving oral opioids (PCOA group, n=41; RN group, n=47), as-treated analyses were performed. There were no differences in study outcomes between the PCOA and RN groups in either analysis. CONCLUSION: PCOA was not superior to RN administration on study outcomes. However, PCOA did not increase opioid use or pain. PCOA remains an important element in the patient-centred care facility. PMID:20195553

Non-vitamin K antagonist oral anticoagulants compared with warfarin at different levels of INR control in atrial fibrillation: A meta-analysis of randomized trials.

PubMed

Carmo, João; Ferreira, Jorge; Costa, Francisco; Carmo, Pedro; Cavaco, Diogo; Carvalho, Salomé; Morgado, Francisco; Adragão, Pedro; Mendes, Miguel

2017-10-01

The efficacy and safety of warfarin for stroke prevention in atrial fibrillation (AF) depend on the time in the therapeutic range (TTR) with an international normalised ratio (INR) of 2.0-3.0. This meta-analysis focused the relative efficacy and safety of non-VKA oral anticoagulants (NOAC) compared with warfarin at different thresholds of centre's TTR (cTTR). We searched PubMed, Embase, CENTRAL and websites of regulatory agencies, limiting searches to randomized phase 3 trials. Primary outcomes were stroke or systemic embolism (SSE) and major or non-major clinically relevant (NMCR) bleeding. We used a random-effects model to pool effect on outcomes according to different thresholds of cTTR. Four TTR sub-studies with a total of 71,222 patients were included. The benefit of NOAC in reducing SSE compared with warfarin was significantly higher in patients at cTTR<60% (HR 0.79, 95% CI 0.68-0.90) and at 60% to <70% (0.82, 0.71-0.95) but not at ≥70% (1.00, 0.82-1.23) with a significant interaction for cTTR<70% or ≥70% (p=0.042). The risk of major or NMCR bleeding was significantly lower with NOAC as compared with warfarin in patients at all sub-groups (0.67, 0.54-0.83 for patients at cTTR<60% and 0.75, 0.63-0.89 at 60% to <70%) except for cTTR≥70% (HR 0.84, 0.64-1.11), but the interaction for cTTR<70% or ≥70% was not statistically significant (p=0.271). The superiority in efficacy of NOAC compared with warfarin for stroke prevention is lost above a cTTR threshold of approximately 70%, but the relative safety appears to be less modified by the centre-based quality of INR control. Copyright © 2017 Elsevier B.V. All rights reserved.

A multi-centre, randomised controlled trial of cognitive therapy to prevent harmful compliance with command hallucinations.

PubMed

Birchwood, Max; Peters, Emmanuelle; Tarrier, Nicholas; Dunn, Graham; Lewis, Shon; Wykes, Til; Davies, Linda; Lester, Helen; Michail, Maria

2011-09-30

Command hallucinations are among the most distressing, high risk and treatment resistant symptoms for people with psychosis; however, currently, there are no evidence-based treatment options available for this group. A cognitive therapy grounded in the principles of the Social Rank Theory, is being evaluated in terms of its effectiveness in reducing harmful compliance with command hallucinations. This is a single blind, intention-to-treat, multi-centre, randomized controlled trial comparing Cognitive Therapy for Command Hallucinations + Treatment as Usual with Treatment as Usual alone. Eligible participants have to fulfil the following inclusion criteria: i) ≥16 years; ii) ICD-10 diagnosis of schizophrenia or related disorder; iii) command hallucinations for at least 6 months leading to risk of harm to self or others. Following the completion of baseline assessments, eligible participants will be randomly allocated to either the Cognitive Therapy for Command Hallucinations + Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at 9 and 18 months post randomization with assessors blind to treatment allocation. The primary outcome is compliance behaviour and secondary outcomes include beliefs about voices' power, distress, psychotic symptoms together with a health economic evaluation. Qualitative interviews with services users will explore the acceptability of Cognitive Therapy for Command Hallucinations. Cognitive behaviour therapy is recommended for people with psychosis; however, its focus and evaluation has primarily revolved around the reduction of psychotic symptoms. In this trial, however, the focus of the cognitive behavioural intervention is on individuals' appraisals, behaviour and affect and not necessarily symptoms; this is also reflected in the outcome measures used. If successful, the results will mark a significant breakthrough in the evidence base for service users and clinicians and will provide a treatment option for this group where none currently exist. The trial will open the way for further breakthrough work with the 'high risk' population of individuals with psychosis, which we would intend to pursue. ISRCTN: ISRCTN62304114.

[Effects of work-related medical rehabilitation in patients with musculoskeletal disorders].

PubMed

Streibelt, M; Hansmeier, T; Müller-Fahrnow, W

2006-06-01

A work-related orientation within medical rehabilitation represents concepts with a stronger focus on the patient's individual vocational requirements and is based on different vocationally-orientated strategies of treatment. "Medical Occupational Orientation" ("Medizinisch-berufliche Orientierung", MBO), the model of Klinik Niedersachsen in Bad Nenndorf, places Functional Capacity Evaluation according to Susan Isernhagen (EFL) at the centre of rehabilitation diagnostics and therapy. This study investigates the effects of the MBO model relative to activities and vocational participation of patients with musculoskeletal disorders faced with vocational problems and on management at the interface between medical and vocational rehabilitation. Presented are findings of a randomized follow-up study aimed at evaluating the MBO model. A total of 494 patients of LVA Westfalen, a regional insurance agency, took part. A need for MBO was diagnosed for 222 patients. These patients were randomly assigned either to the MBO model of treatment (experimental group --> U[+]) or to the conventional medical treatment (control group --> K[+]). Patients without a need for MBO (U[-], K[-]) were treated likewise. The written questionings took place at the beginning (t (1)) and end of rehabilitation (t (2)), as well as six (t (3)) and twelve months (t (4)) after the patients' discharge. Currently, the results are based on the 6-month follow-up. Concerning the activities, an MBO-related effect in the experimental group (U[+]) has been found for the Pain Disability Index (PDI), effect sizes being d (u+) = 0.82; d (k+) = 0.17. The risk of unemployment six months after rehabilitation is decreased for MBO(+) patients who participated in the MBO model. In addition, the clinic can make effective prognosis concerning subsequent participation in vocational rehabilitation for both experimental groups (U[+], U[-]). Established for the first time in a randomized controlled trial, the findings presented show that patients with musculoskeletal disorders who are faced with particular vocational problems will achieve significantly better results concerning activities and vocational reintegration if their medical rehabilitation had been based upon an EFL-centred MBO approach.

Cost effectiveness of interpersonal community psychiatric treatment for people with long-term severe non-psychotic mental disorders: protocol of a multi-centre randomized controlled trial.

PubMed

van Veen, Mark; Koekkoek, Bauke; Mulder, Niels; Postulart, Debby; Adang, Eddy; Teerenstra, Steven; Schoonhoven, Lisette; van Achterberg, Theo

2015-05-02

This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study. Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18-65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts. No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care. Netherlands Trial Register (NTR): 3988 . Registered 13th of May 2013.

Unit cost analysis of training and deploying paid community health workers in three rural districts of Tanzania.

PubMed

Tani, Kassimu; Exavery, Amon; Baynes, Colin D; Pemba, Senga; Hingora, Ahmed; Manzi, Fatuma; Phillips, James F; Kanté, Almamy Malick

2016-07-08

Tanzania, like other African countries, faces significant health workforce shortages. With advisory and partnership from Columbia University, the Ifakara Health Institute and the Tanzanian Training Centre for International Health (TTCIH) developed and implemented the Connect Project as a randomized cluster experimental trial of the childhood survival impact of recruiting, training, and deploying of a new cadre of paid community health workers (CHW), named "Wawazesha wa afya ya Jamii" (WAJA). This paper presents an estimation of the cost of training and deploying WAJA in three rural districts of Tanzania. Costing data were collected by tracking project activity expenditure records and conducting in-depth interviews of TTCIH staff who have led the training and deployment of WAJA, as well as their counterparts at Public Clinical Training Centres who have responsibility for scaling up the WAJA training program. The trial is registered with the International Standard Randomized Controlled Trial Register number ( ISRCTN96819844 ). The Connect training cost was US$ 2,489.3 per WAJA, of which 40.1 % was for meals, 20.2 % for accommodation 10.2 % for tuition fees and the remaining 29.5 % for other costs including instruction and training facilities and field allowance. A comparable training program estimated unit cost for scaling-up this training via regional/district clinical training centres would be US$ 833.5 per WAJA. Of this unit cost, 50.3 % would involve the cost of meals, 27.4 % training fees, 13.7 % for field allowances, 9 % for accommodation and medical insurance. The annual running cost of WAJA in a village will cost US$ 1.16 per capita. Costs estimated by this study are likely to be sustainable on a large scale, particularly if existing regional/district institutions are utilized for this program.

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial

PubMed Central

Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M.; Hagos, Fanah; Castillo Yermenos, Raul E.; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

2018-01-01

Background: Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. Method: The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. Discussion: The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement. PMID:29854386

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

PubMed

Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M; Hagos, Fanah; Castillo Yermenos, Raul E; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

2018-06-01

Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement.

Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

PubMed

Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

2008-01-07

Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

WHO/INRUD patient care and facility-specific drug use indicators at primary health care centres in Eastern province, Saudi Arabia.

PubMed

El Mahalli, A A; Akl, O A M; Al-Dawood, S F; Al-Nehab, A A; Al-Kubaish, H A; Al-Saeed, S; Elkahky, A A A; Salem, A M A A

2012-11-01

This study aimed to measure the performance of primary health care centres in Eastern province, Saudi Arabia, using the WHO/International Network of Rational Use of Drugs patient care and facility-specific drug use indicators. In a cross-sectional study, 10 health centres were selected using systematic random sampling. A total of 300 patients were interviewed while visiting the centre from January to March 2011 and 10 pharmacists from the same centres were interviewed. Average consultation time was 7.3 min (optimal > or = 30 min), percentage of drugs adequately labelled was 10% (optimal 100%) and patient's knowledge of correct dosage was 79.3% (optimal 100%). The percentage of key drugs in stock was only 59.2% (optimal 100%). An overall index of rational facility-specific drug use was calculated and applied to rank the health centres for benchmarking.

Transfusion Indication Threshold Reduction (TITRe2) randomized controlled trial in cardiac surgery: statistical analysis plan.

PubMed

Pike, Katie; Nash, Rachel L; Murphy, Gavin J; Reeves, Barnaby C; Rogers, Chris A

2015-02-22

The Transfusion Indication Threshold Reduction (TITRe2) trial is the largest randomized controlled trial to date to compare red blood cell transfusion strategies following cardiac surgery. This update presents the statistical analysis plan, detailing how the study will be analyzed and presented. The statistical analysis plan has been written following recommendations from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, prior to database lock and the final analysis of trial data. Outlined analyses are in line with the Consolidated Standards of Reporting Trials (CONSORT). The study aims to randomize 2000 patients from 17 UK centres. Patients are randomized to either a restrictive (transfuse if haemoglobin concentration <7.5 g/dl) or liberal (transfuse if haemoglobin concentration <9 g/dl) transfusion strategy. The primary outcome is a binary composite outcome of any serious infectious or ischaemic event in the first 3 months following randomization. The statistical analysis plan details how non-adherence with the intervention, withdrawals from the study, and the study population will be derived and dealt with in the analysis. The planned analyses of the trial primary and secondary outcome measures are described in detail, including approaches taken to deal with multiple testing, model assumptions not being met and missing data. Details of planned subgroup and sensitivity analyses and pre-specified ancillary analyses are given, along with potential issues that have been identified with such analyses and possible approaches to overcome such issues. ISRCTN70923932 .

Weekly iron folate supplementation in adolescent girls--an effective nutritional measure for the management of iron deficiency anaemia.

PubMed

Joshi, Mohan; Gumashta, Raghvendra

2013-03-20

Nutritional anaemia in India is common morbidity seen in late adolescent and young female population. There are many conflicting opinions regarding dosage of iron folic acid supplementation for managing this simple nutritional deficiency disorder. Hence, this 'Randomized Controlled Trial' was undertaken in adolescent girls suffering from Iron Deficiency Anaemia visiting 'Urban Health and Training Centre' situated in urban slum area. The aim of this study was to assess the (a) Impact of weekly iron folic acid supplementation in comparison with daily iron supplementation for the management of Iron Deficiency Anaemia in adolescent girls visiting 'Urban Health and Training Centre'; (b) Adverse drug reaction profile in 'Weekly Iron Folic Acid Supplementation' and 'Daily Iron Folic Acid Supplementation' regimes; (c) Compliance profile for 'Weekly Iron Folic Acid Supplementation' and 'Daily Iron Folic Acid Supplementation' regimes in adolescent girls. Randomized controlled trial was conducted in adolescent girls visiting 'Urban Health and Training Centre' during the study period June, 2011 to October, 2012. The 120 anaemic (Haemoglobin < 12 gm%) adolescent girls (10-19 years) were distributed randomly by block randomization in two groups; one receiving daily Iron and Folic Acid supplementation and in other group receiving weekly Iron and Folic Acid supplementation for 3 months. All the study subjects were given de-worming (Albendazole 400 mg) and required health education separately. Both the groups were monitored for Haemoglobin estimation, compliance and adverse drug reactions, if any. Open-Epi Statistical Software was used for data analysis. The mean age of study subjects in 'Daily Iron and Folic Acid Supplementation' and 'Weekly Iron and Folic Acid Supplementation' group was 13.48 and 13.55 years respectively. Their mean pre intervention Haemoglobin was 10.1±1.1 gm/dl and 10.4±1.1 gm/dl respectively. The mean rise in Haemoglobin after lean period of 1 month in respective groups was almost equal i.e. 1.0±0.7 gm/dl and 1.0±0.8 gm/dl. Adverse Drug Reactions were 8.3% in weekly regime as compared to 13.35% in daily regime, abdominal pain being the commonest adverse drug reaction seen .The compliance calculated as mean of unconsumed 'Iron and Folic Acid' tablets was 6.1±10.98 in 'Daily Iron Folic Acid Supplementation' group, while it was 1.3±3.15 in 'Weekly Iron Folic Acid Supplementation' group (p=0.0012), making weekly regime more promising than daily regime with better treatment compliance. Weekly supplementation of 'Iron and Folic Acid' in 'Iron Deficiency Anaemia' patients is as good as daily supplementation with added benefits of less adverse reactions and better compliance.

Does Improving Joint Attention in Low-Quality Child-Care Enhance Language Development?

ERIC Educational Resources Information Center

Rudd, Loretta C.; Cain, David W.; Saxon, Terrill F.

2008-01-01

This study examined effects of professional development for child-care staff on language acquisition of children ages 14-36 months. Child-care staff from 44 child-care centres agreed to participate in the study. Child-care staff from one-half of the child-care centres were randomly assigned to a one-time, four-hour workshop followed by three…

The adaptive approach for storage assignment by mining data of warehouse management system for distribution centres

NASA Astrophysics Data System (ADS)

Ming-Huang Chiang, David; Lin, Chia-Ping; Chen, Mu-Chen

2011-05-01

Among distribution centre operations, order picking has been reported to be the most labour-intensive activity. Sophisticated storage assignment policies adopted to reduce the travel distance of order picking have been explored in the literature. Unfortunately, previous research has been devoted to locating entire products from scratch. Instead, this study intends to propose an adaptive approach, a Data Mining-based Storage Assignment approach (DMSA), to find the optimal storage assignment for newly delivered products that need to be put away when there is vacant shelf space in a distribution centre. In the DMSA, a new association index (AIX) is developed to evaluate the fitness between the put away products and the unassigned storage locations by applying association rule mining. With AIX, the storage location assignment problem (SLAP) can be formulated and solved as a binary integer programming. To evaluate the performance of DMSA, a real-world order database of a distribution centre is obtained and used to compare the results from DMSA with a random assignment approach. It turns out that DMSA outperforms random assignment as the number of put away products and the proportion of put away products with high turnover rates increase.

The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Approximately 85% of vaginal deliveries are accompanied by perineal trauma. The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma. Methods/design This is a single-centre, randomized controlled trial, with computer-generated randomization in a 1:1 allocation ratio. Women planning their first vaginal delivery (n = 650) are randomized to primary delivery of either the anterior or posterior shoulder. The primary outcome is any perineal trauma. Additional outcomes are the perineal injury subtypes, postpartum bleeding, umbilical artery pH, Apgar score at 5 minutes and any neonatal birth trauma. Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery. All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears. The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries. Data will be analyzed according to the intention-to-treat principle. Recruitment started in January 2013 and the trial is planned to proceed for 24 months. Discussion Most delivery assistance techniques are based on tradition and heritage and lack objective evidence. This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial. The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique. Trial registration ClinicalTrials.gov: NCT01937546. PMID:25047001

[Effectiveness of an intervention to improve quality care in reducing cardiovascular risk in hypertense patients].

PubMed

Gómez Marcos, Manuel A; García Ortiz, Luis; González Elena, Luis Javier; Sánchez Rodríguez, Angel

2006-05-31

To evaluate the effectiveness of an intervention on health workers, based on quality improvement through reduction of cardiovascular risk in patients with hypertension. Quasi-experimental study. Primary care. Two urban health centres. A thousand hypertense patients selected by stratified random sampling. One centre (500) was assigned to implement a quality improvement intervention, while at the other centre (500) "usual care" procedures were followed (control group). The quality improvement intervention consisted of a combined program designed for the medical and nursing staff that comprised audit, feedback, training sessions, and implementation of clinical practice guidelines. Coronary risk using the Framingham scale and cardiovascular mortality risk using the SCORE project. Absolute coronary risk decreased from 16.94% (95% CI, 15.92-17.66) to 13.81% (95% CI, 13.09-14.52) (P<.001) in the intervention group; whilst there was no significant change in the control group, which dropped from 17.63% (95% CI, 16.68-18.53) to 16.82% (95% CI, 15.91-17.74). The intervention led to a 2.28% point decrease (95% CI, 1.35-3.21) (P<.001) in coronary risk. Cardiovascular mortality risk decreased from 2.48% (95% CI, 2.35-2.62) to 2.19% (95% CI, 2.07-2.31) (P<.001) in the intervention group, with no significant change in the control group, which changed from 2.45% (95% CI, 2.30-2.59) to 2.52% (95% CI, 2.38-2.66). The intervention led to a 0.36% point decrease (95% CI, 0.05-0.73) (P<.001) in cardiovascular mortality risk. The quality improvement intervention was effective in decreasing coronary risk and cardiovascular mortality risk in patients with hypertension.

The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC): a randomised cluster controlled trial.

PubMed

Li, Yanping; Hu, Xiaoqi; Zhang, Qian; Liu, Ailing; Fang, Hongyun; Hao, Linan; Duan, Yifan; Xu, Haiquan; Shang, Xianwen; Ma, Jun; Xu, Guifa; Du, Lin; Li, Ying; Guo, Hongwei; Li, Tingyu; Ma, Guansheng

2010-05-02

Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook) and physical activity intervention (Happy 10 program) will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years) will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device), physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the intervention strategies would justify a national school-based program to prevent childhood obesity in China.

An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial.

PubMed

Bonevski, Billie; Guillaumier, Ashleigh; Shakeshaft, Anthony; Farrell, Michael; Tzelepis, Flora; Walsberger, Scott; D'Este, Catherine; Paul, Chris; Dunlop, Adrian; Searles, Andrew; Kelly, Peter; Fry, Rae; Stirling, Robert; Fowlie, Carrie; Skelton, Eliza

2016-06-14

The provision of smoking cessation support in Australian drug and alcohol treatment services is sub-optimal. This study examines the cost-effectiveness of an organisational change intervention to reduce smoking amongst clients attending drug and alcohol treatment services. A cluster-randomised controlled trial will be conducted with drug and alcohol treatment centres as the unit of randomisation. Biochemically verified (carbon monoxide by breath analysis) client 7-day-point prevalence of smoking cessation at 6 weeks will be the primary outcome measure. The study will be conducted in 33 drug and alcohol treatment services in four mainland states and territories of Australia: New South Wales, Australian Capital Territory, Queensland, and South Australia. Eligible services are those with ongoing client contact and that include pharmacotherapy services, withdrawal management services, residential rehabilitation, counselling services, and case management services. Eligible clients are those aged over 16 years who are attending their first of a number of expected visits, are self-reported current smokers, proficient in the English language, and do not have severe untreated mental illness as identified by the service staff. Control services will continue to provide usual care to the clients. Intervention group services will receive an organisational change intervention, including assistance in developing smoke-free policies, nomination of champions, staff training and educational client and service resources, and free nicotine replacement therapy in order to integrate smoking cessation support as part of usual client care. If effective, the organisational change intervention has clear potential for implementation as part of the standard care in drug and alcohol treatment centres. Australian and New Zealand Clinical Trials Registry, ACTRN12615000204549 . Registered on 3 March 2015.

Prophylactic mesh at end-colostomy construction reduces parastomal hernia rate: a randomized trial.

PubMed

Lambrecht, J R; Larsen, S G; Reiertsen, O; Vaktskjold, A; Julsrud, L; Flatmark, K

2015-10-01

Parastomal hernia (PSH) is the most common complication of an end-colostomy and about one-quarter of patients need operative repair, which is often unsuccessful. A randomized trial was carried out to compare the results of using mesh or no mesh at the time of formation of a colostomy with the clinical identification of PSH as the primary outcome. In this two-centre randomized trial (Oslo University Hospital and Sykehuset Innlandet Hospital Trust, Norway), patients with rectal cancer undergoing open pelvic surgery were randomized to receive a retromuscular synthetic mesh (study group, n = 32) or no mesh (control group, n = 26) at the time of end-colostomy formation. Postoperative follow up was not blinded and included clinical examination and routine CT. The median period of follow up was 40 (range: 84) months. There were no differences in demographic variables or complications between the study and control groups. PSH developed in two patients of the study group and in 12 of the control group [OR = 0.04 (95% CI: 0.01-0.30) and hazard ratio 0.134 (95% CI: 0.030-0.603); P < 0.001]. The number needed to treat to avoid one PSH was 2.5 patients. CT demonstrated an increase over time in the size of the fascial orifice in patients with PSH without mesh prophylaxis, in contrast to a stable size in patients with mesh and in the control patients who did not develop PSH. The retromuscular insertion of synthetic mesh at the time of formation of an end-colostomy reduced the risk of PSH. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

The Effect of Head Massage on the Regulation of the Cardiac Autonomic Nervous System: A Pilot Randomized Crossover Trial.

PubMed

Fazeli, Mir Sohail; Pourrahmat, Mir-Masoud; Liu, Mailan; Guan, Ling; Collet, Jean-Paul

2016-01-01

To evaluate the effect of a single 10-minute session of Chinese head massage on the activity of the cardiac autonomic nervous system via measurement of heart rate variability (HRV). In this pilot randomized crossover trial, each participant received both head massage and the control intervention in a randomized fashion. The study was conducted at Children's & Women's Health Centre of British Columbia between June and November 2014. Ten otherwise healthy adults (6 men and 4 women) were enrolled in this study. The intervention comprised 10 minutes of head massage therapy (HMT) in a seated position compared with a control intervention of sitting quietly on the same chair with eyes closed for an equal amount of time (no HMT). The primary outcome measures were the main parameters of HRV, including total power (TP), high frequency (HF), HF as a normalized unit, pre-ejection period, and heart rate (HR). A single short session (10 minutes) of head massage demonstrated an increase in TP continuing up to 20 minutes after massage and reaching statistical significance at 10 minutes after massage (relative change from baseline, 66% for HMT versus -6.6% for no HMT; p = 0.017). The effect on HF also peaked up to 10 minutes after massage (59.4% for HMT versus 4% for no HMT; p = 0.139). Receiving head massage also decreased HR by more than three-fold compared to the control intervention. This study shows the potential benefits of head massage by modulating the cardiac autonomic nervous system through an increase in the total variability and a shift toward higher parasympathetic nervous system activity. Randomized controlled trials with larger sample size and multiple sessions of massage are needed to substantiate these findings.

Effect of trimetazidine on recurrent angina pectoris and left ventricular structure in elderly multivessel coronary heart disease patients with diabetes mellitus after drug-eluting stent implantation: a single-centre, prospective, randomized, double-blind study at 2-year follow-up.

PubMed

Xu, Xiaohan; Zhang, Weijun; Zhou, Yujie; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei; Zhou, Zhiming; Ma, Hanying; Wang, Zhijian; Yu, Miao; Ma, Qian; Gao, Fei; Shen, Hua; Zhang, Jianwei

2014-04-01

Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %. This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF. At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P < 0.01). The E peak to A peak (E/A) ratio in trimetazidine-treated patients and in the control group decreased after 2 years; the E/A ratio in trimetazidine-treated patients was slightly better than that in the control group, without a significant difference (P = 0.170). There was no significant difference in event-free survival for the composite end point including death, myocardial infarction, cerebrovascular accident (P = 0.422) and subsequent revascularization (P = 0.073). Adjunctive therapy with trimetazidine after DES implantation can have a beneficial effect on recurrent angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.

Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres.

PubMed

Bradley, Janet; Jayanna, Krishnamurthy; Shaw, Souradet; Cunningham, Troy; Fischer, Elizabeth; Mony, Prem; Ramesh, B M; Moses, Stephen; Avery, Lisa; Crockett, Maryanne; Blanchard, James F

2017-01-07

Birthing in health facilities in India has increased over the last few years, yet maternal and neonatal mortality rates remain high. Clinical mentoring with case sheets or checklists for nurses is viewed as essential for on-going knowledge transfer, particularly where basic training is inadequate. This paper summarizes a study of the effect of such a programme on staff knowledge and skills in a randomized trial of 295 nurses working in 108 Primary Health Centres (PHCs) in Karnataka, India. Stratifying by district, half of the PHCs were randomly assigned to be intervention sites and provided with regular mentoring visits where case sheet/checklists were a central job and teaching aid, and half to be control sites, where no support was provided except provision of case sheets. Nurses' knowledge and skills around normal labour, labour complications and neonate issues were tested before the intervention began and again one year later. Univariate and multivariate analyses were conducted to examine the effect of mentoring and case sheets. Overall, on none of the 3 measures, did case sheet use without mentoring add anything to the basic nursing training when controlling for other factors. Only individuals who used both case-sheets and received mentoring scored significantly higher on the normal labour and neonate indices, scoring almost twice as high as those who only used case-sheets. This group was also associated with significantly higher scores on the complications of labour index, with their scores 2.3 times higher on average than the case sheet only control group. Individuals from facilities with 21 or more deliveries in a month tended to fare worse on all 3 indices. There were no differences in outcomes according to district or years of experience. This study demonstrates that provision of case sheets or checklists alone is insufficient to improve knowledge and practices. However, on-site mentoring in combination with case sheets can have a demonstrable effect on improving nurse knowledge and skills around essential obstetric and neonatal care in remote rural areas of India. We recommend scaling up of this mentoring model in order to improve staff knowledge and skills and reduce maternal and neonatal mortality in India. This study is registered at clinicaltrials.gov, Identifier No. NCT02004912 , November 27, 2013.

A multi-centre randomized controlled trial comparing arthroscopic osteochondroplasty and lavage with arthroscopic lavage alone on patient important outcomes and quality of life in the treatment of young adult (18-50) femoroacetabular impingement.

PubMed

2015-03-20

Several cross-sectional studies have estimated that the prevalence of femoroacetabular impingement (FAI) ranges from 14-17% among asymptomatic young adults to almost 95% among competitive athletes. With FAI, there is abnormal contact between the proximal femur and the acetabulum, resulting in abnormal mechanics with terminal motion such as hip flexion and rotation. This condition results from bony anomalies of the acetabular rim (Pincer) and or femoral head/neck junction (CAM) and typically causes hip pain and decreased hip function. The development of hip pain potentially serves as an indicator for early cartilage and labral damage that may result in hip osteoarthritis. Although surgical correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to improve hip pain and alter the natural history of degenerative disease, the supportive evidence is based upon low quality observational studies. The Femoroacetabular Impingement RandomiSed controlled Trial (FIRST) compares outcomes following surgical correction of the impingement morphology (arthroscopic osteochondroplasty) with/without labral repair versus arthroscopic lavage of the hip joint in adults aged 18 to 50 diagnosed with FAI. FIRST is a multi-centre, randomized controlled trial with a sample size of 220 patients. Exclusion criteria include the presence of hip syndromes, previous surgery or trauma to the affected hip, and significant medical comorbidities. The primary outcome is pain and the secondary outcomes include patient function, quality of life, complications, and cost-effectiveness--all within one year of follow-up. Patients are stratified based on centre and impingement sub-type. Patients, outcome assessors, data analysts, and the Steering Committee are blinded to surgical allocation. Using an intention-to-treat approach, outcome analyses will be performed using an analysis of covariance and descriptive statistics. Symptomatic FAI is associated with chronic hip pain, functional limitations, and secondary osteoarthritis. Therefore, optimizing treatment has the potential to improve the lives millions of young, active persons who are diagnosed with this condition. Few orthopaedic surgical trials have similar potential to shift the paradigm of care dramatically towards (or away) from surgical bony and soft tissue interventions. The FIRST trial is registered with clinicaltrials.gov (NCT01623843).

Free radicals and antioxidant enzymes in older adults after regular senior elastic band exercising: an experimental randomized controlled pilot study.

PubMed

Liao, Lin Yu; Chung, Wei Sheng; Chen, Kuei Min

2017-01-01

The aim of this study was to pilot test the effects of regular senior elastic band exercises on the generation of free radicals and antioxidant enzyme activities in older adults. Long-term regular exercises have positive health promotion outcomes. On the contrary, high-intensity, high-speed and short-term exercises in older adults may increase free radicals and cause chronic disease and ageing effect. A prospective randomized controlled pilot study. Data were collected during 2012. Twenty-five older adults were recruited from a community care centre, southern Taiwan and were randomly assigned to either an experimental or control group. Twenty-two participants completed the study: experimental group (n = 10) and control group (n = 12). The experimental group performed 6-month senior elastic band exercises while the control group kept regular daily routines. Both groups received blood tests (thiobarbituric acid-reacting substances and glutathione peroxidase) 30 minutes before the study began and 1 hour after the final intervention treatment. At the end of the 6-month senior elastic band exercises, no statistically significant differences in thiobarbituric acid-reacting substances and glutathione peroxidase values between the experimental and control groups. No significant differences existed in both thiobarbituric acid-reacting substances and glutathione peroxidase values before and after the 6-month senior elastic band exercises either. Regular senior elastic band exercises did not increase the generation of free radicals and antioxidant enzyme activities. Senior elastic band exercises have the potential to be promoted among older adults in the community as an exercise option without adverse effects on free radicals and have potential for mitigating ageing and increasing disease control. © 2016 John Wiley & Sons Ltd.

Stimulated luminescence emission from localized recombination in randomly distributed defects.

PubMed

Jain, Mayank; Guralnik, Benny; Andersen, Martin Thalbitzer

2012-09-26

We present a new kinetic model describing localized electronic recombination through the excited state of the donor (d) to an acceptor (a) centre in luminescent materials. In contrast to the existing models based on the localized transition model (LTM) of Halperin and Braner (1960 Phys. Rev. 117 408-15) which assumes a fixed d → a tunnelling probability for the entire crystal, our model is based on nearest-neighbour recombination within randomly distributed centres. Such a random distribution can occur through the entire volume or within the defect complexes of the dosimeter, and implies that the tunnelling probability varies with the donor-acceptor (d-a) separation distance. We first develop an 'exact kinetic model' that incorporates this variation in tunnelling probabilities, and evolves both in spatial as well as temporal domains. We then develop a simplified one-dimensional, semi-analytical model that evolves only in the temporal domain. An excellent agreement is observed between thermally and optically stimulated luminescence (TL and OSL) results produced from the two models. In comparison to the first-order kinetic behaviour of the LTM of Halperin and Braner (1960 Phys. Rev. 117 408-15), our model results in a highly asymmetric TL peak; this peak can be understood to derive from a continuum of several first-order TL peaks. Our model also shows an extended power law behaviour for OSL (or prompt luminescence), which is expected from localized recombination mechanisms in materials with random distribution of centres.

Review of drug treatment of oral submucous fibrosis.

PubMed

Chole, Revant H; Gondivkar, Shailesh M; Gadbail, Amol R; Balsaraf, Swati; Chaudhary, Sudesh; Dhore, Snehal V; Ghonmode, Sumeet; Balwani, Satish; Mankar, Mugdha; Tiwari, Manish; Parikh, Rima V

2012-05-01

This study undertook a review of the literature on drug treatment of oral submucous fibrosis. An electronic search was carried out for articles published between January 1960 to November 2011. Studies with high level of evidence were included. The levels of evidence of the articles were classified after the guidelines of the Oxford Centre for Evidence-Based Medicine. The main outcome measures used were improvement in oral ulceration, burning sensation, blanching and trismus. Only 13 publications showed a high level of evidence (3 randomized controlled trials and 10 clinical trials/controlled clinical trials), with a total of 1157 patients. Drugs like steroids, hyaluronidase, human placenta extracts, chymotrypsin and collagenase, pentoxifylline, nylidrin hydrochloride, iron and multivitamin supplements including lycopene, have been used. Only systemic agents were associated with few adverse effects like gastritis, gastric irritation and peripheral flushing with pentoxifylline, and flushingly warm skin with nylidrin hydrochloride; all other side-effects were mild and mainly local. Few studies with high levels of evidence were found. The drug treatment that is currently available for oral submucous fibrosis is clearly inadequate. There is a need for high-quality randomized controlled trials with carefully selected and standardized outcome measures. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Prospective economic evaluation of image-guided radiation therapy for prostate cancer in the framework of the national programme for innovative and costly therapies assessment].

PubMed

Pommier, P; Morelle, M; Perrier, L; de Crevoisier, R; Laplanche, A; Dudouet, P; Mahé, M-A; Chauvet, B; Nguyen, T-D; Créhange, G; Zawadi, A; Chapet, O; Latorzeff, I; Bossi, A; Beckendorf, V; Touboul, E; Muracciole, X; Bachaud, J-M; Supiot, S; Lagrange, J-L

2012-09-01

The main objective of the economical study was to prospectively and randomly assess the additional costs of daily versus weekly patient positioning quality control in image-guided radiotherapy (IGRT), taking into account the modalities of the 3D-imaging: tomography (CBCT) or gold seeds implants. A secondary objective was to prospectively assess the additional costs of 3D versus 2D imaging with portal imaging for patient positioning controls. Economics data are issued from a multicenter randomized medico-economics trial comparing the two frequencies of patient positioning control during prostate IGRT. A prospective cohort with patient positioning control with PI (control group) was constituted for the cost comparison between 3D (IGRT) versus 2D imaging. The economical evaluation was focused to the radiotherapy direct costs, adopting the hospital's point of view and using a microcosting method applied to the parameters that may lead to cost differences between evaluated strategies. The economical analysis included a total of 241 patients enrolled between 2007 and 2011 in seven centres, 183 in the randomized study (128 with CBCT and 55 with fiducial markers) and 58 in the control group. Compared to weekly controls, the average additional cost per patient of daily controls was €847 (CBCT) and €179 (markers). Compared to PI, the average additional cost per patient was €1392 (CBCT) and €997 (fiducial markers) for daily controls; €545 (CBCT) and €818 (markers) in case of weekly controls. A daily frequency for image control in IGRT and 3D images patient positioning control (IGRT) for prostate cancer lead to significant additional cost compared to weekly control and 2D imaging (PI). Long-term clinical assessment will permit to assess the medico-economical ratio of these innovative radiotherapy modalities. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

A randomized controlled trial of water-based exercise for cardiovascular fitness in individuals with chronic stroke

PubMed Central

Chu, Kelly S; Eng, Janice J; Dawson, Andrew S; Harris, Jocelyn E.; Ozkaplan, Atila; Gylfadóttir, Sif

2011-01-01

Objective To evaluate the effect of an 8-week water-based exercise program (experimental group) over an upper extremity function program (control group) to increase cardiovascular fitness within a community setting for individuals with stroke. Design Single-blind randomized controlled trial Setting Public community centre Participants 12 community-dwelling individuals who have had a stroke with mild to moderate motor deficits; volunteer sample Intervention Experimental and control groups participated in group exercise programs undertaken in one hour sessions, three times per week for 8 weeks. The experimental group undertook chest deep water exercises at targeted heart rates. The control group performed arm and hand exercises while sitting. Main Outcome Measures The primary outcome measure was cardiovascular fitness (VO2max). Secondary measures were maximal workload, muscle strength, gait speed, and the Berg Balance Score. Results The experimental group attained significant improvements over the control group in cardiovascular fitness, maximal workload, gait speed, and paretic lower extremity muscle strength. The relatively short program (8 weeks) of water-based exercise resulted in a large improvement (22%) in cardiovascular fitness in a small group of individuals with stroke with relatively high function. Conclusions A water-based exercise program can be undertaken in the community as a group program and may be an effective means to promote fitness in individuals with stroke. PMID:15179638

The use of mobile phones to deliver acceptance and commitment therapy in the prevention of mother-child HIV transmission in Nigeria.

PubMed

Ishola, A G; Chipps, J

2015-12-01

The objective of this study was to determine if introducing acceptance and commitment therapy in the prevention of mother to child HIV transmission (PMTCT) programme using weekly mobile phone messages would result in improved mental health status of HIV-positive, pregnant women in Nigeria. We used a Solomon four-group (two intervention and two control groups) randomised design. The study population was 144 randomly selected, HIV-positive pregnant women attending four randomly selected PMTCT centres in Nigeria. The intervention groups were exposed to one session of acceptance and commitment therapy with weekly value-based health messages sent by mobile phone for three months during pregnancy. The control groups received only post-HIV test counselling. A total of 132 participants (33 per site) were enrolled in the study from the two intervention and two control sites. In the pre-tests, the intervention and control groups did not differ significantly with regard to demographics. Evaluation of the pre- and post-tests of the intervention group indicated significantly higher Action and Acceptance Questionnaire (AAQ-II) scores. The introduction of a mobile phone acceptance and commitment therapy programme may result in greater psychological flexibility in women diagnosed with HIV. © The Author(s) 2015.

A randomized, controlled comparison of home versus institutional rehabilitation of patients with hip fracture.

PubMed

Kuisma, Raija

2002-08-01

To compare ambulation outcomes between home and institutional rehabilitation of patients with hip fracture. Randomized controlled clinical equivalence trial. The Queen Elizabeth Hospital in Hong Kong. Eighty-one patients with hip fracture. Study group patients (40) were discharged directly home from the acute hospital and visited by a physiotherapist an average of 4.6 times. The control group subjects (41) were discharged to a rehabilitation centre for further treatment lasting on average 36.2 days (SD 14.6) and they received physiotherapy daily. Ambulation ability measured on a categorical scale. The mean age of the subjects was 75 years (SD 8.3 years). Females comprised 60% of all the subjects and majority were retired or home makers. Both groups of patients improved in their ambulation ability during their rehabilitation period but neither group achieved their pre-ambulatory status by the time of completion of the study. The study group achieved significantly higher ambulation scores (p < 0.05) for community and household ambulation compared with the control group by the end of the study, a year after operation. Five visits by a physiotherapist in the patient's home after discharge from an acute hospital after surgical treatment for hip fracture yielded better results in ambulation ability than one month of conventional institution-based rehabilitation.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

Modified Constraint-Induced Therapy for Children with Hemiplegic Cerebral Palsy: A Randomized Trial

ERIC Educational Resources Information Center

Wallen, Margaret; Ziviani, Jenny; Naylor, Olivia; Evans, Ruth; Novak, Iona; Herbert, Robert D.

2011-01-01

Aim: Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study…

Effect of second dose of measles vaccine on measles antibody status: a randomized controlled trial.

PubMed

Fazilli, Anjum; Mir, Abid Ali; Shah, Rohul Jabeen; Bhat, Imtiyaz Ali; Fomda, Bashir Ahmad; Bhat, Mushtaq Ahmad

2013-05-08

To evaluate the effect of the second dose of measles vaccine on measles antibody status during childhood. Immunization centre of Under-five Clinic of the Department of Community Medicine at a tertiary-hospital. Randomized Controlled trial. Children from 6 years to 17 year old. 188 with simple obesity, and 431 with obesity and metabolic abnormalities. 274 age and gender-matched healthy children as controls. Blood samples were collected from all subjects for baseline measles serology by heel puncture at 9-12 months of age. All subjects were given the first dose of measels vaccine. At second visit (3-5 months later), after collecting the blood sample from all, half the children were randomized to receive the second dose of measles vaccine (study group), followed by collection of the third sample six weeks later in all the subjects. A total of 78 children were enrolled and 30 children in each group could be analyzed. 11(36.6%) children in the study group and 13 (43.3%) children in the control group had protective levels of measles IgG at baseline. Around 93.3% of children in the study group had protective measles antibody titers as against 50% in the control group at the end of the trial. The Geometric Mean Titre (GMT) of measles IgG increased from 14.8 NTU/mL to 18.2 NTU/mL from baseline to six weeks following receipt of the second dose of the vaccine in the study group, as compared to a decrease from 16.8 NTU/mL to 12.8 NTU/mL in the control group. A second dose of measles vaccine boosts the measles antibody status in the study population as compared to those who receive only a single dose.

Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double-blinded, double-dummy positive controlled trial.

PubMed

Wu, Qian Lin; Liu, Yu Ping; Lu, Ju Ming; Wang, Chang Jiang; Yang, Tao; Dong, Ji Xiang; Li, Cheng Jiang; Ma, Jian Hua; Xue, Yao Ming; Sun, Rui Hua; Wei, Dong; Tian, Hao Ming

2012-08-01

To evaluate the effect and safety of HbA1c and glycemic control of acarbose chewable tablets in patients with type 2 diabetic. A multicentre, randomized, double-blinded, double-dummy, positive controlled clinical trial was conducted. Two hundred thirty-four Chinese patients with type 2 diabetic were enrolled in eight clinical centres, who were divided randomly into the acarbose chewable tablet group (experimental group, n = 116) and the acarbose treatment group (control group, n = 118). Two hundred seven patients (88.5%) took part in the 12-week trial. At the beginning and end of the clinical trial, HbA1c and blood glucose as well as safety indexes were measured. After the treatment, the level of finger two-hour postprandial blood glucose (PPBG) was decreased 4.15 mmol/L (26.82%) and 3.54 mmol/L (22.77%), respectively, in the experiment group and the control group. The levels of venous two-hour PPBG in the experiment group and the control group were decreased 4.04 mmol/L (25.38%) and 2.75 mmol/L (17.26%), respectively, with the means of HbA1c lowering 11.67% and 12.44%, respectively. Fasting blood glucose (FBG) also was reduced significantly in both groups. Patients in both groups showed obvious weight reduction (P < 0.0001). There were no significant differences in the incidence of adverse events between the two groups. In summary, acarbose chewable tablets have a definite curative effect in treating type 2 diabetic patients as HbA1c and blood glucose levels decreased significantly after the 12-week treatment. © 2012 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Impact of a short home-based yoga programme on blood pressure in patients with hypertension: a randomized controlled trial in primary care.

PubMed

Wolff, M; Rogers, K; Erdal, B; Chalmers, J P; Sundquist, K; Midlöv, P

2016-10-01

The present study was designed to evaluate yoga's impact on blood pressure (BP) and quality of life (QOL) and on stress, depression and anxiety in patients with hypertension in a primary care setting. We conducted a multi-centre randomized controlled trial with follow-up after 12-week intervention completion. Adult primary care patients diagnosed with hypertension were randomly allocated to yoga or usual care. The intervention group performed a short home-based Kundalini yoga programme 15 min twice-daily during the 12-week intervention period. At baseline and follow-up, the participants underwent standardized BP measurements and completed questionnaires on QOL, stress, anxiety and depression. Data obtained from 191 patients (mean age 64.7 years, s.d. 8.4) allocated to yoga intervention (n=96) and control group (n=95), with a total proportion of 52% women, showed a significant reduction in systolic and diastolic BP for both groups (-3.8/-1.7 mm Hg for yoga and -4.5/-3.0 mm Hg for control groups, respectively). However, the BP reduction for the yoga group was not significantly different from control. There were small but significant improvements for the yoga group in some of the QOL and depression measures (P<0.05, Hospital Anxiety and Depression scale, HADS-D) compared with control. The findings of our study, which is the largest study from an OECD country (Organization for Economic Co-operation and Development) to date, do not support the suggestion from previous smaller studies that yoga lowers the BP. Further clinical trials are needed to confirm these findings. However, the yoga patients had other health benefits.

Effects of vibration therapy on hormone response and stress in severely disabled patients: a double-blind randomized placebo-controlled clinical trial.

PubMed

Seco, J; Rodríguez-Pérez, V; López-Rodríguez, A F; Torres-Unda, J; Echevarria, E; Díez-Alegre, M I; Ortega, A; Morán, P; Mendoza-Laíz, N; Abecia Inchaurregui, L C

2015-01-01

To assess the effects of vibration therapy (VT) on quality of life and hormone response in severely disabled patients compared with placebo. A longitudinal prospective, double-blind, randomized placebo-controlled trial, with pre and postintervention assessments. A total of 20 severely disabled individuals were recruited from a National Reference Centre in Spain: 13 (65%) men and 7 (35%) women, 45.5 ± 9.32 years of age (range 41: 22-63). We evaluated their physical stress and state anxiety. No statistically significant changes were found in the socio-psychological variables studied, while in the experimental group state anxiety decreased significantly with p < 0.01 (Z = 2.38; one-tailed p = .009) and, among the biological variables, the level of cortisol fell (p = 0.03). Short periods of exposure to low-frequency and low-amplitude local vibration are a safe and effective mechanical stimulus that can have a positive effect in terms of hormone response. VT can be considered to have an anti-stress effect. © 2013 Association of Rehabilitation Nurses.

The Development and Evaluation of a Life Skills Programme for Young Adult Offenders.

PubMed

Jordaan, Jacques; Beukes, Roelf; Esterhuyse, Karel

2017-10-01

The purpose of this research project was to develop, implement, and evaluate a Life Skills programme for young adult male long-term offenders with the aim of improving their life skills that, in turn, could enable them to adjust more effectively in the correctional environment. Experimental research was used to investigate the effectiveness of the programme. In this study, 96 literate young adult male offenders between the ages of 21 and 25 years, with long sentences, were selected randomly. The participants were assigned randomly into an experimental and a control group. The Solomon four-group design was utilized to control for the effect of pretest sensitization. The measurements of the effectiveness of the programme were conducted before the programme commenced, directly (short term) after, 3 months (medium term) after, and 6 months (long term) after. The findings indicated that the programme had limited success in equipping the offenders with the necessary skills crucial to their survival in a correctional centre. The programme did, however, have significant effects, especially on problem solving and anger management in the short and medium term. These improvements were not long lived.

Using interactive voice response to improve disease management and compliance with acute coronary syndrome best practice guidelines: A randomized controlled trial.

PubMed

Sherrard, Heather; Duchesne, Lloyd; Wells, George; Kearns, Sharon Ann; Struthers, Christine

2015-01-01

There is evidence from large clinical trials that compliance with standardized best practice guidelines (BPGs) improves survival of acute coronary syndrome (ACS) patients. However, their application is often suboptimal. In this study, the researchers evaluated whether the use of an interactive voice response (IVR) follow-up system improved ACS BPG compliance. This was a single-centre randomized control trial (RCT) of 1,608 patients (IVR=803; usual care=805). The IVR group received five automated calls in 12 months. The primary composite outcome was increased medication compliance and decreased adverse events. A significant improvement of 60% in the IVR group for the primary composite outcome was found (RR 1.60, 95% CI: 1.29 to 2.00, p <0.001). There was significant improvement in medication compliance (p <0.001) and decrease in unplanned medical visits (p = 0.023). At one year, the majority of patients ( 85%) responded positively to using the system again. Follow-up by IVR produced positive outcomes in ACS patients.

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

Clustering and Hazard Estimation in the Auckland Volcanic Field, New Zealand

NASA Astrophysics Data System (ADS)

Cronin, S. J.; Bebbington, M. S.

2009-12-01

The Auckland Volcanic Field (AVF) with its 49 eruptive centres formed over the last c. 250 ka presents several unique challenges to our understanding of distributed volcanic field construction and evolution. Due to the youth of the field, high-resolution stratigraphy of eruption centres and ash-fall sequences is possible, allowing time-breaks, soil and peat formation between eruption units to be identified. Radiocarbon dating of sediments between volcanic deposits shows that at least five of the centres have erupted on more than one occasion, with time breaks of 50-100 years between episodes. In addition, paleomagnetic and ash fall evidence implies that there has been strong clustering of eruption events over time, with a specific “flare-up” event involving over possibly up to 19 eruptions occurring between 35-25 ka, in spatially disparate locations. An additional complicating factor is that the only centre that shows any major evidence for evolution out of standard alkali basaltic compositions is also the youngest and largest in volume by several orders of magnitude. All of these features of the AVF, along with relatively poor age-control for many of the vents make spatio-temporal hazard forecasting for the field based on assumptions of past behaviour extremely difficult. Any relationships that take volumetric considerations into account are particularly difficult, since any trend analysis produces unreasonably large future eruptions. The most reasonable model is spatial, via eruption location. We have re-examined the age progression of eruptive events in the AVF, incorporating the most reliable sources of age and stratigraphic data, including developing new correlations between ashfall records in cores and likely vent locations via a probabilistic model of tephra dispersal. A Monte Carlo procedure using the age-progression, stratigraphy and dating constraints can then randomly reproduce likely orderings of events in the field. These were fitted by a clustering-based model of vent locations as originally applied by Magill et al (2005: Mathematical Geol. 37: 227-242) to the Allen and Smith (1994; Geosci. Report Shizuoka Univ 20: 5-14) age ordering of volcanism at AVF. Applying this model, modified by allowing continuation of activity at or around the youngest event, to sampled age orderings from the Monte Carlo procedure shows a very different spatial forecast to the earlier analysis. It is also different to the distribution from randomly ordered events, implying there is at least some clustering control on the location of eruptions in the field. Further iterations of this modelling approach will be tested in relation to eruptive volume and applied to other comparative volcanic fields.

Population deworming every 6 months with albendazole in 1 million pre-school children in north India: DEVTA, a cluster-randomised trial

PubMed Central

Awasthi, Shally; Peto, Richard; Read, Simon; Richards, Susan M; Pande, Vinod; Bundy, Donald; the DEVTA (Deworming and Enhanced Vitamin A) team

2013-01-01

Summary Background In north India many pre-school children are underweight, many have intestinal worms, and 2–3% die at ages 1·0–6·0 years. We used the state-wide Integrated Child Development Service (ICDS) infrastructure to help to assess any effects of regular deworming on mortality. Methods Participants in this cluster-randomised study were children in catchment areas of 8338 ICDS-staffed village child-care centres (under-5 population 1 million) in 72 administrative blocks. Groups of four neighbouring blocks were cluster-randomly allocated in Oxford between 6-monthly vitamin A (retinol capsule of 200 000 IU retinyl acetate in oil, to be cut and dripped into the child's mouth every 6 months), albendazole (400 mg tablet every 6 months), both, or neither (open control). Analyses of albendazole effects are by block (36 vs 36 clusters). The study spanned 5 calendar years, with 11 6-monthly mass-treatment days for all children then aged 6–72 months. Annually, one centre per block was randomly selected and visited by a study team 1–5 months after any trial deworming to sample faeces (for presence of worm eggs, reliably assessed only after mid-study), weigh children, and interview caregivers. Separately, all 8338 centres were visited every 6 months to monitor pre-school deaths (100 000 visits, 25 000 deaths at age 1·0–6·0 years [the primary outcome]). This trial is registered at ClinicalTrials.gov, NCT00222547. Findings Estimated compliance with 6-monthly albendazole was 86%. Among 2589 versus 2576 children surveyed during the second half of the study, nematode egg prevalence was 16% versus 36%, and most infection was light. After at least 2 years of treatment, weight at ages 3·0–6·0 years (standardised to age 4·0 years, 50% male) was 12·72 kg albendazole versus 12·68 kg control (difference 0·04 kg, 95% CI −0·14 to 0·21, p=0·66). Comparing the 36 albendazole-allocated versus 36 control blocks in analyses of the primary outcome, deaths per child-care centre at ages 1·0–6·0 years during the 5-year study were 3·00 (SE 0·07) albendazole versus 3·16 (SE 0·09) control, difference 0·16 (SE 0·11, mortality ratio 0·95, 95% CI 0·89 to 1·02, p=0·16), suggesting absolute risks of dying between ages 1·0 and 6·0 years of roughly 2·5% albendazole versus 2·6% control. No specific cause of death was significantly affected. Interpretation Existing ICDS village staff can be organised to deliver simple pre-school interventions sustainably for many years at low cost, but regular deworming had little effect on mortality in this lightly infected pre-school population. Funding UK Medical Research Council, USAID, World Bank (albendazole donated by GlaxoSmithKline). PMID:23498850

Peritoneal Dialysate Glucose Load and Systemic Glucose Metabolism in Non-Diabetics: Results from the GLOBAL Fluid Cohort Study

PubMed Central

Chess, James; Do, Jun-Young; Noh, Hyunjin; Lee, Hi-Bahl; Kim, Yong-Lim; Summers, Angela; Williams, Paul Ford; Davison, Sara; Dorval, Marc

2016-01-01

Background and Objectives Glucose control is a significant predictor of mortality in diabetic peritoneal dialysis (PD) patients. During PD, the local toxic effects of intra-peritoneal glucose are well recognized, but despite large amounts of glucose being absorbed, the systemic effects of this in non-diabetic patients are not clear. We sought to clarify whether dialysate glucose has an effect upon systemic glucose metabolism. Methods and Materials We analysed the Global Fluid Study cohort, a prospective, observational cohort study initiated in 2002. A subset of 10 centres from 3 countries with high data quality were selected (368 incident and 272 prevalent non-diabetic patients), with multilevel, multivariable analysis of the reciprocal of random glucose levels, and a stratified-by-centre Cox survival analysis. Results The median follow up was 5.6 and 6.4 years respectively in incident and prevalent patients. On multivariate analysis, serum glucose increased with age (β = -0.007, 95%CI -0.010, -0.004) and decreased with higher serum sodium (β = 0.002, 95%CI 0.0005, 0.003) in incident patients and increased with dialysate glucose (β = -0.0002, 95%CI -0.0004, -0.00006) in prevalent patients. Levels suggested undiagnosed diabetes in 5.4% of prevalent patients. Glucose levels predicted death in unadjusted analyses of both incident and prevalent groups but in an adjusted survival analysis they did not (for random glucose 6–10 compared with <6, Incident group HR 0.92, 95%CI 0.58, 1.46, Prevalent group HR 1.42, 95%CI 0.86, 2.34). Conclusions In prevalent non-diabetic patients, random glucose levels at a diabetic level are under-recognised and increase with dialysate glucose load. Random glucose levels predict mortality in unadjusted analyses, but this association has not been proven in adjusted analyses. PMID:27249020

Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial.

PubMed

van Barneveld, Kevin W Y; Smeets, Boudewijn J J; Heesakkers, Fanny F B M; Bosmans, Joanna W A M; Luyer, Misha D; Wasowicz, Dareczka; Bakker, Jaap A; Roos, Arnout N; Rutten, Harm J T; Bouvy, Nicole D; Boelens, Petra G

2016-06-01

To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery. Previously, it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients. A preplanned substudy of a previous prospective, randomized, open-label, single-centre study, comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer. Early enteral nutrition reduced postoperative ileus, anastomotic leakage, and hospital stay. Tertiary referral centre for locally advanced and recurrent rectal cancer. A total of 123 patients with locally advanced or recurrent rectal carcinoma requiring major rectal surgery. Patients were randomized (ALEA web-based external randomization) preoperatively into two groups: early enteral nutrition (early enteral nutrition, intervention) by nasojejunal tube (n = 61) or early parenteral nutrition (early parenteral nutrition, control) by jugular vein catheter (n = 62). Eight hours after the surgical procedure artificial nutrition was started in hemodynamically stable patients, stimulating oral intake in both groups. Blood samples were collected to measure plasma glutamine, citrulline, and arginine concentrations using a validated ultra performance liquid chromatography-tandem mass spectrometric method. Baseline concentrations were comparable for both groups. Directly after rectal surgery, a decrease in plasma amino acids was observed. Plasma glutamine concentrations were higher in the parenteral group than in the enteral group on postoperative day 1 (p = 0.027) and day 5 (p = 0.008). Arginine concentrations were also significantly increased in the parenteral group at day 1 (p < 0.001) and day 5 (p = 0.001). Lower plasma glutamine and arginine concentrations were measured in the enteral group, whereas a better clinical outcome was observed. We conclude that plasma amino acids do not provide a causal explanation for the observed beneficial effects of early enteral feeding after major rectal surgery.

The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial.

PubMed

Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent; Gluud, Christian; Jobes, David A; Nordentoft, Merete

2014-05-29

In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. Clinical Trial.gov: NCT01512602.

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures.

PubMed

2014-06-26

Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813).

Banding versus bonding of first permanent molars: a multi-centre randomized controlled trial.

PubMed

Nazir, Mariyah; Walsh, Tanya; Mandall, Nicky A; Matthew, Susie; Fox, Dee

2011-06-01

To assess the effectiveness of banding versus bonding of first permanent molars during fixed appliance treatment; in terms of attachment failure, patient discomfort and post-treatment enamel demineralization. Multi-centre randomized clinical trial. One District General Hospital Orthodontic Department and two Specialist Orthodontic Practices. Orthodontic patients aged between 10 and 18 years old, randomly allocated to either receive molar bands (n=40) or molar bonds (n=40). Bands were cemented with a conventional glass ionomer cement and tubes were bonded with light-cured composite to all four first permanent molar teeth for each subject. Attachments were reviewed at each recall appointment to assess loosening or loss. The clinical end point of the trial was the day of appliance debond. Enamel demineralization at debond was assessed using the modified International Caries Assessment and Detection System (ICDAS). The first time failure rate for molar bonds was 18·4% and 2·6% for molar bands (P=0·0002). Survival analysis demonstrated molar bonds were more likely to fail compared with molar bands. First permanent molars with bonded tubes experienced more demineralization than those with cemented bands (P=0·027). There was no statistically significant difference in discomfort experienced by patients after banding or bonding first permanent molars (P>0·05). This study shows that as part of fixed appliance therapy, American Orthodontics photoetched first permanent molar bands cemented with 3M ESPE Ketac-Cem perform better than American Orthodontics low profile photo-etched and mesh-based first permanent molar tubes bonded with 3M Unitek Transbond XT in terms of failure behaviour and molar enamel demineralization.

Biomechanical analysis of knee and trunk in badminton players with and without knee pain during backhand diagonal lunges.

PubMed

Lin, Cheng-Feng; Hua, Shiang-Hua; Huang, Ming-Tung; Lee, Hsing-Hsan; Liao, Jen-Chieh

2015-01-01

The contribution of core neuromuscular control to the dynamic stability of badminton players with and without knee pain during backhand lunges has not been investigated. Accordingly, this study compared the kinematics of the lower extremity, the trunk movement, the muscle activation and the balance performance of knee-injured and knee-uninjured badminton players when performing backhand stroke diagonal lunges. Seventeen participants with chronic knee pain (injured group) and 17 healthy participants (control group) randomly performed two diagonal backhand lunges in the forward and backward directions, respectively. This study showed that the injured group had lower frontal and horizontal motions of the knee joint, a smaller hip-shoulder separation angle and a reduced trunk tilt angle. In addition, the injured group exhibited a greater left paraspinal muscle activity, while the control group demonstrated a greater activation of the vastus lateralis, vastus medialis and medial gastrocnemius muscle groups. Finally, the injured group showed a smaller distance between centre of mass (COM) and centre of pressure, and a lower peak COM velocity when performing the backhand backward lunge tasks. In conclusion, the injured group used reduced knee and trunk motions to complete the backhand lunge tasks. Furthermore, the paraspinal muscles contributed to the lunge performance of the individuals with knee pain, whereas the knee extensors and ankle plantar flexor played a greater role for those without knee pain.

Effect of Village Health Team Home Visits and Mobile Phone Consultations on Maternal and Newborn Care Practices in Masindi and Kiryandongo, Uganda: A Community-Intervention Trial

PubMed Central

Mangwi Ayiasi, Richard; Kolsteren, Patrick; Batwala, Vincent; Criel, Bart; Orach, Christopher Garimoi

2016-01-01

Introduction The World Health Organisation recommends home visits conducted by Community Health Workers (in Uganda known as Village Health Teams—VHTs) in order to improve maternal and newborn health. This study measured the effect of home visits combined with mobile phone consultations on maternal and newborn care practices. Method In a community intervention trial design 16 health centres in Masindi and Kiryandongo districts, Uganda were randomly and equally allocated to one of two arms: control and intervention arms. Eight control health centres received the usual maternal and newborn educational messages offered by professional health workers and eight intervention health centres that received an intervention package for maternal care and essential newborn care practices. In the intervention arm VHTs made two prenatal and one postnatal home visit to households. VHTs were provided with mobile phones to enable them make regular telephone consultations with health workers at the health centre serving the catchment area. The primary outcome was health facility delivery. Other outcomes included antenatal attendances, birth preparedness, cord and thermal care and breastfeeding practices. Analysis was by intention-to-treat. Results A total of 1385 pregnant women were analysed: 758 and 627 in the control and intervention arms respectively. Significant post-intervention differences were: delivery place [adjusted Odds Ratio aOR: 17.94(95%CI: 6.26–51.37); p<0.001], cord care [aOR: 3.05(95%CI: 1.81–5.12); p<0.001] thermal care [aOR: 7.58(95%CI: 2.52–22.82); p<0.001], and timely care-seeking for newborn illness [aOR: 4.93(95%CI: 1.59–15.31); p = 0.006]. Conclusion VHTs can have an effect in promoting proper cord and thermal care for the newborn and improve timely care-seeking for health facility delivery and newborn illness, because they could answer questions and refer patients correctly. However, VHTs should be supported by professional health workers through the use of mobile phones. Trial Registration ClinicalTrials.gov NCT02084680 PMID:27101379

Personal navigation increases colorectal cancer screening uptake.

PubMed

Ritvo, Paul G; Myers, Ronald E; Paszat, Lawrence F; Tinmouth, Jill M; McColeman, Joshua; Mitchell, Brian; Serenity, Mardie; Rabeneck, Linda

2015-03-01

Prior randomized, controlled trials (RCTs) indicate that patient navigation can boost colorectal cancer screening rates in primary care. The sparse literature on pragmatic trials of interventions designed to increase colorectal cancer screening adherence motivated this trial on the impact of a patient navigation intervention that included support for performance of the participants' preferred screening test (colonoscopy or stool blood testing). Primary care patients (n = 5,240), 50 to 74 years of age, with no prior diagnosis of bowel cancer and no record of a recent colorectal cancer screening test, were identified at the Group Health Centre in northern Ontario. These patients were randomly assigned to an intervention group (n = 2,629) or a usual care control group (n = 2,611). Intervention group participants were contacted by a trained nurse navigator by telephone to discuss colorectal cancer screening. Interested patients met with the navigator, who helped them identify and arrange for performance of the preferred screening test. Control group participants received usual care. Multivariate analyses were conducted using medical records data to assess intervention impact on screening adherence within 12 months after randomization. Mean patient age was 59 years, and 50% of participants were women. Colorectal cancer screening adherence was higher in the intervention group (35%) than in the control group (20%), a difference that was statistically significant (OR, 2.11; confidence interval, 1.87-2.39). Preference-based patient navigation increased screening uptake in a pragmatic RCT. Patient navigation increased colorectal cancer screening rates in a pragmatic RCT in proportions similar to those observed in explanatory RCTs. ©2014 American Association for Cancer Research.

The effect of massage on immune function and stress in women with breast cancer--a randomized controlled trial.

PubMed

Billhult, A; Lindholm, C; Gunnarsson, Ronny; Stener-Victorin, E

2009-10-05

To examine the short-term effects of light pressure effleurage on circulating lymphocytes by studying the number and activity of peripheral blood natural killer (NK) cells in patients with breast cancer compared to a control group. Furthermore, the effect of light pressure effleurage on salivary cortisol levels, heart rate and blood pressure was studied. Single centre, prospective, randomized and controlled study. Thirty women, aged 50 to 75 years (mean 61 sd=7.2) with breast cancer undergoing radiation therapy in a hospital in southwestern Sweden were enrolled in the study. They were allocated to either receive massage in the form of a full-body light pressure effleurage treatment, or a control visit where they were given an equal amount of attention. Blood samples, saliva, notation of heart rate and blood pressure were collected before and after massage/control visit. Differences in change over time between groups were analyzed by Student's t-test. Light pressure effleurage massage decreased the deterioration of NK cell activity occurring during radiation therapy. Furthermore it lowered heart rate and systolic blood pressure. No effects were demonstrated on cortisol and diastolic pressure. A single full-body light pressure effleurage massage has a short-term effect on NK cell activity, systolic blood pressure and heart rate in patients with breast cancer. However, the long-term clinical importance of these findings needs to be further investigated.

Examining the nutritional quality of food and beverage consumed at Melbourne aquatic and recreation centres.

PubMed

Boelsen-Robinson, Tara; Chung, Alexandra; Khalil, Marianne; Wong, Evelyn; Kurzeme, Ariana; Peeters, Anna

2017-04-01

Examine the nutritional quality of food and beverages consumed across a sample of community aquatic and recreation centres in metropolitan Melbourne, Australia. Interviewer-administered surveys of randomly selected patrons attending four aquatic and recreation centres were conducted to ascertain food and beverage items consumed over two data collection periods (May-June 2014, January-February 2015). We selected centres in and around metropolitan Melbourne with a sit-down cafeteria and children's swimming classes. We classified items by government nutrient profiling guidelines; 'green' (best choice), 'amber' (choose carefully) or 'red' (limit). A total of 2,326 surveys were conducted (response rate 63%). Thirty-five per cent of surveyed patrons consumed food or beverages while at the centre; 54% of patrons purchased from the café and 61% brought items to the centre. More than half the food consumed from the café was 'red', increasing to 92% for children. One in five children visiting the centre consumed a 'red' item bought from the centre café. The nutritional quality of food and beverages consumed at recreation centres was generally poor, with the on-site cafés providing the majority of discretionary items consumed. Implications for public health: Community aquatic and recreation centres provide an opportunity to promote healthy eating by increasing the provision of healthy options and limiting discretionary food and drink items. © 2017 The Authors.

Cross-cultural differences in the management of children and adolescents with diabetes.

PubMed

Greene, A C; Tripaldi, M; Chiarelli, F; McKiernan, P; Morris, A; Newton, R; Greene, S

2002-01-01

Glycaemic control deteriorates frequently in adolescents with diabetes. There is a considerable body of work on the effect of psychological aspects of management in this age group, but few randomized controlled trials of the effect of specific behavioural therapy and lifestyle modification on the improvement of glycaemic control. Of recent interest have been the observations from the Hvidøre Study Group on cross-cultural differences in glycaemic control. The average glycosylated haemoglobin in 22 centres, across 18 countries, varied in young people, with HbA1c levels ranging from 7.6 to 10.2%. No obvious differences in management were identified in this survey that could account for the disparities in glycaemic control. Data from the Scottish Study Group demonstrated similar variation in average glycaemic control in centres across a single culture. Using the qualitative methodology of anthropological research, some specific factors were identified that appear to influence young people's response to diabetes management and strategies employed by health professionals in their advice and care of the diabetes, particularly in relation to intensive insulin regimens. The main cultural factors influencing glycaemic control appear to be communication, reciprocal support between young people and professional heart carers and family structure within an individualistic, as against an egalitarian, society. Shared beliefs about teenage risk behaviour together with the medicalization of adolescence within medical culture also appears to be highly influential. The aim of this educational discussion group was to explore how a variety of health care professionals from distinctive cultures approach diabetes care delivery in this age group. The specific success and difficulties in different cultures in managing the young person with diabetes were investigated. Also discussed was how qualitative research methodology may generate further research in this area. Copyright 2002 S. Karger AG, Basel

Financing Adult Education: How Adequate Are Current Sources in Facilitating Access and Participation in Centres in Murang'a South Sub-County, Murang'a County, Kenya?

ERIC Educational Resources Information Center

Maina, Ndonga James; Orodho, John Aluko

2016-01-01

The thrust of this study was to examine the level of adequacy of current sources in facilitating access and participation in adult education centres in Murang'a South Sub-County, Murang'a County, Kenya. The study adopted the descriptive survey design. Combinations of purposive and stratified random sampling techniques were used to select 82…

A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.

PubMed

Lomax, A; Patel, S; Wang, N; Kakar, K; Kakar, A; Bosma, M L

2017-11-01

In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use. © 2016 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.

Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

PubMed

Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

2017-08-08

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

PubMed

Goebel, Andreas; Baranowski, Andrew; Maurer, Konrad; Ghiai, Artemis; McCabe, Candy; Ambler, Gareth

2010-02-02

Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients. To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions. A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259) University College London Hospitals Pain Management Centre. Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment. IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days. The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment. 13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported. The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation. IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed. Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.

ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline.

PubMed

2005-07-01

The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level; and of intensive glucose lowering, in high-risk individuals with Type 2 diabetes. The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo; and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America. Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11,140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg; the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries. With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk individuals with Type 2 diabetes.

Balance exercise for persons with multiple sclerosis using Wii games: a randomised, controlled multi-centre study.

PubMed

Nilsagård, Ylva E; Forsberg, Anette S; von Koch, Lena

2013-02-01

The use of interactive video games is expanding within rehabilitation. The evidence base is, however, limited. Our aim was to evaluate the effects of a Nintendo Wii Fit® balance exercise programme on balance function and walking ability in people with multiple sclerosis (MS). A multi-centre, randomised, controlled single-blinded trial with random allocation to exercise or no exercise. The exercise group participated in a programme of 12 supervised 30-min sessions of balance exercises using Wii games, twice a week for 6-7 weeks. Primary outcome was the Timed Up and Go test (TUG). In total, 84 participants were enrolled; four were lost to follow-up. After the intervention, there were no statistically significant differences between groups but effect sizes for the TUG, TUGcognitive and, the Dynamic Gait Index (DGI) were moderate and small for all other measures. Statistically significant improvements within the exercise group were present for all measures (large to moderate effect sizes) except in walking speed and balance confidence. The non-exercise group showed statistically significant improvements for the Four Square Step Test and the DGI. In comparison with no intervention, a programme of supervised balance exercise using Nintendo Wii Fit® did not render statistically significant differences, but presented moderate effect sizes for several measures of balance performance.

The effectiveness of foot orthotics in improving postural control in individuals with chronic ankle instability: a critically appraised topic.

PubMed

Gabriner, Michael L; Braun, Brittany A; Houston, Megan N; Hoch, Matthew C

2015-02-01

Chronic ankle instability (CAI) is a condition commonly experienced by physically active individuals. It has been suggested that foot orthotics may increase a CAI patient's postural control. For patients with CAI, is there evidence to suggest that an orthotic intervention will help improve postural control? The literature was searched for studies of level 2 evidence or higher that investigated the effects of foot orthotics on postural control in patients with CAI. The search of the literature produced 5 possible studies for inclusion; 2 studies met the inclusion criteria and were included. One randomized controlled trial and 1 outcomes study were included. Foot orthotics appear to be effective at improving postural control in patients with CAI. There is moderate evidence to support the use of foot orthotics in the treatment of CAI to help improve postural control. There is grade B evidence that foot orthotics help improve postural control in people with CAI. The Centre of Evidence Based Medicine recommends a grade of B for level 2 evidence with consistent findings.

Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

PubMed

de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

2013-05-24

The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive and neuropathic pain. Therefore, pain relief can be thoroughly evaluated. NTR1089.

'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. Methods and design The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams. The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance. Discussion The perspective is to provide new knowledge on contextual effects of different simulation settings. Trial registration ClincialTrials.gov NCT01792674. PMID:23870501

'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial.

PubMed

Sørensen, Jette Led; Van der Vleuten, Cees; Lindschou, Jane; Gluud, Christian; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Albrechtsen, Charlotte Krebs; Pedersen, Berit Woetman; Kjærgaard, Hanne; Weikop, Pia; Ottesen, Bent

2013-07-17

Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams.The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance. The perspective is to provide new knowledge on contextual effects of different simulation settings. ClincialTrials.gov NCT01792674.

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

PubMed

Bilger, Marcel; Wong, Tina T; Howard, Kaye L; Lee, Jia Yi; Toh, Ai Nee; John, Geraldine; Lamoureux, Ecosse L; Finkelstein, Eric A

2016-07-15

Many glaucoma patients do not adhere to their medication regimens because they fail to internalize the (health) costs of non-adherence, which may not occur until years or decades later. Behavioural economic theory suggests that adherence rates can be improved by offering patients a near-term benefit. Our proposed strategy is to offer adherence-contingent rebates on medication and check-up costs. This form of value pricing (VP) ensures that rebates are granted only to those most likely to benefit. Moreover, by leveraging loss aversion, rebates are expected to generate a stronger behavioural response than equivalent financial rewards. The main objective of the Study on Incentives for Glaucoma Medication Adherence (SIGMA) is to test the VP approach relative to usual care (UC) in improving medication adherence. SIGMA is a randomized, controlled, open-label, single-centre superiority trial with two parallel arms. A total of 100 non-adherent (Morisky Medication Adherence Scale ≤6) glaucoma patients from the Singapore National Eye Centre are block-randomized (blocking factor: single versus multiple medications users) into the VP and UC arms in a 1:1 ratio. The treatment received by VP patients will be strictly identical to that received by UC patients, with the only exception being that VP patients can earn either a 50 % or 25 % rebate on their glaucoma-related healthcare costs conditional on being adherent on at least 90 % or 75 % of days as measured by a medication event monitoring system. Masking the arm allocation will be precluded by the behavioural nature of the intervention but blocking size will not be disclosed to protect concealment. The primary outcome is the mean change from baseline in percentage of adherent days at month 6. A day will be counted as adherent when the patients take all their medication(s) within the appropriate dosing windows. This trial will provide evidence on whether adherence-contingent rebates can improve medication adherence among non-adherent glaucoma patients, and more generally whether this approach represents a promising strategy to cost-effectively improve chronic disease management. NCT02271269 . Registered on 19 October 2014.

Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial.

PubMed

Hermanides, J; Nørgaard, K; Bruttomesso, D; Mathieu, C; Frid, A; Dayan, C M; Diem, P; Fermon, C; Wentholt, I M E; Hoekstra, J B L; DeVries, J H

2011-10-01

To investigate the efficacy of sensor-augmented pump therapy vs. multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes. In this investigator-initiated multi-centre trial (the Eurythmics Trial) in eight outpatient centres in Europe, we randomized 83 patients with Type 1 diabetes (40 women) currently treated with multiple daily injections, age 18-65 years and HbA(1c) ≥ 8.2% (≥ 66 mmol/mol) to 26 weeks of treatment with either a sensor-augmented insulin pump (n = 44) (Paradigm(®) REAL-Time) or continued with multiple daily injections (n = 39). Change in HbA(1c) between baseline and 26 weeks, sensor-derived endpoints and patient-reported outcomes were assessed. The trial was completed by 43/44 (98%) patients in the sensor-augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group. Mean HbA(1c) at baseline and at 26 weeks changed from 8.46% (SD 0.95) (69 mmol/mol) to 7.23% (SD 0.65) (56 mmol/mol) in the sensor-augmented insulin pump group and from 8.59% (SD 0.82) (70 mmol/mol) to 8.46% (SD 1.04) (69 mmol/mol) in the multiple daily injections group. Mean difference in change in HbA(1c) after 26 weeks was -1.21% (95% confidence interval -1.52 to -0.90, P < 0.001) in favour of the sensor-augmented insulin pump group. This was achieved without an increase in percentage of time spent in hypoglycaemia: between-group difference 0.0% (95% confidence interval -1.6 to 1.7, P = 0.96). There were four episodes of severe hypoglycaemia in the sensor-augmented insulin pump group and one episode in the multiple daily injections group (P = 0.21). Problem Areas in Diabetes and Diabetes Treatment Satisfaction Questionnaire scores improved in the sensor-augmented insulin pump group. Sensor augmented pump therapy effectively lowers HbA(1c) in patients with Type 1 diabetes suboptimally controlled with multiple daily injections. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

A Cross-Sectional Study of Indoor Tanning in Fitness Centres.

PubMed

Huang, Christina M; Kirchhof, Mark G

Ultraviolet (UV) radiation is a human carcinogen and is associated with the development of skin cancer. The promotion of indoor tanning (IT) at fitness centres is of particular concern as it reinforces the idea that a tan is associated with health and fitness. The purpose of this study was to investigate the prevalence of IT in fitness centres, with an emphasis on determining the financial costs, adherence to regulations, and safety precautions. Ten cities, representing 9 different Canadian provinces, were chosen for the study. From each province, a minimum of 20 and a maximum of 30 fitness centres were randomly selected from the Yellow Pages website. Each fitness centre was contacted by the principal investigator and inquiries were made from a consumer's perspective. Of the 203 gyms surveyed, 43% (88/203) offered tanning facilities. Of these, 10.23% (9/88) were found to be noncompliant with the provincial IT regulations for age and/or time between tanning sessions. Despite the known risks of IT, not all fitness centres are compliant with provincial legislations regarding IT, and some continue to promote tanning access to minors.

Variations in colonoscopy practice in Europe: a multicentre descriptive study (EPAGE).

PubMed

Harris, Jennifer K; Vader, John-Paul; Wietlisbach, Vincent; Burnand, Bernard; Gonvers, Jean-Jacques; Froehlich, Florian

2007-01-01

The volume of colonoscopies performed is increasing and differences in colonoscopy practice over time and between centres have been reported. Examination of current practice is important for bench-marking quality. The objective of this study was to examine variations in colonoscopy practice in endoscopy centres internationally. This observational study prospectively included consecutive patients referred for colonoscopy from 21 centres in 11 countries. Patient, procedure and centre characteristics were collected through questionnaires. Descriptive statistics were performed and the variation between centres while controlling for case-mix was examined. A total of 6004 patients were included in the study. Most colonoscopies (93%; range between centres 70-100%) were performed for diagnostic purposes. The proportion of main indications for colonoscopy showed wide variations between centres, the two most common indications, surveillance and haematochezia, ranging between 7-24% and 5-38%, respectively. High-quality cleansing occurred in 74% (range 51-94%) of patients, and 30% (range 0-100%) of patients received deep sedation. Three-quarters (range 0-100%) of the patients were monitored during colonoscopy, and one-quarter (range 14-35%) underwent polypectomy. Colonoscopy was complete in 89% (range 69-98%) of patients and the median total duration was 20 min (range of centre medians 15-30 min). The variation between centres was not reduced when case-mix was controlled for. This study documented wide variations in colonoscopy practice between centres. Controlling for case-mix did not remove these variations, indicating that centre and procedure characteristics play a role. Centres generally were within the existing guidelines, although there is still some work to be done to ensure that all centres attain the goal of providing high-quality colonoscopy.

Randomized Controlled Trials to Define Viral Load Thresholds for Cytomegalovirus Pre-Emptive Therapy

PubMed Central

Griffiths, Paul D.; Rothwell, Emily; Raza, Mohammed; Wilmore, Stephanie; Doyle, Tomas; Harber, Mark; O’Beirne, James; Mackinnon, Stephen; Jones, Gareth; Thorburn, Douglas; Mattes, Frank; Nebbia, Gaia; Atabani, Sowsan; Smith, Colette; Stanton, Anna; Emery, Vincent C.

2016-01-01

Background To help decide when to start and when to stop pre-emptive therapy for cytomegalovirus infection, we conducted two open-label randomized controlled trials in renal, liver and bone marrow transplant recipients in a single centre where pre-emptive therapy is indicated if viraemia exceeds 3000 genomes/ml (2520 IU/ml) of whole blood. Methods Patients with two consecutive viraemia episodes each below 3000 genomes/ml were randomized to continue monitoring or to immediate treatment (Part A). A separate group of patients with viral load greater than 3000 genomes/ml was randomized to stop pre-emptive therapy when two consecutive levels less than 200 genomes/ml (168 IU/ml) or less than 3000 genomes/ml were obtained (Part B). For both parts, the primary endpoint was the occurrence of a separate episode of viraemia requiring treatment because it was greater than 3000 genomes/ml. Results In Part A, the primary endpoint was not significantly different between the two arms; 18/32 (56%) in the monitor arm had viraemia greater than 3000 genomes/ml compared to 10/27 (37%) in the immediate treatment arm (p = 0.193). However, the time to developing an episode of viraemia greater than 3000 genomes/ml was significantly delayed among those randomized to immediate treatment (p = 0.022). In Part B, the primary endpoint was not significantly different between the two arms; 19/55 (35%) in the less than 200 genomes/ml arm subsequently had viraemia greater than 3000 genomes/ml compared to 23/51 (45%) among those randomized to stop treatment in the less than 3000 genomes/ml arm (p = 0.322). However, the duration of antiviral treatment was significantly shorter (p = 0.0012) in those randomized to stop treatment when viraemia was less than 3000 genomes/ml. Discussion The results illustrate that patients have continuing risks for CMV infection with limited time available for intervention. We see no need to alter current rules for stopping or starting pre-emptive therapy. PMID:27684379

Transient evoked otoacoustic emissions in rock musicians.

PubMed

Høydal, Erik Harry; Lein Størmer, Carl Christian; Laukli, Einar; Stenklev, Niels Christian

2017-09-01

Our focus in this study was the assessment of transient evoked otoacoustic emissions (TEOAEs) in a large group of rock musicians. A further objective was to analyse tinnitus among rock musicians as related to TEOAEs. The study was a cross-sectional survey of rock musicians selected at random. A control group was included at random for comparison. We recruited 111 musicians and a control group of 40 non-musicians. Testing was conducted by using clinical examination, pure tone audiometry, TEOAEs and a questionnaire. TEOAE SNR in the half-octave frequency band centred on 4 kHz was significantly lower bilaterally in musicians than controls. This effect was strongly predicted by age and pure-tone hearing threshold levels in the 3-6 kHz range. Bilateral hearing thresholds were significantly higher at 6 kHz in musicians. Twenty percent of the musicians had permanent tinnitus. There was no association between the TEOAE parameters and permanent tinnitus. Our results suggest an incipient hearing loss at 6 kHz in rock musicians. Loss of TEOAE SNR in the 4 kHz half-octave frequency band was observed, but it was related to higher mean 3-6 kHz hearing thresholds and age. A large proportion of rock musicians have permanent tinnitus.

Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial.

PubMed

Nunn, Andrew J; Rusen, I D; Van Deun, Armand; Torrea, Gabriela; Phillips, Patrick P J; Chiang, Chen-Yuan; Squire, S Bertel; Madan, Jason; Meredith, Sarah K

2014-09-09

In contrast to drug-sensitive tuberculosis, the guidelines for the treatment of multi-drug-resistant tuberculosis (MDR-TB) have a very poor evidence base; current recommendations, based on expert opinion, are that patients should be treated for a minimum of 20 months. A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results. There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings, including patients with HIV-coinfection. STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance. The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to 11 months in the event of delay in smear conversion. The primary outcome is based on the bacteriological status of the patients at 27 months post-randomization. Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and, given a 10% margin of non-inferiority, a total of 400 patients are required to be enrolled. Health economics data are being collected on all patients in selected sites. The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging, but for this regimen to be recommended more widely than in a research setting, robust evidence is needed from a randomized clinical trial. Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB. This trial was registered with clincaltrials.gov (registration number: ISRCTN78372190) on 14 October 2010.

Effects of date palm pollen on fertility: research proposal for a systematic review.

PubMed

Abdi, Fatemeh; Roozbeh, Nasibeh; Mortazavian, Amir Mohammad

2017-08-01

Over 10-15% of couples in different countries are infertile. Male infertility is a contributing factor and the only cause of infertility in respectively 50% and 20-30% of all cases of infertility. According to previous research, micro-elements isolated from date palm pollen (DPP), e.g. estrogen and sterols, may enhance male and female fertility. DPP has also been reported to improve sperm parameters including sperm motility and viability, acrosome reaction, and lipid peroxidation. This article may justify the need for a future systematic review and meta-analysis about the effects of DPP on the reproductive system and DPP's ability to enhance fertility. It will then describe the methodology of such a study. A comprehensive search of relevant randomized and quasi-randomized controlled trials will be performed in MEDLINE, EMBASE, Web of Science, Cochrane Central, ProQuest, and Google Scholar databases. Two authors will independently assess the eligibility of the studies and consult the third author in cases of disagreement. The risk of bias of the randomized controlled trials and animal studies will be evaluated using the Cochrane risk of bias tool and the Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool, respectively. This study will raise no ethical issues as it will review the findings of previous research. The results are intended to be published in a peer-reviewed medical journal.

The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults.

PubMed

Abildsnes, Eirik; Meland, Eivind; Mildestvedt, Thomas; Stea, Tonje H; Berntsen, Sveinung; Samdal, Gro Beate

2017-01-05

The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short- and long-term effects. The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs from June 2014 to Sept 2017. Participants are randomized to behavioural change interventions or a 6-month waiting list control group. A randomized trial of interventions in HLCs has the potential to influence the development of policy and practice for behaviour change interventions and patient education programmes in Norway. We discuss some of the important preconditions for obtaining valid results from a complex intervention and outline some of the characteristics of ecological approaches in health care research that can enable a pragmatic intervention study. The study was retrospectively registered on September 19, 2014 and is available online at ClinicalTrials.gov (ID: NCT02247219 ).

Investigating composition and production rate of healthcare waste and associated management practices in Bandar Abbass, Iran.

PubMed

Koolivand, Ali; Mahvi, Amir Hossein; Alipoor, Vali; Azizi, Kourosh; Binavapour, Mohammad

2012-06-01

The objective of this study was to identify the composition and production rate of healthcare waste and associated management practices in healthcare centres in Bandar Abbas, southern Iran. A total of 90 centres, including 30 physician offices, 30 dental offices and 30 clinics were selected in random way. Two samples in summer and two samples in winter were taken and weighed from each selected centre at the end of successive working day on Mondays and Tuesdays. Results showed that the mean of daily production rate for each clinic, dental and physician office were 2125.3, 498.3 and 374.9 g, respectively. Domestic-type and potentially infectious waste had the highest and chemical and pharmaceutical waste and sharps had the lowest percentages in all centres. Questionnaire results indicated that there were no effective activity for waste minimization, separation, reuse and recycling in healthcare centres and management of sharps, potentially infectious and other hazardous waste was poor.

WHY IS THE CENTER OF EVIDENCE-BASED DERMATOLOGY RELEVANT TO INDIAN DERMATOLOGY?

PubMed Central

Williams, Hywel

2009-01-01

Evidence-based dermatology is the application of high-quality evidence to the care of individual patients with skin diseases. The Centre of Evidence-Based Dermatology in the UK promotes activities in this field through its three interlinking cogs, composed of the international Cochrane Skin Group, the UK Dermatology Clinical Trials Network (UKDCTN), and the UK national electronic library for skin disorders. The Cochrane Skin Group summarises what is already known about health care interventions by supporting systematic reviews of relevant randomized controlled trials (RCTs). The UKDCTN then addresses the key research gaps identified in systematic reviews by coordinating and carrying out well-designed RCTs. The Skin Disorders specialist library then plays a key role in disseminating new knowledge from systematic reviews and RCTs to a community of clinical users. The electronic resources at the Centre of Evidence-Based Dermatology are all freely available to Indian Dermatologists who can use the resources in a way that could benefit their patients. Such new knoweldge only has value if it is shared and used. PMID:20101305

[The most common vital events in women 45-64 years of age. Repercussions as psychophysical stressors].

PubMed

Marín Torrens, R M; Sánchez Cánovas, J; Donat Colomer, F; Dupuy Layo, M J; Salas Trejo, M D

1996-05-15

To find what vital events middle-aged women in our society most often experience and their influence as stress factors on physical health and subjective psychological well-being. A multivariant transversal study. 5 primary care centres in Valencia and Alicante. 306 women chosen at random among those seen at these health centres. Frequency analysis of vital events. Correlation analysis with questionnaires on physical symptoms and diseases, psychological well-being, work situation, emotional behaviour, sexuality and relationships with their partner. ANOVA: dividing the sample into 2 groups based on mean adaptive effort. The most common events numbered 23. The ANOVA showed a significant association between greater adaptive effort and negative emotional behaviour, personal control, material well-being, relationship with the partner, and physical and psychological symptoms. The relevance of daily events as generators of stress was confirmed, as was the impact of these and major events on these women's physical and psychological health. The importance of attending women at this stage of their lives from an integrated and interdisciplinary perspective, which tackles the physiological, psychological and cultural features together, was shown.

Biofeedback assisted control of respiratory sinus arrhythmia as a biobehavioral intervention for depressive symptoms in patients after cardiac surgery: a preliminary study.

PubMed

Patron, Elisabetta; Messerotti Benvenuti, Simone; Favretto, Giuseppe; Valfrè, Carlo; Bonfà, Carlotta; Gasparotto, Renata; Palomba, Daniela

2013-03-01

The current study investigated whether biofeedback training aimed at increasing respiratory sinus arrhythmia (RSA), a measure of cardiac vagal modulation, can reduce depressive symptoms in patients after cardiac surgery. This randomized controlled study enrolled 26 patients after first-time cardiac surgery. The patients were randomly assigned to an RSA-biofeedback group (N = 13) or to a treatment as usual group (N = 13). The biofeedback training consisted of five 45 min sessions designed to increase RSA. The outcome was assessed as changes in RSA and in the Centre for Epidemiologic Studies of Depression (CES-D) values from pre- to post-training. Both groups were comparable for demographic and biomedical characteristics. RSA increased significantly in patients who underwent RSA-biofeedback compared to controls. Moreover, the CES-D scores were reduced significantly from pre- to post-training in the RSA-biofeedback group compared to the controls. Changes in RSA were inversely related to changes in CES-D scores from pre- to post-training. These findings extend the effectiveness of RSA-biofeedback for increasing vagal modulation as well as for reducing depressive symptoms in post-surgical patients. Overall, the current study also suggests that this biobehavioral intervention may add to the efficacy of postoperative risk reduction programs and rehabilitation protocols in cardiac surgery patients.

[Transcultural prevention of alcohol-related disorders : effects of a culture- and migration-sensitive approach in elderly migrants with respect to attitudes and behavior: a cluster randomized controlled trial].

PubMed

Bermejo, Isaac; Frank, F; Komarahadi, F; Albicker, J; Ries, Z; Kriston, L; Härter, M

2015-07-01

For migrants who are older than 50, alcohol frequently becomes a problem. Simultaneously alcohol-related prevention measures only reach this group insufficiently. Therefore, a transcultural concept for preventing alcohol-related disorders in elderly (≥ 45 years) migrants has been developed. The transcultural concept, which consisted of a prevention event as well as a cultural and language-sensitive information booklet, was evaluated in a cluster-randomized controlled trial (n = 310 immigrants). As a control condition there was a prevention event with materials from Deutsche Hauptstelle für Suchtfragen (German Centre for Addiction Issues). Data were obtained before and after the event, as well as after 6 months. All materials were available both in German and in Russian, Italian, Spanish and Turkish. Directly after the event, as well as 6 months thereafter, the transcultural approach was rated significantly better than the general prevention event. 73.4 % of the participants read the cultural and migration-sensitive booklet, whereas only 21.2 % in the control condition (p = 0.0001). Furthermore, significantly more participants of the transcultural approach reported a reduced alcohol consumption (49.4 vs. 16.7 %; p = 0.004) after 6 months. The consideration of diversity with respect to cultural, migration-related, socio demographic und linguistic aspects improves the effectiveness of prevention measures.

Randomized controlled trial of toothbrushing to reduce ventilator-associated pneumonia pathogens and dental plaque in a critical care unit.

PubMed

Needleman, Ian G; Hirsch, Nicholas P; Leemans, Michele; Moles, David R; Wilson, Michael; Ready, Derren R; Ismail, Salim; Ciric, Lena; Shaw, Michael J; Smith, Martin; Garner, Anne; Wilson, Sally

2011-03-01

To investigate the effect of a powered toothbrush on colonization of dental plaque by ventilator-associated pneumonia (VAP)-associated organisms and dental plaque removal. Parallel-arm, single-centre, examiner- and analyst-masked randomized controlled trial. Forty-six adults were recruited within 48 h of admission. Test intervention: powered toothbrush, control intervention: sponge toothette, both used four times per day for 2 min. Groups received 20 ml, 0.2% chlorhexidine mouthwash at each time point. The results showed a low prevalence of respiratory pathogens throughout with no statistically significant differences between groups. A highly statistically significantly greater reduction in dental plaque was produced by the powered toothbrush compared with the control treatment; mean plaque index at day 5, powered toothbrush 0.75 [95% confidence interval (CI) 0.53, 1.00], sponge toothette 1.35 (95% CI 0.95, 1.74), p=0.006. Total bacterial viable count was also highly statistically significantly lower in the test group at day 5; Log(10) mean total bacterial counts: powered toothbrush 5.12 (95% CI 4.60, 5.63), sponge toothette 6.61 (95% CI 5.93, 7.28), p=0.002. Powered toothbrushes are highly effective for plaque removal in intubated patients in a critical unit and should be tested for their potential to reduce VAP incidence and health complications. © 2011 John Wiley & Sons A/S.

Fifteen years of continuous improvement of quality care of type 2 diabetes mellitus in primary care in Catalonia, Spain.

PubMed

Mata-Cases, M; Roura-Olmeda, P; Berengué-Iglesias, M; Birulés-Pons, M; Mundet-Tuduri, X; Franch-Nadal, J; Benito-Badorrey, B; Cano-Pérez, J F

2012-03-01

To assess the evolution of type 2 diabetes mellitus (T2DM) quality indicators in primary care centers (PCC) as part of the Group for the Study of Diabetes in Primary Care (GEDAPS) Continuous Quality Improvement (GCQI) programme in Catalonia. Sequential cross-sectional studies were performed during 1993-2007. Process and outcome indicators in random samples of patients from each centre were collected. The results of each evaluation were returned to each centre to encourage the implementation of correcting interventions. Sixty-four different educational activities were performed during the study period with the participation of 2041 professionals. Clinical records of 23,501 patients were evaluated. A significant improvement was observed in the determination of some annual process indicators: HbA(1c) (51.7% vs. 88.9%); total cholesterol (75.9% vs. 90.9%); albuminuria screening (33.9% vs. 59.4%) and foot examination (48.9% vs. 64.2%). The intermediate outcome indicators also showed significant improvements: glycemic control [HbA(1c) ≤ 7% (< 57 mmol/mol); (41.5% vs. 64.2%)]; total cholesterol [≤ 200 mg/dl (5.17 mmol/l); (25.5% vs. 65.6%)]; blood pressure [≤ 140/90 mmHg; (45.4% vs. 66.1%)]. In addition, a significant improvement in some final outcome indicators such as prevalence of foot ulcers (7.6% vs. 2.6%); amputations (1.9% vs. 0.6%) and retinopathy (18.8% vs. 8.6%) was observed. Although those changes should not be strictly attributed to the GCQI programme, significant improvements in some process indicators, parameters of control and complications were observed in a network of primary care centres in Catalonia. © 2012 Blackwell Publishing Ltd.

Fifteen years of continuous improvement of quality care of type 2 diabetes mellitus in primary care in Catalonia, Spain

PubMed Central

Mata-Cases, M; Roura-Olmeda, P; Berengué-Iglesias, M; Birulés-Pons, M; Mundet-Tuduri, X; Franch-Nadal, J; Benito-Badorrey, B; Cano-Pérez, J F

2012-01-01

Aims To assess the evolution of type 2 diabetes mellitus (T2DM) quality indicators in primary care centers (PCC) as part of the Group for the Study of Diabetes in Primary Care (GEDAPS) Continuous Quality Improvement (GCQI) programme in Catalonia. Methods Sequential cross-sectional studies were performed during 1993–2007. Process and outcome indicators in random samples of patients from each centre were collected. The results of each evaluation were returned to each centre to encourage the implementation of correcting interventions. Sixty-four different educational activities were performed during the study period with the participation of 2041 professionals. Results Clinical records of 23,501 patients were evaluated. A significant improvement was observed in the determination of some annual process indicators: HbA1c (51.7% vs. 88.9%); total cholesterol (75.9% vs. 90.9%); albuminuria screening (33.9% vs. 59.4%) and foot examination (48.9% vs. 64.2%). The intermediate outcome indicators also showed significant improvements: glycemic control [HbA1c ≤ 7% (< 57 mmol/mol); (41.5% vs. 64.2%)]; total cholesterol [≤ 200 mg/dl (5.17 mmol/l); (25.5% vs. 65.6%)]; blood pressure [≤ 140/90 mmHg; (45.4% vs. 66.1%)]. In addition, a significant improvement in some final outcome indicators such as prevalence of foot ulcers (7.6% vs. 2.6%); amputations (1.9% vs. 0.6%) and retinopathy (18.8% vs. 8.6%) was observed. Conclusions Although those changes should not be strictly attributed to the GCQI programme, significant improvements in some process indicators, parameters of control and complications were observed in a network of primary care centres in Catalonia. PMID:22340449

Effects of community health interventions on under-5 mortality in rural Guinea-Bissau (EPICS): a cluster-randomised controlled trial.

PubMed

Boone, Peter; Elbourne, Diana; Fazzio, Ila; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; King, Rebecca; Mann, Vera; Piaggio, Gilda; dos Santos, Albino; Walker, Polly R

2016-05-01

Evidence suggests that community-based interventions that promote improved home-based practices and care-seeking behaviour can have a large impact on maternal and child mortality in regions where rates are high. We aimed to assess whether an intervention package based on the WHO Integrated Management of Childhood Illness handbook and community mobilisation could reduce under-5 mortality in rural Guinea-Bissau, where the health service infrastructure is weak. We did a non-masked cluster-randomised controlled trial (EPICS) in the districts of Tombali and Quinara in Guinea-Bissau. Clusters of rural villages were stratified by ethnicity and distance from a regional health centre, and randomly assigned (1:1) to intervention or control using a computerised random number generator. Women were eligible if they lived in one of the clusters at baseline survey prior to randomisation and if they were aged 15-49 years or were primary caregivers of children younger than 5 years. Their children were eligible if they were younger than 5 years or were liveborn after intervention services could be implemented on July 1, 2008. In villages receiving the intervention, community health clubs were established, community health workers were trained in case management, and traditional birth attendants were trained to care for pregnant women and newborn babies, and promote facility-based delivery. Registered nurses supervised community health workers and offered mobile clinic services. Health centres were not improved. The control group received usual services. The primary outcome was the proportion of children dying under age 5 years, and was analysed in all eligible children up to final visits to villages between Jan 1 and March 31, 2011. This trial is registered with ISRCTN, number ISRCTN52433336. On Aug 30, 2007, we randomly assigned 146 clusters to intervention (73 clusters, 5669 women, and 4573 children) or control (73 clusters, 5840 women, and 4675 children). From randomisation until the end of the trial (last visit by June 30, 2011), the intervention clusters had 3093 livebirths and the control clusters had 3194. 6729 children in the intervention group and 6894 in the control group aged 0-5 years on July 1, 2008, or liveborn subsequently were analysed for mortality outcomes. 311 (4·6%) of 6729 children younger than 5 years died in the intervention group compared with 273 (4·0%) of 6894 in the control group (relative risk 1·16 [95% CI 0·99-1·37]). Our package of community-based interventions did not reduce under-5 mortality in rural Guinea-Bissau. The short timeframe and other trial limitations might have affected our results. Community-based health promotion and basic first-line services in fragile contexts with weak secondary health service infrastructure might be insufficient to reduce child deaths. Effective Intervention. Copyright © 2016 Boone et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.

Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Cognitive Stimulation Therapy (CST) is a psychosocial evidence-based group intervention for people with dementia recommended by the UK NICE guidelines. In clinical trials, CST has been shown to improve cognition and quality of life, but little is known about the best way of ensuring implementation of CST in practice settings. A recent pilot study found that a third of people who attend CST training go on to run CST in practice, but staff identified a lack of support as a key reason for the lack of implementation. Methods/design There are three projects in this study: The first is a pragmatic multi-centre, randomised controlled trial (RCT) of staff training, comparing CST training and outreach support with CST training only; the second, the monitoring and outreach trial, is a phase IV trial that evaluates implementation of CST in practice by staff members who have previously had the CST manual or attended training. Centres will be randomised to receive outreach support. The primary outcome measure for both of these trials is the number of CST sessions run for people with dementia. Secondary outcomes include the number of attenders at sessions, job satisfaction, dementia knowledge and attitudes, competency, barriers to change, approach to learning and a controllability of beliefs and the level of adherence. Focus groups will assess staff members’ perceptions of running CST groups and receiving outreach support. The third study involves monitoring centres running groups in their usual practice and looking at basic outcomes of cognition and quality of life for the person with dementia. Discussion These studies assess the effects of outreach support on putting CST into practice and running groups effectively in a variety of care settings with people with dementia; evaluate the effectiveness of CST in standard clinical practice; and identify key factors promoting or impeding the successful running of groups. Trial registration Clinical trial ISRCTN28793457. PMID:22735077

RESPOND--A patient-centred programme to prevent secondary falls in older people presenting to the emergency department with a fall: protocol for a multicentre randomised controlled trial.

PubMed

Barker, A L; Cameron, P A; Hill, K D; Flicker, L; Haines, T P; Lowthian, J A; Waldron, N; Arendts, G; Redfern, J; Forbes, A; Brand, C A; Etherton-Beer, C D; Hill, A M; Hunter, P; Nyman, S R; Smit, D

2015-02-01

Participation in falls prevention activities by older people following presentation to the emergency department (ED) with a fall is suboptimal. This randomised controlled trial (RCT) will test the RESPOND programme, an intervention designed to improve older persons' participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies. A RCT at two tertiary referral EDs in Melbourne and Perth, Australia. 528 community-dwelling people aged 60-90 years presenting to the ED with a fall and discharged home will be recruited. People who require an interpreter or hands-on assistance to walk; live in residential aged care or >50 km from the trial hospital; have terminal illness, cognitive impairment, documented aggressive behaviour or a history of psychosis; are receiving palliative care or are unable to use a telephone will be excluded. Participants will be randomly allocated to the RESPOND intervention or standard care control group. RESPOND incorporates (1) a home-based risk factor assessment; (2) education, coaching, goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions and (3) healthcare provider communication and community linkage delivered over 6 months. Primary outcomes are falls and fall injuries per person-year. RESPOND builds on prior falls prevention learnings and aims to help individuals make guided decisions about how they will manage their falls risk. Patient-centred models have been successfully trialled in chronic and cardiovascular disease; however, evidence to support this approach in falls prevention is limited. The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000336684). 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 cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol.

PubMed

Rowe, Heather; Wynter, Karen; Lorgelly, Paula; Amir, Lisa H; Ranasinha, Sanjeeva; Proimos, Jenny; Cann, Warren; Hiscock, Harriet; Bayer, Jordana; Burns, Joanna; Ride, Jemimah; Bobevski, Irene; Fisher, Jane

2014-09-23

Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care. 48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother-infant relationship and intimate partner relationship, and healthcare costs and outcomes. Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised. Australian New Zealand Clinical Trials Registry ACTRN12613000506796. UTN: U1111-1125-8208. 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.

Design of a colicin E7 based chimeric zinc-finger nuclease

NASA Astrophysics Data System (ADS)

Németh, Eszter; Schilli, Gabriella K.; Nagy, Gábor; Hasenhindl, Christoph; Gyurcsik, Béla; Oostenbrink, Chris

2014-08-01

Colicin E7 is a natural bacterial toxin. Its nuclease domain (NColE7) enters the target cell and kills it by digesting the nucleic acids. The HNH-motif as the catalytic centre of NColE7 at the C-terminus requires the positively charged N-terminal loop for the nuclease activity—offering opportunities for allosteric control in a NColE7-based artificial nuclease. Accordingly, four novel zinc finger nucleases were designed by computational methods exploiting the special structural features of NColE7. The constructed models were subjected to MD simulations. The comparison of structural stability and functional aspects showed that these models may function as safely controlled artificial nucleases. This study was complemented by random mutagenesis experiments identifying potentially important residues for NColE7 function outside the catalytic region.

Voluntary sway and rapid orthogonal transitions of voluntary sway in young adults, and low and high fall-risk older adults.

PubMed

Tucker, Murray G; Kavanagh, Justin J; Morrison, Steven; Barrett, Rod S

2009-10-01

Falls amongst older people have been linked to reduced postural stability and slowed movement responses. The objective of this study was to examine differences in postural stability and the speed of response between young adults, low fall-risk older adults, and high fall-risk older adults during voluntary postural sway movements. Twenty-five young adults (25+/-4 years), and 32 low fall-risk (74+/-5 years), and 16 high fall-risk (79+/-7 years) older adults performed voluntary sway and rapid orthogonal transitions of voluntary sway between the anterior-posterior and medial-lateral directions. Measures included reaction and movement time and the amplitudes of the centre of pressure, centre of mass, and the separation distance between the centre of pressure and centre of mass. Both fall-risk groups compared to the young had slower reaction and movement time, greater centre of pressure and/or centre of mass amplitude in the orthogonal (non-target) direction during voluntary sway, and reduced anterior-posterior and medial-lateral separation between the centre of pressure and centre of mass during voluntary sway and orthogonal transitions. High compared to low fall-risk individuals had slower reaction and movement time, increased non-target centre of mass amplitude during voluntary sway, and reduced medial-lateral centre of pressure and centre of mass separation during voluntary sway and orthogonal transitions. Age-related deterioration of postural control resulted in slower reactive responses and reduced control of the direction of body movement during voluntary sway and orthogonal transitions. Slower postural reaction and movement time and reduced medial-lateral control of the centre of mass during voluntary sway movements are associated with increased fall-risk in community-living older people.

Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial

PubMed Central

2014-01-01

Background Comprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge. Methods/design To evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index. The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases. Discussion The findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases. Trial registration ISRCTN91433175. PMID:24886382

Protocol for the "four steps to control your fatigue (4-STEPS)" randomised controlled trial: a self-regulation based physical activity intervention for patients with unexplained chronic fatigue

PubMed Central

2012-01-01

Background Unexplained Chronic Fatigue is a medical condition characterized by the presence of persistent, severe and debilitating medically unexplained fatigue, leading to impaired functioning and lower quality of life. Research suggests that physical activity can contribute to the reduction of fatigue and other somatic symptoms and can thus significantly improve physical functioning and quality of life in these patients. Based on the self-regulation (SR) theory of behaviour change, we developed a brief physical activity program for patients suffering from unexplained chronic fatigue which focuses on the training of self-regulation skills, the "4-STEPS to control your fatigue" program. Methods/Design This is a multi-centre, randomised controlled trial (RCT) that will be carried out in local primary care centres and at the Portuguese Fibromyalgia and Chronic Fatigue Syndrome Patients Association. Patients aged between 18 and 65 and fulfilling operationalized criteria for Idiopathic Chronic Fatigue (ICF) and Chronic Fatigue Syndrome (CFS) will be recruited and randomly allocated to standard care (SC) or standard care plus a self-regulation based physical activity program (4-STEPS). Patients will be assessed at baseline, after the intervention (3 months) and at 12 months follow-up. The primary outcome is fatigue severity. Discussion The results of the RCT will provide information about the effectiveness of a brief self-regulation intervention for promoting physical activity in patients with unexplained chronic fatigue. If the program proves to be effective, it may be considered as an adjunctive treatment for these patients. Trial Registration ISRCTN: ISRCTN70763996 PMID:22429404

[Process indicators and result indicators in the control of arterial hypertension].

PubMed

Dalfó Baqué, A; Sisó Almirall, A; Vila Coll, M A; Núñez Vázquez, S; Botinas Martí, M; Gibert Llorach, E

2000-12-01

To find whether better compliance with the indicators of procedure of a hypertension monitoring programme guarantees better control in the final blood pressure figures. Descriptive cross-sectional study. Gòtic Area Health Centre, Barcelona. Annual audit through random sampling of the computerised records of all the hypertense patients attended at the centre in each of 5 years (1992, n = 337; 1993, n = 318; 1994, n = 322; 1995, n = 325; 1996, n = 325). 1. Procedure indicators: complete physical examination took place in 1996 in only 12% of cases, proportion similar to at the start of the development of the programme (12.2%). Completion of at least two of the three records of protocols (complete physical examination, ECG and analysis) dropped during the period and did not cover half the patients. Screening of the various cardiovascular risk factors (CRF) increased markedly in the 1992-1995 period. 2. RESULTS INDICATORS: The proportion of patients under 66 with SP and DP < 140 and 99 mmHg went up from 23.2% in 1992 to 45.2% in 1996. In the over-65 age-group, it went from 58.9% in 1992 to 81.2% in 1996. The procedure indicators are still useful, in that they are necessary for designing a new hypertension programme. However, we must not forget that any health programme is designed in order to achieve good control and population impact (survival) results. The procedure is only an aid to reach these aims.

Does flushing the endometrial cavity with follicular fluid after oocyte retrieval affect pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection? A randomized controlled trial.

PubMed

Hashish, N M; Badway, H S; Abdelmoty, H I; Mowafy, A; Youssef, M A F M

2014-05-01

Follicular fluid of mature oocytes is rich in growth factors and cytokines that may exert paracrine and autocrine effects on implantation. The aim of this study was to investigate if flushing the endometrial cavity with follicular fluid after oocyte retrieval improved pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection (ICSI). One hundred subfertile women undergoing ICSI between April 2012 and September 2012 at the centre for reproductive medicine, Cairo University, Egypt were enrolled in this open label, parallel randomized controlled study. Patients were randomized into two groups at the start of treatment using a computer-generated programme and sealed opaque envelopes: the follicular fluid group (n=50) and the control group (n=50). Inclusion criteria were: age 20-38 years; basal follicle-stimulating hormone <10mIU/ml; body mass index <35kg/m(2); and ostradiol >1000pg/ml and <4000pg/ml on the day of human chorionic gonadotrophin administration. Exclusion criteria were: evidence of endometriosis; uterine myoma; hydrosalpinges; endocrinological disorders; history of implantation failure in previous in-vitro fertilization/ICSI cycles; and severe male factor infertility. Clinical pregnancy and implantation rates were higher in the follicular fluid group compared with the control group [354% (17/48) vs 319% (15/47); p=0718] and (18.6% vs 11.3%; p=0.153), respectively. However, the difference was not statistically significant. Flushing the endometrial cavity with follicular fluid after oocyte retrieval neither improved nor adversely affected clinical pregnancy and implantation rates in subfertile women undergoing ICSI. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery (SPOT), a randomized controlled trial.

PubMed

Springer, Jeremy E; Elkheir, Shiraz; Eskicioglu, Cagla; Doumouras, Aristithes G; Kelly, Stephen; Yang, Ilun; Forbes, Shawn

2018-06-12

Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery. A multicenter, double-blinded, placebo controlled randomized controlled trial. This trial was conducted at two academic tertiary care centres in Ontario, Canada. 118 patients undergoing colorectal surgery. Patients were randomized to receive either a five-day course of oral simethicone (n = 58) or a placebo (n = 60). The primary outcome was time to first passage of flatus. Secondary outcomes included time to first bowel movement, postoperative length of stay, and postoperative pain. Statistical analyses were performed on an intention-to-treat basis. Statistical significance set at p = 0.05. The median time to first passage of flatus in simethicone arm was 25.2 h and 26.7 h in controls (P = 0.98). There were no significant differences in the median time to first bowel movement (simethicone = 41.1 h vs. control = 42.9 h, P = 0.91) or median length of hospital stay (simethicone = 4.5 days vs. control = 4.0 days, P = 0.63). This study failed to show a difference in return of gastrointestinal motility in patients receiving simethicone following colorectal surgery. Postoperative ileus remains a significant clinical and economic burden to the healthcare system and further research is needed to identify a reliable and effective method of treatment. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

The effect of ondansetron, a 5-HT3 receptor antagonist, in chronic fatigue syndrome: a randomized controlled trial.

PubMed

The, Gerard K H; Bleijenberg, Gijs; Buitelaar, Jan K; van der Meer, Jos W M

2010-05-01

Accumulating data support the involvement of the serotonin (5-hydroxytryptamine [5-HT]) system in the pathophysiology of chronic fatigue syndrome. Neuropharmacologic studies point to a hyperactive 5-HT system, and open-label treatment studies with 5-HT(3) receptor antagonists have shown promising results. In this randomized controlled clinical trial, the effect of ondansetron, a 5-HT(3) receptor antagonist, was assessed on fatigue severity and functional impairment in adult patients with chronic fatigue syndrome. A randomized, placebo-controlled, double-blind clinical trial was conducted at Radboud University Nijmegen Medical Centre, The Netherlands. Sixty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention (CDC) criteria for chronic fatigue syndrome and who were free from current psychiatric comorbidity participated in the clinical trial. Participants received either ondansetron 16 mg per day or placebo for 10 weeks. The primary outcome variables were fatigue severity (Checklist Individual Strength fatigue severity subscale [CIS-fatigue]) and functional impairment (Sickness Impact Profile-8 [SIP-8]). The effect of ondansetron was assessed by analysis of covariance. Data were analyzed on an intention-to-treat basis. All patients were recruited between June 2003 and March 2006. Thirty-three patients were allocated to the ondansetron condition, 34 to the placebo condition. The 2 groups were well matched in terms of age, sex, fatigue severity, functional impairment, and CDC symptoms. Analysis of covariance showed no significant differences between the ondansetron- and placebo-treated groups during the 10-week treatment period in fatigue severity and functional impairment. This clinical trial demonstrates no benefit of ondansetron compared to placebo in the treatment of chronic fatigue syndrome. www.trialregister.nl: ISRCTN02536681. ©Copyright 2010 Physicians Postgraduate Press, Inc.

A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

PubMed

Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

2017-07-01

A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial.

PubMed

Finkelstein, Eric A; Tham, Kwang-Wei; Haaland, Benjamin A; Sahasranaman, Aarti

2017-07-01

The prevalence of overweight and obesity has more than doubled in the past three decades, leading to rising rates of non-communicable diseases. This study tests whether adding a payment/rewards (term reward) program to an existing evidence-based weight loss program can increase weight loss and weight loss maintenance. We conducted a parallel-group randomized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals randomized to either control or reward arm in a 1:2 ratio. Control and reward arm participants received a four month weight loss program at the LIFE (Lifestyle Improvement and Fitness Enhancement) Centre at Singapore General Hospital. Those in the reward arm paid a fee of S$165.00 (1US$ = 1.35S$) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals. Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value. The primary outcome was weight loss at months 4, 8, and 12. 161 participants were randomized to control (n = 54) or reward (n = 107) arms. Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded (3.4 kg vs 1.4 kg, p < 0.01), month 8 when rewards concluded (3.3 kg vs 1.8 kg, p < 0.05), and at month 12 (2.3 kg vs 0.8 kg, p < 0.05). These results reveal that a payment/rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence-based weight loss program. Future efforts should attempt to replicate this approach and identify how to cost effectively expand these programs to maximize their reach. This study is registered at www.clinicaltrials.gov (Identifier: NCT01533454). Copyright © 2017 Elsevier Ltd. All rights reserved.

Group antenatal intervention to reduce perinatal stress and depressive symptoms related to intergenerational conflicts: a randomized controlled trial.

PubMed

Leung, Sharron S K; Lam, T H

2012-11-01

Intergenerational conflicts are a major source of stress, which might lead to depression in new mothers. The conflict is heightened when grandparents are involved in childcare. To examine the effectiveness of an interpersonal psychotherapy oriented group intervention to reduce stress and depressive symptoms in new mothers and enhance happiness and self-efficacy in managing intergenerational conflict in childcare. This study is one of the intervention projects of FAMILY: A Jockey Club Initiative for a Harmonious Society, funded by The Hong Kong Jockey Club Charities Trust. Multisite randomized controlled trial with two arms: an intervention group attended an additional 4-week program and a control group who received usual care only. Six Maternal and Child Health Centres in Hong Kong From September 2009 to January 2010, 156 pregnant women who would have grandparents involved in childcare were recruited at their 14-32 weeks' gestation. Participants were randomized to groups using computer generated random sequences by blinded recruitment staff. Primary outcomes were stress and depressive symptoms immediately after the intervention and 6-8 weeks after delivery. Secondary outcomes were happiness and self-efficacy in managing conflict. After screening 2870 pregnant women, 156 eligible participants were randomized. Intention-to-treat analysis showed that the intervention group (n=78) had significantly lower perceived stress (p=0.017; Cohen d=0.38) and greater happiness (p=0.004; Cohen d=0.41) than the control group (n=78) immediately after the intervention. However, the effects were not sustained at postnatal follow-up. Subgroup analysis showed that participants with depressive symptoms (EPDS>12) at baseline reported significantly lower stress, greater happiness (p=0.035 and 0.037, respectively; both Cohen d=0.61), greater self-efficacy in managing conflict (p=0.012; Cohen d=0.76) than the control group after the intervention. Also, after delivery, they had significantly greater self-efficacy in managing conflict (p=0.025; Cohen d=0.61) and more able to cooperate with grandparents in childcare (p=0.046; Cohen d=0.59) than the control group. The intervention was effective in reducing stress and enhancing happiness among new mothers, particularly those with higher EPDS scores. Postnatal follow-up contacts as booster interventions may be needed to achieve lasting effects of the intervention. Copyright © 2012 Elsevier Ltd. All rights reserved.

A Randomized, Rater-Blinded, Parallel Trial of Intensive Speech Therapy in Sub-Acute Post-Stroke Aphasia: The SP-I-R-IT Study

ERIC Educational Resources Information Center

Martins, Isabel Pavao; Leal, Gabriela; Fonseca, Isabel; Farrajota, Luisa; Aguiar, Marta; Fonseca, Jose; Lauterbach, Martin; Goncalves, Luis; Cary, M. Carmo; Ferreira, Joaquim J.; Ferro, Jose M.

2013-01-01

Background: There is conflicting evidence regarding the benefits of intensive speech and language therapy (SLT), particularly because intensity is often confounded with total SLT provided. Aims: A two-centre, randomized, rater-blinded, parallel study was conducted to compare the efficacy of 100 h of SLT in a regular (RT) versus intensive (IT)…

Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial.

PubMed

Liao, Wan-Wen; Wu, Ching-Yi; Hsieh, Yu-Wei; Lin, Keh-Chung; Chang, Wan-Ying

2012-02-01

To compare the outcome of robot-assisted therapy with dose-matched active control therapy by using accelerometers to study functional recovery in chronic stroke patients. Prospective, randomized, controlled trial. Stroke units in three medical centres. Twenty patients post stroke for a mean of 22 months. Robot-assisted therapy (n = 10) or dose-matched active control therapy (n = 10). All patients received either of these two therapies for 90-105 minutes each day, 5 days per week, for four weeks. Outcome measures included arm activity ratio (the ratio of mean activity between the impaired and unimpaired arm) and scores on the Fugl-Meyer Assessment Scale, Functional Independence Measure, Motor Activity Log and ABILHAND questionnaire. The robot-assisted therapy group significantly increased motor function, hemiplegic arm activity and bilateral arm coordination (Fugl-Meyer Assessment Scale: 51.20 ± 8.82, P = 0.002; mean arm activity ratio: 0.76 ± 0.10, P = 0.026; ABILHAND questionnaire: 1.24 ± 0.28, P = 0.043) compared with the dose-matched active control group (Fugl-Meyer Assessment Scale: 40.90 ± 13.14; mean arm movement ratio: 0.69 ± 0.11; ABILHAND questionnaire: 0.95 ± 0.43). Symmetrical and bilateral robotic practice, combined with functional task training, can significantly improve motor function, arm activity, and self-perceived bilateral arm ability in patients late after stroke.

Clinical feasibility of the Nintendo Wii™ for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting.

PubMed

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2014-09-01

To investigate the feasibility and potential efficacy of the Nintendo Wii™ for balance rehabilitation after stroke. Phase II, single-blind, randomized controlled trial. Inpatient rehabilitation facility. Thirty adults (mean age 63.6 (14.7) years) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported. Participants were allocated to a Balance Group, using the 'Wii Fit Plus' in standing, or Upper Limb Group, using the 'Wii Sports/Sports Resort' in sitting. Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care. The primary focus was feasibility, addressed by recruitment, retention, adherence, acceptability and safety. Efficacy was evaluated by balance, mobility and upper limb outcomes. Twenty-one percent of individuals screened were recruited and 86% (n = 30) of eligible people agreed to participate. Study retention and session adherence was 90% and > 99%, respectively, at two weeks; dropping to 70% and 87% at four weeks due to early discharge. All participants reported enjoying the sessions and most felt they were beneficial. No major adverse events occurred. Wii use by the Balance Group was associated with trends for improved balance, with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores. The Upper Limb Group had larger, non-significant changes in arm function. A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation. A larger randomized controlled trial is recommended to further investigate efficacy. © The Author(s) 2014.

Randomized controlled study of customized preventive medicine reminder letters in a community practice.

PubMed Central

Hogg, W. E.; Bass, M.; Calonge, N.; Crouch, H.; Satenstein, G.

1998-01-01

OBJECTIVE: To test the effectiveness of customized, family-oriented reminder letters in activating patients to seek appropriate preventive services. DESIGN: Randomized clinical trial. One group received computer-generated, customized letters explaining recommended preventive procedures for each family member. A second group received a form letter listing recommendations for all preventive procedures for all age and sex groups. A third group (control group) received no letters. SETTING: A private medical centre, without university affiliation, in rural Quebec. PARTICIPANTS: From 8770 patients who met study criteria, 719 families were randomly selected. Data were available for 1971 of 1998 patients in these families. MAIN OUTCOME MEASURES: The Family Received Index is the proportion of all procedures for which a family was overdue that they received. The Family End-of-study Up-to-date Index is the proportion of procedures for which the family was eligible and for which they were up-to-date at the end of the study. RESULTS: The Family Received Index for families mailed customized letters was more than double the index for patients not mailed letters (Kruskal-Wallis P = .0139). Comparison of the Family End-of-study Up-to-date indices also demonstrated that families of patients sent customized letters were more likely to be up-to-date than families not sent letters (Kruskal-Wallis P = .0054). No statistically significant difference appeared between the number of preventive measures received by the control group and the form-letter group. CONCLUSIONS: This study demonstrates a clinically small but statistically significant value to customizing reminder letters. PMID:9481466

Simulation-Based Abdominal Ultrasound Training - A Systematic Review.

PubMed

Østergaard, M L; Ewertsen, C; Konge, L; Albrecht-Beste, E; Bachmann Nielsen, M

2016-06-01

The aim is to provide a complete overview of the different simulation-based training options for abdominal ultrasound and to explore the evidence of their effect. This systematic review was performed according to the PRISMA guidelines and Medline, Embase, Web of Science, and the Cochrane Library was searched. Articles were divided into three categories based on study design (randomized controlled trials, before-and-after studies and descriptive studies) and assessed for level of evidence using the Oxford Centre for Evidence Based Medicine (OCEBM) system and for bias using the Cochrane Collaboration risk of bias assessment tool. Seventeen studies were included in the analysis: four randomized controlled trials, eight before-and-after studies with pre- and post-test evaluations, and five descriptive studies. No studies scored the highest level of evidence, and 14 had the lowest level. Bias was high for 11 studies, low for four, and unclear for two. No studies used a test with established evidence of validity or examined the correlation between obtained skills on the simulators and real-life clinical skills. Only one study used blinded assessors. The included studies were heterogeneous in the choice of simulator, study design, participants, and outcome measures, and the level of evidence for effect was inadequate. In all studies simulation training was equally or more beneficial than other instructions or no instructions. Study designs had significant built-in bias and confounding issues; therefore, further research should be based on randomized controlled trials using tests with validity evidence and blinded assessors. © Georg Thieme Verlag KG Stuttgart · New York.

A randomized study of new sling exercise treatment vs traditional physiotherapy for patients with chronic whiplash-associated disorders with unsettled compensation claims.

PubMed

Vikne, John; Oedegaard, Arit; Laerum, Even; Ihlebaek, Camilla; Kirkesola, Gitle

2007-04-01

Many patients with chronic whiplash-associated disorders have reduced neuromuscular control of the neck and head. It has been proposed that a new sling exercise therapy may promote neuromuscular control of the neck. To compare the effects of traditional physiotherapy vs traditional physiotherapy combined with a new sling exercise therapy on discomfort and function in patients with chronic whiplash-associated disorders who have unsettled compensation claims; and to investigate possible additional effects of guided, long-term home training. A randomized multi-centre trial with 4 parallel groups. A total of 214 patients were assigned randomly to 4 treatment groups, and received either traditional physiotherapy with or without home training, or new sling exercise therapy with or without home training. Outcome measures were pain, disability, psychological distress, sick leave and physical tests. A total of 171 patients (80%) completed the study. There were no important statistical or clinical differences between the groups after 4 months of treatment. There was a small statistically significant effect at 12-month follow-up in both groups with home training regarding pain during rest (p = 0.05) and reported fatigue in the final week (p = 0.02). No statistically significant differences were found between the traditional physiotherapy group and the new sling exercise group, with or without home training. Since the groups were not compared with a control group without treatment, we cannot conclude that the studied treatments are effective for patients with whiplash-associated disorder, only that they did not differ in our study.

Use of a goal setting intervention to increase adherence to low back pain rehabilitation: a randomized controlled trial.

PubMed

Coppack, Russell J; Kristensen, Jakob; Karageorghis, Costas I

2012-11-01

To examine the effects of a goal setting intervention on self-efficacy, treatment efficacy, adherence and treatment outcome in patients undergoing low back pain rehabilitation. A mixed-model 2 (time) × 3 (group) randomized controlled trial. A residential rehabilitation centre for military personnel. UK military personnel volunteers (N = 48); mean age was 32.9 (SD 7.9) with a diagnosis of non-specific low back pain. Subjects were randomly assigned to either a goal setting experimental group (Exp, n = 16), therapist-led exercise therapy group (C1, n = 16) or non-therapist-led exercise therapy group (C2, n = 16). Treatment duration for all groups was three weeks. Self-efficacy, treatment efficacy and treatment outcome were recorded before and after the treatment period. Adherence was rated during regularly scheduled treatment sessions using the Sports Injury Rehabilitation Adherence Scale (SIRAS). The Biering-Sørensen test was used as the primary measure of treatment outcome. ANCOVA results showed that adherence scores were significantly higher in the experimental group (13.70 ± 1.58) compared with C2 (11.74 ± 1.35), (P < 0.025). There was no significant difference for adherence between the experimental group and C1 (P = 0.13). Self-efficacy was significantly higher in the experimental group compared to both C1 and C2 (P < 0.05), whereas no significant difference was found for treatment efficacy. Treatment outcome did not differ significantly between the experimental and two control groups. The findings provide partial support for the use of goal setting to enhance adherence in clinical rehabilitation.

Usage and perceptions of anabolic-androgenic steroids among male fitness centre attendees in Kuwait--a cross-sectional study.

PubMed

Alsaeed, Ibrahim; Alabkal, Jarrah R

2015-08-22

Considering the recent popularity of bodybuilding and the apparent spread of anabolic androgenic steroid (AAS) use amongst bodybuilding enthusiasts in Kuwait, there is a relative lack of scientific investigation into the use, knowledge and attitudes towards AAS amongst the population at risk of abusing it. Therefore, this study aims to investigate the frequency, knowledge, attitudes and practice of AAS use amongst male fitness centre attendees in Kuwait. A cross sectional survey utilizing a self-administered questionnaire was used. Information on demographics as well as knowledge and attitude about and towards the use of AAS was included in the questionnaire. Ten fitness centres in Kuwait were randomly selected and questionnaires were distributed to all individuals leaving each centre on randomly selected days and periods of time for each centre. Overall n = 400 questionnaires were distributed. A total of n = 194 questionnaires were returned completed (~49%). Of the responders, 22.7% used AAS. The 19-25 age group had the highest occurrence (46.8%) of first-time AAS use. In contrast with non-users, most (70.5%) of AAS users believed that having an optimally muscular body can only be achieved by using AAS, and a small minority (6.8%) believed that AAS usage would have significant harms to health. Only 18.2% of AAS users had appropriate knowledge regarding the side effects of AAS. Non-users were as much uninformed as AAS users regarding the side effects of AAS. The usage of AAS is high amongst male gym users in Kuwait and is likely to present an additional burden to the health service. An effective initiative to minimize the burden of AAS abuse should focus on changing the attitudes towards AAS rather than spreading awareness of their side effects.

Determinants of first trimester attendance at antenatal care clinics in the Amazon region of Peru: A case-control study

PubMed Central

Moore, Nora; Blouin, Brittany; Razuri, Hugo; Casapia, Martin; Gyorkos, Theresa W.

2017-01-01

Objective To identify determinants which influence the timing of the first antenatal care (ANC) visit in pregnant women. Design Retrospective matched nested case-control study. Setting Two health centres, Belén and 6 de Octubre, in the Peruvian Amazon. Population All pregnant women who had attended ANC during the years 2010, 2011, and 2012. Methods All cases (819 women initiating ANC in their first trimester) were selected from ANC registries from 2010 to 2012. A random sample of controls (819 women initiating ANC in their second or third trimester) was matched 1:1 to cases on health centre and date of first ANC visit. Data were obtained from ANC registries. Conditional logistic regression analyses were performed. Main outcome measure Case-control status of each woman determined by the gestational age at first ANC visit. Results Cases had higher odds of: 1) being married or cohabiting (aOR = 1.69; 95% CI: 1.19, 2.41); 2) completing secondary school or attending post-secondary school (aOR = 1.45; 95% CI: 1.02, 2.06); 3) living in an urban environment (aOR = 1.79; 95% CI: 1.04, 3.10) and 4) having had a previous miscarriage (aOR = 1.56; 95% CI: 1.13, 2.15), compared to controls. No statistically significant difference in odds was found for parity (aOR = 1.08; 95% CI: 0.85, 1.36). Conclusions This study provides empirical evidence of determinants of first ANC attendance. These findings are crucial to the planning and timing of local interventions, like deworming, aimed at pregnant women so that they can access and benefit fully from all government-provided ANC services. PMID:28207749

Determinants of first trimester attendance at antenatal care clinics in the Amazon region of Peru: A case-control study.

PubMed

Moore, Nora; Blouin, Brittany; Razuri, Hugo; Casapia, Martin; Gyorkos, Theresa W

2017-01-01

To identify determinants which influence the timing of the first antenatal care (ANC) visit in pregnant women. Retrospective matched nested case-control study. Two health centres, Belén and 6 de Octubre, in the Peruvian Amazon. All pregnant women who had attended ANC during the years 2010, 2011, and 2012. All cases (819 women initiating ANC in their first trimester) were selected from ANC registries from 2010 to 2012. A random sample of controls (819 women initiating ANC in their second or third trimester) was matched 1:1 to cases on health centre and date of first ANC visit. Data were obtained from ANC registries. Conditional logistic regression analyses were performed. Case-control status of each woman determined by the gestational age at first ANC visit. Cases had higher odds of: 1) being married or cohabiting (aOR = 1.69; 95% CI: 1.19, 2.41); 2) completing secondary school or attending post-secondary school (aOR = 1.45; 95% CI: 1.02, 2.06); 3) living in an urban environment (aOR = 1.79; 95% CI: 1.04, 3.10) and 4) having had a previous miscarriage (aOR = 1.56; 95% CI: 1.13, 2.15), compared to controls. No statistically significant difference in odds was found for parity (aOR = 1.08; 95% CI: 0.85, 1.36). This study provides empirical evidence of determinants of first ANC attendance. These findings are crucial to the planning and timing of local interventions, like deworming, aimed at pregnant women so that they can access and benefit fully from all government-provided ANC services.

Measuring and understanding the effects of a performance based financing scheme applied to nutrition services in Burundi-a mixed method impact evaluation design.

PubMed

Nimpagaritse, Manassé; Korachais, Catherine; Roberfroid, Dominique; Kolsteren, Patrick; Zine Eddine El Idrissi, Moulay Driss; Meessen, Bruno

2016-06-14

Malnutrition is a huge problem in Burundi. In order to improve the provision of services at hospital, health centre and community levels, the Ministry of Health is piloting the introduction of malnutrition prevention and care indicators within its performance based financing (PBF) scheme. Paying for units of services and for qualitative indicators is expected to enhance provision and quality of these nutrition services, as PBF has done, in Burundi and elsewhere, for several other services. This paper presents the protocol for the impact evaluation of the PBF scheme applied to malnutrition. The research design consists in a mixed methods model adopting a sequential explanatory design. The quantitative component is a cluster-randomized controlled evaluation design: among the 90 health centres selected for the study, half receive payment related to their results in malnutrition activities, while the other half get a budget allocation. Qualitative research will be carried out both during the intervention period and at the end of the quantitative evaluation. Data are collected from 1) baseline and follow-up surveys of 90 health centres and 6,480 households with children aged 6 to 23 months, 2) logbooks filled in weekly in health centres, and 3) in-depth interviews and focus group discussions. The evaluation aims to provide the best estimate of the impact of the project on malnutrition outcomes in the community as well as outputs at the health centre level (malnutrition care outputs) and to describe quantitatively and qualitatively the changes that took place (or did not take place) within health centres as a result of the program. Although PBF schemes are blooming in low in-come countries, there is still a need for evidence, especially on the impact of revising the list of remunerated indicators. It is expected that this impact evaluation will be helpful for the national policy dialogue in Burundi, but it will also provide key evidence for countries with an existing PBF scheme and confronted with malnutrition problems on the appropriateness to extend the strategy to nutrition services. ClinicalTrials.gov PRS Identifier: NCT02721160; registered March 2016.

A comparison of the efficacy of fixed versus removable functional appliances in children with Class II malocclusion: A systematic review.

PubMed

Pacha, Moaiyad Moussa; Fleming, Padhraig S; Johal, Ama

2016-12-01

To systematically compare the efficacy of fixed and removable functional appliances in Class II malocclusion in terms of morphological and patient-centred outcomes. A comprehensive search of electronic databases without language or time restrictions was undertaken, applying a pre-specified search strategy. Supplementary electronic searching of orthodontics journals and references list of included studies was performed. Randomized (RCTs) and controlled (CCTs) clinical trials involving children under 16 years with Class II malocclusion and overjet more than 5mm were included. A range of clinician- and patient-centred outcomes were evaluated and compared. Risk of bias assessment was carried out using the Cochrane Collaboration tool. Only four clinical trials were found to meet our criteria, of which two were RCTs, comparing the Herbst and the Twin Block appliances. Two further CCTs, compared the Activator to the Forsus and the Twin Force Bite Corrector, respectively. One study was assessed to be at unclear and the remaining at high risk of bias, precluding meta-analysis. There was also significant clinical heterogeneity in terms of methodology, type of intervention and the measured outcomes. Both modalities were effective in correcting the overjet with little differences found in cephalometric changes and a shortage of data concerning patient-centred outcomes. There is little evidence concerning the relative effectiveness of fixed and functional appliances or in relation to patient experiences and perceptions of these treatment modalities. Further well-designed clinical trials assessing the relative merits of both clinician- and patient-centred outcomes are needed. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Therapeutic strategies in severe neuropsychiatric systemic lupus erythematosus: experience from a tertiary referral centre.

PubMed

Bortoluzzi, A; Padovan, M; Farina, I; Galuppi, E; De Leonardis, F; Govoni, M

2012-12-20

The management of neuropsychiatric systemic lupus erythematosus (NPSLE) still remains empirical and based on clinical experience due to the lack of randomized controlled trials. To report the experience accumulated in a single tertiary referral centre about treatment of severe cases of NPSLE patients and to discuss therapeutic strategies on the background of EULAR recommendations. Retrospective analysis of all consecutive cases of severe NPSLE treated in our centre since 1990 to 2010, satisfying the 1999 ACR criteria. Among 633 SLE patients who consecutively attended our centre, 231 (36%) displayed at least one neuropsychiatric (NP) manifestation for a total of 408 events attributable to SLE. Thirty-one patients (4.8%), 27 females and 4 males, experienced 35 major NP events requiring immunosuppressive therapy (including 3 relapses and 1 new event). An aggressive immunosuppressive strategy was applied to those patients with an immune mediated inflammatory NP event and to those patients with an increased disease activity as judged by ECLAM and SLEDAI scores. Overall at the end of the therapy 74% of the patients reached clinical remission or significant improvement of their symptoms measured by mean SLEDAI (from 10.09 ± 1.09 to 2.04 ± 0.52, P<0.0001) and ECLAM (from 4 ± 0.34 to 1.38 ± 0.37, P<0.001) scores. The prevalence of NP involvement, described in our case series, is similar to those reported in literature as well as the treatment strategies applied. Nowadays, it is not possible to establish a standardized approach for each single NPSLE manifestation, and different therapeutic strategies must be tailored taking into account the most probable pathogenic mechanism involved, the general disease activity background, the co-morbidities, the type and the stage of the systemic involvement.

Implementing healthy lifestyle promotion in primary care: a quasi-experimental cross-sectional study evaluating a team initiative.

PubMed

Thomas, Kristin; Krevers, Barbro; Bendtsen, Preben

2015-01-22

Non-communicable diseases are a leading cause of death and can largely be prevented by healthy lifestyles. Health care organizations are encouraged to integrate healthy lifestyle promotion in routine care. This study evaluates the impact of a team initiative on healthy lifestyle promotion in primary care. A quasi-experimental, cross-sectional design compared three intervention centres that had implemented lifestyle teams with three control centres that used a traditional model of care. Outcomes were defined using the RE-AIM framework: reach, the proportion of patients receiving lifestyle promotion; effectiveness, self-reported attitudes and competency among staff; adoption, proportion of staff reporting regular practice of lifestyle promotion; implementation, fidelity to the original lifestyle team protocol. Data collection methods included a patient questionnaire (n = 888), a staff questionnaire (n = 120) and structured interviews with all practice managers and, where applicable, team managers (n = 8). The chi square test and problem-driven content analysis was used to analyse the questionnaire and interview data, respectively. Reach: patients at control centres (48%, n = 211) received lifestyle promotion significantly more often compared with patients at intervention centres (41%, n = 169). Effectiveness: intervention staff was significantly more positive towards the effectiveness of lifestyle promotion, shared competency and how lifestyle promotion was prioritized at their centre. Adoption: 47% of staff at intervention centres and 58% at control centres reported that they asked patients about their lifestyle on a daily basis. all intervention centres had implemented multi-professional teams and team managers and held regular meetings but struggled to implement in-house referral structures for lifestyle promotion, which was used consistently among staff. Intervention centres did not show higher rates than control centres on reach of patients or adoption among staff at this stage. All intervention centres struggled to implement working referral structures for lifestyle promotion. Intervention centres were more positive on effectiveness outcomes, attitudes and competency among staff, however. Thus, lifestyle teams may facilitate lifestyle promotion practice in terms of increased responsiveness among staff, illustrated by positive attitudes and perceptions of shared competency. More research is needed on lifestyle promotion referral structures in primary care regarding their configuration and implementation.

Neural pathways for colorectal control, relevance to spinal cord injury and treatment: a narrative review.

PubMed

Callaghan, Brid; Furness, John B; Pustovit, Ruslan V

2018-03-01

Narrative review. The purpose is to review the organisation of the nerve pathways that control defecation and to relate this knowledge to the deficits in colorectal function after SCI. A literature review was conducted to identify salient features of defecation control pathways and the functional consequences of damage to these pathways in SCI. The control pathways for defecation have separate pontine centres under cortical control that influence defecation. The pontine centres connect, separately, with autonomic preganglionic neurons of the spinal defecation centres and somatic motor neurons of Onuf's nucleus in the sacral spinal cord. Organised propulsive motor patterns can be generated by stimulation of the spinal defecation centres. Activation of the somatic neurons contracts the external sphincter. The analysis aids in interpreting the consequences of SCI and predicts therapeutic strategies. Analysis of the bowel control circuits identifies sites at which bowel function may be modulated after SCI. Colokinetic drugs that elicit propulsive contractions of the colorectum may provide valuable augmentation of non-pharmacological bowel management procedures.

Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.

PubMed

Boriani, Giuseppe; Tukkie, Raymond; Manolis, Antonis S; Mont, Lluis; Pürerfellner, Helmut; Santini, Massimo; Inama, Giuseppe; Serra, Paolo; de Sousa, João; Botto, Giovanni Luca; Mangoni, Lorenza; Grammatico, Andrea; Padeletti, Luigi

2014-09-14

Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004). In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF. NCT00262119. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

An intensive social cognitive program (can do treatment) in people with relapsing remitting multiple sclerosis and low disability: a randomized controlled trial protocol.

PubMed

Jongen, Peter Joseph; Heerings, Marco; Ruimschotel, Rob; Hussaarts, Astrid; Evers, Silvia; Duyverman, Lotte; Valkenburg-Vissers, Joyce; Cornelissen, Job; Bos, Michel; van Droffelaar, Maarten; Lemmens, Wim A; Donders, Rogier; van der Zande, Anneke; Visser, Leo H

2016-05-28

In people with multiple sclerosis (MS) disabilities and limitations may negatively affect self-efficacy. Lowered self-efficacy has been associated with decreases in health-related quality of life, physical activity and cognitive performance. In an explorative observational study we found that a 3-day intensive social cognitive program (Can Do Treatment [CDT]) with the participation of support partners was followed by substantial increases in self-efficacy control and health-related quality of life 6 months after treatment in those people with MS who had relapsing remitting disease and low disability. CDT is a sociologically oriented approach, its goal is to uncover and promote existing capabilities, and the notion "stressor" is the central concept. CDT's components are plenary group sessions, small group sessions, consultations, a theatre evening, and start of the day with a joint activity. The small group sessions form the actual training. Depending on their individual goals the participants join the training groups 'Body', 'Feeling' or 'Life', to work out their aims and to reduce their stressors. The multidisciplinary team includes a psychiatrist, psychiatric nurse, neurologist, specialized MS nurse, physiotherapist, dance therapist, and a person with MS. To evaluate the (cost)effectiveness of CDT in persons with relapsing remitting MS and low disability we perform a single-centre, randomized controlled trial in 140 patients, with or without support partners. The primary outcome is self-efficacy control. The secondary outcomes are self-efficacy function, health-related quality of life, autonomy and participation, anxiety, depression, cost effectiveness and cost utility. The tertiary outcome is care-related strain to support partners. Outcomes are assessed at baseline and at 1, 3 and 6 months after CDT. This randomized controlled trial will adequately evaluate the clinical and cost effectiveness of a 3-day intensive social cognitive program in people with relapsing remitting MS and low disability, with self-efficacy control as primary outcome. Application number: 22444.

Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial

PubMed Central

Tebb, Kathleen P.; Rodriguez, Felicia; Pollack, Lance M.; Trieu, Sang Leng; Hwang, Loris; Puffer, Maryjane; Adams, Sally; Ozer, Elizabeth M.; Brindis, Claire D.

2018-01-01

Introduction Teen pregnancy rates in the USA remain higher than any other industrialised nation, and pregnancies among Hispanic adolescents are disproportionately high. Computer-based interventions represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings have demonstrated that the Health-E You/Salud iTu, computer application (app) is feasible to implement, acceptable to Latina adolescents and improves sexual health knowledge and interest in selecting an effective contraceptive method when used in conjunction with a healthcare visit. The app is now ready for efficacy testing. The purpose of this manuscript is to describe patient-centred approaches used both in developing and testing the Health-E You app and to present the research methods used to evaluate its effectiveness in improving intentions to use an effective method of contraception as well as actual contraceptive use. Methods and analysis This study is designed to assess the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, on its ability to reduce health disparities in unintended pregnancies among Latina adolescent girls. This study uses a cluster randomised control trial design in which 18 school-based health centers from the Los Angeles Unified School District were randomly assigned, at equal chance, to either the intervention (Health-E You app) or control group. Analyses will examine differences between the control and intervention group’s knowledge of and attitudes towards contraceptive use, receipt of contraception at the clinic visit and self-reported use of contraception at 3-month and 6-month follow-ups. The study began enrolling participants in August 2016, and a total of 1400 participants (700 per treatment group) are expected to be enrolled by March 2018. Ethics and dissemination Ethics approval was obtained through the University of California, San Francisco Institutional Review Board. Results of this trial will be submitted for publication in peer-reviewed journals. This study is registered with the US National Institutes of Health. Trial registration number NCT02847858. PMID:29326184

Effectiveness of structured patient-clinician communication with a solution focused approach (DIALOG+) in community treatment of patients with psychosis--a cluster randomised controlled trial.

PubMed

Priebe, Stefan; Kelley, Lauren; Golden, Eoin; McCrone, Paul; Kingdon, David; Rutterford, Clare; McCabe, Rosemarie

2013-06-26

Large numbers of patients with psychosis have regular meetings with key clinicians in the community. There is little evidence on how these meetings should be conducted to be therapeutically effective. DIALOG, a computer mediated procedure, was shown to improve outcomes in a European multi-centre trial. DIALOG structures the patient-clinician communication and makes it patient-centred, but does not guide clinicians as to how to respond to patients' concerns. DIALOG has been further developed into DIALOG+, which uses advanced software and, additionally, provides a four step approach--based on a solution focused model--for addressing patients' concerns. We designed a cluster randomised controlled trial to test the effectiveness of DIALOG+ in improving treatment outcomes of patients with psychosis in the community. Key workers are recruited from community mental health teams in East London and randomly allocated to either the intervention or control group. Out of their case loads, we identify patients with schizophrenia (F 20-29) and a moderate or lower level of subjective quality of life (MANSA score <5), who are treated according to the allocation of their key workers. Key workers in the intervention group are trained in using DIALOG+ and use it with each patient over a six-month period. Control patients rate their satisfaction with life and treatment on a tablet to control for the effect of regular ratings and the use of modern technology. We are recruiting up to 42 key workers to reach a total sample size of 180 patients. Clinical and social outcomes including costs are assessed after 3, 6 and 12 months. Primary outcome is subjective quality-of-life at 6 months. The trial aims to evaluate the effectiveness of a novel intervention (DIALOG+) which uses modern technology to support routine patient-clinician meetings in community care, makes the communication patient centred and guides patients and clinicians to address concerns. DIALOG+ is a generic and widely applicable intervention. If shown as effective, it can be used to improve outcomes of community care on a large scale, ensuring that routine encounters are therapeutically effective. DIALOG+ can also be implemented across services at relatively low additional costs. Current Controlled Trials ISRCTN34757603.

The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self-harm compared with treatment as usual. Methods/Design The trial is designed as a single-center, two-armed, parallel-group observer-blinded randomized clinical superiority trial. We will recruit 160 participants with a recent suicide attempt and at least two traits of the borderline personality disorder from the Centre of Excellence in Suicide Prevention, Capital Region of Denmark. Randomization will be performed though a centralized and computer-generated approach that conceals the randomization sequence. The interventions that are offered are a modified version of a dialectical behavior therapy program lasting 16 weeks versus collaborative assessment and management of suicidality-informed supportive psychotherapy, where the duration treatment will vary in accordance with established methods up to 16 weeks. The primary outcome measure is the ratio of deliberate self-harming acts including suicide attempts measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. Trial registration Clinical Trial.gov: NCT01512602. PMID:24885904

Using random forests for assistance in the curation of G-protein coupled receptor databases.

PubMed

Shkurin, Aleksei; Vellido, Alfredo

2017-08-18

Biology is experiencing a gradual but fast transformation from a laboratory-centred science towards a data-centred one. As such, it requires robust data engineering and the use of quantitative data analysis methods as part of database curation. This paper focuses on G protein-coupled receptors, a large and heterogeneous super-family of cell membrane proteins of interest to biology in general. One of its families, Class C, is of particular interest to pharmacology and drug design. This family is quite heterogeneous on its own, and the discrimination of its several sub-families is a challenging problem. In the absence of known crystal structure, such discrimination must rely on their primary amino acid sequences. We are interested not as much in achieving maximum sub-family discrimination accuracy using quantitative methods, but in exploring sequence misclassification behavior. Specifically, we are interested in isolating those sequences showing consistent misclassification, that is, sequences that are very often misclassified and almost always to the same wrong sub-family. Random forests are used for this analysis due to their ensemble nature, which makes them naturally suited to gauge the consistency of misclassification. This consistency is here defined through the voting scheme of their base tree classifiers. Detailed consistency results for the random forest ensemble classification were obtained for all receptors and for all data transformations of their unaligned primary sequences. Shortlists of the most consistently misclassified receptors for each subfamily and transformation, as well as an overall shortlist including those cases that were consistently misclassified across transformations, were obtained. The latter should be referred to experts for further investigation as a data curation task. The automatic discrimination of the Class C sub-families of G protein-coupled receptors from their unaligned primary sequences shows clear limits. This study has investigated in some detail the consistency of their misclassification using random forest ensemble classifiers. Different sub-families have been shown to display very different discrimination consistency behaviors. The individual identification of consistently misclassified sequences should provide a tool for quality control to GPCR database curators.

Effect of family nursing therapeutic conversations on health-related quality of life, self-care and depression among outpatients with heart failure: A randomized multi-centre trial.

PubMed

Østergaard, Birte; Mahrer-Imhof, Romy; Wagner, Lis; Barington, Torben; Videbæk, Lars; Lauridsen, Jørgen

2018-03-07

To evaluate the short-term (3 months) effects of family nursing therapeutic conversations (FNTC) on health-related quality of life, self-care and depression in outpatients with Heart failure (HF). A randomised multi-centre trial was conducted in three Danish HF clinics. The control group (n = 167) received usual care, and the intervention group (n = 180) received FNTCs as supplement to usual care. Primary outcome was clinically significant changes (6 points) in Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score between groups. Secondary outcomes were changes in self-care behaviour and depression scores. Data were assessed before first consultation and repeated after three months. No statistically significant difference was found in the change of KCCQ, self-care and depression scores between the groups. KCCQ scores of patients in the FNTC group changed clinically significant in seven domains, compared to one domain in the control group, with the highest improvement in self-efficacy, social limitation and symptom burden. FNTC was not superior to standard care of patients with HF regarding health-related quality of life, self-care and depression. Addressing the impact of the disease on the family, might improve self-efficacy, social limitation and symptom burden in patients with heart failure. Copyright © 2018 Elsevier B.V. All rights reserved.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Mirror therapy for patients with severe arm paresis after stroke--a randomized controlled trial.

PubMed

Thieme, Holm; Bayn, Maria; Wurg, Marco; Zange, Christian; Pohl, Marcus; Behrens, Johann

2013-04-01

To evaluate the effects of individual or group mirror therapy on sensorimotor function, activities of daily living, quality of life and visuospatial neglect in patients with a severe arm paresis after stroke. Randomized controlled trial. Inpatient rehabilitation centre. Sixty patients with a severe paresis of the arm within three months after stroke. Three groups: (1) individual mirror therapy, (2) group mirror therapy and (3) control intervention with restricted view on the affected arm. Motor function on impairment (Fugl-Meyer Test) and activity level (Action Research Arm Test), independence in activities of daily living (Barthel Index), quality of life (Stroke Impact Scale) and visuospatial neglect (Star Cancellation Test). After five weeks, no significant group differences for motor function were found (P > 0.05). Pre-post differences for the Action Research Arm Test and Fugl-Meyer Test: individual mirror therapy: 3.4 (7.1) and 3.2 (3.8), group mirror therapy: 1.1 (3.1) and 5.1 (10.0) and control therapy: 2.8 (6.7) and 5.2 (8.7). However, a significant effect on visuospatial neglect for patients in the individual mirror therapy compared to control group could be shown (P < 0.01). Furthermore, it was possible to integrate a mirror therapy group intervention for severely affected patients after stroke. This study showed no effect on sensorimotor function of the arm, activities of daily living and quality of life of mirror therapy compared to a control intervention after stroke. However, a positive effect on visuospatial neglect was indicated.

The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational.

PubMed

Mohammedi, Kamel; Potier, Louis; François, Maud; Dardari, Dured; Feron, Marilyne; Nobecourt-Dupuy, Estelle; Dolz, Manuel; Ducloux, Roxane; Chibani, Abdelkader; Eveno, Dominique-François; Crea Avila, Teresa; Sultan, Ariane; Baillet-Blanco, Laurence; Rigalleau, Vincent; Velho, Gilberto; Tubach, Florence; Roussel, Ronan; Dupré, Jean-Claude; Malgrange, Dominique; Marre, Michel

2016-01-01

Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot. ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris), independently to the sponsor. Since 27/10/2013, 13 centres have agreed to participate in this study, 117 participants were included, and 70 have achieved the study schedules. The study completion is expected for the end of 2016, and the main results will be published in 2017. ORTHODIAB trial evaluates an innovating removable off-loading device, seeking to improve diabetic foot healing (ClinicalTrials.gov identifier: NCT01956162).

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

PubMed

Backes, Manouk; Dingemans, Siem A; Schep, Niels W L; Bloemers, Frank W; Van Dijkman, Bart; Garssen, Frank P; Haverlag, Robert; Hoogendoorn, Jochem M; Joosse, Pieter; Mirck, Boj; Postma, Victor; Ritchie, Ewan; Roerdink, W Herbert; Sintenie, Jan Bernard; Soesman, Nicolaj M R; Sosef, Nico L; Twigt, Bas A; Van Veen, Ruben N; Van der Veen, Alexander H; Van Velde, Romuald; Vos, Dagmar I; De Vries, Mark R; Winkelhagen, Jasper; Goslings, J Carel; Schepers, Tim

2015-02-06

In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial.

PubMed

Viveen, Jetske; Doornberg, Job N; Kodde, Izaak F; Goossens, Pjotr; Koenraadt, Koen L M; The, Bertram; Eygendaal, Denise

2017-11-22

The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program. If conservative treatment fails, an operative release of the posttraumatic stiff elbow is often performed. The best Evidence-Based rehabilitation protocol for patients after an operative release is unknown to date and differs per surgeon, hospital and country. Options include early- or delayed motion supervised by a physical therapist, immediate continuous passive motion (CPM), (night) splinting and a static progressive or dynamic splinting program. The SET-Study (Stiff Elbow Trial) is a single-centre, prospective, randomized controlled trial. The primary objective of this study is to compare the active Range of Motion (ROM) (flexion arc and rotational arc) twelve months after surgery between three groups. The first group will receive in-hospital CPM in combination with early motion Physical Therapy (PT) supervised by a physical therapist, the second group will receive only in-hospital early motion PT supervised by a physical therapist and the third group will receive outpatient supervised PT from postoperative day seven till ten. Secondary outcome measures will be Patient Reported Outcome Measures (PROMs) including the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), the quick Disabilities of Arm, Shoulder and Hand (qDASH) score, Visual Analogue pain Scale in rest and activity (VAS), Pain Catastrophizing Scale (PCS), the Short Form (SF)-36, the Centre for Epidemiological Studies Depression Scale Revised (CESD-R) and the Work Rehabilitation Questionnaire (WORQ) for the upper limb. A successful completion of this trial will provide evidence on the best rehabilitation protocol in order to (re)gain optimal motion after surgical release of the stiff elbow. The trial is registered at the Dutch Trial Register: NTR6067 , 31-8-2016.

Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson's disease: a randomized controlled pilot study.

PubMed

Volpe, Daniele; Giantin, Maria Giulia; Maestri, Roberto; Frazzitta, Giuseppe

2014-12-01

Our aim was to evaluate the feasibility of a hydrotherapy treatment in patients with Parkinson's disease and the effectiveness of this treatment on balance parameters in comparison to a traditional land-based physical therapy. A randomized single-blind controlled trial. Outpatients. Thirty-four patients with Parkinson's disease in Hoehn-Yahr stage 2.5-3. Group 1 hydrotherapy treatment, group 2 land-based rehabilitation treatment. The two groups underwent the same rehabilitation period (60 minutes of treatment, five days a week for two months). The primary outcome measures were the centre of the pressure sway area recorded with open and closed eyes, using a stabilometric platform. Secondary outcome measures were Unified Parkinson's Disease Rating Scale II and III, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence Scale, Falls Efficacy Scale, Falls diary and Parkinson's Disease Questionnaire-39. Hydrotherapy treatment proved to be feasible and safe. Patients in both groups had a significant improvement in all outcome variables. There was a better improvement in patients who underwent hydrotherapy than in patients treated with land-based therapy in the centre of pressure sway area closed eyes (mean SD change: 45.4 SD64.9 vs. 6.9 SD45.3, p = 0.05), Berg Balance Scale (51.2 SD3.1 vs. 6.0 SD3.1, p = 0.005), Activities-specific Balance Confidence Scale (16.8 SD10.6 vs. 4.1 SD5.4, p = 0.0001), Falls Efficacy Scale (-5.9 SD4.8 vs. -1.9 SD1.4, p = 0.003), Parkinson's Disease Quetionnaire-39 (-18.4 SD12.9 vs. -8.0 SD7.0, p = 0.006) and falls diary (-2.4 SD2.2 vs. -0.4 SD0.5, p = 0.001). Our study suggests that hydrotherapy may constitute a possible treatment for balance dysfunction in Parkinsonian patients with moderate stage of disease. © The Author(s) 2014.

Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial.

PubMed

Holland, Anne E; Mahal, Ajay; Hill, Catherine J; Lee, Annemarie L; Burge, Angela T; Moore, Rosemary; Nicolson, Caroline; O'Halloran, Paul; Cox, Narelle S; Lahham, Aroub; Ndongo, Rebecca; Bell, Emily; McDonald, Christine F

2013-09-08

Pulmonary rehabilitation is widely advocated for people with chronic obstructive pulmonary disease (COPD) to improve exercise capacity, symptoms and quality of life, however only a minority of individuals with COPD are able to participate. Travel and transport are frequently cited as barriers to uptake of centre-based programs. Other models of pulmonary rehabilitation, including home-based programs, have been proposed in order to improve access to this important treatment. Previous studies of home-based pulmonary rehabilitation in COPD have demonstrated improvement in exercise capacity and quality of life, but not all elements of the program were conducted in the home environment. It is uncertain whether a pulmonary rehabilitation program delivered in its entirety at home is cost effective and equally capable of producing benefits in exercise capacity, symptoms and quality of life as a hospital-based program. The aim of this study is to compare the costs and benefits of home-based and hospital-based pulmonary rehabilitation for people with COPD. This randomised, controlled, equivalence trial conducted at two centres will recruit 166 individuals with spirometrically confirmed COPD. Participants will be randomly allocated to hospital-based or home-based pulmonary rehabilitation. Hospital programs will follow the traditional outpatient model consisting of twice weekly supervised exercise training and education for eight weeks. Home-based programs will involve one home visit followed by seven weekly telephone calls, using a motivational interviewing approach to enhance exercise participation and facilitate self management. The primary outcome is change in 6-minute walk distance immediately following intervention. Measurements of exercise capacity, physical activity, symptoms and quality of life will be taken at baseline, immediately following the intervention and at 12 months, by a blinded assessor. Completion rates will be compared between programs. Direct healthcare costs and indirect (patient-related) costs will be measured to compare the cost-effectiveness of each program. This trial will identify whether home-based pulmonary rehabilitation can deliver equivalent benefits to centre-based pulmonary rehabilitation in a cost effective manner. The results of this study will contribute new knowledge regarding alternative models of pulmonary rehabilitation and will inform pulmonary rehabilitation guidelines for COPD.

Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial.

PubMed

Vos-Vromans, Desirée; Evers, Silvia; Huijnen, Ivan; Köke, Albère; Hitters, Minou; Rijnders, Nieke; Pont, Menno; Knottnerus, André; Smeets, Rob

2017-01-01

A multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking. To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective. A multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes. The data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective. The probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective. ISRCTN77567702.

Efficiency of piezosurgery technique in miniscrew supported en-masse retraction: a single-centre, randomized controlled trial.

PubMed

Tunçer, Nilüfer Irem; Arman-Özçirpici, Ayça; Oduncuoglu, Bahar Füsun; Göçmen, Jülide Sedef; Kantarci, Alpdogan

2017-11-30

Piezoelectric surgery is a newly introduced technique for rapid tooth movement. However, the efficiency of this technique has not been investigated on en-masse retraction cases yet. To investigate the efficiency of piezosurgery technique in accelerating miniscrew supported en-masse retraction and study the biological tissue response. In addition, to show if this technique induces a difference in dental, skeletal and soft tissue changes on lateral cephalograms, and in canine and molar rotations, besides intercanine and intermolar widths on dental casts. We conducted a randomized, single-centred, parallel-group, controlled trial, requiring upper right and left first premolar extractions on 30 patients above the minimum age of 14 years at the beginning of retraction. Piezosurgery-assisted versus conventional en-masse retraction anchored from miniscrews placed between second premolars and first molars, bilaterally. The main outcome was the en-masse retraction rate. Secondary outcomes were gingival crevicular fluid (GCF) volume and GCF content of receptor activator of nuclear factor κβ ligand (RANKL), changes regarding cephalometric and dental cast variables, and miniscrew success rates. Accomplished with opaque, sealed envelopes. Applicable for data assessment only. Commenced in February 2013 and ended in October 2014. Thirty-one patients were included in the study and divided into 2 groups of piezosurgery (n = 16) and control (n = 15). After 9.3 months of follow-up, no statistically significant difference was observed between groups for neither retraction rates (P = 0.958) nor GCF parameters (P > 0.05). Changes in lateral cephalometric and dental cast variables, and miniscrew success rates did not show significant differences either. Based on the results of this study, piezosurgery technique was found to be ineffective in accelerating en-masse retraction, and promoting a difference in the studied GCF parameters, skeletal and dental variables. The trial was not registered. The full protocol of this PhD thesis study can be accessed from tez.yok.gov.tr. This work was supported by Başkent University Research Fund. No conflict of interest was declared. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Kapczynski, W.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) – hence, reducing dependence on hormone therapy programs. PMID:23675005

Impact of caregivers' education regarding respiratory infections on the health status of day-care children: a randomized trial.

PubMed

Alexandrino, Ana S; Santos, Rita; Melo, Cristina; Bastos, José M

2016-10-01

Acute respiratory infections are the most common illness in childhood, and caregivers often make an excessive use of medication and medical consultations. It is vital to design and implement educational interventions in order to minimize the burden of the disease. This study aimed to evaluate the impact of a health education session (HES) about respiratory infections on the indicators of individual health and health care utilization of day-care children. Randomized controlled trial in 10 day-care centres in Porto, including caregivers (parents or legal tutors) of children under 3 years of age. Children's caregivers were randomly distributed into an Intervention Group (IG), who attended a HES, and a Comparison Group (CG). Children's indicators of individual health and health care utilization were evaluated in both groups, during the month after HES. Children whose caregivers attended to the HES had fewer lower respiratory tract infections (IG = 5.8%; CG = 19.0%; P = 0.050) and fewer acute otitis media (IG = 9.5%; CG = 27.0%; P = 0.030), as well as fewer medical consultations (IG = 38.5% versus CG = 61.9%; P = 0.015) and less antibiotic consumption (IG = 11.5% versus CG = 29.5%; P = 0.022). They were also less absent from day care (IG = 21 days versus CG = 59 days; P = 0.037) and their caregivers were less absent from work (IG = 15 days versus CG = 44 days; P = 0.046). Caregivers who attended HES made more use of nasal irrigation (IG = 79.6% versus CG = 53.3%; P = 0.011). The HES about respiratory infections has positively influenced the indicators of individual health and health care utilization of children attending day-care centres in Porto. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Fixation using alternative implants for the treatment of hip fractures (FAITH): design and rationale for a multi-centre randomized trial comparing sliding hip screws and cancellous screws on revision surgery rates and quality of life in the treatment of femoral neck fractures

PubMed Central

2014-01-01

Background Hip fractures are a common type of fragility fracture that afflict 293,000 Americans (over 5,000 per week) and 35,000 Canadians (over 670 per week) annually. Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial. The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures. The secondary objective is to determine the impact on health-related quality of life, functional outcomes, health state utilities, fracture healing, mortality and fracture-related adverse events. Methods/Design FAITH is a multi-centre, multi-national randomized controlled trial utilizing minimization to determine patient allocation. Surgeons in North America, Europe, Australia, and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures. Using central randomization, patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw. Patient outcomes will be assessed at one week (baseline), 10 weeks, 6, 12, 18, and 24 months post initial fixation. We will independently adjudicate revision surgery and complications within 24 months of the initial fixation. Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test. Discussion This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures. This trial will not only change current Orthopaedic practice, but will also set a benchmark for the conduct of future Orthopaedic trials. Trial registration The FAITH trial is registered at ClinicalTrials.gov (Identifier NCT00761813). PMID:24965132

[Team Development in Medical Rehabilitation: Concept and Evaluation of a Team Intervention].

PubMed

Körner, M; Luzay, L; Becker, S; Rundel, M; Müller, C; Zimmermann, L

2016-04-01

Interprofessional collaboration is a main precondition of successful treatment in rehabilitation. In order to improve interprofessional collaboration, a clinic-specific, goal- and solution-oriented and systemic team development approach was designed. The aim of the study is the evaluation of this approach. A multi-centre cluster-randomized controlled study with staff questionnaires. The team development could be implemented successfully in 4 of 5 clinics and led to significant improvements in team organisation, willingness to accept responsibility and knowledge integration. The effects are small and are caused by the opposed development of intervention and control group. The team development approach can be recommended for rehabilitation practice. A train-the-trainer approach will be developed and further studies are planned in order to disseminate the approach and to investigate the conditions of implementation. © Georg Thieme Verlag KG Stuttgart · New York.

Cancer cervix: Establishing an evidence-based strategy, an experience of a tertiary care centre in India.

PubMed

Shrivastava, Shyam Kishore; Lewis, Shirley; Sastri, Supriya Chopra; Lavanya, G; Mahantshetty, Umesh; Engineer, Reena

2018-01-12

Carcinoma cervix is a common cancer among Indian women. Evidence based management is essential for best practice in treatment of carcinoma cervix for its effective control. The current imaging system like CT, MRI and PET CT scans have contributed in identifying the patients for optimal treatment and delivering treatment accurately. For stages IB2 to IV, concurrent chemoradiation is advocated with improvement in overall survival proven with randomized trials. Brachytherapy is an integral part in the radiation treatment. Imaged-guided brachytherapy using MRI is desirable, however less expensive imaging modalities such as CT and ultrasonography has been evaluated. In special situation such as for HIV positive patients and patients with neuroendocrine tumors have role of radiotherapy. For further improvement in control of cancer, it is required to integrate basic research to answer clinically relevant questions. Copyright © 2018 Elsevier Inc. All rights reserved.

Centre characteristics associated with the risk of peritonitis in peritoneal dialysis: a hierarchical modelling approach based on the data of the French Language Peritoneal Dialysis Registry.

PubMed

Béchade, Clémence; Guillouët, Sonia; Verger, Christian; Ficheux, Maxence; Lanot, Antoine; Lobbedez, Thierry

2017-06-01

This study investigated the centre effect on the risk of peritonitis in peritoneal dialysis (PD) patients. This was a retrospective cohort study based on data from the French Language Peritoneal Dialysis Registry. We analysed 5017 incident patients starting PD between January 2008 and December 2012 in 127 PD centres. The end of the observation period was 1 January 2014. The event of interest was the first peritonitis episode. The analysis was performed with a multilevel Cox model and a Fine and Gray model. Among the 5017 patients, 3190 peritonitis episodes occurred in 1796 patients. There was significant heterogeneity between centres (variance of the random effect: 0.11). The variance of the centre effect was reduced by 9% after adjusting for patient characteristics and by 35% after adjusting on centre covariate. In the multivariate analysis with a multilevel Cox model, centre with a nurse specialized in PD or centre providing home visits before dialysis initiation decreased the centre effect on peritonitis. Patients treated in centres with a nurse specialized in PD or in centres providing home visits before dialysis initiation had a lower risk of peritonitis [cause-specific hazard ratio (cs-HR): 0.75 (95% confidence interval, CI, 0.67-0.83) and cs-HR: 0.87 (95% CI 0.76-0.97), respectively]. The data show that neither centre type nor centre volume influenced peritonitis risk. In the competing risk analysis, centre with a nurse specialized in PD and centre with home visits had a protective effect on peritonitis [sub-distribution HR (sd-HR): 0.77 (95% CI 0.70-0.85) and sd-HR: 0.85 (95% CI 0.77-0.94), respectively]. There is a significant centre effect on the risk of peritonitis that can be decreased by home visits before dialysis initiation and by the presence of a nurse specialized in PD. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Effects of stimulant medication on the lateralisation of line bisection judgements of children with attention deficit hyperactivity disorder.

PubMed

Sheppard, D M; Bradshaw, J L; Mattingley, J B; Lee, P

1999-01-01

Deficits in the maintenance of attention may underlie problems in attention deficit hyperactivity disorder (ADHD). Children with ADHD also show asymmetric attention deficits in traditional lateralisation and visuospatial orienting tasks, suggesting right hemispheric (and left hemispace) attentional disturbance. This study aimed to examine the lateralisation of selective attention in ADHD; specifically, the effect of a moving, random dot background, and stimulant medication in the line bisection task. The performance of children with ADHD, on and off methylphenidate, was examined using a computerised horizontal line bisection task with moving and blank backgrounds. Twenty children with a DSM-IV diagnosis of ADHD participated with 20 controls, individually matched for age, sex, grade at school, and IQ. Twelve of the 20 children with ADHD were on stimulant medication at the time of testing. Horizontal lines of varying length were presented in the centre of a computer screen, with either a blank background, or a moving, random dot field. The random dots moved either leftward or rightward across the screen at either 40 mm/s or 80 mm/s. The children with ADHD off medication bisected lines significantly further to the right compared with controls, who showed a small leftward error. Methylphenidate normalised the performance of the children with ADHD for the task with the moving dots. These results support previous evidence for a right hemispheric hypoarousal theory of attentional dysfunction, and are consistent with the emerging picture of a lateralised dysfunction of frontostriatal circuitry in ADHD.

Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

PubMed

Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

2016-09-01

Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

Multiple behaviour change intervention for diarrhoea control in Lusaka, Zambia: a cluster randomised trial.

PubMed

Greenland, Katie; Chipungu, Jenala; Curtis, Val; Schmidt, Wolf-Peter; Siwale, Zumbe; Mudenda, Mweetwa; Chilekwa, Joyce; Lewis, James J; Chilengi, Roma

2016-12-01

Effective prevention and control of diarrhoea requires caregivers to comply with a suite of proven measures, including exclusive breastfeeding, handwashing with soap, correct use of oral rehydration salts, and zinc administration. We aimed to assess the effect of a novel behaviour change intervention using emotional drivers on caregiver practice of these behaviours. We did a cluster randomised controlled trial in Lusaka Province, Zambia. A random sample of 16 health centres (clusters) were selected from a sampling frame of 81 health centres in three of four districts in Lusaka Province using a computerised random number generator. Each cluster was randomly assigned 1:1 to either the intervention-clinic events, community events, and radio messaging-or to a standard care control arm, both for 6 months. Primary outcomes were exclusive breastfeeding (self-report), handwashing with soap (observation), oral rehydration salt solution preparation (demonstration), and zinc use in diarrhoea treatment (self-report). We measured outcome behaviours at baseline before start of intervention and 4-6 weeks post-intervention through repeat cross-sectional surveys with mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea. We compared outcomes on an intention-to-treat population between intervention and control groups adjusted for baseline behaviour. The study was registered with ClinicalTrials.gov, number NCT02081521. Between Jan 20 and Feb 3, 2014, we recruited 306 mothers of an infant aged 0-5 months (156 intervention, 150 standard care) and 343 primary caregiver of a child aged 0-59 months with recent diarrhoea (176 intervention, 167 standard care) at baseline. Between Oct 20 to Nov 7, 2014, we recruited 401 mothers of an infant 0-5 months (234 intervention, 167 standard care) and 410 primary caregivers of a child 0-59 months with recent diarrhoea (257 intervention, 163 standard care) at endline. Intervention was associated with increased prevalence of self-reported exclusive breastfeeding of infants aged 0-5 months (adjusted difference 10·5%, 95% CI 0·9-19·9). Other primary outcomes were not affected by intervention. Cluster intervention exposure ranged from 11-81%, measured by participant self-report with verification questions. Comparison of control and intervention clusters with coverage greater than 35% provided strong evidence of an intervention effect on oral rehydration salt solution preparation and breastfeeding outcomes. The intervention may have improved exclusive breastfeeding (assessed by self-reporting), but intervention effects were diluted in clusters with low exposure. Complex caregiver practices can improve through interventions built around human motives, but these must be implemented more intensely. Absolute Return for Kids (ARK) and Comic Relief. Copyright © 2016 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

The influence of novel compliant floors on balance control in elderly women--A biomechanical study.

PubMed

Wright, Alexander D; Laing, Andrew C

2011-07-01

Novel compliant floors aim to decrease the risk for fall-related injury by providing substantial force attenuation during the impact phase of falls. Certain models of compliant flooring have been shown to have limited influence on postural sway and successful completion of dynamic balance tasks. However, the effects of these products on balance recovery mechanisms following an externally induced perturbation have yet to be quantified. We used a floor translation paradigm to induce a balance perturbation to thirteen elderly community-dwelling women. Outcome measures included the displacement rates and margins of safety for both the underfoot centre-of-pressure and whole-body centre-of-mass across two novel compliant floors (SmartCell, SofTile), two basic foam surfaces (Firm-Foam, Soft-Foam) and a standard 'Rigid' floor as a control condition. The centre-of-mass and centre-of-pressure margins of safety, and all centre-of-mass displacement rates, were not significantly lower for the two novel compliant flooring systems compared to the control floor. The centre-of-pressure displacement rates were similar to the control floor for the SmartCell floor condition. The majority of the margin of safety and displacement rate variables for the foam floors were significantly lower than the control condition. This study illustrates that the SmartCell and SofTile novel compliant floors have minimal influences on balance and balance control responses following externally induced perturbations in older community-dwelling women, and supports pilot installations of these floors to inform decisions regarding the development of clinical trials. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

The influence of novel compliant floors on balance control in elderly women—A biomechanical study

PubMed Central

Wright, Alexander D.; Laing, Andrew C.

2012-01-01

Novel compliant floors aim to decrease the risk for fall-related injury by providing substantial force attenuation during the impact phase of falls. Certain models of compliant flooring have been shown to have limited influence on postural sway and successful completion of dynamic balance tasks. However, the effects of these products on balance recovery mechanisms following an externally induced perturbation have yet to be quantified. We used a floor translation paradigm to induce a balance perturbation to thirteen elderly community-dwelling women. Outcome measures included the displacement rates and margins of safety for both the underfoot centre-of-pressure and whole-body centre-of-mass across two novel compliant floors (Smart-Cell, SofTile), two basic foam surfaces (Firm-Foam, Soft-Foam) and a standard ‘Rigid’ floor as a control condition. The centre-of-mass and centre-of-pressure margins of safety, and all centre-of-mass displacement rates, were not significantly lower for the two novel compliant flooring systems compared to the control floor. The centre-of-pressure displacement rates were similar to the control floor for the SmartCell floor condition. The majority of the margin of safety and displacement rate variables for the foam floors were significantly lower than the control condition. This study illustrates that the SmartCell and SofTile novel compliant floors have minimal influences on balance and balance control responses following externally induced perturbations in older community-dwelling women, and supports pilot installations of these floors to inform decisions regarding the development of clinical trials. PMID:21545881

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

PubMed

Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

2015-02-01

To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Effect of an education program on knowledge, self-care behavior and handwashing competence on prevention of febrile neutropenia among breast cancer patients receiving Doxorubicin and Cyclophosphamide in Chemotherapy Day Centre

PubMed Central

Mak, Wai Chi; Yin Ching, Shirley Siu

2015-01-01

Objective: To evaluate the efficacy of an education program on the prevention of febrile neutropenia (FN) among breast cancer patients receiving AC regimen. Methods: Randomized controlled trial with the repeated-measures design was conducted in a Chemotherapy Day Centre of an acute hospital in Hong Kong. Twenty-five subjects in the intervention group received an individual education session followed by three follow-up sessions and routine care. Twenty-four subjects in the control group received routine care. Primary outcomes included the incidence of admission due to FN, the self-care behavior adherence, the knowledge level on prevention of FN and the self-efficacy in self-management, handwashing competence were assessed by self-designed questionnaires, Chinese version of patient activation measure, and handwashing competence checklist. Results: No statistically significant difference between the intervention group and the control group on the incidence of admission due to FN, the self-efficacy in self-management, and the knowledge on prevention of FN. The self-care behavior adherence was significant at cycle 4 of AC regimen in favor of the intervention group (P = 0.036). Handwashing competence improved more significantly among subjects in the intervention group than the control group (P = 0.009). Conclusions: The education program on the prevention of FN had significantly favorable effects on self-care behavior adherence and handwashing competence across time. However, the intervention did not lead to statistically significant improvement on the incidence of admission due to FN, the self-efficacy in self-management and the knowledge level on prevention of FN. PMID:27981125

The Hermann-Hering grid illusion demonstrates disruption of lateral inhibition processing in diabetes mellitus.

PubMed

Davies, Nigel P; Morland, Antony B

2002-02-01

The Hermann-Hering grid illusion consists of dark illusory spots perceived at the intersections of horizontal and vertical white bars viewed against a dark background. The dark spots originate from lateral inhibition processing. This illusion was used to investigate the hypothesis that lateral inhibition may be disrupted in diabetes mellitus. A computer monitor based psychophysical test was developed to measure the threshold of perception of the illusion for different bar widths. The contrast threshold for illusion perception at seven bar widths (range 0.09 degrees to 0.60 degrees) was measured using a randomly interleaved double staircase. Convolution of Hermann-Hering grids with difference of Gaussian receptive fields was used to generate model sensitivity functions. The method of least squares was used to fit these to the experimental data. 14 diabetic patients and 12 control subjects of similar ages performed the test. The sensitivity to the illusion was significantly reduced in the diabetic group for bar widths 0.22 degrees, 0.28 degrees, and 0.35 degrees (p = 0.01). The mean centre:surround ratio for the controls was 1:9.1 (SD 1.6) with a mean correlation coefficient of R(2) = 0.80 (SD 0.16). In the diabetic group, two subjects were unable to perceive the illusion. The mean centre:surround ratio for the 12 remaining diabetic patients was 1:8.6 (SD 2.1). However, the correlation coefficients were poor with a mean of R(2) = 0.54 (SD 0.27), p = 0.04 in comparison with the control group. A difference of Gaussian receptive field model fits the experimental data well for the controls but does not fit the data obtained for the diabetics. This indicates dysfunction of the lateral inhibition processes in the post-receptoral pathway.

Thrombo-embolic events in left ventricular endocardial pacing: long-term outcomes from a multicentre UK registry.

PubMed

Sawhney, Vinit; Domenichini, Giulia; Gamble, James; Furniss, Guy; Panagopoulos, Dimitrios; Lambiase, Pier; Rajappan, Kim; Chow, Anthony; Lowe, Martin; Sporton, Simon; Earley, Mark J; Dhinoja, Mehul; Campbell, Niall; Hunter, Ross J; Haywood, Guy; Betts, Tim R; Schilling, Richard J

2018-06-01

Endocardial left ventricular (LV) pacing is a viable alternative in patients with failed coronary sinus (CS) lead implantation. However, long-term thrombo-embolic risk remains unknown. Much of the data have come from a small number of centres. We examined the safety and efficacy of endocardial LV pacing to determine the long-term thrombo-embolic risk. Registries from four UK centres were combined to include 68 patients with endocardial leads with a mean follow-up of 20 months. These were compared to a matched 1:2 control group with conventional CS leads. Medical records were reviewed, and patients contacted for follow-up. Ischaemic stroke occurred in four patients (6%) in the endocardial arm providing an annual event rate (AER) of 3.6% over a 20 month follow-up; compared to 9 patients (6.6%) amongst controls with an AER of 3.4% over a 23-month follow-up. Regression analyses showed a significant association between sub-therapeutic international normalized ratio and stroke (P = 0.0001) in the endocardial arm. There was no association between lead material and mode of delivery (transatrial/transventricular) and stroke. Mortality rate was 12 and 15 per 100 patient years in the endocardial and control arm respectively with end-stage heart failure being the commonest cause. Endocardial LV lead in heart failure patients has a good success rate at 1.6 year follow-up. However, it is associated with a thrombo-embolic risk (which is not different from conventional CS leads) attributable to sub-therapeutic anticoagulation. Randomized control trials and studies on non-vitamin K antagonist oral anticoagulants are required to ascertain the potential of widespread clinical application of this therapeutic modality.

Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.

PubMed

Nikamp, Corien Dm; Buurke, Jaap H; van der Palen, Job; Hermens, Hermie J; Rietman, Johan S

2017-06-01

(1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. Randomized controlled trial. Rehabilitation centre. Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.

Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

PubMed

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre; Staessen, Jan A

2014-06-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. ClinicalTrials.gov Identifier: NCT 01505010.

Rationale and design of the Investigator-Steered Project on intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial

PubMed Central

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre

2014-01-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20–69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTNTM, SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. Trial registration: ClinicalTrials.gov Identifier: NCT 01505010. PMID:24742341

Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial.

PubMed

Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

2016-06-01

In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It was decided randomly which port site would be closed with SA. The opposite site was closed with TS. Wounds were assessed after 7-12 days and after 3 months. Cosmetic outcome was measured by a visual analogue scale (VAS) completed by the patient, by the Hollander wound evaluation scale (HWES) and by the judgement of blinded investigators. Seventy-seven subjects were randomized. Complete data from the 3-month follow-up visit were available from 56 patients (72.7 %). The VAS scale ranged from 0 to 100 mm with "0" representing the best possible cosmetic outcome. Median satisfaction was 2 mm in the TS group and 3 mm in the SA group. The mean was high in both groups 4.6 (s = 13.1) versus 3.8 mm (s = 4.6). The outcome was neither clinically nor statistically significant. Cosmetic outcome was assessed by an investigator, and the HWES showed no difference. In regard to complications, no difference was found between SA and TS, either. In conclusion this study demonstrated that closure of laparoscopic port-site wounds leads to equivalent outcomes whether SAs or TSs are used. Complications are rare in both methods. Thus, SAs seem to be a valid alternative to sutures in laparoscopic surgery. Registration site: www.clinicaltrials.gov . NCT02179723.

The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

PubMed Central

Wild, Beate; Friederich, Hans-Christoph; Gross, Gaby; Teufel, Martin; Herzog, Wolfgang; Giel, Katrin E; de Zwaan, Martina; Schauenburg, Henning; Schade-Brittinger, Carmen; Schäfer, Helmut; Zipfel, Stephan

2009-01-01

Background Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective treatment options. However, evidence for treatment efficacy in this area is remarkably weak. A recent Cochrane review states that there is an urgent need for large, well-designed treatment studies for patients with anorexia nervosa. The aim of this particular multi-centre study is to evaluate the efficacy of two standardized outpatient treatments for patients with anorexia nervosa: focal psychodynamic (FPT) and cognitive behavioural therapy (CBT). Each therapeutic approach is compared to a "treatment-as-usual" control group. Methods/Design 237 patients meeting eligibility criteria are randomly and evenly assigned to the three groups – two intervention groups (CBT and FPT) and one control group. The treatment period for each intervention group is 10 months, consisting of 40 sessions respectively. Body weight, eating disorder related symptoms, and variables of therapeutic alliance are measured during the course of treatment. Psychotherapy sessions are audiotaped for adherence monitoring. The treatment in the control group, both the dosage and type of therapy, is not regulated in the study protocol, but rather reflects the current practice of established outpatient care. The primary outcome measure is the body mass index (BMI) at the end of the treatment (10 months after randomization). Discussion The study design surmounts the disadvantages of previous studies in that it provides a randomized controlled design, a large sample size, adequate inclusion criteria, an adequate treatment protocol, and a clear separation of the treatment conditions in order to avoid contamination. Nevertheless, the study has to deal with difficulties specific to the psychopathology of anorexia nervosa. The treatment protocol allows for dealing with the typically occurring medical complications without dropping patients from the protocol. However, because patients are difficult to recruit and often ambivalent about treatment, a drop-out rate of 30% is assumed for sample size calculation. Due to the ethical problem of denying active treatment to patients with anorexia nervosa, the control group is defined as "treatment-as-usual". Trial registration Current Controlled Trials ISRCTN72809357 PMID:19389245

CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study.

PubMed

De Pascale, Gennaro; Pennisi, Mariano Alberto; Vallecoccia, Maria Sole; Bello, Giuseppe; Maviglia, Riccardo; Montini, Luca; Di Gravio, Valentina; Cutuli, Salvatore Lucio; Conti, Giorgio; Antonelli, Massimo

2017-01-01

To determine the safety and clinical efficacy of an innovative integrated airway system (AnapnoGuard™ 100 system) that continuously monitors and controls the cuff pressure (Pcuff), while facilitating the aspiration of subglottic secretions (SS). This was a prospective, single centre, open-label, randomized, controlled feasibility and safety trial. The primary endpoint of the study was the rate of device related adverse events (AE) and serious AE (SAE) as a result of using AnapnoGuard (AG) 100 during mechanical ventilation. Secondary endpoints were: (1) mechanical complications rate (2) ICU staff satisfaction; (3) VAP occurrence; (4) length of mechanical ventilation; (5) length of Intensive Care Unit stay and mortality; (6) volume of evacuated subglottic secretions. Sixty patients were randomized to be intubated with the AG endotracheal-tube (ETT) and connected to the AG 100 system allowing Pcuff adjustment and SS aspiration; or with an ETT combined with SS drainage and Pcuff controlled manually. No difference in adverse events rate was identified between the groups. The use of AG system was associated with a significantly higher incidence of Pcuff determinations in the safety range (97.3% vs. 71%; p<0.01) and a trend to a greater volume of aspirated SS secretions: (192.0[64-413] ml vs. 150[50-200], p = 0.19 (total)); (57.8[20-88.7] ml vs. 50[18.7-62] ml, p = 0.11 (daily)). No inter-group difference was detected using AG system vs. controls in terms of post-extubation throat pain level (0 [0-2] vs. 0 [0-3]; p = 0.7), hoarseness (42.9% vs. 75%; p = 0.55) and tracheal mucosa oedema (16.7% vs. 10%; p = 0.65). Patients enrolled in the AG group had a trend to reduced VAP risk of ventilator-associated pneumonia(VAP) (14.8% vs. 40%; p = 0.06), which were more frequently monomicrobial (25% vs. 70%; p = 0.03). No statistically significant difference was observed in duration of mechanical ventilation, ICU stay, and mortality. The use AG 100 system and AG tube in critically ill intubated patients is safe and effective in Pcuff control and SS drainage. Its protective role against VAP needs to be confirmed in a larger randomized trial. ClinicalTrials.gov NCT01550978. Date of registration: February 21, 2012.

Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

PubMed

Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

2014-09-02

Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition. Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed. International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq).

Ovarian cysts and breast cancer: results from the Women's Contraceptive and Reproductive Experiences Study.

PubMed

Knight, Julia A; Lesosky, Maia; Blackmore, Kristina M; Voigt, Lynda F; Holt, Victoria L; Bernstein, Leslie; Marchbanks, Polly A; Burkman, Ronald T; Daling, Janet R; Whittemore, Alice S

2008-05-01

A diagnosis of ovarian cysts is likely an indicator of hormonal milieu and thus may be related to breast cancer risk. Recent studies have reported an inverse relationship between prior ovarian cyst diagnosis and breast cancer risk. We evaluated this relationship in the Women's Contraceptive and Reproductive Experiences (CARE) Study, a population-based case-control study conducted in Atlanta, Detroit, Philadelphia, Los Angeles, and Seattle. Cases had first primary invasive breast cancer diagnosed between 1994 and 1998 at ages 35-64 years. African American women were over-sampled. Controls were identified through random digit dialling and were frequency matched to cases on centre, race, and five-year age group. A total of 4575 cases and 4682 controls were interviewed. We used unconditional logistic regression adjusted for age and study centre within racial groups to estimate the odds ratio (OR) and 95% confidence interval (CI) for the relationship between prior ovarian cysts and breast cancer. Ovarian cyst diagnosis was associated with a significantly reduced risk among Caucasians (OR=0.85, 95% CI 0.76-0.96) and among African Americans (OR=0.68, 95% CI 0.57-0.81). The association in Caucasians was not significant within subgroups defined by menopausal status, hormone use, or gynecological surgery while the OR estimates in African Americans were consistently lower and frequently significant. These data are consistent with the previously reported inverse association between ovarian cysts and breast cancer, but the evidence for a relationship was stronger in African Americans than Caucasians. Additional studies are required to determine the specific cyst type(s) responsible for the observed relationship.

Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial.

PubMed

Santarius, Thomas; Kirkpatrick, Peter J; Ganesan, Dharmendra; Chia, Hui Ling; Jalloh, Ibrahim; Smielewski, Peter; Richards, Hugh K; Marcus, Hani; Parker, Richard A; Price, Stephen J; Kirollos, Ramez W; Pickard, John D; Hutchinson, Peter J

2009-09-26

Chronic subdural haematoma causes serious morbidity and mortality. It recurs after surgical evacuation in 5-30% of patients. Drains might reduce recurrence but are not used routinely. Our aim was to investigate the effect of drains on recurrence rates and clinical outcomes. We did a randomised controlled trial at one UK centre between November, 2004, and November, 2007. 269 patients aged 18 years and older with a chronic subdural haematoma for burr-hole drainage were assessed for eligibility. 108 were randomly assigned by block randomisation to receive a drain inserted into the subdural space and 107 to no drain after evacuation. The primary endpoint was recurrence needing redrainage. The trial was stopped early because of a significant benefit in reduction of recurrence. Analyses were done on an intention-to-treat basis. This study is registered with the International Standard Randomised Controlled Trial Register (ISRCTN 97314294). Recurrence occurred in ten of 108 (9.3%) people with a drain, and 26 of 107 (24%) without (p=0.003; 95% CI 0.14-0.70). At 6 months mortality was nine of 105 (8.6%) and 19 of 105 (18.1%), respectively (p=0.042; 95% CI 0.1-0.99). Medical and surgical complications were much the same between the study groups. Use of a drain after burr-hole drainage of chronic subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months. Academy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (Neurosciences Theme).

Observation and control of blinking nitrogen-vacancy centres in discrete nanodiamonds.

PubMed

Bradac, C; Gaebel, T; Naidoo, N; Sellars, M J; Twamley, J; Brown, L J; Barnard, A S; Plakhotnik, T; Zvyagin, A V; Rabeau, J R

2010-05-01

Nitrogen-vacancy colour centres in diamond can undergo strong, spin-sensitive optical transitions under ambient conditions, which makes them attractive for applications in quantum optics, nanoscale magnetometry and biolabelling. Although nitrogen-vacancy centres have been observed in aggregated detonation nanodiamonds and milled nanodiamonds, they have not been observed in very small isolated nanodiamonds. Here, we report the first direct observation of nitrogen-vacancy centres in discrete 5-nm nanodiamonds at room temperature, including evidence for intermittency in the luminescence (blinking) from the nanodiamonds. We also show that it is possible to control this blinking by modifying the surface of the nanodiamonds.

A randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm patients using a peak endocardial acceleration sensor vs. standard methods.

PubMed

Ritter, Philippe; Delnoy, Peter Paul H M; Padeletti, Luigi; Lunati, Maurizio; Naegele, Herbert; Borri-Brunetto, Alberto; Silvestre, Jorge

2012-09-01

Non-response rate to cardiac resynchronization therapy (CRT) might be decreased by optimizing device programming. The Clinical Evaluation on Advanced Resynchronization (CLEAR) study aimed to assess the effects of CRT with automatically optimized atrioventricular (AV) and interventricular (VV) delays, based on a Peak Endocardial Acceleration (PEA) signal system. This multicentre, single-blind study randomized patients in a 1 : 1 ratio to CRT optimized either automatically by the PEA-based system, or according to centres' usual practices, mostly by echocardiography. Patients had heart failure (HF) New York Heart Association (NYHA) functional class III/IV, left ventricular ejection fraction (LVEF) <35%, QRS duration >150 or >120 ms with mechanical dyssynchrony. Follow-up was 1 year. The primary endpoint was the proportion of patients who improved their condition at 1 year, based on a composite of all-cause death, HF hospitalizations, NYHA class, and quality of life. In all, 268 patients in sinus rhythm (63% men; mean age: 73.1 ± 9.9 years; mean NYHA: 3.0 ± 0.3; mean LVEF: 27.1 ± 8.1%; and mean QRS duration: 160.1 ± 22.0 ms) were included and 238 patients were randomized, 123 to PEA and 115 to the control group. At 1 year, 76% of patients assigned to PEA were classified as improved, vs. 62% in the control group (P= 0.0285). The percentage of patients with improved NYHA class was significantly (P= 0.0020) higher in the PEA group than in controls. Fatal and non-fatal adverse events were evenly distributed between the groups. PEA-based optimization of CRT in HF patients significantly increased the proportion of patients who improved with therapy, mainly through improved NYHA class, after 1 year of follow-up.

Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

PubMed

Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther

2017-06-20

Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

PubMed

Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

2015-10-09

The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

PubMed

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

Treatment referral system for tuberculosis patients in Dhaka, Bangladesh

PubMed Central

Hirayama, T.; Islam, A.; Ishikawa, N.; Afsana, K.

2015-01-01

Objective: To evaluate the referral system in an urban DOTS-based programme in Dhaka, Bangladesh, including the peri-urban area, and to identify opportunities to strengthen the system. Design: This was a retrospective cohort study in which diagnosed tuberculosis (TB) patients and health providers from DOTS centres were interviewed. Research tools included pre-tested structured questionnaires and the TB patients' referral records. Results: Of 4974 TB patients who were referred to the different treatment centres, only 1756 (35%) of the counterfoils of the referral slips were returned. Of 250 patients randomly selected for interview, 165 reported to a DOTS centre, 69 did not and 16 could not be traced. Variations in educational qualification, residence and the identification of DOTS centres after counselling were statistically significant (P < 0.05). Lower monthly income (RR = 7.84, RR = 5.03), distance from the centre (RR = 36.21) and those receiving treatment from pharmacies (RR = 3) or non-governmental organisations (RR = 28.48) have more risk of irregular treatment. Conclusion: A high proportion of referred patients were registered and initiated treatment, but many did not report to the referral treatment centre. Proper counselling and taking into account the patients' preferences during referral are essential to address access barriers to treatment adherence and improved treatment outcome. PMID:26767176

Climate and the prevalence of symptoms of asthma, allergic rhinitis, and atopic eczema in children

PubMed Central

Weiland, S; Husing, A; Strachan, D; Rzehak, P; Pearce, N

2004-01-01

Aims: To investigate the association between climate and atopic diseases using worldwide data from 146 centres of the International Study of Asthma and Allergies in Childhood (ISAAC). Methods: Between 1992 and 1996, each centre studied random samples of children aged 13–14 and 6–7 years (approx. 3000 per age group and centre) using standardised written and video questionnaires on symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema during the past 12 months. Data on long term climatic conditions in the centres were abstracted from one standardised source, and mixed linear regression models calculated to take the clustering of centres within countries into account. Results: In Western Europe (57 centres in 12 countries), the prevalence of asthma symptoms, assessed by written questionnaire, increased by 2.7% (95% CI 1.0% to 4.5%) with an increase in the estimated annual mean of indoor relative humidity of 10%. Similar associations were seen for the video questionnaire and the younger age group. Altitude and the annual variation of temperature and relative humidity outdoors were negatively associated with asthma symptoms. The prevalence of eczema symptoms correlated with latitude (positively) and mean annual outdoor temperature (negatively). Conclusions: Results suggest that climate may affect the prevalence of asthma and atopic eczema in children. PMID:15208377

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis.

PubMed

Parekh, Manoj; Ramaiah, Girisha; Pashilkar, Prachi; Ramanujam, Ranjani; Johnston, Peter; Ilag, Leodevico L

2017-09-18

Most of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis). A randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of 'cleared' or 'excellent'. All three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group. The Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis. This trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522 ).

Evaluating the effectiveness of a family empowerment program on family function and pulmonary function of children with asthma: A randomized control trial.

PubMed

Yeh, Hsiu-Ying; Ma, Wei-Fen; Huang, Jing-Long; Hsueh, Kai-Chung; Chiang, Li-Chi

2016-08-01

Empowerment can be an effective strategy for changing an individual's health behaviours. However, how to empower whole families to manage their children's asthma is a challenge that requires innovative nursing intervention based on family-centred care. To evaluate the effectiveness of a family empowerment program on family function and pulmonary function of children with asthma compared to those receiving traditional self-management only. A randomized control trial. Sixty-five families were recruited from one asthma clinic in a medical centre in Taiwan. After random assignment, 34 families in the experimental group received the family empowerment program consisting of four counselling dialogues with the child and its family. We empowered the family caregiver's ability to manage their child's asthma problems through finding the problems in the family, discovery and discussion about the way to solve problems, and enabling the family's cooperation and asthma management. The other 31 families received the traditional care in asthma clinics. The Parental Stress Index and Family Environment Scale of family caregivers, and pulmonary function, and asthma signs of children with asthma were collected at pre-test, 3-month post-test, and one-year follow-up. We utilized the linear mixed model in SPSS (18.0) to analyze the effects between groups, across time, and the interaction between group and time. The family empowerment program decreased parental stress (F=13.993, p<.0001) and increased family function (cohesion, expression, conflict solving, and independence) (F=19.848, p<.0001). Children in the experimental group had better pulmonary expiratory flow (PEF) (F=26.483, p<.0001) and forced expiratory volume in first second (FEV1) (F=7.381, p=.001) than children in the comparison group; however, no significant change in forced expiratory volume in first second (FEV1)/forced vital capacity (FVC) was found between the two groups. Sleep problems did not show significant changes but cough, wheezing, and dyspnoea were significantly reduced by family caregiver's observations. We empowered families by listening, dialogues, reflection, and taking action based on Freire's empowerment theory. Nurses could initiate the families' life changes and assist children to solve the problems by themselves, which could yield positive health outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effectiveness of community health workers delivering preventive interventions for maternal and child health in low- and middle-income countries: a systematic review.

PubMed

Gilmore, Brynne; McAuliffe, Eilish

2013-09-13

Community Health Workers are widely utilised in low- and middle-income countries and may be an important tool in reducing maternal and child mortality; however, evidence is lacking on their effectiveness for specific types of programmes, specifically programmes of a preventive nature. This review reports findings on a systematic review analysing effectiveness of preventive interventions delivered by Community Health Workers for Maternal and Child Health in low- and middle-income countries. A search strategy was developed according to the Evidence for Policy and Practice Information and Co-ordinating Centre's (EPPI-Centre) guidelines and systematic searching of the following databases occurred between June 8-11th, 2012: CINAHL, Embase, Ovid Nursing Database, PubMed, Scopus, Web of Science and POPLINE. Google, Google Scholar and WHO search engines, as well as relevant systematic reviews and reference lists from included articles were also searched. Inclusion criteria were: i) Target beneficiaries should be pregnant or recently pregnant women and/or children under-5 and/or caregivers of children under-5; ii) Interventions were required to be preventive and delivered by Community Health Workers at the household level. No exclusion criteria were stipulated for comparisons/controls or outcomes. Study characteristics of included articles were extracted using a data sheet and a peer tested quality assessment. A narrative synthesis of included studies was compiled with articles being coded descriptively to synthesise results and draw conclusions. A total of 10,281 studies were initially identified and through the screening process a total of 17 articles detailing 19 studies were included in the review. Studies came from ten different countries and consisted of randomized controlled trials, cluster randomized controlled trials, before and after, case control and cross sectional studies. Overall quality of evidence was found to be moderate. Five main preventive intervention categories emerged: malaria prevention, health education, breastfeeding promotion, essential newborn care and psychosocial support. All categories showed some evidence for the effectiveness of Community Health Workers; however they were found to be especially effective in promoting mother-performed strategies (skin to skin care and exclusive breastfeeding). Community Health Workers were shown to provide a range of preventive interventions for Maternal and Child Health in low- and middle-income countries with some evidence of effective strategies, though insufficient evidence is available to draw conclusions for most interventions and further research is needed.

The Anticaries Effect of a Food Extract (Shiitake) in a Short-Term Clinical Study

PubMed Central

Lingström, Peter; Zaura, Egija; Hassan, Haidar; Buijs, Mark J.; Hedelin, Pamie; Pratten, Jonathan; Spratt, David; Daglia, Maria; Karbowiak, Aneta; Signoretto, Caterina; Rosema, Martijn; van der Weijden, Fridus; Wilson, Michael

2012-01-01

The main objective was to investigate whether low-molecular-weight fraction of edible mushroom shiitake extract (Lentinus edodes) possesses caries-preventive properties. The study was designed as a double-blind, three-leg, cross-over, randomized, controlled clinical trial carried out on two series of volunteers at the University of Gothenburg, and the Academic Centre for Dentistry Amsterdam. Volunteers rinsed twice daily with a solution containing low-molecular-weight fraction of edible mushroom, placebo (negative control without active ingredients), or Meridol (positive control, AmF-SnF2) for two weeks, with a two-week washout period between each rinsing period. Changes in the acidogenicity of dental plaque before and after a sucrose challenge, shifts in microbial composition, and plaque scores were determined. Frequent rinses with shiitake reduced the metabolic activity of dental plaque. No reduction of plaque scores and no inhibition of the production of organic acids in plaque was found. Minor differences in microbial composition between test sessions were found. To conclude, the results indicate that shiitake extract has anticariogenic potential, but not to the same extent as the positive control. PMID:22500081

A sit-ski design aimed at controlling centre of mass and inertia.

PubMed

Langelier, Eve; Martel, Stéphane; Millot, Anne; Lessard, Jean-Luc; Smeesters, Cécile; Rancourt, Denis

2013-01-01

This article introduces a sit-ski developed for the Canadian Alpine Ski Team in view of the Vancouver 2010 Paralympic games. The design is predominantly based on controlling the mass distribution of the sit-ski, a critical factor in skiing performance and control. Both the antero-posterior location of the centre of mass and the sit-ski moment of inertia were addressed in our design. Our design provides means to adjust the antero-posterior centre of mass location of a sit-ski to compensate for masses that would tend to move the antero-posterior centre of mass location away from the midline of the binding area along the ski axis. The adjustment range provided is as large as 140 mm, thereby providing sufficient adaptability for most situations. The suspension mechanism selected is a four-bar linkage optimised to limit antero-posterior seat movement, due to suspension compression, to 7 mm maximum. This is about 5% of the maximum antero-posterior centre of mass control capacity (151 mm) of a human participant. Foot rest inclination was included in the design to modify the sit-ski inertia by as much as 11%. Together, these mass adjustment features were shown to drastically help athletes' skiing performance.

Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

PubMed Central

Law, Mary; Darrah, Johanna; Pollock, Nancy; Rosenbaum, Peter; Russell, Dianne; Walter, Stephen D; Petrenchik, Theresa; Wilson, Brenda; Wright, Virginia

2007-01-01

Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). Discussion This paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy. Trial registration [clinical trial registration #: NCT00469872] PMID:17900362

Optimizing lay counsellor services for chronic care in South Africa: a qualitative systematic review.

PubMed

Petersen, Inge; Fairall, Lara; Egbe, Catherine O; Bhana, Arvin

2014-05-01

To conduct a qualitative systematic review on the use of lay counsellors in South Africa to provide lessons on optimizing their use for psychological and behavioural change counselling for chronic long-term care in scare-resource contexts. A qualitative systematic review of the literature on lay counsellor services in South Africa. Twenty-nine studies met the inclusion criteria. Five randomized control trials and two cohort studies reported that lay counsellors can provide behaviour change counselling with good outcomes. One multi-centre cohort study provided promising evidence of improved anti-retroviral treatment adherence and one non-randomized controlled study provided promising results for counselling for depression. Six studies found low fidelity of lay counsellor-delivered interventions in routine care. Reasons for low fidelity include poor role definition, inconsistent remuneration, lack of standardized training, and poor supervision and logistical support. Within resource-constrained settings, adjunct behaviour change and psychological services provided by lay counsellors can be harnessed to promote chronic care at primary health care level. Optimizing lay counsellor services requires interventions at an organizational level that provide a clear role definition and scope of practice; in-service training and formal supervision; and sensitization of health managers to the importance and logistical requirements of counselling. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients.

PubMed

Wade, Derick T; Makela, Petra; Robson, Philip; House, Heather; Bateman, Cynthia

2004-08-01

The objective was to determine whether a cannabis-based medicinal extract (CBME) benefits a range of symptoms due to multiple sclerosis (MS). A parallel group, double-blind, randomized, placebo-controlled study was undertaken in three centres, recruiting 160 outpatients with MS experiencing significant problems from at least one of the following: spasticity, spasms, bladder problems, tremor or pain. The interventions were oromucosal sprays of matched placebo, or whole plant CBME containing equal amounts of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) at a dose of 2.5-120 mg of each daily, in divided doses. The primary outcome measure was a Visual Analogue Scale (VAS) score for each patient's most troublesome symptom. Additional measures included VAS scores of other symptoms, and measures of disability, cognition, mood, sleep and fatigue. Following CBME the primary symptom score reduced from mean (SE) 74.36 (11.1) to 48.89 (22.0) following CBME and from 74.31 (12.5) to 54.79 (26.3) following placebo [ns]. Spasticity VAS scores were significantly reduced by CBME (Sativex) in comparison with placebo (P =0.001). There were no significant adverse effects on cognition or mood and intoxication was generally mild.

The effect of a physical activity intervention on preschoolers' fundamental motor skills - A cluster RCT.

PubMed

Wasenius, Niko S; Grattan, Kimberly P; Harvey, Alysha L J; Naylor, Patti-Jean; Goldfield, Gary S; Adamo, Kristi B

2018-07-01

To assess the effect of a physical activity intervention delivered in the childcare centres (CC), with or without a parent-driven home physical activity component, on children's fundamental motor skills (FMS). Six-month 3-arm cluster randomized controlled trial. Preschoolers were recruited from 18 licensed CC. CC were randomly assigned to a typical curriculum comparison group (COM), childcare intervention alone (CC), or childcare intervention with parental component (CC+HOME). FMS was measured with the Test of Gross Motor Development-2. Linear mixed models were performed at the level of the individual while accounting for clustering. Raw locomotor skills score increased significantly in the CC group (mean difference=2.5 units, 95% Confidence Intervals, CI, 1.0-4.1, p<0.001) and the CC+HOME group (mean difference=2.4 units, 95% CI, 0.8-4.0, p<0.001) compared to the COM group. No significant (p>0.05) between group differences were observed in the raw object control skills, sum of raw scores, or gross motor quotient. No significant sex differences were found in any of the measured outcomes. A physical activity intervention delivered in childcare with or without parents' involvement was effective in increasing locomotor skills in preschoolers. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Seroprevalence of HSV-1 and HSV-2 antibodies in Canadian women screened for enrolment in a herpes simplex virus vaccine trial.

PubMed

Gorfinkel, I S; Aoki, F; McNeil, S; Dionne, M; Shafran, S D; Zickler, P; Halperin, S; Langley, J; Bellamy, A; Schulte, J; Heineman, T; Belshe, R

2013-05-01

Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) infections continue to be among the most common and unrecognized sexually transmitted infections in the world. Although treatable, HSV-1 and HSV-2 infections remain incurable. Hence, there is interest in the development of a vaccine to prevent genital herpes. As part of a multicentre, randomized, placebo-controlled trial to test such a vaccine, healthy women 18-30 years were enrolled as volunteers in several Canadian centres between 2005 and 2007. This study reports the seroprevalence of HSV-1 and HSV-2 antibodies in this group. A total of 2694 adult female volunteers in Canada with no known history of herpes simplex were screened for HSV antibodies using Western blot assay (the gold standard for diagnosis of HSV) for potential participation in a randomized, double-blind efficacy field trial of a herpes simplex vaccine. This trial provides a unique opportunity to examine the prevalence of antibodies to HSV-1 and of antibodies to HSV-2 in women with no known history of herpes simplex infection. The prevalence of antibodies to HSV-1 and to HSV-2 is compared with that found in previous Canadian studies that focused on a more general population. The overall seroprevalence of antibody to HSV-1 was 43%; that of HSV-2 was 2.5% and seropositivity to both was 2%. The prevalence of antibody to both HSV-1 and to HSV-2 increased with age. Seronegativity to both HSV-1 and HSV-2 was 56% in participating centres with populations under 250,000 and 46% in participating centres with populations over 250,000. Significant racial differences in seropositivity to HSV-1 and to HSV-2 were noted. The likelihood of participants being seropositive to HSV-1 and to HSV-2 was found to increase with age and to positively correlate with the population of the city in which they resided. Hypotheses are proposed to account for differences in racial seropositivity to HSV-1 and to HSV-2.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C; Etchells, Edward E

2011-05-01

Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). 27 staff physicians, residents and medical students. Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

PubMed Central

Chan, Julie; Shojania, Kaveh G; Easty, Anthony C

2011-01-01

Background Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. Objective We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). Participants 27staff physicians, residents and medical students. Setting Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. Main Measures Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). Results 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. Conclusions The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation. PMID:21486886

Staff immunisation: policy and practice in child care.

PubMed

Spokes, Paula J; Ferson, Mark J; Ressler, Kelly-Anne

2011-08-01

The aims of this study were to determine the level of knowledge among child-care centre directors regarding the National Health and Medical Research Council (NHMRC) recommendations for the immunisation of child-care workers, the extent to which this knowledge was translated into practice and any organisational barriers to the development and implementation of staff immunisation policy. A cross-sectional survey, conducted in August 2006, in which a postal questionnaire was sent to a random sample of 784 NSW child-care centres. Centre directors were asked to complete the questionnaire on immunisation knowledge, policy and practice for the centre. A multivariate logistic-regression model was used to identify factors independently associated with centres with an immunisation policy for staff and centres that offered to pay all or part of the cost of vaccination of staff. Directors from 437 centres participated in the study for a response rate of 56%. Of these, 49% were aware of the NHMRC recommendations, and 57% had a staff immunisation policy in place. In the logistic regression model, centres with a written immunisation policy for staff were more likely to be aware of the NHMRC guidelines and offer long day care services. Centres that offered to pay all or part of the cost of immunisation for staff were more likely to be aware of the NHMRC guidelines, offer other child-care services and not operate for profit. Barriers to staff immunisation were related to the implementation of policy and included cost, time and access to information. The level of awareness of specific staff immunisation recommendations was relatively low. The transition of knowledge to policy was encouraging, although implementation of policies requires further commitment. © 2011 The Authors. Journal of Paediatrics and Child Health © 2011 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Increasing exercise capacity and quality of life of patients with heart failure through Wii gaming: the rationale, design and methodology of the HF-Wii study; a multicentre randomized controlled trial.

PubMed

Jaarsma, Tiny; Klompstra, Leonie; Ben Gal, Tuvia; Boyne, Josiane; Vellone, Ercole; Bäck, Maria; Dickstein, Kenneth; Fridlund, Bengt; Hoes, Arno; Piepoli, Massimo F; Chialà, Oronzo; Mårtensson, Jan; Strömberg, Anna

2015-07-01

Exercise is known to be beneficial for patients with heart failure (HF), and these patients should therefore be routinely advised to exercise and to be or to become physically active. Despite the beneficial effects of exercise such as improved functional capacity and favourable clinical outcomes, the level of daily physical activity in most patients with HF is low. Exergaming may be a promising new approach to increase the physical activity of patients with HF at home. The aim of this study is to determine the effectiveness of the structured introduction and access to a Wii game computer in patients with HF to improve exercise capacity and level of daily physical activity, to decrease healthcare resource use, and to improve self-care and health-related quality of life. A multicentre randomized controlled study with two treatment groups will include 600 patients with HF. In each centre, patients will be randomized to either motivational support only (control) or structured access to a Wii game computer (Wii). Patients in the control group will receive advice on physical activity and will be contacted by four telephone calls. Patients in the Wii group also will receive advice on physical activity along with a Wii game computer, with instructions and training. The primary endpoint will be exercise capacity at 3 months as measured by the 6 min walk test. Secondary endpoints include exercise capacity at 6 and 12 months, level of daily physical activity, muscle function, health-related quality of life, and hospitalization or death during the 12 months follow-up. The HF-Wii study is a randomized study that will evaluate the effect of exergaming in patients with HF. The findings can be useful to healthcare professionals and improve our understanding of the potential role of exergaming in the treatment and management of patients with HF. NCT01785121. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

Crystallography with online optical and X-ray absorption spectroscopies demonstrates an ordered mechanism in copper nitrite reductase.

PubMed

Hough, Michael A; Antonyuk, Svetlana V; Strange, Richard W; Eady, Robert R; Hasnain, S Samar

2008-04-25

Nitrite reductases are key enzymes that perform the first committed step in the denitrification process and reduce nitrite to nitric oxide. In copper nitrite reductases, an electron is delivered from the type 1 copper (T1Cu) centre to the type 2 copper (T2Cu) centre where catalysis occurs. Despite significant structural and mechanistic studies, it remains controversial whether the substrates, nitrite, electron and proton are utilised in an ordered or random manner. We have used crystallography, together with online X-ray absorption spectroscopy and optical spectroscopy, to show that X-rays rapidly and selectively photoreduce the T1Cu centre, but that the T2Cu centre does not photoreduce directly over a typical crystallographic data collection time. Furthermore, internal electron transfer between the T1Cu and T2Cu centres does not occur, and the T2Cu centre remains oxidised. These data unambiguously demonstrate an 'ordered' mechanism in which electron transfer is gated by binding of nitrite to the T2Cu. Furthermore, the use of online multiple spectroscopic techniques shows their value in assessing radiation-induced redox changes at different metal sites and demonstrates the importance of ensuring the correct status of redox centres in a crystal structure determination. Here, optical spectroscopy has shown a very high sensitivity for detecting the change in T1Cu redox state, while X-ray absorption spectroscopy has reported on the redox status of the T2Cu site, as this centre has no detectable optical absorption.

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials.

PubMed

Patel, Vikram; Weobong, Benedict; Nadkarni, Abhijit; Weiss, Helen A; Anand, Arpita; Naik, Smita; Bhat, Bhargav; Pereira, Jesina; Araya, Ricardo; Dimidjian, Sona; Hollon, Steven D; King, Michael; McCambridge, Jim; McDaid, David; Murthy, Pratima; Velleman, Richard; Fairburn, Christopher G; Kirkwood, Betty

2014-04-02

The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials

PubMed Central

2014-01-01

Background The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. Methods/design This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. Discussion These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. Trial registration Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238). PMID:24690184

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

PubMed Central

2011-01-01

Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support agents had a significant effect on uptake of pre-ARV care and appears to be a cost-effective way to increase the prerequisites for timely ARV initiation. Trial registration The trial was registered by Current Controlled Trials Ltd C/OBioMed Central Ltd as ISRCTN94133652 and received financial support from Sida and logistical support from the European Commission. PMID:21794162

Neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD)--a controlled multicenter study of a non-pharmacological treatment approach.

PubMed

Holtmann, Martin; Pniewski, Benjamin; Wachtlin, Daniel; Wörz, Sonja; Strehl, Ute

2014-08-13

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood. However, up to 30% of children treated with stimulants either fail to show an improvement or suffer adverse side effects, including decreased appetite, insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD. A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD, leading to e.g. significant and stable improvement in behavior, attention and IQ. Significant treatment effects of neurofeedback have also been verified in meta-analyses. Most of the trials, however, have been criticized for methodological difficulties, particularly lacking appropriate control conditions and number of patients included. This randomized study examines the efficacy of slow cortical potentials (SCP) -neurofeedback, controlling unspecific effects of the setting by comparing two active treatment modalities. A total of 144 patients with ADHD, older than six and younger than ten years, in some cases with additional pharmacological treatment, are included in this trial. In five trial centres patients are treated either with SCP-feedback or electromyographic (EMG) -feedback in 25 sessions within 3 months. A comprehensive test battery is conducted before and after treatment and at follow-up 6 month later, to assess core symptoms of ADHD, general psychopathology, attentional performance, comorbid symptoms, intelligence, quality of life and cortical arousal. The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study. In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables. Further, the choice of EMG-biofeedback as an active control condition is debated. Current Controlled Trials ISRCTN76187185. Registered 5 February 2009.

Maintenance Cognitive Stimulation Therapy (CST) for dementia: A single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia

PubMed Central

2010-01-01

Background Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. Methods/Design This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks. The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. Discussion A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors. Trial Registration ISRCTN26286067 PMID:20426866

Maintenance Cognitive Stimulation Therapy (CST) for dementia: a single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia.

PubMed

Aguirre, Elisa; Spector, Aimee; Hoe, Juanita; Russell, Ian T; Knapp, Martin; Woods, Robert T; Orrell, Martin

2010-04-28

Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period. This multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks.The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective. A pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors.

Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Merién, A E R; de Wit-Zuurendonk, L D; Houterman, S; Mol, B W; Oei, S G

2012-10-01

To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Cluster randomised controlled trial. The Netherlands. The obstetric departments of 24 Dutch hospitals. The obstetric departments were randomly assigned to a 1-day session of multiprofessional team training in a medical simulation centre or to no such training. Team training was given with high-fidelity mannequins by an obstetrician and a communication expert. More than 6 months following training, two unannounced simulated scenarios were carried out in the delivery rooms of all 24 obstetric departments. The scenarios, comprising a case of shoulder dystocia and a case of amniotic fluid embolism, were videotaped. The team performance and utilisation of appropriate medical skills were evaluated by two independent experts. Team performance evaluated with the validated Clinical Teamwork Scale (CTS) and the employment of two specific obstetric procedures for the two clinical scenarios in the simulation (delivery of the baby with shoulder dystocia in the maternal all-fours position and conducting a perimortem caesarean section within 5 minutes for the scenario of amniotic fluid embolism). Seventy-four obstetric teams from 12 hospitals in the intervention group underwent teamwork training between November 2009 and July 2010. The teamwork performance in the training group was significantly better in comparison to the nontraining group (median CTS score: 7.5 versus 6.0, respectively; P = 0.014). The use of the predefined obstetric procedures for the two clinical scenarios was also significantly more frequent in the training group compared with the nontraining group (83 versus 46%, respectively; P = 0.009). Team performance and medical technical skills may be significantly improved after multiprofessional obstetric team training in a medical simulation centre. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Challenging logics of complex intervention trials: community perspectives of a health care improvement intervention in rural Uganda.

PubMed

Okwaro, Ferdinand M; Chandler, Clare I R; Hutchinson, Eleanor; Nabirye, Christine; Taaka, Lilian; Kayendeke, Miriam; Nayiga, Susan; Staedke, Sarah G

2015-04-01

Health systems in many African countries are failing to provide populations with access to good quality health care. Morbidity and mortality from curable diseases such as malaria remain high. The PRIME trial in Tororo, rural Uganda, designed and tested an intervention to improve care at health centres, with the aim of reducing ill-health due to malaria in surrounding communities. This paper presents the impact and context of this trial from the perspective of community members in the study area. Fieldwork was carried out for a year from the start of the intervention in June 2011, and involved informal observation and discussions as well as 13 focus group discussions with community members, 10 in-depth interviews with local stakeholders, and 162 context descriptions recorded through quarterly interviews with community members, health workers and district officials. Community members observed a small improvement in quality of care at most, but not all, intervention health centres. However, this was diluted by other shortfalls in health services beyond the scope of the intervention. Patients continued to seek care at health centres they considered inadequate as well as positioning themselves and their children to access care through other sources such as research and nongovernmental organization (NGO) projects. These findings point to challenges of designing and delivering interventions within a paradigm that requires factorial (reduced to predictable factors) problem definition with easily actionable and evaluable solutions by small-scale projects. Such requirements mean that interventions often work on the periphery of a health system rather than tackling the murky political and economic realities that shape access to care but are harder to change or evaluate with randomized controlled trials. Highly projectified settings further reduce the ability to genuinely 'control' for different health care access scenarios. We argue for a raised consciousness of how evaluation paradigms impact on intervention choices. Copyright © 2015 Elsevier Ltd. All rights reserved.

Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial.

PubMed

Morley, Kirsten C; Teesson, Maree; Reid, Sophie C; Sannibale, Claudia; Thomson, Clare; Phung, Nghi; Weltman, Martin; Bell, James R; Richardson, Kylie; Haber, Paul S

2006-10-01

To compare the efficacy of acamprosate and naltrexone in the treatment of alcohol dependence. A double-blind, placebo-controlled trial. Three treatment centres in Australia. A total of 169 alcohol dependent subjects were given naltrexone (50 mg/day), acamprosate (1998 mg/day) or placebo for 12 weeks. All subjects were offered manualized compliance therapy, a brief intervention that targets problems that may affect treatment compliance such as ambivalence and misperceptions about medication. Time to the first drink, time to first relapse, drinks per drinking day and cumulative abstinence. In intention-to-treat analyses, there were no differences between groups on outcome measures of drinking, craving or biochemical markers. Similarly, analyses of the 94 subjects that completed the study in full and demonstrated 80% compliance, revealed no significant treatment effects. Differential treatment effects were identified after stratification according to scores on the Alcohol Dependence Scale (ADS) and Depression Anxiety and Stress Scale (DASS). A significant beneficial treatment effect on time to first relapse was revealed for subjects with 'no depression' allocated to naltrexone (n = 56; P < 0.01). In addition, a significant beneficial treatment effect was revealed in subjects with 'low dependence' allocated to naltrexone (n = 34; P < 0.05). The results of this study support the efficacy of naltrexone in the relapse prevention of alcoholism amongst those with low levels of clinical depression and alcohol dependence severity. No effect of acamprosate was found in our sample.

Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting.

PubMed

Jahnavi, G; Sudha, C H

2010-12-01

Wasting is the cardinal feature of tuberculosis, but not much documentary evidence supporting food supplements exists. This study was done to assess the effects of food supplements on body weight, physical function, quality of life and treatment outcomes in patients with tuberculosis and wasting. The study was conducted in 30 Anganwadi centres of 16 villages in the catchment area of Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation and the Gannavaram Directly Observed Treatment Short Course chemotherapy centre from August 2005 to December 2005. A total of 100 patients participated in the study. Patients who were started on anti-tubercular therapy within the previous two weeks were randomly assigned to either the control or the food supplement group. At the end of three months, their body weight was measured and physical function and quality of life were assessed. Treatment outcomes were assessed at the one-year follow-up for both groups. Patients who received supplements had a significant increase in body weight (8.6 percent versus 2.6 percent, p-value less than 0.001) and maximum grip strength (p-value less than 0.001), a higher sputum conversion rate (p-value is 0.039), a higher treatment completion rate (p-value is 0.031) and improvements in the quality of life scores. Intake of food supplements resulted in a definitive increase in body weight and physical function in our study sample. Improvements can be observed in all areas, including psychologically, physiologically, socially and in the treatment outcomes.

Home-based diabetes self-management coaching delivered by paraprofessionals: A randomized controlled trial.

PubMed

Pauley, Tim; Gargaro, Judith; Chenard, Glen; Cavanagh, Helen; McKay, Sandra M

2016-01-01

This study evaluated paraprofessional-led diabetes self-management coaching (DSMC) among 94 clients with type 2 diabetes recruited from a Community Care Access Centre in Ontario, Canada. Subjects were randomized to standard care or standard care plus coaching. Measures included the Diabetes Self-Efficacy Scale (DSES), Insulin Management Diabetes Self-Efficacy Scale (IMDSES), and Hospital Anxiety and Depression Scale (HADS). Both groups showed improvement in DSES (6.6 + 1.5 vs. 7.2 + 1.5, p < .001) and IMDSES (113.5 + 20.6 vs. 125.7 + 22.3, p < .001); there were no between-groups differences. There were no between-groups differences in anxiety (p > .05 for all) or depression scores (p > .05 for all), or anxiety (p > .05 for all) or depression (p > .05 for all) categories at baseline, postintervention, or follow-up. While all subjects demonstrated significant improvements in self-efficacy measures, there is no evidence to support paraprofessional-led DSMC as an intervention which conveys additional benefits over standard care.

EARLY: a pilot study on early diagnosis of atrial fibrillation in a primary healthcare centre.

PubMed

Benito, Luisa; Coll-Vinent, Blanca; Gómez, Eva; Martí, David; Mitjavila, Joan; Torres, Ferran; Miró, Òscar; Sisó, Antoni; Mont, Lluís

2015-11-01

Atrial fibrillation (AF) is associated with high morbidity and mortality. Early diagnosis is likely to improve therapy and prognosis. The study objective was to evaluate the usefulness of a programme for early diagnosis of AF in patients from an urban primary care centre. Participants were recruited from a randomized sample of patients not diagnosed with AF but having relevant risk factors: age ≥ 65 years, ischaemic and/or valvular heart disease, congestive heart failure, hypertension, and/or diabetes. Patients were randomly assigned to the intervention group (IG) or control group (CG). The intervention included (i) initial visit with clinical history, electrocardiogram, and instruction about pulse palpation and warning signs and (ii) electrocardiogram every 6 months during a 2-year follow-up. The main endpoint of the study was the proportion of new cases diagnosed at 6 months. Secondary endpoints were number of new AF diagnoses and complications associated with the arrhythmia in both groups. A total of 928 patients were included (463 IG and 465 CG). At 6 months, AF was diagnosed in 8 IG patients and 1 CG patient (1.7 vs. 0.2%, respectively, P = 0.018). After 2 years of follow-up, 11 IG patients and 6 CG patients had newly diagnosed AF (2.5 vs. 1.3%, respectively, P = 0.132). Time to first diagnosis of AF was shorter in IG patients [median (inter-quartile range): 7 (192) days vs. 227 (188.5) days in CG, P = 0.029]. The simple screening proposed could be useful for the early detection of AF in primary care. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study.

PubMed

Zuberbier, T; Oanta, A; Bogacka, E; Medina, I; Wesel, F; Uhl, P; Antépara, I; Jáuregui, I; Valiente, R

2010-04-01

Bilastine is a novel nonsedative H(1)-receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). The aim of this study was to compare the clinical efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg and placebo in CU patients with moderate-to-severe symptoms. Overall 525 male and female subjects aged 18-70 years were randomized to receive bilastine 20 mg, levocetirizine 5 mg or placebo, once daily for 28 days, in double-blind manner, in 46 centres across Europe and Argentina. Patients rated symptoms of pruritus, number of wheals, and maximum size of wheals (on predefined scales) as reflective (over past 12 h) symptoms twice daily, for assessment of change from baseline in the total symptoms scores (TSS) over 28 days as the primary efficacy measure. Changes in reflective and instantaneous symptoms scores, Dermatology Life Quality Index (DLQI), and CU-associated discomfort and sleep disturbance were assessed as secondary outcomes. Safety was assessed according to adverse events, laboratory tests and electrocardiograms. Bilastine reduced patients' mean reflective and instantaneous TSS from baseline to a significantly greater degree than placebo (P < 0.001); from day 2 onwards of treatment. The DLQI, general discomfort, and sleep disruption were also improved significantly in bilastine-treated patients as compared with placebo-treated patients (P < 0.001 for all parameters). Comparison with levocetirizine indicated both treatments to be equally efficacious as well as equally safe and well tolerated as compared with placebo. Bilastine 20 mg is a novel effective and safe treatment option for the management of CU.

A randomized trial of specialized versus standard neck physiotherapy in cervical dystonia.

PubMed

Counsell, Carl; Sinclair, Hazel; Fowlie, Jillian; Tyrrell, Elaine; Derry, Natalie; Meager, Peter; Norrie, John; Grosset, Donald

2016-02-01

Anecdotal reports suggested that a specialized physiotherapy technique developed in France (the Bleton technique) improved primary cervical dystonia. We evaluated the technique in a randomized trial. A parallel-group, single-blind, two-centre randomized trial compared the specialized outpatient physiotherapy programme given by trained physiotherapists up to once a week for 24 weeks with standard physiotherapy advice for neck problems. Randomization was by a central telephone service. The primary outcome was the change in the total Toronto Western Spasmodic Torticollis Rating (TWSTR) scale, measured before any botulinum injections that were due, between baseline and 24 weeks evaluated by a clinician masked to treatment. Analysis was by intention-to-treat. 110 patients were randomized (55 in each group) with 24 week outcomes available for 84. Most (92%) were receiving botulinum toxin injections. Physiotherapy adherence was good. There was no difference between the groups in the change in TWSTR score over 24 weeks (mean adjusted difference 1.44 [95% CI -3.63, 6.51]) or 52 weeks (mean adjusted difference 2.47 [-2.72, 7.65]) nor in any of the secondary outcome measures (Cervical Dystonia Impact Profile-58, clinician and patient-rated global impression of change, mean botulinum toxin dose). Both groups showed large sustained improvements compared to baseline in the TWSTR, most of which occurred in the first four weeks. There were no major adverse events. Subgroup analysis suggested a centre effect. There was no statistically or clinically significant benefit from the specialized physiotherapy compared to standard neck physiotherapy advice but further trials are warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Do competing demands of physical illness in type 2 diabetes influence depression screening, documentation and management in primary care: a cross-sectional analytic study in Aboriginal and Torres Strait Islander primary health care settings.

PubMed

Schierhout, Gill; Nagel, Tricia; Si, Damin; Connors, Christine; Brown, Alex; Bailie, Ross

2013-06-06

Relatively little is known about how depression amongst people with chronic illness is identified and managed in diverse primary health care settings. We evaluated the role of complex physical needs in influencing current practice of depression screening, documentation and antidepressant prescriptions during a 12-month period, among adults with Type 2 diabetes attending Aboriginal and Torres Strait Islander primary care health centres in Australia. We analysed clinical audit data from 44 health centres participating in a continuous quality improvement initiative, using previously reported standard sampling and data extraction protocols. Eligible patients were those with Type 2 diabetes with health centre attendance within the past 12 months. We compared current practice in depression screening, documentation and antidepressant prescription between patients with different disease severity and co-morbidity. We used random effects multiple logistic regression models to adjust for potential confounders and for clustering by health centre. Among the 1174 patients with diabetes included, median time since diagnosis was 7 years, 19% of patients had a co-existing diagnosis of Ischaemic Heart Disease and 1/3 had renal disease. Some 70% of patients had HbAc1>7.0%; 65% had cholesterol >4.0 mmol1-1 and 64% had blood pressure>130/80 mmHg. Documentation of screening for depression and of diagnosed depression were low overall (5% and 6% respectively) and lower for patients with renal disease (Adjusted odds ratio [AOR] 0.21; 95% confidence interval [CI] 0.14 to 0.31 and AOR 0.34; 95% CI 0.15 to 0.75), and for those with poorly controlled disease (HbA1c>7.00 (AOR 0.40; 95% CI 0.23 to 0.68 and AOR 0.51; 95% CI 0.30 to 84)). Screening for depression was lower for those on pharmaceutical treatment for glycaemic control compared to those not on such treatment. Antidepressant prescription was not associated with level of diabetes control or disease severity. Background levels of depression screening and documentation were low overall and significantly lower for patients with greater disease severity. Strategies to improve depression care for vulnerable populations are urgently required. An important first step in the Australian Indigenous primary care context is to identify and address barriers to the use of current clinical guidelines for depression screening and care.

Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial

PubMed Central

Kabir, Md Iqbal; Rahman, Md Bayzidur; Smith, Wayne; Lusha, Mirza Afreen Fatima; Milton, Abul Hasnat

2015-01-01

Background Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation. Methods This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model. Results None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001) higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model. Conclusions These results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic. PMID:26252381

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial

PubMed Central

2013-01-01

Background Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. Methods/design The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Discussion Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Trial registration Number Dutch Trial registration (Nederlands Trial Register): NTR3437 PMID:23855591

Development and testing of culturally sensitive patient information material for Turkish, Polish, Russian and Italian migrants with depression or chronic low back pain (KULTINFO): study protocol for a double-blind randomized controlled trial.

PubMed

Hölzel, Lars P; Ries, Zivile; Zill, Jördis M; Kriston, Levente; Dirmaier, Jörg; Härter, Martin; Bermejo, Isaac

2014-07-04

Many of the approximately 15 million people with a migration background living in Germany (19% of the population) are inadequately reached by existing healthcare provision. In the literature, the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study, culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain. In this respect, it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation. The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany. Primary care patients with a Turkish, Polish, Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group. In the intervention group, culturally sensitive patient information will be handed to the patient at the end of the physician consultation, while in the control group, standard translated patient information material will be provided. The patients will be surveyed by means of questionnaires following the consultation as well as after 8 weeks and 6 months. In addition to the primary outcome (subjective usefulness), several patient- and physician-rated secondary outcomes will be considered. The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation. Deutsches Register Klinischer Studien (DRKS-ID) DRKS00004241 and Universal Trial Number (UTN) U1111-1135-8043.

Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial.

PubMed

van den Dool, Joost; Visser, Bart; Koelman, J Hans T M; Engelbert, Raoul H H; Tijssen, Marina A J

2013-07-15

Cervical dystonia is characterized by involuntary muscle contractions of the neck and abnormal head positions that affect daily life activities and social life of patients. Patients are usually treated with botulinum toxin injections into affected neck muscles to relief pain and improve control of head postures. In addition, many patients are referred for physical therapy to improve their ability to perform activities of daily living. A recent review on allied health interventions in cervical dystonia showed a lack of randomized controlled intervention studies regarding the effectiveness of physical therapy interventions. The (cost-) effectiveness of a standardized physical therapy program compared to regular physical therapy, both as add-on treatment to botulinum toxin injections will be determined in a multi-centre, single blinded randomized controlled trial with 100 cervical dystonia patients. Primary outcomes are disability in daily functioning assessed with the disability subscale of the Toronto Western Spasmodic Torticollis Rating Scale. Secondary outcomes are pain, severity of dystonia, active range of motion of the head, quality of life, anxiety and depression. Data will be collected at baseline, after six months and one year by an independent blind assessor just prior to botulinum toxin injections. For the cost effectiveness, an additional economic evaluation will be performed with the costs per quality adjusted life-year as primary outcome parameter. Our study will provide new evidence regarding the (cost-) effectiveness of a standardized, tailored physical therapy program for patients with cervical dystonia. It is widely felt that allied health interventions, including physical therapy, may offer a valuable supplement to the current therapeutic options. A positive outcome will lead to a greater use of the standardized physical therapy program. For the Dutch situation a positive outcome implies that the standardized physical therapy program forms the basis for a national treatment guideline for cervical dystonia. Number Dutch Trial registration (Nederlands Trial Register): NTR3437.

Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

PubMed

Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

2005-10-01

To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial.

PubMed

Kabir, Md Iqbal; Rahman, Md Bayzidur; Smith, Wayne; Lusha, Mirza Afreen Fatima; Milton, Abul Hasnat

2015-01-01

Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation. This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model. None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001) higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model. These results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic.

A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis.

PubMed

Sørensen, P; Birket-Smith, M; Wattar, U; Buemann, I; Salkovskis, P

2011-02-01

Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist time required. STPP consisted of individual sessions. Eighty patients randomized to CBT, STPP and the waiting list were assessed on measures of health anxiety and general psychopathology before and after a 6-month treatment period. Waiting-list patients were subsequently offered one of the two active treatments on the basis of re-randomization, and assessed on the same measures post-treatment. Patients were again assessed at 6- and 12-month follow-up points. Patients who received CBT did significantly better on all measures relative to the waiting-list control group, and on a specific measure of health anxiety compared with STPP. The STPP group did not significantly differ from the waiting-list group on any outcome measures. Similar differences were observed between CBT and STPP during follow-up, although some of the significant differences between groups were lost. A modified and time-saving CBT programme is effective in the treatment of hypochondriasis, although the two psychotherapeutic interventions differed in structure.

Does Goal Attainment Scaling improve satisfaction regarding performance of activities of younger knee arthroplasty patients? Study protocol of the randomized controlled ACTION trial.

PubMed

Witjes, Suzanne; Hoorntje, Alexander; Kuijer, P Paul F M; Koenraadt, Koen L M; Blankevoort, Leendert; Kerkhoffs, Gino M M J; van Geenen, Rutger C I

2016-03-02

Knee arthroplasty is being increasingly performed, and also more often in a younger patient population (<65 years of age). Up to 20 % of patients remain dissatisfied after knee arthroplasty, despite the apparent technical success of the operation. Recent studies suggest that the fulfilment of patients' expectations plays an important role in achieving satisfaction. Thus, addressing preoperative expectations more explicitly might improve patient satisfaction. The primary aim of the present study is to investigate the effect of a multidisciplinary, goal attained and individualized rehabilitation on satisfaction of activities of younger patients (<65 years) after knee arthroplasty. A single-centre randomized controlled trial will be conducted. In total, 120 patients (<65 years of age) with knee osteoarthritis who will undergo knee arthroplasty, will be randomly allocated to either goal attainment scaling rehabilitation or usual care rehabilitation. Goal attainment scaling rehabilitation includes drafting individually set rehabilitation goals preoperatively and measuring progress of rehabilitation on a six-point scale (-3 to +2). The primary outcome is patient satisfaction concerning activities in daily life, work and leisure time, including sports. Secondary outcome measures include KOOS, OKS, SQUASH and WORQ questionnaires and activity objectively measured with the Activ8® activity monitor. The findings of this study will help to elucidate whether goal attainment scaling is an effective rehabilitation method for achieving higher levels of patient satisfaction, with a focus on activities, in younger patients after knee arthroplasty. This trial is since June 15(th) 2015 registered at the Dutch Trial Register: NTR5251 .

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Standardized antibacterial honey (Medihoney) with standard therapy in wound care: randomized clinical trial.

PubMed

Robson, Val; Dodd, Susanna; Thomas, Stephen

2009-03-01

This paper is a report of a study to compare a medical grade honey with conventional treatments on the healing rates of wounds healing by secondary intention. There is an increasing body of evidence to support the use of honey to treat wounds, but there is a lack of robust randomized trials on which clinicians can base their clinical judgement. A sample of 105 patients were involved in a single centre, open-label randomized controlled trial in which patients received either a conventional wound dressing or honey. Data were collected between September 2004 and May 2007. The median time to healing in the honey group was 100 days compared with 140 days in the control group. The healing rate at 12 weeks was equal to 46.2% in the honey group compared with 34.0% in the conventional group, and the difference in the healing rates (95% confidence interval, CI) at 12 weeks between the two groups was 12.2% (-13.6%, 37.9%). The unadjusted hazard ratio (95% CI) from a Cox regression was equal to 1.30 (0.77, 2.19), P = 0.321. When the treatment effect was adjusted for confounding factors (sex, wound type, age and wound area at start of treatment), the hazard ratio increased to 1.51 but was again not statistically significant. Wound area at start of treatment and sex are both highly statistically significant predictors of time to healing. These results support the proposition that there are clinical benefits from using honey in wound care, but further research is needed.

Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.

PubMed

Sørensen, P S; Sellebjerg, F; Lycke, J; Färkkilä, M; Créange, A; Lund, C G; Schluep, M; Frederiksen, J L; Stenager, E; Pfleger, C; Garde, E; Kinnunen, E; Marhardt, K

2016-05-01

Combining different therapies may improve disease control in patients with relapsing-remitting multiple sclerosis (RRMS). This study assessed the efficacy and safety of minocycline added to subcutaneous (sc) interferon (IFN) β-1a therapy. This was a double-blind, randomized, placebo-controlled multicentre study. Within 3 months (±1 month) of starting sc IFN β-1a 44 μg three times weekly, patients with RRMS were randomized to minocycline 100 mg twice daily or placebo, added to sc IFN β-1a, for 96 weeks. The primary efficacy endpoint was the time to first qualifying relapse. Secondary efficacy endpoints were the annualized relapse rate for qualifying relapses, the number of new/enlarging T2-weighted lesions and change in brain volume [magnetic resonance imaging (MRI) was performed only in a few selected centres]. In addition, a number of tertiary efficacy endpoints were assessed. One hundred and forty-nine patients received minocycline and 155 received placebo; MRI data were available for 23 and 27 patients, respectively. The time to first qualifying relapse did not differ significantly for minocycline versus placebo (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 0.48). There were no statistically significant differences between the two groups on other efficacy endpoints, although some numerical trends in favour of minocycline were observed. No unexpected adverse events were reported, but more patients discontinued because of adverse events with minocycline versus placebo. Minocycline showed no statistically significant beneficial effect when added to sc IFN β-1a therapy. © 2016 EAN.

Mirror therapy in children with hemiparesis: a randomized observer-blinded trial.

PubMed

Bruchez, Roselyn; Jequier Gygax, Marine; Roches, Sylvie; Fluss, Joel; Jacquier, David; Ballabeni, Pierluigi; Grunt, Sebastian; Newman, Christopher J

2016-09-01

To determine the efficacy of mirror therapy in children with hemiparesis. The design was an observer-blinded parallel-group randomized controlled trial (International Standard Randomised Controlled Trial Number 48748291). Randomization was computer-generated, 1:1 allocation to mirror therapy or comparison groups. The settings were home-based intervention and tertiary centre assessments. Participants were 90 children with hemiparesis aged 7 to 17 years. Intervention was 15 minutes per day of simultaneous arm training, 5 days a week, for 5 weeks. The mirror therapy group used a mirror; those in the comparison group looked at their paretic limb. Assessments comprised measures of upper limb strength, function (Melbourne Assessment 2), daily performance (ABILHAND-Kids), and sensory function at weeks 0 (T0 ), 5 (T1 ), and 10 (T2 ). There were no significant differences in outcomes and their progression over time between the mirror therapy and comparison groups. Post-hoc intention-to-treat analyses showed significant improvements in both groups for grasp strength (T0 -T1 +12.6%), pinch strength (T0 -T2 +9.1%), upper limb function in terms of accuracy (T0 -T2 +2.7%) and fluency (T0 -T2 +5.0%), as well as daily performance (T0 -T2 +16.6%). Per protocol analyses showed additional improvements in dexterity (T0 -T2 +4.0%). The use of the mirror illusion during therapy had no significant effect on treatment outcomes. However, 5 weeks of daily simultaneous arm training significantly improved paretic upper limb strength, function, and daily use. © 2016 Mac Keith Press.

Fibrin sealant for mesh fixation in laparoscopic umbilical hernia repair: 1-year results of a randomized controlled double-blinded study.

PubMed

Eriksen, J R; Bisgaard, T; Assaadzadeh, S; Jorgensen, L N; Rosenberg, J

2013-08-01

Fibrin sealant for mesh fixation has significant positive effects on early outcome after laparoscopic ventral hernia repair (LVHR) compared with titanium tacks. Whether fibrin sealant fixation also results in better long-term outcome is unknown. We performed a randomized controlled trial including patients with umbilical hernia defects from 1.5 to 5 cm at three Danish hernia centres. We used a 12 cm circular mesh. Participants were randomized to fibrin sealant or titanium tack fixation. Patients were seen in the outpatient clinic at 1 and 12 months follow-up. Forty patients were included of whom 34 were available for intention to treat analysis after 1 year. There were no significant differences in pain, discomfort, fatigue, satisfaction or quality of life between the two groups at the 1-year follow-up. Five patients (26 %) in the fibrin sealant group and one (6 %) in the tack group were diagnosed with a recurrence at the 1-year follow-up (p = 0.182) (overall recurrence rate 17 %). Hernia defects in patients with recurrence were significantly larger than in those without recurrence (median 4.0 vs. 2.8 cm, p = 0.009). Patients with larger hernia defects and fibrin sealant mesh fixation had higher recurrence rates than expected, although the study was not powered for assessment of recurrence. There was no significant difference between groups in any parameters after the 1-year follow-up. The beneficial effects of mesh fixation with fibrin sealant on early outcome warrant further studies on optimization of the surgical technique to prevent recurrence.

[Is DRG Coding too Important to be Left to Physicians? - Evaluation of Economic Efficiency by Health Economists in a University Medical Centre].

PubMed

Burger, F; Walgenbach, M; Göbel, P; Parbs, S; Neugebauer, E

2017-04-01

Background: We investigated and evaluated the cost effectiveness of coding by health care economists in a centre for orthopaedics and trauma surgery in Germany, by quantifying and comparing the financial efficiency of physicians with basic knowledge of the DRG-system with the results of healthcare economists with in-depth knowledge (M.Sc.). In addition, a hospital survey was performed to establish how DRG-coding is being performed and the identity of the persons involved. Material and Methods: In a prospective and controlled study, 200 in-patients were coded by a healthcare economist (study group). Prior to that, the same cases were coded by physicians with basic training in the DRG-system, who made up the control group. All cases were picked randomly and blinded without informing the physicians coding the controls, in order to avoid any Hawthorne effect. We evaluated and measured the effective weighting within the G-DRG, the DRG returns per patient, the overall DRG return, and the additional time needed. For the survey, questionnaires were sent to 1200 German hospitals. The completed questionnaire was analysed using a statistical program. Results: The return difference per patient between controls and the study group was significantly greater (2472 ± 337 €; p < 0.05); the overall return was raised by 494,500 €. The mean additional time needed was 11.32 ± 0.8 min per case, resulting in an increase in proceeds of 218 ± 38 € per minute. 2.5 % of all cases had to be devaluated by the health economist after the initial coding by the control group. Returned sheets of 60 hospitals were evaluated. The median level of DRG case reports was 1277 (2500-62,300). Coding was performed in 69 % of cases by doctors, 19 % by skilled specialists for DRG coding and in 8 % together. Overall satisfaction with the DRG was described by 61 % of respondents as good or excellent. Conclusion: Our prospective and controlled study quantifies the cost efficiency of health economists in a centre of orthopaedics and trauma surgery in Germany for the first time. We provide some initial evidence that health economists can enhance the CMI, the resulting DRG return per patient as well as the overall DRG return. Data from the survey shows that in many hospitals there is great reluctance to leave the coding to specialists only. Georg Thieme Verlag KG Stuttgart · New York.

Effect of Modified Otago Exercises on Postural Balance, Fear of Falling, and Fall Risk in Older Fallers With Knee Osteoarthritis and Impaired Gait and Balance: A Secondary Analysis.

PubMed

Mat, Sumaiyah; Ng, Chin Teck; Tan, Pey June; Ramli, Norlisah; Fadzli, Farhana; Rozalli, Faizatul Izza; Mazlan, Mazlina; Hill, Keith D; Tan, Maw Pin

2018-03-01

Osteoarthritis (OA) is considered an established risk factor for falls. Published studies evaluating secondary falls prevention strategies among individuals with OA are limited. To evaluate the effect of a personalized home-based exercise program to improve postural balance, fear of falling, and falls risk in older fallers with knee OA and gait and balance problems. Randomized controlled trial. University of Malaya Medical Centre. Fallers who had both radiological OA and a Timed Up and Go (TUG) score of over 13.5 seconds. Postural sway (composite sway) was quantified with the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) under 4 different sensory conditions: eyes open on firm surface, eyes closed on firm surface, eyes open on unstable foam surface, and eyes closed on unstable foam surface. Participants were asked to stand upright and to attempt to hold their position for 10 seconds for each test condition. The average reading for all conditions were calculated. Participants randomized to the intervention arm received a home-based modified Otago Exercise Program (OEP) as part of a multifactorial intervention, whereas control participants received general health advice and conventional treatment. This was a secondary subgroup analysis from an original randomized controlled trial, the Malaysian Falls Assessment and Intervention Trial (MyFAIT) (trial registration number: ISRCTN11674947). Posturography using a long force plate balance platform (Balancemaster, NeuroCom, USA), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the short-form Falls Efficacy Scale-International (short FES-I) were assessed at baseline and 6 months. Results of 41 fallers with radiological evidence of OA and impaired TUG (intervention, 17; control, 24) were available for the final analysis. Between-group analysis revealed significant improvements in the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), Limits of Stability (LOS), and short FES-I scores by the intervention group compared to the control group at 6 months. No significant difference in time to first fall or in fall-free survival between the intervention and control groups was found. Home-based balance and strength exercises benefited older fallers with OA and gait and balance disorders by improving postural control, with no observable trend in reduction of fall recurrence. Our findings will now inform a future, adequately powered, randomized controlled study using fall events as definitive outcomes. I. Copyright © 2018 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Control of blood pressure in Scotland: the rule of halves.

PubMed

Smith, W C; Lee, A J; Crombie, I K; Tunstall-Pedoe, H

1990-04-14

Audit of detection, treatment, and control of hypertension in adults in Scotland. Cross sectional survey with random population sampling. General practice centres in 22 Scottish districts. 5123 Men and 5236 women aged 40-59 in the Scottish heart health study, randomly selected from 22 districts throughout Scotland, of whom 1262 men and 1061 women had hypertension (defined as receiving antihypertensive treatment or with blood pressure above defined cut off points). Hypertension (assessed by standardised recording, questionnaire on diagnosis, and antihypertensive drug treatment) according to criteria of the World Health Organisation (receiving antihypertensive treatment or blood pressure greater than or equal to 160/95 mm Hg, or both) and to modified criteria of the British Hypertension Society. In half the men with blood pressure greater than or equal to 160/95 mm Hg hypertension was undetected (670/1262, 53%), in half of those in whom it had been detected it was untreated (250/592, 42%), and in half of those receiving treatment it was not controlled (172/342, 50%). In women the numbers were: 486/1061, 46%; 188/575, 33%; and 155/387, 40% respectively. Assessment of blood pressure according to the British Hypertension Society's recommendations showed an improvement, but in only a quarter of men and 42% of women was hypertension detected and treated satisfactorily (142/561, 215/514 respectively). The detection and control of hypertension in Scotland is unsatisfactory, affecting management of this and other conditions, such as high blood cholesterol concentration, whose measurement is opportunistic and selective and depends on recognition of other risk factors.

Effectiveness of an in-office arginine-calcium carbonate paste on dentine hypersensitivity in periodontitis patients: a double-blind, randomized controlled trial.

PubMed

Pepelassi, Eudoxie; Rahiotis, Christos; Peponi, Eleni; Kakaboura, Afrodite; Vrotsos, Ioannis

2015-01-01

The aim of this single-centre, two-cell, double-blind, randomized controlled clinical study was to evaluate the effectiveness of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing relief on dentine hypersensitivity immediately after scaling and root planing and its sustained relief over a 6-week period. Fifty periodontitis subjects presenting hypersensitivity were subjected to scaling and root planing and in-office application of either 8% arginine and calcium carbonate desensitizing paste (25 subjects, test group) or fluoride-free prophylaxis paste (25 subjects, control group). Air-blast hypersensitivity was assessed using Schiff and Visual Analogue (VAS) scales at baseline, post-scaling, post-application, 2, 4 and 6 weeks. At all evaluation times, the test group presented significant % reduction in hypersensitivity relative to post-scaling (t-test, p < 0.05) (Schiff - Test: 57, 58.6, 60.2, 68; 28.6, 22.2, 23, 23) (VAS - Test: 60, 55.6, 60.1, 68.4; 25.9, 18.2, 20.6, 22.7) and significant % hypersensitivity difference relative to control (ancova, p < 0.05) (Schiff: 38.9, 45.9, 47.4, 57.7; VAS: 49.1, 48.9, 52.6, 61). The single in-office application of the 8% arginine-calcium carbonate desensitizing paste after scaling and root planing provided significant immediate reduction in dentine hypersensitivity, which sustained over a 6-week period. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A randomized trial evaluation of the Oswestry Standing Frame for patients after stroke.

PubMed

Bagley, Pam; Hudson, Mary; Forster, Anne; Smith, Jane; Young, John

2005-06-01

Standing is believed to have benefits in addressing motor and sensory impairments after stroke. One device to facilitate standing for severely disabled patients is the Oswestry Standing Frame. To evaluate the effectiveness of the Oswestry Standing Frame for severely disabled stroke patients. A single centre, randomized controlled trial. An inpatient stroke rehabilitation unit. Patients were recruited if they had a clinical diagnosis of stroke, were medically stable and unable to achieve any score on the Trunk Control Test or unable to stand in mid-line without the assistance of two therapists. The intervention (n = 71) and control (n = 69) groups both received usual stroke unit care but the intervention group also received a minimum of 14 consecutive days' treatment using the standing frame. The primary outcome measure was the Rivermead Mobility Index (RMI). Secondary measures included the Barthel Index; the Rivermead Motor Assessment; the balanced sitting and sitting to standing components of the Motor Assessment Scale; the Trunk Control Test and the Hospital Anxiety and Depression Scale. Blind assessment was undertaken at baseline, six weeks, 12 weeks and six months post stroke. Information on resource use was also collected. There was no statistically significant difference between groups in any of the outcome measures or for resource use. Mann-Whitney U-tests for the RMI change from baseline scores to six weeks, 12 weeks and six months post stroke were p = 0.310; p = 0.970 and p = 0.282, respectively. Use of the Oswestry Standing Frame did not improve clinical outcome or provide resource savings for this severely disabled patient group.

Effects of vitamin D supplementation on glycated haemoglobin and fasting glucose levels in hypertensive patients: a randomized controlled trial.

PubMed

Grübler, M R; Gaksch, M; Kienreich, K; Verheyen, N; Schmid, J; Ó Hartaigh, B; Richtig, G; Scharnagl, H; Meinitzer, A; Fahrleitner-Pammer, A; März, W; Tomaschitz, A; Pilz, S

2016-10-01

To investigate the efficacy of vitamin D supplementation on glycaemic control. The Styrian Vitamin D Hypertension Trial was a single-centre, double-blind, placebo-controlled study conducted between 2011 and 2014 at the Medical University of Graz, Austria. We enrolled 200 people with arterial hypertension and 25-hydroxyvitamin D [25(OH)D] concentrations <30 ng/mL. Study participants were randomized to receive either 2800 IU of vitamin D or placebo per day for 8 weeks. The present study was a post hoc analysis that incorporated an analysis of covariance (ancova) approach, while adjusting for baseline differences. A total of 185 participants [mean ± standard deviation age, 60.1 ± 11.3 years; 47% women; mean 25(OH)D 21.2 ± 5.6 ng/mL, mean glycated haemoglobin (HbA1c) 44.8 ± 11.8 mmol/mol and mean body mass index 30.4 ± 5.4 kg/m(2) ] completed the trial. ancova showed a mean treatment effect [95% confidence interval (CI)] on HbA1c of -3.52 (-6.7 to -0.34) mmol/mol (p = .045). There was no difference in fasting glucose -4.7 mg/dL (95% CI -16.3 to 6.9; p = .426). Vitamin D supplementation in obese hypertensive patients with low 25(OH)D reduces HbA1c levels. This finding warrants further investigation into potential vitamin D effects on glucose homeostasis. © 2016 John Wiley & Sons Ltd.

[Telemetric monitoring reduces visits to the emergency room and cost of care in patients with chronic heart failure].

PubMed

Pérez-Rodríguez, Gilberto; Brito-Zurita, Olga Rosa; Sistos-Navarro, Enrique; Benítez-Aréchiga, Zaria Margarita; Sarmiento-Salazar, Gloria Leticia; Vargas-Lizárraga, José Feliciano

2015-01-01

Tele-cardiology is the use of information technologies that help prolong survival, improve quality of life and reduce costs in health care. Heart failure is a chronic disease that leads to high care costs. To determine the effectiveness of telemetric monitoring for controlling clinical variables, reduced emergency room visits, and cost of care in a group of patients with heart failure compared to traditional medical consultation. A randomized, controlled and open clinical trial was conducted on 40 patients with Heart failure in a tertiary care centre in north-western Mexico. The patients were divided randomly into 2 groups of 20 patients each (telemetric monitoring, traditional medical consultation). In each participant was evaluated for: blood pressure, heart rate and body weight. The telemetric monitoring group was monitored remotely and traditional medical consultation group came to the hospital on scheduled dates. All patients could come to the emergency room if necessary. The telemetric monitoring group decreased their weight and improved control of the disease (P=.01). Systolic blood pressure and cost of care decreased (51%) significantly compared traditional medical consultation group (P>.05). Admission to the emergency room was avoided in 100% of patients in the telemetric monitoring group. In patients with heart failure, the telemetric monitoring was effective in reducing emergency room visits and saved significant resources in care during follow-up. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Endoscopic tri-modal imaging for detection of early neoplasia in Barrett's oesophagus: a multi-centre feasibility study using high-resolution endoscopy, autofluorescence imaging and narrow band imaging incorporated in one endoscopy system.

PubMed

Curvers, W L; Singh, R; Song, L-M Wong-Kee; Wolfsen, H C; Ragunath, K; Wang, K; Wallace, M B; Fockens, P; Bergman, J J G H M

2008-02-01

To investigate the diagnostic potential of endoscopic tri-modal imaging and the relative contribution of each imaging modality (i.e. high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI)) for the detection of early neoplasia in Barrett's oesophagus. Prospective multi-centre study. Tertiary referral centres. 84 Patients with Barrett's oesophagus. The Barrett's oesophagus was inspected with HRE followed by AFI. All lesions detected with HRE and/or AFI were subsequently inspected in detail by NBI for the presence of abnormal mucosal and/or microvascular patterns. Biopsies were obtained from all suspicious lesions for blinded histopathological assessment followed by random biopsies. (1) Number of patients with early neoplasia diagnosed by HRE and AFI; (2) number of lesions with early neoplasia detected with HRE and AFI; and (3) reduction of false positive AFI findings after NBI. Per patient analysis: AFI identified all 16 patients with early neoplasia identified with HRE and detected an additional 11 patients with early neoplasia that were not identified with HRE. In three patients no abnormalities were seen but random biopsies revealed HGIN. After HRE inspection, AFI detected an additional 102 lesions; 19 contained HGIN/EC (false positive rate of AFI after HRE: 81%). Detailed inspection with NBI reduced this false positive rate to 26%. In this international multi-centre study, the addition of AFI to HRE increased the detection of both the number of patients and the number of lesions with early neoplasia in patients with Barrett's oesophagus. The false positive rate of AFI was reduced after detailed inspection with NBI.

Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial.

PubMed

Tebb, Kathleen P; Rodriguez, Felicia; Pollack, Lance M; Trieu, Sang Leng; Hwang, Loris; Puffer, Maryjane; Adams, Sally; Ozer, Elizabeth M; Brindis, Claire D

2018-01-10

Teen pregnancy rates in the USA remain higher than any other industrialised nation, and pregnancies among Hispanic adolescents are disproportionately high. Computer-based interventions represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings have demonstrated that the Health-E You/Salud iTu, computer application (app) is feasible to implement, acceptable to Latina adolescents and improves sexual health knowledge and interest in selecting an effective contraceptive method when used in conjunction with a healthcare visit. The app is now ready for efficacy testing. The purpose of this manuscript is to describe patient-centred approaches used both in developing and testing the Health-E You app and to present the research methods used to evaluate its effectiveness in improving intentions to use an effective method of contraception as well as actual contraceptive use. This study is designed to assess the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud  iTu, on its ability to reduce health disparities in unintended pregnancies among Latina adolescent girls. This study uses a cluster randomised control trial design in which 18 school-based health centers from the Los Angeles Unified School District were randomly assigned, at equal chance, to either the intervention ( Health-E You app) or control group. Analyses will examine differences between the control and intervention group's knowledge of and attitudes towards contraceptive use, receipt of contraception at the clinic visit and self-reported use of contraception at 3-month and 6-month follow-ups. The study began enrolling participants in August 2016, and a total of 1400 participants (700 per treatment group) are expected to be enrolled by March 2018. Ethics approval was obtained through the University of California, San Francisco Institutional Review Board. Results of this trial will be submitted for publication in peer-reviewed journals. This study is registered with the US National Institutes of Health. NCT02847858. © 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 Nutrition Supplementation in Children Living with HIV at ART Centre.

PubMed

Thakur, Himabindu Singh; Gottapu, Geetha Srivalliswari; Kadali, Sai Prasad; Kulkarni, Bharati; Mamidi, Raja Sriswan

2016-03-01

To assess the benefits of nutrition supplementation in children living with HIV (CLHIV). A prospective observational study was carried out at antiretroviral therapy (ART)/pediatric centre of excellence (PCOE), Niloufer hospital for a period of one year in CLHIV (N = 164) aged 1 to 18 y referred to ART/PCOE. Nutrition supplementation was given in the form of Ready to Use Food (About 350 kcal and 12 g of protein per day) supplementation to assess improvement in Height for age Z (HAZ), Weight for Age Z (WAZ), Weight for Height Z (WHZ) and Body Mass Index for age Z (BMIZ) scores over a period of one year. At baseline, 65.5 % and 57.5 % of children below and above 5 y respectively were stunted. 24.1 % and 45.3 % children below and above 5 y respectively were wasted/thin (as assessed by BMI for age). Mean BMIZ score significantly improved in both the age groups (0.96 Z score, P < 0.001) in below and above 5 (0.37 Z score, P < 0.001) respectively at the end of 12 mo. Mean HAZ score also significantly improved in children above 5 y (0.09 Z score, P < 0.05) with non-significant improvement below 5 y (0.14 Z score, P < 0.57) by the end of 12 mo. Nutrition supplementation over one year resulted in moderate improvement in the nutritional status of CLHIV. However, it is unclear, whether the improvement in nutritional status was due to regular visits to ART centre that may have resulted in better adherence to treatment or an additional benefit of nutrition intervention. This warrants a well-designed randomized controlled trial to examine the benefits of nutrition supplementation in CLHIV attending ART centre.

Peak-locking centroid bias in Shack-Hartmann wavefront sensing

NASA Astrophysics Data System (ADS)

Anugu, Narsireddy; Garcia, Paulo J. V.; Correia, Carlos M.

2018-05-01

Shack-Hartmann wavefront sensing relies on accurate spot centre measurement. Several algorithms were developed with this aim, mostly focused on precision, i.e. minimizing random errors. In the solar and extended scene community, the importance of the accuracy (bias error due to peak-locking, quantization, or sampling) of the centroid determination was identified and solutions proposed. But these solutions only allow partial bias corrections. To date, no systematic study of the bias error was conducted. This article bridges the gap by quantifying the bias error for different correlation peak-finding algorithms and types of sub-aperture images and by proposing a practical solution to minimize its effects. Four classes of sub-aperture images (point source, elongated laser guide star, crowded field, and solar extended scene) together with five types of peak-finding algorithms (1D parabola, the centre of gravity, Gaussian, 2D quadratic polynomial, and pyramid) are considered, in a variety of signal-to-noise conditions. The best performing peak-finding algorithm depends on the sub-aperture image type, but none is satisfactory to both bias and random errors. A practical solution is proposed that relies on the antisymmetric response of the bias to the sub-pixel position of the true centre. The solution decreases the bias by a factor of ˜7 to values of ≲ 0.02 pix. The computational cost is typically twice of current cross-correlation algorithms.

Mobile phone technology identifies and recruits trained citizens to perform CPR on out-of-hospital cardiac arrest victims prior to ambulance arrival.

PubMed

Ringh, Mattias; Fredman, David; Nordberg, Per; Stark, Tomas; Hollenberg, Jacob

2011-12-01

In a two-parted study, evaluate a new concept were mobile phone technology is used to dispatch lay responders to nearby out-of-hospital cardiac arrests (OHCAs). Mobile phone positioning systems (MPS) can geographically locate selected mobile phone users at any given moment. A mobile phone service using MPS was developed and named Mobile Life Saver (MLS). Simulation study: 25 volunteers named mobile responders (MRs) were connected to MLS. Ambulance time intervals from 22 consecutive OHCAs in 2005 were used as controls. The MRs randomly moved in Stockholm city centre and were dispatched to simulated OHCAs (identical to controls) if they were within a 350 m distance. Real life study: during 25 weeks 1271-1801 MRs trained in CPR were connected to MLS. MLS was activated at the dispatch centre in parallel with ambulance dispatch when an OHCA was suspected. The MRs were dispatched if they were within 500 m from the suspected OHCA. Simulation study: mean response time for the MRs compared to historical ambulance time intervals was reduced by 2 min 20s (44%), p<0.001, (95% CI, 1 min 5s - 3 min 35s). The MRs reached the simulated OHCA prior to the historical control in 72% of cases. Real life study: the MLS was triggered 92 times. In 45% of all suspected and in 56% of all true OHCAs the MRs arrived prior to ambulance. CPR was performed by MRs in 17% of all true OHCAs and in 30% of all true OHCAs if MRs arrived prior to ambulance. Mobile phone technology can be used to identify and recruit nearby CPR-trained citizens to OHCAs for bystander CPR prior to ambulance arrival. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Availability of essential drugs for managing HIV-related pain and symptoms within 120 PEPFAR-funded health facilities in East Africa: a cross-sectional survey with onsite verification.

PubMed

Harding, Richard; Simms, Victoria; Penfold, Suzanne; Downing, Julia; Powell, Richard A; Mwangi-Powell, Faith; Namisango, Eve; Moreland, Scott; Gikaara, Nancy; Atieno, Mackuline; Kataike, Jennifer; Nsubuga, Clare; Munene, Grace; Banga, Geoffrey; Higginson, Irene J

2014-04-01

World Health Organization's essential drugs list can control the highly prevalent HIV-related pain and symptoms. Availability of essential medicines directly influences clinicians' ability to effectively manage distressing manifestations of HIV. To determine the availability of pain and symptom controlling drugs in East Africa within President's Emergency Plan for AIDS Relief-funded HIV health care facilities. Directly observed quantitative health facilities' pharmacy stock review. We measured availability, expiration and stock-outs of specified drugs required for routine HIV management, including the World Health Organization pain ladder. A stratified random sample in 120 President's Emergency Plan for AIDS Relief-funded HIV care facilities (referral and district hospitals, health posts/centres and home-based care providers) in Kenya and Uganda. Non-opioid analgesics (73%) and co-trimoxazole (64%) were the most commonly available drugs and morphine (7%) the least. Drug availability was higher in hospitals and lower in health centres, health posts and home-based care facilities. Facilities generally did not use minimum stock levels, and stock-outs were frequently reported. The most common drugs had each been out of stock in the past 6 months in 47% of facilities stocking them. When a minimum stock level was defined, probability of a stock-out in the previous 6 months was 32.6%, compared to 45.5% when there was no defined minimum stock level (χ (2) = 5.07, p = 0.024). The data demonstrate poor essential drug availability, particularly analgesia, limited by facility type. The lack of strong opioids, isoniazid and paediatric formulations is concerning. Inadequate drug availability prevents implementation of simple clinical pain and symptom control protocols, causing unnecessary distress. Research is needed to identify supply chain mechanisms that lead to these problems.

Improving the organisation of maternal health service delivery and optimising childbirth by increasing vaginal birth after caesarean section through enhanced women-centred care (OptiBIRTH trial): study protocol for a randomised controlled trial (ISRCTN10612254).

PubMed

Clarke, Mike; Savage, Gerard; Smith, Valerie; Daly, Deirdre; Devane, Declan; Gross, Mechthild M; Grylka-Baeschlin, Susanne; Healy, Patricia; Morano, Sandra; Nicoletti, Jane; Begley, Cecily

2015-11-30

The proportion of pregnant women who have a caesarean section shows a wide variation across Europe, and concern exists that these proportions are increasing. Much of the increase in caesarean sections in recent years is due to a cascade effect in which a woman who has had one caesarean section is much more likely to have one again if she has another baby. In some places, it has become common practice for a woman who has had a caesarean section to have this procedure again as a matter of routine. The alternative, vaginal birth after caesarean (VBAC), which has been widely recommended, results in fewer undesired results or complications and is the preferred option for most women. However, VBAC rates in some countries are much lower than in other countries. The OptiBIRTH trial uses a cluster randomised design to test a specially developed approach to try to improve the VBAC rate. It will attempt to increase VBAC rates from 25 % to 40 % through increased women-centred care and women's involvement in their care. Sixteen hospitals in Germany, Ireland and Italy agreed to join the study, and each hospital was randomly allocated to be either an intervention or a control site. If the OptiBIRTH intervention succeeds in increasing VBAC rates, its application across Europe might avoid the 160,000 unnecessary caesarean sections that occur every year at an extra direct annual cost of more than €150 million. Current Controlled Trials ISRCTN10612254 , registered 3 April 2013.

Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer. Methods This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks. For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective. Discussion The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT. PMID:22998983

Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial

PubMed Central

Vignaud, Marie; Paugam-Burtz, Catherine; Garot, Matthias; Jaber, Samir; Slim, Karem; Panis, Yves; Lucet, Jean-Christophe; Bourdier, Justine; Morand, Dominique; Pereira, Bruno; Futier, Emmanuel

2018-01-01

Introduction Surgical site infections (SSIs) account for 30% of all healthcare-associated infections, with reported rates ranging from 8% and 30% after colorectal surgery and are associated with increased morbidity and mortality rates, length of hospital stay and costs in healthcare. Administration of systemic antimicrobial prophylaxis before surgery is recommended to reduce the risk of SSI, but the optimal regimen remains unclear. We aim to evaluate whether a combined oral and intravenous antimicrobial prophylaxis could be more effective to reduce the incidence of SSI after colorectal surgery, as compared with the standard practice of intravenous antimicrobial prophylaxis alone. Methods and analysis Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) trial is a randomised, placebo-controlled, parallel, double-blind, multicentre study of 960 patients undergoing elective colorectal surgery. Patients will be randomly allocated in a 1:1 ratio to receive either combined oral and intravenous antimicrobial prophylaxis or intravenous antibiotic prophylaxis alone, stratified by centre, the surgical procedure (laparoscopic or open surgery) and according to the surgical skin antisepsis (chlorexidine–alcohol or povidione-iodine alcoholic solution). The primary endpoint is the rate of SSI by day 30 following surgery, with SSI defined by the criteria developed by the Centers for Disease Control and Prevention. Data will be analysed on the intention-to-treat principle and a per-protocol basis. Ethics and dissemination COMBINE trial has been approved by an independent ethics committee for all study centres. Participant recruitment began in May 2016. Results will be published in international peer-reviewed medical journals. Trial registration number EudraCT 2015-002559-84; NCT02618720. PMID:29654027

Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

PubMed

Wills, Lucy; Maggs, Rhydian; Lewis, Geraint; Jones, Gareth; Nixon, Lisette; Staffurth, John; Crosby, Tom

2017-11-15

SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres. A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins. 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm 3 ; and PTV volumes 221.9-513.3 cm 3 . For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial. The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol. The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 .

Business Centre Development Model of Airport Area in Supporting Airport Sustainability in Indonesia

NASA Astrophysics Data System (ADS)

Setiawan, MI; Surjokusumo, S.; Ma'soem, DM; Johan, J.; Hasyim, C.; Kurniasih, N.; Sukoco, A.; Dhaniarti, I.; Suyono, J.; Sudapet, IN; Nasihien, RD; Mudjanarko, SW; Wulandari, A.; Ahmar, Ansari S.; Wajdi, MBN

2018-01-01

Airport is expected to play the role in enhancing the economic level of the region, especially the local people around the airport. The Aero City concept in developing an airport might also develop a city centreed in the airport that combining airport oriented business development, business actors and local people around the airport area. This study aims to generate development model of business centre at the airports in Indonesia. This is a mixed method based study. The population includes 296 airports under government management, government subsidiary and military. By using stratified random sampling, there were 151 sample airports. The results show that business centre development in the airport area will be related with the airport management and the commercial property (business centre) growth at the airport. Aero City in Indonesia can be developed by partnership system between government and private sector that consists of construction, development, and implementation of commercial property such as hotel, apartment, retail, office, etc. Based on the result of T-Value test, Airport Performance variable predicted to have significant influence on Gross Regional Domestic Product Central Business District performance.

Development and Impact Evaluation of an E-Learning Radiation Oncology Module

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alfieri, Joanne, E-mail: Joanne.alfieri@mail.mcgill.ca; Portelance, Lorraine; Souhami, Luis

Purpose: Radiation oncologists are faced with the challenge of irradiating tumors to a curative dose while limiting toxicity to healthy surrounding tissues. This can be achieved only with superior knowledge of radiologic anatomy and treatment planning. Educational resources designed to meet these specific needs are lacking. A web-based interactive module designed to improve residents' knowledge and application of key anatomy concepts pertinent to radiotherapy treatment planning was developed, and its effectiveness was assessed. Methods and Materials: The module, based on gynecologic malignancies, was developed in collaboration with a multidisciplinary team of subject matter experts. Subsequently, a multi-centre randomized controlled studymore » was conducted to test the module's effectiveness. Thirty-six radiation oncology residents participated in the study; 1920 were granted access to the module (intervention group), and 17 in the control group relied on traditional methods to acquire their knowledge. Pretests and posttests were administered to all participants. Statistical analysis was carried out using paired t test, analysis of variance, and post hoc tests. Results: The randomized control study revealed that the intervention group's pretest and posttest mean scores were 35% and 52%, respectively, and those of the control group were 37% and 42%, respectively. The mean improvement in test scores was 17% (p < 0.05) for the intervention group and 5% (p = not significant) for the control group. Retrospective pretest and posttest surveys showed a statistically significant change on all measured module objectives. Conclusions: The use of an interactive e-learning teaching module for radiation oncology is an effective method to improve the radiologic anatomy knowledge and treatment planning skills of radiation oncology residents.« less

Effect of an e-Learning Tool on Expectations and Satisfaction Following Total Knee Arthroplasty: A Randomized Controlled Trial.

PubMed

Culliton, Sharon E; Bryant, Dianne M; MacDonald, Steven J; Hibbert, Kathy M; Chesworth, Bert M

2018-07-01

Orthopedic surgeons recognize patient expectations of total knee arthroplasty (TKA) can be managed through education. E-learning is the application of educational technology. The objective of this study was to evaluate whether an e-learning tool could affect whether patients' expectations were met and they were satisfied 1 year following TKA. Patients with osteoarthritis from the London Health Sciences Centre, Canada, were randomly assigned to either a control group (n = 207) receiving standard patient education or an intervention group (n = 209) using the e-learning tool in addition to the standard. We used a web-based system with permuted block sizes, stratified by surgeon and first or second TKA. Preoperative measures were completed following the patients' preadmission clinic visit. Postoperative patient-reported outcome measures were completed at 6 weeks, 3 months, and 1 year after TKA. One year after TKA, risk difference was used to determine between-group differences for patient satisfaction and expectations being met. One year postoperatively, the risk that expectations of patients were not met was 21.8% in the control group and 21.4% in the intervention group for an adjusted risk difference of 1.3% (95% confidence interval, -7.8% to 10.4%, P = .78). The proportion of patients satisfied with their TKA at 1 year postoperative was 78.6% in the intervention and 78.2% in the control groups. There was no between-group difference at 1 year between intervention and control groups for either the risk that expectations of patients were not met or the proportion of patients who were dissatisfied with their TKA. Copyright © 2018 Elsevier Inc. All rights reserved.

Lunch is ready… but not healthy: An analysis of lunches served in childcare centres in two Canadian provinces.

PubMed

Ward, Stephanie; Bélanger, Mathieu; Donovan, Denise; Vatanparast, Hassan; Engler-Stringer, Rachel; Leis, Anne; Carrier, Natalie

2017-11-09

Childcare centres (CCs) typically offer one meal and snacks daily. This study compared what is served in CCs with what the nutritional recommendations are; described and compared the nutritional composition of lunches served in CCs in New Brunswick and Saskatchewan; and examined differences between French and English, and urban and rural centres. The study involved 61 randomly selected CCs in New Brunswick and Saskatchewan, Canada. Lunch content was measured on two consecutive days by weighing each food item served to children and by visually documenting the food items using digital photography. Food items were categorized into food groups according to Health Canada's Eating Well with Canada's Food Guide, and nutrients were analyzed using a nutritional analysis software. One-sample t tests compared lunch content with nutritional recommendations. Independent t tests compared the nutrient and food group content of lunches in New Brunswick and Saskatchewan, French and English, and urban and rural CCs. On average, CCs did not meet provincial recommendations. Lunches in both provinces were low in calories (<517 kcal) and fibre (<7 g). Overall, Saskatchewan centres served greater amounts of food than New Brunswick centres (p < 0.05). French-speaking centres provided less fat (p = 0.047), less saturated fat (p = 0.01), and fewer servings of meat and alternatives (p = 0.02), and more trans fat (p = 0.03) than English-speaking centres. There were no differences between rural and urban centres. Few CC lunches met nutritional recommendations. Interventions are required to improve the quality of foods offered in CCs. Reviewing or developing comprehensive nutrition guidelines is warranted.

Evaluation of the effect of motivational interviewing counselling on hypertension care.

PubMed

Ma, Chunhua; Zhou, Ying; Zhou, Wei; Huang, Chunfeng

2014-05-01

This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients. A randomised controlled trial was used. One hundred and twenty eligible participants were randomly assigned to either the control group (usual care group) or the intervention group (motivational interviewing group). The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence questionnaire were increased in the intervention group (P<0.05), and the systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling (P<0.05). The application of motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour. Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence. A series of training courses on the motivational interviewing technique should be provided to nurses. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

PubMed

Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

2018-03-26

Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

Anomalies in the 1D Anderson model: Beyond the band-centre and band-edge cases

NASA Astrophysics Data System (ADS)

Tessieri, L.; Izrailev, F. M.

2018-03-01

We consider the one-dimensional Anderson model with weak disorder. Using the Hamiltonian map approach, we analyse the validity of the random-phase approximation for resonant values of the energy, E = 2 cos(πr) , with r a rational number. We expand the invariant measure of the phase variable in powers of the disorder strength and we show that, contrary to what happens at the centre and at the edges of the band, for all other resonant energies the leading term of the invariant measure is uniform. When higher-order terms are taken into account, a modulation of the invariant measure appears for all resonant values of the energy. This implies that, when the localisation length is computed within the second-order approximation in the disorder strength, the Thouless formula is valid everywhere except at the band centre and at the band edges.

Supraspinal control of external anal sphincter motility: effects of vesical distension in humans and cats.

PubMed

Vitton, V; Grimaud, J-C; Bouvier, M; Abysique, A

2006-11-01

A pontine centre located near the micturition centre controlling external anal sphincter (EAS) motility via noradrenergic neurones has been described in cats. The aim of this study was to determine (i) whether a similar centre controls EAS motility in humans and (ii) whether this centre is involved in vesico-sphincteric reflexes in cats and humans. The effects of an alpha-1-adrenoceptor antagonist (nicergoline) and those of vesical distension on the electrical activity of the EAS were studied in paraplegic and non-paraplegic volunteers. The effects of vesical distension by injecting saline at physiological levels on the responses of the EAS to pudendal nerve stimulation were investigated in intact cats and cats with nerve sections. In non-paraplegic subjects, nicergoline and vesical distension abolished the activity of the EAS. These effects were no longer observed in paraplegic patients. In cats, vesical distension inhibited the reflex response of the EAS to pudendal nerve stimulation. This vesico-sphincteric reflex, which was no longer observed in spinal animals, persisted after nicergoline injection. These findings indicate that in humans, there exists a supra-spinal centre facilitating the tonic activity of the EAS via noradrenergic neurones not involved in the inhibitory vesico-sphincteric reflex.

Inventory Control System for a Healthcare Apparel Service Centre with Stockout Risk: A Case Analysis

PubMed Central

Hui, Chi-Leung

2017-01-01

Based on the real-world inventory control problem of a capacitated healthcare apparel service centre in Hong Kong which provides tailor-made apparel-making services for the elderly and disabled people, this paper studies a partial backordered continuous review inventory control problem in which the product demand follows a Poisson process with a constant lead time. The system is controlled by an (Q,r) inventory policy which incorporate the stockout risk, storage capacity, and partial backlog. The healthcare apparel service centre, under the capacity constraint, aims to minimize the inventory cost and achieving a low stockout risk. To address this challenge, an optimization problem is constructed. A real case-based data analysis is conducted, and the result shows that the expected total cost on an order cycle is reduced substantially at around 20% with our proposed optimal inventory control policy. An extensive sensitivity analysis is conducted to generate additional insights. PMID:29527283

Inventory Control System for a Healthcare Apparel Service Centre with Stockout Risk: A Case Analysis.

PubMed

Pan, An; Hui, Chi-Leung

2017-01-01

Based on the real-world inventory control problem of a capacitated healthcare apparel service centre in Hong Kong which provides tailor-made apparel-making services for the elderly and disabled people, this paper studies a partial backordered continuous review inventory control problem in which the product demand follows a Poisson process with a constant lead time. The system is controlled by an ( Q , r ) inventory policy which incorporate the stockout risk, storage capacity, and partial backlog. The healthcare apparel service centre, under the capacity constraint, aims to minimize the inventory cost and achieving a low stockout risk. To address this challenge, an optimization problem is constructed. A real case-based data analysis is conducted, and the result shows that the expected total cost on an order cycle is reduced substantially at around 20% with our proposed optimal inventory control policy. An extensive sensitivity analysis is conducted to generate additional insights.

A preliminary study to evaluate a patient-centred asthma education programme on parental control of home environment and asthma signs and symptoms in children with moderate-to-severe asthma.

PubMed

Tzeng, Li-Fen; Chiang, Li-Chi; Hsueh, Kai-Chung; Ma, Wei-Fen; Fu, Lin-Shien

2010-05-01

To evaluate the effectiveness of a nurse-led patient-centred asthma education programme on home environmental control behaviours of parents of children with moderate or severe asthma. Reducing allergic triggers is important self-management behaviour for preventing asthma attacks and patient-centred asthma education has been shown to effectively manage chronic disease. A preliminary quasi-experimental, non-equivalent control group design was used. Dyads (n = 75) of parents and their children with moderate or severe asthma (ages 6-14 years) were purposively recruited from the asthma clinics of two hospitals in central Taiwan. The experimental group of 38 children/parents from one hospital received patient-centred asthma education. The comparison group of 37 children/parents from the other hospital received routine individual education. At pretest and at the end of the three-month patient-centred asthma education programme, we measured parents' control of home environmental triggers, children's asthma signs/symptoms and children's pulmonary function. Data were analysed by the general linear model for repeat measures. The level of improvement in dust and cleaning methods was significantly greater among parents in the experimental group than among those in the comparison group (p < 0.05). Children with moderate or severe asthma in the experimental group had fewer signs/symptoms of asthma and better lung function than children in the comparison group. Our patient-centred asthma education programme improved parents' home environmental control and children's asthma sign/symptoms and lung function. Nurses can play primary roles as patient educators in asthma clinics. Well-trained patient educators can continuously monitor self-management behaviours to improve patients' compliance with home environmental control, thus leading to better physical outcomes in children with asthma than routine individual asthma education alone.

Treatment planning and delivery of involved field radiotherapy in advanced Hodgkin's disease: results from a questionnaire-based audit for the UK Stanford V regimen vs ABVD clinical trial quality assurance programme (ISRCTN 64141244).

PubMed

Diez, P; Hoskin, P J; Aird, E G A

2007-10-01

This questionnaire forms the basis of the quality assurance (QA) programme for the UK randomized Phase III study of the Stanford V regimen versus ABVD for treatment of advanced Hodgkin's disease to assess differences between participating centres in treatment planning and delivery of involved-field radiotherapy for Hodgkin's lymphoma The questionnaire, which was circulated amongst 42 participating centres, consisted of seven sections: target volume definition and dose prescription; critical structures; patient positioning and irradiation techniques; planning; dose calculation; verification; and future developments The results are based on 25 responses. One-third plan using CT alone, one-third use solely the simulator and the rest individualize, depending on disease site. Eleven centres determine a dose distribution for each patient. Technique depends on disease site and whether CT or simulator planning is employed. Most departments apply isocentric techniques and use immobilization and customized shielding. In vivo dosimetry is performed in 7 centres and treatment verification occurs in 24 hospitals. In conclusion, the planning and delivery of treatment for lymphoma patients varies across the country. Conventional planning is still widespread but most centres are moving to CT-based planning and virtual simulation with extended use of immobilization, customized shielding and compensation.

The electron-spin--nuclear-spin interaction studied by polarized neutron scattering.

PubMed

Stuhrmann, Heinrich B

2007-11-01

Dynamic nuclear spin polarization (DNP) is mediated by the dipolar interaction of paramagnetic centres with nuclear spins. This process is most likely to occur near paramagnetic centres at an angle close to 45 degrees with respect to the direction of the external magnetic field. The resulting distribution of polarized nuclear spins leads to an anisotropy of the polarized neutron scattering pattern, even with randomly oriented radical molecules. The corresponding cross section of polarized coherent neutron scattering in terms of a multipole expansion is derived for radical molecules in solution. An application using data of time-resolved polarized neutron scattering from an organic chromium(V) molecule is tested.

Economic evaluation of multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: A randomized controlled trial

PubMed Central

Köke, Albère; Hitters, Minou; Rijnders, Nieke; Pont, Menno

2017-01-01

Background A multi-centre RCT has shown that multidisciplinary rehabilitation treatment (MRT) is more effective in reducing fatigue over the long-term in comparison with cognitive behavioural therapy (CBT) for patients with chronic fatigue syndrome (CFS), but evidence on its cost-effectiveness is lacking. Aim To compare the cost-effectiveness of MRT versus CBT for patients with CFS from a societal perspective. Methods A multi-centre randomized controlled trial comparing MRT with CBT was conducted among 122 patients with CFS diagnosed using the 1994 criteria of the Centers for Disease Control and Prevention and aged between 18 and 60 years. The societal costs (healthcare costs, patient and family costs, and costs for loss of productivity), fatigue severity, quality of life, quality-adjusted life-year (QALY), and cost-effectiveness ratios (ICERs) were measured over a follow-up period of one year. The main outcome of the cost-effectiveness analysis was fatigue measured by the Checklist Individual Strength (CIS). The main outcome of the cost-utility analysis was the QALY based on the EuroQol-5D-3L utilities. Sensitivity analyses were performed, and uncertainty was calculated using the cost-effectiveness acceptability curves and cost-effectiveness planes. Results The data of 109 patients (57 MRT and 52 CBT) were analyzed. MRT was significantly more effective in reducing fatigue at 52 weeks. The mean difference in QALY between the treatments was not significant (0.09, 95% CI: -0.02 to 0.19). The total societal costs were significantly higher for patients allocated to MRT (a difference of €5,389, 95% CI: 2,488 to 8,091). MRT has a high probability of being the most cost effective, using fatigue as the primary outcome. The ICER is €856 per unit of the CIS fatigue subscale. The results of the cost-utility analysis, using the QALY, indicate that the CBT had a higher likelihood of being more cost-effective. Conclusions The probability of being more cost-effective is higher for MRT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT has the highest probability of being more cost-effective. Trial registration ISRCTN77567702. PMID:28574985

Protocol of a mixed method, randomized controlled study to assess the efficacy of a psychosocial intervention to reduce fatigue in patients with End-Stage Renal Disease (ESRD).

PubMed

van der Borg, Wieke E; Schipper, Karen; Abma, Tineke A

2016-07-08

Patients with end-stage renal disease (ESRD) commonly suffer from severe fatigue, which strongly impacts their quality of life (QoL). Although fatigue is often attributed to disease- and treatment characteristics, research also shows that behavioural, psychological and social factors affect perceived fatigue in dialysis patients. Whereas studies on fatigue in other chronic patient groups suggest that psychological or psychosocial interventions are effective in reducing fatigue, such interventions are not yet available for ESRD patients on dialysis treatment. The objective of this study is to examine the efficacy of a psychosocial intervention for dialysis patients aimed at reducing fatigue (primary outcome) and improving QoL (secondary outcome). The intervention consists of counselling sessions led by a social worker. The implementation process and patients' and social workers' expectations and experiences with the intervention will also be evaluated. This study follows a mixed-methods design in which both quantitative and qualitative data will be collected. A multi-centre, randomised controlled trial (RCT) with repeated measures will be conducted to quantitatively assess the efficacy of the psychosocial intervention in reducing fatigue and improving QoL in ESRD patients. Additional secondary outcomes and medical parameters will be assessed. Outcomes will be compared to patients receiving usual care. A sample of 74 severely fatigued dialysis patients will be recruited from 10 dialysis centres. Patients will be randomly assigned to the intervention or control group. Outcomes will be assessed at baseline, post intervention/16 weeks, and at three and six-month follow-ups. A qualitative process evaluation will be conducted parallel to/following the effectiveness RCT. Interviews and focus groups will be conducted to gain insight into patients' and social workers' perspectives on outcomes and implementation procedures. Implementation fidelity will be assessed by audio-taped and written registrations. Participatory methods ensure the continuous input of experiential knowledge, improving the quality of study procedures and the applicability of outcomes. This is the first mixed method study (including an RCT and qualitative process evaluation) to examine the effect and implementation process of a psychosocial intervention on reducing fatigue and improving QoL in ESRD patients on dialysis treatment. NTR5366 , The Netherlands National Trial Register (NTR), registered August 26, 2015.

A family-centred model of care in paediatric speech-language pathology.

PubMed

McKean, Kate; Phillips, Bev; Thompson, Acushla

2012-06-01

Developments in paediatric models of care support family-centred practice (FCP); however, there is limited evidence for its use in speech-language pathology. This randomized controlled study examined whether parent satisfaction with FCP (n = 10) was greater than with usual practice (UP; n = 10) over 14 weeks for children with mild-moderate speech and/or language disorders. The FCP included parental goal decision-making; greater parent responsibility for clinic therapy tasks; and two home visits. There was a non-significant trend for the FCP group to have a higher mean score for the "Providing specific information" scale of the Measures of Process of Care. Goals for the FCP and UP groups were respectively targeted towards the Activities and Participation or the Body Function components of the International Classification of Functioning, Disability and Health-Children and Youth. While there were no significant differences between groups for speech/language outcomes post-intervention; it is clinically interesting that more children in the FCP group improved on the Renfrew Action Picture Test than the UP group. This study did not demonstrate a significant benefit for FCP over a relatively short timeframe in a small sample of children. Further research is warranted to determine if there is evidence for the use of FCP in speech-language pathology.

UK Alcohol Treatment Trial: client-treatment matching effects.

PubMed

2008-02-01

To test a priori hypotheses concerning client-treatment matching in the treatment of alcohol problems and to evaluate the more general hypothesis that client-treatment matching adds to the overall effectiveness of treatment. Pragmatic, multi-centre, randomized controlled trial (the UK Alcohol Treatment Trial: UKATT) with open follow-up at 3 months after entry and blind follow-up at 12 months. Five treatment centres, comprising seven treatment sites, including National Health Service (NHS), social services and joint NHS/non-statutory facilities. Motivational enhancement therapy and social behaviour and network therapy. Matching hypotheses were tested by examining interactions between client attributes and treatment types at both 3 and 12 months follow-up using the outcome variables of percentage days abstinent, drinks per drinking day and scores on the Alcohol Problems Questionnaire and Leeds Dependence Questionnaire. None of five matching hypotheses was confirmed at either follow-up point on any outcome variable. The findings strongly support the conclusion reached in Project MATCH in the United States that client-treatment matching, at least of the kind examined, is unlikely to result in substantial improvements to the effectiveness of treatment for alcohol problems. Possible reasons for this failure to support the general matching hypothesis are discussed, as are the implications of UKATT findings for the provision of treatment for alcohol problems in the United Kingdom.

Quality Assessment of Family Planning Sterilization Services at Health Care Facilities: Case Record Audit.

PubMed

Mathur, Medha; Goyal, Ram Chandra; Mathur, Navgeet

2017-05-01

Quality of sterilization services is a matter of concern in India because population control is a necessity. Family Planning Sterilization (FPS) services provided at public health care facilities need to be as per Standard Operating Procedures. To assess the quality of FPS services by audit of case records at selected health care facilities. This cross-sectional study was conducted for two and a half year duration at selected public health care facilities of central India by simple random sampling where FPS services were provided. As per the standards of Government of India, case records were audited and compliance was calculated to assess the quality of services. Results of record audit were satisfactory but important criteria like previous contraceptive history and postoperative counselling were found to be deviated from standards. At Primary Health Centres (PHCs) only 89.5% and at Community Health Centres (CHCs) 58.7% of records were having details of previous contraceptive history. Other criteria like mental illness (only 70% at CHCs) assessment were also inadequate. Although informed consent was found to be having 100% compliance in all records. Quality of care in FPS services is the matter of concern in present scenario for better quality of services. This study may enlighten the policy makers regarding improvements needed for providing quality care.

Treating TTP/HUS with plasma exchange: a single centre's 25-year experience.

PubMed

Forzley, Brian R; Sontrop, Jessica M; Macnab, Jennifer J; Chen, Salina; Clark, William F

2008-10-01

Thrombotic thrombocytopenic purpura/Haemolytic uremic syndrome (TTP/HUS) is a thrombotic microangiopathy with a 6-month mortality rate of 16-29%. The present study described the clinical features, treatment regime and 6-month all-cause mortality rate of TTP/HUS patients at the London Health Sciences Centre (LHSC), Canada. Data for this retrospective cohort study were obtained from inpatient and outpatient records for all patients referred for plasma exchange therapy at LHSC, Canada between 1981 and 2006. Patients (n = 110) were categorized as: idiopathic primary (38%) or relapsed (16%), and secondary responsive (30%) or non-responsive (16%). Mortality data were available for all but three patients. The all-cause 6-month mortality rate was 19% overall and was 12% and 26% among idiopathic and secondary TTP/HUS patients, respectively. No mortality events occurred among the 17 idiopathic patients who relapsed. Relapsed patients had the least severe presenting characteristics, the fastest response time, and experienced significant improvement in the severity of clinical features between the first and final presentation. These findings suggest an excellent outcome for relapsed TTP/HUS patients. Patient education, surveillance, and aggressive plasma exchange therapy are hypothesized to improve the likelihood of survival: these hypotheses should be tested in a randomized controlled trial.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial.

PubMed

Shakur, Haleema; Roberts, Ian; Bautista, Raúl; Caballero, José; Coats, Tim; Dewan, Yashbir; El-Sayed, Hesham; Gogichaishvili, Tamar; Gupta, Sanjay; Herrera, Jorge; Hunt, Beverley; Iribhogbe, Pius; Izurieta, Mario; Khamis, Hussein; Komolafe, Edward; Marrero, María-Acelia; Mejía-Mantilla, Jorge; Miranda, Jaime; Morales, Carlos; Olaomi, Oluwole; Olldashi, Fatos; Perel, Pablo; Peto, Richard; Ramana, P V; Ravi, R R; Yutthakasemsunt, Surakrant

2010-07-03

Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.govNCT00375258, and South African Clinical Trial RegisterDOH-27-0607-1919. 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14.5%] tranexamic acid group vs 1613 [16.0%] placebo group; relative risk 0.91, 95% CI 0.85-0.97; p=0.0035). The risk of death due to bleeding was significantly reduced (489 [4.9%] vs 574 [5.7%]; relative risk 0.85, 95% CI 0.76-0.96; p=0.0077). Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.

PubMed

Fernández, Anna; Mendive, Juan M; Conejo-Cerón, Sonia; Moreno-Peral, Patricia; King, Michael; Nazareth, Irwin; Martín-Pérez, Carlos; Fernández-Alonso, Carmen; Rodríguez-Bayón, Antonina; Aiarzaguena, Jose Maria; Montón-Franco, Carmen; Serrano-Blanco, Antoni; Ibañez-Casas, Inmaculada; Rodríguez-Sánchez, Emiliano; Salvador-Carulla, Luis; Garay, Paola Bully; Ballesta-Rodríguez, María Isabel; LaFuente, Pilar; Del Mar Muñoz-García, María; Mínguez-Gonzalo, Pilar; Araujo, Luz; Palao, Diego; Gómez, María Cruz; Zubiaga, Fernando; Navas-Campaña, Desirée; Aranda-Regules, Jose Manuel; Rodriguez-Morejón, Alberto; de Dios Luna, Juan; Bellón, Juan Ángel

2018-02-23

Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

PubMed

Bolinder, Jan; Antuna, Ramiro; Geelhoed-Duijvestijn, Petronella; Kröger, Jens; Weitgasser, Raimund

2016-11-05

Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA 1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (<3·9 mmol/L [70 mg/dL]) between baseline and 6 months in the full analysis set (all participants randomised; excluding those who had a positive pregnancy test during the study). This trial was registered with ClinicalTrials.gov, number NCT02232698. Between Sept 4, 2014, and Feb 12, 2015, we enrolled 328 participants. After the screening and baseline phase, 120 participants were randomly assigned to the intervention group and 121 to the control group, with outcomes being evaluated in 119 and 120, respectively. Mean time in hypoglycaemia changed from 3·38 h/day at baseline to 2·03 h/day at 6 months (baseline adjusted mean change -1·39) in the intervention group, and from 3·44 h/day to 3·27 h/day in the control group (-0·14); with the between-group difference of -1·24 (SE 0·239; p<0·0001), equating to a 38% reduction in time in hypoglycaemia in the intervention group. No device-related hypoglycaemia or safety issues were reported. 13 adverse events were reported by ten participants related to the sensor-four of allergy events (one severe, three moderate); one itching (mild); one rash (mild); four insertion-site symptom (severe); two erythema (one severe, one mild); and one oedema (moderate). There were ten serious adverse events (five in each group) reported by nine participants; none were related to the device. Novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. Abbott Diabetes Care. Copyright © 2016 Elsevier Ltd. All rights reserved.

Adjuvant Intrahepatic Injection Iodine-131-Lipiodol Improves Prognosis of Patients with Hepatocellular Carcinoma After Resection: a Meta-Analysis.

PubMed

Hong, Ye; Wu, Lu-Peng; Ye, Feng; Zhou, Yan-Ming

2015-12-01

High incidence of intrahepatic recurrence is a major surgical limitation following hepatectomy of hepatocellular carcinoma (HCC). This study was intended to investigate the effects of adjuvant intrahepatic injection of iodine-131-lipiodol on disease recurrence and survival in patients with HCC who underwent resection. A computerized literature search was performed to identify relevant articles. Data synthesis was performed using Review Manager 5.0 software, and results are presented as odds ratio (OR) with 95 % confidence intervals. Two randomized controlled trials and three case-control studies with a total of 334 participants were analyzed. Iodine-131-lipiodol treatment achieved significantly lower rates of intrahepatic recurrence (OR = 0.48, 95 % confidence interval (95 % CI) = 0.30-0.74; P = 0.001) and early recurrence (<2 year) (OR = 0.45, 95 % CI = 0.23-0.89; P = 0.02). Likewise, iodine-131-lipiodol treatment improved both the 5-year disease-free survival and overall survival significantly (OR = 1.85, 95 % CI = 1.13-3.03; P = 0.01; OR = 2.00, 95 % CI = 0.99-4.04; P = 0.05, respectively). Adjuvant intrahepatic injection of iodine-131-lipiodol resulted in a preventive effect on recurrence and improved survival after resection of HCC. Further larger, multi-centred, randomized prospective trial is warranted.

Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study.

PubMed

Moljord, I E O; Lara-Cabrera, M L; Salvesen, Ø; Rise, M B; Bjørgen, D; Antonsen, D Ø; Olsø, T M; Evensen, G H; Gudde, C B; Linaker, O M; Steinsbekk, A; Eriksen, L

2017-06-01

To investigate the effect of having a contract for self-referral to inpatient treatment (SRIT) in patients with severe mental disorders. A randomized controlled trial with 53 adult patients; 26 participants received a SRIT contract, which they could use to refer themselves into a Community Mental Health Centre up to five days for each referral without contacting a doctor in advance. Outcomes were assessed after 12 months with the self-report questionnaires Patient Activation Measure (PAM-13), Recovery Assessment Scale (RAS), and the Behavior and Symptom Identification Scale (BASIS-32) and analyzed using linear mixed and regression models. There was no significant effect on PAM-13 (estimated mean difference (emd) -0.41, 95% CI (CI):-7.49-6.67), nor on the RAS (emd 0.02, CI:-0.27-0.31) or BASIS-32 (0.09, CI:-0.28-0.45). An exploratory post hoc analysis showed effect of SRIT in those with low PAM below ≤47 (p=0.049). There were no group differences after 12 months, but both groups maintained their baseline levels. SRIT contracts can be recommended as it supports the rights to self-determination, promote user participation in decision-making in own treatment without any indication of adverse effects. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

Maternal and Child Health Handbook use for maternal and child care: a cluster randomized controlled study in rural Java, Indonesia.

PubMed

Osaki, Keiko; Hattori, Tomoko; Toda, Akemi; Mulati, Erna; Hermawan, Lukas; Pritasari, Kirana; Bardosono, Saptawati; Kosen, Soewarta

2018-01-09

Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. We conducted a health centre-based randomized trial, with a 2-year follow-up. Intervention included (i) MCHHB provision at antenatal care visits; (ii) records and guides by health personnel on and with the MCHHB; and (iii) sensitization of care by volunteers using the MCHHB. The follow-up rate was 70.2% (183, intervention area; 271, control area). Respondents in the intervention area received consecutive MCH services including two doses of tetanus toxoid injections and antenatal care four times or more during pregnancy, professional assistance during child delivery and vitamin A supplements administration to their children, after adjustment for confounding variables and cluster effects (OR = 2.03, 95% CI: 1.19-3.47). In the intervention area, home care (continued breastfeeding; introducing complementary feeding; proper feeding order; varied foods feeding; self-feeding training; and care for cough), perceived support by husbands, and lower underweight rates and stunting rates among children were observed. MCHHB use promoted continuous care acquisition and care at home from pregnancy to early child-rearing stages in rural Java. © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health.

The nursing and financial implications of laparoscopic colorectal surgery: data from a randomized controlled trial.

PubMed

Norwood, M G A; Stephens, J H; Hewett, P J

2011-11-01

The issue of cost effectiveness of laparoscopic surgery remains uncertain and its impact on the ward nursing staff is unaddressed. This study investigated these issues using patients from a single centre admitted to a randomized controlled trial. All patients recruited into the Australasian Laparoscopic Colon Cancer Study (ALCCaS) from The Queen Elizabeth Hospital between January 1999 and March 2005 were included in this study. Data relating to hospital cost were collated from the Hospital Patient Costing System. Nursing interventions were calculated in minutes per patient, using the excelcare Software database. Data from 97 patients were analysed (laparoscopy, 53; open surgery, 44). The median number of hours of nursing input per patient was 80 (27.5-907) h in the open surgery group and 58.5 (15-684.5) h in the laparoscopy group. This difference was further increased after exclusion of patients converted from laparoscopy to open surgery. The median total cost of the procedure was AUS $9698/£ 5631 (AUS $3862-90,397) in the open surgery group and AUS $10,951/£ 6219 (AUS$2337-66,237) in the laparoscopy group. These data suggest that laparoscopic colorectal surgery is equivalent in price to open surgery and there may be added benefits in reduced nursing intensity. © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

PubMed

McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

2016-11-01

This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial.

PubMed

Pagel, Judith-Irina; Hulde, Nikolai; Kammerer, Tobias; Schwarz, Michaela; Chappell, Daniel; Burges, Alexander; Hofmann-Kiefer, Klaus; Rehm, Markus

2017-07-10

This study aims to investigate the effects of a modified, balanced crystalloid including phosphate in a perioperative setting in order to maintain a stable electrolyte and acid-base homeostasis in the patient. This is a single-centre, open-label, randomized controlled trial involving two parallel groups of female patients comparing a perioperative infusion regime with sodium glycerophosphate and Jonosteril® (treatment group) or Jonosteril® (comparator) alone. The primary endpoint is to maintain a stable concentration of weak acids [A - ] according to the Stewart approach of acid-base balance. Secondary endpoints are measurement of serum phosphate levels, other acid-base parameters such as the strong ion difference (SID), the onset and severity of postoperative nausea and vomiting (PONV), electrolyte levels and their excretion in the urine, monitoring of renal function and glycocalyx components, haemodynamics, amounts of catecholamines and other vasopressors used and the safety of the infusion regime. Perioperative fluid replacement with the use of currently available crystalloid preparations still fail to maintain a stable acid-base balance and experts agree that common balanced solutions are still not ideal. This study aims to investigate the effectivity and safety of a new crystalloid solution by adding sodium glycerophosphate to a standardized crystalloid preparation in order to maintain a balanced perioperative acid-base homeostasis. EudraCT number 201002422520 . Registered on 30 November 2010.

Assessment of two culturally competent diabetes education methods: individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes.

PubMed

Gucciardi, Enza; Demelo, Margaret; Lee, Ruth N; Grace, Sherry L

2007-04-01

To examine the impact of two culturally competent diabetes education methods, individual counselling and individual counselling in conjunction with group education, on nutrition adherence and glycemic control in Portuguese Canadian adults with type 2 diabetes over a three-month period. The Diabetes Education Centre is located in the urban multicultural city of Toronto, Ontario, Canada. We used a three-month randomized controlled trial design. Eligible Portuguese-speaking adults with type 2 diabetes were randomly assigned to receive either diabetes education counselling only (control group) or counselling in conjunction with group education (intervention group). Of the 61 patients who completed the study, 36 were in the counselling only and 25 in the counselling with group education intervention. We used a per-protocol analysis to examine the efficacy of the two educational approaches on nutrition adherence and glycemic control; paired t-tests to compare results within groups and analysis of covariance (ACOVA) to compare outcomes between groups adjusting for baseline measures. The Theory of Planned Behaviour was used to describe the behavioural mechanisms that influenced nutrition adherence. Attitudes, subjective norms, perceived behaviour control, and intentions towards nutrition adherence, self-reported nutrition adherence and glycemic control significantly improved in both groups, over the three-month study period. Yet, those receiving individual counselling with group education showed greater improvement in all measures with the exception of glycemic control, where no significant difference was found between the two groups at three months. Our study findings provide preliminary evidence that culturally competent group education in conjunction with individual counselling may be more efficacious in shaping eating behaviours than individual counselling alone for Canadian Portuguese adults with type 2 diabetes. However, larger longitudinal studies are needed to determine the most efficacious education method to sustain long-term nutrition adherence and glycemic control.

Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial.

PubMed

Sivaprasad, Sobha; Vasconcelos, Joana C; Prevost, A Toby; Holmes, Helen; Hykin, Philip; George, Sheena; Murphy, Caroline; Kelly, Joanna; Arden, Geoffrey B

2018-05-01

We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema. CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558. Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change -9·2 μm [SE 2·5] for the light mask vs -12·9 μm [SE 2·9] for the sham mask; adjusted mean difference -0·65 μm, 95% CI -6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9-51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one). The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Multicentre cluster randomised controlled trial evaluating implementation of a fire prevention Injury Prevention Briefing in children's centres: study protocol.

PubMed

Deave, Toity; Towner, Elizabeth; McColl, Elaine; Reading, Richard; Sutton, Alex; Coupland, Carol; Cooper, Nicola; Stewart, Jane; Hayes, Mike; Pitchforth, Emma; Watson, Michael; Kendrick, Denise

2014-01-22

The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0-14 years; these injuries have the steepest social gradient of all injuries in the UK. Children's centres provide children under five years old and their families with a range of services and information, including home safety, but their effectiveness in promoting injury prevention has yet to be evaluated. We developed a fire prevention intervention for use in children's centres comprising an Injury Prevention Briefing (IPB) which provides evidence on what works and best practice from those running injury prevention programmes, and a facilitation package to support implementation of the IPB. This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention. Pragmatic, multicentre cluster randomised controlled trial, with a nested qualitative study, in four study centres in England. Children's centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising: IPB with facilitation package; IPB with no facilitation package; usual care (control). The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up. Eleven children's centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20% in either of the two intervention arms compared with the control arm, with 80% power and a 5% significance level (2-sided), an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children's centre. Secondary outcomes include the assessment of the cost-effectiveness of the intervention, other fire safety behaviours and factors associated with degree of implementation of the IPB. This will be the first trial to develop and evaluate a fire prevention intervention for use in children's centres in the UK. Its findings will be generalisable to children's centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury. http://NCT01452191 (date of registration: 13/10/2011).

Multicentre cluster randomised controlled trial evaluating implementation of a fire prevention Injury Prevention Briefing in children’s centres: study protocol

PubMed Central

2014-01-01

Background The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0–14 years; these injuries have the steepest social gradient of all injuries in the UK. Children’s centres provide children under five years old and their families with a range of services and information, including home safety, but their effectiveness in promoting injury prevention has yet to be evaluated. We developed a fire prevention intervention for use in children’s centres comprising an Injury Prevention Briefing (IPB) which provides evidence on what works and best practice from those running injury prevention programmes, and a facilitation package to support implementation of the IPB. This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention. Methods/Design Pragmatic, multicentre cluster randomised controlled trial, with a nested qualitative study, in four study centres in England. Children’s centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising: IPB with facilitation package; IPB with no facilitation package; usual care (control). The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up. Eleven children’s centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20% in either of the two intervention arms compared with the control arm, with 80% power and a 5% significance level (2-sided), an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children’s centre. Secondary outcomes include the assessment of the cost-effectiveness of the intervention, other fire safety behaviours and factors associated with degree of implementation of the IPB. Discussion This will be the first trial to develop and evaluate a fire prevention intervention for use in children’s centres in the UK. Its findings will be generalisable to children’s centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury. Trial registration http://NCT01452191 (date of registration: 13/10/2011). PMID:24450931

Effect of an institutional development plan for user participation on professionals' knowledge, practice, and attitudes. A controlled study

PubMed Central

2011-01-01

Background Governments in several countries attempt to strengthen user participation through instructing health care organisations to plan and implement activities such as user representation in administrational boards, improved information to users, and more individual user participation in clinical work. The professionals are central in implementing initiatives to enhance user participation in organisations, but no controlled studies have been conducted on the effect on professionals from implementing institutional development plans. The objective was to investigate whether implementing a development plan intending to enhance user participation in a mental health hospital had any effect on the professionals' knowledge, practice, or attitudes towards user participation. Methods This was a non-randomized controlled study including professionals from three mental health hospitals in Central Norway. A development plan intended to enhance user participation was implemented in one of the hospitals as a part of a larger re-organizational process. The plan included i.e. establishing a patient education centre and a user office, purchasing of user expertise, appointing contact professionals for next of kin, and improving of the centre's information and the professional culture. The professionals at the intervention hospital thus constituted the intervention group, while the professionals at two other hospitals participated as control group. All professionals were invited to answer the Consumer Participation Questionnaire (CPQ) and additional questions, focusing on knowledge, practice, and attitudes towards user participation, two times with a 16 months interval. Results A total of 438 professionals participated (55% response rate). Comparing the changes in the intervention group with the changes in the control group revealed no statistically significant differences at a 0.05 level. The implementation of the development plan thus had no measurable effect on the professionals' knowledge, practice, or attitudes at the intervention hospital, compared to the control hospitals. Conclusion This is the first controlled study on the effect on professionals from implementing a development plan to enhance user participation in a mental health hospital. The plan had no effect on professionals' knowledge, practice, or attitudes. This can be due to the quality of the development plan, the implementation process, and/or the suitability of the outcome measures. PMID:22047466

Effect of an institutional development plan for user participation on professionals' knowledge, practice, and attitudes. A controlled study.

PubMed

Rise, Marit By; Grimstad, Hilde; Solbjør, Marit; Steinsbekk, Aslak

2011-11-02

Governments in several countries attempt to strengthen user participation through instructing health care organisations to plan and implement activities such as user representation in administrational boards, improved information to users, and more individual user participation in clinical work. The professionals are central in implementing initiatives to enhance user participation in organisations, but no controlled studies have been conducted on the effect on professionals from implementing institutional development plans. The objective was to investigate whether implementing a development plan intending to enhance user participation in a mental health hospital had any effect on the professionals' knowledge, practice, or attitudes towards user participation. This was a non-randomized controlled study including professionals from three mental health hospitals in Central Norway. A development plan intended to enhance user participation was implemented in one of the hospitals as a part of a larger re-organizational process. The plan included i.e. establishing a patient education centre and a user office, purchasing of user expertise, appointing contact professionals for next of kin, and improving of the centre's information and the professional culture. The professionals at the intervention hospital thus constituted the intervention group, while the professionals at two other hospitals participated as control group. All professionals were invited to answer the Consumer Participation Questionnaire (CPQ) and additional questions, focusing on knowledge, practice, and attitudes towards user participation, two times with a 16 months interval. A total of 438 professionals participated (55% response rate). Comparing the changes in the intervention group with the changes in the control group revealed no statistically significant differences at a 0.05 level. The implementation of the development plan thus had no measurable effect on the professionals' knowledge, practice, or attitudes at the intervention hospital, compared to the control hospitals. This is the first controlled study on the effect on professionals from implementing a development plan to enhance user participation in a mental health hospital. The plan had no effect on professionals' knowledge, practice, or attitudes. This can be due to the quality of the development plan, the implementation process, and/or the suitability of the outcome measures.

The pattern of antenatal visits with emphasis on gestational age at booking in Riyadh Health Centres.

PubMed

al-Shammari, S A; Khoja, T; Jarallah, J S

1994-04-01

1344 expectant mothers were selected by random sampling from the catchment population of 15 health centres in Riyadh. The health centres were taken to represent all areas of urban Riyadh. These mothers were asked to complete a pre-designed questionnaire in Arabic and undergo a structured interview by trained midwives to explore their knowledge, attitude and practice toward antenatal visits. It was found that the average gestational age at booking was 13 weeks. The number of antenatal visits achieved during the current pregnancy was 6. 97% of expectant mothers were aware of the importance of antenatal visits. Various demographic characteristics were studied in relation to the number of antenatal visits achieved and the gestational age at booking. It was found that the level of education of both husband and wife and poor obstetric history significantly affected gestational age at booking, (P-values) were less than 0.03 and 0.002 respectively). However the family income and gestational age at booking affected the number of antenatal visits (P-values were less than 0.0003 and 0.0001 respectively). The respondents' most striking reason for non-compliance was related to accessibility to health centre. 23.3% thought that the health centres were far away from their residence and they needed to involve the husbands in driving them to health centres. Recommendations were given to improve aspects of accessibility and inviting more antenatal visits in addition to improving quality of such service.

A person-centred and thriving-promoting intervention in nursing homes - study protocol for the U-Age nursing home multi-centre, non-equivalent controlled group before-after trial.

PubMed

Edvardsson, David; Sjögren, Karin; Lood, Qarin; Bergland, Ådel; Kirkevold, Marit; Sandman, Per-Olof

2017-01-17

The literature suggests that person-centred care can contribute to quality of life and wellbeing of nursing home residents, relatives and staff. However, there is sparse research evidence on how person-centred care can be operationalised and implemented in practice, and the extent to which it may promote wellbeing and satisfaction. Therefore, the U-Age nursing home study was initiated to deepen the understanding of how to integrate person-centred care into daily practice and to explore the effects and meanings of this. The study aims to evaluate effects and meanings of a person-centred and thriving-promoting intervention in nursing homes through a multi-centre, non-equivalent controlled group before-after trial design. Three nursing homes across three international sites have been allocated to a person-centred and thriving-promoting intervention group, and three nursing homes have been allocated to an inert control group. Staff at intervention sites will participate in a 12-month interactive educational programme that operationalises thriving-promoting and person-centred care three dimensions: 1) Doing a little extra, 2) Developing a caring environment, and 3) Assessing and meeting highly prioritised psychosocial needs. A pedagogical framework will guide the intervention. The primary study endpoints are; residents' thriving, relatives' satisfaction with care and staff job satisfaction. Secondary endpoints are; resident, relative and staff experiences of the caring environment, relatives' experience of visiting their relative and the nursing home, as well as staff stress of conscience and perceived person-centredness of care. Data on study endpoints will be collected pre-intervention, post-intervention, and at a six-month follow up. Interviews will be conducted with relatives and staff to explore experiences and meanings of the intervention. The study is expected to provide evidence that can inform further research, policy and practice development on if and how person-centred care may improve wellbeing, thriving and satisfaction for people who reside in, visit or work in nursing homes. The combination of quantitative and qualitative data will illuminate the operationalisation, effects and meaning of person-centred and thriving-promoting care. The trial was registered at ClinicalTrials.gov March 19, 2016, identifier NCT02714452 .

Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial.

PubMed

Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

2017-02-09

Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date. This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1 st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm. The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery. This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.

Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter.

PubMed

Giorgi Rossi, P; Fortunato, C; Barbarino, P; Boveri, S; Caroli, S; Del Mistro, A; Ferro, A; Giammaria, C; Manfredi, M; Moretto, T; Pasquini, A; Sideri, M; Tufi, M C; Cogo, C; Altobelli, E

2015-02-17

We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter. Women aged 30-64 non-responding to screening invitation were eligible. Response rate to first invitation ranged from 30% to 60% between centres. The control was the standard reminder letter to undergo the test used by the programme (Pap test in three centres and HPV DNA test in three other centres). Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV. The analysis was intention-to-treat. In all, 14 041 women were randomised and recruited: 5012 in the control arm, 4516 to receive the self-sampler at home, and 4513 to pick up the self-sampler at a pharmacy. Participation was 11.9% in the control, 21.6% (relative participation: 1.75; 95% CI 1.60-1.93) in home, and 12.0% (relative participation: 0.96; 95% CI 0.86-1.07) in the pharmacy arms, respectively. The heterogeneity between centres was high (excess heterogeneity of that expected due to chance, i.e., I(2), 94.9% and 94.1% for home and pharmacy arm, respectively). The estimated impact on the overall coverage was +4.3% for home mail self-sampling compared with +2.2% for standard reminder. Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes, even in those with HPV as primary testing. Picking up at pharmacies showed effects varying from centre to centre.

Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation.

PubMed

Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Cunningham, Gillian; Gakhal, Kavi; Lawrence-Smith, Geof; Leeson, Verity; Lemonsky, Fenella; Lykomitrou, Georgia; Montgomery, Alan; Morriss, Richard; Paton, Carol; Tan, Wei; Tyrer, Peter; Reilly, Joseph G

2015-07-18

People with borderline personality disorder (BPD) experience rapid and distressing changes in mood, poor social functioning and have high rates of suicidal behaviour. Several small scale studies suggest that mood stabilizers may produce short-term reductions in symptoms of BPD, but have not been large enough to fully examine clinical and cost-effectiveness. A two parallel-arm, placebo controlled randomized trial of usual care plus either lamotrigine or an inert placebo for people aged over 18 who are using mental health services and meet diagnostic criteria for BPD. We will exclude people with comorbid bipolar affective disorder or psychosis, those already taking a mood stabilizer, those who speak insufficient English to complete the baseline assessment and women who are pregnant or contemplating becoming pregnant. Those meeting inclusion criteria and provide written informed consent will be randomized to up to 200mg of lamotrigine per day or an inert placebo (up to 400mg if taking combined oral contraceptives). Participants will be randomized via a remote web-based system using permuted stacked blocks stratified by study centre, severity of personality disorder, and level of bipolarity. Follow-up assessments will be conducted by masked researchers 12, 24 weeks, and 52 weeks after randomization. The primary outcome is the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD). The secondary outcomes are depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, adverse events and withdrawal of trial medication due to adverse effects. The main analyses will use intention to treat without imputation of missing data. The economic evaluation will take an NHS/Personal Social Services perspective. A cost-utility analysis will compare differences in total costs and differences in quality of life using QALYs derived from the EQ-5D. The evidence base for the use of pharmacological treatments for people with borderline personality disorder is poor. In this trial we will examine the clinical and cost-effectiveness of lamotrigine to assess what if any impact offering this has on peoples' mental health, social functioning, and use of other medication and other resources. Current Controlled Trials ISRCTN90916365 (registered 01/08/2012).

A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial.

PubMed

Mansell, Warren; Tai, Sara; Clark, Alexandra; Akgonul, Savas; Dunn, Graham; Davies, Linda; Law, Heather; Morriss, Richard; Tinning, Neil; Morrison, Anthony P

2014-10-24

Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed 'Think Effectively About Mood Swings' (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial. A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach. The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual. This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

PubMed

Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

2016-07-19

The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

Connecting research to the needs of patients and clinicians.

PubMed

Hesse, S; Werner, C

2009-01-15

Modern principles of gait rehabilitation after CNS lesions favour a task-specific repetitive approach, i.e. who wants to regain walking has to walk. Budget constrains and the required effort, e.g. to place the paretic limbs in SCI patients, limit the treatment intensity; accordingly gait machines have been introduced. One can distinguish between an exoskeleton and end-effector approach. Our group opted for the latter, less costs, faster donning and doffing as well as the potential risk of shear forces in case of a malignement between the external and internal joint axis were argumented. On the electromechanical Gait Trainer GT I, the feet are placed on plates, whose movement simulate stance and swing, the vertical and horizontal movements of the centre of mass are controlled, Functional Electrical Stimulation is optional. The HapticWalker is the next step, the foot plate trajectories are fully programmable, so that the patients can also practise stair climbing up and down. In SCI patients of traumatic and non-traumatic origin, case series including gait analysis and a single-centre study based on non-randomized SCI patients admitted to our unit within 2 years are presented. The results corresponded to those reported for the manually assisted gait training. Among the non-traumatic patient group, being elder and more frailer, less than 50% participated in the programme. The future must see controlled trials comparing the various solutions with respect to clinical practicability, effectiveness, and cost-efficiency. Also one should keep in mind that a machine will never substitute a therapist, it is an adjunctive tool.

Bridging barriers to health promotion: a feasibility pilot study of the 'Promoting Aging Migrants' Capabilities study'.

PubMed

Lood, Qarin; Gustafsson, Susanne; Dahlin Ivanoff, Synneve

2015-08-01

Improving the possibilities for ageing persons to take control over their health is an increasingly important public health issue. Health promotion has previously been visualized to succeed with this goal, but research has primarily focused on ageing persons who are native-born, leaving the generalizability to persons who are foreign-born unexplored. Therefore, as part of the development of a larger health promotion initiative for ageing persons who have experienced migration, this study aimed to assess the feasibility of an adapted protocol. The specific feasibility objectives were to assess recruitment procedure, retention rates, study questionnaire administration and variability of collected data. Forty persons who were ≥70 years, and who had migrated from Finland, Bosnia and Herzegovina, Croatia, Montenegro or Serbia to Sweden were randomly allocated to a health promotion programme or a control group. The programme was linguistically adapted with regard to translated information material, bilingual health professionals and evaluators, and a person-centred approach was applied to both programme development and provision. The data analysis was explorative and descriptive. The results visualized structural and linguistic barriers to recruitment and study questionnaire administration, and describe strategies for how to bridge them. Retention rates and data variability were satisfying. Calling for iterative and pragmatic programme design, the findings describe how to move towards a more inclusive health care environment. Person-centred and bilingual approaches with attention to the possibilities for building authentic relationships between participants and providers are emphasized, and a structured methodology for developing study questionnaires is suggested. © 2015 John Wiley & Sons, Ltd.

The safety, effectiveness and cost-effectiveness of cytisine in achieving six-month continuous smoking abstinence in tuberculosis patients - protocol for a double-blind, placebo-controlled randomised trial.

PubMed

Dogar, Omara; Barua, Deepa; Boeckmann, Melanie; Elsey, Helen; Fatima, Razia; Gabe, Rhian; Huque, Rumana; Keding, Ada; Khan, Amina; Kotz, Daniel; Kralikova, Eva; Newell, James N; Nohavova, Iveta; Parrott, Steve; Readshaw, Anne; Renwick, Lottie; Sheikh, Aziz; Siddiqi, Kamran

2018-04-20

Tuberculosis (TB) patients who quit smoking have much better disease outcomes than those who continue to smoke. Behavioural support combined with pharmacotherapy is the most effective strategy in helping people to quit, in general populations. However, there is no evidence for the effectiveness of this strategy in TB patients who smoke. We will assess the safety, effectiveness and cost-effectiveness of cytisine - a low-cost plant-derived nicotine substitute - for smoking cessation in TB patients compared with placebo, over and above brief behavioural support. Two-arm, parallel, double-blind, placebo-controlled, multi-centre (30 sites in Bangladesh and Pakistan), individually randomised trial. TB treatment centres integrated into public health care systems in Bangladesh and Pakistan. Newly diagnosed (in the last four weeks) adult pulmonary TB patients who are daily smokers (with or without dual smokeless tobacco use) and are interested in quitting (n= 2,388). The primary outcome measure is biochemically verified continuous abstinence from smoking at six months post-randomization, assessed using Russell Standard criteria. The secondary outcome measures include continuous abstinence at 12 months, lapses and relapses; clinical TB outcomes; nicotine dependency and withdrawal; and adverse events. This is the first smoking cessation trial of cytisine in low- and middle-income countries evaluating both cessation and tuberculosis (TB) outcomes. If found effective, cytisine could become the most affordable cessation intervention to help TB patients who smoke. This article is protected by copyright. All rights reserved.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

PubMed Central

Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

2017-01-01

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

[Effects of quercetin on the learning and memory ability of neonatal rats with hypoxic-ischemic brain damage].

PubMed

Huang, Jing-Jing; Liu, Xuan; Wang, Xing-Qi; Yang, Li-Hua; Qi, Da-Shi; Yao, Rui-Qin

2012-06-01

To study the effects of quercetin, a flavonoid, on the learning and memory ability of 3-day-old neonatal rats with hypoxic-ischemic brain white matter damage (WMD). Sixty 3-day-old Sprague-Dawley rats were randomly divided into four groups: control, WMD model,and quercetin treatment groups (20 and 40 mg/kg). There were 15 rats in each group. Rats in the WMD model and the two quercetin treatment groups were subjected to right common carotid artery ligation followed by 2 hrs of exposure to 8% O2 to induce periventricular white matter injury. After the operation quercetin was administered daily in the two quercetin treatment groups for 6 weeks. Six weeks later, Morris water maze and open-field tests were carried out to test memory and learning ability as well as behavior and cognition. From the second day of training, escape latency in the Morris water maze test was more prolonged in the WMD model group than in the control group (P<0.01). The escape latency in the two quercetin treatment groups was shortened significantly compared with the WMD model group (P<0.05). The WMD model group crossed the original platform fewer times compared with the control and quercetin treatment groups (P<0.05). The open-field test indicated that the number of rearings increased and time spent in the centre was extended in the WMD model group compared with the control group. Compared with the WMD model group, the number of rearings was significantly reduced (P<0.05) and time spent in the centre was significantly shortened in the quercetin treatment groups (P<0.05). Quercetin treatment can improve memory and learning ability as well as cognitive ability in neonates with WMD, suggesting that quercetin protects against WMD resulting from hypoxia-ischemia.

Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain).

PubMed

Zanaboni, Paolo; Dinesen, Birthe; Hjalmarsen, Audhild; Hoaas, Hanne; Holland, Anne E; Oliveira, Cristino Carneiro; Wootton, Richard

2016-08-22

Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic obstructive pulmonary disease (COPD). However, available resources are often limited, and many patients bear with poor availability of programmes. Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy. In contrast to traditional centre-based PR programmes, telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability. A few studies showed promising results for telerehabilitation, but mostly with short-term interventions. The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with standard care. An international multicentre randomised controlled trial conducted across sites in three countries will recruit 120 patients with COPD. Participants will be randomly assigned to telerehabilitation, treadmill and control, and followed up for 2 years. The telerehabilitation intervention consists of individualised exercise training at home on a treadmill, telemonitoring by a physiotherapist via videoconferencing using a tablet computer, and self-management via a customised website. Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home. Patients in the control arm are offered standard care. The primary outcome is the combined number of hospitalisations and emergency department presentations. Secondary outcomes include changes in health status, quality of life, anxiety and depression, self-efficacy, subjective impression of change, physical performance, level of physical activity, and personal experiences in telerehabilitation. This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD. The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies, especially to those living in remote areas and with no access to centre-based exercise programmes. ClinicalTrials.gov: NCT02258646 .

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

A randomised controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome.

PubMed

Roberts, Lesley M; McCahon, Deborah; Holder, Roger; Wilson, Sue; Hobbs, F D Richard

2013-03-07

Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations. A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS-Constipation or IBS-Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18-65 completed a pre-study diary. Eligible individuals were randomized to consume dairy 'yoghurt' products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life. 179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12. Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data. UK TRIAL REGISTRATION: ISRCTN78863629.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial.

PubMed

Vos-Vromans, D C W M; Smeets, R J E M; Huijnen, I P J; Köke, A J A; Hitters, W M G C; Rijnders, L J M; Pont, M; Winkens, B; Knottnerus, J A

2016-03-01

The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS). Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT. Four rehabilitation centres in the Netherlands. A total of 122 patients participated in the trial. Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation. A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant. This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial. © 2015 The Association for the Publication of the Journal of Internal Medicine.

A Randomized Controlled Trial of the Impact of a Family-Based Adolescent Depression Intervention on both Youth and Parent Mental Health Outcomes.

PubMed

Poole, Lucinda A; Knight, Tess; Toumbourou, John W; Lubman, Dan I; Bertino, Melanie D; Lewis, Andrew J

2018-01-01

This paper presents findings from a multi-centre, double-blind, randomized controlled trial that tested the hypothesis that parent and youth mental health improvements would be superior in a family-based intervention for adolescent depression (BEST MOOD) compared to a treatment-as-usual supportive parenting program (PAST). Eligible participants were families with a young person aged between 12 and 18 years who met diagnostic criteria for a depressive disorder (major, minor or dysthymic). Participating families (N = 64; 73.4% of youth were female) were recruited in Victoria, Australia and allocated to treatment condition using a block randomization procedure (parallel design) with two levels of blinding. This paper reports on the trial's secondary outcomes on youth and parent mental health. General linear mixed models were used to examine the longitudinal effect of treatment group on outcome. Data were analyzed according to intention-to-treat; 31 families were analyzed in BEST MOOD, and 33 families in PAST. Parents in the BEST MOOD group experienced significantly greater reductions in stress and depressive symptoms than parents in the PAST group at 3-month follow-up. A greater reduction in parental anxiety was observed in the BEST MOOD group (d = 0.35) compared with PAST (d = 0.02), although the between-group difference was not significant. Both groups of youth showed similar levels of improvement in depressive symptoms at post-treatment (d = 0.83 and 0.80 respectively), which were largely sustained at a 3-month follow-up. The family-based BEST MOOD intervention appeared superior to treatment-as-usual (PAST) in demonstrating greater reductions in parental stress and depression. Both interventions produced large reductions in youth depressive symptoms.

Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials.

PubMed

Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

2010-01-01

Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with Western medication. We included randomized controlled trials (RCTs) on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journals Fulltext Database VIP, and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials' quality independently. RevMan 5.0.18 software (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark) was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Eight RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding, and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medication in the number of cured patients (RR 2.49, 95% CI 1.91 to 3.24, P < .00001), the number of patients with improved symptoms (RR 1.15, 95% CI 1.05 to 1.26, P = .003), and reducing the incidence rate of postherpetic neuralgia (RR 0.06, 95% CI 0.02 to 0.25, P = .0001). Wet cupping plus medication was significantly better than medication alone on number of cured patients (RR 1.93, 95% CI 1.23 to 3.04, P = .005) but demonstrated no difference in symptom improvement (RR 1.00, 95% CI 0.92 to 1.08, P = .98). There were no serious adverse effects related to wet cupping therapy in the included trials. Wet cupping appears to be effective in the treatment of herpes zoster. However, further large, rigorously designed

The Effectiveness of Family Interventions in Preventing Adolescent Illicit Drug Use: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Vermeulen-Smit, Evelien; Verdurmen, J E E; Engels, R C M E

2015-09-01

In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre (ERIC), MEDLINE, Embase, and PsycINFO for studies published between 1995 and 2013. Results were described separately for different outcomes (marijuana vs. other illicit drugs) and intervention types (universal, selective, and indicated prevention). Meta-analyses were performed when data were sufficient (e.g., marijuana and other illicit drug initiation in universal samples), using random effect models. Otherwise, we provided narrative reviews (e.g., regarding selective and indicated prevention). Thirty-nine papers describing 22 RCTs were eligible for inclusion. Universal family interventions targeting parent-child dyads are likely to be effective in preventing (OR 0.72; 95 % CI 0.56, 0.94) and reducing adolescent marijuana use, but not in preventing other illicit drugs (OR 0.90; 95 % CI 0.60, 1.34). Among high-risk groups, there is no clear evidence for the effectiveness of family interventions in preventing and reducing illicit drug use and drug disorders. The three small RCTs among substance-(ab)using adolescents gave some indication that programs might reduce the frequency of illicit drug use. Family interventions targeting parent-child dyads are likely to be effective in preventing and reducing adolescent marijuana use in general populations, but no evidence for other illicit drug use was found. We underline the need to strengthen the evidence base with more trials, especially among at-risk populations.

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder.

PubMed

van Dongen-Boomsma, Martine; Vollebregt, Madelon A; Slaats-Willemse, Dorine; Buitelaar, Jan K

2013-08-01

A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands. Forty-one children (aged 8-15 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to treatment with either EEG neurofeedback (n = 22) or placebo neurofeedback (n = 19) for 30 sessions, given as 2 sessions per week. The children were stratified by age, electrophysiologic state of arousal, and medication use. Everyone involved in the study, except the neurofeedback therapist and the principal investigator, was blinded to treatment assignment. The primary outcome was severity of ADHD symptoms on the ADHD Rating Scale IV, scored at baseline, during treatment, and at study end. Clinical improvement as measured by the Clinical Global Impressions-Improvement scale (CGI-I) was a secondary outcome. While total ADHD symptoms improved over time in both groups (F1,39 = 26.56, P < .001), there was no significant treatment effect, ie, group × time interaction (F1,39 = 0.36, P = .554); the same was true for clinical improvement as measured by the CGI-I (P = .092). No clinically relevant side effects were observed. Among the children and their parents, guessing treatment assignment was not better than chance level (P = .224 for children, P = .643 for parents). EEG neurofeedback was not superior to placebo neurofeedback in improving ADHD symptoms in children with ADHD. ClinicalTrials.gov identifier: NCT00723684. © Copyright 2013 Physicians Postgraduate Press, Inc.

Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial.

PubMed

Dirkmann, Daniel; Groeben, Harald; Farhan, Hassan; Stahl, David L; Eikermann, Matthias

2015-01-01

This multi-centre, prospective, randomized, double-blind, placebo-controlled study was designed to test the hypotheses that parecoxib improves patients' postoperative analgesia without increasing surgical blood loss following radical open prostatectomy. 105 patients (64 ± 7 years old) were randomized to receive either parecoxib or placebo with concurrent morphine patient controlled analgesia. Cumulative opioid consumption (primary objective) and the overall benefit of analgesia score (OBAS), the modified brief pain inventory short form (m-BPI-sf), the opioid-related symptom distress scale (OR-SDS), and perioperative blood loss (secondary objectives) were assessed. In each group 48 patients received the study medication for 48 hours postoperatively. Parecoxib significantly reduced cumulative opioid consumption by 24% (43 ± 24.1 mg versus 57 ± 28 mg, mean ± SD, p=0.02), translating into improved benefit of analgesia (OBAS: 2(0/4) versus 3(1/5.25), p=0.01), pain severity (m-BPI-sf: 1(1/2) versus 2(2/3), p < 0.01) and pain interference (m-BPI-sf: 1(0/1) versus 1(1/3), p=0.001), as well as reduced opioid-related side effects (OR-SDS score: 0.3(0.075/0.51) versus 0.4(0.2/0.83), p=0.03). Blood loss was significantly higher at 24 hours following surgery in the parecoxib group (4.3 g⋅dL(-1) (3.6/4.9) versus (3.2 g⋅dL(-1) (2.4/4.95), p=0.02). Following major abdominal surgery, parecoxib significantly improves patients' perceived analgesia. Parecoxib may however increase perioperative blood loss. Further trials are needed to evaluate the effects of selective cyclooxygenase-2 inhibitors on blood loss. ClinicalTrials.gov Identifier: NCT00346268.

Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial†

PubMed Central

Thimour-Bergström, Linda; Roman-Emanuel, Christine; Scherstén, Henrik; Friberg, Örjan; Gudbjartsson, Tomas; Jeppsson, Anders

2013-01-01

OBJECTIVES The incidence of surgical site infection (SSI) after open vein harvesting in coronary artery bypass grafting (CABG) patients ranges in different studies between 2 and 20%. Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis. We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting. METHODS An investigator-initiated prospective randomized double-blind single-centre study was performed with 374 patients, randomized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures (Vicryl Plus® and Monocryl Plus®, Ethicon, Somerville, NJ, USA) (n = 184) or identical sutures without triclosan (n = 190) from the same manufacturer. All patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control. Predefined secondary endpoints included culture-proven and antibiotic-treated SSI. RESULTS The primary endpoint occurred in 23 patients (12.5%) with triclosan-coated sutures and in 38 patients (20.0%) in the group without triclosan (P = 0.0497, risk ratio 0.63, (95% confidence interval 0.39–1.00). Corresponding figures for culture-proven infections were 7.6 vs 12.1%, (P = 0.15), and for antibiotic-treated infections, 10.9 vs 18.4%, (P = 0.039). Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups. Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting. CONCLUSIONS Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting. (ClinicalTrials.gov number NCT01212315). PMID:23435526

Effect of OSA on hypoxic and inflammatory markers during CPAP withdrawal: Further evidence from three randomized control trials.

PubMed

Turnbull, Chris D; Rossi, Valentina A; Santer, Peter; Schwarz, Esther I; Stradling, John R; Petousi, Nayia; Kohler, Malcolm

2017-05-01

Obstructive sleep apnoea (OSA) is associated with cardiovascular disease. Intermittent hypoxia, endothelial dysfunction and adipose tissue-mediated inflammation have all been linked to cardiovascular disease in OSA. We therefore explored the effect of OSA on relevant associated blood markers: adrenomedullin (ADM), endocan, endothelin-1 (ET-1), resistin and vascular endothelial growth factor (VEGF). Patients with OSA, established on and compliant with continuous positive airways pressure (CPAP) therapy for >1 year were included from three randomized controlled trials, conducted at two centres. Patients were randomized to either continued therapeutic CPAP or sham CPAP (CPAP withdrawal) for 2 weeks. Blood markers were measured at baseline and at 14 days and the treatment effect between sham CPAP and therapeutic CPAP was analysed. A total of 109 patients were studied (therapeutic CPAP n = 54, sham CPAP n = 55). Sham CPAP was associated with a return of OSA (between-group difference in oxygen desaturation index (ODI) 36.0/h, 95% CI 29.9-42.2, P < 0.001). Sham CPAP was associated with a reduction in ADM levels at 14 days (-26.0 pg/mL, 95% CI -47.8 to -4.3, P = 0.02), compared to therapeutic CPAP. Return of OSA was not associated with changes in endocan, ET-1, resistin or VEGF. Whilst CPAP withdrawal was associated with return of OSA, it was associated with an unexpected significant reduction in the vasodilator ADM and not with expected increases in hypoxia-induced markers, markers of endothelial function or resistin. We propose that the vascular effects occurring in OSA may be brought about by other mechanisms, perhaps partly through a reduction in ADM. © 2016 Asian Pacific Society of Respirology.

Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.

PubMed

Klonizakis, M; Tew, G A; Gumber, A; Crank, H; King, B; Middleton, G; Michaels, J A

2018-05-01

Venous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low-cost, low-risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs. To assess the feasibility of a 12-week supervised exercise programme as an adjunct therapy to compression in patients with VLUs. This was a two-centre, two-arm, parallel-group, randomized feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants' experiences. Seventy-two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise-related adverse events (both increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group. The feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Repetitive transcranial magnetic stimulation and transcranial direct-current stimulation in neuropathic pain due to radiculopathy: a randomized sham-controlled comparative study.

PubMed

Attal, Nadine; Ayache, Samar S; Ciampi De Andrade, Daniel; Mhalla, Alaa; Baudic, Sophie; Jazat, Frédérique; Ahdab, Rechdi; Neves, Danusa O; Sorel, Marc; Lefaucheur, Jean-Pascal; Bouhassira, Didier

2016-06-01

No study has directly compared the effectiveness of repetitive transcranial magnetic stimulation (rTMS) and transcranial direct-current stimulation (tDCS) in neuropathic pain (NP). In this 2-centre randomised double-blind sham-controlled study, we compared the efficacy of 10-Hz rTMS and anodal 2-mA tDCS of the motor cortex and sham stimulation contralateral to the painful area (3 daily sessions) in patients with NP due to lumbosacral radiculopathy. Average pain intensity (primary outcome) was evaluated after each session and 5 days later. Secondary outcomes included neuropathic symptoms and thermal pain thresholds for the upper limbs. We used an innovative design that minimised bias by randomly assigning patients to 1 of 2 groups: active rTMS and tDCS or sham rTMS and tDCS. For each treatment group (active or sham), the order of the sessions was again randomised according to a crossover design. In total, 51 patients were screened and 35 (51% women) were randomized. Active rTMS was superior to tDCS and sham in pain intensity (F = 2.89 and P = 0.023). Transcranial direct-current stimulation was not superior to sham, but its analgesic effects were correlated to that of rTMS (P = 0.046), suggesting common mechanisms of action. Repetitive transcranial magnetic stimulation lowered cold pain thresholds (P = 0.04) and its effect on cold pain was correlated with its analgesic efficacy (P = 0.006). However, rTMS had no impact on individual neuropathic symptoms. Thus, rTMS is more effective than tDCS and sham in patients with NP due to lumbosacral radiculopathy and may modulate the sensory and affective dimensions of pain.

The effect of water-based exercises on balance in persons post-stroke: a randomized controlled trial.

PubMed

Chan, Kelvin; Phadke, Chetan P; Stremler, Denise; Suter, Lynn; Pauley, Tim; Ismail, Farooq; Boulias, Chris

2017-05-01

Water-based exercises have been used in the rehabilitation of people with stroke, but little is known about the impact of this treatment on balance. This study examined the effect of water-based exercises compared to land-based exercises on the balance of people with sub-acute stroke. In this single-blind randomized controlled study, 32 patients with first-time stroke discharged from inpatient rehabilitation at West Park Healthcare Centre were recruited. Participants were randomized into W (water-based + land; n = 17) or L (land only; n = 15) exercise groups. Both groups attended therapy two times per week for six weeks. Initial and progression protocols for the water-based exercises (a combination of balance, stretching, and strengthening and endurance training) and land therapy (balance, strength, transfer, gait, and stair training) were devised. Outcomes included the Berg Balance Score, Community Balance and Mobility Score, Timed Up and Go Test, and 2 Minute Walk Test. Baseline characteristics of groups W and L were similar in age, side of stroke, time since stroke, and wait time between inpatient discharge and outpatient therapy on all four outcomes. Pooled change scores from all outcomes showed that significantly greater number of patients in the W-group showed improvement post-training compared to the L-group (p < 0.05). More patients in W-group showed change scores exceeding the published minimal detectable change scores. A combination of water- and land-based exercises has potential for improving balance. The results of this study extend the work showing benefit of water-based exercise in chronic and less-impaired stroke groups to patients with sub-acute stroke.

Adenocarcinoma in situ of the cervix.

PubMed

Schoolland, Meike; Segal, Amanda; Allpress, Stephen; Miranda, Alina; Frost, Felicity A; Sterrett, Gregory F

2002-12-25

The current study examines 1) the sensitivity of detection and 2) sampling and screening/diagnostic error in the cytologic diagnosis of adenocarcinoma in situ (AIS) of the cervix. The data were taken from public and private sector screening laboratories reporting 25,000 and 80,000 smears, respectively, each year. The study group was comprised of women with a biopsy diagnosis of AIS or AIS combined with a high-grade squamous intraepithelial lesion (HSIL) who were accessioned by the Western Australian Cervical Cytology Registry (WACCR) between 1993-1998. Cervical smears reported by the Western Australia Centre for Pathology and Medical Research (PathCentre) or Western Diagnostic Pathology (WDP) in the 36 months before the index biopsy was obtained were retrieved. A true measure of the sensitivity of detection could not be determined because to the authors' knowledge the exact prevalence of disease is unknown at present. For the current study, sensitivity was defined as the percentage of smears reported as demonstrating a possible or definite high-grade epithelial abnormality (HGEA), either glandular or squamous. Sampling error was defined as the percentage of smears found to have no HGEA on review. Screening/diagnostic error was defined as the percentage of smears in which HGEA was not diagnosed initially but review demonstrated possible or definite HGEA. Sensitivity also was calculated for a randomly selected control group of biopsy proven cases of Grade 3 cervical intraepithelial neoplasia (CIN 3) accessioned at the WACCR in 1999. For biopsy findings of AIS alone, the diagnostic "sensitivity" of a single smear was 47.6% for the PathCentre and 54.3% for WDP. Nearly all the abnormalities were reported as glandular. The sampling and screening/diagnostic errors were 47.6% and 4.8%, respectively, for the PathCentre and 33.3% and 12.3%, respectively, for WDP. The results from the PathCentre were better for AIS plus HSIL than for AIS alone, but the results from WDP were similar for both groups. For the CIN 3 control cases, the "sensitivity" of a single smear was 42.5%. To the authors' knowledge epidemiologic studies published to date have not demonstrated a benefit from screening for precursors of cervical adenocarcinoma. However, in the study laboratories as in many others, reasonable expertise in diagnosing AIS has been acquired only within the last 10-15 years, which may be too short a period in which to demonstrate a significant effect. The results of the current study provide some encouraging baseline data regarding the sensitivity of the Papanicolaou smear in detecting AIS. Further improvements in sampling and cytodiagnosis may be possible. Copyright 2002 American Cancer Society.

The Effect of Acclydine in Chronic Fatigue Syndrome: A Randomized Controlled Trial

PubMed Central

The, Gerard K. H; Bleijenberg, Gijs; van der Meer, Jos W. M

2007-01-01

Objectives: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio). Design: A randomized, placebo-controlled, double-blind clinical trial. Setting: Radboud University Nijmegen Medical Centre, The Netherlands. Participants: Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals. Intervention: Acclydine or placebo for 14 wk. Outcome measures: Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis. Results: There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI −4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI −201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio −0.5 (95% CI −2.8 to +1.7, p = 0.63). Conclusion: We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS. PMID:17525791

The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial.

PubMed

The, Gerard K H; Bleijenberg, Gijs; van der Meer, Jos W M

2007-05-18

It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio). A randomized, placebo-controlled, double-blind clinical trial. Radboud University Nijmegen Medical Centre, The Netherlands. Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals. Acclydine or placebo for 14 wk. Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis. There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI -4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI -201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio -0.5 (95% CI -2.8 to +1.7, p = 0.63). We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS.

A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

PubMed

Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

2017-07-01

We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Oral oxycodone offers equivalent analgesia to intravenous patient-controlled analgesia after total hip replacement: a randomized, single-centre, non-blinded, non-inferiority study.

PubMed

Rothwell, M P; Pearson, D; Hunter, J D; Mitchell, P A; Graham-Woollard, T; Goodwin, L; Dunn, G

2011-06-01

To determine if oral oxycodone (OOXY) could provide equivalent postoperative analgesia and a similar side-effect profile to i.v. patient-controlled morphine in patients undergoing elective primary total hip replacement (THR) under spinal anaesthesia. We studied 110 consecutive patients aged 60-85 yr. After operation, patients were randomly allocated to receive either oral controlled- and immediate-release OOXY or i.v. patient-controlled analgesia (IVPCA) with morphine. Both groups received regular co-analgesia and antiemetics. The primary outcome measures were: (i) postoperative pain at rest and movement and (ii) nausea score recorded 12 hourly. The secondary outcome measures were: (i) time to first mobilization, (ii) total amount of opioid consumed, (iii) number of additional antiemetic doses, and (iv) time to analgesic discontinuation. There were no statistically significant differences in the primary outcome measures of pain at rest and movement (P>0.05, 95% confidence intervals -0.41, +0.96) or nausea score (P>0.5). The secondary outcome measures showed no significant difference in the total amount of opioid consumed (102 vs 63 mg; P>0.05) or time to mobilization (24.45 vs 26.6 h, P=0.2). The number of antiemetic doses required in the first 24 h was significantly lower in the OOXY group (1.1 vs 1.4, P<0.05). The time to analgesic discontinuation was significantly shorter in the OOXY group (50.5 vs 56.6 h, P<0.05). Oral analgesia with OOXY was approximately GBP 10 less expensive per patient than IVPCA. Oral analgesia with OOXY after THR offers non-inferior analgesia to IVPCA and may offer some logistical and cost advantages.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

PubMed Central

Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

2015-01-01

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

Randomized expectancy-enhanced placebo-controlled trial of the impact of Quantum BioEnergetic distant healing and paranormal belief on mood disturbance: a pilot study.

PubMed

Rock, Adam J; Permezel, Fiona E; Storm, Lance

2012-01-01

Previous research has demonstrated the effects of ostensible subtle energy on physical systems and subjective experience. However, one subtle energy technique that has been neglected, despite anecdotal support for its efficacy, is Quantum BioEnergetics (QBE). Furthermore, the influence of paranormal belief and experience (either real belief/experience or suggested belief/experience) on subtle energy effects remains unclear. The aim of the present study was to investigate experimentally the effects of distant QBE healing, and paranormal belief/experience, on mood. A randomized expectancy-enhanced placebo-controlled design was used. Data were collected at the QBE Centre, Melbourne. Participants were students from Deakin University and from the general public. Snowball sampling (ie, word-of-mouth) and convenience sampling using a ballot box placed in the university library. Profile of Mood States-Short Form was used to quantify positive and negative mood states. The QBE condition was associated with (1) significantly less Tension-Anxiety compared with the placebo and control condition; and (2) significantly less Anger-Hostility and Total Mood Disturbance compared with the control condition (but not the placebo condition). Furthermore, there was an interaction of condition and paranormal belief/experience with regard to Depression-Dejection, with believers assigned to the placebo condition scoring lowest on this Mood variable. Findings suggest that the use of QBE by an experienced practitioner reduces mood disturbance. In addition, the placebo condition may have evoked suggestibility effects in believers, which would mean that they may be more likely than nonbelievers to believe that they were receiving healing, thus resulting in lower Depression-Dejection scores. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

TEFL Textbook Evaluation: From Teachers' Perspectives

ERIC Educational Resources Information Center

Tok, Hidayet

2010-01-01

This study aims to examine the advantages and disadvantages of one type of TEFL materials, English language textbook "Spot On", used in state primary schools in Turkey. Sample of the research consists of 46 English teachers chosen randomly from state primary schools in Malatya and Adiyaman city centres. A five-likert type scale was used…

Does foreign aid crowd out government investments? Evidence from rural health centres in Rwanda

PubMed Central

Lu, Chunling; Cook, Benjamin; Desmond, Chris

2017-01-01

Background Rural healthcare facilities in low-income countries play a major role in providing primary care to rural populations. We examined the link of foreign aid with government investments and medical service provision in rural health centres in Rwanda. Methods Using the District Health System Strengthening Tool, a web-based database built by the Ministry of Health in Rwanda, we constructed two composite indices representing provision of (1) child and maternal care and (2) HIV, tuberculosis (TB) and malaria services in 330 rural health centres between 2009 and 2011. Financing variables in a healthcare centre included received funds from various sources, including foreign donors and government. We used multilevel random-effects model in regression analyses and examined the robustness of results to a range of alternative specification, including scale of dependent variables, estimation methods and timing of aid effects. Findings Both government and foreign donors increased their direct investments in the 330 rural healthcare centres during the period. Foreign aid was positively associated with government investments (0.13, 95% CI 0.06 to 0.19) in rural health centres. Aid in the previous year was positively associated with service provision for child and maternal health (0.008, 95% CI 0.002 to 0.014) and service provision for HIV, TB and malaria (0.014, 95% CI 0.004 to 0.022) in the current year. The results are robust when using fixed-effects models. Conclusions These findings suggest that foreign aid did not crowd out government investments in the rural healthcare centres. Foreign aid programmes, conducted in addition to government investments, could benefit rural residents in low-income countries through increased service provision in rural healthcare facilities. PMID:29082015

Does foreign aid crowd out government investments? Evidence from rural health centres in Rwanda.

PubMed

Lu, Chunling; Cook, Benjamin; Desmond, Chris

2017-01-01

Rural healthcare facilities in low-income countries play a major role in providing primary care to rural populations. We examined the link of foreign aid with government investments and medical service provision in rural health centres in Rwanda. Using the District Health System Strengthening Tool, a web-based database built by the Ministry of Health in Rwanda, we constructed two composite indices representing provision of (1) child and maternal care and (2) HIV, tuberculosis (TB) and malaria services in 330 rural health centres between 2009 and 2011. Financing variables in a healthcare centre included received funds from various sources, including foreign donors and government. We used multilevel random-effects model in regression analyses and examined the robustness of results to a range of alternative specification, including scale of dependent variables, estimation methods and timing of aid effects. Both government and foreign donors increased their direct investments in the 330 rural healthcare centres during the period. Foreign aid was positively associated with government investments (0.13, 95% CI 0.06 to 0.19) in rural health centres. Aid in the previous year was positively associated with service provision for child and maternal health (0.008, 95% CI 0.002 to 0.014) and service provision for HIV, TB and malaria (0.014, 95% CI 0.004 to 0.022) in the current year. The results are robust when using fixed-effects models. These findings suggest that foreign aid did not crowd out government investments in the rural healthcare centres. Foreign aid programmes, conducted in addition to government investments, could benefit rural residents in low-income countries through increased service provision in rural healthcare facilities.

SPOT4 Management Centre

NASA Technical Reports Server (NTRS)

Labrune, Yves; Labbe, X.; Roussel, A.; Vielcanet, P.

1994-01-01

In the context of the CNES SPOT4 program CISI is particularly responsible for the development of the SPOT4 Management Centre, part of the SPOT4 ground control system located at CNES Toulouse (France) designed to provide simultaneous control over two satellites. The main operational activities are timed to synchronize with satellite visibilities (ten usable passes per day). The automatic capability of this system is achieved through agenda services (sequence of operations as defined and planned by operator). Therefore, the SPOT4 Management Centre offers limited, efficient and secure human interventions for supervision and decision making. This paper emphasizes the main system characteristics as degree of automation, level of dependability and system parameterization.

Participants' understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START.

PubMed

Shiono, Yoko Narikawa; Zheng, Ying-Fang; Kikuya, Masahiro; Kawai, Masaaki; Ishida, Takanori; Kuriyama, Shinichi; Ohuchi, Noriaki

2014-09-25

It is often difficult to enrol healthy volunteers into a randomized controlled trial (RCT) as there are barriers to participants' proper understanding of a trial. This study aimed to evaluate degrees of understanding of the informed consent (IC) process among healthy volunteers who participated in an RCT. Additionally, factors associated with degree of understanding were investigated. The J-START (the Japan STrategic Anti-cancer Randomized controlled Trial) is an RCT investigating the effectiveness of ultrasonography screening for breast cancer in women aged 40 to 49 years. To evaluate participants' understanding of the J-START, we administered questionnaires to 376 Japanese women on the day of enrolment at five study sites across Japan. The respondents were asked to complete the anonymous questionnaire within 2 weeks. We assessed objective understanding and perceived subjective understanding of IC using a Japanese version of the Quality of Informed Consent scale (QuIC). Then we analyzed the characteristics of women whose understanding was poor, and clarified the association between providing information and their understanding of the study protocol. The average QuIC scores were 78.2 and 82.2 (out of 100 each) for objective and subjective understanding, respectively. These are generally acceptable scores for participants' understanding of an RCT. However, there were four domains with low scores, indicating poor understanding: (1) experimental nature of the study, (2) potential risks or discomfort, (3) benefit to self, and (4) compensation. Healthy volunteers generally well understood the J-START. Nevertheless, there were some domains in need of improvement. In order to facilitate participants' understanding, it is necessary to provide training to reduce differences in information-providing procedures between medical centres and to endeavour to provide consistent information and conditions. The J-START was registered with the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000000757), on July 1, 2007.

Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial

PubMed Central

2012-01-01

Background Postcancer fatigue is a frequently occurring, severe, and invalidating problem, impairing quality of life. Although it is possible to effectively treat postcancer fatigue with cognitive behaviour therapy, the nature of the underlying (neuro)physiology of postcancer fatigue remains unclear. Physiological aspects of fatigue include peripheral fatigue, originating in muscle or the neuromuscular junction; central fatigue, originating in nerves, spinal cord, and brain; and physical deconditioning, resulting from a decreased cardiopulmonary function. Studies on physiological aspects of postcancer fatigue mainly concentrate on deconditioning. Peripheral and central fatigue and brain morphology and function have been studied for patients with fatigue in the context of chronic fatigue syndrome and neuromuscular diseases and show several characteristic differences with healthy controls. Methods/design Fifty seven severely fatigued and 21 non-fatigued cancer survivors will be recruited from the Radboud University Nijmegen Medical Centre. Participants should have completed treatment of a malignant, solid tumour minimal one year earlier and should have no evidence of disease recurrence. Severely fatigued patients are randomly assigned to either the intervention condition (cognitive behaviour therapy) or the waiting list condition (start cognitive behaviour therapy after 6 months). All participants are assessed at baseline and the severely fatigued patients also after 6 months follow-up (at the end of cognitive behaviour therapy or waiting list). Primary outcome measures are fatigue severity, central and peripheral fatigue, brain morphology and function, and physical condition and activity. Discussion This study will be the first randomized controlled trial that characterizes (neuro)physiological factors of fatigue in disease-free cancer survivors and evaluates to which extent these factors can be influenced by cognitive behaviour therapy. The results of this study are not only essential for a theoretical understanding of this invalidating condition, but also for providing an objective biological marker for fatigue that could support the diagnosis and follow-up of treatment. Trial registration The study is registered at http://ClinicalTrials.gov (NCT01096641). PMID:22708881

Does the efficacy of parent-child training depend on maternal symptom improvement? Results from a randomized controlled trial on children and mothers both affected by attention-deficit/hyperactivity disorder (ADHD).

PubMed

Häge, Alexander; Alm, Barbara; Banaschewski, Tobias; Becker, Katja; Colla, Michael; Freitag, Christine; Geissler, Julia; von Gontard, Alexander; Graf, Erika; Haack-Dees, Barbara; Hänig, Susann; Hennighausen, Klaus; Hohmann, Sarah; Jacob, Christian; Jaite, Charlotte; Jennen-Steinmetz, Christine; Kappel, Viola; Matthies, Swantje; Philipsen, Alexandra; Poustka, Luise; Retz, Wolfgang; Rösler, Michael; Schneider-Momm, Katja; Sobanski, Esther; Vloet, Timo D; Warnke, Andreas; Jans, Thomas

2018-01-23

Multimodal treatment of children with ADHD often includes parent-child training (PCT). However, due to the high heritability, parents of children with ADHD are frequently also affected by the disorder, which is likely to constitute a significant barrier to successful treatment of the child. This secondary analysis of our randomized controlled multicentre AIMAC trial (ADHD in mothers and children) investigates whether children's outcomes following parent-child training in combination with maternal ADHD treatment depend on maternal symptom improvement. In a first step focusing on treatment of maternal ADHD, 144 mothers of mother-child dyads were randomized to multimodal ADHD treatment (group psychotherapy plus methylphenidate) or clinical management (mainly supportive counselling). After 12 weeks (T2), a 12-week PCT program (T2-T3) for all mother-child dyads was added to treat children's ADHD. Maternal symptomatology (CAARS-O:L; SCL-90-R) and children's externalizing symptoms (ADHD-ODD Scale, SDQ) were repeatedly assessed (T1 = baseline, T2, T3). Effects of changes in maternal symptomatology (T1-T2) on the change in children's symptom scores (T1-T3) were analysed using a general linear model, controlling for baseline scores, study centre, and maternal treatment group. 125 mother-child dyads were analysed. Mothers showed significant improvements in ADHD symptoms and overall psychopathology [CAARS-O:L ADHD index: mean - 3.54, SE 0.74 p < 0.0001; SCL-90-R Global Severity (GS): mean - 11.03, SE 3.90, p = 0.0056]. Although children's externalizing symptoms improved significantly (ADHD-ODD Scale: mean - 4.46, SE 0.58, p < 0.0001), maternal improvement had no effect on children's outcomes after Bonferroni-Holm correction for multiple testing. The findings do not support our hypothesis that children's outcomes following PCT for ADHD depend on maternal symptom improvements.Trial register CCT-ISRCTN73911400.

Effects of the visual-feedback-based force platform training with functional electric stimulation on the balance and prevention of falls in older adults: a randomized controlled trial.

PubMed

Li, Zhen; Wang, Xiu-Xia; Liang, Yan-Yi; Chen, Shu-Yan; Sheng, Jing; Ma, Shao-Jun

2018-01-01

Force platform training with functional electric stimulation aimed at improving balance may be effective in fall prevention for older adults. Aim of the study is to evaluate the effects of the visual-feedback-based force platform balance training with functional electric stimulation on balance and fall prevention in older adults. A single-centre, unblinded, randomized controlled trial was conducted. One hundred and twenty older adults were randomly allocated to two groups: the control group ( n  = 60, one-leg standing balance exercise, 12 min/d) or the intervention group ( n  = 60, force platform training with functional electric stimulation, 12 min/d). The training was provided 15 days a month for 3 months by physical therapists. Medial-lateral and anterior-posterior maximal range of sway with eyes open and closed, the Berg Balance Scale, the Barthel Index, the Falls Efficacy scale-International were assessed at baseline and after the 3-month intervention. A fall diary was kept by each participant during the 6-month follow-up. On comparing the two groups, the intervention group showed significantly decreased ( p  < 0.01) medial-lateral and anterior-posterior maximal range of sway with eyes open and closed. There was significantly higher improvement in the Berg Balance Scale ( p  < 0.05), the Barthel Index ( p  < 0.05) and the Falls Efficacy Scale-International ( p  < 0.05), along with significantly lesser number of injurious fallers ( p  < 0.05), number of fallers ( p  < 0.05), and fall rates ( p  < 0.05) during the 6-month follow-up in the intervention group. This study showed that the visual feedback-based force platform training with functional electric stimulation improved balance and prevented falls in older adults.

The Effect of a Novel Movement Strategy in Decreasing ACL Risk Factors in Female Adolescent Soccer Players: A Randomized Controlled Trial

PubMed Central

Celebrini, Richard G.; Eng, Janice J.; Miller, William C.; Ekegren, Christina L.; Johnston, James D.; Depew, Thomas A.; MacIntyre, Donna L.

2015-01-01

Objective To determine the effect of a novel movement strategy incorporated within a soccer warm-up on biomechanical risk factors for ACL injury during three sport-specific movement tasks. Design Single-blind, randomized controlled clinical trial. Setting Laboratory setting. Participants 20 top-tier female teenage soccer players. Interventions Subjects were randomized to the Core Position and Control movement strategy (Core-PAC) warm-up or standard warm-up which took place prior to their regular soccer practice over a 6-week period. The Core-PAC focuses on getting the centre of mass closer to the plant foot or base of support. Main Outcome Measures Peak knee flexion angle and abduction moments during a side-hop (SH), side-cut (SC) and unanticipated side-cut (USC) task after the 6-weeks with (intervention group only) and without a reminder to use the Core-PAC strategy. Results The Core-PAC group increased peak flexion angles during the SH task (Mean difference = 6.2°, 95% CI: 1.9–10.5°, effect size = 1.01, P = 0.034) after the 6-week warm-up program without a reminder. In addition, the Core-PAC group demonstrated increased knee flexion angles for the side-cut (Mean difference = 8.5°, 95% CI: 4.8–12.2°, ES = 2.02, P = 0.001) and side-hop (Mean difference = 10.0°, 95% CI: 5.7–14.3°, ES = 1.66, P = 0.001) task after a reminder. No changes in abduction moments were found. Conclusions The results of this study suggest that the Core-PAC may be one method of modifying high-risk soccer-specific movements and can be implemented within a practical, team-based soccer warm-up. The results should be interpreted with caution due to the small sample size. PMID:24184850

The Effect of Adding Magnesium Sulfate to Epidural Bupivacaine and Morphine on Post-Thoracotomy Pain Management: A Randomized, Double-Blind, Clinical Trial.

PubMed

Farzanegan, Behrooz; Zangi, Mahdi; Saeedi, Kimia; Khalili, Ali; Rajabi, Mehdi; Jahangirifard, Alireza; Emami, Habib; Ali Mahboobipour, Amir; Baniasadi, Shadi

2018-05-22

Post-thoracotomy pain is very severe and may cause pulmonary complications. Thoracic epidural analgesia can greatly decrease the pain experience and its consequences. However, finding new methods to decrease the amount of administered opioids is an important issue of research. We aimed to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral centre were enrolled in a randomized, double-blind trial. Patients were randomly allocated to two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) were administered epidurally to all patients at the end of operation. Patients in magnesium (Mg) group received epidural magnesium sulfate (50 mg) and patients in control (C) group received normal saline as an adjuvant. Visual analogue scale (VAS) score and the amount of morphine consumption were measured during 24 hr post-operation. Thirty-nine patients in Mg group and 41 patients in C group completed the study. Patients in Mg group had significantly less VAS score at recovery time (p<0.05), 2 h (p<0.01) and 4 hr (p<0.05) after surgery. The patients-controlled analgesia pump was started earlier in C group than in Mg group (p< 0.05). The amount of morphine needed in Mg group was significantly lower than C group (5.64±1.69 mg/24 hr versus 8.44±3.98 mg/24 hr; P<0.001). Pruritus was seen in C group (9.7%) and absent in Mg group (p<0.05). Co-administration of magnesium sulfate with bupivacaine and morphine for thoracic epidural analgesia after thoracotomy leads to reduction in post-operative pain score and the need for opioid administration. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Patient‐centred physical therapy is (cost‐) effective in increasing physical activity and reducing frailty in older adults with mobility problems: a randomized controlled trial with 6 months follow‐up

PubMed Central

Staal, J Bart; van der Wees, Philip J.; Adang, Eddy M. M.; Akkermans, Reinier; Olde Rikkert, Marcel G. M.; Nijhuis‐van der Sanden, Maria W. G.

2015-01-01

Abstract Background Despite the well‐known health benefits of physical activity, it is a great challenge to stay physically active for frail–older adults with mobility limitations. The aim of this study was to test the (cost‐) effectiveness of a patient‐centred physical therapy strategy (Coach2Move) in which individualized treatment (motivational interviewing, physical examination, individualized goal setting, coaching and advice on self management, and physical training) is combined to increase physical activity level and physical fitness and, thereby, to decrease the level of frailty. Methods A randomized controlled trial was performed in 13 physical therapy practices with measurements at 3 and 6 months. Eligible patients were aged 70 years or over and had mobility problems (i.e. difficulties with walking, moving, getting up and changing position from bed or chair to standing, or stair climbing). The primary outcome was physical activity (total and moderate intensity) in minutes per day. Secondary outcomes were as follows: frailty, walking speed and distance, mobility, and quality of life. Data were analysed using linear mixed models for repeated measurements. Healthcare costs and quality‐adjusted life years (QALYs) were computed and combined using net monetary benefit (NMB) for different willingness to pay thresholds. Data on costs, QALYs, and NMBs were analysed using linear mixed models. Results One hundred and thirty patients participated in this study. At 6 months, the between‐group difference was significant for moderate‐intensity physical activity in favour of the Coach2Move group [mean difference: 17.9 min per day; 95% confidence interval (CI) 4.0 to 34.9; P = 0.012]. The between‐group difference for total physical activity was 14.1 min per day (95% CI −6.6 to 34.9; P = 0.182). Frailty decreased more in the Coach2Move group compared with usual care [mean difference: −0.03 (95% CI: −0.06 to −0.00; P = 0.027)]. Compared with usual treatment, the Coach2Move strategy resulted in cost savings (€849.8; 95% CI: 1607 to 90; P = 0.028), an improvement in QALYs, (0.02; 95% CI: 0.00 to 0.03; P = 0.03), and a higher NMB at every willingness to pay threshold. Conclusions Older adults with mobility problems are able to safely increase physical activity in their own environment and reduce frailty. This study emphasizes both the potential cost‐effectiveness of a patient‐centred approach in the frail elderly and the importance of physical activity promotion in older adults with mobility limitations. PMID:27239405

Patient-centred physical therapy is (cost-) effective in increasing physical activity and reducing frailty in older adults with mobility problems: a randomized controlled trial with 6 months follow-up.

PubMed

de Vries, Nienke M; Staal, J Bart; van der Wees, Philip J; Adang, Eddy M M; Akkermans, Reinier; Olde Rikkert, Marcel G M; Nijhuis-van der Sanden, Maria W G

2016-09-01

Despite the well-known health benefits of physical activity, it is a great challenge to stay physically active for frail-older adults with mobility limitations. The aim of this study was to test the (cost-) effectiveness of a patient-centred physical therapy strategy (Coach2Move) in which individualized treatment (motivational interviewing, physical examination, individualized goal setting, coaching and advice on self management, and physical training) is combined to increase physical activity level and physical fitness and, thereby, to decrease the level of frailty. A randomized controlled trial was performed in 13 physical therapy practices with measurements at 3 and 6 months. Eligible patients were aged 70 years or over and had mobility problems (i.e. difficulties with walking, moving, getting up and changing position from bed or chair to standing, or stair climbing). The primary outcome was physical activity (total and moderate intensity) in minutes per day. Secondary outcomes were as follows: frailty, walking speed and distance, mobility, and quality of life. Data were analysed using linear mixed models for repeated measurements. Healthcare costs and quality-adjusted life years (QALYs) were computed and combined using net monetary benefit (NMB) for different willingness to pay thresholds. Data on costs, QALYs, and NMBs were analysed using linear mixed models. One hundred and thirty patients participated in this study. At 6 months, the between-group difference was significant for moderate-intensity physical activity in favour of the Coach2Move group [mean difference: 17.9 min per day; 95% confidence interval (CI) 4.0 to 34.9; P = 0.012]. The between-group difference for total physical activity was 14.1 min per day (95% CI -6.6 to 34.9; P = 0.182). Frailty decreased more in the Coach2Move group compared with usual care [mean difference: -0.03 (95% CI: -0.06 to -0.00; P = 0.027)]. Compared with usual treatment, the Coach2Move strategy resulted in cost savings (€849.8; 95% CI: 1607 to 90; P = 0.028), an improvement in QALYs, (0.02; 95% CI: 0.00 to 0.03; P = 0.03), and a higher NMB at every willingness to pay threshold. Older adults with mobility problems are able to safely increase physical activity in their own environment and reduce frailty. This study emphasizes both the potential cost-effectiveness of a patient-centred approach in the frail elderly and the importance of physical activity promotion in older adults with mobility limitations.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial.

PubMed

Ashby, Rebecca L; Gabe, Rhian; Ali, Shehzad; Adderley, Una; Bland, J Martin; Cullum, Nicky A; Dumville, Jo C; Iglesias, Cynthia P; Kang'ombe, Arthur R; Soares, Marta O; Stubbs, Nikki C; Torgerson, David J

2014-03-08

Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. NIHR Health Technology Assessment programme (07/60/26). Copyright © 2014 Elsevier Ltd. All rights reserved.

The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool.

PubMed

Okoniewska, Barbara M; Santana, Maria J; Holroyd-Leduc, Jayna; Flemons, Ward; O'Beirne, Maeve; White, Deborah; Clement, Fiona; Forster, Alan; Ghali, William A

2012-11-21

The transition between acute care and community care represents a vulnerable period in health care delivery. The vulnerability of this period has been attributed to changes to patients' medication regimens during hospitalization, failure to reconcile discrepancies between admission and discharge and the burdening of patients/families to take over care responsibilities at discharge and to relay important information to the primary care physician. Electronic communication platforms can provide an immediate link between acute care and community care physicians (and other community providers), designed to ensure consistent information transfer. This study examines whether a transfer-of-care (TOC) communication tool is efficacious and cost-effective for reducing hospital readmission, adverse events and adverse drug events as well as reducing death. A randomized controlled trial conducted on the Medical Teaching Unit of a Canadian tertiary care centre will evaluate the efficacy and cost-effectiveness of a TOC communication tool. Medical in-patients admitted to the unit will be considered for this study. Data will be collected upon admission, and a total of 1400 patients will be randomized. The control group's acute care stay will be summarized using a traditional dictated summary, while the intervention group will have a summary generated using the TOC communication tool. The primary outcome will be a composite, at 3 months, of death or readmission to any Alberta acute-care hospital. Secondary outcomes will be the occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge. Patients with adverse outcomes will have their cases reviewed by two Royal College certified internists or College-certified family physicians, blinded to patients' group assignments, to determine the type, severity, preventability and ameliorability of all detected adverse outcomes. An accompanying economic evaluation will assess the cost per life saved, cost per readmission avoided and cost per QALY gained with the TOC communication tool compared to traditional dictation summaries. This paper outlines the study protocol for a randomized controlled trial evaluating an electronic transfer-of-care communication tool, with sufficient statistical power to assess the impact of the tool on the significant outcomes of post-discharge death or readmission. The study findings will inform health systems around the world on the potential benefits of such tools, and the value for money associated with their widespread implementation. ClinicalTrials.gov NCT01402609.

Efficacy of individualized Chinese herbal medication in osteoarthrosis of hip and knee: a double-blind, randomized-controlled clinical study.

PubMed

Lechner, Matthias; Steirer, Iva; Brinkhaus, Benno; Chen, Yun; Krist-Dungl, Claudia; Koschier, Alexandra; Gantschacher, Martina; Neumann, Kurt; Zauner-Dungl, Andrea

2011-06-01

The objective of this study was to determine the efficacy of individually designed herbal formulas according to the rules of Traditional Chinese Medicine (TCM) in patients with osteoarthritis of the hip and knee. This was a randomized, controlled, double-blind study with two parallel groups. This study was conducted at the University-centre in Gars am Kamp/Austria and was organized by the Institute of TCM and Complementary Medicine of the Danube University Krems /Austria. The study comprised female and male patients with osteoarthritis of hip or knee aged between 45 and 75 years. Patients were randomized into a treatment with individualized, water-based herbal decoctions prepared in a standardized cooking process (Verum group) or to a treatment with nonspecific presumably ineffective, water-based herbal decoctions (Control group). The primary outcome was the comparison of change between the intervention groups in the Western Ontario and McMaster Universities lower limb global index questionnaire (WOMAC global index) between baseline and week 20. Secondary outcomes included subscales of WOMAC for pain (A), stiffness (B), and functional impairment (C) and general quality of life in the form of the SF-36 questionnaire. Altogether, 102 patients were randomized in this trial. The demographic and medical baseline characteristics were comparable in the 2 groups. The change of the WOMAC global index and all three subscales was significant in both groups between week 20 and baseline (verum group, global WOMAC: at baseline 47 [SD ± 11.8] and at week 20: 24 (SD ± 18.3); change of mean 23; p > 0.001; control group; global WOMAC: at baseline: 48 (SD ± 14.7) and at week 20: 25 (SD ± 18.3); change of mean 23; p > 0.001). However, there was no significant difference (p = 0.783) between the treatment groups. There were significant changes in the subscales "physical functioning," "bodily pain," "vitality," "social-functioning," and "role-physical" of the SF-36 in both study groups between 20 weeks and baseline, but again no significant difference between the groups. There were no drug-related serious adverse events. While the individual prescription consisting of medicinal herbs according to TCM diagnosis investigated in this trial tend to improve the osteoarthritis, the same effect was also achieved with the nonspecific prescription.

Optimal random Lévy-loop searching: New insights into the searching behaviours of central-place foragers

NASA Astrophysics Data System (ADS)

Reynolds, A. M.

2008-04-01

A random Lévy-looping model of searching is devised and optimal random Lévy-looping searching strategies are identified for the location of a single target whose position is uncertain. An inverse-square power law distribution of loop lengths is shown to be optimal when the distance between the centre of the search and the target is much shorter than the size of the longest possible loop in the searching pattern. Optimal random Lévy-looping searching patterns have recently been observed in the flight patterns of honeybees (Apis mellifera) when attempting to locate their hive and when searching after a known food source becomes depleted. It is suggested that the searching patterns of desert ants (Cataglyphis) are consistent with the adoption of an optimal Lévy-looping searching strategy.

Increasing girls' physical activity during a short-term organized youth sport basketball program: A randomized controlled trial.

PubMed

Guagliano, Justin M; Lonsdale, Chris; Kolt, Gregory S; Rosenkranz, Richard R; George, Emma S

2015-07-01

To evaluate the short-term efficacy of coach education on basketball players' physical activity (PA) intensity during practices. Intervention effects on players' motivation were also investigated. Randomized controlled trial. This study took place over the course of a 5-day organized youth sport (OYS) basketball program in 2 sports centres in Greater Western Sydney, Australia (September, 2013). A convenience sample of 76 players and 8 coaches were recruited. Players were girls aged 9 to 12 years. Following the first 2 days of the basketball program, coaches allocated into the intervention condition attended 2 coach education sessions where strategies to increase moderate-to-vigorous physical activity (MVPA) and decrease inactivity were discussed. Each coach education session lasted approximately 2h. Compared to the control group, players in the intervention group spent a significantly higher proportion of practice time in MVPA (mean difference [MD]=14.6%; standard error [SE]=2.2%), vigorous PA (VPA; MD=12.6%; SE=1.9%), moderate PA (MD=2.0%; SE=0.5%) and a significantly lower proportion of practice time inactive (MD=-14.5%; SE=2.3%) from baseline to follow-up. There were no significant changes in motivation from baseline to follow-up in either group. Brief coach education sessions can increase MVPA and decrease inactivity without deleterious effects on players' motivation. Also, substantial increases in VPA were found, which is an important finding because VPA has been associated with health benefits, over and above benefits accrued from lower-intensity activity. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Reduction of erosive wear in situ by stannous fluoride-containing toothpaste.

PubMed

Huysmans, M C D N J M; Jager, D H J; Ruben, J L; Unk, D E M F; Klijn, C P A H; Vieira, A M

2011-01-01

Stannous fluoride (SnF) has been suggested as a dental erosion-preventive agent. The aim of this single-centre, randomized, double-blind, in situ study was to evaluate the effect of toothpastes with SnF in the prevention of erosive enamel wear. A combined split-mouth (extra-oral water or toothpaste brushing) and crossover (type of toothpaste) set-up was used. Twelve volunteers wore palatal appliances containing human enamel samples. Three toothpastes were used, in three consecutive runs, in randomized order: two toothpastes containing SnF (coded M and PE) and one toothpaste containing only sodium fluoride (coded C). On day 1 of each run the appliances were worn for pellicle formation. On days 2-5 the samples were also brushed twice with a toothpaste-water slurry or only water (control). Erosion took place on days 2-5 extra-orally 3 times a day (5 min) in a citric acid solution (pH 2.3). Enamel wear depth was quantified by optical profilometry. The effect of toothpastes was tested using General Linear Modeling. Average erosive wear depth of control samples was 23 μm. Both SnF toothpastes significantly reduced erosive wear: M by 34% (SD 39%) and PE by 26% (SD 25%). The control toothpaste reduced erosive wear non-significantly by 7% (SD 20%). Both SnF-containing toothpastes significantly reduced erosive wear compared to the sodium fluoride toothpaste. We conclude that SnF-containing toothpastes are able to reduce erosive tooth wear in situ. Copyright © 2011 S. Karger AG, Basel.

The impact of a Housing First randomized controlled trial on substance use problems among homeless individuals with mental illness.

PubMed

Kirst, Maritt; Zerger, Suzanne; Misir, Vachan; Hwang, Stephen; Stergiopoulos, Vicky

2015-01-01

There is strong evidence that Housing First interventions are effective in improving housing stability and quality of life among homeless people with mental illness and addictions. However, there is very little evidence on the effectiveness of Housing First in improving substance use-related outcomes in this population. This study uses a randomized control design to examine the effects of scatter-site Housing First on substance use outcomes in a large urban centre. Substance use outcomes were compared between a Housing First intervention and treatment as usual group in a sample of 575 individuals experiencing homelessness and mental illness, with or without a co-occurring substance use problem, in the At Home/Chez Soi trial in Toronto, Canada. Generalized linear models were used to compare study arms with respect to change in substance use outcomes over time (baseline, 6, 12, 18 and 24 month). At 24 months, participants in the Housing First intervention had significantly greater reductions in number of days experiencing alcohol problems and amount of money spent on alcohol than participants in the Treatment as Usual group. No differences between the study arms in illicit drug outcomes were found at 24 months. These findings show that a Housing First intervention can contribute to reductions in alcohol problems over time. However, the lack of effect of the intervention on illicit drug problems suggests that individuals experiencing homelessness, mental illness and drug problems may need additional supports to reduce use. Current controlled trials ISRCTN42520374. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial.

PubMed

Boehne, Martin; Jack, Thomas; Köditz, Harald; Seidemann, Kathrin; Schmidt, Florian; Abura, Michaela; Bertram, Harald; Sasse, Michael

2013-02-06

Infused particles induce thrombogenesis, impair microcirculation and modulate immune response. We have previously shown in critically ill children, that particle-retentive in-line filtration reduced the overall complication rate of severe events, length of stay and duration of mechanical ventilation. We now evaluated the influence of in-line filtration on different organ function and thereby elucidated the potential underlying pathophysiological effects of particle infusion. In this single-centre, prospective, randomized controlled trial 807 critically ill children were assigned to either control (n = 406) or filter group (n = 401), the latter receiving in-line filtration for complete infusion therapy. Both groups were compared regarding the differences of incidence rates and its 95% confidence interval (CI) of different organ dysfunction as defined by the International Pediatric Sepsis Consensus Conference 2005. The incidence rates of respiratory (-5.06%; 95% CI, -9.52 to -0.59%), renal (-3.87%; 95% CI, -7.58 to -0.15%) and hematologic (-3.89%; 95% CI, -7.26 to -0.51%) dysfunction were decreased in the filter group. No difference was demonstrated for the occurrence rates of cardiovascular, hepatic, or neurologic dysfunction between both groups. In-line filtration has beneficial effects on the preservation of hematologic, renal and respiratory function in critically ill patients. The presented clinical data further support our hypothesis regarding potential harmful effects of particles. In critically ill patients infused particles may lead to further deterioration of the microcirculation, induce a systemic hypercoagulability and inflammation with consecutive negative effects on organ function. ClinicalTrials.gov number; NCT00209768.

Critical appraisal of nonrandomized studies-A review of recommended and commonly used tools.

PubMed

Quigley, Joan M; Thompson, Juliette C; Halfpenny, Nicholas J; Scott, David A

2018-02-27

When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies. Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed. From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined. There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review. © 2018 John Wiley & Sons, Ltd.

The role of the medial caudate nucleus, but not the hippocampus, in a matching-to sample task for a motor response.

PubMed

Kesner, Raymond P; Gilbert, Paul E

2006-04-01

A delayed-match-to-sample task was used to assess memory for motor responses in rats with control, hippocampus, or medial caudate nucleus (MCN) lesions. All testing was conducted on a cheeseboard maze in complete darkness using an infrared camera. A start box was positioned in the centre of the maze facing a randomly determined direction on each trial. On the sample phase, a phosphorescent object was randomly positioned to cover a baited food well in one of five equally spaced positions around the circumference of the maze forming a 180-degree arc 60 cm from the box. The rat had to displace the object to receive food and return to the start box. The box was then rotated to face a different direction. An identical baited phosphorescent object was placed in the same position relative to the start box. A second identical object was positioned to cover a different unbaited well. On the choice phase, the rat must remember the motor response made on the sample phase and make the same motor response on the choice phase to receive a reward. Hippocampus lesioned and control rats improved as a function of increased angle separation used to separate the correct object from the foil (45, 90, 135, and 180 degrees) and matched the performance of controls. However, rats with MCN lesions were impaired across all separations. Results suggest that the MCN, but not the hippocampus, supports working memory and/or a process aimed at reducing interference for motor response selection based on vector angle information.

Geospatial Analysis and Seasonal Distribution of West Nile Virus Vectors (Diptera: Culicidae) in Southern Ontario, Canada

PubMed Central

Turner, Kevin W.; Hunter, Fiona F.

2018-01-01

The purpose of this study was to establish geospatial and seasonal distributions of West Nile virus vectors in southern Ontario, Canada using historical surveillance data from 2002 to 2014. We set out to produce mosquito abundance prediction surfaces for each of Ontario’s thirteen West Nile virus vectors. We also set out to determine whether elevation and proximity to conservation areas and provincial parks, wetlands, and population centres could be used to improve our model. Our results indicated that the data sets for Anopheles quadrimaculatus, Anopheles punctipennis, Anopheles walkeri, Culex salinarius, Culex tarsalis, Ochlerotatus stimulans, and Ochlerotatus triseriatus were not suitable for geospatial modelling because they are randomly distributed throughout Ontario. Spatial prediction surfaces were created for Aedes japonicus and proximity to wetlands, Aedes vexans and proximity to population centres, Culex pipiens/restuans and proximity to population centres, Ochlerotatus canadensis and elevation, and Ochlerotatus trivittatus and proximity to population centres using kriging. Seasonal distributions are presented for all thirteen species. We have identified both when and where vector species are most abundant in southern Ontario. These data have the potential to contribute to a more efficient and focused larvicide program and West Nile virus awareness campaigns. PMID:29597256

Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

PubMed

Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

2015-07-15

Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol.

PubMed

Zerfu, Taddese Alemu; Taddese, Henok; Nigatu, Tariku; Tenkolu, Girma; Vogel, Joshua P; Khan-Neelofur, Dina; Biadgilign, Sibhatu; Deribew, Amare

2017-01-26

Despite improvements since 1990 to 2014, maternal mortality ratio (MMR) remains high in Ethiopia. One of the key drivers of maternal mortality in Ethiopia is the very low coverage of Skilled Birth attendance (SBA) in rural Ethiopia. This cluster randomized trial piloted an innovative approach of deploying trained community reproductive nurses (CORN) to hard to reach/unreachable rural Ethiopia to improve the coverage of SBA. We used a three-arm cluster randomized trial to test the effect of deploying CORN in rural communities in South Ethiopia to improve SBA and other maternal health indicators. A total of 282 villages/clusters (94 from each arm) were randomly selected in the three districts of the zone for the study. The intervention was implemented in four consecutive phases that aimed at of provision of essential maternal, neonatal and child health (MNCH) services mainly focusing on SBA. The CORN were trained and deployed in health centres (arm 1) and in the community/health posts (arm2). A third arm (arm 3) consisting control villages without the intervention. A baseline and end line assessment was conducted to compare the difference in the proportion of SBA and other MNCH service uptake across the three arms Data was entered into computer, edited, cleaned, and analyzed using Epi-data statistical software. The presentation followed the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines for cluster-randomized trials. This trial is designed to test the impact of an innovative and newly designed means of distribution for the national health extension program strategy with additional service package with no change to the target population. The focus is on effect of CORN in revitalizing the Health Extension Program (HEP) through improving SBA service uptake and other maternal health service uptake indicators. The study findings may guide national policy to strengthen and shape the already existing HEP that has certain limitations to improve maternal health indicators. The competency based training methodology could provide feedback for health science colleges to improve the national nursing or midwifery training curriculum. clinicaltrails.gov NCT02501252 dated on July 14, 2015.

Current status of kilovoltage (kV) radiotherapy in the UK: installed equipment, clinical workload, physics quality control and radiation dosimetry.

PubMed

Palmer, Antony L; Pearson, Michael; Whittard, Paul; McHugh, Katie E; Eaton, David J

2016-12-01

To assess the status and practice of kilovoltage (kV) radiotherapy in the UK. 96% of the radiotherapy centres in the UK responded to a comprehensive survey. An analysis of the installed equipment base, patient numbers, clinical treatment sites, quality control (QC) testing and radiation dosimetry processes were undertaken. 73% of UK centres have at least one kV treatment unit, with 58 units installed across the UK. Although 35% of units are over 10 years old, 39% units have been installed in the last 5 years. Approximately 6000 patients are treated with kV units in the UK each year, the most common site (44%) being basal cell carcinoma. A benchmark of QC practice in the UK is presented, against which individual centres can compare their procedures, frequency of testing and acceptable tolerance values. We propose the use of internal "notification" and "suspension" levels for analysis. All surveyed centres were using recommended Codes of Practice for kV dosimetry in the UK; approximately the same number using in-air and in-water methodologies for medium energy, with two-thirds of all centres citing "clinical relevance" as the reason for choice of code. 64% of centres had hosted an external dosimetry audit within the last 3 years, with only one centre never being independently audited. The majority of centres use locally measured applicator factors and published backscatter factors for treatments. Monitor unit calculations are performed using software in only 36% of centres. A comprehensive review of current kV practice in the UK is presented. Advances in knowledge: Data and discussion on contemporary kV radiotherapy in the UK, with a particular focus on physics aspects.

Current status of kilovoltage (kV) radiotherapy in the UK: installed equipment, clinical workload, physics quality control and radiation dosimetry

PubMed Central

Pearson, Michael; Whittard, Paul; McHugh, Katie E; Eaton, David J

2016-01-01

Objective: To assess the status and practice of kilovoltage (kV) radiotherapy in the UK. Methods: 96% of the radiotherapy centres in the UK responded to a comprehensive survey. An analysis of the installed equipment base, patient numbers, clinical treatment sites, quality control (QC) testing and radiation dosimetry processes were undertaken. Results: 73% of UK centres have at least one kV treatment unit, with 58 units installed across the UK. Although 35% of units are over 10 years old, 39% units have been installed in the last 5 years. Approximately 6000 patients are treated with kV units in the UK each year, the most common site (44%) being basal cell carcinoma. A benchmark of QC practice in the UK is presented, against which individual centres can compare their procedures, frequency of testing and acceptable tolerance values. We propose the use of internal “notification” and “suspension” levels for analysis. All surveyed centres were using recommended Codes of Practice for kV dosimetry in the UK; approximately the same number using in-air and in-water methodologies for medium energy, with two-thirds of all centres citing “clinical relevance” as the reason for choice of code. 64% of centres had hosted an external dosimetry audit within the last 3 years, with only one centre never being independently audited. The majority of centres use locally measured applicator factors and published backscatter factors for treatments. Monitor unit calculations are performed using software in only 36% of centres. Conclusion: A comprehensive review of current kV practice in the UK is presented. Advances in knowledge: Data and discussion on contemporary kV radiotherapy in the UK, with a particular focus on physics aspects. PMID:27730839

[Withdrawal of a specialised diabetes education program in primary care: long term impact on the metabolic control outcomes].

PubMed

Jurado Campos, Jerónimo; Caula Ros, Jacint A; Hernández Anguera, Josep M; Juvinyà Canal, Dolors; Pou Torelló, José M

2009-12-01

To evaluate the possible relationships between a health policy decision, in relation to the diabetes education strategies and the metabolic control outcomes. Longitudinal prospective cohort study. A random cohort sample of 276 type II diabetes mellitus subjects. All primary care centres in three regions of Catalonia. Patients were classified as specialised (n=59) or non-specialised (n=217) groups, as regards whether having received previous diabetes education before the start of the study. HbA1c values were evaluated in all subjects at baseline and after 5 years after receiving only conventional education. Baseline evaluation showed a better metabolic control in the specialised group (P=0.009). The final evaluation showed no significant differences in outcomes between the two groups (P=0.679). When baseline and outcomes values were compared, significant differences were observed in all subjects (P=0.001), the specialised group showed significantly poorer metabolic control (P<0.001), but in the group with previous conventional education no significant differences were observed (P=0.058). Our results suggest that the withdrawal of higher levels of diabetes education may play a major role in poor metabolic control, and that conventional diabetes education does not improve outcomes. Health policy in Primary Care should consider improving the level of diabetes education.

Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G®) during six weeks of rehabilitation - a protocol of a prospective randomized trial.

PubMed

Henkelmann, Ralf; Schneider, Sebastian; Müller, Daniel; Gahr, Ralf; Josten, Christoph; Böhme, Jörg

2017-03-14

Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg. This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks. Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible. NCT02790229 registered on May 29, 2016.

Randomized Controlled Trial of a Brief Versus Extended Internet Intervention for Problem Drinkers.

PubMed

Cunningham, John A; Shorter, Gillian W; Murphy, Michelle; Kushnir, Vladyslav; Rehm, Jürgen; Hendershot, Christian S

2017-10-01

Brief Internet interventions have been shown to reduce alcohol consumption. This trial intended to compare the effects of one such brief intervention to an extended Internet intervention for problem drinkers. Using online advertising, 490 participants, 18 years or older, were recruited and randomized to receive a brief ( CheckYourDrinking.net ) versus an extended ( AlcoholHelpCentre.net ) Internet intervention and were followed up at 6, 12, and 24 months. The per protocol primary analysis assessed difference between condition at the 12-month follow-up. The follow-up rate at 12 months was 83.3 %. ANCOVAs of the primary (Alcohol Use Disorder Identification Test (AUDIT)-C) and secondary outcome variables (drinks in a typical week, highest number of drinks on one occasion-baseline drinking as covariate) revealed no significant (p > 0.05) differences between the interventions. Similarly, combined analyses of the 6-, 12-, and 24-month follow-up revealed no significant differences between interventions at all time points. The present study does not provide support for the added benefit of an extended Internet intervention for problem drinkers over a brief Internet intervention.

Barostat testing of rectal sensation and compliance in humans: comparison of results across two centres and overall reproducibility.

PubMed

Cremonini, F; Houghton, L A; Camilleri, M; Ferber, I; Fell, C; Cox, V; Castillo, E J; Alpers, D H; Dewit, O E; Gray, E; Lea, R; Zinsmeister, A R; Whorwell, P J

2005-12-01

We assessed reproducibility of measurements of rectal compliance and sensation in health in studies conducted at two centres. We estimated samples size necessary to show clinically meaningful changes in future studies. We performed rectal barostat tests three times (day 1, day 1 after 4 h and 14-17 days later) in 34 healthy participants. We measured compliance and pressure thresholds for first sensation, urgency, discomfort and pain using ascending method of limits and symptom ratings for gas, urgency, discomfort and pain during four phasic distensions (12, 24, 36 and 48 mmHg) in random order. Results obtained at the two centres differed minimally. Reproducibility of sensory end points varies with type of sensation, pressure level and method of distension. Pressure threshold for pain and sensory ratings for non-painful sensations at 36 and 48 mmHg distension were most reproducible in the two centres. Sample size calculations suggested that crossover design is preferable in therapeutic trials: for each dose of medication tested, a sample of 21 should be sufficient to demonstrate 30% changes in all sensory thresholds and almost all sensory ratings. We conclude that reproducibility varies with sensation type, pressure level and distension method, but in a two-centre study, differences in observed results of sensation are minimal and pressure threshold for pain and sensory ratings at 36-48 mmHg of distension are reproducible.

Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation.

PubMed

Gude, Wouter T; van Engen-Verheul, Mariëtte M; van der Veer, Sabine N; Kemps, Hareld M C; Jaspers, Monique W M; de Keizer, Nicolette F; Peek, Niels

2016-12-09

The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in the Netherlands. Our participants were multidisciplinary teams in Dutch CR centres who were enrolled in the study between July 2012 and December 2013 and received the intervention for at least 1 year. The intervention included web-based A&F with feedback on clinical performance, facilities for goal setting and action planning, and educational outreach visits. Teams were randomized either to receive feedback that was limited to psychosocial rehabilitation (study group A) or to physical rehabilitation (study group B). The main outcome measure was the difference in performance between study groups in 11 care processes and six patient outcomes, measured at patient level. Secondary outcomes included effects on guideline concordance for the four main CR therapies. Data from 18 centres (14,847 patients) were analysed, of which 12 centres (9353 patients) were assigned to group A and six (5494 patients) to group B. During the intervention, a total of 233 quality improvement goals was identified by participating teams, of which 49 (21%) were achieved during the study period. Except for a modest improvement in data completeness (4.5% improvement per year; 95% CI 0.65 to 8.36), we found no effect of our intervention on any of our primary or secondary outcome measures. Within a multidisciplinary setting, our web-based A&F intervention engaged teams to define local performance improvement goals but failed to support them in actually completing the improvement actions that were needed to achieve those goals. Future research should focus on improving the actionability of feedback on clinical performance and on addressing the socio-technical perspective of the implementation process. NTR3251.

Mobiel Optreden: Verkennend Onderzoek (Mobile Deployment: Investigation)

DTIC Science & Technology

1992-02-01

Koninklijke Luchtmacht 8 1.2 Veranderingen in het Wereldbeeld 9 1.3 Mobiel Optreden 9 1.4 Struktur van het Rapport 11 2 DOELSTELLINGEN STUDIE 13 2.1...militaire gevolgen daarvan die sindsdien plaats; vonden, achterhaalden de uitgangspunten en dnarmee de belangstelling van zowel Koninklijke Luchtmacht...Luchttransport - Secundair: * Vliegbases * Control and Reporting Centre / Military Air Traffic Control Centre. TNO rapport Pagina 9 1.2 Veranderingen in

Complete quantum control of exciton qubits bound to isoelectronic centres.

PubMed

Éthier-Majcher, G; St-Jean, P; Boso, G; Tosi, A; Klem, J F; Francoeur, S

2014-05-30

In recent years, impressive demonstrations related to quantum information processing have been realized. The scalability of quantum interactions between arbitrary qubits within an array remains however a significant hurdle to the practical realization of a quantum computer. Among the proposed ideas to achieve fully scalable quantum processing, the use of photons is appealing because they can mediate long-range quantum interactions and could serve as buses to build quantum networks. Quantum dots or nitrogen-vacancy centres in diamond can be coupled to light, but the former system lacks optical homogeneity while the latter suffers from a low dipole moment, rendering their large-scale interconnection challenging. Here, through the complete quantum control of exciton qubits, we demonstrate that nitrogen isoelectronic centres in GaAs combine both the uniformity and predictability of atomic defects and the dipole moment of semiconductor quantum dots. This establishes isoelectronic centres as a promising platform for quantum information processing.

Electron spin control of optically levitated nanodiamonds in vacuum.

PubMed

Hoang, Thai M; Ahn, Jonghoon; Bang, Jaehoon; Li, Tongcang

2016-07-19

Electron spins of diamond nitrogen-vacancy (NV) centres are important quantum resources for nanoscale sensing and quantum information. Combining NV spins with levitated optomechanical resonators will provide a hybrid quantum system for novel applications. Here we optically levitate a nanodiamond and demonstrate electron spin control of its built-in NV centres in low vacuum. We observe that the strength of electron spin resonance (ESR) is enhanced when the air pressure is reduced. To better understand this system, we investigate the effects of trap power and measure the absolute internal temperature of levitated nanodiamonds with ESR after calibration of the strain effect. We also observe that oxygen and helium gases have different effects on both the photoluminescence and the ESR contrast of nanodiamond NV centres, indicating potential applications of NV centres in oxygen gas sensing. Our results pave the way towards a levitated spin-optomechanical system for studying macroscopic quantum mechanics.

Electron spin control of optically levitated nanodiamonds in vacuum

PubMed Central

Hoang, Thai M.; Ahn, Jonghoon; Bang, Jaehoon; Li, Tongcang

2016-01-01

Electron spins of diamond nitrogen-vacancy (NV) centres are important quantum resources for nanoscale sensing and quantum information. Combining NV spins with levitated optomechanical resonators will provide a hybrid quantum system for novel applications. Here we optically levitate a nanodiamond and demonstrate electron spin control of its built-in NV centres in low vacuum. We observe that the strength of electron spin resonance (ESR) is enhanced when the air pressure is reduced. To better understand this system, we investigate the effects of trap power and measure the absolute internal temperature of levitated nanodiamonds with ESR after calibration of the strain effect. We also observe that oxygen and helium gases have different effects on both the photoluminescence and the ESR contrast of nanodiamond NV centres, indicating potential applications of NV centres in oxygen gas sensing. Our results pave the way towards a levitated spin–optomechanical system for studying macroscopic quantum mechanics. PMID:27432560

Electron spin control of optically levitated nanodiamonds in vacuum

NASA Astrophysics Data System (ADS)

Hoang, Thai M.; Ahn, Jonghoon; Bang, Jaehoon; Li, Tongcang

2016-07-01

Electron spins of diamond nitrogen-vacancy (NV) centres are important quantum resources for nanoscale sensing and quantum information. Combining NV spins with levitated optomechanical resonators will provide a hybrid quantum system for novel applications. Here we optically levitate a nanodiamond and demonstrate electron spin control of its built-in NV centres in low vacuum. We observe that the strength of electron spin resonance (ESR) is enhanced when the air pressure is reduced. To better understand this system, we investigate the effects of trap power and measure the absolute internal temperature of levitated nanodiamonds with ESR after calibration of the strain effect. We also observe that oxygen and helium gases have different effects on both the photoluminescence and the ESR contrast of nanodiamond NV centres, indicating potential applications of NV centres in oxygen gas sensing. Our results pave the way towards a levitated spin-optomechanical system for studying macroscopic quantum mechanics.

Education in the Field Influences Children's Ideas and Interest toward Science

NASA Astrophysics Data System (ADS)

Zoldosova, Kristina; Prokop, Pavol

2006-10-01

This paper explores the idea of informal science education in scientific field laboratory (The Science Field Centre). The experimental group of pupils ( N = 153) was experienced with approximately 5-day lasting field trips and experiments in the Field Centre in Slovakia. After finishing the course, two different research methods were used to discover their interest and ideas toward science. Pupils from the experimental group showed significant differences from those that did not experience education in the Field Centre (control group, N = 365). In comparison to the control group, pupils of the experimental group highly preferred book titles that were related to their program in the Field Centre. There were differences between the drawings of ideal school environment from both pupils groups. In the drawings of the experimental group, we found significantly more items connected with the educational environment of the Field Centre (e.g. laboratory equipment, live animals). We suppose field science education would be one of the most effective ways to increase interest of pupils to study science and to invaluable intrinsic motivation at the expense extrinsic motivation.

Aquatic therapy for boys with Duchenne muscular dystrophy (DMD): an external pilot randomised controlled trial.

PubMed

Hind, Daniel; Parkin, James; Whitworth, Victoria; Rex, Saleema; Young, Tracey; Hampson, Lisa; Sheehan, Jennie; Maguire, Chin; Cantrill, Hannah; Scott, Elaine; Epps, Heather; Main, Marion; Geary, Michelle; McMurchie, Heather; Pallant, Lindsey; Woods, Daniel; Freeman, Jennifer; Lee, Ellen; Eagle, Michelle; Willis, Tracey; Muntoni, Francesco; Baxter, Peter

2017-01-01

Standard treatment of Duchenne muscular dystrophy (DMD) includes regular physiotherapy. There are no data to show whether adding aquatic therapy (AT) to land-based exercises helps maintain motor function. We assessed the feasibility of recruiting and collecting data from boys with DMD in a parallel-group pilot randomised trial (primary objective), also assessing how intervention and trial procedures work. Ambulant boys with DMD aged 7-16 years established on steroids, with North Star Ambulatory Assessment (NSAA) score ≥8, who were able to complete a 10-m walk test without aids or assistance, were randomly allocated (1:1) to 6 months of either optimised land-based exercises 4 to 6 days/week, defined by local community physiotherapists, or the same 4 days/week plus AT 2 days/week. Those unable to commit to a programme, with >20% variation between NSAA scores 4 weeks apart, or contraindications to AT were excluded. The main outcome measures included feasibility of recruiting 40 participants in 6 months from six UK centres, clinical outcomes including NSAA, independent assessment of treatment optimisation, participant/therapist views on acceptability of intervention and research protocols, value of information (VoI) analysis and cost-impact analysis. Over 6 months, 348 boys were screened: most lived too far from centres or were enrolled in other trials; 12 (30% of the targets) were randomised to AT ( n  = 8) or control ( n  = 4). The mean change in NSAA at 6 months was -5.5 (SD 7.8) in the control arm and -2.8 (SD 4.1) in the AT arm. Harms included fatigue in two boys, pain in one. Physiotherapists and parents valued AT but believed it should be delivered in community settings. Randomisation was unattractive to families, who had already decided that AT was useful and who often preferred to enrol in drug studies. The AT prescription was considered to be optimised for three boys, with other boys given programmes that were too extensive and insufficiently focused. Recruitment was insufficient for VoI analysis. Neither a UK-based RCT of AT nor a twice weekly AT therapy delivered at tertiary centres is feasible. Our study will help in the optimisation of AT service provision and the design of future research. ISRCTN41002956.

Test-retest and interobserver reliability of quantitative sensory testing according to the protocol of the German Research Network on Neuropathic Pain (DFNS): a multi-centre study.

PubMed

Geber, Christian; Klein, Thomas; Azad, Shahnaz; Birklein, Frank; Gierthmühlen, Janne; Huge, Volker; Lauchart, Meike; Nitzsche, Dorothee; Stengel, Maike; Valet, Michael; Baron, Ralf; Maier, Christoph; Tölle, Thomas; Treede, Rolf-Detlef

2011-03-01

Quantitative sensory testing (QST) is an instrument to assess positive and negative sensory signs, helping to identify mechanisms underlying pathologic pain conditions. In this study, we evaluated the test-retest reliability (TR-R) and the interobserver reliability (IO-R) of QST in patients with sensory disturbances of different etiologies. In 4 centres, 60 patients (37 male and 23 female, 56.4±1.9years) with lesions or diseases of the somatosensory system were included. QST comprised 13 parameters including detection and pain thresholds for thermal and mechanical stimuli. QST was performed in the clinically most affected test area and a less or unaffected control area in a morning and an afternoon session on 2 consecutive days by examiner pairs (4 QSTs/patient). For both, TR-R and IO-R, there were high correlations (r=0.80-0.93) at the affected test area, except for wind-up ratio (TR-R: r=0.67; IO-R: r=0.56) and paradoxical heat sensations (TR-R: r=0.35; IO-R: r=0.44). Mean IO-R (r=0.83, 31% unexplained variance) was slightly lower than TR-R (r=0.86, 26% unexplained variance, P<.05); the difference in variance amounted to 5%. There were no differences between study centres. In a subgroup with an unaffected control area (n=43), reliabilities were significantly better in the test area (TR-R: r=0.86; IO-R: r=0.83) than in the control area (TR-R: r=0.79; IO-R: r=0.71, each P<.01), suggesting that disease-related systematic variance enhances reliability of QST. We conclude that standardized QST performed by trained examiners is a valuable diagnostic instrument with good test-retest and interobserver reliability within 2days. With standardized training, observer bias is much lower than random variance. Quantitative sensory testing performed by trained examiners is a valuable diagnostic instrument with good interobserver and test-retest reliability for use in patients with sensory disturbances of different etiologies to help identify mechanisms of neuropathic and non-neuropathic pain. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Synthesis of wavelet envelope in 2-D random media having power-law spectra: comparison with FD simulations

NASA Astrophysics Data System (ADS)

Sato, Haruo; Fehler, Michael C.

2016-10-01

The envelope broadening and the peak delay of the S-wavelet of a small earthquake with increasing travel distance are results of scattering by random velocity inhomogeneities in the earth medium. As a simple mathematical model, Sato proposed a new stochastic synthesis of the scalar wavelet envelope in 3-D von Kármán type random media when the centre wavenumber of the wavelet is in the power-law spectral range of the random velocity fluctuation. The essential idea is to split the random medium spectrum into two components using the centre wavenumber as a reference: the long-scale (low-wavenumber spectral) component produces the peak delay and the envelope broadening by multiple scattering around the forward direction; the short-scale (high-wavenumber spectral) component attenuates wave amplitude by wide angle scattering. The former is calculated by the Markov approximation based on the parabolic approximation and the latter is calculated by the Born approximation. Here, we extend the theory for the envelope synthesis of a wavelet in 2-D random media, which makes it easy to compare with finite difference (FD) simulation results. The synthetic wavelet envelope is analytically written by using the random medium parameters in the angular frequency domain. For the case that the power spectral density function of the random velocity fluctuation has a steep roll-off at large wavenumbers, the envelope broadening is small and frequency independent, and scattering attenuation is weak. For the case of a small roll-off, however, the envelope broadening is large and increases with frequency, and the scattering attenuation is strong and increases with frequency. As a preliminary study, we compare synthetic wavelet envelopes with the average of FD simulation wavelet envelopes in 50 synthesized random media, which are characterized by the RMS fractional velocity fluctuation ε = 0.05, correlation scale a = 5 km and the background wave velocity V0 = 4 km s-1. We use the radiation of a 2 Hz Ricker wavelet from a point source. For all the cases of von Kármán order κ = 0.1, 0.5 and 1, we find the synthetic wavelet envelopes are a good match to the characteristics of FD simulation wavelet envelopes in a time window starting from the onset through the maximum peak to the time when the amplitude decreases to half the peak amplitude.

Implementing self sustained quality control procedures in a clinical laboratory.

PubMed

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

Charge state manipulation of qubits in diamond

PubMed Central

Grotz, Bernhard; Hauf, Moritz V.; Dankerl, Markus; Naydenov, Boris; Pezzagna, Sébastien; Meijer, Jan; Jelezko, Fedor; Wrachtrup, Jörg; Stutzmann, Martin; Reinhard, Friedemann; Garrido, Jose A.

2012-01-01

The nitrogen-vacancy (NV) centre in diamond is a promising candidate for a solid-state qubit. However, its charge state is known to be unstable, discharging from the qubit state NV− into the neutral state NV0 under various circumstances. Here we demonstrate that the charge state can be controlled by an electrolytic gate electrode. This way, single centres can be switched from an unknown non-fluorescent state into the neutral charge state NV0, and the population of an ensemble of centres can be shifted from NV0 to NV−. Numerical simulations confirm the manipulation of the charge state to be induced by the gate-controlled shift of the Fermi level at the diamond surface. This result opens the way to a dynamic control of transitions between charge states and to explore hitherto inaccessible states, such as NV+. PMID:22395620

Improving the layout of recycling centres by use of lean production principles.

PubMed

Sundin, Erik; Björkman, Mats; Eklund, Mats; Eklund, Jörgen; Engkvist, Inga-Lill

2011-06-01

There has been increased focus on recycling in Sweden during recent years. This focus can be attributed to external environmental factors such as tougher legislation, but also to the potential gains for raw materials suppliers. Recycling centres are important components in the Swedish total recycling system. Recycling centres are manned facilities for waste collection where visitors can bring, sort and discard worn products as well as large-sized, hazardous, and electrical waste. The aim of this paper was to identify and describe the main flows and layout types at Swedish recycling centres. The aim was also to adapt and apply production theory for designing and managing recycling centre operations. More specifically, this means using lean production principles to help develop guidelines for recycling centre design and efficient control. Empirical data for this research was primarily collected through interviews and questionnaires among both visitors and employees at 16 Swedish recycling centres. Furthermore, adapted observation protocols have been used in order to explore visitor activities. There was also close collaboration with a local recycling centre company, which shared their layout experiences with the researchers in this project. The recycling centres studied had a variety of problems such as queues of visitors, overloading of material and improper sorting. The study shows that in order to decrease the problems, the recycling centres should be designed and managed according to lean production principles, i.e. through choosing more suitable layout choices with visible and linear flows, providing better visitor information, and providing suitable technical equipment. Improvements can be achieved through proper planning of the layout and control of the flow of vehicles, with the result of increased efficiency and capacity, shorter visits, and cleaner waste fractions. The benefits of a lean production mindset include increased visitor capacity, waste flexibility, improved sorting quality, shorter time for visits and improved working conditions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Posion Prevention in the Home

PubMed Central

Burnside, Sandra; Trepanier, Donna; McGuigan, Michael A.

1983-01-01

The Poison Control Centre at Toronto's Hospital for Sick Children received over 25,000 telephone inquiries in 1981. Those at greatest risk of accidental poisoning are children under age five. Education on poison prevention should begin at the first postnatal visit. This article lists the most common household poisons, including plants, resources that parents and physicians can use, and the telephone numbers of Canadian poison control centres. ImagesFig. 2Fig. 3Fig. 4

How does practise of internal Chinese martial arts influence postural reaction control?

PubMed

Gorgy, Olivier; Vercher, Jean-Louis; Coyle, Thelma

2008-04-01

The aim of this study was to determine the effects of Chinese martial arts practice on postural reaction control after perturbation. Participants standing in Romberg tandem posture were subjected to an unexpected lateral platform translation with the eyes open or closed at two translation amplitudes. The peak displacement of the centre of pressure and of the centre of mass, and the onset latency of muscular activity (tibialis anterior, gastrocnemius, lumbodorsal muscular group, and rectus abdominis), were evaluated for martial arts practitioners and for sport and non-sport participants. Compared with the sport and non-sport participants, the martial arts group showed lower maximal centre of pressure and centre of mass peak displacements in both the lateral and anterior - posterior directions, but no difference was found in the onset of muscular responses. We conclude that martial arts practice influences postural reaction control during a fixed-support strategy in a tandem task. The martial arts group used the ankle joint more frequently than the sport and non-sport participants, especially in the eyes-closed conditions. Our results suggest that the better balance recovery in the martial arts group is a consequence of better control of biomechanical properties of the lower limbs (e.g. through muscular response by co-contraction), not a change in the neuromuscular temporal pattern.

Evaluation of a Core Team Centred Professional Development Programme for Building a Whole-School Cooperative Problem Solving Approach to Conflict

ERIC Educational Resources Information Center

White, Andrew Jonathan; Wertheim, Eleanor H.; Freeman, Elizabeth; Trinder, Margot

2013-01-01

This study evaluated a professional learning approach using a core team (CT) model to assist primary (elementary) schools to develop whole-school collaborative conflict resolution processes. Thirteen schools were matched and randomly assigned to the enhancing relationships in school communities programme ("n"?=?10) or a non-programme…

Task Card Instruction: The Effect of Different Cue Sequences on Students' Learning in Tennis

ERIC Educational Resources Information Center

Iserbyt, Peter; Madou, Bob; Elen, Jan; Behets, Daniel

2010-01-01

In physical education, task cards are often used in student-centred learning models. Consequently, a better understanding of how to deliver effective instructions by means of task cards would make a contribution to the literature. In this study, 80 right-handed university students in kinesiology were randomized across three experimental conditions…

Science Teacher Training Programme in Rural Schools: An ODL Lesson from Zimbabwe

ERIC Educational Resources Information Center

Mhishi, Misheck; Bhukuvhani, Crispen Erinos; Sana, Abel Farikai

2012-01-01

This case study looked at 76 randomly selected preservice science teachers from Mbire and Guruve districts who were learning at the Mushumbi Centre in Zimbabwe and assessed their motivations for enrolling under the Bindura University of Science Education (BUSE)'s Virtual and Open Distance Learning (VODL) programme. It also looked at the challenges…

Lesion Neuroanatomy of the Sustained Attention to Response Task

ERIC Educational Resources Information Center

Molenberghs, Pascal; Gillebert, Celine R.; Schoofs, Hanne; Dupont, Patrick; Peeters, Ronald; Vandenberghe, Rik

2009-01-01

The Sustained Attention to Response task is a classical neuropsychological test that has been used by many centres to characterize the attentional deficits in traumatic brain injury, ADHD, autism and other disorders. During the SART a random series of digits 1-9 is presented repeatedly and subjects have to respond to each digit (go trial) except…

Cluster Supervision Practices in Primary School of Jimma Zone

ERIC Educational Resources Information Center

Afework, E. A.; Frew, A. T.; Abeya, G. G.

2017-01-01

The main objective of this study was to assess the supervisory practice of cluster resource centre (CRC) supervisors in Jimma Zone primary schools. To achieve this purpose, the descriptive survey design was employed. Data were collected from 238 randomly selected teachers, and 60 school principals with a response rate of 98.6%. Moreover, 12 CRC…

Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study.

PubMed

von Wolff, M; Rösner, S; Germeyer, A; Jauckus, J; Griesinger, G; Strowitzki, T

2013-12-01

Does intrauterine application of diluted seminal plasma (SP) at the time of ovum pick-up improve the pregnancy rate by ≥14% in IVF treatment? Intrauterine instillation of diluted SP at the time of ovum pick-up is unlikely to increase the pregnancy rate by ≥14% in IVF. SP modulates endometrial function, and sexual intercourse around the time of embryo transfer has been suggested to increase the likelihood of pregnancy. A previous randomized double-blind pilot study demonstrated a strong trend towards increased pregnancy rates following the intracervical application of undiluted SP. As this study was not conclusive and as the finding could have been confounded by sexual intercourse, the intrauterine application of diluted SP was investigated in the present trial. A single-centre, prospective, double-blind, placebo-controlled, randomized, superiority trial on women undergoing IVF was conducted from April 2007 until February 2012 at the University Department of Gynaecological Endocrinology and Reproductive Medicine, Heidelberg, Germany. The study was powered to detect an 14% increase in the clinical pregnancy rate and two sequential tests were planned using the Pocock spending function. At the first interim analysis, 279 women had been randomly assigned to intrauterine diluted SP (20% SP in saline from the patients' partner) (n = 138) or placebo (n = 141) at the time of ovum pick-up. The clinical pregnancy rate per randomized patient was 37/138 (26.8%) in the SP group and 41/141 (29.1%) in the placebo group (difference: -2.3%, 95% confidence interval of the difference: -12.7 to +8.2%; P = 0.69). The live birth rate per randomized patient was 28/138 (20.3%) in the SP group and 33/141 (23.4%) in the placebo group (difference: -3.1%, 95% confidence interval of the difference: -12.7 to +6.6%; P = 0.56). It was decided to terminate the trial due to futility at the first interim analysis, at a conditional power of 62%. The confidence interval of the difference remains wide, thus clinically relevant differences cannot reliably be excluded based on this single study. The results of this study cast doubt on the validity of the concept that SP increases endometrial receptivity and thus implantation in humans. Funding was provided by the department's own research facilities. DRKS00004615.

Effects of a 3-year nurse-based case management in aged patients with acute myocardial infarction on rehospitalisation, mortality, risk factors, physical functioning and mental health. a secondary analysis of the randomized controlled KORINNA study.

PubMed

Kirchberger, Inge; Hunger, Matthias; Stollenwerk, Björn; Seidl, Hildegard; Burkhardt, Katrin; Kuch, Bernhard; Meisinger, Christa; Holle, Rolf

2015-01-01

Home-based secondary prevention programs led by nurses have been proposed to facilitate patients' adjustment to acute myocardial infarction (AMI). The objective of this study was to conduct secondary analyses of the three-year follow-up of a nurse-based case management for elderly patients discharged from hospital after an AMI. In a single-centre randomized two-armed parallel group trial of hospitalized patients with AMI ≥65 years, patients hospitalized between September 2008 and May 2010 in the Hospital of Augsburg, Germany, were randomly assigned to case management or usual care. The case-management intervention consisted of a nurse-based follow-up for three years including home visits and telephone calls. Study endpoints were time to first unplanned readmission or death, clinical parameters, functional status, depressive symptoms and malnutrition risk. Persons who assessed three-year outcomes and validated readmission data were blinded. The intention-to-treat approach was applied to the statistical analyses which included Cox Proportional Hazards models. Three hundred forty patients were allocated to receive case-management (n = 168) or usual care (n = 172). During three years, in the intervention group there were 80 first unplanned readmissions and 6 deaths, while the control group had 111first unplanned readmissions and 3 deaths. The intervention did not significantly affect time to first unplanned readmission or death (Hazard Ratio 0.89, 95% confidence interval (CI) 0.67-1.19; p = 0.439), blood pressure, cholesterol level, instrumental activities of daily life (IADL) (only for men), and depressive symptoms. However, patients in the intervention group had a significantly better functional status, as assessed by the HAQ Disability Index, IADL (only for women), and hand grip strength, and better SCREEN-II malnutrition risk scores than patients in the control group. A nurse-based management among elderly patients with AMI did not significantly affect time to unplanned readmissions or death during a three-year follow-up. However, the results indicate that functional status and malnutrition risk can be improved. Current Controlled Trials ISRCTN02893746.

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

PubMed

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study concluded that Carica papaya leaf extract (CPLE) does significantly increase the platelet count in patients with thrombocytopenia associated with dengue with fewer side effects and good tolerability.

Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial.

PubMed

Espí-López, G V; Rodríguez-Blanco, C; Oliva-Pascual-Vaca, A; Benítez-Martínez, J C; Lluch, E; Falla, D

2014-12-01

Tension-type headache (TTH) is the most common type of primary headache however there is no clear evidence as to which specific treatment is most effective or whether combined treatment is more effective than individual treatments. To assess the effectiveness of manual therapy techniques, applied to the suboccipital region, on aspects of disability in a sample of patients with tension-type headache. Randomized Controlled Trial. Specialized centre for headache treatment. Seventy-six (62 women) patients (age: 39.9 ± 10.9 years) with episodic chronic TTH. Patients were randomly divided into four treatment groups: 1) suboccipital soft tissue inhibition; 2) occiput-atlas-axis manipulation; 3) combined treatment of both techniques; 4) control. Four sessions were applied over 4 weeks and disability was assessed before and after treatment using the Headache Disability Inventory (HDI). Headache frequency, severity and the functional and emotional subscales of the questionnaire were assessed. Photophobia, phonophobia and pericranial tenderness were also monitored. Headache frequency was significantly reduced with the manipulative and combined treatment (P<0.05), and the severity and functional subscale of the HDI changed in all three treatment groups (P<0.05). Manipulation treatment also reduced the score on the emotional subscale of the HDI (P<0.05). The combined intervention showed a greater effect at reducing the overall HDI score compared to the group that received suboccipital soft tissue inhibition and to the control group (both P<0.05). In addition, photophobia, phonophobia and pericranial tenderness only improved in the group receiving combined therapy (P<0.05). When given individually, suboccipital soft tissue inhibition and occiput-atlas-axis manipulation resulted in changes in different parameters related to the disability caused by TTH. However, when the two treatments were combined, effectiveness was noted for all aspects of disability and other symptoms including photophobia, phonophobia and pericranial tenderness. Although individual manual therapy treatments showed a positive change in headache features, measures of photophobia, photophobia and pericranial tenderness only improved in the group that received the combined treatment suggesting that combined treatment is the most appropriate for symptomatic relief of TTH.

Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

PubMed

Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

2011-06-01

To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

Investigation into three dimensional hip anatomy in anterior dislocation after THA. Influence of the position of the hip rotation centre.

PubMed

Sariali, Elhadi; Klouche, Shahnez; Mamoudy, Patrick

2012-07-01

The components position is a major factor under the surgeon's control in determining the risk of dislocation post total hip arthroplasty. The aim of this study was to investigate the proper three-dimensional components position including the centre of rotation in the case of anterior dislocation. Among 1764 consecutive patients who underwent total hip arthroplasty using a direct anterior approach, 27 experienced anterior dislocation. The three-dimensional hip anatomy was investigated in 12 patients who were paired with 12 patients from the same initial cohort who did not experience dislocation and also with 36 control patients with osteoarthritis. A pelvic Cartesian referential was defined to perform the acetabular analysis. The coordinates were expressed as percentages of the pelvic width, height and depth. The anteversion angles were measured. The hip centre of rotation was significantly shifted medially and posteriorly in the dislocation group when compared to the non-dislocation group and also to the control group. There was no significant difference in component angular position between the dislocation-group and the non-dislocation group. However, the stem anteversion in the dislocation group was increased in comparison to the mean natural femoral anteversion of the control group. A medial and posterior displacement of the hip rotation centre was found to correlate to anterior dislocation post total hip arthoplasty. These results suggest the importance of an accurate restoration of the centre of rotation, whilst avoiding an excessive acetabular reaming which may induce a medial and a posterior displacement. III comparative non randomised. Copyright © 2011 Elsevier Ltd. All rights reserved.

Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men.

PubMed

Crombie, Iain K; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Petrie, Dennis; Jones, Claire; Norrie, John; Evans, Josie M M; Emslie, Carol; Rice, Peter M; Slane, Peter W; Humphris, Gerry; Ricketts, Ian W; Melson, Ambrose J; Donnan, Peter T; Hapca, Simona M; McKenzie, Andrew; Achison, Marcus

2018-06-01

To test the effectiveness of a theoretically based text-message intervention to reduce binge drinking among socially disadvantaged men. A multi-centre parallel group, pragmatic, individually randomized controlled trial. Community-based study conducted in four regions of Scotland. A total of 825 men aged 25-44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. A series of 112 interactive text messages was delivered by mobile phone during a 12-week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence-based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post-intervention. The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57-1.08; absolute reduction 5.7%, 95% CI = -13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. A theoretically based text-messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12-month follow-up. © 2018 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

pRotective vEntilation with veno-venouS lung assisT in respiratory failure: A protocol for a multicentre randomised controlled trial of extracorporeal carbon dioxide removal in patients with acute hypoxaemic respiratory failure.

PubMed

McNamee, J J; Gillies, M A; Barrett, N A; Agus, A M; Beale, R; Bentley, A; Bodenham, A; Brett, S J; Brodie, D; Finney, S J; Gordon, A J; Griffiths, M; Harrison, D; Jackson, C; McDowell, C; McNally, C; Perkins, G D; Tunnicliffe, W; Vuylsteke, A; Walsh, T S; Wise, M P; Young, D; McAuley, D F

2017-05-01

One of the few interventions to demonstrate improved outcomes for acute hypoxaemic respiratory failure is reducing tidal volumes when using mechanical ventilation, often termed lung protective ventilation. Veno-venous extracorporeal carbon dioxide removal (vv-ECCO 2 R) can facilitate reducing tidal volumes. pRotective vEntilation with veno-venouS lung assisT (REST) is a randomised, allocation concealed, controlled, open, multicentre pragmatic trial to determine the clinical and cost-effectiveness of lower tidal volume mechanical ventilation facilitated by vv-ECCO 2 R in patients with acute hypoxaemic respiratory failure. Patients requiring intubation and mechanical ventilation for acute hypoxaemic respiratory failure will be randomly allocated to receive either vv-ECCO 2 R and lower tidal volume mechanical ventilation or standard care with stratification by recruitment centre. There is a need for a large randomised controlled trial to establish whether vv-ECCO 2 R in acute hypoxaemic respiratory failure can allow the use of a more protective lung ventilation strategy and is associated with improved patient outcomes.

Clinical risk factors, bacterial aetiology, and outcome of urinary tract infection in children hospitalized with diarrhoea in Bangladesh.

PubMed

Das, R; Ahmed, T; Saha, H; Shahrin, L; Afroze, F; Shahid, A S M S B; Shahunja, K M; Bardhan, P K; Chisti, M J

2017-04-01

Urinary tract infection (UTI) is common in children aged <5 years with diarrhoea, but little is known about risk factors, aetiology and outcome of such children. We aimed to evaluate these knowledge gaps of UTI in children aged <5 years with diarrhoea. We enrolled all children aged <5 years with diarrhoea admitted to Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh, between May 2011 and April 2013, who had history of fever (⩾38 °C) and obtained a urine sample for culture. Diarrhoea with UTI (confirmed by culture) constituted cases (n = 26) and those without UTI constituted controls (n = 78). Threefold controls were randomly selected. The case-fatality rate was comparable in cases and controls (4% vs. 1%, P = 0·439). Escherichia coli (69%) and Klebsiella (15%) were the most commonly isolated pathogens. Persistent diarrhoea, pneumonia and prior antibiotics use were identified as risk factors for UTI in logistic regression analysis (P < 0·05 for all). Thus, children with diarrhoea presenting with persistent diarrhoea, pneumonia, and prior antibiotic use should be investigated for UTI for their prompt management that may reduce morbidity.

The Effect of Joint Mobilization on Dynamic Postural Control in Patients With Chronic Ankle Instability: A Critically Appraised Topic.

PubMed

Kosik, Kyle B; Gribble, Phillip A

2018-01-01

Clinical Scenario: Dorsiflexion range of motion is an important factor in the performance of the Star Excursion Balance Test (SEBT). While patients with chronic ankle instability (CAI) commonly experience decreased reach distances on the SEBT, ankle joint mobilization has been suggested to be an effective therapeutic intervention for targeting dorsiflexion range of motion. What is the evidence to support ankle joint mobilization for improving performance on the SEBT in patients with CAI? Summary of Key Findings: The literature was searched for articles examining the effects of ankle joint mobilization on scores of the SEBT. A total of 3 peer-reviewed articles were retrieved, 2 prospective individual cohort studies and 1 randomized controlled trial. Only 2 articles demonstrated favorable results following 6 sessions of ankle joint mobilization. Clinical Bottom Line: Despite the mixed results, the majority of the available evidence suggests that ankle joint mobilization improves dynamic postural control. Strength of Recommendation: In accordance with the Centre of Evidence Based Medicine, the inconsistent results and the limited high-quality studies indicate that there is level C evidence to support the use of ankle joint mobilization to improve performance on the SEBT in patients with CAI.

Evaluation of two educative models in a primary care hypertension programme.

PubMed

Martínez-Amenós, A; Fernández Ferré, M L; Mota Vidal, C; Alsina Rocasalbas, J

1990-08-01

This study was planned in the context of a regional high blood pressure programme, to compare the efficacy of two educative methods. The group of 722 hypertensive patients (58.8% women), mean age 61 years, was randomly selected from 19 primary care centres. Initial assessment was based on a patient interview including 22 questions on high blood pressure, its consequences and treatment. Patients agreeing to participate in an active education team programme were distributed into three groups: individual education, team education and a control group. Those who declined to participate formed two groups: individual education and controls. Team education consisted of two audiovisual sessions attended by groups of 8-12 patients and conducted by treating physicians and nurses. Individual education included comments related to the 22 questions. Follow-up assessment was made after two months. An increase in the level of hypertension control was observed only in the accepting group, in which educative action was followed by increased knowledge. Results were similarly favourable for both the individual and team education groups and suggested the need to consider educational factors together with those influencing patient attitude towards an active educational programme.

Effects of the architecture of tissue engineering scaffolds on cell seeding and culturing.

PubMed

Melchels, Ferry P W; Barradas, Ana M C; van Blitterswijk, Clemens A; de Boer, Jan; Feijen, Jan; Grijpma, Dirk W

2010-11-01

The advance of rapid prototyping techniques has significantly improved control over the pore network architecture of tissue engineering scaffolds. In this work, we have assessed the influence of scaffold pore architecture on cell seeding and static culturing, by comparing a computer designed gyroid architecture fabricated by stereolithography with a random pore architecture resulting from salt leaching. The scaffold types showed comparable porosity and pore size values, but the gyroid type showed a more than 10-fold higher permeability due to the absence of size-limiting pore interconnections. The higher permeability significantly improved the wetting properties of the hydrophobic scaffolds and increased the settling speed of cells upon static seeding of immortalised mesenchymal stem cells. After dynamic seeding followed by 5 days of static culture gyroid scaffolds showed large cell populations in the centre of the scaffold, while salt-leached scaffolds were covered with a cell sheet on the outside and no cells were found in the scaffold centre. It was shown that interconnectivity of the pores and permeability of the scaffold prolonged the time of static culture before overgrowth of cells at the scaffold periphery occurred. Furthermore, novel scaffold designs are proposed to further improve the transport of oxygen and nutrients throughout the scaffolds and to create tissue engineering grafts with a designed, pre-fabricated vasculature. Copyright © 2010 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Effects of residency training in family medicine v. internship training on professional attitudes and practice patterns.

PubMed Central

Maheux, B; Beaudoin, C; Jacques, A; Lambert, J; Lévesque, A

1992-01-01

OBJECTIVES: To determine whether the professional attitudes and practice patterns of physicians with residency training in family medicine differ from those of generalists with internship training. DESIGN: Mail survey conducted in 1985-86. SETTING: Province of Quebec. PARTICIPANTS: A stratified random sample of French-speaking family and general practitioners who graduated after 1972 (325 physicians with residency training and 304 with internship training) (response rate 82%). MAIN RESULTS: Physicians with residency training were 3 years younger on average than those with internship training, were more likely to be female (38% v. 18%, p less than 0.001) and were more likely to work on a salaried basis in CLSCs (public community health centres) (36% v. 14%, p less than 0.001). Even after these confounding factors were controlled for, physicians with residency training seemed to be more sensitive to the psychosocial aspects of patient care and tended to attach more importance to informing patients about useful materials and resources concerning their health problems. They were not, however, more likely to value health counselling or integrate it in medical practice. CONCLUSION: Our findings provide some evidence that the new requirement that physicians complete a residency in family medicine to obtain medical licensure in general practice in Quebec may foster a more patient-centred approach to health care. PMID:1544077

Impact of study design on recruitment of patients to a primary care trial: an observational time series analysis of the Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA) study.

PubMed

Fletcher, K; Mant, J; Roalfe, A; Hobbs, F D R

2010-12-01

recruitment targets to randomized controlled trials (RCTs) are often not met. Many interventions are used to improve recruitment but there is little empirical evidence on whether these approaches work. to examine whether changes to the design and conduct of a primary care-based RCT were associated with changes in patient recruitment. an observational time series analysis of recruitment to a primary care-based multi-centre RCT of aspirin versus warfarin for stroke prevention, which involved 330 practices. Several changes to the trial protocol and procedures were made over the 4 years of patient recruitment. For each quarter throughout the recruitment period, the recruitment rate per 1000 total population in active practices was calculated. the recruitment target of 930 patients was exceeded. Fluctuations in recruitment rate occurred during the recruitment period. Following protocol changes aimed to reduce clinical workload, there was a significant increase in recruitment during the final 6 months of the study, during a period when there was not a similarly large increase in the total population available. these findings suggest that the conduct of a trial is an important consideration if studies are to recruit successfully. Expanding the number of centres may not be the most effective way to improve recruitment.

Family-centred music therapy to promote social engagement in young children with severe autism spectrum disorder: a randomized controlled study.

PubMed

Thompson, G A; McFerran, K S; Gold, C

2014-11-01

Limited capacity for social engagement is a core feature of autism spectrum disorder (ASD), often evident early in the child's development. While these skills are difficult to train, there is some evidence that active involvement in music-making provides unique opportunities for social interaction between participants. Family-centred music therapy (FCMT) endeavours to support social engagement between child and parent within active music-making, yet the extent of benefits provided is unknown. This study investigated the impacts of FCMT on social engagement abilities. Twenty-three children (36-60 months) with severe ASD received either 16 weeks of FCMT in addition to their early intervention programmes (n = 12), or their early intervention programme only (n = 11). Change in social engagement was measured with standardized parent-report assessments, parent interviews and clinician observation. Intention-to-treat analysis for the Vineland Social Emotional Early Childhood Scale indicated a significant effect in favour of FCMT. Thematic qualitative analysis of the parent interviews showed that the parent-child relationship grew stronger. FCMT improves social interactions in the home and community and the parent-child relationship, but not language skills or general social responsiveness. This study provides preliminary support for the use of FCMT to promote social engagement in children with severe ASD. © 2013 John Wiley & Sons Ltd.

Using a smartphone-based self-management platform to support medication adherence and clinical consultation in Parkinson's disease.

PubMed

Lakshminarayana, Rashmi; Wang, Duolao; Burn, David; Chaudhuri, K Ray; Galtrey, Clare; Guzman, Natalie Valle; Hellman, Bruce; Ben James; Pal, Suvankar; Stamford, Jon; Steiger, Malcolm; Stott, R W; Teo, James; Barker, Roger A; Wang, Emma; Bloem, Bastiaan R; van der Eijk, Martijn; Rochester, Lynn; Williams, Adrian

2017-01-01

The progressive nature of Parkinson's disease, its complex treatment regimens and the high rates of comorbid conditions make self-management and treatment adherence a challenge. Clinicians have limited face-to-face consultation time with Parkinson's disease patients, making it difficult to comprehensively address non-adherence. Here we share the results from a multi-centre (seven centres) randomised controlled trial conducted in England and Scotland to assess the impact of using a smartphone-based Parkinson's tracker app to promote patient self-management, enhance treatment adherence and quality of clinical consultation. Eligible Parkinson's disease patients were randomised using a 1:1 ratio according to a computer-generated random sequence, stratified by centre and using blocks of variable size, to intervention Parkinson's Tracker App or control (Treatment as Usual). Primary outcome was the self-reported score of adherence to treatment (Morisky medication adherence scale -8) at 16 weeks. Secondary outcomes were Quality of Life (Parkinson's disease questionnaire -39), quality of consultation for Parkinson's disease patients ( Patient-centred questionnaire for Parkinson's disease ), impact on non-motor symptoms (Non-motor symptoms questionnaire), depression and anxiety (Hospital anxiety and depression scale) and beliefs about medication (Beliefs about Medication Questionnaire) at 16 weeks. Primary and secondary endpoints were analysed using a generalised linear model with treatment as the fixed effect and baseline measurement as the covariate. 158 patients completed the study (Parkinson's tracker app = 68 and TAU = 90). At 16 weeks Parkinson's tracker app significantly improved adherence, compared to treatment as usual (mean difference: 0.39, 95%CI 0.04-0.74; p  = 0.0304) with no confounding effects of gender, number of comorbidities and age. Among secondary outcomes, Parkinson's tracker app significantly improved patients' perception of quality of consultation (0.15, 95% CI 0.03 to 0.27; p  = 0.0110). The change in non-motor symptoms was -0.82 (95% CI -1.75 to 0.10; p  = 0.0822). 72% of participants in the Parkinson's tracker app group continued to use and engage with the application throughout the 16-week trial period. The Parkinson's tracker app can be an effective and novel way of enhancing self-reported medication adherence and quality of clinical consultation by supporting self-management in Parkinson's disease in patients owning smartphones. Further work is recommended to determine whether the benefits of the intervention are maintained beyond the 16 week study period.

The impact of distance and duration of travel on participation rates and participants’ satisfaction: results from a pilot study at one study centre in Pretest 2 of the German National Cohort

PubMed Central

Schweitzer, Aparna; Akmatov, Manas K; Kindler, Florentina; Kemmling, Yvonne; Kreienbrock, Lothar; Krause, Gérard; Pessler, Frank

2015-01-01

Objectives In this pilot study within the Pretest 2 phase of the German National Cohort, we aimed to (1) test the hypothesis that distance and duration of travel to a study centre may affect participation rates and participants’ satisfaction and (2) to obtain data that would help to select recruitment areas around the study centre Hannover with the greatest projected participation rate for the main study. Setting Mixed urban/suburban environment in Northern Germany with approximately 600 000 inhabitants. 4 recruitment areas with divergent estimated mean distances (range, 7–40 km) and duration of travel to the study centre Hannover were selected. Participants 1050 men and women (ratio, 1:1), aged 20–69 years, were randomly selected from the population registries of the 4 recruitment areas and invited by mail to participate in the Pretest 2 study programme at the study centre Hannover, covering a variety of questionnaire-based and physical assessments. 166 individuals participated (16%). Interventions All 166 participants completed a travel questionnaire containing 5 items relating to travel duration and satisfaction, amounting to a participation rate of 100% in the questionnaire-based part of the study. Results Participation rates in the Pretest 2 programme at the study centre Hannover by area ranged from 11% (area farthest from the study centre, estimated median distance 38 km) to 18% (nearest area, 2 km). The odds of non-participation were highest in the area farthest from the study centre (adjusted OR 2.06; p=0.01; CI 1.28 to 3.32). Nonetheless, 97% of participants were satisfied with travel duration. Conclusions Increasing distance was associated with a lower participation rate. However, acceptance of duration of travel was high, irrespective of distance or duration. Thus, recruiting in farther away locations may select individuals with a greater frustration tolerance for travel to the study centre, perhaps due to a greater interest in participating in health-oriented studies and thus different health-related behaviour. PMID:26297358

The impact of distance and duration of travel on participation rates and participants' satisfaction: results from a pilot study at one study centre in Pretest 2 of the German National Cohort.

PubMed

Schweitzer, Aparna; Akmatov, Manas K; Kindler, Florentina; Kemmling, Yvonne; Kreienbrock, Lothar; Krause, Gérard; Pessler, Frank

2015-08-21

In this pilot study within the Pretest 2 phase of the German National Cohort, we aimed to (1) test the hypothesis that distance and duration of travel to a study centre may affect participation rates and participants' satisfaction and (2) to obtain data that would help to select recruitment areas around the study centre Hannover with the greatest projected participation rate for the main study. Mixed urban/suburban environment in Northern Germany with approximately 600,000 inhabitants. 4 recruitment areas with divergent estimated mean distances (range, 7-40 km) and duration of travel to the study centre Hannover were selected. 1050 men and women (ratio, 1:1), aged 20-69 years, were randomly selected from the population registries of the 4 recruitment areas and invited by mail to participate in the Pretest 2 study programme at the study centre Hannover, covering a variety of questionnaire-based and physical assessments. 166 individuals participated (16%). All 166 participants completed a travel questionnaire containing 5 items relating to travel duration and satisfaction, amounting to a participation rate of 100% in the questionnaire-based part of the study. Participation rates in the Pretest 2 programme at the study centre Hannover by area ranged from 11% (area farthest from the study centre, estimated median distance 38 km) to 18% (nearest area, 2 km). The odds of non-participation were highest in the area farthest from the study centre (adjusted OR 2.06; p=0.01; CI 1.28 to 3.32). Nonetheless, 97% of participants were satisfied with travel duration. Increasing distance was associated with a lower participation rate. However, acceptance of duration of travel was high, irrespective of distance or duration. Thus, recruiting in farther away locations may select individuals with a greater frustration tolerance for travel to the study centre, perhaps due to a greater interest in participating in health-oriented studies and thus different health-related behaviour. 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.

Cognitive task load in a naval ship control centre: from identification to prediction.

PubMed

Grootjen, M; Neerincx, M A; Veltman, J A

Deployment of information and communication technology will lead to further automation of control centre tasks and an increasing amount of information to be processed. A method for establishing adequate levels of cognitive task load for the operators in such complex environments has been developed. It is based on a model distinguishing three load factors: time occupied, task-set switching, and level of information processing. Application of the method resulted in eight scenarios for eight extremes of task load (i.e. low and high values for each load factor). These scenarios were performed by 13 teams in a high-fidelity control centre simulator of the Royal Netherlands Navy. The results show that the method provides good prediction of the task load that will actually appear in the simulator. The model allowed identification of under- and overload situations showing negative effects on operator performance corresponding to controlled experiments in a less realistic task environment. Tools proposed to keep the operator at an optimum task load are (adaptive) task allocation and interface support.

Eye Carduino: A Car Control System using Eye Movements

NASA Astrophysics Data System (ADS)

Kumar, Arjun; Nagaraj, Disha; Louzardo, Joel; Hegde, Rajeshwari

2011-12-01

Modern automotive systems are rapidly becoming highly of transportation, but can be a web integrated media centre. This paper explains the implementation of a vehicle control defined and characterized by embedded electronics and software. With new technologies, the vehicle industry is facing new opportunities and also new challenges. Electronics have improved the performance of vehicles and at the same time, new more complex applications are introduced. Examples of high level applications include adaptive cruise control and electronic stability programs (ESP). Further, a modern vehicle does not have to be merely a means using only eye movements. The EyeWriter's native hardware and software work to return the co-ordinates of where the user is looking. These co-ordinates are then used to control the car. A centre-point is defined on the screen. The higher on the screen the user's gaze is, the faster the car will accelerate. Braking is done by looking below centre. Steering is done by looking left and right on the screen.

Magnesium in cardioplegia: Is it necessary?

PubMed Central

Shakerinia, Tooraj; Ali, Idris M.; Sullivan, John A.P.

1996-01-01

Objective To study the effectiveness of magnesium in cardioplegic solution in preventing postoperative arrhythmias and perioperative ischemia. Design Randomized, control study. Setting The cardiovascular surgery division of a major referral centre for the maritime provinces of Canada. Patients Fifty patients scheduled to undergo coronary artery bypass who had a normal ejection fraction, normal preoperative serum magnesium level and no history of atrial or ventricular arrhythmia were randomized into two groups of 25 patients. One group received magnesium sulfate (15 mmol/L) in the cardioplegic solution (group 1), the other (control) group did not receive magnesium sulfate in the cardioplegic solution (group 2). Intervention Coronary artery bypass grafting during which myocardial protection was provided by intermittent cold blood cardioplegia. Outcome Measures Postoperative serum magnesium levels, cardiac-related death, infarction and arrhythmias. Results All group 2 patients had a lower postoperative serum magnesium level than group 1 patients. There were no cardiac-related deaths in either group. More group 2 patients had ischemic electrocardiographic changes than group 1 patients (p < 0.03). Non-Q-wave myocardial infarction occurred in two patients (one in each group). Eight patients in group 2 had atrial fibrillation compared with five patients in group 1. Ventricular ectopia occurred significantly (p < 0.01) more frequently in group 2 than in group 1. Conclusion The addition of magnesium to the cardioplegic solution is beneficial in reducing the incidence of perioperative ischemia and ventricular arrhythmia in patients who undergo coronary bypass grafting. PMID:8857989

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study

PubMed Central

Juhász, Márk; Nagy, Viktor L.; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F.

2014-01-01

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m−1 gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. PMID:25008086

Botulinum toxin A injections and occupational therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial.

PubMed

Lidman, Git; Nachemson, Ann; Peny-Dahlstrand, Marie; Himmelmann, Kate

2015-08-01

To investigate the effects of repeated botulinum toxin A (BoNT-A) injections combined with occupational therapy, including a splint, compared with occupational therapy alone on hand function in children with unilateral spastic cerebral palsy (USCP), in all International Classification of Functioning, Disability and Health (ICF) domains. This was a randomized controlled study, population-based and evaluator-blinded for primary outcome (October 2004 to September 2010). Twenty children (14 males; median age 3y 1mo) with USCP, recruited at a rehabilitation centre in Sweden, were assigned to one of two parallel groups using concealed allocation. In the course of one year, 10 children received occupational therapy, while 10 received repeated BoNT-A plus occupational therapy (BoNT-A/OT). Primary outcome (Assisting Hand Assessment [AHA]), and secondary outcome measures (range of movement [ROM], and Canadian Occupational Performance Measure), were measured at baseline, 3, 6, 9, and 12 months. AHA revealed a superior effect in the BoNT-A/OT group at 12 months: 6 out of 10 improved compared with 1 out of 10 in the occupational therapy group (p<0.03). A 95% Peskun exact confidence interval for the difference in proportions is given as 0.01 to 0.81. Secondary outcomes improved in both groups. Repeated BoNT-A/OT appeared superior to occupational therapy alone for bimanual performance in young children with USCP. Active ROM and goal performance improved in both groups. © 2015 Mac Keith Press.

Effectiveness of aquatic exercises compared to patient-education on health status in individuals with knee osteoarthritis: a randomized controlled trial.

PubMed

Taglietti, Marcelo; Facci, Ligia Maria; Trelha, Celita Salmaso; de Melo, Fernanda Cristiane; da Silva, Daniela Wosiack; Sawczuk, Geovane; Ruivo, Thamires Marques; de Souza, Thaisley Barbosa; Sforza, Chiarella; Cardoso, Jefferson Rosa

2018-06-01

To compare the effectiveness of aquatic exercises with patient-education in individuals with knee osteoarthritis. Randomized controlled trial with blinded assessor and intention-to-treat analysis. Aquatic Physiotherapy Centre and Primary Health Care Unit. A total of 60 patients, aged 68.3 (SD = 4.8) with clinical symptoms and radiographic grading (Kellgren-Lawrence 1-4) of knee osteoarthritis were included. An eight-week treatment protocol of aquatic exercise ( n = 31) (16 individual sessions, twice a week) and an educational program (group sessions, once a week) ( n = 29). Before, after eight-week intervention, and a three-month follow-up with results for the following outcome measures: pain, function, quality of life, functional mobility, and depression. At the end of treatment, the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) functional capacity values reduced in favour of the aquatic exercise group for both the total score MD (mean difference) = -14.2; 95% CI (confidence interval) (-18; -10.5), P = 0.04 and the pain domain MD = -3.8 points; 95% CI (-8.71; -1), P = 0.021. The total score also reduced in the follow-up: MD = -12.3 points; 95% CI (-24.7; -6.1), P = 0.017. No differences were found for the outcomes functional mobility or depression. Aquatic exercise improved pain and function after eight weeks, and function at the three-month follow-up compared to the patient-education program.

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

PubMed

Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Generation of (F+2)_AH Centres in Sodium Ion Doped KCl:CO^{2-3}

NASA Astrophysics Data System (ADS)

Diaf, M.; Chihi, I.; Hamaïdia, A.; Akrmi, El.

1996-01-01

We demonstrate that (F+2)AH centres of KCl may be obtained from crystals doped with K{2}CO{3} and NaCl, grown by the Czochralski method in open atmosphere. The optical properties of (F+2)AH centres thus produced are exactly the same as those of (F+2)AH centres prepared by the usual technique, which involves superoxide doping and a controlled atmosphere. Nous montrons que les centres (F+2)AH de KCl peuvent être obtenus à partir de cristaux dopés par K{2}CO{3} et NaCl, fabriqués par la méthode de Czochralski à l'air libre. Les propriétés optiques des centres (F+2)AH ainsi produits sont exactement les mêmes que celles des centres (F+2)AH préparés par la technique habituelle, qui comporte le dopage par un superoxyde et l'emploi d'une atmosphère contrôlée.

Effectiveness of nickel-titanium springs vs elastomeric chains in orthodontic space closure: A systematic review and meta-analysis.

PubMed

Mohammed, H; Rizk, M Z; Wafaie, K; Almuzian, M

2018-02-01

The aim of this study is to explore the effectiveness of nickel titanium closing springs (NiTi-CS) and elastomeric power chains (EPC) in orthodontic space closure and to assess the adverse periodontal effects, cost efficiency and patient-centred outcomes between both of these methods. An electronic search of online databases (Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Scopus, LILACS and Web of Science), reference lists and grey literature as well as hand search were conducted without language restriction up to November/2017. Two authors blindly and in duplicate were involved in study selection, quality assessment and the extraction of data. Only randomized clinical trials (RCTs) were included. The quality of the studies was assessed using the Cochrane Collaboration's risk of bias tool. 95% confidence intervals and mean difference for continuous data were calculated. A meta-analysis that generated a random-effect model for the comparable outcomes was conducted, and heterogeneity was measured using I 2 statistic. Of 187 records, 4 RCTs met the criteria and were included in the quantitative synthesis featuring 290 test quadrants. Faster space closure with NiTi-CS was observed with a mean difference of (0.20 mm/month, 95% CI: 0.12 to 0.28). Loss of anchorage appears to be similar within both groups when synthesized qualitatively. With exception to anchorage loss, secondary outcomes could not be investigated in the included trials. There is a moderate quality of evidence suggesting a faster orthodontic space closure with the NiTi-CS when compared to EPC. A comparable amount of anchorage loss was observed regardless of the utilized method of space closure. Further high-quality RCTs with parallel-groups, reporting on the adverse effects and patient-centred values, are recommended. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Screening versus routine practice in detection of atrial fibrillation in patients aged 65 or over: cluster randomised controlled trial

PubMed Central

Fitzmaurice, David A; Jowett, Sue; Mant, Jonathon; Murray, Ellen T; Holder, Roger; Raftery, J P; Bryan, S; Davies, Michael; Lip, Gregory Y H; Allan, T F

2007-01-01

Objectives To assess whether screening improves the detection of atrial fibrillation (cluster randomisation) and to compare systematic and opportunistic screening. Design Multicentred cluster randomised controlled trial, with subsidiary trial embedded within the intervention arm. Setting 50 primary care centres in England, with further individual randomisation of patients in the intervention practices. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practices. Interventions Patients in intervention practices were randomly allocated to systematic screening (invitation for electrocardiography) or opportunistic screening (pulse taking and invitation for electrocardiography if the pulse was irregular). Screening took place over 12 months in each practice from October 2001 to February 2003. No active screening took place in control practices. Main outcome measure Newly identified atrial fibrillation. Results The detection rate of new cases of atrial fibrillation was 1.63% a year in the intervention practices and 1.04% in control practices (difference 0.59%, 95% confidence interval 0.20% to 0.98%). Systematic and opportunistic screening detected similar numbers of new cases (1.62% v 1.64%, difference 0.02%, −0.5% to 0.5%). Conclusion Active screening for atrial fibrillation detects additional cases over current practice. The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography. Trial registration Current Controlled Trials ISRCTN19633732. PMID:17673732

Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial

PubMed Central

Østergaard, Lars; Børrestad, Line A B; Tarp, Jakob; Andersen, Lars Bo

2012-01-01

Objectives To investigate whether bicycling to school improves cardiometabolic risk factor profile and cardiorespiratory fitness among children. Design Prospective, blinded, randomised controlled trial. Setting Single centre study in Odense, Denmark Participants 43 children previously not bicycling to school were randomly allocated to control group (n=20) (ie, no change in lifestyle) or intervention group (ie, bicycling to school) (n=23). Primary and secondary outcome measures Change in cardiometabolic risk factor score and change in cardiorespiratory fitness. Results All participants measured at baseline returned at follow-up. Based upon intention-to-treat (ITT) analyses, clustering of cardiometabolic risk factors was lowered by 0.58 SD (95% CI −1.03 to −0.14, p=0.012) in the bicycling group compared to the control group. Cardiorespiratory fitness (l O2/min) per se did not increase significantly more in the intervention than in the control group (β=0.0337, 95% CI −0.06 to 0.12, p=0.458). Conclusions Bicycling to school counteracted a clustering of cardiometabolic risk factors and should thus be recognised as potential prevention of type 2 diabetes mellitus and cardiovascular disease (CVD). The intervention did, however, not elicit a larger increase in cardiorespiratory fitness in the intervention group as compared with the control group. Trial registration Registered at http://www.clinicaltrials.gov (NCT01236222). PMID:23117560

Defibrotide for prophylaxis of hepatic veno-occlusive disease in paediatric haemopoietic stem-cell transplantation: an open-label, phase 3, randomised controlled trial.

PubMed

Corbacioglu, Selim; Cesaro, Simone; Faraci, Maura; Valteau-Couanet, Dominique; Gruhn, Bernd; Rovelli, Attilio; Boelens, Jaap J; Hewitt, Annette; Schrum, Johanna; Schulz, Ansgar S; Müller, Ingo; Stein, Jerry; Wynn, Robert; Greil, Johann; Sykora, Karl-Walter; Matthes-Martin, Susanne; Führer, Monika; O'Meara, Anne; Toporski, Jacek; Sedlacek, Petr; Schlegel, Paul G; Ehlert, Karoline; Fasth, Anders; Winiarski, Jacek; Arvidson, Johan; Mauz-Körholz, Christine; Ozsahin, Hulya; Schrauder, Andre; Bader, Peter; Massaro, Joseph; D'Agostino, Ralph; Hoyle, Margaret; Iacobelli, Massimo; Debatin, Klaus-Michael; Peters, Christina; Dini, Giorgio

2012-04-07

Hepatic veno-occlusive disease is a leading cause of morbidity and mortality after haemopoietic stem-cell transplantation (HSCT). We aimed to assess whether defibrotide can reduce the incidence of veno-occlusive disease in this setting. In our phase 3 open-label, randomised controlled trial, we enrolled patients at 28 European university hospitals or academic medical centres. Eligible patients were younger than 18 years, had undergone myeloablative conditioning before allogeneic or autologous HSCT, and had one or more risk factor for veno-occlusive disease based on modified Seattle criteria. We centrally assigned eligible participants on the basis of a computer-generated randomisation sequence (1:1), stratified by centre and presence of osteopetrosis, to receive intravenous defibrotide prophylaxis (treatment group) or not (control group). The primary endpoint was incidence of veno-occlusive disease by 30 days after HSCT, adjudicated by a masked, independent review committee, in eligible patients who consented to randomisation (intention-to-treat population), and was assessed with a competing risk approach. Patients in either group who developed veno-occlusive disease received defibrotide for treatment. We assessed adverse events to 180 days after HSCT in all patients who received allocated prophylaxis. This trial is registered with ClinicalTrials.gov, number NCT00272948. Between Jan 25, 2006, and Jan 29, 2009, we enrolled 356 eligible patients to the intention-to-treat population. 22 (12%) of 180 patients randomly allocated to the defibrotide group had veno-occlusive disease by 30 days after HSCT compared with 35 (20%) of 176 controls (risk difference -7·7%, 95% CI -15·3 to -0·1; Z test for competing risk analysis p=0·0488; log-rank test p=0·0507). 154 (87%) of 177 patients in the defibrotide group had adverse events by day 180 compared with 155 (88%) of 176 controls. Defibrotide prophylaxis seems to reduce incidence of veno-occlusive disease and is well tolerated. Thus, such prophylaxis could present a useful clinical option for this serious complication of HSCT. Gentium SpA, European Group for Blood and Marrow Transplantation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Nurses' willingness to take care of people living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS)--does a teaching intervention make a difference?

PubMed

Mockiene, Vida; Suominen, Tarja; Välimäki, Maritta; Razbadauskas, Arturas; Caplinskas, Saulius; Martinkenas, Arvydas

2011-08-01

The aim of this study is to describe the impact of an education intervention programme on nurses' willingness to care for HIV-positive people in Lithuania. The study utilizes a randomized controlled trial design (RCT). The total sample comprises 185 nurses working in medical, surgical and gynaecological units, and primary health care centres from the same hospital areas in three Lithuanian hospitals. The data were analyzed using SPSS 12.0 and descriptive statistics. Our educational intervention did not have an impact on the nurses' willingness to take care of people living with HIV (PLHIV), as their level of willingness was high already before the education intervention. Further research on this issue is needed to try to understand the forces acting on our nursing staff in order to ensure appropriate care for PLHIV. Copyright © 2010 Elsevier Ltd. All rights reserved.

Evaluation of the clinical effect of an on-line course for community nurses on post-partum emotional distress: a community-based longitudinal time-series quasi-experiment.

PubMed

Thome, Marga; Orlygsdottir, Brynja; Elvarsson, Bjarki Thor

2012-09-01

About 14% of Icelandic women suffer post-partum from frequent depressive symptoms, and of those, 12% also report a high degree of parenting stress. Education of nurses and midwives on post-partum distress is crucial in reducing its degree. The purpose of the study is to evaluate the clinical effect of an on-line course for community nurses on post-partum emotional distress. A community-based, longitudinal, time-series quasi-experiment was conducted in four stages from 2001 to 2005. Mothers attending 16 health centres throughout Iceland and scoring ≥ 12 on the Edinburgh Postnatal Depression Scale (EPDS) at the 9th week post-partum were eligible to participate. Health centres were divided into experimental (EHC) and control centres (CHC), and control centres were crossed over to experimental centres the following year and new control centres recruited. Nurses at EHC attended an on-line course on post-partum emotional distress. Participating mothers answered the EPDS; the Parenting Stress Index/Short form and the Fatigue Scale. Nursing diagnoses and interventions were recorded at all study centres. Of the women who were eligible (n = 163), 57% (n = 93) participated. At baseline, 9 weeks post-partum, there were no significant differences between groups of women in the rate of depressive symptoms, fatigue or parenting stress. Women in all groups improved on all distress indicators over time; however, those from the EHC improved statistically and clinically significantly more on depressive symptoms than those from the CHC. Documentation of particular nursing diagnoses and interventions was significantly more frequent at the EHC, but referrals to specialists were significantly less frequent. On-line education for nurses on post-partum emotional distress is feasible and is related to improvement in post-partum depressive symptoms. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

The impact of restorative treatment on tooth loss prevention.

PubMed

Caldas Junior, Arnaldo de França; Silveira, Renata Cimões Jovino; Marcenes, Wagner

2003-01-01

A cross-sectional study was carried out to analyze tooth loss resulting from caries in relation to the number of times the extracted tooth had been restored, the type of caries diagnosed (primary or secondary), and socioeconomic indicators of patients from the city of Recife, Brazil. Ten public health centres and ten centres associated with health insurance companies were randomly selected. The size of the sample was calculated using a standard error of 2.5%. A confidence interval of 95% and a 50% prevalence of reasons for extractions were used for calculating the sample. The minimum size of the sample for meeting these requirements was 381 patients. Patients were randomly selected from the list of adults registered at each centre. A total of 410 patients were invited to take part in the study. The response rate was 100%, but 6 patients were excluded due to incompleteness of data in the questionnaire applied. An assessment was made to obtain the number of decayed, missing or filled teeth (DMFT index) and the reasons for extraction. The results showed a highly significant (p < 0.001) relationship between the number of times the tooth indicated for extraction had been restored and the reason for extraction being caries. Furthermore, the majority of teeth extracted due to caries had been restored two or more times. A highly statistically significant association was also observed between one indicator of use of dental services (F/DMFT) and extraction due to caries (p < 0.001). The findings questioned the belief that tooth loss can be prevented in the general population by merely providing restorative treatment.

Can access to spirometry in asthma education centres influence the referral rate by primary physicians for education?

PubMed Central

Labrecque, M; Lavallée, M; Beauchesne, MF; Cartier, A; Boulet, LP

2006-01-01

BACKGROUND AND OBJECTIVES: Asthma remains uncontrolled in a large number of asthmatic patients. Recent surveys have shown that a minority of asthmatic patients are referred to asthma educators. The objective of the present study was to assess the influence of increased access to spirometry in asthma education centres (AECs) on the rate of patient referrals to these centres by general practitioners. METHODS: A one-year, prospective, randomized, multicentric, parallel group study was conducted over two consecutive periods of six months each, with added spirometry being offered in the second six-month period to the experimental group. Ten AECs were enrolled in the project. An advertisement describing the AECs’ services was sent by mail to a total of 303 general practitioners at the start of each period, inviting them to refer their patients. Measures of the frequency of medical referrals to the AECs were assessed for each period. RESULTS: The group of AECs randomly selected for spirometry in the second six-month period received 48 medical referrals during the first period and 32 during the second one, following proposed spirometry. AECs that had not offered spirometry received five referrals during the first period and seven during the second period. One AEC withdrew a few weeks after the study began and others encountered administrative problems, reducing their ability to provide interventions. CONCLUSIONS: Referral to AECs is not yet integrated into the primary care of asthma and offering more rapid access to spirometry in the AECs does not seem to be a significant incentive for such referrals. PMID:17149461

Can access to spirometry in asthma education centres influence the referral rate by primary physicians for education?

PubMed

Labrecque, M; Lavallée, M; Beauchesne, M F; Cartier, A; Boulet, L P

2006-01-01

Asthma remains uncontrolled in a large number of asthmatic patients. Recent surveys have shown that a minority of asthmatic patients are referred to asthma educators. The objective of the present study was to assess the influence of increased access to spirometry in asthma education centres (AECs) on the rate of patient referrals to these centres by general practitioners. A one-year, prospective, randomized, multicentric, parallel group study was conducted over two consecutive periods of six months each, with added spirometry being offered in the second six-month period to the experimental group. Ten AECs were enrolled in the project. An advertisement describing the AECs' services was sent by mail to a total of 303 general practitioners at the start of each period, inviting them to refer their patients. Measures of the frequency of medical referrals to the AECs were assessed for each period. The group of AECs randomly selected for spirometry in the second six-month period received 48 medical referrals during the first period and 32 during the second one, following proposed spirometry. AECs that had not offered spirometry received five referrals during the first period and seven during the second period. One AEC withdrew a few weeks after the study began and others encountered administrative problems, reducing their ability to provide interventions. Referral to AECs is not yet integrated into the primary care of asthma and offering more rapid access to spirometry in the AECs does not seem to be a significant incentive for such referrals.

Knowledge and Implementation of Tertiary Institutions' Social Health Insurance Programme (TISHIP) in Nigeria: a case study of Nnamdi Azikiwe University, Awka.

PubMed

Anetoh, Maureen Ugonwa; Jibuaku, Chiamaka Henrietta; Nduka, Sunday Odunke; Uzodinma, Samuel Uchenna

2017-01-01

Tertiary Institutions' Social Health Insurance Programme (TISHIP) is an arm of the National Health Insurance Scheme (NHIS), which provides quality healthcare to students in Nigerian higher institutions. The success of this scheme depends on the students' knowledge and awareness of its existence as well as the level of its implementation by healthcare providers. This study was therefore designed to assess students' knowledge and attitude towards TISHIP and its implementation level among health workers in Nnamdi Azikiwe University Medical Centre. Using a stratified random sampling technique, 420 undergraduate students of Nnamdi Azikiwe University, Awka were assessed on their level of awareness and general assessment of TISHIP through an adapted and validated questionnaire instrument. The level of implementation of the scheme was then assessed among 50 randomly selected staff of the University Medical Center. Data collected were analyzed using Statistical Package for Social Sciences (SPSS) version 20 software. Whereas the students in general, showed a high level of TISHIP awareness, more than half of them (56.3%) have never benefited from the scheme with 52.8% showing dissatisfaction with the quality of care offered with the scheme. However, an overwhelming number of the students (87.9%) opined that the scheme should continue. On the other hand, the University Medical Centre staff responses showed a satisfactory scheme implementation. The study found satisfactory TISHIP awareness with poor attitude among Nnamdi Azikiwe University students. Furthermore, the University Medical Centre health workers showed a strong commitment to the objectives of the scheme.

F-actin mechanics control spindle centring in the mouse zygote

NASA Astrophysics Data System (ADS)

Chaigne, Agathe; Campillo, Clément; Voituriez, Raphaël; Gov, Nir S.; Sykes, Cécile; Verlhac, Marie-Hélène; Terret, Marie-Emilie

2016-01-01

Mitotic spindle position relies on interactions between astral microtubules nucleated by centrosomes and a rigid cortex. Some cells, such as mouse oocytes, do not possess centrosomes and astral microtubules. These cells rely only on actin and on a soft cortex to position their spindle off-centre and undergo asymmetric divisions. While the first mouse embryonic division also occurs in the absence of centrosomes, it is symmetric and not much is known on how the spindle is positioned at the exact cell centre. Using interdisciplinary approaches, we demonstrate that zygotic spindle positioning follows a three-step process: (1) coarse centring of pronuclei relying on the dynamics of an F-actin/Myosin-Vb meshwork; (2) fine centring of the metaphase plate depending on a high cortical tension; (3) passive maintenance at the cell centre. Altogether, we show that F-actin-dependent mechanics operate the switch between asymmetric to symmetric division required at the oocyte to embryo transition.

Sustainability of a water, sanitation and hygiene education project in rural Bangladesh: a 5-year follow-up.

PubMed Central

Hoque, B. A.; Juncker, T.; Sack, R. B.; Ali, M.; Aziz, K. M.

1996-01-01

An integrated water supply, sanitation and hygiene (WSH) education intervention project was run by the International Centre for Diarrhoeal Disease Research, Bangladesh, over the period 1983-87. In the intervention area the project provided handpumps, pit latrines, and hygiene education to about 800 households. The control population did not receive any interventions, but had access to the usual government and private WSH facilities. After 1987 no external support was provided to maintain these provisions. A cross-sectional follow-up survey, which was carried out in 1992, involved about 500 randomly selected households from the intervention and control areas. In 1992 about 82% of the pumps were still in good functional condition and of these, 94% had been functioning well in 1987. Fewer latrines were functional in 1992 (64%) than at the end of 1987 (93%). In the former intervention area about 84% of the adults were using sanitary latrines in 1992 compared with only 7% in the control area. Knowledge related to disease transmission, however, was poor and similar in both areas. People claimed that they used the WSH facilities to improve the quality of their lives. The prevalence of diarrhoeal diseases in the 1992 survey among the control population was about twice that among those in the intervention area. PMID:8823966