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.

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.

[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.

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.).

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

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.

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.

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.

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.

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.

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

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.

Conducting a paediatric multi-centre RCT with an industry partner: challenges and lessons learned.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2012-11-01

There are many benefits of multi-centred research including large sample sizes, statistical power, timely recruitment and generalisability of results. However, there are numerous considerations when planning and implementing a multi-centred study. This article reviews the challenges and successes of planning and implementing a multi-centred prospective randomised control trial involving an industry partner. The research investigated the impact on psychosocial functioning of a cosmetic camouflage product for children and adolescents with burn scarring. Multi-centred studies commonly have many stakeholders. Within this study, six Australian and New Zealand paediatric burn units as well as an industry partner were involved. The inclusion of an industry partner added complexities as they brought different priorities and expectations to the research. Further, multifaceted ethical and institutional approval processes needed to be negotiated. The challenges, successes, lessons learned and recommendations from this study regarding Australian and New Zealand ethics and research governance approval processes, collaboration with industry partners and the management of differing expectations will be outlined. Recommendations for future multi-centred research with industry partners include provision of regular written reports for the industry partner; continual monitoring and prompt resolution of concerns; basic research practices education for industry partners; minimisation of industry partner contact with participants; clear roles and responsibilities of all stakeholders and utilisation of single ethical review if available. © 2012 The Authors. Journal of Paediatrics and Child Health © 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

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.

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.

'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

PubMed

Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

2015-11-06

'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. 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

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).

'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.

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.

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.

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

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.

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.

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

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.

Self Assessment and Student-Centred Learning

ERIC Educational Resources Information Center

McDonald, Betty

2012-01-01

This paper seeks to show how self assessment facilitates student-centred learning (SCL) and fills a gap in the literature. Two groups of students were selected from a single class in a tertiary educational institution. The control group of 25 was selected randomly by the tossing of an unbiased coin (heads = control group). They were trained in the…

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.

Effects of person-centred care on health outcomes-A randomized controlled trial in patients with acute coronary syndrome.

PubMed

Pirhonen, Laura; Olofsson, Elisabeth Hansson; Fors, Andreas; Ekman, Inger; Bolin, Kristian

2017-02-01

To study the effects of person-centred care provided to patients with acute coronary syndrome, using four different health-related outcome measures. Also, to examine the performance of these outcomes when measuring person-centred care. The data used in this study consists of primary data from a multicentre randomized parallel group, controlled intervention study for patients with acute coronary syndrome at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention and control group consisted of 94 and 105 patients, respectively. The effect of the intervention on health-related outcomes was estimated, controlling for socio-economic and disease-related variables. Patients in the intervention group reported significantly higher general self-efficacy than those in the control group six months after intervention start-up. Moreover, the intervention group returned to work in a greater extent than controls; their physical activity level had increased more and they had a higher EQ-5D score, meaning higher health-related quality of life. These latter effects are not significant but are all pointing towards the beneficial effects of person-centred care. All the effects were estimated while controlling for important socio-economic and disease-related variables. The effectiveness of person-centred care varies between different outcomes considered. A statistically significant beneficial effect was found for one of the four outcome measures (self-efficacy). The other measures all captured beneficial, but not significant, effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

[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.

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

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.

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.

Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study.

PubMed

Karasu, Ayça Utkan; Batur, Elif Balevi; Karataş, Gülçin Kaymak

2018-05-08

To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Assessment Scale for Stroke Patients, Timed Up and Go Test and Static Balance Index. Secondary outcome measures were postural sway, as assessed with Emed-X, Functional Independence Measure Transfer and Ambulation Scores. An evaluator who was blinded to the groups made assessments immediately before (baseline), immediately after (post-treatment), and 4 weeks after completion of the study (follow-up). Group-time interaction was significant in the Berg Balance Scale, Functional Reach Test, anteroposterior and mediolateral centre of pressure displacement with eyes open, anteroposterior centre of pressure displacement with eyes closed, centre of pressure displacement during weight shifting to affected side, to unaffected side and total centre of pressure displacement during weight shifting. Demonstrating significant group-time interaction in those parameters suggests that, while both groups exhibited significant improvement, the experimental group showed greater improvement than the control group. Virtual reality exercises with the Nintendo Wii system could represent a useful adjunctive therapy to traditional treatment to improve static and dynamic balance in stroke patients.

Optimal service using Matlab - simulink controlled Queuing system at call centers

NASA Astrophysics Data System (ADS)

Balaji, N.; Siva, E. P.; Chandrasekaran, A. D.; Tamilazhagan, V.

2018-04-01

This paper presents graphical integrated model based academic research on telephone call centres. This paper introduces an important feature of impatient customers and abandonments in the queue system. However the modern call centre is a complex socio-technical system. Queuing theory has now become a suitable application in the telecom industry to provide better online services. Through this Matlab-simulink multi queuing structured models provide better solutions in complex situations at call centres. Service performance measures analyzed at optimal level through Simulink queuing model.

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

PubMed Central

2010-01-01

Background Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and pre-operative fluid therapy in high-risk surgical patients undergoing major elective surgery. Methods/Design A multi-centre randomised controlled trial with a 2 * 2 factorial design. The first randomisation is to pre-operative fluid therapy or standard regimen and the second randomisation is to routine intensive care versus high dependency care during the early post-operative period. We intend to recruit 204 patients undergoing major elective and urgent abdominal and thoraco-abdominal surgery who fulfil high-risk surgical criteria. The primary outcome for the comparison of level of care is cost-effectiveness at six months and for the comparison of fluid optimisation is the number of hospital days after surgery. Discussion We believe that the results of this study will be invaluable in determining the future care and clinical resource utilisation for this group of patients and thus will have a major impact on clinical practice. Trial Registration Trial registration number - ISRCTN32188676 PMID:20398378

Cardiovascular risk factors in multi-ethnic middle school students: the HEALTHY primary prevention trial.

PubMed

Willi, S M; Hirst, K; Jago, R; Buse, J; Kaufman, F; El Ghormli, L; Bassin, S; Elliot, D; Hale, D E

2012-06-01

The objective of this study was to examine the effects of an integrated, multi-component, school-based intervention programme on cardiovascular disease (CVD) risk factors among a multi-ethnic cohort of middle school students. HEALTHY was a cluster randomized, controlled, primary prevention trial. Middle school was the unit of randomization and intervention. Half of the schools were assigned to an intervention programme consisting of changes in the total school food environment and physical education classes, enhanced by educational outreach and behaviour change activities and promoted by a social marketing campaign consisting of reinforcing messages and images. Outcome data reported (anthropometrics, blood pressure and fasting lipid levels) were collected on a cohort of students enrolled at the start of 6th grade (∼11-12 years old) and followed to end of 8th grade (∼13-14 years old). Forty-two middle schools were enrolled at seven field centres; 4363 students provided both informed consent and CVD data at baseline and end of study. The sample was 52.7% female, 54.5% Hispanic, 17.6% non-Hispanic Black, 19.4% non-Hispanic White and 8.5% other racial/ethnic combinations, and 49.6% were categorized as overweight or obese (body mass index ≥ 85th percentile) at baseline. A significant intervention effect was detected in the prevalence of hypertension in non-Hispanic Black and White males. The intervention produced no significant changes in lipid levels. The prevalence of some CVD risk factors is high in minority middle school youth, particularly males. A multi-component, school-based programme achieved only modest reductions in these risk factors; however, promising findings occurred in non-Hispanic Black and White males with hypertension. © 2012 The Authors. Pediatric Obesity © 2012 International Association for the Study of Obesity.

[The role of CCLINs in the event of an epidemic of multi-drug and highly resistant bacteria].

PubMed

Landriu, Danièle

2015-01-01

The management of epidemics of multi-drug and highly resistant bacteria must be based on a structured organisation. Within each region it requires the expertise of centres for the interregional coordination of nosocomial infection control (CCLINs) and their regional branches of nosocomial infection control (Arlin) which support hospitals in reporting these types of epidemics. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Multi-port versus single-port cholecystectomy: results of a multi-centre, randomised controlled trial (MUSIC trial).

PubMed

Arezzo, Alberto; Passera, Roberto; Bullano, Alberto; Mintz, Yoav; Kedar, Asaf; Boni, Luigi; Cassinotti, Elisa; Rosati, Riccardo; Fumagalli Romario, Uberto; Sorrentino, Mario; Brizzolari, Marco; Di Lorenzo, Nicola; Gaspari, Achille Lucio; Andreone, Dario; De Stefani, Elena; Navarra, Giuseppe; Lazzara, Salvatore; Degiuli, Maurizio; Shishin, Kirill; Khatkov, Igor; Kazakov, Ivan; Schrittwieser, Rudolf; Carus, Thomas; Corradi, Alessio; Sitzman, Guenther; Lacy, Antonio; Uranues, Selman; Szold, Amir; Morino, Mario

2017-07-01

Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC). This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727). The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

PubMed Central

2013-01-01

Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder. PMID:23289935

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

2017-03-01

To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. Multicentre, open, cluster randomised controlled trial. Obstetric units in the Netherlands. Women with a singleton pregnancy beyond 24 weeks of gestation. Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training. Intention-to-treat analyses were performed at the cluster level, including a measurement 1 year prior to the intervention. Primary outcome was a composite outcome of obstetric complications during the first year post-intervention, including low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischaemic encephalopathy. Maternal and perinatal mortality were also registered. Each study group included 12 units with a median unit size of 1224 women, combining for a total of 28 657 women. In total, 471 medical professionals received the training course. The composite outcome of obstetric complications did not differ between study groups [odds ratio (OR) 1.0, 95% confidence interval (CI) 0.80-1.3]. Team training reduced trauma due to shoulder dystocia (OR 0.50, 95% CI 0.25-0.99) and increased invasive treatment for severe postpartum haemorrhage (OR 2.2, 95% CI 1.2-3.9) compared with no intervention. Other outcomes did not differ between study groups. A 1-day, off-site, simulation-based team training, focusing on teamwork skills, did not reduce a composite of obstetric complications. 1-day, off-site, simulation-based team training did not reduce a composite of obstetric complications. © 2016 Royal College of Obstetricians and Gynaecologists.

Design and baseline characteristics of the Food4Me study: a web-based randomised controlled trial of personalised nutrition in seven European countries.

PubMed

Celis-Morales, Carlos; Livingstone, Katherine M; Marsaux, Cyril F M; Forster, Hannah; O'Donovan, Clare B; Woolhead, Clara; Macready, Anna L; Fallaize, Rosalind; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Kolossa, Silvia; Hartwig, Kai; Tsirigoti, Lydia; Lambrinou, Christina P; Moschonis, George; Godlewska, Magdalena; Surwiłło, Agnieszka; Grimaldi, Keith; Bouwman, Jildau; Daly, E J; Akujobi, Victor; O'Riordan, Rick; Hoonhout, Jettie; Claassen, Arjan; Hoeller, Ulrich; Gundersen, Thomas E; Kaland, Siv E; Matthews, John N S; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Gibney, Eileen R; Brennan, Lorraine; Walsh, Marianne C; Lovegrove, Julie A; Alfredo Martinez, J; Saris, Wim H M; Daniel, Hannelore; Gibney, Mike; Mathers, John C

2015-01-01

Improving lifestyle behaviours has considerable potential for reducing the global burden of non-communicable diseases, promoting better health across the life-course and increasing well-being. However, realising this potential will require the development, testing and implementation of much more effective behaviour change interventions than are used conventionally. Therefore, the aim of this study was to conduct a multi-centre, web-based, proof-of-principle study of personalised nutrition (PN) to determine whether providing more personalised dietary advice leads to greater improvements in eating patterns and health outcomes compared to conventional population-based advice. A total of 5,562 volunteers were screened across seven European countries; the first 1,607 participants who fulfilled the inclusion criteria were recruited into the trial. Participants were randomly assigned to one of the following intervention groups for a 6-month period: Level 0-control group-receiving conventional, non-PN advice; Level 1-receiving PN advice based on dietary intake data alone; Level 2-receiving PN advice based on dietary intake and phenotypic data; and Level 3-receiving PN advice based on dietary intake, phenotypic and genotypic data. A total of 1,607 participants had a mean age of 39.8 years (ranging from 18 to 79 years). Of these participants, 60.9 % were women and 96.7 % were from white-European background. The mean BMI for all randomised participants was 25.5 kg m(-2), and 44.8 % of the participants had a BMI ≥ 25.0 kg m(-2). Food4Me is the first large multi-centre RCT of web-based PN. The main outcomes from the Food4Me study will be submitted for publication during 2015.

A guide to multi-centre ethics for surgical research in Australia and New Zealand.

PubMed

Boult, Maggi; Fitzpatrick, Kate; Maddern, Guy; Fitridge, Robert

2011-03-01

This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

The Contribution of Command and Control to Unity of Effort

DTIC Science & Technology

2002-09-01

Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia Author contact: 6 Frank Street St Morris SA 5068... Mawson Lakes, South Australia, , 8. PERFORMING ORGANIZATION REPORT NUMBER 9. SPONSORING/MONITORING AGENCY NAME(S) AND ADDRESS(ES) 10. SPONSOR/MONITOR’S...Noel Sproles PhD Systems Engineering and Evaluation Centre University of South Australia Mawson Lakes, South Australia While joint and multi-national

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

PubMed Central

Voigt-Radloff, Sebastian; Graff, Maud; Leonhart, Rainer; Schornstein, Katrin; Vernooij-Dassen, Myrra; Olde-Rikkert, Marcel; Huell, Michael

2009-01-01

Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. Methods/Design A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. Discussion The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment. The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform. PMID:19799779

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

PubMed

Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

2013-11-15

Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Current Controlled Trials ISRCTN35911035.

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

PubMed Central

2013-01-01

Background Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Methods Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Results Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Conclusions Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and providing collaborator incentives. Barriers to recruitment included fewer eligible women than anticipated, patient’s preference to be allocated to the treatment group, lack of support staff, and variations in approval systems and GP referral procedures. To improve the evidence base on clinical trial recruitment, trialists need to publish their experiences and lessons learned. Future RCTs should evaluate, where possible, the effect of strategies designed to improve recruitment and retention. Trial registration Current Controlled Trials ISRCTN35911035 PMID:24228935

Summary Protocol for a Multi-Centre Randomised Controlled Trial of Enteral Lactoferrin Supplementation in Newborn Very Preterm Infants (ELFIN).

PubMed

2018-06-11

In a multi-centre randomised controlled trial (RCT), we are assessing whether giving very preterm (i.e., born at < 32 weeks' gestation) infants prophylactic enteral bovine lactoferrin supplementation (150 mg/kg/day) from shortly after birth until 34 weeks' post-menstrual age reduces the incidence of late-onset invasive infection (primary outcome), all-cause mortality, bronchopulmonary dysplasia, necrotising enterocolitis, retinopathy of prematurity, and the duration of antibiotic exposure, intensive care, and hospital admission. The trial is recruiting 2,200 participants from 37 neonatal care centres in the UK over 4 years. We will undertake an economic evaluation within the RCT to evaluate cost-effectiveness and provide an estimate of incremental costs for differences in the pre-specified outcomes in primary and subgroup analyses. If a statistically significant and clinically important effect on the primary outcome is detected, we will seek further funding and approval to assess the impact of enteral lactoferrin supplementation on rates of adverse neuro-developmental outcomes in the participating infants when they are 5 years old. © 2018 S. Karger AG, Basel.

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.

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

Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64.

PubMed

Miller, Julie M; Dewey, Marc; Vavere, Andrea L; Rochitte, Carlos E; Niinuma, Hiroyuki; Arbab-Zadeh, Armin; Paul, Narinder; Hoe, John; de Roos, Albert; Yoshioka, Kunihiro; Lemos, Pedro A; Bush, David E; Lardo, Albert C; Texter, John; Brinker, Jeffery; Cox, Christopher; Clouse, Melvin E; Lima, João A C

2009-04-01

Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective "CORE-64" trial ("Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors"). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows.

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

PubMed

Shah, Gaurang R; Chaudhari, Manojkumar V; Patankar, Suresh B; Pensalwar, Shrikant V; Sabale, Vilas P; Sonawane, Navneet A

2012-09-15

Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P < 0.0001). Similar results were observed in each of the remaining four domains of the IIEF (orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P < 0.001. Thirty-five out of 39 (90%) subjects from the VXP group and one (3%) from the placebo group wished to continue with the treatment they received. Investigator's global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

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

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 .

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.

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial.

PubMed

van Bloemendaal, Maijke; Bus, Sicco A; de Boer, Charlotte E; Nollet, Frans; Geurts, Alexander C H; Beelen, Anita

2016-10-01

Many stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation (MFES)-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients. In a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up. This study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial. This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).

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.

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.

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

Activity Begins in Childhood (ABC) - inspiring healthy active behaviour in preschoolers: study protocol for a cluster randomized controlled trial.

PubMed

Adamo, Kristi B; Barrowman, Nick; Naylor, Patti Jean; Yaya, Sanni; Harvey, Alysha; Grattan, Kimberly P; Goldfield, Gary S

2014-07-29

Today's children are more overweight than previous generations and physical inactivity is a contributing factor. Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits. The social and physical environments where children spend their time have a powerful influence on behaviour. Since the majority of preschool children spend time in care outside of the home, this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour. This study aims to evaluate the efficacy of the Activity Begins in Childhood (ABC) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers' overall physical activity levels and, specifically, the time spent in moderate to vigorous physical activity. This study is a single site, three-arm, cluster-randomized controlled trial design with a daycare centre as the unit of measurement (clusters). All daycare centres in the National Capital region that serve children between the ages of 3 and 5, expressing an interest in receiving the ABC intervention will be invited to participate. Those who agree will be randomly assigned to one of three groups: i) ABC program delivered at a daycare centre only, ii) ABC program delivered at daycare with a home/parental education component, or iii) regular daycare curriculum. This study will recruit 18 daycare centres, 6 in each of the three groups. The intervention will last approximately 6 months, with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6 months. Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health. Opportunities for physical activity and motor development in early childhood may, over the lifespan, influence the maintenance of a healthy body weight and reduce cardiovascular disease risk. If successful, the ABC program may be implemented in daycare centres as an effective way of increasing healthy activity behaviours of preschoolers. Current Controlled Trials: ISRCTN94022291. Registered in December 2012, first cluster randomized in April 2013.

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.

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.

The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial.

PubMed

Ammendolia, Carlo; Côté, Pierre; Rampersaud, Y Raja; Southerst, Danielle; Budgell, Brian; Bombardier, Claire; Hawker, Gillian

2016-01-01

Lumbar spinal stenosis (LSS) causing neurogenic claudication is a leading cause of pain, disability and loss of independence in older adults. The prevalence of lumbar spinal stenosis is growing rapidly due to an aging population. The dominant limitation in LSS is walking ability. Postural, physical and psychosocial factors can impact symptoms and functional ability. LSS is the most common reason for spine surgery in older adults yet the vast majority of people with LSS receive non-surgical treatment. What constitutes effective non-surgical treatment is unknown. The purpose of this study is to evaluate the effectiveness of a multi-modal and self-management training program, known as the Boot Camp Program for LSS aimed at improving walking ability and other relevant patient-centred outcomes. We will use a pragmatic two-arm randomized controlled single blinded (assessor) study design. Eligible and consenting participants will be randomized to receive from licensed chiropractors either a 6-week (twice weekly) self-management training program (manual therapy, education, home exercises) with an instructional workbook and video and a pedometer or a single instructional session with an instructional workbook and video and pedometer. The main outcome measure will be the self-paced walking test measured at 6 months. We will also assess outcomes at 8 weeks and 3 and 12 months. Symptoms and functional limitations in LSS are variable and influenced by changes in spinal alignment. Physical and psychological factors result in chronic disability for patients with LSS. The Boot Camp Program is a 6-week self-management training program aimed at the multi-faceted aspects of LSS and trains individuals to use self-management strategies. The goal is to provide life-long self-management strategies that maximize walking and overall functional abilities and quality of life. ClinicalTrials.gov ID: NCT02592642.

Standing up in multiple sclerosis (SUMS): protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis.

PubMed

Freeman, J A; Hendrie, W; Creanor, S; Jarrett, L; Barton, A; Green, C; Marsden, J; Rogers, E; Zajicek, J

2016-05-05

Multiple sclerosis (MS) is an incurable, unpredictable but typically progressive neurological condition. It is the most common cause of neurological disability in young adults. Within 15 years of diagnosis, approximately 50 % of affected people are unable to walk unaided, and over time an estimated 25 % depend on a wheelchair. Typically, people with such limited mobility are excluded from clinical trials. Severely impaired people with MS spend much of their day sitting, often with limited ability to change position. In response, secondary complications can occur including: muscle wasting, pain, reduced skin integrity, spasms, limb stiffness, constipation, and associated psychosocial problems such as depression and lowered self-esteem. Effective self-management strategies, which can be implemented relatively easily and cheaply within people's homes, are needed to improve or maintain mobility and reduce sedentary behaviour. However this is challenging, particularly in the latter stages of disease. Regular supported standing using standing frames is one potential option. SUMS is a pragmatic multi-centre randomised controlled trial evaluating use of Oswestry standing frames with blinded outcome assessment and full economic evaluation. Participants will be randomly allocated (1:1) to either a home-based, self-management standing programme (with advice and support) along with their usual care or to usual care alone. Those in the intervention group will be asked to stand for a minimum of 30 min three times weekly over 20 weeks. Each participant will be followed-up at 20 and 36 weeks post baseline. The primary clinical outcome is motor function, assessed using the Amended Motor Club Assessment. The primary economic endpoint is quality-adjusted life years. The secondary outcomes include measures of explanatory physical impairments, key clinical outcomes, and health-related quality of life. An embedded qualitative component will explore participant's and carer's experiences of the standing programme. This is the first large scale multi-centre trial to assess the clinical and cost effectiveness of a home based standing frame programme for people who are severely impaired by MS. If demonstrated to be effective and cost-effective, we will use this evidence to develop recommendations for a health service delivery model which could be implemented across the United Kingdom. ISRCTN69614598 DATE OF REGISTRATION: 3.2.16 (retrospectively registered).

Effects and feasibility of a multi-disciplinary orientation program for newly registered cancer patients: design of a randomised controlled trial.

PubMed

Chan, Raymond; Webster, Joan; Bennett, Linda

2009-11-11

Diagnosis and treatment of cancer can contribute to psychological distress and anxiety amongst patients. Evidence indicates that information giving can be beneficial in reducing patient anxiety, so oncology specific information may have a major impact on this patient group. This study investigates the effects of an orientation program on levels of anxiety and self-efficacy amongst newly registered cancer patients who are about to undergo chemotherapy and/or radiation therapy in the cancer care centre of a large tertiary Australian hospital. The concept of interventions for orienting new cancer patients needs revisiting due to the dynamic health care system. Historically, most orientation programs at this cancer centre were conducted by one nurse. A randomised controlled trial has been designed to test the effectiveness of an orientation program with bundled interventions; a face-to-face program which includes introduction to the hospital facilities, introduction to the multi-disciplinary team and an overview of treatment side effects and self care strategies. The aim is to orientate patients to the cancer centre and to meet the health care team. We hypothesize that patients who receive this orientation will experience lower levels of anxiety and distress, and a higher level of self-efficacy. An orientation program is a common health care service provided by cancer care centres for new cancer patients. Such programs aim to give information to patients at the beginning of their encounter at a cancer care centre. It is clear in the literature that interventions that aim to improve self-efficacy in patients may demonstrate potential improvement in health outcomes. Yet, evidence on the effects of orientation programs for cancer patients on self-efficacy remains scarce, particularly with respect to the use of multidisciplinary team members. This paper presents the design of a randomised controlled trial that will evaluate the effects and feasibility of a multidisciplinary orientation program for new cancer patients. Current Controlled Trials ACTRN12609000018213.

Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

PubMed

Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

2015-07-10

Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

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

CCS-MIP: Low cost Customizable Control Centre

NASA Technical Reports Server (NTRS)

Labezin, Christian; Vielcanet, Pierre

1994-01-01

The positioning and station keeping of French national satellites are among the main missions of CNES French Space Agency CNES. The related experience and skills of the Toulouse Space Centre are reknown and often required at international level for a wide range of missions. CISI, a software engineering company, has been contributing during the last 20 years to the development of the French space programs, particularly in the field of space missions ground control segments. The CCS-MIP system, presented here, is a satellite positioning and station-keeping system designed to answer the CNES multi-mission needs, easily adaptable for a wide range of applications.

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.

Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee.

PubMed

von Elm, Erik; Röllin, Alexandra; Blümle, Anette; Huwiler, Karin; Witschi, Mark; Egger, Matthias

2008-04-05

Not all clinical trials are published, which may distort the evidence that is available in the literature. We studied the publication rate of a cohort of clinical trials and identified factors associated with publication and nonpublication of results. We analysed the protocols of randomized clinical trials of drug interventions submitted to the research ethics committee of University Hospital (Inselspital) Bern, Switzerland from 1988 to 1998. We identified full articles published up to 2006 by searching the Cochrane CENTRAL database (issue 02/2006) and by contacting investigators. We analyzed factors associated with the publication of trials using descriptive statistics and logistic regression models. 451 study protocols and 375 corresponding articles were analyzed. 233 protocols resulted in at least one publication, a publication rate of 52%. A total of 366 (81%) trials were commercially funded, 47 (10%) had non-commercial funding. 346 trials (77%) were multi-centre studies and 272 of these (79%) were international collaborations. In the adjusted logistic regression model non-commercial funding (Odds Ratio [OR] 2.42, 95% CI 1.14-5.17), multi-centre status (OR 2.09, 95% CI 1.03-4.24), international collaboration (OR 1.87, 95% CI 0.99-3.55) and a sample size above the median of 236 participants (OR 2.04, 95% CI 1.23-3.39) were associated with full publication. In this cohort of applications to an ethics committee in Switzerland, only about half of clinical drug trials were published. Large multi-centre trials with non-commercial funding were more likely to be published than other trials, but most trials were funded by industry.

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.

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.

Cost-effectiveness of simulation-based team training in obstetric emergencies (TOSTI study).

PubMed

van de Ven, J; van Baaren, G J; Fransen, A F; van Runnard Heimel, P J; Mol, B W; Oei, S G

2017-09-01

Team training is frequently applied in obstetrics. We aimed to evaluate the cost-effectiveness of obstetric multi-professional team training in a medical simulation centre. We performed a model-based cost-effectiveness analysis to evaluate four strategies for obstetric team training from a hospital perspective (no training, training without on-site repetition and training with 6 month or 3-6-9 month repetition). Data were retrieved from the TOSTI study, a randomised controlled trial evaluating team training in a medical simulation centre. We calculated the incremental cost-effectiveness ratio (ICER), which represent the costs to prevent the adverse outcome, here (1) the composite outcome of obstetric complications and (2) specifically neonatal trauma due to shoulder dystocia. Mean costs of a one-day multi-professional team training in a medical simulation centre were €25,546 to train all personnel of one hospital. A single training in a medical simulation centre was less effective and more costly compared to strategies that included repetition training. Compared to no training, the ICERs to prevent a composite outcome of obstetric complications were €3432 for a single repetition training course on-site six months after the initial training and €5115 for a three monthly repetition training course on-site after the initial training during one year. When we considered neonatal trauma due to shoulder dystocia, a three monthly repetition training course on-site after the initial training had an ICER of €22,878. Multi-professional team training in a medical simulation centre is cost-effective in a scenario where repetition training sessions are performed on-site. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

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.

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.

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.

Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

PubMed Central

Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

2013-01-01

Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. PMID:24028942

Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention.

PubMed

Robinson, Thomas N; Matheson, Donna; Desai, Manisha; Wilson, Darrell M; Weintraub, Dana L; Haskell, William L; McClain, Arianna; McClure, Samuel; Banda, Jorge A; Sanders, Lee M; Haydel, K Farish; Killen, Joel D

2013-11-01

To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families. © 2013 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-12-15

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

The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol

PubMed Central

2014-01-01

Background Insertion of a ventriculoperitoneal shunt (VPS) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK, but failures caused by infection occur in approximately 8% of primary cases. VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service. Antibiotic-impregnated (rifampicin and clindamycin) and silver-impregnated VPS have been developed to reduce infection rates. Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection, there are no randomised controlled trials (RCTs) to support their routine use. Methods/design Overall, 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland. Patients of any age undergoing insertion of their first VPS are eligible. Patients with previous indwelling VPS, active and on-going cerebrospinal fluid (CSF) or peritoneal infection, multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy, and ventriculoatrial or ventriculopleural shunt planned will be excluded. Patients will be randomised 1:1:1 to either standard silicone (comparator), antibiotic-impregnated, or silver-impregnated VPS. The primary outcome measure is time to VPS infection. Secondary outcome measures include time to VPS failure of any cause, reason for VPS failure (infection, mechanical failure, or patient failure), types of bacterial VPS infection (organism type and antibiotic resistance), and incremental cost per VPS failure averted. Discussion The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS. The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN49474281. PMID:24383496

Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

PubMed

Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

2013-01-01

To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p < .01). Compared with multi-port surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

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.

Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

PubMed

Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

2011-09-01

To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

PubMed

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

2015-02-01

Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

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.

Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent.

PubMed

Tomlin, Zelda; deSalis, Isabel; Toerien, Merran; Donovan, Jenny L

2014-10-01

With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming 'sites of evidence production' yet, little is known about how they are recruited as participants; there is some evidence that 'substantively valid consent' is difficult to achieve. To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering. Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis). Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions. The views of recruiting nurses about their recruitment role; the extent to which nurse-patient interactions were patient-centred; the nature of the nurses' interactional strategies and the nature and extent of patient participation in the discussion. The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions. Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence-based medicine, poses a challenge to patient-centred practice and more research and relevant training are needed. © 2012 John Wiley & Sons Ltd.

Investigating the Impact of Working in Multi-Agency Service Delivery Settings in the UK on Early Years Practitioners' Beliefs and Practices

ERIC Educational Resources Information Center

Anning, Angela

2005-01-01

In the UK Centres of Excellence were funded by the DfES to model high quality, multi-agency, early years services for young children and their families. They were precursors to Children's Centres to be established across the UK. Early Excellence Centres were evaluated at national and local levels. This article will draw on data from local…

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.

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

PubMed

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

PubMed Central

Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

Faecal consistency and risk factors for diarrhoea and constipation in cats in UK rehoming shelters.

PubMed

German, Allison C; Cunliffe, Nigel A; Morgan, Kenton L

2017-01-01

Objectives The aim of the study was to describe faecal consistency, prevalence and risk factors for diarrhoea and constipation in a rescue cat population. Methods Faecal samples in litter trays from a stratified random sample of cats in pens at 25 UK rehoming centres were scored for consistency in two discrete time periods, summer and winter. A six-point scale was used, with diarrhoea ⩽3, severe diarrhoea ⩽2 and constipation as 6. The effect on faecal consistency of age, number of cats per pen and season was investigated using multivariable hierarchical logistic regression with centre and pen as random effects. Intraclass correlation coefficients were used to estimate the effect of pen and centre. Results Overall, 11.9% (95% confidence interval [CI]:10.4-13.7) of cats had diarrhoea, 2.4% (95% CI 1.6-3.7) had severe diarrhoea and 5.6% (95% CI 4.2-7.5) were constipated. The prevalence of diarrhoea (median 11.0%, interquartile range [IQR] 5.0-14.5%) and constipation (median 4.2%, IQR 1.8-5.9) varied at the centre level. Diarrhoea was associated with being a kitten (odds ratio [OR] 2.54, 95% CI 1.45-4.46; P = 0.001) and being in a multi-cat pen (OR 1.24, 95% CI 1.04-1.48; P = 0.02) but not with season (OR 0.99, 95% CI 0.55-1.77; P = 0.96). Severe diarrhoea was associated with senior cats (OR 4.66, 95% CI 1.25-17.44; P = 0.02). Constipation was associated with increasing age (OR 1.01; 95% CI 1.00-1.01; P = 0.02) and winter (OR 0.43, 95% CI 0.21-0.89; P = 0.02). Both diarrhoea and constipation showed moderate correlation with pens within a centre. Conclusions and relevance From IQRs, we suggest acceptable levels for diarrhoea and constipation of 11% and 4%, respectively, targets of 5% and 2%, and intervention at 15% and 6%. Increasing age was associated with decreased risk of diarrhoea and increased risk of constipation. However, severe diarrhoea was associated with being a senior cat. Season (winter) was a risk factor for constipation; multi-cat pens were a risk factor for diarrhoea. Describing the prevalence and risk factors for diarrhoea and constipation in cats will assist their management in this population. Understanding and managing constipation may be more important than interventions to reduce severe diarrhoea.

Ventricular enlargement as a possible measure of Alzheimer's disease progression validated using the Alzheimer's disease neuroimaging initiative database

PubMed Central

Nestor, Sean M.; Rupsingh, Raul; Borrie, Michael; Smith, Matthew; Accomazzi, Vittorio; Wells, Jennie L.; Fogarty, Jennifer

2008-01-01

Ventricular enlargement may be an objective and sensitive measure of neuropathological change associated with mild cognitive impairment (MCI) and Alzheimer's disease (AD), suitable to assess disease progression for multi-centre studies. This study compared (i) ventricular enlargement after six months in subjects with MCI, AD and normal elderly controls (NEC) in a multi-centre study, (ii) volumetric and cognitive changes between Apolipoprotein E genotypes, (iii) ventricular enlargement in subjects who progressed from MCI to AD, and (iv) sample sizes for multi-centre MCI and AD studies based on measures of ventricular enlargement. Three dimensional T1-weighted MRI and cognitive measures were acquired from 504 subjects (NEC n = 152, MCI n = 247 and AD n = 105) participating in the multi-centre Alzheimer's Disease Neuroimaging Initiative. Cerebral ventricular volume was quantified at baseline and after six months using semi-automated software. For the primary analysis of ventricle and neurocognitive measures, between group differences were evaluated using an analysis of covariance, and repeated measures t-tests were used for within group comparisons. For secondary analyses, all groups were dichotomized for Apolipoprotein E genotype based on the presence of an ε4 polymorphism. In addition, the MCI group was dichotomized into those individuals who progressed to a clinical diagnosis of AD, and those subjects that remained stable with MCI after six months. Group differences on neurocognitive and ventricle measures were evaluated by independent t-tests. General sample size calculations were computed for all groups derived from ventricle measurements and neurocognitive scores. The AD group had greater ventricular enlargement compared to both subjects with MCI (P = 0.0004) and NEC (P < 0.0001), and subjects with MCI had a greater rate of ventricular enlargement compared to NEC (P = 0.0001). MCI subjects that progressed to clinical AD after six months had greater ventricular enlargement than stable MCI subjects (P = 0.0270). Ventricular enlargement was different between Apolipoprotein E genotypes within the AD group (P = 0.010). The number of subjects required to demonstrate a 20% change in ventricular enlargement was substantially lower than that required to demonstrate a 20% change in cognitive scores. Ventricular enlargement represents a feasible short-term marker of disease progression in subjects with MCI and subjects with AD for multi-centre studies. PMID:18669512

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

Association between smoking status and the parameters of vascular structure and function in adults: results from the EVIDENT study.

PubMed

Recio-Rodriguez, Jose I; Gomez-Marcos, Manuel A; Patino Alonso, Maria C; Martin-Cantera, Carlos; Ibañez-Jalon, Elisa; Melguizo-Bejar, Amor; Garcia-Ortiz, Luis

2013-12-01

The present study analyses the relation between smoking status and the parameters used to assess vascular structure and function. This cross-sectional, multi-centre study involved a random sample of 1553 participants from the EVIDENT study. The smoking status, peripheral augmentation index and ankle-brachial index were measured in all participants. In a small subset of the main population (265 participants), the carotid intima-media thickness and pulse wave velocity were also measured. After controlling for the effect of age, sex and other risk factors, present smokers have higher values of carotid intima-media thickness (p = 0.011). Along the same lines, current smokers have higher values of pulse wave velocity and lower mean values of ankle-brachial index but without statistical significance in both cases. Among the parameters of vascular structure and function analysed, only the IMT shows association with the smoking status, after adjusting for confounders.

Association between smoking status and the parameters of vascular structure and function in adults: results from the EVIDENT study

PubMed Central

2013-01-01

Background The present study analyses the relation between smoking status and the parameters used to assess vascular structure and function. Methods This cross-sectional, multi-centre study involved a random sample of 1553 participants from the EVIDENT study. Measurements: The smoking status, peripheral augmentation index and ankle-brachial index were measured in all participants. In a small subset of the main population (265 participants), the carotid intima-media thickness and pulse wave velocity were also measured. Results After controlling for the effect of age, sex and other risk factors, present smokers have higher values of carotid intima-media thickness (p = 0.011). Along the same lines, current smokers have higher values of pulse wave velocity and lower mean values of ankle-brachial index but without statistical significance in both cases. Conclusions Among the parameters of vascular structure and function analysed, only the IMT shows association with the smoking status, after adjusting for confounders. PMID:24289208

The study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants.

PubMed

Johnston, Vanessa; Walker, Natalie; Thomas, David P; Glover, Marewa; Chang, Anne B; Bullen, Chris; Morris, Peter; Brown, Ngiare; Vander Hoorn, Stephen; Borland, Ron; Segan, Catherine; Trenholme, Adrian; Mason, Toni; Fenton, Debra; Ellis, Kane

2010-03-07

Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori. This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants. Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.

Improving urban African Americans' blood pressure control through multi-level interventions in the Achieving Blood Pressure Control Together (ACT) study: a randomized clinical trial.

PubMed

Ephraim, Patti L; Hill-Briggs, Felicia; Roter, Debra L; Bone, Lee R; Wolff, Jennifer L; Lewis-Boyer, LaPricia; Levine, David M; Aboumatar, Hanan J; Cooper, Lisa A; Fitzpatrick, Stephanie J; Gudzune, Kimberly A; Albert, Michael C; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary J; Fagan, Peter J; Ramamurthi, Hema C; Ameling, Jessica M; Charlston, Jeanne; Sam, Tanyka S; Carson, Kathryn A; Wang, Nae-Yuh; Crews, Deidra C; Greer, Raquel C; Sneed, Valerie; Flynn, Sarah J; DePasquale, Nicole; Boulware, L Ebony

2014-07-01

Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients' management of a variety of chronic illnesses. However, studies of multi-level interventions designed specifically to improve urban African American patients' blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients' improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients' blood pressure control at 12months. Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients' hypertension control. Copyright © 2014 Elsevier Inc. All rights reserved.

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

PubMed

Montero-Odasso, Manuel; Almeida, Quincy J; Burhan, Amer M; Camicioli, Richard; Doyon, Julien; Fraser, Sarah; Li, Karen; Liu-Ambrose, Teresa; Middleton, Laura; Muir-Hunter, Susan; McIlroy, William; Morais, José A; Pieruccini-Faria, Frederico; Shoemaker, Kevin; Speechley, Mark; Vasudev, Akshya; Zou, G Y; Berryman, Nicolas; Lussier, Maxime; Vanderhaeghe, Leanne; Bherer, Louis

2018-04-16

Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

Therapeutic equivalence of two formulations of calcipotriol-betamethasone ointment: a multi-centre, randomized, double-blind study in adult patients with chronic plaque psoriasis.

PubMed

Habjanic, N; Koytchev, R; Yankova, R; Kerec-Kos, M; Grabnar-Peklar, D

2018-06-26

Topical agents are the first-line therapy for psoriasis and treatment of choice for mild to moderate chronic plaque psoriasis. Patients with severe psoriasis often use topical therapies at least for selected body areas. 1,2 Corticosteroids and vitamin D analogues are effective, commonly used topical therapies for mild to moderate plaque psoriasis and are often used in combination due to their complementary pharmacodynamic activities. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Overcoming the Barriers Experienced in Conducting a Medication Trial in Adults with Aggressive Challenging Behaviour and Intellectual Disabilities

ERIC Educational Resources Information Center

Oliver-Africano, P.; Dickens, S.; Ahmed, Z.; Bouras, N.; Cooray, S.; Deb, S.; Knapp, M.; Hare, M.; Meade, M.; Reece, B.; Bhaumik, S.; Harley, D.; Piachaud, J.; Regan, A.; Ade Thomas, D.; Karatela, S.; Rao, B.; Dzendrowskyj, T.; Lenotre, L.; Watson, J.; Tyrer, P.

2010-01-01

Background: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. Method: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs…

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.

Multi-dimensional single-spin nano-optomechanics with a levitated nanodiamond

NASA Astrophysics Data System (ADS)

Neukirch, Levi P.; von Haartman, Eva; Rosenholm, Jessica M.; Nick Vamivakas, A.

2015-10-01

Considerable advances made in the development of nanomechanical and nano-optomechanical devices have enabled the observation of quantum effects, improved sensitivity to minute forces, and provided avenues to probe fundamental physics at the nanoscale. Concurrently, solid-state quantum emitters with optically accessible spin degrees of freedom have been pursued in applications ranging from quantum information science to nanoscale sensing. Here, we demonstrate a hybrid nano-optomechanical system composed of a nanodiamond (containing a single nitrogen-vacancy centre) that is levitated in an optical dipole trap. The mechanical state of the diamond is controlled by modulation of the optical trapping potential. We demonstrate the ability to imprint the multi-dimensional mechanical motion of the cavity-free mechanical oscillator into the nitrogen-vacancy centre fluorescence and manipulate the mechanical system's intrinsic spin. This result represents the first step towards a hybrid quantum system based on levitating nanoparticles that simultaneously engages optical, phononic and spin degrees of freedom.

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.

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.

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

PubMed

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

2015-09-02

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

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

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.

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.

Protocol for digital intervention for effective health promotion of small children-A cluster randomized trial.

PubMed

Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

2018-03-08

This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a 4-month follow-up. The data are being collected from 200 families with a 4-year-old child. Cluster randomization is being performed at the municipality level. Municipalities (N = 4) located in Southwest Finland, comprising child health clinics (N = 15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a 4-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. © 2018 John Wiley & Sons Ltd.

The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence.

PubMed

Müller, Ueli C; Asherson, Philip; Banaschewski, Tobias; Buitelaar, Jan K; Ebstein, Richard P; Eisenberg, Jaques; Gill, Michael; Manor, Iris; Miranda, Ana; Oades, Robert D; Roeyers, Herbert; Rothenberger, Aribert; Sergeant, Joseph A; Sonuga-Barke, Edmund Js; Thompson, Margaret; Faraone, Stephen V; Steinhausen, Hans-Christoph

2011-04-07

The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 unselected siblings. The aim was to describe and analyse questionnaire data and IQ measures from all probands and siblings. In particular, to investigate the influence of age, gender, family status (proband vs. sibling), informant, and centres on sample homogeneity in psychopathological measures. Conners' Questionnaires, Strengths and Difficulties Questionnaires, and Wechsler Intelligence Scores were used to describe the phenotype of the sample. Data were analysed by use of robust statistical multi-way procedures. Besides main effects of age, gender, informant, and centre, there were considerable interaction effects on questionnaire data. The larger differences between probands and siblings at home than at school may reflect contrast effects in the parents. Furthermore, there were marked gender by status effects on the ADHD symptom ratings with girls scoring one standard deviation higher than boys in the proband sample but lower than boys in the siblings sample. The multi-centre design is another important source of heterogeneity, particularly in the interaction with the family status. To a large extent the centres differed from each other with regard to differences between proband and sibling scores. When ADHD probands are diagnosed by use of fixed symptom counts, the severity of the disorder in the proband sample may markedly differ between boys and girls and across age, particularly in samples with a large age range. A multi-centre design carries the risk of considerable phenotypic differences between centres and, consequently, of additional heterogeneity of the sample even if standardized diagnostic procedures are used. These possible sources of variance should be counteracted in genetic analyses either by using age and gender adjusted diagnostic procedures and regional normative data or by adjusting for design artefacts by use of covariate statistics, by eliminating outliers, or by other methods suitable for reducing heterogeneity.

All optical mode controllable Er-doped random fiber laser with distributed Bragg gratings.

PubMed

Zhang, W L; Ma, R; Tang, C H; Rao, Y J; Zeng, X P; Yang, Z J; Wang, Z N; Gong, Y; Wang, Y S

2015-07-01

An all-optical method to control the lasing modes of Er-doped random fiber lasers (RFLs) is proposed and demonstrated. In the RFL, an Er-doped fiber (EDF) recoded with randomly separated fiber Bragg gratings (FBG) is used as the gain medium and randomly distributed reflectors, as well as the controllable element. By combining random feedback of the FBG array and Fresnel feedback of a cleaved fiber end, multi-mode coherent random lasing is obtained with a threshold of 14 mW and power efficiency of 14.4%. Moreover, a laterally-injected control light is used to induce local gain perturbation, providing additional gain for certain random resonance modes. As a result, active mode selection of the RFL is realized by changing locations of the laser cavity that is exposed to the control light.

Evaluation of a nurse-led dementia education and knowledge translation programme in primary care: A cluster randomized controlled trial.

PubMed

Wang, Yao; Xiao, Lily Dongxia; Ullah, Shahid; He, Guo-Ping; De Bellis, Anita

2017-02-01

The lack of dementia education programmes for health professionals in primary care is one of the major factors contributing to the unmet demand for dementia care services. To determine the effectiveness of a nurse-led dementia education and knowledge translation programme for health professionals in primary care; participants' satisfaction with the programme; and to understand participants' perceptions of and experiences in the programme. A cluster randomized controlled trial was used as the main methodology to evaluate health professionals' knowledge, attitudes and care approach. Focus groups were used at the end of the project to understand health professionals' perceptions of and experiences in the programme. Fourteen community health service centres in a province in China participated in the study. Seven centres were randomly assigned to the intervention or control group respectively and 85 health professionals in each group completed the programme. A train-the-trainer model was used to implement a dementia education and knowledge translation programme. Outcome variables were measured at baseline, on the completion of the programme and at 3-month follow-up. A mixed effect linear regression model was applied to compare the significant differences of outcome measures over time between the two groups. Focus groups were guided by four semi-structured questions and analysed using content analysis. Findings revealed significant effects of the education and knowledge translation programme on participants' knowledge, attitudes and a person-centred care approach. Focus groups confirmed that the programme had a positive impact on dementia care practice. A dementia education and knowledge translation programme for health professionals in primary care has positive effects on their knowledge, attitudes, care approach and care practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

Childhood obesity prevention and control in city recreation centres and family homes: the MOVE/me Muevo Project.

PubMed

Elder, J P; Crespo, N C; Corder, K; Ayala, G X; Slymen, D J; Lopez, N V; Moody, J S; McKenzie, T L

2014-06-01

Interventions to prevent and control childhood obesity have shown mixed results in terms of short- and long-term changes. 'MOVE/me Muevo' was a 2-year family- and recreation centre-based randomized controlled trial to promote healthy eating and physical activity among 5- to 8-year-old children. It was hypothesized that children in the intervention group would demonstrate lower post-intervention body mass index (BMI) values and improved obesity-related behaviours compared with the control group children. Thirty recreation centres in San Diego County, California, were randomized to an intervention or control condition. Five hundred forty-one families were enrolled and children's BMI, diet, physical activity and other health indicators were tracked from baseline to 2 years post-baseline. Analyses followed an intent-to-treat approach using mixed-effects models. No significant intervention effects were observed for the primary outcomes of child's or parent's BMI and child's waist circumference. Moderator analyses, however, showed that girls (but not boys) in the intervention condition reduced their BMI. At the 2-year follow-up, intervention condition parents reported that their children were consuming fewer high-fat foods and sugary beverages. Favourable implementation fidelity and high retention rates support the feasibility of this intervention in a large metropolitan area; however, interventions of greater intensity may be needed to achieve effects on child's BMI. Also, further research is needed to develop gender-specific intervention strategies so that both genders may benefit from such efforts. © 2013 The Authors. Pediatric Obesity © 2013 International Association for the Study of Obesity.

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.

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.

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.

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

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).

Multi-photon excited coherent random laser emission in ZnO powders

NASA Astrophysics Data System (ADS)

Tolentino Dominguez, Christian; Gomes, Maria De A.; Macedo, Zélia S.; de Araújo, Cid B.; Gomes, Anderson S. L.

2014-11-01

We report the observation and analysis of anti-Stokes coherent random laser (RL) emission from zinc oxide (ZnO) powders excited by one-, two- or three-photon femtosecond laser radiation. The ZnO powders were produced via a novel proteic sol-gel, low-cost and environmentally friendly route using coconut water in the polymerization step of the metal precursor. One- and two-photon excitation at 354 nm and 710 nm, respectively, generated single-band emissions centred at about 387 nm. For three-photon excitation, the emission spectra showed a strong ultraviolet (UV) band (380-396 nm) attributed to direct three-photon absorption from the valence band to the conduction band. The presence of an intensity threshold and a bandwidth narrowing of the UV band from about 20 to 4 nm are clear evidence of RL action. The observation of multiple sub-nanometre narrow peaks in the emission spectra for excitation above the RL threshold is consistent with random lasing by coherent feedback.

The oral food desensitization in the Italian allergy centres.

PubMed

Meglio, P; Caminiti, L; Pajno, G B; Dello Iacono, I; Tripodi, S; Verga, M C; Martelli, A

2015-05-01

Attempts aimed at inducing food tolerance through oral food desensitization (OFD) for the treatment of IgE-mediated food allergies are increasing. In Italy, a number of allergy centres offer this procedure. To collect information on how these centres are organized, how patients are selected, the methods used to administer OFD and how adverse reactions are managed. A questionnaire was e-mailed to all the Italian allergy centres offering OFD. The survey shows a high degree of variability between centres. A correct diagnosis of food allergy is crucial for selecting patients for OFD. In the Italian allergy centres, oral food challenges are mostly open label (84%), but in 16% of cases they are single-blind (8%) or double-blind (8%). A high proportion of allergy centres (83%) offer OFD to children presenting forms of anaphylaxis triggered by traces--or very low doses--of food allergen. The majority of allergy centres (76%) enroll patients over 3 years of age, with 44% enrolling patients above the age of 5. Not-controlled asthma, unreliability of parents in the management of OFD and/or risk of adverse events, are the main reasons for exclusion from the procedure. Although OFD may sometimes be successful and may be considered a valid alternative to an elimination diet, further randomized controlled trials are needed, in order to clarify some controversial points, such as the characteristics of the child undergoing OFD, and the methods of food preparation and administration. Moreover, further studies should further investigate OFD safety, efficacy and costs.

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.

Cooperative Solutions in Multi-Person Quadratic Decision Problems: Finite-Horizon and State-Feedback Cost-Cumulant Control Paradigm

DTIC Science & Technology

2007-01-01

CONTRACT NUMBER Problems: Finite -Horizon and State-Feedback Cost-Cumulant Control Paradigm (PREPRINT) 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER...cooperative cost-cumulant control regime for the class of multi-person single-objective decision problems characterized by quadratic random costs and... finite -horizon integral quadratic cost associated with a linear stochastic system . Since this problem formation is parameterized by the number of cost

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol.

PubMed

Serra-Paya, Noemi; Ensenyat, Assumpta; Real, Jordi; Castro-Viñuales, Iván; Zapata, Amalia; Galindo, Gisela; Solé-Mir, Eduard; Bosch-Muñoz, Jordi; Mur, Jose Maria; Teixidó, Concepció

2013-10-23

Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children's obesity. The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. ClinicalTrials.gov, NCT01878994.

Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

PubMed Central

2013-01-01

Background Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing. The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity. Methods/Design The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups. Discussion This trial will provide new evidence for the long-term effects of childhood obesity management, as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres. Trial registration ClinicalTrials.gov, NCT01878994 PMID:24153001

High-speed laser photoacoustic imaging system combined with a digital ultrasonic imaging platform

NASA Astrophysics Data System (ADS)

Zeng, Lvming; Liu, Guodong; Ji, Xuanrong; Ren, Zhong; Huang, Zhen

2009-07-01

As a new field of combined ultrasound/photoacoustic imaging in biomedical photonics research, we present and demonstrate a high-speed laser photoacoustic imaging system combined with digital ultrasound imaging platform. In the prototype system, a new B-mode digital ultrasonic imaging system is modified as the hardware platform with 384 vertical transducer elements. The centre resonance frequency of the piezoelectric transducer is 5.0 MHz with greater than 70% pulse-echo -6dB fractional bandwidth. The modular instrument of PCI-6541 is used as the hardware control centre of the testing system, which features 32 high-speed channels to build low-skew and multi-channel system. The digital photoacoustic data is transported into computer for subsequent reconstruction at 25 MHz clock frequency. Meantime, the software system for controlling and analyzing is correspondingly explored with LabVIEW language on virtual instrument platform. In the breast tissue experiment, the reconstructed image agrees well with the original sample, and the spatial resolution of the system can reach 0.2 mm with multi-element synthetic aperture focusing technique. Therefore, the system and method may have a significant value in improving early detecting level of cancer in the breast and other organs.

Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

PubMed

Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

2017-09-26

Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).

Does Maintenance CBT Contribute to Long-Term Treatment Response of Panic Disorder with or without Agoraphobia? A Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

White, Kamila S.; Payne, Laura A.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.; Saksa, John R.; Barlow, David H.

2013-01-01

Objective: We examined the possibility that maintenance cognitive behavior therapy (M-CBT) may improve the likelihood of sustained improvement and reduced relapse in a multi-site randomized controlled clinical trial of patients who met criteria for panic disorder with or without agoraphobia. Method: Participants were all patients (N = 379) who…

A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

PubMed Central

Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

2010-01-01

Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

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.

Cost-effectiveness of a nurse facilitated, cognitive behavioural self-management programme compared with usual care using a CBT manual alone for patients with heart failure: secondary analysis of data from the SEMAPHFOR trial.

PubMed

Mejía, Aurelio; Richardson, Gerry; Pattenden, Jill; Cockayne, Sarah; Lewin, Robert

2014-09-01

To assess the cost-effectiveness of a nurse facilitated, cognitive behavioural self-management programme for patients with heart failure compared with usual care including the un-facilitated access to the same manual, from the perspective of the NHS. Data were obtained from a pragmatic, multi-centre, randomized controlled 'open' trial conducted in seven centres in the UK between 2006 and 2008. Effectiveness was estimated as Quality-Adjusted Life Years. Resource use was measured prospectively on all patients using information provided by patients in postal questionnaires, case-note review, electronic record review and interviews with patients. Unit costs were obtained from the literature and applied to the relevant resource use to estimate total costs. Multiple imputation was used to handle missing data. There were no substantial differences in the utility scores between treatment groups in all follow-up assessments, in the use of medication or outpatient visits and both groups report a similar frequency of contact with health care professionals. After controlling for baseline utility and using imputed dataset, treatment was associated with a reduction in QALY of 0.004 and a additional cost of £69.49. The probability that the intervention is cost-effective for thresholds between £20,000 and £30,000 is around 45%. There is little evidence that the addition of the intervention had any effect on costs or outcomes. The uncertainty around both estimates of cost and effectiveness mean that it is not reasonable to make recommendations based on cost-effectiveness alone. Copyright © 2014 Elsevier Ltd. All rights reserved.

Study protocol. IDUS - Instrumental delivery & ultrasound: a multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

PubMed

Murphy, Deirdre J; Burke, Gerard; Montgomery, Alan A; Ramphul, Meenakshi

2012-09-13

Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 - 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Current Controlled Trials ISRCTN72230496.

A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan.

PubMed

Lo, Jessica W; Bunce, Catey; Charteris, David; Banerjee, Philip; Phillips, Rachel; Cornelius, Victoria R

2016-08-02

Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. ASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity). ISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.

Reappraisal of known malaria resistance loci in a large multi-centre study

PubMed Central

Rockett, Kirk A.; Clarke, Geraldine M.; Fitzpatrick, Kathryn; Hubbart, Christina; Jeffreys, Anna E.; Rowlands, Kate; Craik, Rachel; Jallow, Muminatou; Conway, David J.; Bojang, Kalifa A.; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A.; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D.; Bougouma, Edith C.; Sirima, Sodiomon B.; Modiano, David; Amenga-Etego, Lucas N.; Ghansah, Anita; Koram, Kwadwo A.; Wilson, Michael D.; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M.; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N.; Manjurano, Alphaxard; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J.; Phu, Nguyen Hoan; Ngoc Quyen, Nguyen Thi; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy M. E.; Michon, Pascal; Mueller, Ivo; Green, Angie; Molloy, Sile; Johnson, Kimberly J.; Kerasidou, Angeliki; Cornelius, Victoria; Hart, Lee; Vanderwal, Aaron; SanJoaquin, Miguel; Band, Gavin; Le, Si Quang; Pirinen, Matti; Sepúlveda, Nuno; Spencer, Chris C.A.; Clark, Taane G.; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P.

2015-01-01

Many human genetic associations with resistance to malaria have been reported but few have been reliably replicated. We collected data on 11,890 cases of severe malaria due to Plasmodium falciparum and 17,441 controls from 12 locations in Africa, Asia and Oceania. There was strong evidence of association with the HBB, ABO, ATP2B4, G6PD and CD40LG loci but previously reported associations at 22 other loci did not replicate in the multi-centre analysis. The large sample size made it possible to identify authentic genetic effects that are heterogeneous across populations or phenotypes, a striking example being the main African form of G6PD deficiency, which reduced the risk of cerebral malaria but increased the risk of severe malarial anaemia. The finding that G6PD deficiency has opposing effects on different fatal complications of P. falciparum infection indicates that the evolutionary origins of this common human genetic disorder are more complex than previously supposed. PMID:25261933

Managing multicentre clinical trials with open source.

PubMed

Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan

2014-03-01

Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

Evidence for the use of Levomepromazine for symptom control in the palliative care setting: a systematic review

PubMed Central

2013-01-01

Background Levomepromazine is an antipsychotic drug that is used clinically for a variety of distressing symptoms in palliative and end-of-life care. We undertook a systematic review based on the question “What is the published evidence for the use of levomepromazine in palliative symptom control?”. Methods To determine the level of evidence for the use of levomepromazine in palliative symptom control, and to discover gaps in evidence, relevant studies were identified using a detailed, multi-step search strategy. Emerging data was then scrutinized using appropriate assessment tools, and the strength of evidence systematically graded in accordance with the Oxford Centre for Evidence-Based Medicine’s ‘levels of evidence’ tool. The electronic databases Medline, Embase, Cochrane, PsychInfo and Ovid Nursing, together with hand-searching and cross-referencing provided the full research platform on which the review is based. Results 33 articles including 9 systematic reviews met the inclusion criteria: 15 on palliative sedation, 8 regarding nausea and three on delirium and restlessness, one on pain and six with other foci. The studies varied greatly in both design and sample size. Levels of evidence ranged from level 2b to level 5, with the majority being level 3 (non-randomized, non-consecutive or cohort studies n = 22), with the quality of reporting for the included studies being only low to medium. Conclusion Levomepromazine is widely used in palliative care as antipsychotic, anxiolytic, antiemetic and sedative drug. However, the supporting evidence is limited to open series and case reports. Thus prospective randomized trials are needed to support evidence-based guidelines. PMID:23331515

A survey of contemporary opinions and practices of surgical and intensive care specialists towards peri-operative venous thromboembolism prophylaxis in Asia.

PubMed

Lee, L; Liew, N C; Gee, T

2012-12-01

This survey was conducted to determine the opinions and practices of peri-operative venous thromboembolism (VTE) prophylaxis among surgical and intensive care specialists in Asia. A set of questionnaire was distributed to surgeons and intensivists from different countries in Asia. The specialties included were general surgery and its sub-specialties, orthopaedic surgery, gynaecological surgery and intensive care unit. This survey involved teaching institutions, general hospitals and private hospitals. To gauge if the respondents were from hospitals that would likely encounter VTE cases, the hospital's bed-strength, intensive care facility and sub-specialty services were recorded. Over a period of six months, questionnaires and feedbacks were collected and analyzed. One hundred and ninety-one responses were received from 8 countries throughout Asia. Fifty-six percent of these were from large hospitals (800 bedded or more) and 62% of these hospitals have large intensive care facility (20 or more beds). Only half of the respondents practice routine thromboprophylaxis in moderate and high risk surgeries. Thirty six percent of them practices selective thromboprophylaxis and only 3% do not believe in any thromboprophylaxis. A third prescribed thromboprophylaxis for 3 to 5 days; another third extended it until patient is mobile. About 48.6% of the respondents do not have VTE guidelines in their institutions. Majority of the respondents agreed that more evidence is needed in the form of multi-centre randomized controlled trials to influence their decision on thromboprophylaxis. Despite the availability of strong epidemiological data, randomized controlled trials and multicentre case-controlled studies, perioperative VTE prophylactic practices are still suboptimal in Asia.

The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

PubMed Central

2011-01-01

Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT) and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive/impulsive symptoms. Conclusions Despite a symptom-based standardized inclusion procedure according to DSM-IV criteria with defined symptom thresholds, centres may differ markedly in probands' ADHD symptom frequencies. Both the diagnostic procedure and the multi-centre design influence the behavioural characteristics of a sample and, thus, may bias statistical analyses, particularly in genetic or neurobehavioral studies. PMID:21473745

Uncoordinated MAC for Adaptive Multi Beam Directional Networks: Analysis and Evaluation

DTIC Science & Technology

2016-08-01

control (MAC) policies for emerging systems that are equipped with fully digital antenna arrays which are capable of adaptive multi-beam directional...Adaptive Beam- forming, Multibeam, Directional Networking, Random Access, Smart Antennas I. INTRODUCTION Fully digital beamforming antenna arrays that...are capable of adaptive multi-beam communications are quickly becoming a reality. These antenna arrays allow users to form multiple simultaneous

A Randomized Controlled Trial of the Social Tools and Rules for Teens (START) Program: An Immersive Socialization Intervention for Adolescents with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Vernon, Ty W.; Miller, Amber R.; Ko, Jordan A.; Barrett, Amy C.; McGarry, Elizabeth S.

2018-01-01

Adolescents with ASD face numerous personal and contextual barriers that impede the development of social motivation and core competencies, warranting the need for targeted intervention. A randomized controlled trial was conducted with 40 adolescents to evaluate the merits of a multi-component socialization intervention that places emphasis on…

Preschool Teachers Can Use a PBS KIDS Transmedia Curriculum Supplement to Support Young Children's Mathematics Learning: Results of a Randomized Controlled Trial

ERIC Educational Resources Information Center

Llorente, Carlin; Pasnik, Shelley; Moorthy, Savitha; Hupert, Naomi; Rosenfeld, Deborah; Gerard, Sarah

2015-01-01

The current study, a randomized controlled trial, explores how technology and educational transmedia resources can enhance prekindergarten math teaching and learning in preschools, especially those serving children who may be at risk for academic difficulties due to economic and social disadvantages. This research is part of a multi-year summative…

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.

Lessons learned from a practice-based, multi-site intervention study with nurse participants

PubMed Central

Friese, Christopher R.; Mendelsohn-Victor, Kari; Ginex, Pamela; McMahon, Carol M.; Fauer, Alex J.; McCullagh, Marjorie C.

2016-01-01

Purpose To identify challenges and solutions to the efficient conduct of a multi-site, practice-based randomized controlled trial to improve nurses’ adherence to personal protective equipment use in ambulatory oncology settings. Design The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a web-based continuing education video. Approach The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies. Findings Noteworthy challenges included variation in human subjects protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled web conferences, site-based study champions, site visits by the principal investigator, and centrally-based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials. Conclusions Multi-site studies of nursing personnel are rare and challenging to existing infrastructure. These barriers can be overcome with strong engagement and planning. Clinical Relevance Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial. PMID:28098951

PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.

PubMed

Yates, Tom; Griffin, Simon; Bodicoat, Danielle H; Brierly, Gwen; Dallosso, Helen; Davies, Melanie J; Eborall, Helen; Edwardson, Charlotte; Gillett, Mike; Gray, Laura; Hardeman, Wendy; Hill, Sian; Morton, Katie; Sutton, Stephen; Troughton, Jacqui; Khunti, Kamlesh

2015-07-02

The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change. This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. ISRCTN83465245 Trial registration date: 14/06/2012.

CADASIL: Treatment and Management Options.

PubMed

Bersano, Anna; Bedini, Gloria; Oskam, Joshua; Mariotti, Caterina; Taroni, Franco; Baratta, Silvia; Parati, Eugenio Agostino

2017-09-01

CADASIL is a life-threatening and disabling disease. Despite the progress achieved so far, no therapies able to limit the disease progression have been found and only empiric treatments can be employed to relieve the main disease symptoms. Further in vivo studies as well as data aggregation and multi-centre controlled clinical trials are needed to confirm the emerging findings in order to identify evidence-based therapies for CADASIL.

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

Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

PubMed Central

2013-01-01

Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been unsuccessful. By using a stepped wedge design, and obtain high management commitment and support we intend to improve implementation and aim to establish the effectiveness of a multi-faceted intervention to prevent low back pain. This study will potentially provide knowledge of prevention of low back pain and its consequences among nurses’ aides. Results are expected to be published in 2015–2016. Trial registration The study is registered as ISRCTN78113519. PMID:24261985

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 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.

Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with Type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study

PubMed Central

Bajaj, M; Gilman, R; Patel, S; Kempthorne-Rawson, J; Lewis-D'Agostino, D; Woerle, H-J

2014-01-01

Aims To investigate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with Type 2 diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone. Methods This was a multi-centre, phase 3, randomized, double-blind, placebo-controlled study comparing linagliptin 5 mg once daily (n = 183) and placebo (n = 89) as add-on to metformin and pioglitazone. The primary endpoint was the change from baseline in glycated haemoglobin (HbA1c) after 24 weeks. Results The placebo-corrected adjusted mean (se) change in HbA1c from baseline to 24 weeks was –6 (1) mmol/mol [–0.57 (0.13)%] (P < 0.0001). In patients with baseline HbA1c ≥ 53 mmol/mol (7.0%), 32.4% of patients in the linagliptin group and 13.8% in the placebo group achieved HbA1c < 53 mmol/mol (7.0%) (odds ratio 2.94; P = 0.0033). The placebo-corrected adjusted mean (se) change from baseline in fasting plasma glucose at week 24 was –0.57 (0.26) mmol/l [–10.4 (4.7) mg/dl] (P = 0.0280). The incidence of serious adverse events was 2.2% with linagliptin and 3.4% with placebo. Investigator-defined hypoglycaemia occurred in 5.5% of the linagliptin group and 5.6% of the placebo group. No meaningful changes in mean body weight were noted for either group. Conclusions Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control, without an additional risk of hypoglycaemia or weight gain (Clinical Trials Registry No: NCT 00996658). PMID:24824197

Effectiveness of Activity-Based Therapy in Comparison with Surface Spinal Stimulation in People with Traumatic Incomplete Spinal Cord Injury for Activation of Central Pattern Generator for Locomotion: Study Protocol for a 24-Week Randomized Controlled Trial.

PubMed

Bedi, Parneet Kaur; Arumugam, Narkeesh; Chhabra, Harvinder Singh

2018-06-01

A multi-centric randomized controlled trial to be conducted at two sites, department of phyhysiotherapypy, Punjabi University, Patiala and rehabilitation department, Indian Spinal Injury Centre, New Delhi, India. To determine the effectiveness of activity-based therapy in comparison with surface spinal stimulation (SSS) in traumatic incomplete spinal cord injury (SCI) with special reference to locomotion-a central pattern generator controlled function. A major goal for many patients after SCI is to regain the function of locomotion. It is crucial that rehabilitation strives to maximize locomotor ability and functional recovery after SCI. Experimental evidence of improvement in stepping and motor control after activity-based training in animal models and human SCI has been translated into clinical neuro-rehabilitation. Control group participants will undertake an intensive 24-week duration thrice weekly program of activity-based therapy. In addition to this the participants in experimental group will also receive a session of 45 minutes of SSS on thrice weekly basis. The primary analysis for our study will be at 24 weeks. Linear regression will be used to determine the mean between-group differences and 95% confidence interval for all continuous outcomes using baseline scores and group allocation as covariates. The primary outcome measure is improvement in the level of walking index for SCI-II. The secondary outcome measures are modified Ashworth scale, Penn spasm frequency score, spinal cord independence measure-III, SCI functional ambulation inventory, Hoffman's reflex, somatosensory evoked potential, and American Spinal Injury Association Impairment Scale scores. An insight into training-induced mechanisms will be of great importance to fine tune such combined treatments and vindicate their efficacy in restoration of locomotion and functional activities in individuals with SCI.

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

21 CFR 343.80 - Professional labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... group on the aspirin molecule. This acetyl group is responsible for the inactivation of cyclo-oxygenase... event rate was reduced to 5 percent from the 10 percent rate in the placebo group. Chronic Stable Angina...

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

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.

The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial.

PubMed

Vanova, Martina; Irazoki, Eider; García-Casal, J Antonio; Martínez-Abad, Fernando; Botella, Cristina; Shiells, Kate R; Franco-Martín, Manuel A

2018-02-12

Cognitive rehabilitation is a highly individualised, non-pharmacological intervention for people with mild cognitive impairment (MCI) and dementia, which in recent years has also been developed for various IT platforms. In this study, we aim to evaluate the effectiveness of the cognitive rehabilitation software GRADIOR in a multi-centre, single-blinded randomised controlled trial with people with MCI and mild dementia. A total of 400 people with MCI and mild dementia will be randomly allocated to one of four groups. This trial will compare the cognitive rehabilitation treatment using the GRADIOR programme with a psychosocial stimulation intervention (PSS) using the ehcoBUTLER platform, with a combined treatment consisting of GRADIOR and ehcoBUTLER, and with a group receiving treatment as usual during a period of 1 year. The outcomes of this clinical trial will be to determine any relevant changes in cognition, mood, quality of life, activities of daily living and quality of patient-carer relationship after 4 months and 1 year of intervention in a cross-sectional group comparison. Participants will be followed-up for 1 year to investigate potential long-term effects of the conducted treatments. Current Controlled Trials ISRCTN, ID: 15742788 . Registered on 12 June 2017.

Computerized Multi-Media Instructional Television. COMIT. Proceedings of a Symposium.

ERIC Educational Resources Information Center

Andrews, Gordon C., Ed.; Knapper, Christopher K., Ed.

A joint research project in educational techniques, which was conducted by the University of Waterloo and the IBM Corporation, explored the use of color television with random-access videotape under computer control. At the end of the three-year project, papers were solicited from all COMIT (Computerized Multi-Media Instructional Television)…

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 ).

Addiction research centres and the nurturing of creativity: The Centre for Addictions Research of British Columbia, Canada

PubMed Central

Stockwell, Tim; Reist, Dan; Macdonald, Scott; Benoit, Cecilia; Jansson, Mikael

2015-01-01

The Centre for Addictions Research of British Columbia (CARBC) was established as a multi-campus and multi-disciplinary research centre administered by the University of Victoria (UVic) in late 2003. Its core funding is provided from interest payments on an endowment of CAD$10.55 million. It is supported by a commitment to seven faculty appointments in various departments at UVic. The Centre has two offices, an administration and research office in Victoria and a knowledge exchange unit in Vancouver. The two offices are collaborating on the implementation of CARBC’s first 5-year plan which seeks to build capacity in British Columbia for integrated multi-disciplinary research and knowledge exchange in the areas substance use, addictions and harm reduction. Present challenges include losses to the endowment caused by the 2008/2009 economic crisis and difficulties negotiating faculty positions with the university administration. Despite these hurdles, to date each year has seen increased capacity for the Centre in terms of affiliated scientists, funding and staffing as well as output in terms of published reports, electronic resources and impacts on policy and practice. Areas of special research interest include: drug testing in the work-place, epidemiological monitoring, substance use and injury, pricing and taxation policies, privatization of liquor monopolies, poly-substance use, health determinants of indigenous peoples, street-involved youth and other vulnerable populations at risk of substance use problems. Further information about the Centre and its activities can be found on http://www.carbc.ca. PMID:20078479

WebBioBank: a new platform for integrating clinical forms and shared neurosignal analyses to support multi-centre studies in Parkinson's Disease.

PubMed

Rossi, Elena; Rosa, Manuela; Rossi, Lorenzo; Priori, Alberto; Marceglia, Sara

2014-12-01

The web-based systems available for multi-centre clinical trials do not combine clinical data collection (Electronic Health Records, EHRs) with signal processing storage and analysis tools. However, in pathophysiological research, the correlation between clinical data and signals is crucial for uncovering the underlying neurophysiological mechanisms. A specific example is the investigation of the mechanisms of action for Deep Brain Stimulation (DBS) used for Parkinson's Disease (PD); the neurosignals recorded from the DBS target structure and clinical data must be investigated. The aim of this study is the development and testing of a new system dedicated to a multi-centre study of Parkinson's Disease that integrates biosignal analysis tools and data collection in a shared and secure environment. We designed a web-based platform (WebBioBank) for managing the clinical data and biosignals of PD patients treated with DBS in different clinical research centres. Homogeneous data collection was ensured in the different centres (Operative Units, OUs). The anonymity of the data was preserved using unique identifiers associated with patients (ID BAC). The patients' personal details and their equivalent ID BACs were archived inside the corresponding OU and were not uploaded on the web-based platform; data sharing occurred using the ID BACs. The system allowed researchers to upload different signal processing functions (in a .dll extension) onto the web-based platform and to combine them to define dedicated algorithms. Four clinical research centres used WebBioBank for 1year. The clinical data from 58 patients treated using DBS were managed, and 186 biosignals were uploaded and classified into 4 categories based on the treatment (pharmacological and/or electrical). The user's satisfaction mean score exceeded the satisfaction threshold. WebBioBank enabled anonymous data sharing for a clinical study conducted at multiple centres and demonstrated the capabilities of the signal processing chain configuration as well as its effectiveness and efficiency for integrating the neurophysiological results with clinical data in multi-centre studies, which will allow the future collection of homogeneous data in large cohorts of patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia--a multi-centre randomised controlled trial.

PubMed

Priebe, Stefan; Savill, Mark; Reininghaus, Ulrich; Wykes, Til; Bentall, Richard; Lauber, Christoph; McCrone, Paul; Röhricht, Frank; Eldridge, Sandra

2013-01-14

Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Current Controlled Trials ISRCTN84216587.

Effectiveness and cost-effectiveness of body psychotherapy in the treatment of negative symptoms of schizophrenia – a multi-centre randomised controlled trial

PubMed Central

2013-01-01

Background Negative symptoms of schizophrenia are frequently associated with poor long term outcomes. Established interventions have little, if any, positive effects on negative symptoms. Arts Therapies such as Body Psychotherapy (BPT) have been suggested to reduce negative symptoms, but the existing evidence is limited. In a small exploratory trial a manualised form of group BPT led to significantly lower negative symptom levels both at the end of treatment and at 4 months follow-up as compared to supportive counseling. We designed a large multi-site trial to assess the effectiveness of a manualised BPT intervention in reducing negative symptoms, compared to an active control. Methods/Design In a randomised controlled trial, 256 schizophrenic outpatients with negative symptoms will be randomly allocated either to BPT or Pilates groups. In both conditions, patients will be offered two 90 minutes sessions per week in groups of about 8 patients over a period of 10 weeks. Outcomes are assessed at the end of treatment and at six months follow-up. The primary outcome is severity of negative symptoms, as measured by the Positive and Negative Symptom Scale (PANSS), whilst a range of secondary outcome measures include general psychopathology, social contacts, and quality of life. We will also assess the cost-effectiveness of the intervention. Discussion The study aims to evaluate the effectiveness of a promising form of group therapy which may help alleviate negative symptoms that are associated with unfavourable long-term outcomes and have so far been difficult to treat. If the trial is successful, it will add a new and effective option in the treatment of negative symptoms. Group BPT is manualised, might be attractive to many patients because of its unusual approach, and could potentially be rolled out to services at relatively little additional cost. Trial registration Current Controlled Trials ISRCTN84216587 PMID:23317474

[Multi-central controlled study on three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen].

PubMed

Zhou, Yun-feng; Wei, Yu-long; Zhang, Pu-lin; Gao, Shan; Ning, Guo-li; Zhang, Zhen-qiang; Hu, Bin; Wang, Dan-yi; Yan, Mei-rong; Liu, Wen-jun

2006-06-01

To make multi-central clinical evaluation for three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen. One hundred and sixty-six cases were randomly divided into a test group (n = 84) and a control group (n = 82). Multi-central, randomized and controlled methods were adopted. The test group were treated by the three-part massage therapy, i. e. acupoints at the head, abdomen and back were massaged, once each day; and the control group by oral administration of Guipi Pills [symbol: see text], 8 pills each time, thrice daily. The treatment was given for 15 consecutive days and then the therapeutic effects were observed. Sixty-seven cases were cured, 11 markedly effective, 3 effective, and 3 ineffective in the test group, and the corresponding figures were 10, 21, 29 and 22 in the control group with a very significant difference between the two groups (P< 0.001). The test group was superior to the control group in improvement for Pittsburgh Sleep Quality Index (PSQI), Sleepless Anxiety Scale (SAS) and Sleepless Depression Scale (SDS) (P < 0.001). The three-part massage therapy has definite therapeutic effect on insomnia of deficiency of both the heart and spleen with safety.

An elementary quantum network using robust nuclear spin qubits in diamond

NASA Astrophysics Data System (ADS)

Kalb, Norbert; Reiserer, Andreas; Humphreys, Peter; Blok, Machiel; van Bemmelen, Koen; Twitchen, Daniel; Markham, Matthew; Taminiau, Tim; Hanson, Ronald

Quantum registers containing multiple robust qubits can form the nodes of future quantum networks for computation and communication. Information storage within such nodes must be resilient to any type of local operation. Here we demonstrate multiple robust memories by employing five nuclear spins adjacent to a nitrogen-vacancy defect centre in diamond. We characterize the storage of quantum superpositions and their resilience to entangling attempts with the electron spin of the defect centre. The storage fidelity is found to be limited by the probabilistic electron spin reset after failed entangling attempts. Control over multiple memories is then utilized to encode states in decoherence protected subspaces with increased robustness. Furthermore we demonstrate memory control in two optically linked network nodes and characterize the storage capabilities of both memories in terms of the process fidelity with the identity. These results pave the way towards multi-qubit quantum algorithms in a remote network setting.

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…

SLA-based optimisation of virtualised resource for multi-tier web applications in cloud data centres

NASA Astrophysics Data System (ADS)

Bi, Jing; Yuan, Haitao; Tie, Ming; Tan, Wei

2015-10-01

Dynamic virtualised resource allocation is the key to quality of service assurance for multi-tier web application services in cloud data centre. In this paper, we develop a self-management architecture of cloud data centres with virtualisation mechanism for multi-tier web application services. Based on this architecture, we establish a flexible hybrid queueing model to determine the amount of virtual machines for each tier of virtualised application service environments. Besides, we propose a non-linear constrained optimisation problem with restrictions defined in service level agreement. Furthermore, we develop a heuristic mixed optimisation algorithm to maximise the profit of cloud infrastructure providers, and to meet performance requirements from different clients as well. Finally, we compare the effectiveness of our dynamic allocation strategy with two other allocation strategies. The simulation results show that the proposed resource allocation method is efficient in improving the overall performance and reducing the resource energy cost.

The challenges of implementing a multi-centre audit of end-of-life care in care homes.

PubMed

Levy, Jean; Kinley, Julie; Conway, Frances

2016-11-02

This article aims to share the experience of a hospice in facilitating a multi-centre audit of end-of-life care in care homes, particularly noting the challenges and enablers of carrying out the audit. The audit was a retrospective multi-centre survey of bereaved relatives/next of kin of residents who died in the care home, using an anonymous, validated questionnaire: the Family Perception of Care Scale. Questionnaires were sent 3-months after bereavement. Returned questionnaires were analysed using SPSS and Excel. The care homes were in areas encompassing outer and inner city populations. The team identified eight challenges to the audit process, in particular, embedding procedures within the care homes, non-responses and developing action plans for improvement. Overall, the audit provided an indication of where improvements could be made and where care was already excellent, built confidence and increased expertise in the care-home staff.

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.

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.

Is "Object-Centred Neglect" a Homogeneous Entity?

ERIC Educational Resources Information Center

Gainotti, Guido; Ciaraffa, Francesca

2013-01-01

The nature of object-centred (allocentric) neglect and the possibility of dissociating it from egocentric (subject-centred) forms of neglect are controversial. Originally, allocentric neglect was described by and in patients who reproduced all the elements of a multi-object scene, but left unfinished the left side of one or more of them. More…

A multi-centre evaluation of oral cancer in Southern and Western Nigeria: an African oral pathology research consortium initiative.

PubMed

Omitola, Olufemi Gbenga; Soyele, Olujide Oladele; Sigbeku, Opeyemi; Okoh, Dickson; Akinshipo, Abdulwarith Olaitan; Butali, Azeez; Adeola, Henry Ademola

2017-01-01

Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa. In this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL). Of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6 th and 7 th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071). A multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar

PubMed Central

Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-01-01

Objectives To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. Methods A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Findings Pupae per person index (PPI) decreased at the last evaluation by 5.7% (0.35–0.33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63.6% (0.33–0.12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18.6% in evaluation 2 and 44.1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. Conclusions The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment. PMID:23318238

Community-centred eco-bio-social approach to control dengue vectors: an intervention study from Myanmar.

PubMed

Wai, Khin Thet; Htun, Pe Than; Oo, Tin; Myint, Hla; Lin, Zaw; Kroeger, Axel; Sommerfeld, Johannes; Petzold, Max

2012-12-01

To build up and analyse the feasibility, process, and effectiveness of a partnership-driven ecosystem management intervention in reducing dengue vector breeding and constructing sustainable partnerships among multiple stakeholders. A community-based intervention study was conducted from May 2009 to January 2010 in Yangon city. Six high-risk and six low-risk clusters were randomized and allocated as intervention and routine service areas, respectively. For each cluster, 100 households were covered. Bi-monthly entomological evaluations (i.e. larval and pupal surveys) and household acceptability surveys at the end of 6-month intervention period were conducted, supplemented by qualitative evaluations. Intervention description: The strategies included eco-friendly multi-stakeholder partner groups (Thingaha) and ward-based volunteers, informed decision-making of householders, followed by integrated vector management approach. Pupae per person index (PPI) decreased at the last evaluation by 5·7% (0·35-0·33) in high-risk clusters. But in low-risk clusters, PPI remarkably decreased by 63·6% (0·33-0·12). In routine service area, PPI also decreased due to availability of Temephos after Cyclone Nargis. As for total number of pupae in all containers, when compared to evaluation 1, there was a reduction of 18·6% in evaluation 2 and 44·1% in evaluation 3 in intervention area. However, in routine service area, more reduction was observed. All intervention tools were found as acceptable, being feasible to implement by multi-stakeholder partner groups. The efficacy of community-controlled partnership-driven interventions was found to be superior to the vertical approach in terms of sustainability and community empowerment.

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

Multi-component access to a commercially available weight loss program: A randomized controlled trial

USDA-ARS?s Scientific Manuscript database

This study examined weight loss between a community-based, intensive behavioral counseling program (Weight Watchers PointsPlus that included three treatment access modes and a self-help condition. A total of 292 participants were randomized to a Weight Watchers (WW; n=147) or a self-help condition (...

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.

CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

PubMed

Feig, Denice S; Asztalos, Elizabeth; Corcoy, Rosa; De Leiva, Alberto; Donovan, Lois; Hod, Moshe; Jovanovic, Lois; Keely, Erin; Kollman, Craig; McManus, Ruth; Murphy, Kellie; Ruedy, Katrina; Sanchez, J Johanna; Tomlinson, George; Murphy, Helen R

2016-07-18

Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy. A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes. This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes. ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012.

The Friendly Schools Friendly Families Programme: Three-Year Bullying Behaviour Outcomes in Primary School Children

ERIC Educational Resources Information Center

Cross, Donna; Waters, Stacey; Pearce, Natasha; Shaw, Therese; Hall, Margaret; Erceg, Erin; Burns, Sharyn; Roberts, Clare; Hamilton, Greg

2012-01-01

Purpose: This three-year group randomized controlled trial assessed whether a multi-age, multi-level bullying prevention and intervention with staff capacity building, can reduce bullying among primary school children. Methods: This study comprised two intervention and one comparison conditions. Student self-report data were collected from 2552…

Transitioning Together: A Multi-Family Group Psychoeducation Program for Adolescents with ASD and Their Parents

ERIC Educational Resources Information Center

DaWalt, Leann Smith; Greenberg, Jan S.; Mailick, Marsha R.

2018-01-01

Currently there are few evidence-based programs available for families of individuals with ASD during the transition to adulthood. The present study provided a preliminary evaluation of a multi-family group psychoeducation intervention using a randomized waitlist control design (n = 41). Families in the intervention condition participated in…

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 .

Improving Urban African Americans’ Blood Pressure Control through Multi-level Interventions in the Achieving Blood Pressure Control Together (ACT) Study: A Randomized Clinical Trial

PubMed Central

Ephraim, Patti L.; Hill-Briggs, Felicia; Roter, Debra; Bone, Lee; Wolff, Jennifer; Lewis-Boyer, LaPricia; Levine, David; Aboumatar, Hanan; Cooper, Lisa A; Fitzpatrick, Stephanie; Gudzune, Kimberly; Albert, Michael; Monroe, Dwyan; Simmons, Michelle; Hickman, Debra; Purnell, Leon; Fisher, Annette; Matens, Richard; Noronha, Gary; Fagan, Peter; Ramamurthi, Hema; Ameling, Jessica; Charlston, Jeanne; Sam, Tanyka; Carson, Kathryn A.; Wang, Nae-Yuh; Crews, Deidra; Greer, Raquel; Sneed, Valerie; Flynn, Sarah J.; DePasquale, Nicole; Boulware, L. Ebony

2014-01-01

Background Given their high rates of uncontrolled blood pressure, urban African Americans comprise a particularly vulnerable subgroup of persons with hypertension. Substantial evidence has demonstrated the important role of family and community support in improving patients’ management of a variety of chronic illnesses. However, studies of multilevel interventions designed specifically to improve urban African American patients’ blood pressure self-management by simultaneously leveraging patient, family, and community strengths are lacking. Methods/Design We report the protocol of the Achieving Blood Pressure Control Together (ACT) study, a randomized controlled trial designed to study the effectiveness of interventions that engage patient, family, and community-level resources to facilitate urban African American hypertensive patients’ improved hypertension self-management and subsequent hypertension control. African American patients with uncontrolled hypertension receiving health care in an urban primary care clinic will be randomly assigned to receive 1) an educational intervention led by a community health worker alone, 2) the community health worker intervention plus a patient and family communication activation intervention, or 3) the community health worker intervention plus a problem-solving intervention. All participants enrolled in the study will receive and be trained to use a digital home blood pressure machine. The primary outcome of the randomized controlled trial will be patients’ blood pressure control at 12 months. Discussion Results from the ACT study will provide needed evidence on the effectiveness of comprehensive multi-level interventions to improve urban African American patients’ hypertension control. PMID:24956323

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.

Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV–tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis

PubMed Central

Sudarsanam, T. D.; John, J.; Kang, G.; Mahendri, V.; Gerrior, J.; Franciosa, M.; Gopal, S.; John, K. R.; Wanke, C. A.; Muliyil, J.

2014-01-01

Summary OBJECTIVE To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis (TB) with and without human immunodeficiency virus (HIV) coinfection on anti-tuberculous therapy. METHOD Randomized controlled trial on the effect of a locally prepared cereal–lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB–HIV-coinfected patients, among whom 51 received and 52 did not receive the supplement. The primary outcome evaluated at completion of TB therapy was outcome of TB treatment, as classified by the national programme. Secondary outcomes were body composition, compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation. RESULTS There was no significant difference in TB outcomes at the end of treatment, but HIV–TB coinfected individuals had four times greater odds of poor outcome than those with TB alone. Among patients with TB, 1/35 (2.9%) supplemented and 5/42(12%) of those not supplemented had poor outcomes, while among TB–HIV-coinfected individuals, 4/13 (31%) supplemented and 3/7 (42.8%) non-supplemented patients had poor outcomes at the end of treatment, and the differences were more marked after 1 year of follow-up. Although there was some trend of benefit for both TB alone and TB–HIV coinfection, the results were not statistically significant at the end of TB treatment, possibly because of limited sample size. CONCLUSION Nutritional supplements in patients are a potentially feasible, low-cost intervention, which could impact patients with TB and TB–HIV. The public health importance of these diseases in resource-limited settings suggests the need for large, multi-centre randomized control trials on nutritional supplementation. PMID:21418447

Intravenous midazolam-droperidol combination, droperidol or olanzapine monotherapy for methamphetamine-related acute agitation: subgroup analysis of a randomized controlled trial.

PubMed

Yap, Celene Y L; Taylor, David McD; Knott, Jonathan C; Taylor, Simone E; Phillips, Georgina A; Karro, Jonathan; Chan, Esther W; Kong, David C M; Castle, David J

2017-07-01

To examine the efficacy and safety of (1) midazolam-droperidol versus droperidol and (2) midazolam-droperidol versus olanzapine for methamphetamine-related acute agitation. A multi-centre, randomized, double-blind, controlled, clinical trial was conducted in two Australian emergency departments, between October 2014 and September 2015. Three hundred and sixty-one patients, aged 18-65 years, requiring intravenous medication sedation for acute agitation, were enrolled into this study. We report the results of a subgroup of 92 methamphetamine-affected patients. Patients were assigned randomly to receive either an intravenous bolus of midazolam 5 mg-droperidol 5 mg combined, droperidol 10 mg or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg or olanzapine 5 mg, respectively. The primary outcome was the proportion of patients sedated adequately at 10 minutes. Odds ratios with 95% confidence intervals (ORs, 95% CI) were estimated. The baseline characteristics of patients in the three groups were similar. At 10 minutes, significantly more patients in the midazolam-droperidol group [29 of 34 (85.3%)] were sedated adequately compared with the droperidol group [14 of 30 (46.7%), OR = 6.63, 95% CI = 2.02-21.78] or with the olanzapine group [14 of 28 (50.0%), OR 5.80, 95% CI = 1.74-19.33]. The number of patients who experienced an adverse event (AE) in the midazolam-droperidol, droperidol and olanzapine groups was seven of 34, two of 30 and six of 28, respectively. The most common AE was oxygen desaturation. A midazolam-droperidol combination appears to provide more rapid sedation of patients with methamphetamine-related acute agitation than droperidol or olanzapine alone. © 2017 Society for the Study of Addiction.

Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis.

PubMed

Sudarsanam, T D; John, J; Kang, G; Mahendri, V; Gerrior, J; Franciosa, M; Gopal, S; John, K R; Wanke, C A; Muliyil, J

2011-06-01

To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis (TB) with and without human immunodeficiency virus (HIV) coinfection on anti-tuberculous therapy. Randomized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB-HIV-coinfected patients, among whom 51 received and 52 did not receive the supplement. The primary outcome evaluated at completion of TB therapy was outcome of TB treatment, as classified by the national programme. Secondary outcomes were body composition, compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation. There was no significant difference in TB outcomes at the end of treatment, but HIV-TB coinfected individuals had four times greater odds of poor outcome than those with TB alone. Among patients with TB, 1/35 (2.9%) supplemented and 5/42(12%) of those not supplemented had poor outcomes, while among TB-HIV-coinfected individuals, 4/13 (31%) supplemented and 3/7 (42.8%) non-supplemented patients had poor outcomes at the end of treatment, and the differences were more marked after 1 year of follow-up. Although there was some trend of benefit for both TB alone and TB-HIV coinfection, the results were not statistically significant at the end of TB treatment, possibly because of limited sample size. Nutritional supplements in patients are a potentially feasible, low-cost intervention, which could impact patients with TB and TB-HIV. The public health importance of these diseases in resource-limited settings suggests the need for large, multi-centre randomized control trials on nutritional supplementation. © 2011 Blackwell Publishing Ltd.

Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Gyejibongnyeong-hwan (GJBNH) is one of the most popular Korean medicine formulas for menstrual pain of dysmenorrhea. The concept of blood stagnation in Korean medicine is considered the main factor of causing abdominal pain, or cramps, during menstrual periods. To treat the symptoms, GJBNH is used to fluidify the stagnated blood and induce the blood flow to be smooth, reducing pain as the result. The purpose of this trial is to identify the efficacy of GJBNH in dysmenorrhea caused by blood stagnation. Methods This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35) will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline), all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1) through the second follow-up (Visit 6) the entire process will take 25 weeks. Discussion This trial will provide evidence for the effectiveness of GJBNH in treating periodical pain due to dysmenorrhea that is caused by blood stagnation. The primary outcome between the two groups will be measured by changes in the Visual Analogue Score (VAS) of pain. The secondary outcome will be measured by the Blood Stagnation Scale, the Short-form McGill questionnaire and the COX menstrual symptom scale. Analysis of covariance (ANCOVA) and repeated measured ANOVA will be used to analyze the data analysis. Trial registration Current Controlled Trials: ISRCTN30426947 PMID:22217258

Effects of a healthy Nordic diet on plasma 25-hydroxyvitamin D concentration in subjects with metabolic syndrome: a randomized, [corrected] controlled trial (SYSDIET).

PubMed

Brader, Lea; Rejnmark, Lars; Carlberg, Carsten; Schwab, Ursula; Kolehmainen, Marjukka; Rosqvist, Fredrik; Cloetens, Lieselotte; Landin-Olsson, Mona; Gunnarsdottir, Ingibjorg; Poutanen, Kaisa S; Herzig, Karl-Heinz; Risérus, Ulf; Savolainen, Markku J; Thorsdottir, Inga; Uusitupa, Matti; Hermansen, Kjeld

2014-06-01

At northern latitudes, vitamin D is not synthesized endogenously during winter, causing low plasma 25-hydroxyvitamin D (25(OH)D) concentrations. Therefore, we evaluated the effects of a healthy Nordic diet based on Nordic nutrition recommendations (NNR) on plasma 25(OH)D and explored its dietary predictors. In a Nordic multi-centre trial, subjects (n = 213) with metabolic syndrome were randomized to a control or a healthy Nordic diet favouring fish (≥300 g/week, including ≥200 g/week fatty fish), whole-grain products, berries, fruits, vegetables, rapeseed oil and low-fat dairy products. Plasma 25(OH)D and parathyroid hormone were analysed before and after 18- to 24-week intervention. At baseline, 45 % had vitamin D inadequacy (<50 nmol/l), whereas 8 % had deficiency (<25 nmol/l). Dietary vitamin D intake was increased by the healthy Nordic diet (P < 0.001). The healthy Nordic and the control diet reduced the prevalence of vitamin D inadequacy by 42 % (P < 0.001) and 19 % (P = 0.002), respectively, without between-group difference (P = 0.142). Compared with control, plasma 25(OH)D (P = 0.208) and parathyroid hormone (P = 0.207) were not altered by the healthy Nordic diet. Predictors for 25(OH)D were intake of vitamin D, eicosapentaenoic acids (EPA), docosahexaenoic acids (DHA), vitamin D supplement, plasma EPA and plasma DHA. Nevertheless, only vitamin D intake and season predicted the 25(OH)D changes. Consuming a healthy Nordic diet based on NNR increased vitamin D intake but not plasma 25(OH)D concentration. The reason why fish consumption did not improve vitamin D status might be that many fish are farmed and might contain little vitamin D or that frying fish may result in vitamin D extraction. Additional ways to improve vitamin D status in Nordic countries may be needed.

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.

Effect of multi-strain probiotics (multi-strain microbial cell preparation) on glycemic control and other diabetes-related outcomes in people with type 2 diabetes: a randomized controlled trial.

PubMed

Firouzi, Somayyeh; Majid, Hazreen Abdul; Ismail, Amin; Kamaruddin, Nor Azmi; Barakatun-Nisak, Mohd-Yusof

2017-06-01

Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing. However, the effect of multi-strain probiotics in people with type 2 diabetes remains unclear. This study investigated the effect of multi-strain microbial cell preparation-also refers to multi-strain probiotics-on glycemic control and other diabetes-related outcomes in people with type 2 diabetes. A randomized, double-blind, parallel-group, controlled clinical trial. Diabetes clinic of a teaching hospital in Kuala Lumpur, Malaysia. A total of 136 participants with type 2 diabetes, aged 30-70 years, were recruited and randomly assigned to receive either probiotics (n = 68) or placebo (n = 68) for 12 weeks. Primary outcomes were glycemic control-related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract. Intention-to-treat (ITT) analysis was performed on all participants, while per-protocol (PP) analysis was performed on those participants who had successfully completed the trial with good compliance rate. With respect to primary outcomes, glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0.02 % in the placebo group in PP analysis (p < 0.05, small effect size of 0.050), while these changes were not significant in ITT analysis. Fasting insulin increased by 1.8 µU/mL in placebo group and decreased by 2.9 µU/mL in probiotics group in PP analysis. These changes were significant between groups at both analyses (p < 0.05, medium effect size of 0.062 in PP analysis and small effect size of 0.033 in ITT analysis). Secondary outcomes did not change significantly. Probiotics successfully passed through the gastrointestinal tract. Probiotics modestly improved HbA1c and fasting insulin in people with type 2 diabetes.

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 .

Systematic review and meta-analysis: Multi-strain probiotics as adjunct therapy for Helicobacter pylori eradication and prevention of adverse events

PubMed Central

Huang, Ying; Wang, Lin; Malfertheiner, Peter

2015-01-01

Background Eradication rates with triple therapy for Helicobacter pylori infections have currently declined to unacceptable levels worldwide. Newer quadruple therapies are burdened with a high rate of adverse events. Whether multi-strain probiotics can improve eradication rates or diminish adverse events remains uncertain. Methods Relevant publications in which patients with H. pylori infections were randomized to a multi-strain probiotic or control were identified in PubMed, Cochrane Databases, and other sources from 1 January 1960–3 June 2015. Primary outcomes included eradication rates, incidence of any adverse event and the incidence of antibiotic-associated diarrhea. As probiotic efficacy is strain-specific, pooled relative risks and 95% confidence intervals were calculated using meta-analysis stratified by similar multi-strain probiotic mixtures. Results A total of 19 randomized controlled trials (20 treatment arms, n = 2730) assessing one of six mixtures of strains of probiotics were included. Four multi-strain probiotics significantly improved H. pylori eradication rates, five significantly prevented any adverse reactions and three significantly reduced antibiotic-associated diarrhea. Only two probiotic mixtures (Lactobacillus acidophilus/Bifidobacterium animalis and an eight-strain mixture) had significant efficacy for all three outcomes. Conclusions Our meta-analysis found adjunctive use of some multi-strain probiotics may improve H. pylori eradication rates and prevent the development of adverse events and antibiotic-associated diarrhea, but not all mixtures were effective. PMID:27536365

DEMAT: A multi-institutional dosimetry audit of rotational and static intensity-modulated radiotherapy.

PubMed

Lafond, Caroline; Chiavassa, Sophie; Bertaut, Cindy; Boussion, Nicolas; Chapel, Nathalie; Chapron, Lucie; Coste, Frédéric; Crespin, Sylvain; Dy, Gilles; Faye, Papa Abdoulaye; Leleu, Cyril; Bouvier, Jeanne; Madec, Ludovic; Mesgouez, Jérôme; Palisson, Jérémy; Vela, Anthony; Delpon, Grégory

2016-05-01

Static beam intensity-modulated-radiation-therapy (IMRT) and/or Volumetric-Modulated-Arc-Therapy (VMAT) are now available in many regional radiotherapy departments. The aim of this multi-institutional audit was to design a new methodology based on radiochromic films to perform an independent quality control. A set of data were sent to all participating centres for two clinical localizations: prostate and Head and Neck (H&N) cancers. The agreement between calculations and measurements was verified in the Octavius phantom (PTW) by point measurements using ionization chambers and by 2D measurements using EBT3 radiochromic films. Due to uncertainties in the whole procedure, criteria were set to 5% and 3% in local dose and 3mm in distance excluding doses lower than 10% of the maximum doses. No normalization point or area was used for the quantitative analysis. 13 radiotherapy centres participated in this audit involving 28 plans (12 IMRT, 16 VMAT). For point measurements, mean errors were -0.18±1.54% and 0.00±1.58% for prostate and H&N cases respectively. For 2D measurements with 5%/3mm criteria, gamma map analysis showed a pixel pass rate higher than 95% for prostate and H&N. Mean gamma index was lower than 0.4 for prostate and 0.5 for H&N. Both techniques yielded similar results. This study showed the feasibility of an independent quality control by peers for conventional IMRT and VMAT. Results from all participating centres were found to be in good agreement. This regional study demonstrated the feasibility of our new methodology based on radiochromic films without dose normalization on a specific point. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

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.

Early home-based group education to support informed decision-making among patients with end-stage renal disease: a multi-centre randomized controlled trial.

PubMed

Massey, Emma K; Gregoor, Peter J H Smak; Nette, Robert W; van den Dorpel, Marinus A; van Kooij, Anthony; Zietse, Robert; Zuidema, Willij C; Timman, Reinier; Busschbach, Jan J; Weimar, Willem

2016-05-01

The aim was to test the effectiveness of early home-based group education on knowledge and communication about renal replacement therapy (RRT). We conducted a randomized controlled trial using a cross-over design among 80 end-stage renal disease (ESRD) patients. Between T0 and T1 (weeks 1-4) Group 1 received the intervention and Group 2 received standard care. Between T1 and T2 (weeks 5-8) Group 1 received standard care and Group 2 received the intervention. The intervention was a group education session on RRT options held in the patient's home given by social workers. Patients invited members from their social network to attend. Self-report questionnaires were used at T0, T1 and T2 to measure patients' knowledge and communication, and concepts from the Theory of Planned Behaviour such as attitude. Comparable questionnaires were completed pre-post intervention by 229 attendees. Primary RRT was registered up to 2 years post-intervention. Multilevel linear modelling was used to analyse patient data and paired t-tests for attendee data. Statistically significant increases in the primary targets knowledge and communication were found among patients and attendees after receiving the intervention. The intervention also had a significant effect in increasing positive attitude toward living donation and haemodialysis. Of the 80 participants, 49 underwent RRT during follow-up. Of these, 34 underwent a living donor kidney transplant, of which 22 were pre-emptive. Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

PubMed

Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

2018-03-01

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. Copyright © 2018.

The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy.

PubMed

Schurmans, Céline; De Baetselier, Irith; Kestelyn, Evelyne; Jespers, Vicky; Delvaux, Thérèse; Agaba, Stephen K; van Loen, Harry; Menten, Joris; van de Wijgert, Janneke; Crucitti, Tania

2015-04-10

Research is ongoing to develop multipurpose vaginal rings to be used continuously for contraception and to prevent Human Immunodeficiency Virus (HIV) infection. Contraceptive vaginal rings (CVRs) are available in a number of countries and are most of the time used intermittently i.e. three weeks out of a 4-week cycle. Efficacy trials with a dapivirine-containing vaginal ring for HIV prevention are ongoing and plans to develop multi-purpose vaginal rings for prevention of both HIV and pregnancy have been elaborated. In contrast with the CVRs, multi-purpose vaginal rings will have to be used continuously. Women who continuously use a CVR will no longer have menses. Furthermore, some safety aspects of CVR use have never been studied in-depth in the past, such as the impact of the vaginal ring on the vaginal microbiota, biofilm formation and induction of inflammation. We studied acceptability and these novel aspects of safety in Rwandan women. Although significant progress has been made over the past decade, Rwanda still has a high unmet need for contraception (with 47% unplanned births) and a generalized HIV epidemic, and CVRs are not yet available. We will conduct an open label, single centre, randomized controlled trial. A total of 120 HIV-negative women will be randomized to intermittent CVR use (to allow menstruation) or continuous CVR use. Women will be followed for a maximum of 14 weeks. In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology. In addition to evaluating the safety and acceptability of intermittent and continuous CVR use in Rwandan women, we hope that our findings will inform the development of future multipurpose vaginal rings, will prepare Rwandan study populations for future clinical trials of multipurpose vaginal rings, and will pave the way for introduction of CVRs on African markets. Clinicaltrials.gov NCT01796613 . Registered 14 February 2013.

Effectiveness of Exercise Interventions to Improve Postural Control in Older Adults: A Systematic Review and Meta-Analyses of Centre of Pressure Measurements.

PubMed

Low, Daniel C; Walsh, Gregory S; Arkesteijn, Marco

2017-01-01

Previous reviews have shown balance in older adults to be improved with exercise. However, it is currently unclear whether postural control, indicated by centre of pressure (COP) measurement, can be improved in older adults and thus whether postural control could be a mechanism to improve balance. The purpose of this systematic review was to assess the effectiveness of force platform COP variables to identify changes in postural control following exercise interventions in older adults. In addition, a secondary purpose was to determine whether the exercise types (balance, resistance or multi-component exercise interventions) are equally effective to improve postural control. Randomised controlled trials were identified using searches of databases and reference lists (PROSPERO registration number CRD42014010617). Trials performing exercise interventions, reporting force platform COP measurements, in participants with a mean age of ≥60 years were included. Risk of bias assessments were performed following the Cochrane guidelines. Data were pooled in meta-analyses, and standardised mean differences (SMDs) with 95 % confidence intervals (CIs) were calculated. Twenty-three trials met the inclusion criteria for the systematic review. Twenty-two trials could be defined as either utilising a balance, resistance or multi-component exercise intervention. These 22 trials were used in the meta-analyses. All trials reported measurements of double leg stance; eight trials reported additional stance conditions. The meta-analyses of double leg stance showed that balance exercise interventions significantly decreased total sway path length/velocity [SMD -1.13, 95 % CI -1.75 to -0.51 (eyes open); SMD -0.79, 95 % CI -1.33 to -0.26 (eyes closed)] and anterior-posterior sway path length/velocity [SMD -1.02, 95 % CI -2.01 to -0.02 (eyes open); SMD -0.82, 95 % CI -1.46 to -0.17 (eyes closed)] in both eyes open and eyes closed conditions. Balance exercise interventions also decreased sway area in eyes closed conditions (SMD -0.57, 95 % CI -1.01 to -0.13) and medio-lateral sway path length/velocity in eyes open conditions (SMD -0.8, 95 % CI -1.48 to -0.12). In contrast, neither resistance nor multi-component exercise interventions affected any of the included COP measurements. Postural control is improved by balance exercise interventions. In contrast, strength or multi-component exercise interventions did not influence postural control measurements in older adults. In addition, a lack of standardisation in collection protocol and COP variables calculated across trials was identified.

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

Umbilical Cord Blood Use for Admission Blood Tests of VLBW (Very Low Birth Weight) Preterm Neonates: A Multi-center Randomized Clinical Trial

DTIC Science & Technology

2016-09-12

agents (erythropoietin and darbepoetin alfa ), and limiting phlebotomy via use of point-of-care testing devices, benchtop laboratory analyzers, and...Manual, 2014. 18: p. 571-592. 6. Ohls, R.K., et al., A randomized, masked, placebo-controlled study of darbepoetin alfa in preterm infants. Pediatrics

Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial.

PubMed

Khan, Habib Rehman; Kralj-Hans, Ines; Haldar, Shouvik; Bahrami, Toufan; Clague, Jonathan; De Souza, Anthony; Francis, Darrel; Hussain, Wajid; Jarman, Julian; Jones, David Gareth; Mediratta, Neeraj; Mohiaddin, Raad; Salukhe, Tushar; Jones, Simon; Lord, Joanne; Murphy, Caroline; Kelly, Joanna; Markides, Vias; Gupta, Dhiraj; Wong, Tom

2018-02-20

Atrial fibrillation is the commonest arrhythmia which raises the risk of heart failure, thromboembolic stroke, morbidity and death. Pharmacological treatments of this condition are focused on heart rate control, rhythm control and reduction in risk of stroke. Selective ablation of cardiac tissues resulting in isolation of areas causing atrial fibrillation is another treatment strategy which can be delivered by two minimally invasive interventions: percutaneous catheter ablation and thoracoscopic surgical ablation. The main purpose of this trial is to compare the effectiveness and safety of these two interventions. Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF) is a prospective, multi-centre, randomised controlled trial within three NHS tertiary cardiovascular centres specialising in treatment of atrial fibrillation. Eligible adults (n = 120) with symptomatic, long-standing, persistent atrial fibrillation will be randomly allocated to either catheter ablation or thoracoscopic ablation in a 1:1 ratio. Pre-determined lesion sets will be delivered in each treatment arm with confirmation of appropriate conduction block. All patients will have an implantable loop recorder (ILR) inserted subcutaneously immediately following ablation to enable continuous heart rhythm monitoring for at least 12 months. The devices will be programmed to detect episodes of atrial fibrillation and atrial tachycardia ≥ 30 s in duration. The patients will be followed for 12 months, completing appropriate clinical assessments and questionnaires every 3 months. The ILR data will be wirelessly transmitted daily and evaluated every month for the duration of the follow-up. The primary endpoint in the study is freedom from atrial fibrillation and atrial tachycardia at the end of the follow-up period. The CASA-AF Trial is a National Institute for Health Research-funded study that will provide first-class evidence on the comparative efficacy, safety and cost-effectiveness of thoracoscopic surgical ablation and conventional percutaneous catheter ablation for long-standing persistent atrial fibrillation. In addition, the results of the trial will provide information on the effects on patients' quality of life. ISRCTN Registry, ISRCTN18250790 . Registered on 24 April 2015.

The Effects of Collaborative Strategic Reading Instruction on the Reading Comprehension of Middle School Students: Year 2 Replication

ERIC Educational Resources Information Center

Swanson, Elizabeth; Mohammed, Sarojani S.; Boardman, Alison Gould; Vaughn, Sharon; Klingner, Janette; Roberts, Greg; Leroux, Audrey; Solis, Michael

2011-01-01

The current study is the second in a series of multi-site, multi-year randomized control trials designed to test the efficacy of a fully developed intervention, Collaborative Strategic Reading (CSR), with adolescent readers. In year 1, the research questions were: (1) Does CSR improve reading comprehension for adolescent readers attending…

Effect of Multi Modal Representations on the Critical Thinking Skills of the Fifth Grade Students

ERIC Educational Resources Information Center

Öz, Muhittin; Memis, Esra Kabatas

2018-01-01

The purpose of this study was to explore the effects of multi modal representations within writing to learn activities on students' critical thinking. Mixed method was used. The participants included 32 students 5th grade from elementary school. The groups were randomly selected as a control group and the other class was selected as the…

The Dutch Birth Centre Study: study design of a programmatic evaluation of the effect of birth centre care in the Netherlands.

PubMed

Hermus, Marieke A A; Wiegers, Therese A; Hitzert, Marit F; Boesveld, Inge C; van den Akker-van Marle, M Elske; Akkermans, Henk A; Bruijnzeels, Marc A; Franx, Arie; de Graaf, Johanna P; Rijnders, Marlies E B; Steegers, Eric A P; van der Pal-de Bruin, Karin M

2015-07-16

Birth centres are regarded as settings where women with uncomplicated pregnancies can give birth, assisted by a midwife and a maternity care assistant. In case of (threatening) complications referral to a maternity unit of a hospital is necessary. In the last decade up to 20 different birth centres have been instituted in the Netherlands. This increase in birth centres is attributed to various reasons such as a safe and easy accessible place of birth, organizational efficiency in integration of care and direct access to obstetric hospital care if needed, and better use of maternity care assistance. Birth centres are assumed to offer increased integration and quality of care and thus to contribute to better perinatal and maternal outcomes. So far there is no evidence for this assumption as no previous studies of birth centres have been carried out in the Netherlands. The aims are 1) Identification of birth centres and measuring integration of organization and care 2) Measuring the quality of birth centre care 3) Effects of introducing a birth centre on regional quality and provision of care 4) Cost-effectiveness analysis 5) In depth longitudinal analysis of the organization and processes in birth centres. Different qualitative and quantitative methods will be used in the different sub studies. The design is a multi-centre, multi-method study, including surveys, interviews, observations, and analysis of registration data and documents. The results of this study will enable users of maternity care, professionals, policy makers and health care financers to make an informed choice about the kind of birth location that is appropriate for their needs and wishes.

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.

Implementing training and support, financial reimbursement, and referral to an internet-based brief advice program to improve the early identification of hazardous and harmful alcohol consumption in primary care (ODHIN): study protocol for a cluster randomized factorial trial.

PubMed

Keurhorst, Myrna N; Anderson, Peter; Spak, Fredrik; Bendtsen, Preben; Segura, Lidia; Colom, Joan; Reynolds, Jillian; Drummond, Colin; Deluca, Paolo; van Steenkiste, Ben; Mierzecki, Artur; Kłoda, Karolina; Wallace, Paul; Newbury-Birch, Dorothy; Kaner, Eileen; Gual, Toni; Laurant, Miranda G H

2013-01-24

The European level of alcohol consumption, and the subsequent burden of disease, is high compared to the rest of the world. While screening and brief interventions in primary healthcare are cost-effective, in most countries they have hardly been implemented in routine primary healthcare. In this study, we aim to examine the effectiveness and efficiency of three implementation interventions that have been chosen to address key barriers for improvement: training and support to address lack of knowledge and motivation in healthcare providers; financial reimbursement to compensate the time investment; and internet-based counselling to reduce workload for primary care providers. In a cluster randomized factorial trial, data from Catalan, English, Netherlands, Polish, and Swedish primary healthcare units will be collected on screening and brief advice rates for hazardous and harmful alcohol consumption. The three implementation strategies will be provided separately and in combination in a total of seven intervention groups and compared with a treatment as usual control group. Screening and brief intervention activities will be measured at baseline, during 12 weeks and after six months. Process measures include health professionals' role security and therapeutic commitment of the participating providers (SAAPPQ questionnaire). A total of 120 primary healthcare units will be included, equally distributed over the five countries. Both intention to treat and per protocol analyses are planned to determine intervention effectiveness, using random coefficient regression modelling. Effective interventions to implement screening and brief interventions for hazardous alcohol use are urgently required. This international multi-centre trial will provide evidence to guide decision makers.

British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints.

PubMed

Whinnett, Zachary I; Sohaib, S M Afzal; Jones, Siana; Kyriacou, Andreas; March, Katherine; Coady, Emma; Mayet, Jamil; Hughes, Alun D; Frenneaux, Michael; Francis, Darrel P

2014-04-03

Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources. BRAVO is a multi-centre, randomized, cross-over, non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device. Patients are randomly allocated to six months in each arm. In the echocardiographic arm, AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI. In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography. At the end of each six month arm, patients undergo the primary outcome measure of objective exercise capacity, quantified as peak oxygen uptake (VO2) on a cardiopulmonary exercise test. Secondary outcome measures are echocardiographic measurement of left ventricular remodelling, quality of life score and N-terminal pro B-type Natriuretic Peptide (NT-pro BNP). The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014. If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented. Clinicaltrials.gov NCT01258829.

The effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes.

PubMed

Hermanns, Norbert; Kulzer, Bernhard; Maier, Berthold; Mahr, Marina; Haak, Thomas

2012-02-01

In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC). We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight. 186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.2±1.1% to 7.8±1.5%) in the ACC and 0.63% (from 8.5±1.5% to 7.9±1.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.4±7.1) than in ACC (0.4±9.0; p=0.31). MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress. MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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.

Diagnosis of neglected tropical diseases among patients with persistent digestive disorders (diarrhoea and/or abdominal pain ≥14 days): Pierrea multi-country, prospective, non-experimental case-control study.

PubMed

Polman, Katja; Becker, Sören L; Alirol, Emilie; Bhatta, Nisha K; Bhattarai, Narayan R; Bottieau, Emmanuel; Bratschi, Martin W; Burza, Sakib; Coulibaly, Jean T; Doumbia, Mama N; Horié, Ninon S; Jacobs, Jan; Khanal, Basudha; Landouré, Aly; Mahendradhata, Yodi; Meheus, Filip; Mertens, Pascal; Meyanti, Fransiska; Murhandarwati, Elsa H; N'Goran, Eliézer K; Peeling, Rosanna W; Ravinetto, Raffaella; Rijal, Suman; Sacko, Moussa; Saye, Rénion; Schneeberger, Pierre H H; Schurmans, Céline; Silué, Kigbafori D; Thobari, Jarir A; Traoré, Mamadou S; van Lieshout, Lisette; van Loen, Harry; Verdonck, Kristien; von Müller, Lutz; Yansouni, Cédric P; Yao, Joel A; Yao, Patrick K; Yap, Peiling; Boelaert, Marleen; Chappuis, François; Utzinger, Jürg

2015-08-18

Diarrhoea still accounts for considerable mortality and morbidity worldwide. The highest burden is concentrated in tropical areas where populations lack access to clean water, adequate sanitation and hygiene. In contrast to acute diarrhoea (<14 days), the spectrum of pathogens that may give rise to persistent diarrhoea (≥14 days) and persistent abdominal pain is poorly understood. It is conceivable that pathogens causing neglected tropical diseases play a major role, but few studies investigated this issue. Clinical management and diagnostic work-up of persistent digestive disorders in the tropics therefore remain inadequate. Hence, important aspects regarding the pathogenesis, epidemiology, clinical symptomatology and treatment options for patients presenting with persistent diarrhoea and persistent abdominal pain should be investigated in multi-centric clinical studies. This multi-country, prospective, non-experimental case-control study will assess persistent diarrhoea (≥14 days; in individuals aged ≥1 year) and persistent abdominal pain (≥14 days; in children/adolescents aged 1-18 years) in up to 2000 symptomatic patients and 2000 matched controls. Subjects from Côte d'Ivoire, Indonesia, Mali and Nepal will be clinically examined and interviewed using a detailed case report form. Additionally, each participant will provide a stool sample that will be examined using a suite of diagnostic methods (i.e., microscopic techniques, rapid diagnostic tests, stool culture and polymerase chain reaction) for the presence of bacterial and parasitic pathogens. Treatment will be offered to all infected participants and the clinical treatment response will be recorded. Data obtained will be utilised to develop patient-centred clinical algorithms that will be validated in primary health care centres in the four study countries in subsequent studies. Our research will deepen the understanding of the importance of persistent diarrhoea and related digestive disorders in the tropics. A diversity of intestinal pathogens will be assessed for potential associations with persistent diarrhoea and persistent abdominal pain. Different diagnostic methods will be compared, clinical symptoms investigated and diagnosis-treatment algorithms developed for validation in selected primary health care centres. The findings from this study will improve differential diagnosis and evidence-based clinical management of digestive syndromes in the tropics. ClinicalTrials.gov; identifier: NCT02105714 .

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

Caring letters for suicide prevention: implementation of a multi-site randomized clinical trial in the U.S. military and Veteran Affairs healthcare systems.

PubMed

Luxton, David D; Thomas, Elissa K; Chipps, Joan; Relova, Rona M; Brown, Daphne; McLay, Robert; Lee, Tina T; Nakama, Helenna; Smolenski, Derek J

2014-03-01

Caring letters is a suicide prevention intervention that entails the sending of brief messages that espouse caring concern to patients following discharge from treatment. First tested more than four decades ago, this intervention is one of the only interventions shown in a randomized controlled trial to reduce suicide mortality rates. Due to elevated suicide risk among patients following psychiatric hospitalization and the steady increase in suicide rates among the U.S. military personnel, it is imperative to test interventions that may help prevent suicide among high-risk military personnel and veterans. This paper describes the design, methods, study protocol, and regulatory implementation processes for a multi-site randomized controlled trial that aims to evaluate the effectiveness of a caring emails intervention for suicide prevention in the military and VA healthcare systems. The primary outcome is suicide mortality rates to be determined 24 months post-discharge from index hospital stay. Healthcare re-utilization rates will also be evaluated and comprehensive data will be collected regarding suicide risk factors. Recommendations for navigating the military and VA research regulatory processes and implementing a multi-site clinical trial at military and VA hospitals are discussed. Published by Elsevier Inc.

Ecological, biological and social dimensions of dengue vector breeding in five urban settings of Latin America: a multi-country study.

PubMed

Quintero, Juliana; Brochero, Helena; Manrique-Saide, Pablo; Barrera-Pérez, Mario; Basso, César; Romero, Sonnia; Caprara, Andrea; De Lima Cunha, Jane Cris; Beltrán-Ayala, Efraín; Mitchell-Foster, Kendra; Kroeger, Axel; Sommerfeld, Johannnes; Petzold, Max

2014-01-21

Dengue is an increasingly important public health problem in most Latin American countries and more cost-effective ways of reducing dengue vector densities to prevent transmission are in demand by vector control programs. This multi-centre study attempted to identify key factors associated with vector breeding and development as a basis for improving targeted intervention strategies. In each of 5 participant cities in Mexico, Colombia, Ecuador, Brazil and Uruguay, 20 clusters were randomly selected by grid sampling to incorporate 100 contiguous households, non-residential private buildings (businesses) and public spaces. Standardized household surveys, cluster background surveys and entomological surveys specifically targeted to obtain pupal indices for Aedes aegypti, were conducted in the dry and wet seasons. The study clusters included mainly urban low-middle class populations with satisfactory infrastructure and -except for Uruguay- favourable climatic conditions for dengue vector development. Household knowledge about dengue and "dengue mosquitoes" was widespread, mainly through mass media, but there was less awareness around interventions to reduce vector densities. Vector production (measured through pupal indices) was favoured when water containers were outdoor, uncovered, unused (even in Colombia and Ecuador where the large tanks used for household water storage and washing were predominantly productive) and -particularly during the dry season- rainwater filled. Larval infestation did not reflect productive container types. All productive container types, including those important in the dry season, were identified by pupal surveys executed during the rainy season. A number of findings are relevant for improving vector control: 1) there is a need for complementing larval surveys with occasional pupal surveys (to be conducted during the wet season) for identifying and subsequently targeting productive container types; 2) the need to raise public awareness about useful and effective interventions in productive container types specific to their area; and 3) the motivation for control services that-according to this and similar studies in Asia- dedicated, targeted vector management can make a difference in terms of reducing vector abundance.

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

PubMed

Augestad, Knut M; Vonen, Barthold; Aspevik, Ranveig; Nestvold, Torunn; Ringberg, Unni; Johnsen, Roar; Norum, Jan; Lindsetmo, Rolv-Ole

2008-06-25

All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve. This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

[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.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Fibre optical spectroscopy and sensing innovation at innoFSPEC Potsdam

NASA Astrophysics Data System (ADS)

Haynes, Roger; Reich, Oliver; Rambold, William; Hass, Roland; Janssen, Katja

2010-07-01

In October 2009, an interdisciplinary centre for fibre spectroscopy and sensing, innoFSPEC Potsdam, has been established as joint initiative of the Astrophysikalisches Institut Potsdam (AIP) and the Physical Chemistry group of Potsdam University (UPPC), Germany. The centre focuses on fundamental research in the two fields of fibre-coupled multi-channel spectroscopy and optical fibre-based sensing. Thanks to its interdisciplinary approach, the complementary methodologies of astrophysics on the one hand, and physical chemistry on the other hand, are expected to spawn synergies that otherwise would not normally become available in more standard research programmes. innoFSPEC Potsdam targets future innovations for next generation astrophysical instrumentation, environmental analysis, manufacturing control and process analysis, medical diagnostics, non-invasive imaging spectroscopy, biopsy, genomics/proteomics, high throughput screening, and related applications.

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

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

Multi-Cellular Logistics of Collective Cell Migration

PubMed Central

Yamao, Masataka; Naoki, Honda; Ishii, Shin

2011-01-01

During development, the formation of biological networks (such as organs and neuronal networks) is controlled by multicellular transportation phenomena based on cell migration. In multi-cellular systems, cellular locomotion is restricted by physical interactions with other cells in a crowded space, similar to passengers pushing others out of their way on a packed train. The motion of individual cells is intrinsically stochastic and may be viewed as a type of random walk. However, this walk takes place in a noisy environment because the cell interacts with its randomly moving neighbors. Despite this randomness and complexity, development is highly orchestrated and precisely regulated, following genetic (and even epigenetic) blueprints. Although individual cell migration has long been studied, the manner in which stochasticity affects multi-cellular transportation within the precisely controlled process of development remains largely unknown. To explore the general principles underlying multicellular migration, we focus on the migration of neural crest cells, which migrate collectively and form streams. We introduce a mechanical model of multi-cellular migration. Simulations based on the model show that the migration mode depends on the relative strengths of the noise from migratory and non-migratory cells. Strong noise from migratory cells and weak noise from surrounding cells causes “collective migration,” whereas strong noise from non-migratory cells causes “dispersive migration.” Moreover, our theoretical analyses reveal that migratory cells attract each other over long distances, even without direct mechanical contacts. This effective interaction depends on the stochasticity of the migratory and non-migratory cells. On the basis of these findings, we propose that stochastic behavior at the single-cell level works effectively and precisely to achieve collective migration in multi-cellular systems. PMID:22205934

Performance comparison among the major healthcare financing systems in six cities of the Pearl River Delta region, mainland China.

PubMed

Wong, Martin C S; Wang, Harry H X; Wong, Samuel Y S; Wei, Xiaolin; Yang, Nan; Zhang, Zhenzhen; Li, Haitao; Gao, Yang; Li, Donald K T; Tang, Jinling; Wang, Jiaji; Griffiths, Sian M

2012-01-01

The healthcare system of mainland China is undergoing drastic reform and the optimal models for healthcare financing for provision of primary care will need to be identified. This study compared the performance indicators of the community health centres (CHCs) under different healthcare financing systems in the six cities of the Pearl River Delta region. Approximately 300 hypertensive patients were randomly recruited from the computerized chronic disease management records provided by one CHC in each of the six cities in 2011 using a multi-stage cluster random sampling method. The major outcome measures included the treatment rate of hypertension, defined as prescription of ≥ one antihypertensive agent; and the control rate of hypertension, defined as systolic blood pressure levels <140 mmHg and diastolic blood pressure levels <90 mmHg in patients without diabetes mellitus, or <130/80 mmHg among patients with concomitant diabetes. Binary logistic regression analyses were conducted with these two measures as outcome variables, respectively, controlling for patients' socio-demographic variables. The financing system (Hospital- vs. Government- vs. private-funded) was the independent variable tested for association with the outcomes. From 1,830 patients with an average age of 65.9 years (SD 12.8), the overall treatment and control rates were 75.4% and 20.2%, respectively. When compared with hospital-funded CHCs, patients seen in the Government-funded (adjusted odds ratio [AOR] 0.462, 95% C.I. 0.325-0.656) and private-funded CHCs (AOR 0.031, 95% C.I. 0.019-0.052) were significantly less likely to be prescribed antihypertensive medication. However, the Government-funded CHC was more likely to have optimal BP control (AOR 1.628, 95% C.I. 1.157-2.291) whilst the privately-funded CHC was less likely to achieve BP control (AOR 0.146, 95% C.I. 0.069-0.310), irrespective of whether antihypertensive drugs were prescribed. Privately-funded CHCs had the lowest rates of BP treatment and control due to a variety of potential factors as discussed.

Nurse-led empowerment strategies for patients with hypertension: a questionnaire survey.

PubMed

Rasjö Wrååk, G; Törnkvist, L; Hasselström, J; Wändell, P E; Josefsson, K

2015-06-01

Hypertension is common and may lead to cerebrovascular and cardiovascular events and mortality. District nurses frequently encounter patients requiring blood pressure monitoring, lifestyle counsel and support. Empowerment as a method enables patients to both increase their control over their health and improve it. This study aims to describe the effects of the counsel and support from district nurses to patients with hypertension. A randomized controlled intervention trial. Questionnaires were answered by patients with hypertension before and after the intervention comprising district nurses' counsel and support based upon empowerment. A specially developed card for blood pressure monitoring was also used. Blood pressure decreased in intervention and the control groups. The intervention group experienced significantly improved health, with better emotional and physical health, and reduced stress. Living habits did not change significantly in either group. Satisfaction with knowledge of hypertension increased significantly in both groups. The intervention group reported that their care was based upon their health needs. Conducting large multi-centre studies with long follow-ups is complicated and results sometimes have a tendency to decline with time. A shorter follow-up might have shown a greater difference between the groups. Nursing interventions through district nurses' counsel and support with empowerment improved patients' health. More research is needed to evaluate nursing interventions' effect on hypertension. This study highlighted that district nurses' counsel and support increased patients' health and decreased stress by focusing on empowerment. © 2015 International Council of Nurses.

CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pilot Trial: rationale and design.

PubMed

Potter, J; Robinson, T; Ford, G; James, M; Jenkins, D; Mistri, A; Bulpitt, C; Drummond, A; Jagger, C; Knight, J; Markus, H; Beevers, G; Dewey, M; Lees, K; Moore, A; Paul, S

2005-03-01

High and low blood pressure (BP) levels are common following acute stroke, with up to 60% of patients being hypertensive (SBP > 160 mmHg) and nearly 20% having relative hypotension (SBP < or = 140 mmHg), within the first few hours of ictus, both conditions being associated with an adverse prognosis. At present, the optimum management of blood pressure in the immediate post-stroke period is unclear. The primary aim of the Controlling Hypertension and Hypotension Immediately Post-Stroke (CHHIPS) Pilot Trial is to assess whether hypertension and relative hypotension, manipulated therapeutically in the first 24 h following acute stroke, affects short-term outcome measures. The CHHIPS Pilot Trial is a UK based multi-centre, randomized, double-blind, placebo-controlled, titrated dose trial. Acute stroke and medical units in teaching and district general hospitals, in the UK. The CHHIPS Pilot Study aims to recruit 2050 patients, with clinically suspected stroke, confirmed by brain imaging, who have no compelling indication or contraindication for BP manipulation. The primary outcome measure will be the effects of acute pressor therapy (initiated < or = 12 h from stroke onset) or depressor therapy (started < or = 24 h post-ictus) on death and dependency at 14 days post-stroke. Secondary outcome measures will include the influence of therapy on early neurological deterioration, the effectiveness of treatment in manipulating BP levels, the influence of time to treatment and stroke type on response and a cost-effectiveness analysis.

Development of a QFD-based expert system for CNC turning centre selection

NASA Astrophysics Data System (ADS)

Prasad, Kanika; Chakraborty, Shankar

2015-12-01

Computer numerical control (CNC) machine tools are automated devices capable of generating complicated and intricate product shapes in shorter time. Selection of the best CNC machine tool is a critical, complex and time-consuming task due to availability of a wide range of alternatives and conflicting nature of several evaluation criteria. Although, the past researchers had attempted to select the appropriate machining centres using different knowledge-based systems, mathematical models and multi-criteria decision-making methods, none of those approaches has given due importance to the voice of customers. The aforesaid limitation can be overcome using quality function deployment (QFD) technique, which is a systematic approach for integrating customers' needs and designing the product to meet those needs first time and every time. In this paper, the adopted QFD-based methodology helps in selecting CNC turning centres for a manufacturing organization, providing due importance to the voice of customers to meet their requirements. An expert system based on QFD technique is developed in Visual BASIC 6.0 to automate the CNC turning centre selection procedure for different production plans. Three illustrative examples are demonstrated to explain the real-time applicability of the developed expert system.

Staff regard towards working with substance users: a European multi-centre study.

PubMed

Gilchrist, Gail; Moskalewicz, Jacek; Slezakova, Silvia; Okruhlica, Lubomir; Torrens, Marta; Vajd, Rajko; Baldacchino, Alex

2011-06-01

To compare regard for working with different patient groups (including substance users) among different professional groups in different health-care settings in eight European countries. A multi-centre, cross-sectional comparative study. Primary care, general psychiatry and specialist addiction services in Bulgaria, Greece, Italy, Poland, Scotland, Slovakia, Slovenia and Spain. A multi-disciplinary convenience sample of 866 professionals (physicians, psychiatrists, psychologists, nurses and social workers) from 253 services. The Medical Condition Regard Scale measured regard for working with different patient groups. Multi-factor between-subjects analysis of variance determined the factors associated with regard for each condition by country and all countries. Regard for working with alcohol (mean score alcohol: 45.35, 95% CI 44.76, 45.95) and drug users (mean score drugs: 43.67, 95% CI 42.98, 44.36) was consistently lower than for other patient groups (mean score diabetes: 50.19, 95% CI 49.71, 50.66; mean score depression: 51.34, 95% CI 50.89, 51.79) across all countries participating in the study, particularly among staff from primary care compared to general psychiatry or specialist addiction services (P<0.001). After controlling for sex of staff, profession and duration of time working in profession, treatment entry point and country remained the only statistically significant variables associated with regard for working with alcohol and drug users. Health professionals appear to ascribe lower status to working with substance users than helping other patient groups, particularly in primary care; the effect is larger in some countries than others. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Taking a low glycemic index multi-nutrient supplement as breakfast improves glycemic control in patients with type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Li, Di; Zhang, Peiwen; Guo, Honghui; Ling, Wenhua

2014-12-10

Dietary therapy is the mainstay of treatment for diabetes. This study examined the effect of a low glycemic index (GI) multi-nutrient supplement, consumed in place of breakfast, on glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 71 participants were randomized at a 2:1 ratio into either a breakfast replacement group or a normal breakfast group for a 12-week interventional study. The primary outcome measure was change in hemoglobin A1c (HbA1c). Nutrition status and somatometry were studied as secondary outcomes. The breakfast replacement group displayed a -0.2% absolute reduction in HbA1c (95% CI (confidence interval), -0.38% to -0.07%, p = 0.004), while the HbA1c of the control group increased 0.3% (95% CI, 0.1% to 0.5%, p = 0.005). The baseline Mini Nutritional Assessment score for both groups was 26.0 and no significant changes occurred following intervention. However, there was a statistically significant difference in body mass index between the treatment and control groups (p = 0.032) due to the weight gain in the control group (increased 0.5 kg, 95% CI was 0.2 to 0.9, p = 0.007). These data suggest that breakfast replacement with a low GI multi-nutrient supplement can improve glycemic and weight control in T2DM.

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.

Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study.

PubMed

Boccia, Ralph V; Gordan, Lucio N; Clark, Gemma; Howell, Julian D; Grunberg, Steven M

2011-10-01

A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV). Six hundred forty-one patients were randomized to oral (2 mg/day, 3-5 days) or transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The prespecified non-inferiority margin was 15%. Five hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3). Both treatments were well tolerated, the most common adverse event being constipation. The GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7 days that is as effective as oral granisetron.

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.

Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial.

PubMed

Wenborn, Jennifer; Hynes, Sinéad; Moniz-Cook, Esme; Mountain, Gail; Poland, Fiona; King, Michael; Omar, Rumana; Morris, Steven; Vernooij-Dassen, Myrra; Challis, David; Michie, Susan; Russell, Ian; Sackley, Catherine; Graff, Maud; O'Keeffe, Aidan; Crellin, Nadia; Orrell, Martin

2016-02-03

A community-based occupational therapy intervention for people with mild to moderate dementia and their family carers (Community Occupational Therapy in Dementia (COTiD)) was found clinically and cost effective in the Netherlands but not in Germany. This highlights the need to adapt and implement complex interventions to specific national contexts. The current trial aims to evaluate the United Kingdom-adapted occupational therapy intervention for people with mild to moderate dementia and their family carers living in the community (COTiD-UK) compared with treatment as usual. This study is a multi-centre, parallel-group, pragmatic randomised trial with internal pilot. We aim to allocate 480 pairs, with each pair comprising a person with mild to moderate dementia and a family carer, who provides at least 4 hours of practical support per week, at random between COTiD-UK and treatment as usual. We shall assess participants at baseline, 12 and 26 weeks, and by telephone at 52 and 78 weeks (first 40% of recruits only) after randomisation. The primary outcome measure is the Bristol Activities of Daily Living Scale (BADLS) at 26 weeks. Secondary outcome measures will include quality of life, mood, and resource use. To assess intervention delivery, and client experience, we shall collect qualitative data via audio recordings of COTiD-UK sessions and conduct semi-structured interviews with pairs and occupational therapists. COTiD-UK is an evidence-based person-centred intervention that reflects the current priority to enable people with dementia to remain in their own homes by improving their capabilities whilst reducing carer burden. If COTiD-UK is clinically and cost effective, this has major implications for the future delivery of dementia services across the UK. Current Controlled Trials ISRCTN10748953 Date of registration: 18 September 2014.

Spatial analysis of county-based gonorrhoea incidence in mainland China, from 2004 to 2009.

PubMed

Yin, Fei; Feng, Zijian; Li, Xiaosong

2012-07-01

Gonorrhoea is one of the most common sexually transmissible infections in mainland China. Effective spatial monitoring of gonorrhoea incidence is important for successful implementation of control and prevention programs. The county-level gonorrhoea incidence rates for all of mainland China was monitored through examining spatial patterns. County-level data on gonorrhoea cases between 2004 and 2009 were obtained from the China Information System for Disease Control and Prevention. Bayesian smoothing and exploratory spatial data analysis (ESDA) methods were used to characterise the spatial distribution pattern of gonorrhoea cases. During the 6-year study period, the average annual gonorrhoea incidence was 12.41 cases per 100000 people. Using empirical Bayes smoothed rates, the local Moran test identified one significant single-centre cluster and two significant multi-centre clusters of high gonorrhoea risk (all P-values <0.01). Bayesian smoothing and ESDA methods can assist public health officials in using gonorrhoea surveillance data to identify high risk areas. Allocating more resources to such areas could effectively reduce gonorrhoea incidence.

Generalisation and extension of a web-based data collection system for clinical studies using Java and CORBA.

PubMed

Eich, H P; Ohmann, C

1999-01-01

Inadequate informatical support of multi-centre clinical trials lead to pure quality. In order to support a multi-centre clinical trial a data collection via WWW and Internet based on Java has been developed. In this study a generalization and extension of this prototype has been performed. The prototype has been applied to another clinical trial and a knowledge server based on C+t has been integrated via CORBA. The investigation and implementation of security aspects of web-based data collection is now under evaluation.

[Poison cases and types of poisons based on data obtained of patients hospitalized from 1995-2009 with acute poisoning in the second internal ward in a multi-profile provincial hospital in Tarnow].

PubMed

Lata, Stanisław; Janiszewski, Jacek

2010-01-01

The thesis presents a short history and organization of an acute poisoning centre in the1995 functioning within the internal diseases department in a multi-profile provincial hospital. The data show the number of patients treated beetween 1995-2009 an the types of toxic substances that caused poisoning. The conclusions presented refer to the role of the centre to help people suffering from acute poisoning within the city of Tarnow.

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.

Comparison of applying particulate demineralized bone matrix (DBM), putty DBM and open flap debridement in periodontal horizontal bone defects. A 12-month longitudinal, multi-centre, triple-blind, split-mouth, randomized, controlled clinical study. Part 2 - evaluation of the interdental soft tissue.

PubMed

Kaya, Y; Yalim, M; Bahçecitapar, M; Baloş, K

2009-07-01

To date, there have been many studies clinically evaluating periodontal regenerative procedures by the help of routinely used hard and soft tissue parameters; however, these parameters are not capable of assessing interdental soft tissue located above the regenerative periodontal surgery area. The purpose of this study was to assess interproximal soft tissue changes following application of (i) particulate form demineralized bone matrix (DBM), (ii) putty form DBM and (ii) open flap debridement (OFD, control), using modified curtain technique in the treatment of interproximal suprabony (horizontal) defects located in anterior maxillary region, as previously reported. Twenty-five chronic periodontitis patients with 125 interproximal surgery sites (radiologically >or=4 mm horizontal bone defect) were also participate in this second stage of the triple-blind, split mouth, randomized, controlled clinical trial. Surgery sites were assessed by (i) plaque index (PI), (ii) gingival index (GI), (iii) the presence of interdental soft tissue clefts or craters and (iv) the loss of interdental papilla height by using papilla presence index (PPI), during the healing period. At the baseline and 3, 6, 9 and 12 months after the operations, these measurements were repeated. In all groups, there is a significant increase in the prevalence of soft tissue cleft and crater formation (P < 0.01), with increase in PI and GI scores at interdental soft tissue defect areas (P < 0.001), 3 months after the operations. There was also an increase in PPI scores after the operations in all treatment groups (P < 0.01). Three procedures affected the interproximal soft tissues similarly. There was no significant difference among groups in terms of all parameters (P > 0.05). Particulate DBM, putty DBM and OFD demostrated similar interproximal soft tissue changes especially increasing interproximal PI and GI scores in 3 months follow-up.

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.

77 FR 40889 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-11

... evaluation study will be conducted using a group-randomized controlled trial multi-time series design. Four... their time. Estimated Annualized Burden Hours Number of Average burden Respondents Number of responses...

Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of a smart server.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

Serological markers of hepatitis B in patients with alcoholic liver disease: a multi-centre survey

PubMed Central

Hislop, WS; Follett, EAC; Bouchier, IAD; MacSween, RNM

1981-01-01

In a study of 195 patients derived from five centres in northern Britain and with histologically confirmed alcoholic liver disease we have found an increased prevalence of serological markers of hepatitis B. This increased prevalence was found in each of the five centres; the overall frequency ranged from 11% sero-positivity in fatty liver, 12% in alcoholic hepatitis and 27% in cirrhosis. PMID:7276216

Project Based Learning in Multi-Grade Class

ERIC Educational Resources Information Center

Ciftci, Sabahattin; Baykan, Ayse Aysun

2013-01-01

The purpose of this study is to evaluate project based learning in multi-grade classes. This study, based on a student-centered learning approach, aims to analyze students' and parents' interpretations. The study was done in a primary village school belonging to the Centre of Batman, already adapting multi-grade classes in their education system,…

To drain or not to drain? Predictors of tube thoracostomy insertion and outcomes associated with drainage of traumatic hemothoraces.

PubMed

Wells, Bryan J; Roberts, Derek J; Grondin, Sean; Navsaria, Pradeep H; Kirkpatrick, Andrew W; Dunham, Michael B; Ball, Chad G

2015-09-01

Historical data suggests that many traumatic hemothoraces (HTX) can be managed expectantly without tube thoracostomy (TT) drainage. The purpose of this study was to identify predictors of TT, including whether the quantity of pleural blood predicted tube placement, and to evaluate outcomes associated with TT versus expected management (EM) of traumatic HTXs. A retrospective cohort study of all trauma patients with HTXs and an Injury Severity Score (ISS) ≥12 managed at a level I trauma centre between April 1, 2005 and December 31, 2012 was completed. Mixed-effects models with a subject-specific random intercept were used to identify independent risk factors for TT. Logistic and log-linear regression were used to compute odds ratios (ORs) for mortality and empyema and percent increases in length of hospital and intensive care unit stay between patients managed with TT versus EM, respectively. A total of 635 patients with 749 HTXs were included in the study. Overall, 491 (66%) HTXs were drained while 258 (34%) were managed expectantly. Independent predictors of TT placement included concomitant ipsilateral flail chest [OR 3.03; 95% confidence interval (CI) 1.04-8.80; p=0.04] or pneumothorax (OR 6.19; 95% CI 1.79-21.5; p<0.01) and the size of the HTX (OR per 10cc increase 1.12; 95% CI 1.04-1.21; p<0.01). Although the adjusted odds of mortality were not significantly different between groups (OR 3.99; 95% CI 0.87-18.30; p=0.08), TT was associated with a 47.14% (95% CI, 25.57-69.71%; p<0.01) adjusted increase in hospital length of stay. Empyemas (n=29) only occurred among TT patients. Expectant management of traumatic HTX was associated with a shorter length of hospital stay, no empyemas, and no increase in mortality. Although EM of smaller HTXs may be safe, these findings must be confirmed by a large multi-centre cohort study and randomized controlled trials before they are used to guide practice. Copyright © 2015 Elsevier Ltd. All rights reserved.

Communication and Distributed Control in Multi-Agent Systems

DTIC Science & Technology

2011-08-01

centre of mass of the simulated aircraft and moving with them, we can identify three class of rotations allowed to the MAVs: yaw, pitch, and roll. In...a customised version of the swinglet1 (see Figure 1), a 420g light 80cm wing-span mono/fixed-wing MAV produced by senseFlyTM2, generally used for...replicate its work in a faithful way. 2.3.2 Customised (Parker’s-based) implementation of Reynolds’ algo- rithm As aforementioned there are some degrees of

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

PubMed Central

2013-01-01

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

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

PubMed

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

2015-11-11

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

The role and potential contribution of clinical research nurses to clinical trials.

PubMed

Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

2008-02-01

This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Antenatal psychosomatic programming to reduce postpartum depression risk and improve childbirth outcomes: a randomized controlled trial in Spain and France

PubMed Central

2014-01-01

Background Postpartum depression (PPD) and poor childbirth outcomes are associated with poverty; these variables should be addressed by an adapted approach. The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery, regarding the risk of PPD and childbirth outcomes in disadvantaged women. Methods A multi-centre, randomized, controlled trial comparing a novel to standard antenatal programme. Primary outcome was depressive symptoms (using EPDS) and secondary outcome was preterm childbirth (fewer 37 weeks). The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview. The study was conducted in three public hospitals with comparable standards of perinatal care. Women were randomly distributed in to an experimental group (EG) or a control group (CG), and evaluated twice: during pregnancy (T1) and four weeks post-partum (T2). At T2, the variables were compared using the chi square test. Data analysis was based on intention to treat. The novel programme used the Tourné psychosomatic approach focusing on body awareness sensations, construction of an individualized childbirth model, and attachment. The 10 group antenatal sessions each lasted two hours, with one telephone conversation between sessions. In the control group, the participants choose the standard model of antenatal education, i.e., 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis. Results A difference of 11.2% was noted in postpartum percentages of PPD risk (EPDS ≥ 12): 34.3% (24) in EG and 45.5% (27) in CG (p = 0.26). The number of depressive symptoms among EG women decreased at T2 (intragroup p = 0.01). Premature childbirth was four times less in EG women: three (4.4%) compared to 13 (22.4%) among CG women (p = 0.003). Birth weight was higher in EG women (p = 0.01). Conclusions The decrease of depressive symptoms in women was not conclusive. However, because birth weight was higher and the rate of preterm childbirth was lower in the EG, our results suggest that the psychosomatic approach may be more helpful to the target population than the standard antenatal programs. PMID:24422605

Antenatal psychosomatic programming to reduce postpartum depression risk and improve childbirth outcomes: a randomized controlled trial in Spain and France.

PubMed

Ortiz Collado, Maria Assumpta; Saez, Marc; Favrod, Jérôme; Hatem, Marie

2014-01-15

Postpartum depression (PPD) and poor childbirth outcomes are associated with poverty; these variables should be addressed by an adapted approach. The aim of this research was to evaluate the impact of an antenatal programme based on a novel psychosomatic approach to pregnancy and delivery, regarding the risk of PPD and childbirth outcomes in disadvantaged women. A multi-centre, randomized, controlled trial comparing a novel to standard antenatal programme. Primary outcome was depressive symptoms (using EPDS) and secondary outcome was preterm childbirth (fewer 37 weeks). The sample comprised 184 couples in which the women were identified to be at PPD risk by validated interview. The study was conducted in three public hospitals with comparable standards of perinatal care. Women were randomly distributed in to an experimental group (EG) or a control group (CG), and evaluated twice: during pregnancy (T1) and four weeks post-partum (T2). At T2, the variables were compared using the chi square test. Data analysis was based on intention to treat. The novel programme used the Tourné psychosomatic approach focusing on body awareness sensations, construction of an individualized childbirth model, and attachment. The 10 group antenatal sessions each lasted two hours, with one telephone conversation between sessions. In the control group, the participants choose the standard model of antenatal education, i.e., 8 to 10 two-hour sessions focused on childbirth by obstetrical prophylaxis. A difference of 11.2% was noted in postpartum percentages of PPD risk (EPDS ≥ 12): 34.3% (24) in EG and 45.5% (27) in CG (p = 0.26). The number of depressive symptoms among EG women decreased at T2 (intragroup p = 0.01). Premature childbirth was four times less in EG women: three (4.4%) compared to 13 (22.4%) among CG women (p = 0.003). Birth weight was higher in EG women (p = 0.01). The decrease of depressive symptoms in women was not conclusive. However, because birth weight was higher and the rate of preterm childbirth was lower in the EG, our results suggest that the psychosomatic approach may be more helpful to the target population than the standard antenatal programs.

Osteo-cise: Strong Bones for Life: Protocol for a community-based randomised controlled trial of a multi-modal exercise and osteoporosis education program for older adults at risk of falls and fractures

PubMed Central

2012-01-01

Background Osteoporosis affects over 220 million people worldwide, and currently there is no ‘cure’ for the disease. Thus, there is a need to develop evidence-based, safe and acceptable prevention strategies at the population level that target multiple risk factors for fragility fractures to reduce the health and economic burden of the condition. Methods/design The Osteo-cise: Strong Bones for Life study will investigate the effectiveness and feasibility of a multi-component targeted exercise, osteoporosis education/awareness and behavioural change program for improving bone health and muscle function and reducing falls risk in community-dwelling older adults at an increased risk of fracture. Men and women aged ≥60 years will participate in an 18-month randomised controlled trial comprising a 12-month structured and supervised community-based program and a 6-month ‘research to practise’ translational phase. Participants will be randomly assigned to either the Osteo-cise intervention or a self-management control group. The intervention will comprise a multi-modal exercise program incorporating high velocity progressive resistance training, moderate impact weight-bearing exercise and high challenging balance exercises performed three times weekly at local community-based fitness centres. A behavioural change program will be used to enhance exercise adoption and adherence to the program. Community-based osteoporosis education seminars will be conducted to improve participant knowledge and understanding of the risk factors and preventative measures for osteoporosis, falls and fractures. The primary outcomes measures, to be collected at baseline, 6, 12, and 18 months, will include DXA-derived hip and spine bone mineral density measurements and functional muscle power (timed stair-climb test). Secondary outcomes measures include: MRI-assessed distal femur and proximal tibia trabecular bone micro-architecture, lower limb and back maximal muscle strength, balance and function (four square step test, functional reach test, timed up-and-go test and 30-second sit-to-stand), falls incidence and health-related quality of life. Cost-effectiveness will also be assessed. Discussion The findings from the Osteo-cise: Strong Bones for Life study will provide new information on the efficacy of a targeted multi-modal community-based exercise program incorporating high velocity resistance training, together with an osteoporosis education and behavioural change program for improving multiple risk factors for falls and fracture in older adults at risk of fragility fracture. Trial registration Australian New Zealand Clinical Trials Registry reference ACTRN12609000100291 PMID:22640372

Multi-muscle FES force control of the human arm for arbitrary goals.

PubMed

Schearer, Eric M; Liao, Yu-Wei; Perreault, Eric J; Tresch, Matthew C; Memberg, William D; Kirsch, Robert F; Lynch, Kevin M

2014-05-01

We present a method for controlling a neuroprosthesis for a paralyzed human arm using functional electrical stimulation (FES) and characterize the errors of the controller. The subject has surgically implanted electrodes for stimulating muscles in her shoulder and arm. Using input/output data, a model mapping muscle stimulations to isometric endpoint forces measured at the subject's hand was identified. We inverted the model of this redundant and coupled multiple-input multiple-output system by minimizing muscle activations and used this inverse for feedforward control. The magnitude of the total root mean square error over a grid in the volume of achievable isometric endpoint force targets was 11% of the total range of achievable forces. Major sources of error were random error due to trial-to-trial variability and model bias due to nonstationary system properties. Because the muscles working collectively are the actuators of the skeletal system, the quantification of errors in force control guides designs of motion controllers for multi-joint, multi-muscle FES systems that can achieve arbitrary goals.

Low social interactions in eating disorder patients in childhood and adulthood: a multi-centre European case control study.

PubMed

Krug, Isabel; Penelo, Eva; Fernandez-Aranda, Fernando; Anderluh, Marija; Bellodi, Laura; Cellini, Elena; di Bernardo, Milena; Granero, Roser; Karwautz, Andreas; Nacmias, Benedetta; Ricca, Valdo; Sorbi, Sandro; Tchanturia, Kate; Wagner, Gudrun; Collier, David; Treasure, Janet

2013-01-01

The objective of this article was to examine lifestyle behaviours in eating disorder (ED) patients and healthy controls. A total of 801 ED patients and 727 healthy controls from five European countries completed the questions related to lifestyle behaviours of the Cross-Cultural Questionnaire (CCQ). For children, the ED sample exhibited more solitary activities (rigorously doing homework [p<0.001] and watching TV [p<0.05] and less socializing with friends [p<0.05]) than the healthy control group and this continued in adulthood. There were minimal differences across ED sub-diagnoses and various cross-cultural differences emerged. Reduced social activities may be an important risk and maintaining factor for ED symptomatology.

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.

The effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial

PubMed Central

Chochinov, Harvey Max; Kristjanson, Linda J.; Breitbart, William; McClement, Susan; Hack, Thomas F; Hassard, Tom; Harlos, Mike

2011-01-01

Objectives Dignity Therapy is a unique, individualized, brief psychotherapy, developed for patients (and their families) living with life threatening or life limiting illness. The purpose of this study was to determine if Dignity Therapy could mitigate distress and/or bolster end-of-life experience for patients nearing death. Trial Design Multi-site randomized controlled trial, with patients assigned to Dignity Therapy, Client Centred Care or Standard Palliative Care. Study arm assignment was based on a computer-generated table of random numbers. Blinding was achieved using opaque sealed envelopes, containing allocations that were only opened once consent had been obtained. Participants Patients receiving hospital or community (hospice or home) based palliative care, in Winnipeg, New York, or Perth, randomly assigned to, Dignity Therapy [n=108], Client Centered Care [n=107] and Standard Palliative Care (n=111). Main Outcome Measures The primary outcome measures included the FACIT Spiritual Well-Being Scale, the Patient Dignity Inventory, the Hospital Anxiety and Depression Scale; items from the Structured Interview for Symptoms and Concerns, the Quality of Life Scale and a modified Edmonton Symptom Assessment Scale. Mean changes between baseline and end of intervention ratings were determined. Secondary outcomes, examining self-report end-of-life experience, consisted of a post-study survey administered across all study arms. Intervention Dignity Therapy, a novel, brief psychotherapy, provides patients with life threatening and life limiting illnesses an opportunity to speak about things that matter most to them. These recorded conversations form the basis of a generativity document, which patients can bequeath to individuals of their choosing. Client Centred Care is a supportive psychotherapeutic approach, in which research nurse/therapists guide patients through discussions focusing on here and now issues. Findings No significant differences across study arms, between the primary study outcome measures of pre and post distress, were found. However, on the secondary outcomes, comprised of the post study survey, patients reported that Dignity Therapy was significantly more likely to be experienced as helpful (χ2=35.501; p<0.001), improve quality of life (χ2 =14.520; p<0.001), sense of dignity (χ2 =12.655; p=0.002); change how their family sees and appreciates them (χ2 =33.811; p<0.001) and be helpful to their family (χ2=33.864; p<0.001). Interpretation Despite the beneficial effects of Dignity Therapy, its ability to mitigate outright distress, such as depression, desire for death or suicidality, has yet to be proven. However, there is currently ample evidence supporting its clinical application for patients nearing death, as a means of enhancing their end-of-life experience. PMID:21741309

Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background X-ray mammography remains the predominant test for screening for breast cancer, with the aim of reducing breast cancer mortality. In the English NHS Breast Screening Programme each woman’s mammograms are examined separately by two expert readers. The two readers read each batch in the same order and each indicates if there should be recall for further tests. This is a highly skilled, pressurised, repetitive and frequently intellectually unchallenging activity where readers examine one or more batches of 30–50 women’s mammograms in each session. A vigilance decrement or performance decrease over time has been observed in similar repetitive visual tasks such as radar operation. Methods/Design The CO-OPS study is a pragmatic, multi-centre, two-arm, double blind cluster randomised controlled trial of a computer software intervention designed to reduce the effects of a vigilance decrement in breast cancer screening. The unit of randomisation is the batch. Intervention batches will be examined in the opposite order by the two readers (one forwards, one backwards). Control batches will be read in the same order as one another, as is current standard practice. The hypothesis is that cancer detection rates will be higher in the intervention group because each readers’ peak performance will occur when examining different women’s mammograms. The trial will take place in 44 English breast screening centres for 1 year and 4 months. The primary outcome is cancer detection rate, which will be extracted from computer records after 1 year of the trial. The secondary outcomes include rate of disagreement between readers (a more statistically powerful surrogate for cancer detection rate), recall rate, positive predictive value, and interval cancer rate (cancers found between screening rounds which will be measured three years after the end of the trial). Discussion This is the first trial of an intervention to ameliorate a vigilance decrement in breast cancer screening. Trial registration ISRCTN46603370 (submitted: 24 October 2012, date of registration: 26 March 2013). PMID:24411004

Effectiveness of multi-drug regimen chemotherapy treatment in osteosarcoma patients: a network meta-analysis of randomized controlled trials.

PubMed

Wang, Xiaojie; Zheng, Hong; Shou, Tao; Tang, Chunming; Miao, Kun; Wang, Ping

2017-03-29

Osteosarcoma is the most common malignant bone tumour. Due to the high metastasis rate and drug resistance of this disease, multi-drug regimens are necessary to control tumour cells at various stages of the cell cycle, eliminate local or distant micrometastases, and reduce the emergence of drug-resistant cells. Many adjuvant chemotherapy protocols have shown different efficacies and controversial results. Therefore, we classified the types of drugs used for adjuvant chemotherapy and evaluated the differences between single- and multi-drug chemotherapy regimens using network meta-analysis. We searched electronic databases, including PubMed (MEDLINE), EmBase, and the Cochrane Library, through November 2016 using the keywords "osteosarcoma", "osteogenic sarcoma", "chemotherapy", and "random*" without language restrictions. The major outcome in the present analysis was progression-free survival (PFS), and the secondary outcome was overall survival (OS). We used a random effect network meta-analysis for mixed multiple treatment comparisons. We included 23 articles assessing a total of 5742 patients in the present systematic review. The analysis of PFS indicated that the T12 protocol (including adriamycin, bleomycin, cyclophosphamide, dactinomycin, methotrexate, cisplatin) plays a more critical role in osteosarcoma treatment (surface under the cumulative ranking (SUCRA) probability 76.9%), with a better effect on prolonging the PFS of patients when combined with ifosfamide (94.1%) or vincristine (81.9%). For the analysis of OS, we separated the regimens to two groups, reflecting the disconnection. The T12 protocol plus vincristine (94.7%) or the removal of cisplatinum (89.4%) is most likely the best regimen. We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients, and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients, particularly in combination with ifosfamide or vincristine. The OS analysis showed that the T12 protocol plus vincristine or the T12 protocol with the removal of cisplatinum might be a better regimen for improving the OS of patients. However, well-designed randomized controlled trials of chemotherapeutic protocols are still necessary.

The investigation of social networks based on multi-component random graphs

NASA Astrophysics Data System (ADS)

Zadorozhnyi, V. N.; Yudin, E. B.

2018-01-01

The methods of non-homogeneous random graphs calibration are developed for social networks simulation. The graphs are calibrated by the degree distributions of the vertices and the edges. The mathematical foundation of the methods is formed by the theory of random graphs with the nonlinear preferential attachment rule and the theory of Erdôs-Rényi random graphs. In fact, well-calibrated network graph models and computer experiments with these models would help developers (owners) of the networks to predict their development correctly and to choose effective strategies for controlling network projects.

When Triple Helix Unravels: A Multi-Case Analysis of Failures in Industry-University Cooperative Research Centres

ERIC Educational Resources Information Center

Gray, Denis; Sundstrom, Eric; Tornatzky, Louis G.; McGowen, Lindsey

2011-01-01

Cooperative research centres (CRCs) increasingly foster Triple Helix (industry-university-government) collaboration and represent significant vehicles for cooperation across sectors, the promotion of knowledge and technology transfer and ultimately the acceleration of innovation. A growing social science literature on CRCs focuses on their…

The Information System at CeSAM

NASA Astrophysics Data System (ADS)

Agneray, F.; Gimenez, S.; Moreau, C.; Roehlly, Y.

2012-09-01

Modern large observational programmes produce important amounts of data from various origins, and need high level quality control, fast data access via easy-to-use graphic interfaces, as well as possibility to cross-correlate informations coming from different observations. The Centre de donnéeS Astrophysique de Marseille (CeSAM) offer web access to VO compliant Information Systems to access data of different projects (VVDS, HeDAM, EXODAT, HST-COSMOS,…), including ancillary data obtained outside Laboratoire d'Astrophysique de Marseille (LAM) control. The CeSAM Information Systems provides download of catalogues and some additional services like: search, extract and display imaging and spectroscopic data by multi-criteria and Cone Search interfaces.

SITHON: A Wireless Network of in Situ Optical Cameras Applied to the Early Detection-Notification-Monitoring of Forest Fires

PubMed Central

Tsiourlis, Georgios; Andreadakis, Stamatis; Konstantinidis, Pavlos

2009-01-01

The SITHON system, a fully wireless optical imaging system, integrating a network of in-situ optical cameras linking to a multi-layer GIS database operated by Control Operating Centres, has been developed in response to the need for early detection, notification and monitoring of forest fires. This article presents in detail the architecture and the components of SITHON, and demonstrates the first encouraging results of an experimental test with small controlled fires over Sithonia Peninsula in Northern Greece. The system has already been scheduled to be installed in some fire prone areas of Greece. PMID:22408536

Typology of birth centres in the Netherlands using the Rainbow model of integrated care: results of the Dutch Birth Centre Study.

PubMed

Boesveld, Inge C; Bruijnzeels, Marc A; Hitzert, Marit; Hermus, Marieke A A; van der Pal-de Bruin, Karin M; van den Akker-van Marle, M E; Steegers, Eric A P; Franx, Arie; de Vries, Raymond G; Wiegers, Therese A

2017-06-21

The goal of integrated care is to offer a continuum of care that crosses the boundaries of public health, primary, secondary, and tertiary care. Integrated care is increasingly promoted for people with complex needs and has also recently been promoted in maternity care systems to improve the quality of care. Especially when located near an obstetric unit, birth centres are considered to be ideal settings for the realization of integrated care. At present, however, we know very little about the degree of integration in these centres and we do not know if increased levels of integration improve the quality of the care delivered. The Dutch Birth Centre Study is designed to evaluate birth centres and their contribution to the Dutch maternity care system. The aim of this particular sub-study is to classify birth centres in clusters with similar characteristics based on integration profiles, to support the evaluation of birth centre care. This study is based on the Rainbow Model of Integrated Care. We used a survey followed by qualitative interviews in 23 birth centres in the Netherlands to determine which integration profiles can be distinguished and to describe their discriminating characteristics. Cluster analysis was used to classify the birth centres. Birth centres were classified into three clusters: 1)"Mono-disciplinary-oriented birth centres" (n = 10): which are mainly owned by primary care organizations and established as physical facilities to provide an alternative birthplace for low risk births; 2) "Multi-disciplinary-oriented birth centres" (n = 6): which are mainly multi-disciplinary oriented and can be regarded as facilities to give birth, with a focus on integrated birth care; 3) "Mixed Cluster of birth centres" (n = 7): which have a range of organizational forms that differentiate them from centres in the other clusters. We identified a recognizable classification, with similar characteristics between birth centres in the clusters. The results of this study can be used to relate integration profiles of birth centres to quality of care, costs, and perinatal outcomes. This assessment makes it possible to develop recommendations with regard to the type and degree of integration of Dutch birth centres in the future.

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

PubMed

Nölker, Georg; Gutleben, Klaus-Jürgen; Muntean, Bogdan; Vogt, Jürgen; Horstkotte, Dieter; Dabiri Abkenari, Lara; Akca, Ferdi; Szili-Torok, Tamas

2012-12-01

Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

The systematic activation method as a nursing intervention in depressed elderly: a protocol for a multi-centre cluster randomized trial.

PubMed

Clignet, Frans; van Meijel, Berno; van Straten, Annemiek; Cuijpers, Pim

2012-09-18

Depression in later life is a common mental disorder with a prevalence rate of between 3% and 35% for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation (BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy accessible intervention for both patients and health care workers (such as nurses), there is no research on the effectiveness of the intervention in inpatient depressed elderly.The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD. The study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60 years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d = 0.7, we intend to include 51 participants per condition (n = 102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life. To our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly population. This research has been approved by the medical research ethics committee for health-care settings in the Netherlands (No. NL26878.029.09) and is listed in the Dutch Trial Register (NTR No.1809).

The systematic activation method as a nursing intervention in depressed elderly: a protocol for a multi – centre cluster randomized trial

PubMed Central

2012-01-01

Background Depression in later life is a common mental disorder with a prevalence rate of between 3% and 35% for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation (BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy accessible intervention for both patients and health care workers (such as nurses), there is no research on the effectiveness of the intervention in inpatient depressed elderly. The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD. Methods/design The study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60 years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d = 0.7, we intend to include 51 participants per condition (n = 102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life. Discussion To our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly population. This research has been approved by the medical research ethics committee for health-care settings in the Netherlands (No. NL26878.029.09) and is listed in the Dutch Trial Register (NTR No.1809). PMID:22989021

Sampled-Data Consensus of Linear Multi-agent Systems With Packet Losses.

PubMed

Zhang, Wenbing; Tang, Yang; Huang, Tingwen; Kurths, Jurgen

In this paper, the consensus problem is studied for a class of multi-agent systems with sampled data and packet losses, where random and deterministic packet losses are considered, respectively. For random packet losses, a Bernoulli-distributed white sequence is used to describe packet dropouts among agents in a stochastic way. For deterministic packet losses, a switched system with stable and unstable subsystems is employed to model packet dropouts in a deterministic way. The purpose of this paper is to derive consensus criteria, such that linear multi-agent systems with sampled-data and packet losses can reach consensus. By means of the Lyapunov function approach and the decomposition method, the design problem of a distributed controller is solved in terms of convex optimization. The interplay among the allowable bound of the sampling interval, the probability of random packet losses, and the rate of deterministic packet losses are explicitly derived to characterize consensus conditions. The obtained criteria are closely related to the maximum eigenvalue of the Laplacian matrix versus the second minimum eigenvalue of the Laplacian matrix, which reveals the intrinsic effect of communication topologies on consensus performance. Finally, simulations are given to show the effectiveness of the proposed results.In this paper, the consensus problem is studied for a class of multi-agent systems with sampled data and packet losses, where random and deterministic packet losses are considered, respectively. For random packet losses, a Bernoulli-distributed white sequence is used to describe packet dropouts among agents in a stochastic way. For deterministic packet losses, a switched system with stable and unstable subsystems is employed to model packet dropouts in a deterministic way. The purpose of this paper is to derive consensus criteria, such that linear multi-agent systems with sampled-data and packet losses can reach consensus. By means of the Lyapunov function approach and the decomposition method, the design problem of a distributed controller is solved in terms of convex optimization. The interplay among the allowable bound of the sampling interval, the probability of random packet losses, and the rate of deterministic packet losses are explicitly derived to characterize consensus conditions. The obtained criteria are closely related to the maximum eigenvalue of the Laplacian matrix versus the second minimum eigenvalue of the Laplacian matrix, which reveals the intrinsic effect of communication topologies on consensus performance. Finally, simulations are given to show the effectiveness of the proposed results.

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

Computerized detection of breast lesions in multi-centre and multi-instrument DCE-MR data using 3D principal component maps and template matching

NASA Astrophysics Data System (ADS)

Ertas, Gokhan; Doran, Simon; Leach, Martin O.

2011-12-01

In this study, we introduce a novel, robust and accurate computerized algorithm based on volumetric principal component maps and template matching that facilitates lesion detection on dynamic contrast-enhanced MR. The study dataset comprises 24 204 contrast-enhanced breast MR images corresponding to 4034 axial slices from 47 women in the UK multi-centre study of MRI screening for breast cancer and categorized as high risk. The scans analysed here were performed on six different models of scanner from three commercial vendors, sited in 13 clinics around the UK. 1952 slices from this dataset, containing 15 benign and 13 malignant lesions, were used for training. The remaining 2082 slices, with 14 benign and 12 malignant lesions, were used for test purposes. To prevent false positives being detected from other tissues and regions of the body, breast volumes are segmented from pre-contrast images using a fast semi-automated algorithm. Principal component analysis is applied to the centred intensity vectors formed from the dynamic contrast-enhanced T1-weighted images of the segmented breasts, followed by automatic thresholding to eliminate fatty tissues and slowly enhancing normal parenchyma and a convolution and filtering process to minimize artefacts from moderately enhanced normal parenchyma and blood vessels. Finally, suspicious lesions are identified through a volumetric sixfold neighbourhood connectivity search and calculation of two morphological features: volume and volumetric eccentricity, to exclude highly enhanced blood vessels, nipples and normal parenchyma and to localize lesions. This provides satisfactory lesion localization. For a detection sensitivity of 100%, the overall false-positive detection rate of the system is 1.02/lesion, 1.17/case and 0.08/slice, comparing favourably with previous studies. This approach may facilitate detection of lesions in multi-centre and multi-instrument dynamic contrast-enhanced breast MR data.

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

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

PubMed Central

2010-01-01

Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders. Trial registration ClinicalTrials.gov NCT00052078. PMID:20051130

Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

PubMed

Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

2012-04-01

The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

An optical investigation of nano-crystalline CaF2 particles doped with Nd3+ ions

NASA Astrophysics Data System (ADS)

O'Dwyer, C.; James, H. J.; Cheu, B.; Jaque, F.; Han, T. P. J.

2017-10-01

Good crystalline quality CaF2 sub-micron size particles doped with neodymium ions have been produced by the co-precipitation process and their crystallinity have been further improved by thermal treatment at 500 °C. Core and surface related luminescence defect centres have been identified and the effects of Y3+ and Yb3+ codopants are also investigated. Core defects centres are associated with single-ion and multi-ion defect centres as observed in bulk single crystal whereas the origin of the surface or near surface defect, A‧, centre has been ascertained to be derived from a single-ion centre most probably charge compensated by a hydroxyl group.

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.

Developing Online Learning Resources: Big Data, Social Networks, and Cloud Computing to Support Pervasive Knowledge

ERIC Educational Resources Information Center

Anshari, Muhammad; Alas, Yabit; Guan, Lim Sei

2016-01-01

Utilizing online learning resources (OLR) from multi channels in learning activities promise extended benefits from traditional based learning-centred to a collaborative based learning-centred that emphasises pervasive learning anywhere and anytime. While compiling big data, cloud computing, and semantic web into OLR offer a broader spectrum of…

Students Learning from Patients: Let's Get Real in Medical Education

ERIC Educational Resources Information Center

Bleakley, Alan; Bligh, John

2008-01-01

Medical students must be prepared for working in inter-professional and multi-disciplinary clinical teams centred on a patient's care pathway. While there has been a good deal of rhetoric surrounding patient-centred medical education, there has been little attempt to conceptualise such a practice beyond the level of describing education of…

Interacting with… What? Exploring Children's Social and Sensory Practices in a Science Discovery Centre

ERIC Educational Resources Information Center

Dicks, Bella

2013-01-01

This paper presents findings from a qualitative UK study exploring the social practices of schoolchildren visiting an interactive science discovery centre. It is promoted as a place for "learning through doing", but the multi-modal, ethnographic methods adopted suggest that children were primarily engaged in (1) sensory pleasure-taking…

MultiBLUP: improved SNP-based prediction for complex traits.

PubMed

Speed, Doug; Balding, David J

2014-09-01

BLUP (best linear unbiased prediction) is widely used to predict complex traits in plant and animal breeding, and increasingly in human genetics. The BLUP mathematical model, which consists of a single random effect term, was adequate when kinships were measured from pedigrees. However, when genome-wide SNPs are used to measure kinships, the BLUP model implicitly assumes that all SNPs have the same effect-size distribution, which is a severe and unnecessary limitation. We propose MultiBLUP, which extends the BLUP model to include multiple random effects, allowing greatly improved prediction when the random effects correspond to classes of SNPs with distinct effect-size variances. The SNP classes can be specified in advance, for example, based on SNP functional annotations, and we also provide an adaptive procedure for determining a suitable partition of SNPs. We apply MultiBLUP to genome-wide association data from the Wellcome Trust Case Control Consortium (seven diseases), and from much larger studies of celiac disease and inflammatory bowel disease, finding that it consistently provides better prediction than alternative methods. Moreover, MultiBLUP is computationally very efficient; for the largest data set, which includes 12,678 individuals and 1.5 M SNPs, the total analysis can be run on a single desktop PC in less than a day and can be parallelized to run even faster. Tools to perform MultiBLUP are freely available in our software LDAK. © 2014 Speed and Balding; Published by Cold Spring Harbor Laboratory Press.

Counseling African Americans to Control Hypertension (CAATCH) Trial: A Multi-level Intervention to Improve Blood Pressure Control in Hypertensive African Americans

PubMed Central

Ogedegbe, Gbenga; Tobin, Jonathan N.; Fernandez, Senaida; Gerin, William; Diaz-Gloster, Marleny; Cassells, Andrea; Khalida, Chamanara; Pickering, Thomas; Schoenthaler, Antoinette; Ravenell, Joseph

2009-01-01

Background Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive African Americans. The goal of this study is to evaluate the effectiveness of a multi-level, multi-component, evidence-based intervention compared to usual care in improving BP control among hypertensive African Americans who receive care in Community Health Centers (CHCs). The primary outcomes are BP control rate at 12 months; and maintenance of intervention one year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost effectiveness of the intervention. Methods and Results Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with two conditions: Intervention Condition (IC) and Usual Care (UC). Thirty CHCs were randomly assigned equally to the IC group (N=15) or the UC group (N=15). The intervention is comprised of three components targeted at patients (interactive computerized hypertension education; home BP monitoring; and monthly behavioral counseling on lifestyle modification) and two components targeted at physicians (monthly case rounds based on JNC-7 guidelines; chart audit and provision of feedback on clinical performance and patients’ home BP readings). All outcomes are assessed at quarterly study visits for one year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Conclusions Poor BP control is one of the major reasons for the mortality gap between African Americans and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population. PMID:20031845

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.

The safe and responsible disposal of unused controlled drugs.

PubMed

Ahmed, Iftikhar; Majeed, Amer

There are well-defined legal requirements for the safe storage, handling and disposal of controlled drugs (CDs): The Misuse of Drugs Act 1971, and Safer Management of Controlled Drugs (Department of Health, 2007). Clinical staff involved in the prescription and administration of CDs to patients are responsible and accountable for the appropriate disposal of these drugs because of the risk of substance abuse. A review of current practice, as followed by staff involved in the use and disposal of CDs, has been evaluated in a multi-centre audit. This audit showed that a wide variation in attitude towards disposal of CDs exists among medical and non-medical staff, and that the sample hospitals are falling short of meeting proposed standards.

Balance training with multi-task exercises improves fall-related self-efficacy, gait, balance performance and physical function in older adults with osteoporosis: a randomized controlled trial.

PubMed

Halvarsson, Alexandra; Franzén, Erika; Ståhle, Agneta

2015-04-01

To evaluate the effects of a balance training program including dual- and multi-task exercises on fall-related self-efficacy, fear of falling, gait and balance performance, and physical function in older adults with osteoporosis with an increased risk of falling and to evaluate whether additional physical activity would further improve the effects. Randomized controlled trial, including three groups: two intervention groups (Training, or Training+Physical activity) and one Control group, with a 12-week follow-up. Stockholm County, Sweden. Ninety-six older adults, aged 66-87, with verified osteoporosis. A specific and progressive balance training program including dual- and multi-task three times/week for 12 weeks, and physical activity for 30 minutes, three times/week. Fall-related self-efficacy (Falls Efficacy Scale-International), fear of falling (single-item question - 'In general, are you afraid of falling?'), gait speed with and without a cognitive dual-task at preferred pace and fast walking (GAITRite®), balance performance tests (one-leg stance, and modified figure of eight), and physical function (Late-Life Function and Disability Instrument). Both intervention groups significantly improved their fall-related self-efficacy as compared to the controls (p ≤ 0.034, 4 points) and improved their balance performance. Significant differences over time and between groups in favour of the intervention groups were found for walking speed with a dual-task (p=0.003), at fast walking speed (p=0.008), and for advanced lower extremity physical function (p=0.034). This balance training program, including dual- and multi-task, improves fall-related self-efficacy, gait speed, balance performance, and physical function in older adults with osteoporosis. © The Author(s) 2014.

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

Multi-step resistive switching behavior of Li-doped ZnO resistance random access memory device controlled by compliance current

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lin, Chun-Cheng; Department of Mathematic and Physical Sciences, R.O.C. Air Force Academy, Kaohsiung 820, Taiwan; Tang, Jian-Fu

2016-06-28

The multi-step resistive switching (RS) behavior of a unipolar Pt/Li{sub 0.06}Zn{sub 0.94}O/Pt resistive random access memory (RRAM) device is investigated. It is found that the RRAM device exhibits normal, 2-, 3-, and 4-step RESET behaviors under different compliance currents. The transport mechanism within the device is investigated by means of current-voltage curves, in-situ transmission electron microscopy, and electrochemical impedance spectroscopy. It is shown that the ion transport mechanism is dominated by Ohmic behavior under low electric fields and the Poole-Frenkel emission effect (normal RS behavior) or Li{sup +} ion diffusion (2-, 3-, and 4-step RESET behaviors) under high electric fields.

Effects of the choice of reference on the selectivity of a multi-contact nerve cuff electrode.

PubMed

Koh, Ryan G L; Zariffa, Jose

2016-08-01

Tripolar referencing is typically used in nerve cuff electrode recordings due to its ability to maximize the signal-to-noise ratio of contacts at the centre, but this may not be the optimal choice for a multi-contact nerve cuff consisting of contacts in off-centre rings. We conducted a simulation study to compare the effects of 3 different reference types on the recording selectivity of a multi-contact nerve cuff: the tripolar reference (TPR), common average reference (CAR), and multiple tripolar references based on consecutive groups of 3 rings (cTPR). For this purpose, we introduce a novel measure called the contact information metric (CIM). Selectivity was tested in 2 noise settings, one in which white Gaussian noise was added inside the nerve cuff electrode and the other in which electromyogram (EMG) noise was added outside the nerve cuff electrode. The mean CIMs values calculated for the best 8 contacts were 3.42±6.25, 2.70±3.37, and 3.65±1.90 for the TPR, the CAR and the cTPR, respectively, in the case of EMG noise added outside the nerve cuff electrode. This study shows that the use of cTPR reference is the optimal choice for selectivity when using a multi-contact nerve cuff electrode which contains off-centre rings.

Efficacy and safety of imidacloprid 10% plus moxidectin 2.5% spot-on in the treatment of sarcoptic mange and otoacariosis in dogs: results af a European field study.

PubMed

Krieger, K; Heine, J; Dumont, P; Hellmann, K

2005-10-01

Efficacy and safety of treatment with imidacloprid 10%+moxidectin 2.5% spot-on (Advocate, Advantage multi; Bayer AG, Leverkusen, Germany) were tested in dogs naturally infested with Sarcoptes scabiei or Otodectes cynotis in a multi-centre, controlled, randomized, blinded field study conducted in France, Germany, Albania and the UK. The study was performed according to a non-inferiority design to demonstrate that the efficacy of imidacloprid/moxidectin spot-on was not inferior to that of a control product containing selamectin (Stronghold spot-on; Pfizer). All Sarcoptes-infested dogs were topically treated twice (days 0 and 28) with the dosage recommended by the respective manufacturer (27 dogs with imidacloprid/moxidectin, 26 with selamectin). All Otodectes-infested dogs were treated on day 0 (35 dogs with imidacloprid/moxidectin, 34 with selamectin), and only those still positive on day 28 received a second treatment. Parasitological cure rate in Sarcoptes-infested dogs was 100% for both treatments, while parasitological cures rates in the Otodectes-infested dogs at day 28 and day 56 were 68.6 and 85.7% with imidacloprid/moxidectin, and 64.7 and 88.2% with Stronghold. Non-inferiority of Advocate was confirmed statistically. Clinical assessment of skin lesion scores at day 56 showed that with either product >96% of the dogs treated against sarcoptic mange were improved or cured, the difference between the groups being non-significant. On the basis of a final clinical assessment of lesion scores, 80% of the dogs treated with imidacloprid/moxidectin against otoacariosis and 85.3% of those treated with selamectin were rated cured or improved. Only three mild, possibly drug-related adverse reactions were observed among alI treated animals (two in the imidacloprid/moxidectin group, one in the selamectin group). It is concluded that imidacloprid/moxidectin spot-on is an effective and safe treatment for sarcoptic mange and otoacariosis in the dog.

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.

8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information.

PubMed

Zhang, Rujun; Persaud, Navindra

2017-01-01

We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Double blinded, multi-centred, randomized placebo-controlled study. 14 clinics in the United States. 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. The available information about this "8-way Bendectin" trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. Not registered.

Real-time visual communication to aid disaster recovery in a multi-segment hybrid wireless networking system

NASA Astrophysics Data System (ADS)

Al Hadhrami, Tawfik; Wang, Qi; Grecos, Christos

2012-06-01

When natural disasters or other large-scale incidents occur, obtaining accurate and timely information on the developing situation is vital to effective disaster recovery operations. High-quality video streams and high-resolution images, if available in real time, would provide an invaluable source of current situation reports to the incident management team. Meanwhile, a disaster often causes significant damage to the communications infrastructure. Therefore, another essential requirement for disaster management is the ability to rapidly deploy a flexible incident area communication network. Such a network would facilitate the transmission of real-time video streams and still images from the disrupted area to remote command and control locations. In this paper, a comprehensive end-to-end video/image transmission system between an incident area and a remote control centre is proposed and implemented, and its performance is experimentally investigated. In this study a hybrid multi-segment communication network is designed that seamlessly integrates terrestrial wireless mesh networks (WMNs), distributed wireless visual sensor networks, an airborne platform with video camera balloons, and a Digital Video Broadcasting- Satellite (DVB-S) system. By carefully integrating all of these rapidly deployable, interworking and collaborative networking technologies, we can fully exploit the joint benefits provided by WMNs, WSNs, balloon camera networks and DVB-S for real-time video streaming and image delivery in emergency situations among the disaster hit area, the remote control centre and the rescue teams in the field. The whole proposed system is implemented in a proven simulator. Through extensive simulations, the real-time visual communication performance of this integrated system has been numerically evaluated, towards a more in-depth understanding in supporting high-quality visual communications in such a demanding context.

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

Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10-School Randomized Controlled Trial.

PubMed

Ockene, Judith K; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Jolicoeur, Denise G; Murray, David M; Shoben, Abigail B; David, Sean P; Ferguson, Kristi J; Huggett, Kathryn N; Adams, Michael; Okuliar, Catherine A; Gross, Robin L; Bass, Pat F; Greenberg, Ruth B; Leone, Frank T; Okuyemi, Kola S; Rudy, David W; Waugh, Jonathan B; Geller, Alan C

2016-02-01

Early in medical education, physicians must develop competencies needed for tobacco dependence treatment. To assess the effect of a multi-modal tobacco dependence treatment curriculum on medical students' counseling skills. A group-randomized controlled trial (2010-2014) included ten U.S. medical schools that were randomized to receive either multi-modal tobacco treatment education (MME) or traditional tobacco treatment education (TE). Students from the classes of 2012 and 2014 at ten medical schools participated. Students from the class of 2012 (N = 1345) completed objective structured clinical examinations (OSCEs), and 50 % (N = 660) were randomly selected for pre-intervention evaluation. A total of 72.9 % of eligible students (N = 1096) from the class of 2014 completed an OSCE and 69.7 % (N = 1047) completed pre and post surveys. The MME included a Web-based course, a role-play classroom demonstration, and a clerkship booster session. Clerkship preceptors in MME schools participated in an academic detailing module and were encouraged to be role models for third-year students. The primary outcome was student tobacco treatment skills using the 5As measured by an objective structured clinical examination (OSCE) scored on a 33-item behavior checklist. Secondary outcomes were student self-reported skills for performing 5As and pharmacotherapy counseling. Although the difference was not statistically significant, MME students completed more tobacco counseling behaviors on the OSCE checklist (mean 8.7 [SE 0.6] vs. mean 8.0 [SE 0.6], p = 0.52) than TE students. Several of the individual Assist and Arrange items were significantly more likely to have been completed by MME students, including suggesting behavioral strategies (11.8 % vs. 4.5 %, p < 0.001) and providing information regarding quitline (21.0 % vs. 3.8 %, p < 0.001). MME students reported higher self-efficacy for Assist, Arrange, and Pharmacotherapy counseling items (ps ≤0.05). Inclusion of only ten schools limits generalizability. Subsequent interventions should incorporate lessons learned from this first randomized controlled trial of a multi-modal longitudinal tobacco treatment curriculum in multiple U.S. medical schools. NIH Trial Registry Number: NCT01905618.

Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

PubMed

Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

2010-11-09

Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye) and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls), of which 263 cases had undergone cataract surgery ("operated cases"). At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007), assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate poverty and achieve the Millennium Development Goals.

Food security is related to adult type 2 diabetes control over time in a United States safety net primary care clinic population.

PubMed

Shalowitz, M U; Eng, J S; McKinney, C O; Krohn, J; Lapin, B; Wang, C-H; Nodine, E

2017-05-15

Successful Type 2 diabetes management requires adopting a high nutrient-density diet made up of food items that both meet dietary needs and preferences and can be feasibly obtained on a regular basis. However, access to affordable, nutrient-dense foods often is lacking in poorer neighbourhoods. Therefore, low food security should directly impair glucose control, even when patients have full access to and utilize comprehensive medical management. The present study sought to determine whether food security is related longitudinally to glucose control, over-and-above ongoing medication management, among Type 2 diabetes patients receiving comprehensive care at a Midwestern multi-site federally qualified health centre (FQHC). In this longitudinal observational study, we completed a baseline assessment of patients' food security (using the US Household Food Security Module), demographics (via Census items), and diabetes history/management (using a structured clinical encounter form) when patients began receiving diabetes care at the health centre. We then recorded those patients' A1C levels several times during a 24-month follow-up period. Three hundred and ninety-nine patients (56% with low food security) had a baseline A1c measurement; a subsample of 336 (median age=52 years; 56% female; 60% Hispanic, 27% African American, and 9% White) also had at least one follow-up A1c measurement. Patients with lower (vs higher) food security were more likely to be on insulin and have higher A1c levels at baseline. Moreover, the disparity in glucose control by food security status persisted throughout the next 2 years. Although results were based on one multi-site FQHC, potentially limiting their generalizability, they seem to suggest that among Type 2 diabetes patients, low food security directly impairs glucose control-even when patients receive full access to comprehensive medical management-thereby increasing their long-term risks of high morbidity, early mortality, and high health-care utilization and cost.

Dosimetry and field matching for radiotherapy to the breast and superclavicular fossa

NASA Astrophysics Data System (ADS)

Winfield, Elizabeth

Radiotherapy for early breast cancer aims to achieve local disease control and decrease loco-regional recurrence rates. Treatment may be directed to breast or chest wall alone or, include regional lymph nodes. When using tangential fields to treat the breast a separate anterior field directed to the axilla and supraclavicular fossa (SCF) is needed to treat nodal areas. The complex geometry of this region necessitates matching of adjacent radiation fields in three dimensions. The potential exists for zones of overdosage or underdosage along the match line. Cosmetic results may be compromised if treatment fields are not accurately aligned. Techniques for field matching vary between centres in the UK. A study of dosimetry across the match line region using different techniques, as reported in the multi-centre START Trial Quality Assurance (QA) programme, was undertaken. A custom-made anthropomorphic phantom was designed to assess dose distribution in three dimensions using film dosimetry. Methods with varying degrees of complexity were employed to match tangential and SCF beams. Various techniques combined half beam blocking and machine rotations to achieve geometric alignment. Matching of asymmetric beams allowed a single isocentre technique to be used. Where field matching was not undertaken a gap between tangential and SCF fields was employed. Results demonstrated differences between techniques in addition to variations within the same technique between different centres. Geometric alignment techniques produced more homogenous dose distributions in the match region than gap techniques or those techniques not correcting for field divergence. For this multi-centre assessment of match plane techniques film dosimetry used in conjunction with a breast shaped phantom provided relative dose information. This study has highlighted the difficulties of matching treatment fields to achieve homogenous dose distribution through the region of the match plane and the degree of inhomogeneity as a consequence of a gap between treatment fields.

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut.

PubMed

Ciesinski, Lisa; Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9-30.2% multi-resistant E. coli compared to 5.8-14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters.

High dietary zinc feeding promotes persistence of multi-resistant E. coli in the swine gut

PubMed Central

Guenther, Sebastian; Pieper, Robert; Kalisch, Martin; Bednorz, Carmen; Wieler, Lothar H.

2018-01-01

High levels of zinc oxide are used frequently as feed additive in pigs to improve gut health and growth performance and are still suggested as an alternative to antimicrobial growth promoters. However, we have recently described an increase of multi-resistant E. coli in association to zinc feeding in piglets. This previous study focused on clonal diversity of E. coli, observing the effect on multi-resistant strains by chance. To shed further light into this highly important topic and falsify our previous findings, we performed a zinc pig feeding trial where we specifically focused on in-depth analysis of antimicrobial resistant E. coli. Under controlled experimental conditions, piglets were randomly allocated to a high dietary zinc (zinc group) and a background zinc feeding group (control group). At different ages samples were taken from feces, digesta, and mucosa and absolute E. coli numbers were determined. A total of 2665 E. coli isolates were than phenotypically tested for antimicrobial resistance and results were confirmed by minimum inhibitory concentration testing for random samples. In piglets fed with high dietary zinc, we detected a substantial increase of multi-resistant E. coli in all gut habitats tested, ranging from 28.9–30.2% multi-resistant E. coli compared to 5.8–14.0% in the control group. This increase was independent of the total number of E. coli. Interestingly, the total amount of the E. coli population decreased over time. Thus, the increase of the multi-resistant E. coli populations seems to be linked with persistence of the resistant population, caused by the influence of high dietary zinc feeding. In conclusion, these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters. PMID:29373597

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

PubMed

Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

2014-11-01

Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals. Copyright © 2014 Elsevier Inc. All rights reserved.

FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.

PubMed

Baumgaertner, Annette; Grewe, Tanja; Ziegler, Wolfram; Floel, Agnes; Springer, Luise; Martus, Peter; Breitenstein, Caterina

2013-09-23

Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative.The primary analysis tests for differences between the therapy group and an untreated (waiting list) control group with respect to pre- versus post 3-week-therapy (or waiting period, respectively) scores on the ANELT A-scale. Statistical between-group comparisons of primary and secondary outcome measures will be conducted in intention-to-treat analyses.Long-term stability of treatment effects will be assessed six months post intensive SLT (primary and secondary endpoints). Registered in ClinicalTrials.gov with the Identifier NCT01540383.

Corruption and research.

PubMed

Luna, Florencia

1999-07-01

Last year there was a heated debate regarding clinical trials with AZT carried out in developing countries. AIDS vaccine trials also posed various dilemmas and ethical problems. In this paper I will consider the possibility of corruption in bioethics, and international multi-centre research will be taken as an example. International clinical trials will be seen from another perspective. I will try to show that the possibility of systemic corruption should be considered when designing an international multi-centre research trial which may involve countries in very different situations regarding corruption. I will analyze three different approaches to this problem and suggest some strategies regarding their capacity to exclude the possibility of corruption.

Rationale and design of the CONFIRM-HF study: a double-blind, randomized, placebo-controlled study to assess the effects of intravenous ferric carboxymaltose on functional capacity in patients with chronic heart failure and iron deficiency.

PubMed

Ponikowski, Piotr; van Veldhuisen, Dirk J; Comin-Colet, Josep; Ertl, Georg; Komajda, Michel; Mareev, Viacheslav; McDonagh, Theresa A; Parkhomenko, Alexander; Tavazzi, Luigi; Levesque, Victoria; Mori, Claudio; Roubert, Bernard; Filippatos, Gerasimos; Ruschitzka, Frank; Anker, Stefan D

2014-09-01

Iron deficiency (ID) is a common co-morbidity associated with chronic heart failure (CHF), which has unfavourable clinical and prognostic consequences. In Ferinject Assessment in Patients with IRon Deficiency and Chronic Heart Failure (FAIR-HF), the treatment with i.v. ferric carboxymaltose (FCM) improved symptoms and quality of life over a 24 week period. Ferric CarboxymaltOse evaluatioN on perFormance in patients with IRon deficiency in coMbination with chronic Heart Failure (CONFIRM-HF) was designed to test a simplifieddosage scheme of FCM during a longer follow-up period. CONFIRM-HF, a double-blind, multi-centre, prospective, randomized, two-arm study, enrolled ambulatory patients with symptomatic CHF [New York Heart Association (NYHA) class II/III] with left ventricular ejection fraction ≤45%, BNP >100 pg/mL, or NT-proBNP >400 pg/mL, presence of ID [defined as ferritin <100 ng/mL, or ferritin 100-300 ng/mL if transferrin saturation (TSAT) <20%], and haemoglobin (Hb) <15 g/dL. Patients were randomized 1:1 to treatment with FCM or placebo for 52 weeks. Primary endpoint is change in 6-minute walk test (6MWT) distance from baseline to Week 24. Secondary endpoints are: change in 6MWT from baseline to Weeks 6, 12, 36, and 52; Patient Global Assessment score at Weeks 6, 12, 24, 36, and 52; and change from baseline to Weeks 6, 12, 24, 36, and 52 in NYHA class, fatigue score, and quality of life. Safety endpoints include overall safety over the treatment period of 52 weeks. Study medication was administered in single doses as undiluted bolus injection of up to 1000 mg of iron or normal saline at Day 0 and Week 6 up to iron repletion. Further doses of study medication could be administered at Weeks 12, 24, and 36 if a patient still had ID. Overall, 304 patients were recruited in 41 centres in nine countries. This study will provide further information on the efficacy and safety of iron therapy with i.v. FCM in CHF patients with ID over a 1 year period using a simplified dosing scheme. © 2014 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

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

PubMed

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

2016-04-23

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

A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

PubMed

Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

2012-08-01

To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

TELEMAM: a cluster randomised trial to assess the use of telemedicine in multi-disciplinary breast cancer decision making.

PubMed

Kunkler, I H; Prescott, R J; Lee, R J; Brebner, J A; Cairns, J A; Fielding, R G; Bowman, A; Neades, G; Walls, A D F; Chetty, U; Dixon, J M; Smith, M E; Gardner, T W; Macnab, M; Swann, S; Maclean, J R

2007-11-01

The TELEMAM trial aimed to assess the clinical effectiveness and costs of telemedicine in conducting breast cancer multi-disciplinary meetings (MDTs). Over 12 months 473 MDT patient discussions in two district general hospitals (DGHs) were cluster randomised (2:1) to the intervention of telemedicine linkage to breast specialists in a cancer centre or to the control group of 'in-person' meetings. Primary endpoints were clinical effectiveness and costs. Economic analysis was based on a cost-minimisation approach. Levels of agreement of MDT members on a scale from 1 to 5 were high and similar in both the telemedicine and standard meetings for decision sharing (4.04 versus 4.17), consensus (4.06 versus 4.20) and confidence in the decision (4.16 versus 4.07). The threshold at which the telemedicine meetings became cheaper than standard MDTs was approximately 40 meetings per year. Telemedicine delivered breast cancer multi-disciplinary meetings have similar clinical effectiveness to standard 'in-person' meetings.

A French network of bipolar expert centres: a model to close the gap between evidence-based medicine and routine practice.

PubMed

Henry, Chantal; Etain, Bruno; Mathieu, Flavie; Raust, Aurélie; Vibert, Jean-Francois; Scott, Jan; Leboyer, Marion

2011-06-01

Bipolar disorders are a major public health concern. Efforts to provide optimal care by general practitioners and psychiatrists are undermined by the complexity of the disorder and difficulties in applying clinical practice guidelines and new research findings to the spectrum of cases seen in day to day practice. A national network of bipolar expert centres was established. Each centre has established strong links to local health services and provides support to clinicians in delivering personalized care plans derived from systematic case assessments undertaken at the centre. A common set of diagnostic and clinical assessment tools has been adopted at eight centres. Evaluations are undertaken by trained assessors and cross-centre reliability is monitored. A web application, e-bipolar© is used to record data in a common computerized medical file. Anonymized data is entered into a shared national database for use in multi-centre audit and research. Instead of offering treatment advice based on clinical practice guidelines recommendations for selected sub-populations of patients (a 'top-down' approach), the French bipolar network offers systematic, comprehensive, longitudinal, and multi-dimensional assessments of cases representative of general bipolar populations. This 'bottom-up' strategy may offer a more efficient and effective way to transfer knowledge and share expertise as the referrer can appreciate the rationale underpinning suggested treatment protocols and more readily apply such principles and approaches to other cases. The network also builds an infrastructure for clinical cohort and comparative-effectiveness research on more representative patient populations. Copyright © 2010 Elsevier B.V. All rights reserved.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia.

PubMed

Vallila-Rohter, Sofia; Kiran, Swathi

2015-08-01

Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive-linguistic assessments. Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities.

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.

The Hi Five study: design of a school-based randomized trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark.

PubMed

Johansen, Anette; Denbæk, Anne Maj; Bonnesen, Camilla Thørring; Due, Pernille

2015-03-01

Infectious illnesses such as influenza and diarrhea are leading causes of absenteeism among Danish school children. Interventions in school settings addressing hand hygiene have shown to reduce the number of infectious illnesses. However, most of these studies include small populations and almost none of them are conducted as randomized controlled trials. The overall aim of the Hi Five study was to develop, implement and evaluate a multi-component school-based intervention to improve hand hygiene and well-being and to reduce the prevalence of infections among school children in intervention schools by 20% compared to control schools. This paper describes the development and the evaluation design of Hi Five. The Hi Five study was designed as a tree-armed cluster-randomized controlled trial. A national random sample of schools (n = 44) was randomized to one of two intervention groups (n = 29) or to a control group with no intervention (n = 15). A total of 8,438 six to fifteen-year-old school children were enrolled in the study. The Hi Five intervention consisted of three components: 1) a curriculum component 2) mandatory daily hand washing before lunch 3) extra cleaning of school toilets during the school day. Baseline data was collected from December 2011 to April 2012. The intervention period was August 2012 to June 2013. The follow-up data was collected from December 2012 to April 2013. The Hi Five study fills a gap in international research. This large randomized multi-component school-based hand hygiene intervention is the first to include education on healthy and appropriate toilet behavior as part of the curriculum. No previous studies have involved supplementary cleaning at the school toilets as an intervention component. The study will have the added value of providing new knowledge about usability of short message service (SMS, text message) for collecting data on infectious illness and absenteeism in large study populations. Current Controlled Trials ISRCTN19287682 , 21 December 2012.

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.

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.

Effect of randomness on multi-frequency aeroelastic responses resolved by Unsteady Adaptive Stochastic Finite Elements

NASA Astrophysics Data System (ADS)

Witteveen, Jeroen A. S.; Bijl, Hester

2009-10-01

The Unsteady Adaptive Stochastic Finite Elements (UASFE) method resolves the effect of randomness in numerical simulations of single-mode aeroelastic responses with a constant accuracy in time for a constant number of samples. In this paper, the UASFE framework is extended to multi-frequency responses and continuous structures by employing a wavelet decomposition pre-processing step to decompose the sampled multi-frequency signals into single-frequency components. The effect of the randomness on the multi-frequency response is then obtained by summing the results of the UASFE interpolation at constant phase for the different frequency components. Results for multi-frequency responses and continuous structures show a three orders of magnitude reduction of computational costs compared to crude Monte Carlo simulations in a harmonically forced oscillator, a flutter panel problem, and the three-dimensional transonic AGARD 445.6 wing aeroelastic benchmark subject to random fields and random parameters with various probability distributions.

Multi-centre audit of VMAT planning and pre-treatment verification.

PubMed

Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

2017-08-01

We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. All rights reserved.

Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability.

PubMed

Bartels, Ronald H M A; Hosman, Allard J F; van de Meent, Henk; Hofmeijer, Jeannette; Vos, Pieter E; Slooff, Willem Bart; Öner, F Cumhur; Coppes, Maarten H; Peul, Wilco C; Verbeek, André L M

2013-01-31

Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care), duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Gov: NCT01367405.

Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the Trial to reduce cardiovascular events with Aranesp therapy (TREAT) study.

PubMed

Locatelli, Francesco; Aljama, Pedro; Canaud, Bernard; Covic, Adrian; De Francisco, Angel; Macdougall, Iain C; Wiecek, Andrzej; Vanholder, Raymond

2010-09-01

The European Renal Best Practice (ERBP), which are issued by ERA-EDTA, are suggestions for clinical practice in areas in which evidence is lacking or weak, together with position statements on recently published randomized controlled trials, or on existing guidelines and recommendations. In 2009, the Anaemia Working Group of ERBP published its first position statement about the haemoglobin target to aim for with erythropoietin-stimulating agents (ESA) and on issues that were not covered by K-DOQI in 2006-07. This second position paper of the group follows the publication of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study. This multi-centre, placebo-controlled trial compared cardiovascular and renal outcomes in 4038 patients with type 2 diabetes, chronic kidney disease not on dialysis, and anaemia who were randomized to complete anaemia correction (haemoglobin target of 13 g/dL using darbepoetin alpha) or placebo (with a haemoglobin rescue value of 9 g/dL). Following the findings of the TREAT study, the Anaemia Working Group of ERBP maintains its view that 'Hb values of 11-12 g/dL should be generally sought in the CKD population without intentionally exceeding 13 g/dL' and that the doses of ESA therapy to achieve the target haemoglobin should also be considered. More caution is suggested when treating anaemia with ESA therapy in patients with type 2 diabetes not undergoing dialysis (and probably in diabetics at all CKD stages). In those with ischaemic heart disease or with a previous history of stroke, possible benefits should be weighed up against an increased risk of stroke recurrence, when deciding which Hb level to aim for. These recommendations are not intended to represent a new guideline as they are not the result of a systematic review of the evidence.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

PubMed

Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-10-01

While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial

PubMed Central

Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-01-01

Background While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this “Treatment of Early Neuropathy in Leprosy” (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. Methods In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient’s body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. Results We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. Conclusion In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment. PMID:28976976

Hybrid Solution of Stochastic Optimal Control Problems Using Gauss Pseudospectral Method and Generalized Polynomial Chaos Algorithms

DTIC Science & Technology

2012-03-01

0-486-41183-4. 15. Brown , Robert G. and Patrick Y. C. Hwang . Introduction to Random Signals and Applied Kalman Filtering. Wiley, New York, 1996. ISBN...stability and perfor- mance criteria. In the 1960’s, Kalman introduced the Linear Quadratic Regulator (LQR) method using an integral performance index...feedback of the state variables and was able to apply this method to time-varying and Multi-Input Multi-Output (MIMO) systems. Kalman further showed

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial

PubMed Central

Worthley, Stephen G.; Tsioufis, Costas P.; Worthley, Matthew I.; Sinhal, Ajay; Chew, Derek P.; Meredith, Ian T.; Malaiapan, Yuvi; Papademetriou, Vasilios

2013-01-01

Aims Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN™ multi-electrode system. Methods and results We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN™ system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by −28/10, −27/10 and −26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Conclusion Renal sympathetic denervation, using the EnligHTN™ multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN™ system delivers a promising therapy for the treatment of drug-resistant hypertension. PMID:23782649

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial.

PubMed

Worthley, Stephen G; Tsioufis, Costas P; Worthley, Matthew I; Sinhal, Ajay; Chew, Derek P; Meredith, Ian T; Malaiapan, Yuvi; Papademetriou, Vasilios

2013-07-01

Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN(™) multi-electrode system. We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P < 0.0001). No acute renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

PubMed

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

Ecological, biological and social dimensions of dengue vector breeding in five urban settings of Latin America: a multi-country study

PubMed Central

2014-01-01

Background Dengue is an increasingly important public health problem in most Latin American countries and more cost-effective ways of reducing dengue vector densities to prevent transmission are in demand by vector control programs. This multi-centre study attempted to identify key factors associated with vector breeding and development as a basis for improving targeted intervention strategies. Methods In each of 5 participant cities in Mexico, Colombia, Ecuador, Brazil and Uruguay, 20 clusters were randomly selected by grid sampling to incorporate 100 contiguous households, non-residential private buildings (businesses) and public spaces. Standardized household surveys, cluster background surveys and entomological surveys specifically targeted to obtain pupal indices for Aedes aegypti, were conducted in the dry and wet seasons. Results The study clusters included mainly urban low-middle class populations with satisfactory infrastructure and –except for Uruguay- favourable climatic conditions for dengue vector development. Household knowledge about dengue and “dengue mosquitoes” was widespread, mainly through mass media, but there was less awareness around interventions to reduce vector densities. Vector production (measured through pupal indices) was favoured when water containers were outdoor, uncovered, unused (even in Colombia and Ecuador where the large tanks used for household water storage and washing were predominantly productive) and –particularly during the dry season- rainwater filled. Larval infestation did not reflect productive container types. All productive container types, including those important in the dry season, were identified by pupal surveys executed during the rainy season. Conclusions A number of findings are relevant for improving vector control: 1) there is a need for complementing larval surveys with occasional pupal surveys (to be conducted during the wet season) for identifying and subsequently targeting productive container types; 2) the need to raise public awareness about useful and effective interventions in productive container types specific to their area; and 3) the motivation for control services that-according to this and similar studies in Asia- dedicated, targeted vector management can make a difference in terms of reducing vector abundance. PMID:24447796

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.

Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age.

PubMed

Gorse, Geoffrey J; Falsey, Ann R; Johnson, Carol M; Morrison, Dennis; Fried, David L; Ervin, John E; Greenberg, David P; Ozol-Godfrey, Ayca; Landolfi, Victoria; Tsang, Peter H

2013-12-05

This clinical trial examined the safety and immunogenicity of annual revaccination with Fluzone(®) Intradermal (Sanofi Pasteur, Swiftwater, PA) vaccine compared to a standard intramuscular (IM) split-virion trivalent influenza vaccine (Fluzone(®), Sanofi Pasteur). This phase II, active-controlled, multi-centre, open-label trial was conducted in 2009 and 2010, and enrolled 1250 adults 18-64 years of age who were randomly selected from participants in a phase III influenza vaccine trial the previous year (NCT00772109). Subjects who had previously received the ID vaccine were randomized 2:1 to be revaccinated with the ID or IM vaccine and those who previously received the IM vaccine were randomized 1:1. Solicited reactions were recorded on the day of vaccination and continuing for the next 7 days, non-serious adverse events for 28 days, and serious adverse events for 6 months after vaccination. Hemagglutination inhibition antibody titres were assessed pre-vaccination and at day 28. Reactions were well-tolerated and resolved in the first 7 days, but erythema, induration, swelling, pruritus and ecchymosis were reported by more subjects receiving the ID vaccine than the IM vaccine. Compared to receipt of IM vaccine in the previous year, ID vaccine in the previous year led to statistically higher rates of erythema, swelling and induration after IM vaccine in the second year. Injection-site pain and systemic reactions did not differ between ID and IM vaccines. No treatment-related serious adverse events were reported. Geometric mean antibody titres, seroprotection rates, and seroconversion rates were non-inferior for the ID and IM vaccines for all three viral strains. The ID vaccine was as immunogenic as the IM vaccine, and raised no safety concerns. It can be used interchangeably with the IM vaccine for annual revaccination in adults 18-64 years of age in consecutive years without safety concerns. Copyright © 2013 Elsevier Ltd. All rights reserved.

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.

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.

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.

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention.

PubMed

Brendryen, Håvar; Kraft, Pål

2008-03-01

To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Subjects (n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Abstinence was defined as 'not even a puff of smoke, for the last 7 days', and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12-3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change.

Rationale, design and methods of the HEALTHY study behavior intervention component

USDA-ARS?s Scientific Manuscript database

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

A randomized controlled trial of a commercially available weight loss program

USDA-ARS?s Scientific Manuscript database

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians refer obese adults for intensive, multi-component behavioral counseling, yet most obese Americans choose a self-help approach to lose weight. The current study examined weight loss between a community-based, intensive behavi...

The burden of endometriosis: costs and quality of life of women with endometriosis and treated in referral centres.

PubMed

Simoens, Steven; Dunselman, Gerard; Dirksen, Carmen; Hummelshoj, Lone; Bokor, Attila; Brandes, Iris; Brodszky, Valentin; Canis, Michel; Colombo, Giorgio Lorenzo; DeLeire, Thomas; Falcone, Tommaso; Graham, Barbara; Halis, Gülden; Horne, Andrew; Kanj, Omar; Kjer, Jens Jørgen; Kristensen, Jens; Lebovic, Dan; Mueller, Michael; Vigano, Paola; Wullschleger, Marcel; D'Hooghe, Thomas

2012-05-01

This study aimed to calculate costs and health-related quality of life of women with endometriosis-associated symptoms treated in referral centres. A prospective, multi-centre, questionnaire-based survey measured costs and quality of life in ambulatory care and in 12 tertiary care centres in 10 countries. The study enrolled women with a diagnosis of endometriosis and with at least one centre-specific contact related to endometriosis-associated symptoms in 2008. The main outcome measures were health care costs, costs of productivity loss, total costs and quality-adjusted life years. Predictors of costs were identified using regression analysis. Data analysis of 909 women demonstrated that the average annual total cost per woman was €9579 (95% confidence interval €8559-€10 599). Costs of productivity loss of €6298 per woman were double the health care costs of €3113 per woman. Health care costs were mainly due to surgery (29%), monitoring tests (19%) and hospitalization (18%) and physician visits (16%). Endometriosis-associated symptoms generated 0.809 quality-adjusted life years per woman. Decreased quality of life was the most important predictor of direct health care and total costs. Costs were greater with increasing severity of endometriosis, presence of pelvic pain, presence of infertility and a higher number of years since diagnosis. Our study invited women to report resource use based on endometriosis-associated symptoms only, rather than drawing on a control population of women without endometriosis. Our study showed that the economic burden associated with endometriosis treated in referral centres is high and is similar to other chronic diseases (diabetes, Crohn's disease, rheumatoid arthritis). It arises predominantly from productivity loss, and is predicted by decreased quality of life.

Exploring the Rationale for Group Music Activities for Parents and Young Children: Parents' and Practitioners' Perspectives

ERIC Educational Resources Information Center

Pitt, Jessica; Hargreaves, David

2017-01-01

Children's Centres are widespread in England and comprise multi-professional staff teams seeking to work with families with children aged 0-5 years. Although parent-child group music sessions appear frequently in Children's Centre activity programmes, the rationale for their inclusion remains unclear. This article presents the results from phase…

[R]MIT Research Centre at Delft University of Technology: A Bridge between Research, Education, Society and Profession

ERIC Educational Resources Information Center

Zijlstra, Hielkje

2009-01-01

In 2006, we launched the [R]MIT Research Centre (Modification, Intervention Transformation) at the Faculty of Architecture at Delft University of Technology. [R]MIT was founded to respond to the need for an integrated, multi-disciplinary approach to the transformation of the built environment. [R]MIT aims to bring momentum to the renewal of…

Comparing Quality of Childcare and Kindergarten Centres: The Need for a Strong and Equal Partnership in the Greek Early Childhood Education System

ERIC Educational Resources Information Center

Gregoriadis, A.; Tsigilis, N.; Grammatikopoulos, V.; Kouli, O.

2016-01-01

The purpose of this study was to examine whether kindergartens and childcare centres differ in terms of educational and caregiving components. More specifically, two aspects of the process quality of the early childhood education and care were examined regarding the "Activities" and the "Programme Structure." A multi-stage…

Design and rationale of the MR-INFORM study: stress perfusion cardiovascular magnetic resonance imaging to guide the management of patients with stable coronary artery disease.

PubMed

Hussain, Shazia T; Paul, Matthias; Plein, Sven; McCann, Gerry P; Shah, Ajay M; Marber, Michael S; Chiribiri, Amedeo; Morton, Geraint; Redwood, Simon; MacCarthy, Philip; Schuster, Andreas; Ishida, Masaki; Westwood, Mark A; Perera, Divaka; Nagel, Eike

2012-09-19

In patients with stable coronary artery disease (CAD), decisions regarding revascularisation are primarily driven by the severity and extent of coronary luminal stenoses as determined by invasive coronary angiography. More recently, revascularisation decisions based on invasive fractional flow reserve (FFR) have shown improved event free survival. Cardiovascular magnetic resonance (CMR) perfusion imaging has been shown to be non-inferior to nuclear perfusion imaging in a multi-centre setting and superior in a single centre trial. In addition, it is similar to invasively determined FFR and therefore has the potential to become the non-invasive test of choice to determine need for revascularisation. The MR-INFORM study is a prospective, multi-centre, randomised controlled non-inferiority, outcome trial. The objective is to compare the efficacy of two investigative strategies for the management of patients with suspected CAD. Patients presenting with stable angina are randomised into two groups: 1) The FFR-INFORMED group has subsequent management decisions guided by coronary angiography and fractional flow reserve measurements. 2) The MR-INFORMED group has decisions guided by stress perfusion CMR. The primary end-point will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at one year. Clinical trials.gov identifier NCT01236807. MR INFORM will assess whether an initial strategy of CMR perfusion is non-inferior to invasive angiography supplemented by FFR measurements to guide the management of patients with stable coronary artery disease. Non-inferiority of CMR perfusion imaging to the current invasive reference standard (FFR) would establish CMR perfusion imaging as an attractive non-invasive alternative to current diagnostic pathways.

Issues in conducting cross-cultural research: implementation of an agreed international protocol [corrected] designed by the WHOQOL Group for the conduct of focus groups eliciting the quality of life of older adults.

PubMed

Hawthorne, Graeme; Davidson, Natasha; Quinn, Kathryn; McCrate, Farah; Winkler, Ines; Lucas, Ramona; Kilian, Reinhold; Molzahn, Anita

2006-09-01

Multi-centre and cross-cultural research require the use of common protocols if the results are to be either pooled or compared. All too often adherence to protocols is not discussed in reports and where it is reported poor adherence is frequently noted. This paper discusses the use of international guidelines developed by WHOQOL Field Centres to conduct and report focus groups aimed at eliciting key concepts of quality of life among older adults. This was the first step in the development of the WHOQOL-OLD instrument. Although there was overall adherence to the agreed guidelines, there were some differences in the level of reporting, even after participating Field Centres had the opportunity to explain their reports. The reasons for these discrepancies are reported. It is concluded that because of local situations, it is difficult to achieve identical implementation of multi-centre cross-cultural protocols and that the highest standards of auditing are required if findings are to be compared. Suggestions for how such protocols can be improved are given.

The role of dosimetry audit in lung SBRT multi-centre clinical trials.

PubMed

Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

2017-12-01

Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Development of multi-mission satellite data systems at the German Remote Sensing Data Centre

NASA Astrophysics Data System (ADS)

Lotz-Iwen, H. J.; Markwitz, W.; Schreier, G.

1998-11-01

This paper focuses on conceptual aspects of the access to multi-mission remote sensing data by online catalogue and information systems. The system ISIS of the German Remote Sensing Data Centre is described as an example of a user interface to earth observation data. ISIS has been designed to support international scientific research as well as operational applications by offering online access to the database via public networks. It provides catalogue retrieval, visualisation and transfer of image data, and is integrated in international activities dedicated to catalogue and archive interoperability. Finally, an outlook is given on international projects dealing with access to remote sensing data in distributed archives.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

PubMed Central

2012-01-01

Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1), stratified by center, anastomotic height (proximal or distal of peritoneal reflection) and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification < 4. Oral mechanical bowel preparation is mandatory and patients with signs of peritonitis are excluded. The C-seal student team will perform the randomization procedure, supports the operating surgeon during the C-seal application and achieves the monitoring of the trial. Patients are followed for one year after randomization en will be analyzed on an intention to treat basis. Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080 PMID:23153188

Low-order black-box models for control system design in large power systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1996-02-01

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting from the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

Low-order black-box models for control system design in large power systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1995-12-31

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting form the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

PubMed

Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

2011-01-01

Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

PubMed Central

2011-01-01

Introduction Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. Methods This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. Results A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Conclusions Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Trial registration Prospective Clinical Trials, ISRCTN32188676 PMID:22177541

Evaluation of complex community-based childhood obesity prevention interventions.

PubMed

Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Robenacoxib vs. carprofen for the treatment of canine osteoarthritis; a randomized, noninferiority clinical trial.

PubMed

Reymond, N; Speranza, C; Gruet, P; Seewald, W; King, J N

2012-04-01

Robenacoxib is a member of the coxib class of nonsteroidal anti-inflammatory drugs (NSAID), with high selectivity for the cyclooxygenase (COX)-2 isoform of COX. In this study, the efficacy and tolerability of robenacoxib were compared with those of carprofen in canine osteoarthritis in a multi-centre, prospective, randomized, blinded, positive-controlled noninferiority clinical trial. Both drugs were administered orally once daily at recommended dosages: robenacoxib at 1-2 mg/kg (n = 125 dogs) and racemic carprofen at 2-4 mg/kg (n = 63 dogs) for a total of 12 weeks. The efficacy of the test compounds was assessed by veterinary investigators and owners using numerical rating scales at baseline and days 7, 14, 28, 56 and 84. In both groups, all scores were significantly (P < 0.0001) improved compared with baseline at all time points (days 7-84). Robenacoxib had noninferior efficacy to carprofen for the primary endpoint, the global functional disability, both for all dogs and for the subgroup of dogs in which robenacoxib was not administered during meals. Noninferiority was also demonstrated for three of six veterinary investigator secondary endpoints and four of six owner efficacy endpoints. For haematology and clinical chemistry variables, there were some significant differences from baseline levels but no differences between groups. There were no differences between groups in the frequencies of adverse events, which were reported in 46% dogs with robenacoxib and 52% with carprofen (P = 0.44), which were most frequently mild events affecting the gastrointestinal tract. In conclusion, noninferior efficacy and tolerability of robenacoxib compared with carprofen was demonstrated in dogs with osteoarthritis. © 2011 Blackwell Publishing Ltd.

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.

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).

Extraction Site Preservation Using FDBA With Bioxclude vs. FDBA With Bio-Gide: A Randomized Clinical Trial

DTIC Science & Technology

2015-06-01

neovascularization. J Surgical Res 2015; 193(2): 953-962 48. Zelen CM, Gould L, Serena TE, et al . A prospective, randomized, controlled, multi-center...tissue repair and regeneration. Tiss Eng 2002; 8(2): 295-308. 24. Niknejad H, Peirovi H, Jmjani M, et al . Properties of the amniotic membrane for...Guler R, Ercan MT, Ulutuncel M, et al . Measurement of blood flow by the 133Xe clearance technique to grafts of amnion used in vestibuloplasty. Brit J

Development of a web-based register for the Dutch national study on biologicals in JIA: www.ABC-register.nl.

PubMed

Prince, F H M; Ferket, I S; Kamphuis, S; Armbrust, W; Ten Cate, R; Hoppenreijs, E P A H; Koopman-Keemink, Y; van Rossum, M A J; van Santen-Hoeufft, M; Twilt, M; van Suijlekom-Smit, L W A

2008-09-01

Most clinical studies use paper case record forms (CRFs) to collect data. In the Dutch multi-centre observational study on biologicals we encountered several disadvantages of using the paper CRFs. These are delay in data collection, lack of overview in collected data and difficulties in obtaining up-to-date interim reports. Therefore, we wanted to create a more effective method of data collection compared with CRFs on paper in a multi-centre study. We designed a web-based register with the intention to make it easy to use for participating physicians and at the same time accurate and up-to-date. Security demands were taken into account to secure the safety of the patient data. The web-based register was tested with data from 161 juvenile idiopathic arthritis patients from nine different centres. Internal validity was obtained and user-friendliness guaranteed. To secure the completeness of the data automatically generated e-mail alerts were implemented into the web-based register. More transparency of data was achieved by including the option to automatically generate interim reports of data in the web-based register. The safety was tested and approved. By digitalizing the CRF we achieved our aim to provide easy, rapid and safe access to the database and contributed to a new way of data collection. Although the web-based register was designed for the current multi-centre observational study, this type of instrument can also be applied to other types of studies. We expect that especially collaborative study groups will find it an efficient tool to collect data.

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.

Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early-onset sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study.

PubMed

Stocker, Martin; Hop, Wim C J; van Rossum, Annemarie M C

2010-12-08

Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with nonspecific symptoms are started on antibiotic treatment before the presence of sepsis has been proven. With our recently published single-centre intervention study we were able to show that Procalcitonin determinations allowed to shorten the duration of antibiotic therapy in newborns with suspected early-onset sepsis. The study is designed as randomized controlled international multicenter intervention trial on the efficacy and safety of Procalcitonin guided treatment. Term and near-term infants (gestational age ≥ 34 0/7 weeks) with suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy will be included. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the likelihood of infection (infection unlikely, possible, probable or proven). In the Procalcitonin group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive Procalcitonin values are within the normal range. Co-primary outcome measures are the duration of antibiotic therapy (superiority aspect of the trial) and the proportion of infants with a recurrence of infection requiring additional courses of antibiotic therapy and/or death in the first month of life (safety of study intervention, non-inferiority aspect of the trial). The number of infants to be included equals 800 per arm. With these numbers the power of the study to demonstrate superiority for duration of antibiotic therapy as well as non-inferiority regarding safety, i.e. excluding a disadvantage difference larger than 2% for the experimental arm, will both be greater than 80%. Benefit of the study is a possible limitation of unnecessary use of antibiotics. The results of our first study suggest that there is a low risk on discontinuing antibiotic treatment too early, resulting in the development of a neonatal infection with its morbidity and mortality. This trial is registered in the U.S. National Institutes of Health's register, located at http://www.clinicaltrials.gov. (NCT00854932).

Dietary practices in propionic acidemia: A European survey.

PubMed

Daly, A; Pinto, A; Evans, S; Almeida, M F; Assoun, M; Belanger-Quintana, A; Bernabei, S M; Bollhalder, S; Cassiman, D; Champion, H; Chan, H; Dalmau, J; de Boer, F; de Laet, C; de Meyer, A; Desloovere, A; Dianin, A; Dixon, M; Dokoupil, K; Dubois, S; Eyskens, F; Faria, A; Fasan, I; Favre, E; Feillet, F; Fekete, A; Gallo, G; Gingell, C; Gribben, J; Kaalund Hansen, K; Ter Horst, N M; Jankowski, C; Janssen-Regelink, R; Jones, I; Jouault, C; Kahrs, G E; Kok, I L; Kowalik, A; Laguerre, C; Le Verge, S; Lilje, R; Maddalon, C; Mayr, D; Meyer, U; Micciche, A; Och, U; Robert, M; Rocha, J C; Rogozinski, H; Rohde, C; Ross, K; Saruggia, I; Schlune, A; Singleton, K; Sjoqvist, E; Skeath, R; Stolen, L H; Terry, A; Timmer, C; Tomlinson, L; Tooke, A; Vande Kerckhove, K; van Dam, E; van den Hurk, T; van der Ploeg, L; van Driessche, M; van Rijn, M; van Wegberg, A; Vasconcelos, C; Vestergaard, H; Vitoria, I; Webster, D; White, F J; White, L; Zweers, H; MacDonald, A

2017-12-01

The definitive dietary management of propionic acidaemia (PA) is unknown although natural protein restriction with adequate energy provision is of key importance. To describe European dietary practices in the management of patients with PA prior to the publication of the European PA guidelines. This was a cross-sectional survey consisting of 27 questions about the dietary practices in PA patients circulated to European IMD dietitians and health professionals in 2014. Information on protein restricted diets of 186 PA patients from 47 centres, representing 14 European countries was collected. Total protein intake [PA precursor-free L-amino acid supplements (PFAA) and natural protein] met WHO/FAO/UNU (2007) safe protein requirements for age in 36 centres (77%). PFAA were used to supplement natural protein intake in 81% (n = 38) of centres, providing a median of 44% (14-83%) of total protein requirement. Seventy-four per cent of patients were prescribed natural protein intakes below WHO/FAO/UNU (2007) safe levels in one or more of the following age groups: 0-6 m, 7-12 m, 1-10 y, 11-16 y and > 16 y. Sixty-three per cent (n = 117) of patients were tube fed (74% gastrostomy), but only 22% received nocturnal feeds. There was high use of PFAA with intakes of natural protein commonly below WHO/FAO/UNU (2007) safe levels. Optimal dietary management can only be determined by longitudinal, multi-centre, prospective case controlled studies. The metabolic instability of PA and small patient cohorts in each centre ensure that this is a challenging undertaking.

Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia--a randomized controlled trial.

PubMed

Larsson, Anette; Palstam, Annie; Löfgren, Monika; Ernberg, Malin; Bjersing, Jan; Bileviciute-Ljungar, Indre; Gerdle, Björn; Kosek, Eva; Mannerkorpi, Kaisa

2015-06-18

Fibromyalgia (FM) is characterized by persistent widespread pain, increased pain sensitivity and tenderness. Muscle strength in women with FM is reduced compared to healthy women. The aim of this study was to examine the effects of a progressive resistance exercise program on muscle strength, health status, and current pain intensity in women with FM. A total of 130 women with FM (age 22-64 years, symptom duration 0-35 years) were included in this assessor-blinded randomized controlled multi-center trial examining the effects of progressive resistance group exercise compared with an active control group. A person-centred model of exercise was used to support the participants' self-confidence for management of exercise because of known risks of activity-induced pain in FM. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists. Primary outcome measure was isometric knee-extension force (Steve Strong®), secondary outcome measures were health status (FIQ total score), current pain intensity (VAS), 6MWT, isometric elbow-flexion force, hand-grip force, health related quality of life, pain disability, pain acceptance, fear avoidance beliefs, and patient global impression of change (PGIC). Outcomes were assessed at baseline and immediately after the intervention. Long-term follow up comprised the self-reported questionnaires only and was conducted after 13-18 months. Between-group and within-group differences were calculated using non-parametric statistics. Significant improvements were found for isometric knee-extension force (p = 0.010), health status (p = 0.038), current pain intensity (p = 0.033), 6MWT (p = 0.003), isometric elbow flexion force (p = 0.02), pain disability (p = 0.005), and pain acceptance (p = 0.043) in the resistance exercise group (n = 56) when compared to the control group (n = 49). PGIC differed significantly (p = 0.001) in favor of the resistance exercise group at post-treatment examinations. No significant differences between the resistance exercise group and the active control group were found regarding change in self-reported questionnaires from baseline to 13-18 months. Person-centered progressive resistance exercise was found to be a feasible mode of exercise for women with FM, improving muscle strength, health status, and current pain intensity when assessed immediately after the intervention. ClinicalTrials.gov identification number: NCT01226784, Oct 21, 2010.

The comparative clinical study of efficacy of Gamisoyo-San (Jiaweixiaoyaosan) on generalized anxiety disorder according to differently manufactured preparations: multicenter, randomized, double blind, placebo controlled trial.

PubMed

Park, Dae-Myung; Kim, Seok-Hwan; Park, Yang-Chun; Kang, Wee-Chang; Lee, Sang-Ryong; Jung, In-Chul

2014-12-02

Gamisoyo-San (GSS) is a well-known Traditional Korean Medicine shown to be effective on mood disorders. The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations. Multicenter, randomized, double-blinded, placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010. They were given Gamisoyo-San individual extract mixture (extraction done for each crude materia medica separately) or Gamisoyo-San multi-compound extract (extraction done for whole materia medica at once) or controlled medication. Hamilton Rating Scale for Anxiety (HAM-A), Korean State-Trait Anxiety Inventory (K-STAI), Penn State Worry Questionnaire (PSWQ), Korean Beck Depression Inventroy (K-BDI), Symptom Checklist-90-Revised (SCL-90-R), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were evaluated. We also applied Pattern Identification tool for 'JingJi and ZhengChong (, Traditional Korean Medicine term which correlates with generalized anxiety disorder)' to patients to evaluate different responses among 9 patterns. HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group, but the difference was insignificant. WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group. In Heart blood deficiency pattern, the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group. Gamisoyo-San did not improve anxiety level of GAD patients. However, it can be useful to improve quality of life, and reduce depressive, obsessive-compulsive, somatic symptoms of generalized anxiety disorder. Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture, especially in Heart blood deficiency pattern. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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.

Train the trainer? A randomized controlled trial of a multi-tiered oral health education programme in community-based residential services for adults with intellectual disability.

PubMed

Mac Giolla Phadraig, Caoimhin; Guerin, Suzanne; Nunn, June

2013-04-01

To assess the impact of a multi-tiered oral health education programme on care staff caring for people with intellectual disability (ID). Postal questionnaires were sent to all care staff of a community-based residential care service for adults, randomly assigned to control and intervention groups. A specifically developed training programme was delivered to residential staff nominees, who then trained all staff within the intervention group. The control group received no training. Post-test questionnaires were sent to both groups. Paired-samples t-test was used to compare oral health-related knowledge (K) and behaviour, attitude and self-efficacy (BAS) scores. Of the initial 219 respondents, 154 (response rate between 40% and 35.8%, with attrition rate of 29.7% from baseline to repeat) returned completed questionnaires at post-test (M=8.5 months, range=6.5-11 months). Control and intervention groups were comparable for general training, employment and demographic variables. In the intervention group, mean Knowledge Index score rose from K=7.2 to K=7.9 (P<0.001) and mean BAS scale score rose from BAS=4.7 to BAS=5.4 (P<0.001). There was no statistically significant increase in mean scores from test (K=7.0, BAS=4.7) to post-test (K=7.2, BAS=4.9) for the control group. Mean scores regarding knowledge, attitude, self-efficacy and reported behaviour increased significantly at 8.5 months in staff where training was provided. The results indicate that a multi-tiered training programme improved knowledge, attitude, self-efficacy and reported behaviour amongst staff caring for people with ID. © 2012 John Wiley & Sons A/S.

Multi-criteria correlation of tephra deposits to source centres applied in the Auckland Volcanic Field, New Zealand

NASA Astrophysics Data System (ADS)

Hopkins, Jenni L.; Wilson, Colin J. N.; Millet, Marc-Alban; Leonard, Graham S.; Timm, Christian; McGee, Lucy E.; Smith, Ian E. M.; Smith, Euan G. C.

2017-07-01

Linking tephras back to their source centre(s) in volcanic fields is crucial not only to reconstruct the eruptive history of the volcanic field but also to understand tephra dispersal patterns and thus the potential hazards posed by a future eruption. Here we present a multi-disciplinary approach to correlate distal basaltic tephra deposits from the Auckland Volcanic Field (AVF) to their source centres using proximal whole-rock geochemical signatures. In order to achieve these correlations, major and trace element tephra-derived glass compositions are compared with published and newly obtained whole-rock geochemical data for the entire field. The results show that incompatible trace element ratios (e.g. (Gd/Yb)N, (La/Yb)N, (Zr/Yb)N) vary widely across the AVF (e.g. (La/Yb)N = 5 to 40) but show a more restricted range within samples from a single volcanic centre (e.g. (La/Yb)N = 5 to 10). These ratios are also the least affected by fractional crystallisation and are therefore the most appropriate geochemical tools for correlation between tephra and whole-rock samples. However, findings for the AVF suggest that each volcanic centre does not have a unique geochemical signature in the field as a whole, thus preventing unambiguous correlation of tephras to source centre using geochemistry alone. A number of additional criteria are therefore combined to further constrain the source centres of the distal tephras including age, eruption scale, and location (of centres, and sites where tephra were sampled). The combination of tephrostratigraphy, 40Ar/39Ar dating and morphostratigraphic constraints allow, for the first time, the relative and absolute ordering of 48 of 53 volcanic centres of the Auckland Volcanic Field to be resolved. Eruption frequencies are shown to vary between 0.13 and 1.5 eruptions/kyr and repose periods between individual eruptions vary from <0.1 to 13 kyr, with 23 of the 48 centres shown to have pre-eruptive repose periods of <1000 years. No spatial evolutionary trends are noted, although a relationship between short repose periods and closely spaced eruption locations is identified for a number of centres. In addition, no temporal-geochemical trends are noted, but a relationship between geochemical signature and eruption volume is highlighted.

The foundation of NCVD PCI Registry: the Malaysia's first multi-centre interventional cardiology project.

PubMed

Liew, H B; Rosli, M A; Wan Azman, W A; Robaayah, Z; Sim, K H

2008-09-01

The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database.

Oxygen titration after resuscitation from out-of-hospital cardiac arrest: A multi-centre, randomised controlled pilot study (the EXACT pilot trial).

PubMed

Bray, Janet E; Hein, Cindy; Smith, Karen; Stephenson, Michael; Grantham, Hugh; Finn, Judith; Stub, Dion; Cameron, Peter; Bernard, Stephen

2018-04-21

Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%. Initially (Sept 2015-March 2016) patients were randomised 1:1 to either 2 L/minute (L/min) oxygen (titrated) or >10 L/min oxygen (control) via a bag-valve reservoir. However, one site experienced a high number of desaturations (SpO2 < 94%) in the titrated arm and this arm was changed (April 2016) to an initial reduction of oxygen to 4 L/min then, if tolerated, to 2 L/min, and the desaturation limit was decreased to <90%. We randomised 61 patients to titrated (n = 37: 2L/min = 20 and 2-4 L/min = 17) oxygen or control (n = 24). Patients allocated to titrated oxygen were more likely to desaturate compared to controls ((SpO2 < 94%: 43% vs. 4%, p = 0.001; SpO2 < 90%: 19% vs. 4%, p = 0.09). The majority of desaturations (81%) occurred at 2L/min. On arrival at hospital the majority of patients had a SpO2 ≥ 94% (titrated: 90% vs. control: 100%) and all patients had a SpO2 ≥ 90%. One patient (control) re-arrested. Survival to hospital discharge was similar. Oxygen titration post-ROSC is feasible in the prehospital environment, but incremental titration commencing at 4L/min oxygen flow may be needed to maintain an oxygen saturation >90% (NCT02499042). Copyright © 2018 Elsevier B.V. All rights reserved.

Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

PubMed

Zhang, Zhe; Zhang, Fan; Wang, Yang; Du, Yi; Zhang, Huiyong; Kong, Dezhao; Liu, Yue; Yang, Guanlin

2014-10-30

Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris. This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed. The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology. ChiCTR-TRC-13003608, registered 18 June 2013.

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.

PubMed

Travier, Noémie; Velthuis, Miranda J; Steins Bisschop, Charlotte N; van den Buijs, Bram; Monninkhof, Evelyn M; Backx, Frank; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J; Rodenhuis, Carla; de Roos, Marnix A J; Verhaar, Marlies; ten Bokkel Huinink, Daan; van der Wall, Elsken; Peeters, Petra H M; May, Anne M

2015-06-08

Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up. Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.

Occupational voice demands and their impact on the call-centre industry.

PubMed

Hazlett, D E; Duffy, O M; Moorhead, S A

2009-04-20

Within the last decade there has been a growth in the call-centre industry in the UK, with a growing awareness of the voice as an important tool for successful communication. Occupational voice problems such as occupational dysphonia, in a business which relies on healthy, effective voice as the primary professional communication tool, may threaten working ability and occupational health and safety of workers. While previous studies of telephone call-agents have reported a range of voice symptoms and functional vocal health problems, there have been no studies investigating the use and impact of vocal performance in the communication industry within the UK. This study aims to address a significant gap in the evidence-base of occupational health and safety research. The objectives of the study are: 1. to investigate the work context and vocal communication demands for call-agents; 2. to evaluate call-agents' vocal health, awareness and performance; and 3. to identify key risks and training needs for employees and employers within call-centres. This is an occupational epidemiological study, which plans to recruit call-centres throughout the UK and Ireland. Data collection will consist of three components: 1. interviews with managers from each participating call-centre to assess their communication and training needs; 2. an online biopsychosocial questionnaire will be administered to investigate the work environment and vocal demands of call-agents; and 3. voice acoustic measurements of a random sample of participants using the Multi-dimensional Voice Program (MDVP). Qualitative content analysis from the interviews will identify underlying themes and issues. A multivariate analysis approach will be adopted using Structural Equation Modelling (SEM), to develop voice measurement models in determining the construct validity of potential factors contributing to occupational dysphonia. Quantitative data will be analysed using SPSS version 15. Ethical approval is granted for this study from the School of Communication, University of Ulster. The results from this study will provide the missing element of voice-based evidence, by appraising the interactional dimensions of vocal health and communicative performance. This information will be used to inform training for call-agents and to contribute to health policies within the workplace, in order to enhance vocal health.

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.

Add-on anticholinergic therapy for residual nocturia in patients with lower urinary tract symptoms receiving α1-blocker treatment: a multi-centre, prospective, randomised study.

PubMed

Yokoyama, Osamu; Tsujimura, Akira; Akino, Hironobu; Segawa, Naoki; Tamada, Satoshi; Oguchi, Naoki; Kitagawa, Yasuhide; Tsuji, Hidenori; Watanabe, Akihiko; Inamoto, Teruo; Shimizu, Nobutaka; Fujiuchi, Yasuyoshi; Katsuoka, Yoji; Azuma, Haruhito; Matsuda, Tadashi; Namiki, Mikio; Uemura, Hirotsugu; Okuyama, Akihiko; Nonomura, Norio; Fuse, Hideki; Nakatani, Tatsuya

2015-05-01

To evaluate the efficacy and safety of imidafenacin (IM), a novel short half-life anticholinergic, as add-on therapy for male LUTS with nocturia and nocturnal polyuria. This multicenter, prospective, randomized, open-labelled study was conducted and involved men who had frequency, urgency, and nocturia despite receiving a stable dose of α1-blocker for ≥1 month. Subjects were randomised to control (α1-blocker alone), IM twice/day (α1-blocker +0.1 mg imidafenacin twice daily), or IM nightly (α1-blocker plus 0.1 mg imidafenacin nightly) group; the treatment period was 8 weeks. Primary endpoints included improvements in night-time frequency and Nocturia Quality of Life Questionnaire (N-QOL) scores. Secondary endpoints included changes from the baseline in frequency volume chart variables, and post-void residual volume. Compared with the controls, IM twice/day and IM nightly patients had a significantly lower night-time frequency (changes from baseline: 0.1 ± 0.8 in control, -0.6 ± 0.9 in IM twice/day, and -0.4 ± 1.0 in IM nightly, p = 0.5227, 0.0006 and 0.0143, respectively). The hours of undisturbed sleep and N-QOL score were significantly improved in IM twice/day group, though not IM nightly group. Nocturnal urine volume was significantly reduced in IM nightly group, although total urine volume remained unchanged. A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving α1-blocker treatment. Anticholinergic administration nightly could reduce the nocturnal urine volume.

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol.

PubMed

Vas, Jorge; Aguilar, Inmaculada; Campos, M Angeles; Méndez, Camila; Perea-Milla, Emilio; Modesto, Manuela; Caro, Paloma; Martos, Francisco; García-Ruiz, Antonio J

2008-07-06

Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. Current Controlled Trials ISRCTN01897462.

Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol

PubMed Central

Vas, Jorge; Aguilar, Inmaculada; Campos, M Ángeles; Méndez, Camila; Perea-Milla, Emilio; Modesto, Manuela; Caro, Paloma; Martos, Francisco; García-Ruiz, Antonio J

2008-01-01

Background Uncomplicated chronic rachialgia is a highly prevalent complaint, and one for which therapeutic results are contradictory. The aim of the present study is to evaluate the effectiveness and safety of treatment with auriculopressure, in the primary healthcare sector, carried out by trained healthcare professionals via a 30-hour course. Methods/Design The design consists of a multi-centre randomized controlled trial, with placebo, with two parallel groups, and including an economic evaluation. Patients with chronic uncomplicated rachialgia, whose GP is considering referral for auriculopressure sensory stimulation, are eligible for inclusion. Sampling will be by consecutive selection, and randomised allocation to one of the two study arms will be determined using a centralised method, following a 1:1 plan (true auriculopressure; placebo auriculopressure). The implants (true and placebo) will be replaced once weekly, and the treatment will have a duration of 8 weeks. The primary outcome measure will be the change in pain intensity, measured on a visual analogue scale (VAS) of 100 mm, at 9 weeks after beginning the treatment. A follow up study will be performed at 6 months after beginning treatment. An assessment will also be made of the changes measured in the Spanish version of the McGill Pain Questionnaire, of the changes in the Lattinen test, and of the changes in quality of life (SF-12). Also planned is an analysis of cost-effectiveness and also, if necessary, a cost-benefit analysis. Discussion This study will contribute to developing evidence on the use of auriculotherapy using Semen vaccariae [wang bu liu xing] for the treatment of uncomplicated chronic rachialgia. Trial registration Current Controlled Trials ISRCTN01897462. PMID:18601750

A Non Linear Scoring Approach for Evaluating Balance: Classification of Elderly as Fallers and Non-Fallers

PubMed Central

Audiffren, Julien; Bargiotas, Ioannis; Vayatis, Nicolas; Vidal, Pierre-Paul; Ricard, Damien

2016-01-01

Almost one third of population 65 years-old and older faces at least one fall per year. An accurate evaluation of the risk of fall through simple and easy-to-use measurements is an important issue in current clinic. A common way to evaluate balance in posturography is through the recording of the centre-of-pressure (CoP) displacement (statokinesigram) with force platforms. A variety of indices have been proposed to differentiate fallers from non fallers. However, no agreement has been reached whether these analyses alone can explain sufficiently the complex synergies of postural control. In this work, we study the statokinesigrams of 84 elderly subjects (80.3+− 6.4 years old), which had no impairment related to balance control. Each subject was recorded 25 seconds with eyes open and 25 seconds with eyes closed and information pertaining to the presence of problems of balance, such as fall, in the last six months, was collected. Five descriptors of the statokinesigrams were computed for each record, and a Ranking Forest algorithm was used to combine those features in order to evaluate each subject’s balance with a score. A classical train-test split approach was used to evaluate the performance of the method through ROC analysis. ROC analysis showed that the performance of each descriptor separately was close to a random classifier (AUC between 0.49 and 0.54). On the other hand, the score obtained by our method reached an AUC of 0.75 on the test set, consistent over multiple train-test split. This non linear multi-dimensional approach seems appropriate in evaluating complex postural control. PMID:27936060

A Non Linear Scoring Approach for Evaluating Balance: Classification of Elderly as Fallers and Non-Fallers.

PubMed

Audiffren, Julien; Bargiotas, Ioannis; Vayatis, Nicolas; Vidal, Pierre-Paul; Ricard, Damien

2016-01-01

Almost one third of population 65 years-old and older faces at least one fall per year. An accurate evaluation of the risk of fall through simple and easy-to-use measurements is an important issue in current clinic. A common way to evaluate balance in posturography is through the recording of the centre-of-pressure (CoP) displacement (statokinesigram) with force platforms. A variety of indices have been proposed to differentiate fallers from non fallers. However, no agreement has been reached whether these analyses alone can explain sufficiently the complex synergies of postural control. In this work, we study the statokinesigrams of 84 elderly subjects (80.3+- 6.4 years old), which had no impairment related to balance control. Each subject was recorded 25 seconds with eyes open and 25 seconds with eyes closed and information pertaining to the presence of problems of balance, such as fall, in the last six months, was collected. Five descriptors of the statokinesigrams were computed for each record, and a Ranking Forest algorithm was used to combine those features in order to evaluate each subject's balance with a score. A classical train-test split approach was used to evaluate the performance of the method through ROC analysis. ROC analysis showed that the performance of each descriptor separately was close to a random classifier (AUC between 0.49 and 0.54). On the other hand, the score obtained by our method reached an AUC of 0.75 on the test set, consistent over multiple train-test split. This non linear multi-dimensional approach seems appropriate in evaluating complex postural control.

The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial.

PubMed

Rothgangel, Andreas Stefan; Braun, Susy; Schulz, Ralf Joachim; Kraemer, Matthias; de Witte, Luc; Beurskens, Anna; Smeets, Rob Johannes

2015-01-01

Non-pharmacological interventions such as mirror therapy are gaining increased recognition in the treatment of phantom limb pain; however, the evidence in people with phantom limb pain is still weak. In addition, compliance to self-delivered exercises is generally low. The aim of this randomised controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and limitations in daily activities compared to traditional mirror therapy and care as usual in people following lower limb amputation. A three-arm multi-centre randomised controlled trial will be performed. Participants will be randomly assigned to care as usual, traditional mirror therapy or mirror therapy supported by telerehabilitation. During the first 4 weeks, at least 10 individual sessions will take place in every group. After the first 4 weeks, participants will be encouraged to perform self-delivered exercises over a period of 6 weeks. Outcomes will be assessed at 4 and 10 weeks after baseline and at 6 months follow-up. The primary outcome measure is the average intensity of phantom limb pain during the last week. Secondary outcome measures include the different dimensions of phantom limb pain, pain-related limitations in daily activities, global perceived effect, pain-specific self-efficacy, and quality of life. Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

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.

An Examination of Strategy Implementation During Abstract Nonlinguistic Category Learning in Aphasia

PubMed Central

Kiran, Swathi

2015-01-01

Purpose Our purpose was to study strategy use during nonlinguistic category learning in aphasia. Method Twelve control participants without aphasia and 53 participants with aphasia (PWA) completed a computerized feedback-based category learning task consisting of training and testing phases. Accuracy rates of categorization in testing phases were calculated. To evaluate strategy use, strategy analyses were conducted over training and testing phases. Participant data were compared with model data that simulated complex multi-cue, single feature, and random pattern strategies. Learning success and strategy use were evaluated within the context of standardized cognitive–linguistic assessments. Results Categorization accuracy was higher among control participants than among PWA. The majority of control participants implemented suboptimal or optimal multi-cue and single-feature strategies by testing phases of the experiment. In contrast, a large subgroup of PWA implemented random patterns, or no strategy, during both training and testing phases of the experiment. Conclusions Person-to-person variability arises not only in category learning ability but also in the strategies implemented to complete category learning tasks. PWA less frequently developed effective strategies during category learning tasks than control participants. Certain PWA may have impairments of strategy development or feedback processing not captured by language and currently probed cognitive abilities. PMID:25908438

Transdisciplinary synthesis for ecosystem science, policy and management: The Australian experience.

PubMed

Lynch, A J J; Thackway, R; Specht, A; Beggs, P J; Brisbane, S; Burns, E L; Byrne, M; Capon, S J; Casanova, M T; Clarke, P A; Davies, J M; Dovers, S; Dwyer, R G; Ens, E; Fisher, D O; Flanigan, M; Garnier, E; Guru, S M; Kilminster, K; Locke, J; Mac Nally, R; McMahon, K M; Mitchell, P J; Pierson, J C; Rodgers, E M; Russell-Smith, J; Udy, J; Waycott, M

2015-11-15

Mitigating the environmental effects of global population growth, climatic change and increasing socio-ecological complexity is a daunting challenge. To tackle this requires synthesis: the integration of disparate information to generate novel insights from heterogeneous, complex situations where there are diverse perspectives. Since 1995, a structured approach to inter-, multi- and trans-disciplinary(1) collaboration around big science questions has been supported through synthesis centres around the world. These centres are finding an expanding role due to ever-accumulating data and the need for more and better opportunities to develop transdisciplinary and holistic approaches to solve real-world problems. The Australian Centre for Ecological Analysis and Synthesis (ACEAS ) has been the pioneering ecosystem science synthesis centre in the Southern Hemisphere. Such centres provide analysis and synthesis opportunities for time-pressed scientists, policy-makers and managers. They provide the scientific and organisational environs for virtual and face-to-face engagement, impetus for integration, data and methodological support, and innovative ways to deliver synthesis products. We detail the contribution, role and value of synthesis using ACEAS to exemplify the capacity for synthesis centres to facilitate trans-organisational, transdisciplinary synthesis. We compare ACEAS to other international synthesis centres, and describe how it facilitated project teams and its objective of linking natural resource science to policy to management. Scientists and managers were brought together to actively collaborate in multi-institutional, cross-sectoral and transdisciplinary research on contemporary ecological problems. The teams analysed, integrated and synthesised existing data to co-develop solution-oriented publications and management recommendations that might otherwise not have been produced. We identify key outcomes of some ACEAS working groups which used synthesis to tackle important ecosystem challenges. We also examine the barriers and enablers to synthesis, so that risks can be minimised and successful outcomes maximised. We argue that synthesis centres have a crucial role in developing, communicating and using synthetic transdisciplinary research. Copyright © 2015 Elsevier B.V. All rights reserved.

Is employment-focused case management effective for patients with substance use disorders? Results from a controlled multi-site trial in Germany covering a 2-years-period after inpatient rehabilitation.

PubMed

Saal, Susanne; Forschner, Lukas; Kemmann, Dietmar; Zlatosch, Jacqueline; Kallert, Thomas W

2016-08-05

Substance use disorders are associated with unemployment. An employment-focused case management (CMRE) has been conceptualised as a specific intervention to help substance use disorder patients return to competitive employment immediately after inpatient rehabilitation. This study investigated the effect of the intervention on return to work of persons with substance use disorders. The study was conducted in four German inpatient rehabilitation departments, and included unemployed patients (aged between 18 and 63 years) with a main clinical diagnosis of ICD-10 F10-19 disorders. Six weeks before discharge, patients were randomly allocated to CMRE or standard care (SC) using a quasi-randomised approach. The primary outcome measure was integration into competitive employment 24 months after discharge from rehabilitation. Secondary outcome domains were abstinence, duration of employment, proportion of publicly funded employment, satisfaction with life, precarious housing situation and precarious financial situation, and use of follow-up services. Outcome measures were assessed 6 weeks and 1-2 days prior to discharge, and 12 and 24 months after discharge from rehabilitation. One hundred sixty patients were allocated into the CMRE group and 160 patients into the control group. 267 resp. 179 participants could be included in the analyses performed for the 12-, and the 24-months follow-up assessments. At the study endpoint the rate of integration into the primary labour market was 35.6 % in the CMRE group and 41.2 % in the control group, respectively (Relative Risk 0.92, 95 % CI, 0.47; 1.79). There was a significantly higher proportion in the CMRE group, however, which immediately after discharge linked with services of the Federal Employment Agency or Job Centres. There were no statistically significant differences in other outcomes between the groups. Compared to SC, the additional specific CMRE intervention did not result in superior effects on return to work rates, abstinence, satisfaction with life, and housing and precarious financial situation. But CMRE was more effective on linking substance use disorder patients with services of the Federal Employment Agency or Job Centres. Reasons for the finding that such close linking does not have an impact on return to work rates are discussed in detail. Identifier: DRKS00003574 ; March 12, 2012. The trial was retrospectively registered.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

Multi Criteria Decision Making to evaluate control strategies of contagious animal diseases.

PubMed

Mourits, M C M; van Asseldonk, M A P M; Huirne, R B M

2010-09-01

The decision on which strategy to use in the control of contagious animal diseases involves complex trade-offs between multiple objectives. This paper describes a Multi Criteria Decision Making (MCDM) application to illustrate its potential support to policy makers in choosing the control strategy that best meets all of the conflicting interests. The presented application focused on the evaluation of alternative strategies to control Classical Swine Fever (CSF) epidemics within the European Union (EU) according to the preferences of the European Chief Veterinary Officers (CVO). The performed analysis was centred on the three high-level objectives of epidemiology, economics and social ethics. The appraised control alternatives consisted of the EU compulsory control strategy, a pre-emptive slaughter strategy, a protective vaccination strategy and a suppressive vaccination strategy. Using averaged preference weights of the elicited CVOs, the preference ranking of the control alternatives was determined for six EU regions. The obtained results emphasized the need for EU region-specific control. Individual CVOs differed in their views on the relative importance of the various (sub)criteria by which the performance of the alternatives were judged. Nevertheless, the individual rankings of the control alternatives within a region appeared surprisingly similar. Based on the results of the described application it was concluded that the structuring feature of the MCDM technique provides a suitable tool in assisting the complex decision making process of controlling contagious animal diseases. 2010 Elsevier B.V. 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 .

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…

Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial.

PubMed

Andrews, Jeannette O; Mueller, Martina; Dooley, Mary; Newman, Susan D; Magwood, Gayenell S; Tingen, Martha S

2016-09-01

To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority. Copyright © 2016 Elsevier Inc. All rights reserved.

Efficacy and safety of artemisinin-naphthoquine versus dihydroartemisinin-piperaquine in adult patients with uncomplicated malaria: a multi-centre study in Indonesia

PubMed Central

2012-01-01

Background A practical and simple regimen for all malaria species is needed towards malaria elimination in Indonesia. It is worth to compare the efficacy and safety of a single dose of artemisinin-naphthoquine (AN) with a three-day regimen of dihydroartemisinin-piperaquine (DHP), the existing programme drug, in adults with uncomplicated symptomatic malaria. Methods This is a phase III, randomized, open label using sealed envelopes, multi-centre, comparative study between a single dose of AN and a three-day dose of DHP in Jayapura and Maumere. The modified WHO inclusion and exclusion criteria for efficacy study were used in this trial. A total of 401 eligible adult malaria subjects were hospitalized for three days and randomly treated with AN four tablets single dose on day 0 or DHP three to four tablets single daily dose for three days, and followed for 42 days for physical examination, thick and thin smears microscopy, and other necessary tests. The efficacy of drug was assessed by polymerase chain reaction (PCR) uncorrected and corrected. Results There were 153 Plasmodium falciparum, 158 Plasmodium vivax and 90 P. falciparum/P. vivax malaria. Mean of fever clearance times were similar, 13.0 ± 10.3 hours in AN and 11.3 ± 7.3 hours in DHP groups. The mean of parasite clearance times were longer in AN compared with DHP (28.0 ± 11.7 hours vs 25.5 ± 12.2 hours, p = 0.04). There were only 12 PCR-corrected P. falciparum late treatment failures: seven in AN and five in DHP groups. The PCR uncorrected and corrected on day −42 of adequate clinical and parasitological responses for treatment of any malaria were 93.7% (95% Cl: 90.3–97.2) and 96.3% (95% Cl: 93.6–99.0) in AN, 96.3% (95% Cl: 93.5–99.0) and 97.3% (95% Cl: 95.0–99.6) in DHP groups. Few and mild adverse events were reported. All the abnormal haematology and blood chemistry values had no clinical abnormality. Conclusion AN and DHP are confirmed very effective, safe and tolerate for treatment of any malaria. Both drugs are promising for multiple first-line therapy policies in Indonesia. PMID:22554203

Hybrid time-variant reliability estimation for active control structures under aleatory and epistemic uncertainties

NASA Astrophysics Data System (ADS)

Wang, Lei; Xiong, Chuang; Wang, Xiaojun; Li, Yunlong; Xu, Menghui

2018-04-01

Considering that multi-source uncertainties from inherent nature as well as the external environment are unavoidable and severely affect the controller performance, the dynamic safety assessment with high confidence is of great significance for scientists and engineers. In view of this, the uncertainty quantification analysis and time-variant reliability estimation corresponding to the closed-loop control problems are conducted in this study under a mixture of random, interval, and convex uncertainties. By combining the state-space transformation and the natural set expansion, the boundary laws of controlled response histories are first confirmed with specific implementation of random items. For nonlinear cases, the collocation set methodology and fourth Rounge-Kutta algorithm are introduced as well. Enlightened by the first-passage model in random process theory as well as by the static probabilistic reliability ideas, a new definition of the hybrid time-variant reliability measurement is provided for the vibration control systems and the related solution details are further expounded. Two engineering examples are eventually presented to demonstrate the validity and applicability of the methodology developed.

Multimodal exercise training in multiple sclerosis: A randomized controlled trial in persons with substantial mobility disability.

PubMed

Sandroff, Brian M; Bollaert, Rachel E; Pilutti, Lara A; Peterson, Melissa L; Baynard, Tracy; Fernhall, Bo; McAuley, Edward; Motl, Robert W

2017-10-01

Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability. 83 participants with substantial MS-related mobility disability underwent initial mobility, gait, fitness, and cognitive processing speed assessments and were randomly assigned to 6-months of supervised multimodal (progressive aerobic, resistance, and balance) exercise training (intervention condition) or stretching-and-toning activities (control condition). Participants completed the same outcome assessments halfway through and immediately following the 6-month study period. There were statistically significant improvements in six-minute walk performance (F(2158)=3.12, p=0.05, η p 2 =0.04), peak power output (F(2150)=8.16, p<0.01, η p 2 =0.10), and Paced Auditory Serial Addition Test performance (F(2162)=4.67, p=0.01, η p 2 =0.05), but not gait outcomes, for those who underwent the intervention compared with those who underwent the control condition. This RCT provides novel, preliminary evidence that multimodal exercise training may improve endurance walking performance and cognitive processing speed, perhaps based on improvements in cardiorespiratory capacity, in persons with MS with substantial mobility disability. This is critical for informing the development of multi-site exercise rehabilitation programs in larger samples of persons with MS-related mobility disability. Copyright © 2017 Elsevier Inc. All rights reserved.

Vector nature of multi-soliton patterns in a passively mode-locked figure-eight fiber laser.

PubMed

Ning, Qiu-Yi; Liu, Hao; Zheng, Xu-Wu; Yu, Wei; Luo, Ai-Ping; Huang, Xu-Guang; Luo, Zhi-Chao; Xu, Wen-Cheng; Xu, Shan-Hui; Yang, Zhong-Min

2014-05-19

The vector nature of multi-soliton dynamic patterns was investigated in a passively mode-locked figure-eight fiber laser based on the nonlinear amplifying loop mirror (NALM). By properly adjusting the cavity parameters such as the pump power level and intra-cavity polarization controllers (PCs), in addition to the fundamental vector soliton, various vector multi-soliton regimes were observed, such as the random static distribution of vector multiple solitons, vector soliton cluster, vector soliton flow, and the state of vector multiple solitons occupying the whole cavity. Both the polarization-locked vector solitons (PLVSs) and the polarization-rotating vector solitons (PRVSs) were observed for fundamental soliton and each type of multi-soliton patterns. The obtained results further reveal the fundamental physics of multi-soliton patterns and demonstrate that the figure-eight fiber lasers are indeed a good platform for investigating the vector nature of different soliton types.

The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids.

PubMed

Tiernan, Jim; Hind, Daniel; Watson, Angus; Wailoo, Allan J; Bradburn, Michael; Shephard, Neil; Biggs, Katie; Brown, Steven

2012-10-25

Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique. The aim of this study is to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic second or third degree (Grade II or Grade III) haemorrhoids. A multi-centre, parallel group randomised controlled trial. The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention. 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals. A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group. The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids. ISRCTN41394716.

Influence of magnetic field strength and image registration strategy on voxel-based morphometry in a study of Alzheimer's disease.

PubMed

Marchewka, Artur; Kherif, Ferath; Krueger, Gunnar; Grabowska, Anna; Frackowiak, Richard; Draganski, Bogdan

2014-05-01

Multi-centre data repositories like the Alzheimer's Disease Neuroimaging Initiative (ADNI) offer a unique research platform, but pose questions concerning comparability of results when using a range of imaging protocols and data processing algorithms. The variability is mainly due to the non-quantitative character of the widely used structural T1-weighted magnetic resonance (MR) images. Although the stability of the main effect of Alzheimer's disease (AD) on brain structure across platforms and field strength has been addressed in previous studies using multi-site MR images, there are only sparse empirically-based recommendations for processing and analysis of pooled multi-centre structural MR data acquired at different magnetic field strengths (MFS). Aiming to minimise potential systematic bias when using ADNI data we investigate the specific contributions of spatial registration strategies and the impact of MFS on voxel-based morphometry in AD. We perform a whole-brain analysis within the framework of Statistical Parametric Mapping, testing for main effects of various diffeomorphic spatial registration strategies, of MFS and their interaction with disease status. Beyond the confirmation of medial temporal lobe volume loss in AD, we detect a significant impact of spatial registration strategy on estimation of AD related atrophy. Additionally, we report a significant effect of MFS on the assessment of brain anatomy (i) in the cerebellum, (ii) the precentral gyrus and (iii) the thalamus bilaterally, showing no interaction with the disease status. We provide empirical evidence in support of pooling data in multi-centre VBM studies irrespective of disease status or MFS. Copyright © 2013 Wiley Periodicals, Inc.

Design and rationale of the medical students learning weight management counseling skills (MSWeight) group randomized controlled trial.

PubMed

Ockene, Judith K; Ashe, Karen M; Hayes, Rashelle B; Churchill, Linda C; Crawford, Sybil L; Geller, Alan C; Jolicoeur, Denise; Olendzki, Barbara C; Basco, Maria Theresa; Pendharkar, Jyothi A; Ferguson, Kristi J; Guck, Thomas P; Margo, Katherine L; Okuliar, Catherine A; Shaw, Monica A; Soleymani, Taraneh; Stadler, Diane D; Warrier, Sarita S; Pbert, Lori

2018-01-01

Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE). Eight U.S. medical schools were pair-matched and randomized in a group randomized controlled trial to evaluate whether a multi-modal education (MME) intervention compared to traditional education (TE) improves observed WMC skills. The MME intervention includes innovative components in years 1-3: a structured web-course; a role play exercise, WebPatientEncounter, and an enhanced outpatient internal medicine or family medicine clerkship. This evidence-supported curriculum uses the 5As framework to guide treatment and incorporates patient-centered counseling to engage the patient. The primary outcome is a comparison of scores on an Objective Structured Clinical Examination (OSCE) WMC case among third year medical students. The secondary outcome compares changes in scores of medical students from their first to third year on an assessment of perceived WMC skills and self-efficacy. MSWeight is the first RCT in medical schools to evaluate whether interventions integrated into the curriculum improve medical students' WMC skills. If this educational approach for teaching WMC is effective, feasible and acceptable it can affect how medical schools integrate WMC teaching into their curriculum. Copyright © 2017 Elsevier Inc. All rights reserved.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

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

Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving perinatal outcomes (PPROMEXIL - III trial).

PubMed

van Teeffelen, Augustinus S P; van der Ham, David P; Willekes, Christine; Al Nasiry, Salwan; Nijhuis, Jan G; van Kuijk, Sander; Schuyt, Ewoud; Mulder, Twan L M; Franssen, Maureen T M; Oepkes, Dick; Jansen, Fenna A R; Woiski, Mallory D; Bekker, Mireille N; Bax, Caroline J; Porath, Martina M; de Laat, Monique W M; Mol, Ben W; Pajkrt, Eva

2014-04-04

Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, β-error 0.2 and α-error 0.05). This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. NTR3492 Dutch Trial Register (http://www.trialregister.nl).

Longitudinal analysis of meta-analysis literatures in the database of ISI Web of Science.

PubMed

Zhu, Changtai; Jiang, Ting; Cao, Hao; Sun, Wenguang; Chen, Zhong; Liu, Jinming

2015-01-01

The meta-analysis is regarded as an important evidence for making scientific decision. The database of ISI Web of Science collected a great number of high quality literatures including meta-analysis literatures. However, it is significant to understand the general characteristics of meta-analysis literatures to outline the perspective of meta-analysis. In this present study, we summarized and clarified some features on these literatures in the database of ISI Web of Science. We retrieved the meta-analysis literatures in the database of ISI Web of Science including SCI-E, SSCI, A&HCI, CPCI-S, CPCI-SSH, CCR-E, and IC. The annual growth rate, literature category, language, funding, index citation, agencies and countries/territories of the meta-analysis literatures were analyzed, respectively. A total of 95,719 records, which account for 0.38% (99% CI: 0.38%-0.39%) of all literatures, were found in the database. From 1997 to 2012, the annual growth rate of meta-analysis literatures was 18.18%. The literatures involved in many categories, languages, fundings, citations, publication agencies, and countries/territories. Interestingly, the index citation frequencies of the meta-analysis were significantly higher than that of other type literatures such as multi-centre study, randomize controlled trial, cohort study, case control study, and cases report (P<0.0001). The increasing numbers, intensively global influence and high citations revealed that the meta-analysis has been becoming more and more prominent in recent years. In future, in order to promote the validity of meta-analysis, the CONSORT and PRISMA standard should be continuously popularized in the field of evidence-based medicine.

Building clinical trial capacity to develop a new treatment for multidrug-resistant tuberculosis.

PubMed

Tupasi, Thelma; Gupta, Rajesh; Danilovits, Manfred; Cirule, Andra; Sanchez-Garavito, Epifanio; Xiao, Heping; Cabrera-Rivero, Jose L; Vargas-Vasquez, Dante E; Gao, Mengqiu; Awad, Mohamed; Gentry, Leesa M; Geiter, Lawrence J; Wells, Charles D

2016-02-01

New drugs for infectious diseases often need to be evaluated in low-resource settings. While people working in such settings often provide high-quality care and perform operational research activities, they generally have less experience in conducting clinical trials designed for drug approval by stringent regulatory authorities. We carried out a capacity-building programme during a multi-centre randomized controlled trial of delamanid, a new drug for the treatment of multidrug-resistant tuberculosis. The programme included: (i) site identification and needs assessment; (ii) achieving International Conference on Harmonization - Good Clinical Practice (ICH-GCP) standards; (iii) establishing trial management; and (iv) increasing knowledge of global and local regulatory issues. Trials were conducted at 17 sites in nine countries (China, Egypt, Estonia, Japan, Latvia, Peru, the Philippines, the Republic of Korea and the United States of America). Eight of the 10 sites in low-resource settings had no experience in conducting the requisite clinical trials. Extensive capacity-building was done in all 10 sites. The programme resulted in improved local capacity in key areas such as trial design, data safety and monitoring, trial conduct and laboratory services. Clinical trials designed to generate data for regulatory approval require additional efforts beyond traditional research-capacity strengthening. Such capacity-building approaches provide an opportunity for product development partnerships to improve health systems beyond the direct conduct of the specific trial.

Clobazam : in patients with Lennox-Gastaut syndrome.

PubMed

Yang, Lily P H; Scott, Lesley J

2012-11-01

Clobazam, as with other benzodiazepines, has a long history of use in the treatment of epilepsy. More recently, it was approved in the USA as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥2 years. In the pivotal, placebo-controlled CONTAIN trial in paediatric and adult patients with Lennox-Gastaut syndrome (n = 217 evaluable), adjunctive therapy with clobazam 5-40 mg/day for 12 weeks significantly reduced mean weekly drop seizure rates from baseline compared with adjunctive placebo (primary endpoint), with a significant dosage-dependent improvement in these rates. Results from a dosage-ranging, double-blind, multi-centre, phase II trial add further support for the efficacy of clobazam in paediatric and adult patients with Lennox-Gastaut syndrome (n = 61 evaluable). Improvements in mean weekly drop seizure rates with adjunctive clobazam treatment in these short-term trials was maintained in an ongoing, open-label extension study, with a 91.6 % reduction in mean weekly drop seizure rates from baseline (at randomization in the initial trials) to 24 months in the overall population. Treatment with adjunctive clobazam was generally well tolerated in these clinical trials and after at least 2 years of treatment in an open-label extension study. Most adverse events were mild or moderate and similar to those typically observed with other benzodiazepines.

A radial map of multi-whisker correlation selectivity in the rat barrel cortex

PubMed Central

Estebanez, Luc; Bertherat, Julien; Shulz, Daniel E.; Bourdieu, Laurent; Léger, Jean- François

2016-01-01

In the barrel cortex, several features of single-whisker stimuli are organized in functional maps. The barrel cortex also encodes spatio-temporal correlation patterns of multi-whisker inputs, but so far the cortical mapping of neurons tuned to such input statistics is unknown. Here we report that layer 2/3 of the rat barrel cortex contains an additional functional map based on neuronal tuning to correlated versus uncorrelated multi-whisker stimuli: neuron responses to uncorrelated multi-whisker stimulation are strongest above barrel centres, whereas neuron responses to correlated and anti-correlated multi-whisker stimulation peak above the barrel–septal borders, forming rings of multi-whisker synchrony-preferring cells. PMID:27869114

A radial map of multi-whisker correlation selectivity in the rat barrel cortex.

PubMed

Estebanez, Luc; Bertherat, Julien; Shulz, Daniel E; Bourdieu, Laurent; Léger, Jean-François

2016-11-21

In the barrel cortex, several features of single-whisker stimuli are organized in functional maps. The barrel cortex also encodes spatio-temporal correlation patterns of multi-whisker inputs, but so far the cortical mapping of neurons tuned to such input statistics is unknown. Here we report that layer 2/3 of the rat barrel cortex contains an additional functional map based on neuronal tuning to correlated versus uncorrelated multi-whisker stimuli: neuron responses to uncorrelated multi-whisker stimulation are strongest above barrel centres, whereas neuron responses to correlated and anti-correlated multi-whisker stimulation peak above the barrel-septal borders, forming rings of multi-whisker synchrony-preferring cells.

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.

School-based programmes for preventing smoking.

PubMed

Thomas, R; Perera, R

2006-07-19

Smoking rates in adolescents are rising in some countries. Helping young people to avoid starting smoking is a widely endorsed goal of public health, but there is uncertainty about how to do this. Schools provide a route for communicating with a large proportion of young people, and school-based programmes for smoking prevention have been widely developed and evaluated. To review all randomized controlled trials of behavioural interventions in schools to prevent children (aged 5 to12) and adolescents (aged 13 to18) starting smoking. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Tobacco Addiction Group's Specialized Register, MEDLINE, EMBASE, PsyclNFO, ERIC, CINAHL, Health Star, Dissertation Abstracts and studies identified in the bibliographies of articles. Individual MEDLINE searches were made for 133 authors who had undertaken randomized controlled trials in this area. Types of studies: those in which individual students, classes, schools, or school districts were randomized to the intervention or control groups and followed for at least six months. Children (aged 5 to12) or adolescents (aged 13 to18) in school settings. Types of interventions: Classroom programmes or curricula, including those with associated family and community interventions, intended to deter use of tobacco. We included programmes or curricula that provided information, those that used social influences approaches, those that taught generic social competence, and those that included interventions beyond the school into the community. We included programmes with a drug or alcohol focus if outcomes for tobacco use were reported. Types of outcome measures: Prevalence of non-smoking at follow up among those not smoking at baseline. We did not require biochemical validation of self-reported tobacco use for study inclusion. We assessed whether identified citations were randomized controlled trials. We assessed the quality of design and execution, and abstracted outcome data. Because of the marked heterogeneity of design and outcomes, we computed pooled estimates only for those trials that could be analyzed together and for which statistical data were available. We predominantly synthesized the data using narrative systematic review. We grouped studies by intervention method (information; social competence; social influences; combined social influences/social competence; multi-modal programmes). Within each group, we placed them into three categories (low, medium and high risk of bias) according to validity using quality criteria for reported study design. Of the 94 randomized controlled trials identified, we classified 23 as category one (most valid). There was one category one study of information-giving and two of teaching social comeptence. There were thirteen category one studies of social influences interventions. Of these, nine found some positive effect of intervention on smoking prevalence, and four failed to detect an effect on smoking prevalence. The largest and most rigorous study, the Hutchinson Smoking Prevention Project, found no long-term effect of an intensive eight-year programme on smoking behaviour. There were three category one RCTs of combined social influences and social competence interventions: one provided significant results and one only for instruction by health educators compared to self-instruction. There was a lack of high quality evidence about the effectiveness of combinations of social influences and social competence approaches. There was one category one study providing data on social influences compared with information giving. There were four category one studies of multi-modal approaches but they provided limited evidence about the effectiveness of multi-modal approaches including community initiatives. There is one rigorous test of the effects of information-giving about smoking. There are well-conducted randomized controlled trials to test the effects of social influences interventions: in half of the group of best quality studies those in the intervention group smoke less than those in the control, but many studies failed to detect an effect of the intervention. There are only three high quality RCTs which test the effectiveness of combinations of social influences and social competence interventions, and four which test multi-modal interventions; half showed significant positive results.

A Randomized Controlled Trial of the Child Anxiety Multi-Day Program (CAMP) for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich-May, Jill

2013-01-01

While the efficacy of cognitive behavior therapy for childhood anxiety disorders, including separation anxiety disorder (SAD), has been established, tailoring such treatments to particular interests and needs may enhance uptake of evidence-based interventions. The current investigation evaluates the feasibility and preliminary efficacy of an…

A Randomized Controlled Trial of a Multi-Dose Bystander Intervention Program Using Peer Education Theater

ERIC Educational Resources Information Center

McMahon, Sarah; Winter, Samantha C.; Palmer, Jane E.; Postmus, Judy L.; Peterson, N. Andrew; Zucker, Sharon; Koenick, RuthAnne

2015-01-01

This article reports findings from a longitudinal, experimental evaluation of a peer education theater program, Students Challenging Realities and Educating Against Myths (SCREAM) Theater. This study examines the impact of SCREAM Theater on a range of bystander-related outcomes (i.e. bystander intentions, bystander efficacy, perception of friend…

A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

PubMed

Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

2015-02-03

Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

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.

Regional Workshop on Strengthening Linkages and Networks through Community Learning Centres (CLCs) (Bandung, Indonesia, September 5-9, 2005)

ERIC Educational Resources Information Center

Online Submission, 2006

2006-01-01

The Community Learning Centre (CLC) Project has been carried out since 1998 within the framework of the Asia Pacific Program of Education for All (APPEAL). CLC is a multi-purpose learning center that serves as a local venue for adults, youth and children to engage in all kinds of learning. After a few years' implementation, some countries have…

Open pre-schools at integrated health services-A program theory.

PubMed

Abrahamsson, Agneta; Samarasinghe, Kerstin

2013-04-01

Family centres in Sweden are integrated services that reach all prospective parents and parents with children up to their sixth year, because of the co-location of the health service with the social service and the open pre-school. The personnel on the multi-professional site work together to meet the needs of the target group. The article explores a program theory focused on the open pre-schools at family centres. A multi-case design is used and the sample consists of open pre-schools at six family centres. The hypothesis is based on previous research and evaluation data. It guides the data collection which is collected and analysed stepwise. Both parents and personnel are interviewed individually and in groups at each centre. The hypothesis was expanded to a program theory. The compliance of the professionals was the most significant element that explained why the open access service facilitated positive parenting. The professionals act in a compliant manner to meet the needs of the children and parents as well as in creating good conditions for social networking and learning amongst the parents. The compliance of the professionals in this program theory of open pre-schools at family centres can be a standard in integrated and open access services, whereas the organisation form can vary. The best way of increasing the number of integrative services is to support and encourage professionals that prefer to work in a compliant manner.

A multi target approach to control chemical reactions in their inhomogeneous solvent environment

NASA Astrophysics Data System (ADS)

Keefer, Daniel; Thallmair, Sebastian; Zauleck, Julius P. P.; de Vivie-Riedle, Regina

2015-12-01

Shaped laser pulses offer a powerful tool to manipulate molecular quantum systems. Their application to chemical reactions in solution is a promising concept to redesign chemical synthesis. Along this road, theoretical developments to include the solvent surrounding are necessary. An appropriate theoretical treatment is helpful to understand the underlying mechanisms. In our approach we simulate the solvent by randomly selected snapshots from molecular dynamics trajectories. We use multi target optimal control theory to optimize pulses for the various arrangements of explicit solvent molecules simultaneously. This constitutes a major challenge for the control algorithm, as the solvent configurations introduce a large inhomogeneity to the potential surfaces. We investigate how the algorithm handles the new challenges and how well the controllability of the system is preserved with increasing complexity. Additionally, we introduce a way to statistically estimate the efficiency of the optimized laser pulses in the complete thermodynamical ensemble.

Six weeks of multi-station program on the knee proprioception and performance of futsal players.

PubMed

Pérez-Silvestre, Ángel; Albert-Lucena, Daniel; Gómez-Chiguano, Guido F; Plaza-Manzano, Gustavo; Pecos-Martín, Daniel; Gallego-Izquierdo, Tomás; Martín-Casas, Patricia; Romero-Franco, Natalia

2018-03-27

Proprioception and vertical jump are important parameters in the performance and prevention of injuries in futsal. However, very few studies have analyzed the role of multi-station exercises to improve these variables. The purpose of this study was to assess the effects of a six-week multi-station exercise program on knee joint position sense (JPS) and countermovement jump (CMJ) of futsal players. Thirty-four male futsal players randomly classified into experimental (n = 17) or control group (n = 17). The experimental group included a multi-station exercise protocol to their training routines (2 times/week - 6 weeks); the control group continued their training routines. All the players completed similar training routines outside of the multi-station exercises. Before (baseline), just after the intervention (Post6Wk) and four weeks later (Post10Wk), CMJ and knee JPS (absolute, relative and variable angular error: AAE, RAE and VAE, respectively) were evaluated. ANOVA showed that the experimental group significantly decreased VAE at Post10Wk compared to baseline, suggestive of greater proprioceptive precision, while the control group significantly increased AAE, RAE and VAE at Post10Wk compared to baseline. The experimental group exhibited lower and thus, better AAE and VAE than the control group at Post10Wk, although no significant differences were found at Post6Wk. No significant differences was found in the CMJ. A six weeks of multi-station program may help improve proprioceptive precision of futsal players, even one month after finishing the 6-wk multi-station training program. However, this is not long enough to improve proprioceptive acuity and maximum vertical jump. Therefore, the meaningful of these results in term of performance are unclear.

Effects of cooking using multi-ply cookware on absorption of potassium and vitamins: a randomized double-blind placebo control study

PubMed Central

Mori, Mari; Hamada, Atsumi; Mori, Hideki; Yamori, Yukio; Tsuda, Kinsuke

2012-01-01

This 2-week interventional study involved a randomized allocation of subjects into three groups: Group A (daily ingestion of 350 g vegetables cooked without water using multi-ply [multilayer-structured] cookware), Group B (daily ingestion of 350g vegetables; ordinary cookware) and Group C (routine living). Before and after intervention, each subject underwent health examination with 24-h urine sampling. Blood vitamin C significantly increased after intervention from the baseline in Group A (P < 0.01) and Group B (P < 0.05). β-Carotene levels also increased significantly after intervention in Group A (P < 0.01) and Group B (P < 0.01). Oxidized low-density lipoprotein decreased significantly after intervention in Group A (P < 0.01). In Group A, 24-h urinary potassium excretion increased significantly (P < 0.01) and 24-h urinary sodium (Na)/K ratio improved significantly (P < 0.05) after intervention. In conclusion, a cooking method modification with multi-ply cookware improved absorption of nutrients from vegetables and enhanced effective utilization of the antioxidant potentials of vegetable nutrients. PMID:22229802

Person-centred web-based support--development through a Swedish multi-case study.

PubMed

Josefsson, Ulrika; Berg, Marie; Koinberg, Ingalill; Hellström, Anna-Lena; Nolbris, Margaretha Jenholt; Ranerup, Agneta; Lundin, Carina Sparud; Skärsäter, Ingela

2013-10-19

Departing from the widespread use of the internet in modern society and the emerging use of web applications in healthcare this project captures persons' needs and expectations in order to develop highly usable web recourses. The purpose of this paper is to outline a multi-case research project focused on the development and evaluation of person-centred web-based support for people with long-term illness. To support the underlying idea to move beyond the illness, we approach the development of web support from the perspective of the emergent area of person-centred care. The project aims to contribute to the ongoing development of web-based supports in health care and to the emerging field of person-centred care. The research design uses a meta-analytical approach through its focus on synthesizing experiences from four Swedish regional and national cases of design and use of web-based support in long-term illness. The cases include children (bladder dysfunction and urogenital malformation), young adults (living close to persons with mental illness), and two different cases of adults (women with breast cancer and childbearing women with type 1 diabetes). All of the cases are ongoing, though in different stages of design, implementation, and analysis. This, we argue, will lead to a synthesis of results on a meta-level not yet described. To allow valid comparisons between the four cases we explore and problematize them in relation to four main aspects: 1) The use of people's experiences and needs; 2) The role of use of theories in the design of person-centred web-based supports; 3) The evaluation of the effects of health outcomes for the informants involved and 4) The development of a generic person-centred model for learning and social support for people with long-term illness and their significant others. Person-centred web-based support is a new area and few studies focus on how web-based interventions can contribute to the development of person-centred care. In summary, the main intention of the project outlined here is to contribute with both a synthesis of results on meta-level from four cases and a substantial contribution to the field person-centred care.

Consumption of predefined 'Nordic' dietary items in ten European countries - an investigation in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort.

PubMed

Roswall, Nina; Olsen, Anja; Boll, Katja; Christensen, Jane; Halkjær, Jytte; Sørensen, Thorkild I A; Dahm, Christina C; Overvad, Kim; Clavel-Chapelon, Françoise; Boutron-Ruault, Marie C; Cottet, Vanessa; Teucher, Birgit; Kaaks, Rudolf; Boeing, Heiner; von Ruesten, Anne; Trichopoulou, Antonia; Oikonomou, Eleni; Vasilopoulou, Effie; Pala, Valeria; Sacerdote, Carlotta; Mattiello, Amalia; Masala, Giovanna; Peeters, Petra H M; Bueno-de-Mesquita, H Bas; Engeset, Dagrun; Skeie, Guri; Asli, Lene A; Amiano, Pilar; Jakszyn, Paula; Ardanaz, Eva; Huerta, José M; Quirós, José R; Molina-Montes, Esther; Nilsson, Lena M; Johansson, Ingegerd; Wirfält, Elisabet; Drake, Isabel; Mulligan, Angela A; Khaw, Kay T; Romaguera, Dora; Vergnaud, Anne-Claire; Key, Tim; Riboli, Elio; Tjønneland, Anne

2014-12-01

Health-beneficial effects of adhering to a healthy Nordic diet index have been suggested. However, it has not been examined to what extent the included dietary components are exclusively related to the Nordic countries or if they are part of other European diets as well, suggesting a broader preventive potential. The present study describes the intake of seven a priori defined healthy food items (apples/pears, berries, cabbages, dark bread, shellfish, fish and root vegetables) across ten countries participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) and examines their consumption across Europe. Cross-sectional study. A 24 h dietary recall was administered through a software program containing country-specific recipes. Sex-specific mean food intake was calculated for each centre/country, as well as percentage of overall food groups consumed as healthy Nordic food items. All analyses were weighted by day and season of data collection. Multi-centre, European study. Persons (n 36 970) aged 35-74 years, constituting a random sample of 519 978 EPIC participants. The highest intakes of the included diet components were: cabbages and berries in Central Europe; apples/pears in Southern Europe; dark bread in Norway, Denmark and Greece; fish in Southern and Northern countries; shellfish in Spain; and root vegetables in Northern and Central Europe. Large inter-centre variation, however, existed in some countries. Dark bread, root vegetables and fish are strongly related to a Nordic dietary tradition. Apples/pears, berries, cabbages, fish, shellfish and root vegetables are broadly consumed in Europe, and may thus be included in regional public health campaigns.

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.

The effect of images of Michelle Obama's face on trick-or-treaters' dietary choices: A randomized control trial.

PubMed

Aronow, Peter M; Karlan, Dean; Pinson, Lauren E

2018-01-01

To evaluate the microfoundations of a personality-inspired public health campaign's influence on minors. Multi-year randomized control trial. Economics professor's front porch in New Haven, CT. 1223 trick-or-treaters in New Haven over three years; on average, 8.5 years old and 53% male (among children whose gender was identifiable). Trick-or-treaters over the age of three that approached the house. Random assignment to the Michelle Obama side of the porch or the Comparison side of the porch. Selection of fruit over candy. Difference-in-means estimates. We estimate that viewing a photograph of Michelle Obama's face relative to control conditions caused children to be 19% more likely to choose fruit over candy. Michelle Obama's initiative to reduce childhood obesity has influenced children's dietary preferences. Whether this influence extends beyond Halloween trick-or-treating in New Haven, CT on the porch of an economics professor requires further research.

Harmonization Process and Reliability Assessment of Anthropometric Measurements in the Elderly EXERNET Multi-Centre Study

PubMed Central

Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A.; Olivares, Pedro R.; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A.; Ara, Ignacio

2012-01-01

Background The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. Purpose To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. Materials and Methods A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain) participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. Results For height, intra-rater technical errors of measurement (TEMs) were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. Conclusion The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population. PMID:22860013

8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information

PubMed Central

Zhang, Rujun; Persaud, Navindra

2017-01-01

Objectives We report information about an unpublished 1970s study (“8-way” Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. Design Double blinded, multi-centred, randomized placebo-controlled study. Setting 14 clinics in the United States. Participants 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. Interventions Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxine, dicylomine/pyridoxine, doxylamine, dicyclomine/pyridoxine, pyridoxine and dicyclomine. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Outcomes Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. Results Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were “evaluated moderate or excellent” was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/pyridoxine (21; 95% CI 11 to 30), dicylomine/pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. Conclusion The available information about this “8-way Bendectin” trial indicates it should not be used to support the efficacy of doxylamine, pyridoxine or dicyclomine for the treatment of nausea and vomiting during pregnancy because of a high risk of bias. Trial registration Not registered. PMID:28052111

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).

The Regulation of Multi-Age Groupings in Canadian Centre-based Child Care Settings: An Analysis of Provincial and Territorial Policies, Legislation and Regulations.

ERIC Educational Resources Information Center

Bernhard, Judith; Pollard, June; Chud, Gyda; Vukelich, Goranka; Pacini-Ketchabaw, Veronica

2000-01-01

Examined the ways Canadian provincial and territorial policies address the inclusion of infants in multi-age early childhood education settings and the ways practitioners and licensing personnel interpret these policies. Noted policy patterns that affect the inclusion of infants and older children. Derived recommendations for policymakers and…

Antibiotic resistance and population structure of cystic fibrosis Pseudomonas aeruginosa isolates from a Spanish multi-centre study.

PubMed

López-Causapé, Carla; de Dios-Caballero, Juan; Cobo, Marta; Escribano, Amparo; Asensio, Óscar; Oliver, Antonio; Del Campo, Rosa; Cantón, Rafael; Solé, Amparó; Cortell, Isidoro; Asensio, Oscar; García, Gloria; Martínez, María Teresa; Cols, María; Salcedo, Antonio; Vázquez, Carlos; Baranda, Félix; Girón, Rosa; Quintana, Esther; Delgado, Isabel; de Miguel, María Ángeles; García, Marta; Oliva, Concepción; Prados, María Concepción; Barrio, María Isabel; Pastor, María Dolores; Olveira, Casilda; de Gracia, Javier; Álvarez, Antonio; Escribano, Amparo; Castillo, Silvia; Figuerola, Joan; Togores, Bernat; Oliver, Antonio; López, Carla; de Dios Caballero, Juan; Tato, Marta; Máiz, Luis; Suárez, Lucrecia; Cantón, Rafael

2017-09-01

The first Spanish multi-centre study on the microbiology of cystic fibrosis (CF) was conducted from 2013 to 2014. The study involved 24 CF units from 17 hospitals, and recruited 341 patients. The aim of this study was to characterise Pseudomonas aeruginosa isolates, 79 of which were recovered from 75 (22%) patients. The study determined the population structure, antibiotic susceptibility profile and genetic background of the strains. Fifty-five percent of the isolates were multi-drug-resistant, and 16% were extensively-drug-resistant. Defective mutS and mutL genes were observed in mutator isolates (15.2%). Considerable genetic diversity was observed by pulsed-field gel electrophoresis (70 patterns) and multi-locus sequence typing (72 sequence types). International epidemic clones were not detected. Fifty-one new and 14 previously described array tube (AT) genotypes were detected by AT technology. This study found a genetically unrelated and highly diverse CF P. aeruginosa population in Spain, not represented by the epidemic clones widely distributed across Europe, with multiple combinations of virulence factors and high antimicrobial resistance rates (except for colistin). Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

LapTrain: multi-modality training curriculum for laparoscopic cholecystectomy-results of a randomized controlled trial.

PubMed

Kowalewski, K F; Garrow, C R; Proctor, T; Preukschas, A A; Friedrich, M; Müller, P C; Kenngott, H G; Fischer, L; Müller-Stich, B P; Nickel, F

2018-02-12

Multiple training modalities for laparoscopy have different advantages, but little research has been conducted on the benefit of a training program that includes multiple different training methods compared to one method only. This study aimed to evaluate benefits of a combined multi-modality training program for surgical residents. Laparoscopic cholecystectomy (LC) was performed on a porcine liver as the pre-test. Randomization was stratified for experience to the multi-modality Training group (12 h of training on Virtual Reality (VR) and box trainer) or Control group (no training). The post-test consisted of a VR LC and porcine LC. Performance was rated with the Global Operative Assessment of Laparoscopic Skills (GOALS) score by blinded experts. Training (n = 33) and Control (n = 31) were similar in the pre-test (GOALS: 13.7 ± 3.4 vs. 14.7 ± 2.6; p = 0.198; operation time 57.0 ± 18.1 vs. 63.4 ± 17.5 min; p = 0.191). In the post-test porcine LC, Training had improved GOALS scores (+ 2.84 ± 2.85 points, p < 0.001), while Control did not (+ 0.55 ± 2.34 points, p = 0.154). Operation time in the post-test was shorter for Training vs. Control (40.0 ± 17.0 vs. 55.0 ± 22.2 min; p = 0.012). Junior residents improved GOALS scores to the level of senior residents (pre-test: 13.7 ± 2.7 vs. 18.3 ± 2.9; p = 0.010; post-test: 15.5 ± 3.4 vs. 18.8 ± 3.8; p = 0.120) but senior residents remained faster (50.1 ± 20.6 vs. 25.0 ± 1.9 min; p < 0.001). No differences were found between groups on the post-test VR trainer. Structured multi-modality training is beneficial for novices to improve basics and overcome the initial learning curve in laparoscopy as well as to decrease operation time for LCs in different stages of experience. Future studies should evaluate multi-modality training in comparison with single modalities. German Clinical Trials Register DRKS00011040.

Haloperidol versus placebo for delirium prevention in acutely hospitalised older at risk patients: a multi-centre double-blind randomised controlled clinical trial.

PubMed

Schrijver, Edmée J M; de Vries, Oscar J; van de Ven, Peter M; Bet, Pierre M; Kamper, Ad M; Diepeveen, Sabine H A; van Marum, Rob J; van Strien, Astrid M; Anten, Sander; Lagaay, Anne M; Boelaarts, Leo; Bloemers, Frank W; Kramer, Mark H H; Nanayakkara, Prabath W B

2018-01-01

because the few randomised placebo-controlled trials investigating the potential role for prophylactic haloperidol in delirium prevention have focused on specific surgical populations, we investigated its efficacy and safety in acutely hospitalised older patients. this multi-centre, double-blind, stratified, block randomised, placebo-controlled trial was conducted at six Dutch hospitals. Patients age ≥70 years, acutely admitted through the emergency department for general medicine or surgical specialties and at risk for delirium were randomised (n = 245) to haloperidol or placebo 1 mg orally twice-daily (maximum of 14 doses) on top of standard nonpharmacological prevention strategies. The primary outcome was delirium incidence. Other endpoints included delirium severity and duration, drug safety and clinical outcomes. intention-to-treat analysis included 242 participants (calculated sample size n = 390, statistical power of current sample 59%) allocated to haloperidol (n = 118) or placebo (n = 124). In the haloperidol and placebo group, delirium incidence was 19.5 versus 14.5% (OR 1.43, 95% CI 0.72 to 2.78); median (IQR) delirium duration 4 (2, 5) versus 3 (1, 6) days (P = 0.366); maximum DRS-R-98 score 16 (9.8, 19.5) versus 10 (5.5, 22.5) (P = 0.549; 53.7% missing data); hospital LOS 7 (4, 10.3) versus 7 (5, 11.8) days (P = 0.343); 3-month mortality 9.9 versus 12.5% (OR 0.77, 95% CI 0.34 to 1.75), respectively. No treatment-limiting side effects were noted. prophylactic low-dose oral haloperidol did not reduce delirium incidence in acutely hospitalised older patients. Therefore, prophylactic use of haloperidol in this population is not recommended. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

Field efficacy of a new mosaic long-lasting mosquito net (PermaNet® 3.0) against pyrethroid-resistant malaria vectors: a multi centre study in Western and Central Africa

PubMed Central

2010-01-01

Background Due to the spread of pyrethroid-resistance in malaria vectors in Africa, new strategies and tools are urgently needed to better control malaria transmission. The aim of this study was to evaluate the performances of a new mosaic long-lasting insecticidal net (LLIN), i.e. PermaNet® 3.0, against wild pyrethroid-resistant Anopheles gambiae s.l. in West and Central Africa. Methods A multi centre experimental hut trial was conducted in Malanville (Benin), Vallée du Kou (Burkina Faso) and Pitoa (Cameroon) to investigate the exophily, blood feeding inhibition and mortality induced by PermaNet® 3.0 (i.e. a mosaic net containing piperonyl butoxide and deltamethrin on the roof) comparatively to the WHO recommended PermaNet® 2.0 (unwashed and washed 20-times) and a conventionally deltamethrin-treated net (CTN). Results The personal protection and insecticidal activity of PermaNet 3.0 and PermaNet® 2.0 were excellent (>80%) in the "pyrethroid-tolerant" area of Malanville. In the pyrethroid-resistance areas of Pitoa (metabolic resistance) and Vallée du Kou (presence of the L1014F kdr mutation), PermaNet® 3.0 showed equal or better performances than PermaNet® 2.0. It should be noted however that the deltamethrin content on PermaNet® 3.0 was up to twice higher than that of PermaNet® 2.0. Significant reduction of efficacy of both LLIN was noted after 20 washes although PermaNet® 3.0 still fulfilled the WHO requirement for LLIN. Conclusion The use of combination nets for malaria control offers promising prospects. However, further investigations are needed to demonstrate the benefits of using PermaNet® 3.0 for the control of pyrethroid resistant mosquito populations in Africa. PMID:20423479

A multi-stage drop-the-losers design for multi-arm clinical trials.

PubMed

Wason, James; Stallard, Nigel; Bowden, Jack; Jennison, Christopher

2017-02-01

Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cause problems when applying for funding as the cost will also be generally highly variable. This motivates a type of design that provides the efficiency advantages of a group-sequential multi-arm multi-stage design, but has a fixed sample size. One such design is the two-stage drop-the-losers design, in which a number of experimental treatments, and a control treatment, are assessed at a prescheduled interim analysis. The best-performing experimental treatment and the control treatment then continue to a second stage. In this paper, we discuss extending this design to have more than two stages, which is shown to considerably reduce the sample size required. We also compare the resulting sample size requirements to the sample size distribution of analogous group-sequential multi-arm multi-stage designs. The sample size required for a multi-stage drop-the-losers design is usually higher than, but close to, the median sample size of a group-sequential multi-arm multi-stage trial. In many practical scenarios, the disadvantage of a slight loss in average efficiency would be overcome by the huge advantage of a fixed sample size. We assess the impact of delay between recruitment and assessment as well as unknown variance on the drop-the-losers designs.

A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.

PubMed

Shepperd, Sasha; Cradduck-Bamford, Andrea; Butler, Chris; Ellis, Graham; Godfrey, Mary; Gray, Alastair; Hemsley, Anthony; Khanna, Pradeep; Langhorne, Peter; McCaffrey, Patricia; Mirza, Lubena; Pushpangadan, Maj; Ramsay, Scott; Schiff, Rebekah; Stott, David; Young, John; Yu, Ly-Mee

2017-10-23

There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. We are conducting a multi-site randomised open trial of geriatrician-led admission avoidance hospital at home, compared with admission to hospital. We are recruiting older people with markers of frailty or prior dependence who have been referred to admission avoidance hospital at home for an acute medical event. This includes patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. Participants are randomised using a computerised random number generator to geriatrician-led admission avoidance hospital at home or a control group of inpatient admission in a 2:1 ratio in favour of the intervention. The primary endpoint 'living at home' (the inverse of death or living in a residential care setting) is measured at 6 months follow-up, and we also collect data on this outcome at 12 months. Secondary outcomes include the incidence of delirium, mortality, new long-term residential care, cognitive impairment, activities of daily living, quality of life and quality-adjusted survival, length of stay, readmission or transfer to hospital. We will conduct a parallel economic evaluation, and a process evaluation that includes an interview study to explore the experiences of patients and carers. Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will provide evidence on alternative models of healthcare for older people who require hospital admission. ISRCTN60477865 : Registered on 10 March 2014. Trial Sponsor: University of Oxford. Version 3.1, 14/06/2016.

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.

Cervical cancer screening in women referred to healthcare centres in Tabriz, Iran.

PubMed

Farshbaf-Khalili, Azizeh; Salehi-Pourmehr, Hanieh; Shahnazi, Mahnaz; Yaghoubi, Sina; Gahremani-Nasab, Parvaneh

2015-01-01

Cervical cancer is the second most common cancer among Iranian women and among the few cancers that could be easily diagnosed in the pre-malignant stage. We aimed to assess the status of cervical cancer screening in women referred to health care centres in Tabriz, northwest Iran. This descriptive-analytical study was done on 441 women referred to health care centres of Tabriz, northwest Iran. The centres were selected using the multi-stage cluster sampling method. The participants were selected from the active records of those centres. A questionnaire regarding the socio-demographic characteristics and cervical cancer screening and reasons for referring or not referring for screening was completed by the participants A P < 0.05 was considered as significant. Out of the participants 49.4% of women had done the Pap smear test while 50.6% had never done this test. The main reason why women had not performed cervical cancer screening was being unaware of the importance of it (46.1%). Logistic regression analysis with adjustment showed a significant relationship between screening and awareness scores (OR = 1.17, CI = 95%:1.12-1.23), when the effect of other confounding factors [total awareness scores, risk factors (marriage or having sexual intercourse at a young age, history of obvious cervical infection, cautery, cryotherapy or repeated curettage), age and type of family planning] in screening was controlled. Suitable and continuous educational programmes especially for high risk women should be implemented through the health care services. Preparing educational brochures and pamphlets and providing adequate training on the necessity of early referral and marriage counseling could also be effective in improving woman's awareness and performance.

Intraclass Correlations for Three-Level Multi-Site Cluster-Randomized Trials of Science Achievement

ERIC Educational Resources Information Center

Westine, Carl D.

2015-01-01

A cluster-randomized trial (CRT) relies on random assignment of intact clusters to treatment conditions, such as classrooms or schools (Raudenbush & Bryk, 2002). One specific type of CRT, a multi-site CRT (MSCRT), is commonly employed in educational research and evaluation studies (Spybrook & Raudenbush, 2009; Spybrook, 2014; Bloom,…

Optimizing Constrained Single Period Problem under Random Fuzzy Demand

NASA Astrophysics Data System (ADS)

Taleizadeh, Ata Allah; Shavandi, Hassan; Riazi, Afshin

2008-09-01

In this paper, we consider the multi-product multi-constraint newsboy problem with random fuzzy demands and total discount. The demand of the products is often stochastic in the real word but the estimation of the parameters of distribution function may be done by fuzzy manner. So an appropriate option to modeling the demand of products is using the random fuzzy variable. The objective function of proposed model is to maximize the expected profit of newsboy. We consider the constraints such as warehouse space and restriction on quantity order for products, and restriction on budget. We also consider the batch size for products order. Finally we introduce a random fuzzy multi-product multi-constraint newsboy problem (RFM-PM-CNP) and it is changed to a multi-objective mixed integer nonlinear programming model. Furthermore, a hybrid intelligent algorithm based on genetic algorithm, Pareto and TOPSIS is presented for the developed model. Finally an illustrative example is presented to show the performance of the developed model and algorithm.

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.

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.

Magnesium sulphate in acute severe asthma in children (MAGNETIC): a randomised, placebo-controlled trial.

PubMed

Powell, Colin; Kolamunnage-Dona, Ruwanthi; Lowe, John; Boland, Angela; Petrou, Stavros; Doull, Iolo; Hood, Kerenza; Williamson, Paula

2013-06-01

Little evidence is available for the effect of nebulised magnesium sulphate (MgSO(4)) in acute asthma in children. We assessed the effect of MgSO(4) treatment in children with severe acute asthma. In this randomised placebo-controlled, multi-centre, parallel trial, we enrolled children (aged 2-16 years) with severe acute asthma who did not respond to standard inhaled treatment from 30 hospitals in the UK. Children were randomly allocated (1:1) to receive nebulised salbutamol and ipratropium bromide with either 2·5 mL of isotonic MgSO(4) (250 mmol/L; 151 mg per dose; MgSO(4) group) or 2·5 mL of isotonic saline (placebo group) on three occasions at 20-min intervals. Randomisation was done with a computer-generated randomisation sequence, with random block sizes of two to four. Both patients and researchers were masked to treatment allocation. The primary outcome measure was the Yung Asthma Severity Score (ASS) at 60 min post-randomisation. We used a statistical significance level of p<0·05 for a between-group difference, but regarded a between-group difference in ASS of 0·5 as the minimal clinically significant treatment effect. Analysis was done by intention to treat. This trial is registered with controlled-trials.com, number ISRCTN81456894. Between Jan 3, 2009, and March 20, 2011, we recruited and randomly assigned 508 children to treatment: 252 to MgSO(4) and 256 to placebo. Mean ASS at 60 min was lower in the MgSO(4) group (4·72 [SD 1·37]) than it was in the placebo group (4·95 [SD 1·40]; adjusted difference -0·25, 95% CI -0·48 to -0·02; p=0·03). This difference, however, was not clinically significant. The clinical effect was larger in children with more severe asthma exacerbation (p=0·03) and those with symptoms present for less than 6 h (p=0·049). We detected no difference in the occurrence of adverse events between groups. Overall, nebulised isotonic MgSO(4), given as an adjuvant to standard treatment, did not show a clinically significant improvement in mean ASS in children with acute severe asthma. However, the greatest clinical response was seen in children with more severe attacks (SaO(2)<92%) at presentation and those with preceding symptoms lasting less than 6 h. National Institute for Health Research Health Technology Assessment Programme. Copyright © 2013 Elsevier Ltd. All rights reserved.

The application of Firefly algorithm in an Adaptive Emergency Evacuation Centre Management (AEECM) for dynamic relocation of flood victims

NASA Astrophysics Data System (ADS)

ChePa, Noraziah; Hashim, Nor Laily; Yusof, Yuhanis; Hussain, Azham

2016-08-01

Flood evacuation centre is defined as a temporary location or area of people from disaster particularly flood as a rescue or precautionary measure. Gazetted evacuation centres are normally located at secure places which have small chances from being drowned by flood. However, due to extreme flood several evacuation centres in Kelantan were unexpectedly drowned. Currently, there is no study done on proposing a decision support aid to reallocate victims and resources of the evacuation centre when the situation getting worsens. Therefore, this study proposes a decision aid model to be utilized in realizing an adaptive emergency evacuation centre management system. This study undergoes two main phases; development of algorithm and models, and development of a web-based and mobile app. The proposed model operates using Firefly multi-objective optimization algorithm that creates an optimal schedule for the relocation of victims and resources for an evacuation centre. The proposed decision aid model and the adaptive system can be applied in supporting the National Security Council's respond mechanisms for handling disaster management level II (State level) especially in providing better management of the flood evacuating centres.

CADC and CANFAR: Extending the role of the data centre

NASA Astrophysics Data System (ADS)

Gaudet, Severin

2015-12-01

Over the past six years, the CADC has moved beyond the astronomy archive data centre to a multi-service system for the community. This evolution is based on two major initiatives. The first is the adoption of International Virtual Observatory Alliance (IVOA) standards in both the system and data architecture of the CADC, including a common characterization data model. The second is the Canadian Advanced Network for Astronomical Research (CANFAR), a digital infrastructure combining the Canadian national research network (CANARIE), cloud processing and storage resources (Compute Canada) and a data centre (Canadian Astronomy Data Centre) into a unified ecosystem for storage and processing for the astronomy community. This talk will describe the architecture and integration of IVOA and CANFAR services into CADC operations, the operational experiences, the lessons learned and future directions

Effective techniques for the identification and accommodation of disturbances

NASA Technical Reports Server (NTRS)

Johnson, C. D.

1989-01-01

The successful control of dynamic systems such as space stations, or launch vehicles, requires a controller design methodology that acknowledges and addresses the disruptive effects caused by external and internal disturbances that inevitably act on such systems. These disturbances, technically defined as uncontrollable inputs, typically vary with time in an uncertain manner and usually cannot be directly measured in real time. A relatively new non-statistical technique for modeling, and (on-line) identification, of those complex uncertain disturbances that are not as erratic and capricious as random noise is described. This technique applies to multi-input cases and to many of the practical disturbances associated with the control of space stations, or launch vehicles. Then, a collection of smart controller design techniques that allow controlled dynamic systems, with possible multi-input controls, to accommodate (cope with) such disturbances with extraordinary effectiveness are associated. These new smart controllers are designed by non-statistical techniques and typically turn out to be unconventional forms of dynamic linear controllers (compensators) with constant coefficients. The simplicity and reliability of linear, constant coefficient controllers is well-known in the aerospace field.

Sensorimotor Assessment and Rehabilitative Apparatus

DTIC Science & Technology

2016-10-01

Support: Title: Tinnitus Retraining Treatment Trial Data Coordinating Center (TRTT) (GRANT RECENTLY ENDED) Grant Number/PI: U01 DC007422 (Scherer...Description of project’s goals: The Tinnitus Retraining Therapy Trial is a multi-center randomized controlled trial testing the efficacy of tinnitus ...retraining therapy versus usual care as a treatment for severe debilitating tinnitus in patients with functionally normal hearing. Title

75 FR 6033 - Agency Information Collection Request; 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... Initial Telephone Screen........ Active Control 2400 1 20 minutes 800 hours Group (ACG)/ Experimental Group (EG) In-person interview EG 1200 1 1.25 hours 1,500 hours Jump start phone call EG 1200 1 30... care insurance who are age 75 and over using a multi- tiered random experimental research design to...

75 FR 19976 - Agency Information Collection Request; 30-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

...) hours Initial Telephone Screen...... Experimental 240 1 20/60 80 Group. In-person interview 240 1 80/60... Telephone Screen...... Active Control 240 1 20/60 80 Group. Quarterly phone calls......... 240 4 10/60 160... private long-term care insurance who are age 75 and over using a multi- tiered random experimental...

Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non obese humans

USDA-ARS?s Scientific Manuscript database

Calorie restriction (CR) inhibits inflammation and slows aging in many animal species, but in rodents housed in pathogen-free facilities, CR impairs immunity against certain pathogens. However, little is known about the effects of long-term moderate CR on immune function in humans. In this multi-cen...

Using multi-trait and random regression models to identify genetic variation in tolerance of pigs to Porcine Reproductive and Respiratory Syndrome virus

USDA-ARS?s Scientific Manuscript database

Background A host can adopt two response strategies to infection: resistance (reduce pathogen load) and tolerance (minimize impact of infection on performance). Both strategies may be under genetic control and could thus be targeted for genetic improvement. Although there is evidence in support of a...

Making Healthy Eating and Physical Activity Policy Practice: Process Evaluation of a Group Randomized Controlled Intervention in Afterschool Programs

ERIC Educational Resources Information Center

Weaver, R. Glenn; Beets, Michael W.; Hutto, Brent; Saunders, Ruth P.; Moore, Justin B.; Turner-McGrievy, Gabrielle; Huberty, Jennifer L.; Ward, Dianne S.; Pate, Russell R.; Beighle, Aaron; Freedman, Darcy

2015-01-01

This study describes the link between level of implementation and outcomes from an intervention to increase afterschool programs' (ASPs) achievement of healthy eating and physical activity (HE-PA) Standards. Ten intervention ASPs implemented the Strategies-To-Enhance-Practice (STEPs), a multi-component, adaptive intervention framework identifying…

Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

PubMed

Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

2017-10-18

The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic information exchange methods, technical assistance through a knowledge broker, and organizational changes to support evidence-based public health approaches. Evaluation methods comprise surveys at baseline and the three crossover time points, abstraction of local-level diabetes and chronic disease control program plans and progress reports, and social network analysis to understand the relationships and contextual issues that influence EBPP adoption. ClinicalTrial.gov, NCT03211832.

Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

PubMed

Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

2017-01-01

We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

Smart Care Based on Telemonitoring and Telemedicine for Type 2 Diabetes Care: Multi-center Randomized Controlled Trial.

PubMed

Jeong, Ji Yun; Jeon, Jae-Han; Bae, Kwi-Hyun; Choi, Yeon-Kyung; Park, Keun-Gyu; Kim, Jung-Guk; Won, Kyu Chang; Cha, Bong Soo; Ahn, Chul Woo; Kim, Dong Won; Lee, Chang Hee; Lee, In-Kyu

2018-01-17

This study was performed to determine the effectiveness of the Smart Care service on glucose control based on telemedicine and telemonitoring compared with conventional treatment in patients with type 2 diabetes. This 24-week prospective multi-center randomized controlled trial involved 338 adult patients with type 2 diabetes at four university hospitals in South Korea. The patients were randomly assigned to a control group (group A, n = 113), a telemonitoring group (group B, n = 113), or a telemedicine group (group C, n = 112). Patients in the telemonitoring group visited the outpatient clinic regularly, accompanied by an additional telemonitoring service that included remote glucose monitoring with automated patient decision support by text. Remote glucose monitoring was identical in the telemedicine group, but assessment by outpatient visits was replaced by video conferencing with an endocrinologist. The adjusted net reductions in HbA1c concentration after 24 weeks were similar in the conventional, telemonitoring, and telemedicine groups (-0.66% ± 1.03% vs. -0.66% ± 1.09% vs. -0.81% ± 1.05%; p > 0.05 for each pairwise comparison). Fasting glucose concentrations were lower in the telemonitoring and telemedicine groups than in the conventional group. Rates of hypoglycemia were lower in the telemedicine group than in the other two groups, and compliance with medication was better in the telemonitoring and telemedicine than in the conventional group. No serious adverse events were associated with telemedicine. Telehealthcare was as effective as conventional care at improving glycemia in patients with type 2 diabetes without serious adverse effects.

Outcomes from a randomized controlled trial of a multi-component alcohol use preventive intervention for urban youth: project northland Chicago.

PubMed

Komro, Kelli A; Perry, Cheryl L; Veblen-Mortenson, Sara; Farbakhsh, Kian; Toomey, Traci L; Stigler, Melissa H; Jones-Webb, Rhonda; Kugler, Kari C; Pasch, Keryn E; Williams, Carolyn L

2008-04-01

The goal of this group-randomized trial was to test the effectiveness of an adapted alcohol use preventive intervention for urban, low-income and multi-ethnic settings. Sixty-one public schools in Chicago were recruited to participate, were grouped into neighborhood study units and assigned randomly to intervention or 'delayed program' control condition. The study sample (n = 5812 students) was primarily African American, Hispanic and low-income. Students, beginning in sixth grade (age 12 years), received 3 years of intervention strategies (curricula, family interventions, youth-led community service projects, community organizing). Students participated in yearly classroom-based surveys to measure their alcohol use and related risk and protective factors. Additional evaluation components included a parent survey, a community leader survey and alcohol purchase attempts. Overall, the intervention, compared with a control condition receiving 'prevention as usual', was not effective in reducing alcohol use, drug use or any hypothesized mediating variables (i.e. related risk and protective factors). There was a non-significant trend (P = 0.066) that suggested the ability to purchase alcohol by young-appearing buyers was reduced in the intervention communities compared to the control communities, but this could be due to chance. Secondary outcome analyses to assess the effects of each intervention component indicated that the home-based programs were associated with reduced alcohol, marijuana and tobacco use combined (P = 0.01), with alcohol use alone approaching statistical significance (P = 0.06). Study results indicate the importance of conducting evaluations of previously validated programs in contexts that differ from the original study sample. Also, the findings highlight the need for further research with urban, low-income adolescents from different ethnic backgrounds to identify effective methods to prevent and reduce alcohol use.

Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

PubMed

Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

2018-02-01

Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

A Randomized Placebo-Controlled Trial of Citalopram for Anxiety Disorders Following Traumatic Brain Injury

DTIC Science & Technology

2005-04-01

WRAMC and all other sites in the multi-center study have been trained to use our electronic data capture system. Recent literature on Escitalopram , the...Disorder (GAD). Based on the merits of three placebo- controlled studies, Forest Laboratories announced the FDA approval of Escitalopram for the treatment...therefore there are no conclusions that can be made at this time. References: Davidson JR, Bose A, Korotzer A, Hongije Z. Escitalopram in the

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

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

Multi-parameter fiber optic sensors based on fiber random grating

NASA Astrophysics Data System (ADS)

Xu, Yanping; Zhang, Mingjiang; Lu, Ping; Mihailov, Stephen; Bao, Xiaoyi

2017-04-01

Two novel configurations of multi-parameter fiber-optic sensing systems based on the fiber random grating are reported. The fiber random grating is fabricated through femtosecond laser induced refractive index modification over a 10cm standard telecom single mode fiber. In one configuration, the reflective spectrum of the fiber random grating is directly detected and a wavelength-division spectral cross-correlation algorithm is adopted to extract the spectral shifts for simultaneous measurement of temperature, axial strain, and surrounding refractive index. In the other configuration, a random fiber ring laser is constructed by incorporating the random feedback from the random grating. Numerous polarization-dependent spectral filters are formed along the random grating and superimposed to provide multiple lasing lines with high signal-to-noise ratio up to 40dB, which enables a high-fidelity multi-parameter sensing scheme by monitoring the spectral shifts of the lasing lines. Without the need of phase mask for fabrication and with the high physical strength, the random grating based sensors are much simpler and more compact, which could be potentially an excellent alternative for liquid medical sample sensing in biomedical and biochemical applications.

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.

Do Parents Know Best? Examining the Relationship Between Parenting Profiles, Prevention Efforts, and Peak Drinking in College Students1

PubMed Central

Mallett, Kimberly A.; Turrisi, Rob; Ray, Anne E.; Stapleton, Jerod; Abar, Caitlin; Mastroleo, Nadine R.; Tollison, Sean; Grossbard, Joel; Larimer, Mary E.

2013-01-01

The study examined parent profiles among high school athletes transitioning to college and their association with high-risk drinking in a multi-site, randomized trial. Students (n = 587) were randomized to a control or combined parent-based and brief motivational intervention condition and completed measures at baseline and at 5- and 10-month follow-ups. Four parent profiles (authoritative, authoritarian, permissive, indifferent) were observed among participants. Findings indicated control participants with authoritarian parenting were at the greatest risk for heavy drinking. Alternately, students exposed to permissive or authoritarian parenting reported lower peak drinking when administered the combined intervention, compared to controls. Findings suggest the combined intervention was efficacious in reducing peak alcohol consumption among high-risk students based on athlete status and parenting profiles. PMID:24109150

Probability-based constrained MPC for structured uncertain systems with state and random input delays

NASA Astrophysics Data System (ADS)

Lu, Jianbo; Li, Dewei; Xi, Yugeng

2013-07-01

This article is concerned with probability-based constrained model predictive control (MPC) for systems with both structured uncertainties and time delays, where a random input delay and multiple fixed state delays are included. The process of input delay is governed by a discrete-time finite-state Markov chain. By invoking an appropriate augmented state, the system is transformed into a standard structured uncertain time-delay Markov jump linear system (MJLS). For the resulting system, a multi-step feedback control law is utilised to minimise an upper bound on the expected value of performance objective. The proposed design has been proved to stabilise the closed-loop system in the mean square sense and to guarantee constraints on control inputs and system states. Finally, a numerical example is given to illustrate the proposed results.

Using routine Haemophilia Joint Health Score for international comparisons of haemophilia outcome: standardization is needed.

PubMed

Nijdam, A; Bladen, M; Hubert, N; Pettersson, M; Bartels, B; van der Net, J; Liesner, R; Petrini, P; Kurnik, K; Fischer, K

2016-01-01

Haemophilia Joint Health Score (HJHS) is the most sensitive validated score for physical examination of joint health in haemophilia. HJHS performed at regular intervals can be used for clinical monitoring as well as for comparative outcomes research. To determine whether routinely collected HJHS could be used to compare outcome of three different prophylactic regimens in children with severe haemophilia A (primary) and which parameters caused variability in HJHS (secondary). International retrospective observational multi-centre study comparing routine HJHS in 127 children with severe haemophilia A born from 1995 to 2009, from London, Stockholm and Utrecht centres. Patient and treatment data were collected from the European Paediatric Network for Haemophilia Management registry and patient files. The independent effects of regimens, physiotherapists, age and inhibitor status on HJHS were explored, using multivariable regression analysis. Prophylaxis varied across participating centres, with differences in initial frequency of infusions (1× per week vs. 3× per week), age at reaching infusions ≥3× per week, and dose kg(-1) week(-1) at HJHS assessment. Evaluation at median age of 11 years showed an illogical association of HJHS with treatment regimen: the least intensive regimen had the lowest HJHS. The HJHS increased with age and history of inhibitor, as expected (internal validity). But the comparison of prophylactic regimens was obscured by systematic differences in assessment between physiotherapists, both within and between centres. Inter-physiotherapist discrepancies in routine HJHS hamper comparison of scores between treatment regimens. For multi-centre research, additional inter-observer standardization for HJHS scoring is needed. © 2015 John Wiley & Sons Ltd.

Suppression of population transport and control of exciton distributions by entangled photons

PubMed Central

Schlawin, Frank; Dorfman, Konstantin E.; Fingerhut, Benjamin P.; Mukamel, Shaul

2013-01-01

Entangled photons provide an important tool for secure quantum communication, computing and lithography. Low intensity requirements for multi-photon processes make them idealy suited for minimizing damage in imaging applications. Here we show how their unique temporal and spectral features may be used in nonlinear spectroscopy to reveal properties of multiexcitons in chromophore aggregates. Simulations demostrate that they provide unique control tools for two-exciton states in the bacterial reaction centre of Blastochloris viridis. Population transport in the intermediate single-exciton manifold may be suppressed by the absorption of photon pairs with short entanglement time, thus allowing the manipulation of the distribution of two-exciton states. The quantum nature of the light is essential for achieving this degree of control, which cannot be reproduced by stochastic or chirped light. Classical light is fundamentally limited by the frequency-time uncertainty, whereas entangled photons have independent temporal and spectral characteristics not subjected to this uncertainty. PMID:23653194

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.

Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

PubMed Central

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-01-01

Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial.

PubMed

Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

2015-11-01

Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs. A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter+DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter+DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3-8; extraction). Enrollment commenced summer 2015 with results in summer 2016. This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. Copyright © 2015 Elsevier Inc. All rights reserved.