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Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

ABSTRACT: The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.'We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach.The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support.The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial.The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

SUBMITTER: Yeh HC

PROVIDER: S-EPMC3266125 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

Yeh Hsin-Chieh HC Clark Jeanne M JM Emmons Karen E KE Moore Reneé H RH Bennett Gary G GG Warner Erica T ET Sarwer David B DB Jerome Gerald J GJ Miller Edgar R ER Volger Sheri S Louis Thomas A TA Wells Barbara B Wadden Thomas A TA Colditz Graham A GA Appel Lawrence J LJ

Clinical trials (London, England) 20100623 4

<h4>Background</h4>The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction ...[more]

PMID: 20573639

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Project description:BackgroundThe conceptualization of the home as a care environment and maintaining a high standard of care requires different professionals to collaborate. This study will explore collaborative practice in home care, needs and expectations of the stakeholders involved, and identify their roles and tasks. Secondly, it will investigate possible strategies to improve home care management and, more particularly, optimize collaborative practice in home care.MethodsThe study will be conducted during three distinct consecutive phases, within a multiphase mixed-methods design. Phase 1 will use a quantitative approach in which a social network analysis will be conducted to have an overview of collaborative practice in home care in French-speaking Switzerland. Phases 2 and 3 will be qualitative and focus on three different situations involving different locations (rural and urban) and different home care functioning (home care provided by agencies and home care providing by independent caregivers). In each situation, semi-structured interviews will be conducted with home care recipients and their home caregivers. In phase 2, results of phase 1's network analysis will be discussed, such as roles, needs, and expectations of all stakeholders involved in home care. In phase 3, phase 2's findings will be discussed and strategies to improve home care and to optimize collaborative practice will be explored.DiscussionOver the past years, home care has grown considerably. Therefore, more and more different caregivers are involved in the recipients' homes. Since optimal coordination between these different caregivers is a prerequisite for quality and safe care, it is essential to investigate the existing collaborative practice and how it is functioning. This study will provide knowledge on roles, needs and expectations of different caregivers involved in home care. It will also allow for strategies to optimize collaborative practice and thus ensure comprehensive care for recipients. Finally, it will serve as a basis for future studies that can be conducted to address identified needs.

Project description:In 2008, the National Institute for Health Research (NIHR) began funding a major 5-year pilot research programme of translational research in England, establishing nine 'Collaborations for Leadership in Applied Health Research and Care' (CLAHRCs). A number of evaluations were carried out to examine whether or not the various collaborations worked as intended and why. In this paper, we examine what the theory of co-production adds to understanding of processes of knowledge creation and translation we observed in one of the CLAHRCs.A case study of a successful knowledge translation project was identified from our wider realist evaluation of the mechanisms of closer collaboration at play in the CLAHRC. In the project, a computer simulation model of an emergency pathway for acute ischaemic stroke was built to explore if and how the time between the onset and treatment of the condition could be minimised by redesigning the pathway. The aim of the case study was to improve our understanding of the nature and workings of the mechanisms of closer collaboration that were associated with the more successful projects by examining the relevance of the theory of co-production. Qualitative methods of analysis were used to explore the fit between the mechanisms of closer collaboration we observed in the realist evaluation and the principles of co-production we identified from the literature.We found a close fit between the nine mechanisms of closer collaboration at work in the project and the principles of co-production (active agents; equality of partners; reciprocity and mutuality; transformative; and facilitated). The successful style of collaborative working exemplified by the project was consistent with a strong form of co-production.In our view, the theory of co-production provides useful insights into what it is about the qualities of collaborative working that inspire the requisite mechanisms for generating knowledge that is translated into practice. The theory provides a potentially useful basis for future knowledge translation programmes and projects in applied health research in a range of contexts.

Project description:BackgroundVegetarian diets may promote weight loss, but evidence remains inconclusive.MethodsPubMed, EMBASE and UpToDate databases were searched through September 22, 2014, and investigators extracted data regarding study characteristics and assessed study quality among selected randomized clinical trials. Population size, demographic (i.e., gender and age) and anthropometric (i.e., body mass index) characteristics, types of interventions, follow-up periods, and trial quality (Jadad score) were recorded. The net changes in body weight of subjects were analyzed and pooled after assessing heterogeneity with a random effects model. Subgroup analysis was performed based on type of vegetarian diet, type of energy restriction, study population, and follow-up period.ResultsTwelve randomized controlled trials were included, involving a total of 1151 subjects who received the intervention over a median duration of 18 weeks. Overall, individuals assigned to the vegetarian diet groups lost significantly more weight than those assigned to the non-vegetarian diet groups (weighted mean difference, -2.02 kg; 95 % confidence interval [CI]: -2.80 to -1.23). Subgroup analysis detected significant weight reduction in subjects consuming a vegan diet (-2.52 kg; 95 % CI: -3.02 to -1.98) and, to a lesser extent, in those given lacto-ovo-vegetarian diets (-1.48 kg; 95 % CI: -3.43 to 0.47). Studies on subjects consuming vegetarian diets with energy restriction (ER) revealed a significantly greater weight reduction (-2.21 kg; 95 % CI: -3.31 to -1.12) than those without ER (-1.66 kg; 95 % CI: -2.85 to -0.48). The weight loss for subjects with follow-up of <1 year was greater (-2.05 kg; 95 % CI: -2.85 to -1.25) than those with follow-up of ≥1 year (-1.13 kg; 95 % CI: -2.04 to -0.21).ConclusionsVegetarian diets appeared to have significant benefits on weight reduction compared to non-vegetarian diets. Further long-term trials are needed to investigate the effects of vegetarian diets on body weight control.

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Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

Publications

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

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