Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.
Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.
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DOI：
10.1177/1740774510374213
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发表时间：
2010-08
期刊：
影响因子：
--
通讯作者：
Appel LJ
中科院分区：
文献类型：
--
作者：
Yeh HC;Clark JM;Emmons KE;Moore RH;Bennett GG;Warner ET;Sarwer DB;Jerome GJ;Miller ER;Volger S;Louis TA;Wells B;Wadden TA;Colditz GA;Appel LJ
国家心肺血液研究所（NHLBI）资助了三个机构在初级保健环境中进行减肥干预措施的有效性试验。与传统的多中心临床试验不同，每项研究都是独立的试验，具有不同的方案。尽管如此，还是努力协调审判的几个方面并使之标准化。这三项试验组成了一个合作小组，即“基于实践的减肥机会（POWER）试验合作研究小组”。我们描述了三个试验的共同和独特的特点，协作组的主要特征，以及从这种新颖的组织方法中吸取的教训。合作研究小组由三个单独的研究组成：“Be Fit，Be Well”（圣路易斯华盛顿大学/哈佛大学），“POWER霍普金斯”（约翰霍普金斯）和“POWER-UP”（宾夕法尼亚大学）。共有15家诊所参与，约有1 100人参加。常见的主要结局是随访24个月时的体重变化，但每个方案都有试验特定的要素，包括不同的干预措施和不同的次要结局。约翰霍普金斯大学的一个资源协调股提供行政支助。合作研究小组确定了共同组成部分，以便利可能的跨地点比较。这种方法的主要优点是，当没有足够的证据来测试一种或两种方法时，可以开发和评估几种干预措施，就像传统的多中心试验一样。组织设计的挑战包括复杂的决策过程、潜在数据汇集的程度、标准化报告的时间密集型工作以及DSMB监测三种不同方案的额外职责。POWER试验协作研究组是一个案例研究的替代组织模式进行独立的，但协调的试验。这种模型越来越多地被用于NHLBI支持的试验，特别是考虑到比较有效性研究的兴趣。然而，在试验完成之前，人们不会完全理解这种模式的最终效用。
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 ~1,100 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. The POWER Trials Collaborative Research Group is a case study of an alternative organizational model to conduct independent, yet coordinated trials. Such a model is increasingly being used in NHLBI supported trials , especially given the interest in comparative effectiveness research. Nevertheless, the ultimate utility of this model will not be fully understood until the trials are completed.
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
影响因子：
--
作者：
Ashley, JM;St Jeor, ST;Bovee, V
通讯作者：
Bovee, V
影响因子：
158.5
作者：
Gerstein, Hertzel C.;Miller, Michael E.;Friedewald, William T.
通讯作者：
Friedewald, William T.
DOI：
10.1002/j.1550-8528.1998.tb00322.x
发表时间：
1998-03-01
期刊：
OBESITY RESEARCH
影响因子：
--
作者：
Wolf, AM;Colditz, GA
通讯作者：
Colditz, GA
影响因子：
120.7
作者：
Svetkey, Laura P.;Stevens, Victor J.;Aicher, Kathleen
通讯作者：
Aicher, Kathleen