Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.
Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.
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DOI：
10.1177/1740774509344440
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发表时间：
2009-10
期刊：
影响因子：
--
通讯作者：
Look AHEAD and ACCORD Research Groups
中科院分区：
文献类型：
--
作者：
Mount DL;Feeney P;Fabricatore AN;Coday M;Bahnson J;Byington R;Phelan S;Wilmoth S;Knowler WC;Hramiak I;Osei K;Sweeney ME;Espeland MA;Look AHEAD and ACCORD Research Groups
比较不同试验的结果对于选择治疗方案是必要的，但是研究队列之间的差异可能会阻碍这些比较。作为一项案例研究，在两项大型随机对照临床试验中检查研究队列的重叠，这些试验评估了降低2型糖尿病成人主要心血管疾病事件风险的干预措施，以探索交叉试验比较的可行性。（Look AHEAD）和控制糖尿病心血管风险行动（雅阁）试验分别招募了5，145名和10，251名2型糖尿病成人。Look AHEAD评估了旨在减轻体重的强化生活方式干预的有效性;雅阁测试了控制肥胖、高脂血症和高血压的药物治疗。主要心血管疾病事件的发生率是两项试验的主要结局。构建了一个样本，包括来自每个试验的参与者，他们似乎符合资格标准，并且是其他试验干预措施的合适候选人。人口统计学特征，健康状况，和结果的成员和非成员的这个构建的样本进行了比较。预计近80%的Look AHEAD参与者不符合雅阁的资格;不符合资格主要是由于血糖控制较好或无早期心血管疾病史。大约30%的雅阁参与者预计不符合展望未来的资格，通常是由于健康状况较差的原因。根据可能与保留、依从性和研究结局相关的因素，预计共同有资格参加两项试验的受试者的特征继续反映了试验之间的差异。方案之间的差异阻碍了交叉试验合格性的准确确定。尽管有一些相似之处，展望未来和雅阁队列代表不同的人群。即使在似乎符合两种干预模式试验条件和适当候选人的参与者子集中，差异仍然存在。直接比较来自生活方式和药物干预的单独试验的结果受到招募队列中显著差异的影响。
Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5,145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial’s interventions. Demographic characteristics, health status, and outcomes of members and non-members of this constructed sample were compared. Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.
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影响因子：
18.4
作者：
Mueller-Riemenschneider, F.;Reinhold, T.;Willich, S. N.
通讯作者：
Willich, S. N.
影响因子：
5.4
作者：
SCHWARTZ, CE;FOX, BH
通讯作者：
FOX, BH
影响因子：
2.8
作者：
Cushman, William C.;Grimm, Richard H., Jr.;Basile, Jan N.
通讯作者：
Basile, Jan N.
超重和肥胖 2 型糖尿病患者的运动能力和心血管/代谢特征 - Look AHEAD 临床试验
影响因子：
16.2
作者：
Ribisl, Paul M.;Lang, Wei;Soberman, Judith E.
通讯作者：
Soberman, Judith E.
影响因子：
158.5
作者：
Gerstein, Hertzel C.;Miller, Michael E.;Friedewald, William T.
通讯作者：
Friedewald, William T.