Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review.
Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review.
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DOI：
10.1136/bmj.c3920
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发表时间：
2010-08-18
期刊：
影响因子：
--
通讯作者：
Gøtzsche PC
中科院分区：
文献类型：
--
作者：
Cordoba G;Schwartz L;Woloshin S;Bae H;Gøtzsche PC
目的研究如何定义、报告和解释将多个组成部分组合成一个单一指标的复合结局。设计：对2008年发表的报告二元复合结局的平行组随机临床试验进行系统回顾。两名独立观察员使用标准化数据表提取数据，另外两名观察员对结果不知情，选择最重要的组分。结果纳入的40篇临床试验中，29篇（73%）涉及心血管主题，24篇（60%）完全或部分由行业资助。复合结局的中位数为3个组成部分（范围2-9）。死亡或心血管死亡是33项试验中最重要的组成部分（83%）。只有一项试验为组件的选择提供了良好的依据。我们判断，在28项试验（70%）中，这些组分的重要性不同;在其中20项试验中，死亡与住院合并。其他主要问题是摘要、方法和结果部分之间复合结局定义的变化（13项试验）;缺失、模糊或无法解释的数据（9项试验）;以及复合结局的事后构建（4项试验）。只有24项试验（60%）提供了复合材料及其组分的可靠估计值，只有6项试验（15%）具有相似或可能相似的临床重要性组分并提供了可靠估计值。在16项具有统计学显着复合材料的试验中，有11项的抽象结论错误地暗示该效应也适用于最重要的成分。结论在试验中使用复合结局是有问题的。各组成部分往往不合理地组合在一起，定义不一致，报告不充分。这些问题会让许多读者感到困惑，往往对干预措施的效果有一种夸大的看法。
Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted. Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component. Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component. Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work.
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