Composite Outcomes in Cardiovascular Research: A Survey of Randomized Trials
Composite Outcomes in Cardiovascular Research: A Survey of Randomized Trials
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DOI：
10.7326/0003-4819-149-9-200811040-00004
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发表时间：
2008-11-04
影响因子：
39.2
通讯作者：
Altman, Douglas G.
中科院分区：
文献类型：
--
作者：
Lim, Eric;Brown, Adam;Altman, Douglas G.
背景资料：复合终点在临床试验中很常见。目的：描述复合终点在心血管试验中是如何使用、构建和报告的，并评估单个终点对这些试验中复合效应估计的贡献。设计：审查2组平行设计，2000年1月1日至2007年1月1日，在14种临床期刊上发表的使用复合终点的随机心血管试验。在心血管内科和外科中发表的随机试验。参与者：2000年1月1日至2007年1月1日在14种主要的普通医学、心脏病学和心胸外科杂志上发表的两组平行设计试验。测量：包括在复合结局中的个体事件的类型和数量以及复合结局的P值和风险估计。在已发表的304项使用复合结局的试验中，221项（73%）报告了复合主要结局，83项（27%）报告了复合次要结局。复合结局包括中位数为3（四分位距，3 - 4）的个体结局;死亡是最常见的个体结局。在79%的试验中，个体事件总数和复合结局所代表的事件总数不同。复合结局的P值小于0.050的频率高于0.050或更高。死亡作为一个单独的终点对试验的复合终点所总结的效果估计的贡献相对较小，而血运重建的贡献较大。局限性：全因死亡率和心血管死亡率没有区分，研究结果可能不适用于其他领域的试验。心血管试验中的复合结局很常见，通常包括3至4个临床意义不同的个体终点。试验中个体事件总数与复合结局报告的事件总数之间的差异很常见。单个结果对综合指标的贡献并不相等，因此不能假设综合指标的总体效应估计值同样适用于其每个单独结果。
Background: Composite end points are common in clinical trials.Objective: To describe how composite outcomes are used, constructed, and reported in cardiovascular trials and to evaluate the contribution of individual end points to the composite estimate of effect in those trials.Design: Review of 2-group, parallel-design, randomized cardiovascular trials that used composite end points and were published in 14 clinical journals from 1 January 2000 to 1 January 2007.Setting: Published randomized trials in cardiovascular medicine and surgery.Participants: Two-group, parallel-design trials published in 14 leading general medical, cardiology, and cardiothoracic surgery journals from 1 January 2000 to 1 January 2007.Measurements: The types and numbers of individual events included in the composite outcome and P values and risk estimates for the composite outcome.Results: Of 304 trials published that used composite outcomes, 221 (73%) reported a composite primary outcome and 83 (27%) reported a composite secondary outcome. Composite outcomes comprised a median of 3 (interquartile range, 3 to 4) individual outcomes; death was the most common individual outcome. The total number of individual events and the total number of events represented by the composite outcome differed in 79% of trials. P values for composite outcomes were less than 0.050 more frequently than they were 0.050 or greater. Death as an individual end point made a relatively minimal contribution to estimates of effect summarized by the trials' composite end points, whereas revascularization made a greater contribution.Limitation: All-cause and cardiovascular mortality were not distinguished, and the findings might not apply to trials in other fields.Conclusion: Composite outcomes in cardiovascular trials are frequent and commonly comprise 3 to 4 individual end points that vary in clinical significance. Discrepancies between the total number of individual events in a trial and those reported for composite outcomes are common. Individual outcomes do not contribute equally to composite measures, so the overall estimate of effect for a composite measure cannot be assumed to apply equally to each of its individual outcomes.