Composite outcomes in randomized clinical trials: arguments for and against.

Composite outcomes in randomized clinical trials: arguments for and against.
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DOI:
10.1016/j.ajog.2006.10.903
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发表时间:
2007-02-01
影响因子:
9.8
通讯作者:
Ross, Sue
Ross, Sue
中科院分区:
医学1区
文献类型:
--
作者:
Ross, Sue

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联合收割机结合了许多个体结局(如发病率类型)的复合结局经常用作产科试验的主要结局。使用它们的主要理由是确保试验能够及时回答重要的临床问题,而不需要大量的样本。反对其使用的论点是,复合结果可能难以使用和解释,导致样本量估计错误,可能相互矛盾的试验结果,以及难以解释结果。这些问题可能会降低研究的可信度,并可能影响研究结果的实施。复合结局是一种有吸引力的解决方案,有助于克服临床试验可用资源有限的问题。然而,未来的研究在使用复合结果之前应仔细考虑其优点和缺点。如果要使研究有用,就必须严格制定和报告综合结果。
Composite outcomes that combine a number of individual outcomes (such as types of morbidity) are frequently used as primary outcomes in obstetrical trials. The main argument for their use is to ensure that trials can answer important clinical questions in a timely fashion, without needing huge sample sizes. Arguments against their use are that composite outcomes may be difficult to use and interpret, leading to errors in sample size estimation, possible contradictory trial results, and difficulty in interpreting findings. Such problems may reduce the credibility of the research, and may impact on the implementation of findings. Composite outcomes are an attractive solution to help to overcome the problem of limited available resources for clinical trials. However, future studies should carefully consider both the advantages and disadvantages before using composite outcomes. Rigorous development and reporting of composite outcomes is essential if the research is to be useful.