University of Texas School of Public Health-Houston, Houston, TX, USA.
Prog Cardiovasc Dis. 2012 Jan-Feb;54(4):338-42. doi: 10.1016/j.pcad.2011.07.005.
Subgroup analysis in a clinical trial is the evaluation of the effect of a randomly allocated intervention within only a fraction of the patients in the entire research cohort. This article provides several examples of the use of subgroup analysis, discusses some of the interpretative difficulties that occur during the assessment of the effect of therapy within subgroups, and provides a summary of recent recommendations on reporting subgroup analyses in the literature. Although subgroup analyses can provide new, provocative, and sometimes clinically relevant findings, this group of evaluations must be handled with extreme care.
临床试验中的亚组分析是在整个研究队列的一小部分患者中评估随机分配干预措施的效果。本文提供了一些亚组分析使用的示例，讨论了在评估亚组内治疗效果时出现的一些解释性困难，并总结了文献中亚组分析报告的最新建议。尽管亚组分析可以提供新的、有启发性的，有时甚至是临床相关的发现，但必须非常谨慎地处理这组评估。
