Andrade Chittaranjan
Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, India
J Clin Psychiatry. 2015 Oct;76(10):e1320-3. doi: 10.4088/JCP.15f10377.
The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.
主要结局指标是研究者在研究中要考察的众多结局里认为最重要的那个结局。主要结局需要在研究设计时就加以定义。这样做有两个原因：它降低了对众多结局进行统计检验导致假阳性错误的风险，并且通过为估算有足够检验效能的研究所必需的样本量提供依据，降低了假阴性错误的风险。本文讨论了主要结局指标的设定、其必要性、次要结局结果中假阳性和假阴性错误风险的增加、如何看待未陈述主要结局的文章、当次要结局具有统计学显著性但主要结局不具有统计学显著性时如何解读结果，以及临床试验研究中主要结局指标概念的局限性。
