The Primary Outcome Measure and Its Importance in Clinical Trials
The Primary Outcome Measure and Its Importance in Clinical Trials
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DOI：
10.4088/jcp.15f10377
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发表时间：
2015-10-01
影响因子：
5.3
通讯作者：
Andrade, Chittaranjan
中科院分区：
文献类型：
--
作者：
Andrade, Chittaranjan
主要结局指标是研究者认为在研究中要检查的许多结局中最重要的结局。主要结局需要在研究设计时确定。其原因有两个：它降低了许多结果的统计检验导致的假阳性错误的风险，并通过为充分把握度研究所需的样本量估计提供基础来降低假阴性错误的风险。本文讨论了主要结局指标的设置、主要结局指标的必要性、次要结局结果中假阳性和假阴性错误的风险增加、如何看待未说明主要结局的文章、当次要结局具有统计学显著性但不是主要结局时如何解释结果以及临床试验研究中主要结局指标概念的局限性。
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.