Power estimations for non-primary outcomes in randomised clinical trials
Power estimations for non-primary outcomes in randomised clinical trials
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DOI：
10.1136/bmjopen-2018-027092
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发表时间：
2019-06-01
期刊：
影响因子：
2.9
通讯作者：
Wetterslev, Jorn
中科院分区：
文献类型：
--
作者：
Jakobsen, Janus Christian;Ovesen, Christian;Wetterslev, Jorn
目的和方法：很少有试验者报告对非主要结果的威力估计。在这篇文章中，我们将描述如何在随机临床试验中定义有效的结果等级，以限制I型和II型错误的问题，使用对结果的临床相关性和功率估计的考虑。结论：对非主要结果的威力估计可以指导试验人员将非主要结果分类为次要或探索性的。威力估计很简单，如果系统地使用它们，可以定义更合适的结果等级，试验结果将变得更容易解释。
Objective and methods: It is rare that trialists report power estimations of non-primary outcomes. In the present article, we will describe how to define a valid hierarchy of outcomes in a randomised clinical trial, to limit problems with Type I and Type II errors, using considerations on the clinical relevance of the outcomes and power estimations. Conclusion: Power estimations of non-primary outcomes may guide trialists in classifying non-primary outcomes as secondary or exploratory. The power estimations are simple and if they are used systematically, more appropriate outcome hierarchies can be defined, and trial results will become more interpretable.