Power estimations for non-primary outcomes in randomised clinical trials

被引:23
作者
Jakobsen, Janus Christian [1 ,2 ]
Ovesen, Christian [3 ]
Winkel, Per [1 ]
Hilden, Jorgen [4 ]
Gluud, Christian [1 ]
Wetterslev, Jorn [1 ]
机构
[1] Copenhagen Univ Hosp, Rigshosp, Ctr Clin Intervent Res, Copenhagen Trial Unit, Copenhagen, Denmark
[2] Holbaek Cent Hosp, Dept Cardiol, Holbaek, Denmark
[3] Univ Copenhagen, Bispebjerg Hosp, Dept Neurol, Copenhagen, Denmark
[4] Univ Copenhagen, Sect Biostat, Dept Publ Hlth Res, Copenhagen, Denmark
来源
BMJ OPEN | 2019年 / 9卷 / 06期
关键词
Clinical Trials; Quality In Health Care;
D O I
10.1136/bmjopen-2018-027092
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页数:3
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