Power estimations for non-primary outcomes in randomised clinical trials

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 clinic...

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Bibliographic Details
Main Authors: Per Winkel, Janus Christian Jakobsen, Jørgen Hilden, Christian Gluud, Jørn Wetterslev, Christian Ovesen
Format: Article
Language:English
Published: BMJ Publishing Group 2019-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/6/e027092.full
Description
Summary: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.
ISSN:2044-6055