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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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Detalles Bibliográficos
Autores principales: Jakobsen, Janus Christian, Ovesen, Christian, Winkel, Per, Hilden, Jørgen, Gluud, Christian, Wetterslev, Jørn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588976/
https://www.ncbi.nlm.nih.gov/pubmed/31175197
http://dx.doi.org/10.1136/bmjopen-2018-027092
Descripción
Sumario: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.