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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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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
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author Jakobsen, Janus Christian
Ovesen, Christian
Winkel, Per
Hilden, Jørgen
Gluud, Christian
Wetterslev, Jørn
author_facet Jakobsen, Janus Christian
Ovesen, Christian
Winkel, Per
Hilden, Jørgen
Gluud, Christian
Wetterslev, Jørn
author_sort Jakobsen, Janus Christian
collection PubMed
description 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.
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spelling pubmed-65889762019-07-05 Power estimations for non-primary outcomes in randomised clinical trials Jakobsen, Janus Christian Ovesen, Christian Winkel, Per Hilden, Jørgen Gluud, Christian Wetterslev, Jørn BMJ Open Research Methods 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. BMJ Publishing Group 2019-06-06 /pmc/articles/PMC6588976/ /pubmed/31175197 http://dx.doi.org/10.1136/bmjopen-2018-027092 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research Methods
Jakobsen, Janus Christian
Ovesen, Christian
Winkel, Per
Hilden, Jørgen
Gluud, Christian
Wetterslev, Jørn
Power estimations for non-primary outcomes in randomised clinical trials
title Power estimations for non-primary outcomes in randomised clinical trials
title_full Power estimations for non-primary outcomes in randomised clinical trials
title_fullStr Power estimations for non-primary outcomes in randomised clinical trials
title_full_unstemmed Power estimations for non-primary outcomes in randomised clinical trials
title_short Power estimations for non-primary outcomes in randomised clinical trials
title_sort power estimations for non-primary outcomes in randomised clinical trials
topic Research Methods
url 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
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