Power estimations for non-primary outcomes in randomised clinical trials

Janus Christian Jakobsen; Christian Ovesen; Per Winkel; Jørgen Hilden; Christian Gluud; Jørn Wetterslev

doi:10.1136/bmjopen-2018-027092

Power estimations for non-primary outcomes in randomised clinical trials

Janus Christian Jakobsen^*, Christian Ovesen, Per Winkel, Jørgen Hilden, Christian Gluud, Jørn Wetterslev

^*Corresponding author af dette arbejde

Medicinsk Afdeling

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

Abstract

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.

Originalsprog	Engelsk
Sider (fra-til)	e027092
Tidsskrift	BMJ Open
Vol/bind	9
Udgave nummer	6
DOI	https://doi.org/10.1136/bmjopen-2018-027092
Status	Udgivet - 6 jun. 2019

Bibliografisk note

� 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.

Adgang til dokumentet

10.1136/bmjopen-2018-027092

Citationsformater

@article{255164b77c894eada6de475de8bb2127,

title = "Power estimations for non-primary outcomes in randomised clinical trials",

abstract = "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.",

author = "Jakobsen, {Janus Christian} and Christian Ovesen and Per Winkel and J{\o}rgen Hilden and Christian Gluud and J{\o}rn Wetterslev",

note = "� 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.",

year = "2019",

month = jun,

day = "6",

doi = "10.1136/bmjopen-2018-027092",

language = "English",

volume = "9",

pages = "e027092",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

}

TY - JOUR

T1 - Power estimations for non-primary outcomes in randomised clinical trials

AU - Jakobsen, Janus Christian

AU - Ovesen, Christian

AU - Winkel, Per

AU - Hilden, Jørgen

AU - Gluud, Christian

AU - Wetterslev, Jørn

N1 - � 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.

PY - 2019/6/6

Y1 - 2019/6/6

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2018-027092

DO - 10.1136/bmjopen-2018-027092

M3 - Article

C2 - 31175197

SN - 2044-6055

VL - 9

SP - e027092

JO - BMJ Open

JF - BMJ Open

IS - 6

ER -

Power estimations for non-primary outcomes in randomised clinical trials

Abstract

Bibliografisk note

Adgang til dokumentet

Fingeraftryk

Citationsformater