Evidence map›Paper›PMID 31175197›Full record

ArticleBMJ open2019

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

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

Abstract read
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Christian OvesenDepartment of Neurology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Per WinkelCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jørgen HildenDepartment of Public Health Research, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OBJECTIVE AND

methodsIt 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.

conclusionPower 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.

Indexed as

HumansRandomized Controlled Trials as TopicResearch DesignClinical TrialsQuality In Health Care

Identifiers

PMID31175197
PMCPMC6588976

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.