Evidence map›Paper›PMID 31208463›Full record

ArticleTrials2019

The randomization-induced risk of a trial failing to attain its target power: assessment and mitigation.

Hubert Wong, Yongdong Ouyang, Mohammad Ehsanul Karim

Abstract readLetter
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Efficacy and Safety of Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion: A Meta-Analysis.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2024
    Pooled it
  2. 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

3 authors.

Hubert WongSchool of Population & Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada. hubert.wong@ubc.ca.ORCID http://orcid.org/0000-0001-8840-4509
Yongdong OuyangSchool of Population & Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.
Mohammad Ehsanul KarimSchool of Population & Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.

Funding

BC SUPPORT Unit RWCT-03
6 · The paper itself

Abstract

Health researchers are familiar with the concept of trial power, a number that prior to the start of a trial is intended to describe the probability that the results of the trial will correctly conclude that the intervention has an effect. Trial power, as calculated using standard software, is an expected power that arises from averaging hypothetical trial results over all possible treatment allocations that could be generated by the randomization algorithm. However, in the trial that ultimately is conducted, only one treatment allocation will occur, and the corresponding attained power (conditional on the allocation that occurred) is not guaranteed to be equal to the expected power and may be substantially lower. We provide examples illustrating this issue, discuss some circumstances when this issue is a concern, define and advocate the examination of the pre-randomization power distribution for evaluating the risk of obtaining unacceptably low attained power, and suggest the use of randomization restrictions to reduce this risk. In trials that randomize only a modest number of units, we recommend that trial designers evaluate the risk of getting low attained power and, if warranted, modify the randomization algorithm to reduce this risk.

Indexed as

Research DesignCluster AnalysisHumansRandom AllocationRandomized Controlled Trials as TopicRiskAttained powerPowerPower distributionRestricted randomizationStepped-wedge design

Identifiers

PMID31208463
PMCPMC6580524

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.