Evidence map›Paper›PMID 25497979›Full record

ArticleJournal of clinical epidemiology2015

Covariate adjustment had similar benefits in small and large randomized controlled trials.

Douglas D Thompson, Hester F Lingsma, William N Whiteley, Gordon D Murray, Ewout W Steyerberg

Abstract read
In one paragraph

Article in Journal of clinical epidemiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing 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

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

  1. Pooled it
  2. Foundational Number Sense Training Gains Are Predicted by Hippocampal-Parietal Circuits.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2022
    Pooled it
  3. Trial
  4. Trial
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  7. Article
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  11. The benefits of covariate adjustment for adaptive multi-arm designs.Statistical methods in medical research · 2022
    Article
  12. Two-stage matching-adjusted indirect comparison.BMC medical research methodology · 2022
    Article
  13. Article
  14. Article
  15. Article
  16. Lessons from the CONSCIOUS-1 Study.Journal of clinical medicine · 2020
    Review
  17. Review
  18. Article
  19. Article
  20. Article
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

5 authors.

Douglas D ThompsonEdinburgh Hub for Trials Methodology Research, Centre for Population Health Sciences University of Edinburgh, Edinburgh EH89AG, UK. Electronic address: d.thompson-3@sms.ed.ac.uk.
Hester F LingsmaDepartment of Public Health, Centre for Medical Decision Sciences, Erasmus MC, Rotterdam, The Netherlands.
William N WhiteleyEdinburgh Hub for Trials Methodology Research, Centre for Population Health Sciences University of Edinburgh, Edinburgh EH89AG, UK; Centre for Clinical Brain Sciences, Chancellor's Building, Royal Infirmary of Edinburgh, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
Gordon D MurrayEdinburgh Hub for Trials Methodology Research, Centre for Population Health Sciences University of Edinburgh, Edinburgh EH89AG, UK.
Ewout W SteyerbergDepartment of Public Health, Centre for Medical Decision Sciences, Erasmus MC, Rotterdam, The Netherlands.

Funding

Value of Personalized Risk InformationU01NS086294 · NINDS · TUFTS MEDICAL CENTER · PI KENT, DAVID M, NEUMANN, PETER · 2013 to 2017
$2.6M
Medical Research Council G0800803Medical Research Council G0902303NINDS NIH HHS 1U01-NS086294-01NINDS NIH HHS U01 NS086294
6 · The paper itself

Abstract

objectivesCovariate adjustment is a standard statistical approach in the analysis of randomized controlled trials. We aimed to explore whether the benefit of covariate adjustment on statistical significance and power differed between small and large trials, where chance imbalance in prognostic factors necessarily differs. STUDY DESIGN AND

settingWe studied two large trial data sets [Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO-I), N = 30,510 and International Stroke Trial (IST), N = 18,372] repeatedly drawing random samples (500,000 times) of sizes 300 and 5,000 per arm and simulated each primary outcome using the control arms. We empirically determined the treatment effects required to fix power at 80% for all unadjusted analyses and calculated the joint probabilities in the discordant cells when cross-classifying adjusted and unadjusted results from logistic regression models (ie, P < 0.05 vs. P ≥ 0.05).

resultsThe power gained from an adjusted analysis for small and large samples was between 5% and 6%. Similar proportions of discordance were noted irrespective of the sample size in both the GUSTO-I and the IST data sets.

conclusionThe proportions of change in statistical significance from covariate adjustment of strongly prognostic characteristics were the same for small and large trials with similar gains in statistical power. Covariate adjustment is equally recommendable in small and large trials.

Indexed as

Models, StatisticalRandomized Controlled Trials as TopicAgedAged, 80 and overBrain IschemiaComputer SimulationFemaleHumansMaleMiddle AgedMyocardial InfarctionOutcome Assessment, Health CareResearch DesignSample SizeStrokeChance imbalanceCovariate adjustmentLogistic regression analysisRandomized trialSample sizeSimulation

Identifiers

PMID25497979
PMCPMC5708297

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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.