Evidence mapPaperPMID 31269898Full record

SynthesisBMC medical research methodology2019

Ideal vs. real: a systematic review on handling covariates in randomized controlled trials.

Jody D Ciolino, Hannah L Palac, Amy Yang, Mireya Vaca, Hayley M Belli

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed, 2 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

5 authors.

Jody D CiolinoDepartment of Preventive Medicine, Biostatistics Collaboration Center, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Drive, Suite 1400, Chicago, IL, 60611-4402, USA. jody.ciolino@northwestern.edu.ORCID 0000-0002-9060-5657
Hannah L PalacAbbVie Inc, North Chicago, IL, USA.
Amy YangAY analytics, Chicago, IL, USA.
Mireya VacaAbbVie Inc, North Chicago, IL, USA.
Hayley M BelliDepartment of Population Health, New York University Langone Health, New York, NY, USA.

Funding

NRSA Training CoreTL1TR001447 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2022 to 2025
$2.1M
NCATS NIH HHS TL1 TR001447NCATS NIH HHS UL1 TR001422
6 · The paper itself

Abstract

backgroundIn theory, efficient design of randomized controlled trials (RCTs) involves randomization algorithms that control baseline variable imbalance efficiently, and corresponding analysis involves pre-specified adjustment for baseline covariates. This review sought to explore techniques for handling potentially influential baseline variables in both the design and analysis phase of RCTs.

methodsWe searched PubMed for articles indexed "randomized controlled trial", published in the NEJM, JAMA, BMJ, or Lancet for two time periods: 2009 and 2014 (before and after updated CONSORT guidelines). Upon screening (343), 298 articles underwent full review and data abstraction.

resultsTypical articles reported on superiority (86%), multicenter (92%), two-armed (79%) trials; 81% of trials involved covariates in the allocation and 84% presented adjusted analysis results. The majority reported a stratified block method (69%) of allocation, and of the trials reporting adjusted analyses, 91% were pre-specified. Trials published in 2014 were more likely to report adjusted analyses (87% vs. 79%, p = 0.0100) and more likely to pre-specify adjustment in analyses (95% vs. 85%, p = 0.0045). Studies initiated in later years (2010 or later) were less likely to use an adaptive method of randomization (p = 0.0066; 7% of those beginning in 2010 or later vs. 31% of those starting before 2000) but more likely to report a pre-specified adjusted analysis (p = 0.0029; 97% for those initiated in 2010 or later vs. 69% of those started before 2000).

conclusionWhile optimal reporting procedures and pre-specification of adjusted analyses for RCTs tend to be progressively more prevalent over time, we see the opposite effect on reported use of covariate-adaptive randomization methods.

Indexed as

HumansMultivariate AnalysisOutcome Assessment, Health CarePeriodicals as TopicRandomized Controlled Trials as TopicResearch DesignResearch ReportAllocationCONSORTMinimizationRandomizationStratification

Identifiers

PMID31269898
PMCPMC6610785

What Socratic 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 Socratic graph.