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

ABSTRACT: BACKGROUND:In 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. METHODS:We 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. RESULTS:Typical 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). CONCLUSION:While 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.

SUBMITTER: Ciolino JD

PROVIDER: S-EPMC6610785 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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

Ciolino Jody D JD Palac Hannah L HL Yang Amy A Vaca Mireya M Belli Hayley M HM

BMC medical research methodology 20190703 1

<h4>Background</h4>In 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.<h4>Methods</h4>We searched PubMed for articles indexed "randomized controlled trial", published ...[more]

PMID: 31269898

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

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

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