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Influential methods reports for group-randomized trials and related designs.

David M Murray1

  • 1Office of Disease Prevention, National Institutes of Health, North Bethesda, MD, USA.

Clinical Trials (London, England)
|January 7, 2022
PubMed
Summary
This summary is machine-generated.

This study identifies key methods reports for group-randomized trials and related designs. It highlights influential publications guiding researchers in design, analysis, and sample size for cluster-based studies.

Keywords:
Group-randomized trialcluster-randomized trialindividually randomized group treatment trialstepped wedge cluster-randomized trialstepped wedge group-randomized trial

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Epidemiology

Background:

  • Interventions delivered to groups often exhibit positive correlations among participants within the same group.
  • Group-randomized trials (GRTs), individually randomized group treatment trials (IRGTs), and stepped wedge group-randomized trials (SW-GRTs) are used to evaluate such interventions.
  • These designs present unique methodological challenges compared to individually randomized controlled trials.

Purpose of the Study:

  • To identify the most influential methods reports for GRTs, IRGTs, and SW-GRTs published up to 2020.
  • To provide researchers with a curated list of essential resources for these complex trial designs.

Main Methods:

  • A comprehensive PubMed search was conducted to identify relevant methods reports.
  • Reports were supplemented by the author's known publications.
  • Influence was assessed using citation counts and the relative citation ratio (RCR).

Main Results:

  • 55 influential reports were identified from 1043 candidates, including 32 for GRTs, 7 for IRGTs, and 16 for SW-GRTs.
  • Influential reports included early foundational papers, textbooks, and publications on specific analytic methods (e.g., unequal cluster size, attrition, repeated measures).
  • CONSORT statements for each design were among the highest-ranked reports by RCR.

Conclusions:

  • The identified influential reports cover critical topics for investigators considering group-based trial designs.
  • These resources offer guidance on selecting appropriate designs, and on methods for design, analysis, and sample size determination.
  • This collection aids researchers in navigating the complexities of group-randomized and related trial methodologies.