Evidence map›Paper›PMID 41733160›Full record

ArticleMedical care2026

Designing Cluster Randomized Trials: A Practical Guide for Investigators.

Kendra Davis-Plourde, Xiaoying Yu, Jeanne A Teresi

Abstract read
In one paragraph

Article in Medical care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

3 authors.

Kendra Davis-PlourdeDepartment of Biostatistics, Yale School of Public Health, New Haven, CT.ORCID 0000-0001-6654-0710
Xiaoying YuDepartment of Biostatistics and Data Science, University of Texas Medical Branch at Galveston, Galveston, TX.
Jeanne A TeresiColumbia University Stroud Center at New York State Psychiatric Institute, New York, NY.

Funding

Yale Study Support Suite (YES3): Dashboard and Web Portal Software Supporting Research Workflow through integrated, customizable REDCap External ModulesP30AG021342 · NIA · YALE UNIVERSITY · PI Lauren Ferrante · 2002 to 2026
$37.9M
UTMB OAIC Research Education Component (REC)P30AG024832 · NIA · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI JAMES S. GOODWIN, MD, MELISSA M. MORROW · 2005 to 2026
$26.7M
Residing in the Community with Dementia at the End of Life: Understanding Hospice Use and Residential SettingP30AG028741 · NIA · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI ALBERT L SIU · 2010 to 2026
$21.9M
NIA NIH HHS P30 AG021342NIA NIH HHS P30 AG024832NIA NIH HHS P30 AG028741
6 · The paper itself

Abstract

backgroundAn important consideration in the design stage of randomized controlled trials is whether individuals within each site should or can be randomized to study arms (an individually randomized controlled trial) or whether entire sites should be randomized (a cluster randomized trial) where the clusters are sites. Recently, cluster randomized trials have grown in popularity; however, investigators have expressed a need for guidelines related to selection of the best design-especially when considering more complex designs such as stepped wedge. This commentary attempts to provide such guidance.

methodsIn this commentary, we address common misconceptions surrounding the appropriate use of cluster randomization and crossover designs (such as the stepped wedge design). The intracluster correlation coefficients for different levels of clustering are presented, and the impact of different designs on sample size discussed. We provide practical recommendations that are accessible to investigators from all disciplines, regardless of their level of statistical training. On the basis of these recommendations, we present a flowchart to help researchers identify a suitable trial design for their study. In addition, we provide a table of commonly used statistical definitions related to cluster randomized trials and a table of design considerations for more complex designs to support effective consultation with a statistician during the design phase.

conclusionOn the basis of these guidelines, it is recommended that researchers prioritize the use of individual randomization and a parallel trial design when the goal of the study is to assess the efficacy or effectiveness of an intervention.

Indexed as

Randomized Controlled Trials as TopicResearch DesignCluster AnalysisCross-Over StudiesGuidelines as TopicHumansSample Sizecluster randomized trialscrossover designsintracluster correlationparallel designsrandomized controlled trial designstepped wedge

Identifiers

PMID41733160
PMCPMC13288263

What OpenQuestion holds

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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.