Evidence map›Paper›PMID 36931478›Full record

ArticleJournal of clinical epidemiology2023

A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials.

Pascale Nevins, Kendra Davis-Plourde, Jules Antoine Pereira Macedo, Yongdong Ouyang, Mary Ryan, Guangyu Tong, Xueqi Wang, Can Meng, Luis Ortiz-Reyes, Fan Li and 2 more

Abstract readScoping Review
In one paragraph

Article in Journal of clinical epidemiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Evaluation of injury prevention interventions using the stepped wedge cluster randomised trial design: key considerations.Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention · 2026
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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

12 authors.

Pascale NevinsClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Kendra Davis-PlourdeDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA; Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT, USA.
Jules Antoine Pereira MacedoUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France.
Yongdong OuyangClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Mary RyanDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
Guangyu TongDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA; Center for Methods in Implementation and Prevention Science, Yale University, New Haven, CT, USA.
Xueqi WangDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA; Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Can MengYale Center for Analytical Sciences, Yale School of Public Health, New Haven, CT, USA.
Luis Ortiz-ReyesClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Fan LiDepartment of Biostatistics, Yale School of Public Health, New Haven, CT, USA; Center for Methods in Implementation and Prevention Science, Yale University, New Haven, CT, USA.
Agnès CailleUniversité de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France; INSERM CIC 1415, CHRU de Tours, Tours, France.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mtaljaard@ohri.ca.

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI JOSEPH E. GAUGLER · 2019 to 2026
$125.9M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NIA NIH HHS U54 AG063546
6 · The paper itself

Abstract

objectivesIn stepped-wedge cluster randomized trials (SW-CRTs), clusters are randomized not to treatment and control arms but to sequences dictating the times of crossing from control to intervention conditions. Randomization is an essential feature of this design but application of standard methods to promote and report on balance at baseline is not straightforward. We aimed to describe current methods of randomization and reporting of balance at baseline in SW-CRTs. STUDY DESIGN AND

settingWe used electronic searches to identify primary reports of SW-CRTs published between 2016 and 2022.

resultsAcross 160 identified trials, the median number of clusters randomized was 11 (Q1-Q3: 8-18). Sixty-three (39%) used restricted randomization-most often stratification based on a single cluster-level covariate; 12 (19%) of these adjusted for the covariate(s) in the primary analysis. Overall, 50 (31%) and 134 (84%) reported on balance at baseline on cluster- and individual-level characteristics, respectively. Balance on individual-level characteristics was most often reported by condition in cross-sectional designs and by sequence in cohort designs. Authors reported baseline imbalances in 72 (45%) trials.

conclusionSW-CRTs often randomize a small number of clusters using unrestricted allocation. Investigators need guidance on appropriate methods of randomization and assessment and reporting of balance at baseline.

Indexed as

Research DesignCluster AnalysisCross-Sectional StudiesHumansRandom AllocationRandomized Controlled Trials as TopicBaseline balanceCovariate adjustmentCovariate constrained randomizationRandom allocationReporting guidelinesStratification

Identifiers

PMID36931478
PMCPMC10546924

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.