Evidence map›Paper›PMID 27267471›Full record

ReviewBMC medical research methodology2016

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available.

D Barker, P McElduff, C D'Este, M J Campbell

2 registry-linked trialsAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMC medical research methodology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 87 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 4 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.

NCT03633916 nacompletednot on this mapstarted 2018, after this paper: background citation

Effects of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among School-going Adolescents in New Delhi, India: Study Protocol for a Stepped-wedge Cluster Randomized Controlled Trial

TypeinterventionalSponsorSangathRan2018 to 2018Enrolled835ConditionsHelp-Seeking BehaviorArmsClassroom sensitization session, School-level sensitization activities
NCT04789902 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

A Stepped Wedge Cluster Randomized Trial Designed to Evaluate the Effects of SurgeCon: A Quality Improvement Surge Management Platform

TypeinterventionalSponsorMemorial University of NewfoundlandRan2021 to 2026Enrolled436,052ConditionsLength of Stay, Emergency DepartmentsArmsSurgeCon
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  9. Implementation of Coach McLungsBMC medical informatics and decision making · 2022
    Trial
  10. Random effect misspecification in stepped wedge designs.Clinical trials (London, England) · 2022
    Trial
  11. Encouraging older adults with pre-frailty and frailty to "MoveStrong": an analysis of secondary outcomes for a pilot randomized controlled trial.Health promotion and chronic disease prevention in Canada : research, policy and practice · 2022
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27 more citing papers are in PubMed but not listed here.

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

4 authors.

D BarkerSchool of Medicine and Public Health, Faculty of Health, CCEB, HMRI Building, Level 4 West, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia. daniel.barker@newcastle.edu.au.
P McElduffSchool of Medicine and Public Health, Faculty of Health, CCEB, HMRI Building, Level 4 West, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.
C D'EsteSchool of Medicine and Public Health, Faculty of Health, CCEB, HMRI Building, Level 4 West, University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia.
M J CampbellMedical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials.

methodsLiterature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design.

resultsThis review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used.

conclusionsMany studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.

Indexed as

Cluster AnalysisData Interpretation, StatisticalHumansModels, StatisticalRandomized Controlled Trials as TopicTreatment OutcomeCluster randomisedStatistical methodologyStepped wedge

Identifiers

PMID27267471
PMCPMC4895892

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.