Skip navigation
Skip navigation

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

Barker, Daniel; McElDuff, Patrick; D'Este, Catherine; Campbell, M.J

Description

BACKGROUND:Previous 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. METHODS:Literature Review. The Medline, Embase,...[Show more]

dc.contributor.authorBarker, Daniel
dc.contributor.authorMcElDuff, Patrick
dc.contributor.authorD'Este, Catherine
dc.contributor.authorCampbell, M.J
dc.date.accessioned2018-11-29T22:55:08Z
dc.date.available2018-11-29T22:55:08Z
dc.identifier.issn1471-2288
dc.identifier.urihttp://hdl.handle.net/1885/153057
dc.description.abstractBACKGROUND:Previous 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. METHODS:Literature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design. RESULTS: This 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. CONCLUSIONS: Many 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.
dc.format.mimetypeapplication/pdf
dc.publisherBioMed Central
dc.sourceBMC Medical Research Methodology
dc.titleStepped wedge cluster randomised trials: a review of the statistical methodology used and available
dc.typeJournal article
local.description.notesImported from ARIES
local.identifier.citationvolume16
dc.date.issued2016
local.identifier.absfor111706 - Epidemiology
local.identifier.absfor111711 - Health Information Systems (incl. Surveillance)
local.identifier.absfor010401 - Applied Statistics
local.identifier.ariespublicationu4102339xPUB73
local.type.statusPublished Version
local.contributor.affiliationBarker, Daniel , University of Newcastle
local.contributor.affiliationMcElDuff, Patrick, University of Newcastle
local.contributor.affiliationD'Este, Catherine, College of Health and Medicine, ANU
local.contributor.affiliationCampbell, M.J, Medical Statistics Group, ScHARR, University of Sheffield, Sheffield, UK
local.bibliographicCitation.issue69
local.bibliographicCitation.startpage1
local.bibliographicCitation.lastpage19
local.identifier.doi10.1186/s12874-016-0176-5
local.identifier.absseo929999 - Health not elsewhere classified
dc.date.updated2018-11-29T08:04:42Z
local.identifier.scopusID2-s2.0-85007523837
local.identifier.thomsonID000377534500002
dcterms.accessRightsOpen Access
CollectionsANU Research Publications

Download

File Description SizeFormat Image
01_Barker_Stepped_wedge_cluster_2016.pdf802.85 kBAdobe PDFThumbnail


Items in Open Research are protected by copyright, with all rights reserved, unless otherwise indicated.

Updated:  19 May 2020/ Responsible Officer:  University Librarian/ Page Contact:  Library Systems & Web Coordinator