Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.
Cluster randomized trials
group-randomized trials
heterogeneity
intraclass correlation coefficient
mixed-effects regression
pragmatic clinical trials
sample size calculation
Journal
Statistical methods in medical research
ISSN: 1477-0334
Titre abrégé: Stat Methods Med Res
Pays: England
ID NLM: 9212457
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
pubmed:
8
7
2020
medline:
3
8
2021
entrez:
8
7
2020
Statut:
ppublish
Résumé
The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.
Identifiants
pubmed: 32631142
doi: 10.1177/0962280220932962
pmc: PMC7785651
mid: NIHMS1650457
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
612-639Subventions
Organisme : Department of Health
ID : SRF-2017-10-002
Pays : United Kingdom
Organisme : NIDA NIH HHS
ID : UH3 DA047003
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
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