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Key concepts in clinical epidemiology: Stepped wedge trials [PDF]

Journal of Clinical Epidemiology, 2021
A stepped wedge trial evaluates an intervention that is implemented over a number of time periods according to a staggered timetable. Stepped wedge trials are usually cluster randomized, the intervention being delivered at some geographical, service or other cluster level.
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Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial [PDF]

Pediatrics, 2020
OBJECTIVES: To evaluate the effectiveness of a stepped-wedge randomized trial of Development of Systems and Education for Human Papillomavirus Vaccination (DOSE HPV), a multilevel intervention. METHODS:
Rebecca B, Perkins, Aaron, Legler, Emily, Jansen, Judith, Bernstein, Natalie, Pierre-Joseph, Terresa J, Eun, Dea L, Biancarelli, Thomas J, Schuch, Karin, Leschly, Anny T H R, Fenton, William G, Adams, Jack A, Clark, Mari-Lynn, Drainoni, Amresh, Hanchate   +13 more
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Admissible multiarm stepped‐wedge cluster randomized trial designs [PDF]

Statistics in Medicine, 2018
Numerous publications have now addressed the principles of designing, analyzing, and reporting the results of stepped‐wedge cluster randomized trials. In contrast, there is little research available pertaining to the design and analysis of multiarm stepped‐wedge cluster randomized trials, utilized to evaluate the effectiveness of multiple experimental ...
Grayling, Michael J, Mander, Adrian P, Wason, James MS   +2 more
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Sample size calculation for a stepped wedge trial [PDF]

Trials, 2015
Stepped wedge trials (SWTs) can be considered as a variant of a clustered randomised trial, although in many ways they embed additional complications from the point of view of statistical design and analysis. While the literature is rich for standard parallel or clustered randomised clinical trials (CRTs), it is much less so for SWTs.
Baio, G, Copas, A, Ambler, G, Hargreaves, J, Beard, E, Omar, RZ   +5 more
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Response adaptive intervention allocation in stepped‐wedge cluster randomized trials

Statistics in Medicine, 2022
BackgroundStepped‐wedge cluster randomized trial (SW‐CRT) designs are often used when there is a desire to provide an intervention to all enrolled clusters, because of a belief that it will be effective. However, given there should be equipoise at trial commencement, there has been discussion around whether a pre‐trial decision to provide the ...
Grayling, Michael J, Wason, James MS, Villar, Sofía S   +2 more
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Group sequential designs for stepped-wedge cluster randomised trials [PDF]

Clinical Trials, 2017
Background/Aims: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses.
Grayling MJ, Wason JMS, Mander AP
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HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

Trials, 2017
Background A pragmatic, stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life settings. However, there are certain pitfalls that need to be considered.
Noor Heim, Henk F. van Stel, Roelof G. Ettema, Roos C. van der Mast, Sharon K. Inouye, Marieke J. Schuurmans   +5 more
doaj   +1 more source

Promoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial

Trials, 2021
Background Home care service providers are increasingly supporting clients living with dementia. Targeted and comprehensive dementia-specific training for home care staff is necessary to meet this need. This study evaluates a training programme delivered
Steven Savvas, Anita M. Y. Goh, Frances Batchelor, Colleen Doyle, Erica Wise, Esther Tan, Anita Panayiotou, Sue Malta, Margaret Winbolt, Phillip Clarke, Jason Burton, Lee-Fay Low, Samantha M. Loi, Anne Fairhall, Meg Polacsek, Jay Stiles, Fenny Muliadi, Nadia Chau, Samuel Scherer, David Ames, Tanara Vieira Sousa, Briony Dow   +21 more
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Permutation tests for stepped-wedge cluster-randomized trials [PDF]

The Stata Journal: Promoting communications on statistics and Stata, 2019
Permutation tests are useful in stepped-wedge trials to provide robust statistical tests of intervention-effect estimates. However, the permute command does not produce valid tests in this setting because individual observations are not exchangeable. We introduce the swpermute command, which permutes clusters to sequences to maintain exchangeability ...
Jennifer Thompson, Calum Davey, Richard Hayes, James Hargreaves, Katherine Fielding   +4 more
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The impact of varying cluster size in cross-sectional stepped-wedge cluster randomised trials

BMC Medical Research Methodology, 2019
Background Cluster randomised trials with unequal sized clusters often have lower precision than with clusters of equal size. To allow for this, sample sizes are inflated by a modified version of the design effect for clustering.
James Thomas Martin, Karla Hemming, Alan Girling   +2 more
doaj   +1 more source