Stepped Wedge Cluster Randomized Trials: A Methodological Overview
Overview
Affiliations
Background: Stepped wedge cluster randomized trials enable rigorous evaluations of health intervention programs in pragmatic settings. In the present study, we aimed to update neurosurgeon scientists on the design of stepped wedge randomized trials.
Methods: We have presented an overview of recent methodological developments for stepped wedge designs and included an update on the newer associated methodological tools to aid with future study designs.
Results: We defined the stepped wedge trial design and reviewed the indications for the design in depth. In addition, key considerations, including mainstream methods of analysis and sample size determination, were discussed.
Conclusions: Stepped wedge designs can be attractive for study intervention programs aiming to improve the delivery of patient care, especially when examining a small number of heterogeneous clusters.
Walter K, Khandekar P, Kline A, Miggantz E, Otis N, Glassman L Contemp Clin Trials Commun. 2024; 42:101407.
PMID: 39735169 PMC: 11681889. DOI: 10.1016/j.conctc.2024.101407.
How to achieve model-robust inference in stepped wedge trials with model-based methods?.
Wang B, Wang X, Li F Biometrics. 2024; 80(4).
PMID: 39499239 PMC: 11536888. DOI: 10.1093/biomtc/ujae123.
Statistical Considerations for the Design and Analysis of Pragmatic Trials in Aging Research.
Kammar-Garcia A, Fernandez-Urrutia L, Guevara-Diaz J, Mancilla-Galindo J Geriatrics (Basel). 2024; 9(3).
PMID: 38920431 PMC: 11203240. DOI: 10.3390/geriatrics9030075.
Generalizing the information content for stepped wedge designs: A marginal modeling approach.
Li F, Kasza J, Turner E, Rathouz P, Forbes A, Preisser J Scand Stat Theory Appl. 2023; 50(3):1048-1067.
PMID: 37601275 PMC: 10434823. DOI: 10.1111/sjos.12615.
Hershey M, Chang C, Sotos-Prieto M, Fernandez-Montero A, Cash S, Christophi C JAMA Netw Open. 2023; 6(8):e2329147.
PMID: 37589978 PMC: 10436136. DOI: 10.1001/jamanetworkopen.2023.29147.