98%
921
2 minutes
20
Background: Standard stepped wedge trials, where clusters switch from the control to the intervention condition in a staggered manner, can be costly and burdensome. Recent work has shown that the amount of information contributed by each cluster in each period differs, with some cluster-periods contributing a relatively small amount of information. We investigate the patterns of the information content of cluster-period cells upon iterative removal of low-information cells, assuming a model for continuous outcomes with constant cluster-period size, categorical time period effects, and exchangeable and discrete-time decay intracluster correlation structures.
Methods: We sequentially remove pairs of "centrosymmetric" cluster-period cells from an initially complete stepped wedge design which contribute the least amount of information to the estimation of the treatment effect. At each iteration, we update the information content of the remaining cells, determine the pair of cells with the lowest information content, and repeat this process until the treatment effect cannot be estimated.
Results: We demonstrate that as more cells are removed, more information is concentrated in the cells near the time of the treatment switch, and in "hot-spots" in the corners of the design. For the exchangeable correlation structure, removing the cells from these hot-spots leads to a marked reduction in study precision and power, however the impact of this is lessened for the discrete-time decay structure.
Conclusions: Removing cluster-period cells distant from the time of the treatment switch may not lead to large reductions in precision or power, implying that certain incomplete designs may be almost as powerful as complete designs.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10324156 | PMC |
http://dx.doi.org/10.1186/s12874-023-01969-7 | DOI Listing |
Stat Med
April 2025
School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Stepped wedge trials can be costly and burdensome. Recent work has investigated the iterative removal of cluster-period cells from stepped wedge designs, producing a series of candidate incomplete designs that are less burdensome. We propose a novel way to explore the space of incomplete stepped wedge designs, by considering their cost efficiency, seeking to identify designs that retain high power while limiting the total trial cost.
View Article and Find Full Text PDFOphthalmology
June 2024
Bascom Palmer Eye Institute, University of Miami, Miami, Florida.
Purpose: To evaluate the performance of an intensive, clustered testing approach in identifying eyes with rapid glaucoma progression over 6 months in the Fast Progression Assessment through Clustered Evaluation (Fast-PACE) Study.
Design: Prospective cohort study.
Participants: A total of 125 eyes from 65 primary open-angle glaucoma (POAG) subjects.
J Stat Plan Inference
March 2024
Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
The stepped wedge design is increasingly popular in pragmatic trials and implementation science research studies for evaluating system-level interventions that are perceived to be beneficial to patient populations. An important step in planning a stepped wedge design is to understand the efficiency of the treatment effect estimator and hence the power of the study. We develop several novel analytical results for designing stepped wedge cluster randomized trials analyzed through generalized estimating equations under a misspecified working independence correlation structure.
View Article and Find Full Text PDFBMC Med Res Methodol
July 2023
School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Background: Standard stepped wedge trials, where clusters switch from the control to the intervention condition in a staggered manner, can be costly and burdensome. Recent work has shown that the amount of information contributed by each cluster in each period differs, with some cluster-periods contributing a relatively small amount of information. We investigate the patterns of the information content of cluster-period cells upon iterative removal of low-information cells, assuming a model for continuous outcomes with constant cluster-period size, categorical time period effects, and exchangeable and discrete-time decay intracluster correlation structures.
View Article and Find Full Text PDFBiom J
August 2023
Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Johannes Gutenberg University Mainz, Mainz, Germany.
Stepped wedge cluster randomized trials (SWCRT) are increasingly used for the evaluation of complex interventions in health services research. They randomly allocate treatments to clusters that switch to intervention under investigation at variable time points without returning to control condition. The resulting unbalanced allocation over time periods and the uncertainty about the underlying correlation structures at cluster-level renders designing and analyzing SWCRTs a challenge.
View Article and Find Full Text PDF