SoftwareX. 2025 Sep;31:102288. doi: 10.1016/j.softx.2025.102288. Epub 2025 Aug 7.
ABSTRACT
Stepped wedge cluster randomized trials (SWCRTs) have become increasingly popular across various disciplines, particularly in public health and clinical research, as they allow evaluations of interventions rolled out sequentially across clusters. SWCRTsimulator is a user-friendly, web-based RShiny application designed to facilitate sample size and statistical power estimation for an interval-censored time-to-event outcome in a SWCRT. Leveraging Monte Carlo simulations, the platform accommodates various study design features, including heterogeneity in intervention effect across different clusters, to provide a more accurate and reliable statistical approach to sample size and power estimates as compared to the approximate methods based on study design features when a closed-form solution is not feasible. SWCRTsimulator provides customizable visualizations for simulation results. We also illustrate the practical application of this platform using the Sankofa 2 trial, an active multi-clinic SWCRT of a pediatric HIV disclosure intervention in Ghana, underscoring the importance of accounting for real-world complexities in the design and analysis of such trials.
PMID:41036414 | PMC:PMC12483528 | DOI:10.1016/j.softx.2025.102288
