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SWCRTsimulator: A simulation-based platform for power estimation in stepped wedge cluster randomized trials with
Xintong Lu1, Lee Kennedy-Shaffer1, Veronika Shabanova1,2
1Yale School of Public Health, Department of Biostatistics, New Haven, CT, USA.
Softwarex
|October 2, 2025
Summary
A new RShiny application, SWCRTsimulator, aids researchers in estimating sample size and statistical power for stepped wedge cluster randomized trials (SWCRTs) with interval-censored time-to-event outcomes.
Area of Science:
- Biostatistics
- Clinical Trials Methodology
- Public Health Research
Background:
- Stepped wedge cluster randomized trials (SWCRTs) are increasingly utilized for intervention evaluation in public health and clinical research.
- Accurate sample size and power estimation are critical for the design of SWCRTs, especially for complex outcomes.
- Existing methods for sample size calculation may not fully capture the nuances of SWCRT designs.
Purpose of the Study:
- To introduce SWCRTsimulator, a web-based RShiny application for sample size and statistical power estimation.
- To provide a reliable statistical approach using Monte Carlo simulations for interval-censored time-to-event outcomes in SWCRTs.
- To accommodate study design complexities, such as intervention effect heterogeneity across clusters.
Main Methods:
- Development of a user-friendly, web-based RShiny application (SWCRTsimulator).
- Utilizing Monte Carlo simulations to estimate sample size and statistical power.
- Incorporating features for interval-censored time-to-event outcomes and heterogeneity in intervention effects.
- Demonstrating application with a real-world pediatric HIV disclosure intervention trial (Sankofa 2).
Main Results:
- SWCRTsimulator offers a more accurate and reliable estimation method compared to approximate analytical approaches.
- The platform accommodates various study design features, enhancing the precision of sample size and power calculations.
- Customizable visualizations aid in interpreting simulation results.
Conclusions:
- SWCRTsimulator provides a valuable tool for researchers designing SWCRTs, particularly those with interval-censored time-to-event data.
- The application facilitates robust sample size and power estimations by accounting for real-world study complexities.
- Accurate planning is essential for the successful design and analysis of complex public health and clinical trials.
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