SMART Binary: Sample Size Calculation for Comparing Adaptive Interventions in SMART studies with Longitudinal Binary Outcomes

Sequential Multiple-Assignment Randomized Trials (SMARTs) play an increasingly important role in psychological and behavioral health research. This experimental approach enables researchers to answer scientific questions about how best to sequence and match interventions to the unique and changing needs of individuals. A variety of sample size calculations have been developed in recent years, enabling researchers to plan SMARTs for addressing different types of scientific questions. However, relatively limited attention has been given to planning SMARTs with binary (dichotomous) outcomes, which often require higher sample sizes relative to continuous outcomes. Existing resources for estimating sample size requirements for SMARTs with binary outcomes do not consider the potential ability to improve power by including a baseline measurement and/or multiple longitudinal measurements. The current paper addresses this issue by providing sample size formulas for longitudinal binary outcomes and exploring their performance via simulations.