Aude Allemang-Trivalle, Annabel Maruani, Bruno Giraudeau
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Sample Size Calculation for an Individual Stepped-Wedge Randomized Trial
In the individual stepped-wedge randomized trial (ISW-RT), subjects are allocated to sequences, each sequence being defined by a control period followed by an experimental period. The total follow-up time is the same for all sequences, but the duration of the control and experimental periods varies among sequences. To our knowledge, there is no validated sample size calculation formula for ISW-RTs unlike stepped-wedge cluster randomized trials (SW-CRTs). The objective of this study was to adapt the formula used for SW-CRTs to the case of individual randomization and to validate this adaptation using a Monte Carlo simulation study. The proposed sample size calculation formula for an ISW-RT design yielded satisfactory empirical power for most scenarios except scenarios with operating characteristic values near the boundary (i.e., smallest possible number of periods, very high or very low autocorrelation coefficient). Overall, the results provide useful insights into the sample size calculation for ISW-RTs.
期刊介绍：
Biometrical Journal publishes papers on statistical methods and their applications in life sciences including medicine, environmental sciences and agriculture. Methodological developments should be motivated by an interesting and relevant problem from these areas. Ideally the manuscript should include a description of the problem and a section detailing the application of the new methodology to the problem. Case studies, review articles and letters to the editors are also welcome. Papers containing only extensive mathematical theory are not suitable for publication in Biometrical Journal.
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