Sample Size Calculation for an Individual Stepped-Wedge Randomized Trial

被引：0
|
作者：
Allemang-Trivalle, Aude [1 ,2 ]
Maruani, Annabel [1 ,2 ,3 ]
Giraudeau, Bruno [1 ,2 ]
机构：
[1] Univ Nantes, Univ Tours, INSERM, U1246,SPHERE, Tours, France
[2] CHRU Tours, INSERM, CIC1415, Tours, France
[3] CHRU Tours, Reference Ctr Genodermatoses & Rare Skin Dis Malad, Dept Dermatol, Tours, France
来源：
BIOMETRICAL JOURNAL | 2024年 / 66卷 / 05期
关键词：
clinical trials; individual autocorrelation; individual stepped-wedge randomized trial; sample size calculation; stepped-wedge cluster randomized trial; DESIGNS;
D O I：
10.1002/bimj.202300167
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
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.
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页数：8
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