期刊
CONTEMPORARY CLINICAL TRIALS
卷 64, 期 -, 页码 274-280出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.09.015
关键词
Sample size; Clinical trial; Before-after study; Experimental design; Binary outcome
资金
- NIH [1UL1TR001105, 1R03AG039689-01A1]
- AHRQ [R24HS22418]
- CPRIT [RP110562-C1, RP120670-C1]
- NSF [IIS-1302497-02]
We investigate sample size calculation for before-after experiments where the outcome of interest is binary and the enrolled subjects contribute a mixed type of data: some subjects contribute complete pairs of before- and after-intervention outcomes, while some subjects contribute incomplete data (before-intervention only or after-intervention only). We use the GEE approach to derive a closed-form sample size formula by treating the incomplete observations as missing data in a generalized linear model. The impacts of various designing factors are appropriately accounted for in the sample size formula, including intervention effect, baseline response rate, within-subject correlation, and distribution of missing values in the before- and after-intervention periods. We illustrate sample size estimation using a real application example. We conduct simulation studies to demonstrate that the proposed sample size maintains the nominal power and type I error under a wide spectrum of trial configurations. (C) 2015 Elsevier Inc. All rights reserved.
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