Journal
BIOMETRICAL JOURNAL
Volume 46, Issue 2, Pages 214-232Publisher
WILEY
DOI: 10.1002/bimj.200310018
Keywords
controlled clinical trials; generalized estimating equations; missing data; sample size calculations; weighted estimating equations
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Generalized estimating equations (GEE) for the analysis of clustered data have gained increasing popularity. Recently, the first monograph on this method has been published. GEE have been repeatedly applied in controlled clinical trials. They have, however, been generally used as secondary or supplementary analysis. Instead, the primary analysis was mostly based on a classical method that usually ignored the clustered - mostly longitudinal - nature of the data. In this paper, we discuss the applicability of GEE as primary analysis in controlled clinical trials. From theoretical results in the literature, we derive recommendations how GEE should be used in therapeutic studies for testing statistical hypotheses. We hope that our paper is the starting point for a thorough discussion on the most appropriate analysis of controlled clinical trials with clustered dependent variables.
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