Journal
PHARMACEUTICAL STATISTICS
Volume 13, Issue 2, Pages 103-109Publisher
WILEY-BLACKWELL
DOI: 10.1002/pst.1605
Keywords
sensitivity analysis; identifying restriction; missing not at random
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Pattern-mixture models provide a general and flexible framework for sensitivity analyses of nonignorable missing data in longitudinal studies. The placebo-based pattern-mixture model handles missing data in a transparent and clinically interpretable manner. We extend this model to include a sensitivity parameter that characterizes the gradual departure of the missing data mechanism from being missing at random toward being missing not at random under the standard placebo-based pattern-mixture model. We derive the treatment effect implied by the extended model. We propose to utilize the primary analysis based on a mixed-effects model for repeated measures to draw inference about the treatment effect under the extended placebo-based pattern-mixture model. We use simulation studies to confirm the validity of the proposed method. We apply the proposed method to a clinical study of major depressive disorders. Copyright (c) 2013 John Wiley & Sons, Ltd.
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