Abstract

Randomized clinical trials with outcome measured longitudinally are frequently analyzed using either random effect models or generalized estimating equations. Both approaches assume that the dropout mechanism is missing at random (MAR) or missing completely at random (MCAR). We propose a Bayesian pattern-mixture model to incorporate missingness mechanisms that might be missing not at random (MNAR), where the distribution of the outcome measure at the follow-up time , conditional on the prior history, differs across the patterns of missing data. We then perform sensitivity analysis on estimates of the parameters of interest. The sensitivity parameters relate the distribution of the outcome of interest between subjects from a missing-data pattern at time with that of the observed subjects at time . The large number of the sensitivity parameters is reduced by treating them as random with a prior distribution having some pre-specified mean and variance, which are varied to explore the sensitivity of inferences. The missing at random (MAR) mechanism is a special case of the proposed model, allowing a sensitivity analysis of deviations from MAR. The proposed approach is applied to data from the Trial of Preventing Hypertension.

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