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A pattern‐mixture model approach for handling missing continuous outcome data in longitudinal cluster randomized trials
Authors:Mallorie H. Fiero  Chiu‐Hsieh Hsu  Melanie L. Bell
Affiliation:1. Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA;2. Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona, USA
Abstract:We extend the pattern‐mixture approach to handle missing continuous outcome data in longitudinal cluster randomized trials, which randomize groups of individuals to treatment arms, rather than the individuals themselves. Individuals who drop out at the same time point are grouped into the same dropout pattern. We approach extrapolation of the pattern‐mixture model by applying multilevel multiple imputation, which imputes missing values while appropriately accounting for the hierarchical data structure found in cluster randomized trials. To assess parameters of interest under various missing data assumptions, imputed values are multiplied by a sensitivity parameter, k, which increases or decreases imputed values. Using simulated data, we show that estimates of parameters of interest can vary widely under differing missing data assumptions. We conduct a sensitivity analysis using real data from a cluster randomized trial by increasing k until the treatment effect inference changes. By performing a sensitivity analysis for missing data, researchers can assess whether certain missing data assumptions are reasonable for their cluster randomized trial.
Keywords:cluster randomized trials  missing data  multiple imputation  pattern‐mixture model
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