title: Randomization-based adjustment of multiple treatment hazard ratios for covariates with missing data.
abstract: Clinical trials are designed to compare treatment effects when applied to samples from the same population. Randomization is used so that the samples are not biased with respect to baseline covariates that may influence the efficacy of the treatment. We develop randomization-based covariance adjustment methodology to estimate the log hazard ratios and their confidence intervals of multiple treatments in a randomized clinical trial with time-to-event outcomes and missingness among the baseline covariates. The randomization-based covariance adjustment method is a computationally straight-forward method for handling missing baseline covariate values.
authors.affiliation: a Department of Biostatistics , University of North Carolina , Chapel Hill , North Carolina , USA.|b School of Medicine , University of Maryland , Baltimore , Maryland , USA.
authors.forename: Diana
authors.initials: D
authors.lastname: Lam
authors.affiliation: a Department of Biostatistics , University of North Carolina , Chapel Hill , North Carolina , USA.
authors.forename: Gary G
authors.initials: GG
authors.lastname: Koch
authors.affiliation: a Department of Biostatistics , University of North Carolina , Chapel Hill , North Carolina , USA.
authors.forename: John S
authors.initials: JS
authors.lastname: Preisser
authors.affiliation: c Berry Consultants , Austin , Texas , USA.|d Department of Biostatistics , Vanderbilt University School of Medicine , Nashville , Tennessee , USA.
authors.forename: Benjamin R
authors.initials: BR
authors.lastname: Saville
authors.affiliation: e International Drug Development Institute , Raleigh , North Carolina , USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Hussey
mesh_terms: D003198:Computer Simulation; D016001:Confidence Intervals; D000068598:Data Accuracy; D003627:Data Interpretation, Statistical; D006801:Humans; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
keywords: Amyotrophic lateral sclerosis; hazard ratio; missing covariate data; multiple treatments; randomization-based adjustment