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Generalizing causal inferences from individuals in randomized trials to all trial-eligible individuals

TitleGeneralizing causal inferences from individuals in randomized trials to all trial-eligible individuals
Publication TypeJournal Article
Year of Publication2018
AuthorsDahabreh, IJ, Robertson, SE, Tchetgen, EJT, Stuart, EA, Hernan, MA
JournalBiometrics
Date PublishedNov 29
ISBN Number0006-341x
Accession Number30488513
Keywordscausal inference, clinical trials, double robustness, Generalizability, observational studies, Transportability
Abstract

We consider methods for causal inference in randomized trials nested within cohorts of trial-eligible individuals, including those who are not randomized. We show how baseline covariate data from the entire cohort, and treatment and outcome data only from randomized individuals, can be used to identify potential (counterfactual) outcome means and average treatment effects in the target population of all eligible individuals. We review identifiability conditions, propose estimators, and assess the estimators' finite-sample performance in simulation studies. As an illustration, we apply the estimators in a trial nested within a cohort of trial-eligible individuals to compare coronary artery bypass grafting surgery plus medical therapy versus medical therapy alone for chronic coronary artery disease. This article is protected by copyright. All rights reserved.