title: The use of propensity scores to assess the generalizability of results from randomized trials.
abstract: Randomized trials remain the most accepted design for estimating the effects of interventions, but they do not necessarily answer a question of primary interest: Will the program be effective in a target population in which it may be implemented? In other words, are the results generalizable? There has been very little statistical research on how to assess the generalizability, or "external validity," of randomized trials. We propose the use of propensity-score-based metrics to quantify the similarity of the participants in a randomized trial and a target population. In this setting the propensity score model predicts participation in the randomized trial, given a set of covariates. The resulting propensity scores are used first to quantify the difference between the trial participants and the target population, and then to match, subclassify, or weight the control group outcomes to the population, assessing how well the propensity score-adjusted outcomes track the outcomes actually observed in the population. These metrics can serve as a first step in assessing the generalizability of results from randomized trials to target populations. This paper lays out these ideas, discusses the assumptions underlying the approach, and illustrates the metrics using data on the evaluation of a schoolwide prevention program called Positive Behavioral Interventions and Supports.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health Departments of Mental Health and Biostatistics, 624 N Broadway, 8th Floor, Baltimore, MD; estuart@jhsph.edu ; 410-502-6222.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stuart
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health and Center for AIDS Research, University of North Carolina, Chapel Hill, NC.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Cole
authors.affiliation: Department of Mental Health and Center for the Prevention of Youth Violence, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Baltimore, MD.
authors.forename: Catherine P
authors.initials: CP
authors.lastname: Bradshaw
authors.affiliation: Department of Mental Health and Center for the Prevention of Youth Violence, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Baltimore, MD.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Leaf
keywords: Causal inference; External validity; Positive Behavioral Interventions and Supports; Research synthesis