Mediation Analysis With Principal Stratification

Loading...
Thumbnail Image
Penn collection
Statistics Papers
Degree type
Discipline
Subject
principal stratification
mediating variables
direct effects
principal strata probabilities
heterogeneous variances
Statistics and Probability
Vital and Health Statistics
Funder
Grant number
License
Copyright date
Distributor
Related resources
Author
Gallop, Robert
Small, Dylan S
Lin, Julia Y
Elliott, Michael R
Joffe, Marshall M
Ten Have, Thomas R
Contributor
Abstract

In assessing the mechanism of treatment efficacy in randomized clinical trials, investigators often perform mediation analyses by analyzing if the significant intent-to-treat treatment effect on outcome occurs through or around a third intermediate or mediating variable: indirect and direct effects, respectively. Standard mediation analyses assume sequential ignorability, i.e. conditional on covariates the intermediate or mediating factor is randomly assigned, as is the treatment in a randomized clinical trial. This research focuses on the application of the principal stratification (PS) approach for estimating the direct effect of a randomized treatment but without the standard sequential ignorability assumption. This approach is used to estimate the direct effect of treatment as a difference between expectations of potential outcomes within latent subgroups of participants for whom the intermediate variable behavior would be constant, regardless of the randomized treatment assignment. Using a Bayesian estimation procedure, we also assess the sensitivity of results based on the PS approach to heterogeneity of the variances among these principal strata. We assess this approach with simulations and apply it to two psychiatric examples. Both examples and the simulations indicated robustness of our findings to the homogeneous variance assumption. However, simulations showed that the magnitude of treatment effects derived under the PS approach were sensitive to model mis-specification.

Advisor
Date Range for Data Collection (Start Date)
Date Range for Data Collection (End Date)
Digital Object Identifier
Series name and number
Publication date
2009-03-30
Journal title
Statistics in Medicine
Volume number
Issue number
Publisher
Publisher DOI
Journal Issue
Comments
Recommended citation
Collection