Principal stratification with predictors of compliance for randomized trials with 2 active treatments

In behavioral medicine trials, such as smoking cessation trials, 2 or more active treatments are often compared.Noncompliance by some subjects with their assigned treatment poses a challenge to the data analyst.The principal stratification framework permits inference about causal effects among subpopulations characterized by potential compliance.However, in the absence of prior information, there are 2 significant limitations: (1) the causal effects cannot be point identified for some strata and (2) individuals in the subpopulations (strata) cannot be identified.We propose to use additional information.compliance-predictive covariates.to help identify the causal effects and to help describe characteristics of the subpopulations.The probability of membership in each principal stratum is modeled as a function of these covariates.The model is constructed using marginal compliance models (which are identified) and a sensitivity parameter that captures the association between the 2 marginal distributions.We illustrate our methods in both a simulation study and an analysis of data from a smoking cessation trial.