Application of the principal stratification approach to the Faenza randomized experiment on breast self-examination.

In this article we present an extended framework based on the principal stratification approach (Frangakis and Rubin, 2002, Biometrics 58, 21-29), for the analysis of data from randomized experiments which suffer from treatment noncompliance, missing outcomes following treatment noncompliance, and "truncation by death." We are not aware of any previous work that addresses all these complications jointly. This framework is illustrated in the context of a randomized trial of breast self-examination.