Adherence adjustment in the Coronary Drug Project: A call for better per-protocol effect estimates in randomized trials.

ABSTRACT:

Background

In many randomized controlled trials, patients and doctors are more interested in the per-protocol effect than in the intention-to-treat effect. However, valid estimation of the per-protocol effect generally requires adjustment for prognostic factors associated with adherence. These adherence adjustments have been strongly questioned in the clinical trials community, especially after 1980 when the Coronary Drug Project team found that adherers to placebo had lower 5-year mortality than non-adherers to placebo.

Methods

We replicated the original Coronary Drug Project findings from 1980 and re-analyzed the Coronary Drug Project data using technical and conceptual developments that have become established since 1980. Specifically, we used logistic models for binary o

SUBMITTER: Murray EJ 

PROVIDER: S-EPMC4942353 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature