Estimating causal effects of treatment in a randomized trials when some participants only partially adhere.

The intention-to-treat analysis evaluates the causal effect of treatment assignment in a randomized controlled trial; however, participants do not always adhere to assigned treatment and the intention to treat effect may differ from the effect of treatment receipt. Although more recent adherence-based methods assess a well-defined causal effect of receiving treatment, adherence is assumed to be dichotomized as all or none. This approach can lack precision in the real world because adherence is a complex and heterogeneous phenomenon. In this paper, we illustrate a simple method that provides estimates of bounds on the causal effect of full adherence to treatment in the presence of partial adherence. We first define three types of partial adherence (delayed, partial-dose, post-treatment). We then use casual diagrams to show that categorizing partial adherence as non-adherence in a sensitivity analysis can lead to a violation of the exclusion restriction principle. Finally, we apply recently published sensitivity analyses related to principal stratification that allow for creating bound estimates around the causal effect of treatment in the presence of partial adherence. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.

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