The Effect of Treatment Compliance in a Placebo-controlled Trial: Regression with Unpaired Data

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Abstract:

The causal effect of a treatment is estimated at different levels of treatment compliance, in a placebo-controlled trial on the reduction of blood pressure. The structural nested mean model makes no direct assumptions on selected treatment compliance levels and placebo prognosis but relies on the randomization assumption and a parametric form for causal effects. It can be seen as a regression model for unpaired data, where pre- and post-randomization covariables are treated differently. The causal parameters are found as solutions to estimating equations involving estimated placebo response and treatment compliance based on base-line covariates for all subjects. Our example considers a linear effect of the percentage of prescribed dose taken on achieved diastolic blood pressure reduction. We propose an exploration of structural model checks. In the example, this reveals an interaction between the causal effect of active dose taken and the base-line body weight of the patient.

Keywords: Causal inference; Estimating equations; Non-compliance; Placebo-controlled clinical trial; Structural nested mean models; Unpaired data regression

Document Type: Original Article

DOI: http://dx.doi.org/10.1111/1467-9876.00074

Affiliations: 1: Maastricht University, The Netherlands and Limburgs Universitair Centrum, Diepenbeek, Belgium, 2: University of Tartu, Liivi, Estonia

Publication date: August 1, 1997

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