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Biostatistics 4:327-340 (2003)
© 2003 Oxford University Press

The compliance score as a regressor in randomized trials

Marshall M. Joffe*, Thomas R. Ten Have and Colleen Brensinger

Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, 602 Blockley Hall, 423 Guardian Dr, Philadelphia, PA 19104-6021, USA mjoffe{at}cceb.upenn.edu

*To whom correspondence should be addressed

The compliance score in randomized trials is a measure of the effect of randomization on treatment received. It is in principle a group-level pretreatment variable and so can be used where individual-level measures of treatment received can produce misleading inferences. The interpretation of models with the compliance score as a regressor of interest depends on the link function. Using the identity link can lead to valid inference about the effects of treatment received even in the presence of nonrandom noncompliance; such inference is more problematic for nonlinear links. We illustrate these points with data from two randomized trials.

Keywords: Causal inference; Instrumental variables; Noncompliance; Potential outcomes; Randomized trials


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