Non-compliance in lifestyle intervention studies: the instrumental variable method provides insight into the bias.

Objective: In lifestyle intervention trials, participants of the control group often change their behavior despite the request to maintain their usual lifestyle pattern. These changes in the control group and changes in addition to the intended in the intervention group can lead to undesirable confounding effects. Study Design and Setting: We address several considerations for study design to prevent noncompliance or minimize its effects. Furthermore, we demonstrate how the instrumental variable method can give insight into the extent of bias introduced by noncompliance in randomized trials, within the context of the Sex Hormones and Physical Exercise study. Results: Noncompliance can be prevented by measures taken in the design phase of a study, for example, limited duration of the study, clear recommendations, power calculation, intensity of the intervention, involvement of the control group, waiting-list control group, and single-consent design nested within an observational study. When nevertheless noncompliance does occur, the instrumental variable method estimates the intervention effect of treatment among the compliers. Conclusion: Noncompliance can seriously affect validity of lifestyle trial results. Its occurrence should be prevented by taking measures during the design phase of a study. The instrumental variable method can give insight into confounding by noncompliance in randomized trials. © 2010 Elsevier Inc. All rights reserved