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The Wisconsin Smoker's Health Study (WSHS2) was a longitudinal trialconducted to compare the effectiveness of two commonly used smoking cessationtreatments, varenicline and combination nicotine replacement therapy (cNRT)with the less intense standard of care, nicotine patch. The main outcome of theWSHS2 study was that all three treatments had equivalent treatment effects.However, in-depth analysis of the compliance data collected via ecologicalmomentary assessment (EMA) were not analyzed. Compliance to the treatmentregimens may represent a confounder as varenicline and cNRT are more intensetreatments and would likely have larger treatment effects if all subjectscomplied. In order to estimate the causal compliance effect, we view thecounterfactual, the outcome that would have been observed if the subject wasallocated to the treatment counter to the fact, as a missing data problem andproceed to impute the counterfactual. Our contribution to the methodologicalliterature lies in the extension of this idea to a more general analyticapproach that includes mediators and confounders of the mediator-outcomerelationship. Simulation results suggest that our method works well andapplication to the WSHS2 data suggest that the treatment effect of nicotinepatch, varenicline, and cNRT are equivalent after accounting for differences intreatment compliance.

Estimating the impact of treatment compliance over time on smoking cessation using data from ecological momentary assessments (EMA)