Revisiting the washout period in the incident user study design: why 6–12 months may not be sufficient

Abstract

The 6- and 12-month washouts excluded 75 and 85% of the samples, respectively. Half of subjects in the 6-month washout cohorts were actually prevalent users, and the 12-month washout period resulted in 30% misclassified. Using common washout periods of 6-12 months may insufficiently address prevalent user bias in large commercial claims databases.