Self-Controlled Crossover Observational PharmacoEpidemiologic Studies
Self-controlled Crossover Observational PharmacoEpidemiologic (SCOPE) studies are “trigger” designs that examine the association between transient exposures and abrupt outcomes. SCOPE designs have become increasingly common due to their inherent control for for time-invariant confounding. However, our team’s systematic review found that terminology, reporting, and implementation of these designs is largely inconsistent. Dr. Cadarette lead a team of experts to provide guidance on SCOPE designs as Chair of the International Society for Pharmacoepidemiology Self-controlled Study Designs Working Group.
Our upcoming Foundational Guidance Paper provides an overview of different SCOPE designs, including outcome-anchored (case-crossover [CCO], case-time control [CTC], case-case-time control [CCTC]) and exposure-anchored (self-controlled case-series [SCCS]) study designs. The paper also highlights key methodological features of SCOPE designs and proposes common language to facilitate their reporting: Cadarette SM, Maclure M, Delaney JAC, Gagne JJ, Whitaker HJ, Hayes KN, Wang SV, Tadrous M, Gagne JJ, Consiglio GP, Hallas J. Control yourself: ISPE-sponsored guidance for the application of self-controlled study designs in pharmacoepidemiology. Pharmacoepiedmiol Drug Saf, 2021; In Press.