Pharmacoepidemiology and Drug Safety | 2021
Control yourself: ISPE‐endorsed guidance in the application of self‐controlled study designs in pharmacoepidemiology
Abstract
Consensus is needed on conceptual foundations, terminology and relationships among the various self‐controlled “trigger” study designs that control for time‐invariant confounding factors and target the association between transient exposures (potential triggers) and abrupt outcomes. The International Society for Pharmacoepidemiology (ISPE) funded a working group of ISPE members to develop guidance material for the application and reporting of self‐controlled study designs, similar to Standards of Reporting Observational Epidemiology (STROBE). This first paper focuses on navigation between the types of self‐controlled designs to permit a foundational understanding with guiding principles.