Advancing Health Equity in Europe: Explore, Tailor, Implement, and Evaluate (ETIE)-A Framework of Diversity and Fairness in Pharmacoepidemiologic Research

Abstract

Pharmacoepidemiology should represent and benefit populations equitably, embracing diversity and equity, and ensuring fairness. This article describes equity and fairness in pharmacoepidemiology, depicts key diversity domains, and provides an operational framework and call for action to implement diversity and fairness in pharmacoepidemiologic research. To ensure fairness, studies should address diversity and inclusion while providing equal opportunities and benefits for everyone in the target population. To implement and evaluate fairness in pharmacoepidemiology, we defined the following diversity domains: biological sex, socially constructed gender, age, life stages (e.g., pregnancy, menopause), ethnicity, race, migration, nationality, socioeconomic status, education, health literacy, and health status and capabilities. These are determinants of health, either through biological pathways or through social norms, discrimination, and barriers to healthcare or research participation. They are interlinked, their impact is study- and context-specific, and due to their sensitive and evolving nature, they should be handled with caution. Implementing diversity domains enables researchers to assess the generalizability of findings, identify and address health inequities, account for determinants of health, and ensure the fairness of algorithms, implementations, and recommendations. To successfully implement diversity domains and ensure fair pharmacoepidemiologic research, we recommend researchers to follow the Explore, Tailor, Implement, and Evaluate (ETIE) framework: Explore the role/implication of the diversity domains in the study, tailor their definitions to the study context, implement them appropriately and evaluate the study findings in their context. Increased availability of diversity data is needed, and support from stakeholders is essential. This manuscript was endorsed by the International Society for Pharmacoepidemiology (ISPE).