Integrating the patient voice into pharmacoepidemiology research on the benefits and harms of medication

Abstract

Patient engagement has traditionally been limited to involving patients in decision-making regarding their healthcare choices. The goal of this paper was to assess patients’ perspectives on how they might be involved as a research partner in the design and implementation of pharmacoepidemiology research studies. Qualitative research methods were used to elicit patient perspectives on their involvement in pharmacoepidemiologic research. A total of 20 patients participated in five focus groups held from April to August 2016. Each focus group represented one of five chronic conditions, namely: human immunodeficiency virus/acquired immunodeficiency syndrome (HIV)/(AIDS), diabetes, mental health conditions, mild cognitive impairment/Alzheimer’s disease (AD), and cardiovascular disease (CVD)/hypertension. A semi-structured field guide was used to elicit views on drug safety and effectiveness and to identify which aspects of the design and implementation of a research study individuals felt most comfortable contributing to. The discussions were audio-recorded, transcribed verbatim, and analyzed following a grounded theory approach to identify the key themes that consequently emerged. For the most part, individuals equated safety with side-effects. There were several dimensions of effectiveness that corresponded with biological, clinical, and psychological aspects of well-being. Most individuals (84%) were comfortable deciding what information should be collected, and 74% felt they could help researchers select target outcomes to study. Fewer (58%) were confident they could advise on selecting comparator drugs. There is a need for training the patient community and for adapting existing patient engagement standards to expand patient involvement in pharmacoepidemiologic research.