Involving Patients in Pharmacoepidemiology Studies Conducted on Healthcare Administrative Database: Results of a...

Patient and public involvement in pharmacoepidemiology using healthcare administrative databases remains limited despite its potential to enhance research relevance and societal impact. We evaluated the feasibility and benefits of involving patients as research partners in a Patient Committee for a pharmacoepidemiological study using the French nationwide health insurance database (SNDS).

A participatory feasibility study was conducted through the establishment of a Patient Committee alongside the study's Scientific Committee. A mixed-methods evaluation assessed feasibility combining quantitative indicators, analysis of group dynamics, and thematic analysis of the transcription of the second meeting. Benefits were evaluated based on changes made in protocol, statistical analysis, and civil society dissemination plans based on patients' proposals. The McMaster tool was used to assess the involvement process.

Three patients were recruited out of the minimum expected five. Of the five meetings, three were attended by all participants. Consensus was reached on most points discussed and a good cohesion was observed within the Committee. The questions asked to the moderators focused primarily on the progress of the research and on the availability of data beyond the reimbursement-related data available in the SNDS, as data related to the patient's perspective (quality of life or anxiety). At the second meeting, only 13% of coded exchanges fell within the categories previously predefined according to the meeting's objectives. The remaining themes were unrelated to their illness, drug utilisation or care pathways. Patient involvement led to an effective modification of a primary outcome in the research protocol and an additional statistical analysis. Patient Committee also contributed several points for discussion and produced two visual abstracts. Finally, patients expressed satisfaction with their participation, feeling that their opinions had been listened to and taken into account. Project team members involved in project management appeared satisfied with the process, except in logistical needs (very long research timeline with specific deadlines to be met).

Although benefits of patient involvement were observed, feasibility was partial due to several obstacles related to participant recruitment and patients' understanding of the SDNS. To improve feasibility, future initiatives should co-construct appropriate methodologies with stakeholders and provide adequate training tailored to the complexity of pharmacoepidemiology research.

The study was conducted in collaboration with the patient partner from the research laboratory. She was involved in recruiting the Patient Committee and drafting the recruitment materials (flyer and email). The patient partner also proofread the content of the training session.