Presentation (CTI)

OBJECTIVES: Real-world studies often rely on site-based healthcare professional mediated data collection, which can limit participant reach and data collection across settings of care. The I-OPERA (IQVIA Obesity Pilot in Europe to test a new patient-centric Research Approach) study tests a new methodology based on participants mediating access to their own health record data and completing a patient-reported outcome questionnaire. Patient and public feedback was sought before implementing this new patient-centric data collection methodology in order to improve quality, impact, and trust.
METHODS: I-OPERA is a multi-country, non-interventional study planned to be conducted remotely in Europe, starting in England, enrolling adults with BMI ≥27 kg/m². Patient feedback on the study design, the participant information sheet and consent form was sought from King’s Clinical Research Facility (London), under the Patient and Public Involvement and Engagement (PPIE) framework in the United Kingdom. Six PPIE contributors, most with lived experience of obesity, reviewed patient-facing materials through a structured feedback process; comments were synthesised thematically to identify areas requiring clarification, simplification, or reassurance.
RESULTS: The PPIE review provided an early patient perspective before the ethics review process and indicated positive perception of the patient-mediated model, with contributors recognising the value of combining patient-reported outcomes with health-record data. Prominent cross-cutting themes included clearer explanation of artificial intelligence-supported data processing, responsibility for retrieving or uploading electronic medical records, plain language for technical and legal terms, and an upfront summary of key consent information. These insights informed refinements to explanations for the potential participants of technology-enabled processing, medical record access, data flow, and participant burden.
CONCLUSIONS: PPIE input strengthened I-OPERA’s participant-facing materials by improving clarity and transparency before wider implementation, supporting a better participant experience in this innovative patient-centric research approach.