I-OPERA: A European Study Testing a New Way to Do Health Research.

Background: Obesity is a highly prevalent chronic condition in Europe, affecting nearly 60% of adults and contributing substantially to morbidity, mortality, and healthcare costs. Traditional real world evidence (RWE) studies rely on site based recruitment and data collection, which can be costly, logistically complex, and insufficiently representative of real patient care pathways, particularly when care is fragmented across multiple providers. Additionally, key clinical variables such as body mass index (BMI) are often missing or inconsistently recorded in medical records.

Recent advances in data protection regulation, notably the General Data Protection Regulation (GDPR, and UK GDPR), have strengthened individuals' rights to access and transfer their health data, enabling participant mediated research approaches.

Rationale: This observational study aims to evaluate the feasibility of a participant mediated direct to participant (DtP) observational research approach among adults living with obesity in Europe (England, France, Germany, with 35 participants enrolled in each country). This novel research model allows broader participation and facilitates the combined collection of secondary clinical data from medical records (retrospectively) and primary patient reported data (prospectively). Obesity represents a relevant use case due to its high prevalence, fragmented care pathways, importance of patient experience, and frequent incompleteness of routinely collected clinical data.

Primary Objective: To assess the feasibility and operational performance of a participant mediated DtP approach for observational research in adults with obesity in England, France, and Germany, specifically by evaluating:

• Success rates and timelines for medical record retrieval
• Healthcare professional compliance with Data Subject Access Request (DSAR) Authorization Form requests (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)
• Data quality and completeness
• Concordance between self reported data and medical record data
• Regional and national differences

Secondary Objectives: • To describe the clinical, demographic, and socio economic characteristics of adults with obesity identified through this approach

• To describe health related quality of life (Short Form 36, SF 36 questionnaire) and "food noise" (Thrive Food Noise Assessment, TFNA questionnaire)
• To compare self reported quality of life across countries and against published reference data

Study Design: Multinational, multicentre, ambispective (retrospective and prospective) observational pilot study (England, France, Germany), conducted entirely remotely via the IQVIA Health Research Space (HRS) platform. Participants will sign a consent form (in the three countries) and authorize access to their medical records through DSAR rights (only for England and Germany). Data will be collected from online questionnaire and medical records obtained from healthcare providers (England and Germany) or uploaded directly by participants (France).

Inclusion criteria

• Age ≥18 years
• Resident in England, France, or Germany
• Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²

Exclusion criteria

• Unable to provide electronic informed consent form (ICF)
• Unable to name at least one HCP involved in their care and the affiliated institution, where applicable
• Unwilling to authorise medical records access via DSAR (where applicable) or direct upload
• Unable to complete online surveys (approximately 30 minutes) on own device (computer, smartphone, or tablet)
• Participants whose HCPs are exclusively located outside the participant's country of residence, where applicable