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

Overview

The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire. The main questions it aims to answer are: 1. Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) 2. How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.) 3. Is the information collected through this approach complete and of sufficient quality for research purposes? 4. How closely does information reported by participants match the information contained in their medical records? 5. Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries. There is no comparison group or study treatment, as this is an observational study. Participants will: * Provide electronic informed consent to participate in the study. * Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) * Complete an online questionnaire about their health, quality of life, and experiences related to obesity. * Allow researchers to combine information from questionnaire with data obtained from their medical records. * Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required. Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.

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).