Clinical Research Directory

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

Sponsor: IQVIA RDS Spain, SL

Summary

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.

Official title: The I-OPERA Study: IQVIA Obesity Pilot in Europe to Test a New Patient-centric Research Approach

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