The I-OPERA Study: IQVIA Obesity Pilot in Europe to Test a New Patient-centric Research Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 主要终点
- This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity.
研究概览
简要总结
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:
- 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.)
- 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.)
- Is the information collected through this approach complete and of sufficient quality for research purposes?
- How closely does information reported by participants match the information contained in their medical records?
- 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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Resident in England, France, or Germany
- •Self-reported height and weight corresponding to a calculated BMI ≥27 kg/m²
排除标准
- •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
结局指标
主要结局
This study will collect a focused set of self-reported descriptive and participant-reported measures relevant to the real-world experience of adults with obesity.
时间窗: Retrospective clinical data covering up to approximately five years prior to enrolment.
* Demographics (age, sex, city and country of residence) * Anthropometrics (weight, height, waist circumference and hip circumference) * PROs: * HRQoL will be assessed using the SF-36 (including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health) * 'Food noise' will be captured with the Thrive Food Noise Assessment * Lifestyle and behavioural factors habits (dietary habits and physical activity, smoking, alcohol consumption) * Social determinants of health (key social and environmental factors, including economic status, education and health literacy) * Treatment Patterns: data on current and past obesity-related treatments will be collected via participant self-report and medical record abstraction * HCRU (e.g., hospitalisations, outpatient visits) will be collected to describe the burden associated with living with obesity
次要结局
未报告次要终点