Presentation (CTI)

OBJECTIVES: Patient-reported outcome measures (PROMs) such as the EQ-5D-5L are central to Health Economics and Outcomes Research (HEOR) and increasingly required for Health Technology Assessment (HTA) submissions, including EU joint clinical assessments. However, the integration of PROMs with routinely collected real-world data remains limited by heterogeneous data structures and insufficient interoperability across institutions. Whether PROMs can be digitally captured in an interoperable manner and mapped to the OMOP Common Data Model (CDM) to support reproducible analyses across federated data networks has not been systematically demonstrated. Using the EQ-5D-5L, a widely used measure of health-related quality of life, as a worked example, we therefore aimed to develop and implement an end-to-end pipeline spanning data capture, exchange, and OMOP transformation.
METHODS: EQ-5D-5L responses are collected digitally through a validated, GDPR-compliant smartphone app, exchanged as Fast Healthcare Interoperability Resources (FHIR), and mapped to the OMOP CDM using an open-source real-world evidence platform. We focused on the technical pipeline for the EQ-5D-5L index score, a weighted composite derived from country-specific value sets.
RESULTS: The pipeline enables the flow of EQ-5D-5L responses to analysis-ready OMOP datasets. It is fully implemented and operational. Dimension-level responses and index scores are correctly represented in the OMOP OBSERVATION and MEASUREMENT tables respectively. We illustrate its utility for two HEOR use cases: (1) population-level drug effectiveness and safety studies using EQ-5D-5L as a patient-centered endpoint, and (2) health economic analyses using index scores for QALY estimation.
CONCLUSIONS: Standardized digital collection and OMOP-based mapping are essential for making PROMs fit for HTA purposes at scale. The developed pipeline enables interoperable collection and reproducible, federated HEOR within OMOP networks using the EQ-5D-5L. This has direct relevance for cross-national HTA submissions and EU joint clinical assessments. Remaining challenges include limited adoption of the OMOP COST table, comparability of utility indices across country-specific value sets, and data governance.