Standardizing registry data to the OMOP Common Data Model: experience from three pulmonary hypertension databases

Area of Science:

• Health Informatics
• Observational Data Standards
• Rare Disease Research

Background:

• The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) standardizes observational health data for cross-database analysis.
• Generating real-world evidence (RWE) is crucial for rare diseases like pulmonary hypertension (PH), where data is often limited.
• Pulmonary arterial hypertension (PAH) presents unique challenges for RWE generation due to its rare subgroups.

Purpose of the Study:

• To document the process and outcomes of transforming PH registry data into the OMOP CDM.
• To identify and address challenges encountered during the data transformation process.
• To propose potential solutions for improving future data harmonization efforts in rare diseases.

Main Methods:

• Three observational studies (OPUS, OrPHeUS, EXPOSURE) were converted from Clinical Data Interchange Standards Consortium (CDISC) SDTM to OMOP CDM format.
• OMOP CDM version 5.3.1 and its associated vocabularies were utilized for the transformation.
• Imputation rules for missing dates and custom target concepts for enhanced granularity were applied.

Main Results:

• A total of 6457 out of 6622 patient records (97.5%) from three registries were successfully mapped to the OMOP CDM.
• Custom concepts were developed for PAH subgroups and World Health Organization functional classes.
• Exclusion of non-event records resulted in minimal data loss: 4% (OPUS), 2% (OrPHeUS), and 1% (EXPOSURE).

Conclusions:

• SDTM data from three registries were effectively transformed to the OMOP CDM with minimal data exclusion.
• The documented strategy and methods can be adapted for data transformation in other disease areas, particularly rare diseases.
• Mapping registry data to OMOP CDM enhances research collaboration and supports the development of federated data networks.