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Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons
Timothy Beukelman1, Lang Chen1, Narender Annapureddy2
1Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Pharmacoepidemiology and Drug Safety
|April 3, 2023
Summary
Electronic health record (EHR) data from clinical research networks (CRNs) misclassify tumor necrosis factor inhibitor (TNFi) use and underestimate infections. Supplementing CRN data with claims data improves accuracy for pharmacoepidemiology studies.
Area of Science:
- Health Informatics
- Pharmacoepidemiology
- Rheumatology
Background:
- Electronic Health Records (EHRs) are increasingly used in research.
- Clinical Research Networks (CRNs) aggregate EHR data for large-scale studies.
- Tumor Necrosis Factor inhibitors (TNFi) are biologic drugs used to treat autoimmune diseases.
Purpose of the Study:
- To evaluate the suitability of pooled EHR data from CRNs for studying TNFi and infection risk.
- To assess the accuracy of EHR data in identifying TNFi users and subsequent infections.
- To compare infection rates derived from EHR data versus claims data.
Main Methods:
- Pooled EHR data from three CRNs for patients with seven autoimmune diseases.
- Linked EHR data with Centers for Medicare and Medicaid Services (CMS) claims data.
- Assessed misclassification of TNFi exposure using filled prescriptions from CMS claims as the gold standard.
- Compared rates of hospitalized infections between EHR and CMS data.
Main Results:
- 45,483 new TNFi users were included; 1416 linked to CMS claims.
- 44% of EHR TNFi prescriptions lacked corresponding medication claims.
- EHR data underestimated hospitalized infection rates by 2- to 8-fold compared to claims data.
- Misclassification rates for prevalent TNFi use ranged from 3.5% to 16.4%.
Conclusions:
- EHR data significantly misclassify TNFi exposure and underestimate infection incidence.
- EHR-based new user definitions showed reasonable accuracy.
- Utilizing CRN data for pharmacoepidemiology, particularly for biologics, presents challenges and benefits from data supplementation.
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