Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned.
Pharmacoepidemiol Drug Saf
; 32(9): 969-977, 2023 09.
Article
em En
| MEDLINE
| ID: mdl-37005701
ABSTRACT
PURPOSE:
We assessed the suitability of pooled electronic health record (EHR) data from clinical research networks (CRNs) of the patient-centered outcomes research network to conduct studies of the association between tumor necrosis factor inhibitors (TNFi) and infections.METHODS:
EHR data from patients with one of seven autoimmune diseases were obtained from three CRNs and pooled. Person-level linkage of CRN data and Centers for Medicare and Medicaid Services (CMS) fee-for-service claims data was performed where possible. Using filled prescriptions from CMS claims data as the gold standard, we assessed the misclassification of EHR-based new (incident) user definitions. Among new users of TNFi, we assessed subsequent rates of hospitalized infection in EHR and CMS data.RESULTS:
The study included 45 483 new users of TNFi, of whom 1416 were successfully linked to their CMS claims. Overall, 44% of new EHR TNFi prescriptions were not associated with medication claims. Our most specific new user definition had a misclassification rate of 3.5%-16.4% for prevalent use, depending on the medication. Greater than 80% of CRN prescriptions had either zero refills or missing refill data. Compared to using EHR data alone, there was a 2- to 8-fold increase in hospitalized infection rates when CMS claims data were added to the analysis.CONCLUSIONS:
EHR data substantially misclassified TNFi exposure and underestimated the incidence of hospitalized infections compared to claims data. EHR-based new user definitions were reasonably accurate. Overall, using CRN data for pharmacoepidemiology studies is challenging, especially for biologics, and would benefit from supplementation by other sources.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Farmacoepidemiologia
/
Registros Eletrônicos de Saúde
Limite:
Aged
/
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Pharmacoepidemiol Drug Saf
Assunto da revista:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Estados Unidos