ELECTRONIC HEALTH RECORDS VERSUS ADMINISTRATIVE CLAIMS TO SUPPORT PHARMACOVIGILANCE REVIEW OF SAFETY EVENTS: A FIT-FOR-PURPOSE EVALUATION
Author(s)
Lili Zhou, PhD1, Catherine Fu, MS2, Joanne Tse, BS, MPH1, Ayad K. Ali, PhD1;
1BeOne Medicines, Ltd, San Carlos, CA, USA, 2BeOne Medicines, San Carlos, CA, USA
1BeOne Medicines, Ltd, San Carlos, CA, USA, 2BeOne Medicines, San Carlos, CA, USA
OBJECTIVES: Advances in informatics have expanded the availability of real-world data (RWD) to support pharmacovigilance (PV). However, fit-for-purpose (FFP) assessments are needed to evaluate data relevance and quality. This study compared the incidence of infections, hospitalizations, and mortality in patients with chronic lymphocytic leukemia (CLL), receiving Bruton tyrosine kinase inhibitors (BTKis), across three RWD databases: Symphony (open claims), TriNetX (general electronic health records [EHR]), and an oncology practice EHR (name cannot be disclosed due to contractual restrictions).
METHODS: Adults with CLL receiving BTKis from 2019 to 2023 were identified in the databases. First treatment record was the index date. Outcomes assessed were the incidence of overall infections (excluding COVID-19), specific infection subtypes (eg, pneumonia, shingles), and use of injectable antimicrobials within 2-year follow-up. All-cause hospitalizations and all-cause mortality were also evaluated, where data were available.
RESULTS: In the BTKi cohort, 14,075 patients were identified in Symphony, 4573 in TriNetX, and 2712 in the oncology practice EHR. The 2-year incidence of overall infections (excluding COVID-19) was comparable between Symphony and TriNetX but significantly lower in the oncology practice EHR (27.5% vs 26.7% vs 6.8%). Injectable antimicrobial use was also similar between Symphony and TriNetX (10.6% vs 9.5%) but not available in the oncology practice EHR. A similar pattern was found for all-cause hospitalization. In contrast, all-cause mortality was highly reported in the oncology practice EHR compared to TriNetX (24.6% vs 12.6%), while mortality data were unavailable in Symphony.
CONCLUSIONS: There were differences between EHR, the oncology practice EHR, and claims RWD in data relevance, quality, and extensiveness. Infection incidence and all-cause hospitalizations were comparable between Symphony and TriNetX but substantially underreported in the oncology practice EHR. In contrast, the oncology practice EHR captured mortality data more comprehensively. These findings highlight the importance of conducting an FFP assessment when utilizing RWD for PV research.
METHODS: Adults with CLL receiving BTKis from 2019 to 2023 were identified in the databases. First treatment record was the index date. Outcomes assessed were the incidence of overall infections (excluding COVID-19), specific infection subtypes (eg, pneumonia, shingles), and use of injectable antimicrobials within 2-year follow-up. All-cause hospitalizations and all-cause mortality were also evaluated, where data were available.
RESULTS: In the BTKi cohort, 14,075 patients were identified in Symphony, 4573 in TriNetX, and 2712 in the oncology practice EHR. The 2-year incidence of overall infections (excluding COVID-19) was comparable between Symphony and TriNetX but significantly lower in the oncology practice EHR (27.5% vs 26.7% vs 6.8%). Injectable antimicrobial use was also similar between Symphony and TriNetX (10.6% vs 9.5%) but not available in the oncology practice EHR. A similar pattern was found for all-cause hospitalization. In contrast, all-cause mortality was highly reported in the oncology practice EHR compared to TriNetX (24.6% vs 12.6%), while mortality data were unavailable in Symphony.
CONCLUSIONS: There were differences between EHR, the oncology practice EHR, and claims RWD in data relevance, quality, and extensiveness. Infection incidence and all-cause hospitalizations were comparable between Symphony and TriNetX but substantially underreported in the oncology practice EHR. In contrast, the oncology practice EHR captured mortality data more comprehensively. These findings highlight the importance of conducting an FFP assessment when utilizing RWD for PV research.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH112
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
SDC: Oncology