Overview
Safety surveillance using EHR data requires the underlying data be relevant and reliable. One approach to exploring whether EHR data is suitable for safety surveillance is identifying known treatment-associated adverse events (AEs) using EHR data and comparing AE rates to those in previously reported studies.
This study utilized the UK Flatiron Health Research Database to assess the incidence of neutropenia among women treated with CDK4/6is as captured in structured EHR-data. The cohort included women who began treatment on or after January 1, 2017 who had undergone a full blood count prior to initiating treatment. Researchers assessed neutropenia based on absolute neutrophil counts reported from lab test results as well as presence of ICD-10 coding, and AEs were categorized by severity. Findings using lab results, but not ICD-10 codes, align with previous studies and clinical expectations.
Why this matters
This research suggests that use of structured lab result data in the UK Flatiron Health Research Database can effectively identify neutropenia AEs—and potentially other lab-based AEs—within expected ranges in advanced breast cancer patients treated with CKD4/6is. Safety surveillance of lab-based AEs requires comprehensive lab result and dosing data to ensure valid estimation of AE rates and capture of AE management for initiators of oncologic therapies. The results of this study lay the foundation for the development and implementation of a safety surveillance system for lab-based AEs, critical for healthcare providers to monitor and manage potential side effects, ultimately improving treatment outcomes and patient safety.