Follow the data: tracking data quality and completeness in oncology real-world data

Objectives: Electronic Health Record (EHR) data are increasingly used in cancer research, yet the fidelity of this data when exchanged between systems remains poorly quantified. This study investigated the agreement in essential biomarker data after they are passed from the EHR into the cancer registry and Fast Healthcare Interoperability Resources (FHIR) extracts. Materials and Methods: This single-institution retrospective study compared demographics and 6 biomarkers from 30 lung cancer patients seen between July 2020 and July 2022. Manual review from the EHR served as the gold standard, with concordance tested between the source EHR, Institutional Cancer Registry, and FHIR exports. Results: Demographics showed high concordance across databases. In contrast, biomarker data present in the source EHR were missing in 80%-100% of FHIR extracts. The demographic registry variables were highly concordant. Discussion: This study reports a significant loss in biomarker data availability across real-world data (RWD) sources. Results underscore critical gaps in RWD extraction or exchange methods and highlight risks of relying on RWD without validation.