Validation of a Composite Real-World Mortality Variable Among Patients with Hematologic Malignancies Treated in the United States
Real-world data (RWD) is being increasingly used to support clinical and regulatory decisions where utilization of clinical trial data is difficult or impractical. With this expanded utilization comes a need to ensure RWD is of sufficient quality and completeness to adequately answer relevant research questions. Given the importance of overall survival (OS) for oncology research, treatment and care, complete and accurate real-world mortality data capture is of critical importance. This study sought to validate and benchmark a composite real-world mortality variable, using the COTA real-world database, a de-identified database derived from the electronic health records (EHRs) of partnered healthcare providers in the United States, against the gold standard data source from the National Death Index (NDI). The final study population included 21,567 patients across 7 cancer types. Within the overall study population, validation analysis comparing the real-world composite mortality variable to the NDI demonstrated high sensitivity (87.8) and specificity (95.7). Date concordance between the real-world composite mortality variable and NDI dates of death was high. In the study population (N=21,567), exact date concordance was observed in 88.0% of patients. These findings are critical to ensure the reliability of results generated using RWD, and further establish the use of a composite real-world mortality variable as best practice.
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