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VOLUME 53 | NUMBER 6 | DECEMBER 2018


Development and Validation of a HighQuality Composite RealWorld Mortality Endpoint

Objective: To create a highquality electronic health record (EHR)–derived mortality dataset for retrospective and prospective realworld evidence generation.

Data Sources/Study Setting: Oncology EHR data, supplemented with external commercial and US Social Security Death Index data, benchmarked to the National Death Index (NDI).

Study Design: We developed a recent, linkable, highquality mortality variable amalgamated from multiple data sources to supplement EHR data, benchmarked against the highest completeness U.S. mortality data, the NDI. Data quality of the mortality variable version 2.0 is reported here.

Principal Findings: For advanced nonsmallcell lung cancer, sensitivity of mortality information improved from 66 percent in EHR structured data to 91 percent in the composite dataset, with high date agreement compared to the NDI. For advanced melanoma, metastatic colorectal cancer, and metastatic breast cancer, sensitivity of the final variable was 85 to 88 percent. Kaplan–Meier survival analyses showed that improving mortality data completeness minimized overestimation of survival relative to NDIbased estimates.

Conclusions: For EHRderived data to yield reliable realworld evidence, it needs to be of known and sufficiently high quality. Considering the impact of mortality data completeness on survival endpoints, we highlight the importance of data quality assessment and advocate benchmarking to the NDI.

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