This report summarizes alternative methods for validating selected health outcomes of interest (HOIs), which included linkage to registries and external data sources, as compared to chart validation. The project explored methods that are less costly and time consuming than medical chart review, which has been the standard method for HOI algorithm validation. The HOIs were selected based on the dearth of validated algorithms with high performance characteristics in the existing literature, and prioritization by FDA. They were rated as feasible, potentially feasible, or unlikely/not feasible for linkage based on the availability and accessibility of alternate data sources, cost of linking these data sources to the Mini-Sentinel Distributed Database (MSDD), and the extent of overlap of these databases with the MSDD.
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Glen Schumock PharmD, PhD, MBA; University of Illinois at Chicago, Chicago, IL
Todd Lee, PharmD, PhD; Simon Pickard, PhD; Wan-Ju Lee, BPharm, MS; Hari Patel, PharmD; Priyameth Dilokthornsakul, PharmD; University of Illinois at Chicago, Chicago, IL
Azadeh Shoaibi, MS, MHS and Patrick Archdeacon, MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD