A Path to Real-World Evidence in Critical Care Using Open-Source Data Harmonization Tools

• Type of Material: Article
• Authors: Smith F Heavner, CURE Drug Repurposing Collaboratory, Critical Path Institute, Tucson, AZ.; Wesley Anderson, Quantitative Medicine, Critical Path Institute, Tucson, AZ.; Rahul Kashyap, Mayo Clinic, Rochester; Pamela Dasher, CURE Drug Repurposing Collaboratory, Critical Path Institute, Tucson, AZ.; Ewy A Mathé, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda; Laura Merson, University of Oxford; Philippe J Guerin, University of Oxford; Jeff Weaver, Emory University; Matthew Robinson, Johns Hopkins University, Baltimore, MD.; Marco Schito, CURE Drug Repurposing Collaboratory, Critical Path Institute, Tucson, AZ.; Vishakha K Kumar, Society for Critical Care Medicine, Mount Prospect, IL.; Paul Nagy, Johns Hopkins University School of Medicine, Baltimore, MD.
• Language: English
• Date: 2023-04-03
• Publisher: Wolters Kluwer Health
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1097/CCE.0000000000000893
• Title of Journal or Parent Work: Critical Care Explorations
• Volume: 5
• Issue: 4
• Grant/Funding Information: This work was supported in part by the Intramural Research Program of the National Center for Advancing Translational Sciences, National Institutes of Health (1ZIATR000056-07). Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by nongovernment source(s), totaling $11,196,634.
• Keywords: Observational Medical Outcomes Partnership (OMOP); data harmonization; real-world data; drug repurposing; electronic health record; critical care
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

COVID-19 highlighted the need for use of real-world data (RWD) in critical care as a near real-time resource for clinical, research, and policy efforts. Analysis of RWD is gaining momentum and can generate important evidence for policy makers and regulators. Extracting high quality RWD from electronic health records (EHRs) requires sophisticated infrastructure and dedicated resources. We sought to customize freely available public tools, supporting all phases of data harmonization, from data quality assessments to de-identification procedures, and generation of robust, data science ready RWD from EHRs. These data are made available to clinicians and researchers through CURE ID, a free platform which facilitates access to case reports of challenging clinical cases and repurposed treatments hosted by the National Center for Advancing Translational Sciences/National Institutes of Health in partnership with the Food and Drug Administration. This commentary describes the partnership, rationale, process, use case, impact in critical care, and future directions for this collaborative effort.