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

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.

Keywords: Observational Medical Outcomes Partnership (OMOP); critical care; data harmonization; drug repurposing; electronic health record; real-world data.

Figure 1.

Partners in the CURE Drug Repurposing Collaboratory (CRDC). FDA = Food and Drug Administration, IDDO = Infectious Diseases Data Observatory, ISARIC DB = International Severe Acute Respiratory and emerging Infection Consortium Data Base, NCATS = National Center for Advancing Translational Sciences, NIH = National Institutes of Health, PCC = Partnership Coordinating Center, SCCM = Society for Critical Care Medicine, VIRUS = Viral Infection and Respiratory Illness Universal Study.

Figure 2.

Structure of tools within the Edge Tool software. CDM = common data model, EHR = electronic health record, ETL = extract, transform, and load, HADES = Health Analytics Data-To-Evidence Suite, OMOP = Observational Medical Outcomes Partnership.