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Author Notes:

Smith F. Heavner, sheavner@c-path.org

Dr. Heavner led writing and review of this article, provided supervision, project administration and resources management for the project, validated findings, and assisted with conceptualization and funding acquisition. Dr. Anderson assisted with writing and coordinating review and editing. Ms. Dasher provided project administration and assisted with writing, review, and editing. Dr. Kashyap and Ms. Merson assisted with project administration and review and editing. Dr. Guerin and Mr. Weaver provided review and editing. Drs. Robinson, Schito, Kumar, and Nagy assisted with conceptualization, supervision, funding acquisition, writing, review, and editing.

We gratefully acknowledge the contributions and leadership of Heather Stone, MPH, and Leonard Sacks, MD.

The authors have disclosed that they do not have any potential conflicts of interest.

Subject:

Research Funding:

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:

  • critical care
  • data harmonization
  • drug repurposing
  • electronic health record
  • real-world data
  • Observational Medical Outcomes Partnership (OMOP)

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

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Tools:

Journal Title:

Critical Care Explorations

Volume:

Volume 5, Number 4

Publisher:

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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