• Pain Med · Jul 2023

    NIH HEAL Clinical Data Elements (CDE) Implementation: NIH HEAL Initiative IMPOWR Network IDEA-CC.

    • AdamsMeredith C BMCB0000-0002-3969-4279Departments of Anesthesiology, Biomedical Informatics, and Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, United States., Robert W Hurley, Andrew Siddons, Umit Topaloglu, and Laura D Wandner.
    • Departments of Anesthesiology, Biomedical Informatics, and Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157, United States.
    • Pain Med. 2023 Jul 5; 24 (7): 743749743-749.

    ObjectiveThe National Institutes of Health (NIH) HEAL Initiative is making data findable, accessible, interoperable, and reusable (FAIR) to maximize the value of the unprecedented federal investment in pain and opioid-use disorder research. This involves standardizing the use of common data elements (CDE) for clinical research.MethodsThis work describes the process of the selection, processing, harmonization, and design constraints of CDE across a pain and opioid use disorder clinical trials network (NIH HEAL IMPOWR).ResultsThe network alignment allowed for incorporation of newer data standards across the clinical trials. Specific advances included geographic coding (RUCA), deidentified patient identifiers (GUID), shareable clinical survey libraries (REDCap), and concept mapping to standardized concepts (UMLS).ConclusionsWhile complex, harmonization across a network of chronic pain and opioid use disorder clinical trials with separate interventions can be optimized through use of CDEs and data standardization processes. This standardization process will support the robust secondary data analyses. Scaling this process could standardize CDE results across interventions or disease state which could help inform insurance companies or government organizations about coverage determinations. The development of the HEAL CDE program supports connecting isolated studies and solutions to each other, but the practical aspects may be challenging for some studies to implement. Leveraging tools and technology to simplify process and create ready to use resources may support wider adoption of consistent data standards.© The Author(s) 2023. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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