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. 2023 Jul 5;24(7):743-749.
doi: 10.1093/pm/pnad018.

NIH HEAL Clinical Data Elements (CDE) implementation: NIH HEAL Initiative IMPOWR network IDEA-CC

Meredith C B Adams  1 , Robert W Hurley  2 , Andrew Siddons  3 , Umit Topaloglu  4 , Laura D Wandner  3
Affiliations

NIH HEAL Clinical Data Elements (CDE) implementation: NIH HEAL Initiative IMPOWR network IDEA-CC

Meredith C B Adams et al. Pain Med. .

Erratum in

Abstract

Objective: The 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.

Methods: This 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).

Results: The 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).

Conclusions: While 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.

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Figures

Figure 1.
Figure 1.
NIH HEAL required chronic pain CDE.
Figure 2.
Figure 2.
NIH HEAL IMPOWR required common data elements.
Figure 3.
Figure 3.
Lifecycle and timeline for common data element (CDE) network harmonization.
Figure 4.
Figure 4.
Definitions of Global Unique Identifier (GUID) and Rural Urban Coding (RUCA).
See this image and copyright information in PMC

References

    1. NIH HEAL Initiative. Accessed January 28, 2023. https://heal.nih.gov/about.
    1. HEAL Data FAIR Principles. Accessed January 28, 2023. https://www.healdatafair.org/.
    1. Wandner LD, Domenichiello AF, Beierlein J, et al. NIH's helping to end addiction long-term(SM) initiative (NIH HEAL Initiative) clinical pain management common data element program. J Pain. 2022;23(3):370–378. - PubMed
    1. HEAL Data Ecosystem. Accessed January 28, 2023. https://heal.nih.gov/data/heal-data-ecosystem.
    1. HEAL Common Data Elements. Accessed January 28, 2023. https://heal.nih.gov/data/common-data-elements.

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