• Pain Med · Nov 2024

    The NIH Pain Common Data Elements: A Great Start but a Long Way to the Finish Line.

    • AdamsMeredith C BMCB0000-0002-3969-4279Departments of Anesthesiology, Artificial Intelligence, Translational Neuroscience and Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157., Afton L Hassett, Daniel J Clauw, and Robert W Hurley.
    • Departments of Anesthesiology, Artificial Intelligence, Translational Neuroscience and Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157.
    • Pain Med. 2024 Nov 4.

    BackgroundThe NIH Pain Common Data Elements (CDEs) provide a standardized framework for pain research, but their implementation and interpretation present challenges.ObjectivesTo review the NIH CDE Program's selected pain domains, provide best practices for implementing required questions, and offer a checklist for appropriate CDE use in clinical trials and secondary data analysis.MethodsThis work analyzed the ten core pain research domains selected by the NIH CDE Program and discuss their limitations and considerations for use.ResultsThe manuscript provides an overview of the ten core pain research domains, including pain intensity, interference, physical function, sleep, catastrophizing, depression, anxiety, global impression of change, substance use screening, and quality of life. It offers sample scenarios for implementing required questions and presents a checklist to guide researchers in using pain CDEs effectively for clinical trials and secondary data analysis.DiscussionKey challenges identified include contextual variability, lack of validation across all pain conditions and populations, and potential misuse or misinterpretation of measures. This work proposes solutions such as supplementary measures, context-specific guidance, comprehensive training programs, and ongoing refinement of the CDE framework.ConclusionWhile NIH Pain CDEs are valuable tools for standardizing pain assessment in research, addressing challenges in their implementation and interpretation is crucial for improving the consistency, validity, and interpretability of pain research data, ultimately advancing the field and enhancing patient care.© The Author(s) 2024. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

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