The NIH HEAL pain common data elements (CDE): a great start but a long way to the finish line

Background: The National Institutes of Health (NIH) Pain Common Data Elements (CDEs) provide a standardized framework for pain research, but their implementation and interpretation present challenges. Objectives: To 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. This work analyzed the 10 core pain research domains selected by the NIH CDE Program and discuss their limitations and considerations for use. Results: The manuscript provides an overview of the 10 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. Conclusion: Key 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. While 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.