Robert D Kerns, PhD
Professor Emeritus, Yale University
Senior Research Scientist, Department of Psychiatry, Yale School of Medicine
In its seminal report, “Relieving Pain in America: A Blueprint for Transforming Pain Prevention, Care, Education, and Research,” the Institute of Medicine (IOM; now the National Academy of Medicine) asserted that pain is a significant public health problem (Institute of Medicine, 2011). The report highlighted the high prevalence of pain and chronic pain and associated high rates of disability, high costs of care, and disability compensation, differences and disparities in pain prevalence, care seeking, and access to care, among other concerns. Recent estimates suggest that 20% of U.S. adults report chronic pain that is pain present on most days in the past six months, and that 8% endorse “high impact chronic pain” that is pain that interferes with work and daily activities on most days in the past six months (Dahlhamer et al., 2018). Complicating the assessment and management of pain is our incomplete understanding of pain as a subjective experience influenced by a range of biological, psychological, and social/environmental factors (Raja et al., 2020). Moreover, pain in one site or associated with a specific medical condition commonly co-exists with other pain sites and conditions and with other medical, mental health, and substance use disorders (Maixner et al., 2016).
Following the recommendations of this report, the Department of Health and Human Services published a National Pain Strategy (NPS) that offered a comprehensive framework for transforming pain care in America (Health and Human Services, 2016). Key findings and recommendations for this transformation are that pain care should be tailored to each person’s experience of pain and be comprised of integrated multimodal and team-based plans of care that are consistent with patient preferences. Research highlighting patient harms associated with long-term opioid therapy and other pain medications and invasive procedures raise concerns about widespread reliance on these approaches. In contrast, a growing array of evidence-based nonpharmacological approaches, including acupuncture, cognitive-behavioral therapy, hypnosis, massage, mindfulness-based stress reduction, and spinal manipulation, among others, may reduce risk of harms and hold special appeal to persons with pain, delivered either in conjunction or alone as alternatives to traditional medical and rehabilitation approaches (Becker et al., 2018). Unfortunately, the NPS also cited evidence that these recommendations are rarely enacted, and a range of organizational, clinician, and patient-level barriers to their adoption in health care settings were articulated.
Military service members and veterans are particularly vulnerable populations demonstrating high prevalence rates and complexity of chronic pain. National survey data document that veterans have higher prevalence rates of chronic pain relative to civilians (Dahlhamer et al., 2018). Presence of pain in these populations is highly comorbid with depressive and anxiety disorders (Bair et al., 2008), post-traumatic stress disorder (Lew et al., 2009), and substance use disorders (Seal et al., 2012). Among female veterans, pain is associated with high rates of military and non-military sexual harassment and trauma (Haskell et al., 2008). Finally, pain is also among the costliest disorders treated in Department of Veterans Affairs (VA) healthcare settings (Yu et al., 2003).
The VA and subsequently the Department of Defense (DOD) have developed important initiatives to optimize pain care. Recently, VA has made a major funding investment to support the expansion of integrated, interdisciplinary pain teams across its healthcare system, and a growing array of veteran and clinician resources are available to support this initiative. Complementing these initiatives to promote improved pain management, DOD, VA, and National Institutes of Health (NIH/National Center for Complementary and Integrative Health (NCCIH) have launched strategic initiatives that encourage attention to the person with pain, as opposed to pain per se, consistent with an overarching objective of health promotion and “whole person health.” Consistent with this objective, approaches are encouraged that attend to the broad health and social concerns of veterans and military service members and their families. A recent report from the National Academies of Science, Engineering, and Medicine, Achieving Whole Health: A New Approach for Veterans and the Nation, highlights opportunities afforded by this approach for addressing the broad health care needs and well-being of these communities (National Academies of Science, Engineering, and Medicine, 2023).
The NPS highlighted a critical gap between science and practice in pain management, and DOD and VA are aggressively taking steps to address this gap. However, despite major initiatives and growing evidence of the effectiveness of integrated models of pain care and several nonpharmacological approaches for the management of pain, until recently no large scale, pragmatic effectiveness studies have been conducted that can inform clinical practice and policy.
In 2017, a highly significant and innovative tri-government agency partnership was launched to address this gap. The NIH-DOD-VA Pain Management Collaboratory (PMC) was established to support multiple large scale, multisite, pragmatic clinical trials (PCTs) designed to test the effectiveness of integrated models of care and nonpharmacological approaches for the management of pain and co-occurring conditions in DOD and VA healthcare systems (Kerns et al., 2019; 2024). Eleven PCTs were initially funded by either NIH, DOD, or VA. NIH, specifically the NCCIH, additionally supports a PMC Coordinating Center (PMC3). In the past two years, five additional PCTs were funded and are now addressing key project milestones. It is anticipated that additional PCTs will be sponsored in the future.
Over the past six years, the PMC and PMC3 have accomplished key milestones for success consistent with their objectives and aims and anticipated innovations. Through PMC3-managed Work Groups, a Patient Resource Group and External Board, and theme-based Discussion Groups, technical policy guidelines and best practices have been developed, adapted, and adopted to support the PMC and future PCTs. These actions have complemented an overarching collaborative framework and provided operational, technical, design and logistical support to PCT teams to develop, initiate and successfully implement their PCTs. A comprehensive communication plan has been enacted to widely disseminate PMC endorsed policies, best practices, and lessons learned. The PCTs are beginning to publish their principal findings (Burgess et al., 2024), and most projects are expected to complete data collection and analyses within the next year.
Across these trials, a diverse, geographically representative sample of over 11,000 participants has been enrolled across research sites that span all corners of the U.S. Approximately 100 articles have been published, and many more products have been disseminated via presentations at national conferences and other venues. In late 2024, the PMC sponsored a journal supplement that includes 19 original articles, commentaries, and editorials reporting on important lessons learned and best practice recommendations for the conduct of similar PCTs. The PMC website (www.painmanagementcollaboratory.org) continues to expand its already substantial reach and provides timely updates and resources emerging from the PMC. Notable innovations have been made in the areas of study design to adapt to the COVID-19 pandemic, data harmonization, phenotyping, adverse event/adherence monitoring, optimized use of electronic health record data, addressing ethical and regulatory concerns, engagement of veterans and other key partners, and dissemination and implementation plans.
In summary, the PMC addresses important scientific knowledge and practice gaps that are being addressed within the context of a shared commitment to improving pain care for recipients of care in DOD and VA settings with important implications for other clinical practice settings. Recommendations for continued advances in the design and successful conduct of pragmatic clinical trials can also be anticipated. Finally, the PMC is a bold example of opportunities afforded by strong inter-government agency partnerships in addressing pain as a significant public health concern.
References
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Becker, W. C., DeBar, L. L., Heapy, A. A., Higgins, D., Krein, S. L., Lisi, A., Makris, U. E., & Allen, K. D. (2018). A research agenda for advancing non-pharmacological management of chronic musculoskeletal pain: Findings from a VHA State-of-the-art Conference. Journal of General Internal Medicine, 33, 11-15.
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Haskell, S. G., Papas, R. K., Heapy, A., Reid, M. C., & Kerns, R .D. (2008). The association of sexual trauma with persistent pain in a sample of women veterans receiving primary care. Pain Medicine, 9, 710-717.
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Kerns, R. D., Brandt, C. A., & Peduzzi, P. (2024). Pain Management Collaboratory: Updates, lessons learned, and future directions. Pain Medicine, 25, S1-S3. doi.org/https://doi.org/10.1093/pm/pnae097
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Seal, K. H., Shi, Y., Cohen, G., Cohen, B. E., Maguen, S., Krebs, E. E., & Neylan, T. C. (2012). Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. Journal of the American Medical Association, 307(9), 940–947. https://doi.org/10.1001/jama.2012.234
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