Introduction: Pain Management Collaboratory: updates, lessons learned, and future directions

Since its launch in 2017, the Pain Management Collaboratory (PMC) has emerged as an important resource for the field of pain management. A strong and growing multidisciplinary PMC community consists of clinical pain scientists; methodologists; sponsors of clinical pain research; persons with lived experience of pain, especially military service members and their dependents and military veterans; and policy and practice leaders, particularly those from the Veterans Health Administration (VHA) and Defense Health Agency (DHA). The PMC is recognized as a highly significant and innovative tri-government agency partnership and investment involving the National Institutes of Health and the Departments of Defense and Veterans Affairs that addresses the gap between evidence of the effectiveness of integrated models of pain care that incorporate nonpharmacological approaches, including complementary and integrative health approaches, and the uptake of these models of care and approaches in routine clinical care. The PMC can highlight significant contributions to the scientific and scholarly literature, as well as contributions that have helped inform major clinical practice and policy initiatives in the VHA and DHA. To date, Collaboratory investigators, in partnership with patients and organizational leaders, have contributed more than 70 original, peer-reviewed publications in leading journals, including articles reporting on lessons learned, best practices, and related innovations for improving the science of pragmatic clinical trials (PCTs) and related topics and for optimizing integrated, evidence-based pain care. A diverse group of more than 11 000 recipients of care in the VHA and DHA have benefited from participation in the 11 originally funded PCTs examining the effectiveness of evidence-based nonpharmacological approaches for the management of pain and co-occurring conditions when delivered in real-world clinical settings. A robust website (www.painmanagementcollaboratory.org) continues to mature to promote access to information about the Collaboratory and about nonpharmacological approaches and integrated models of pain care. As the original PCTs complete their data collection and planned analyses, the Collaboratory is increasingly focused on promoting sustainment of effective interventions in the clinical settings in which the trials were enacted and broader implementation in the VHA and DHA. Overall, the PMC will continue to address previously noted scientific knowledge and clinical practice gaps that spurred research leaders from the National Institutes of Health, particularly the National Center for Complementary and Integrative Health, to partner with VHA and DHA research programs to support this important initiative. In the fall of 2020, the PMC partnered with the journal Pain Medicine to publish a supplement that included the design of the originally funded Collaboratory PCTs, complemented by editorials and related commentaries.1 The present supplement is designed to continue to disseminate updates, lessons learned, and best practices from the Collaboratory to inform future PCTs, as well as major VHA and DHA policy and practice initiatives. Complementing this introductory editorial, the supplement includes a second editorial from senior policy and practice leaders in the VHA and DHA highlighting the significance of the Collaboratory in informing continued efforts to fulfill the vision of these organizations’ Stepped Care Model of Pain Management and initiatives to promote objectives of their respective Whole Health initiatives.2 These editorials offer a framework for considering the remaining articles that comprise this supplement, including descriptions of protocols for two recently funded PCTs that are now included in the PMC portfolio of projects. The PMC has prioritized initiatives and activities designed to optimize its scientific and clinical impact. From the earliest days, a key mantra has been to ensure that the overall impact of the Collaboratory is “greater than the sum of the parts,” that is, prioritizing efforts to optimize the impact of the PCTs as a collective whole. Four articles in this supplement report on cross-Collaboratory projects that serve foundational roles in promoting future analyses that take advantage of shared measurement approaches. Central to this effort is the effort led by the PMC Phenotypes and Outcomes Work Group that resulted in agreement across the trials to incorporate a core set of measures to promote comparisons and analyses across the trials, including analyses of heterogeneity of treatment effects.3 A second article provides guidance for extracting patient-reported outcomes from electronic health records of military treatment facilities.4 Two other articles report on novel measures of participant-level impacts of COVID-195 and participant reports of use of nonpharmacological approaches, a key secondary outcome measure for several trials.6 Other common challenges experienced in the PCTs and potential solutions are described for data sharing and the use of electronic health record / observational data to support pragmatic studies within the DHA and VHA. An article based on contributions from the PMC Electronic Health Record Work Group describes key activities and lessons learned as the PCTs evolved and provides a summarization of challenges noted for using electronic health record data in PCTs.7 An article from the Data Sharing Work Group discusses issues that PCTs face for sharing study results and the potential for future data and resource sharing with newer studies as policies and regulations evolve.8 Three articles that emerged from the Biostatistics and Study Design Work Group are related to methodological and analytical issues. One article addresses the utility of using the PICOTS (Population, Intervention, Comparator, Outcomes, Timepoints, Setting) framework to assess clinical trial disruptions as applied to monitoring the impact of COVID-19 in the PMC.9 Use of PICOTS, not only during the trial planning phase to anticipate trial disruptions that might occur, but also while the trial is being conducted as a framework for monitoring any disruptions, has the potential to enhance the quality of PCTs. A second article addresses modifying statistical analysis plans and provides guidance about when changes to statistical analysis plans are acceptable, what changes need be documented, and how to document such changes.10 A third article provides recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the PMC.11 As a best practice for PCTs, they recommend early and regular adherence/fidelity monitoring to determine whether intervention delivery is as intended. Complementing this article is one reporting on the association between baseline perceptions of nonpharmacological approaches and subsequent adherence to therapist recommendations during treatment.12 Two articles address the important issue of adverse event monitoring in PCTs. One article from the Ethics and Regulatory Work Group offers recommendations for monitoring and reporting adverse events in PCTs testing nonpharmacological pain management interventions based on the experiences in the PMC.13 A companion article describes the outcomes and benefits of an approach to adverse event monitoring and reporting in one of the PMC trials.14 PCTs are considered particularly important in promoting adoption of targeted interventions into real-world settings. As such, the PMC Implementation Science Work Group plays a central role in addressing knowledge gaps and barriers to successful sustainment and implementation of interventions with strong effectiveness evidence. One article provides compelling support for pragmatic-implementation trials to propel adoption of interventions with real-world evidence of effectiveness by simultaneously providing evidence of feasible pathways to implementation.15 A related hallmark of the PMC is the emphasis on optimizing engagement of key partners, including patients, clinicians, and policy leaders and administrators, as highlighted in the article from the PMC Partner Engagement Work Group.16 A companion article reports on the implementation approach used in one of the PMC trials.17 This issue concludes with descriptions of two PCTs that were recently added to the PMC portfolio. One trial investigates the effectiveness of a tele-collaborative pain care intervention vs. minimally enhanced usual care among rural veterans with chronic musculoskeletal pain.18 Building on their successful original PMC trial, Rosen and Martino and their colleagues examine the use of case managers trained in Screening, Brief Intervention, and Referral for Treatment for Pain Management (SBIRT-PM) in the Military2VA program to improve veterans’ clinical outcomes (reducing the pain and risky substance use) and increase the engagement in nonpharmacological pain treatments.19 The PMC continues to invest in optimizing the capacity and benefits of integrated pain care in the military and veteran health systems while simultaneously learning about PCTs. Already, many participants in the PMC trials have accrued personal benefit in terms of reduced pain and pain-related limitations in functioning, among other indicators of improved quality of life. The potential is great for emerging results of our trials to directly inform national implementation of effective nonpharmacological interventions and integrated pathways of care. The guest editors express our sincere gratitude for the powerful community of investigators and partners that comprise the PMC and for the inspiring sense of camaraderie and shared learning within our community. The guest editors wish to thank Ms. Margaret Antonelli for her significant contributions to the preparation of this supplement. Research reported in this publication was made possible by Grant Number U24 AT009769 from the National Center for Complementary and Integrative Health (NCCIH) and by the Office of Behavioral and Social Sciences Research (OBSSR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCCIH, OBSSR, and the National Institutes of Health. Conflicts of interest: R.D.K.: Honorarium as Executive Editor of Pain Medicine; honorarium as member of the Scientific Advisory Board of the Canadian Chronic Pain Centre of Excellence; voluntary service as Vice-Chair of the Board of Directors of A Place to Nourish your Health (APNH). P.P.: None. C.A.B.: None. This article appears as part of the supplement titled “Pain Management Collaboratory: Updates, Lessons Learned, and Future Directions.” This manuscript is a product of the Pain Management Collaboratory. For more information about the Collaboratory, visit https://painmanagementcollaboratory.org/.

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