IPRCC Meeting - 04/17/2015

Introduction

The sixth meeting of the Interagency Pain Research Coordinating Committee (IPRCC) was convened on April 17, 2015, at 8:30 a.m. in Building 1, Wilson Hall, National Institutes of Health (NIH), Bethesda, Maryland. In accordance with Public Law 92-463, the meeting was open to the public. Walter Koroshetz, MD, Acting Director, National Institute of Neurological Disorders and Stroke (NINDS), presided as chair.

In attendance were the following members of the IPRCC:

Federal Members: Walter Koroshetz, MD., Charles G. Helmick, III, MD; Sharon Hertz, MD, Audrey Kusiak, PhD, Richard Ricciardi, PhD, CRNP, Martha J. Somerman, DDS, PhD, Chester Buckenmaier, M.D. for Maj. Gen. Richard W. Thomas, MD, DDS

Scientific Members: Allan Basbaum, PhD, FRS, Rami Burstein, PhD, William Maixner, DDS, PhD, Judith Paice, PhD, RN, FAAN, Richard Payne, MD, Wally R. Smith, MD

Public Members: Myra J. Christopher, Penney Cowan, Christina Spellman, PhD, Cindy Steinberg, Tina M. Tockarshewsky, Christin L. Veasley

Ex-Officio Members: Josephine P. Briggs, MD., David Thomas, Ph.D. for Nora D. Volkow, MD Absent: Patricia A. Grady, PhD

Executive Officer: Linda L. Porter, PhD

NIH Staff

NINDS Office of Pain Policy - Cheryse A. Sankar, PhD, Khara M. Ramos, PhD; National Center for Complementary and Integrative Health - Mark Pitcher, PhD

Opening Session

Welcome

Dr. Koroshetz welcomed the committee members and guests. He remarked that this meeting was his first as acting chair, following the retirement of NINDS’s former director, Dr. Story Landis in October 2014. For the benefit of committee members who had not met him previously, Dr. Koroshetz provided a quick biographical summary: before joining NINDS in 2006, he was a Professor of Neurology at Harvard Medical School and Vice Chair of the Department of Neurology at Massachusetts General Hospital and director of clinical activities. His research experience spans biophysics, gene identification, neuroimaging and stroke clinical trials. Working as a clinical neurologist, he said, included pain management, which fostered his interest in discovering and making available pain treatments that are both more effective and lack the problems of current methods.

In his current role, he noted the NINDS’s continued commitment to the National Pain Strategy (NPS), released for public comment April 2, 2015. The day’s discussions of IPRCC activities include an update on the status of the NPS and achieving its short-term deliverables, as well as discussion of efforts to initiate a Federal Pain Research Strategy to complement and support the NPS.

Announcements & Updates

IPRCC Membership Additions

At the time of the September 2014 meeting, a slate of pending committee members had not yet been approved within the Department of Health and Human Services, though approval was obtained shortly thereafter. The new members are:

• Dr. Sharon Hertz, Deputy Director of the Division of Anesthesia, Analgesia, and Addiction Products at the Food and Drug Administration 
• Dr. Rami Burstein, Professor and Vice Chairman for Research in the Department of Anesthesia and Critical Care at the Beth Israel Deaconess Medical Center and Academic Director at the Harvard Headache Center 
• Dr. Judith Paice, Professor of Medicine and Director of the Cancer Pain Program at Northwestern University, Feinberg School of Medicine 
• Dr. Richard Payne, Professor of Medicine and Divinity at Duke University Medical Center
• Dr. Christina Spellman, Executive Director of The Mayday Fund, a foundation dedicated to alleviating the incidence, degree, and consequences of human physical pain
• Ms. Cindy Steinberg, National Director of Policy and Advocacy at the U.S. Pain Foundation, a member of the Steering Council of the Massachusetts Pain Initiative (MassPI), and Chair of MassPI’s Policy Council.

IPRCC Membership Rotations 

In addition, a number of IPRCC members will complete their terms at the end of July and rotate off the committee. Dr. Koroshetz acknowledged their contributions, thanked them for their work in moving the committee’s agenda forward, and promised a plaque to come later in the summer. They are:

• Myra Christopher, Kathleen M. Foley Chair in Pain and Palliative Care, Center for Practical Bioethics
• Christin L. Veasley, Co-Founder, Chronic Pain Research Alliance
• Wally R. Smith, MD, Professor and Vice-Chair, Department of General Internal Medicine, Virginia Commonwealth University Medical Center and
• Tina Tockarshewsky, former President and CEO, The Neuropathy Association.

Advances in Federally Supported Research Related to Pain

Dr. Koroshetz described seven significant research advances of the past few months that hold promise for improving pain care or policy:

1) development of a new way to model human pain conditions using easy-to-obtain human skin-derived fibroblasts reprogrammed into functional types of neurons, including nociceptors. This advance overcomes past difficulties in obtaining actual human nervous system tissue.[1]

2) development of a sophisticated new noninvasive tool for studying pain mechanisms and transmission of pain signals in freely moving animals using light (optogenetics). This technique avoids expensive and time-consuming development of transgenic mice and is a good example of how research not tied to a particular disease can have broad applications.[2]

3) demonstration that changes in TRPV1 activity at central terminals—spurred by serotonergic inputs—underlie pain hypersensitivity in a mouse model of neuropathic pain.  These receptors represent new targets for analgesic drug development.[3]

4) demonstration of the analgesic efficacy of adenosine subunit A3 agonists in alleviating persistent pain states without affecting normal sensation or engaging the endogenous opioid system. These agonists already are used as anti-inflammatory/anti-cancer agents and their established safety record in humans may expedite clinical studies.[4]

5) observations through positron emission tomography (PET) imaging that patients with chronic low back pain have elevated brain levels of glial translocator proteins indicating increased glial activation that is associated with chronic pain—These results provide the first evidence of neuroinflammation in the brains of chronic pain patients and may provide an objective approach to measuring chronic pain. [5]

6) assessment of a large national sample of veterans with chronic pain diagnoses revealed that black veterans were less likely than whites to receive opioid prescriptions (and pain management in general) for moderate to high levels of pain. These findings show the persistence of racial disparities in pain care [6] and were included in informational material (PDF, 1,136 KB) prepared by the NIH Pain Consortium.

7) a retrospective study of hospitalized cancer patients found reductions in reported pain and anxiety of 47 and 56 percent, respectively, after integrative medicine therapy. These results suggest integrative approaches could be an important adjunct to other methods of pain treatment.[7]
Dr. Koroshetz commented that the development of new tools like those he described show there are many innovative ways to be successful in neuroscience careers, which may attract more young investigators to the field. The broad community interested in neurological research can foster excitement about these advances.

Approval of the September 24, 2014, minutes

The announcements and updates concluded, Dr. Porter requested approval of the minutes of the September 24, 2014, meeting. There being no additions or corrections, the minutes were approved. 

Updates from IPRCC Members

National Pain Strategy,

Dr. Linda Porter 

Briefly reviewing the history of the National Pain Strategy (NPS), Dr. Porter reminded the group that in October 2012, the Assistant Secretary for Health (then Dr. Howard Koh) asked the IPRCC and NIH to respond to recommendation 2-2 of the 2011 Institute of Medicine report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, which said the Department of Health and Human Services should: develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources.

The IPRCC recognized that this charge was beyond its usual research interests and sought assistance from a cadre of national experts to carry out this effort. In particular, Dr. Porter acknowledged the contributions of Sean Mackey, MD, PhD, her co-chair of the NPS oversight panel. This panel guided a set of expert workgroups in six specific areas (population research, service delivery and reimbursement, care and prevention, disparities, public education and communication, and professional education and training). The efforts of these leaders produced a draft of the NPS that has received approval by the Secretary, Department of Health and Human Service for release to the public for comment on April 2, 2015.

To ensure adequate opportunity for public comment, IPRCC has distributed information about the NPS as widely as possible. These comments are helpful to HHS to gauge public support, as well as to identify any missing ideas. The public comment period will close May 20, 2015, and the plan will be revised to reflect the advice received and again go through an HHS approval process, with subsequent roll-out in a few months, probably by early fall 2015. Already NIH is working with public and private sector stakeholders likely to be involved in the plan’s implementation and coordinating these efforts with other ongoing HHS projects. The community’s willingness to collaborate on implementation and its enthusiasm for the plan will be essential to its long-term impact.

As the Department’s internal approval process was under way, substantial changes occurred in the Office of the Assistant Secretary for Health. The current Acting Assistant Secretary for Health, Dr. Karen DeSalvo, as well as the Deputy Assistant Secretary (Science and Medicine), Dr. Anand Parekh, remain supportive of the project as it moves forward. Dr. Parekh addressed the IPRCC at its September meeting and has provided continuity during these leadership changes. 

NPS and Healthy People 2020

Dr. Chad Helmick 

Dr. Koh requested that as part of the NPS, chronic pain objectives should be included in Healthy People 2020. Healthy People is a project first announced by HHS Secretary Joseph Califano in 1979 that has been in operation ever since.Healthy People provides science-based, 10-year national objectives for improving the health of all Americans, establishes benchmarks, and monitors progress over time. Its overarching goals are to:

• Attain high-quality, longer lives free of preventable disease, disability, injury, and premature death
• Achieve health equity, eliminate disparities, and improve the health of all groups
• Create social and physical environments that promote good health for all and
• Promote quality of life, healthy development, and healthy behavior across all life stages.

Under these goals are many specific HP 2020 objectives that have been in the planning stage for a number of years now, and an NPS sub-work group led by Dr. Helmick had to move quickly to put chronic pain objectives onto the agenda for consideration and to develop the research base that will enable benchmarking and progress assessment.
For the present, the chronic pain objective will focus on high-impact chronic pain and the collection of data relevant to it. These data will be collected through questions on the National Health Interview Survey in 2016 and 2017. A Healthy People 2020 Chronic Pain Workgroup met twice and involved Drs. Porter and Helmick, IPRCC members Christin Veasley, Penney Cowan, Josie Briggs, Judith Paice, and a number of other national experts—many of whom participated in the NPS process. 

The workgroup created four developmental objectives for pain:

1. Decrease the prevalence of adults having high-impact chronic pain
2. Increase public awareness/knowledge of high-impact chronic pain
3. Increase self-management of high-impact chronic pain
4. Reduce the impact of high-impact chronic pain on family/significant others

The first step in developing the supporting data for these objectives is to define high-impact chronic pain, which requires new survey questions. These questions will undergo cognitive testing to make sure respondents interpret them as intended. Testing will take place in June 2015 and will be funded by NINDS. The four objectives will remain developmental until supporting data are gathered, whereupon they can become established objectives.

It may be possible to use or adapt questions from the NIH’s Patient Reported Outcomes Measurement Information System (PROMIS), instruments used in the Profile of Chronic Pain, or questions developed in conjunction with the NPS, in which high-impact chronic pain is defined as persistent pain with enduring participation restrictions in work, social, or self-care activities. The NPS questions have been pilot-tested using a stratified random sample and found to produce estimates similar to those of larger population studies with respect to the population with severe, disabling chronic pain (13.7 percent prevalence in the pilot test) and moderate-to-severe chronic pain (18.9 percent). 

The specific questions asked that produced these results received considerable committee discussion. The questions were:

Over the past six months,

1. have you had pain on at least half the days? Yes/no
2. how much has pain interfered with your life activities? No/mild/moderate/severe interference
3. how often did pain limit your life or work activities, including household chores? Never/ rarely/ sometimes/ usually/ always 

In addition to prevalence estimates, the pilot test found that:

• People with high-impact chronic pain (versus others) had substantially higher average pain intensity, interference with activities, and interference with enjoyment of life activities (using 0 – 10 scales).
• People with high-impact chronic pain were substantially more likely than others to report pain at large numbers of anatomical locations and to report daily pain and daily pain without a break.
• People with moderate-impact chronic pain had “intermediate findings.”
• It is feasible to assess low, moderate, and high-impact chronic pain in population surveys using a limited number of simple questions asking about pain in general and without prior questions asking about pain at specific anatomical sites.

Next, it will be necessary to develop and test questions for the other three objectives (public awareness, self-management, and family impact).  Dr. Mark Pitcher is examining questions from the 2012 National Health Interview Survey that relate to pain and disability, as well as pain and co-morbid conditions, to determine whether they might be useful in addressing these concepts.

Discussion

In the discussion period, Dr. Smith asked why the group used “half the days” for establishing frequency of pain. Dr. Helmick explained this approach was the consensus of the NPS population working group. Several committee members weighed in on whether there might be overlap between questions 2 and 3, with respect to the concepts of “interfered with” and “limit” in key functional areas. Dr. Helmick responded that cognitive testing may reveal any problem of this kind. In general, he said, chronic pain is easier to define than high-impact chronic pain.

Asked how the pilot test information might guide future steps, Dr. Helmick said it will enable a focus on people whose lives are most affected by pain. This focus is a necessary, although insufficient step toward funding necessary services for them.

Ms. Veasley pointed out that the findings from these survey questions can be correlated with other National Health Interview Survey findings, which will give a fuller picture of the impact of pain. For example, in the disability section of the survey, questions are asked about mood, sleep, and so on. Dr. Helmick added that the findings also can be correlated with and compared to other self-reported data developed at regional and state levels.

Ms. Christopher asked about the use of the definition, saying it should not eventuate that only people with high-impact chronic pain will be eligible for certain benefits. For one thing, self-reports may not adequately adjust for people who are stoic or who deny they have pain. “How do we minimize the negative impact the definition may have on some people” she asked.

Dr. Helmick responded that the questions will be used in population analyses, not in clinical decision-making for individual patients, which led to a question regarding whether there would be follow-up with people who do report high-impact chronic pain.

Dr. Basbaum said that some people may not report negative effects of chronic pain because they are on a treatment plan that works. Thus, this population of “effectively treated” individuals will not be included in the prevalence estimates. Several committee members acknowledged that, while it may be difficult to include questions about the extent and efficacy of pain treatment, omitting treatment may be misleading. Dr. Hertz pointed out that the data also might be confounded by people who believe their pain treatment interferes with their life activities.

Related to these issues, Dr. Porter said that, at present these questions are just a first step toward understanding high-impact chronic pain.

Several committee members said they would like to use these questions in other research, once the cognitive testing is complete. Dr. Helmick said he would share these results of the testing with the committee.

Dr. Maixner said these questions are the entry point to a range of issues and can provide baseline data. Although the questions must be clear, Dr. Koroshetz said, they cannot answer everything, and the responses to them must be carefully interpreted.  What they will be useful for is developing a national goal.

The Safe Use of Opioids Training Tool

Linda Harris, PhD, Director, Division of Health, Communication, and eHealth, Office of Disease Prevention and Health Promotion, DHHS 

Dr. Harris, who co-chaired the NPS Public Education and Communication working group, presented a new interactive training tool for health care professionals, launched April 15, 2015.[8] The tool, which is intended to prevent adverse drug events in patients taking long-term opioids for chronic pain management, combines video and text and enables users to follow four different pathways in a pain management journey from the perspective of the patient, physician, nurse, or pharmacist. At multiple points choices are possible that lead to different outcomes, good choices are reinforced, decisions are reviewed, and less effective choices are discouraged. Physicians can receive a free continuing medical education credit for successfully completing this course.

The training tool addresses the goals of three national action plans: the NPS, the National Action Plan to Improve Health Literacy, and the National Action Plan for Adverse Drug Event Prevention. Not only does the tool incorporate insights from the recommendations in these three areas, it also models respectful provider-patient interactions and provides a resource library for clinicians.

Consistent with the NPS, the Pathways training dramatizes:

• A biopsychosocial approach to treating chronic pain
• The stigma and misperceptions about chronic pain and its seriousness
• Health literacy strategies such as shared decision-making and the teach-back method
• Informed and thorough pain assessment, and
• Integrated, multimodal, and interdisciplinary treatment approaches that balance effectiveness with concerns for safety. 

Excerpts of the training program were shown. 

Discussion 

Dr. Harris was joined in responding to questions by her colleague, Briana Rider, PharmD.

Dr. Basbaum asked whether prescription monitoring is a state or a federal issue. The subsequent discussion revealed that there are interstate differences; however, every state except Missouri has established a prescription drug monitoring program, said Ms. Steinberg, and it is left to the states to determine the details.  Ms. Christopher said prescription monitoring should be managed at the federal level because of these differences and because, in this situation, two important public health issues are at loggerheads: addiction and drug abuse, on one hand, and chronic pain management, on the other. Bridges are needed between these interests.

Gaining the attention of individual caregivers is a problem, said Dr. Hertz, as is the unavailability of effective alternative treatments.

Asked whether patients participated in the preparation of the training tool, Dr. Harris said that the NPS public education and communications workgroup, on which the tool was in part based, did include people with chronic pain. Ms. Cowan said the tool’s focus on the patient’s goals, rather than on attempts to achieve complete freedom from pain, was useful.

Dr. Rider clarified that the tool is intended for health professionals and that, although at present there is only one “playable” patient, the tool includes interactions with additional patients who have differing situations. Dissemination plans are ongoing through multiple channels, including professional organizations, such as the American Medical Association, and a list provided by Dr. Porter. Dr. Maixner said specialty societies and accrediting bodies might also be interested.

Asked whether the tool explores the possibility of addiction, Dr. Rider said the producers tried to stay away from this issue, although the resources include some addiction screening tools. 

Core Competencies for Pain in Medical Education 

Introduced by Dr. Christina Spellman and Presented by Scott Fishman, MD, Professor and Chief, Division of Pain Medicine, Executive Vice Chair, Department of Anesthesiology, and Director, Center for Advancing Pain Relief, University of California-Davis School of Medicine 

IPRCC member Dr. Spellman introduced Dr. Fishman, who served on the NPS professional training workgroup.  He spoke to the group over a video hookup about the need to change education about pain across professional groups. In the past, he said, these efforts have been unsuccessful, and pointed to the disconnect between the need for adequate pain treatment and the provision of it. Although a large U.S. population has chronic pain that causes a huge toll in suffering, disability, and economic burden, treatment is often delayed, disorganized, inaccessible, or ineffective, and overly reliant on the prescription of opioid drugs.

Dr. Fishman said the basic problem is an inadequate diffusion of knowledge about pain and a lack of medical training in appropriate and effective pain management. He quoted an article from The Journal of Pain that said, “Given that the twin dangers of pain under-treatment and the abuse of pain medications are among our society’s deepest public health concerns, pain medicine does not receive the attention that it deserves in medical education.”[9] To illustrate, he cited a Canadian study showing that veterinary medicine programs offer five times the amount of pain education medical doctors receive.[10] In that study, only one in three faculties could identify designated pain content hours in health sciences. What content existed inadequately addressed the key areas of pain assessment, monitoring, and addressing misbeliefs. While the findings are for Canada, the situation appears to be no better in the United States.

Competencies for pain have not been developed across health professional or pre-licensure clinical education, the typical places that practice expectations are set. Dr. Fishman and Heather M. Young, PhD, RN, FAAN, have been working to identify these core competencies. Their first step was to hold a two-day summit in August 2012 to build consensus across clinical professions: dentistry, medicine, nursing, pharmacy, physical therapy, psychology social work, alternative and complementary medicine, and veterinary medicine.

A dozen core values and principles also have been identified: advocacy, collaboration, communication, compassion, comprehensive care, cultural inclusiveness, empathy, ethical treatment, evidence-based practice, health disparities reduction, interprofessional teamwork, and patient-centered care.

He said that these core values and principles, as well as the competencies should guide curriculum. While some good curricula exist, such as that of the International Association for the Study of Pain (IASP), it has been left to each profession and training program to implement them. The core competencies program is synchronizing its efforts with the IASP curriculum, including the adoption of these four principal domains and their implications for clinical practice:

1. The multidimensional nature of pain: What is pain?
2. Pain assessment and measurement: How is pain recognized?
3. Management of pain: How is pain relieved?
4. Clinical conditions: How does context influence pain management?

The 21 consensus-based competencies developed by the summit participants fall into the above four domains. They have been published on an open access website[11] and in journals relevant to each of the professions. They have been widely presented at professional conferences, where they have been well received. The work group is hoping for widespread endorsement, adoption, and implementation with improvements and revisions made as needed.

Among the endorsements received to date are those of the American Academy of Pain Medicine, the American Pain Society, the Commission on Collegiate Nursing Education, the Council on Social Work Education, the International Association for the Study of Pain, the National Association of Social Workers, and the American Council of Academic Physical Therapy. Support also has been received from other groups, including the Association of American Medical Colleges (AAMC), the American Psychological Association, and the American Nurses Association.

The competencies ultimately should be included in educational institution accreditation standards and the certification process for individual clinicians, for example, the U.S. Medical Licensing Examination (USMLE), which every U.S. allopathic physician must pass in order to be licensed, as well as in continuing medical education requirements.

The UC-Davis ECHO pain management program is a practice improvement program that uses the core pain competencies as the foundation for continuing medical education. It uses a multidisciplinary, peer-to-peer tele-mentoring approach to facilitate improvements in pain management in almost 20 primary care sites in California, including some in remote rural areas or in Medicaid health plans where high-level pain consultancy services would not otherwise be available. The two-year project, which has been well received by clinicians, aims to establish multiple centers of excellence in pain management and will be fully evaluated for treatment quality, safety, access, resource utilization, and any clinician changes in knowledge, attitudes, or behavior.

Another UC-Davis project is attempting to develop interprofessional training programs for students of pre-licensure health professions schools. The program is based on a review of learning strategies and clinical scenarios developed through a second consensus summit. This activity supports a general movement toward competency-based education across all health professions. Six pain competencies and six interprofessional practice competencies have been dentified in this effort.

Dr. Fishman reported that a review of the AAMC’s 58 broad competencies for general medicine physicians revealed that “pain” is not specifically mentioned once, despite being one of the most frequent causes for physician visits. Nevertheless, at least 16 of the 21 pain competencies could be covered, in whole or in part, by one or more of the AAMC competencies, and pain-related concepts could be readily incorporated into two of the key AAMC competencies.

Similarly, in the American Association of Colleges of Nursing’s nine Essentials of Baccalaureate Education for Professional Nursing Practice (2008), pain is not mentioned, except briefly as possible “sample content.” Again, all 21 pain competencies are covered in the Essentials and could be readily made more explicit, he said.

An expert and confidential review of the USMLE content related to pain and pain management found that 15 percent of all questions were at least partially related to pain, and 6 percent were fully related to pain.

This constellation of projects, Dr. Fishman said, contributes to the well-timed NPS professional education and training objective “to develop, review, promulgate, and regularly update core competencies for pain care education and licensure and certification at the undergraduate and graduate levels.” He believes however, that educators will resist curriculum changes unless required by their accrediting and licensing bodies.

Discussion 

Ms. Christopher suggested the Coalition for Physician Accountability as an organization that should hear about this work and the NPS in general.

When asked who holds the key to curriculum changes besides the testing bodies, Dr. Fishman said that curriculum committees are difficult to work with, but will respond to changing demands by the Liaison Committee on Medical Education (the schools’ accrediting body). In addition, even if there is pain content in a curriculum, the important focus should be on pain outcomes.

Ms. Steinberg asked whether state licensing boards offered a potential pressure point. Dr. Fishman said there is a lot of variation across states, though all do require passage of the USMLE. State’s boards tend to have greater impact on graduate medical education and continuing medical education. This is why it is important to have core competencies that are relevant at all levels of education.

Dr. Maixner asked whether clinicians report feeling inadequately prepared to manage pain appropriately, and Dr. Fishman said they do have very negative beliefs about pain patients and pain care. The ECHO project, for example, has collected some information on this problem and is trying to counter it.

The Centers of Excellence in Pain Education and the Role of Opioids in the Treatment of Chronic Pain 

Dr. David Thomas 

Dr. Thomas began with the observation that that 80 percent of heroin users previously took prescription opioids for recreational use and that growth of heroin use in the United States appears to be linked to increasing difficulty in obtaining prescription opioid medications.[12] Data from the CDC Wonder database show that, although heroin-overdose deaths have grown rapidly in recent years, from 3,036 in 2010 to 8,257 in 2013, twice that number occurred from an overdose of prescription opioids (16,235 in 2013).[13] Moreover, for every death, there are 32 emergency department visits for misuse or abuse, an estimated 130 people who abuse or are dependent on the drug, and 825 non-medical users.

Both a reduction of prescription opioid abuse and improved pain treatment urgently need to be addressed, in part through increased clinical education.[14] That is a mission of the NIH Pain Consortium’s Centers of Excellence in Pain Education (CoEPEs). Ten NIH Institutes and Centers are involved in the CoEPEs program, which has established a dozen centers across the nation. These centers are developing pain curriculum resources that will be available on the NIH Pain Consortium website and elsewhere, and will be leveraged to achieve one of the NPS educational objectives. Students who received training through the first completed case-based pain scenario scored higher (statistically significant at the P <.001 level) than those without the training in an objective examination of their knowledge of appropriate pain care.

An NIH sponsored Pathways to Prevention conference was held in September 2014, in which information regarding the safety and efficacy of opioids in the treatment of chronic pain was presented to a “jury” of non-pain experts, who developed conclusions and recommendations on the level of evidence for long term clinical management of chronic pain with opioids. The urgent needs the jury identified included the following:

• Enhance research to identify which types of pain, specific diseases, and patients are most likely to benefit and incur harm from opioids.
• Facilitate the development and evaluation of multidisciplinary pain interventions, including cost-benefit analyses and identification of barriers to dissemination.
• Sponsor research to develop and validate research measurement tools for identification of patient risk and outcomes (benefit and harm) related to long-term opioid use that can be adapted for clinical settings.
• Incorporate decision support for pain management into EHRs and facilitate export of clinical data to be combined with data from other health systems to identify patients who benefit from or are harmed by opioid use.
• Use of innovative clinical trial design to study effectiveness and harm of opioids. 
• Sponsor research on risk identification and mitigation strategies, including drug monitoring, prior to widespread integration of these into clinical care.
• Enhance research and quality improvement efforts to facilitate evidence-based decision-making at every step of the clinical decision process.
• In the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain  should be treated with opioids, and about how best to monitor patients and mitigate risk for harm.
• Federal agencies should sponsor conferences to promote harmonization of guidelines of professional organizations to facilitate their implementation more consistently in clinical care.

A full report on the workshop has been published.[15]

Discussion 

Ms. Christopher commented that this is a rare opportunity for members of the health care community to work together on an issue and to coordinate their efforts.

Dr. Smith asked about the role of the Centers for Medicare and Medicaid Services in this discussion, as they may influence what pain management services are offered or obtained. Dr. Porter noted that CMS is considered an important stakeholder in the NPS and that HHS is aware therefore, of the need for their collaboration in addressing these issues through the NPS. 

Long-Term Strategy for Federal Pain Research

Overview of the Planning Process

The Affordable Care Act included provisions asking the IPRCC to coordinate pain research efforts within HHS and other departments, in order to reduce redundancies and identify research gaps. To accomplish this, a strategy is needed to both move forward and monitor development over time, with input from the IPRCC and national experts on proposed targets. In addition, the IPRCC has the responsibility to address the primary research concerns in IOM recommendation 2.2. The NPS deliberately set the research component aside (except for population research) for later consideration by the IPRCC, and now as the research strategy is being developed, it will be aligned with the NPS.

A planning committee for the Federal Pain Research Strategy was formed that comprises IPRCC members (Allan Basbaum, Christin Veasley, Chester Buckenmaier, Audrey Kusiak, Charles Helmick, Sharon Hertz, and Richard Ricciardi) and other NIH representatives (Wen Chen and Partap Khalsa, NCCIH; John Kusiak, NIDCR; Sue Marden, NINR; Ann O’Mara, NCI; Linda Porter, NINDS; Wendy Smith, OD, and David Thomas, NIDA).

Proposed Operational Structure

Dr. Linda Porter 

The proposed three-level operational structure for the pain research strategy would have the IPRCC at the top, a steering committee with co-chairs, and a set of thematic work groups in key topic areas. Dr. Porter said the steering committee and work groups should comprise primarily outside experts along with IPRCC members who are able to work toward a common effort, not just represent their own research or institutional interests.

Specifically, the IPRCC’s roles would be to:

• Review and approve the organizational and operational structure for the strategy
• Provide input for a request for information (RFI) to inform the work groups
• Set the charge to the steering committee
• Provide feedback throughout the process through the steering committee and
• Provide final approval of the strategy. 

The steering committee will be chaired by one federal and one non-federal IPRCC scientist.  Dr. Allan Basbaum and Dr. Linda Porter will serve in this capacity.  The committee will comprise eight to 12 members, mostly external, and have a balanced range of expertise across broad areas: patient advocacy, ethics, and science, including basic, translational, clinical, population, dissemination, and implementation pain research, and non-pain disciplines. Its roles would be to:

• Revise and complete the RFI
• Select work group co-chairs
• Set the charge to the work groups with RFI feedback considered
• Provide liaison to the IPRCC and work groups through its co-chairs
• Monitor work group progress through the work group co-chairs
• Coordinate and integrate work group discussions and
• Oversee the prioritization of recommendations across the work groups (a modified Delphi methodology has been used to set priorities in other NIH projects).

Dr. Koroshetz added that the steering committee would be “a high-level sounding board,” not in the trenches.

Dr. Porter said communication within and across this three-part structure will be important. NINDS and the Office of Pain Policy would provide resources, logistics, and technical support. A key resource is the federal pain research database, which is now updated through 2012.

A draft timetable has been established for the activity, which aims to conclude with the research strategy rollout in May 2016. 

Thematic Work Groups

Dr. Basbaum 

The planning committee already has given much consideration to the selection of appropriate themes for the work groups. Dr. Basbaum said that the federal pain research portfolio currently is based on nine themes; however, these themes are not sufficiently cross-cutting to develop a comprehensive and effective research strategy. Examination of themes employed in other research priority-setting efforts (for autism and muscular dystrophy, for example) are not useful models, as they address needs related to a single medical condition.

By contrast, research themes for this project must take into account pain’s multidisciplinary nature and the continuum of pain from prevention to chronicity, which has become an overarching principle for the work groups, consistent with the NPS. To reflect this principle, Dr. Basbaum said, work groups should take into account that:

• Pain is a temporal process
• Pain begins with an acute stage
• Acute pain may progress to a chronic state
• Mechanisms activated in the acute pain setting influence chronic pain development
• Chronic pain has a variable onset and duration and may occur post injury or surgery and
• Individual variation influences chronic pain susceptibility.

Dr. Basbaum proposed five themes: prevention; acute pain and its management; the transition from acute to chronic pain; chronic pain and its management; and disparities. For each of these five themes, important questions can be asked that relate to different research domains:

• What happens and to whom? (questions for basic and clinical research)
• Why and how does it happen? (research questions related to understanding biopsychosocial mechanisms)
• How can it best be managed? (a research question on translating mechanisms into treatment efficacy and effectiveness)

Expanding on the basis for each of the themes and their alignment with the NPS, he said:

1. Theme 1, which covers the prevention of acute and chronic pain, refers to

• Primary pain prevention (efforts to reduce injuries or disease that may result in pain)
• Secondary pain prevention (reducing the likelihood that acute pain transitions into chronic pain) and
• Tertiary pain prevention (limiting the development of disabilities and other complications of chronic pain).

2. Theme 2, which addresses acute pain and its management, refers to pain that

• Is time-limited, an expected physiologic consequence of trauma, disease, surgery, or illness, and may progress to a chronic pathological state and
• May be treated through self-management, pharmacological or nonpharmacological approaches.

3. Theme 3, related to the transition from acute to chronic pain,

• Addresses contributors to the transition (such as the nature of the initial insult, mechanisms activated in the acute pain setting, and patient-related risk factors) and
• Seeks clarification of the complex mechanisms that underlie the transition

4. Theme 4, related to chronic pain and its management, takes into account that chronic pain has profound effects on quality of life and is

• A complex biopsychosocial condition with distinct pathology and biological, psychological, and cognitive correlates
• May interfere with many aspects of a person’s life (especially high-impact chronic pain) and
• May require a biopsychosocial approach involving multidisciplinary, multimodal, integrated care.

5. Theme 5, which addresses the cross-cutting issue of disparities, reflects that

• Health disparities differentially affect vulnerable populations with respect to the occurrence of pain; pain assessment; access to and quality of pain care; pain care outcomes
• The risk of experiencing disparities is associated with a person’s race or ethnicity, religion, sex, gender, age, mental health, cognition, and socioeconomic and other factors linked to discrimination or exclusion. 

Cross-Cutting Issues

Ms. Christin Veasley 

Returning to the five themes, Ms. Veasley described cross-cutting research issues that should be considered within and across the topic areas as the work groups develop their priorities;

• Prevention: research on pain mechanisms, changes across the lifespan, and means for dissemination and implementation of research findings
• Acute pain; research on epidemiology, diagnosis and assessment, mechanisms, treatment, and means for dissemination and implementation of research findings
• Pain transition; research on diagnosis and assessment, susceptibility and resilience, mechanisms, treatment, and means for dissemination and implementation of research findings
• Chronic pain; research on epidemiology, diagnosis and assessment, susceptibility and resilience, mechanisms, lifespan, treatment, and means for dissemination and implementation of research findings
• Disparities; research on epidemiology, mechanisms, treatment, and means for dissemination and implementation of research findings

Discussion of the Proposed Federal Pain Research

Strategic Planning Proposal

Members debated whether, because the continuum of pain, separate boxes for acute and chronic pain are needed, but the sense of the group was that, because of the implications for prevention and preclinical phases of acute versus chronic pain are somewhat different, the distinction should be retained.  Dr. Hertz said the distinction is important, because it generally reflects changes over time. Although pain is not necessarily divisible into discrete silos, areas of opportunity exist along the continuum.           

Dr. Briggs asked whether the distinction is useful in a research strategy—for example, in understanding emotional and psychosocial factors. Dr. Basbaum responded that those kinds of factors are dealt with through the cross-cutting issues, and Ms. Veasley said that the strategic plan is for the entire field of pain, and that the set of definitions and crosscutting issues is the best that can be done for now. Dr. Maixner said the boxes necessarily reflect the current state of knowledge and endorses the approach of being “anatomically agnostic.”

Dr. Smith noted that it isn’t possible to prescribe serendipity. There will be scientific discoveries that may be very useful for pain (as are some described by Dr. Koroshetz earlier in the day) that were not originally intended for pain.

Dr. Koroshetz said that the plan development process should include people who are big-picture thinkers who won’t be constrained by the boxes and will be creative in the application of new methods. Dr. Porter added that pain is indeed a continuum and the suggested topic areas were not meant to establish sharp boundaries between work groups.  The cross-cutting issues to be addressed by the work groups are meant to link the themes through the continuum.

Dr. Paice noted the existence of health care system practices that impede good pain management. They create issues that go beyond the difficulty of obtaining multidisciplinary, multimodal care. Can the impact of more systemic factors be tested? Dr. Payne responded that systems issues are the domain of health services and cost-effectiveness research, which he believes should fit in the treatment and the dissemination and implementation boxes.  One important research topic for health services and cost-effectiveness research is, as Dr. Helmick suggested, the gaps in knowledge about best current treatments and how to get the more effective pain treatment methods adopted in practice, as opposed to the many treatments for which there is no evidence of effectiveness at all.

Dr. Smith said there is emerging technology enabling patients to provide outcome information in a non-random way, through treatment registries like CHOIR and PASTOR, both of which use the PROMIS health status measures developed by NIH.[16] In general, however, information systems that depend on patient completion of forms are intended primarily for making care decisions, not for research.

However, Dr. Maixner said, these data can be collected and integrated across sources. A challenge is figuring out how to do that. Ms. Veasley said the strategy should be looking at the opportunities presented by such alternative research methods, not just randomized controlled trials (RCTs), and suggested that a representative from the Patient-Centered Outcomes Research Institute be added to the planning committee.[17] A good use of patient-generated data may be in identifying and mitigating adverse side effects, given that a problem with clinical trials is that they do not necessarily reflect the diversity of the population. In addition, as one committee member put it, “pain is a life experience” that is not well reflected within RCTs. Patient-generated data also may suggest more meaningful outcome measures.

In summarizing the discussion, Dr. Porter said there appeared to be consensus about using the boxes as they area. However, there clearly are cross-cutting issues. She will write up a charge from the IPRCC to the steering committee that includes the issues raised and make a second request for committee nominations. With respect to logistics for the planners’ next step, the committee will ensure that what they develop meets different agencies’ missions and those of private funders, Dr. Porter said.

Ms. Veasley commented that there should be more than one person who is not a pain scientist on the steering committee and in each of the working groups. Dr. Ricciardi suggested that individuals who work with complex chronic conditions might be helpful group members.
In response to a question, Dr. Porter confirmed that committee members can share whatever information is available about this project with people they hope to nominate for the steering committee or working groups.

Dr. Smith moved that that the IPRCC accept this version of the strategy development plan, acknowledging the committee’s understanding that the steering committee may need to make refinements as the project moves forward. Dr. Buckenmaier seconded, and the plan was approved.

Proposed Request for Information 

Dr. Porter presented a proposed Request for Information related to the Federal Pain Research Strategy, which could be reviewed now, in order to obtain general information for the strategic planning process or could wait until the project was somewhat farther along and the issues on which input is sought better defined.

The consensus of the IPRCC was to table this activity for the present.

Col. Buckenmaier moved that the committee approve implementing an RFI, with the understanding that it can be modified and that it will not be released until a draft strategy is posted on the Web for public viewing. Dr. Paice seconded the motion, and it was approved.

Public Comment Period

There were no public comments, and the meeting adjourned.

We certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Linda Porter, Ph.D.
Executive Secretary
Interagency Pain Research Coordinating Committee
Pain Policy Advisor, National Institute of Neurological Disorders and Stroke

Walter Koroshetz, Ph.D.
Chairperson Interagency Pain Research Coordinating Committee
Director, National Institute of Neurological Disorders and Stroke

These minutes have been formally approved by the committee.

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[2] Iyer, SM, KL Montgomery, C Towne, SY Lee, C Ramakrishnan, K Deisseroth, and SL Delp. 2014. Virally mediated optogenetic excitation and inhibition of pain in freely moving nontransgenic mice. Nature Biotechnology 32(3):274-278.
[3] Kim, YS, Y Chu, L Han, M Li, Z Li, PC Lavinka . . . and X Dong. 2014. Central terminal sensitization of TRPV1 by descending serotonergic facilitation modulates chronic pain. Neuron 81(4): 873-887.
[4] Little, JW, A Ford, AM Symons-Liguori, Z Chen, K Janes, T Doyle . . . and D Salvemini. 2015. Endogenous adenosine A3 receptor activation selectively alleviates persistent pain states. Brain 138(1):28-35.
[5] Loggia, ML, DB Chonde, O Akeju, G Arabasz, C Catana, R R Edwards . . . and JM Hooker. 2015. Evidence for brain glial activation in chronic pain patients. Brain 138(Pt 3): 604-615.
[6] Burgess, DJ, DB Nelson, AA Gravely, MJ Bair, RD Kerns, DM Higgins . . . and MR Partin. 2014. Racial differences in prescription of opioid analgesics for chronic noncancer pain in a national sample of veterans. The Journal of Pain 15(4): 447-455.
[7] Johnson, JR, DJ Crespin, KH Griffin, MD Finch, and JA Dusek. 2014. Effects of integrative medicine on pain and anxiety among oncology inpatients. J National Cancer Institute Monograph 2014(50): 330-337.
[8] Health.gov- Training Pathways
[9] Mezei, L, B.B. Murinson, and the Johns Hopkins Pain Curriculum Development Team. 2011. Pain education in North American medical schools. The Journal of Pain 12(12): 1199-1208.
[10] Watt-Watson J, M McGillion, J Hunter, M Choiniere, AJ Clark, A Dewar . . . and  K Webber. 2009. A survey of prelicensure pain curricula in health science faculties in Canadian universities. Pain Res Manage 14(6):439–444.
[11] University of California Davis- Center for Advancing Pain Relief
[12] P Muhuri, J Gfroerer, MC Davies, August 2013. Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. SAMHSA Center for Behavioral Health Statistics and Quality Data Review.
[13] Centers for Disease Control and Prevention, National Center for Health Statistics. Multiple Causes of Death 1999-2013 on CDC WONDER Online Database, released 2015.
[14] See, for example, D Thomas, J Frascella, T Hall, W Smith, W Compton, W Koroshetz, . . . and N. Volkow. 2014. Reflections on the role of opioids in the treatment of chronic pain: A shared solution for prescription opioid abuse and pain. J Intern Med [published online 2 Feb 2015]. doi: 10.1111/joim.12345.
[15] Reuben, DB, AAH Alvanzo, T Ashikaga, GA Bogat, CM Callahan, V Ruffing, and DC Steffens. 2015. National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain. NIH Pathways to Prevention
[16] CHOIR is the Collaborative Health Outcomes Information Registry at Stanford University, Stanford Medicine Systems Neuroscience and Pain Lab; PASTOR is the Pain Assessment Screening Tool and Outcomes Registry at the Defense and Veterans Center for Integrative Pain Management. PROMIS is the Patient Reported Outcomes Measurement Information System to measure aspects of physical, mental, and social well-being.
[17] PCORI, the Patient-Centered Outcomes Research Institute, is a nonprofit, nongovernmental organization established by Congress in the Affordable Care Act.