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Appendix A Data Sources and Methods The Committee on Advancing Pain Research, Care, and Education was asked to assess the current state of the science with respect to pain research, care, and education and explore approaches to advancing the field. The purpose of this study was to review the public heath significance of pain; identify barriers to appropriate pain care and strategies for reducing those barriers; identify popula - tions undertreated for pain; identify tools and strategies for enhancing training of pain researchers; and examine opportunities for public–private partnerships to support pain research, care, and education. To respond comprehensively to its charge, the committee examined data from a variety of sources. These sources included a review of the recent literature, public input obtained through a series of meetings, a commissioned paper, and written public comments on aspects of the study charge. The study was conducted over a 10-month period. DESCRIPTION OF THE STUDY COMMITTEE The study committee comprised 19 individuals with expertise in pain re- search, pain management, pharmacology, the behavioral sciences, clinical specialties (pediatrics, oncology, infectious disease, neurology, neurosurgery, anesthesiology, pain medicine, dentistry, and complementary medicine), chronic disease, clinical teaching, epidemiology, ethics, and consumer education, as well as those who have suffered personally from chronic pain and could reflect the perspectives of the many people affected by pain. See Appendix D for biographi- cal sketches of the committee members. The committee convened for five 2-day meetings in November 2010, January 2011, February 2011, March 2011, and April 2011. 281

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282 RELIEVING PAIN IN AMERICA LITERATURE REVIEW Several strategies were used to identify literature relevant to the com mittee’s charge. First, a search of bibliographic databases, including MEDLINE and PsycINFO, was conducted to obtain articles from peer-reviewed journals. In addition, WorldCat and the New York Academy of Medicine’s Grey Literature database was searched for books, reports, and other types of grey literature. The searches focused on pain epidemiology, assessment, treatment, education, and training. The keywords used included pain and diagnosis, treatment, manage- ment, analgesics, drug prescriptions, complementary therapies, practice pat- terns, public health, epidemiology, chronic disease, acute pain, communication barriers, physician-patient relations, caregivers, health services accessibility, health knowledge and attitudes, health care delivery, education (medical, con - tinuing, graduate, internship and residency, nursing, pharmacy, psychology, public health professional, nonprofessional, non-medical, professional develop - ment, professional standards), curriculum, ethnic groups, population groups, aged, child, cognition disorders, women, sex factors, comorbidity, disparities, racial and ethnic differences, stereotyping, psychology, research (behavioral, bio- medical, genetic, translational, interdisciplinary, qualitative, empirical), food and drug administration, department of veterans affairs, military medicine, depart- ment of defense, and public-private sector partnerships. Staff sorted through ap- proximately 3,500 articles to identify those that were relevant to the com mittee’s charge and created an EndNote database. In addition, committee members, meet- ing participants, and the public submitted articles and reports on these topics. The committee’s database included more than 2,600 relevant articles and reports. PUBLIC MEETINGS The committee hosted four public meetings to obtain additional information on specific aspects of the study charge. These meetings were held in conjunc- tion with the committee’s November, January, February, and March meetings. The committee determined the topics and speakers for the public meetings. The committee also held open forums at each public meeting at which members of the public were encouraged to provide testimony on any topics related to the study charge. The first meeting was intended to focus on a discussion of the commit - tee’s task. Representatives from the study’s sponsors reviewed and discussed the charge to the committee. The second meeting focused on data collection on pain and opportunities for public–private partnerships. The third meeting featured speakers who discussed cultural and anthropological views on pain and financing of pain care. The final meeting addressed the basic science of pain and its transla - tion to clinical practice, as well as the regulation of pain drugs. At each meeting, the committee heard testimony and comments from a broad range of stakeholders,

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283 APPENDIX A including individuals living with pain, family members of people living with pain, health care providers, representatives of the pharmaceutical industry, and individuals representing pain advocacy groups. The committee found this input to be highly informative for its deliberations. Agendas for the four meetings are presented in Boxes A-1 through A-4. In addition to testimony at these meetings, the committee solicited public input on topics relevant to its charge through its website. More than 2,000 indi- viduals provided written testimony. A summary of these comments can be found in Appendix B. COMMISSIONED PAPER The committee commissioned a paper on the economic burden of pain. The specific aim of this work was to provide an assessment of the economic and societal costs of pain and pain care, including such topics as health care expendi - tures, out-of-pocket costs, costs related to lost work or unemployment, and other individual-level impacts (see Appendix C).

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284 RELIEVING PAIN IN AMERICA BOX A-1 Committee on Advancing Pain Research, Care, and Education The National Academies Keck Building 500 Fifth Street N.W. Washington, D.C. AGENDA FOR PUBLIC SESSIONS Monday, November 22, 2010 Room 201 1:00 p.m. WELCOME AND INTRODUCTIONS Philip A. Pizzo, M.D. Chair 1:15 p.m. DELIVERY OF STUDY CHARGE Lawrence A. Tabak, D.D.S., Ph.D. NIH Principal Deputy Director 1:30 p.m. DISCUSSION OF STUDY CHARGE WITH SPONSOR 2:30 p.m. ADJOURN OPEN SESSION Tuesday, November 23, 2010 Room 100 9:00 a.m. WELCOME AND COMMITTEE INTRODUCTIONS Philip A. Pizzo, M.D. 9:15 a.m. STAKEHOLDER PERSPECTIVES Tina M. Tockarshewsky President and CEO The Neuropathy Association Terrie Cowley President The TMJ Association, Ltd. Peter Reinecke Principal Reinecke Strategic Solutions, Inc.

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285 APPENDIX A Gwenn Herman, LCSW-C, DCSW Executive Director Pain Connection Chronic Pain Outreach Center, Inc. Malcolm Herman, Esq. The American Pain Foundation Romy Gelb-Zimmer, MPP Associate Director Federal Regulatory and Payment Policy American Academy of Nurse Anesthetists Robert J. Saner Principal Powers, Pyles, Sutter & Verville PC 11:30 a.m. ADJOURN

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286 RELIEVING PAIN IN AMERICA BOX A-2 Committee on Advancing Pain Research, Care, and Education The National Academies Keck Building 500 Fifth Street N.W. Washington, D.C. AGENDA FOR PUBLIC SESSION Tuesday, January 4, 2011 Room 101 10:00 a.m. WELCOME AND INTRODUCTIONS Philip A. Pizzo, M.D., Chair 10:10 a.m. PUBLIC COMMENTS Michael Ashburn, M.D., M.P.H. American Pain Society (APS) and American Society of Anesthesiologists (ASA) 11:00 a.m. DATA COLLECTION ON PAIN AT THE FEDERAL LEVEL C enters for Disease Control and Prevention, National Center for Health Statistics J ennifer Madans, Ph.D. Co-Deputy Director Associate Director for Science Veterans Health Administration Lynette Nilan, R.N., Ed.D. Director, Strategic Planning and Measurement Patient Care Services Michael E. Clark, Ph.D. Clinical Director, Pain Rehabilitation Program James A. Haley Veterans Hospital, Tampa Department of Defense CDR Necia Williams, M.C., United States Navy Chief, Integrated Anesthesia Services Walter Reed Army Medical Center National Naval Medical Center

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287 APPENDIX A LTC Scott R. Griffith, M.D., United States Army Consultant, Pain Management Walter Reed Army Medical Center 12:30 p.m. BREAK FOR LUNCH Committee will meet in closed session for lunch. Members of the public may obtain lunch in the cafeteria located in the third floor Atrium. 1:15 p.m. PUBLIC–PRIVATE PATNERSHIPS Robert Dworkin, Ph.D. University of Rochester Medical Center Director, Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION), a public-private partnership with the FDA Story C. Landis, Ph.D. Director, National Institute of Neurological Disorders and Stroke 2:15 p.m. PUBLIC COMMENTS Andrew Bertagnolli American Chronic Pain Association Penney Cowan Founder, Executive Director American Chronic Pain Association David St. Peter, M.D., F.H.M. Society of Hospital Medicine and Pacira Pharmaceuticals, Inc. Carol Drury Associate Director Endometriosis Association Chip Amoe Assistant Director, Federal Affairs American Society of Anesthesiologists 2:45 p.m. ADJOURN OPEN SESSION

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288 RELIEVING PAIN IN AMERICA BOX A-3 Committee on Advancing Pain Research, Care, and Education Hotel Monteleone 214 Royal Street New Orleans, LA 70130­2201 AGENDA FOR PUBLIC SESSIONS Tuesday, February 8, 2011 10:00 a.m. WELCOME AND INTRODUCTIONS Philip A. Pizzo, M.D., Chair 10:10 a.m. CULTURAL VIEWS OF PAIN David B. Morris, Ph.D. Emeritus Professor of English University of Virginia Mary-Jo DelVecchio Good, Ph.D. Professor of Social Medicine Harvard Medical School Linda Garro, Ph.D. Professor Department of Anthropology University of California, Los Angeles 12:00 p.m. COMMITTEE WILL MEET IN CLOSED SESSION FOR LUNCH 1:00 p.m. FINANCING AND RESOURCES FOR PAIN CARE Jeffrey Livovich, M.D. Medical Director, Aetna Inc. National Medical Policy and Operations 2:00 p.m. PUBLIC COMMENTS Todd Sitzman, M.D. Medical Director Advanced Pain Therapy, LLC Barbara St. Marie, MA, RN-BC, CS, ANP, GNP Nurse Practitioner Healthcare Foundation

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289 APPENDIX A Harry Gould, M.D. Professor Department of Neurology LSU Health Sciences Center Dennis Paul, M.D. Associate Professor Department of Pharmacology LSU Health Sciences Center Art Morelli, M.D. Vice President, Medical Affairs Clovidien Pharmaceuticals Philip A. Saigh, Jr. Executive Director American Academy of Pain Medicine Angie Gravois Patient and Nurse, Picayune, Mississippi Janet Chambers President Association for Fibromyalgia and Chronic Pain Jon Russell, M.D., Ph.D. Associate Professor Department of Medicine University of Texas Health Science Center at San Antonio 3:00 p.m. ADJOURN OPEN SESSION

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290 RELIEVING PAIN IN AMERICA BOX A-4 Committee on Advancing Pain Research, Care, and Education The National Academies Beckman Center 100 Academy Irvine, CA 92617 AGENDA FOR PUBLIC SESSIONS Monday, March 14, 2011 1:00 p.m. WELCOME AND INTRODUCTIONS Philip A. Pizzo, M.D., Chair 1:05 p.m. BASIC SCIENCE OF PAIN AND APPROACHES TO PAIN TREATMENT Clifford J. Woolf, M.D., Ph.D. Professor of Neurobiology Harvard Medical School Howard L. Fields, M.D., Ph.D. Professor, Neurology and Physiology University of California, San Francisco Frank Porreca, Ph.D. Professor of Pharmacology and Anesthesiology University of Arizona 2:20 p.m. Discussion 3:00 p.m. Break 3:15 p.m. REGULATION OF PAIN DRUGS: PERSPECTIVES FROM THE FDA Bob A. Rappaport, M.D. (by phone) Director Division of Anesthesia and Analgesia Products Center for Drug Evaluation and Research, FDA 4:00 p.m. PUBLIC COMMENTS Heather Grace American Pain Foundation/Intractable Pain Patients United Lakewood, CA

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291 APPENDIX A Douglas Cook American Pain Foundation/Intractable Pain Patients United Lancaster, CA Radene Marie Cook American Pain Foundation Lancaster, CA 5:00 p.m. ADJOURN OPEN SESSION

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