Welcome Please be seated by 10:40. The teleconference will go live - PowerPoint PPT Presentation

Welcome Please be seated by 10:40. The teleconference will go live at 10:45. 1

Assessment of Prevention, Diagnosis, and Treatment Options Advisory Panel Meeting January 13 – 14 th , 2014 2

Welcome: 10:45 am – 11:15 am David Hickam, MD, MPH Program Director Clinical Effectiveness Research PCORI 3

Housekeeping Today’s teleconference is open to the public and is being recorded  Members of the public are invited to listen to this teleconference  Meeting materials can be found on the PCORI website  Comments may be submitted via email to advisorypanels@pcori.org; no public comment period is scheduled For those in the room, please remember to speak loudly and clearly into a microphone Where possible, we encourage you to avoid technical language in your discussion 4

Meeting Objectives Discuss important research gaps for 2 clinical topics and prioritize high priority research questions for both topics.  Treatment of migraine headaches  Treatment of osteoarthritis Prioritize 14 new clinical topics and select a subset of topics for further consideration as research priority areas. 5

Background: Topic Prioritization 1,300+ Research Topics Received 841 Topics Accepted • Program director screened and 594 Assigned to consolidated topics Assessment of Options • Topics scored on 4 criteria • In April 2013, Advisory Panel reviewed 20 High Scoring and prioritized 20 topics Topics Considered • (1) Bipolar Disorder • (2) Ductal Carcinoma in situ 4 Priority • (3) Migraine Headache Topics • (4) Osteoarthritis Selected 6

Introductions: The Clinical Effectiveness Research Program Team Jana-Lynn Louis, MPH Diane Bild, MD, MPH David Hickam, MD, MPH Katie Rader Hal Sox, MD Stanley Ip, MD Julie McCormack, MA Sandi Myers

Moderators Alvin I. Mushlin, MD, ScM Chair, Panel on the Assessment of Options Chairman, Department of Public Health, Weill Cornell Medical College; Public Health Physician-in-Chief, New York Presbyterian Hospital/Weill Cornell Medical Center Margaret F. Clayton, RN, PhD Co-chair, Panel on the Assessment of Options Associate Professor, College of Nursing and Co-Director of the PhD Program, University of Utah 8

Welcome New Panel Member Angela Smith, MD Assistant Professor, Surgery / Urology Lineberger Comprehensive Cancer Center UNC-Chapel Hill School of Medicine 9

Advisory Panel Members 10

Thank you Denise Kruzikas, PhD, MPH Director, Health Economics & Reimbursement, Ultrasound; Director, Healthymagination, Global Ultrasound Strategy, GE Healthcare Margo Halm, PhD, RN, ACNS-BC Director of Nursing Research, Professional Practice and Magnet, Salem Hospital 11

Agenda Overview Time Agenda Item Welcome and Overview of the Agenda 10:45-11:15 a.m. Procedures for Research Question Prioritization 11:15-11:30 a.m. Discussion of Key Research Questions for Migraine Headache 11:30-1:00 p.m. Lunch 1:00-2:00 p.m. 2:00-2:15 p.m. Voting – Migraine Headache Discussion of Key Research Questions for Osteoarthritis 2:15-3:30 p.m. Break 3:30-3:45 p.m. 3:45-4:00 p.m. Voting – Osteoarthritis 4:00-4:15 p.m. Update on the Bipolar Topic Update on the DCIS Topic 4:15-4:30 p.m. Review Voting Results 4:30-4:45 p.m. 4:45-5:00 p.m. Next Steps/Announcements 5:00pm Adjourn 12

Voting Process for Research Question Prioritization Forced-ranking prioritization method  For migraine, 5 votes per person, which could be allocated to any of the 13 research priorities  For osteoarthritis, 5 votes per person, which could be allocated to any of the 12 research priorities  Maximum of 3 votes per item Rankings will be completed after discussion of topic 13

Future Research Prioritization: Management Strategies for Migraine Headache: 11:30 am – 1:00 pm Douglas McCrory, MD, MHS Duke Evidence Synthesis Group 14

Future Research Prioritization: Preventive Treatments for Episodic and Chronic Migraine in Adults Douglas McCrory MD, MHS Duke Evidence Synthesis Group January 13, 2014

Treatment Strategies for Episodic and Chronic Migraine Migraine is a recurring disorder characterized by severe headache, generally associated with nausea, vomiting, and other neurologic symptoms during attacks, with no symptoms between attacks  Can be episodic or chronic (occurs on 15 or more days per month for more than 3 months) Precipitating factors include stress, menstruation, weather changes, fasting, wine (aged or fermented food/drink) Focus of management is on prevention Management options include: drug treatments, behavioral therapies, spinal manipulation, other physical treatments Uncertainty in the effectiveness of preventive treatment for migraine

During the April 2013 meeting, this PCORI Advisory Panel ranked preventive treatments for episodic and chronic migraine in adults as HIGH PRIORITY for targeted future research funding

Overall Project Goal To work with stakeholders to help PCORI identify, refine, and prioritize future research evidence gaps in the area of strategies for treating patients with episodic or chronic migraine

Overview of Project 1. Identifying Known Evidence Gaps 2. Creation of Stakeholder Group 3. Expansion of Evidence Gaps 4. Analytic Framework 5. Stakeholder Prioritization 6. Horizon Scan 7. Study Design Considerations

Identifying Known Evidence Gaps Review of published systematic reviews, clinical practice guidelines, and future research needs documents Initial 30 evidence gaps explored:  Specific populations or subgroups of patients  Comparative safety and effectiveness of available interventions and comparators  Impact of treatment of specific outcomes of interest  Optimal timing or setting for treatment

Creation of Stakeholder Group Alliance for Headache Disorders American Neurological Advocacy Association American Academy of Family American Society for Clinical Physicians Pharmacology and Therapeutics American Academy of International Headache Society Neurology Migraine Research Foundation American Academy of Pain National Headache Foundation Management Society for Pain Practice American Academy of Pain Management Medicine Society of Behavioral Medicine American Council for Headache World Federation of Neurology Education (ACHE) Patient Advocates American Headache Society American Migraine Foundation

Stakeholders Bray Patrick-Lake, M.F.S. Andrew Blumenfeld, M.D. Kaiser Permanente Patient Representative Headache Center of Southern California Elizabeth Loder, M.D. Roger K. Cady, M.D. Chief, Division of Headache and Pain Associate Executive Chairman Brigham and Women’s Department of Neurology Headache Care Center Donald Penzien, Ph.D. Seymour Diamond, M.D. Director, Head Pain Center Director Emeritus and Founder Professor, University of Mississippi National Headache Foundation Alan M. Rapoport, M.D. Frederick Freitag, D.O., F.A.H.S. Clinical Professor of Neurology Associate Professor David Geffen School of Medicine UCLA Medical College of Wisconsin Cathy Glaser Stephen D. Silberstien, M.D., F.A.C.P. President Director Migraine Research Foundation Jefferson Headache Center Richard B. Lipton, M.D. Heather Zantisch Director Patient Representative Montefiore Headache Center

Stakeholder Discussions Expanded initial list of 30 gaps to 34 evidence gaps  4 questions deleted  2 questions merged  9 new questions created (3 related to populations, 2 to interventions, 4 to outcomes) Recognition of central role that patients play in the prevention and management of their migraine Overlapping nature of the clinical conditions commonly referred to as chronic migraine, chronic daily headache, and medication overuse headache Consideration of comorbidity (i.e., anxiety, depression, and other pain syndromes)

Future Research Needs Broad Topic Areas Covering 34 Questions 1. Population differences (disease/patient characteristics, treatment modifying effects, comorbidities) 2. Pharmacologic and nonpharmacologic interventions 3. Episodic and chronic migraine (and transformation) 4. Decision making interventions 5. Patient-centered outcomes 6. Timing and setting