Collaborative Spine Advisory Council

1. Collaborative Spine Advisory Council Priority Setting and Development of Research Agenda Webinar July 30, 2012

2. Jeff Wang, MD—UCLAZoher Ghogawala, MD—LaheyPaul McCormick, MD—Columbia Moderators:

3. Advisory Council WEBINAR AGENDA Welcome & introductions Webinar instructions Background Research agenda: process & timelines Review & discussion of submitted topics Next steps

5. Collaborative Spine: 501(c)3 application pending • New joint initiative between 2 established Foundations (OREF, NREF) • Unconflicted, rigorous, independent peer review processes—researchand fellowship grants

8. Advisory Council Charge • Collaborative Spine Goals and Objectives: Identify the most critical clinical research issues through the creation of a broad-based Advisory Council that includes academic societies, industry, insurers and individual physicians. • Advisory Council: Submit, evaluate, set priorities and recommend research topics and areas for consideration within the Collaborative Spine research agenda

10. Collaborative Spine Advisory Council Members

11. Advisory Council Members as of September 5, 2012 REPRESENTING COLLABORATIVE SPINE BOARD OF DIRECTORS Zoher Ghogawala, MD, FAANS, FACS Paul C. McCormick, MD, MPH, FAANS, FACS Jeffrey C. Wang, MD

12. Advisory Council Members as of September 5, 2012 REPRESENTING SPINE-CARE SOCIETIES Greg Anderson, Society for Minimally Invasive Spine Surgery Jens Chapman, MD, AO Spine North America Joseph Cheng, MD, MS, FAANS, American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Section on Disorders of the Spine and Peripheral Nerves Michael G. Fehlings, MD, PhD, FAANS, Cervical Spine Research Society Steve Garfin, MD, International Society for the Advancement of Spine Surgery Daniel Resnick, MD, MS, FAANS, North American Spine Society Dilip K. Sengupta, MD, Scoliosis Research Society Lawrence Vogel, MD, American Spinal Injury Association Thomas Zdeblick, MD, Lumbar Spine Research Society

13. Advisory Council Members as of September 5, 2012 REPRESENTING THE RESEARCH COMMUNITY Keith Bridwell, MD, Association of Collaborative Spine Research—Deformity Brenda A. Frederick, Orthopaedic Research Society Ziya Gokaslan, MD, FAANS, FACS, Association of Collaborative Spine Research—Oncology Regis Haid, MD, FAANS, Association of Collaborative Spine Research—Degenerative James Iatridis, PhD, Orthopaedic Research Society Michael Liebschner, PhD, Orthopaedic Research Society Theodore Miclau, MD, Orthopaedic Research Society Firoz Miyanji, MD, FRCS, Pediatric Orthopaedic Society of North America Alex Vaccaro, MD, FACS, Association of Collaborative Spine Research—Trauma

14. Advisory Council Members as of June 29, 2012 REPRESENTING MEDICAL DEVICE & HEALTH SERVICES/INSURANCE COMPANIES Kevin Carouge, Globus Medical, Inc. Amy Fredrick, EOS Imaging Steve Healy, Zimmer Spine William C. Horton III, MD, DuPuy Orthopaedics, Inc. Kelli Howell, MS, NuVasive Doug King, Medtronic Spine Stephen E. Koenigsberg, Stryker Spine John Kostuik, MD, K2M, Inc. Bryan McMillan, Orthofix David E. Mino, MD, MBA, Cigna Healthcare Steve Schwartz, Synthes Spine

15. Why Collaborative Spine?

16. The Challenge of Spine Care Spine Conditions • High prevalence, broad etiologies • Specific condition heterogeneity • Severity, natural history, response to treatment Spine Treatment • Many treatment options, specialties • High costs, morbidity, suboptimal outcomes • Uncertainty • What works, which patient, what circumstances

17. The Science and Practice of Spine Care • Fragmented, uncoordinated, competitive • Physicians, study groups, societies, organizations, industry • Weak evidence base • Increased burden of disease despite rising cost/use of treatments

18. Collaborative Spine: A Clinical Research Enterprise

19. Collaborative Spine: A Clinical Research Enterprise • Not just passively fund investigator- determined research topics • Establish broad research agenda • Needs assessment, knowledge gaps • Community of stakeholders • Active RFP process

20. Collaborative Spine: A Clinical Research Enterprise The Research Agenda • Not just treatment assessments but methods of investigation, study design, scientific evidence creation • Systems of care- surgeon, specialty level • Not just what procedures are performed but how, where, in whom and by whom • Not just efficacy but effectiveness, quality, value

21. Collaborative Spine: A Clinical Research Enterprise • Responsible not just for funding, but also for the results of research funded and the processes that produced them • Establish standards, provide oversight, support • Manner and methods of research conduct • Study design, data collection, analysis • Ensure validity, completeness, accuracy, accountability of data/results

22. Collaborative Spine: A Clinical Research Enterprise Not just attainment of knowledge but also: • Dissemination of results • Identification and provision of tools and mechanisms • Incorporation into clinical practice to improve care

23. Collaborative Spine: A Clinical Research Enterprise Not just recurring, ‘one and done’ funding cycles • Learning model that advances, grows • Infrastructure, competencies, experience, knowledge • Platforms, standards, templates, consortia

24. Collaborative Spine: A Clinical Research Enterprise • Comprehensive, unified, cooperative effort • Community of stakeholders with a common goal: reduce burden of spine disease • Broad research agenda • Assessment, methods, systems • Coordinated plan • Topics, funding, methods, dissemination, incorporation • Enduring model

25. Priority Setting and Development of Research Agenda • Advisory Council (AC) • Professional societies, research community, industry, health services • Questionnaire • Open to public (June 29–August 15) on Survey Monkey • Press releases, updates to AC members • AC Webinars • Recommendations to CSRF board

26. Jeff Wang/Zo Ghogawala

31. Questionnaire Results (as of July 23, 2012) • 107 responses • 22 nonresponsive or duplicate • 85 nominated topics • Neurosurgery 40 (47.0%) • Orthopaedic 20 (23.5%) • Industry 20 (23.5%) • Health Svcs. 5 ( 6.0%)

32. Questionnaire Results (as of July 23, 2012) Research Area • Assessment (e.g. prevention, diagnosis, treatments)…52 (61%) • Methods of Research (e.g. study design, data collection, analysis)… 17 (21%) • Health Systems and Delivery (e.g. decision-making, quality care, processes, access)…16 (19%) S

33. Questionnaire Results (as of July 23, 2012) Topic Area • Degenerative 45 (53%) • Trauma 8 ( 9%) • Deformity 7 ( 8%) • Tumor 3 ( 4%) • All 22 (26%)

34. Common themes • A3:Cost effectiveness lumbar fusion for DDD (Ortho) • A8:Clinical efficacy of lumbar fusion (Industry) • A9: Effectiveness of lumbar fusion for DDD (Industry) • A11: Effectiveness of surgery for LBP/no deformity (HS/I) • A35:Effective patient/treatment selection for DDD (Neuro)

35. Zoher Ghogawala, MD

36. Research Areas • Assessment (e.g. prevention, diagnosis, treatments) • Methods of Research (e.g. study design, data collection, analysis) • Health Systems and Delivery (e.g. decision-making, quality care, processes, access)

37. Questionnaire Results: Assessment • Evaluation of options for the diagnosis, treatment or prevention of specific spinal conditions. • Study topics may be very broad and common or may be more tailored and include rare conditions or focused patient populations. • Analytic and synthetic evidence constructs, experimental and observational study design, and population- and patient-level perspective. • Direct diagnostic, treatment or prevention comparisons in accordance with CER criteria; clinical effectiveness and cost effectiveness in real world practice evaluations; and observational ‘prognosis with treatment’ studies.

38. Questionnaire Results: Assessment Treatment efficacy/effectiveness • Establish efficacy for fusion in appropriate patient • Effectiveness of surgery for LBP without deformity • Effectiveness of surgery for degenerative cervical disease • Effectiveness of fusion for degenerative scoliosis patients >65 years

39. Questionnaire Results: Assessment Procedural efficacy/effectiveness • Comparison of surgical treatments degen. spondylolisthesis • Operative vs. nonoperative treatment of adolescent scoliosis • MIS vs. open approaches • Comparative effectiveness of surgical treatments for DDD • CE of interbody vs. post. fusion for degen. spondylolisthesis • Safety and effectiveness of cement in trauma • Effectiveness and safety of rhBMP • Focused vs. conventional RT for postoperative malignancy

40. Questionnaire Results: Assessment Cost effectiveness for: • Surgery for adolescent idiopathic scoliosis • Lumbar fusion for degenerative disc disease • Multiple injection therapy, PT, surgery for DDD • Spinal cord stimulation vs. surgery for DDD • Artificial disc replacement

41. Questionnaire Results: Assessment Management strategies/prognosis with treatment • Delayed vs. acute surgery for spinal cord injury • Can 3D imaging improve surgical outcomes • Effect of fusion levels on outcomes for scoliosis • Relationship between sagittal balance and fusion outcomes • Risk factors for adjacent segment disease after fusion • Effectiveness of intra-operative monitoring • Utility of diffusion tensor imaging on outcomes for SCI • Effect of clinical guidelines on pediatric infection rates

42. Questionnaire Results: Methods • Study design, data collection, analysis • Investigations that seek to further the science and methods of clinical spine research—through advances or refinement of study design, methods and infrastructure of data identification, quality assurance, validation and analysis

43. Questionnaire Results: Methods Quantify/validate outcome measures • Pain generator identification for low back pain • Assess MCID and MCED • Societal assessment of the burden of scoliosis • Cost effectiveness of nonoperative treatment of adult deformity • Relative value of various spinal surgical treatments from payer, hospital and societal perspectives

44. Questionnaire Results: Methods Develop/validate methods for data collection • Develop spine registry for spinal trauma patients • The development of a comprehensive database for spinal deformity • Establish a prospective registry to compare the effectiveness of treatment strategies for low back pain • What are the standardized methods that should be applied to national, real-world, prospective spine registries in order to minimize bias and confounding to maximize the validity of evidence generated

45. Questionnaire Results: Health Systems and Delivery • Focuses on the processes of care access and delivery • Individualized, such as a local quality improvement initiatives, or broad in scope for the development of national practice standards, quality measures, best practices or risk adjustment. • May be focused time-limited projects or the involve development of enduring capabilities and infrastructure that may be utilized as learning systems and templates for the advancement of spine care. • Systems research will also include mechanisms and requirements for data source linkage (EMR, administrative databases, longitudinal follow-up), dissemination and incorporation of knowledge into clinical practice, and enhanced patient-centered decision making.

46. Questionnaire Results: Systems Investigate and develop systems and processes of care to assess and improve quality, access, effectiveness and value of care • Determine optimal care/clinical pathways for LBP • Effect of guidelines/pathways on clinical care • Establish cost/comparative effectiveness of spine care in community practices • Evaluate strategies to improve care, reduce complications and enhance patient decision-making • Develop integrated information systems to coordinate/improve care • Define real-world health systems and care delivery factors that influence effectiveness of spine care

47. Paul McCormick, MD

48. Questionnaire: Preliminary Advisory Council Voting Results • 85 nominated topics • 50 points allocated to each member • Up to 10 points/topic, no score=0 • Response rate ~ 50% • Point total/frequency of AC votes (>1/3)

49. Questionnaire: Preliminary Advisory Council Voting results • Vote value range 0-10, 0 or 5 most common • Lowest # graded=5, highest # graded=21 • 24 submissions received no points • For 8 submissions: points awarded > 1/3 AC members • For 0 submissions: points awarded >50% AC members

50. Questionnaire: Preliminary Advisory Council Voting results • A3: To determine the cost-effectiveness of lumbar fusion of degenerative disc disease • A6: Delayed vs. acute decompression for Central Cord Syndrome without fracture • A11: Effectiveness of surgery for LBP without deformity • A24:True incidence of morbidity and indications for use of rhBMP for anterior cervical surgery