Collaborative Spine Advisory Council
Priority Setting and Development of Research
Agenda WebinarJuly 30, 2012
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Jeff Wang, MD—UCLAZoher Ghogawala, MD—LaheyPaul McCormick, MD—Columbia
Moderators:
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Advisory Council WEBINAR AGENDA
Welcome & introductions
Webinar instructions
Background
Research agenda: process & timelines
Review & discussion of submitted topics
Next steps
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Collaborative Spine: 501(c)3 application pending
New joint initiative between 2 established Foundations (OREF, NREF)Unconflicted, rigorous, independent peer
review processes—research and fellowship grants
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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
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Collaborative Spine Advisory Council Members
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Advisory Council Members as of September 5, 2012 REPRESENTING COLLABORATIVE SPINE BOARD OF DIRECTORSZoher Ghogawala, MD, FAANS, FACS Paul C. McCormick, MD, MPH, FAANS, FACS Jeffrey C. Wang, MD
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Advisory Council Members as of September 5, 2012 REPRESENTING SPINE-CARE SOCIETIESGreg Anderson, Society for Minimally Invasive Spine SurgeryJens Chapman, MD, AO Spine North AmericaJoseph Cheng, MD, MS, FAANS, American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Section on Disorders of the Spine and Peripheral NervesMichael G. Fehlings, MD, PhD, FAANS, Cervical Spine Research SocietySteve Garfin, MD, International Society for the Advancement of Spine SurgeryDaniel Resnick, MD, MS, FAANS, North American Spine SocietyDilip K. Sengupta, MD, Scoliosis Research SocietyLawrence Vogel, MD, American Spinal Injury AssociationThomas Zdeblick, MD, Lumbar Spine Research Society
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Advisory Council Members as of September 5, 2012 REPRESENTING THE RESEARCH COMMUNITYKeith Bridwell, MD, Association of Collaborative Spine Research—DeformityBrenda A. Frederick, Orthopaedic Research SocietyZiya Gokaslan, MD, FAANS, FACS, Association of Collaborative Spine Research—OncologyRegis Haid, MD, FAANS, Association of Collaborative Spine Research—DegenerativeJames Iatridis, PhD, Orthopaedic Research SocietyMichael Liebschner, PhD, Orthopaedic Research SocietyTheodore Miclau, MD, Orthopaedic Research SocietyFiroz Miyanji, MD, FRCS, Pediatric Orthopaedic Society of North AmericaAlex Vaccaro, MD, FACS, Association of Collaborative Spine Research—Trauma
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Advisory Council Members as of June 29, 2012 REPRESENTING MEDICAL DEVICE & HEALTH SERVICES/INSURANCE COMPANIESKevin Carouge, Globus Medical, Inc.Amy Fredrick, EOS ImagingSteve Healy, Zimmer SpineWilliam C. Horton III, MD, DuPuy Orthopaedics, Inc.Kelli Howell, MS, NuVasiveDoug King, Medtronic SpineStephen E. Koenigsberg, Stryker SpineJohn Kostuik, MD, K2M, Inc.Bryan McMillan, OrthofixDavid E. Mino, MD, MBA, Cigna HealthcareSteve Schwartz, Synthes Spine
Why Collaborative Spine?
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The Challenge of Spine CareSpine Conditions
High prevalence, broad etiologiesSpecific condition heterogeneity
Severity, natural history, response to treatment
Spine TreatmentMany treatment options, specialtiesHigh costs, morbidity, suboptimal outcomesUncertainty
What works, which patient, what circumstances
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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
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Collaborative Spine: A Clinical Research Enterprise
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Collaborative Spine: A Clinical Research EnterpriseNot just passively fund investigator-
determined research topics
Establish broad research agendaNeeds assessment, knowledge gapsCommunity of stakeholdersActive RFP process
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Collaborative Spine: A Clinical Research EnterpriseThe 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
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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 conductStudy design, data collection, analysisEnsure validity, completeness, accuracy,
accountability of data/results
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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
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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
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Collaborative Spine: A Clinical Research EnterpriseComprehensive, unified, cooperative effort
Community of stakeholders with a common goal: reduce burden of spine disease
Broad research agendaAssessment, methods, systems
Coordinated planTopics, funding, methods, dissemination, incorporation
Enduring model
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Priority Setting and Development of Research Agenda Advisory Council (AC)
Professional societies, research community, industry, health services
QuestionnaireOpen to public (June 29–August 15) on Survey
MonkeyPress releases, updates to AC members
AC Webinars
Recommendations to CSRF board
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Jeff Wang/Zo Ghogawala
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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%)
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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%)
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Questionnaire Results (as of July 23, 2012)
Topic Area
Degenerative 45 (53%)
Trauma 8 ( 9%)
Deformity 7 ( 8%)
Tumor 3 ( 4%)
All 22 (26%)
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Common themesA3: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)
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Zoher Ghogawala, MD
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Research AreasAssessment (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)
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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.
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Questionnaire Results: Assessment
Treatment efficacy/effectivenessEstablish efficacy for fusion in appropriate patientEffectiveness of surgery for LBP without deformityEffectiveness of surgery for degenerative cervical
diseaseEffectiveness of fusion for degenerative scoliosis
patients >65 years
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Questionnaire Results: AssessmentProcedural efficacy/effectiveness
Comparison of surgical treatments degen. spondylolisthesisOperative vs. nonoperative treatment of adolescent scoliosisMIS vs. open approachesComparative effectiveness of surgical treatments for DDDCE of interbody vs. post. fusion for degen. spondylolisthesisSafety and effectiveness of cement in traumaEffectiveness and safety of rhBMPFocused vs. conventional RT for postoperative malignancy
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Questionnaire Results: AssessmentCost effectiveness for:
Surgery for adolescent idiopathic scoliosisLumbar fusion for degenerative disc diseaseMultiple injection therapy, PT, surgery for
DDDSpinal cord stimulation vs. surgery for DDDArtificial disc replacement
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Questionnaire Results: AssessmentManagement strategies/prognosis with treatment
Delayed vs. acute surgery for spinal cord injuryCan 3D imaging improve surgical outcomesEffect of fusion levels on outcomes for scoliosisRelationship between sagittal balance and fusion
outcomesRisk factors for adjacent segment disease after fusionEffectiveness of intra-operative monitoringUtility of diffusion tensor imaging on outcomes for SCIEffect of clinical guidelines on pediatric infection rates
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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
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Questionnaire Results: MethodsQuantify/validate outcome measures
Pain generator identification for low back painAssess MCID and MCED Societal assessment of the burden of scoliosisCost effectiveness of nonoperative treatment of
adult deformityRelative value of various spinal surgical treatments
from payer, hospital and societal perspectives
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Questionnaire Results: MethodsDevelop/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
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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.
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Questionnaire Results: SystemsInvestigate 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
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Paul McCormick, MD
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Questionnaire: Preliminary Advisory Council Voting Results85 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)
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Questionnaire: Preliminary Advisory Council Voting resultsVote 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
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Questionnaire: Preliminary Advisory Council Voting resultsA3: 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
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Questionnaire: Preliminary Advisory Council Voting resultsA26: Define incidence and risk factors for adjacent segment
stenosis following lumbar decompression and fusion
A27:Comparative effectiveness of interbody fusion vs. lateral tx. pr. fusion for degenerative spondylolisthesis
A34: Effectiveness and safety of rhBMP for posterior lumbar fusion
A52: Develop appropriateness criteria for surgical procedures for degenerative scoliosis
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Questionnaire: Preliminary Advisory Council Voting resultsM9: Establish a prospective registry to compare the
effectiveness of treatment strategies for low back pain without neurological deficit or spinal deformity
M72: Compare the effectiveness of treatment strategies (e.g., artificial cervical discs, spinal fusion, pharmacologic treatment with physical therapy) for cervical disc and neck pain
S11: Evaluate strategies to reduce the incidence of wound infection following instrumented spinal fusion.
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Discussion, Comments,Questions
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Collaborative Spine Advisory Council: Next StepsForward comments/questions to Jeff, Zo, Paul
Encourage online questionnaire submission
Refine/consolidate research submissions
Second round of voting via e-mail
Possible second Webinar
Future communication
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Thanks for your participationJeff Wang, Zo Ghogawala, Paul McCormick
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