collaborative spine advisory council

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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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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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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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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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

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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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collaborative spine advisory council

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