1. Comparative Effectiveness in Orthopaedics: Stakeholder Perspectives Kevin J. Bozic, MD, MBA Associate Professor and Vice Chair UCSF Department of Orthopaedic Surgery and Philip R. Lee Institute for Health Policy Studies

2. Disclosures/Conflicts of Interest External Advisory Role: AAOS (HCSC, GTOC) AAHKS (Education, Health Policy, EBPC) COA (Executive Committee) CMS (MedCAC) UCSF Medical Center (HTAP) United Health Care, BCBSA, Integrated Healthcare Association, Pacific Business Group on Health Research Support: OREF, AHRQ, NIH

3. Objectives 1. To identify considerations in the decision making process for the adoption of new technologies in orthopaedics 2. To understand the strengths and limitations of comparative effectiveness research 3. To develop an algorithm for evaluating and adopting new technologies in an orthopaedic practice

4. Technology in Orthopaedics

5. Implant Factors Surgeon Factors Patient Factors Hospital Factors What Factors Influence Patient Outcomes?

6. Benefits of Technology

7. Technology: Unintended consequences

8. Technology: Cost Implications “The general consensus among health economists is that growth in real health care spending over the past 4 decades was principally the result of the emergence of new medical technologies and their adoption and widespread diffusion by the U.S. health care system.” -CBO Report, “Technological Change and the Growth of Health Care Spending”, Feb, 2008 “…however, the benefit of many of these new technologies has not yet been rigorously demonstrated.”

9. Comparative Effectiveness: Value 1.5-2X 4-6X 2-3X Cost Value? ??

10. Evaluating Technologies: Perspective Surgeons “Evidence standard” Adequacy of evidence Magnitude of benefit Relationships with industry Peers Hospitals/payers Short-term cost-containment Patients Internet, friends, family DTCA Policymakers Comparative Effectiveness

11. Clinician Perspective Level of Evidence (I-V) Efficacy The extent to which medical interventions achieve health improvements under ideal circumstances Effectiveness The extent to which medical interventions achieve health improvements in real practice settings

12. Effectiveness: Registry Data

14. Hospital Perspective 1990’s2000’s

15. UCSF Healthcare Technology Assessment Program (HTAP) “HTA is the bridge between the world of research and the world of clinical decision making” Alan Garber, Health Affairs, 2004 Considerations Patient population Surgeon experience Relationships with vendor, hospital Price Service Programmatic needs

16. Patient Perspective: DTCA

17. DTCA: Policy Implications DTCA $$

18. Policy Maker Perspective: Comparative Effectiveness?

19. Comparative Effectiveness Research “As applied in the health care sector, an analysis of comparative effectiveness is simply a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.” Congressional Budget Office, 2007 See: http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18- ComparativeEffectiveness.pdf

20. Evolutionary or Revolutionary?

21. Trends in Orthopaedic Implant Costs in the U.S.

22. “Overshooting” the Needs of our Patients “The functionality of today’s healthcare technologies, although impressive, often outstrips the ability of consumers to absorb it”

23. Impact of Technology on Surgeon “Value” “Take hip replacement surgery for example. Here much of the cost and “skill”, as it were, have moved from the surgeon to the device.”

24. Considerations in Technology Decisions Is there a clinical need? Patient population Results with existing technology Use data whenever possible Factors influencing decision Device company Peers Hospital Patients Impact on Patient outcomes Hospital margins O.R. Efficiency

25. My Algorithm Versatility of product line Service Price Benefits vs. Risks of switching Potential improvement in clinical outcomes Uncertainty in patient outcomes Impact on efficiency Price

26. Summary Explosion of new technologies in orthopaedics Consumerism Increased scrutiny, transparency regarding costs, clinical effectiveness Questions: Comparative effectiveness: Clinical effectiveness vs. gold- standard? Cost-effectiveness? Impact on clinical, shared decision making

27. “Newer” Is Not Always “Better” “Novelty cannot necessarily be equated with benefit, and an intervention or device’s value resides not in it’s newness but rather in its ability to improve patient outcomes, reduce morbidity, and/or reduce the overall cost of care. “ Emanuel EJ, Fuchs VR, Garber AM. Essential elements of a technology and outcomes assessment initiative. JAMA. Sep 19 2007;298(11):1323-1325.

28. Thank You!!!