Comparative Effectiveness Research

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1 Comparative Effectiveness Research 2

2 Nelson F. SooHoo, MD Associate Professor UCLA Dept. of Orthopaedic Surgery 8

3 Objectives Define comparative effectiveness research Relevance to orthopaedic surgeons Opportunities for orthopaedic surgery 3

4 What is Comparative Effectiveness Research? 2

5 Definition Agency for Healthcare Research and Quality Medicare Modernization Act 2003 mandated AHRQ to conduct and support CER. (effectivehealthcare.ahrq.gov) CER is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, and ways to deliver health care. 4

6 American Recovery and Reinvestment Act (ARRA) of 2009 Allotted $1.1 billion for CER Federal Coordinating Council (15 members appointed by Institute of Medicine) 6

7 Definition Patient-Centered Outcomes Research Institute (PCORI) Patient Protection and Affordable Care Act 2010 established non-profit PCORI independent from government. CER compares the effectiveness and safety of preventative, diagnostic, and treatment options to create a foundation of information for personalized decision making. This research places emphasis on: the practical utility of the comparisons; the examination of all outcomes that may be important to patients; and the possible differences in outcomes across patient subgroups. 5

8 Types of CER Researchers look at existing clinical trials Systematic reviews Meta-analysis Practice guidelines Researchers generate new evidence Clinical trials Observational studies Clinical Registries (CJRR, AJRR) 7

9 Why is this important for orthopaedic surgeons? 12

10 Healthcare Policy Rising cost of healthcare Orthopaedic procedures Variations in care Differences in use and outcomes of procedures 9

11 Orthopaedic surgery and rising costs Hip and knee replacement Spine surgery 10

12 Variations in outcomes Outcomes Readmission Reoperation Predictors Patient factors Age Comorbidities Provider factors Hospital Surgeon 11

13 11

14 Practice Implications Centers of excellence Case-study: Blue Cross/Blue Shield of America Blue Distinction Centers for joint replacement and spine surgery 14

15 Blue Cross/Blue Shield Centers of Distinction BCBSA 39 plans with 100 million enrollees Established Centers of Distinction program 2007 Total joint replacement Spine surgery Criteria established with expert panel 15

16 16

17 Blue Cross/Blue Shield Centers of Distinction 17

18 Blue Cross/Blue Shield Centers of Distinction 18

19 Spinal Surgery Composite Complication Rates 19

20 Spinal Surgery 90-day Episode Costs 20

21 Blue Cross/Blue Shield Centers of Distinction No differences in 90-day episode cost Limited differences in complication rates Total joint replacement Spine surgery Implications of centers of excellence programs 21

22 What are the Key CER Opportunities for Orthopaedic Surgery? 14

23 Orthopaedic CER Priorities Institute of Medicine (IOM) 2009 report Ranked top 100 priorities in quartiles 1st quartile Establish a prospective registry to compare the effectiveness of treatment strategies for low back pain without neurological deficit or spinal deformity. 2nd quartile Compare the effectiveness of treatment strategies (e.g., artificial cervical discs, spinal fusion, pharmacologic treatment with physical therapy) for cervical disc and neck pain. 23

24 Orthopaedic CER Priorities Institute of Medicine (IOM) 2009 report 3rd quartile Establish a prospective registry to compare the effectiveness of surgical and nonsurgical strategies for treating cervical spondylotic myelopathy (CSM) in patients with different characteristics to delineate predictors of improved outcomes. 4th quartile Compare the effectiveness (e.g., pain relief, functional outcomes) of different surgical strategies for symptomatic cervical disc herniation in patients for whom appropriate nonsurgical care has failed. 24

25 Orthopaedic CER Priorities Institute of Medicine (IOM) 2009 report 4th quartile Compare the effectiveness of anticoagulant therapies (e.g., lowintensity warfarin, aspirin, injectable anticoagulants) for patients undergoing hip or knee arthroplasty surgery. Compare the effectiveness of different treatment strategies in the prevention of progression and disability from osteoarthritis. 25

26 Opportunities in CER Total hip and knee replacement Joint registries American Joint Replacement Registry California Joint Replacement Registry 13

27 Opportunities in CER Total hip and knee replacement Implants Approaches Thromboprophylaxis Patient factors 13

28 CJRR Update Pilot Complete 2,894 Enrollees Current Expansion 12 hospitals in 2013 Over 300 patients/month 28

29 CJRR Update Comparative Effectiveness Implants Approaches Surgeons Hospitals Patients 29

30 Types of CER Researchers look at existing clinical trials Systematic reviews Meta-analysis Practice guidelines Researchers generate new evidence Clinical trials Observational studies Clinical Registries (CJRR, AJRR) 7

31 Variations in orthopaedic procedures Outcomes Implant Approach Surgeon Hospital Appropriateness Patient factors 11

32 Summary Comparative-effectiveness research Practical importance Opportunities for individual surgeons and hospital partners 32

33 20

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