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CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE (OAK CPG) AAOS Board Of Directors Webinar 1 Dial-in via telephone: (866) 394-4146.

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Presentation on theme: "CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE (OAK CPG) AAOS Board Of Directors Webinar 1 Dial-in via telephone: (866) 394-4146."— Presentation transcript:

1 CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE (OAK CPG) AAOS Board Of Directors Webinar 1 Dial-in via telephone: (866) Access Code: # MONDAY, MAY :30 – 8:30 PM CDT

2 Tonight’s Agenda Rationale for AAOS EBM/Quality programs Rationale for AAOS EBM/Quality programs Brief description of AAOS Clinical Practice Guidelines (CPG) processes Brief description of AAOS Clinical Practice Guidelines (CPG) processes Review of the “Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee” (OAK CPG) Review of the “Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee” (OAK CPG) 2

3 Why does AAOS invest in EBM/Quality? Patient’s trust physicians Patient’s trust physicians Decrease variation Decrease variation Synthesize orthopaedic literature Synthesize orthopaedic literature Improve patient care Improve patient care 3

4 *Sinaiko and Rosenthal, AJMC, 2010 Who Will Define ‘Quality’ in Orthopaedics?

5 Goals of CPGs, AUCs  Improve quality of care  Reduce variation  Decrease inefficiencies  Address rising costs  Define role of new technologies, procedures

6 5,000? per day 1,500 per day 95 per day (>1/day orthopaedic)

7 Clinical Practice Guidelines (CPGs) “ Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” -Institute of Medicine

8 AAOS CPG Development Process

9 AAOS Evidence Rating System EvidenceRating > 2 HIGH quality studiesStrong 1 HIGH or 2 Moderate quality studies Moderate 1 Moderate or 2 LOW quality studies Limited 1 LOW quality study, Contradictory studies, Lack of evidence (no studies) Inconclusive Expert Opinion (no studies)Consensus

10 IOM CPG Standards AAOS Guidelines vs. Proprietary Guidelines IOM StandardAAOS Guidelines Proprietary Guidelines 1. Establishing transparencyYes No 2. Management of Conflict of InterestYes Unknown 3. Guideline development group composition No – Currently no patient representative Unknown 4. Clinical practice guideline – systematic review intersectionYes Unknown 5. Establishing evidence foundations for and rating strength of recommendationsYes Unknown 6. Articulation of recommendationsYes Not easily available 7. External reviewYes Unknown 8. UpdatingYes Unknown

11 DAVID JEVSEVAR MD, MBA Chair, Committee on Evidence-Based Quality and Value (EBQV) KEVIN BOZIC MD, MBA Chair, Council on Research and Quality (CORQ) AAOS Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee 11 Revision / Update

12 12 April 2010 Nov 2012 Mar 2013

13 Summary of Peer Review Responses: 2013 OAK CPG Overall, would you recommend these guidelines for use in clinical practice? 13 N=16

14 Public Comment 14  Specialty Societies (5)  Individuals (29) (15 signed/ 14 anonymous)  Industry (9) (8 signed/ 1 anonymous) Public Comments are published on the AAOS website with the Clinical Practice Guideline following BOD approval.. AAOS received 43 public comments representing:

15 This 2013 AAOS OAK CPG will update and replace the 2008 OAK CPG. Agency for Healthcare Research and Quality (AHRQ) evidence report, “Treatment of Primary and Secondary Osteoarthritis of the Knee” Agency for Healthcare Research and Quality (AHRQ) evidence report, “Treatment of Primary and Secondary Osteoarthritis of the Knee” OARSI guidelines OARSI guidelines The Cochrane Database of Systematic Reviews (through February 22, 2008) The Cochrane Database of Systematic Reviews (through February 22, 2008) 15 Evidence Base for 2008 CPG

16 Meta-analysis When it is methodologically appropriate, the AAOS conducts a meta-analysis and determines clinical significance. When it is methodologically appropriate, the AAOS conducts a meta-analysis and determines clinical significance. In this OAK CPG, meta-analysis was used for these recommendations: In this OAK CPG, meta-analysis was used for these recommendations:  3a, 6, 8 and 9.  MCII and MID (*see AAOS Now )  MCII and MID (*see AAOS Now article) 16

17 Minimally Important Difference (MID) Meta-analysis Obtain proportion of patients that achieve MID Obtain proportion of patients that achieve MID “Although we focus on disease specific HRQL, the method can be applied to any meta-analysis of RCTs that employ patient important continuous outcome measures.” “Although we focus on disease specific HRQL, the method can be applied to any meta-analysis of RCTs that employ patient important continuous outcome measures.” 17 Johnston et al. Health and Quality of Life Outcomes 2010, 8:116

18 Minimally Important Differences 18 MID MID 0.5 Threshold 0 Favors TreatmentFavors Placebo Many Patients Gain Effect The red line indicates 1 MCII 1 Some Patients Gain Effect Small/Very Small # of Patients Gain Effect

19 RECOMMENDATION 3B We are unable to recommend for or against the use of physical agents (including electrotherapeutic modalities) in patients with symptomatic osteoarthritis of the knee. Strength of Recommendation: Inconclusive 19

20 RECOMMENDATION 3C We are unable to recommend for or against manual therapy in patients with symptomatic osteoarthritis of the knee. Strength of Recommendation: Inconclusive 20

21 RECOMMENDATION 9 (before peer review) We recommend against using hyaluronic acid for patients with symptomatic osteoarthritis of the knee. Strength of Recommendation: Strong 21

22 RECOMMENDATION 9 We cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee. Strength of Recommendation: Strong 22

23 23 Rec 9 Figure 1: HA vs placebo (WOMAC and VAS pain)

24 24 Rec 9 Figure 2: HA WOMAC function

25 25 Rec 9 Figure 3: HA WOMAC stiffness

26 Minimally Important Differences 26 MCII Statistically Significant 0 Favors TreatmentFavors Placebo Clinically Significant The red line indicates the MCII

27 Minimally Important Differences 27 MCII Statistically Significant 0 Favors TreatmentFavors Placebo Possibly Clinically Significant

28 Minimally Important Differences 28 MCII Statistically Significant 0 Favors TreatmentFavors Placebo Not Clinically Significant

29 Minimally Important Differences 29 MCII Statistically Significant 0 Favors TreatmentFavors Placebo Inconclusive

30 Rec 9 Hyaluronic Acid Versus Placebo: WOMAC Pain (original analysis) 30 Figure 79

31 Rec 9 Hyaluronic Acid Versus Placebo: VAS Weight Bearing Pain (original analysis) This forest plot indicates statistically significant effects compared to placebo. However, two studies 1;2 found corticosteroids to be less effective than hyaluronic acid and needle lavage, which we are recommending against due to lack of clinically significant efficacy compared to placebo. Reference List (1) Caborn D, Rush J, Lanzer W, Parenti D, Murray C. A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. J Rheumatol 2004;31(2): PM: (2) Arden NK, Reading IC, Jordan KM et al. A randomised controlled trial of tidal irrigation vs corticosteroid injection in knee osteoarthritis: the KIVIS Study. Osteoarthritis Cartilage 2008;16(6): PM: Figure 80 The red line indicates the MCII

32 Rec 9 Hyaluronic Acid Versus Placebo: Function (original analysis) 32 Figure 81

33 Rec 9 Hyaluronic Acid Versus Placebo: WOMAC Stiffness (original analysis) 33 Figure 82

34 34 Week Outcome Lequesne index ●● VAS Pain ● VAS weight bearing pain ● WOMAC Function ● WOMAC Stiffness ● WOMAC Total ● WOMAC Pain ●●●● Evaluator assessment of improvement ● Patient assessment of improvement ● Adverse events ●●● Local adverse event ● Severe adverse events ●● Treatment related adverse events ●●● Figure 78. Results Summary: High Versus Low Molecular Weight HA Key: ● =Not Significant; ●=Statistically Significant in Favor of High Molecular Weight; ●=Possibly Clinically Significant in Favor of HMW Rec 9: High vs Low Molecular Weight HA (1of 3) Individual Studies – Not Pooled results

35 Molecular Weight ComparisonALL OUTCOMES 6 million Da vs million DaNOT SIGNIFICANT 6 million DA vs million DaNOT SIGNIFICANT 6 million DA vs. 800kda-1200 DaNOT SIGNIFICANT 6 million DA vs 1 million DaNOT SIGNIFICANT 35 Rec 9: High vs Low Molecular Weight HA (2 of 3) Molecular Weight ComparisonOUTCOMES All molecular weights >.75k DA vs k DA VAS painNOT SIGNIFICANT ICOAP-total, constant, and intermittent pain NOT SIGNIFICANT VAS weight bearing pain NOT SIGNIFICANT WOMAC painPossibly Clinically Significant

36 OTHER SOURCES HYALURONIC ACID (Rec 9)  American College of Rheumatology  Osteoarthritis Research Society International  Annals of Internal Medicine 36

37 OARSI “ The pooled effect size.. in 22 placebo controlled RCTs was.32.. an asymmetric funnel plot and a positive Egger test suggested the possibility of publication bias.. and the identification of two unpublished trials with a pooled effect size of.07 [not statistically significant].. further suggested that the overall effect size might have been overestimated.” (p.147-8) 37 Zhang et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage (2008); 16, ; ©2008, Osteoarthritis Research Society International

38 38 Viscosupplementation for Knee Osteoarthritis. Annals of Internal Medicine Aug;157(3):I-36. AUTHORS DISCOURAGE THE USE OF VISCOSUPPLEMENTATION FOR KNEE OSTEOARTHRITIS.

39 Limitations Poor quality of many of the trials.   A major limitation is the poor methodological quality and reporting quality of many of the included trials, as previously described for a larger body of osteoarthritis trials (28, 124, 125). Some trials (78, 80) showed unrealistically large effect sizes—2 to 3 times that of what would be expected for total joint replacement (10). 39 Viscosupplementation for Knee Osteoarthritis Annals of Internal Medicine. 2012Aug; 157(3): I-36.

40 Funnel Plot 40 Viscosupplementation for Knee Osteoarthritis Annals of Internal Medicine. 2012Aug; 157(3): I-36. Effect Size Pain

41 ACR – 2012 Recommendations for Osteoarthritis of Hand, Hip and Knee 41 No recommendation For intraarticular hyaluronates Arthritis Care & Research Vol. 64, No.4, April ©2012, ACR

42 Before CORQ A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and/or that the quality of the supporting evidence is high. A Strong recommendation means that the benefits of the recommended approach clearly exceed the potential harm (or that the potential harm clearly exceeds the benefits in the case of a strong negative recommendation), and/or that the quality of the supporting evidence is high. 42

43 After CORQ A Strong recommendation means that the quality of the supporting evidence is high. A harms analysis on this recommendation was not performed. A Strong recommendation means that the quality of the supporting evidence is high. A harms analysis on this recommendation was not performed. 43

44 RECOMMENDATION 13 We are unable to recommend for or against arthroscopic partial meniscectomy in patients with osteoarthritis of the knee with a torn meniscus. Strength of Recommendation: Inconclusive 44

45 EBQV Committee Gregory A. Brown, MD, MBA Gregory A. Brown, MD, MBA William B. Ericson, Jr. MD William B. Ericson, Jr. MD Charles A. Reitman, MD Charles A. Reitman, MD Bruce Rougraff, MD Bruce Rougraff, MD William O. Shaffer, MD, BS William O. Shaffer, MD, BS Walter Stanwood, MD Walter Stanwood, MD Brent Graham, MD Brent Graham, MD Michael H. Heggeness, MD Michael H. Heggeness, MD Michael Warren Keith, MD Michael Warren Keith, MD Bruce Laron Smith, Jr. MD Bruce Laron Smith, Jr. MD Charles T. Mehlman, DO, MPH Charles T. Mehlman, DO, MPH David S. Jevsevar, MD, MBA -Chair, EBQV James O. Sanders, MD AUC Section Leader Michael J. Goldberg, MD GOC Section Leader William Timothy Brox, MD James L. Carey, MD Robert H. Haralson, III, MD, MBA William T. Obremskey, MD, MPH Robert H. Quinn, MD Nelson Fong SooHoo, MD 45 Staff  Deborah Cummins, PhD  Sharon Song, PhD  Patrick Donnelly, M.A.  Leeaht Gross, MPH  Kaitlyn Sevarino

46 COMMENTS – QUESTIONS DISCUSSION AAOS Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee Treatment of Osteoarthritis of the Knee 46 THANK YOU


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