clinical practice guideline on the treatment of osteoarthritis of the knee (oak cpg) aaos board of...

CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE (OAK CPG)

AAOS Board Of Directors WebinarAAOS Board Of Directors Webinar

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Dial-in via telephone: Dial-in via telephone: (866) 394-4146(866) 394-4146

Access Code: Access Code: 34434932#34434932#

MONDAY, MAY 6 20137:30 – 8:30 PM CDT

Tonight’s Agenda

Rationale for AAOS EBM/Quality Rationale for AAOS EBM/Quality programsprograms

Brief description of AAOS Clinical Practice Brief description of AAOS Clinical Practice Guidelines (CPG) processesGuidelines (CPG) processes

Review of the “Clinical Practice Guideline Review of the “Clinical Practice Guideline on the Treatment of Osteoarthritis of the on the Treatment of Osteoarthritis of the Knee” (OAK CPG)Knee” (OAK CPG)

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

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*Sinaiko and Rosenthal, AJMC, 2010

Who Will Define ‘Quality’ in Orthopaedics?

Goals of CPGs, AUCs

Improve quality of careImprove quality of care Reduce variationReduce variation Decrease inefficienciesDecrease inefficiencies Address rising costsAddress rising costs Define role of new Define role of new

technologies, procedurestechnologies, procedures

Kevin Bozic

Deborah/David: I took these from the version Madeleine sent, but please modify/edit as appropriate

0

500000

1000000

1500000

2000000

2500000

Biomedical MEDLINE Trials Diagnostic?

Med

ical

Art

icle

s p

er Y

ear

5,000?per day

1,500 per day

95 per day (>1/day

orthopaedic)

Clinical Practice Guidelines (CPGs)

““Systematically developed statements to Systematically developed statements to assist practitioner and patient decisions assist practitioner and patient decisions about appropriate health care for about appropriate health care for specific clinical circumstancesspecific clinical circumstances””

--Institute of MedicineInstitute of Medicine

AAOS CPG Development Process

AAOS Evidence Rating SystemEvidence Rating> 2 HIGH quality studies Strong

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

IOM CPG Standards AAOS Guidelines vs. Proprietary Guidelines

IOM Standard AAOS GuidelinesProprietary Guidelines

1. Establishing transparency Yes No2. Management of Conflict of Interest Yes Unknown

3. Guideline development group composition

No – Currently no patient

representative Unknown4. Clinical practice guideline – systematic review intersection Yes Unknown5. Establishing evidence foundations for and rating strength of recommendations Yes Unknown6. Articulation of recommendations Yes Not easily available7. External review Yes Unknown8. Updating Yes Unknown

DAVID JEVSEVAR MD, MBAChair, Committee on Evidence-Based Quality and Value (EBQV)

KEVIN BOZIC MD, MBAChair, Council on Research and Quality (CORQ)

AAOS Clinical Practice AAOS Clinical Practice Guideline on the Treatment Guideline on the Treatment of Osteoarthritis of the Kneeof Osteoarthritis of the Knee

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Revision / Update

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April 2010 Nov 2012

Mar 2013

Summary of Peer Review Responses: 2013 OAK CPG

Overall, would you recommend these guidelines for Overall, would you recommend these guidelines for use in clinical practice? use in clinical practice?

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N=16N=16

Public Comment

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Specialty Societies (5)Specialty Societies (5) Individuals (29) Individuals (29)

(15 signed/ 14 anonymous) (15 signed/ 14 anonymous)

Industry (9) Industry (9) (8 signed/ 1 anonymous)(8 signed/ 1 anonymous)

Public Comments are published on the AAOS website with the Clinical Public Comments are published on the AAOS website with the Clinical Practice Guideline following BOD approval.Practice Guideline following BOD approval.

..

AAOS received 43 public comments representing:

This 2013 AAOS OAK CPG will update and replace the 2008 OAK CPG.

Agency for Healthcare Research and Agency for Healthcare Research and Quality (AHRQ) evidence report, Quality (AHRQ) evidence report, “Treatment of Primary and Secondary “Treatment of Primary and Secondary Osteoarthritis of the Knee” Osteoarthritis of the Knee”

OARSI guidelines OARSI guidelines The Cochrane Database of Systematic The Cochrane Database of Systematic

Reviews (through February 22, 2008) Reviews (through February 22, 2008)

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Evidence Base for 2008 CPG

Meta-analysis

When it is methodologically appropriate, When it is methodologically appropriate, the AAOS conducts a meta-analysis and the AAOS conducts a meta-analysis and determines clinical significance. determines clinical significance.

In this OAK CPG, meta-analysis was used In this OAK CPG, meta-analysis was used for these recommendations:for these recommendations: 3a, 6, 8 and 93a, 6, 8 and 9.. MCII and MID (*see MCII and MID (*see AAOS Now AAOS Now article))

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Minimally Important Difference (MID) Meta-analysis Obtain proportion of patients that achieve Obtain proportion of patients that achieve

MIDMID ““Although we focus on disease specific Although we focus on disease specific

HRQL, the method can be applied to any HRQL, the method can be applied to any meta-analysis of RCTs that employ patient meta-analysis of RCTs that employ patient important continuous outcome measures.”important continuous outcome measures.”

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Johnston et al. Health and Quality of Life Outcomes 2010, 8:116

Minimally Important Differences

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MID MID 0.5 Threshold

0Favors Treatment Favors Placebo

Many Patients Gain Effect

The red line indicates 1 MCII 1

Some Patients Gain Effect

Small/Very Small # of Patients Gain Effect

RECOMMENDATION 3B

We are unable to recommend for or against We are unable to recommend for or against the use of the use of physical agents physical agents (including (including electrotherapeutic modalities) in patients with electrotherapeutic modalities) in patients with symptomatic osteoarthritis of the knee.symptomatic osteoarthritis of the knee.

Strength of Recommendation: Strength of Recommendation: InconclusiveInconclusive

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RECOMMENDATION 3C

We are unable to recommend for or against We are unable to recommend for or against manual therapy manual therapy in patients with in patients with symptomatic osteoarthritis of the knee.symptomatic osteoarthritis of the knee.


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

Strength of Recommendation: Strength of Recommendation: StrongStrong

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RECOMMENDATION 9

We cannot recommend using We cannot recommend using hyaluronic acid hyaluronic acid for patients with symptomatic osteoarthritis for patients with symptomatic osteoarthritis of the knee. of the knee.

Strength of Recommendation: Strength of Recommendation: StrongStrong

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

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Rec 9 Figure 2: HA WOMAC function

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Rec 9 Figure 3: HA WOMAC stiffness


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MCII Statistically Significant


Clinically Significant

The red line indicates the MCII


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Possibly Clinically Significant


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Not Clinically Significant


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Inconclusive

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

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Rec 9 Hyaluronic Acid Versus Placebo: VAS Weight Bearing Pain (original analysis)

31Figure 80

The red line indicates the MCII

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

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

33Figure 82

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Week

Outcome 6 12 13 20 24 26 52

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

Molecular Weight Comparison ALL OUTCOMES

6 million Da vs. 1-2.9 million Da NOT SIGNIFICANT

6 million DA vs. 2.2-2.7 million Da NOT SIGNIFICANT

6 million DA vs. 800kda-1200 Da NOT SIGNIFICANT

6 million DA vs 1 million Da NOT SIGNIFICANT

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Rec 9: High vs Low Molecular Weight HA (2 of 3)

Molecular Weight Comparison OUTCOMES

All molecular weights >.75k DAvs. .5 -.75k DA

VAS pain NOT SIGNIFICANT

ICOAP-total, constant, and intermittent pain

NOT SIGNIFICANT

VAS weight bearing pain

NOT SIGNIFICANT

NOT SIGNIFICANT

WOMAC pain Possibly Clinically Significant

OTHER SOURCES

HYALURONIC ACID (Rec 9)HYALURONIC ACID (Rec 9)American College of RheumatologyAmerican College of RheumatologyOsteoarthritis Research Society InternationalOsteoarthritis Research Society InternationalAnnals of Internal MedicineAnnals of Internal Medicine

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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)

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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, 137-162; ©2008, Osteoarthritis Research Society International

http://annals.org/article.aspx?articleid=1305532http://annals.org/article.aspx?articleid=1305532

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Viscosupplementation for Knee Osteoarthritis. Annals of Internal Medicine. 2012 Aug;157(3):I-36.

AUTHORS DISCOURAGE THE USE OF VISCOSUPPLEMENTATION FOR KNEE OSTEOARTHRITIS.

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).

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Viscosupplementation for Knee OsteoarthritisAnnals of Internal Medicine. 2012Aug; 157(3): I-36.

Funnel Plot

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Viscosupplementation for Knee OsteoarthritisAnnals of Internal Medicine. 2012Aug; 157(3): I-36.

Effect Size

Pain

ACR – 2012 Recommendations for Osteoarthritis of Hand, Hip and Knee

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No recommendationFor intraarticularhyaluronates

Arthritis Care & ResearchVol. 64, No.4, April 2012465-474 ©2012, ACR

Before CORQ

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

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After CORQ

A A StrongStrong recommendation means that recommendation means that the quality of the supporting evidence is the quality of the supporting evidence is high. A harms analysis on this high. A harms analysis on this recommendation was not performed. recommendation was not performed.

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RECOMMENDATION 13We are unable to recommend for or againstWe are unable to recommend for or against

arthroscopic partial meniscectomy arthroscopic partial meniscectomy in in patients with osteoarthritis of the knee with patients with osteoarthritis of the knee with a torn meniscus.a torn meniscus.


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EBQV Committee Gregory A. Brown, MD, MBAGregory A. Brown, MD, MBA William B. Ericson, Jr. MDWilliam B. Ericson, Jr. MD Charles A. Reitman, MDCharles A. Reitman, MD Bruce Rougraff, MDBruce Rougraff, MD William O. Shaffer, MD, BSWilliam O. Shaffer, MD, BS Walter Stanwood, MDWalter Stanwood, MD Brent Graham, MDBrent Graham, MD Michael H. Heggeness, MDMichael H. Heggeness, MD Michael Warren Keith, MDMichael Warren Keith, MD Bruce Laron Smith, Jr. MDBruce Laron Smith, Jr. MD Charles T. Mehlman, DO, Charles T. Mehlman, DO,

MPHMPH

David S. Jevsevar, MD, David S. Jevsevar, MD, MBA -Chair, EBQVMBA -Chair, EBQV

James O. Sanders, MDJames O. Sanders, MD

AUC Section LeaderAUC Section Leader Michael J. Goldberg, MDMichael J. Goldberg, MD

GOC Section LeaderGOC Section Leader William Timothy Brox, MDWilliam Timothy Brox, MD James L. Carey, MDJames L. Carey, MD Robert H. Haralson, III, MD, Robert H. Haralson, III, MD,

MBAMBA William T. Obremskey, MD, William T. Obremskey, MD,

MPHMPH Robert H. Quinn, MDRobert H. Quinn, MD Nelson Fong SooHoo, MDNelson Fong SooHoo, MD

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Staff Deborah Cummins, Deborah Cummins, PhD PhD Sharon Song, PhDSharon Song, PhD Patrick Donnelly, Patrick Donnelly, M.A.M.A. Leeaht Gross, MPHLeeaht Gross, MPH Kaitlyn SevarinoKaitlyn Sevarino

COMMENTS – QUESTIONSDISCUSSION

AAOS Clinical Practice Guideline on theAAOS Clinical Practice Guideline on the

Treatment of Osteoarthritis of the KneeTreatment of Osteoarthritis of the Knee

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THANK YOU

clinical practice guideline on the treatment of osteoarthritis of the knee (oak cpg) aaos board of...

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