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      Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States

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          Abstract

          Objective:

          A workgroup of clinical experts has developed an Appropriate Use Criteria (AUC) for the use of hyaluronic acid (HA) in the treatment of osteoarthritis (OA) of the knee. The increasingly broad and varied use of HA injections, lack of published clinical guidance, and limited coverage for their use has created the imperative to establish appropriateness criteria.

          Methods:

          The experts of this workgroup represent rheumatology, orthopedic surgery, physiatry, sports medicine, and nursing clinicians with substantive knowledge of intra-articular HA therapy. This workgroup utilized the results of a systematic review of evidence, expert clinical opinion, and current evidence-based clinical practice guidelines to develop appropriateness criteria for the use of intra-articular HA for knee OA in 17 real-world clinical scenarios.

          Results:

          The workgroup scored the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as appropriate (7-9), uncertain (4-6), or inappropriate (1-3). Six scenarios were scored as appropriate, 10 scenarios were scored as uncertain, and 1 scenario was scored as inappropriate.

          Conclusion:

          This article can assist clinicians in shared decision-making by providing best practices in considering HA injections for knee OA treatment. Moreover, this AUC article can aid payers and policy makers in determining reimbursement and preauthorization policies and more appropriately managing health care resources. It is clear that further research is still necessary—particularly in patient populations differentiated by OA severity—that may benefit the greatest from the use of HA injections for the treatment of knee OA.

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          Most cited references58

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          Lifetime risk of symptomatic knee osteoarthritis.

          To estimate the lifetime risk of symptomatic knee osteoarthritis (OA), overall and stratified by sex, race, education, history of knee injury, and body mass index (BMI). The lifetime risk of symptomatic OA in at least 1 knee was estimated from logistic regression models with generalized estimating equations among 3,068 participants of the Johnston County Osteoarthritis Project, a longitudinal study of black and white women and men age >or=45 years living in rural North Carolina. Radiographic, sociodemographic, and symptomatic knee data measured at baseline (1990-1997) and first followup (1999-2003) were analyzed. The lifetime risk of symptomatic knee OA was 44.7% (95% confidence interval [95% CI] 40.0-49.3%). Cohort members with history of a knee injury had a lifetime risk of 56.8% (95% CI 48.4-65.2%). Lifetime risk rose with increasing BMI, with a risk of 2 in 3 among those who were obese. Nearly half of the adults in Johnston County will develop symptomatic knee OA by age 85 years, with lifetime risk highest among obese persons. These current high risks in Johnston County may suggest similar risks in the general US population, especially given the increase in 2 major risk factors for knee OA, aging, and obesity. This underscores the immediate need for greater use of clinical and public health interventions, especially those that address weight loss and self-management, to reduce the impact of having knee OA.
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            Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition.

            Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline, 2nd Edition, is based on a systematic review of the current scientific and clinical research. This guideline contains 15 recommendations, replaces the 2008 AAOS clinical practice guideline, and was reevaluated earlier than the 5-year recommendation of the National Guideline Clearinghouse because of methodologic concerns regarding the evidence used in the first guideline. The current guideline does not support the use of viscosupplementation for the treatment of osteoarthritis of the knee. In addition, the work group highlighted the need for better research in the treatment of knee osteoarthritis.
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              Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis.

              To compare the efficacy of intraarticular hyaluronic acid with corticosteroids for knee osteoarthritis (OA). Our data sources were Medline, EMBASE, CINAHL, BIOSIS, and the Cochrane database, as well as hand- searched reviews, manuscripts, and supplements. For unpublished data we used author contacts. Randomized trials that reported effects of intraarticular hyaluronic acid versus corticosteroids on knee OA were selected based on inclusion criteria. Two reviewers extracted data independently. Using a random-effects model, we computed effect sizes for pain change from baseline at 2, 4, 8, 12, and 26 weeks. We also performed multivariate analyses accounting for within and between-study covariance. We performed sensitivity analyses for trials that reported intent-to-treat (ITT) analysis and blinding, and directly compared Hyalgan with methylprednisolone. The 7 eligible trials included 606 participants. Five reported ITT analyses. At week 2 the effect size was -0.39 (95% confidence interval [95% CI], -0.65, -0.12) favoring corticosteroids; at week 4 it was -0.01 (95% CI -0.23, 0.21) suggesting equal efficacy. At week 8 the effect size was 0.22 (95% CI -0.05, 0.49) favoring hyaluronic acid, and at week 12 it was 0.35 (95% CI 0.03, 0.66) favoring hyaluronic acid. At week 26 the effect size was 0.39 (95% CI 0.18, 0.59), favoring hyaluronic acid. The multivariate analyses and sensitivity analyses generated consistent results. From baseline to week 4, intraarticular corticosteroids appear to be relatively more effective for pain than intraarticular hyaluronic acid. By week 4, the 2 approaches have equal efficacy, but beyond week 8, hyaluronic acid has greater efficacy. Understanding this trend is useful to clinicians when treating knee OA.
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                Author and article information

                Journal
                Cartilage
                Cartilage
                CAR
                spcar
                Cartilage
                SAGE Publications (Sage CA: Los Angeles, CA )
                1947-6035
                1947-6043
                10 August 2016
                July 2017
                : 8
                : 3
                : 234-254
                Affiliations
                [1 ]Northeast Orthopedics and Sports Medicine, Airmont, NY, USA
                [2 ]Ronald Reagan UCLA Medical Center, Los Angeles, CA, USA
                [3 ]LSU Health Sciences Center Department of Orthopaedics, New Orleans, LA, USA
                [4 ]LSU School of Medicine, New Orleans, LA, USA
                [5 ]Quinnipiac University School of Nursing, Joint Appointment Frank Netter School of Medicine, North Haven, CT, USA
                [6 ]Orthopedic Associates, Farmington, CT, USA
                [7 ]Department of Orthopaedics and Rehabilitation, New York-Presbyterian/Queens Hospital, New York, NY, USA
                [8 ]Weill Medical College of Cornell University, New York, NY, USA
                [9 ]Hospital for Special Surgery, Weill Medical College of Cornell University, New York, NY, USA
                [10 ]Rothman Institute at Jefferson, Philadelphia, PA, USA
                [11 ]Avalere Health, Washington, DC, USA
                Author notes
                [*]Arup K. Bhadra, Northeast Orthopedics and Sports Medicine, 327 Route 59, Airmont, NY 10952, USA. Email: arupbhadra@ 123456yahoo.com
                Article
                10.1177_1947603516662503
                10.1177/1947603516662503
                5625860
                28618868
                f23c454f-bb38-4814-a232-dbe34c0490e6
                © The Author(s) 2016

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Funding
                Funded by: Advanced Medical Technology Association (Advamed), ;
                Categories
                Clinical Research Articles

                appropriate use criteria,hyaluronic acid,knee,osteoarthritis,viscosupplementation

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