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      Long-term clinical benefit and cost-effectiveness of an 8-week multimodal knee osteoarthritis management program incorporating intra-articular sodium hyaluronate (Hyalgan ®) injections

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          Abstract

          Background

          Given the poor long-term effectiveness of focused nonsurgical knee osteoarthritis (OA) treatments, alternative therapies are needed for patients who have unsuccessfully exhausted nonsurgical options.

          Methods

          A telephone interview was conducted in patients who participated in a single 8-week multimodal knee OA treatment program (mean follow-up: 3.7 years, range: 2.7–4.9 years). The program consisted of five intra-articular knee injections of sodium hyaluronate (Hyalgan ®), with each injection given 1 week apart, structured physical therapy, knee bracing, and patient education. Clinical outcomes included knee pain severity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscores, current medication use, and history of total knee arthroplasty. Base-case, subgroup, and sensitivity analyses were conducted to determine the incremental cost-effectiveness ratio (ICER) of the treatment program with comparisons made to historical literature controls undergoing usual care.

          Results

          A total of 218 patients (54%) provided long-term follow-up data. Knee pain severity decreased 60% and WOMAC subscores decreased 33%–42% compared to baseline (all p<0.001). Total knee arthroplasty was performed in 22.8% (81/356) of knees during followup. The treatment program was highly cost-effective compared to usual care with a base-case ICER of $6,000 per quality-adjusted life year (QALY). Results of subgroup analyses, one-way deterministic sensitivity analyses, and second-order probabilistic sensitivity analyses resulted in ICERs ranging from $3,996 to $10,493 per QALY. The percentage of simulations with an ICER below willingness-to-pay limits was 97.2%, 98.9%, and 99.4% for the $50,000, $100,000, and $150,000 per QALY thresholds, respectively.

          Conclusion

          Participation in a single 8-week knee OA treatment program, which included one cycle of five intra-articular knee injections of sodium hyaluronate given at weekly intervals, is highly cost-effective and provides clinically meaningful reductions in patient symptoms that are maintained over 3.7 years mean follow-up.

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          Most cited references 32

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          Analysis of serial measurements in medical research.

          In medical research data are often collected serially on subjects. The statistical analysis of such data is often inadequate in two ways: it may fail to settle clinically relevant questions and it may be statistically invalid. A commonly used method which compares groups at a series of time points, possibly with t tests, is flawed on both counts. There may, however, be a remedy, which takes the form of a two stage method that uses summary measures. In the first stage a suitable summary of the response in an individual, such as a rate of change or an area under a curve, is identified and calculated for each subject. In the second stage these summary measures are analysed by simple statistical techniques as though they were raw data. The method is statistically valid and likely to be more relevant to the study questions. If this method is borne in mind when the experiment is being planned it should promote studies with enough subjects and sufficient observations at critical times to enable useful conclusions to be drawn. Use of summary measures to analyse serial measurements, though not new, is potentially a useful and simple tool in medical research.
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            Pathogenesis and management of pain in osteoarthritis.

            The term osteoarthritis describes a common, age-related, heterogeneous group of disorders characterised pathologically by focal areas of loss of articular cartilage in synovial joints, associated with varying degrees of osteophyte formation, subchondral bone change, and synovitis. Joint damage is caused by a mixture of systemic factors that predispose to the disease, and local mechanical factors that dictate its distribution and severity. Various genetic abnormalities have been described, but most sporadic osteoarthritis probably depends on minor contributions from several genetic loci. Osteoarthritic joint damage may be associated with clinical problems, but the severity of joint disease is only weakly related to that of the clinical problem. For this reason the associations and pathogenesis of pain are in as much need of investigation as joint damage. Subchondral bone and synovium may be responsible for nociceptive stimuli, and peripheral neuronal sensitisation is an important feature, and can result in normal activities (such as walking) causing pain. Central pain sensitisation can also occur, and psychosocial factors are important determinants of pain severity. We present a stepwise approach to the management of osteoarthritis.
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              • Article: not found

              Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94.

              To estimate the US national prevalence of tibiofemoral radiographic knee osteoarthritis (RKOA) with and without symptoms, and its influence on functional tasks. Radiographic and interview data from the National Health and Nutrition Examination Survey (NHANES III), a nationally representative cross-sectional health examination survey, were used to estimate lifetime RKOA prevalence in adults age 60 years and older. Demographic trends, self-reported activity limitations, physical performance test results, and patterns of recent analgesic use were analyzed. Among US adults, the prevalence of RKOA and symptomatic RKOA was 37.4% and 12.1%, respectively. RKOA prevalence was greater among women than men (42.1% vs 31.2%). Women had significantly more Kellgren-Lawrence Grade 3-4 changes (12.9% vs 6.5% in men). However, symptomatic RKOA prevalence did not differ by sex. Additionally, some 1.6% of US adults had knee joint replacement. Multivariable analysis showed significantly higher odds of both RKOA and symptomatic RKOA with greater body mass index (BMI > or = 30), greater age, non-Hispanic Black race/ethnicity, and among men with manual labor occupations. Only symptomatic RKOA was significantly associated with self-reported activity limitations: difficulty walking, stooping, standing from a seated position, and stair climbing. Adults with symptomatic RKOA used significantly more assistive walking devices, had slower measured gait velocities, and used significantly more prescription nonsteroidal antiinflammatory drugs and prescription narcotics, and nonprescription acetaminophen. NHANES III data provide an overall national assessment of the prevalence, demographic distributions, and functional impact of symptomatic knee OA, which affects more than 1 in 10, or 4.3 million older US adults.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2017
                05 May 2017
                : 10
                : 1045-1054
                Affiliations
                [1 ]Miller Scientific Consulting, Inc., Asheville, NC
                [2 ]RMG Holding, Inc., Florence
                [3 ]Doctors Care, PA, Columbia, SC
                [4 ]Arrowhead Health Centers, Glendale, AZ
                [5 ]Fidia Pharma USA Inc., Parsippany, NJ, USA
                Author notes
                Correspondence: Larry E Miller, Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC 28803, USA, Tel +1 828 450 1895, Email larry@ 123456millerscientific.com
                Article
                jpr-10-1045
                10.2147/JPR.S132497
                5426467
                © 2017 Miller et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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