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| 2. |
- Gossec, Laure, et al.
(författare)
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OARSI/OMERACT Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee Osteoarthritis. An OMERACT 10 Special Interest Group
- 2011
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Ingår i: Journal of Rheumatology. - : The Journal of Rheumatology. - 0315-162X .- 1499-2752. ; 38:8, s. 1765-1769
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Tidskriftsartikel (refereegranskat)abstract
- Objective. To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of "need for joint replacement surgery," for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA). Methods. New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons' indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA. Results. In the international cross-sectional study, there was substantial overlap in symptom levels between patients with and patients without indication for joint replacement; indeed, it was not possible to determine cutpoints for pain and function defining this indication. The post hoc analysis of trial data showed that the prevalence of cases that combined radiological progression, high level of pain, and high degree of function impairment was low (2%-12%). The most discriminatory cutpoint to define an indication for joint replacement was found to be [pain (0-100) + physical function (0-100) > 80]. Conclusion. These results do not support a specific level of pain or function that defines an indication for joint replacement. However, a tentative cutpoint for pain and physical function levels is proposed for further evaluation. Potentially, this symptom level, coupled with radiographic progression, could be used to define "nonresponders" to disease-modifying drugs in OA clinical trials. (J Rheumatol 2011;38:1765-9; doi:10.3899/jrheum.110403)
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| 3. |
- Gossec, Laure, et al.
(författare)
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OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis
- 2007
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Ingår i: Journal of Rheumatology. - 0315-162X. ; 34:6, s. 1432-1435
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Tidskriftsartikel (refereegranskat)abstract
- Objective. Time to theoretical indication of joint replacement surgery has been proposed as a primary outcome for potential structure-modifying interventions for osteoarthritis (OA). The objectives of this OMERACT/OARSI Working Group were to identify pain, physical function, and structure states that represent the progression from early to late disease for individuals with OA of the hip and knee, and to create a composite measure of these 3 domains to define states of OA severity and a surrogate measure of "need for joint replacement surgery." Methods. For pain, focus groups and one-on-one interviews were used. For function, Rasch analysis was performed on existing indices - the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the Knee injury and Osteoarthritis Outcome Score (KOOS), each of which subsumes the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questions. For structure, a comparison of existing indices (Kellgren-Lawrence, OARSI stages, and joint space width) was performed for the hip and the knee. Results. For pain, key features of pain that are most distressing to people with OA from early to late disease were identified. For function, the reduction of the number of items based on the existing indices continues. For structure, the analysis is also ongoing. Conclusion. Preliminary results were presented at OMERACT 8; the final objective will be to combine the 3 domains (pain, function, and structure) and to create a composite index that could define states of severity and "need for total joint replacement," which could be used to evaluate treatment response to disease-modifying drugs in OA clinical trials.
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- Roos, Eva M., et al.
(författare)
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ICRS recommendation document : Patient-reported outcome instruments for use in patients with articular cartilage defects
- 2011
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Ingår i: Cartilage. - : SAGE Publications. - 1947-6035 .- 1947-6043. ; 2:2, s. 122-136
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The purpose of this article is to describe and recommend patient-reported outcome instruments for use in patients with articular cartilage lesions undergoing cartilage repair interventions. Methods: Nonsystematic literature search identifying measures addressing pain and function evaluated for validity and psychometric properties in patients with articular cartilage lesions. Results: The knee-specific instruments, titled the International Knee Documentation Committee Subjective Knee Form and the Knee injury and Osteoarthritis and Outcome Score, both fulfill the basic requirements for reliability, validity, and responsiveness in cartilage repair patients. A major difference between them is that the former results in a single score and the latter results in 5 subscores. A single score is preferred for simplicity’s sake, whereas subscores allow for evaluation of separate constructs at all levels according to the International Classification of Functioning. Conclusions: Because there is no obvious superiority of either instrument at this time, both outcome measures are recommended for use in cartilage repair. Rescaling of the Lysholm Scoring Scale has been suggested, and confirmatory longitudinal studies are needed prior to recommending this scale for use in cartilage repair. Inclusion of a generic measure is feasible in cartilage repair studies and allows analysis of health-related quality of life and health economic outcomes. The Marx or Tegner Activity Rating Scales are feasible and have been evaluated in patients with knee injuries. However, activity measures require age and sex adjustment, and data are lacking in people with cartilage repair.
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| 5. |
- Dougados, Maxime, et al.
(författare)
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OARSI/OMERACT Criteria of Being Considered a Candidate for Total Joint Replacement in Knee/Hip Osteoarthritis as an Endpoint in Clinical Trials Evaluating Potential Disease Modifying Osteoarthritic Drugs
- 2009
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Ingår i: Journal of Rheumatology. - : The Journal of Rheumatology. - 1499-2752 .- 0315-162X. ; 36:9, s. 2097-2099
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Konferensbidrag (refereegranskat)abstract
- Objective. A disease-modifying osteoarthritic drug (DMOAD) should interfere with the cartilage breakdown observed and improve symptoms or prevent deterioration of the patient's clinical condition. We propose a composite index including structural and symptomatic variables of osteoarthritis (OA) as criteria for being considered a candidate for total joint replacement as an endpoint in clinical trials evaluating potential DMOAD. Methods. An OARSI/OMERACT task force conducted this study in 3 steps: (1) The 3 main domains - pain, function, structure - were revisited; (2) For each of the domains a "non-acceptable state" and a "relevant" progression for their structure were defined; and (3) a set of criteria was proposed combining the information from these 3 domains. Results. A questionnaire was elaborated for the domains "pain" and "function." Systematic research of the literature and evaluation of different databases concluded that the domain "structure" should be evaluated by radiological joint space width in millimeters. An unacceptable radiographic progression was defined as a change in the joint space width over the measurement error. An international, cross-sectional study is proposing a definition of a "nonacceptable symptom state." Conclusion. The objective of the ongoing OARSI/OMERACT initiative is to propose criteria for being considered a candidate for total joint replacement to be used as an endpoint in clinical trials evaluating potential DMOAD. The preliminary steps of this initiative have been completed. (J Rheumatol 2009;36:2097-9; doi:10.3899/jrheum.090365)
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