Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis
Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis
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DOI：
10.1016/j.joca.2004.10.012
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发表时间：
2005-01-01
影响因子：
7
通讯作者：
Reginster, JY
中科院分区：
文献类型：
--
作者：
Altman, RD;Abadie, E;Reginster, JY
目的：尊重伦理与卓越科学组织（GREES）组织了一个工作组，评估关节手术时间作为髋关节或膝关节骨关节炎（OA）潜在治疗失败结果标准在评估潜在结构修饰剂中的价值。方法：检索PubMed 1976 ~ 2004年的文献。在为期1天的会议上讨论了相关研究。结果：关节置换手术的“时间”和“适应症”尚无公认的指导方针。有限数量的试验在研究人群中检查了关节置换手术。一些参数，特别是关节间隙狭窄（骨间距离），与手术干预相关。然而，在膝关节水平，没有一个参数对关节置换术的阳性预测值高于30%。相比之下，缺乏明显的关节间隙变窄对关节置换术有很强的负面预测价值（> 90%），在控制OA疼痛严重程度后仍然如此。结论：目前，GREES不能推荐关节手术时间作为髋关节或膝关节oa结构修改试验失败的主要终点，因为该参数具有敏感性，但缺乏特异性。相比之下，在现有的试验中，关节间隙狭窄缺乏进展的预测价值为bbb90 %，不需要手术。GREES建议在髋关节和膝关节结构改变试验中，使用关节间隙狭窄（例如，> 0.3-0.7 mm）和缺乏临床相关症状改善（例如，大于或等于20-25%）作为次要结果的“失败”。(C) 2004国际骨关节炎研究学会。Elsevier Ltd.出版。版权所有。
Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents.Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting.Results: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (> 90%), that remains after controlling for OA pain severity.Conclusion: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of > 90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., > 0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., greater than or equal to 20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.