OARSI-OMERACT definition of relevant radiological progression in hip/knee osteoarthritis.
OARSI-OMERACT definition of relevant radiological progression in hip/knee osteoarthritis.
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DOI：
10.1016/j.joca.2009.01.007
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发表时间：
2009-07
影响因子：
7
通讯作者：
Dougados M
中科院分区：
文献类型：
--
作者：
Ornetti P;Brandt K;Hellio-Le Graverand MP;Hochberg M;Hunter DJ;Kloppenburg M;Lane N;Maillefert JF;Mazzuca SA;Spector T;Utard-Wlerick G;Vignon E;Dougados M
关节间隙宽度(JSW)在平片上以毫米为单位进行评估，是目前公认的评估骨关节炎(OA)结构进展的最佳技术。所获得的数据可以在组一级显示(例如，变化的平均值±标准差)。这样的陈述使得对所报道结果的临床相关性的解释变得困难。因此，个人层面的演示(例如，进度百分比)似乎更有吸引力，但需要确定一个分界点。目前已经提出了几种截止点的定义方法：任意选择截止点，基于预测相关终点的有效性的截止点，如全关节置换的要求，或基于测量误差，如最小可检测差值的截止点。OARSI-OMERACT计划的目标是确定平片上以毫米为单位评估的临界值，高于该临界值的JSW的变化可被认为与髋关节和膝关节骨性关节炎患者相关。第一步是利用Medline数据库进行系统的文献研究，直至2007年7月，以获取1990至2007年间发表的所有手稿，其中报告了膝关节或髋关节水平以毫米为单位的JSw分界值。第二步是在现有证据的支持下，以11位专家的最佳知识为基础达成协商一致。在检索到的506篇文章中，有47篇报道了JSW的截止日期(以毫米为单位)。截断值存在广泛的异质性，无论采用何种方法或考虑骨性关节炎的定位(例如，当考虑基于可靠性获得的数据时，膝关节(七项研究)和髋部(七项研究)的截止值分别为0.12至0.84 mm和0.22至0.78 mm)。根据从文献中提取的数据，专家委员会提出了基于普通X射线、以毫米为单位的JSW的绝对变化以及使用Bland和Altman技术计算SDD等测量误差的相关变化的定义。JSW的分析结果应该用一个二分变量来表示(例如，进展者是/否)：在此类SDD的研究过程中，JSW值发生变化的患者将符合“进展者”的定义。此外，旨在评估测量误差的初步研究应反映初步研究的不同特点，在初步研究中，放射学结果的分析将基于(患者特征、中心特征、读者)。这一倡议基于循证医学(系统文献研究)和专家意见方法，产生了一项关于骨性关节炎相关放射进展的定义的建议，作为临床试验的终点，并就允许进行这种定义的可靠性研究提出了建议。
Joint space width (JSW) evaluated in millimeters on plain X-rays is the currently optimal recognized technique to evaluate osteoarthritis (OA) structural progression. Data obtained can be presented at the group level (e.g., mean ± standard deviation of the changes). Such presentation makes difficult the interpretation of the clinical relevance of the reported results. Therefore, a presentation at the individual level (e.g., % progressors) seems more attractive but requires to determining a cut-off. Several methodologies have been proposed to define cut-offs in JSW: arbitrary chosen cut-off, cut-off based on the validity to predict a relevant end-point such as the requirement of total articular replacement or cut-off based on the measurement error such as smallest detectable difference (SDD). The objective of this OARSI–OMERACT initiative was to define a cut-off evaluated in millimeters on plain X-rays above which a change in JSW could be considered as relevant in patients with hip and knee OA. The first step consisted in a systematic literature research performed using Medline database up to July 2007 to obtain all manuscripts published between 1990 and 2007 reporting a cut-off value in JSW evaluated in millimeters at either the knee or hip level. The second step consisted in a consensus based on the best knowledge of the 11 experts with the support of the available evidence. Among the 506 articles selected by the search, 47 articles reported cut-off of JSW in millimeters. There was a broad heterogeneity in cut-off values, whatever the methodologies or the OA localization considered (e.g., from 0.12 to 0.84 mm and from 0.22 to 0.78 mm for Knee (seven studies) and hip (seven studies), respectively when considering the data obtained based on the reliability). Based on the data extracted in the literature, the expert committee proposed a definition of relevant change in JSW based on plain X-rays, on an absolute change of JSW in millimeters and on the measurement error e.g., calculation of the SDD using the Bland and Altman technique. The results of the analysis of JSW should be expressed in terms of a dichotomous variable (e.g., progressors yes/no): a patient with a change in JSW during the study over such SDD will fulfill the definition of “progressor”. Moreover, the pilot study aimed at evaluating the measurement error should be designed to reflect the different characteristics of the primary study in which the analysis of the radiological findings will be based on (patient’s characteristics, centers characteristics, readers). This initiative based on both an Evidence Based Medicine (Systematic Literature Research) and Expert Opinion approach resulted in a proposal of definition of relevant radiological progression in OA to be used as end-point in clinical trials and also recommendations on the conduct of the reliability study allowing such definition.
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