Paris Descartes University, Medicine Faculty, Paris, France.
J Rheumatol. 2011 Aug;38(8):1765-9. doi: 10.3899/jrheum.110403.
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).
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.
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].
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.
定义疼痛和身体功能的切点，结合结构严重程度，定义“需要关节置换手术”的替代衡量标准，作为骨关节炎（OA）潜在结构修饰干预的结局衡量标准。
为膝关节和髋关节 OA 开发了新的疼痛和身体功能评分。在 1909 名患者中进行了一项国际横断面研究，以定义与骨科医生关节置换指征相对应的基于数据的切点。对 8 项随机临床试验（1379 名患者）的事后分析评估了在有症状髋/膝关节 OA 患者中，切点的患病率和有效性。
在国际横断面研究中，有手术指征和无手术指征的患者之间的症状水平存在很大重叠；事实上，无法确定定义该指征的疼痛和功能切点。试验数据的事后分析表明，联合影像学进展、高疼痛水平和高功能障碍程度的病例患病率较低（2%-12%）。发现最具鉴别力的定义手术指征的切点是[疼痛（0-100）+身体功能（0-100）>80]。
这些结果不支持定义手术指征的特定疼痛或功能水平。但是，建议进一步评估疼痛和身体功能水平的暂定切点。潜在地，这种症状水平，加上影像学进展，可用于定义 OA 临床试验中疾病修饰药物的“无反应者”。
