Special article:Response criteria for clinical trials on osteoarthritis of the knee and hip: A report of the Osteoarthritis Research Society International Standing Committee for Clinical Initiative
Special article:Response criteria for clinical trials on osteoarthritis of the knee and hip: A report of the Osteoarthritis Research Society International Standing Committee for Clinical Initiative
复制标题
特别文章：膝关节和髋关节骨关节炎临床试验的反应标准：骨关节炎研究会国际临床倡议常务委员会的报告
DOI：
--
复制
发表时间：
2000
期刊：
影响因子：
--
通讯作者：
R. Altman
中科院分区：
文献类型：
--
作者：
M. Dougados;P. Leclaire;D. Heijde;D. A. Bolch;Nicholas Bellamy;R. Altman
背景：疼痛、功能和患者总体评估领域被确定为核心变量，在髋关节和膝关节骨关节炎患者的临床试验中经常被测量。目的：建立基于疼痛、功能和患者总体评估的髋膝关节骨性关节炎的反应标准。方法：通过骨关节炎研究会国际临床试验常设委员会、生物统计学家、制药公司代表和卫生机构代表的互动，开发了一种方法学。先前进行的安慰剂对照临床试验的数据被标准化和整理。数据按OA的位置(膝盖、髋关节)、临床试验中使用的活性物质(非类固醇抗炎药、其他药物)和给药途径(口服、关节内)进行分组。统计分析确定了最能区分活性药物和安慰剂的反应标准。结果：基于对14项研究(总计1886名患者)的数据和一致意见的分析，对于OA的位置、要使用的活性物质和给药途径，最佳应答者标准集不同。由于几乎相同的统计结果，提出了两套响应者标准：(1)对于三个领域中的至少两个领域：疼痛、功能和患者的整体评估，提出了“高”的疼痛反应，或者，作为替代，对于三个领域中的至少两个领域，提出了“中等”的反应；(2)对于疼痛或功能，或者，对于三个领域的至少两个领域：疼痛、功能和患者的整体评估，提出了至少两个的“中等”反应。敏感性(即有效组中应答者的百分比)在52%到96%之间，特异度(即对照组中无应答者的百分比)在47%到73%之间。结论：基于临床试验的数据，已经制定了两套反应标准，可以对临床试验中个体对治疗的反应进行分类。这些应答者标准需要在其他数据集中进行验证。(C)2000年国际骨性关节炎研究会。
Background: The domains of pain, function and patient's global assessment are identified as core variables and frequently measured in clinical trials of patients with osteoarthritis (OA) of the hip and knee. Objective: To develop response criteria for OA of hip and knee based on the domains of pain, function and patient's global assessment. Methods: A methodology was developed by an interaction of the Osteoarthritis Research Society International Standing Committee on Clinical Trials, biostatisticians, pharmaceutical company representatives and health agency representatives. Data from previously conducted placebo-controlled clinical trials were normalized and collated. Data were subset by location of OA (knee, hip), active agent used in the clinical trial (non-steroidal anti-inflammatory drug, other agent) and route of administration (oral, intra-articular). Statistical analysis identified response criteria which best discriminate active agent from placebo. Results: Based on the analysis of data from 14 studies (totaling 1886 patients) and consensus opinion, the optimal responder criteria set differed for location of OA, active agent to be used, and route of administration. Because of nearly identical statistical results, two sets of responder criteria are proposed: (1) 'high' pain response or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment; (2) 'high' response for either pain or function or, alternatively, a 'moderate' response for at least two of three domains: pain, function and patient's global assessment. The sensitivity (i.e., the percentage of responders in the active group) ranged from 52 to 96% and the specificity (i.e., the percentage of nonresponders in the control group) from 47 to 73%. Conclusion: Based on data from clinical trials, two sets of responder criteria have been developed that can categorize an individual's responses to treatment in a clinical trial. These responder criteria require validation in additional datasets. (C) 2000 OsteoArthritis Research Society International.
影响因子：
--
作者：
MEENAN, RF;MASON, JH;KAZIS, LE
通讯作者：
KAZIS, LE