Outcome measures in osteoarthritis: randomized controlled trials.
Outcome measures in osteoarthritis: randomized controlled trials.
复制标题
DOI：
10.1007/s11926-004-0080-6
复制
发表时间：
2004-02-01
影响因子：
5
通讯作者：
Kelman, Ariella
中科院分区：
文献类型：
--
作者：
Strand, Vibeke;Kelman, Ariella
骨关节炎（OA）随机对照试验（RCT）中公认的结局指标包括患者报告的身体功能和健康相关生活质量（HRQOL）评估。当在临床重要改善方面观察到统计学显著变化时，可用数据可以为治疗决策提供信息。在OA中验证的患者报告结局包括疼痛、疾病活动度以及身体功能和HRQOL的疾病特异性和通用指标的总体评估。最小临床重要差异（MCID）的定义来自物理治疗、非甾体抗炎药（NSAID）和环氧合酶-2选择性药物的RCT。MCID的定义应仅作为基于治疗组平均变化的指南，并不一定反映个体患者的临床有意义的改善。它们有助于解释跨治疗和患者人群的数据。MCID的定义可能因评估的干预类型而异;在评估非药物治疗时，必须解决其他方法学问题。基于评估物理治疗、环氧合酶-2药物和非甾体抗炎药的OA随机对照试验，西安大略和麦克马斯特骨关节炎指数有效、可靠、对变化敏感，并且与通用医疗结局调查简表36 HRQOL指标密切相关。在评价RCT数据时，了解结局指标的推导和MCID值有助于做出有关治疗干预的知情治疗决策。
Accepted outcome measures in randomized controlled trials (RCTs) in osteoarthritis (OA) include patient-reported assessments of physical function and health-related quality of life (HRQOL). Available data can inform treatment decisions when statistically significant changes are viewed in terms of clinically important improvements. Patient-reported outcomes validated in OA include global assessments of pain, disease activity, and disease-specific and generic measures of physical function and HRQOL. Definitions of minimum clinically important differences (MCID) have been derived from RCTs with physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and cyclooxygenase-2 selective agents. Definitions of MCID should serve only as guidelines based on mean changes in a treatment group, and do not necessarily reflect clinically meaningful improvements for an individual patient. They help to interpret data across treatments and patient populations. Definitions of MCID may differ for the type of intervention assessed; additional methodologic issues must be addressed when evaluating nonpharmacologic treatments. Based on RCTs in OA evaluating physical therapy, cyclooxygenase-2 agents, and NSAIDs, the Western Ontario and McMaster Osteoarthritis Index is valid, reliable, sensitive to change, and correlates closely with the generic Medical Outcomes Survey Short-Form 36 measure of HRQOL. When evaluating RCT data, understanding derivation and MCID values of outcome measures facilitates informed therapeutic decisions regarding therapeutic interventions.