Strand Vibeke, Kelman Ariella
Division of Immunology and Rheumatology, Stanford University, 306 Ramona Road, Portola Valley, CA 94028, USA.
Curr Rheumatol Rep. 2004 Feb;6(1):20-30. doi: 10.1007/s11926-004-0080-6.
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.
骨关节炎（OA）随机对照试验（RCT）中公认的疗效指标包括患者报告的身体功能评估和健康相关生活质量（HRQOL）评估。当从具有临床重要意义的改善角度看待具有统计学显著意义的变化时，现有数据可为治疗决策提供参考。在OA中得到验证的患者报告结局包括疼痛的总体评估、疾病活动度以及身体功能和HRQOL的疾病特异性及通用指标。最小临床重要差异（MCID）的定义源自物理治疗、非甾体抗炎药（NSAIDs）和环氧化酶-2选择性药物的RCT。MCID的定义仅应作为基于治疗组平均变化的指导原则，不一定反映个体患者具有临床意义的改善情况。它们有助于解释不同治疗方法和患者群体的数据。对于所评估的干预类型，MCID的定义可能不同；在评估非药物治疗时，必须解决其他方法学问题。基于OA中评估物理治疗、环氧化酶-2药物和NSAIDs的RCT，西安大略和麦克马斯特大学骨关节炎指数有效、可靠、对变化敏感，并且与HRQOL的通用医疗结局调查简表36密切相关。在评估RCT数据时，了解结局指标的推导过程和MCID值有助于做出有关治疗干预的明智治疗决策。
