Sharrack B, Hughes R A, Soudain S, Dunn G
Department of Neurology, UMDS, Guy's Hospital, London, UK.
Brain. 1999 Jan;122 ( Pt 1):141-59. doi: 10.1093/brain/122.1.141.
OullII;l y Many clinical rating scales have been proposed to assess the impact of multiple sclerosis on patients, but only few have been evaluated formally for reliability, validity and responsiveness. We assessed the psychometric properties of five commonly used scales in multiple sclerosis, the Expanded Disability Status Scale (EDSS), the Scripps Neurological Rating Scale (SNRS), the Functional Independence Measure (FIM), the Ambulation Index (AI) and the Cambridge Multiple Sclerosis Basic Score (CAMBS). The score frequency distributions of all five scales were either bimodal (EDSS and AI) or severely skewed (SNRS, FIM and CAMBS). The reliability of each scale depended on the definition of 'agreement'. Inter-and intra-rater reliabilities were high when 'agreement' was considered to exist despite a difference of up to 1.0 EDSS point (two 0.5 steps), 13 SNRS points, 9 FIM points, 1 AI point and 1 point on the various CAMBS domains. The FIM, AI, and the relapse and progression domains of the CAMBS were sensitive to clinical change, but the EDSS and the SNRS were unresponsive. The validity of these scales as impairment (SNRS and EDSS) and disability (EDSS, FIM, AI and the disability domain of the CAMBS) measures was established. All scales correlated closely with other measures of handicap and quality of life. None of these scales satisfied the psychometric requirements of outcome measures completely, but each had some desirable properties. The SNRS and the EDSS were reliable and valid measures of impairment and disability, but they were unresponsive. The FIM was a reliable, valid and responsive measure of disability, but it is cumbersome to administer and has a limited content validity. The AI was a reliable and valid ambulation-related disability scale, but it was weakly responsive. The CAMBS was a reliable (all four domains) and responsive (relapse and progression domains) outcome measure, but had a limited validity (handicap domain). These psychometric properties should be considered when designing further clinical trials in multiple sclerosis.
已经提出了许多临床评定量表来评估多发性硬化症对患者的影响，但只有少数量表经过了可靠性、有效性和反应性的正式评估。我们评估了多发性硬化症中常用的五个量表的心理测量特性，即扩展残疾状态量表（EDSS）、斯克里普斯神经学评定量表（SNRS）、功能独立性测量（FIM）、步行指数（AI）和剑桥多发性硬化症基础评分（CAMBS）。所有五个量表的得分频率分布要么是双峰的（EDSS和AI），要么是严重偏态的（SNRS、FIM和CAMBS）。每个量表的可靠性取决于“一致性”的定义。当尽管EDSS相差高达1.0分（两个0.5步）、SNRS相差13分、FIM相差9分、AI相差1分以及CAMBS各个领域相差1分时仍认为存在“一致性”时，评分者间和评分者内的可靠性都很高。FIM、AI以及CAMBS的复发和进展领域对临床变化敏感，但EDSS和SNRS无反应。确立了这些量表作为损伤（SNRS和EDSS）和残疾（EDSS、FIM、AI以及CAMBS的残疾领域）测量方法的有效性。所有量表都与其他残疾和生活质量测量方法密切相关。这些量表中没有一个完全满足结局测量的心理测量要求，但每个量表都有一些理想的特性。SNRS和EDSS是可靠且有效的损伤和残疾测量方法，但它们无反应。FIM是一种可靠、有效且对残疾有反应的测量方法，但实施起来很麻烦且内容效度有限。AI是一种可靠且有效的与步行相关的残疾量表，但反应较弱。CAMBS是一种可靠的（所有四个领域）且有反应的（复发和进展领域）结局测量方法，但有效性有限（残疾领域）。在设计进一步的多发性硬化症临床试验时应考虑这些心理测量特性。
