Noseworthy J H, Vandervoort M K, Wong C J, Ebers G C
Department of Clinical Neurological Sciences, University of Western Ontario, London, Canada.
Neurology. 1990 Jun;40(6):971-5. doi: 10.1212/wnl.40.6.971.
We describe the interrater variability in the Expanded Disability Status Scale (EDSS) and Functional Systems (FS) in a multiple sclerosis clinical trial. Two physicians blinded to their previous assessments and to each other's scores consecutively examined 168 patients (545 paired examinations). Perfect agreement on the assignment of the disability scores ranged from 48% (cerebellar functional group) to 69% (EDSS and pyramidal functional group). Only 31% to 62% of this agreement occurred independently of that expected by chance (kappa). With the exception of the cerebellar and sensory functional groups, agreement within 1 step occurred in at least 92% of cases. These findings suggest that differences of a single step on these scales may not reflect an important functional change. We recommend that at least a 2-step change (1.0 point on the EDSS and 2 points on the FS) is needed to be confident of an important change in the degree of disability or response to treatment in this disease.
我们描述了在一项多发性硬化症临床试验中，扩展残疾状态量表（EDSS）和功能系统（FS）的评分者间变异性。两名对彼此先前评估及评分不知情的医生，对168名患者进行了连续检查（共545次配对检查）。残疾评分分配的完全一致性范围从48%（小脑功能组）到69%（EDSS和锥体功能组）。这种一致性中只有31%至62%是独立于偶然预期（kappa值）的。除小脑和感觉功能组外，至少92%的病例在1个等级内达成一致。这些发现表明，这些量表上1个等级的差异可能并不反映重要的功能变化。我们建议，要确信该疾病的残疾程度或治疗反应有重要变化，至少需要2个等级的变化（EDSS上1.0分，FS上2分）。
