Cohen Y C, Hassin-Baer S, Olmer L, Barishev R, Goldhammer Y, Freedman L, Mozes B
Gertner Institute for Health Policy Research, Sheba Medical Center, Tel-Hashomer, Israel.
Mult Scler. 2000 Oct;6(5):355-61. doi: 10.1177/135245850000600511.
Kurtzke's EDSS remains the most widely-used measure for clinical evaluation of MS patients. However, several studies have demonstrated the limited reliability of this tool. We introduce a computerized instrument, MS-CANE (Multiple Sclerosis Computer-Aided Neurological Examination), for clinical evaluation and follow up of patients with multiple sclerosis (MS) and to compare its reliability to that of conventional Expanded Disability Status Scale (EDSS) assessment. We developed a computerized interactive instrument, based on the following principles: structured gathering of neurological findings, reduction of compound notions to their basic components, use of precise definitions, priority setting and automated calculations of EDSS and functional systems scores. An expert panel examined the consistency of MS-CANE with Kurtzke's specifications. To determine the effect of MS-CANE on the reliability of EDSS assessment, 56 MS patients underwent paired conventional EDSS and MS-CANE-based evaluations. The inter-observer agreement in both methods was determined and compared using the kappa statistic. The expert panel judged the tool to be compatible with the basic concepts of Kurtzke's EDSS. The use of MS-CANE increased the reliability of EDSS assessment: Kappa statistic was found to be 0.42 (i.e. moderate agreement) for conventional EDSS assessment versus 0.69 (i.e. substantial agreement) for MS-CANE (P=0.002). We conclude that the use of this tool may contribute towards a standardized and reliable assessment of EDSS. Within clinical trials, this could increase the power to detect effects, thus reducing trial duration and the cohort size required. Multiple Sclerosis (2000) 6 355 - 361
库尔茨克的扩展残疾状态量表(EDSS)仍是评估多发性硬化症(MS)患者临床状况最广泛使用的方法。然而,多项研究表明该工具的可靠性有限。我们引入了一种计算机化工具——MS-CANE(多发性硬化症计算机辅助神经学检查),用于多发性硬化症患者的临床评估和随访,并将其可靠性与传统的扩展残疾状态量表(EDSS)评估进行比较。我们基于以下原则开发了一种计算机化交互式工具:对神经学检查结果进行结构化收集,将复合概念简化为基本组成部分,使用精确的定义,设定优先级以及自动计算EDSS和功能系统评分。一个专家小组检查了MS-CANE与库尔茨克标准的一致性。为了确定MS-CANE对EDSS评估可靠性的影响,56例MS患者接受了传统EDSS评估和基于MS-CANE的评估。使用kappa统计量确定并比较了两种方法中观察者间的一致性。专家小组判定该工具与库尔茨克EDSS的基本概念相符。使用MS-CANE提高了EDSS评估的可靠性:传统EDSS评估的kappa统计量为0.42(即中度一致性),而MS-CANE为0.69(即高度一致性)(P = 0.002)。我们得出结论,使用该工具可能有助于对EDSS进行标准化和可靠的评估。在临床试验中,这可以提高检测效果的能力,从而缩短试验持续时间并减少所需的队列规模。《多发性硬化症》(2000年)6 355 - 361