Cohen J A, Fischer J S, Bolibrush D M, Jak A J, Kniker J E, Mertz L A, Skaramagas T T, Cutter G R
Mellen Center for Multiple Sclerosis Treatment and Research, Department of Neurology, Cleveland Clinic Foundation, OH 44195, USA.
Neurology. 2000 Feb 22;54(4):802-6. doi: 10.1212/wnl.54.4.802.
To assess practice effects, and intrarater and interrater reliability of the MS functional composite (MSFC) outcome measure.
To address the poor reliability and insensitivity to change of available MS clinical rating scales, the National MS Society's Clinical Outcomes Assessment Task Force developed the MSFC, a multidimensional quantitative clinical outcome measure that includes tests of leg function/ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test).
Ten patients with secondary progressive MS underwent six testing sessions over a 2-week period. The MSFC was administered by the same examining technician in the first five sessions and by the other technician in the sixth. Patients were reassessed by both technicians after 6 months (sessions 7 and 8). The MSFC score was calculated as the mean of the Z scores of the three components. A pooled dataset derived from secondary progressive MS patients in the placebo arms of previous clinical trials and natural history studies served as the reference population to standardize scores.
Practice effects were evident initially but stabilized by the fourth administration. The intraclass correlation coefficient (ICC) was 0.97 for the MSFC for session 4 versus session 5 (intrarater reliability). The ICC was 0.95 for session 5 versus session 6 (interrater reliability), and was 0.96 for session 7 versus session 8 when patients were reassessed 6 months later.
The MS functional composite (MSFC) outcome measure had excellent intrarater and interrater reliability when standardized procedures were used to train examining technicians and to assess patients. Prebaseline testing sessions should be included in clinical trials employing the MSFC to compensate for practice effects.
评估多发性硬化症功能综合指标（MSFC）结果测量的练习效应、评估者内信度和评估者间信度。
为解决现有多发性硬化症临床评定量表信度差且对变化不敏感的问题，美国国家多发性硬化症协会临床结果评估特别工作组开发了MSFC，这是一种多维定量临床结果测量方法，包括腿部功能/步行测试（25英尺定时步行）、手臂功能测试（九孔插板测试）和认知功能测试（听觉节律性连续加法测试）。
10例继发进展型多发性硬化症患者在2周内接受了6次测试。在前五次测试中由同一名检查技术员进行MSFC测试，第六次由另一名技术员进行测试。6个月后（第7次和第8次测试），两名技术员对患者进行重新评估。MSFC分数计算为三个组成部分Z分数的平均值。从先前临床试验和自然史研究的安慰剂组中的继发进展型多发性硬化症患者获得的汇总数据集用作标准化分数的参考人群。
最初练习效应明显，但在第四次测试时趋于稳定。第4次测试与第5次测试的MSFC组内相关系数（ICC）为0.97（评估者内信度）。第5次测试与第6次测试的ICC为0.95（评估者间信度），6个月后患者重新评估时，第7次测试与第8次测试的ICC为0.96。
当采用标准化程序培训检查技术员并评估患者时，多发性硬化症功能综合指标（MSFC）结果测量具有出色的评估者内信度和评估者间信度。采用MSFC的临床试验应包括基线前测试环节，以补偿练习效应。
