Miller D M, Rudick R A, Cutter G, Baier M, Fischer J S
Mellen Center for Multiple Sclerosis Treatment and Research, U-10, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA.
Arch Neurol. 2000 Sep;57(9):1319-24. doi: 10.1001/archneur.57.9.1319.
The Multiple Sclerosis Functional Composite (MSFC) was recommended by a task force of the National Multiple Sclerosis Society as a new clinical outcome measure for clinical trials. The task force recommended that the MSFC be validated against other measures of the disease, such as patient-reported quality of life.
Three hundred patients with multiple sclerosis (MS) representing the spectrum of disease severity were included in this cross-sectional study. The MSFC and Kurtzke Expanded Disability Status Scale (EDSS) were used as measures of disease severity. Clinical relevance of the disease severity scores was analyzed using measures included in the Multiple Sclerosis Quality of Life Inventory. The MSFC and EDSS scores were correlated with self-reported employment status, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Sickness Impact Profile (SIP).
The MSFC and EDSS scores were strongly correlated (r = -0.80, P<.001). The MSFC scores were correlated with patient-reported physical functioning (SIP Physical Summary Scale: r = -0.71, P<.001; SF-36 Physical Component Score: r = -0.41, P<.001). The MSFC scores were significantly but more weakly correlated with emotional functioning (SIP Psychosocial Summary Scale: r = -0.34, P<.001). After controlling for EDSS scores, there were significant residual correlations between the MSFC scores and measures of health-related quality of life, suggesting that the MSFC accounts for the variability in health-related quality of life measures not reflected by the EDSS.
The observed strong correlations between MSFC scores and validated measures of self-reported quality of life indicate that the MSFC scores are clinically relevant. This study supports a recommendation by the National Multiple Sclerosis Society Task Force to use the MSFC as a clinical outcome measure.
美国国家多发性硬化症协会的一个特别工作组推荐多发性硬化症功能综合评分（MSFC）作为临床试验的一项新的临床结局指标。该特别工作组建议将MSFC与该疾病的其他指标进行验证，比如患者报告的生活质量。
本横断面研究纳入了300例代表疾病严重程度范围的多发性硬化症（MS）患者。MSFC和库尔特克扩展残疾状态量表（EDSS）被用作疾病严重程度的指标。使用多发性硬化症生活质量量表中包含的指标分析疾病严重程度评分的临床相关性。MSFC和EDSS评分与自我报告的就业状况、医学结局研究简明健康调查问卷（SF-36）以及疾病影响量表（SIP）相关。
MSFC和EDSS评分高度相关（r = -0.80，P <.001）。MSFC评分与患者报告的身体功能相关（SIP身体综合量表：r = -0.71，P <.001；SF-36身体成分评分：r = -0.41，P <.001）。MSFC评分与情绪功能显著相关，但相关性较弱（SIP心理社会综合量表：r = -0.34，P <.001）。在控制EDSS评分后，MSFC评分与健康相关生活质量指标之间存在显著的残余相关性，这表明MSFC解释了EDSS未反映的健康相关生活质量指标的变异性。
观察到的MSFC评分与经过验证的自我报告生活质量指标之间的强相关性表明MSFC评分具有临床相关性。本研究支持美国国家多发性硬化症协会特别工作组使用MSFC作为临床结局指标的建议。
