The Multiple Sclerosis Functional Composite measure (MSFC): an integrated approach to MS clinical outcome assessment

The Multiple Sclerosis Functional Composite measure (MSFC): an integrated approach to MS clinical outcome assessment
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DOI:
10.1177/135245859900500409
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发表时间:
1999-08-01
影响因子:
5.8
通讯作者:
Reingold, SC
Reingold, SC
中科院分区:
医学2区
文献类型:
--
作者:
Fischer, JS;Rudick, RA;Reingold, SC

文献摘要

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由于多发性硬化(MS)症状的多样性和波动性,多发性硬化(MS)的临床结局评估具有挑战性。传统的临床量表,如EDSS是不充分的,在他们的评估PAS的关键临床维度(如认知功能),他们有心理测量学的局限性作为纬。基于对自然史研究和临床试验中安慰剂组的汇总数据的分析,国家多发性硬化症协会临床结局评估工作组最近提出了一种新的多维临床结局指标,即多发性硬化症功能复合指标(MSFC)。MSFC包括MS的三个关键临床维度的定量功能测量:腿部功能性截肢、臂/手功能和认知功能。将组分测量的分数转换为标准分数(z分数),将其平均以形成单个MSFC分数。初步分析证实:(1)MSFC的三个临床维度相对独立;(2)MSFC对1年和2年间隔的临床变化敏感;(3)MSFC具有可接受的标准有效性(即,预测同时和随后的EDSS变化)。将定量功能结果的措施,如MSFC合作数据库的优点和潜在的局限性进行了讨论。
Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of PAS (e.g, cognitive function), and they have psychometric limitations as weft. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg functional ambulation, arm/hand function, and cognitive function. scores on component measures are converted to standard scores (z-scores), which ore averaged to form a single MSFC score. Preliminary analyses confirm that (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e, predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.