Outcome measures for multiple sclerosis clinical trials: relative measurement precision of the Expanded Disability Status Scale and Multiple Sclerosis Functional Composite
Outcome measures for multiple sclerosis clinical trials: relative measurement precision of the Expanded Disability Status Scale and Multiple Sclerosis Functional Composite
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DOI：
10.1191/1352458504ms983oa
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发表时间：
2004-02-01
影响因子：
5.8
通讯作者：
Thompson, A
中科院分区：
文献类型：
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作者：
Hobart, J;Kalkers, N;Thompson, A
我们比较了扩展残疾状态量表（EDSS）和多发性硬化功能复合量表（MSFC）的相对测量精度（RMP），以区分已知多发性硬化（MS）程度不同的患者组。共有133名患者接受了EDSS和MSFC评分，并进行了磁共振成像（MRI）扫描。根据MRI表现（T1和T2加权病变负荷、实质和心室分数-分别为TILL、T2 LL、PF、VF）对患者进行分组，并使用组间差异法确定RMP。对于每个MRI参数，总样本按大小升序排列，并分为2、3、4和5个相似大小的组。对于每个分区（2、3、4或5组），使用参数（配对样本t检验，单因素ANOVA）和非参数（Wilcoxon秩和检验，Kruskal-Wallis方差分析）统计方法比较各组的EDSS和MSFC评分，并估计RMP。EDSS与MSFC呈显著正相关（r= -0.64）。相对于MSFC，EDSS的测量精度较差，无论总样本被分成多少组，或统计方法。然而，与MSFC相比，EDSS的RMP从2%到86%不等。结果表明，MSCF比EDSS更好地检测患者组之间的差异，由这些MS的MRI标记物定义。然而，这两个尺度与MRI标记物弱相关的发现表明，它们作为MRI定义的MS病理学的预测因子是有限的。对这种公认的临床-MRI悖论的解释是，评定量表和MRI测量MS的根本不同表现。
We compared the relative measurement precision (RMP) of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) for discriminating between groups of patients known to differ in their extent of multiple sclerosis (MS). A total of 133 patients were rated with the EDSS and MSFC and had magnetic resonance imaging (MRI) scans. Patients were grouped on the basis of MRI appearances (T1- and T2-weighted lesion loads, parenchymal and ventricular fractions - TILL, T2LL, PF, VF, respectively) and RMP was determined using the method of group differences. For each MRI parameter, the total sample was arranged in ascending order of magnitude and divided into two, three, four and five similar sized groups. For each division (two, three, four or five groups), EDSS and MSFC scores for the groups were compared using parametric (paired samples t-tests, one-way ANOVA) and nonparametric (Wilcoxon's rank-sum test, Kruskal-Wallis analysis of variance) statistical methods and RMP was estimated. The EDSS and MSFC were correlated substantially (r= -0.64). Relative to the MSFC, the EDSS had inferior measurement precision regardless of the number of groups into which the total sample was divided, or the statistical method. However, the RMP of the EDSS compared with the MSFC varied from 2% to 86%. Results suggest the MSCF is better than the EDSS for detecting differences between groups of patients, defined by these MRI markers of MS. However, the finding that both scales correlated weakly with MRI markers, indicated that they are limited as predictors of MS pathology as defined by MRI. An explanation for this well-established clinical-MRI paradox is that rating scales and MRI measure fundamentally different manifestations of MS.