Mehta Lahar, McNeill Manjit, Hobart Jeremy, Wyrwich Kathleen W, Poon Jiat-Ling, Auguste Priscilla, Zhong John, Elkins Jacob
Biogen, Cambridge, MA, USA.
Biogen, Maidenhead, UK.
Mult Scler J Exp Transl Clin. 2015 Aug 5;1:2055217315596993. doi: 10.1177/2055217315596993. eCollection 2015 Jan-Dec.
The 12-question Multiple Sclerosis Walking Scale (MSWS-12v1) is a widely-used patient-reported outcome (PRO) measure of walking ability in multiple sclerosis (MS).
To estimate the magnitude of an important change in MSWS-12v1 scores for the interpretation of meaningful subject-level improvements across a 6-month trial of MS patients with walking disability.
MOBILE was a 6-month exploratory study assessing fampridine's effect on walking ability in 132 people with MS. Three PRO measures assessed walking ability: MSWS-12v1, EuroQol 5-Dimension-5 Level (EQ-5D-5L) mobility question, and a patient global impression of change (PGIC) in overall walking ability. Pre-specified anchor- and distribution-based analyses estimated the MSWS-12v1 change scores representing an important change for participants. Results were triangulated to propose a single best value indicating meaningful improvement.
Using baseline to week 2 through week 24 change scores, anchor-based analyses demonstrated mean and median improvements of 5.2-6.6 (PGIC) and 9.7-13.4 (EQ-5D-5L mobility) points on the MSWS-12v1, indicating meaningful improvements. The distribution-based estimate was 6.8 points. Triangulation across the results suggested an 8-point reduction in MSWS-12v1 score represents an important subject-level change in these participants.
In similar MS clinical trials, an 8-point improvement on the MSWS-12v1 is a reasonable estimate of meaningful improvement in walking ability.
12项问题的多发性硬化症步行量表（MSWS-12v1）是一种广泛使用的患者报告结局（PRO）指标，用于评估多发性硬化症（MS）患者的步行能力。
估计MSWS-12v1评分的重要变化幅度，以便在一项为期6个月的针对有步行障碍的MS患者的试验中解释有意义的个体水平改善情况。
MOBILE是一项为期6个月的探索性研究，评估氨吡啶对132例MS患者步行能力的影响。三项PRO指标评估步行能力：MSWS-12v1、欧洲五维健康量表5级（EQ-5D-5L）中的活动能力问题以及患者对整体步行能力变化的总体印象（PGIC）。预先指定的基于锚定和分布的分析估计了代表参与者重要变化的MSWS-12v1变化分数。对结果进行三角测量以提出一个表明有意义改善的单一最佳值。
使用从基线到第2周直至第24周的变化分数，基于锚定的分析表明，MSWS-12v1上的平均和中位数改善分别为5.2 - 6.6分（PGIC）和9.7 - 13.4分（EQ-5D-5L活动能力），表明有意义的改善。基于分布的估计为6.8分。对结果进行三角测量表明，MSWS-12v1评分降低8分代表这些参与者个体水平的重要变化。
在类似的MS临床试验中，MSWS-12v1评分提高8分是对步行能力有意义改善的合理估计。
