Timed 25-Foot Walk Direct evidence that improving 20% or greater is clinically meaningful in MS
Timed 25-Foot Walk Direct evidence that improving 20% or greater is clinically meaningful in MS
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DOI：
10.1212/wnl.0b013e31828cf7f3
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发表时间：
2013-04-01
期刊：
影响因子：
9.9
通讯作者：
Putzki, Norman
中科院分区：
文献类型：
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作者：
Hobart, Jeremy;Blight, Andrew R.;Putzki, Norman
目的：在本研究中，我们使用达芬吡啶（美国境外的芬吡啶）临床试验数据重新检验定时 25 英尺步行 (T25FW) 变化的临床意义。 方法：对达芬吡啶治疗多发性硬化症 (MS) (n = 533) 的 2 项 III 期随机安慰剂对照临床试验的汇总数据进行分析。在治疗前和治疗期间多次同时测量步行速度 (T25FW) 和患者报告的步行能力（MS Walking Scale-12 [MSWS-12]）。我们检查了访问内和访问之间的 T25FW 速度变异性、T25FW 速度与 MSWS-12 评分的相关性，以及与 T25FW 变化百分比相关的 MSWS-12 变化（平均评分、效应大小）。结果：T25FW 速度变异性很小（访问内和访问间平均值 = 7.2%-8.7% 和 14.4%-16.3%）。 T25FW 和 MSWS-12 值之间的相关性较低（-0.20 至 -0.30），但其变化值之间的相关性相对较强（-0.33 至 -0.41）。使用 MSWS-12 变化评分和效应量标准，速度提高 >= 20%，甚至可能为 15%，与自我报告的步行能力的有临床意义的变化相关。结论：本研究建立在现有研究的基础上，并提供直接证据，表明 T25FW 速度提高 >= 20% 对 MS 患者有意义。达芬吡啶数据使得以前无法进行的检查成为可能，包括自发和诱导的速度变化、与自我报告的步行能力变化相关的速度变化以及速度变化概况。结果支持 T25FW 作为 MS 临床试验的具有临床意义的结果测量。
Objective: In this study, we used data from clinical trials of dalfampridine (fampridine outside the United States) to re-examine the clinical meaningfulness of Timed 25-Foot Walk (T25FW) changes.Methods: Pooled data were analyzed from 2 phase III randomized placebo-controlled clinical trials of dalfampridine in multiple sclerosis (MS) (n = 533). Walking speed (T25FW) and patient-reported walking ability (MS Walking Scale-12 [MSWS-12]) were measured, concurrently, multiple times before and during treatment. We examined T25FW speed variability within and between visits, correlations of T25FW speed withMSWS-12 score, and changes in MSWS-12 (mean scores, effect sizes) associated with percent T25FW changes.Results: T25FW speed variability was small (within- and between-visit averages = 7.2%-8.7% and 14.4%-16.3%). Correlations between T25FW and MSWS-12 values were low (-0.20 to -0.30), but relatively stronger between their change values (-0.33 to -0.41). Speed improvements of >= 20%, and possibly 15%, were associated with clinically meaningful changes in self-reported walking ability using MSWS-12 change score and effect size criteria.Conclusions: This study builds on existing research and provides direct evidence that improvements in T25FW speed of >= 20% are meaningful to people with MS. The dalfampridine data enabled examinations previously not possible, including spontaneous and induced speed changes, speed change anchored to change in self-reported walking ability, and a profile of speed changes. Results support the T25FW as a clinically meaningful outcome measure for MS clinical trials.