Minimally important clinical difference of the Timed 25-Foot Walk Test: results from a randomized controlled trial in patients with multiple sclerosis
Minimally important clinical difference of the Timed 25-Foot Walk Test: results from a randomized controlled trial in patients with multiple sclerosis
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DOI：
10.1185/03007995.2011.639752
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发表时间：
2012-01-01
影响因子：
2.3
通讯作者：
Marinucci, Lawrence N.
中科院分区：
文献类型：
--
作者：
Coleman, Craig I.;Sobieraj, Diana M.;Marinucci, Lawrence N.
背景：有限的数据定义了多发性硬化症 (MS) 定时 25 英尺步行 (T25FW) 的临床显着变化的构成因素；然而，大多数研究表明该值 >= 20%。通过分析估计 MS 患者 T25FW 测量的步行速度的最小重要临床差异 (MICD)。方法：MS-F203 的数据用于计算 T25FW 测试的 MICD（绝对值和百分比值）。使用锚定（使用临床医生整体印象 [CGI]）和基于分布（2.77 X 测量标准误差或 0.50 标准差单位）的方法。使用基于锚的估计，确定了达芬吡啶组和安慰剂组在 MS-F203 中达到至少 MICD 的患者比例。 结果：发现双盲期结束时 T25FW 速度变化与 CGI 之间存在相关性（Spearman r = -0.39，p = 0.36 英尺/秒，或与平均基线步行速度 2.1 英尺/秒相比有 17.2% 的相对变化） （效果大小 = 0.49）；代表 MICD 估计值的 0.35 和 0.37 英尺/秒是使用基于分布的方法生成的，接受达芬吡啶的患者达到 >= 0.36 英尺/秒（12/72 与 78/224，p = 0.007）和 17.2%（11/72 与 0.37 英尺/秒）。 87/224，p = 0.0005）与安慰剂相比，T25FW 速度有所改善。局限性：此分析的 MICD 估计可能不适用于具有与 MS-F203 不同疾病特征的患者。不同的锚可能会导致不同的 MICD 估计。结论：我们对 T25FW 改善的 MICD 估计接近于之前估计的 20% 变化。金额。
Background:Limited data define what constitutes a clinically significant change on the Timed 25-Foot Walk (T25FW) in multiple sclerosis (MS); however, most studies suggest a value of >= 20%. Analyses were undertaken to estimate the minimally important clinical difference (MICD) in walking speed as measured by the T25FW in patients with MS.Methods:Data from MS-F203, a randomized trial of dalfampridine extended release tablets, 10 mg twice daily (prolonged-release/sustained-release fampridine outside the US) in patients with MS, were used to calculate the MICD, as an absolute and percentage value, for the T25FW test. Both anchor- (using the Clinician Global Impression [CGI]) and distribution-based (2.77 X standard error of measurement or 0.50 standard deviation units) approaches were used. Using the anchor-based estimations, the proportion of patients in the dalfampridine and placebo groups achieving at least a MICD in MS-F203 was determined.Results:A correlation between change in T25FW speed during and CGI at the end of double-blind period was found (Spearman r = -0.39, p= 0.36 feet/second or a 17.2% relative change from an average baseline walking speed of 2.1 feet/second (effect size = 0.49); values representing MICDs. MICD estimates of 0.35 and 0.37 feet/second were generated using distribution-based approaches. In MS-F203, a greater proportion of patients receiving dalfampridine achieved >= 0.36 feet/second (12/72 vs. 78/224, p = 0.007) and a 17.2% (11/72 vs. 87/224, p = 0.0005) improvement in T25FW speed compared to placebo.Limitations:MICD estimates from this analysis may not apply to patients with different disease characteristics from MS-F203. A different anchor may result in a different MICD estimation.Conclusion:Our MICD estimate for an improvement in T25FW is close to previous estimates of 20% change. Dalfampridine may improve walking speed in a considerable proportion of patients by a clinically relevant amount.