Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis
Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis
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DOI：
10.1016/j.rmed.2015.04.008
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发表时间：
2015-07-01
影响因子：
4.3
通讯作者：
King, Talmadge E., Jr.
中科院分区：
文献类型：
--
作者：
Nathan, Steven D.;du Bois, Roland M.;King, Talmadge E., Jr.
背景资料：6分钟步行测试距离（6 MWD）已被证明是特发性肺纤维化（IPF）患者的有效和响应性结局指标。分析的基础上，但是，在一个单一的3期试验，并需要在一个独立的coherent.Objective验证：为了确认的性能特点和估计的最小临床重要差异（MCID）的6 MWD在一个独立的队列patients with IPF.Methods：患者随机分配到安慰剂的3期CAPACITY试验谁有基线6 MWD测量包括在这些分析。在基线和24周间隔测量6 MWD和其他功能参数（肺功能、呼吸困难和健康相关生活质量）。使用斯皮尔曼相关系数检验有效性和反应性。MCID估计使用分布和锚为基础的methods.Results：分析包括338例患者。基线6 MWD与肺功能指标、患者报告结局和生活质量指标（有效性）显著相关。与基线6 MWD相比，6 MWD（反应性）的变化与肺功能参数和生活质量指标的变化具有更强的相关性。由加州圣地亚哥大学呼吸短促问卷测量的呼吸困难与6 MWD的相关性最强（基线：系数-0.35; 48周变化：系数-0.37;均p < 0.001）。使用测量标准误对MCID进行基于分布的分析得出MCID为37 m，按效应量进行基于分布的分析得出MCID为29.2 m。MCID锚为基础的分析，使用标准参考（住院或死亡的健康事件）为21.7米。结论：6分钟步行距离是一个有效的和响应的临床终点，它提供了客观的和有临床意义的信息功能状态和近期预后。这些结果证实了先前在一个独立的IPF患者队列中的发现。(C)2015作者由爱思唯尔有限公司发布
Background: The 6-minute walk test distance (6MWD) has been shown to be a valid and responsive outcome measure in patients with idiopathic pulmonary fibrosis (IPF). The analyses were based, however, on a single phase 3 trial and require validation in an independent cohort.Objective: To confirm the performance characteristics and estimates of minimal clinically important difference (MCID) of 6MWD in an independent cohort of patients with IPF.Methods: Patients randomized to placebo in the phase 3 CAPACITY trials who had a baseline 6MWD measurement were included in these analyses. The 6MWD and other functional parameters (lung function, dyspnea, and health-related quality of life) were measured at baseline and 24-week intervals. Validity and responsiveness were examined using Spearman correlation coefficients. The MCID was estimated using distribution-and anchor-based methods.Results: The analysis comprised 338 patients. Baseline 6MWD was significantly correlated with lung function measures, patient-reported outcomes, and quality-of-life measures (validity). Compared with baseline 6MWD, change in 6MWD (responsiveness) showed stronger correlations with change in lung function parameters and quality-of-life measures. Dyspnea measured by the University of California San Diego Shortness of Breath Questionnaire showed the strongest correlations with 6MWD (baseline: coefficient -0.35; 48-week change: coefficient -0.37; both p < 0.001). The distribution-based analyses of MCID using standard error of measurement yielded an MCID of 37 m, and distribution-based analyses by effect size resulted in 29.2 m. The MCID by anchor-based analysis using criterion referencing (health events of hospitalization or death) was 21.7 m.Conclusions: The 6MWD is a valid and responsive clinical endpoint, which provides objective and clinically meaningful information regarding functional status and near-term prognosis. These results confirm previous findings in an independent cohort of patients with IPF. (C) 2015 The Authors. Published by Elsevier Ltd.