成人哮喘患者脉冲振荡法的最小临床重要差异
2023/02/20
摘要
背景：脉冲振荡法（IOS）被认可对哮喘患者的小气道功能进行独立评估。不幸的是，IOS测量缺乏确定的最小临床重要差异（MCID）。本研究中，我们提供了常用IOS测量的MCID，即哮喘患者的电阻频率依赖性（FDR）和电抗面积（AX）。
方法：我们在基线和1年后对轻度至重度哮喘的成年患者（n=235）进行了IOS测量。在两步方法中，我们首先应用基于分布的方法来统计确定MCID。接下来，我们根据哮喘生活质量问卷（AQLQ）、哮喘控制问卷（ACQ）和哮喘控制测试（ACT）的患者报告结果测量（PROM）验证了所提出的MCID。我们使用多变量分析来研究所提出的MCID作为与FEV1的已建立MCID相比PROM改善的预测因子。
结果：FDR和AX的MCID分别下降≥0.06 kPa·L-1·s-1和≥0.65 kPa·L－1。FDR和AX的变化超过MCID的患者在所有胎膜早破方面的改善都比没有变化的患者大。PROM的平均改善超过了ACQ和AQLQ的既定MCID，接近ACT评分的MCID。多变量分析表明FDR和AX的MCID是所有PROM MCID的独立预测因子。FDR的MCID比FEV1的MCID更能预测所有PROM。
结论：本研究为成人哮喘患者IOS衍生的测量提供了MCID，并强调小气道功能是优于常规FEV1测量的一个显著终点。
Minimal Clinically Important Difference for Impulse Oscillometry in Adults with Asthma
Mustafa Abdo, Anne-Marie Kirsten, Erika von Mutius, Matthias Kopp, Gesine Hansen, Klaus F Rabe, Henrik Watz, Frederik Trinkmann, Thomas Bahmer; ALLIANCE study group
Abstract
Background: Impulse oscillometry (IOS) allows an effort-independent evaluation of small airway function in asthma. Unfortunately, well-determined minimal clinically important differences (MCID) for IOS-measures are lacking. Here, we provide MCIDs for frequently used IOS-measures, namely frequency dependence of resistance (FDR) and area of reactance (AX) in patients with asthma.
Methods: We performed IOS at baseline and 1 year later in adult patients with mild to severe asthma (n=235). In a two-step approach, we first applied a distribution-based method to statistically determine the MCID. Next, we validated the proposed MCID according to patient-reported outcome measures (PROMs) of Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Control Test (ACT). We used multivariable analyses to investigate the proposed MCIDs as predictors for improvements in PROMs in comparison to the established MCID of FEV1.
Results: The proposed MCID was a decline of≥0.06 kPa·L-1·s-1 and≥0.65 kPa·L-1 for FDR and AX, respectively. Patients who had changes beyond the MCID for both FDR and AX showed greater improvements in all PROMs than those who had not. The mean improvements in PROMs were beyond the established MCID for ACQ and AQLQ and approximated the MCID for ACT score. Multivariable analyses demonstrated the MCID for both FDR and AX as independent predictors for the MCID of all PROMs. The MCID for FDR was a stronger predictor of all PROMs than the MCID for FEV1.
Conclusion: This study provides MCIDs for IOS-derived measures in adult patients with asthma and emphasizes that small airway function is a distinguished endpoint beyond the conventional measure of FEV1.
背景：脉冲振荡法（IOS）被认可对哮喘患者的小气道功能进行独立评估。不幸的是，IOS测量缺乏确定的最小临床重要差异（MCID）。本研究中，我们提供了常用IOS测量的MCID，即哮喘患者的电阻频率依赖性（FDR）和电抗面积（AX）。
方法：我们在基线和1年后对轻度至重度哮喘的成年患者（n=235）进行了IOS测量。在两步方法中，我们首先应用基于分布的方法来统计确定MCID。接下来，我们根据哮喘生活质量问卷（AQLQ）、哮喘控制问卷（ACQ）和哮喘控制测试（ACT）的患者报告结果测量（PROM）验证了所提出的MCID。我们使用多变量分析来研究所提出的MCID作为与FEV1的已建立MCID相比PROM改善的预测因子。
结果：FDR和AX的MCID分别下降≥0.06 kPa·L-1·s-1和≥0.65 kPa·L－1。FDR和AX的变化超过MCID的患者在所有胎膜早破方面的改善都比没有变化的患者大。PROM的平均改善超过了ACQ和AQLQ的既定MCID，接近ACT评分的MCID。多变量分析表明FDR和AX的MCID是所有PROM MCID的独立预测因子。FDR的MCID比FEV1的MCID更能预测所有PROM。
结论：本研究为成人哮喘患者IOS衍生的测量提供了MCID，并强调小气道功能是优于常规FEV1测量的一个显著终点。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(Eur Respir J. 2023 Feb 9;2201793. doi: 10.1183/13993003.01793-2022.)
(Eur Respir J. 2023 Feb 9;2201793. doi: 10.1183/13993003.01793-2022.)
Minimal Clinically Important Difference for Impulse Oscillometry in Adults with Asthma
Mustafa Abdo, Anne-Marie Kirsten, Erika von Mutius, Matthias Kopp, Gesine Hansen, Klaus F Rabe, Henrik Watz, Frederik Trinkmann, Thomas Bahmer; ALLIANCE study group
Abstract
Background: Impulse oscillometry (IOS) allows an effort-independent evaluation of small airway function in asthma. Unfortunately, well-determined minimal clinically important differences (MCID) for IOS-measures are lacking. Here, we provide MCIDs for frequently used IOS-measures, namely frequency dependence of resistance (FDR) and area of reactance (AX) in patients with asthma.
Methods: We performed IOS at baseline and 1 year later in adult patients with mild to severe asthma (n=235). In a two-step approach, we first applied a distribution-based method to statistically determine the MCID. Next, we validated the proposed MCID according to patient-reported outcome measures (PROMs) of Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and Asthma Control Test (ACT). We used multivariable analyses to investigate the proposed MCIDs as predictors for improvements in PROMs in comparison to the established MCID of FEV1.
Results: The proposed MCID was a decline of≥0.06 kPa·L-1·s-1 and≥0.65 kPa·L-1 for FDR and AX, respectively. Patients who had changes beyond the MCID for both FDR and AX showed greater improvements in all PROMs than those who had not. The mean improvements in PROMs were beyond the established MCID for ACQ and AQLQ and approximated the MCID for ACT score. Multivariable analyses demonstrated the MCID for both FDR and AX as independent predictors for the MCID of all PROMs. The MCID for FDR was a stronger predictor of all PROMs than the MCID for FEV1.
Conclusion: This study provides MCIDs for IOS-derived measures in adult patients with asthma and emphasizes that small airway function is a distinguished endpoint beyond the conventional measure of FEV1.
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