LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany
Pulmonary Research Institute at the LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.
Eur Respir J. 2023 May 5;61(5). doi: 10.1183/13993003.01793-2022. Print 2023 May.
Impulse oscillometry (IOS) allows an effort-independent evaluation of small airway function in asthma. Unfortunately, well-determined minimal clinically important differences (MCIDs) 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.
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): Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire-7 (ACQ-7) and Asthma Control Test (ACT). We used multivariable analyses to investigate the proposed MCIDs as predictors for improvements in PROMs compared with the established MCID of forced expiratory volume in 1 s (FEV).
The proposed MCID was a decline of ≥0.06 kPa·L·s and ≥0.65 kPa·L for FDR and AX, respectively. Patients who had changes beyond the MCIDs 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 MCIDs for ACQ-7 and AQLQ, and approximated the MCID for ACT. Multivariable analyses demonstrated the MCIDs for both FDR and AX as independent predictors for the MCIDs of all PROMs. The MCID for FDR was a stronger predictor of all PROMs than the MCID for FEV.
This study provides MCIDs for IOS-derived measures in adult patients with asthma and emphasises that small airway function is a distinguished end-point beyond the conventional measure of FEV.
脉冲振荡法(IOS)可在哮喘患者中进行与努力无关的小气道功能评估。遗憾的是,IOS 测量的明确最小临床重要差异(MCID)尚不清楚。在此,我们提供了哮喘患者中常用的 IOS 测量指标,即阻力频率依赖性(FDR)和电抗面积(AX)的 MCID。
我们对 235 例轻至重度哮喘成人患者进行了基线和 1 年后的 IOS 检查。我们采用两步法,首先应用基于分布的方法进行统计学确定 MCID。然后,根据患者报告的结果测量(PROM)验证所提出的 MCID:哮喘生活质量问卷(AQLQ)、哮喘控制问卷-7(ACQ-7)和哮喘控制测试(ACT)。我们使用多变量分析来研究提出的 MCID 作为与 1 秒用力呼气量(FEV)的既定 MCID相比改善 PROM 的预测指标。
提出的 MCID 为 FDR 和 AX 分别下降≥0.06 kPa·L·s 和≥0.65 kPa·L。与 FDR 和 AX 的 MCID 均发生变化的患者在所有 PROM 中的改善程度均大于未发生变化的患者。PROM 的平均改善程度超过了 ACQ-7 和 AQLQ 的既定 MCID,且接近 ACT 的 MCID。多变量分析表明,FDR 和 AX 的 MCID 是所有 PROM 的 MCID 的独立预测指标。FDR 的 MCID 是所有 PROM 的比 FEV 的 MCID 更强的预测指标。
本研究为哮喘成人患者的 IOS 衍生测量指标提供了 MCID,并强调小气道功能是超越常规 FEV 测量的有区别的终点。