Rutgers New Jersey Medical School, Newark, NJ.
Baylor College of Medicine, Houston, TX.
Chest. 2023 Nov;164(5):1087-1096. doi: 10.1016/j.chest.2023.06.029. Epub 2023 Jun 27.
Studies examining agreement between home and clinic spirometry in patients with asthma are limited, with conflicting results. Understanding the strengths and limitations of telehealth and home spirometry is particularly important considering the SARS-CoV-2 pandemic.
How well do home and clinic measurements of trough FEV agree in patients with uncontrolled asthma?
This post hoc analysis used trough FEV data from the randomized double-anonymized parallel-group phase 3A CAPTAIN (205715; NCT02924688) and phase 2B 205832 (NCT03012061) trials in patients with uncontrolled asthma. CAPTAIN evaluated the impact of adding umeclidinium to fluticasone furoate/vilanterol via a single inhaler; the 205832 trial investigated adding umeclidinium to fluticasone furoate vs placebo. Trough FEV measurements were collected via home spirometry and supervised in-person spirometry in the research clinic. To compare home and clinic spirometry, we examined the time-course analyses of home and clinic trough FEV, and generated post hoc Bland-Altman plots to assess agreement between home and clinic spirometry.
Data from 2,436 patients (CAPTAIN trial) and 421 patients (205832 trial) were analyzed. Treatment-related improvements in FEV were observed in both trials, using home and clinic spirometry. Improvements measured by home spirometry were of lower magnitude and less consistent than clinic measurements. Bland-Altman plots suggested poor agreement between home and clinic trough FEV at baseline and week 24.
This post hoc comparison of home and clinic spirometry is the largest conducted in asthma. Results showed that home spirometry was less consistent than and lacked agreement with clinic spirometry, suggesting that unsupervised home readings are not interchangeable with clinic measurements. However, these findings may only be applicable to home spirometry using the specific device and coaching methods employed in these studies. Postpandemic, further research to optimize home spirometry use is needed.
ClinicalTrials.gov; Nos.: NCT03012061 and NCT02924688; URL: www.
gov.
目前评估哮喘患者家庭和诊所肺功能测定仪之间一致性的研究十分有限，且结果相互矛盾。鉴于 SARS-CoV-2 大流行，了解远程医疗和家庭肺功能测定仪的优势和局限性尤为重要。
未控制哮喘患者家庭和诊所测量的谷值 FEV 之间的一致性如何？
本事后分析使用了未控制哮喘患者随机双盲平行组 3A 期 CAPTAIN（205715；NCT02924688）和 2B 期 205832（NCT03012061）试验中的谷值 FEV 数据。CAPTAIN 评估了通过单一吸入器添加乌美溴铵对糠酸氟替卡松/维兰特罗的影响；205832 试验研究了添加乌美溴铵与安慰剂相比对糠酸氟替卡松的影响。通过家庭肺功能测定仪和研究诊所的监督下的肺功能仪收集谷值 FEV 测量值。为了比较家庭和诊所肺功能测定仪，我们检查了家庭和诊所谷值 FEV 的时间进程分析，并生成事后 Bland-Altman 图来评估家庭和诊所肺功能测定仪之间的一致性。
对来自 2,436 例患者（CAPTAIN 试验）和 421 例患者（205832 试验）的数据进行了分析。使用家庭和诊所肺功能测定仪，在两项试验中均观察到与治疗相关的 FEV 改善。家庭肺功能测定仪测量的改善程度较小，且不如诊所测量值一致。Bland-Altman 图表明，在基线和第 24 周时，家庭和诊所谷值 FEV 之间的一致性较差。
这是哮喘患者中进行的最大规模的家庭和诊所肺功能测定仪的事后比较。结果表明，家庭肺功能测定仪不如诊所肺功能测定仪一致，提示未经监督的家庭读数与诊所测量值不可互换。然而，这些发现可能仅适用于这些研究中使用的特定设备和辅导方法的家庭肺功能测定仪。大流行后，需要进一步研究以优化家庭肺功能测定仪的使用。
ClinicalTrials.gov；编号：NCT03012061 和 NCT02924688；网址：www.clinicaltrials.gov。
