背景：间质性肺病（ILD）患者需要定期就诊并转诊至专科ILD诊所。获得护理的困难或延误可能会限制监测疾病轨迹和治疗反应的机会。而COVID-19大流行又增加了这些挑战。因此,家庭监控技术,如家用手持肺活量测定，获得了更多的关注，因为它们可能有助于改善ILD患者获得护理的机会。然而,虽然一些研究表明，ILD的家庭手持肺活量测定对大多数患者来说是可以接受的，来自临床试验的数据不足以支持将其用作主要终点.这篇综述讨论了最近三项ILD研究中手持肺活量测定遇到的挑战，其中包括家庭肺活量测定作为主要终点，并强调需要进一步优化和研究ILD中的家用手持式肺活量测定的地方。在最近完成的三项研究中，通过每日家庭手持肺活量测定法与现场肺活量测定法测得的强迫肺活量（FVC）下降率是主要兴趣：STARLINER（NCT03261037），STARMAP和吡非尼酮在进行性纤维化不可分类ILD中的II期研究(NCT03099187)。意外的实际和技术问题导致估计FVC下降的问题。在所有三项研究中，家庭手持肺活量测定与现场肺活量测定的横断面相关性在基线和更晚的时间点强/中等，但纵向相关性较弱。在家庭手持肺活量测定数据中观察到的其他问题包括：家庭手持FVC测量中的高患者内部变异性；家庭手持肺活量测定数据中未反映在站点肺活量测定中的不合理纵向模式；以及FVC变化的极端估计速率。
结论：ILD中的家庭手持肺活量测定需要进一步优化和研究，以确保FVC测量的准确性和可靠性，然后才能将其用作临床试验的终点。复习训练,问题和FVC变化的自动警报，和病人的支持可以帮助克服一些实际问题。尽管面临挑战,将家庭手持肺活量测定纳入临床实践是有价值的，而COVID-19大流行凸显了家庭监测技术帮助改善ILD患者获得护理的潜力。
BACKGROUND: Patients with interstitial lung disease (ILD) require regular physician visits and referral to specialist ILD clinics. Difficulties or delays in accessing care can limit opportunities to monitor disease trajectory and response to treatment, and the COVID-19 pandemic has added to these challenges. Therefore, home monitoring technologies, such as home handheld spirometry, have gained increased attention as they may help to improve access to care for patients with ILD. However, while several studies have shown that home handheld spirometry in ILD is acceptable for most patients, data from clinical trials are not sufficiently robust to support its use as a primary endpoint. This
review discusses the challenges that were encountered with handheld spirometry across three recent ILD studies, which included home spirometry as a primary endpoint, and highlights where further optimisation and research into home handheld spirometry in ILD is required. Rate of decline in forced vital capacity (FVC) as measured by daily home handheld spirometry versus site spirometry was of primary interest in three recently completed studies: STARLINER (NCT03261037), STARMAP and a Phase II study of pirfenidone in progressive fibrosing unclassifiable ILD (NCT03099187). Unanticipated practical and technical issues led to problems with estimating FVC decline. In all three studies, cross-sectional correlations for home handheld versus site spirometry were strong/moderate at baseline and later timepoints, but longitudinal correlations were weak. Other issues observed with the home handheld spirometry data included: high within-patient variability in home handheld FVC measurements; implausible longitudinal patterns in the home handheld spirometry data that were not reflected in site spirometry; and extreme estimated rates of FVC change.
CONCLUSIONS: Home handheld spirometry in ILD requires further optimisation and research to ensure accurate and reliable FVC measurements before it can be used as an endpoint in clinical trials. Refresher training, automated alerts of problems and FVC changes, and patient support could help to overcome some practical issues. Despite the challenges, there is value in incorporating home handheld spirometry into clinical practice, and the COVID-19 pandemic has highlighted the potential for home monitoring technologies to help improve access to care for patients with ILD.
