Accuracy, Reproducibility, and Responsiveness to Treatment of Home Spirometry in Cystic Fibrosis: Multicenter, Retrospective, Observational Study.

Abstract

Background: Portable spirometers are increasingly used to measure lung function at home, but doubts about the accuracy of these devices persist. These doubts stand in the way of the digital transition of chronic respiratory disease care, hence there is a need to address the accuracy of home spirometry in routine care across multiple settings and ages.

Objective: This study aimed to assess the accuracy, reproducibility, and responsiveness to the treatment of home spirometry in long-term pediatric and adult cystic fibrosis care.

Methods: This retrospective observational study was carried out in 5 Dutch cystic fibrosis centers. Home spirometry outcomes (forced expiratory volume in one second [FEV₁], and forced vital capacity [FVC]) for 601 anonymized users were collected during 3 years. For 81 users, data on clinic spirometry and elexacaftor/tezacaftor/ivacaftor (ETI) use were available. Accuracy was assessed using Bland-Altman plots for paired clinic-home measurements on the same day and within 7 days of each other (nearest neighbor). Intratest reproducibility was assessed using the American Thoracic Society/European Respiratory Society repeatability criteria, the coefficient of variation, and spirometry quality grades. Responsiveness was measured by the percentage change in home spirometry outcomes after the start of ETI.

Results: Bland-Altman analysis was performed for 86 same-day clinic-home spirometry pairs and for 263 nearest neighbor clinic-home spirometry pairs (n=81). For both sets and for both FEV₁ and FVC, no heteroscedasticity was present and hence the mean bias was expressed as an absolute value. Overall, home spirometry was significantly lower than clinic spirometry (mean ΔFEV_1clinic-home 0.13 L, 95% CI 0.10 to 0.19; mean ΔFVC_clinic-home 0.20 L, 95% CI 0.14 to 0.25) and remained lower than clinic spirometry independent of age and experience. One-way ANOVA with post hoc comparisons showed significantly lower differences in clinic-home spirometry in adults than in children (Δmean 0.11, 95% CI -0.20 to -0.01) and teenagers (Δmean 0.14, 95% CI -0.25 to -0.02). For reproducibility analyses, 2669 unique measurement days of 311 individuals were included. Overall, 87.3% (2331/2669) of FEV₁ measurements and 74.3% (1985/2669) of FVC measurements met reproducibility criteria. Kruskal-Wallis with pairwise comparison demonstrated that for both FVC and FEV₁, coefficient of variation was significantly lower in adults than in children and teenagers. A total of 5104 unique home measurements were graded. Grade E was given to 2435 tests as only one home measurement was performed. Of the remaining 2669 tests, 43.8% (1168/2669) and 43.6% (1163/2669) received grade A and B, respectively. The median percentage change in FEV₁ from baseline after initiation of ETI was 19.2% after 7-14 days and remained stable thereafter (n=33).

Conclusions: Home spirometry is feasible but not equal to clinic spirometry. Home spirometry can confirm whether lung functions remain stable, but the context of measurement and personal trends are more relevant than absolute outcomes.