Compliance Analysis for Remote Spirometry in Subjects with Mild to Moderate Asthma

Abstract

RATIONALE Remote spirometry measures performed by means of handheld spirometers connected to smartphone applications have gained increased attention as a convenient data collection technique for patients. Additionally, this method provides more frequent data than clinical visits and allows researchers to control for data variability (diurnal variation, seasonal/environmental changes) by increasing statistical degrees of freedom. Moreover, remote and clinic spirometry data was shown to be comparable in patients with asthma and COPD. The need for remote assessments became more acute during the COVID-19 pandemic when healthcare professionals were urged to keep clinic visits to an absolute minimum to minimize the risk of infection to patients. However, a concern about remote spirometry modality is related to patient compliance remains valid: will patients perform spirometry maneuvers remotely while unsupervised? METHODS We analyzed remote spirometry compliance data from 2 clinical trials of patients with mild to moderate asthma conducted in the US and 1 in the UK. The former were single centers studies of 28-day duration and recruited 32 subjects. The latter was a multicenter study which recruited 39 subjects for 5-6 months;however only the first 28-day treatment data was analyzed to match the timeframe of the other studies. The study subjects received both experimental and standard of care treatments. All study subjects were instructed to perform pulmonary function tests at home twice daily, received a handheld spirometer, a dedicated smart phone along with training how to perform spirometry maneuvers remotely. All studies deployed mobile spirometer devices that synchronize with the smartphone application. Patients were asked to contribute spirometry data at predefined time windows (morning and evening). Compliance rates were calculated as a percentage of pulmonary function tests comprising a minimum of 2 complete maneuvers twice daily versus twice days on study. RESULTS The twice daily data compliance across three studies was 88.9%, the compliance for performing spirometry maneuvers within the specified time windows was 85% and compliance for no missing day during the study period was 83%. Additionally, we analyzed the number of compliant subjects over time across all studies: the number of compliant subjects did not decline over the period of 28 days. Moreover, the compliance analysis stratified by the time of the day and weekday/weekend demonstrated no difference in compliance. CONCLUSIONS Our results demonstrate good compliance for remote spirometry data collection for 28-day period indicating that remote spirometry data collection is feasible in the multi-center clinical trials recruiting asthma patients. .