The characterisation of a patient cohort that had home spirometry devices and opted into sharing their data with the US Cystic Fibrosis Foundation

ABSTRACT

Objectives: To analyse characteristics of people with cystic fibrosis (PwCF) who were using home spirometry devices (HS) during 2020–2021 Methods: During the COVID-19 pandemic, the CF Foundation (CFF) partnered with a technology vendor, ZephyRx, to distribute MIR HS devices to eligible PwCF. During 04/2020–12/2021, 20,157 spirometers were shipped to PwCF. PwCF enrolled in the CFF patient Registry (CFFPR) provided an additional consent to have their HS values linked to their CFFPR data. An application programming interface (API) was built to allow transfers of HS data (FEV1, FVC, FEF25–75, sex, date of birth, height) from each device. Each record contained a CFFPR ID to enable its linkage to the CFFPR. This analysis uses CFFPR data to describe the HS cohort and the data obtained through API to characterise HS utilisation trends. Demographic and clinical characteristics between the HS cohort and the 2019–2020 CFFPR population ages 7 and older were also compared. Results: 272 (94.4%) CF programs participated in the HS program. Records of 1,537 patients, who had activated their device by January 10, 2021, or earlier were linked to CFFPR. The cohort was 69.8% adult, 89.5% Caucasian, 57.8% female, and had a mean age of 27.8, and mean FEV1 of 79.9% predicted. When compared to the CFFPR population, the HS cohort was older, contained more Caucasians and females, and had lower lung function. The median number of acceptable FEV1 measurements supplied per PwCF was 4 (IQR 2–8). 1065 (69%) PwCF in the HS cohort continued to use their device 6 months from activation. Conclusions: HS data has the potential to augment care and research databases like the CFFPR. Little is known about PwCF’s long-term usage of HS devices in a real-world setting. While the HS cohort is small and may be biased compared to the CFFPR population, we have established a reliable channel for collecting HS data and that PwCF’s usage patterns suggests that most are using the devices on a regular basis.