183 Chest computed tomography assessment to monitor cystic fibrosis structural lung disease progression in bronchiectasis during late childhood and adolescence

Background: Home spirometry holds promise as a primary endpoint for clinical trials.Qualitative needs assessments describing the practices and perspectives of people with cystic fibrosis (PwCF), caregivers of PwCF, and research coordinators (RCs) regarding home spirometry can inform strategies for incorporating home spirometry into clinical trials.Methods: We conducted a series of focus groups that engaged PwCF, caregivers, or RCs (separately), led by an experienced facilitator and conducted via videoconference.PwCF aged 14 and older and caregivers with experience performing home spirometry were recruited through the Cystic Fibrosis Foundation (CFF) Community Voice.RCs with experience coaching home spirometry were recruited through the CFF Therapeutics Development Network from sites participating in the PROMISE study.Participants provided informed consent and completed an online survey before the focus group to describe their demographic characteristics and home spirometry devices.Focus groups elicited current experiences and barriers to and facilitators of home spirometry across six target areas, followed by discussion and prioritization.Target areas for PwCF and caregivers included research incentives, burden of procedures, reminders, remote coaching, training, and spirometry results.Target areas for RCs included participant and RC training, remote coaching, monitoring progress, participant engagement, and institution-specific issues.Qualitative analyses followed the deductive approach of template analysis [1].Common themes identified in each session were reviewed in all PwCF or RC sessions to identify areas of consensus, which were used to formulate recommendations for future clinical trials.Results: From September to November 2021, 27 PwCF and six caregivers stratified according to age and role (teens, adults aged 18-39, adults aged ≥40, caregivers) participated in seven sessions, and 24 RCs participated in five sessions.Groups identified barriers to and facilitators of use of home spirometry.Although most PwCF and caregivers found home spirometry convenient, many experienced technical barriers, reported a learning curve to home measurement, and expressed uncertainty about the quality and reliability of measurements.Major barriers that RCs identified involved tailoring participant training to individual needs, scheduling remote coaching, and performing effective coaching remotely.Participants offered age-specific recommendations in key domains: training materials and procedures (for PwCF and RCs), remote coaching, monitoring progress, maintaining engagement, and other areas, including differences in the conduct and interpretation of research versus clinical and home versus office spirometry.Conclusions: Recommendations from this qualitative needs assessment of PwCF, caregivers, and RCs regarding home spirometry in the research setting have been incorporated into the design of OUTREACH, a CFFfunded, multicenter, prospective study of the accuracy, variability, feasibility, and acceptability of home spirometry as a clinical trial endpoint.Our results can also help inform the design of future remote clinical trials.Acknowledgements: This work was supported by