(182) A Qualitative Needs Assessment of People with CF and Research Coordinators to Inform Future Clinical Trials Incorporating Home Spirometry as an Endpoint

Background: Home spirometry holds promise as a primary endpoint for clinical trials of the future. Qualitative needs assessments describing the practices and perspectives of people with CF (PwCF), caregivers of PwCF and research coordinators (RCs) regarding home spirometry can inform strategies for incorporating home spirometry into future 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 age >13 years and caregivers with experience performing home spirometry were recruited through CFF Community Voice. RCs with experience coaching home spirometry were recruited through the CF Therapeutics Development Network from sites participating in the PROMISE study. Participants provided informed consent and completed an online survey prior to the focus group to describe their demographics and home spirometry devices.

Focus groups elicited current experiences, barriers and facilitators of home spirometry across 6 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 (Crabtree, 1992). Common themes were identified within each session; these themes were reviewed across 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 6 caregivers participated in 7 sessions, stratified by age and role (teens, adults 18-39, adults 40+, caregivers) and 24 RCs participated in 5 sessions.

Groups identified barriers and facilitators in their use of home spirometry. While 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 identified by RCs revolved around 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 vs. clinical and home vs. 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 CFF-funded multicenter, prospective study of the accuracy, variability, feasibility and acceptability of home spirometry as a clinical trial endpoint. Additionally, our results can help to inform the design of remote clinical trials of the future.

Acknowledgements: This work was supported by CFF ROSENF21A0
Thanks to all the focus group participants

References: < !Crabtree, A. A template approach to text analysis: developing and using code-books. Doing Qualitative Research. 1992;3:93-109.