Usability evaluation of proof-of-concept electronic version of the COPD Exacerbation diary card

<bold>OBJECTIVES:</bold> The COPD Exacerbation diary card is a well-established, validated PRO tool used in the detection of exacerbation events. With the move to transition paper-based PROs to electronic platforms to improve clinical trial efficiency and quality, it is essential to demonstrate the electronic versions as faithful migrations of the original, paper-based versions, while also being user-friendly. <bold>METHODS:</bold> Using industry best practices, we electronically migrated the paper version of the COPD Exacerbation diary card, and undertook qualitative research to identify the suitability of, and potential improvements in, the electronic format for use in COPD clinical trials and routine care. Feedback was obtained from 17 participants (Male: 10/17; Female: 7/17) from the London COPD Cohort, aged 60+ (60-79: 9/17; 80+: 8/17), after demonstration of the electronic prototype by an administrator. <bold>RESULTS:</bold> 76% of participants indicated they were familiar with smartphones and technology. 47% considered the electronic prototype easy or very easy to use, and 29% perceived it to be difficult or very difficult to use. While majority (63%) preferred the existing paper format, likely due to familiarity with the existing diary card, 82% indicated they would be willing to use the electronic format if asked by their doctor and given the appropriate training. <bold>CONCLUSIO</bold><bold>N:</bold> The usability of the electronic implementation was satisfactory. However, this research provided useful insights into this cohort’s experiences towards electronic data collection, such as the careful consideration of training in older cohorts and simplicity in diary design to mitigate technology literacy and confidence in this patient population.