OBJECTIVES: eDiary assessment of pruritus in atopic dermatitis (AD) clinical trials using patient-reported outcome measures (PROMs), such as the validated Peak Pruritus Numerical Rating Scale (PP-NRS), is invaluable in supplementing endpoint data and determining the study medication’s effectiveness. Device alarms can be used ensure timely completion of assessments and drive compliance. This study investigated the impact of device alarms on completion compliance of PP-NRS eDiaries in adult and pediatric participants in AD clinical trials.

METHODS: Over 680,000 completed PP-NRS eDiary entries were collected from adult (n=5532) or pediatric participants (n=1191) across 8 ongoing AD studies. Alarms were programmed for each eDiary reporting window, and the difference between the participant’s alarm time and the time the eDiary was first opened was compared.

RESULTS: Across the studies, sixty-seven percent (67%) of adults and seventy-eight percent (78%) of children opened their eDiaries after the scheduled alarm time. Fifty-eight percent (58%) of adults and forty-six percent (46%) of children answered their eDiaries within 30 minutes after the scheduled alarm time, and eighty-three percent (83%) of adults and sixty-four percent (64%) of children within 2 hours after the scheduled alarm time. The observed trend in the differences between alarm time and eDiary opening time appeared similar in both age groups, suggesting that both age groups tended to open their eDiaries around the same time windows.

CONCLUSIONS: This analysis suggests that eDiary alarms are useful in driving completion compliance in adult and pediatric participants, encouraging them to answer their eDiary within two-hours of their scheduled alarm time. Although this supports the use of eDiary alarms to enhance completion compliance in AD clinical trials, sites and study teams should continue to communicate the importance of eDiary completion to participants, and proactively follow up non-compliant patients, throughout the trial to ensure optimal compliance and proper completion of assessments.