The utility of electronic diaries in adverse event notification in a COPD study

Résumé fourni par la source

Introduction: Electronic diaries (e-diaries) can be used for monitoring symptoms and medication use in COPD. However, its utility in research studies to notify sites of mild exacerbations and early identification of respiratory adverse events is still uncertain. Aim: To demonstrate the utility of e-diaries in the adverse event notification in a COPD study. Method Subjects eligible for an interventional trial were given a handheld device with pre-loaded software. Subjects were advised to complete daily e-diaries and contact the site at the start of any illness and/or prior to starting treatment. Notifications were received if subjects entered additional medications or did not complete the e-diary on 2 consecutive days. Results: 14 subjects completed 12 months follow-up. The mean age was 70.4 years, 64.3% were male. Mean compliance rate was 99.2%. There were 13 respiratory adverse events, 12 moderate and 1 severe. Subjects contacted the site for 5 events. The e-diaries detected 100% of adverse events. 37 notifications were the first notification related to ‘additional medication use’. 15 notifications were for additional inhaler use alone: none were related to an exacerbation. 21 notifications were related to treatment for moderate exacerbation and 1 for severe. Subject-contact was made for all notifications with a mean time of 1.6 days. 264 notifications were for poor compliance: poor signal/upload issue 89.8%, unwell subject 9.5% and true poor compliance 0.7%. Conclusion: The daily questionnaires were able to notify sites of moderate/severe respiratory adverse events. Further work is required to optimise the system to differentiate mild exacerbations from inhaler use that is unrelated to exacerbations.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.