Self-Management Maintenance Inhalation Therapy With eHealth (SELFIE): Observational Study on the Use of an Electronic Monitoring Device in Respiratory Patient Care and Research (Preprint)

Abstract

BACKGROUND Electronic inhalation monitoring devices (EIMDs) are available to remind patients with respiratory diseases to take their medication and register inhalations for feedback to patients and health care providers as well as for data collection in research settings. OBJECTIVE This study aimed to assess the validity as well as the patient-reported usability and acceptability of an EIMD. METHODS This observational study planned to include 21 community pharmacies in the Netherlands. Patient-reported inhalations were collected and compared to EIMD registrations to evaluate the positive predictive value of these registrations as actual patient inhalations. Patients received questionnaires on their experiences and acceptance. RESULTS A convenience sample of 32 patients was included from across 18 pharmacies, and 932 medication doses were validated. Of these, 796 registrations matched with patient-reported use (true-positive, 85.4%), and 33 inhalation registrations did not match with patient-reported use (false-positive, 3.5%). The positive predictive value was 96.0%, and 103 patient-reported inhalations were not recorded in the database (false-negative, 11.1%). Overall, patients considered the EIMD to be acceptable and easy to use, but many hesitated to continue its use. Reminders and motivational messages were not appreciated by all users, and more user-tailored features in the app were desired. CONCLUSIONS Patients’ interaction with the device in real-world settings is critical for objective measurement of medication adherence. The positive predictive value of this EIMD was found to be acceptable. However, patients reported false-negative registrations and a desire to include more user-tailored features to increase the usability and acceptability of the EIMD.