OBJECTIVES: Ascertaining medication usage in real-world settings using classical observational studies is often slow and costly. For patients with multiple sclerosis treated with interferon beta-1b a CE-certified medical app is available, allowing them to document injection-related data and their wellbeing (“wellness tracker”). Among patients also using an electronic autoinjector, which automatically records injection data, injection data are transferred into the app. All data are stored in an independently hosted database. We investigate medication usage among patients using the app-autoinjector system.

METHODS: This digital-observational study among all users (registered accounts N=1334, actively used accounts N=522, December 2017) of the CE-certified medical app in Germany employed a mixed retrospective/prospective approach. From September until December 2017 all users received two invitations on their app asking to participate and were provided with further information if they were interested in participating. An e-consenting process was established in the app. We used descriptive statistics to investigate medication usage over six months and wellness tracker usage over three month.

RESULTS: Ninety-five patients were enrolled, follow-up ended in May 2018. One patient withdrew consent, leaving 94 patients for analysis. Mean age was 46.6 years; 53.2% were women. After six months persistence was 95.7%, mean compliance (% of planned injections) 93.6% and adherence (% of patients with ≥80% compliance) 89.4%. Results did not differ by gender. The wellness tracker was used by 21.3% of participants (mean entries/user: 3.1).

CONCLUSIONS: This pilot study proves feasibility of the described study design employing recruitment, consenting, and data collection via the CE-certified medical app as well as data retrieving and processing in a time and cost efficient way. The study provides important information on medication usage and consenting behavior of patients in digital studies. In future studies this approach may allow to rapidly implement patients’ feedback into existing digital solutions.