Patients prefer easy adverse event reporting: Observational study within clinical trial.

Abstract

Background: Digital intervention safety is crucial for regulatory approval and clinical adoption. However, the evaluation and reporting of adverse events (AEs) in clinical trials are often insufficient. Digital qualitative self-reporting could enhance the detection of AEs, but patient preferences for using such channels remain understudied.

Methods: This observational study was conducted in Finland between 2022 and 2024 within a randomized controlled trial evaluating the efficacy of Meliora, a game-based digital intervention for patients living with major depressive disorder. We assessed the preferences of 1001 patients for self-reporting AEs across four channels: a prompted, within-intervention questionnaire (CORTO: Contextual, One-item, Repeated, Timely, Open-ended), a Jira questionnaire, email, and phone.

Results: 148 (14.8%) patients reported AEs during the study. We found a significant imbalance between the channels: 11.3% (n = 113) of patients reported AEs using CORTO, 4.1% (n = 41) using email, 1.1% (n = 11) using Jira, and 0.4% (n = 4) using phone.

Conclusions: These findings reveal that patients prefer low-effort methods for reporting AEs and are more likely to report AEs via a prompted, within-intervention questionnaire (CORTO) than through other methods. Integrating qualitative self-report channels into digital interventions may enhance AE detection rates, improve clinical trial safety monitoring, and support post-market surveillance.