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Patients prefer easy adverse event reporting : Observational study within clinical trial
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A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä
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en
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12
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Digital Health, Volume 11, pp. 1-12
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.
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Publisher Copyright: © The Author(s) 2025.
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Lukka, L, Vesterinen, M, Juvonen, J J, Palva, S & Palva, J M 2025, 'Patients prefer easy adverse event reporting : Observational study within clinical trial', Digital Health, vol. 11, 20552076251345894, pp. 1-12. https://doi.org/10.1177/20552076251345894