ArticleDigital health
Patients prefer easy adverse event reporting: Observational study within clinical trial.
Article in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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 Results: 148 (14.8%) patients reported AEs during the study. We found a significant imbalance between the channels: 11.3% ( 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.