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Identifying, Monitoring, and Reporting Adverse Events in Digital Mental Health: Guidance from a Co-Production Workshop and Consensus Consultation in the UK
ABSTRACT
Background:
Digital mental health trials underreport adverse events (AEs), leading to insufficient understanding of risk. Previous research suggests unique challenges in AE reporting in digital mental health, many of which may be mitigated.
Objective:
The Adverse Events in Digital Mental Health (AVERT) study aimed to develop guidance for identifying, monitoring, and reporting AEs in digital mental health interventions.
Methods:
We followed an established methodology, adapted to support involvement of people with lived experience. A literature review identifying existing challenges and gaps in AE reporting in digital mental health trials was shared during an online co-production workshop in November 2023, attended by eight academics and five individuals with lived experience expertise (n=13). This promoted discussions on AE identification, monitoring, and reporting, and voting on key definitions to inform the initial set of guidance. A structured online consultation followed involving 12 respondents from research, regulatory, and lived experience backgrounds. Consensus was defined as ≥80% agreement and qualitative feedback was analysed to refine the guidance for clarity, and applicability to digital mental health contexts.
Results:
The workshops indicated six areas where additional guidance is needed in the context of digital mental health. Guidance was developed to address; trial oversight, how AEs are defined, how they are monitored, ensuring transparent AE processes, new or unexpected AEs, and improvements to the quality of reporting. This included examples and rationale to support understanding.
Conclusions:
The AVERT guidelines provide clear recommendations that complement existing guidelines as a minimum standard for UK-based researchers and developers to identify, monitor, and report AEs in digital mental health trials.
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