Accepted for/Published in: JMIR Mental Health
Date Submitted: Sep 6, 2022
Date Accepted: Dec 9, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
How are adverse events identified and categorised in trials of digital mental health interventions? A narrative systematic review of trials in the ISRCTN registry
ABSTRACT
Background:
To contextualise the benefits of an intervention it is important that adverse events (AEs) are reported. This is potentially difficult in trials of digital mental health interventions, where delivery may be remote and the mechanisms of actions less understood.
Objective:
We aimed to explore the reporting of AEs in digital mental health intervention randomised controlled trials (RCTs).
Methods:
The International Standard Randomised Controlled Trial Number (ISRCTN) database was searched for trials registered before May 2022. Using advanced search filters, 2,546 trials in the category of mental and behavioural disorders were identified. These were independently reviewed by two researchers against the eligibility criteria. Trials were included where digital mental health interventions for participants with a mental health disorder were evaluated through a completed RCT (protocol and primary results publication (PRP) published). Published protocols and PRPs were then retrieved. Data were extracted independently by three researchers, with discussion to reach consensus when required.
Results:
Twenty-one trials met the eligibility criteria, of which 14 (66%) included a statement on AEs within a publication but only six (29%) reported AEs within their PRP. Seriousness was referred to by six trials, relatedness by four, and expectedness by two. More interventions delivered with human support (80%) than those with only remote support (50%) included a statement on AEs, but they did not report more AEs. Several reasons for participant dropout were identified by trials that did not report AEs, of which some are identifiable or related to AEs including serious AEs.
Conclusions:
There is significant variation in the reporting of AEs in trials of digital mental health interventions. This may reflect limited reporting processes and/ or difficulty recognising AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.
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