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. 2023 Feb 22:10:e42501.
doi: 10.2196/42501.

Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry

Aislinn D Gómez Bergin #  1   2   3 , Althea Z Valentine  1   3 , Stefan Rennick-Egglestone  4 , Mike Slade  4   5 , Chris Hollis  1   2   3 , Charlotte L Hall  1   2   3
Affiliations

Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry

Aislinn D Gómez Bergin et al. JMIR Ment Health. .

Abstract

Background: To contextualize 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 randomized controlled trials of digital mental health interventions.

Methods: The International Standard Randomized Controlled Trial Number database was searched for trials registered before May 2022. Using advanced search filters, we identified 2546 trials in the category of mental and behavioral disorders. These trials were independently reviewed by 2 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 randomized controlled trial (protocol and primary results publication published). Published protocols and primary results publications were then retrieved. Data were extracted independently by 3 researchers, with discussion to reach consensus when required.

Results: Twenty-three trials met the eligibility criteria, of which 16 (69%) included a statement on AEs within a publication, but only 6 (26%) reported AEs within their primary results publication. Seriousness was referred to by 6 trials, relatedness by 4, and expectedness by 2. More interventions delivered with human support (9/11, 82%) than those with only remote or no support (6/12, 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 were 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 variation may reflect limited reporting processes and difficulty recognizing AEs related to digital mental health interventions. There is a need to develop guidelines specifically for these trials to improve future reporting.

Keywords: adverse events; clinical trials; digital; harm; mobile phone; psychological interventions; review.

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Conflict of interest statement

Conflicts of Interest: All authors have completed the International Committee of Medical Journal Editors uniform disclosure form. AZV, MS, and SR-E declare no conflict of interests. ADGB, CLH, and CH contributed to at least one study [35] included in this review but declare no other conflicts of interest.

Figures

Figure 1
Figure 1
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. CONSORT: Consolidated Standards Of Reporting Trials; ISRCTN: International Standard Randomized Controlled Trial Number.
See this image and copyright information in PMC

References

    1. Hollis C, Falconer CJ, Martin JL, Whittington C, Stockton S, Glazebrook C, Davies EB. Annual Research Review: Digital health interventions for children and young people with mental health problems - a systematic and meta-review. J Child Psychol Psychiatry. 2017 Apr;58(4):474–503. doi: 10.1111/jcpp.12663. - DOI - PubMed
    1. Rozental A, Andersson G, Boettcher J, Ebert DD, Cuijpers P, Knaevelsrud C, Ljótsson B, Kaldo V, Titov N, Carlbring P. Consensus statement on defining and measuring negative effects of Internet interventions. Internet Interventions. 2014 Mar;1(1):12–19. doi: 10.1016/j.invent.2014.02.001. - DOI
    1. Ioannidis JP, Evans Stephen J W, Gøtzsche Peter C, O'Neill Robert T, Altman Douglas G, Schulz Kenneth, Moher David, CONSORT Group Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004 Nov 16;141(10):781–8. doi: 10.7326/0003-4819-141-10-200411160-00009. https://www.acpjournals.org/doi/abs/10.7326/0003-4819-141-10-200411160-0... 141/10/781 - DOI - DOI - PubMed
    1. Eysenbach G, CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923. https://www.jmir.org/2011/4/e126/ v13i4e126 - DOI - PMC - PubMed
    1. E2D post-approval safety data management: definitions and standards for expedited reporting. USFDA. [2023-02-16]. https://tinyurl.com/39j9ber2 .

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