PMID- 36811940 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230322 IS - 2368-7959 (Print) IS - 2368-7959 (Electronic) IS - 2368-7959 (Linking) VI - 10 DP - 2023 Feb 22 TI - 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. PG - e42501 LID - 10.2196/42501 [doi] LID - e42501 AB - 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. CI - (c)Aislinn D Gomez Bergin, Althea Z Valentine, Stefan Rennick-Egglestone, Mike Slade, Chris Hollis, Charlotte L Hall. Originally published in JMIR Mental Health (https://mental.jmir.org), 22.02.2023. FAU - Gomez Bergin, Aislinn D AU - Gomez Bergin AD AUID- ORCID: 0000-0002-4276-3466 AD - National Institute for Health and Care Research MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom. AD - National Institute for Health and Care Research Nottingham Biomedical Research Centre, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom. AD - Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom. FAU - Valentine, Althea Z AU - Valentine AZ AUID- ORCID: 0000-0003-2129-9278 AD - National Institute for Health and Care Research MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom. AD - Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom. FAU - Rennick-Egglestone, Stefan AU - Rennick-Egglestone S AUID- ORCID: 0000-0003-4187-011X AD - School of Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom. FAU - Slade, Mike AU - Slade M AUID- ORCID: 0000-0001-7020-3434 AD - School of Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom. AD - Faculty of Medicine and Health Sciences, Nord University, Namsos, Norway. FAU - Hollis, Chris AU - Hollis C AUID- ORCID: 0000-0003-1083-6744 AD - National Institute for Health and Care Research MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom. AD - National Institute for Health and Care Research Nottingham Biomedical Research Centre, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom. AD - Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom. FAU - Hall, Charlotte L AU - Hall CL AUID- ORCID: 0000-0002-5412-6165 AD - National Institute for Health and Care Research MindTech MedTech Co-operative, Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom. AD - National Institute for Health and Care Research Nottingham Biomedical Research Centre, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom. AD - Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom. LA - eng GR - MR/T046864/1/MRC_/Medical Research Council/United Kingdom GR - MR/W002450/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article PT - Review DEP - 20230222 PL - Canada TA - JMIR Ment Health JT - JMIR mental health JID - 101658926 PMC - PMC9996423 OTO - NOTNLM OT - adverse events OT - clinical trials OT - digital OT - harm OT - mobile phone OT - psychological interventions OT - review COIS- 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. EDAT- 2023/02/23 06:00 MHDA- 2023/02/23 06:01 PMCR- 2023/02/22 CRDT- 2023/02/22 16:06 PHST- 2022/09/06 00:00 [received] PHST- 2022/12/09 00:00 [accepted] PHST- 2022/11/11 00:00 [revised] PHST- 2023/02/22 16:06 [entrez] PHST- 2023/02/23 06:00 [pubmed] PHST- 2023/02/23 06:01 [medline] PHST- 2023/02/22 00:00 [pmc-release] AID - v10i1e42501 [pii] AID - 10.2196/42501 [doi] PST - epublish SO - JMIR Ment Health. 2023 Feb 22;10:e42501. doi: 10.2196/42501.