Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports

Stephanie Allan; Thomas Ward; Emily Eisner; Imogen H Bell; Matteo Cella; Imran B Chaudhry; John Torous; Tayyeba Kiran; Thomas Kabir; Aansha Priyam; Cara Richardson; Ulrich Reininghaus; Anita Schick; Matthias Schwannauer; Suzy Syrett; Xiaolong Zhang; Sandra Bucci

doi:10.1093/schbul/sbae031

Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports

Schizophr Bull. 2024 Apr 6:sbae031. doi: 10.1093/schbul/sbae031. Online ahead of print.

Authors

Stephanie Allan¹, Thomas Ward^{2

3}, Emily Eisner⁴, Imogen H Bell^{5

6}, Matteo Cella^{2

3}, Imran B Chaudhry^{4

7

8}, John Torous⁹, Tayyeba Kiran⁶, Thomas Kabir¹⁰, Aansha Priyam⁴, Cara Richardson⁴, Ulrich Reininghaus^{2

11}, Anita Schick^{10

11}, Matthias Schwannauer¹², Suzy Syrett¹, Xiaolong Zhang⁴, Sandra Bucci^{4

13}

Affiliations

¹ School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
² School of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
³ South London & Maudsley NHS Foundation Trust, London, UK.
⁴ Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, UK.
⁵ Orygen, Parkville, VIC, Australia.
⁶ Centre for Youth Mental Health, University of Melbourne, Parkville, VIC, Australia.
⁷ Ziauddin University and Hospital Karachi, Karachi, Pakistan.
⁸ Pakistan Institute of Living & Learning, Karachi, Pakistan.
⁹ Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
¹⁰ Department of Psychiatry, University of Oxford, Oxford, UK.
¹¹ Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
¹² Department of Clinical and Health Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, UK.
¹³ Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.

PMID: 38581410
DOI: 10.1093/schbul/sbae031

Abstract

Background: Digital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs.

Study design: A systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports.

Study results: We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants.

Conclusions: The results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided.

Keywords: adverse effects; digital health; psychosis; safety; schizophrenia.

Abstract

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