Adverse events reporting in digital interventions evaluations for psychosis: A systematic literature search and individual level content analysis of adverse event reports.

the iCharts network

Research output: Contribution to journalArticlepeer-review

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.
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.
Results: We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were pre-identified by these 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.
Original languageEnglish
Article numbersbae031
JournalSchizophrenia Bulletin
Early online date6 Apr 2024
DOIs
Publication statusE-pub ahead of print - 6 Apr 2024

Keywords

  • Psychosis
  • Schizophrenia
  • Adverse Effects
  • Digital Health
  • Safety

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