Your browser doesn't support javascript.
loading
Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports.
Allan, Stephanie; Ward, Thomas; Eisner, Emily; Bell, Imogen H; Cella, Matteo; Chaudhry, Imran B; Torous, John; Kiran, Tayyeba; Kabir, Thomas; Priyam, Aansha; Richardson, Cara; Reininghaus, Ulrich; Schick, Anita; Schwannauer, Matthias; Syrett, Suzy; Zhang, Xiaolong; Bucci, Sandra.
Afiliación
  • Allan S; School of Health and Wellbeing, University of Glasgow, Glasgow, UK.
  • Ward T; School of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
  • Eisner E; South London & Maudsley NHS Foundation Trust, London, UK.
  • Bell IH; 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.
  • Cella M; Orygen, Parkville, VIC, Australia.
  • Chaudhry IB; Centre for Youth Mental Health, University of Melbourne, Parkville, VIC, Australia.
  • Torous J; School of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
  • Kiran T; South London & Maudsley NHS Foundation Trust, London, UK.
  • Kabir T; 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.
  • Priyam A; Ziauddin University and Hospital Karachi, Karachi, Pakistan.
  • Richardson C; Pakistan Institute of Living & Learning, Karachi, Pakistan.
  • Reininghaus U; Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
  • Schick A; Centre for Youth Mental Health, University of Melbourne, Parkville, VIC, Australia.
  • Schwannauer M; Department of Psychiatry, University of Oxford, Oxford, UK.
  • Syrett S; 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.
  • Zhang X; 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.
  • Bucci S; School of Mental Health and Psychological Sciences, Department of Psychology Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Schizophr Bull ; 2024 Apr 06.
Article en En | MEDLINE | ID: mdl-38581410
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.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Schizophr Bull Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Schizophr Bull Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos