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

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

University of Glasgow
Cardiff University
South London and Maudsley NHS Foundation Trust, London, UK.
School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester , Manchester, England, UK; Manchester University NHS Foundation Trust , Manchester M13 9WL, UK
Orygen, The National Centre of Excellence in Youth Mental Health and Orygen Youth Health Research Centre, Melbourne, VIC, Australia.
Department of Computational Biology - USR 3756 CNRS), Institut Pasteur, Paris, France; Department of Epidemiology, Harvard T. H. Chan School of Public Health, Harvard Medical School, Boston, MA, USA.
University of Melbourne
Oxford Autoimmune Neurology Group, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.; Department of Neurology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Natbrainlab, Department of Forensic & Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK; Sacker Institute for Translational Neurodevelopment, Department of Forensic & Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
1Department of Hepatology, Imperial College London, London, UK. 2Institute of Liver Studies at King's College School of Medicine at King's College Hospital, London, UK. 3Institute of Human Health and Performance, University College London, London, UK. 4Department of Asthma Allergy and Lung Biology, King's College London, London, UK. 5Division of Critical Care Medicine, University of Alberta, Edmonton, Canada.
Department of Public Mental Health
Institute of Medical Psychology and Medical Sociology, University Medical Center Schleswig Holstein, Kiel University, 24118 Kiel, Germany; Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159 Mannheim, Germany; Institute of Cognitive and Clinical Neuroscience, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159 Mannheim, Germany
Heidelberg Univ, Ruprecht Karl University Heidelberg, Mannheim Univ Hosp
Usher Institute, University of Edinburgh, Edinburgh, UK

Research output: Contribution to journal › Article › peer-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.

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.

Original language	English
Pages (from-to)	1436-1455
Number of pages	20
Journal	Schizophrenia Bulletin
Volume	50
Issue number	6
Early online date	6 Apr 2024
DOIs	https://doi.org/10.1093/schbul/sbae031
Publication status	Published - 1 Nov 2024

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10.1093/schbul/sbae031

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Allan, S., Ward, T., Eisner, E., Bell, I. H., Cella, M., Chaudhry, I. B., Torous, J., Kiran, T., Kabir, T., Priyam, A., Richardson, C., Reininghaus, U., Schick, A., Schwannauer, M., Syrett, S., Zhang, X., & Bucci, S. (2024). Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports. Schizophrenia Bulletin, 50(6), 1436-1455. https://doi.org/10.1093/schbul/sbae031

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

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.",

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

note = "{\textcopyright} The Author(s) 2024. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.",

year = "2024",

month = nov,

day = "1",

doi = "10.1093/schbul/sbae031",

language = "English",

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Allan, S, Ward, T, Eisner, E, Bell, IH, Cella, M, Chaudhry, IB, Torous, J, Kiran, T, Kabir, T, Priyam, A, Richardson, C, Reininghaus, U, Schick, A, Schwannauer, M, Syrett, S, Zhang, X & Bucci, S 2024, 'Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports', Schizophrenia Bulletin, vol. 50, no. 6, pp. 1436-1455. https://doi.org/10.1093/schbul/sbae031

TY - JOUR

T1 - Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports

AU - Allan, Stephanie

AU - Ward, Thomas

AU - Eisner, Emily

AU - Bell, Imogen H

AU - Cella, Matteo

AU - Chaudhry, Imran B

AU - Torous, John

AU - Kiran, Tayyeba

AU - Kabir, Thomas

AU - Priyam, Aansha

AU - Richardson, Cara

AU - Reininghaus, Ulrich

AU - Schick, Anita

AU - Schwannauer, Matthias

AU - Syrett, Suzy

AU - Zhang, Xiaolong

AU - Bucci, Sandra

PY - 2024/11/1

Y1 - 2024/11/1

N2 - 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.

AB - 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.

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DO - 10.1093/schbul/sbae031

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SN - 0586-7614

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EP - 1455

JO - Schizophrenia Bulletin

JF - Schizophrenia Bulletin

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ER -

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

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