학술논문
Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures.
Document Type
Academic Journal
Author
Eisner E; Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.; Richardson C; Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Thomas N; Centre for Mental Health and Brain Sciences, Swinburne University of Technology, Melbourne, Australia.; Monash Alfred Psychiatry Research Centre, Alfred Hospital, Melbourne, Australia.; Rus-Calafell M; Mental Health Research and Treatment Centre, Ruhr-Universität Bochum, Bochum, Germany.; Syrett S; School of Health and Wellbeing, University of Glasgow, Glasgow, UK.; NHS Research Scotland Mental Health Network, Edinburgh, UK.; Firth J; Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.; Gumley A; School of Health and Wellbeing, University of Glasgow, Glasgow, UK.; Hardy A; Institute of Psychiatry, Psychology, and Neuroscience; King's College London, London, UK.; South London & Maudsley NHS Foundation Trust, London, UK.; Allan S; School of Health and Wellbeing, University of Glasgow, Glasgow, UK.; Kabir T; McPin Foundation, London, UK.; Departments of Experimental Psychology & Psychiatry, Oxford University, Oxford, UK.; Ward T; Institute of Psychiatry, Psychology, and Neuroscience; King's College London, London, UK.; South London & Maudsley NHS Foundation Trust, London, UK.; Priyam A; Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.; Bucci S; Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.; Research and Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Source
Publisher: Oxford University Press Country of Publication: United States NLM ID: 0236760 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1745-1701 (Electronic) Linking ISSN: 05867614 NLM ISO Abbreviation: Schizophr Bull Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Given the rapid expansion of research into digital health interventions (DHIs) for severe mental illness (SMI; eg, schizophrenia and other psychosis diagnoses), there is an emergent need for clear safety measures. Currently, measurement and reporting of adverse events (AEs) are inconsistent across studies. Therefore, an international network, iCharts, was assembled to systematically identify and refine a set of standard operating procedures (SOPs) for AE reporting in DHI studies for SMI.
Design: The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature.
Results: A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified.
Conclusions: The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.)
Design: The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature.
Results: A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified.
Conclusions: The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.)