RT Journal Article
SR 00
ID 10.1093/schbul/sbae048
A1 Eisner, Emily
A1 Richardson, Cara
A1 Thomas, Neil
A1 Rus-Calafell, Mar
A1 Syrett, Suzy
A1 Firth, Joseph
A1 Gumley, Andrew
A1 Hardy, Amy
A1 Allan, Stephanie
A1 Kabir, Thomas
A1 Ward, Thomas
A1 Priyam, Aansha
A1 Bucci, Sandra
A1 Myin-Germeys, Inez
A1 Reininghaus, Ulrich
A1 Chaudhry, Imran
A1 Alvarez, Mario
A1 Gleeson, John
A1 Granholm, Eric
A1 Schwannauer, Matthias
A1 Garety, Philippa
A1 Torous, John
A1 Cella, Matteo
A1 Bell, Imogen
A1 van Aubel, Evelyne
A1 Kiran, Tayyeba
A1 Schick, Anita
A1 Zhang, Xiaolong
T1 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
JF Schizophrenia Bulletin
YR 2024
FD 2024-04-29
AB 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.
NO This work was supported by a Schizophrenia International Research Society (SIRS) Research Harmonisation Award: Digital Health awarded to Professor Bucci at The University of Manchester. Other funding or part-funding for individual authors was provided by an NIHR Research Professorship (Sandra Bucci; NIHR300794), NIHR Maudsley Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London (Amy Hardy), and UK Research and Innovation Future Leaders Fellowship (Joseph Firth; MR/T021780/1), with support from the NIHR Manchester Biomedical Research Centre (Sandra Bucci, Emily Eisner, Joseph Firth; NIHR203308).
PB Oxford University Press
SN 0586-7614
LK https://eprints.gla.ac.uk/325411/