Rayan Taher
Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context
Taher, Rayan; Bhanushali, Palak; Allan, Stephanie; Alvarez-Jimenez, Mario; Bolton, Heather; Dennison, Laura; Wallace, Brian E; Hadjistavropoulos, Heather D; Hall, Charlotte L; Hardy, Amy; Henry, Alasdair L; Lane, Sam; Maguire, Tess; Moreton, Adam; Moukhtarian, Talar R; Perez Vallejos, Elvira; Shergill, Sukhi; Stahl, Daniel; Thew, Graham R; Timulak, Ladislav; van den Berg, David; Viganò, Noemi; Wensley Stock, Ben; Young, Katherine S; Yiend, Jenny
Authors
Palak Bhanushali
Stephanie Allan
Mario Alvarez-Jimenez
Heather Bolton
Laura Dennison
Brian E Wallace
Heather D Hadjistavropoulos
CHARLOTTE HALL CHARLOTTE.HALL@NOTTINGHAM.AC.UK
Principal Research Fellow
Amy Hardy
Alasdair L Henry
Sam Lane
Tess Maguire
Adam Moreton
Talar R Moukhtarian
ELVIRA PEREZ VALLEJOS elvira.perez@nottingham.ac.uk
Professor of Digital Technology For Mental Health
Sukhi Shergill
Daniel Stahl
Graham R Thew
Ladislav Timulak
David van den Berg
Noemi Viganò
Ben Wensley Stock
Katherine S Young
Jenny Yiend
Abstract
Background
Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence.
Aims
The aim of this study was to generate an experts’ consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs.
Method
An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health.
Results
Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general.
Conclusion
The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.
Citation
Taher, R., Bhanushali, P., Allan, S., Alvarez-Jimenez, M., Bolton, H., Dennison, L., …Yiend, J. (2024). Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context. BJPsych Open, 10(4), Article e126. https://doi.org/10.1192/bjo.2024.713
Journal Article Type | Article |
---|---|
Acceptance Date | Apr 23, 2024 |
Online Publication Date | Jun 3, 2024 |
Publication Date | 2024-07 |
Deposit Date | Apr 25, 2024 |
Publicly Available Date | Apr 25, 2024 |
Journal | BJPsych Open |
Electronic ISSN | 2056-4724 |
Publisher | Cambridge University Press |
Peer Reviewed | Peer Reviewed |
Volume | 10 |
Issue | 4 |
Article Number | e126 |
DOI | https://doi.org/10.1192/bjo.2024.713 |
Keywords | Digital mental health interventions, consensus, mental health, safety, MHRA |
Public URL | https://nottingham-repository.worktribe.com/output/34105230 |
Publisher URL | https://www.cambridge.org/core/journals/bjpsych-open/article/bridging-the-gap-from-medical-to-psychological-safety-assessment-consensus-study-in-a-digital-mental-health-context/91014B17B1C8F872E686CF6316A94363 |
Additional Information | Copyright: Copyright © The Author(s), 2024. Published by Cambridge University Press on behalf of Royal College of Psychiatrists; License: This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.; Free to read: This content has been made available to all. |
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