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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

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Authors

Rayan Taher

Palak Bhanushali

Stephanie Allan

Mario Alvarez-Jimenez

Heather Bolton

Laura Dennison

Brian E Wallace

Heather D Hadjistavropoulos

Amy Hardy

Alasdair L Henry

Sam Lane

Tess Maguire

Adam Moreton

Talar R Moukhtarian

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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