Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context

Rayan Taher; Palak Bhanushali; Stephanie Allan; Mario Alvarez-Jimenez; Heather Bolton; Laura Dennison; Brian E. Wallace; Heather D. Hadjistavropoulos; Charlotte L. Hall; Amy Hardy; Alasdair L. Henry; Sam Lane; Tess Maguire; Adam Moreton; Talar R. Moukhtarian; Elvira Perez Vallejos; Sukhi Shergill; Daniel Stahl; Graham R. Thew; Ladislav Timulak; David Van Den Berg; Noemi Viganò; Ben Wensley Stock; Katherine S. Young; Jenny Yiend

doi:10.1192/bjo.2024.713

Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context

Rayan Taher, Palak Bhanushali, Stephanie Allan, Mario Alvarez-Jimenez, Heather Bolton, Laura Dennison, Brian E. Wallace, Heather D. Hadjistavropoulos, Charlotte L. Hall, Amy Hardy, Alasdair L. Henry, Sam Lane, Tess Maguire, Adam Moreton, Talar R. Moukhtarian, Elvira Perez Vallejos, Sukhi Shergill, Daniel Stahl, Graham R. Thew, Ladislav TimulakDavid Van Den Berg, Noemi Viganò, Ben Wensley Stock, Katherine S. Young, Jenny Yiend^*

^*Corresponding author for this work

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

4 Citations (Scopus)

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.

Original language	English
Article number	e126
Journal	BJPsych Open
Volume	10
Issue number	4
DOIs	https://doi.org/10.1192/bjo.2024.713
Publication status	Published - 3 Jun 2024

Keywords

consensus
Digital mental health interventions
mental health
MHRA
safety

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10.1192/bjo.2024.713

Cite this

Taher, R., Bhanushali, P., Allan, S., Alvarez-Jimenez, M., Bolton, H., Dennison, L., Wallace, B. E., Hadjistavropoulos, H. D., Hall, C. L., Hardy, A., Henry, A. L., Lane, S., Maguire, T., Moreton, A., Moukhtarian, T. R., Vallejos, E. P., Shergill, S., Stahl, D., Thew, G. R., ... 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

@article{7fd6c226d32d45b6ab37043d3a9446db,

title = "Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context",

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{\textquoteright} 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.",

keywords = "consensus, Digital mental health interventions, mental health, MHRA, safety",

author = "Rayan Taher and Palak Bhanushali and Stephanie Allan and Mario Alvarez-Jimenez and Heather Bolton and Laura Dennison and Wallace, {Brian E.} and Hadjistavropoulos, {Heather D.} and Hall, {Charlotte L.} and Amy Hardy and Henry, {Alasdair L.} and Sam Lane and Tess Maguire and Adam Moreton and Moukhtarian, {Talar R.} and Vallejos, {Elvira Perez} and Sukhi Shergill and Daniel Stahl and Thew, {Graham R.} and Ladislav Timulak and {Van Den Berg}, David and Noemi Vigan{\`o} and Stock, {Ben Wensley} and Young, {Katherine S.} and Jenny Yiend",

note = "Publisher Copyright: Copyright {\textcopyright} The Author(s), 2024. Published by Cambridge University Press on behalf of Royal College of Psychiatrists.",

year = "2024",

month = jun,

day = "3",

doi = "10.1192/bjo.2024.713",

language = "English",

volume = "10",

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Taher, R, Bhanushali, P, Allan, S, Alvarez-Jimenez, M, Bolton, H, Dennison, L, Wallace, BE, Hadjistavropoulos, HD, Hall, CL, Hardy, A, Henry, AL, Lane, S, Maguire, T, Moreton, A, Moukhtarian, TR, Vallejos, EP, Shergill, S , Stahl, D, Thew, GR, Timulak, L, Van Den Berg, D, Viganò, N, Stock, BW, Young, KS & Yiend, J 2024, 'Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context', BJPsych Open, vol. 10, no. 4, e126. https://doi.org/10.1192/bjo.2024.713

TY - JOUR

T1 - Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context

AU - Taher, Rayan

AU - Bhanushali, Palak

AU - Allan, Stephanie

AU - Alvarez-Jimenez, Mario

AU - Bolton, Heather

AU - Dennison, Laura

AU - Wallace, Brian E.

AU - Hadjistavropoulos, Heather D.

AU - Hall, Charlotte L.

AU - Hardy, Amy

AU - Henry, Alasdair L.

AU - Lane, Sam

AU - Maguire, Tess

AU - Moreton, Adam

AU - Moukhtarian, Talar R.

AU - Vallejos, Elvira Perez

AU - Shergill, Sukhi

AU - Stahl, Daniel

AU - Thew, Graham R.

AU - Timulak, Ladislav

AU - Van Den Berg, David

AU - Viganò, Noemi

AU - Stock, Ben Wensley

AU - Young, Katherine S.

AU - Yiend, Jenny

PY - 2024/6/3

Y1 - 2024/6/3

N2 - 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.

AB - 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.

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KW - Digital mental health interventions

KW - mental health

KW - MHRA

KW - safety

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JO - BJPsych Open

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ER -

Bridging the gap from medical to psychological safety assessment: Consensus study in a digital mental health context

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