Taher, Rayan, Bhanushali, Palak, Allan, Stephanie, Alvarez-Jimenez, Mario, Bolton, Heather, Dennison, Laura, Wallace, Brian E, Hadjistavropoulos, Heather D, Hall, Charlotte L, Hardy, Amy, and others. (2024) Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context. BJPsych open, 10 (4). Article Number e126. E-ISSN 2056-4724. (doi:10.1192/bjo.2024.713) (KAR id:106321)
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| Official URL: https://doi.org/10.1192/bjo.2024.713 |
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Abstract
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. 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. 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. 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. 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.
| Item Type: | Article |
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| DOI/Identification number: | 10.1192/bjo.2024.713 |
| Uncontrolled keywords: | Digital mental health interventions, consensus, mental health, safety, MHRA |
| Subjects: | R Medicine |
| Divisions: | Divisions > Division of Natural Sciences > Kent and Medway Medical School |
| Funders: | University of Kent (https://ror.org/00xkeyj56) |
| SWORD Depositor: | JISC Publications Router |
| Depositing User: | JISC Publications Router |
| Date Deposited: | 19 Jun 2024 13:54 UTC |
| Last Modified: | 05 Nov 2024 13:12 UTC |
| Resource URI: | https://kar.kent.ac.uk/id/eprint/106321 (The current URI for this page, for reference purposes) |
University of Kent Author Information
Shergill, Sukhi S..
| Creator's ORCID: |
 https://orcid.org/0000-0003-4928-9100
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