دورية أكاديمية
Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.
| العنوان: | Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context. |
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| المؤلفون: | Taher R; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK., Bhanushali P; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK., Allan S; Institute of Health and Wellbeing, University of Glasgow, UK., Alvarez-Jimenez M; Centre for Youth Mental Health, University of Melbourne, Australia.; Orygen, Parkville, Australia., Bolton H; Unmind, London, UK., Dennison L; School of Psychology, University of Southampton, UK., Wallace BE; Calmsie, Warsaw, Poland., Hadjistavropoulos HD; Department of Psychology, University of Regina, Canada., Hall CL; NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK., Hardy A; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK., Henry AL; Big Health Ltd, London, UK., Lane S; SilverCloud by Amwell, Boston, USA., Maguire T; School of Psychology, University of Southampton, UK., Moreton A; ORCHA, Daresbury, UK., Moukhtarian TR; Mental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK., Vallejos EP; NIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK., Shergill S; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.; Kent and Medway Medical School, Canterbury, UK., Stahl D; Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK., Thew GR; Department of Experimental Psychology, University of Oxford, UK.; Oxford Health NHS Foundation Trust, Oxford, UK., Timulak L; School of Psychology, Trinity College Dublin, Ireland., van den Berg D; Department of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands., Viganò N; SilverCloud by Amwell, Boston, USA., Stock BW; University of Oxford Medical Sciences Division, University of Oxford, UK., Young KS; SilverCloud by Amwell, Boston, USA.; Social Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK., Yiend J; Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK. |
| المصدر: | BJPsych open [BJPsych Open] 2024 Jun 03; Vol. 10 (4), pp. e126. Date of Electronic Publication: 2024 Jun 03. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Cambridge University Press Country of Publication: England NLM ID: 101667931 Publication Model: Electronic Cited Medium: Print ISSN: 2056-4724 (Print) Linking ISSN: 20564724 NLM ISO Abbreviation: BJPsych Open Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Publication: 2019- : [Cambridge] : Cambridge University Press Original Publication: London : Royal College of Psychiatrists, [2015]- |
| مستخلص: | 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. |
| فهرسة مساهمة: | Keywords: Digital mental health interventions; MHRA; consensus; mental health; safety |
| تواريخ الأحداث: | Date Created: 20240603 Latest Revision: 20240603 |
| رمز التحديث: | 20240603 |
| DOI: | 10.1192/bjo.2024.713 |
| PMID: | 38828683 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2056-4724 |
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| DOI: | 10.1192/bjo.2024.713 |