Evidence map›Paper›PMID 38828683›Full record

ArticleBJPsych open2024

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 and 15 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BJPsych open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Rayan TaherDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.ORCID https://orcid.org/0000-0001-8592-527X
Palak BhanushaliDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Stephanie AllanInstitute of Health and Wellbeing, University of Glasgow, UK.ORCID https://orcid.org/0000-0002-4175-0591
Mario Alvarez-JimenezCentre for Youth Mental Health, University of Melbourne, Australia.
Heather BoltonUnmind, London, UK.
Laura DennisonSchool of Psychology, University of Southampton, UK.
Brian E WallaceCalmsie, Warsaw, Poland.
Heather D HadjistavropoulosDepartment of Psychology, University of Regina, Canada.
Charlotte L HallNIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK.
Amy HardyDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Alasdair L HenryBig Health Ltd, London, UK.ORCID https://orcid.org/0000-0003-2217-3052
Sam LaneSilverCloud by Amwell, Boston, USA.
Tess MaguireSchool of Psychology, University of Southampton, UK.
Adam MoretonORCHA, Daresbury, UK.
Talar R MoukhtarianMental Health and Wellbeing Unit, Warwick Medical School, University of Warwick, UK.
Elvira Perez VallejosNIHR MindTech-MedTech Co-operative, NIHR Nottingham Biomedical Research Centre, School of Medicine, Institute of Mental Health, University of Nottingham, UK.
Sukhi ShergillDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Daniel StahlDepartment of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.
Graham R ThewDepartment of Experimental Psychology, University of Oxford, UK.
Ladislav TimulakSchool of Psychology, Trinity College Dublin, Ireland.
David van den BergDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research, Amsterdam, Netherlands.
Noemi ViganòSilverCloud by Amwell, Boston, USA.
Ben Wensley StockUniversity of Oxford Medical Sciences Division, University of Oxford, UK.
Katherine S YoungSilverCloud by Amwell, Boston, USA.
Jenny YiendDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDigital 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.

aimsThe 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.

methodAn 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.

resultsSixty-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.

conclusionThe 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.

Indexed as

consensusDigital mental health interventionsmental healthMHRAsafety

Identifiers

PMID38828683
PMCPMC11363077

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.