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27 results

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  • 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
  • Journal:
    BJPsych Open / Volume 10 / Issue 4 / July 2024
    Published online by Cambridge University Press:
    03 June 2024, e126
    • Article
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      • Open access
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  • 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.

Office Gynecology
  • A Case-Based Approach
  • Edited by David Chelmow, Nicole W. Karjane, Hope A. Ricciotti, Amy E. Young
  • Published online:
    20 February 2019
    Print publication:
    31 January 2019
  • This case-based guide covers 100 gynecologic problems commonly encountered in office practice settings, from the simple to the complex. It encourages evidence-based care and incorporates up-to-date guidance on evaluation and management in office practice. Clinical problems are discussed in a clear, case-based format. The book integrates current guidelines and recommendations, supplemented with carefully-researched and vetted expert opinion for situations for which no guidelines exist. Each gynecologic problem is assessed through a brief case presentation followed by an in-depth discussion with visual aids. Question and answer sections feature teaching points. Cases and discussions are detailed enough to guide practice, yet remain focused and concise, with each case designed to be read in the time available when seeing a patient in clinical practice. An invaluable reference guide for gynecologists, family physicians, internal medicine providers, and other women's health care providers who offer office-based gynecologic care.

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