Dataset Information

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' 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.

SUBMITTER: Taher R

PROVIDER: S-EPMC11363077 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Taher Rayan R Bhanushali Palak P Allan Stephanie S Alvarez-Jimenez Mario M Bolton Heather H Dennison Laura L Wallace Brian E BE Hadjistavropoulos Heather D HD Hall Charlotte L CL Hardy Amy A Henry Alasdair L AL Lane Sam S Maguire Tess T Moreton Adam A Moukhtarian Talar R TR Vallejos Elvira Perez EP Shergill Sukhi S Stahl Daniel D Thew Graham R GR Timulak Ladislav L van den Berg David D Viganò Noemi N Stock Ben Wensley BW Young Katherine S KS Yiend Jenny J

BJPsych open 20240603 4

<h4>Background</h4>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.<h4>Aims</h4>The ai ...[more]

PMID: 38828683

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Project description:When confronted with non-psychotic mental disorders, pregnant women often refrain from using synthetic drugs. Instead, they resort to well-known herbal medicines (phytopharmaceuticals) such as St. John's wort, California poppy, valerian, lavender, and hops, which have proven sedative, anxiolytic, or antidepressant properties. Nevertheless, these herbal medicines are not officially approved in pregnancy due to lack of safety data. Using a variety of in vitro methods (determination of cytotoxicity, apoptosis induction, genotoxicity, effects on metabolic properties, inhibition/induction of differentiation) in a commonly used placental cell line (BeWo b30), we could previously show that extracts from these plants are likely to be safe at usual clinical doses. In the present work, we wanted to deepen our safety assessment of these herbal medicines by (i) looking for possible effects on gene expression and (ii) using the same in vitro methods to characterize effects of selected phytochemicals that might conceivably cause safety issues. Proteomics results were promising as none of the five extracts significantly affected the protein expression by up- or down-regulation. Protopine (contained in California poppy), valerenic acid (in valerian), and linalool (in lavender) were inconspicuous in all experiments and showed no adverse effects. Hyperforin and hypericin (two constituents from St. John's wort) and valtrate (typical for valerian) were the most discernible phytochemicals with respect to the selected safety parameters (cytotoxic and apoptotic effects). A decrease in BeWo b30 viability was evident with hypericin (≥ 1 µM) and valtrate (≥ 10 µM), whereas hyperforin (≥ 3 µM), hypericin (30 µM) and valtrate (≥ 10 µM) induced cell apoptosis. None of the tested phytochemicals resulted in genotoxic effects at concentrations of 0.1 and 1 µM and thus are not DNA damaging. No decrease in glucose consumption or lactate production was observed under the influence of the phytochemicals, except for valtrate (at all concentrations). No compound induced or inhibited BeWo b30 cell differentiation, except for hyperforin (≥ 1 µM) that had an inhibitory effect. This study confirms previous observations suggesting that the extracts from St. John's wort, California poppy, valerian, lavender, and hops are likely to be safe during pregnancy. Attainment of high plasma concentrations of a few relevant compounds – hyperforin and hypericin from St. John's wort and valtrate from valerian – deserves though special attention. Clinical studies during pregnancy are needed to substantiate these in vitro data.

Dataset Information

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

Background

Aims

Method

Results

Conclusion

Publications

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

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