RESUMO
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.
RESUMO
BACKGROUND: Posttraumatic stress disorder (PTSD) in response to psychosis and associated experiences (psychosis-related PTSD, or PR-PTSD) is the subject of a growing field of research. However, a wide range of PR-PTSD prevalence rates has been reported. This may be due to definitional and methodological inconsistencies in the assessment of PR-PTSD. OBJECTIVE: The focus of the review is two-fold. (1) To identify factors that enhance, or detract from, the robustness of PR-PTSD assessment and (2) to critically evaluate the evidence in relation to these identified criteria, including the impact on PR-PTSD prevalence rates. METHOD: Four quality criteria, whose development was informed by mainstream PTSD research, were selected to evaluate findings on PR-PTSD prevalence. Two criteria related to assessment of psychosis-related stressors (participant identification of worst moments of discrete threat events; psychometrically robust trauma measure) and two focussed on PR-PTSD symptom measurement (adequate time elapsed since trauma; use of validated PTSD interview) in the context of psychosis. RESULTS: Twenty-one studies of PR-PTSD, with prevalence rates ranging from 11 to 51%, were evaluated. Fourteen studies (67%) used robust PTSD measures but PR-trauma was not specifically defined or assessed with validated measures. Eleven studies (52%) assessed PTSD before sufficient time had elapsed since the trauma. Due to significant methodological limitations, it was not possible to review PR-PTSD rates and provide a revised estimate of prevalence. CONCLUSIONS: Methodological limitations are common in existing studies of PR-PTSD prevalence. Specific recommendations for improving assessment of psychosis-related trauma are made to guide the development of this new and emerging field. The review concludes with a proposed conceptualisation of PR-PTSD in the context of current diagnostic systems. The utility of the PR-PTSD term and its theoretical underpinnings are discussed.