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

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.

The Safety of Digital Mental Health Interventions: Systematic Review and Recommendations.

BACKGROUND: Evidence suggests that digital mental health interventions (DMHIs) for common mental health conditions are effective. However, digital interventions, such as face-to-face therapies, pose risks to patients. A safe intervention is considered one in which the measured benefits outweigh the identified and mitigated risks. OBJECTIVE: This study aims to review the literature to assess how DMHIs assess safety, what risks are reported, and how they are mitigated in both the research and postmarket phases and building on existing recommendations for assessing, reporting, and mitigating safety in the DMHI and standardizing practice. METHODS: PsycINFO, Embase, and MEDLINE databases were searched for studies that addressed the safety of DMHIs. The inclusion criteria were any study that addressed the safety of a clinical DMHI, even if not as a main outcome, in an adult population, and in English. As the outcome data were mainly qualitative in nature, a meta-analysis was not possible, and qualitative analysis was used to collate the results. Quantitative results were synthesized in the form of tables and percentages. To illustrate the use of a single common safety metric across studies, we calculated odds ratios and CIs, wherever possible. RESULTS: Overall, 23 studies were included in this review. Although many of the included studies assessed safety by actively collecting adverse event (AE) data, over one-third (8/23, 35%) did not assess or collect any safety data. The methods and frequency of safety data collection varied widely, and very few studies have performed formal statistical analyses. The main treatment-related reported AE was symptom deterioration. The main method used to mitigate risk was exclusion of high-risk groups. A secondary web-based search found that 6 DMHIs were available for users or patients to use (postmarket phase), all of which used indications and contraindications to mitigate risk, although there was no evidence of ongoing safety review. CONCLUSIONS: The findings of this review show the need for a standardized classification of AEs, a standardized method for assessing AEs to statically analyze AE data, and evidence-based practices for mitigating risk in DMHIs, both in the research and postmarket phases. This review produced 7 specific, measurable, and achievable recommendations with the potential to have an immediate impact on the field, which were implemented across ongoing and future research. Improving the quality of DMHI safety data will allow meaningful assessment of the safety of DMHIs and confidence in whether the benefits of a new DMHI outweigh its risks. TRIAL REGISTRATION: PROSPERO CRD42022333181; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=333181.

Personalising care for patients: implementing a treatment summary folder following cytoreductive surgery.

BACKGROUND: A patient survey highlighted that patients treated with cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) at one NHS trust lacked confidence with the transition of care between teams. A personalised folder of treatment information was designed and given to patients prior to discharge. AIMS: To obtain patient feedback on the implementation and content of the folder. METHODS: 30 consecutive patients were given the folder at discharge. Participants completed an online questionnaire to determine whether the information in the folder was appropriate, given at the right time in the pathway and enhanced confidence on discharge. FINDINGS: 90% response rate was achieved. Of the respondents, 96% strongly agreed/agreed that the folder was helpful, 4% disagreed; 92% strongly agreed/agreed that the amount of information was right, 8% preferred more information, none less; 74% agreed/strongly agreed that the folder was provided at the right time; 96% said that the content met their expectations. CONCLUSION: Patients treated with CRS and HIPEC have specific needs related to their treatment. Implementation of the patient information folder at discharge increases patient confidence.

Pilot study to evaluate hypercoagulation and inflammation using rotational thromboelastometry and calprotectin in COVID-19 patients.

INTRODUCTION: Abnormal coagulation and inflammation are hallmarks of SARs-COV-19. Stratifying affected patients on admission to hospital may help identify those who at are risk of developing severe disease early on. Rotational Thromboelastometry (ROTEM) is a point of care test that can be used to measure abnormal coagulation and calprotectin is a measure of inflammation. AIM: Assess if ROTEM can measure hypercoagulability on admission and identify those who will develop severe disease early on. Assess if calprotectin can measure inflammation and if there is a correlation with ROTEM and calprotectin. METHODS: COVID-19 patients were recruited on admission and ROTEM testing was undertaken daily for a period of 7 days. Additionally inflammatory marker calprotectin was also tested for the same period. RESULTS: 33 patients were recruited to the study out of which 13 were admitted to ITU and 20 were treated on the ward. ROTEM detected a hypercoagulable state on admission but did not stratify between those admitted to a ward or escalated to ITU. Calprotectin levels were raised but there was no statistical difference (p = 0.73) between patients admitted to a ward or escalated to ITU. Significant correlations were observed between FIBA5 (r = 0.62; p<0.00), FIBCFT (r = -0.57; p<0.00), FIBMCF (r = 0.64; p<0.00) and INMCF (r = 0.57; p<0.00) and calprotectin. CONCLUSION: COVID-19 patients were hypercoagulable on admission. The correlations between ROTEM and calprotectin underline the interactions between inflammation and coagulation.

Fear of Cancer Recurrence in peritoneal malignancy patients following treatment: a cross-sectional study.

PURPOSE: To assess Fear of Cancer Recurrence (FCR)-its prevalence, trajectory, and relationship to several demographic and clinical characteristics, and quality of life-in a sample of peritoneal malignancy survivors, up to 5 years post-surgery. METHODS: The Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) and 36-Item Short-Form Health Survey (SF-36) were used to collect cross-sectional data from peritoneal malignancy survivors to assess their Fear of Cancer Recurrence and quality of life respectively as well as other demographic and clinical data. RESULTS: The results show that more than two-thirds of the participants (N = 301) experience severe/clinical FCR. FCR is relatively stable over time. Younger patients who are struggling with anxiety or depression or receiving professional mental health support at the time of the surgery are at a higher risk of FCR. FCR is associated with a worse quality of life. CONCLUSIONS: Peritoneal malignancy survivors are at a high risk of FCR, and it compromises their psychological, mental, and social well-being (quality of life). IMPLICATIONS FOR CANCER SURVIVORS: Raise awareness about the high risk of FCR in this population and the demographic and clinical factors that are associated with it. Encourage peritoneal malignancy services and health professionals to address FCR in this population by normalizing it and providing support for those struggling with it.

Fear of cancer recurrence in peritoneal malignancy patients following complete cytoreductive surgery (CCRS) and hyperthermic intraperitoneal chemotherapy (HIPEC): an observational study protocol.

INTRODUCTION: Fear of cancer recurrence (FCR) is correlated with higher depression levels, worse quality of life and increased utilisation of healthcare services. There is no research on FCR in peritoneal malignancy (PM) patients-a rare type of abdominal cancer. This study aims to explore the prevalence, trajectory, demographic and clinical characteristics that are associated with FCR and its relationship with quality of life in PM patients. METHODS AND ANALYSIS: This is a cross-sectional study. Validated measures will be used to collect data on the levels of FCR (Fear of Cancer Recurrence Inventory-Short Form) and quality of life (36-Item Short-Form Health Survey) of PM patients who have had surgery in the last 5 years at the Peritoneal Malignancy Institute in Basingstoke Hospital (minimum N=260). Descriptive statistics, Pearson χ2 tests and correlational tests will be used to analyse the data. ETHICS AND DISSEMINATION: Ethical approval was obtained from the HRA and Health and Care Research Wales (HCRW). The results of this study will be shared with the participants of this study, presented at conferences and PM patients' days in the form of presentations or posters, and published in a scientific journal. DISCUSSION: The results of this exploratory study will be used to inform a multicentre observational study to explore the effect of FCR on PM patients' mental health (depression and anxiety), quality of life and healthcare utilisation which will inform a multicentre randomised controlled trial to assess the effectiveness of using evidenced-based interventions to lower FCR in PM patients.