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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

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.

BACKGROUND Evidence suggests that Digital Mental Health Interventions (DMHIs) for common mental health conditions can be effective. However, these digital interventions, like face-to-face therapies, pose risks to patients. OBJECTIVE Review the literature to assess how DMHIs are assessing safety, what risks are reported, and how they are mitigated both in research and post-market. To build on existing recommendations for assessing, reporting, and mitigating safety in DMHI and standardizing practice. METHODS Psycinfo, EMBASE, and Medline were searched for studies that address 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. Results were synthesized in the form of tables and percentages. We calculated odds ratios and confidence intervals, wherever published data permitted, to illustrate the use of a single common safety metric across studies. RESULTS Twenty-three studies were included in this review. While many of the included studies assessed safety by actively collecting adverse events data, over one third did not assess or collect any safety data. The methods and frequency of safety data collection varied widely and very few studies performed any formal statistical analyses. The main treatment-related reported adverse event was deterioration in symptoms. The main method used to mitigate risk was exclusion of high-risk groups. A secondary online search found that six DMHIs were available for users/patients to use (post-market), all of which used indications and contraindications for use to mitigate risk although there was no evidence of ongoing safety review. CONCLUSIONS This review produced seven specific, measurable and achievable recommendations with the potential to bring immediate impact to the field, were they to be implemented across ongoing and future research. Beyond this, the review highlighted a pressing need for consensus-building research to standardize practice across a number of areas, including measurement, classification, analysis, interpretation and post-market refresh of safety. Improving the quality of DMHI safety data will allow meaningful assessment of the safety of DMHIs and confidence about whether the benefits of a new DMHI outweigh its risks. CLINICALTRIAL PROSPERO CRD42022333181.

Introduction: Abnormal coagulation and inflammation are hallmarks of SARs-COV-19.  Stratifying affected patients on admission to hospital may help identify those who are risk of developing severe disease early on.  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. 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 groups.  Significant correlations were observed between FIBA5 (p<0.00), FIBCFT (p<0.00), FIBMCF (p<0.00) and INMCF (p<0.00) and calprotectin.   Conclusion: COVID19 patients were hypercoagulable in admission. The correlations between ROTEM and calprotectin underline the interactions between inflammation and coagulation.