Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports.

BACKGROUND: Digital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs. STUDY DESIGN: A systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports. STUDY RESULTS: We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants. CONCLUSIONS: The results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided.

Measurement of Adverse Events in Studies of Digital Health Interventions for Psychosis: Guidance and Recommendations Based on a Literature Search and Framework Analysis of Standard Operating Procedures.

BACKGROUND: Given the rapid expansion of research into digital health interventions (DHIs) for severe mental illness (SMI; eg, schizophrenia and other psychosis diagnoses), there is an emergent need for clear safety measures. Currently, measurement and reporting of adverse events (AEs) are inconsistent across studies. Therefore, an international network, iCharts, was assembled to systematically identify and refine a set of standard operating procedures (SOPs) for AE reporting in DHI studies for SMI. DESIGN: The iCharts network comprised experts on DHIs for SMI from seven countries (United Kingdom, Belgium, Germany, Pakistan, Australia, United States, and China) and various professional backgrounds. Following a literature search, SOPs of AEs were obtained from authors of relevant studies, and from grey literature. RESULTS: A thorough framework analysis of SOPs (n = 32) identified commonalities for best practice for certain domains, along with significant gaps in others; particularly around the classification of AEs during trials, and the provision of training/supervision for research staff in measuring and reporting AEs. Several areas which could lead to the observed inconsistencies in AE reporting and handling were also identified. CONCLUSIONS: The iCharts network developed best-practice guidelines and a practical resource for AE monitoring in DHI studies for psychosis, based on a systematic process which identified common features and evidence gaps. This work contributes to international efforts to standardize AE measurement and reporting in this emerging field, ensuring that safety aspects of DHIs for SMI are well-studied across the translational pathway, with monitoring systems set-up from the outset to support safe implementation in healthcare systems.

A germ-free humanized mouse model shows the contribution of resident microbiota to human-specific pathogen infection.

Germ-free (GF) mice, which are depleted of their resident microbiota, are the gold standard for exploring the role of the microbiome in health and disease; however, they are of limited value in the study of human-specific pathogens because they do not support their replication. Here, we develop GF mice systemically reconstituted with human immune cells and use them to evaluate the role of the resident microbiome in the acquisition, replication and pathogenesis of two human-specific pathogens, Epstein-Barr virus (EBV) and human immunodeficiency virus (HIV). Comparison with conventional (CV) humanized mice showed that resident microbiota enhance the establishment of EBV infection and EBV-induced tumorigenesis and increase mucosal HIV acquisition and replication. HIV RNA levels were higher in plasma and tissues of CV humanized mice compared with GF humanized mice. The frequency of CCR5+ CD4+ T cells throughout the intestine was also higher in CV humanized mice, indicating that resident microbiota govern levels of HIV target cells. Thus, resident microbiota promote the acquisition and pathogenesis of two clinically relevant human-specific pathogens.

Psychosocial factors that distinguish between men and women who have suicidal thoughts and attempt suicide: findings from a national probability sample of adults.

BACKGROUND: Previous research has highlighted the importance of understanding which psychosocial factors distinguish between those with suicide thoughts compared to those who attempt suicide. This study aims to investigate these distinguishing factors further within an ideation-to-action framework and to explore sex differences in suicide risk. METHODS: Participants (n = 7546, aged 16+) were from the cross-sectional Adult Psychiatric Morbidity Survey (APMS; 2014) of England. Face-to-face and self-completion questionnaires assessed lifetime suicidal ideation, lifetime suicide attempts, demographic characteristics, life experiences, social support, health and mental illness. Multinomial logistic regression examined factors differentiating between those with suicidal ideation only and suicide attempt histories (with or without suicidal ideation) in men and women. RESULTS: Overall men were less likely to report suicidal thoughts and attempts, compared to females. More factors differentiated between suicidal thoughts and attempts in women compared to in men; these included hospital admission for mental illness, below degree level qualifications, being single and childhood adversity. In men, factors which significantly differentiated between suicidal thoughts and attempts included self-report of professional diagnosis of mental illness and childhood adversity. Higher levels of social support were associated with being in the suicidal thoughts group v. in the attempts group in men. CONCLUSION: This study identified some key differences between men and women in factors associated with suicide attempts compared to suicidal thoughts. The findings support the use of the ideation-to-action framework to investigate sex differences in suicidal behaviour. Future research should examine the extent to which these factors are associated with suicide risk over time.

The core minimum dataset for measuring pain outcomes in pain services across Scotland. Developing and testing a brief multi-dimensional questionnaire.

Background: There is currently no agreed minimum dataset to inform specialist chronic pain service provision. We aimed to develop a Core Minimum Dataset (CMD) for pain services in Scotland and perform preliminary analysis to evaluate its psychometric properties in adults with chronic pain. Methods: The questionnaire was developed following a review of existing relevant data collection instruments and national consultation. The CMD questionnaire was completed alongside a routine pre-clinic questionnaire by patients attending two pain services over 3 months. Concurrent validity was tested by comparing scores between the CMD and pre-existing questionnaires. Reliability was assessed by test-retest and discriminative validity via receiver operating characteristic (ROC) curves. Results: The final CMD questionnaire consisted of five questions on four domains: pain severity (Chronic Pain Grade [CPG] Q1); pain interference (CPG Q5); emotional impact (Patient Health Questionnaire-2 [PHQ-2], two questions); and quality of life (Short Form Health Survey-36 [SF-36] Q1). 530 patients completed the questionnaire. Strong correlation was found with the Hospital Anxiety and Depression Scale (rs = 0.753, p < 0.001). Moderate correlations were found with the Brief Pain Inventory for pain interference (rs = 0.585, p < 0.001) and pain severity (rs = 0.644, p < 0.001). Moderate to good reliability was demonstrated (Intra-class Correlation Coefficient = 0.572-0.845). All items indicated good discrimination for relevant health states. Conclusions: The findings represent initial steps towards developing an accurate questionnaire that is feasible for assessing chronic pain in adults attending specialist pain clinics and measuring service improvements in Scotland. Further validation testing, in clinical settings, is now required.

The Male Experience of Suicide Attempts and Recovery: An Interpretative Phenomenological Analysis.

Suicidal behaviour is a complex phenomenon-its aetiology spans biological, psychological, environmental, social and cultural facets. Men's deaths by suicide outnumber women in every country in the world. This study explored the male experience of suicide attempts and recovery as well as factors which may be protective for men. Men (n = 12) participated in semi-structured face-to-face interviews which were subjected to Interpretative Phenomenological Analysis (IPA). Four master themes were identified: (1) "characteristics of attempt/volitional factors", (2) "dealing with suicidal thoughts and negative emotions", (3) "aftermath" and (4) "protective factors". The theoretical and clinical implications of this study are discussed, including help seeking, emotional expression, the long-term impact of suicide attempt as well as the applied contribution to established theories.

A systematic review of suicidal behaviour in men: A narrative synthesis of risk factors.

RATIONALE: Suicides by men outnumber those by women in every country of the world. To date, there has not been a comprehensive systematic review of risk factors for suicidal behaviour in men to better understand the excess deaths by suicide in men. OBJECTIVE: The present systematic review seeks to determine the nature and extent of the risk factors to predict suicidal behaviour in men over time. METHODS: A range of databases (CINAHL, PsycINFO, Web of Science Core Collection, Pubmed, Embase, and Psychology and Behavioural Sciences Collection) were searched from inception to January 2020 for eligible articles. The findings were collated through a narrative synthesis of the evidence. RESULTS: An initial 601 studies were identified. Following the inclusion and exclusion criteria, there were 105 eligible studies (62 prospective and 43 retrospective) identified. Overall, the risk factors with the strongest evidence predicting suicidal behaviour in men were alcohol and/or drug use/dependence; being unmarried, single, divorced, or widowed; and having a diagnosis of depression. In the prospective studies, the most consistent evidence was for sociodemographic factors (19 risk factors), mental health/psychiatric illness (16 risk factors), physical health/illness (13 risk factors), and negative life events/trauma (11 risk factors). There were a small number of psychological factors (6 factors) and characteristics of suicidal behaviour (3 factors) identified. The findings from the retrospective studies provided further evidence for the risk factors identified in the prospective studies. CONCLUSIONS: This systematic review has highlighted the wide range of risk factors for suicidal behaviour in men, in this review alone 68 different risk factors were identified. Many factors can interact and change in relevance throughout an individual's life. This review has identified extensive gaps in our knowledge as well as suggestions for future research.

The IASP classification of chronic pain for ICD-11: applicability in primary care.

The International Classification of Diseases, 11th Revision (ICD-11), proposes, for the first time, a coding system for chronic pain. This system contains 1 code for "chronic primary pain," where chronic pain is the disease, and 6 codes for chronic secondary pain syndromes, where pain developed in the context of another disease. This provides the opportunity for routine, standardised coding of chronic pain throughout all health care systems. In primary care, this will confer many important, novel advantages over current or absent coding systems. Chronic pain will be recognized as a centrally important condition in primary care. The capacity to measure incidence, prevalence, and impact will help in identification of human, financial, and educational needs required to address chronic pain in primary care. Finally, opportunities to match evidence-based treatment pathways to distinct chronic pain subtypes will be enhanced.