A consensus has yet to be reached on whether the appraisal of risk is best represented quantitatively (e.g. probability estimates) or qualitatively (e.g. formulation). A more fundamental issue, though, is how to use the agreed representation to inform practice so as to reduce the likelihood of harm. The real-world implementation of risk representations in clinical practice is dependent on how these representations inform clinical decision-making. Clinical decision-making takes place in a complex system of interacting agents, entities, and processes. To date, risk-related research and practice guidance has not paid sufficient attention to studying this system.

To develop a standardised model for representing those complex mental health systems in which appraisals of ‘risk of harm to others’ are used.

In order to identify a generally applicable representation of the system, practice experts in the field of risk of harm to others reflexively examined the systems within which they worked to firstly identify the actual individual agents, entities and processes in their systems. A thematic review of the elements was then undertaken so as the inform the development of more generally applicable characterisation of the system for wider use.

The generalisable characterisation of the system (with illustrative local examples in parenthesis) is presented in Figure 1.Image 1:

Risk-related practice by mental health clinicians involves the development of quantitative and/or qualitative representations of risk which are used to guide decisions. In practice, the use of the risk representations to guide decisions is also heavily dependent on the complex system in which the decisions are made. This study has generated a model to characterise risk-related systems which can be used for service improvement and planning, and for future research into risk-related practice.

None Declared

Diabetes distress, whereby people with diabetes experience distressing psychological symptoms associated with living with their condition, is an emerging problem in India. Diabetes distress leads to self-care deficits, suboptimal glycaemic control (which can lead to increasing risks of complications) and impaired quality of life.

To determine the burden of diabetes distress and its associated factors in an Indian tertiary care centre in Trichy, Tamil Nadu, India, covering a population of 1.25 million.

This prospective observational study involved a structured questionnaire covering demographic and clinical details, which was given to patients. The Diabetes Distress Scale 17 (DDS-17) was used to assess diabetes distress levels. The DDS-17 also measures four subdomains: emotional burden, physician-related distress, regimen-related distress and diabetes-related interpersonal distress. Patients were divided into two groups based on their DDS-17 score: no diabetes distress (DDS-17 score <2) versus diabetes distress (DDS-17 score ≥2) and compared. Correlation analysis, chi-squared tests and t-tests were used, with P < 0.05 considered statistically significant.

Of 1019 respondents (mean age 56 years; 59.6% male, 40.4% female), diabetes distress was reported in 24.4% (n = 249). Factors significantly associated with higher DDS-17 scores were younger age (<45 years) (P < 0.0001), long-standing diabetes (>10 years) (P < 0.0001), and smoking and alcohol (P < 0.05). Significant protective factors for diabetes distress included working, daily exercise, no comorbidities and medical insurance cover (P < 0.05). Significant positive correlation between DDS-17 score and all four subdomains was observed (P < 0.0001).

Our findings highlight the need for routine psychological screening and holistic management strategies in diabetes care, to improve patient outcomes and quality of life.

We analysed cardiac MRI and catheterisation variables during pre-Fontan evaluations for associations with major adverse cardiac events including Fontan takedown, mechanical circulatory support, heart transplantation, or death.

In this single-centre retrospective study, we gathered pre-operative MRI and catheterisation data for all patients who underwent Fontan operation at Children’s Medical Center, Dallas, from April 2017 to November 2022. Patients were grouped according to the presence or absence of adverse events, and MRI and catheterisation parameters were compared between groups. We used the Mann–Whitney U Test for non-parametric data, Student’s T-test for parametric continuous variables, and Fisher’s Exact Test for categorical variables.

Of the 119 combined evaluations, 81 proceeded with Fontan palliation. Adverse events were recorded in 10% of patients (n = 8). One had a Fontan takedown, one underwent transplant, one required mechanical circulatory support, and five died in a median 21-month follow-up. Factors significantly associated with adverse events included heterotaxy syndrome (p = 0.04), higher combined pulmonary vascular resistance (p = 0.03), and moderate-severe (≥30%) atrioventricular valve regurgitation (p = 0.046). While combined pulmonary vascular resistance calculated from both catheterisation and MRI data predicted outcome, pulmonary vascular resistance calculated using data solely from catheterisation showed no discriminative ability.

Post-Fontan major adverse cardiac events were associated with heterotaxy syndrome, higher combined pulmonary vascular resistance, and moderate-severe atrioventricular valve regurgitation identified on pre-Fontan MRI and catheterisation. Combined pulmonary vascular resistance using transpulmonary gradient from catheterisation data and effective pulmonary blood flow from MRI data may help predict outcome.

Describe the hemodynamic implications of anaesthetic choice among children with heart disease undergoing cardiac catheterisation.

Study 1 was a secondary analysis of data obtained during catheterisation-based hemodynamic assessment of infants with hypoplastic left heart syndrome following Stage 1 palliation, randomised in the Single Ventricle Reconstruction trial. Measured and calculated hemodynamics including pulmonary and systemic vascular resistance indexed to body surface area (PVRi and SVRi respectively) and pulmonary/systemic blood flow (Qp/Qs) were analysed with respect to anaesthetic employed during catheterisation, classified as moderate sedation or general anaesthesia. Study 2 consisted of a single centre, prospective analysis of patients requiring percutaneous closure of a patent ductus arteriosus or endomyocardial biopsy after orthotopic heart transplant. Participants underwent hemodynamic assessment first using inhaled volatile anaesthesia (IA), and then transitioned to total intravenous anaesthesia, comparing hemodynamic measures with respect to anaesthetic approach.

In Study 1, independent of shunt type, PVRi, and patient size, moderate sedation was associated with a greater than two-fold odds of a Qp/Qs >1 (OR 2.12, 95%CI 1.18–3.87, p = 0.013). In Study 2, while PVRi was similar, SVRi was significantly higher using total intravenous anaesthesia. Among the patent ductus arteriosus subgroup, Qp/Qs increased significantly with a total intravenous anaesthesia relative to IA (p = 0.003); additionally, among the orthotopic heart transplant subgroup, left ventricular end diastolic pressure increased following a transition to total intravenous anaesthesia (p = 0.002).

Analyses of hemodynamics during catheterisation support a significant impact of anaesthetic type on hemodynamic values including SVRi, left ventricular end diastolic pressure, and Qp/Qs. Anaesthesia choice and intraprocedural management of SVRi are important considerations when making clinical decisions based on hemodynamic data.

Although there is good empirical data on factors that predict harmful outcomes, and standardised approaches to risk assessment have been developed, there remains a disconnect between the academic study of risk and routine clinical practice. This is exemplified by (i) the outstanding uncertainty about how to use predictive models for everyday clinical decision-making, and (ii) the use of predictive methodology to test tools that eschew prediction. The disconnect is, in part, a consequence of the varied use of the notion of ‘risk’ within and between academia and clinical practice.

To derive a more nuanced understanding of the meaning of ‘risk’ in clinical practice.

After reading clinical vignettes, participants (all practising clinicians, n=18) took part in semi-structured interviews regarding clinical decision-making. The interview transcripts were subject to thematic analysis using a novel approach to the analysis of ideas in expressed language (in this case the idea of ‘risk’) which draws on philosophical and intellectual history methodologies (derived from the work of Wittgenstein, and Skinner respectively).

The use of risk by participants varied according to the extent and type of its spatial location (figure 1).

In many cases, ‘risk’ was used in a disembodied (i.e., dislocated) way (e.g., ‘what is the risk,’ ‘risk will increase’).

When locatable, it was evident that participants located risk in:

1. a) the patient (e.g., ‘the patient’s risk’) which was sometimes qualified by the type of harm envisaged (e.g., ‘his risk involved hurting staff’);

2. b) clinical activity (e.g., risk assessment, positive risk-taking, risk management);

3. c) the clinician (e.g., risk tolerances and thresholds); and

4. d) the system (e.g., ‘our system is… quite risk averse,’ ‘who holds the risk’).

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This study demonstrates the varied use of ‘risk’ in practice. By empirically delineating the different expressed forms ‘risk’ takes in clinicians’ language (and thinking), the findings of this study can inform (i) the development of risk study methodologies that are more applicable to practice, and (ii) improvements in clinical practice by clarifying how risk can be understood and spoken about.

None Declared

Genetic research on nicotine dependence has utilized multiple assessments that are in weak agreement.

We conducted a genome-wide association study (GWAS) of nicotine dependence defined using the Diagnostic and Statistical Manual of Mental Disorders (DSM-NicDep) in 61,861 individuals (47,884 of European ancestry [EUR], 10,231 of African ancestry, and 3,746 of East Asian ancestry) and compared the results to other nicotine-related phenotypes.

We replicated the well-known association at the CHRNA5 locus (lead single-nucleotide polymorphism [SNP]: rs147144681, p = 1.27E−11 in EUR; lead SNP = rs2036527, p = 6.49e−13 in cross-ancestry analysis). DSM-NicDep showed strong positive genetic correlations with cannabis use disorder, opioid use disorder, problematic alcohol use, lung cancer, material deprivation, and several psychiatric disorders, and negative correlations with respiratory function and educational attainment. A polygenic score of DSM-NicDep predicted DSM-5 tobacco use disorder criterion count and all 11 individual diagnostic criteria in the independent National Epidemiologic Survey on Alcohol and Related Conditions-III sample. In genomic structural equation models, DSM-NicDep loaded more strongly on a previously identified factor of general addiction liability than a “problematic tobacco use” factor (a combination of cigarettes per day and nicotine dependence defined by the Fagerström Test for Nicotine Dependence). Finally, DSM-NicDep showed a strong genetic correlation with a GWAS of tobacco use disorder as defined in electronic health records (EHRs).

Our results suggest that combining the wide availability of diagnostic EHR data with nuanced criterion-level analyses of DSM tobacco use disorder may produce new insights into the genetics of this disorder.

Bipolar depression remains difficult to treat, and people often experience ongoing residual symptoms, decreased functioning and impaired quality of life. Adjunctive therapies targeting novel pathways can provide wider treatment options and improve clinical outcomes. Garcinia mangostana Linn. (mangosteen) pericarp has serotonogenic, antioxidant anti-inflammatory and neurogenic properties of relevance to the mechanisms of bipolar depression.

The current 28-week randomised, multisite, double-blind, placebo-controlled trial investigated mangosteen pericarp extract as an adjunct to treatment-as-usual for treatment of bipolar depression.

This trial was prospectively registered on the Australia New Zealand Clinical Trials Registry (no. ACTRN12616000028404). Participants aged 18 years and older with a diagnosis of bipolar I or II and with at least moderate depressive symptoms were eligible for the study. A total of 1016 participants were initially approached or volunteered for the study, of whom 712 did not progress to screening, with an additional 152 screened out. Seventy participants were randomly allocated to mangosteen and 82 to a placebo control. Fifty participants in the mangosteen and 64 participants in the placebo condition completed the treatment period and were analysed.

Results indicated limited support for the primary hypothesis of superior depression symptom reduction following 24 weeks of treatment. Although overall changes in depressive symptoms did not substantially differ between conditions over the course of the trial, we observed significantly greater improvements for the mangosteen condition at 24 weeks, compared with baseline, for mood symptoms, clinical impressions of bipolar severity and social functioning compared with controls. These differences were attenuated at week 28 post-discontinuation assessment.

Adjunctive mangosteen pericarp treatment appeared to have limited efficacy in mood and functional symptoms associated with bipolar disorder, but not with manic symptoms or quality of life, suggesting a novel therapeutic approach that should be verified by replication.

To evaluate the impact of implementing a multi-step Clostridioides difficile infection (CDI) testing algorithm on hospital-onset (HO)-CDI rates and clinical outcomes.

Retrospective pre-intervention/post-intervention study.

Two academic hospitals in Pittsburgh, Pennsylvania.

In the pre-intervention period, a standalone polymerase chain reaction (PCR) assay was used for diagnosing CDI. In the post-intervention period, positive PCR assays were reflexed to a glutamate dehydrogenase antigen test and an enzyme immunoassay for toxin A/B.

The implementation of a multi-step testing algorithm resulted in a significant reduction in HO-CDI cases per 10,000 patient days from 5.92 to 2.36 (P < 0.001). Despite the decrease in reportable HO-CDI cases, there were no significant differences in clinical outcomes such as hospital length of stay, intensive care unit admissions, and treatment courses. In addition, there was a significant reduction in all-cause 30-day readmissions in the post-intervention group, though CDI-related readmissions remained similar.

The multi-step testing algorithm significantly reduced HO-CDI rates without compromising clinical outcomes. The study supports the use of a multi-step CDI testing algorithm to assist healthcare providers with CDI management decisions and potentially to reduce financial penalties burdened on healthcare systems.

Previous studies (various designs) present contradicting insights on the potential causal effects of diet/physical activity on depression/anxiety (and vice versa). To clarify this, we employed a triangulation framework including three methods with unique strengths/limitations/potential biases to examine possible bidirectional causal effects of diet/physical activity on depression/anxiety.

Study 1: 3-wave longitudinal study (n = 9,276 Dutch University students). Using random intercept cross-lagged panel models to study temporal associations. Study 2: cross-sectional study (n = 341 monozygotic and n = 415 dizygotic Australian adult twin pairs). Using a co-twin control design to separate genetic/environmental confounding. Study 3: Mendelian randomization utilizing data (European ancestry) from genome-wide association studies (n varied between 17,310 and 447,401). Using genetic variants as instrumental variables to study causal inference.

Study 1 did not provide support for bidirectional causal effects between diet/physical activity and symptoms of depression/anxiety. Study 2 did provide support for causal effects between fruit/vegetable intake and symptoms of depression/anxiety, mixed support for causal effects between physical activity and symptoms of depression/anxiety, and no support for causal effects between sweet/savoury snack intake and symptoms of depression/anxiety. Study 3 provides support for a causal effect from increased fruit intake to the increased likelihood of anxiety. No support was found for other pathways. Adjusting the analyses including diet for physical activity (and vice versa) did not change the conclusions in any study.

Triangulating the evidence across the studies did not provide compelling support for causal effects of diet/physical activity on depression/anxiety or vice versa.

To assess the prevalence of obesity and investigate any changes in body mass index in children with CHD compared to age-matched healthy controls, in Southwestern Ontario.

The body mass index z-scores of 1259 children (aged 2–18) with CHD were compared with 2037 healthy controls. The body mass index z-scores of children who presented to our paediatric cardiology outpatient clinic from 2018 to 2021 were compared with previously collected data from 2008 to 2010. A longitudinal analysis of patients with data in both cohorts was also completed.

In total, 21.4% of patients with CHD and 26.6% of healthy controls were found to be overweight or obese (p < 0.001). The 2018–2021 cohort of CHD patients and controls had significantly higher body mass index z-scores compared to the 2008–2010 cohort (p < 0.001). Longitudinal analysis showed that body mass index z-scores significantly increased over time for CHD patients with data in both cohorts (2018–2021: M = 0.59, SD = 1.26; 2008–2010: M = −0.04, SD = 1.05; p < 0.001).

The prevalence of obesity in all children, irrespective of CHD, is rising. The coexistence of obesity and CHD may pose additional cardiovascular risks and complications.