Artificial Neural Network Analysis Examining Substance Use Problems Co-Occurring with Anxiety and Depressive Disorders Among Adults Receiving Mental Health Treatment.

Objective: The co-occurrence of anxiety disorders, depressive disorders, and substance use problems was examined. Methods: The Mental Health Client-Level Data dataset was used to conduct logistic regression models and an artificial neural network analysis. Logistic regression analyses were conducted among adults with anxiety (n = 547,473) or depressive disorders (n = 1,610,601) as their primary diagnosis who received treatment in a community mental health center. The artificial neural network analysis was conducted with the entire sample (N = 2,158,074). Results: Approximately 30% of the sample had co-occurring high-risk substance use or substance use disorder. Characteristics including region of treatment receipt, age, education, gender, race and ethnicity, and the presence of co-occurring anxiety and depressive disorders were associated with the co-occurring high-risk substance use or a substance use disorder. Conclusions: Findings from this study highlight the importance of mental health facilities to screen for and provide integrated treatment for co-occurring disorders.

Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial.

BACKGROUND: Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine how much these adverse prognostic AF effects could be mitigated by the restoration of sinus rhythm (SR) and whether the method used mattered. METHODS: The CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) randomized 2204 AF patients to ablation versus drug therapy, of which 1240 patients were monitored in follow-up using the CABANA ECG rhythm monitoring system. To assess the prognostic benefits of SR, we performed a prespecified analysis using Cox survival modeling with heart rhythm as a time-dependent variable and randomized treatment group as a stratification factor. RESULTS: In the 1240 patient study cohort, 883 (71.2%) had documented AF at some point during their postblanking follow-up. Among the 883 patients, 671 (76.0%) experienced AF within the first year of postblanking follow-up, and 212 (24.0%) experienced their first AF after ≥1 year of postblanking follow-up. The primary CABANA end point (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 95 (10.8%) of the 883 patients with documented AF and in 29 (8.1%) of the 357 patients with no AF recorded during follow-up. In multivariable time-dependent analysis, the presence of SR (compared with non-SR) was associated with a significantly reduced risk of the primary end point (adjusted hazard ratio, 0.57 [95% CI, 0.38-0.85]; P=0.006; independent of treatment strategy [ablation versus drugs]). Corresponding results for all-cause mortality were adjusted hazard ratio of 0.59 [95% CI, 0.35-1.01]; P=0.053). CONCLUSIONS: In patients in the CABANA trial with detailed long-term rhythm follow-up, increased time in SR was associated with a clinically consequential decrease in mortality and other adverse prognostic events. The predictive value of SR was independent of the therapeutic approach responsible for reducing the burden of detectable AF. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.

Regional differences in outcomes with ablation versus drug therapy for atrial fibrillation: Results from the CABANA trial.

BACKGROUND: The finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations in outcome and in the effectiveness of atrial fibrillation (AF) ablation versus drug therapy in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. This paper describes these differences and investigates potential causes. METHODS: The examination of treatment effects by geographic region was a prespecified analysis. CABANA enrolled patients from 10 countries, with 1,285 patients at 85 North American (NA) sites and 919 at 41 non-NA sites. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Death and first atrial fibrillation recurrence were secondary endpoints. RESULTS: At least 1 primary endpoint event occurred in 157 patients (12.2%) from NA and 33 (3.6%) from non-NA sites over a median 54.9 and 40.5 months of follow-up, respectively (NA/non-NA adjusted hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.48-3.21, P < .001). In NA patients, 78 events occurred in the ablation and 79 in the drug arm, (HR 0.91, 95% CI 0.66, 1.24) while 11 and 22 events occurred in non-NA patients (HR 0.51, 95% CI 0.25,1.05, interaction P = .154). Death occurred in 53 ablation and 51 drug therapy patients in the NA group (HR 0.96, 95% CI 0.65,1.42) and in 5 ablation and 16 drug therapy patients in the non-NA group (HR 0.32, 95% CI 0.12,0.86, interaction P = .044). Adjusting for baseline regional differences or prognostic risk variables did not account for the regional differences in treatment effects. Atrial fibrillation recurrence was reduced by ablation in both regions (NA: HR 0.54, 95% CI 0.46, 0.63; non-NA: HR 0.44, 95% CI 0.30, 0.64, interaction P = .322). CONCLUSIONS: In CABANA, primary outcome events occurred significantly more often in the NA group but assignment to ablation significantly reduced all-cause mortality in the non-NA group only. These differences were not explained by regional variations in procedure effectiveness, safety, or patient characteristics. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0091150; https://clinicaltrials.gov/study/NCT00911508.

Developmental dyscalculia is not associated with atypical brain activation: A univariate fMRI study of arithmetic, magnitude processing, and visuospatial working memory.

Functional neuroimaging serves as a tool to better understand the cerebral correlates of atypical behaviors, such as learning difficulties. While significant advances have been made in characterizing the neural correlates of reading difficulties (developmental dyslexia), comparatively little is known about the neurobiological correlates of mathematical learning difficulties, such as developmental dyscalculia (DD). Furthermore, the available neuroimaging studies of DD are characterized by small sample sizes and variable inclusion criteria, which make it problematic to compare across studies. In addition, studies to date have focused on identifying single deficits in neuronal processing among children with DD (e.g., mental arithmetic), rather than probing differences in brain function across different processing domains that are known to be affected in children with DD. Here, we seek to address the limitations of prior investigations. Specifically, we used functional magnetic resonance imaging (fMRI) to probe brain differences between children with and without persistent DD; 68 children (8-10 years old, 30 with DD) participated in an fMRI study designed to investigate group differences in the functional neuroanatomy associated with commonly reported behavioral deficits in children with DD: basic number processing, mental arithmetic and visuo-spatial working memory (VSWM). Behavioral data revealed that children with DD were less accurate than their typically achieving (TA) peers for the basic number processing and arithmetic tasks. No behavioral differences were found for the tasks measuring VSWM. A pre-registered, whole-brain, voxelwise univariate analysis of the fMRI data from the entire sample of children (DD and TA) revealed areas commonly associated with the three tasks (basic number processing, mental arithmetic, and VSWM). However, the examination of differences in brain activation between children with and without DD revealed no consistent group differences in brain activation. In view of these null results, we ran exploratory, Bayesian analyses on the data to quantify the amount of evidence for no group differences. This analysis provides supporting evidence for no group differences across all three tasks. We present the largest fMRI study comparing children with and without persistent DD to date. We found no group differences in brain activation using univariate, frequentist analyses. Moreover, Bayesian analyses revealed evidence for the null hypothesis of no group differences. These findings contradict previous literature and reveal the need to investigate the neural basis of DD using multivariate and network-based approaches to brain imaging.

Single Live Cell Imaging of Multidrug Resistance Using Silver Ultrasmall Nanoparticles as Biosensing Probes in Triple-Negative Breast Cancer Cells.

Silver ultrasmall nanoparticles (Ag UNPs) (size < 5 nm) were used as biosensing probes to analyze the efflux kinetics contributing to multidrug resistance (MDR) in single live triple-negative breast cancer (TNBC) cells by using dark-field optical microscopy to follow their size-dependent localized surface plasmon resonance. TNBC cells lack expression of estrogen (ER-), progesterone (PR-), and human epidermal growth factor 2 (HER2-) receptors and are more likely to acquire resistance to anticancer drugs due to their ability to transport harmful substances outside the cell. The TNBC cells displayed greater nuclear and cytoplasmic efflux, resulting in less toxicity of Ag UNPs in a concentration-independent manner. In contrast, more Ag UNPs and an increase in cytotoxic effects were observed in the receptor-positive breast cancer cells that have receptors for ER+, PR+, and HER2+ and are known to better respond to anticancer therapies. Ag UNPs accumulated in receptor-positive breast cancer cells in a time-and concentration-dependent mode and caused decreased cellular growth, whereas the TNBC cells due to the efflux were able to continue to grow. The TNBC cells demonstrated a marked increase in survival due to their ability to have MDR determined by efflux of Ag UNPs outside the nucleus and the cytoplasm of the cells. Further evaluation of the nuclear efflux kinetics of TNBC cells with Ag UNPs as biosensing probes is critical to gain a better understanding of MDR and potential for enhancement of cancer drug delivery.

Implementing a Child Mental Health Intervention in Child Welfare Services: Stakeholder Perspectives on Feasibility.

This pilot study integrated quantitative and qualitative data to examine the feasibility of implementing a modified version of a multiple family group behavioral parent training intervention (The 4Rs and 2Ss for Strengthening Families Program [4Rs and 2Ss]) in child welfare (CW) placement prevention services, from the perspectives of participating caregivers (n = 12) and CW staff (n = 12; i.e., 6 caseworkers, 4 supervisors, and 2 administrators). Quantitative surveys were administered to caregivers and CW staff followed by semi-structured interviews to examine the feasibility of implementing the modified 4Rs and 2Ss program, as well as factors impacting feasibility. Results indicated that quantitative benchmarks for high feasibility were met in all assessed areas (e.g., family recruitment, caseworker fidelity ratings, CW staff feasibility ratings) except for family attendance, which was markedly lower than desired. Factors facilitating feasibility included agency and research support, intervention ease-of-use, perceived benefits to existing CW practice, as well as logistical support (e.g., food, transportation, childcare) promoting attendance. Factors hindering feasibility included conflicts between research-based eligibility criteria and existing client population demographics, research-related processes resulting in delays, CW staff role conflicts, added workload burden, complex family issues, and power differentials inherent to CW services which complicated families' voluntary participation.

Maternal distress and parenting during COVID-19: differential effects related to pre-pandemic distress?

BACKGROUND: Distinguishing whether and how pre-existing characteristics impact maternal responses to adversity is difficult: Does prior well-being decrease the likelihood of encountering stressful experiences? Does it protect against adversity's negative effects? We examine whether the interaction between relatively uniformly experienced adversity (due to COVID-19 experience) and individual variation in pre-existing (i.e., pre-pandemic onset) distress predicted mothers' pandemic levels of distress and insensitive caregiving within a country reporting low COVID-19 death rates, and strict nationwide regulations. METHOD: Fifty-one Singaporean mothers and their preschool-aged children provided data across two waves. Pre- pandemic onset maternal distress (i.e., psychological distress, anxiety, and parenting stress) was captured via self-reports and maternal sensitivity was coded from videos. Measures were repeated after the pandemic's onset along with questionnaires concerning perceived COVID-19 adversity (e.g., COVID-19's impact upon stress caring for children, housework, job demands, etc.) and pandemic-related objective experiences (e.g., income, COVID-19 diagnoses, etc.). Regression analyses (SPSS v28) considered pre-pandemic onset maternal distress, COVID-19 stress, and their interaction upon post-pandemic onset maternal distress. Models were re-run with appropriate covariates (e.g., objective experience) when significant findings were observed. To rule out alternative models, follow up analyses (PROCESS Model) considered whether COVID-19 stress mediated pre- and post-pandemic onset associations. Models involving maternal sensitivity followed a similar data analytic plan. RESULTS: Pre-pandemic maternal distress moderated the association between COVID-19 perceived stress and pandemic levels of maternal distress (ß = 0.22, p < 0.01) but not pandemic assessed maternal sensitivity. Perceived COVID-19 stress significantly contributed to post-pandemic onset maternal distress for mothers with pre-pandemic onset distress scores above (ß = 0.30, p = 0.05), but not below (ß = 0.25, p = 0.24), the median. Objective COVID-19 adversity did not account for findings. Post-hoc analyses did not suggest mediation via COVID-19 stress from pre-pandemic to pandemic maternal distress. CONCLUSIONS: Pre-existing risk may interact with subsequent perceptions of adversity to impact well-being. In combination with existing research, this small study suggests prevention programs should focus upon managing concurrent mental health and may highlight the importance of enhanced screening and proactive coping programs for people entering high stress fields and/or phases of life.

Alcohol Use and Physical Intimate Partner Violence Perpetration Among Black Men: The Moderating Effect of Interpersonal Social Support.

Studies have consistently shown an association between alcohol use in adulthood and intimate partner violence (IPV) perpetration. Yet, no known studies have examined this relationship when considering social support as a potential moderator with a sample of Black men. To address this gap in knowledge, we examined the moderating role of interpersonal social support on alcohol use in adulthood and physical IPV perpetration among Black men. Data for 1,127 Black men were obtained from the National Epidemiologic Survey of Alcohol and Related Condition (NESARC, Wave 2). Descriptive and logistic regression models were run with weighted data using STATA 16.0. Results from logistic regression analyses revealed that alcohol use in adulthood significantly predicted IPV perpetration (odds ratio [OR] = 1.18, p < .001). Interpersonal social support significantly moderated (OR = 1.01, p = .002) the relationship between alcohol use and IPV perpetration among Black men. Additionally, age, income, and perceived stress were significantly associated with IPV perpetration among Black men. Our study findings highlight the role of alcohol use and social support in exacerbating IPV perpetration among Black men, and the need for culturally responsive interventions to address these public health concerns throughout the life course.

Variation in maternal sensitivity and the development of memory biases in preschoolers.

Introduction: Links between maternal sensitivity, hippocampal development, and memory abilities suggests early life insensitive care may shape structures and schemas influencing future decisions and stress management, biasing children to negative information. While it is possible that this pattern of neurodevelopment may have adaptive consequences, for example, preventing children from encountering untoward experience with future adversity, it may also leave some children at risk for the development of internalizing problems. Methods: Here, in a Two Wave Study, we examine whether insensitive care predicts sub sequentially assessed memory biases for threatening (but not happy) stimuli in preschoolers (n = 49), and if such relations cut across different forms of relational memory, i.e., memory for relations between two "items," between an "item" and its spatial location, and an "item" and its temporal sequence. In a subset (n = 18) we also examine links between caregiving, memory, and hippocampal subregion volume. Results: Results indicate no main or interactive influence of gender on relational memory. However, insensitive caregiving predicted the difference between Angry and Happy memory during the Item-Space condition (B = 2.451, se = 0.969, p = 0.014, 95% CI (0.572, 4.340)], as well as memory for Angry (but not Happy) items [B = -2.203, se = 0.551, p < 0.001, 95% CI (-3.264,-1.094)]. Memory for the difference between Angry and Happy stimuli in the Space condition associated with larger right hippocampal body volumes (Rho = 0.639, p = 0.004). No relations were observed with internalizing problems. Discussion: Results are discussed with reference to developmental stage and in consideration of whether negative biases may serve as an intermediate factor linking early life insensitive care and later socioemotional problems including an increased incidence of internalizing disorders.

Heterogeneity in children at risk of math learning difficulties.

This study recruited 428 Singaporean children at risk of math learning difficulties (MLD; Mage  = 83.9 months, SDage  = 4.35 months; 41% female). Using a factor mixture model that considered both quantitative and qualitative differences in math ability, two qualitatively different groups were identified: one with generalized difficulties across different math skills and the other with more focal difficulties in arithmetic fluency. Reading, working memory capacity, and numeracy (number line estimation skills and numerical discrimination) uniquely explained group membership. Children within each group differed in the extent of difficulties they exhibited, with numeracy variables differentially contributing to math ability in each group. Findings speak against a dimensional view of MLD and underscore the conceptual limitations of using basic numeracy performance to profile learning difficulties.

Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial.

Background Women with atrial fibrillation (AF) demonstrate more AF-related symptoms and worse quality of life (QOL). Whether increased use of ablation in women reduces sex-related QOL differences is unknown. Sex-related outcomes for ablation versus drug therapy was a prespecified analysis in the CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial. Methods and Results Symptoms were assessed periodically over 60 months with the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score, and QOL was assessed with the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary and component scores. Women had lower baseline QOL scores than men (mean AFEQT scores 55.9 and 65.6, respectively). Ablation patients improved more than drug therapy patients with similar treatment effect by sex: AFEQT 12-month mean adjusted treatment difference in women 6.1 points (95% CI, 3.5-8.6) and men 4.9 points (95% CI, 3.0-6.9). Participants with baseline AFEQT summary scores <70 had greater QOL improvement, with a mean treatment difference at 12 months of 7.6 points for women (95% CI, 4.3-10.9) and 6.4 points for men (95% CI, 3.3-9.4). The mean adjusted difference in MAFSI frequency score between women randomized to ablation versus drug therapy at 12 months was -2.5 (95% CI, -3.4 to -1.6); for men, the difference was -1.3 (95% CI, -2.0 to -0.6). Conclusions Compared with drug therapy for AF, ablation resulted in more QOL improvement in both sexes, primarily driven by improvements in those with lower baseline QOL. Ablation did not eliminate the AF-related QOL gap between women and men. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.

Development and validation of the Inventory of Stress and Coping for African American Survivors of Homicide Victims.

OBJECTIVE: African Americans disproportionately experience homicide. However, validated measures designed to assess the traumatic impact of coping with murder for surviving family members and friends of homicide victims are absent from research. This article describes four studies that contributed to the development and preliminary validation of the Inventory of Stress and Coping for African American Survivors of Homicide Victims (ISCASHV). The ISCASHV is a measure that assesses multicomponents (e.g., stress, appraisals, stigma, coping) of the sociocultural and psychological processes in which African Americans cope with homicide. METHOD AND RESULTS: Studies 2-4 provide strong support for the multicomponent 42-item scale consisting of five factors: cultural trauma, reactions to homicide, culture of homicide, racial appraisal, and coping. The ISCASHV demonstrates strong construct validity evidence and good internal consistency estimates. Each of the five measures demonstrated a high test-retest estimate for a 2-week period, suggesting the temporal stability of the factors. CONCLUSIONS: Results suggest that the ISCASHV is a promising multicomponent measure that assesses the racial- and sociocultural-bound manifestation of homicide-related grief for African American survivors of homicide victims. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A general method for chemogenetic control of peptide function.

Natural or engineered peptides serve important biological functions. A general approach to achieve chemical-dependent activation of short peptides will be valuable for spatial and temporal control of cellular processes. Here we present a pair of chemically activated protein domains (CAPs) for controlling the accessibility of both the N- and C-terminal portion of a peptide. CAPs were developed through directed evolution of an FK506-binding protein. By fusing a peptide to one or both CAPs, the function of the peptide is blocked until a small molecule displaces them from the FK506-binding protein ligand-binding site. We demonstrate that CAPs are generally applicable to a range of short peptides, including a protease cleavage site, a dimerization-inducing heptapeptide, a nuclear localization signal peptide, and an opioid peptide, with a chemical dependence up to 156-fold. We show that the CAPs system can be utilized in cell cultures and multiple organs in living animals.

How do distracting events influence children's arithmetic performance?

To understand how distraction influences children's arithmetic performance, we examined effects of irrelevant sounds on children's performance while they solve arithmetic problems. Third and fifth graders were asked to verify true/false, one-digit addition problems (e.g., 9 + 4 = 12. True? False?) under silence and sound conditions. The sounds began when the problems started to appear on the screen (Experiment 1; N = 76) or slightly after (Experiment 2; N = 92) and continued until participants responded. The results showed that (a) children solved arithmetic problems more quickly in the sound condition than in the silence condition when the sounds started with problem display (phasic arousal effects); (b) children were slower on the arithmetic problem verification task when the sounds was played slightly after the problems started to appear on the screen (distraction effects); (c) phasic arousal effects were found only in third graders, whereas distraction effects were found in both grades, although their magnitudes were smaller in fifth graders; (d) distraction effects increased with increasing latencies in third graders but did not change across the entire latency distribution in fifth graders; and (e) distraction effects on current trials were smaller after sound trials than after silence trials in both age groups (sequential modulations of distraction effects). These findings have important implications for furthering our understanding of effects of irrelevant sounds on arithmetic performance as well as cognitive processes involved in children's arithmetic.

Psychometric Assessment of the Handwriting Proficiency Screening Questionnaire (HPSQ)-Thai Version for Primary School-Aged Children.

In this study, the original Handwriting Proficiency Screening Questionnaire (HPSQ) was translated into Thai and cross-culturally adapted for use among school-aged children in Thailand. Additionally, the initial psychometric properties of the new Thai version were assessed, including internal consistency, construct validity, and content validity. The original HPSQ was forward-translated by two independent translators from English to Thai and then back-translated. A final consolidation was conducted by an expert committee to develop the Thai HPSQ. In the psychometric evaluation, content validity was quantified using the item-objective congruence (IOC) value for each item. Intra-rater and inter-rater reliabilities were also assessed. Internal consistency was measured using Cronbach's alpha coefficient, and confirmatory factor analysis models were used to examine its construct validity. The Thai version of the HPSQ had excellent internal consistency (α = 0.92), good construct, and content validity (IOC value > 0.6). Intra-rater reliability was good (intraclass correlation coefficient (ICC) = 0.98), and inter-rater reliability ranged from fair to good (ICC = 0.46−0.77). Factor analysis revealed that a three-factor model best fitted the data. Thus, the Thai version of the HPSQ is a reliable and valid instrument for handwriting evaluation among Thai school-aged children. It can be useful for teachers and therapists to identify students with handwriting problems.

Earning Too Little And Worrying Too Much: The Role Of Income And Financial Worries On Parents' Well-Being In Hong Kong And Bangkok.

Research has shown that financial worries are key determinants of parents' well-being. However, less is known about the relative role of income and financial worries on parents' well-being; especially from a cross-cultural perspective. Guided by need and aspiration theories, we examined the roles of income and financial worries on happiness and distress among parents from Hong Kong (N = 258) and Bangkok (N = 190). Bayesian structural equation modelling revealed that greater income and lower financial worries were correlated, on a bivariate level, with higher levels of happiness and lower levels of distress in both societies. However, regressing happiness on both income and financial worries shows that income is uniquely associated with happiness in Bangkok, but not in Hong Kong. Financial worries uniquely explained variance in distress in both societies. These findings suggest that income and financial worries play different roles in parents' psychological well-being in the two cities. To promote parents' well-being, future policy or intervention programs should target financial worries in Hong Kong. Targeting income and financial worries are more likely to be efficacious in Bangkok.

Protecting children from COVID-19: examining U.S. parents motivation and behaviour using an integrated model of self-determination theory and the theory of planned behaviour.

OBJECTIVES: This longitudinal study applied the integrated model of self-determination theory (SDT) and the theory of planned behaviour (TPB) to explain COVID-19 preventive behaviours among parents of young children in the United States. DESIGN: The study adopted a two-wave longitudinal study design. Parents (N = 681) completed self-report questionnaires related to measures of SDT and the TPB constructs and behavioural adherence at baseline and after one month. We used standardised residual change scores to test the structural relationships of the integrated model. RESULTS: The parameter estimates of the model (CFI > .96, TLI > .86, RMSEA = .05, SRMR = .03) fit acceptably well to the data. Psychological need support was positively and significantly linked to autonomous and controlled motivation and amotivation. Autonomous motivation was positively and significantly correlated with TPB factors, and intention. Intention was a significant and positive predictor of behavioural adherence. CONCLUSION: The integrated model of SDT and the TPB appeared to be applicable to the explanation of COVID-19 prevention among the U.S. parents. Longitudinal data showed that a psychological need supportive social environment was related to favourable motivation, social cognition beliefs, intention and behavioural adherence to the preventive behaviours of parents protecting their young children from COVID-19.

Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions.

In the last decade there has been a significant increase in the literature discussing the use of benefit-risk methods in medical product (including devices) development. Government agencies, medical product industry groups, academia, and collaborative consortia have extensively discussed the advantages of structured benefit-risk assessments. However, the abundance of information has not resulted in a consistent way to utilize these findings in medical product development. Guidelines and papers on methods, even though well structured, have not led to a firm consensus on a clear and consistent approach. This paper summarizes the global landscape of benefit-risk considerations for product- or program-level decisions from available literature and regulatory guidance, providing the perspectives of three stakeholder groups-regulators, collaborative groups and consortia, and patients. The paper identifies key themes, potential impact on benefit-risk assessments, and significant future trends.

A systematic review of primary school teachers' experiences with digital technologies curricula.

Many countries around the world have now introduced Digital Technology concepts and pedagogical practices to their primary school curricula to ensure students develop the understanding, competences and values that will enable them to contribute to and benefit from their future labour market and society. This study aimed to explore teachers' experiences with these curricula in order to understand how teachers can be supported to raise their implementation efforts. An analysis of twenty-three studies across eleven countries was undertaken and found there was a lack of consensus of an appropriate age and approach to introducing Digital Technology concepts within primary schools. Teachers' Digital Technology self-efficacy, Digital Technology self-esteem/ Digital Technology confidence was seen to greatly influence their implementation, and many challenges to implementation were discussed. Professional Learning and Development was raised as a solution to boost teachers' confidence and overcome common implementation barriers.

Weekday breakfast habits and mood at the start of the school morning.

BACKGROUND: Good nutrition, regular physical activity, and adequate sleep are important for promoting health. However, it is not well characterized how these lifestyle behaviours are associated with mood at the start of school days. AIM: To identify the weekday health-related behaviours (breakfast intake, physical activity, and sleep) of Singaporean adolescents and explore their associations with mood at the beginning of the school morning. METHODS: 365 adolescents (52.3% boys, 47.7% girls) aged 14-19 years (M = 16.9, SD = 1.3 years) completed a survey set on breakfast habits, physical activity participation, sleep duration, and mood. RESULTS: More than one-third (38.6%) of participants never (15.0%) or irregularly (23.6%) consumed breakfast on weekdays. Adolescents consuming breakfast irregularly reported significantly higher negative mood scores than regular breakfast consumers (p = .002; d = .404). Almost two-thirds (64.1%) of adolescents did <60 min of moderate-to-vigorous physical activity (MVPA) on weekdays and reported lower positive morning mood scores than those who ≥60 min of MVPA (p = .014; d = .284). Although most (88.3%) adolescents slept <8 h each night, sleep duration was not related to either positive mood or negative mood. CONCLUSION: The present study suggests that eating breakfast on a regular basis and completing for ≥60 min of weekday MVPA are useful behaviours to start school days in a better mood. Parents and health educators should recognise the importance of establishing these habits and support students by instigating practical approaches so they can achieve a regular breakfast intake and physical activity engagement.