Exploring regulatory flexibility to create novel incentives to optimize drug discovery.

Efforts by governments, firms, and patients to deliver pioneering drugs for critical health needs face a challenge of diminishing efficiency in developing those medicines. While multi-sectoral collaborations involving firms, researchers, patients, and policymakers are widely recognized as crucial for countering this decline, existing incentives to engage in drug development predominantly target drug manufacturers and thereby do little to stimulate collaborative innovation. In this mini review, we consider the unexplored potential within pharmaceutical regulations to create novel incentives to encourage a diverse set of actors from the public and private spheres to engage in the kind of collaborative knowledge exchange requisite for fostering enhanced innovation in early drug development.

Examining trauma, anxiety, and depression as predictors of dropout from residential treatment for substance use disorders.

Substance use disorders (SUDs) are highly prevalent and have deleterious effects on one's health and well-being. Inpatient treatment for SUDs reduces patient relapse, which subsequently ameliorates these negative effects on the individual and society. Additionally, those who complete treatment are less likely to relapse compared to those who do not complete treatment. Thus, maintaining patient engagement in treatment and reducing the rates of those leaving against medical advice (AMA) is particularly important. Examining the factors and comorbidities that may contribute to treatment dropout has the potential to identify at-risk patients in need of additional individualized intervention. The current study aimed to examine comorbid anxiety, depression, and posttraumatic stress disorder (PTSD) symptoms as predictors of dropout AMA in a residential substance use treatment population. Results showed that patients with social anxiety were more likely to leave treatment AMA, while those with PTSD were more likely to complete treatment. Findings suggest that PTSD-specific treatment, as offered in this facility, may help with patient retention, while group focused therapy may be distressing to those with social anxiety. Clinical implications of this research may include incorporating evidence-based practice for social anxiety early during inpatient treatment to reduce anxiety such that patients may better engage with SUDs treatment.

Intimate Partner Violence Perpetration Among Sexual Minority Young Adults: Associations With Alcohol Use, PTSD Symptoms, Internalized Homophobia, and Heterosexist Discrimination.

Lesbian, gay, bisexual, queer, and other sexual minority (LGBQ+) young adults report similar or higher rates of intimate partner violence (IPV) perpetration than their heterosexual peers. Elevated IPV risk among LGBQ+ young adults may be attributable to experiencing heterosexist discrimination and internalized homophobia. In addition, LGBQ+ people report disproportionate posttraumatic stress disorder (PTSD) symptoms, alcohol use, and IPV perpetration in dating relationships. Thus, this study explored which combinations of IPV risk factors (i.e., experiencing heterosexist discrimination, internalized homophobia, PTSD symptoms, alcohol use) related to forms of IPV perpetration, inclusive of psychological, physical, and sexual forms, in a sample of 342 LGBQ+ young adults. Internalized homophobia was related to psychological IPV perpetration at high and medium levels of PTSD symptoms and only high levels of alcohol use. PTSD symptoms and alcohol use interacted to predict psychological IPV perpetration; and PTSD symptoms related to increased psychological IPV perpetration at high and medium, but not low, alcohol use levels. Alcohol use was positively related to physical IPV perpetration. No other risk factors or interactions were significantly related to physical or sexual IPV perpetration. Results were consistent with prior findings that linked internalized homophobia, alcohol use, and PTSD symptoms to IPV perpetration and highlight the interacting nature of these IPV perpetration risk factors. Comprehensive IPV interventions with LGBQ+ young adults should evaluate the impact of simultaneously targeting these multiple IPV risk factors considering their interacting contributions to IPV perpetration risk. More research is needed to examine the temporal relations between minority stress, PTSD symptoms, alcohol use, and IPV perpetration.

Reflective learning conversations model for simulation debriefing: a co-design process and development innovation.

BACKGROUND: Health practitioners must be equipped with effective clinical reasoning skills to make appropriate, safe clinical decisions and avoid practice errors. Under-developed clinical reasoning skills have the potential to threaten patient safety and delay care or treatment, particularly in critical and acute care settings. Simulation-based education which incorporates post-simulation reflective learning conversations as a debriefing method is used to develop clinical reasoning skills while patient safety is maintained. However, due to the multidimensional nature of clinical reasoning, the potential risk of cognitive overload, and the varying use of analytic (hypothetical-deductive) and non-analytic (intuitive) clinical reasoning processes amongst senior and junior simulation participants, it is important to consider experience, competence, flow and amount of information, and case complexity related factors to optimize clinical reasoning while attending group- based post-simulation reflective learning conversations as a debriefing method. We aim to describe the development of a post-simulation reflective learning conversations model in which a number of contributing factors to achieve clinical reasoning optimization were addressed. METHODS: A Co-design working group (N = 18) of doctors, nurses, researchers, educators, and patients' representatives collaboratively worked through consecutive workshops to co-design a post-simulation reflective learning conversations model to be used for simulation debriefing. The co-design working group established the model through a theoretical and conceptual-driven process and multiphasic expert reviews. Concurrent integration of appreciative inquiry, plus/delta, and Bloom's Taxonomy methods were considered to optimize simulation participants' clinical reasoning while attending simulation activities. The face and content validity of the model were established using the Content Validity Index CVI and Content Validity Ratio CVR methods. RESULTS: A Post-simulation reflective learning conversations model was developed and piloted. The model was supported with worked examples and scripted guidance. The face and content validity of the model were evaluated and confirmed. CONCLUSIONS: The newly co-designed model was established in consideration to different simulation participants' seniority and competence, flow and amount of information, and simulation case complexity. These factors were considered to optimize clinical reasoning while attending group-based simulation activities.

An Integrative Model of Youth Anxiety: Cognitive-Affective Processes and Parenting in Developmental Context.

Multiple theoretical frameworks have been proposed to provide a more comprehensive picture of the risk factors that influence anxiety-related developmental trajectories. Nonetheless, there remains a need for an integrative model that outlines: (1) which risk factors may be most pertinent at different points in development, and (2) how parenting may maintain, exacerbate, or attenuate an affective style that is characterized by high negative emotional reactivity to unfamiliar, uncertain, and threatening situations. A developmentally informed, integrative model has the potential to guide treatment development and delivery, which is critical to reducing the public health burden associated with these disorders. This paper outlines a model integrating research on many well-established risk mechanisms for anxiety disorders, focusing on (1) the developmental progression from emotional reactivity constructs early in life to those involving higher-level cognitive processes later in youth, and (2) potential pathways by which parenting may impact the stability of youth's cognitive-affective responses to threat-relevant information across development.

Alcohol Use and Compulsive Sexual Behaviors in College Students: The Moderating Effect of Alcohol-Related Sexual Expectancies.

Compulsive sexual behaviors (CSB) and alcohol use are prevalent among college students. Alcohol use frequently co-occurs with CSB; however, further examination of risk factors of co-occurring alcohol use and CSB is needed. We examined the moderating effect of alcohol-related sexual expectancies, specifically sexual drive and affect expectancies, on the association between alcohol use/problems and CSB among 308 college students from a large university in the southeastern United States. Alcohol use/problems and CSB had a positive significant relationship among college students high in sexual drive expectancies and high and average in sexual affect expectancies. These findings suggest that alcohol-related sexual expectancies may be a risk factor for alcohol-related CSB.

Sexual Narcissism and Hypersexuality Relate to Sexual Coercion in Hookups among U.S. University Students.

Sexual violence remains a prevalent issue on college campuses. Sexual coercion, a form of sexual violence, is frequently employed within casual sexual encounters (i.e., hookups). The present study investigated hypersexuality and sexual narcissism as unique predictors of sexual coercion and examined whether there were gender differences in these associations. Participants (N = 793, ages 18-25) were undergraduate students at a large southeastern university who have: (1) engaged in sexual activity within the past six months and (2) had at least one prior hookup experience. Respondents completed surveys online assessing levels of sexual narcissism, hypersexuality, and sexual coercion perpetration in hookups. Participants primarily identified as female (71.7%), White (84.2%), and heterosexual (86.6%), with an average of 9.77 sexual engagements per month. Bivariate correlations and independent samples t-tests were conducted to examine associations between and gender differences across study variables, respectively. We assessed the factor structure of study variables using confirmatory factor analysis and tested hypotheses using structural equation modeling. Compared to women, men scored higher on sexual exploitation and all hypersexuality subscales. After establishing good-fitting measurement models, we found that both sexual narcissism and hypersexuality predicted increased sexual coercion perpetration and that gender did not moderate these associations. Study findings demonstrated that sexual narcissism and hypersexuality are risk factors for sexual coercion perpetration in hookups across gender. Although associations were consistent across gender, men may report higher levels of sexual coercion perpetration risk factors. Future researchers could focus on gender differences in the etiology of sexual coercion risk factors.

Assessment of Clinical Reasoning While Attending Critical Care Postsimulation Reflective Learning Conversation: A Scoping Review.

BACKGROUND: The critical care environment is characterized with a high level of workload, complexity, and risk of committing practice mistakes. To avoid clinical errors, health care professionals should be competent with effective clinical reasoning skills. To develop effective clinical reasoning skills, health care professionals should get the chance to practice and be exposed to different patient experiences. To minimize safety risks to patients and health care professionals, clinical reasoning with a focus on reflective learning conversation opportunities can be practiced in simulated settings. OBJECTIVES: To explore the most valid and reliable tools to assess clinical reasoning while attending adult critical care-related simulation-based courses in which reflective learning conversations are used. METHODS: A scoping review was conducted following Joanna Briggs Institute and Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews. Eight electronic databases were searched, and full-text review was completed for 26 articles. RESULTS: The search resulted in no studies conducted to measure clinical reasoning while attending adult critical care-related, simulation-based courses in which the reflective learning conversation method was embedded. DISCUSSION: This highlights the need to evaluate current available clinical reasoning tools or develop new tools within the context of adult critical care simulation where reflective learning forms a key part of the simulation procedures.

Systematic review of fNIRS studies reveals inconsistent chromophore data reporting practices.

Significance: Functional near-infrared spectroscopy (fNIRS) is unique among neuroimaging techniques in its ability to estimate changes in both oxyhemoglobin (HbO) and deoxyhemoglobin (HbR). However, fNIRS research has applied various data reporting practices based on these chromophores as measures of neural activation. Aim: To quantify the variability of fNIRS chromophore data reporting practices and to explore recent data reporting trends in the literature. Approach: We reviewed 660 fNIRS papers from 2015, 2018, and 2021 to extract information on fNIRS chromophore data reporting practices. Results: Our review revealed five general practices for reporting fNIRS chromophores: (1) HbO only, (2) HbR only, (3) HbO and HbR, (4) correlation-based signal improvement, and (5) either the total (HbT) or difference (HbDiff) in concentration between chromophores. The field was primarily divided between reporting HbO only and reporting HbO and HbR. However, reporting one chromophore (HbO) was consistently observed as the most popular data reporting practice for each year reviewed. Conclusions: Our results highlight the high heterogeneity of chromophore data reporting in fNIRS research. We discuss its potential implications for study comparison efforts and interpretation of results. Most importantly, our review demonstrates the need for a standard chromophore reporting practice to improve scientific transparency and, ultimately, to better understand how neural events relate to cognitive phenomena.

Eating Competence Among Caregivers of Toddlers: Associations With Caregiver and Child Overweight/Obesity.

OBJECTIVE: To examine the association between caregiver eating competence and child overweight/obesity and caregiver obesity. DESIGN: Longitudinal cohort. SETTING: A large US children's hospital. PARTICIPANTS: Caregiver-child dyads (n = 288 with complete data at 2 time points) were sampled in 2017-2019 from those who received care at Nationwide Children's Hospital. MAIN OUTCOME MEASURE(S): Child overweight/obesity at 24 months of age (body mass index [BMI]) z-score >2 per World Health Organization standards and caregiver weight status (underweight/healthy [BMI < 25 kg/m2], overweight [BMI ≥ 25 and < 30 kg/m2], or obese [BMI ≥ 30 kg/m2]). ANALYSIS: Log-binomial models examined the relationship between caregiver eating competence (ecSatter Inventory) at 18 months and child overweight/obesity at 24 months of age. Proportional odds models investigated the relationship between caregivers' eating competence and weight status. RESULTS: Eating competent caregivers had more than twice the odds (odds ratio, 2.11; 95% confidence interval, 1.30-3.42) of having a lower BMI category and had lower average BMI than noneating competent caregivers. Child overweight/obesity at 24 months did not differ by caregiver eating competence. CONCLUSIONS AND IMPLICATIONS: Although child overweight/obesity did not vary by caregiver eating competence, caregiver eating competence was related to their weight status. Longer-term studies are needed to clarify the role of caregiver eating competence as children develop. Promoting caregivers' eating competence may translate into healthier behaviors and skills for caregivers and their children long term.

Inhibition of androgenic pathway impairs encoding of cerebellar-dependent motor learning in male rats.

Cerebellar-dependent learning is essential for the adaptation of motor and no motor behaviors to changing contexts, and neuroactive steroids-mainly referred to as estrogens-may regulate this process. However, the role of androgens in this process has not been established, although they may affect cerebellar physiology. Thus, this study aims to determine whether the activation of androgenic neural pathways may take part in controlling the vestibuloocular (VOR) and optokinetic reflexes (OKR), which depend on a defined cerebellar circuitry. To answer this question, we acutely blocked the activation of androgen receptors (Ars) using systemic administration of the Ars antagonist flutamide (FLUT; 20 mg/Kg) in peripubertal male rats. Then, we evaluated the FLUT effect on general oculomotor performance in the VOR and OKR as well as VOR adaptive gain increases and decreases. We used a paradigm causing fast VOR adaptation that combined in phase/out phase visuo-vestibular stimulations. We found that FLUT impaired the gain increase and decrease in VOR adaptation. However, FLUT altered neither acute nor overtime basal ocular-motor performance in the VOR or OKR. These findings indicate that the activation of androgenic neural pathways participates in phenomena leading to fast VOR adaptation, probably through the modulation of plasticity mechanisms that underlie adaptation of this reflex. Conversely, androgens may not be essential for neural information processing demands in basal ocular-motor reflexes. Moreover, our results suggest that androgens, possibly testosterone and dihydrotestosterone, could rapidly regulate motor memory encoding in the VOR adaptation, acting at both cerebellar and extracerebellar plasticity sites.

The Impact of Simulation-Based Education on Nurses' Perceived Predeployment Anxiety During the COVID-19 Pandemic Within the Cultural Context of a Middle Eastern Country.

Anxiety related to the COVID-19 pandemic is prevalent among the nursing workforce and has the potential to affect well-being and performance in the workplace. This paper reports on a joint education/nursing and midwifery workforce quality improvement initiative in the State of Qatar to address an urgent need for COVID-19 preparedness during the second wave of infection. A Simulation-Based Education (SBE) program was developed and delivered over a period of 2 months (February to April 2021) to prepare nurses for deployment to COVID-19 facilities. Perceived anxiety scores related to COVID-19 deployment were collected from 121 nurses before and after SBE attendance. The data demonstrates that SBE is an effective method to reduce deployment-related anxiety among registered nurses.

Knowledge of Infant Development and Parent Well-Being: Cross-Sectional Analysis of Toddlers.

OBJECTIVE: Knowledge about child development is associated with parenting and children's outcomes. Parents with less accurate knowledge about developmental milestones may have unrealistic expectations for their child's behavior, which may affect parent well-being. Limited research has examined this topic relative to depression, but other aspects of parent well-being (e.g., parenting stress) are unexplored. METHODS: Cross-sectional analysis of an ongoing prospective cohort study of 300 families in central Ohio enrolled when children were a mean (SD) calendar age of 18.2 (0.7) months. Children of all gestational ages at birth are included, and 37% were born preterm (<37 weeks' gestation.) Primary caregivers (93% mothers) completed the 20-item Knowledge of Infant Development Index (KIDI) and questionnaires for child temperament and 3 aspects of parent well-being (depressive and anxious symptoms, parenting stress, and general health). Covariate-adjusted regression models assessed relationships between the KIDI score and each well-being outcome. We hypothesized that parents with less knowledge would have more symptoms of depression and anxiety, greater parenting stress, and poorer health. Whether associations were stronger for parents of children born preterm or who had high negative affect was explored. RESULTS: Knowledge of Infant Development Index scores were associated with sociodemographic characteristics, child temperament, and gestational age (more knowledge: higher socioeconomic position, less child negative affect, and full-term birth). KIDI scores did not predict any aspect of parent well-being, and there was no evidence that child temperament or preterm birth altered these findings. CONCLUSION: In this sample of parents of toddlers assessed in 2018/19, greater knowledge of infant development was not associated with parent well-being.

The perceived relationship between reflective learning conversation and clinical reasoning skills amongst critical care and trauma nurses: A cross sectional parallel mixed method.

BACKGROUND: To enhance clinical reasoning skills and reflective practices, Hamad Medical Corporation implemented a new educational initiative known as the reflective learning conversations method. The educational method was designed to discuss reflectively post real patient experiences. The reflective conversations aim to improve nurses' practices and ensure patient safety in the critical care and trauma units. OBJECTIVES: This study investigates the perceived relationship between reflective learning conversations method and clinical reasoning skills amongst critical care and trauma nurses, and explores how clinical reasoning skills can be developed through learning conversation activities. DESIGN: A cross sectional parallel mixed methods study was conducted in Hamad Medical Corporation critical care and trauma units. Anonymous self-reported questionnaires were collected from 236 critical care and trauma nurses who attended the reflective learning conversation activities. Focus group interviews were concurrently conducted alongside the questionnaire survey. RESULTS: Attending reflective learning conversations educational activities has a significantly positive impact on critical care and trauma nurses' clinical reasoning skills. Reflective practice can be promoted and enhanced through the use of reflective learning conversations method. However, attending group reflection and the fear of feeling threatened are perceived barriers to reflective learning conversations. CONCLUSIONS: Reflective learning conversations are perceived as an effective clinical education method to enhance the clinical reasoning skills of critical care and trauma nurses. There are barriers to effective learning conversation methods which need further in depth investigations considering gender and seniority factors.

Beginning Restorative Activities Very Early: Implementation of an Early Mobility Initiative in a Pediatric Onco-Critical Care Unit.

INTRODUCTION: Children with underlying oncologic and hematologic diseases who require critical care services have unique risk factors for developing functional impairments from pediatric post-intensive care syndrome (PICS-p). Early mobilization and rehabilitation programs offer a promising approach for mitigating the effects of PICS-p in oncology patients but have not yet been studied in this high-risk population. METHODS: We describe the development and feasibility of implementing an early mobility quality improvement initiative in a dedicated pediatric onco-critical care unit. Our primary outcomes include the percentage of patients with consults for rehabilitation services within 72 h of admission, the percentage of patients who are mobilized within 72 h of admission, and the percentage of patients with a positive delirium screen after 48 h of admission. RESULTS: Between January 2019 and June 2020, we significantly increased the proportion of patients with consults ordered for rehabilitation services within 72 h of admission from 25 to 56% (p<0.001), increased the percentage of patients who were mobilized within 72 h of admission to the intensive care unit from 21 to 30% (p=0.02), and observed a decrease in patients with positive delirium screens from 43 to 37% (p=0.46). The early mobility initiative was not associated with an increase in unplanned extubations, unintentional removal of central venous catheters, or injury to patient or staff. CONCLUSIONS: Our experience supports the safety and feasibility of early mobility initiatives in pediatric onco-critical care. Additional evaluation is needed to determine the effects of early mobilization on patient outcomes.

Feeding Infants at the Breast or Feeding Expressed Human Milk: Long-Term Cognitive, Executive Function, and Eating Behavior Outcomes at Age 6 Years.

OBJECTIVE: To examine how expressed milk feeding diverges from feeding at the breast in its association with neurodevelopment and behavior. We hypothesized that longer and exclusive feeding at the breast only (ie, no formula, no feeding expressed milk) would be associated with the optimal cognitive developmental, executive function, and eating behaviors and that expressed milk feeding would be associated with less-optimal outcomes. STUDY DESIGN: The Moms2Moms cohort (Ohio, US) reported infant feeding practices at 12 months postpartum and children's global cognitive ability, executive function, and eating behaviors at 6 years. Linear and log-binomial regression models estimated associations with durations of feeding at the breast, expressed milk, human milk (modes combined), and formula. RESULTS: Among 285 participants, each month of exclusive feeding at the breast only was associated with a decreased risk of clinically meaningful executive function (working memory) deficit (adjusted relative risk [RR] 0.78, 95% CI 0.63-0.96) but was unassociated with inhibition (adjusted RR 0.92, 95% CI 0.85-1.01). Feeding expressed milk was not clearly related to executive function outcomes. No associations with global cognitive ability were observed. Weak associations were observed with eating behaviors for some feeding practices. CONCLUSIONS: Feeding at the breast may offer advantages to some aspects of executive function that expressed milk may not. Large, prospective studies exploring mechanisms could further distinguish the effect of feeding mode from that of nutrients.

Piloting of a nursing and midwifery competence framework in the cultural context of a middle eastern country.

Clinical competence amongst nurses and midwives is vital for the delivery of safe and consistent patient care. However, worldwide there is a lack of agreement on definitions and notions about what constitutes competence and how it can be determined in everyday clinical practice. This situation poses professional dilemmas in situations where competing dialogues exist. This is particularly evident in countries that employ nurses and midwives from diverse national backgrounds with differing professional and educational experiences. To address potential misunderstandings, ensure a consistent approach to the confirmation of clinical competency and assure patient safety, a strategic decision was taken by the nursing and midwifery leadership of the country's major healthcare organisation to develop an organisationally and culturally sensitive competence framework model. This article reports on the design, development and piloting of an educationally led framework model. The model, referred to as 'Q-PACE: Qatar's Practice, Appraisal, Competence and Education', links previously fragmented activities regarding confirmation of clinical competence of staff into a unified holistic process that provides assurance regarding the competence of new and existing employees.

Simulation-based education programme for upskilling non-critical care nurses for COVID-19 deployment.

Background: The coronavirus disease 2019 (COVID-19) crisis created pressure on healthcare institutions to be prepared with maximum workforce and bed capacity. Clinical education during COVID-19 has high risk of disease transmission to learners due to contamination of equipment, supplies and surfaces, in addition to increased clinical-related stress and fear. Simulation-based education (SBE) has potential to help manage the pandemic by rapidly upskilling nurses' clinical responsibilities. Methods: Upskilling of 445 non-critical care nurses was conducted using SBE between 14th March and 30 May 2020. Training consisted of completing a mandatory online critical care awareness module, followed by 3 hours of critical care simulation-based scenarios using demonstration and return-demonstration approach. Results: All 445 non-critical care nurses completed required modules and simulation experiences. The critical care simulation-based upskilling programme was evaluated as an effective way to learn how to manage critically ill patients. The majority of evaluation items were rated over 95% for effectiveness of the education; four items were less than 95% (88-94%). Lower rated items considered training and practice time, improved competency and commitment to apply learning. Conclusion: Rapidly developed and implemented upskilling of critical care nurses was effectively accomplished with SBE. However, learners noted the need for longer learning times and increased practice opportunity to improve competency. Lack of intent to apply the patient care techniques requires further study. SBE has potential as an effective educational method for rapid preparedness in future crisis.

New frontiers in translational research: Touchscreens, open science, and the mouse translational research accelerator platform.

Many neurodegenerative and neuropsychiatric diseases and other brain disorders are accompanied by impairments in high-level cognitive functions including memory, attention, motivation, and decision-making. Despite several decades of extensive research, neuroscience is little closer to discovering new treatments. Key impediments include the absence of validated and robust cognitive assessment tools for facilitating translation from animal models to humans. In this review, we describe a state-of-the-art platform poised to overcome these impediments and improve the success of translational research, the Mouse Translational Research Accelerator Platform (MouseTRAP), which is centered on the touchscreen cognitive testing system for rodents. It integrates touchscreen-based tests of high-level cognitive assessment with state-of-the art neurotechnology to record and manipulate molecular and circuit level activity in vivo in animal models during human-relevant cognitive performance. The platform also is integrated with two Open Science platforms designed to facilitate knowledge and data-sharing practices within the rodent touchscreen community, touchscreencognition.org and mousebytes.ca. Touchscreencognition.org includes the Wall, showcasing touchscreen news and publications, the Forum, for community discussion, and Training, which includes courses, videos, SOPs, and symposia. To get started, interested researchers simply create user accounts. We describe the origins of the touchscreen testing system, the novel lines of research it has facilitated, and its increasingly widespread use in translational research, which is attributable in part to knowledge-sharing efforts over the past decade. We then identify the unique features of MouseTRAP that stand to potentially revolutionize translational research, and describe new initiatives to partner with similar platforms such as McGill's M3 platform (m3platform.org).