The Coronavirus Pandemic and Mental Health Presentations of Young Children.

Children under the age of four are emotionally vulnerable to global disasters, such as the COVID-19 pandemic given the lack of socialization opportunities and coping mechanisms, and susceptibility to heightened caregiver stress. Currently, the extent to which the pandemic impacted the mental health of clinically referred young children is unknown. To evaluate how children's mental health outcomes were impacted during the pandemic, interRAI Early Years assessments (N = 1343) were obtained from 11 agencies across the Province of Ontario, during pre-pandemic and pandemic timepoints.

Cardiotoxicity of BRAF/MEK Inhibitors: A Longitudinal Study Incorporating Contemporary Definitions and Risk Scores.

Background: Rapidly accelerated fibrosarcoma B-type (BRAF) and mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors have revolutionized treatment for patients with BRAF-mutated melanoma. Although left ventricular systolic dysfunction associated with these therapies has been reported in clinical trials, the real-world incidence is poorly defined, as are risk factors for its development.

Objectives: This study sought to characterize the incidence, time course, and risk factors for cancer therapy-related cardiac dysfunction (CTRCD) in patients with melanoma receiving BRAF and MEK inhibitors.

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.

Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to date in enhancing regulatory harmonization and convergence on the African continent via the Regional Economic Communities (RECs) and with the establishment of the Africa Medicines Agency (AMA). In this article, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Africa Regulatory Network (ARN) presents its perspective based on the available literature review and results from a survey conducted with innovative biopharmaceutical companies to gather experiences using regional joint assessment procedures (JAPs) in Africa, such as the East African Community Medicines Regulatory Harmonization (EAC-MRH), the West African Medicines Regulatory Harmonization (WA-MRH), and the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration (ZaZiBoNa), and provides best practices in this evolving landscape.

VA-Based Peritoneal Dialysis Program Feasibility Considerations and Process Outline.

Background: Home dialysis utilization is lower among veterans than in the general US population. Several sociodemographic factors and comorbidities contribute to peritoneal dialysis (PD) underutilization. In 2019, the Veterans Health Administration (VHA) Kidney Disease Program Office convened a PD workgroup to address this concern.

UK Dietary Practices for Tyrosinaemias: Time for Change.

In the UK, different dietary systems are used to calculate protein or tyrosine/phenylalanine intake in the dietary management of hereditary tyrosinaemia, HTI, II and III (HT), with no systematic evidence comparing the merits and inadequacies of each. This study aimed to examine the current UK dietary practices in all HTs and, using Delphi methodology, to reach consensus agreement about the best dietary management system. Over 12 months, five meetings were held with UK paediatric and adult dietitians working in inherited metabolic disorders (IMDs) managing HTs.

Suitability and Allocation of Protein-Containing Foods According to Protein Tolerance in PKU: A 2022 UK National Consensus.

Introduction: There is little practical guidance about suitable food choices for higher natural protein tolerances in patients with phenylketonuria (PKU). This is particularly important to consider with the introduction of adjunct pharmaceutical treatments that may improve protein tolerance. Aim: To develop a set of guidelines for the introduction of higher protein foods into the diets of patients with PKU who tolerate >10 g/day of protein.

Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide : Joint Position from EFPIA, IFPMA and Vaccines Europe.

Post-approval changes (PACs) to the registered information of authorised medicinal products are introduced routinely worldwide to enhance the robustness and efficiency of the manufacturing process, ensure timely supply in case of increased demand, improve quality control techniques, respond to changes in regulatory requirements and upgrade to state-of-the-art facilities. These are critical to prevent supply disruption and continuously improve existing medicines and vaccines. Due to the complexity of current PAC systems across markets, a change can take 3 to 5 years to approval globally (Hoath et al in BioProcess Int, 2016) thus hindering innovation and increasing the risk of shortages.

A Systems Thinking approach for the creation of effective competency-based medical education programs.

Successful and sustainable implementation of Competency-based Medical Education (CBME) programs is a significant and daunting challenge facing medical education worldwide. Our manuscript endorses for the first time, Systems Thinking as a concept for transforming and redesigning CBME programs employing the full 7-system elements as advocated by the Biomatrix Systems Theory. The majority of internationally recommended actions and processes for such an endeavor are highlighted, each within its system element.

Dietetic Management of Adults with Phenylketonuria (PKU) in the UK: A Care Consensus Document.

There is an increasing number of adults and elderly patients with phenylketonuria (PKU) who are either early, late treated, or untreated. The principal treatment is a phenylalanine-restricted diet. There is no established UK training for dietitians who work with adults within the specialty of Inherited Metabolic Disorders (IMDs), including PKU.

Mechanisms of obesity in children and adults with phenylketonuria on contemporary treatment.

Background & Aims: Obesity prevalence in people with phenylketonuria (PKU) is comparable to that of the general population but the underlying aetiology remains unknown. To assess body composition, dietary intake, moderate physical activity duration (MPAD) and energy expenditure (MPAEE), resting metabolic rate (RMR), diet-induced thermogenesis (DIT), fasting and postprandial fat (FOx) and carbohydrate oxidation (CHOOx), in PKU people and healthy Controls.

Methods: Participants were PKU people (n = 16) and healthy controls (n = 15).

Uniformity of Food Protein Interpretation Amongst Dietitians for Patients with Phenylketonuria (PKU): 2020 UK National Consensus Statements.

In phenylketonuria (PKU), variable dietary advice provided by health professionals and social media leads to uncertainty for patients/caregivers reliant on accurate, evidence based dietary information. Over four years, 112 consensus statements concerning the allocation of foods in a low phenylalanine diet for PKU were developed by the British Inherited Metabolic Disease Dietitians Group (BIMDG-DG) from 34 PKU treatment centres, utilising 10 rounds of Delphi consultation to gain a majority (≥75%) decision. A mean of 29 UK dietitians (range: 18-40) and 18 treatment centres (range: 13-23) contributed in each round.

Improved Eating Behaviour and Nutrient Intake in Noncompliant Patients with Phenylketonuria after Reintroducing a Protein Substitute: Observations from a Multicentre Study.

Noncompliance is widespread in adults with PKU and is associated with adverse metabolic, nutritional and cognitive abnormalities. Returning to the PKU diet is important for this at-risk population, yet for many this is challenging to achieve. Strategies that ease the return to the PKU diet, while offering nutritional and cognitive advantages, are needed.

Development of national consensus statements on food labelling interpretation and protein allocation in a low phenylalanine diet for PKU.

Background: In the treatment of phenylketonuria (PKU), there was disparity between UK dietitians regarding interpretation of how different foods should be allocated in a low phenylalanine diet (allowed without measurement, not allowed, or allowed as part of phenylalanine exchanges). This led to variable advice being given to patients.

Methodology: In 2015, British Inherited Metabolic Disease Group (BIMDG) dietitians (n = 70) were sent a multiple-choice questionnaire on the interpretation of protein from food-labels and the allocation of different foods.

Meaningful components of a community-based exercise program for individuals with disabilities: A qualitative study.

Background: Enhanced methods of evaluation are necessary to identify community-based exercise interventions that promote physical activity and improve health and participation for individuals with disabilities. The heterogeneity of the populations served, interventions implemented, and outcome measures used remains a barrier to effectively evaluate programs and generate evidence to inform best practice.

Objective: To explore goals and benefits of community-based exercise for individuals with disabilities and determine barriers and facilitators to evaluation in a community setting.

See food diet? Cultural differences in estimating fullness and intake as a function of plate size.

Previous research has suggested that manipulations of plate size can have a direct impact on perception of food intake, measured by estimated fullness and intake. The present study, involving 570 individuals across Canada, China, Korea, and New Zealand, is the first empirical study to investigate cultural influences on perception of food portion as a function of plate size. The respondents viewed photographs of ten culturally diverse dishes presented on large (27 cm) and small (23 cm) plates, and then rated their estimated usual intake and expected fullness after consuming the dish, using 100-point visual analog scales.

Estrogen Receptors and Signaling in Fibroids: Role in Pathobiology and Therapeutic Implications.

Uterine fibroids are the most common gynecologic tumors with a significant medical and financial burden. Several genetic, hormonal, and biological factors have been shown to contribute to the development and growth of fibroid tumors. Of these factors, estrogen is particularly critical since fibroids are considered estrogen dependent because no prepubertal cases have been described in the literature and tumors tend to regress after menopause.

The Mre11/Rad50/Nbs1 complex limits adeno-associated virus transduction and replication.

Adeno-associated virus (AAV) is a parvovirus with a small single-stranded DNA genome that relies on cellular replication machinery together with functions supplied by coinfecting helper viruses. The impact of host factors on AAV infection is not well understood. We explored the connection between AAV helper functions supplied by adenovirus and cellular DNA repair proteins.