A Qualitative Exploration of Peer Supporters' Experiences of Undertaking a Co-Produced Mental Health and Emotional Well-Being Training Programme.

Introduction: Peer supporters play a crucial role in mental health and support services, but their own mental health and emotional well-being are often neglected by themselves, and, frequently, their organisations. Here, we report findings from a qualitative interview study of peer supporters who completed a co-produced emotional well-being training programme.

Method: Ten semi-structured interviews with peer supporters working in the North East of England were conducted to explore their experiences of the training programme.

Psychosocial Aspects of the Lived Experience of Long COVID: A Systematic Review and Thematic Synthesis of Qualitative Studies.

Background: Despite increasing recognition of long COVID, the psychosocial impacts of the lived experience on individuals remain underexplored. This systematic review sought to fill this gap by identifying key themes that describe the psychosocial dimensions of long COVID.

Objective: The aim of this study is to identify key themes illustrating the psychosocial aspects of individuals' lived experience of long COVID.

QTc Interval Prolongation and Its Association With Electrolyte Abnormalities and Psychotropic Drug Use Among Patients With Eating Disorders.

Background: Eating disorders (EDs) often develop during adolescence with high mortality rates. Sudden cardiac death in these patients has been associated with corrected QT (QTc) interval prolongation. The significance of extrinsic factors on QTc prolongation in populations with EDs remains controversial.

Peer supporters' mental health and emotional wellbeing needs: Key factors and opportunities for co-produced training.

Introduction: Peer supporters are a valuable asset to mental health and support services, but their own mental health needs are often overlooked in research and practice. This study explored peer supporters' perceived challenges of maintaining their mental health and emotional wellbeing and co-produced training needs.

Methods: A qualitative approach was used to explore factors affecting peer supporters' mental health and emotional wellbeing.

The Expanded Exercise Addiction Inventory (EAI-3): Towards Reliable and International Screening of Exercise-Related Dysfunction.

Exercise addiction (EA) refers to excessive exercise, lack of control, and health risks. The Exercise Addiction Inventory (EAI) is one of the most widely used tools in its assessment. However, the cross-cultural psychometric properties of the EAI could be improved because it misses three pathological patterns, including guilt, exercise despite injury, and experienced harm.

Static digestion model adapted to the general older adult population: an INFOGEST international consensus.

Understanding the mechanisms of food digestion is of paramount importance to determine the effect foods have on human health. Significant knowledge on the fate of food during digestion has been generated in healthy adults due to the development of physiologically-relevant digestion models. However, it appears that the performance of the oro-gastrointestinal tract is affected by ageing and that a model simulating the digestive conditions found in a younger adult (<65 years) is not relevant for an older adult (>65 years).

Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children.

Many medicines are used "off-label" in children outside the terms of the license. Feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children.

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.

Even with recent substantive improvements in health care in pediatric populations, considerable need remains for additional safe and effective interventions for the prevention and treatment of diseases in children. The approval of prescription drugs and biological products for use in pediatric settings, as in adults, requires demonstration of substantial evidence of effectiveness and favorable benefit-to-risk. For diseases primarily affecting children, such evidence predominantly would be obtained in the pediatric setting.

Extrapolation as a Default Strategy in Pediatric Drug Development.

Pediatric drug development lags adult development by about 8 years (Mulugeta et al. in Pediatr Clin 64(6):1185-1196, 2017). In such context, many incentives, regulations, and innovative techniques have been proposed to address the disparity for pediatric patients.

Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.

Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified.

Multi-Stakeholder Retrospective Acceptability of a Peer Support Intervention for Exercise Referral.

Perceived social support opportunities are central to successful exercise referral scheme (ERS) client experiences. However, there remains a lack of guidance on how ERSs can embed social support opportunities within their provision. This study presents retrospective acceptability findings from a 12-week social-identity-informed peer support intervention to enhance perceived social support among clients of an English ERS.

Incorporating Innovative Techniques Toward Extrapolation and Efficient Pediatric Drug Development.

The conduct of pediatric clinical trials is legally required, monitored, and encouraged in major geographic areas such as the United States and Europe. However, because pediatric patients are considered vulnerable populations, they should only be enrolled as research subjects in a clinical trial if enrolling adult subjects will not be able to answer the scientific question related to the health and welfare of children. Thus, there is an ethical obligation to build the foundation for the use of pediatric extrapolation and related innovative analytical strategies with appropriately designed pediatric and adult clinical trials to reduce the amount of, or general need for, additional information needed from children to reach conclusions.

Recommendations for the design of therapeutic trials for neonatal seizures.

Although seizures have a higher incidence in neonates than any other age group and are associated with significant mortality and neurodevelopmental disability, treatment is largely guided by physician preference and tradition, due to a lack of data from well-designed clinical trials. There is increasing interest in conducting trials of novel drugs to treat neonatal seizures, but the unique characteristics of this disorder and patient population require special consideration with regard to trial design. The Critical Path Institute formed a global working group of experts and key stakeholders from academia, the pharmaceutical industry, regulatory agencies, neonatal nurse associations, and patient advocacy groups to develop consensus recommendations for design of clinical trials to treat neonatal seizures.

Social physique anxiety and physical activity behaviour of male and female exercisers.

Despite females consistently reporting greater social physique anxiety (SPA), previous literature has yet to demonstrate whether SPA gender differences are linked to the way males and females perform physical activity. This study investigated an association between SPA and physical activity frequency, history of exercise, and physical activity intensity. Participants were represented by currently active users (N = 33 males; N = 31 females) of an on-campus university-run gym and completed a background physical activity questionnaire and the nine-item Social Physique Anxiety Scale.

Enrollment of Neonates in More Than One Clinical Trial.

Because the highest rates of morbidity and mortality in neonates are seen in those born at <32 weeks' gestation, this group has the most urgent need for novel therapies to improve survival and outcome. Legislative efforts in the United States and Europe have attempted to address this issue by requiring the study of drugs, biological and nutritional products, devices, and other therapies in this population through a combination of high-quality regulatory and clinical trials, quality improvement initiatives, and observational studies. Because there are relatively small numbers of very preterm neonates born each year in any 1 country or continent, and because a significant number of clinical trials are recruiting at any 1 time, a neonate may meet enrollment criteria for >1 clinical trial.

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.

The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance developed by regulatory agencies worldwide does not fully address the specificities of neonatal drug development, especially among extremely premature newborns who currently survive. Consequently, an international consortium from Canada, Europe, Japan, and the United States was organized by the Critical Path Institute to address the content of guidance.

Special article: 2014 Pediatric Clinical Trials Forum.

In November 2014, the American Academy of Pediatrics convened key stakeholders to discuss the feasibility of accelerating children's medical advances by creating an independent global Pediatric Clinical Trials Network. The Forum identified challenges posed by the U.S.