Involving People With Lived Experience in Electronic Health Record Database Studies Reflections and Learning From the CHOOSE Study.

Background: Patient and public involvement and engagement (PPIE) is integral to health research. Reporting of PPIE methods and impact is becoming increasingly common in health research. However, reporting on PPIE in studies using large, routinely collected electronic health record data sets is less common.

Jugular Approach for the Transcatheter Pacemaker Implant - Better Access for Smaller Hearts?

Background: The Micra leadless pacemaker was developed to fit inside the right ventricle, thereby reducing overall complications by 48% compared with a historical control group. The current labeling restricts implants to the femoral approach. In this article we used 3-dimensional computer models of human hearts to demonstrate why implants can be difficult in small patients and how using the jugular approach reduces these difficulties.

Temporal trends in eating disorder and self-harm incidence rates among adolescents and young adults in the UK in the 2 years since onset of the COVID-19 pandemic: a population-based study.

Background: Self-harm and eating disorders share multiple risk factors, with onset typically during adolescence or early adulthood. We aimed to examine the incidence rates of these psychopathologies among young people in the UK in the 2 years following onset of the COVID-19 pandemic.

Methods: We conducted a population-based study using the primary care electronic health records of patients aged 10-24 years in the UK Clinical Practice Research Datalink (CPRD).

A qualitative study exploring the benefits of involving young people in mental health research.

Introduction: It is increasingly accepted that young people need to be centrally involved in research on issues that affect them. The aim of this study was to explore young people's perceptions of the benefits for them of being involved in mental health research and the processes that enabled these benefits.

Methods: Qualitative interviews were conducted by co-researchers (young people with lived experience and/or interest in mental health) with 13 young people (aged 13-24 years) who had experience of being involved in mental health research when they were between 11 and 16 years of age.

The Epstein-Barr Virus Glycoprotein BDLF2 Is Essential for Efficient Viral Spread in Stratified Epithelium.

Epstein-Barr virus (EBV) is a ubiquitous human pathogen that infects the majority of the adult population regardless of socioeconomic status or geographical location. EBV primarily infects B and epithelial cells and is associated with different cancers of these cell types, such as Burkitt lymphoma and nasopharyngeal carcinoma. While the life cycle of EBV in B cells is well understood, EBV infection within epithelium is not, largely due to the inability to model productive replication in epithelium .

Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019.

Importance: Older age may be accompanied by changes in the pharmacokinetics or pharmacodynamics or both of medications that can result in altered safety and efficacy profiles.

Objective: To assess representation of older adults in clinical trials of new drug applications (NDAs) and biologics license applications (BLAs).

Design, Setting, And Participants: This cross-sectional study analyzed US Food and Drug Administration (FDA) data for NDAs and BLAs approved from 2010 through 2019.

Communication in youth mental health clinical encounters: Introducing the agential stance.

When young people seek support from mental health care practitioners, the encounters may affect the young people's sense of self, and in particular undermine their sense of agency. For this study, an interdisciplinary team of academics and young people collaboratively analysed video-recorded encounters between young people and mental healthcare practitioners in emergency services. They identified five communication techniques that practitioners can use to avoid undermining the young person's sense of agency in the clinical encounter.

Innovative digital solution supporting sun protection and vitamin D synthesis by using satellite-based monitoring of solar radiation.

Public health campaigns advise minimising UV radiation (UVR) exposure to prevent skin cancer and precancer, e.g. actinic keratosis (AK).

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

Importance: Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment.

Objective: To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs.

Priorities for Future Research About Screen Use and Adolescent Mental Health: A Participatory Prioritization Study.

Introduction: This study aimed to identify research priorities for future research on screen use and adolescent mental health, from the perspectives of young people, parents/carers, and teachers.

Methods: The study design was informed by the James Lind Alliance Priority Setting Partnership approach. A three-stage consensus-based process of consultation to identify research priorities using qualitative and quantitative methods.

A myth-busting mental health tour of the National Gallery in London: Facilitators and challenges to its development and evaluation.

This paper describes a mental health-awareness audio tour of the National Gallery, London, and evaluates the development and implementation of the tour. This smartphone-based audio tour was co-produced by Gallery staff, young people with lived experience of mental health issues, academics, and technologists. Interviews (N = 22) were conducted with developers and data-collectors (who had gathered feedback from Gallery visitors who undertook the tour) with responses analysed thematically.

Impact on public attitudes of a mental health audio tour of the National Gallery in London.

Aim: The arts have the potential to increase public awareness about mental health and reduce stigma. However, arts-based projects to raise awareness have been small-scale. In this study, a mental health-awareness audio tour of The National Gallery in London was co-produced and narrated by young adults with relevant lived experience.

Host Lung Environment Limits Aspergillus fumigatus Germination through an SskA-Dependent Signaling Response.

Aspergillus fumigatus isolates display significant heterogeneity in growth, virulence, pathology, and inflammatory potential in multiple murine models of invasive aspergillosis. Previous studies have linked the initial germination of a fungal isolate in the airways to the inflammatory and pathological potential, but the mechanism(s) regulating A. fumigatus germination in the airways is unresolved.

Roadmap to 2030 for Drug Evaluation in Older Adults.

Changes that accompany older age can alter the pharmacokinetics (PK), pharmacodynamics (PD), and likelihood of adverse effects (AEs) of a drug. However, older adults, especially the oldest or those with multiple chronic health conditions, polypharmacy, or frailty, are often under-represented in clinical trials of new drugs. Deficits in the current conduct of clinical evaluation of drugs for older adults and potential steps to fill those knowledge gaps are presented in this communication.

U.S. racial and ethnic participation in global clinical trials by therapeutic areas.

What Is Known And Objective: The discussion about health equity in the United States frequently involves concerns over racial and ethnic minority under-representation in clinical trials and particularly in trials conducted in support of product approvals. The FDA has long worked to encourage diverse participation in clinical trials and through its Drug Trials Snapshots (DTS) program, the U.S.

Encouragement of subgroup assessment by the FDA.

Responses to a drug treatment can differ among subgroups of the population, including demographic subgroups, groups with different disease characteristics, and groups with different metabolic or excretory functions. The differences can be pharmacokinetic (PK) or pharmacodynamic (PD) affecting toxicity or effectiveness. In recent years wide availability of drug blood level data, including metabolite data, has made PK differences in subgroups very readily detectable, but PD differences are more difficult to detect and need to be carefully examined by assessment of effectiveness and toxicity in demographic and other subgroups, as illustrated by the forest plots examining multiple subgroups typically presented for cardiovascular outcome studies.

Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants.

Importance: Before reviewing drug applications, the US Food and Drug Administration (FDA) conducts "filing reviews" to assess whether they are complete enough for full review. If the applications are incomplete, the FDA issues refuse-to-file (RTF) letters identifying deficiencies. The FDA does not make these RTF letters public at the time of issuance.

Understanding practitioners' and young people's views of a risk calculator for future psychopathology and poor functioning in young people victimised during childhood.

Background: Although children who are exposed to victimisation (including abuse, neglect, domestic violence and bullying) have an increased risk of later psychopathology and functional impairment, not all go on to develop these outcomes. Risk calculators that generate individualised probabilities of a victimised child developing future psychopathology and poor functioning have the potential to help practitioners identify the most vulnerable children and efficiently target preventive interventions.

Aim: This study explored the views of young people and practitioners regarding the acceptability and feasibility of potentially using a risk calculator to predict victimised children's individual risk of poor outcomes.