Optimising research investment by simulating and evaluating monitoring strategies to inform a trial: a simulation of liver fibrosis monitoring.

Background: The aim of the study was to investigate the development of evidence-based monitoring strategies in a population with progressive or recurrent disease. A simulation study of monitoring strategies using a new biomarker (ELF) for the detection of liver cirrhosis in people with known liver fibrosis was undertaken alongside a randomised controlled trial (ELUCIDATE).

Methods: Existing data and expert opinion were used to estimate the progression of disease and the performance of repeat testing with ELF.

School food policy in secondary schools in England and its impact on adolescents' diets and dental health: the FUEL multiple-methods study.

Background: School food standards are a legal requirement for state-funded schools in England and are designed to promote healthy eating in pupils. However, state-funded academies/free schools established between 2010 and 2014 are exempt from this legislation. To complement the school food standards, the government launched the School Food Plan in 2013, which outlines voluntary actions that schools can take to support healthy eating and increase school meal uptake.

Within-subject variation of C-reactive protein and high-sensitivity C-reactive protein: A systematic review and meta-analysis.

Background: C-reactive protein (CRP) and high-sensitivity C-reactive protein (hsCRP) are measures of inflammation used in diagnosis, to guide treatment decisions, and in disease prediction. Variability in measured CRP and hsCRP may affect their clinical utility but estimates of within-subject variability are based on limited data.

Methods: A systematic review and meta-analysis was performed to estimate longitudinal within-subject variability of CRP and hsCRP over any time period.

National school food standards in England: a cross-sectional study to explore compliance in secondary schools and impact on pupil nutritional intake.

Background: Many countries have introduced school food standards to improve the dietary intakes of school-aged children. England has school food standards (SFS) legislation in place but little is known about how well secondary schools comply with this. We aimed to assess compliance with the SFS legislation in English secondary schools and explore the impact of the SFS on pupils' nutritional intake.

Experiences as a clinical teaching fellow: interviews with clinical teaching fellows in the West Midlands.

Background: The majority of junior doctors in the UK do not proceed directly into specialty training after completing mandatory foundation training but instead take a year out of training. A common post undertaken during a year out of training is a clinical teaching fellow (CTF) role which is used to provide undergraduate medical student teaching. There is only a small amount of literature available regarding CTF posts, and very little of this explores experiences or reasons for taking up such as post.

Strengthening Clinician-Researchers' Communication and Knowledge Translation Skills: An Innovative Game Model From the Breathe Well Group.

Communication is a core component of a clinician's role; however, when clinicians conduct research, communicating the emerging findings and recommendations to different types of stakeholders can be unfamiliar territory. Communicating research to advocate for change can be even more challenging. Clinician researchers seeking to be agents for change need to conceive and craft specific, evidence-based messages and communicate these effectively to different stakeholders to negotiate action.

Accuracy of glomerular filtration rate estimation using creatinine and cystatin C for identifying and monitoring moderate chronic kidney disease: the eGFR-C study.

Background: Estimation of glomerular filtration rate using equations based on creatinine is widely used to manage chronic kidney disease. In the UK, the Chronic Kidney Disease Epidemiology Collaboration creatinine equation is recommended. Other published equations using cystatin C, an alternative marker of kidney function, have not gained widespread clinical acceptance.

The Clinical Teaching Fellow role: exploring expectations and experiences.

Background: Many UK junior doctors are now taking a year out of the traditional training pathway, usually before specialty training, and some choose to work as a clinical teaching fellow (CTF). CTFs primarily have responsibility for delivering hospital-based teaching to undergraduate medical students. Only a very small amount of literature is available regarding CTF posts, none of which has explored why doctors choose to undertake the role and their expectations of the job.

Cluster randomised controlled trial of specialist-led integrated COPD care (INTEGR COPD).

Objective: Studies in hospital settings demonstrate that there is greater guideline adherence when care is delivered by a respiratory specialist, however, this has not been explored in primary care. The aim of this study is to determine the impact integrating respiratory specialists into primary care has on the delivery of guideline adherent chronic obstructive pulmonary disease (COPD) care.

Methods: 18 general practitioner (GP) practices were randomised to provide either usual or specialist-led COPD care.

Development and quality appraisal of a new English breast screening linked data set as part of the age, test threshold, and frequency of mammography screening (ATHENA-M) study.

Objectives: To build a data set capturing the whole breast cancer screening journey from individual breast cancer screening records to outcomes and assess data quality.

Methods: Routine screening records (invitation, attendance, test results) from all 79 English NHS breast screening centres between January 1, 1988 and March 31, 2018 were linked to cancer registry (cancer characteristics and treatment) and national mortality data. Data quality was assessed using comparability, validity, timeliness, and completeness.

Translating the potential of the urine steroid metabolome to stage NAFLD (TrUSt-NAFLD): study protocol for a multicentre, prospective validation study.

Introduction: Non-alcoholic fatty liver disease (NAFLD) affects approximately one in four individuals and its prevalence continues to rise. The advanced stages of NAFLD with significant liver fibrosis are associated with adverse morbidity and mortality outcomes. Currently, liver biopsy remains the 'gold-standard' approach to stage NAFLD severity.

Engaging stakeholders to level up COPD care in LMICs: lessons learned from the "Breathe Well" programme in Brazil, China, Georgia, and North Macedonia.

Background: Effective stakeholder engagement in health research is increasingly being recognised and promoted as an important pathway to closing the gap between knowledge production and its use in health systems. However, little is known about its process and impacts, particularly in low-and middle-income countries. This opinion piece draws on the stakeholder engagement experiences from a global health research programme on Chronic Obstructive Pulmonary Disease (COPD) led by clinician researchers in Brazil, China, Georgia and North Macedonia, and presents the process, outcomes and lessons learned.

Duke Activity Status Index and Liver Frailty Index predict mortality in ambulatory patients with advanced chronic liver disease: A prospective, observational study.

Background: There remains a lack of consensus on how to assess functional exercise capacity and physical frailty in patients with advanced chronic liver disease (CLD) being assessed for liver transplantation (LT). Aim To investigate prospectively the utility of the Duke Activity Status Index (DASI) and Liver Frailty Index (LFI) in ambulatory patients with CLD.

Aim: To investigate prospectively the utility of the Duke Activity Status Index (DASI) and Liver Frailty Index (LFI) in ambulatory patients with CLD.

Urine steroid metabolomics as a diagnostic tool in primary aldosteronism.

Primary aldosteronism (PA) causes 5-10% of hypertension cases, but only a minority of patients are currently diagnosed and treated because of a complex, stepwise, and partly invasive workup. We tested the performance of urine steroid metabolomics, the computational analysis of 24-hour urine steroid metabolome data by machine learning, for the identification and subtyping of PA. Mass spectrometry-based multi-steroid profiling was used to quantify the excretion of 34 steroid metabolites in 24-hour urine samples from 158 adults with PA (88 with unilateral PA [UPA] due to aldosterone-producing adenomas [APAs]; 70 with bilateral PA [BPA]) and 65 sex- and age-matched healthy controls.

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0).

Introduction: Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.

Developing and Validating a Multivariable Prognostic-Predictive Classifier for Treatment Escalation of Oropharyngeal Squamous Cell Carcinoma: The PREDICTR-OPC Study.

Purpose: While there are several prognostic classifiers, to date, there are no validated predictive models that inform treatment selection for oropharyngeal squamous cell carcinoma (OPSCC).Our aim was to develop clinical and/or biomarker predictive models for patient outcome and treatment escalation for OPSCC.

Experimental Design: We retrospectively collated clinical data and samples from a consecutive cohort of OPSCC cases treated with curative intent at ten secondary care centers in United Kingdom and Poland between 1999 and 2012.

Randomised controlled trial testing effectiveness of feedback about lung age or exhaled CO combined with very brief advice for smoking cessation compared to very brief advice alone in North Macedonia: findings from the Breathe Well group.

Introduction: In 2019, smoking prevalence in North Macedonia was one of the world's highest at around 46% in adults. However, access to smoking cessation treatment is limited and no co-ordinated smoking cessation programmes are provided in primary care.

Methods: We conducted a three parallel-armed randomised controlled trial (n = 1368) to investigate effectiveness and cost-effectiveness of lung age (LA) or exhaled carbon monoxide (CO) feedback combined with very brief advice (VBA) to prompt smoking cessation compared with VBA alone, delivered by GPs in primary care in North Macedonia.

Within-subject variation of HbA1c: A systematic review and meta-analysis.

Background: Glycosylated haemoglobin (HbA1c) measurement is used to diagnose and to guide treatment of diabetes mellitus. Within-subject variability in measured HbA1c affects its clinical utility and interpretation, but no comprehensive systematic review has described within-subject variability.

Methods: A systematic review and meta-analysis was performed of within-subject variability of HbA1c.

Smartphones, social Media and Adolescent mental well-being: the impact of school policies Restricting dayTime use-protocol for a natural experimental observational study using mixed methods at secondary schools in England (SMART Schools Study).

Introduction: Smartphone and social media use is prevalent during adolescence, with high levels of use associated with lower levels of mental well-being. Secondary schools in the UK have introduced policies that restrict daytime use of smartphones and social media, but there is no evaluation on the impact of these policies on adolescent mental well-being. The SMART Schools Study aims to determine the impact of daytime restrictions of smartphone and social media use on indicators of adolescent mental well-being, anxiety, depression, physical activity, sleep, classroom behaviour, attainment and addictive social media use.

Interobserver variability studies in diagnostic imaging: a methodological systematic review.

Objectives: To review the methodology of interobserver variability studies; including current practice and quality of conducting and reporting studies.

Methods: Interobserver variability studies between January 2019 and January 2020 were included; extracted data comprised of study characteristics, populations, variability measures, key results, and conclusions. Risk of bias was assessed using the COSMIN tool for assessing reliability and measurement error.

The Clinical Teaching Fellow role: views of the Heads of Academy in the West Midlands.

Background: Increasingly junior doctors are taking a year out of the traditional training pathway, and some opt to spend a year in a clinical teaching fellow (CTF) post. The CTF post mainly involves delivering hospital-based teaching to undergraduate medical students. In NHS hospital Trusts in the West Midlands, Heads of Academy (HoAs) have oversight of medical education at each Trust and therefore have responsibility for employing and directing the work of CTFs.

Classic and 11-oxygenated androgens in serum and saliva across adulthood: a cross-sectional study analyzing the impact of age, body mass index, and diurnal and menstrual cycle variation.

Objective: 11-oxygenated androgens significantly contribute to the circulating androgen pool. Understanding the physiological variation of 11-oxygenated androgens and their determinants is essential for clinical interpretation, for example, in androgen excess conditions. We quantified classic and 11-oxygenated androgens in serum and saliva across the adult age and body mass index (BMI) range, also analyzing diurnal and menstrual cycle-dependent variation.

An assessment of the impact of formal preparation activities on performance in the University Clinical Aptitude Test (UCAT): a national study.

Background: Previous studies have shown performance in the University Clinical Aptitude Test (UCAT) to be associated with measures of candidate socio-economic advantage such as parental occupation and type of school attended. It is possible that access to preparation support and materials may in part explain these associations. In this paper we determine whether use of formal preparation resources is associated with higher UCAT scores and whether differences in use of preparation resources exist between socio-demographic groups.

Feasibility of a pulmonary rehabilitation programme for patients with symptomatic chronic obstructive pulmonary disease in Georgia: a single-site, randomised controlled trial from the Breathe Well Group.

Objectives: To assess the feasibility of delivering a culturally tailored pulmonary rehabilitation (PR) programme and conducting a definitive randomised controlled trial (RCT).

Design: A two-arm, randomised feasibility trial with a mixed-methods process evaluation.

Setting: Secondary care setting in Georgia, Europe.