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Objectives: The objective of this study is to investigate early-to-late postdoctoral clinical academic progression and the experiences of NIHR Clinical Lectureship (CL) fellows, considering enablers and barriers to success, and identifying the factors associated with immediate progression to a clinical academic role following completion of the award., Setting: Datasets of CL awardees across the UK., Participants: For semistructured interviews, n=40 CL awardees that had finished their award within the previous 5 years. For quantitative analysis, n=1226 completed or currently active CL awardees., Outcome Measures: The responses from the semistructured interviews to the defined questions on experiences during the award, postaward progression, and enablers and barriers to academic progression. Other primary outcome measures were quantitative data on first destinations postaward, demographic data, and whether an awardee had previously held an NIHR Academic Clinical Fellowship (ACF) or was a recipient of the Academy of Medical Sciences (AMS) Starter Grant., Results: CL awardees identified numerous benefits to the award, with the majority achieving their aims. Most awardees progressed to a clinical academic role; however, some returned to a clinical only position, citing concerns around the time pressure associated with balancing clinical and academic responsibilities, and the competition to attain further postdoctoral awards. The region of the award partnership, year of award end and success in applying for an AMS Starter Grant were associated with progression to a clinical academic role. Gender, holding an ACF and having a craft or non-craft specialty had no independent statistical association with clinical academic progression., Conclusions: The CL is a valued element of the Integrated Academic Pathway. By addressing issues around later postdoctoral progression opportunities, responding to challenges experienced by CLs, and by understanding the factors identified in this study associated with clinical academic progression, it should be possible to increase the proportion of CLs that become fully independent clinical academic research leaders., Participants: 1226 NIHR CLs active or completed on the award between 2006 and 2020., Competing Interests: Competing interests: JH, MRM and HH were employed by the University of Leeds while working on the manuscript, JH was a member then Chair of a selection panel for NIHR Academy Fellowships between 2006 and 2014. MMR and CM are employed by the Academy of Medical Sciences. The remaining authors are all employed by NIHR CC., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Gross anatomy is a crucial course in medical school; it sets the foundation for future coursework and is highly valued by clinicians. While both medical students and faculty recognize the importance of pre-medical school anatomy experience, few medical schools require it as a prerequisite. Consequently, medical school gross anatomy courses have a diverse range of prior anatomy experience among students. Prior studies have shown mixed results regarding the impact of pre-medical school anatomy experience on medical school gross anatomy performance, often using final exam scores as the metric of analysis. In this study, we investigated the relationship between pre-medical school anatomy experience and medical school gross anatomy performance among students at New York Institute of Technology, College of Osteopathic Medicine. We surveyed students from all four matriculated years and analyzed their individual anatomy laboratory exam scores and final anatomy laboratory course scores. We found that students with prior anatomy experience performed significantly better on the first anatomy laboratory exam, leading to an overall positive effect on their final anatomy laboratory score. However, this advantage seemed to diminish in subsequent exams, suggesting that students without prior experience rapidly adjusted to the course challenges. Students with prior anatomy experience felt more prepared for the anatomy course, reported lower stress levels, and believed they had an advantage over peers without prior experience. Our study highlights the importance of pre-medical school anatomy experience, particularly for early performance in the anatomy course.

Abstract Background The potential impact of specific food additives, common in Western diets, on the risk of developing type 2 diabetes is not well understood. This study focuses on carrageenan, a widely used food additive known to induce insulin resistance and gut inflammation in animal models, and its effects on human health. Methods In a randomised, double-blind, placebo-controlled, cross-over trial conducted at a university hospital metabolic study centre, 20 males (age 27.4 ± 4.3 years, BMI 24.5 ± 2.5 kg/m2) participated. The intervention involved oral intake of carrageenan (250 mg) or placebo in the morning and in the evening and each intervention lasted 2 weeks. The primary outcome measured was insulin sensitivity (using oral glucose tolerance test [OGTT] and hyperinsulinaemic-euglycaemic clamp). Additional end-points included whole body and hepatic insulin sensitivity, MRI-measured brain inflammation and insulin resistance, intestinal permeability (via lactulose-mannitol test and plasma zonulin levels), and gut microbiome composition. Immune-cell activation and pro-inflammatory cytokine release from peripheral blood mononuclear cells were measured. Results Overall insulin sensitivity did not show significant differences between the treatments. However, interactions between BMI and treatment were observed (OGTT-based insulin sensitivity index: p=0.04, fasting insulin resistance: p=0.01, hepatic insulin sensitivity index: p=0.04). In overweight participants, carrageenan exposure resulted in lower whole body and hepatic insulin sensitivity, a trend towards increased brain inflammation, and elevated C-reactive protein (CRP) and IL-6 levels compared to placebo. Additionally, carrageenan was associated with increased intestinal permeability. In vitro natural killer (NK-)cell activation and increased pro-inflammatory cytokine release were found after carrageenan exposure in the participant’s peripheral blood mononuclear cells. Conclusions These findings suggest that carrageenan, a common food additive, may contribute to insulin resistance and subclinical inflammation in overweight individuals through pro-inflammatory mechanisms in the gut. Further investigation into the long-term health impacts of carrageenan and other food additives is warranted. Trial registration NCT02629705.

Abstract Background In England, the number of takeaway food outlets (‘takeaways’) has been increasing for over two decades. Takeaway management zones around schools are an effective way to restrict the growth of new takeaways but their impacts on population health have not been estimated. Methods To model the impact of takeaway management zones on health, we used estimates of change in and exposure to takeaways (across home, work, and commuting buffers) based on a previous evaluation suggesting that 50% of new outlets were prevented from opening because of management zones. Based on previous cross-sectional findings, we estimated changes in body mass index (BMI) from changes in takeaway exposure, from 2018 to 2040. We used PRIMEtime, a proportional multistate lifetable model, and BMI change to estimate the impact of the intervention, in a closed-cohort of adults (25–64 years), on incidence of 12 non-communicable diseases, obesity prevalence, quality-adjusted life years (QALYs), and healthcare costs saved by 2040 in six local authorities (LAs) across the rural–urban spectrum in England (Wandsworth, Manchester, Blackburn with Darwen, Sheffield, North Somerset, and Fenland). Results By 2031, compared to no intervention, reductions in outlet exposure ranged from 3 outlets/person in Fenland to 28 outlets/person in Manchester. This corresponded to mean per person reductions in BMI of 0.08 and 0.68 kg/m2, respectively. Relative to no intervention, obesity prevalence was estimated to be reduced in both sexes in all LAs, including by 2.3 percentage points (PP) (95% uncertainty interval:2.9PP, 1.7PP) to 1.5PP (95%UI:1.9PP, 1.1PP) in males living in Manchester and Wandsworth by 2040, respectively. Model estimates showed reductions in incidence of disease, including type II diabetes (e.g. 964 (95% UI: 1565, 870) fewer cases/100,000 population for males in Manchester)), cardiovascular diseases, asthma, certain cancers, and low back pain. Savings in healthcare costs (millions) ranged from £1.65 (95% UI: £1.17, £2.25)/100,000 population in North Somerset to £2.02 (95% UI: £1.39, £2.83)/100,000 population in Wandsworth. Gains in QALYs/100,000 person were broadly similar across LAs. Conclusions Takeaway management zones in England have the potential to meaningfully contribute towards reducing obesity prevalence and associated healthcare burden in the adult population, at the local level and across the rural–urban spectrum.

Abstract Whiteflies (Bemisia tabaci) and the diseases they transmit are a major detriment to crop yields and a significant contributor to world hunger. The highly evolved interactions of host plant, phloem-feeding insect vector with endosymbionts and persistently transmitted virus represent a tremendous challenge for interdisciplinary study. Presented here is the establishment of a colony of axenic whiteflies on tissue-cultured plants. Efficient colony establishment was achieved by a surface sterilization of eggs laid on axenic phototrophically tissue-cultured plants. The transfer of emerging whiteflies through coupled tissue culture vessels to new axenic plants facilitates robust subculturing and produces hundreds of whitefly adults per month. Whitefly proliferation on more than two dozen plant species is shown as well as in vitro testing of whitefly preference for different plants. This novel multi-organism system provides the high-level of biocontainment required by Federal permitting to conduct virus transmission experiments. Axenic whitefly adults were able to acquire and transmit a begomovirus into tissue-cultured plants, indicating that culturable gut microorganisms are not required for virus transmission. The approach described enables a wide range of hypotheses regarding whitefly phytopathology without the expense, facilities, and contamination ambiguity associated with current approaches.

Abstract Investigators in neuroscience have turned to Big Data to address replication and reliability issues by increasing sample size. These efforts unveil new questions about how to integrate data across distinct sources and instruments. The goal of this study was to link scores across common auditory verbal learning tasks (AVLTs). This international secondary analysis aggregated multisite raw data for AVLTs across 53 studies totaling 10,505 individuals. Using the ComBat-GAM algorithm, we isolated and removed the component of memory scores associated with site effects while preserving instrumental effects. After adjustment, a continuous item response theory model used multiple memory items of varying difficulty to estimate each individual’s latent verbal learning ability on a single scale. Equivalent raw scores across AVLTs were then found by linking individuals through the ability scale. Harmonization reduced total cross-site score variance by 37% while preserving meaningful memory effects. Age had the largest impact on scores overall (− 11.4%), while race/ethnicity variable was not significant (p > 0.05). The resulting tools were validated on dually administered tests. The conversion tool is available online so researchers and clinicians can convert memory scores across instruments. This work demonstrates that global harmonization initiatives can address reproducibility challenges across the behavioral sciences.

Objectives The Newcastle Sjogren’s Stratification Tool (NSST) stratifies Sjogren’s disease patients into four subtypes. Understanding the stability of the subtypes is vital if symptom-based stratification is to be more broadly adopted. In this study, we stratify patients longitudinally to understand how symptom-based subtypes vary over time and factors influencing subtype change.Methods 274 patients from the United Kingdom Primary Sjögren’s Syndrome Registry (UKPSSR) with data permitting NSST subtype assignment from two study visits were included. The French Assessment of Systemic Signs and Evolution of Sjogren’s Syndrome (ASSESS) cohort (n=237) acted as an independent comparator. Group analyses of significant differences were performed, with logistic regression models used to assess covariates of subtype stability.Results UKPSSR and ASSESS cohorts showed a broadly similar proportion of subjects in each subtype and similar baseline clinical characteristics except body mass index (BMI). Several baseline characteristics differ significantly between the subtypes, most notably anti-Ro status and BMI. Subtype membership was reasonably stable in both cohorts with 60% and 57% retaining subtype. The high-symptom burden subtype was the most stable over time with 70% and 67% retaining subtype. Higher baseline probability score was the greatest predictor of subtype stability with higher C4 levels, antidepressant use, and a higher CCI score also predicting increased stability.Conclusion NSST subtype membership remains stable over time in a large proportion of patients. When subtype transition is associated with factors at baseline, it is most strongly associated with an uncertain subtype allocation. Our findings support the hypothesis that symptom-based subtypes reflect genuine pathobiological endotypes and therefore maybe important to consider in trial design and clinical management.

Summary: Background: We report extended follow-up of TROG99.03, a randomised phase III trial in early-stage follicular lymphoma (ESFL) including new information on the role of adjuvant rituximab and translational studies. Methods: Patients with ESFL were randomised to involved field radiotherapy (IFRT) or IFRT plus 6-cycles cyclophosphamide/vincristine/prednisolone (IFRT + CVP). From 2006 rituximab was added to IFRT + CVP (IFRT + R-CVP). Clinical and multi-omic parameters were evaluated. Findings were validated in two independent ESFL cohorts (99 and 60 patients respectively). Findings: Between 2000 and 2012, 150 (75 per arm) patients were recruited. 48% were positron emission tomography (PET)-staged. By protocol, at median follow-up 11.3-years, progression-free survival (PFS) remained superior for IFRT+(R)CVP vs. IFRT (hazard ratio [HR] = 0.60, 95% CI = 0.37–0.98, p = 0.043; 10-year PFS 62% vs. 43%) respectively. Although no significant difference in overall survival was observed (HR = 0.44, 95% CI = 0.16–1.18, p = 0.11, 10-year OS 95% vs. 84%), patients receiving IFRT+(R)CVP experienced fewer composite (histological transformation and death) events (p = 0.045). PFS of IFRT + R-CVP-treated patients compared with all other treatments lacking rituximab (IFRT alone plus IFRT + CVP) was superior (HR = 0.36, 95% CI = 0.13–0.82, p = 0.013). Amongst PET-staged patients, PFS differences between IFRT + R-CVP vs. IFRT were maintained (HR = 0.38, 95% CI = 0.16–0.89, p = 0.027) indicating benefit distinct from stage migration. FL-related mutations and BCL2-translocations were not associated with PFS. However, by multivariate analysis elevated CD8A gene expression in diagnostic biopsy tissue was independently associated with improved PFS (HR = 0.45, 95% CI = 0.26–0.79, p = 0.037), a finding confirmed in both ESFL validation cohorts. CD8A gene expression was raised (p = 0.02) and CD8+ T-cell density higher within follicles in ESFL vs. advanced-stage FL (p = 0.047). Human leucocyte antigen class I specific neoantigens were detected in 43% of patients, suggesting neoantigen-specific CD8+ T-cells have a role in confining the spread of the disease. Interpretation: Adjuvant R-CVP and elevated intratumoural CD8 expression were independently associated with sustained disease control after radiotherapy in ESFL. Funding: Cancer Council Victora; National Health and Medical Research Council; Leukaemia Foundation; Mater Foundation.

Summary: Background: Crimean-Congo Haemorrhagic Fever (CCHF) is a viral haemorrhagic fever with a case fatality rate of 5–25% that has been prioritised for research and development by the World Health Organisation. There are no CCHF rapid diagnostic tests (RDTs) commercially available. We describe the development and evaluation of an antigen-targeting lateral flow immunoassay RDT for CCHF. Methods: Prospective clinical samples were collected and tested between July and October 2023 in Türkiye. Retrospective stored samples were obtained from the Central Public Health Laboratory, Baghdad, Iraq. The sensitivity and specificity of the CCHF RDT was compared to reverse transcription quantitative polymerase chain reaction assays. Findings: On prospective clinical samples in Türkiye, the sensitivity and specificity of the CCHF RDT was 90.4% [95% CI 81.5–95.3%] (n = 73) and 96.2% [95% CI 87.0–99.3%] (n = 52), respectively with a sensitivity of 92.9% [95% CI 84.3–96.9%] (n = 70) in samples with a cycle threshold (Ct) ≤30. On retrospective stored samples in Iraq, sensitivity and specificity of the RDT was 71.7% [95% CI 59.2–81.5%] (n = 60) and 92.5% [95% CI 80.1–97.8%] (n = 40), respectively with a sensitivity of 82.2% [95% CI 68.7–90.7%] (n = 45) in samples of Ct ≤30. Interpretation: The CCHF RDT was an effective rapid diagnostic test in this preliminary clinical evaluation, showing this RDT has the potential diagnostic capability for use at the point-of-care. Definitive evaluation is now required to ensure the RDT meets the regulatory requirements for commercialisation. Funding: The Liverpool School of Tropical Medicine, National Institute for Health Research Health Protection Research Unit in Emerging Zoonotic Infections, The Medical Research Council and The Pandemic Institute.

Background: In line with international best practices, the South African Committee of Medical Deans, supported by the Colleges of Medicine of South Africa, has called for institutions educating medical specialists to start integrating workplace-based assessment (WBA) in 2025. Workplace-based assessment requires that clinical supervisors observe trainees in the real world of clinical practice, provide feedback and foster reflective practice, while foregrounding patient safety. Despite a large literature on WBA in the global north and an emerging literature in South Africa, a framework for WBA implementation, grounded in South African realities, does not exist. The study aimed to determine current WBA-related knowledge and practices among registrar educators. Methods: A cross-sectional observational study, using an online 5-point Likert scale questionnaire, explored current knowledge and practices of WBA-related activities. The questionnaire variables were categorical, and the data were analysed descriptively. Frequencies, proportions and appropriate graphics were used to present the data. Results: The key findings relate to relatively high levels of knowledge of what constitutes WBA (82.5% agreed that they had knowledge of WBA), juxtaposed against large variability in the levels of implementation of WBA practices. Conclusion: The study surveyed postgraduate supervisors in a low- and middle-income country (LMIC) context regarding their understanding and current practices of WBA. Self-reported knowledge levels were high while practices were variable Contribution: The study provides insights into areas to focus on, with the future development and implementation of a comprehensive WBA strategy in South Africa.

The evaluation of physician competency prior to issuing an initial medical license has been a fundamental responsibility of medical boards. Growing public expectation holds that medical boards will ensure competency throughout a physician's career. The Federation of State Medical Boards (FSMB) strongly supports the right of state medical boards to require physicians to demonstrate continuing qualification for medical licensure. The FSMB views continuing medical education (CME) as an important component of any maintenance-of-competence initiative. Most medical boards require CME as part of their license renewal process. Learner-focused CME with measurable outcomes enables the medical profession's emphasis on core competencies, training, and assessment, and the general public's expectation for maintenance of physician competence. To effectively move their licensee populations toward the most effective CME tools and structure, medical boards must recognize physicians' educational needs and preferences. Medical boards can be proactive by fostering educational consortia involving medical boards, medical societies, and academic medical centers and featuring educational sessions that represent the best in current CME practices.

Background: Prior to measles vaccine introduction in 1963, measles virus caused hundreds of thousands of annual reported cases, which led to substantial US morbidity, mortality, and costs. Similarly, congenital rubella syndrome (CRS) led to highly visible and tragic lifelong disability for thousands of Americans, before rubella vaccine introduction in 1969. The US certified national virus transmission elimination of indigenous measles in 2000 and rubella in 2004. Methods: Applying an existing integrated transmission and economic model, this analysis characterizes the net benefits of US investments in measles (1963–2030) and rubella (1969–2030) immunization assuming continued high routine immunization coverage. Due to importation risks, the US maintains two doses of both vaccines in its routine immunization schedule. Results: This analysis estimates total US costs of 8.1 billion (economics reported in 2023 US dollars) for measles immunization for 1963–2023 and 14.1 billion for rubella immunization for 1969–2023. The analysis estimates an additional approximately 1.2 billion for measles immunization and 1.5 billion for rubella immunization expected for 2024–2030. Historical and future US investments prevented an estimated approximately 237 million measles infections, 228,000 measles deaths, 193 million rubella infections, and 166,000 CRS cases. These investments imply net benefits (from avoided treatment costs minus immunization costs) of approximately 310 billion for measles and 430 billion for rubella and CRS, even without incorporating avoided productivity losses and intangible costs. Conclusions: US investments in measles and rubella immunization continue to provide enormous savings of human and financial costs and to prevent substantial mortality and morbidity.

The Linker of Nucleoskeleton and Cytoskeleton (LINC) complex serves to connect the nuclear envelope and the cytoskeleton, influencing cellular processes such as nuclear arrangement, architecture, and mechanotransduction. The role LINC plays in mechanotransduction pathways in bone progenitor cells has been well studied; however, the mechanisms by which LINC complexes govern in vivo bone formation remain less clear. To bridge this knowledge gap, we established a murine model disrupting LINC using transgenic Prx-Cre mice and floxed Tg(CAG-LacZ/EGFP-KASH2) mice. Prx-Cre mice express the Cre recombinase enzyme controlled by the paired-related homeobox gene-1 promoter (Prrx1), a pivotal regulator of skeletal development. Prx-Cre animals have been widely used in the bone field to target bone progenitor cells. Tg(CAG-LacZ/EGFP-KASH2) mice carry a lox-stop-lox flanked LacZ gene allowing for the overexpression of an EGFP-KASH2 fusion protein via cre recombinase mediated deletion of the LacZ cassette. This disrupts endogenous Nesprin-Sun binding in a dominant negative manner disconnecting nesprin from the nuclear envelope. By combining these lines, we generated a Prrx1(+) cell-specific LINC disruption model to study its impact on the developing skeleton and subsequently exercise-induced bone accrual. The findings presented here indicate Prx-driven LINC disruption (PDLD) cells exhibit no change in osteogenic and adipogenic potential compared to controls in vitro nor are there bone quality changes when compared to in sedentary animals at 8 weeks. While PDLD animals displayed increased voluntary running activity andPrrx1(+) cell-specific LINC disruption abolished the exercise-induced increases in osteoid volume and surface after a 6-week exercise intervention, no other changes in bone microarchitecture or mechanical properties were found.

Describes an interactive videodisc application program developed to train army medics. Indicates that reduced instructor teaching time and a high degree of student satisfaction in mastering complex, high-stress tasks are the optimum results achieved by the program. (JN)

Objectives Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.Design In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.Setting UK stroke services.Participants 3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.Results Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.Conclusion It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.Trial registration number ISRCTN83290762; Post-results.

Introduction There is a clear need for improved care quality and quality monitoring in aged care. Aged care providers collect an abundance of data, yet rarely are these data integrated and transformed in real-time into actionable information to support evidence-based care, nor are they shared with older people and informal caregivers. This protocol describes the co-design and testing of a dashboard in residential aged care facilities (nursing or care homes) and community-based aged care settings (formal care provided at home or in the community). The dashboard will comprise integrated data to provide an ‘at-a-glance’ overview of aged care clients, indicators to identify clients at risk of fall-related hospitalisations and poor quality of life, and evidence-based decision support to minimise these risks. Longer term plans for dashboard implementation and evaluation are also outlined.Methods This mixed-method study will involve (1) co-designing dashboard features with aged care staff, clients, informal caregivers and general practitioners (GPs), (2) integrating aged care data silos and developing risk models, and (3) testing dashboard prototypes with users. The dashboard features will be informed by direct observations of routine work, interviews, focus groups and co-design groups with users, and a community forum. Multivariable discrete time survival models will be used to develop risk indicators, using predictors from linked historical aged care and hospital data. Dashboard prototype testing will comprise interviews, focus groups and walk-through scenarios using a think-aloud approach with staff members, clients and informal caregivers, and a GP workshop.Ethics and dissemination This study has received ethical approval from the New South Wales (NSW) Population & Health Services Research Ethics Committee and Macquarie University’s Human Research Ethics Committee. The research findings will be presented to the aged care provider who will share results with staff members, clients, residents and informal caregivers. Findings will be disseminated as peer-reviewed journal articles, policy briefs and conference presentations.

Background Classifying individuals at high chronic obstructive pulmonary disease (COPD)-risk creates opportunities for early COPD detection and active intervention.Objective To develop and validate a statistical model to predict 10-year probabilities of COPD defined by post-bronchodilator airflow obstruction (post-BD-AO; forced expiratory volume in 1 s/forced vital capacity

Introduction Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.Methods and analysis A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.Ethics and dissemination Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.Trial registration number ISRCTN47776579; Pre-results.

Objectives To determine the need for recovery (NFR) among emergency physicians and to identify demographic and occupational characteristics associated with higher NFR scores.Design Cross-sectional electronic survey.Setting Emergency departments (EDs) (n=112) in the UK and Ireland.Participants Emergency physicians, defined as any registered physician working principally within the ED, responding between June and July 2019.Main outcome measure NFR Scale, an 11-item self-administered questionnaire that assesses how work demands affect intershift recovery.Results The median NFR Score for all 4247 eligible, consented participants with a valid NFR Score was 70.0 (95% CI: 65.5 to 74.5), with an IQR of 45.5–90.0. A linear regression model indicated statistically significant associations between gender, health conditions, type of ED, clinical grade, access to annual and study leave, and time spent working out-of-hours. Groups including male physicians, consultants, general practitioners (GPs) within the ED, those working in paediatric EDs and those with no long-term health condition or disability had a lower NFR Score. After adjusting for these characteristics, the NFR Score increased by 3.7 (95% CI: 0.3 to 7.1) and 6.43 (95% CI: 2.0 to 10.8) for those with difficulty accessing annual and study leave, respectively. Increased percentage of out-of-hours work increased NFR Score almost linearly: 26%–50% out-of-hours work=5.7 (95% CI: 3.1 to 8.4); 51%–75% out-of-hours work=10.3 (95% CI: 7.6 to 13.0); 76%–100% out-of-hours work=14.5 (95% CI: 11.0 to 17.9).Conclusion Higher NFR scores were observed among emergency physicians than reported in any other profession or population to date. While out-of-hours working is unavoidable, the linear relationship observed suggests that any reduction may result in NFR improvement. Evidence-based strategies to improve well-being such as proportional out-of-hours working and improved access to annual and study leave should be carefully considered and implemented where feasible.

Introduction Most cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its impact on lifestyle change remains unclear. This study aims to determine whether providing visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC)) can result in healthful diet and lifestyle change.Methods and analysis This study, including men and women aged 60–80 years, is a 12-week, two-arm, multisite randomised controlled trial. At baseline, all participants will have AAC assessed from a lateral spine image captured using a bone densitometer. Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks. All participants will receive information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake by at least one serve per day, (2) improve other aspects of the diet and (3) reduce sitting time and increase physical activity. Clinical assessments will be performed at baseline and 12 weeks.Outcomes The primary outcome is a change in serum carotenoid concentrations as an objective measure of FV intake. The study design, procedures and treatment of data will adhere to Standard Protocol Items for Randomized Trials guidelines.Ethics and dissemination Ethics approval for this study has been granted by the Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers: 20513 HODGSON and 2019-220, respectively). Results of this study will be published in peer-reviewed academic journals and presented in scientific meetings and conferences. Information regarding consent, confidentiality, access to data, ancillary and post-trial care and dissemination policy has been disclosed in the participant information form.Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN12618001087246).

Introduction The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on ‘healthful’ improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.Methods and analysis The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing ‘healthful’ behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.Ethics and dissemination The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.Trial registration number ACTRN12618001087246.

Background To develop items for an early warning score (RECAP: REmote COVID-19 Assessment in Primary Care) for patients with suspected COVID-19 who need escalation to next level of care.Methods The study was based in UK primary healthcare. The mixed-methods design included rapid review, Delphi panel, interviews, focus groups and software development. Participants were 112 primary care clinicians and 50 patients recovered from COVID-19, recruited through social media, patient groups and snowballing. Using rapid literature review, we identified signs and symptoms which are commoner in severe COVID-19. Building a preliminary set of items from these, we ran four rounds of an online Delphi panel with 72 clinicians, the last incorporating fictional vignettes, collating data on R software. We refined the items iteratively in response to quantitative and qualitative feedback. Items in the penultimate round were checked against narrative interviews with 50 COVID-19 patients. We required, for each item, at least 80% clinician agreement on relevance, wording and cut-off values, and that the item addressed issues and concerns raised by patients. In focus groups, 40 clinicians suggested further refinements and discussed workability of the instrument in relation to local resources and care pathways. This informed design of an electronic template for primary care systems.Results The prevalidation RECAP-V0 comprises a red flag alert box and 10 assessment items: pulse, shortness of breath or respiratory rate, trajectory of breathlessness, pulse oximeter reading (with brief exercise test if appropriate) or symptoms suggestive of hypoxia, temperature or fever symptoms, duration of symptoms, muscle aches, new confusion, shielded list and known risk factors for poor outcome. It is not yet known how sensitive or specific it is.Conclusions Items on RECAP-V0 align strongly with published evidence, clinical judgement and patient experience. The validation phase of this study is ongoing.Trial registration number NCT04435041.

Introduction Work absenteeism due to chronic non-malignant pain (CNMP) is a major societal and individual cause of concern that requires effective treatments.Objective We present a protocol for a systematic review and network meta-analysis (NMA) aiming to compare available interventions for return to work (RTW) in adults with CNMP.Methods and analysis PubMed, Embase, PsycINFO, Web of Knowledge and Cochrane Central Register of Controlled Trials databases will be searched till 31 August 2020 for randomised controlled trials (RCTs) examining interventions for RTW outcomes among patients with CNMP. Two independent investigators will search the databases, perform data extraction and assess the methodological quality of the selected RCTs. The primary outcome will be RTW, if possible, full-time or part-time after work absence due to chronic pain from baseline to the last available follow-up. Secondary outcomes will include self-reported workability or work capacity, or self-reported physical functioning and quality of life as measured by any validated scale. Pairwise meta-analysis and NMA will be conducted for each outcome using a random-effects model. For the primary outcomes, we will also obtain the ranking of all competing interventions within each NMA using surface under the cumulative ranking curve. The assumption of coherence (ie, that direct and indirect evidence are in statistical agreement) will be examined using both a local and a global approach. We will also conduct subgroup and meta-regression analyses, whenever feasible, to investigate the unexplained variation in effect size. The comparison-adjusted funnel plot will be used to evaluate small-study effects. The overall quality of evidence will be rated with the Confidence in Network Meta-Analysis tool. Data analysis will be conducted using Stata V.16.0.Ethics and dissemination This systematic review does not require ethical approval since it will not disseminate any private patient data. The results of this study will be disseminated through peer-reviewed publication.PROSPERO registration number CRD42020171429.

Introduction Diagnostic tests for influenza in Australia are currently only authorised for use in clinical settings. At-home diagnostic testing for influenza could reduce the need for patient contact with healthcare services, which potentially could contribute to symptomatic improvement and reduced spread of influenza. We aim to determine the accuracy of an app-guided nasal self-swab combined with a lateral flow immunoassay for influenza conducted by individuals with influenza-like illness (ILI).Methods and analysis Adults (≥18 years) presenting with ILI will be recruited by general practitioners (GP) participating in Australian Sentinel Practices Research Network. Eligible participants will have a nasal swab obtained by their GP for verification of influenza A/B status using reverse transcription polymerase chain reaction (RT-PCR) test at an accredited laboratory. Participants will receive an influenza test kit and will download an app that collects self-reported symptoms and influenza risk factors, then instructs them in obtaining a low-nasal self-swab, running a QuickVue influenza A+B lateral flow immunoassay (Quidel Corporation) and interpreting the results. Participants will also interpret an enhanced image of the test strip in the app. The primary outcome will be the accuracy of participants’ test interpretation compared with the laboratory RT-PCR reference standard. Secondary analyses will include accuracy of the enhanced test strip image, accuracy of an automatic test strip reader algorithm and validation of prediction rules for influenza based on self-reported symptoms. A post-test survey will be used to obtain participant feedback on self-test procedures.Ethics and dissemination The study was approved by the Human Research and Ethic Committee (HREC) at the University of Adelaide (H-2019-116). Protocol details and any amendments will be reported to https://www.tga.gov.au/. Results will be published in the peer-reviewed literature, and shared with stakeholders in the primary care and diagnostics communities.Trial registration number Australia New Zealand Clinical Trial Registry (U1111-1237-0688).

Objectives To describe the uptake and outputs of the National Health Service Health Check (NHSHC) programme in England.Design Observational study.Setting National primary care data extracted directly by NHS Digital from 90% of general practices (GP) in England.Participants Individuals aged 40–74 years, invited to or completing a NHSHC between 2012 and 2017, defined using primary care Read codes.Intervention The NHSHC, a structured assessment of non-communicable disease risk factors and 10-year cardiovascular disease (CVD) risk, with recommendations for behavioural change support and therapeutic interventions.Results During the 5-year cycle, 9 694 979 individuals were offered an NHSHC and 5 102 758 (52.6%) took up the offer. There was geographical variation in uptake between local authorities across England ranging from 25.1% to 84.7%. Invitation methods changed over time to incorporate greater digitalisation, opportunistic delivery and delivery by third-party providers.The population offered an NHSHC resembled the English population in ethnicity and deprivation characteristics. Attendees were more likely to be older and women, but were similar in terms of ethnicity and deprivation, compared with non-attendees. Among attendees, risk factor prevalence reflected population survey estimates for England. Where a CVD risk score was documented, 25.9% had a 10-year CVD risk ≥10%, of which 20.3% were prescribed a statin. Advice, information and referrals were coded as delivered to over 2.5 million individuals identified to have risk factors.Conclusion This national analysis of the NHSHC programme, using primary care data from over 9.5 million individuals offered a check, reveals an uptake rate of over 50% and no significant evidence of inequity by ethnicity or deprivation. To maximise the anticipated value of the NHSHC, we suggest continued action is needed to invite more eligible people for a check, reduce geographical variation in uptake, prioritise engagement with non-attendees and promote greater use of evidence-based interventions especially where risk is identified.

Objective We aimed to explore the patient-centred outcomes (PCOs) radiologists and radiologic technologists perceive to be important to patients undergoing imaging procedures.Design We conducted a qualitative study of individual semi-structured interviews.Participants We recruited multiple types of radiologists including general, musculoskeletal neuroradiology, body and breast imagers as well as X-ray, ultrasound, CT or MRI radiologic technologists from Washington and Idaho.Outcome Thematic analysis was conducted to identify themes and subthemes related to PCOs of imaging procedures.Results Ten radiologists and six radiology technologists participated. Four main domains of PCOs were identified: emotions, physical factors, knowledge and patient burden. In addition to these outcomes, we also identified patient and provider factors that can potentially moderate these outcomes.Conclusions Radiologists and technologists perceived outcomes related to the effect of imaging procedures on patients’ emotions, physical well-being, knowledge and burden from financial and opportunity costs to be important to patients undergoing imaging procedures. There are opportunities for the radiology community to measure and use these PCOs in comparisons of imaging procedures and potentially identify areas where these outcomes can be leveraged to drive a more patient-centred approach to radiology.

Objective Lung cancer is increasingly recognised as a heterogeneous disease. Recent advances with targeted therapies for lung cancer with oncogenic mutations have greatly improved the prognosis for this subset of patients, yet little is known about their experiences. This study aimed to identify the needs and explore the healthcare experiences of these advanced patients with oncogenic mutation driven lung cancer.Design Qualitative interviews with patients with advanced or metastatic non-small cell lung cancer with oncogenic alterations in anaplastic lymphoma kinase, epidermal growth factor receptor or c-ros oncogene 1.Settings Patients were recruited from online lung cancer support groups within the USA. Interviews were conducted remotely or in person, transcribed verbatim and analysed using an iterative inductive and deductive process.Participants We included 39 patients (11 males and 28 females) with a median age of 48.Results Two primary theme categories emerged: patients' unmet needs and improving healthcare experiences. Unmet needs are related to patients’ desire to view their disease as a chronic illness, aspire to live a meaningful existence without financial devastation, desire for understanding along with emotional support and needing help with practical matters. Improving healthcare experiences involved patients’ desire to trust the expertise of clinical providers, receive reliable care and be treated holistically and as informed partners.Conclusions Patients with lung cancer with oncogenic mutations live uncharted experiences. Targeted therapy brings hope, but uncertainty is daunting. Patients grapple with the meaning and purpose of their lives while day-to-day obligations remain challenging. Healthcare teams are instrumental in their care experiences, and patients desire providers who are up-to-date on advances in the field and treat them as whole persons.

Objectives Severe asthma imposes a significant burden on individuals, families and the healthcare system. New treatment and management approaches are emerging as effective options for severe asthma. Translating new knowledge to multidisciplinary healthcare professionals is a priority. We developed ‘The Severe Asthma Toolkit’ (https://toolkit.severeasthma.org.au) to increase awareness of severe asthma, provide evidence-based resources and support decisionmaking by healthcare providers.Setting Roundtable discussions and a survey of Australians clinicians were conducted to determine clinician preferences, format and content for a severe asthma resource.Participants A reference group from stakeholder and consumer bodies and severe asthma experts provided advice and feedback. A multidisciplinary team of international experts was engaged to develop content. Written content was based on up-to-date literature. Peer and editorial review were performed to finalise content and inform web design. Website design focused on user experience, navigation, engagement, interactivity and tailoring of content for a clinical audience.Results A web-based resource was developed. Roundtable discussions and a needs assessment survey identified the need for dedicated severe asthma management resources to support skills training. The end-product, which launched 26 March 2018, includes an overview of severe asthma, diagnosis and assessment, management, medications, comorbidities, living with severe asthma, establishing a clinic, paediatrics/adolescents and clinical resources. Analytics indicate access by users worldwide (32 169 users from 169 countries). User survey results (n=394) confirm access by the target audience (72% health professionals), who agreed the toolkit increased their knowledge (73%) and confidence in managing severe asthma (66%), and 75% are likely to use the resource in clinic.Conclusions The Severe Asthma Toolkit is a unique, evidence-based internet resource to support healthcare professionals providing optimal care for people with severe asthma. It is a comprehensive, accessible and independent resource developed by leading severe asthma experts to improve clinician knowledge and skills in severe asthma management.

Objectives To investigate nursing and medical students’ readiness for interprofessional learning before and after implementing geriatric interprofessional education (IPE), based on problem-based learning (PBL) case scenarios. To define the optimal number of geriatric IPE sessions, the size and the ratio of participants from each profession in the learner groups, the outcomes related to the Kirkpatrick four-level typology of learning evaluation, students’ concerns about joint learning and impact of geriatric IPE on these concerns. The study looked at the perception of roles and expertise of the ‘other’ profession in interprofessional teams, and students’ choice of topics for future sessions. Students’ expectations, experience, learning points and the influence on the understanding of IP collaboration, as well as their readiness to participate in such education again were investigated.Design A controlled before–after study (2014/2015, 2015/2016) with data collected immediately before and after the intervention period. Study includes additional comparison of the results from the intervention with a control group of students. Outcomes were determined with a validated ‘Readiness for Interprofessional Learning’ questionnaire, to which we added questions with free comments, combining quantitative and qualitative research methods. The teaching sessions were facilitated by experienced practitioners/educators, so each group had both, a clinician (either geratology consultant or registrar) and a senior nurse.Participants 300 medical, 150 nursing students.Setting Tertiary care university teaching hospital.Results Analysis of the returned forms in the intervention group had shown that nursing students scored higher on teamwork and collaboration post-IPE (M=40.78, SD=4.05) than pre-IPE (M=34.59, SD=10.36)—statistically significant. On negative professional identity, they scored lower post-IPE (M=7.21, SD=4.2) than pre-IPE (M=8.46, SD=4.1)—statistically significant. The higher score on positive professional identity post-IPE (M=16.43, SD=2.76) than pre-IPE (M=14.32, SD=4.59) was also statistically significant. Likewise, the lower score on roles and responsibilities post-IPE (M=5.41, SD=1.63) than pre-IPE (M=6.84, SD=2.75).Medical students scored higher on teamwork and collaboration post-IPE (M=36.66, SD=5.1) than pre-IPE (M=32.68, SD=7.4)—statistically significant. Higher positive professional identity post-IPE (M=14.3, SD=3.2) than pre-IPE (M=13.1, SD=4.31)—statistically significant. The lower negative professional identity post-IPE (M=7.6, SD=3.17) than pre-IPE (M=8.36, SD=2.91) was not statistically significant. Nor was the post-IPE difference over roles and responsibilities (M=7.4, SD=1.85), pre-IPE (M=7.85, SD=2.1).In the control group, medical students scored higher for teamwork and collaboration post-IPE (M=36.07, SD=3.8) than pre-IPE (M=33.95, SD=3.37)—statistically significant, same for positive professional identity post-IPE (M=13.74, SD=2.64), pre-IPE (M=12.8, SD=2.29), while negative professional identity post-IPE (M=8.48, SD=2.52), pre-IPE (M=9, SD=2.07), and roles and responsibilities post-IPE (M=7.89, SD=1.69), pre-IPE (M=7.91, SD=1.51) shown no statistically significant differences. Student concerns, enhanced understanding of collaboration and readiness for future joint work were addressed, but not understanding of roles.Conclusions Educators with nursing and medical backgrounds delivered geriatric IPE through case-based PBL. The optimal learner group size was determined. The equal numbers of participants from each profession for successful IPE are not necessary. The IPE delivered by clinicians and senior nurses had an overall positive impact on all participants, but more markedly on nursing students. Surprisingly, it had the same impact on medical students regardless if it was delivered to the mixed groups with nursing students, or to medical students alone. Teaching successfully addressed students’ concerns about joint learning and communication and ethics were most commonly suggested topics for the future.

Objectives People with chronic kidney diseases (CKD) have identified exercise as a research priority. To inform the research agenda, we surveyed nephrologists on their practice patterns, available resources and research priorities for exercise and physical activity (PA) in CKD.Design Cross-sectional international survey.Setting and participants 19-item electronic survey was administered to practising nephrologists with publicly available email addresses in Canada (n=354) and Australia and New Zealand (ANZ) and via newsletters for the Australian and New Zealand Society of Nephrology (n=598).Outcomes Frequency and predictors of exercise and PA counselling in practice and research priorities.Results 189 respondents (20% response) completed the survey. Eighty-one per cent of ANZ and 42% of Canadian respondents reported that their renal programmes did not have any exercise programmes or resources. The most frequently reported barrier for exercise programme implementation was a lack of funding (77%). Ninety per cent of respondents thought regular exercise provides ‘health benefits’ for all CKD stages; 59% reported that exercise counselling was within the nephrologists’ scope of practice and 47% reported ‘frequently’ or ‘always’ counselling patients. In multivariable analysis, female gender (OR 2.31; 95% CI 1.16 to 4.58) and older age (OR 1.94 per age category increase; 95% CI 1.15 to 3.26) were associated with exercise counselling. Out of 194 research priorities, 65 (34%) were clinical outcomes (cardiovascular parameters) and 30% were patient-reported outcomes (quality of life).Conclusions Most nephrologists consider exercise and PA counselling as within their scope of practice and beneficial but, due to competing priorities, do not regularly counsel patients. This suggests a need for the evaluation of effective and efficient counselling strategies and a role for the routine involvement of exercise specialists in kidney care. Cardiovascular parameters and quality of life were identified as important outcomes for future exercise trials.

Objectives To explore socioeconomic differences in screen-viewing at ages 6 and 9, and how these are related to different media uses.Design Longitudinal cohort study.Setting Children recruited from 57 state-funded primary schools in Southwest England, UK.Participants 1299 children at ages 5–6, 1223 children at ages 8–9, including 685 children at both time points.Outcome measures Children’s total screen-viewing time (parent-reported) and time spent using multiple screen devices simultaneously (multiscreen viewing), for weekdays and weekends.Methods Negative binomial regression was used to model associations between socioeconomic variables (highest household education and area deprivation) and total screen-viewing at age 6 and the change from age 6 to 9. We additionally adjusted for child characteristics, parental influences and media devices in the home. Multiscreen viewing was analysed separately.Results Household education was associated with children’s screen-viewing at age 6 with lower screen-viewing in higher socioeconomic groups (21%–27% less in households with a Degree or Higher Degree, compared with General Certificate of Secondary Education: GCSE). These differences were explained by the presence of games consoles, parental limits on screen-viewing and average parent screen-viewing. Between ages 6 and 9, there were larger increases in screen-viewing for children from A level and Degree households (13% and 6%, respectively, in the week) and a decrease in Higher Degree households (16%), compared with GCSE households. Differences by household education remained when adjusting for media devices and parental factors.Conclusions Children’s screen-viewing patterns differ by parental education with higher levels of viewing among children living in households with lower educational qualifications. These differences are already present at age 6, and continue at age 9. Strategies to manage child sedentary time, and particularly screen-viewing, may need to take account of the socioeconomic differences and target strategies to specific groups.

Introduction Choosing Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change. In Australia, Choosing Wisely has developed a 5 Questions resource to facilitate better conversations. The primary aim of this study is to evaluate the impact of the Choosing Wisely Australia 5 Questions resource and a video designed to prepare patients for question-asking and participation in shared decision-making on (a) self-efficacy to ask questions and participate in shared decision-making, (b) intention to participate in shared decision-making and (c) a range of secondary outcomes. The secondary aim of this study is to determine whether participants’ health literacy modifies the effects of the interventions.Methods and analysis We will use 2×2×2 between-subjects factorial design (preparation video: yes, no × Choosing Wisely 5 Questions resource: yes, no × health literacy: adequate, inadequate). Participants will be recruited by an online market research company, presented with a hypothetical non-specific low back pain scenario, and randomised to study groups stratified by health literacy. Quantitative primary and secondary outcome data will be analysed as intention-to-treat using appropriate regression models (ie, linear regression for continuous outcomes, logistic regression for dichotomous categorical outcomes).Ethics and dissemination Ethical approval for this study was obtained from the University of Sydney Human Research Ethics Committee (protocol number: 2018/965). The results from this work will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies. Resources developed for this study will be made available to patients and clinicians following trial completion.Trial registration number This trial has been registered with the Australia New Zealand Clinical Trials Registry (trial number: 376477) and the stage is Pre-results.

Introduction Interparental conflict exposure places adolescents at risk for problems with stress and anxiety; existing prevention/intervention strategies focus on reducing interparental conflict. Mindfulness-based programmes may be a promising treatment strategy for this population, but studies have not yet tested whether they are effective in this high-conflict context. In addition, evidence suggests that extensions to traditional treatments, such as delivering components in daily life that are tailored to moments of need, can increase treatment efficacy, particularly when combined with in-person treatments and particularly for adolescents. However, there are no such extensions to mindfulness interventions available. The Moving 2 Mindful study aims to (1) develop an ecological momentary intervention (EMI) supplement to Learning to BREATHE (L2B), an evidence-based mindfulness intervention for adolescents; (2) refine the EMI programme and determine the best delivery plan; (3) examine the feasibility and acceptability of L2B Plus (L2B plus the developed supplement) and (4) examine the potential for L2B Plus to reduce stress and anxiety for adolescents from high-conflict homes.Methods and analysis The Moving 2 Mindful study proposes a mixed-methods approach to developing and refining a multimethod adaptive supplement to L2B. Feasibility, acceptability and potential effectiveness will be tested in a sample of 38 families, who will be randomly assigned to receive L2B Plus or an active health and wellness control condition and followed until 3 months postintervention. A range of psychosocial and physiological factors will be assessed at multiple time points. This study is registered with clinicaltrials.gov (ID NCT03869749; pre-results).Ethics and dissemination The Institutional Review Board at Colorado State University has approved this study. Findings will be disseminated in scientific journals and conferences, whether they are positive, negative or inconclusive.

Introduction School readiness is a multidimensional construct that includes cognitive, behavioural and emotional aspects of a child’s development. School readiness is strongly associated with a child’s future school success and well-being. The Early Development Instrument (EDI) is a reliable and valid teacher-completed tool for assessing school readiness in children at kindergarten age. A substantial knowledge gap exists in understanding how early child growth, health behaviours, nutrition, cardiometabolic risk and development impact school readiness. The primary objective was to determine if growth patterns, measured by body mass index trajectories in healthy children aged 0–5 years, are associated with school readiness at ages 4–6 years (kindergarten age). Secondary objectives were to determine if other health trajectories, including health behaviours, nutrition, cardiometabolic risk and development, are associated with school readiness at ages 4–6 years. This paper presents the Fit for School Study protocol.Methods and analysis This is an ongoing prospective cohort study. Parents of children enrolled in the The Applied Health Research Group for Kids (TARGet Kids!) practice-based research network are invited to participate in the Fit for School Study. Child growth, health behaviours, nutrition, cardiometabolic risk and development data are collected annually at health supervision visits and linked to EDI data collected by schools. The primary and secondary analyses will use a two-stage process: (1) latent class growth models will be used to first determine trajectory groups, and (2) generalised linear mixed models will be used to examine the relationship between exposures and EDI results.Ethics and dissemination The research ethics boards at The Hospital for Sick Children, Unity Health Toronto and McMaster University approved this study, and research ethics approval was obtained from each school board with a student participating in the study. The findings will be presented locally, nationally and internationally and will be published in peer-reviewed journals.Trial registration number NCT01869530.

Objective This project aimed to develop and propose a standardised reporting guideline for kidney disease research and clinical data reporting, in order to improve kidney disease data quality and integrity, and combat challenges associated with the management and challenges of ‘Big Data’.Methods A list of recommendations was proposed for the reporting guideline based on the systematic review and consolidation of previously published data collection and reporting standards, including PhenX measures and Minimal Information about a Proteomics Experiment (MIAPE). Thereafter, these recommendations were reviewed by domain-specialists using an online survey, developed in Research Electronic Data Capture (REDCap). Following interpretation and consolidation of the survey results, the recommendations were mapped to existing ontologies using Zooma, Ontology Lookup Service and the Bioportal search engine. Additionally, an associated eXtensible Markup Language schema was created for the REDCap implementation to increase user friendliness and adoption.Results The online survey was completed by 53 respondents; the majority of respondents were dual clinician-researchers (57%), based in Australia (35%), Africa (33%) and North America (22%). Data elements within the reporting standard were identified as participant-level, study-level and experiment-level information, further subdivided into essential or optional information.Conclusion The reporting guideline is readily employable for kidney disease research projects, and also adaptable for clinical utility. The adoption of the reporting guideline in kidney disease research can increase data quality and the value for long-term preservation, ensuring researchers gain the maximum benefit from their collected and generated data.

Introduction Research on the relationship between digital media exposure and child development is complex, inconsistent and fraught with debate. A highlighted area of inadequacy surrounds the methodological limitations of measuring digital media use for both researchers and clinicians, alike. This protocol aims to (1) identify core concepts in the area of screen time and digital media use in children and adolescents (2) map existing research paradigms and screening/measurement tools that serve to underpin and operationalise core concepts and (3) provide an initial step in integrating these findings into a consolidated screening toolkit. It is expected this enterprise will help advance research and clinical evaluation in fields concerned with digital media use, namely medicine, child development and the social sciences.Methods and analysis The planned scoping review will search relevant electronic databases, including Ovid MEDLINE, PsycINFO and Scopus, in addition to grey literature. All empirical investigations and presentation of original research will be considered, and measurement/screening tools for digital media usage in children and adolescents will be identified and reported on. Two reviewers will pilot test the screening criteria, and data extraction forms prior to independently screening all relevant literature and extracting the data. A three-stage synthesis process will be used to map the existent measurement and screening tools for digital media usage in children and adolescents.Ethics and dissemination There are no ethical considerations for this scoping review. Plans for dissemination include publication in a top-tier, open-access journal, public presentations and conference proceedings. Presentation of the full scoping review has been accepted to the American Academy of Child & Adolescent Psychiatry 66th Annual Meeting.

Introduction Severe limb ischaemia (SLI) is the end stage of peripheral arterial occlusive disease where the viability of the limb is threatened. Around 25% of patients with SLI will ultimately require a major lower limb amputation, which has a substantial adverse impact on quality of life. A newly established rapid-access vascular limb salvage clinic and modern revascularisation techniques may reduce amputation rate. The aim of this study was to investigate the 12-month amputation rate in a contemporary cohort of patients and compare this to a historical cohort. Secondary aims are to investigate the use of frailty and cognitive assessments, and cardiac MRI in risk-stratifying patients with SLI undergoing intervention and establish a biobank for future biomarker analyses.Methods and analysis This single-centre prospective cohort study will recruit patients aged 18–110 years presenting with SLI. Those undergoing intervention will be eligible to undergo additional venepuncture (for biomarker analysis) and/or cardiac MRI. Those aged ≥65 years and undergoing intervention will also be eligible to undergo additional frailty and cognitive assessments. Follow-up will be at 12 and 24 months and subsequently via data linkage with NHS Digital to 10 years postrecruitment. Those undergoing cardiac MRI and/or frailty assessments will receive additional follow-up during the first 12 months to investigate for perioperative myocardial infarction and frailty-related outcomes, respectively. A sample size of 420 patients will be required to detect a 10% reduction in amputation rate in comparison to a similar sized historical cohort, with 90% power and 5% type I error rate. Statistical analysis of this comparison will be by adjusted and unadjusted logistic regression analyses.Ethics and dissemination Ethical approval for this study has been granted by the UK National Research Ethics Service (19/LO/0132). Results will be disseminated to participants via scientific meetings, peer-reviewed medical journals and social media.Trial registration number NCT04027244.

Introduction Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journeying through Dementia (JtD) intervention was created. A randomised controlled trial (RCT), based on a pilot study, is in progress.Methods and analysis The RCT is a pragmatic, two-arm, parallel group trial designed to test the clinical and cost-effectiveness of JtD compared with usual care. Recruitment will be through NHS services, third sector organisations and Join Dementia Research. The sample size is 486 randomised (243 to usual care and 243 to the intervention usual care). Participants can choose to ask a friend or relative (supporter) to become involved in the study. The primary outcome measure for participants is Dementia-Related Quality of Life (DEMQOL), collected at baseline and at 8 months’ postrandomisation. Secondary outcome measures will be collected from participants and supporters at those visits. Participants will also be followed up at 12 months’ postrandomisation with a reduced set of measures. A process evaluation will be conducted through qualitative and fidelity substudies. Analyses will compare the two arms of the trial on an intention to treat as allocated basis. The primary analyses will compare the mean DEMQOL scores of the participants at 8 months between the two study arms. A cost-effectiveness analysis will consider the incremental cost per Quality Adjusted Life Years of the intervention compared with usual care. Qualitative and fidelity substudies will be analysed through framework analysis and fidelity assessment tools respectively.Ethics and dissemination REC and HRA approval were obtained. A Data Monitoring and Ethics Committee has been constituted. Dissemination will be via publications, conferences and social media. Intervention materials will be made open access.Trial registration number ISRCTN17993825.

Objectives To quantify the economic and psychological impact of the cancellation of operations due to winter pressures on patients, their families and the economy.Design This questionnaire study was designed with the help of patient groups. Data were collected on the economic and financial burden of cancellations. Emotions were also quantified on a 5-point Likert scale.Setting Five NHS Hospital Trusts in the East Midlands region of England.Participants We identified 796 participants who had their elective operations cancelled between 1 November 2017 and 31 March 2018 and received responses from 339 (43%) participants.Interventions Participants were posted a modified version of a validated quality of life questionnaire with a prepaid return envelope.Main outcome measures The primary outcome measures were the financial and psychological impact of the cancellation of elective surgery on patients and their families.Results Of the 339 respondents, 163 (48%) were aged

Introduction Congenital anomalies are the fifth leading cause of death in children

Introduction The prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.Method A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and dissemination This trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration number ISRCTN17631228.Protocol V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

Introduction Postoperative acute kidney injury (AKI) is a common complication in cardiac surgery. Levels of intravascular haemolysis are strongly associated with postoperative AKI and with prolonged (>90 min) use of cardiopulmonary bypass (CPB). Ferrous plasma haemoglobin released into the circulation acts as a scavenger of nitric oxide (NO) produced by endothelial cells. Consequently, the vascular bioavailability of NO is reduced, leading to vasoconstriction and impaired renal function. In patients with cardiovascular risk factors, the endothelium is dysfunctional and cannot replenish the NO deficit. A previous clinical study in young cardiac surgical patients with rheumatic fever, without evidence of endothelial dysfunction, showed that supplementation of NO gas decreases AKI by converting ferrous plasma haemoglobin to ferric methaemoglobin, thus preserving vascular NO. In this current trial, we hypothesised that 24 hours administration of NO gas will reduce AKI following CPB in patients with endothelial dysfunction.Methods This is a single-centre, randomised (1:1) controlled, parallel-arm superiority trial that includes patients with endothelial dysfunction, stable kidney function and who are undergoing cardiac surgery procedures with an expected CPB duration >90 min. After randomisation, 80 parts per million (ppm) NO (intervention group) or 80 ppm nitrogen (N2, control group) are added to the gas mixture. Test gases (N2 or NO) are delivered during CPB and for 24 hours after surgery. The primary study outcome is the occurrence of AKI among study groups. Key secondary outcomes include AKI severity, occurrence of renal replacement therapy, major adverse kidney events at 6 weeks after surgery and mortality. We are recruiting 250 patients, allowing detection of a 35% AKI relative risk reduction, assuming a two-sided error of 0.05.Ethics and dissemination The Partners Human Research Committee approved this trial. Recruitment began in February 2017. Dissemination plans include presentations at scientific conferences, scientific publications and advertising flyers and posters at Massachusetts General Hospital.Trial registration number NCT02836899.

Objectives (1) To explore professional and lay stakeholder views on the design and delivery of services in the area of consanguinity and genetic risk. (2) To identify principles on which there is sufficient consensus to warrant inclusion in a national guidance document. (3) To highlight differences of opinion that necessitate dialogue. (4) To identify areas where further research or development work is needed to inform practical service approaches.Design Delphi exercise. Three rounds and one consensus conference.Setting UK, national, web-based and face-to-face.Participants Recruitment via email distribution lists and professional networks. 42 participants with varied professional and demographic backgrounds contributed to at least one round of the exercise. 29 people participated in statement ranking across both rounds 2 and 3.Results Over 700 individual statements were generated in round 1 and consolidated into 193 unique statements for ranking in round 2, with 60% achieving 80% or higher agreement. In round 3, 74% of statements achieved 80% or higher agreement. Consensus conference discussions resulted in a final set of 148 agreed statements, providing direction for both policy-makers and healthcare professionals. 13 general principles were agreed, with over 90% agreement on 12 of these. Remaining statements were organised into nine themes: national level leadership and coordination, local level leadership and coordination, training and competencies for healthcare and other professionals, genetic services, genetic literacy, primary care, referrals and coordination, monitoring and evaluation and research. Next steps and working groups were also identified.Conclusions There is high agreement among UK stakeholders on the general principles that should shape policy and practice responses in this area: equity of access, cultural competence, coordinated inter-agency working, co-design and empowerment and embedded evaluation. The need for strong national leadership to ensure more efficient sharing of knowledge and promotion of more equitable and consistent responses across the country is emphasised.

Introduction Recent evidence suggests an underlying movement disruption may be a core component of autism spectrum disorder (ASD) and a new, accessible early biomarker. Mobile smart technologies such as iPads contain inertial movement and touch screen sensors capable of recording subsecond movement patterns during gameplay. A previous pilot study employed machine learning analysis of motor patterns recorded from children 3–5 years old. It identified those with ASD from age-matched and gender-matched controls with 93% accuracy, presenting an attractive assessment method suitable for use in the home, clinic or classroom.Methods and analysis This is a phase III prospective, diagnostic classification study designed according to the Standards for Reporting Diagnostic Accuracy Studies guidelines. Three cohorts are investigated: children typically developing (TD); children with a clinical diagnosis of ASD and children with a diagnosis of another neurodevelopmental disorder (OND) that is not ASD. The study will be completed in Glasgow, UK and Gothenburg, Sweden. The recruitment target is 760 children (280 TD, 280 ASD and 200 OND). Children play two games on the iPad then a third party data acquisition and analysis algorithm (Play.Care, Harimata) will classify the data as positively or negatively associated with ASD. The results are blind until data collection is complete, when the algorithm’s classification will be compared against medical diagnosis. Furthermore, parents of participants in the ASD and OND groups will complete three questionnaires: Strengths and Difficulties Questionnaire; Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations Questionnaire and the Adaptive Behavioural Assessment System-3 or Vineland Adaptive Behavior Scales-II. The primary outcome measure is sensitivity and specificity of Play.Care to differentiate ASD children from TD children. Secondary outcomes measures include the accuracy of Play.Care to differentiate ASD children from OND children.Ethics and dissemination This study was approved by the West of Scotland Research Ethics Service Committee 3 and the University of Strathclyde Ethics Committee. Results will be disseminated in peer-reviewed publications and at international scientific conferences.Trial registration number NCT03438994; Pre-results.