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Objective Since the emergence of COVID-19, university education has drastically transformed into digital-based learning (DBL). Online education has been well recognised as a promising mode of teaching; however, only a limited number of studies have reported the students’ preferred format for academic learning.Design Cross-sectional.Setting The study was conducted in a university setting in Japan. A Google Forms online questionnaire was distributed to the participants between April and May 2022.Participants A total of 939 undergraduate medical, nursing and pharmaceutical students in the pre-clinical grade were recruited, and 344 were included in the final analysis.Primary and secondary outcome The questionnaire assessed students’ format preferences between paper-based learning (PBL) and DBL as it pertained to academic performance and eyestrain. In terms of academic performance, comprehension, memory retention and absorption (concentration) were assessed. We also explored the association between students’ daily time spent using DBL and their digital preference by the Cochran-Armitage trend test and logistic regression analysis.Results A total of 344 (191 medical, 73 nursing and 80 pharmaceutical) university students completed the questionnaire (response rate 36.6%). An even distribution was observed in the preferred learning format for comprehension: PBL (32.0%), both formats equivalent (32.8%) and DBL (35.2%; digital preference). Only few students preferred DBL for memory retention (6.1%), absorption (6.7%) and eyestrain (1.2%). Although a positive association was observed between daily time spent using DBL and digital preference for comprehension, there was no association for memory retention, absorption and eyestrain.Conclusion Among university students, DBL was just as preferred as PBL for comprehension; however, only a few students reported that DBL was better in terms of memory retention, absorption and eyestrain. A learning environment where students can study using PBL should be continued.

Introduction Paediatric concussion is a common injury. Approximately 30% of youth with concussion will experience persisting postconcussion symptoms (PPCS) extending at least 1 month following injury. Recently, studies have shown the benefit of early, active, targeted therapeutic strategies. However, these are primarily prescribed from the specialty setting. Early access to concussion specialty care has been shown to improve recovery times for those at risk for persisting symptoms, but there are disparities in which youth are able to access such care. Mobile health (mHealth) technology has the potential to improve access to concussion specialists. This trial will evaluate the feasibility of a mHealth remote patient monitoring (RPM)-based care handoff model to facilitate access to specialty care, and the effectiveness of the handoff model in reducing the incidence of PPCS.Methods and analysis This study is a non-randomised type I, hybrid implementation-effectiveness trial. Youth with concussion ages 13–18 will be enrolled from the emergency department of a large paediatric healthcare network. Patients deemed a moderate-to-high risk for PPCS using the predicting and preventing postconcussive problems in paediatrics (5P) stratification tool will be registered for a web-based chat platform that uses RPM to collect information on symptoms and activity. Those patients with escalating or plateauing symptoms will be contacted for a specialty visit using data collected from RPM to guide management. The primary effectiveness outcome will be the incidence of PPCS, defined as at least three concussion-related symptoms above baseline at 28 days following injury. Secondary effectiveness outcomes will include the number of days until return to preinjury symptom score, clearance for full activity and return to school without accommodations. The primary implementation outcome will be fidelity, defined as the per cent of patients meeting specialty care referral criteria who are ultimately seen in concussion specialty care. Secondary implementation outcomes will include patient-defined and clinician-defined appropriateness and acceptability.Ethics and dissemination This study was approved by the Institutional Review Board of the Children’s Hospital of Philadelphia (IRB 22-019755). Study findings will be published in peer-reviewed journals and disseminated at national and international meetings.Trial registration number NCT05741411.

Introduction While research into adolescent mental health has developed a considerable understanding of environmental and psychosocial risk factors, equivalent biological evidence is lacking and is not representative of economic, social and ethnic diversity in the adolescent population. It is important to understand the possible barriers and facilitators to conduct this research. This will then allow us to improve our understanding of how biology interacts with environmental and psychosocial risk factors during adolescence. The objective of this scoping review is to identify and understand the needs, barriers and facilitators related to the collection of biological data in adolescent mental health research.Methods and analysis Reviewers will conduct a systematic search of PubMed, Medline, Scopus, Cochrane, ERIC, EMBASE, ProQuest, EBSCO Global Health electronic databases, relevant publications and reference lists to identify studies published in the English language at any time. This scoping review will identify published studies exploring mental health/psychopathology outcomes, with biological measures, in participants between the ages of 11 and 18 and examine the reported methodology used for data collection. Data will be summarised in tabular form with narrative synthesis and will use the methodology of Levac et al, supplemented by subsequent recommendations from the Joanna Briggs Institute Scoping Review Methodology.Ethics and dissemination Ethical approval is not required for this scoping review. The scoping review will be conducted with input from patient and public involvement, specifically including young people involved in our study (‘Co-producing a framework of guiding principles for Engaging representative and diverse cohorts of young peopLE in Biological ReseArch in menTal hEalth’—www.celebrateproject.co.uk) Youth Expert Working Group. Dissemination will include publication in peer-reviewed journals, academic presentations and on the project website.

Objectives To map the current use of paper-based and/or screen-based media for health education aimed at older people.Design A scoping review was reported following the Preferred Reporting Items of Systematic Reviews and Meta-analyses for Scoping Reviews checklist.Data sources The search was carried out in seven databases (Scopus, Web of Science, Embase, Medline, CINAHL, ACM Guide to Computing Literature, PsycINFO), with studies available from 2012 to the date of the search in 2022, in English, Portuguese, Italian or Spanish. In addition, Google Scholar was searched to check the grey literature. The terms used in the search strategy were older adults, health education, paper and screen-based media, preferences, intervention and other related terms.Eligibility criteria Studies included were those that carried out health education interventions for older individuals using paper and/or screen-based media and that described barriers and/or facilitators to using these media.Data extraction and synthesis The selection of studies was carried out by two reviewers. A data extraction form was developed with the aim of extracting and recording the main information from the studies. Data were analysed descriptively using Bardin’s content analysis.Results The review included 21 studies that carried out health education interventions with different purposes, the main ones being promotion of physical activity, hypertension prevention and psychological health. All 21 interventions involved screen-based media on computers, tablets, smartphones and laptops, while only 4 involved paper-based media such as booklets, brochures, diaries, flyers and drawings. This appears to reflect a transition from paper to screen-based media for health education for the older population, in research if not in practice. However, analysis of facilitators and barriers to using both media revealed 10 design factors that could improve or reduce their use, and complementarity in their application to each media type. For example, screen-based media could have multimedia content, additional functionality and interactivity through good interaction design, but have low accessibility and require additional learning due to complex interface design. Conversely, paper-based media had static content and low functionality but high accessibility and availability and a low learning cost.Conclusions We recommend having improved screen-based media design, continued use of paper-based media and the possible combination of both media through the new augmented paper technology.Registration number Open Science Framework (DOI: 10.17605/OSF.IO/GKEAH).

Objectives Current mental health practices for people living in residential aged care (RAC) facilities are poor. In Australia, there are no mechanisms to monitor and promote mental health for people living in RAC, including those who experience changed behaviours and psychological symptoms. The aim of this study is to improve current practices and mental health outcomes for people living in RAC facilities by codesigning a Mental Health benchmarking Industry Tool for residential aged Care (MHICare Tool).Methods A two-stage sequential and mixed methods codesign methodology will be used. Stage 1 will include qualitative interviews and focus groups to engage with residents, family/care partners and RAC staff to ascertain mental healthcare practices and outcomes of greatest significance to them. Adapted concept mapping methods will be used to rank identified issues of concern in order of importance and changeability, and to generate draft quality indicators. Stage 2 will comprise a Delphi procedure to gain the wider consensus of expert panel views (aged care industry, academic, clinical) on the performance indicators to be included, resulting in the codesigned MHICare Tool.Ethics and dissemination This study has been reviewed and approved by the University of Queensland Human Research Ethics Committee (HREC/2019002096). This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through social media.Conclusion This protocol reports structured methods to codesign and develop a mental health performance indicator tool for use in Australian RAC.

Introduction Air pollution is a global issue that poses a significant threat to public health. Children, due to their developing physiology, are particularly susceptible to the inhalation of environmental pollutants. Exposure can trigger immune modulation and organ damage, increasing susceptibility to respiratory diseases. Therefore, we aim to examine the association between heavy metal and particulate matter exposure with tuberculosis in children.Methods and analysis As a case–control study, we will include children diagnosed with pulmonary tuberculosis (n=60) and matched healthy controls (n=80) recruited from the same communities in Dhaka, Bangladesh. Exposure data for both cases and controls will be collected by a trained field team conducting home visits. They will administer an exposure questionnaire, measure child anthropometry, collect blood and household dust samples and instal 48-hour air quality monitors. The blood samples will be analysed by inductively coupled plasma mass spectrometry for serum heavy metal concentrations (lead, cadmium, arsenic, mercury and chromium), as a representative marker of exposure, and the presence of inflammatory biomarkers. Descriptive and inferential statistics, including independent samples t-tests, analysis of variance and conditional regression analysis, will be used to quantify heavy metal and particulate matter exposure status in tuberculosis cases compared with healthy controls, while accounting for potential confounders. Dust samples and air quality results will be analysed to understand household sources of heavy metal and particulate matter exposure. To test the study hypothesis, there is a positive association between exposure and tuberculosis diseases, we will also measure the accumulated effect of simultaneous exposures using Bayesian statistical modelling.Ethics and dissemination This study has been approved by International Centre for Diarrhoeal Disease Research, Bangladesh’s Institutional Review Board (PR-22030). The study findings will be disseminated at conferences and published in peer-reviewed journals.

Introduction One in six people live with disability in Australia with higher levels of disability of people from diverse communities, such as those with culturally and linguistically diverse (CALD) backgrounds. In Australia, CALD refers to people from diverse ethnicity and cultures, nationalities, societal structures and religions that may or may not speak a language other than English. This study employs researchers with lived experience of disability and peer support to study the impact of peer support for people with disability, including people from CALD backgrounds, in two peer-led organisations in New South Wales (NSW) Australia.Methods and analysis This study uses participatory action research and inclusive research design with researchers with lived experience, having lived experience of disability and a peer in the disability community, leading the research.Over three years, three different groups will be recruited through Community Disability Alliance Hunter (CDAH) and Diversity and Disability Alliance (DDAlliance): (1) peers with disability, (2) peer leaders with disability and (3) researchers with lived experience of disability and peer support. Data collection and creation methods include semistructured interviews, surveys and focus groups. Qualitative data will be analysed using thematic analysis through the lens of the researchers with lived experience.Ethics and dissemination Ethical approval was granted by the University of Newcastle Human Research Ethics Committee (Approval No: H-2021-0088). Dissemination includes peer-reviewed publications, presentations at local, national and international conferences and written reports for user-led organisations, disability service providers, disability agencies and people with disability.

Introduction Nutrition education is the cornerstone to maintain optimal pregnancy outcomes including gestational weight gain (GWG). Nevertheless, default for appointments is common and often lead to suboptimal achievement of GWG, accompanied with unfavourable maternal and child health outcomes. While mobile health (mHealth) usage is increasing and helps minimising barriers to clinic appointments among pregnant mothers, its effectiveness on health outcomes has been inconclusive. Therefore, this study aimed to address the gap between current knowledge and clinical care, by exploring the effectiveness of mHealth on GWG as the primary outcome, hoping to serve as a fundamental work to achieve optimal health outcomes with the improvement of secondary outcomes such as physical activity, psychosocial well-being, dietary intake, quality of life and sleep quality among pregnant mothers.Methods and analysis A total of 294 eligible participants will be recruited and allocated into 3 groups comprising of mHealth intervention alone, mHealth intervention integrated with personal medical nutrition therapy and a control group. Pretested structured questionnaires are used to obtain the respondents’ personal information, anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary intake, quality of life, sleep quality and GWG. There will be at least three time points of data collection, with all participants recruited during their first or second trimester will be followed up prospectively (after 3 months or/and after 6 months) until delivery. Generalised linear mixed models will be used to compare the mean changes of outcome measures over the entire study period between the three groups.Ethics and dissemination Ethical approvals were obtained from the ethics committee of human subjects research of Universiti Putra Malaysia (JKEUPM-2022-072) and medical research & ethics committee, Ministry of Health Malaysia: NMRR ID-22-00622-EPU(IIR). The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.Trial registration number Clinicaltrial.gov ID: NCT05377151.

Introduction Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials.Methods and analysis SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs.Ethics and dissemination The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included.Trial registration SWAT169.

To evaluate aerobic capacity, strength and other physiological, nutritional, and psychological variables which may influence the performance of transgender women (TW) athletes and compare them to cisgender women (CW) and cisgender men (CM) athletes, as well as changes in TW performance over the course of a year. Prospective cohort study including three groups: TW, CW and CM volleyball athletes. Subjects will be comprehensively assessed at two different moments: baseline and after 6–12 months of adequate hormonal therapy. Evaluation will comprise clinical, medical, nutritional and psychological interviews, incremental treadmill cardiopulmonary exercise testing, hand grip strength test, vertical jump test, analysis of sleep quality (Pittsburgh Sleep Quality Index), hormonal profile, echocardiogram, analysis of resting energy expenditure, assessment of bone mass and body composition through dual-energy X-ray absorptiometry scans, and untargeted metabolomic analysis. CW and CM matched by age, body mass index and level of physical activity will undergo a similar evaluation. The assessment of the strength, aerobic capacity, haematological, nutritional and psychological status of TW using gold-standard tests will contribute to understanding the impact of oestrogen therapy on the exercise performance of these athletes and how they compare with CW and CM.

Vision plays an important role in an athletes’ success. In sports, nearly 80% of perceptual input is visual, and eye health and sports medicine are closely intertwined fields of utmost importance to athletes. The physical nature of sports activities renders individuals more prone to various eye injuries than the general population. Ocular trauma can lead to lifelong sequelae, and impaired vision requires careful follow-up and management. Apart from injuries, athletes may also experience vision problems that can hamper their performance, including blurred vision, double vision, and light sensitivity.The interdisciplinary nature of sports medicine necessitates collaboration between sports medicine professionals and ophthalmologists. Through such collaborations, athletes can receive appropriate eye care, education on proper eye protection and guidance on adopting good eye health practices. If any inconspicuous symptoms are not detected and treated promptly, athletes may acquire systemic injuries because of defective vision, preventing them from achieving high level athletic performance in competitions.The protection of the elite athlete is the responsibility of all of us in sports medicine. To advance a more unified, evidence-informed approach to ophthalmic health assessment and management in athletes and as relevant for sports medicine physicians, the International Olympic Committee Consensus Group aims for a critical evaluation of the current state of the science and practice of ophthalmologic issues and illness in high-level sports, and present recommendations for a unified approach to this important issue.

Introduction Cabozantinib monotherapy is an option for treatment of advanced renal cell carcinoma (RCC). However, cabozantinib dose modification and discontinuation due to symptomatic adverse events (AEs) remains a challenge. The use of patient-reported outcomes (PROs) may help manage symptomatic AEs, which is reported to lead to improved quality of life (QOL), avoidance of drug discontinuation and better survival. This study aims to investigate the clinical benefits of PROs in patients with RCC receiving cabozantinib and the most appropriate medium for PRO monitoring (electronic [e]-PRO or paper-PRO).Methods and analysis This study is being conducted at about 35 sites in Japan. Patients aged ≥18 years with unresectable or metastatic RCC initiating treatment with cabozantinib monotherapy are eligible and will be randomised to: (1) e-PRO monitoring, (2) paper-PRO monitoring or (3) usual care without PRO monitoring. Recruitment began in December 2021 (target sample size, 105). Patients start treatment with cabozantinib 60 mg once daily, and in the PRO groups, will record daily medication intake, weight, temperature, blood pressure and AEs. Endpoints include the proportion of patients with a ≥5-point deterioration on the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI-19; primary endpoint), progression-free survival, QOL, dose adjustments, relative dose intensity, treatment-emergent AEs and frequency of interventions for AEs outside of the scheduled visits. Patient and physician opinions of the PRO monitoring systems and patient compliance with e-PRO/paper-PRO input are also being measured.Ethics and dissemination The study is being conducted in compliance with the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice and the Clinical Trials Act. Written informed consent is being obtained from all patients, and the protocol has been approved by the Hokkaido University Hospital Certified Review Board (approval number, CRB021-005). The results will be presented at conferences and submitted to a peer-reviewed journal.Trial registration number jRCTs011210055.

Introduction With technological advancement and the COVID-19 pandemic, paper-based media are giving way to screen-based media to promote healthy ageing. However, there is no review available covering paper and screen media use by older people, so the objective of this review is to map the current use of paper-based and/or screen-based media for health education aimed at older people.Methods and analysis The literature will be searched in Scopus, Web of Science, Medline, Embase, Cinahl, The ACM Guide to Computing Literature and Psyinfo databases. Studies in English, Portuguese, Italian or Spanish published from 2012 to the date of the search will be examined. In addition, an additional strategy will be carried out, which will be a Google Scholar search, in which the first 300 studies according to Google’s relevance algorithm will be verified. The terms used in the search strategy will be focused on older adults, health education, paper-based and screen-based media, preferences, intervention and other related terms. This review will include studies where the average age of the participants was 60 years or older and were users of health education strategies through paper-based or screen-based media. Two reviewers will carry out the selection of studies in five steps: identification of studies and removal of duplicates, pilot test, selection by reading titles and abstracts, full-text inclusion and search for additional sources. A third reviewer will resolve disagreements. To record information from the included studies, a data extraction form will be used. The quantitative data will be presented in a descriptive way and the qualitative data through Bardin’s content analysis.Ethics and dissemination Ethical approval is not applicable to the scoping review. The results will be disseminated through presentations at significant scientific events and published in journals in the area.Protocol registration number Open science framework (DOI: DOI 10.17605/OSF.IO/GKEAH).

Introduction The success rate of in vitro fertilisation (IVF) treatment for couples with infertility remains low due to lack of a reliable tool in selecting euploid embryos for transfer. This study aims to compare the efficacy in embryo selection based on morphology alone compared with non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) and morphology in infertile women undergoing IVF.Methods and analysis This is a randomised double-blind controlled trial conducted in two tertiary assisted reproduction centres. A total of 500 infertile women will be recruited and undergo IVF as indicated. They will be randomly assigned on day 6 after oocyte retrieval into two groups: the intervention group using morphology and niPGT-A and the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of spent culture medium will be replaced first. The primary outcome is a live birth per the first embryo transfer. The statistical analysis will be performed with the intention to treat and per protocol.Ethics and dissemination Ethics approval was sought from the institutional review board of the two participating units. All participants will provide written informed consent before joining the study. The results of the study will be submitted to scientific conferences and peer-reviewed journals.Trial registration number NCT04474522.

Introduction The Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population.Methods We propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either ‘standard’ perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient’s treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year.Ethics and dissemination This study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals.Trial registration number ACTRN12619001543178.

Introduction Falls are an important public health issue with consequences that include injuries, quality of life reduction and high healthcare costs. Studies show that falls prevention strategies are effective in reducing falls rate among community-dwelling older adults. However, the evaluation for effectiveness was usually done in a controlled setting with homogeneous population, and thus may not be generalisable to a wider population. This study aims to evaluate the impact of community falls prevention programmes with group-based strength and balance exercises, on falls risk and health outcomes for older adults with falls risk in Singapore.Methods and analysis This is a pragmatic closed cohort stepped-wedge cluster randomised trial design study, which involves sequential crossover of clusters from the waitlist control condition to the intervention condition, with the sequence of crossover randomly determined. The intervention will be sequentially rolled out to 12 clusters (a minimum of 5 participants/cluster), over 6 time periods with 8-week intervals in Central and North regions of Singapore. The primary analysis will be conducted under the intention-to-treat principle. A general linear mixed model or generalised estimating equation analysis appropriate for a multilevel longitudinal study incorporating an appropriate error distribution and link function will be used. Markov model will be developed to estimate the incremental cost per quality-adjusted life years and incremental cost per fall prevented from the implementation of falls prevention strategies from a societal perspective. Conditional on there being clinically relevant differences in short-term outcomes, we will implement simulation modelling to project the long-term divergence in trajectories for outcomes and costs using the Markov model.Ethics and dissemination Ethics approval has been obtained. Results will be disseminated in publications and other relevant platforms.Trial registration number NCT04788251.

Introduction The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.Methods and analysis A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.Ethics and dissemination The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration number ChiCTR2100050914.

Purpose To generate a large cohort of those in 2019 seriously considering applying to study Medicine, collecting data on a range of socioeconomic and other demographic factors that influence choice of medical schools and to link to other datasets to form a longitudinal study of progress through medical school and careers in medicine.Design Cross-sectional questionnaire studies, part of the longitudinal UK Medical Applicant Cohort Study (UKMACS).Setting UK medical school admissions in 2020.Participants UK residents aged 16+ and seriously considering applying to study Medicine. The cohort was primarily drawn from those registering in 2019 for the U(K)CAT (University Clinical Aptitude Test (formerly the UK Clinical Aptitude Test)) with additional potential applicants responding to an open call. Participants consented to their data being linked within the UK Medical Education Database.Findings to date UKMACS Wave 1 questionnaire respondents consisted of 6391 consenting respondents from across the UK. In 2019, 14 980 of the 17 470 UK-domiciled medicine applicants were first-time applicants. The questionnaires show that many of these applicants have a need for more help and guidance to make informed choices, with less advantaged groups reporting themselves as being at a disadvantage when applying due to limited understanding of information and limited access to guidance to enable informed and effective decision-making.Future plans To link the cohort with successive Universities and Colleges Admissions Service and other datasets to analyse outcomes of applications and establish national longitudinal evidence to understand how medical choices are made and how they impact on educational, career and workforce outcomes.

Introduction Understanding the complexities of change in eating behaviours, mental health, well-being and weight is crucial to inform healthcare and service provision, particularly in light of the exacerbating effects of the COVID-19 pandemic. This study aims to address the need for more comprehensive cross-sectional and longitudinal evidence, by tracking eating behaviours, mental health, health related behaviours and weight over a 12-month period, in a sample of young adults (18–35 years) in the UK and Australia.Methods and analysis Online surveys administered via the Prolific online research platform will be used for data collection at baseline, 6 months and 12 months. The survey (approximately 45 min) measures demographics, the impact of COVID-19, body mass index (BMI), weight management and health service usage, eating behaviours, personality, mental health, and health-related behaviours. An optional substudy component at each time point aims to validate self-reported weight in the main survey through images. Study inclusion criteria are; aged 18–34 years at baseline, BMI ≥20 kg/m2, and residing in the UK or Australia. A target of 500 participants at baseline was set, recruited through Prolific, and with recruitment stratified by BMI, sex and country. The proposed analyses include creating static predictive models using baseline data (eg, using latent class analysis, factor analysis or similar), and mapping changes longitudinally (eg, using multivariate regressions). These analyses will enable changes in the study measures to be identified, as well as predictors and outcomes of change.Ethics and dissemination Ethical approval was granted by Leeds Beckett University, UK (reference number 86004) and the University of Newcastle, Australia (reference number H-2022–0110). Study findings will be disseminated through scientific journals, conferences, institute websites and social media, and briefings tailored to policy, practice and the public, with the intention to help inform the future development of health and well-being care and support for young adults across Australia and the UK.

Introduction Unwarranted variation in patient care among physicians is associated with negative patient outcomes and increased healthcare costs. Care variation likely also exists for resident physicians. Despite the global movement towards outcomes-based and competency-based medical education, current assessment strategies in residency do not routinely incorporate clinical outcomes. The widespread use of electronic health records (EHRs) may enable the implementation of in-training assessments that incorporate clinical care and patient outcomes.Methods and analysis The General Medicine Inpatient Initiative Medical Education Database (GEMINI MedED) is a retrospective cohort study of senior residents (postgraduate year 2/3) enrolled in the University of Toronto Internal Medicine (IM) programme between 1 April 2010 and 31 December 2020. This study focuses on senior IM residents and patients they admit overnight to four academic hospitals. Senior IM residents are responsible for overseeing all overnight admissions; thus, care processes and outcomes for these clinical encounters can be at least partially attributed to the care they provide. Call schedules from each hospital, which list the date, location and senior resident on-call, will be used to link senior residents to EHR data of patients admitted during their on-call shifts. Patient data will be derived from the GEMINI database, which contains administrative (eg, demographic and disposition) and clinical data (eg, laboratory and radiological investigation results) for patients admitted to IM at the four academic hospitals. Overall, this study will examine three domains of resident practice: (1) case-mix variation across residents, hospitals and academic year, (2) resident-sensitive quality measures (EHR-derived metrics that are partially attributable to resident care) and (3) variations in patient outcomes across residents and factors that contribute to such variation.Ethics and dissemination GEMINI MedED was approved by the University of Toronto Ethics Board (RIS#39339). Results from this study will be presented in academic conferences and peer-reviewed journals.

Introduction Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers.Methods and analysis A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians.Ethics and dissemination Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

Introduction Asthma is the most common chronic respiratory disease in children and adults. Asthma results in significant disease-related morbidity, healthcare costs and, in some cases, death. Despite efforts through implementation of national guidelines to improve asthma care, the UK has one of the highest asthma-related morbidity and mortality rates in the western world. New approaches are necessary to prevent asthma attacks in children and adults. The objectives of this study are to assess the association between demographic and clinical factors and asthma-related hospital admissions in children and adults, describe the epidemiology of asthma phenotypes among hospital attenders, and externally validate existing asthma risk prediction models.Methods and analysis This is a retrospective cohort study of children and adults with asthma. Data will be extracted from the Clinical Practice Research Datalink (CPRD) Aurum database, which holds anonymised primary care data for over 13 million actively registered patients and covers approximately 19% of the UK population. The primary outcome will be asthma-related hospital admissions. The secondary outcomes will be prescriptions of short courses of oral corticosteroids (as a surrogate measure for asthma exacerbations), a composite outcome measure including hospital admissions and prescriptions of short courses of oral corticosteroids and delivery of asthma care management following hospital discharge. The primary analysis will use a Poisson regression model to assess the association between demographic and clinical risk factors and the primary and secondary outcomes. Latent class analysis will be used to identify distinct subgroups, which will further our knowledge on potential phenotypes of asthma among patients at high risk of asthma-related hospital admissions. A Concordance statistic (C-statistic) and logistic regression model will also be used to externally validate existing risk prediction models for asthma-related hospitalisations to allow for the optimal model to be identified and evaluated provide evidence for potential use of the optimal performing risk prediction model in primary care.Ethics and dissemination This study was approved by the CPRD Independent Scientific Advisory Committee (reference number: 21_000512). Findings from this study will be published in a peer-reviewed journal and disseminated at national and international conferences.

Introduction Lung cancer is the leading cause of cancer mortality, comprising the largest national cancer disease burden in Australia and New Zealand. Regional reports identify substantial evidence-practice gaps, unwarranted variation from best practice, and variation in processes and outcomes of care between treating centres. The Australia and New Zealand Lung Cancer Registry (ANZLCR) will be developed as a Clinical Quality Registry to monitor the safety, quality and effectiveness of lung cancer care in Australia and New Zealand.Methods and analysis Patient participants will include all adults >18 years of age with a new diagnosis of non-small-cell lung cancer (NSCLC), SCLC, thymoma or mesothelioma. The ANZLCR will register confirmed diagnoses using opt-out consent. Data will address key patient, disease, management processes and outcomes reported as clinical quality indicators. Electronic data collection facilitated by local data collectors and local, state and federal data linkage will enhance completeness and accuracy. Data will be stored and maintained in a secure web-based data platform overseen by registry management. Central governance with binational representation from consumers, patients and carers, governance, administration, health department, health policy bodies, university research and healthcare workers will provide project oversight.Ethics and dissemination The ANZLCR has received national ethics approval under the National Mutual Acceptance scheme. Data will be routinely reported to participating sites describing performance against measures of agreed best practice and nationally to stakeholders including federal, state and territory departments of health. Local, regional and (bi)national benchmarks, augmented with online dashboard indicator reporting will enable local targeting of quality improvement efforts.

Introduction Vitreoretinal lymphoma is a rare ocular cancer with high morbidity and mortality despite treatment. Diagnosis by cytopathology is often delayed, and various molecular and image-based investigations have been developed. Diverse treatments are used, but there is a limited medical evidence to differentiate their effectiveness. We designed an international registry that would collect diagnostic, treatment and outcomes data, to establish new evidence for the management of this cancer.Methods and analysis The International Vitreoretinal B-Cell Lymphoma Registry will accrue data retrospectively for individuals aged 18 years or older, diagnosed with new or recurrent vitreoretinal B-cell lymphoma on or after 1 January 2020. A steering committee of subspecialised ophthalmologists identified 20 key clinical data items that describe patient demographics, tissue involvements, diagnostic testing, ocular and systemic treatments and treatment complications, and visual acuity and survival outcomes. Customised software was designed to permit collection of these data across a single baseline and multiple follow-up forms. The platform collects data without identifiers and at 3 month reporting intervals. Outcomes of the project will include: (1) descriptions of clinical presentations, and diagnostic and therapeutic preferences; (2) associations between clinical presentations, and diagnostics and treatments, and between diagnostics and treatments (assessed by ORs with 95% CIs); and (3) estimations of rates of vision loss, and progression-free and overall survival (assessed by Kaplan-Meier estimates).Ethics and dissemination The registry has received Australia-wide approval by a national human research ethics committee. Sites located outside Australia are required to seek local human research ethics review. Results generated through the registry will be disseminated primarily by peer-reviewed publications that are expected to inform clinical practice, as well as educational materials.

Introduction Participation from racial and ethnic minorities in clinical trials has been burdened by issues surrounding mistrust and access to healthcare. There is emerging use of machine learning (ML) in clinical trial recruitment and evaluation. However, for individuals from groups who are recipients of societal biases, utilisation of ML can lead to the creation and use of biased algorithms. To minimise bias, the design of equitable ML tools that advance health equity could be guided by community engagement processes. The Howard University Partnership with the National Institutes of Health for Equitable Clinical Trial Participation for Racial/Ethnic Communities Underrepresented in Research (HoPeNET) seeks to create an ML-based infrastructure from community advisory board (CAB) experiences to enhance participation of African-Americans/Blacks in clinical trials.Methods and analysis This triphased cross-sectional study (24 months, n=56) will create a CAB of community members and research investigators. The three phases of the study include: (1) identification of perceived barriers/facilitators to clinical trial engagement through qualitative/quantitative methods and systems-based model building participation; (2) operation of CAB meetings and (3) development of a predictive ML tool and outcome evaluation. Identified predictors from the participant-derived systems-based map will be used for the ML tool development.Ethics and dissemination We anticipate minimum risk for participants. Institutional review board approval and informed consent has been obtained and patient confidentiality ensured.

The 100 most-cited papers on age-related macular degeneration (AMD) were analysed using a bibliographic study. The bibliographic databases of the Institute for Scientific Information Web of Knowledge were searched, limited to research articles published between 1965 and 2020 in peer-reviewed journals. The papers were ranked in order of number of citations since publication. Five of the top 10 (and 3 of the top 4) papers reported randomised clinical trial results for either anti-vascular endothelial growth factor agents or nutritional supplements. Four of the top 10 papers reported genotype-phenotype associations between AMD and variants in Complement Factor H. This bibliographic study provides perspective and insight into many of the most influential contributions in the understanding and management of AMD and its evolution over time.

Introduction Front-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysis Study areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and dissemination Ethics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration number PACTR201904664660639; Pre-results.

Aim To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.Method The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.Results We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge.Conclusion The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials.

Introduction Health Data Research UK designated seven UK-based Hubs to facilitate health data use for research. PIONEER is the Hub in Acute Care. PIONEER delivered workshops where patients/public citizens agreed key principles to guide access to unconsented, anonymised, routinely collected health data. These were used to inform the protocol.Methods This paper describes the PIONEER infrastructure and data access processes. PIONEER is a research database and analytical environment that links routinely collected health data across community, ambulance and hospital healthcare providers. PIONEER aims ultimately to improve patient health and care, by making health data discoverable and accessible for research by National Health Service, academic and commercial organisations. The PIONEER protocol incorporates principles identified in the public/patient workshops. This includes all data access requests being reviewed by the Data Trust Committee, a group of public citizens who advise on whether requests should be supported prior to licensed access.Ethics and dissemination East Midlands–Derby REC (20/EM/0158): Confidentiality Advisory Group (20/CAG/0084). www.PIONEERdatahub.co.uk

Introduction Hormone replacement therapy (HRT) can help women experiencing menopausal symptoms, but usage has declined due to uncertainty around risks of cancer and some cardiovascular diseases (CVD). Moreover, improved cancer survival rates mean that more women who survive cancer go on to experience menopausal symptoms. Understanding these relationships is important so that women and their clinicians can make informed decisions around the risks and benefits of HRT. This study’s primary aim is to determine the association between HRT use after cancer diagnosis and the risk of cancer-specific mortality. The secondary aims are to investigate the risks of HRT on subsequent cancer, all-cause mortality and CVD.Methods and analysis We will conduct a population-based longitudinal cohort study of 18–79 year-old women diagnosed with cancer between 1998 and 2020, using the QResearch database. The main exposure is HRT use, categorised based on compound, dose and route of administration, and modelled as a time-varying covariate. Analysis of HRT use precancer and postcancer diagnosis will be conducted separately. The primary outcome is cancer-specific mortality, which will be stratified by cancer site. Secondary outcomes include subsequent cancer diagnosis, CVD (including venous thrombo-embolism) and all-cause mortality. Adjustment will be made for key confounders such as age, body mass index, ethnicity, deprivation index, comorbidities, and cancer grade, stage and treatment. Statistical analysis will include descriptive statistics and Cox proportional hazards models to calculate HRs and 95% CIs.Ethics and dissemination Ethical approval for this project was obtained from the QResearch Scientific Committee (Ref: OX24, project title ‘Use of hormone replacement therapy and survival from cancer’). This project has been, and will continue to be, supported by patient and public involvement panels. We intend to the submit the findings for peer-reviewed publication in an academic journal and disseminate them to the public through Cancer Research UK.