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Objective We report on: (1) the proportion of patients with known atrial fibrillation (AF); and (2) demographic, clinical or radiological differences between patients with known AF (and not treated) and patients with newly diagnosed AF, in a cohort of patients who presented with ischaemic stroke or transient ischaemic attack (TIA) not previously treated with anticoagulation.Design We reviewed cross-sectional baseline demographic and clinical data from a prospective observational cohort study, (CROMIS-2).Setting Patients were recruited from 79 hospital stroke centres throughout the UK and one centre in the Netherlands.Participants Patients were eligible if they were adults who presented with ischaemic stroke or TIA and AF and had not been previously treated with oral anticoagulation.Main outcome measures Proportion of patients with known AF before index ischaemic stroke or TIA from a cohort of patients who have not been previously treated with oral anticoagulation. Secondary analysis includes the comparison of CHA2DS2-VASc and HAS-BLED scores and other demographics and risk factors between those with newly diagnosed AF and those with previously known AF.Results Of 1470 patients included in the analysis (mean age 76 years (SD 10)), 622 (42%) were female; 999 (68%) patients had newly diagnosed AF and 471 (32%) patients had known AF. Of the 471 patients with known AF, 68% had a strong indication for anticoagulation and 89% should have been considered for anticoagulation based upon CHA2DS2-VASc score. Patients with known AF were more likely to have a prior history of dementia (4% vs 2%, p=0.02) and had higher HAS-BLED scores (median 3 vs 2). CHA2DS2-VASc, other risk factors and demographics were similar.Conclusions About 1/3 of patients who present with stroke and have AF who have not been treated with oral anticoagulation have previously known AF. Of these patients, at least 68% were not adequately treated with oral anticoagulation.Trial registration number NCT02513316.

Introduction: Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). The strong association between gut and liver inflammation has driven several pathogenic hypotheses to which the intestinal microbiome is proposed to contribute. Pilot studies of faecal microbiota transplantation (FMT) in PSC and IBD are demonstrated to be safe and associated with increased gut bacterial diversity. However, the longevity of such changes and the impact on markers of disease activity and disease progression have not been studied. The aim of this clinical trial is to determine the effects of repeated FMT as a treatment for PSC-IBD., Methods and Analysis: FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO) is a phase IIa randomised placebo-controlled trial to assess the efficacy and safety of repeated colonic administration of FMT in patients with non-cirrhotic PSC-IBD. Fifty-eight patients will be recruited from six sites across England and randomised in a 1:1 ratio between active FMT or FMT placebo arms. FMT will be manufactured by the University of Birmingham Microbiome Treatment Centre, using stool collected from rigorously screened healthy donors. A total of 8 weekly treatments will be delivered; the first through colonoscopic administration (week 1) and the remaining seven via once-weekly enema (up to week 8). Participants will then be followed on a 12-weekly basis until week 48 from the first treatment visit. The primary efficacy outcome will be to determine the effect of FMT on serum alkaline phosphatase values over time (end of study at 48 weeks). Key secondary outcomes will be to evaluate the impact of FMT on other liver biochemical parameters, PSC risk scores, circulating and imaging markers of liver fibrosis, health-related quality of life measures, IBD activity and the incidence of PSC-related clinical events. Key translational objectives will be to identify mucosal metagenomic, metatranscriptomic, metabolomic and immunological pathways associated with the administration of FMT., Ethics and Dissemination: The protocol was approved by the South Central-Hampshire B Research Ethics Committee (REC 23/SC/0147). Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications., Trial Registration Number: The trial was registered at ClinicalTrials.gov on 23 February 2024 (NCT06286709). Weblink: Study Details | FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis | ClinicalTrials.gov., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Mental health problems are the most significant cause of disability and have high annual economic costs; hence, they are a priority for the government, service providers and policymakers. Consisting of largely coastal and rural communities, the populations of Norfolk and Suffolk, UK, have elevated burdens of mental health problems, areas with high levels of deprivation and an increasing migrant population. However, these communities are underserved by research and areas with the greatest mental health needs are not represented or engaged in research. This National Institute of Health and Care Research-funded project aims to bring together key stakeholders to conduct extensive scoping work to identify mental health needs and priorities as a basis for conducting larger research to address the identified priorities over the next 5 years., Methods and Analysis: This 12-month mixed-methods research-priority-setting project consists of five phases. It is being conducted in Norfolk and Suffolk counties in the East of England, UK. Underpinned by Delphi methodology, it will adopt the James Lind Alliance approach to identify priorities for mental health research for the populations of Norfolk and Suffolk. The project will use multiple methods, including mapping and identification of stakeholders, online questionnaires, face-to-face focus groups and interviews, and consensus meetings with experts and mental health stakeholders. Key evidence-informed priorities will be collaboratively ranked and documented, and a final top 10 research priorities will be identified to inform future research, policy and service provision., Ethics and Dissemination: This study was approved by the University of East Anglia's Faculty of Medicine and Health Research Ethics Committee (reference: ETH2324-2542), Norwich, UK. Research findings will be disseminated through workshops with stakeholders and collaborators and via peer-reviewed scientific publications, presentations at academic societies, blogs and social media., Competing Interests: Competing interests: On behalf of all authors, the corresponding author states that there are no conflicts of interest., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.)

Objectives: This study aimed to determine the clinical utility of the androgen deprivation therapy (ADT)+docetaxel (DOCE)+androgen receptor-targeted agent (ARTA) triplet therapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the UK., Design: A modified Delphi method. A steering group of eight UK healthcare professionals experienced in prostate cancer care discussed treatment challenges, developing 39 consensus statements across four topics. Agreement with the statements was tested with a broader panel of professionals within this therapeutic area in the UK through an anonymous survey, using a four-point Likert scale. This was distributed by the steering group members and an independent third party. Following the survey, the steering group convened to discuss the results and formulate recommendations., Setting: The steering group convened online for discussions. The survey was distributed via email by the clinicians and the independent third party., Participants: Healthcare professionals involved in the provision of prostate cancer care, working in relevant professional roles (oncology, urology or geriatric consultant, oncology nurse specialist, and hospital pharmacist) within the UK. No patients or members of the public were involved within the study., Interventions: None., Primary and Secondary Outcome Measures: Consensus was defined as high (≥75% agreement) and very high (≥90% agreement)., Results: Responses were received from 120 healthcare professionals, including oncologists (n=73), urologists (n=16), geriatricians (n=15), nurse specialists (n=11) and hospital pharmacists (n=5). Consensus was reached for 37 out of 39 (95%) statements, and 27/39 (69%) statements achieved very high agreement ≥90%. Consensus was not reached for 2/39 (5%) statements., Conclusions: Based on the consensus observed, the steering group developed a set of recommendations for the clinical utility of ADT+DOCE+ARTA in treating patients with mHSPC in the UK. Following these recommendations enables clinicians to identify appropriate patients with mHSPC for triplet treatment, thereby improving patients' outcomes., Competing Interests: Competing interests: All authors received funding from Bayer while undertaking this study. Client commissioned Triducive Partners Limited to facilitate the project and analyse the responses to the consensus statements in line with the Delphi methodology. HG has received honoraria from ACCORD, Astellas, AstraZeneca, Bayer, Ferring, Janssen, and Pfizer. AB has received honoraria, and undertaken advisory boards and meeting sponsorships for ACCORD, Astellas, Bayer, BMS, Janssen, and Novartis. AB has received institutional research grants from Bayer, Janssen, and Regeneron. LF has received honoraria from ACCORD, Astellas, AstraZeneca, Bayer, Ipsen, and Novartis. NC has received honoraria, and undertaken advisory boards and lectures for Astellas, AstraZeneca, Bayer, Ipsen, Janssen, Merck and Pfizer. NC has received research funding via the STAMPEDE Trial from Astellas, Janssen, and Novartis. NC reports academic conflicts from STAMPEDE, Radicals, Propel, and Patch trials. SJ has received honoraria for advisory boards, speaker fees, consultancy, and travel from ACCORD, Accuray, Astellas, AstraZeneca, Bayer, Boston Scientific, BXT Nanotherapy, Janssen, and Pfizer. TK has received honoraria from AstraZeneca, Bayer, ESMO, and Janssen for educational events and expert consensus work. VK has received honoraria and non-financial support for advisory, speaker forums and conferences from Accuray, Astellas, Astra Zeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, Merck Serono, Merck Sharp & Dohme, and Novartis. JM has received honoraria from Astellas and Bayer., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To determine the distribution of kidney function values as measured by glomerular filtration rate (GFR), and the rate of decline with age in male and female healthy subjects without pre-existing medical conditions., Design: Systematic review and structured synthesis., Search Sources: PubMed, Embase, Cochrane Central Register of Controlled Trials and Web of Science, from database inception to 25 October 2023. Unpublished studies were searched from clinical trial registries and the grey literature., Selection Criteria: Observational cohort studies, including non-treatment arms of randomised, pseudorandomised and non-randomised controlled trials that assessed the age-related decline in kidney function over time., Main Outcome Measures: Primary outcomes were rate of change of kidney function over time (absolute and relative change) and rate of change of kidney function with age. Secondary outcomes included rate of change of kidney function compared with baseline GFR, gender, ethnicity and proportion of participants >60 years defined as having chronic kidney disease., Data Collection and Analysis: Two review authors independently screened studies for inclusion, extracted data and assessed risk of bias. Data could not be pooled because of significant heterogeneity. Instead, a descriptive analysis was used to synthesise results., Results: 12 studies between 1958 and 2021 reported the decline rate of kidney function in healthy individuals: six prospective cohort studies, four retrospective cohort studies and two randomised controlled clinical trials, which included 129 359 healthy participants (range from 15 to 46 682) and ranged from 2 to 23 years duration. Annual decline rates ranged from -0.24 to -3.60 mL/min/1.73 m 2 /year (-0.37 to -1.07 in subjects without hypertension). Results were mixed as to whether decline rates sped up or slowed down with age, and whether decline rates differed between women and men, with studies showing conflicting results. This study was unable to determine the decline rates in different ethnicities., Conclusions: This study is the first systematic review to investigate the longitudinal decline in kidney function with age in healthy individuals. The normal decline rate could be considered between -0.37 and -1.07 mL/min/1.73 m 2 /year in healthy adults without hypertension. Kidney function decline rates in healthy adults may be helpful to clinicians anticipating patients' kidney trajectory and determining whether chronic kidney disease-specific care is required., Prospero Registration Number: CRD42023096888., Competing Interests: Competing interests: PG and JD report grants from the Australian National Health and Medical Research Council (NHMRC) during the period of this study. MG, PG and JD received a grant from the Royal Australian College of General Practitioners Foundation to undertake this research. DVO receives support through an Australian Government Research Training Program Scholarship, the Royal Australian Society of Nephrology Jacquot Research Entry Scholarship and the NHMRC Clinical Trials Centre Postgraduate Research Scholarship. ETT, JC and MJ report no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To identify patient-safety-related unintended consequences of healthcare technologies experienced by their primary users: patients, carers and healthcare providers (HCPs)., Design: Qualitative study based on data collected in online focus groups. Transcripts were analysed inductively after each focus group using reflexive thematic analysis, focusing on identifying unintended consequences of healthcare technologies with implications for patient safety. Patient safety was broadly conceptualised to include a more subjective concept of 'feeling safe' as well as risks of actual harm., Setting: Patient/public and HCP participants from the UK with experience in healthcare technologies were recruited using a mixture of purposive, convenience and snowball sampling., Participants: 40 participants (29 patients/public, 11 HCPs) took part in 5 focus groups between November 2021 and February 2022., Results: We identified five main themes of unintended consequences with implications for patient safety: inequity of access, increased end-user burden, loss of the human element of healthcare, over-reliance on technology and unclear responsibilities. Both groups of participants identified unintended consequences directly affecting patients; HCPs also described those affecting themselves. Some unintended consequences are described in previous literature, including alert fatigue, the 'illusion of communication', reduced opportunities for face-to-face interactions and increased end-user burden. Others are potentially novel, including patients' psychological dependence on technologies, 'gaming' of data entry and incorrect interpretation of health data., Conclusions: Drawing on the perspectives of patients/public as well as HCPs, we identified five areas of patient-safety-related unintended consequences associated with healthcare technologies. These should be considered when developing tools to identify and mitigate the patient-safety-related unintended consequences of healthcare technologies., Competing Interests: Competing interests: ALN and BDF are theme leads of the NIHR North West London Patient Safety Research Collaboration (PSRC). BDF is also director of this PSRC. SA is a research assistant in this PSRC. JL and JN, the PPI partners in this study, received honoraria as per the NIHR INVOLVE guidelines. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: This study defined a retrospective cohort of patients in England with primary advanced or recurrent (A/R) endometrial cancer (EC) who may have been eligible for clinical trials evaluating immune checkpoint inhibitors (ICIs) in the first-line (1L) setting within a real-world dataset, and described the characteristics, treatment patterns and outcomes within this cohort., Design: This was a retrospective, population-based study., Setting: Routine population-level data from the National Cancer Registration and Analysis Service in England were used. Patients diagnosed with A/R EC between 1 January 2013 and 31 December 2019 were included (follow-up until 23 August 2021). ICI-eligible patients who received any 1L therapy (defined as first systemic treatment for A/R EC with or without radiotherapy) and met key eligibility criteria for the RUBY trial (NCT03981796; 1L cohort) were included. A subpopulation who solely received carboplatin-paclitaxel at 1L (carboplatin-paclitaxel subcohort) was identified., Methods: Demographics, characteristics and therapy received were reported. Overall survival (OS), time to next treatment (TTNT) and time to treatment discontinuation (TTD) from 1L chemotherapy initiation were assessed using Kaplan-Meier methodology., Results: Of 13 954 patients identified, 2376 ICI-eligible patients were included in the 1L cohort (median [range] age: 67.9 [26.7-94.0] years); 902 patients received solely carboplatin-paclitaxel at 1L. Demographics and disease characteristics were generally similar between cohorts. Median (95% CI) OS, TTNT and TTD from 1L chemotherapy were 27.2 (24.7, 30.2), 16.9 (15.8, 18.5) and 3.4 (3.4, 3.4) months, respectively, in the 1L cohort, and 17.2 (15.5, 19.0), 12.4 (11.6, 13.5) and 3.4 (3.4, 3.4) months, respectively, in the carboplatin-paclitaxel subcohort., Conclusion: Long-term outcomes were poor for both cohorts, particularly the carboplatin-paclitaxel subcohort, where patients did not receive radiotherapy and had predominantly metastatic disease. This reflects the unmet need for more durable treatment options to prevent relapse and prolong survival in this patient population. This real-world study will help contextualise outcomes from ongoing phase III clinical trials investigating 1L ICI treatments., Competing Interests: Competing interests: SB received research grants from AstraZeneca and GSK; was on advisory boards for Amgen, AstraZeneca, Epsilogen, GSK, Immunogen, Merck Sharpe Dohme, Merck Sereno, Mersana, Myriad, Novartis, Oncxerna, Regeneron, Seagen, and Shattuck Labs; received honoraria for lectures from Amgen, AstraZeneca, Clovis, GSK, Immunogen, Merck Sharpe Dohme, Mersana, Myriad, Pfizer, Roche, and Takeda. KH and JG are employees of GSK. TR and CP are employees of Health Data Insight CIC in partnership with the National Disease Registration Service (NHS England). AIRG has no disclosures to make., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Over half of patients who spend >48 hours in the intensive care unit (ICU) are fed via a nasogastric (NG) tube. Current guidance recommends continuous delivery of feed throughout the day and night. Emerging evidence from healthy human studies shows that NG feeding in an intermittent pattern (rather than continuous) promotes phasic hormonal, digestive and metabolic responses that are important for effective nutrition. It is not yet known whether this will translate to the critically ill population. Here, we present the protocol for a proof-of-concept study comparing diurnal intermittent vs continuous feeding on hormonal and metabolic outcomes for patients in the ICU., Methods and Analysis: The study is a single-centre, prospective, randomised, open-label trial comparing intermittent enteral nutrition with the current standard practice of continuous enteral feeding. It aims to recruit participants (n=30) needing enteral nutrition via an NG tube for >24 hours who will be randomised to a diurnal intermittent or a continuous feeding regimen with equivalent nutritional value. The primary outcome is peak plasma insulin/c-peptide within 3 hours of delivering the morning intermittent feed on the second study day, compared with that seen in the continuous feed delivery group at the same time point. Secondary outcomes include feasibility, tolerability, efficacy and metabolic/hormonal profiles., Ethics and Dissemination: We obtained ethical approval from the Wales Research Ethics Committee 3 prior to data collection (reference 23/WA/0297). We will publish the results of this study in an open-access peer-reviewed journal., Trial Registration Number: NCT06115044., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Adherence to medicines in osteoporosis is poor, with estimated 1 year persistence rates between 16% and 60%. Poor adherence is complex, relating to combinations of fear of side effects, beliefs about medication being unnecessary, doubts about effectiveness and the burden of medication management. This is compounded by an absence of monitoring, as many patients are effectively discharged from ongoing care following the initial prescription. Clinical pharmacists in general practice are a relatively new workforce in the UK NHS; this is an unexplored professional group that could provide person-centred, adherence-focused interventions in an osteoporosis context.A model consultation intervention to be delivered by clinical pharmacists in general practice for patients already prescribed fracture prevention medications will be developed using existing evidence and theory and empirical qualitative work outlined in this protocol., Methods and Analysis: We will investigate the current practice and barriers and facilitators to a clinical pharmacist-led osteoporosis intervention, including exploring training needs, through focus groups with people living with osteoporosis, pharmacists, general practitioners, osteoporosis specialists and service designers/commissioners. Framework analysis will identify and prioritise salient themes, followed by mapping codes to the theoretical domains framework and normalisation process theory to understand integration and implementation issues.We will further develop the content and model of care for the new consultation intervention through co-design workshops with stakeholder and patient and public involvement and engagement group members. The intervention in practice will be refined in a sequential process with workshops and in-practice testing with people prescribed fracture prevention medication, pharmacists and the multidisciplinary team., Ethics and Dissemination: Ethical approval was obtained from NHS North West-Greater Manchester South Research Ethics Committee (Ref 23/NW/0199). Dissemination and knowledge mobilisation will be facilitated through a range of national bodies/stakeholders. Impact and implementation plans will accelerate this research towards a future clinical trial to determine cost and clinical effectiveness., Competing Interests: Competing interests: ZP has received financial support for non-promotional consultancy for UCB Pharma.EC has received the following research grants: Unrestricted research grant from Royal Osteoporosis Society Ref 505. Three additional unrestricted research grants from Royal Osteoporosis Society Res 510, 511 and 462. Unrestricted research grant from NIHR; RfPB NIHR 203026. HQIP contract to analyse the national Joint Registry. Honorarium from the Bone Research Society for lecturing at the Clinical Training Course in 2022 and 2023. Honorarium from Danske Fysiorapeuter for lecturing at the Danish Osteoporosis Course for Physiotherapists in 2021, 2022 and 2023. Trustee of the Royal Osteoporosis Society since 2023 (unpaid)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To examine the impact of the COVID-19 pandemic on deprivation-related inequalities in hospitalisations for cardiovascular disease (CVD) conditions in Denmark and England between March 2018 and December 2021., Design: Time-series studies in England and Denmark., Setting: With the approval of National Health Service England, we used English primary care electronic health records, linked to secondary care and death registry data through the OpenSAFELY platform and nationwide Danish health registry data., Participants: We included adults aged 18 and over without missing age, sex or deprivation information. On 1 March 2020, 16 234 700 people in England and 4 491 336 people in Denmark met the inclusion criteria., Primary Outcome Measures: Hospital admissions with the primary reason for myocardial infarction (MI), ischaemic or haemorrhagic stroke, heart failure and venous thromboembolism (VTE)., Results: We saw deprivation gradients in monthly CVD hospitalisations in both countries, with differences more pronounced in Denmark. Based on pre-pandemic trends, in England, there were an estimated 2608 fewer admissions than expected for heart failure in the most deprived quintile during the pandemic compared with an estimated 979 fewer admissions in the least deprived quintile. For all other outcomes, there was little variation by deprivation quintile. In Denmark, there were an estimated 1013 fewer admissions than expected over the pandemic for MI in the most deprived quintile compared with 619 in the least deprived quintile. Similar trends were seen for stroke and VTE, though absolute numbers were smaller. Heart failure admissions were similar to pre-pandemic levels with little variation by deprivation quintile., Conclusions: Overall, we did not find that the pandemic substantially worsened pre-existing deprivation-related differences in CVD hospitalisations, though there were exceptions in both countries., Competing Interests: Competing interests: REC has personal shares in AstraZeneca (AZ) unrelated to this work. BM is also employed by National Health Service ( NHS) England (all declarations are openly available at: https://www.whopaysthisdoctor.org/doctor/491/active ). JH has grant funding from UKRI and the Wellcome Trust, has a patent with Juli Health unrelated to this work and has received consultancy fees from Juli Health and the Wellcome Trust unrelated to this work. RM is supported by Barts Charity (MGU0504), receives salary contributions from Genes & Health and has received consultancy fees from Amgen. JKQ has grants from MRC, HDR UK, GlaxoSmithKline (GSK), BI, Asthma + Lung UK and AZ and has received fees from GSK, Evidera, AZ and Insmed. SL was co-founder and co-chair of the RECORD steering committee and has a leadership role at Health Data Research UK. KM has received consultancy fees from Amgen. LAT has grant funding from MRC, the Wellcome Trust, has consulted for Bayer and is on the MHRA expert advisory group (Women’s health) and is a member of four non-industry funded trial advisory committees (unpaid). AYSW is funded by British Heart Foundation (FS/19/19/34175) and AIR@InnoHK administered by Innovation and Technology Commission. AM has received consultancy fees from induction health and is a member of RCGP health informatics group and the NHS Digital GP data Professional Advisory Group. Department of Clinical Epidemiology, Aarhus University, receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies have any relation to the present study. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: With the potential to identify a vast number of rare diseases soon after birth, genomic newborn screening (gNBS) could facilitate earlier interventions and improve health outcomes. Designing a gNBS programme will involve balancing stakeholders' opinions and addressing concerns. The views of medical students-future clinicians who would deliver gNBS-have not yet been explored., Methods: We conducted a nationwide online survey of UK medical students via the REDCap platform. Perceptions of gNBS, including scope of testing and potential benefits and drawbacks, were explored using a mix of multiple-choice questions, Likert scales, visual analogue scales and free-text questions., Results: In total, 116 medical students across 16 universities participated. Overall, 45% supported gNBS, with a positively skewed mean support score of 3.24 (SD 1.26, range: 1.0-5.0), and 55% felt it relevant to their future practice. Almost all agreed that infant-onset and childhood-onset diseases and conditions with effective treatments should be included. Most felt that earlier interventions and personalised care would be the most important benefit of gNBS. Other perceived benefits included earlier diagnoses, diagnosing more patients and enabling research for new treatments. However, several perceived challenges were highlighted: risk of genomic discrimination, incidental or uncertain findings, data security and breaching children's future autonomy. Students expressed conflicting opinions on the psychological impact on families, but most were concerned about a lack of support due to current resource limitations in health services. Students frequently reported having insufficient knowledge to form an opinion, which may reflect gaps in genomics education at medical school and the current lack of evidence base for gNBS., Conclusion: Although some support for gNBS was demonstrated, ethicolegal and social challenges were raised, emphasising a need for ongoing discussions about the implications of gNBS., Competing Interests: Competing interests: AP is an employee of Genomics England, a company wholly owned by the United Kingdom Department of Health and Social Care and funded to deliver the Generation Study., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Clinical academics lead research to deliver medical advancements while also teaching in medical schools to maintain high-quality medical services. The objective of this project was to determine if there is a sufficient supply of clinical academics for UK medical schools., Design: Retrospective cohort study., Setting: Data were extracted from the UK Medical Education Database and the General Medical Council (GMC) annual National Trainee Survey between 2012 and 2022., Participants: 1769 registered UK doctors with academic training and a certificate of completion of training., Main Outcome Measure: The percentage of doctors with clinical and academic training who ended up as incumbent clinical academics at UK medical schools., Results: Approximately 50% of doctors with clinical and academic training were matched as incumbent clinical academics at UK medical schools. There was a low annual rate of incumbent clinical academics leaving their post., Conclusion: Either clinical academic trainees do not find jobs at medical schools, or they do not want the jobs that are available. These results are indicative but not conclusive as generalisation is compromised by inconsistent disclosure of data by medical schools. We discuss variables which may contribute to the loss of clinical academics and explore the health economic case for clinical academic incentive packages to improve return on training investment., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To illustrate an evidence-, theory- and person-based approach to codesign the COMMUNICATE films that support parental decision-making about the human papillomavirus (HPV) vaccine for their teenagers., Design: Codesign study., Setting: Localities covered by two immunisation teams in London and the south-west of England., Methods: The intervention planning phase involved combining evidence from a literature review with qualitative interview data to identify barriers and facilitators to HPV vaccine uptake, as well as design features that should be incorporated within the COMMUNICATE films. The intervention development phase involved identifying guiding principles for the COMMUNICATE films, mapping behaviour change techniques onto the behaviour change wheel and codesigning the COMMUNICATE films. Feedback from users informed modifications to maximise acceptability and feasibility and to support behaviour change., Results: The primary and secondary evidence highlighted important content to include within the COMMUNICATE films: emphasise the benefits of the HPV vaccine, provide transparent information about the safety profile and side effects and emphasise the universality and commonality of HPV infection. A series of scripts were used to guide 4 film shoots to create the content in multiple community languages with 16 participants, including vaccine-hesitant, ethnically diverse parents and professionals. Overall, participants were positive about the films. Potential messengers and ways the films could be distributed, identified by parents, include local social media networks or text messages from general practices. The need for information about the HPV vaccine to be shared by schools ahead of consent being sought was also raised., Conclusions: By using an integrated approach to intervention development, this study has begun to address the need for an intervention to support vaccine-hesitant, ethnically diverse parents' decision-making about the HPV vaccination programme. A future study to codesign, implement and evaluate a communication strategy for the COMMUNICATE films is planned., Competing Interests: Competing interests: AF is a member of the Joint Committee on Vaccination and Immunization and was, until December 2022, chair of the WHO European Technical Advisory Group of Experts on Immunization committee. The other authors have no relevant conflicts of interest to declare., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Adolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite such recommendations, few rigorous evaluations of such interventions currently exist. The main objective of this study is to examine the potential effect of a text message intervention targeting parents and adolescents on adolescent susceptibility to e-cigarette use (eg, intentions towards using e-cigarettes). Secondary objectives are to (1): examine the effect of the intervention on adolescent e-cigarette and combustible tobacco use and (2) examine the acceptability of the intervention., Methods and Analysis: A randomised controlled trial employing a 2×2 factorial design will be conducted with parent-adolescent dyads (aged 12-15 years). Dyads will be randomly allocated to one of four arms: arm 1-a text message intervention delivered to adolescents only; arm 2-a text message intervention delivered to the parents of adolescents only; arm 3-a text message intervention delivered to both the parents and adolescents; and arm 4-an information only control, consisting of an e-cigarette factsheet provided to parents only. Participant recruitment commenced in March 2023 with the aim to recruit 120 parent-adolescent dyads. Data collection to assess study outcomes will occur at baseline, 6, 12 and 24 months post the commencement of the intervention. The primary endpoint will be 6-month follow-up. The primary outcome will be adolescent susceptibility to e-cigarette use, assessed using validated items. Analyses of trial outcomes will be undertaken under an intention-to-treat framework, with all participants included in the analysis in the group they were allocated., Ethics and Dissemination: Ethics approval has been obtained from the human research ethics committee of the University of Newcastle (H-2022-0340). Findings will be disseminated in peer-reviewed journals and at conferences., Trial Registration Number: The trial was registered prospectively with Australian New Zealand Clinical Trials Registry (ACTRN12623000079640)., Competing Interests: Competing interests: All authors declare that they have no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Inappropriate prescribing of antibiotics is a key driver of antimicrobial resistance. This study aimed to describe urine sampling rates and antibiotic prescribing for patients with lower urinary tract infections (UTIs) in English general practice., Design: A retrospective population-based study using administrative data., Setting: IQVIA Medical Research Database (IMRD) data from general practices in England, 2015-2022., Participants: Patients who have consulted with an uncomplicated UTI in England general practices captured in the IMRD., Outcome Measures: Trends in UTI episodes (episodes were defined as UTI diagnosis codes occurring within 14 days of each other), testing and antibiotic prescribing on the same day as initial UTI consultation were assessed from January 2015 to December 2022. Associations, using univariate and multivariate logistic regressions, were examined between consultation and demographic factors on the odds of a urine test., Results: There were 743 350 UTI episodes; 50.8% had a urine test. Testing rates fluctuated with an upward trend and large decline in 2020. Same-day UTI antibiotic prescribing occurred in 78.2% of episodes. In multivariate modelling, factors found to decrease odds of a urine test included age ≥85 years (0.83, 95% CI 0.82 to 0.84), consultation type (remote vs face to face, 0.45, 95% CI 0.45 to 0.46), episodes in London compared with the South (0.74, 95% CI 0.72 to 0.75) and increasing practice size (0.77, 95% CI 0.76 to 0.78). Odds of urine tests increased in males (OR 1.11, 95% CI 1.10 to 1.13), for those episodes without a same-day UTI antibiotic (1.10, 95% CI 1.04 to 1.16) for episodes for those with higher deprivation status (Indices of Multiple Deprivation 8 vs 1, 1.51, 95% CI 1.48 to 1.54). Compared with 2015, 2016-2019 saw increased odds of testing while 2020 and 2021 saw decreases, with 2022 showing increased odds., Conclusion: Urine testing for UTI in general practice in England showed an upward trend, with same-day antibiotic prescribing remaining consistent, suggesting greater alignment to national guidelines. The COVID-19 pandemic impacted testing rates, though as of 2022, they began to recover., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Supervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of time-limited SIOT using injectable hydromorphone delivered in an existing Australian public opioid treatment programme, with secondary outcomes of safety, cost, changes in drug use and other health outcomes. If feasible, the goal is to scale up the intervention to be more widely available in Australia., Methods and Analysis: Between 20 and 30 participants will be offered two times per day hydromorphone to inject under direct observation, in addition to their current opioid agonist treatment (OAT), for up to 2 years. At the end of 2 years of supervised hydromorphone treatment, participants will be continued on standard OAT only. Informed consent will be obtained from all participants included in the study. This is a single-site, uncontrolled, open-label study where quantitative and qualitative interview data will be collected at baseline, 12 months and lastly at 3 months following their final hydromorphone dose. The main outcome measures are feasibility, as assessed by recruitment, retention and participation in treatment, and acceptability to participants, clinic staff and other stakeholders assessed by qualitative interviews. Secondary outcome measures of safety, as assessed by adverse events, and cost will also be assessed, as well as a range of other drug and health outcomes., Ethics and Dissemination: This study received ethical approval from the St Vincent's Hospital Human Research Ethics Committee (2019/ETH00418). This will be the first study of time-limited SIOT in the Australian setting. All results will be submitted to peer-reviewed journals, scientific conferences and local practice meetings. A preliminary report on outcomes will also be presented to local health policy makers. A consumer and community forum will also be held to feedback results to a broader audience., Trial Registration Number: ACTRN12621001729819., Competing Interests: Competing interests: JS, through his university, has worked with several pharmaceutical companies to identify new or improved treatments and his employer (King’s College London) has received grants, travel costs and/or consultancy payments. None of these is related to the FOpIT study described in this paper. NL has received funding for independent research from Indivior and Camurus for work unrelated to this project. KJS and NE have received funding from the Australian Department of Health and Aged Care, and is employed by the University of New South Wales and St Vincent’s Hospital, Sydney. WvdB has worked with several pharmaceutical companies to identify new or improved treatments and received speaker fees, travel costs and/or consultancy payments. None of these is related to the FOpIT study described in this paper., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The social determinants of health contribute to poorer health outcomes for children with cerebral palsy (CP) and are barriers to families accessing health services. At an individual level, social determinants of health are experienced as unmet social needs, for example, unsafe housing conditions. There is emerging evidence that clinical pathways for the systematic identification and referral to services for unmet social needs can support families to address these needs. These clinical pathways have not been implemented for children with CP. The objectives are to investigate the feasibility and acceptability of two co-designed social needs clinical pathways for parents/caregivers of children with CP-social prescribing (ie, Community Linker plus resource pack) compared with resource pack only., Methods and Analysis: This pilot randomised controlled trial will run at the three tertiary paediatric rehabilitation services in New South Wales, Australia. A total of 120 participants will be recruited, with randomisation stratified by study site. A survey tool will be used to identify families experiencing unmet social needs. Parents/caregivers who report one or more unmet social need/s and consent will be eligible. The active control group will receive a resource pack containing information on community services to support unmet social needs. The social prescribing intervention group will receive one-on-one Community Linker support, in addition to the resource pack. The survey tool, intervention, logic model, and resource pack were co-designed with patient families and their healthcare workers. Feasibility of the research design and the clinical pathways will be evaluated using the number/proportion of parents/caregivers who complete the survey tool, consent, engage with the intervention, and complete research measures. Acceptability will be evaluated using questionnaires and qualitative interviews., Ethics and Dissemination: Human research ethics approval was granted by the Sydney Children's Hospitals Network Human Research Ethics Committee (2022/ETH01688). Participants and stakeholders will receive updates and findings via regular communication channels including meetings, presentations, and publications., Trial Registration Number: Australia New Zealand Clinical Trials Registry: 12622001459718., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Acne vulgaris (acne) is a common skin condition sometimes needing topical or oral antibiotic treatment. Pharmacists and pharmacy technicians (together known as pharmacy professionals) working in general practice are well placed to ensure their appropriate use., Objectives: The objectives of this study are to pilot an evidence-based intervention ('How to…' tool) to review treatments in the management of acne and evaluate the capability, opportunity, motivation and behaviour (COM-B) of pharmacy professionals working in general practice before and after the use of this tool., Design, Setting and Participants: A quantitative electronic survey was developed asking UK-based pharmacy professionals working in general practice to rate their agreement with 21 predefined statements related to the COM-B model., Intervention: Participants were sent an initial survey, given time to access and use the 'How to…' acne resources and then sent a follow-up survey 2 weeks later., Outcome Measures: Primary outcome was change in 5-point Likert scale responses to statements on capability, opportunity and motivation in the management of acne. Secondary outcome was the perceived usefulness of the toolkit., Results: 141 pharmacy professionals completed the initial survey; 19 completed the follow-up survey. Significant improvement in the 5-point Likert scale means that responses were observed after implementation of the acne 'How to' resource; capability 3.68 (SD 0.40) versus 4.11 (SD 0.29), t (189) =-5.10, p <0.001; opportunity 3.85 (SD 0.24) versus 4.07 (SD 0.29), t (94)=-2.50, p=0.007 and motivation 4.35 (SD 0.47) versus 4.51 (SD 0.32), t (113)=-2.51, p=0.007. The 'How to' resources were rated as being useful (4.06, SD 0.12) and supportive (4.08, SD 0.18) to help pharmacy professionals in all areas of managing acne., Conclusion: The acne 'How to' resources are useful to pharmacy professionals in managing acne in general practice and may improve their capability. Further work is needed with greater numbers of participants to demonstrate generalisability of this outcome., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Participation in bowel cancer screening is lower in regions where there is high ethnic diversity and/or socioeconomic deprivation. Interventions, such as text message reminders and patient navigation (PN), have the potential to increase participation in these areas. As such, there is interest in the comparative effectiveness of these interventions to increase bowel cancer screening participation, as well as their relative cost-effectiveness., Methods and Analysis: This study will use a three-arm randomised controlled trial design to compare the effectiveness and cost-effectiveness of text message reminders and PN to increase the uptake of bowel cancer screening in London. Participants will be individuals who have not returned a completed faecal immunochemical test kit within 13 weeks of receiving a routine invitation from the London bowel cancer screening hub. Participants will be randomised (in a 1:1:1 ratio) to receive either (1) usual care (ie, 'no intervention'), (2) a text message reminder at 13 weeks, followed by repeated text message reminders at 15, 17 and 19 weeks (in the event of non-response) or (3) a text message reminder at 13 weeks, followed by PN telephone calls at 15, 17 and 19 weeks in the event of non-response. The primary endpoint will be participation in bowel cancer screening, defined as 'the return of a completed kit by week 24'. Statistical analysis will use multivariate logistic regression and will incorporate pairwise comparisons of all three groups, adjusted for multiple testing., Ethics and Dissemination: Approvals to conduct the research have been obtained from University College London's Joint Research Office (Ref: 150666), the Screening Research, Innovation and Development Advisory Committee ('RIDAC', Ref: 2223 014 BCSP Kerrison), the Health Research Authority (Ref: 22/WM/0212) and the Confidentiality Advisory Group (Ref: 22/CAG/0140). Results will be conveyed to stakeholders, notably those managing the screening programme and published in peer-reviewed journals/presented at academic conferences., Trial Registration Number: ISRCTN17245519., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces., Methods and Analysis: The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months., Ethics and Dissemination: This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal., Trial Registration Number: ISRCTN35574247., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: The diagnosis of neovascular age-related macular degeneration (nAMD), the leading cause of visual impairment in the developed world, relies on the interpretation of various imaging tests of the retina. These include invasive angiographic methods, such as Fundus Fluorescein Angiography (FFA) and, on occasion, Indocyanine-Green Angiography (ICGA). Newer, non-invasive imaging modalities, predominately Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA), have drastically transformed the diagnostic approach to nAMD. The aim of this study is to undertake a comprehensive diagnostic accuracy assessment of the various imaging modalities used in clinical practice for the diagnosis of nAMD (OCT, OCTA, FFA and, when a variant of nAMD called Polypoidal Choroidal Vasculopathy is suspected, ICGA) both alone and in various combinations., Methods and Analysis: This is a non-inferiority, prospective, randomised diagnostic accuracy study of 1067 participants. Participants are patients with clinical features consistent with nAMD who present to a National Health Service secondary care ophthalmology unit in the UK. Patients will undergo OCT as per standard practice and those with suspicious features of nAMD on OCT will be approached for participation in the study. Patients who agree to take part will also undergo both OCTA and FFA (and ICGA if indicated). Interpretation of the imaging tests will be undertaken by clinicians at recruitment sites. A randomised design was selected to avoid bias from consecutive review of all imaging tests by the same clinician. The primary outcome of the study will be the difference in sensitivity and specificity between OCT+OCTA and OCT+FFA (±ICGA) for nAMD detection as interpreted by clinicians at recruitment sites., Ethics and Dissemination: The study has been approved by the South Central-Oxford B Research Ethics Committee with reference number 21/SC/0412.Dissemination of study results will involve peer-review publications, presentations at major national and international scientific conferences., Trial Registration Number: ISRCTN18313457., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: Assess understanding of impactibility modelling definitions, benefits, challenges and approaches., Design: Qualitative assessment., Setting: Two workshops were developed. Workshop 1 was to consider impactibility definitions and terminology through moderated open discussion, what the potential pros and cons might be, and what factors would be best to assess. In workshop 2, participants appraised five approaches to impactibility modelling identified in the literature., Participants: National Health Service (NHS) analysts, policy-makers, academics and members of non-governmental think tank organisations identified through existing networks and via a general announcement on social media. Interested participants could enrol after signing informed consent., Outcome Measures: Descriptive assessment of responses to gain understanding of the concept of impactibility (defining impactibility analysis), the benefits and challenges of using this type of modelling and most relevant approach to building an impactibility model for the NHS., Results: 37 people attended 1 or 2 workshops in small groups (maximum 10 participants): 21 attended both workshops, 6 only workshop 1 and 10 only workshop 2. Discussions in workshop 1 illustrated that impactibility modelling is not clearly understood, with it generally being viewed as a cross-sectional way to identify patients rather than considering patients by iterative follow-up. Recurrent factors arising from workshop 2 were the shortage of benchmarks; incomplete access to/recording of primary care data and social factors (which were seen as important to understanding amenability to treatment); the need for outcome/action suggestions as well as providing the data and the risk of increasing healthcare inequality., Conclusions: Understanding of impactibility modelling was poor among our workshop attendees, but it is an emerging concept for which few studies have been published. Implementation would require formal planning and training and should be performed by groups with expertise in the procurement and handling of the most relevant health-related real-world data., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Hospitalisation due to medication-related problems is a major health concern, particularly for those with pre-existing, or those at high risk of developing cardiovascular disease (CVD). Postdischarge medication reviews (PDMRs) may form a core component of reducing hospital readmissions due to medication-related problems. This study aimed to explore postdischarge CVD patients' perspectives of, and experiences with, pharmacist-led medication management services. A secondary aim explored attitudes towards the availability of PDMRs., Design: An interpretative qualitative study involving 16 semistructured interviews. Data were analysed using an inductive thematic approach., Setting: Patients with CVD discharged to a community setting from the John Hunter Hospital, an 820-bed tertiary referral hospital based in New South Wales, Australia., Participants: Patients with pre-existing or newly diagnosed CVD who were recently discharged from the hospital., Results: A total of 16 interviews were conducted to reach thematic saturation. Nine participants (56%) were male. The mean age of participants was 57.5 (±13.2) years. Three emergent themes were identified: (1) poor medication understanding impacts transition from the hospital to home; (2) factors influencing medication concordance following discharge and (3) perceived benefits of routine PDMRs., Conclusions: There is a clear need to further improve the quality use of medicines and health literacy of transition-of-care patients with CVD. Our findings indicate that the engagement of transition-of-care patients with CVD with pharmacist-led medication management services is minimal. Pharmacists are suitable to provide essential and tailored medication review services to patients with CVD as part of a multidisciplinary healthcare team. The implementation of routine, pharmacist-led PDMRs may be a feasible means of providing patients with access to health education following their transition from hospital back to community, improving their health literacy and reducing rehospitalisations due to medication-related issues., Competing Interests: Competing interests: JB is a credentialed pharmacist who can provide domiciliary medication management reviews funded by the Australian Government Department of Health and Aged Care., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Venous thromboembolism (VTE) is a major cause of morbidity and mortality globally, with hospital-associated thrombosis (HAT) accounting for at least half of VTE. We set out to understand more about deaths from HAT in England, to focus improvement efforts where they are needed most., Design: A retrospective cohort combining death certification and hospital activity data to identify people with an inpatient or day case hospitalisation where no VTE diagnosis was recorded, and who died from VTE in a hospital or within 90 days of discharge, between April 2017 and March 2020., Setting: All deaths occurring in England and all National Health Service-funded hospital care in England., Participants: After 0.1% of cases were excluded due to duplicate but conflicting records, a cohort of 13 995 deaths remained; 54% were women, and 26% were aged under 70 years., Outcome Measures: Analysis of age, gender, primary diagnosis, type of admission, specialties and (for day cases) procedure types were preplanned., Results: Only 5% of these deaths followed planned inpatient admissions. Day case admissions preceded 7% of VTE deaths. Emergency inpatient admissions, medical specialties and infection-related primary diagnoses predominated in people who died from VTE after hospitalisation where no VTE diagnosis was recorded. Most deaths occurred in a hospital or within 30 days of discharge., Conclusions: International efforts to reduce HAT historically focused on planned inpatient admissions. Further initiatives and research to prevent deaths from VTE after hospitalisation should focus on the emergency care pathway where most deaths occurred, with people undergoing day case procedures an important additional focus., Competing Interests: Competing interests: RA has received speaker fees from Cardinal Health and Sanofi. The other authors have no interests to declare, (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan., Methods and Analysis: This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge., Ethics and Dissemination: Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations., Competing Interests: Competing interests: PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this project. There are no competing interests in this project., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care., Methods and Analysis: We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs ( Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms., Ethics and Dissemination: Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484)., Trial Registration Number: NCT05723484., Competing Interests: Competing interests: The last authors, J-AP and LM, declare sharing a patent for the biomarkers for GIFT: patent number PCT/IB 2014/065740, October 2014., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses., Objective: This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019., Design: Observational pharmacoepidemiologic study SETTING: US Medicare and Medicaid naloxone claims INTERVENTION: The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019., Outcome Measures: States with naloxone prescription rates that were outliers of quartile analysis were noted., Results: The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees., Conclusions: This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted., Competing Interests: Competing interests: BJP was (2019–2021) part of an osteoarthritis research team supported by Pfizer and Eli Lilly. He is also a principal investigator with the Pennsylvania Academic Clinical Research Centre (2022–2023 and 2023–2025). The other authors have no disclosures., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To examine inequalities in birth before arrival (BBA) at hospitals in South West England, understand which groups are most likely to experience BBA and how this relates to hypothermia and outcomes (phase A). To investigate opportunities to improve temperature management advice given by emergency medical services (EMS) call-handlers during emergency calls regarding BBA in the UK (phase B)., Design: A two-phase multimethod study. Phase A analysed anonymised data from hospital neonatal records between January 2018 and January 2021. Phase B analysed anonymised EMS call transcripts, followed by focus groups with National Health Service (NHS) staff and patients., Setting: Six Hospital Trusts in South West England and two EMS providers (ambulance services) in South West and North East England., Participants: 18 multidisciplinary NHS staff and 22 members of the public who had experienced BBA in the UK., Results: 35% (64/184) of babies conveyed to hospital were hypothermic on arrival. When compared with national data on all births in the South West, we found higher percentages of women with documented safeguarding concerns at booking, previous live births and 'late bookers' (booking their pregnancy >13 weeks gestation). These women may, therefore, be more likely to experience BBA. Preterm babies, babies to first-time mothers and babies born to mothers with disability or safeguarding concerns at booking were more likely to be hypothermic following BBA. Five main themes emerged from qualitative data on call-handler advice: (1) importance placed on neonatal temperature; (2) advice on where the baby should be placed following birth; (3) advice on how to keep the baby warm; (4) timing of temperature management advice and (5) clarity and priority of instructions., Conclusions: Findings identified factors associated with BBA and neonatal hypothermia following BBA. Improvements to EMS call-handler advice could reduce the number of babies arriving at hospital hypothermic., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Many clinically extremely vulnerable rheumatology patients have only recently ceased shielding from COVID-19, while some continue to minimise in-person contact. The objective of this study was to understand the impact of shielding and associated support needs in patients with rheumatic conditions and to understand how rheumatology teams can meet these needs both currently and in future pandemics., Design, Participants and Setting: The study was conducted in the Southwest of England using a case-study design. The participants were 15 patients with rheumatic conditions who were advised to shield and/or chose to shield at any time during the COVID-19 pandemic., Methods: Qualitative data collected via telephone and online semi-structured interviews and analysed using reflexive thematic analysis., Results: Fifteen interviews were conducted. Three main themes represent the data:'Just shove them over there in the corner' captures changes in patients' self-perception. They felt different to most other people, vulnerable and left behind. The initial sense of shock was followed by a sense of loss as changes became long term.'A long and lonely road' captures patients' psychological isolation due to a perceived lack of understanding and support. This included having to prove their health status and justify their shielding behaviours, which impacted their relationships. At times, they felt abandoned by their healthcare providers.'You can't just flip a switch' captures the difficulty of getting back to pre-pandemic normal after shielding. Patients did not recognise themselves physically and mentally. They wanted to collaborate with health professionals and identified the need for specific guidance to support their recovery., Conclusion: Patients are dealing with lasting physical and mental effects from shielding and consequences of delayed healthcare. Health professionals need time and resources to ask about patients' well-being, identify their health needs and refer/signpost to appropriate sources of support., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes., Methods: We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres., Discussion: The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)