First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.

Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.

The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.

ISRCTN74193022

Globally, the circulation of influenza and other seasonal respiratory viruses changed dramatically during the COVID-19 pandemic. This study aims to determine the trends of acute respiratory infections (ARIs) caused by SARS-CoV-2, influenza A, influenza B and respiratory syncytial viruses (RSVs) in patients presenting to hospitals in the Lao People’s Democratic Republic (PDR) (Laos).

Prospective surveillance study.

Four provincial hospitals across Laos between March 2021 and July 2023.

Participants of all ages who met our case definition for an ARI (axillary temperature ≥37.5°C or history of fever AND cough or other respiratory symptoms/signs OR loss of smell and/or taste) presenting to the hospital less than 10 days after symptom onset were eligible to be enrolled in the study. Combined nasopharyngeal and throat swabs were tested for SARS-CoV-2, influenza A, influenza B and human RSV (hRSV) using probe-based real-time RT (Reverse transcription)-PCR assays.

The proportion of patients in whom SARS-CoV-2, influenza A, influenza B and hRSV was detected.

There were 4203 patients recruited, of whom 898 (21%) were children aged under 5 years. SARS-CoV-2 was detected in 16.9% of patients, followed by influenza A, influenza B and hRSV (8.4%, 7.2% and 4.7%, respectively). 98 patients (2.3%) were diagnosed with probable co-infection, with at least two viruses detected. After May 2022, the number of cases of influenza A, influenza B and hRSV increased rapidly. Six per cent of patients (263) had a quick Sequential Organ Failure Assessment score of ≥2, and 34 (0.8%) patients died, of whom 11 tested positive for a respiratory virus.

During the COVID-19 pandemic in Laos, few respiratory viruses were detected by passive surveillance until the relaxation of non-pharmaceutical interventions implemented for infection control. After restrictions were lifted, influenza A, influenza B and hRSV emerged rapidly, showing the importance of continuous surveillance.

Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment.

The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making.

This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Paediatric major trauma patients with more severe injuries and physiological or biochemical abnormalities as a result of the injury are more likely to require invasive management in the form of an operation/interventional radiology (IR). Adverse psychological outcomes, such as post-traumatic stress disorder, anxiety, depression and adjustment disorder, are frequently observed in paediatric patients with major trauma. Similarly, it is recognised that children and adolescents who have invasive management are also at an increased risk of adverse psychological outcomes. However, it is not known to what extent major trauma patients requiring invasive management are at risk of adverse psychological outcomes compared with those managed conservatively. This study aims to determine whether paediatric major trauma patients who require an operation/IR have increased odds of having an adverse psychological outcome compared with those who are managed conservatively.

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. The databases Medline (via Ovid), Embase (via Ovid), PsycInfo (via Ebscohost) and Cinahl (via Ebscohost) will be searched from inception to February 2025. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. For randomised controlled trials, the Cochrane Risk of Bias Tool will be employed, while for non-randomised studies, the Newcastle-Ottawa Quality Assessment Scale will be used. We will assess bias using contoured funnel plots (with p set at 0.01, 0.05 and 0.10), non-parametric trim-fill analysis, leave-one-out analysis and Galbraith plotting. We will execute formal (Egger) testing for funnel plot asymmetry and also calculate prediction intervals if sufficient study N of 10 is accrued. Certainty and confidence in cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethical review is not required as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.

CRD42025643459.

To evaluate the feasibility and acceptability of integrating point-of-care ultrasound scan (POCUS) by midwives into routine antenatal care (ANC) services.

Prospective, observational, multiphase, implementation science study.

Primary outcomes included the proportion of midwives who completed training and competency checks for basic obstetric scanning using a POCUS device; the feasibility and acceptability of midwife-delivered POCUS from the perspectives of midwives and pregnant women captured on structured questionnaires; and the proportion of scans meeting predefined quality standards. Secondary outcomes included responses to acceptability-related questionnaires administered to midwives and pregnant women.

Rural, periurban and urban health centres in Blantyre District, Malawi.

Pregnant women attending ANC and midwives providing care at participating health facilities.

Obstetric registrars trained and mentored 45 midwives, and 42 (93%) completed the training. Most midwives (95%, n=40) found providing POCUS during ANC was feasible and acceptable. Overall, device durability was rated positively. Of the 1499 pregnant women who received a scan, 99% (n=1484) reported that receiving an ultrasound from a midwife during ANC was acceptable. Independent assessors determined that over 70% of the subsample of reviewed scans met minimum quality standards.

Midwife-delivered POCUS is feasible and highly acceptable in diverse antenatal settings in Malawi. These findings support task-sharing models as a means of expanding access to this essential ANC service, particularly in low-resource settings.

To assess the impact of opening a large community-based asynchronous review ophthalmic clinic on attendance delays among patients with stable chronic eye disease attending a London teaching eye hospital network.

Interrupted time-series analysis of routine electronic health records of appointment attendances.

A large eye hospital network with facilities across London, UK, between June 2018 and April 2023.

We analysed 69 257 attendances from 39 357 patients, with glaucoma and medical retina accounting for 62% (n=42 982) and 38% (n=26 275) of visits, respectively. Patients over 65 made up 54% (n=37 824) of attendances, while 53% (n=37 014) were from the more deprived half of the population, and 51% (n=35 048) were males.

An asynchronous review clinic opened in a shopping centre in London, in autumn 2021, following the COVID-19 lockdown in spring 2020.

Average attendance delays (days), calculated as the difference between follow-up attendance date and the latest clinically appropriate date determined at the preceding attendance.

Pre-COVID-19, attendance delays for chronic eye disease monitoring were increasing by 0.9 days per week (95% CI, 0.8 to 0.9) on average, worsening to 2.0 days per week (95% CI, 2.0 to 2.0) after the first COVID-19 national lockdown, mid-March 2020. Opening the asynchronous review clinic increased appointment capacity, with delays decreasing on average by 8.1 days per week (95% CI, 8.1 to 8.2) shortly after opening. The rate of decrease slowed to 0.3 days per week (95% CI, 0.3 to 0.3) after 5 months. We found no significant differences in average attendance delays by age, gender or level of deprivation.

The asynchronous review clinic significantly reduced attendance delays across the hospital network, addressing pre-existing backlog for stable chronic eye diseases. The reduction appeared to be maintained after the initial backlog had been cleared.

Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.

214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.

The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

ISRCTN11380842.

For every 100 women having a vaginal birth, approximately four will experience a severe (third-degree or fourth-degree) perineal tear. Severe perineal tears are associated with significant short-term and long-term consequences if not recognised and repaired. There are global efforts to reduce incidence of severe perineal tears including initiatives to strengthen education and training of clinicians in perineal anatomy and perineal tear assessment and classification. This systematic review aimed to describe and evaluate the effectiveness of these initiatives.

Systematic review, reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Medline (Ovid), CINAHL Complete (EBSCO), MIDIRS and EMBASE (Ovid) were searched through 15 February 2024.

Studies reporting simple or complex interventions aimed at improving the skills and knowledge of clinicians in perineal anatomy and/or the clinical assessment and classification of perineal tears were eligible.

Two reviewers independently screened studies for eligibility and appraised the quality of individual studies using the Cochrane Risk of Bias (RoB) 2.0 tool or Risk of Bias in Non-Randomised Studies of Interventions (ROBINS-I) tool.

In total, 7645 citations were screened and 39 studies included. We identified nine unique interventions including training programmes, short workshops and senior obstetrician supervision. Many studies were from high-income countries, in primary care settings and at high risk of bias.

Effective education included practical components, such as hands-on skills and training in perineal anatomy, assessment and classification, rather than senior supervision alone. Ongoing review of practice appears to be crucial for maintaining knowledge and skills. Future research should focus on interventions tailored to limited-resource settings, and the optimal length and intensity of training programmes to assess and classify perineal tears.

CRD42020185431.

Transition of care from hospital is a period when the risks of medication errors and adverse events are high, with 50% of adults discharged having at least one medication-related problem. Pharmacist-led medication reviews can reduce medication errors and unplanned readmission when completed promptly post-discharge; however, they are underutilised. A Transition of Care Stewardship pharmacist has been proposed to facilitate and coordinate a patient’s discharge process and facilitate a timely post-discharge medication review. Access to pharmacist medication review in rural and regional areas can be limited. This protocol describes a randomised controlled trial (RCT) to determine whether a virtual Transition of Care Stewardship pharmacist reduces medication-related harm in rural and regional Australia.

Multicentre RCT involving patients at high risk of medication-related harm discharged from regional and rural hospitals to a domiciliary residence. Eligible patients must be aged≥18 years, admitted under a medical specialty, be discharged to a domiciliary setting, have a regular general practitioner (GP) or be willing to visit a GP or an Aboriginal Medical Service after discharge for medical follow-up, have a Medicare card and be at high risk of readmission. High risk of readmission is defined as either a previous admission to the hospital or Emergency Department (ED) presentation in the past 6 months AND≥three regular medications OR on at least ONE high-risk medication. A total of 922 participants will be recruited into the study. Enrolled participants will be randomised to the intervention or control (usual care). The intervention will include a virtual Transition Of Care Stewardship pharmacist to ensure that patients receive discharge medication reconciliation, medication counselling, medication list and communicate directly with primary care providers to facilitate a timely post-discharge medication review. Usual care will include informing the patient’s clinical inpatient treating team that the patient is at high risk of medication misadventure and may benefit from a post-discharge Home Medicines Review (a GP-referred pharmacist medication review funded by the Australian Government).

Data analysis will be performed on a modified intent-to-treat basis. The primary outcome assessed is a composite of a first unplanned medication-related hospitalisation or ED presentation within 30 days of hospital discharge. Comparisons between the intervention and usual care groups for the primary outcome will be made using a mixed-effects logistic regression model, adjusting for site-level clustering as a random effect.

This study is approved to be conducted at the Western New South Wales Local Health District via the Research Ethics and Governance Information System (approval number: 2023/ETH00978). To ensure the needs of Aboriginal and Torres Strait Islander patients are appropriately addressed, ethics for this study were submitted and approved by the Aboriginal Health and Medical Research Council (approval number: 2148/23). Manuscripts resulting from this trial will be submitted to peer-reviewed journals. Results may also be disseminated at scientific conferences and meetings with key stakeholders.

ACTRN12623000727640.

Breast cancer risk can be substantially reduced with risk-reducing medications (RRMeds). Despite their efficacy, and guidelines which support their use for women at substantially increased risk of breast cancer, they are underused. Barriers to their use in Australia include a lack of awareness of RRMeds by women and clinicians, and a primary care workforce that reports a lack of knowledge and confidence in discussing and/or prescribing these medications. In contrast, Australian clinicians have reported specialist support and guidance as a key facilitator. The Preventing Cancer with Medications (PCMed) Telehealth Service was therefore developed to provide this specialist support and to bridge the evidence–implementation gap. The PCMed Service endeavours to increase the appropriate use of RRMeds and support women and their doctors throughout treatment. The aim of this research is to evaluate the effectiveness, adoption, acceptability, feasibility, fidelity and cost of this new Service, and to determine any adaptations that might be required.

The research uses a mixed methods approach. Effectiveness of the PCMed Service will be evaluated by determining whether the PCMed Service is associated with increased uptake of RRMeds compared with historical data. Secondary outcomes include: adoption of the Service, specifically, the proportion of women who attend a PCMed Service consultation; acceptability of the Service for clients and referring clinicians (using a brief survey and semistructured interviews); feasibility and fidelity by evaluating the adherence to the planned Service processes; and the cost, by reporting the difference between funding received per woman and the cost for service delivery.

This study was approved by the institutional Human Research Ethics Committee (EC00235): HREC/101142/PMCC. The findings will inform future iterations of the Service prior to scaling up. Research findings will be disseminated at scientific meetings and in peer-reviewed journals.

ISRCTN15718519.

Campaigns to support pictorial health warning labels (HWLs) for cigarettes have enhanced their effectiveness, but little to no research on campaign messages to support little cigars and cigarillos (LCC) pictorial HWLs exists. The goal of this study was to examine the effectiveness of messages to augment pictorial HWLs on LCCs among priority populations.

Online survey-based experiment.

Qualtrics research panel online of US adults, recruited between January and February 2023.

Adults ages 21–29 who reported current cigar use and reside in the USA.

Participants (n=315) were randomly assigned to one of three conditions: (1) messages designed to elaborate pictorial HWLs, (2) pictorial HWLs alone and (3) messages and pictorial HWLs paired together.

Within conditions, participants were shown six negative health effects of LCCs and answered questions about perceived message effectiveness (PME), negative affect, thinking about risks (TAR) and self-reported learning (SRL) as well as questions on quit intention, concern about their health and reactance. Using mixed-effects models and ANOVA, we evaluated for differences across conditions.

Most participants identified as male (60%) and either Black (45%) or White (45%). PME was very high across all three conditions (≥ 3.85) but no difference between conditions in a statistically significant manner (p=0.18). Mixed-effects models indicated that negative affect varied across conditions, highest in condition 2 (3.76; 95% CI 3.58, 3.94) and lowest in condition 3 (3.44; 95% CI 3.27, 3.61) (p=0.01), and showed no statistically significant difference between conditions for SRL (p=0.31) or TAR (p=0.43). No statistically significant difference was noted for quit intentions (p=0.16), health concern (p=0.28) or reactance (p=0.84).

Pictorial HWLs, campaign messages and the combination of the conditions were all perceived as very effective, with little differences in PME. Such findings indicate that pictorial HWLs on LCCs and communication messages about LCCs both appear as promising approaches to reducing LCC use among target populations. Longitudinal studies with ongoing exposure may identify factors that can enhance the effectiveness of campaign messages to enhance pictorial HWLs for LCCs.

Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

To identify facilitators and barriers to fit note certification among nurses, occupational therapists, pharmacists and physiotherapists (NOPPs), and identify ongoing training needs.

An online survey informed by the Theoretical Domains Framework (TDF) was used to gather data from NOPPs to identify implementation barriers and personal, social and environmental influences on fit note certification.

Data were analysed using descriptive statistics. Mean TDF domain scores were calculated (mean scores ≤3.5 indicated barriers, ≥5 indicated facilitators). Free-text data were thematically analysed using the TDF.

United Kingdom.

The survey was completed by 198 respondents: physiotherapists (n=66, 33%), occupational therapists (n=49, 25%), nurses (n=44, 22%), pharmacists (n=39, 20%).

Only 47 (24%) of survey respondents had certified fit notes; 66 (37%) had completed training, most pharmacists had done neither. TDF analysis indicated three barriers: 1) ‘skills’ (being able to certify, review and practice completing fit notes) (mean=3.32, SD=0.75, 95% CI 1.84, 4.80); 2) ‘goals’ (the level of priority given to fit note completion) (mean=3.22, SD=0.51, 95% CI 2.21, 4.22); 3) ‘memory, attention and decision processes’ (disagreeing with the statement: ‘certifying fit notes is something I do automatically’) (mean=2.73, SD=0). Free-text comments suggested that low ‘skills’ rates may be due to lack of opportunity to do training. The low priority afforded to completing fit notes, which was not done automatically as part of their role, may reflect the lack of organisational policies/guidelines or priorities.

The only facilitator identified was ‘belief about consequences’ (mean=5.74, SD=0.12, 95% CI: 5.50, 5.98). Participants believed that certifying fit notes was useful and worthwhile.

Legislation allowing NOPPs to undertake fit note certification does not appear to have been successfully implemented. Further resources are required to provide NOPPs with the necessary skills/confidence (e.g., via training) to certify fit notes, supporting more patients to return to and remain in work.

Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.

This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.

Ethics approval for the study was received from the Royal Children’s Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.

Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.