To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.

Growing evidence suggests that vaccines targeting respiratory pathogens have non-specific and broader effects. We aimed to investigate the non-specific effects of respiratory vaccines on acute lower respiratory infection (ALRI) hospitalisations and associated outcomes in children

Systematic review and meta-analysis.

We searched online databases including Medline, Embase, CINAHL, Scopus and Clinical Trials.gov from inception to 24 January 2024.

We included human studies involving non-specific/off-target effects of respiratory vaccines (including maternal, infant and childhood vaccines) and excluded studies investigating the Bacille Calmette-Guérin vaccine and non-pathogen-confirmed outcomes following pneumococcal conjugate vaccination (PCV).

We used Research Screener, a machine learning tool, to semi-automate the abstract screening process and Covidence, a management and streamlining software for full-text reviews and data extraction. A meta-analysis was conducted if four or more studies reported on the same outcome and the same exposure vaccine.

After removing duplicates, 9727 articles were identified. After screening and full-text reviews, 20 articles were eligible. Of those, four met the requirements for a meta-analysis which showed a 21% vaccine effectiveness (VE) (95% CI 8.0% to 32.0%) of maternal influenza vaccine against all-cause ALRI hospitalisations in infants

Our review demonstrated both protective and neutral non-specific effects of respiratory vaccines against ALRI-hospitalisations and related outcomes in young children. Such effects should be considered as part of the full value of a vaccine and how vaccine investments are prioritised. Further research on the impact of respiratory vaccines on antibiotic prescribing rates is essential as consistent reductions may help contribute to reducing the global burden of antimicrobial resistance.

CRD 42023476038.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.

High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

NCT04499859.

Allergic rhinitis (AR) is a common chronic inflammatory condition that significantly impairs quality of life (QoL) through symptoms such as nasal congestion, rhinorrhoea, sneezing and itching. Conventional treatments often show limitations, prompting interest in complementary therapies like herbal medicine (HM). HM is widely used in East Asian countries and has demonstrated potential in modulating immune responses and reducing AR symptoms. In Korea, a government pilot project expanded in 2024 to include AR under limited insurance coverage for HM, highlighting the need for robust clinical evidence on its safety and effectiveness.

This study is a multicentre, prospective registry conducted in 21 Korean Medicine (KM) clinics across Republic of Korea. The registry systematically collects real-world data on HM treatments for AR, focusing on patient demographics, treatment patterns and clinical outcomes. Participants meeting predefined criteria will receive HM or other KM therapies as part of routine care. Data will be collected bi-weekly for the first 4 weeks, with additional follow-ups at 6 and 12 months. Primary outcomes include changes in Total Nasal Symptom Score, QoL scores and safety evaluations, analysed using descriptive and inferential statistical methods.

This study was approved by the Institutional Review Board of Kyung Hee University on 11 December 2024 (Approval No. KHSIRB-24–631). The study findings will be published in peer-reviewed journals and presented at academic conferences.

KCT0010172.

Body image dissatisfaction (BID) is relatively common in Chinese female undergraduates. This study aims to explore the reasons for BID among female undergraduates to develop effective early intervention strategies.

A qualitative research approach was used through semi-structured interviews, allowing for an in-depth understanding of the experiences of participants.

The study was conducted from April 2024 to November 2024 at Yibin University in Sichuan province, China.

The study involved 25 female undergraduates with an average age of 19.8±1.3 years. These participants were selected to provide rich qualitative data about their experiences and views regarding BID.

The participants showed a high level of BID, and the thematic analysis revealed five overarching themes regarding the causes of BID among female undergraduates: (1) individual factors; (2) media factors; (3) family factors; (4) peer factors; and (5) overall societal impact.

The thematic analysis revealed that dissatisfaction with body image among female undergraduates is a multidimensional issue influenced by various factors, including individual and sociocultural elements. The conclusion emphasises the necessity of strengthening comprehensive intervention measures to address these influencing factors.

Despite global efforts, gender disparities in oncology may persist. Understanding these disparities within the context of major conferences can inform strategies to promote gender inclusiveness in the field. This study evaluates the participation of women and men at the American Society of Clinical Oncology (ASCO) 2024 congress, focusing on chairs, speakers and audience questioners.

Observational study.

152 recorded sessions of the ASCO 2024 annual meeting, one of the largest conferences in the field of oncology, available on the ASCO website.

Individuals serving as chairs, speakers and audience members who asked questions.

In this observational study, gender for chairs, speakers and audience questioners across 152 sessions of the ASCO 2024 congress was assessed by two independent reviewers using audio and video recordings. Speaking times for questions and responses were also evaluated. Statistical analyses, including ² and unpaired t-tests, were conducted to analyse the data.

Women were well represented as chairs (n=124) and speakers (n=402) in 66% and 95% of sessions, respectively. However, only 21% of questions from the audience were posed by women, while 37% of questions were asked by men and 42% online or by chairs/speakers. Women were more likely to pose questions when the sessions were chaired by women (71% vs 53%; p=0.047). There were no statistically significant gender disparities concerning speaking time (questions: p=0.30; responses: 0.53). The response dynamics indicated a pattern of gender homogeneity, with individuals more frequently responding to questions from their own gender.

While the balanced representation of women in leadership roles at the ASCO 2024 congress reflects positive development in gender equality, disparities in active participation persist. These findings underscore the need for strategies that not only promote women in visible roles but also foster an environment that supports their active engagement in scientific discussions.

Ventilation tube insertion for paediatric otitis media (POM), including acute otitis media (AOM) and otitis media with effusion (OME), has been signalled in the past for potential unwarranted treatment variation. Quality improvement initiatives, like Audit & Feedback (A&F), often ignore the care pathway when identifying such variation, possibly overestimating variation at a specific care step. To gain more insight into the effect of prior care steps, this study examined (1) the degree of regional variation in each step of the care pathway (general practitioner (GP) contacts, referrals and surgeries) and (2) investigated the effect of adjusting for prior care steps.

Observational study using general practice electronic health record data linked to specialist claims data.

272 790 children ≤12 years with and without POM registered in 320 GP practices between 2017 and 2018.

Using multilevel logistic regression, the degree of regional variation in each step of the POM care pathway was assessed by calculating the coefficient of variation (CV).

The effect of adjusting for prior care steps was determined by estimating correlations between subsequent care steps and analysing the impact on the CV.

Regional variation in POM treatment was larger in each subsequent step in the care pathway (CV POM GP contacts 0.110; referral 0.179; surgery 0.239). In regions with a higher proportion of children with frequent AOM/persistent OME, referral rates were higher (POM: OR: 1.06; 95% CI: 1.02 to 1.11) and surgical rates were higher (for OME only: OR: 1.08; 95% CI: 1.02 to 1.15). Regional variation in referrals and surgery decreased after adjusting for the regional frequent AOM/persistent OME rate (CV referrals POM 0.103 vs 0.128; CV surgery OME 0.047 vs 0.059).

Regional variation is observed in GP contact rates for POM and is larger in referrals and surgeries. Adjusting for the proportion of frequent AOM/persistent OME significantly reduces regional variation in POM treatment. Future A&F should adjust for prior care processes and develop tailored interventions for quality improvement.

Air pollution is a significant global health concern, with studies from the USA and Europe linking long-term exposure to respiratory issues and poor school attendance in children. While Indian cities experience much higher pollution levels, the impact on lung development in Indian children remains unclear. This study aims to assess the burden of impaired lung function in Indian children and identify key factors contributing to pollution-induced lung injury.

This longitudinal, prospective cohort study is conducted in four cities categorised by particulate matter 2.5 (PM_2.5) levels: ‘very high’ (Delhi), ‘high’ (Mumbai, Bangalore) and ‘moderate’ (Mysore). A total of 4000 participants (1000 from each city) will be included in the study. Participants will complete a structured questionnaire covering sociodemographics, asthma and allergy history (International Study of Asthma and Allergies in Childhood core questionnaire), dietary intake (24-hour recall and Food Frequency Questionnaire), Physical Activity-C Questionnaire and air pollution exposure. Spirometry and Forced Oscillation Technique will be used to assess lung function. Blood samples will be collected for identification of biomarkers to predict lung impairment. After quality checks, data will be compiled, summarising pulmonary function parameters alongside covariates and confounders. Analysis of Variance (ANOVA) will assess between-city and within-city differences in lung function.

We anticipate a higher prevalence of reduced lung function in children residing in cities with very high and high PM_2.5 levels compared with the moderately polluted city. Findings from this study could establish normal age-appropriate lung function reference values for Indian urban children, aiding in clinical diagnosis.If a reliable biomarker for identifying children at risk of lung impairment is available, it could serve as an early predictor of poor lung health in asymptomatic children.

The approval from individual site institutional review board (IRB) is obtained prior to initiation of the study from institutional ethics committee, St. John’s Medical College and Hospital, Bangalore; institutional ethics committee, JSS Medical College, Mysore; institute ethics committee, Indian Institute of Technology Bombay and institute ethics committee, All India Institute of Medical Sciences. Findings from this study will be disseminated through conference presentations, peer-reviewed publications and establishment of normal age-appropriate lung function reference values for children living in urban India.

Sleep is a biological necessity with vital effects on all tissues and organs of the body. Preoperative sleep disturbance is associated with increased postoperative pain intensity and opioid consumption. Given that insomnia is a potentially modifiable risk factor, interventions targeting sleep prior to surgery may improve postoperative pain control and enhance key outcomes of recovery.

Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) is a randomised, parallel group, two arm, controlled trial evaluating the effects of preoperative sleep-promotion on postoperative pain control, brain health and physical recovery. The main objective is to investigate whether preoperative insomnia treatment in patients scheduled to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA) may improve acute postoperative pain control. 100 adults with insomnia disorder (Insomnia Severity Index score >10 and confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for persistent insomnia disorder), scheduled to undergo primary TKA or THA, will be randomised to preoperative cognitive behavioural therapy for insomnia (CBT-I) or an active comparator control intervention, sleep education therapy (SET). Both interventions will be delivered over 4 weeks in hybrid format through a digital self-guided platform in combination with weekly telehealth video sessions with a psychologist (CBT-I) or research nurse (SET). A video-assisted booster session will be provided 1–2 weeks postoperatively. The primary outcome measure is acute postoperative pain intensity, averaged over the first 7 postoperative days (POD). Secondary outcome measures include long-term postoperative pain control, changes in quantitative sensory testing variables (eg, temporal summation, conditioned pain modulation), sleep, cognition (eg, attention, memory, processing speed, executive function), mental health, health-related function, physical activity, quality of life and blood biomarkers. Participants will undergo on-site evaluation preoperative (preintervention and postintervention) and 6 months postoperative. Additional remote assessments will take place during POD1–7, 3 and 12 months postoperative.

The Swedish Ethical Review Authority has approved the PROSAP-A trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.

NCT06145516.

Traditional peoples and communities (TPCs), such as indigenous peoples and quilombolas (communities descended from escaped African slaves), face challenges related to food security and the impact of the food environment on their health. Changes in food systems, urbanisation and loss of territorial rights have contributed to less healthy eating patterns, with increased consumption of ultra-processed foods and a higher prevalence of chronic non-communicable diseases. Despite this, there are gaps in knowledge about how the food environments of these communities are investigated, especially in relation to the physical, economic, political and sociocultural dimensions.

This scoping review will be conducted following the methodological framework developed by the Joanna Briggs Institute for scoping reviews, and its reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews checklist. A systematic search will be carried out in the following databases: PubMed, SciELO, Web of Science, Embase and EBSCO, using terms related to traditional populations and food environments. The studies to be included will be selected according to the inclusion and exclusion criteria defined based on the population, concept and context technique. The study population will include TPCs, such as indigenous peoples and quilombolas; the concept will address the food environment in its physical, economic, political and sociocultural dimensions; and the context will encompass studies conducted at a global level, without any restrictions on geographic location. The study type will include original articles and grey literature. The screening of studies will involve independent reviewers and predefined inclusion and exclusion criteria. Data synthesis will be presented in tables, including information on focus, geographic scope and methodology of the selected studies. The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies of Exposure tool.

As the study does not involve the collection of primary data or human participants, it does not require ethical approval. The results will be submitted to peer-reviewed journals and presented at public health and nutrition conferences, contributing to the advancement of knowledge on food environments of TPCs.

Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.

This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.

The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.