To understand how public health practitioners (PHPs) are using parental guidance on talking to children in their work with parents. In 2021, evidence-based guidance was produced for parents of young children to facilitate these conversations, but it is unclear how this guidance is being promoted to parents or used by PHPs.

Qualitative study, consisting of in-depth, semistructured interviews.

Local authority, National Health Service or other healthy weight service providers in the UK.

Participants were PHPs working on children’s healthier lifestyles programmes in the UK as part of the UK’s National Child Measurement Programme (NCMP). Invitations to participate were distributed via the Department of Health and Social Care and regional and national networks.

24 participants were interviewed. Practice varied between organisations with the guidance being used in NCMP letters to parents, in follow-up phone calls with parents and in training NCMP staff and other health or education professionals. Participants valued the evidence-based guidance and its compassionate tone, feeling it gave them and parents, confidence in addressing a sensitive topic. Some felt it was too lengthy for parents with learning disabilities or low literacy levels. Others identified a need for similar guidance for older children. Though helpful, participants acknowledged the guidance was only one small part of a necessary systems-wide approach to promoting healthy weight.

The guidance is a useful tool but needs systematic promotion to increase use and effectiveness. Further work is warranted to develop adapted versions for other populations.

The study evaluated the feasibility and efficacy of a non-immersive virtual reality (VR) system on upper extremity (UE) recovery in ischaemic stroke patients in comparison to a conventional physiotherapy.

An open-label, parallel-group, randomised controlled trial randomly assigned the participants to two groups, VR intervention or conventional physiotherapy.

Two tertiary stroke care centres in South India participated in the study.

Sixty first-ever ischaemic stroke patients (1–6 months of stroke onset) having spasticity grades of 1 or 1+ as per Modified Ashworth scale and Brunnstrom recovery stages of 3, 4 or 5 in the UE were included in the intention-to-treat analysis.

High-intensity non-immersive VR-based comprehensive rehabilitation gaming system with a duration of 12 weeks (3 days/week) was compared with equally intensive conventional physiotherapy.

The feasibility outcome was the compliance with the treatment. The primary efficacy outcome was the improvement in the motor function assessed by the Fugl-Meyer assessment (FMA) and Wolf motor function test (WMFT). The secondary outcomes included the performance in activities of daily living by the Barthel index (BI) and the quality of life by the 36-item short form health survey (SF-36).

The treatment compliance was similar in two groups (p=0.19). Both groups improved in motor performance, activities of daily living and quality of life. However, there were no significant differences in the FMA (p=0.58), WMFT (functional ability scale, p=0.33; performance time, p=0.44), BI (p=0.84) and SF-36 (physical, p=0.87; mental, p=0.99) scores between the groups.

The non-immersive VR system was feasible, effective and safe; however, it was not found to be superior to conventional physiotherapy. The trial was stopped early and did not reach its proposed sample size and hence, the findings are to be interpreted cautiously.

Clinical trial registry India: CTRI/2021/11/038339 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NTc1OTI=&Enc=&userName=CTRI/2021/11/038339).

Racialised immigrant communities in Western nations face disproportionate risks for sexually transmitted and blood-borne infections (STBBIs) due to systemic barriers, including racism, stigma and limited access to culturally appropriate care. While the need is well-established, a comprehensive synthesis of effective, culturally responsive sexual health interventions is lacking. This scoping review aims to map the available evidence on sexual health intervention needs and protective factors of racialised immigrants, and to identify and describe existing culturally appropriate programmes in Western nations.

The review will follow the JBI methodology for scoping reviews and be reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. A systematic search strategy, developed and peer-reviewed by a health sciences librarian, will be executed in MEDLINE, Embase, CINAHL and Scopus, alongside grey literature sources, with no date limit. Two independent reviewers will screen titles/abstracts and full texts against the inclusion criteria. Data will be extracted using a standardised tool, analysed via narrative synthesis and framed by a socio-ecological model to categorise interventions across individual, interpersonal, community and structural levels.

Ethical approval is not required for this review. Findings will be disseminated through a peer-reviewed publication, academic presentations and tailored summaries for community organisations and policy-makers to ensure practical application.

Open Science Framework (https://osf.io/9qah6).

Salivary gland carcinomas (SGC) are rare tumours. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it difficult to reach high patient numbers for individual entities in clinical studies, leading to pooling patients with different histological subtypes to attain sufficient participants. The different histological subtypes of SGC differ significantly in their clinicopathological features, such as their grading, their occurrence and their outcome. SGCs are usually stratified into low-grade, intermediate-grade or high-grade tumours. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. In order to integrate IT as a therapeutic option for SGC and to facilitate therapeutic decisions based on tumour (immune) biology, predictive and prognostic immunological biomarkers are indispensable.

In this prospective study, 500 patients will be enrolled, who are distributed in three arms. The observational cohort includes patients with malignant salivary gland tumours, whereas patients with benign tumours of a salivary gland are grouped in the control group 1. In the control cohort, 2 patients do not have a salivary gland tumour but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status from the tumour tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analysed before and after surgery and after the adjuvant and definitive chemoradiotherapy, if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modelling approaches will finally be applied to identify interactions of local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.

Approval from the institutional review board of the Friedrich-Alexander-Universität Erlangen-Nürnberg was granted in September 2023 (application number 23-292-B). The results will be disseminated to the scientific audience and the general public via presentations at conferences and publication in peer-reviewed journals.

NCT06047236.

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

The primary objective of this clinical trial is to determine the clinical and cost-effectiveness of psychoeducation and emotional stabilisation (PES), together with eye movement desensitisation and reprocessing (EMDR) plus treatment-as-usual (TAU) in reducing symptoms of post-traumatic stress disorder (PTSD) among adults with intellectual disabilities compared with TAU. Secondary objectives include: (1) determining whether PES/EMDR plus TAU is superior to TAU in improving mental health problems and quality of life (QoL) among adults with intellectual disabilities who had a diagnosis of PTSD and (2) completing a process evaluation to examine intervention implementation and acceptability.

This is a two-arm parallel single-blind randomised controlled trial comparing PES-EMDR+TAU to TAU including an internal pilot phase. Outcome data will be captured prior to randomisation, and at 4 (after PES), 8 (after EMDR) and 14 months postrandomisation by masked assessors. 144 adults with intellectual disabilities with a diagnosis of PTSD will be allocated (1:1) randomly using minimisation from National Health Service (NHS) community and inpatients services for adults with intellectual disabilities in England. Participants are eligible to take part in this trial if: (1) they are aged 18 or older, but younger than 66, (2) have a Full Scale IQ

The primary outcome will be assessed using an intention-to-treat analysis. Baseline characteristics will be compared between arms to determine whether any potentially influential imbalance occurred. The primary outcome will be analysed by analysis of covariance, adjusting for baseline values of the outcome and any variables used in the randomisation process. Secondary outcomes will be analysed using linear or logistic regression models as appropriate reflecting the distribution of the outcome variable. The treatment effect will be estimated as an adjusted difference between sample means, presented with 95% CIs and p values. A complier average causal effect analysis will be considered should the data availability be sufficient to estimate the impact of non-compliance. A series of subgroup analyses on the primary outcomes will be considered considering differences in the Impact of Event Scale–Intellectual Disabilities scores at 14 months for (1) differing levels of general intellectual functioning and (2) PTSD versus complex PTSD.

This clinical trial was designed to allow for conclusions about whether PES/EMDR+TAU is efficacious in reducing symptoms of PTSD, relative to TAU, for adults with intellectual disabilities. A favourable ethical opinion has been received from an NHS ethics committee in the UK. The findings from this trial will be published within peer-reviewed journals and shared at national and international conferences. We will also aim to record and distribute podcasts detailing our findings together with our partners.

ISRCTN35167485.

Cancer-related cognitive impairment is frequently reported by patients with breast cancer after chemotherapy. These difficulties can hinder return to work. It is therefore particularly important to assess and manage these impairments, especially to facilitate employment. We propose the Cog-VR pilot study to assess patient adherence to a virtual reality (VR)-based cognitive rehabilitation programme to support employment.

This prospective interventional pilot study aims to assess adherence to a VR-based cognitive rehabilitation programme in patients with breast cancer (n=23) treated by chemotherapy reporting cognitive complaints following cancer and its treatments. The programme consists of six weekly individual sessions (1 hour/week), including cognitive training, psychoeducation and VR immersion (10–15 min). VR tasks train executive functions, attention, memory and processing speed. The primary endpoint is the programme adherence, defined as completing at least five out of six VR sessions, each lasting a minimum of 5 min. The main secondary endpoints are objective cognitive tests and patient-reported outcomes (subjective cognitive functioning (Functional Assessment of Cancer Therapy—Cognitive Scale), anxiety/depression (Hospital Anxiety and Depression Scale) and fatigue (Functional Assessment of Chronic Illness Therapy—Fatigue)) assessed before and after the programme. Furthermore, cyber sickness (Simulator Sickness Questionnaire) at each session, VR usability (System Usability Scale—third session) and patient satisfaction to the programme will also be assessed.

The study was approved by the local ethics committee (French Ouest II personal protection committee no. ID RCB: 2023-A02163-42) on January 2024. It was validated by the review board of the participating center. An individual participant data-sharing statement is not planned. Written informed consent will be obtained from all patients before any study procedure. The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

NCT06267014.

Haematological malignancies and their treatments are known for their significant adverse effects on health-related quality of life (QoL). During high-dose cytotoxic therapy in haematological intensive care units (HICU), adapted physical activity (APA) is recognised for its role in maintaining physical fitness and limiting fatigue. Psychological and emotional states are also impaired, with anxiety levels significantly increasing in this specific context. Limited information is available about this topic. However, APA has been shown to reduce anxiety in various populations, including oncological patients. Furthermore, adding new technology, such as exergaming or heart rate variability biofeedback (HRVB) relaxation tools, could be an effective way to regulate emotions during treatments while providing the health benefits of APA. APA, Exergaming and Relaxation by Biofeedback in Haematological Intensive Care Unit protocol is a randomised, controlled trial. Our study is designed to evaluate the effects of APA programmes during high-dose cytotoxic therapy in HICU on anxiety, fatigue level, functional capacities, immune system activity and global QoL. Additionally, we aim to analyse the added value of using specific devices, such as Exergaming and HRVB relaxation, on the aforementioned parameters. We expect a difference in effectiveness between the programmes concerning emotional regulation.

90 patients (18–75 years), with various forms of haematological malignancies admitted to HICU, with haematologist’s approval for APA, who have given their written informed consent, will be randomly allocated in a 1:1:1 ratio to three 3-week APA groups: APA only (APA), APA by exergaming (EXER), APA+Biofeedback relaxation (BIO) (30:30:30). APA sessions will consist of moderate aerobic training on cyclo-ergometer (classical stationary bicycle for APA, BIO and connected ergometer in EXER), three times per week. The HRVB training will consist of controlled breathing exercises with biofeedback of heart rate variability at the end of each APA session (BIO). The primary outcome is to evaluate the effect of three short APA programmes on state anxiety (Hospital Anxiety and Depression Scale and State and Trait Anxiety Inventory-YA (STAI-YA)). The secondary outcomes will assess the effects on fatigue (Multidimensional Fatigue Inventory–20), physical fitness (2-minute walk test; five-times sit to stand test), QoL (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnary ; EORTC-QLQ-C30) and immune system functioning (blood samples). All of these assessments are evaluated initially (T0) and directly after intervention (T2).

Approval was obtained from the French South Mediterranean III ethical committee. Subjects are recruited after providing written consent after receiving the information provided by the investigator. According to French law and the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés ; CNIL), we are not authorised to publicly share individual participant data. The results of the Adapted Physical Activity, Exergaming and Relaxation by Biofeedback in Haematological Intensive Care Unit study will be disseminated through publication in peer-reviewed journals, presentations at scientific conferences and communication with stakeholders and participants.

French Sud Mediteranian III ethical committee and registered on ClinicalTrials.gov: NCT05475600.

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

NCT06335420.

This study aimed to assess construct validity against commonly used patient-reported outcome measures (PROMs), test–retest reliability and responsiveness of seven Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CATs) in Dutch adults with type 2 diabetes (T2D), and assess their acceptability in healthcare providers and people with T2D.

A cross-sectional observational study in people with T2D and qualitative study involving both people with T2D and healthcare professionals.

Participants with T2D were recruited from the ongoing Hoorn Diabetes Care System cohort in the West-Friesland area of the Netherlands. Additionally, people with T2D and advanced chronic kidney disease were recruited at the outpatient clinics of Amsterdam University Medical Centre and ‘Niercentrum aan de Amstel’, both in the Amsterdam area of the Netherlands. The healthcare professionals involved in the qualitative part were recruited at the Amsterdam University Medical Centre.

314 people with T2D (age 64.0±10.8 years, 63.7% men).

Participants completed seven PROMIS CATs (assessing (1) Physical Function, (2) Pain Interference, (3) Fatigue, (4) Sleep Disturbance, (5) Anxiety, (6) Depression and (7) Ability to Participate in Social Roles and Activities), and PROMs measuring similar constructs. After 2 weeks and 6 months, participants completed the CATs measures again, together with seven Global Rating Scales (GRS) on perceived change in each domain. Construct validity was assessed using Pearson’s correlations. Test–retest reliability was assessed by the intraclass correlation coefficient (ICC). Measurement error was assessed by the standard error of measurement (SEM) and minimal detectable change (MDC). Responsiveness was assessed by correlations between change scores on the PROMIS CAT and GRS. Acceptability was assessed through focus groups and interviews in healthcare providers and people with T2D.

Except for Fatigue, all PROMIS CAT domains demonstrated sufficient construct validity, since ≥75% of the results was in accordance with a priori hypotheses. All seven PROMIS CATs showed sufficient test–retest reliability (ICCs 0.73–0.91). SEM and MDC ranged from 2.1 to 2.7 and from 5.7 to 7.4, respectively. Responsiveness was rated as insufficient in this study design as there was almost no change in participants’ own rating of their health compared with 6 months ago according to a global rating of change.

During the focus groups and interviews, healthcare providers and people with T2D agreed that CATs could serve as a conversation starter in routine care, but should never replace personal consultations with a doctor. If implemented, participants would be willing to spend 15 min to complete the PROMIS CATs.

The PROMIS CATs showed sufficient construct validity and test–retest reliability in most domains in people with T2D. Responsiveness needs to be evaluated in a population with poorer diabetes control or in a study design with longer follow-up. The CATs are well accepted to be used in care to identify relevant topics, but should not replace personal contact with the doctor.

On 1 January 2023, Ontario expanded pharmacists’ scope of practice, allowing them to prescribe medications for 13 minor ailments, including antibiotics for uncomplicated urinary tract infections (UTIs) and Lyme disease (LD) prophylaxis. This study evaluates pharmacist billing claims and pharmacist and physician antibiotic-prescribing rates before and after policy implementation.

An interrupted time series analysis measuring changes in prescribing trends post-implementation.

This retrospective study analysed visit claims and antibiotic prescribing for UTIs and LD prophylaxis before policy implementation (2022) and after (2023–2024) in Ontario.

Data from Ontarians

Prescribing rates were standardised per 1000 inhabitants, stratified by provider type, patient age and sex, and antibiotic type.

In 2023 and 2024, pharmacists submitted over 1.47 million minor ailment claims, with UTIs making up 34.2% and LD prophylaxis making up 2.6% of total claims. UTI claims were primarily for women aged 25–64, and LD prophylaxis peaked in spring and fall. Pharmacist prescribing of eligible urinary drugs in females increased by 33.3 per 1000 person-years (95% CI 30.8 to 36.6) while physician prescribing decreased by 23.3 (95% CI –32.2 to –15.3), leading to a modest net increase of 10.1 (95% CI 0.0 to 18.7). Pharmacist prescribing of doxycycline was offset by decreased physician prescribing, resulting in no change (0.0, 95% CI –1.0 to 0.9). Pharmacist prescribing for other antibiotics was low over the study timeframe, while physician prescribing increased, which was driven by increased prescribing of penicillins and macrolides.

There was a clear increase in pharmacist prescribing for eligible drugs in the eligible population post-policy implementation. Pharmacists in Ontario appear to be prescribing within policy limits for uncomplicated UTIs and LD prophylaxis.

Three-quarters of mental health problems start before the age of 25. However, young people are the least likely to receive mental healthcare. Some young people (such as those from ethnic minorities) are even less likely to receive mental healthcare than others. Long-term impacts of mental health problems include poorer physical health, relationships, education and employment. We aim to elicit the views, experiences and needs of diverse young people (aged 16–24 years), to better understand (1) their experiences of under-representation, mental health and coping, (2) mechanisms that shape mental health trajectories and (3) how online arts and culture might be made engaging and useful for young people’s mental health. We also aim to do this with autistic young people.

Narrative inquiry will be employed as a tool for gathering young people’s perspectives for an iterative analysis. The narrative method proposes that critical insights and knowledge are distributed across social systems and can be discovered in personal stories and that knowledge can be relayed, stored and retrieved through these stories. Data will be transcribed and explored using a combination of thematic and intersectional analysis. Young people will be core members of the research team, shape the research and be involved in the coding of data and interpretation of the findings.

This study (IRAS project ID 340259) has received ethical approval from the HRA and Health and Care Research Wales (REC reference 24/SC/0083). The outputs will identify touch points and refine the logic model of how online arts and culture might support the mental health of those from under-represented backgrounds. We will share knowledge with young people, policy makers, health professionals, carers, teachers, social workers and people who work in arts and culture. We will produce research papers, blogs, newsletters, webinars, videos and podcasts.

Deaths related to drug overdose and suicide in the USA have increased 500% and 35%, respectively, over the last two decades. The human and economic costs to society associated with these ‘deaths of despair’ are immense. Great efforts and substantial investments have been made in treatment and prevention, yet these efforts have not abated these increasing trajectories of deaths over time. The COVID-19 pandemic has exacerbated and highlighted these problems. Notably, some geographical areas (eg, Appalachia, farmland) and some communities (eg, low-income persons, ‘essential workers’, minoritised populations) have been disproportionately affected. Risk factors have been identified for substance use and suicide deaths: forms of adversity, neglect, opportunity indexes and trauma. Yet, the biological, psychological and social mechanisms driving risk are not uniform. Notably, most people exposed to risk factors do not become symptomatic and could broadly be considered resilient. Achieving a better understanding of biological, psychological and social mechanisms underlying both pathology and resilience will be crucial for improving approaches for prevention and treatment and creating precision medicine approaches for more efficient and effective treatment.

The State of Ohio Adversity and Resilience (SOAR) study is a prospective, longitudinal, multimodal, integrated familial study designed to identify biological, psychological and social risk and resilience factors and processes leading to mental health disorders, substance use disorders, substance overdose, suicide and associated psychological/medical comorbidities which reduce life expectancy and quality of life. It includes two nested longitudinal samples: (1) WD Survey: an address-based random population epidemiological sample of 15 000 individuals (unique households) representative of the state of Ohio assessed for psychosocial, psychiatric, behavioural health and substance use factors and (2) Brain Health Study: a family-based, multimodal, deep-phenotyping study conducted in 1200 families (up to 3600 persons aged 12–72 years) including MRI, electroencephalography, blood biomarkers and psychiatric diagnostic interviews, as well as neuropsychological, psychosocial functioning and family/community history, dynamics and support assessments. SOAR is designed to discover, develop and deploy advanced predictive analytics and interventions to transform mental health prevention, diagnosis, treatment and recovery.

All participants will provide written informed consent (or parental permission and assent for minors). The study was approved by The Ohio State University Institutional Review Board (study numbers 2023H0316 (Brain Health) and 2023H0350 (Wellness Survey). The Brain Health study was also approved by institutional review boards at each partnering institution involved in conducting participant assessments. Findings will be disseminated to academic peers, clinicians and healthcare consumers, policymakers and the general public, using local and international academic channels (academic journals, evidence briefs and conferences) and outreach (workshops and seminars).

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

CT EU 2022-502060-21-00; NCT05935358.

During the first wave of the COVID-19 pandemic, there was a notable decline in emergency department (ED) usage in many jurisdictions. This study assessed changes in ED use during this period and explored how the pandemic may have aggravated existing healthcare access inequities.

Our primary objective was to assess pandemic-related changes to ED visits and emergency hospitalisations for distinct demographic groups.

We conducted a retrospective observational study using population-based provincial administrative data.

We analysed data from all the 109 EDs and urgent care centres in Alberta, Canada, during the first wave of the COVID-19 pandemic (15 March 2020 to 30 June 2020), and during the corresponding (control) period 1 year earlier. We conducted subgroup analyses by age, First Nations status, sex, location and material deprivation. We repeated all analyses for pre-selected life-threatening emergency diagnoses.

We examined outcomes for a priori subgroups, including female and ‘other’ sex patients, paediatric patients (age 0–17 years), seniors (age 65 years and older), patients living in remote areas (greater than 200 km from an urban centre), First Nations members and patients living in materially deprived postal codes falling into the two most deprived Pampalon Index quintiles.

Primary outcomes were number of ED visits, number of ED visits with admission to hospital and number of ED visits resulting in patient death in the ED. A secondary outcome was change in ED use for life-threatening diagnoses (eg, cardiac conditions and hepatic disease).

ED visits in the COVID-19 period decreased by 34% (Poisson means test p

Reductions in critical emergency care and emergency hospital admissions were unequally distributed across demographic groups during the COVID-19 period. Study methods could be used to monitor and support equitable access to emergency care among distinct populations.