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.

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.

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.

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).

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.

The number of people living with dementia is increasing worldwide. Alzheimer’s disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs.

Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale – Cognitive by an assessor blinded to the randomisation. Participants’ memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability.

Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412).

Clinicaltrials.gov, NCT06611878.

Providing care in a patient’s preferred language improves health outcomes and patient satisfaction. In Ontario, access to French-speaking physicians (FSPs) is estimated using FSP-to-Francophone population ratios and compared with total physician-to-total population ratios. This approach fails to consider the fact that FSPs also serve non-Francophone patients and that Francophones must compete with the entire population to access FSPs. As a result, this approach inaccurately suggests that Francophones have better access to language-concordant care than Anglophones/Allophones. We propose a novel approach to address this issue, enabling unbiased comparisons of access to language-concordant care across linguistic groups.

This secondary analysis of publicly available data containing linguistic variables for the Ontario population (Statistics Canada, 2021 Census) and for family physicians (FPs) (College of Physicians and Surgeons of Ontario, January 2024) calculated competition-adjusted ratios and probabilities of accessing language-concordant care.

Ontario, Canada.

Census and publicly available data on FPs (ie, those providing comprehensive family medicine care to the community) and the Ontario population were obtained.

Province-wide, the crude ratio of FSPs per 1000 Francophones was 3.46. After adjusting for competition, the ratio of FSP per 1000 population was 0.12, compared with a general physicians-per-1000 population ratio of 1.05. Anglophones/Allophones attached to a FP have a 100% probability of receiving care in English compared with an 11.4% probability for Francophones to receive care from a FSP. Expressed otherwise, Anglophones/Allophones are 8.8 times more likely to receive language-concordant care (ie, care in English) than Francophones.

Although crude physician-to-population ratios overestimate Francophones’ access to FSPs, competition-adjusted ratios and probabilities demonstrate that they are much less likely to access language-concordant care than Anglophones/Allophones. This novel approach has equity implications for health human resources planning and can be applied to other linguistic minority groups and healthcare providers.

The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.

We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.

We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.

One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.

From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.

This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.

Lateral hip pain due to hip abductor tendon pathology (ie, gluteal tendinopathy or tendon rupture) is a relatively new diagnosis. This patient group has previously been described as a clinical dilemma due to the often-short-lived effects of treatment. In the process of identifying the underlying pathology, however, more targeted treatment strategies have been explored. Recent research recommends exercise as a first-line treatment for this patient group along with patient education. However, patients seen in a hospital setting (secondary healthcare) often present recalcitrant lateral hip pain, tendon ruptures and multiple comorbidities. Whether patient education and exercise therapy are beneficial for patients in secondary healthcare has only been sparsely investigated. Therefore, this study aims to investigate changes in lateral hip pain following a 3 month physiotherapist-led patient education and exercise intervention in patients with MRI-proven hip abductor tendon pathology seen in a hospital setting.

In this prospective cohort trial, 60 patients, presenting lateral hip pain and MRI-verified hip abductor tendon pathology at the orthopaedic outpatient clinic at Horsens Regional Hospital, Denmark, a public teaching hospital, are included. Hip abductor tendon pathology will be diagnosed by clinical tests and MRI. The intervention consists of seven physiotherapist-led patient education and exercise sessions at the hospital during 3 months. The instructions will guide the patients in their daily home-based exercise sessions.

The primary outcome is change in lateral hip pain measured by the ‘pain’ subscale from the patient-reported outcome measure: the revised Copenhagen Hip And Groin Outcome Score (HAGOS). Secondary outcomes are changes in the remaining subscales of the revised HAGOS, Oxford Hip Score, Victorian Institute of Sports Assessment-Gluteal Questionnaire, European Questionnaire-Five Dimensions Five-Level, lateral hip pain (numeric rating scale score, 0–10), hip muscle strength and the 30 s chair stand test. Also, patient-reported Global Rating of Change in hip condition, as well as adherence and harms, will be reported.

This trial has been accepted by the Central Denmark Regions Ethics Committee (1-10-72-136-22). The study is registered at the Central Denmark Region List of Research Projects (Journal No 1-16-02-180-24) and clinicaltrials.gov (NCT06418217).

All results from this study, regardless of the direction, will be published in a peer-reviewed journal and presented at national and international congresses.

NCT06418217.

The healthcare sector has significant environmental impacts, particularly through greenhouse gas emissions. Reducing its climate footprint is therefore essential for achieving political goals such as net-zero and climate-friendly healthcare. While health economic evaluation (HEE) methods compare the costs and consequences of two or more interventions, these analyses rarely consider climate impacts. Some studies have begun to determine climate impacts parallel to or integrated into HEEs. Life cycle assessment (LCA) could be used to integrate climate impacts by considering these results as effects or monetised climate footprints. However, a reporting standard is needed for using these climate-extended economic evaluations in evidence-based decision-making. This protocol describes using an online Delphi process to incorporate climate impacts into the Consolidated Health Economic Evaluation Reporting Standard (CHEERS), called CHEERS Climate Extension (CHEERS ClimatE).

The development of CHEERS ClimatE will proceed through five key stages. First, the preliminary steering group develops in consultation with an advisory board a proposal for the CHEERS ClimatE reporting standard based on a transparency checklist that combines three standards for carbon footprint calculations into the CHEERS framework. The mapping was complemented by reviewing studies that incorporate climate impacts in HEE. Second, for the Delphi process, international experts in HEE and LCA with at least one year of academic experience will be invited to participate in an online pre-survey. We aim to recruit at least 40 participants. Expecting various drop-outs, we aim to reach a consensus with at least 20 participants per Delphi round. Third, an expected three-round Delphi process will be conducted to validate and refine the proposed elements. Participants will rate each item using a 9-point Likert scale and will have the opportunity to comment on each item and propose new items. Consensus is defined with the target of a 70% agreement. Unless consensus is reached, a moderated video conference may be held as a fourth round. Fourth, following other CHEERS extensions, the consented checklist will be piloted using thematically relevant case studies. While substantial changes are not anticipated, minor revisions to individual items may be considered and ratified by the steering group and advisory board. The fifth stage is the publication of the final checklist.

This study has been approved by the ethics committee of the University of Bremen (2024–25). The findings of the Delphi study will be published in a peer-reviewed journal and presented at conferences.

There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.

We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.

The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.

It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).

NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.

Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.

The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.

The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.

NCT06678438.

Regular physical exercise has well-known health benefits and is generally considered safe for adults with congenital heart disease (ACHD). However, many individuals with ACHD remain insufficiently physically active. This study explored the barriers and needs related to physical exercise as experienced by people with ACHD to inform the development of tailored strategies that support and promote increased physical activity.

Qualitative study using semistructured interviews conducted between March and May 2023. The interview guide was based on the Fear Avoidance Model, Tampa Scale for Kinesiophobia Heart and European Society of Cardiology guidelines on sports cardiology and exercise for cardiovascular diseases. Interviews were coded and thematically analysed to identify specific physical exercise barriers and needs.

Data saturation was reached after interviewing 19 individuals living with ACHD (median age 46 years (range 24–75), 10 women). Thematic analysis identified four main barriers: (1) physical symptoms and negative past experiences, (2) alienation from peers, (3) perceived decline in physical fitness over time and (4) lack of knowledge about personal physical boundaries. Two needs were identified: (1) personalised, disease-specific exercise information and advice and (2) structured support and guidance from healthcare professionals.

People with ACHD face multiple barriers to engaging in physical exercise. There is a clear need for specific, personalised exercise advice from healthcare providers and the development of long-term programmes and interventions to overcome relevant barriers.