The principal aim of our study is to provide a comprehensive overview of the trends in vascular intestinal disorder (VID) mortality with respect to different demographic factors and identify which patient populations are at the highest risk for mortality. Secondarily, we aim to examine and discuss the underlying reasons behind disparities in mortality rates.

Retrospective ecological study.

Centers for Disease Control and Prevention’s Wide-Ranging Online Data for Epidemiologic Research Multiple Causes of Death database of US residents.

375 938 patients residing in the USA ≥15 years old with VID listed on their death certificate between 1999 and 2022.

None.

Age-adjusted mortality rate (AAMR) across the overall population and stratified by gender, race, census region and urban/rural location.

There were 375 938 deaths overall, with 61.5% of deaths occurring in females and 38.5% in males. The overall AAMR was highest in 1999 and lowest in 2018, increasing from 2019 to 2021. American Indian and Alaska Native patients had the highest overall AAMR for the majority of the study period. In contrast, Asian or Pacific Islander individuals had the lowest overall AAMR. On average, AAMR was highest in the Midwest and lowest in the Northeast. For most of the study period, AAMR in rural areas remained higher than in urban areas.

While VID mortality has decreased overall, this study has revealed several nuances demonstrating disproportionately higher mortality among certain demographic groups and geographic areas. Efforts to improve preventative care, early diagnoses and effective interventions for these groups are necessary and would make a significant impact on the overall mortality from VID in the USA.

Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.

Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

NCT03991728.

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

Self-efficacy is a major factor in enabling individuals to follow behavioural goals. This applies to health behaviours including physical activity and exercise behaviour, a health topic especially important for persons suffering from health conditions. In subjects with already existing conditions, self-efficacy in exercise behaviour is a research field with a high volume of published articles, yet it has never been charted in its entirety. This systematic evidence map (SEM) provides a comprehensive overview of the current state in published empirical research.

Collecting, categorising and visualising the breadth of evidence via SEM following the Methods of Evidence Mapping by Schmucker et al.

Medline (via PubMed) and PsycINFO (via EbscoHost).

We searched for the terms ‘self-efficacy’ and any of the search terms ‘sport’ and ‘exercise’ in titles and abstracts. We included all empirical research studies published until 2022 that measured self-efficacy in relation to exercise. This SEM includes all studies on humans with a pre-existing condition. We extracted the data points authors, title, year, sample size (N), age groups, pre-existing condition(s), surveyed sport and method of measuring self-efficacy.

We extracted the data points from the full text (if available). In addition to a data table, we created a freely accessible evidence map in the form of graphs in this article.

The number of publications grew over time from single publications per year in the 1980s to over 100 per year in the beginning of the 2020s, adding up to 1342 included studies. Most research focuses on middle-aged and older adults. Research covers a wide variety of conditions, with endocrine, nutritional and metabolic diseases (22%) as well as diseases of the circulatory system (19%) being the most common disease groups. Most included studies (71%) do not specify a sport. Most (55%) papers used validated scales to measure self-efficacy, and we discovered 235 individually named scales among them.

This paper offers the first ever comprehensive list of empirical publications on self-efficacy in exercise behaviour in persons with pre-existing conditions in the form of a SEM. The research field was as wide as anticipated concerning total numbers, number of individual scales for measuring self-efficacy, as well as range in diagnosed conditions. Most research focusing on advanced age may be due to many diseases only manifesting later in life, and the lack of specification in types of sport points to the choice of sport being less important than getting enough exercise in general. Future research should examine the strength of evidence and the robustness and comparability of self-efficacy scales as well as underrepresented disease groups for public health considerations.

Since no primary data was collected, an ethics approval is not required for the presented work. In addition to the result being disseminated via the publication at hand, the data is being shared in detail via the Open Science Framework platform.

Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.

The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.

The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.

The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.

Cardiac surgical procedures are associated with a high incidence of postoperative infection, a risk attributed to their inherently invasive nature and extended duration. The goal of this study is to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with standard dressings in preventing sternal scar dehiscence in patients undergoing cardiac surgery via complete vertical midline sternotomy, comparing a 3 day change system (NPWT 3/7 d) versus a 7 day wear system (NPWT 7d) versus standard dressings.

The PRISTER study is a prospective open-label multicentre, randomised, controlled, three-arm trial. Patients aged ≥18 years and meeting all the following inclusion criteria: patients undergoing scheduled or semiurgent cardiac surgery, with or without extracorporeal circulation, and patients managed by complete vertical median sternotomy will be recruited. Total sample size will consist of 660 patients. The primary outcome, surgical wound dehiscence after complete median sternotomy, expressed as occurrence or non-occurrence during the first 30 postoperative days, will be assessed by tablet calibrated photos analysed by an independent blinded staff. The secondary outcomes will be the number of dressing repairs between D7 (excluding initial protocol) and D90, length of initial hospital stay, occurrence of surgical site infection and its classification collected on day 90 (D90), use of an anti-infectious treatment and its duration, incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples, incidence of surgical revision for dehiscence of the surgical wound at D90 and collection of all operations involving surgical revision of the sternotomy wound, number of rehospitalisations (including hospital consultations) and their duration (evaluated at D90). Medicoeconomic assessment will be assessed by evaluation of hospital and extrahospital costs (number of days in hospital, consultations, rehospitalisations, imaging, biology and drugs), dressing costs and patient quality of life by EQ-5D-5L.

The study was approved by the French Agency for the Safety of Health Products (ANSM, Agence National de Sécurité du Médicament) as well as by the Ethics Committee (CPP Ile de France VIII) N°ID-RCB: 2023-A01782-43. Recruitment began in April 2024 and ended on 26 May 2025.

clinicaltrials.gov NCT06207630.

Refugees experience significant health needs and well-being inequities. Smoking tobacco, nutrition disorders, alcohol use and physical inactivity are potential contributors to developing non-communicable diseases and mental health conditions. This study aims to explore refugees’ health promotion needs in a regional town in New South Wales (NSW), Australia, suggest appropriate health promotion methods, and co-design a health promotion intervention. Privileging refugees’ voices and experiences is central to co-designing appropriate health promotion interventions.

We will employ a two-phase participatory qualitative co-design method. As there is a lack of knowledge about refugees’ health needs, a participatory research design has the potential to explore the topics holistically. The social–ecological model and the behaviour change wheel model will guide this study. During Phase 1, a semistructured interview guide will be used for in-depth interviews and focus group discussions with refugees. A deductive reflexive thematic analysis will be applied to analyse data using NVivo. In Phase 2, two workshops will be conducted with refugees and health professionals. A reflexive thematic analysis will be performed to identify the top health promotion strategies.

Ethical approval was obtained from the Human Research Ethics Committee (HREC) of the North Coast NSW Local Health District (HREA370 2023/ETH00444). The Human Research Ethics Committee approved a minimisation of duplication at a regional university in Australia (SCU HREC 2024/106). Study findings will be disseminated through embedding chapters in the PhD thesis, publishing high-quality papers and presenting at conferences, lay reports, newsletters and media.

Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.

We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.

Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.

NCT06156176

Despite the growing volume of research in surgical education (SurgED), the integration of evidence into teaching practice remains fragmented and inconsistent. A structured and continuously updated synthesis is needed to support data-informed curriculum development and promote best practices across training programmes.

This protocol describes the development of a living systematic review and evidence map of SurgED research. Studies will be identified through comprehensive searches of CENTRAL, PubMed and Web of Science, and screened independently by two reviewers, supported by an Artificial Intelligence (AI)-assisted screening tool to improve efficiency. Eligible studies will include both quantitative and qualitative designs involving medical students, surgical residents and faculty. Studies will be categorised across key educational domains such as simulation-based training, competency-based assessment, feedback, mentoring and technology-enhanced learning. The evidence map will be updated at least quarterly, with new studies screened and added in near real-time to ensure that the map remains current and actionable.

As this study does not involve human participants, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, presentations at national and international conferences and open access integration into the Evidence at a glance (EVIglance) evidence platform.

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.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.

This prospective, population-based observational study will include newborns ≥36 weeks’ gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.

Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.

ClinicalTrials.gov ID: NCT06322732.