Postextubation swallowing disorders (SD) are common in the intensive care unit (ICU) and are associated with severe complications, including aspiration pneumonia, a three-fold increase in reintubation risk and higher mortality. While fibreoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy are gold standards for diagnosis, they are often impractical or impossible to perform on intubated patients. The use of ultrasound offers a non-invasive, bedside alternative to evaluate the musculoskeletal structures involved in swallowing. The Echographie Identifier les troubles de Déglutition Acquis en Réanimation (EIDAR) study aims to evaluate the diagnostic performance of pre-extubation ultrasound in identifying patients at risk of SD following mechanical ventilation.

This prospective, monocentric diagnostic study conducted at the Dijon University Hospital ICU will include 100 adult patients ventilated for ≥48 hours. The primary outcome is the presence of SD, defined as a Penetration-Aspiration Scale score >2 during a FEES procedure performed 3 to 24 hours postextubation and independently assessed by an otolaryngologist blinded to index test results. Pre-extubation cervical ultrasound (Index Test) will be performed within 3 hours prior to extubation and measure hyoid bone ascension (primary variable of interest), geniohyoid muscle surface area and digastric muscle cross-sectional area. The diagnostic performance of cervical ultrasonographic parameters will be assessed using their discriminative capacity via a receiver operating characteristic curve. The feasibility of the ultrasound procedure in a critical care setting will also be assessed.

The study received a favourable opinion from the independent ethics committee CPP Ouest III and is registered with the French health authority ANSM (national agency on safety in medicine and health products). It is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Participants or their proxies provide free and informed oral consent. Results will be submitted for publication in peer-reviewed medical journals and presented at international conferences.

RCB 2023-A00461-44 and NCT05922085

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (² p

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

NCT04610515.

Hypertension is the leading global risk factor for mortality, causing over 10 million deaths annually. In sub-Saharan Africa, hypertension prevalence is high, particularly in rural areas, where it is less likely to be diagnosed, treated or controlled effectively. This results in a high burden of complications, including heart failure, stroke and kidney disease. Community-centred approaches using community health workers (CHWs), risk-based approaches and simplified treatment regimens have shown promise in improving hypertension management. However, there is limited evidence on the effectiveness of such approaches in rural sub-Saharan Africa.

The primary aim of this study is to assess the feasibility of a community-centred intervention for hypertension management in rural Kenya and The Gambia. The objectives are to evaluate the intervention’s adoption, fidelity, reach and dose; understand the mechanisms of action and contextual factors affecting its implementation; assess acceptability from the perspectives of patients, healthcare providers and policymakers; estimate the costs associated with the intervention; and evaluate study procedures to inform the design of a future full-scale trial.

We will conduct a mixed-methods, non-randomised, single-arm feasibility study, designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) framework and checklist for feasibility and pilot studies, including best practice guidance for non-randomised feasibility studies. The study will be conducted in two rural sites: Kilifi, Kenya and Kiang West, The Gambia. The intervention was codesigned with stakeholders and includes community-based hypertension screening by CHWs, risk stratification and hypertension-mediated organ damage assessment at primary healthcare facilities, followed by treatment initiation using single-pill combination (SPC) antihypertensive therapy for eligible individuals. Training will be provided to all healthcare providers involved in the study. We will screen 500 participants aged 30–80 years at their residence (250 from each country), and we expect that about 45% will be referred for additional assessments and of these 25% (or 10% of the total sample) will be prescribed treatment with SPC. Data collection to evaluate the intervention and its implementation will involve quantitative measures of feasibility and clinical outcomes; observations to assess fidelity and costing measures; and qualitative interviews and focus group discussions with patients, healthcare providers and policymakers to understand the acceptability and contextual influences on intervention implementation.

Ethics approval was obtained from the Kenyan National Committee for Science, Technology and Innovation (ref: 415561), the Gambia Government/Medical Research Council Joint Ethics Committee (ref: 31372) and the London School of Hygiene and Tropical Medicine Ethics Committee (ref: 31372). Study findings will be disseminated through peer-reviewed publications, conferences, policy briefs, community engagement forums and accessible summaries shared via the Improving Hypertension Control in Rural sub-Saharan Africa and partner newsletters.

This study is registered with the ISRCTN- The UK’s Clinical Study Registry (ISRCTN81228019), and Pan African Clinical Trials Registry (PACTR202504839027548).

Given the role of emotions in reasoning, we hypothesised that emotional competence (EC), defined as the ability to identify, understand, express, regulate and use emotions, would increase the quality of physician’s clinical reasoning (CR). The objectives of this study were to map the existing literature on the impact of EC on physician’s CR and to identify any literature gaps.

This study is a scoping review.

We included articles from Medline (via Ovid), Embase and Psychinfo and articles found manually, with no limitations in terms of publication date or location.

Inclusion criteria were all physicians and medical students and articles focusing on one or more dimensions of EC (based on the model of Mikolajczak et al) and of CR (based on the framework of Young et al). We excluded non-research articles and articles concerning other health professionals, physicians’ psychiatric disorders or the impact of emotions on well-being, instrument-handling skills or students’ academic learning.

Data were extracted by two independent reviewers. Results were summarised using descriptive analyses and a narrative synthesis.

After removing duplicates, we identified 12 046 articles. Following a review of their titles and abstracts, we assessed 268 articles for eligibility and included 98 in the scoping review. Most studies examined the effects of emotional regulation strategies, empathy and global EC scores on clinical performance. Positive effects of EC on uncertainty management and intuitive reasoning have been well documented, as have its effects on diagnostic and therapeutic performance and the development of CR in the context of life-threatening situations. A smaller number of studies suggest a favourable impact on clinical performance in the surgical context and on the quality of prescriptions. The impact of EC on diagnostic and therapeutic performance outside emergency and intraoperative contexts and on patient outcomes remains uncertain. The effects of EC on CR were most evident under conditions of high acute stress, likely due to the increased cognitive load associated with such conditions.

EC has been found to have a positive impact on CR mainly when dealing with uncertainty and life-threatening emergencies. Stress regulation and the resulting reduction in cognitive load appear to be a key modulator of EC’s impact on CR. Further research should focus on the impact of EC on diagnostic and therapeutic performance outside emergency conditions and on patient outcomes.

The BioCaPPE (Biomarkers of Prostate Cancer/Prevention and Environment) study is a multicentre prospective observational cohort designed to identify biomarkers associated with prostate cancer (PCa) risk that may be modifiable through lifestyle factors. This paper describes the cohort, along with the data and bio-samples available for future studies in PCa risk assessment.

Canadian men at risk of PCa were enrolled based on one of two criteria (1) negative first prostate biopsy within 6 months from enrolment (Group 1); or (2) a prostate-specific antigen (PSA) blood level between 2.5 and 10 ng/mL without prior prostate biopsy (Group 2). At baseline, blood samples and comprehensive data were collected. PCa incidence and lifestyle factors were updated for all participants over 2 years, with extended follow-up for those who provided additional consent.

Recruitment was conducted across four health centres in Quebec, Canada. A total of 2053 men were enrolled—1499 in Group 1 and 554 in Group 2. All participants completed the initial visit, which included collection of medical and family history, anthropometric measurements, demographic information, dietary and alcohol intake, physical activity, tobacco use, medication use, and quality of life assessments, and candidate biomarker measurements. At the 2-year mark, 7.2% of participants had developed PCa; this figure has since increased to 15.3% (median follow-up: 6.1 years). Additionally, 84% (n=1718) consented to ongoing annual follow-up.

This large, prospective cohort of men at risk of PCa offers valuable resources for risk stratification and primary prevention. The BioCaPPE biosamples and data are available to support the identification of lifestyle-related biomarkers associated with PCa risk in this population.

ClinicalTrials.gov Identifier: NCT03383016.

Recovery after extremity fracture is influenced by injury-related impairments, functional capacity, symptom severity and psychosocial well-being, emphasising the need for patient-reported outcome measures (PROMs). Despite increasing adoption of Patient-Reported Outcomes Measurement Information System (PROMIS) and legacy PROMs in orthopaedic research, substantial knowledge gaps remain regarding their measurement properties, comparability and clinical utility, particularly in fracture populations. Our aim is to develop meaningful guidance to clinicians regarding the use of PROMs in treating orthopaedic fracture patients.

A prospective cohort of 1500 patients across 14 centres presenting with isolated extremity fractures being treated operatively or non-operatively will be recruited prospectively. We will aim to recruit 300 patients for each of five fracture types: isolated hip, tibial shaft, ankle/pilon, proximal humerus and distal radius fracture. All procedures and management will be performed according to the site’s standard of care and treatment protocol. For patients treated non-operatively, the index visit (first study assessment) will be performed at the first orthopaedic treatment encounter (eg, emergency department visit or outpatient fracture clinic). Surgically treated patients will have PROMs collected anytime from the day of the surgery up to discharge from hospital for the index visit. Follow-up visits will be performed at 2–3 weeks, 6–8 weeks, 10–13 weeks, 6 months and 1 year after the index visit. At baseline, we will document injury data, demographic and sociodemographic data, and radiographic classification using the AO classification system. Patient-perceived functioning will be assessed with PROMIS Physical Function (PF), PROMIS Upper Extremity, PROMIS Global Health, Knee and Injury Osteoarthritis Outcome Score-12, Hip Disability and Osteoarthritis Outcome Score-12, Foot and Ankle Ability Measure and Quick Disabilities of the Arm, Shoulder and Hand. The following domains and PROMs will also be captured: symptoms of anxiety and depression (PROMIS Anxiety; PROMIS Depression), patient activation (Patient Activation Measures (PAM)-10) and a patient’s ability to fulfil social roles (PROMIS Social Roles).

The range and normative limits of the PROMs collected will be defined using standard descriptive statistics. We will crosswalk or validate PROMIS measures with legacy instruments for PF using an Item Response Theory (IRT)-based linking model and compare it to non-IRT models (such as equipercentile linking). Lastly, we will assess the PROM-based recovery trajectory after fracture, overall and after adjusting for relevant demographic, clinical or biopsychosocial factors.

Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board at each of the participating sites prior to patient enrolment. Austin: Institutional Review Board University of Texas at Austin, STUDY00000262; Boston: Mass General Brigham, 2019P000397; Los Angeles: Cedars-Sinai, Office of Research Compliance and Quality Improvement, STUDY00000081; Miami: University of Miami Human Subject Research Office, 20221353; Bogotá: Comité Corporativo de Ética en Investigación, CCEI-15607-2023; Berlin: GoFitFast: under Homburg approval; Recovery/Linking: Ethikkommission Charité Universitätsmedizin Berlin, EA2/026/21; Homburg: GoFitFast: Ethikkommission der Ärztekammer des Saarlandes, 232/19; Recovery/Linking: under Charité approval; Murnau: under umbrella from Homburg and Charité, GoFitFast: under Homburg approval, Recovery/Linking: under Charité approval; Tübingen: GoFitFast: Ethik-Kommission, Universitätsklinikum Tübingen, 393/2022BO2; Freiburg: Ethik-Kommission Albert-Ludwigs-Universität Freiburg, 21–1401; Rostock: Ethikkommission an der Universitätsmedizin Rostock, A 2024–0113; Innsbruck: Ethikkommission der Medizinischen Universität Innsbruck, 1258/2021; Oxford: HRA and Health and Care Research Wales, 20/EE/0051; London: HRA and Health and Care Research Wales, 20/EE/0051; Groningen: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver; Zwolle: Medical Ethics Review Board University Medical Center Groningen, METc 2023/187 16882; Non-WMO waiver. The results of this study will be published in peer-reviewed journals and presented at different conferences.

NCT04113044

To explore the lived experiences of children with type 1 diabetes (T1D) and their caregivers in Armenia, a post-Soviet country, and to identify system-level barriers to care from the community perspective.

Qualitative study using a phenomenological design with inductive thematic analysis.

Muratsan Hospital Complex, the primary national referral centre for paediatric endocrinology, Yerevan, Armenia.

12 children aged 13–17 years with T1D and their caregivers, recruited through purposive sampling across 7 of Armenia’s 10 administrative regions.

Five themes emerged from the data: (1) barriers to care, (2) quality of care, (3) perceived control of T1D, (4) knowledge of T1D and (5) government and non-governmental organisation (NGO) support. Participants described unreliable government-supplied glucose strips, geographical barriers rooted in the centralisation of specialist care in the capital, abrupt withdrawal of state support at age 18, reliance on the KATIL NGO to fill gaps in both clinical and psychosocial support and pervasive stigma encountered across family, school and clinical settings.

Children with T1D in Armenia navigate a post-Soviet health system where provisions exist but remain fragmented, limited by centralised care, geographical barriers and variable support. This unique context shapes the relationship and expectations patients have of the healthcare system. Community perspectives are indispensable in these settings, surfacing system-level gaps that conventional data cannot capture. These findings have relevance for other health systems navigating similar structural transitions.

Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

NCT05415267.