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This study aimed to determine the associations between adherence to the 24-hour movement guidelines and symptoms of anxiety and depression among Colombian university students.
Cross-sectional study.
1125 individuals (mean age 20.2±2.5 years; 56.7% female).
Students sampled from a single public university.
Participants completed validated self-report instruments: the International Physical Activity Questionnaire-Short Form to assess physical activity (PA), sedentary behaviour (SB) and the Pittsburgh Sleep Quality Index to assess sleep duration. Symptoms of depression and anxiety were measured using the Hospital Anxiety and Depression Scale, with a score of ≥11 used to classify elevated symptoms. Binary logistic regression models were used to estimate associations between adherence to the 24-hour movement guidelines (meeting all three, two, one or none) and mental health outcomes, adjusting for potential confounders.
Only 15.5% of students met all three components of the 24-hour movement guidelines. Meeting a greater number of components was significantly associated with lower odds of depressive and anxiety symptoms. In fully adjusted analyses, students who met all three guidelines were less likely to report anxiety symptoms (OR=0.26; 95%CI 0.13 to 0.54) and depressive symptoms (OR=0.42; 95%CI 0.22 to 0.79) compared with those who met none. Among individual behaviours, sufficient PA and adequate sleep were independently associated with lower odds of both outcomes, whereas high SB was associated with higher odds of elevated symptoms.
In this cross-sectional study, adherence to a greater number of 24-hour movement guideline components was associated with lower levels of anxiety and depressive symptoms in a graded manner. However, the cross-sectional design precludes inference regarding directionality or causality, and bidirectional associations or residual confounding remain possible. Longitudinal and interventional studies are needed to determine whether integrated daily movement behaviours influence mental health outcomes in young adults, particularly in Latin American populations.
Approximately 40% of women stop endocrine therapy for hormone-receptor-positive breast cancer within the first 5 years of prescribed treatment because of side effects. Musculoskeletal complaints are among the most frequently reported side effects. The Cancer Of the BReast Asanas (COBRA) study examines the effect of an 18-week yoga programme on endocrine therapy-associated musculoskeletal complaints in women with breast cancer.
In total, 140 women will be randomised in a 1:1 ratio to the intervention or waitlist control group. The intervention programme consists of two times a week 1-hour supervised Hatha or (easy) Vinyasa yoga classes at a yoga or sports centre for 18 weeks and once per week a half-hour at home using videos. The waitlist control group is asked to maintain their habitual lifestyle during the first 18 weeks and will participate in a similar yoga programme to the intervention group for the following 18 weeks. The control group yoga programme is offered live-remote. The primary outcome (musculoskeletal complaints) is assessed with the Brief Pain Inventory questionnaire at baseline and 18 weeks (primary comparison) and additionally at 36 weeks. Secondary outcomes include lower and upper extremity joint complaints, menopausal symptoms, fatigue, sleep, quality of life, anxiety and depression, cognitive complaints and habitual physical activity (all patient-reported), vital signs and anthropometrics, physical fitness, blood biomarkers, medication use, safety data and patient and teacher experiences. At baseline and 18 weeks, cognitive complaints are also assessed with an online neuropsychological test battery.
The COBRA study was approved by the Medical Ethical Committee of the University Medical Center Utrecht. The study started on 8 October 2024, and 65 participants have been included (20 January 2026). Results will be submitted to an international peer-reviewed journal.
Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalance in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often relies on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell secretomes, are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.
A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne.
This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies.
Weight stigma and internalised weight bias are associated with poor mental, social and physical health. Weight-neutral approaches prioritise well-being and sustainable health behaviours. However, the feasibility and acceptability of weight-neutral interventions remain uncertain.
Weight-Neutral Health Intervention (WIN) is an investigator-initiated single-arm feasibility study enrolling 56 adults with body mass index ≥30 kg/m2 in the Capital Region of Denmark. The study investigates a codesigned weight-neutral health intervention. The 6-month intervention comprises 1 preparatory session and 11 group sessions led by trained practitioners, focusing on intuitive eating, body acceptance and self-compassion; optional components include support-network events, up to three individual online sessions and access to ‘size-inclusive yoga’ and ‘body competence’ courses. The primary feasibility outcome is follow-up completion. Recruitment proportion and adherence are secondary feasibility outcomes. These will be assessed using a set of predefined ‘traffic-light’ stop/go progression criteria. Exploratory feasibility outcomes include data completeness for other outcomes and participant engagement with the intervention. Exploratory clinical outcomes include questionnaire data (quality of life, depression, weight bias internalisation, eating behaviours, self-esteem, body image, stress and life satisfaction), clinical measures (weight, heart rate and blood pressure), biomarkers (blood samples and hair cortisol), 7-day actigraphy (physical activity and sleep) and serious adverse events. Qualitative interviews, focus groups and fieldnotes will be used to explore acceptability and contextual factors. If progression criteria are met, the study will inform the design of a pragmatic, multicentre, randomised trial. The exploratory outcomes will inform outcome selection, setting, sample size and procedures.
Approved by the Regional Ethics Committee of the Capital Region of Denmark (H-25013213). Results will be disseminated through peer-reviewed publications, conferences and public platforms.
Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.
The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).
A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.
The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.
ACTRN12618000932268.
We aim to identify trajectories of probable maternal common mental disorders (CMD), as well as risk and protective factors associated with maternal mental health among postpartum women during the pandemic using life course theory approach.
Prospective individual level cohort study from the Iracema-COVID Study.
Mothers (n=335) at postpartum period who delivered during the COVID-19 pandemic in the fourth largest city in Brazil.
Probable CMDs were accessed using validated instruments in five cohort waves at postpartum period. Sequence analyses (SA) were employed to extract CMD trajectories, and a set of generalised binomial logistic and log-Poisson multivariable regression models with robust variance were employed to assess risk and protective factors for probable CMDs diagnosis.
Trajectories patterns of probable maternal common mental disorders.
Fit indices demonstrated a two-cluster-SA solution of probable CMD. The patterns of probable CMDs indicated that 335 mothers were clustered into occasional/transitory (n=240, 71.64%) and mostly/persistent (n=95, 28.36%) CMD trajectories. We found that mothers with low education (OR: 2.44; 95% CI 1.13 to 5.23), single (OR: 1.97; 95% CI 1.03 to 3.75) or in a stable union (OR: 2.00; 95% CI 1.02 to 3.90) and travel time spent to access the nearest primary healthcare unit (OR: 1.02; 95% CI 1.006 to 1.04) were associated with increased OR of belonging to the mostly/persistent CMD trajectory. Deprived green areas acted as a risk factor to maternal CMDs prevalence (OR: 1.37; 95% CI 1.002 to 1.87).
This study provides evidence that individual vulnerabilities and neighbourhood deprivation play an important role in understanding maternal mental health, beyond the patterns and trajectories of probable maternal CMD due to issues confronted during the COVID-19 outbreak in the northeastern region of Brazil. Policies to prevent and treat maternal mental health issues and improvement in neighbourhood deprivation need to be developed and addressed to avoid exacerbation of probable maternal CMDs.
Antenatal care (ANC) plays a critical role in improving maternal and neonatal health outcomes. However, incomplete ANC attendance in Somaliland is associated with adverse maternal and birth outcomes. Barriers to ANC attendance may increase the risk of pregnancy-related complications, including maternal morbidity, mortality and poor neonatal health outcomes. Understanding the effect of ANC attendance on maternal and birth outcomes is crucial for informing policies and interventions aimed at reducing these risks. Hence, this study aimed to assess the effect of ANC attendance on maternal and birth outcomes in Somaliland.
A prospective cohort study was conducted among 1205 pregnant women enrolled by systematic sampling method.
The study was conducted in the Republic of Somaliland, which is situated in the Horn of Africa. Baseline data were collected at recruitment, and participants were followed up to delivery for the collection of outcome variables. The number of ANCs was considered to be a dichotomous independent variable; incomplete attendance (≤ 3 visits) and complete attendance (≥4 visits). The risk of pregnancy outcome among those with incomplete ANC was assessed using multi-variable logistic regression.
The outcome variables of the study were the maternal and birth outcomes. The independent variables included socio-demographic characteristics, such as age, residence, educational status, occupation, family size, wealth index and marital status, and reproductive factors, such as parity, gestational age at first ANC visit, current pregnancy desirability and previous pregnancy history.
Out of the total participants, 43.3% of women had complete attendance. The incidence of postpartum haemorrhage was 10.0% (95% CI 8.6 to 12.3); antepartum haemorrhage, 3.6% (95% CI 2.6 to 4.7); caesarean section, 14.8% (95% CI 12.9 to 16.8); preterm delivery, 13.7% (95% CI 11.7 to 15.4); low birth weight, 25.8% (95% CI 23.4 to 28.1); and stillbirth, 3.2% (95% CI 2.3 to 4.2). Complete attendance to ANC significantly reduced the risk of antepartum haemorrhage, caesarean section, preterm delivery and admission to the neonatal intensive care unit and stillbirth.
Nearly more than half of women in Somaliland had less than four ANC visits. The incidence of maternal and birth complications is higher among pregnant women who attended
To address whether eating disorders (ED) or insulin omission (IOM) in adult persons living with type 1 diabetes (pwT1D) are associated with impaired glycaemic control.
Cross-sectional analysis.
The French-Speaking Diabetes Society—Type 1 Diabetes Cohort (SFDT1) is an ongoing epidemiological cohort study that includes pwT1D in France who attend hospitals or private ambulatory diabetes centres.
Adult participants from the SFDT1 study, with data on ED and IOM. The current analysis was performed on data collected during the baseline visit in participants enrolled between December 2020 and March 2024.
Using the SCOFF, a self-reported questionnaire to screen for ED, and a single question on IOM to screen for IOM, we described four categories of pwT1D: no ED & no IOM, ED & no IOM, no ED & IOM and ED & IOM. We performed unadjusted and adjusted (for age, sex, diabetes duration, social vulnerability, smoking, alcohol status and insulin treatment) multinomial logistic regression models with the four categories as the outcome and glycaemic variables as explanatory variables, including continuous glucose monitoring (CGM) variables and HbA1c. No ED & no IOM was the reference outcome for all comparisons. We stratified each model by sex and fear of hypoglycaemia.
We included 1113 participants, 51% males, median (IQR) age 38 (29–50) years, diabetes duration 21 (12–32) years. Prevalences were as follows: no ED & no IOM: 68% (n=758), ED & no IOM: 11% (n=124), no ED & IOM: 16% (n=177) and ED & IOM: 5% (n=54). With the fully adjusted model, and compared with the group no ED & no IOM, time in range (OR (95% CI) 0.5 (0.4 to 0.7)) and time below range (0.5 (0.3 to 0.8)) were inversely associated with ED & IOM. Moreover, time in range (0.4 (0.4 to 0.5)) was associated with IOM & no ED. Time above range (2.2 (1.6 to 2.9)), Glycaemic Risk Index (1.8 (1.3 to 2.5)), glucose monitoring indicator (2.2 (1.7 to 2.9)) and HbA1c (2.0 (1.5 to 2.5)) were directly associated with ED & IOM. We did not observe associations between CGM variables and ED & no IOM. Most associations were valid in both men and women. The associations were stronger in participants with a fear of hypoglycaemia. However, the associations remained even in people with a fear of hypoglycaemia.
Both ED and IOM are frequent in pwT1D, and IOM seems to be associated with impaired glycaemic control. As our analysis was cross-sectional, we cannot infer causality and cannot know whether IOM was a result of glycaemic control or the inverse (reverse causality). Our results suggest that IOM should be systematically screened in clinical practice. Further research is needed to better identify and care for EDs, with or without IOM, in T1D.
Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.
TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including 18F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).
The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.
Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.
The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.
Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.
Health literacy (HL) is defined as the ability to access, understand, evaluate and apply health-related information, which can influence individuals’ health outcomes. Blue-collar workers, who often have lower educational attainment and experience language barriers, are at increased risk of limited HL. This systematic review aims to assess the prevalence of limited HL among blue-collar workers to inform the development of appropriate interventions for its improvement.
The systematic review will assess the prevalence of limited HL among blue-collar workers. We will include all quantitative study designs using any instrument for measuring general HL. We will exclude studies that focus on specific types of HL and specific health conditions. We have performed a literature search from inception up to 30 April 2025, in the Medline, Embase, CINAHL, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) databases. We will also search eligible articles from Google Scholar and Open Grey as sources of unpublished studies/gray literature. Two independent reviewers will conduct the primary screening of articles, data extraction and quality assessment (using the Cochrane risk-of-bias tool for randomised trials and risk of bias in non-randomised studies of exposure), with a third individual available to resolve conflicts. We will assess heterogeneity using the ² test and I² test. If there is sufficient homogeneity, we will pool studies in a meta-analysis or summarise the findings narratively if heterogeneity is too high. We will use a random effects model for our analysis, and we will use funnel plots to evaluate potential publication bias. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to assess the certainty of findings.
Ethical approval will not be required for this review as there is no primary data collection involving humans. The results will be published in a peer-reviewed journal and presented at relevant conferences.
CRD42024597732.
Using network analysis, which takes a holistic approach to health systems, we aimed to identify which psychosocial burden dimensions are the most central and, thus, critical to prioritising to improve the overall health of people with type 1 diabetes (PwT1D).
A cross-sectional network analysis.
We used data from participants attending 44 diabetes centres in France, who were enrolled in the SFDT1 cohort study between June 2020 and February 2024.
We included 1430 PwT1D (52% women, median age (IQR) 41 (31–52.8) years) who had completed questionnaires on diabetes burden.
The items from questionnaires on diabetes distress, fear of hypoglycaemia, quality of life, treatment burden and the impact of diabetes on education and work.
The network was highly stable (correlation stability coefficient=0.75). We observed nine domains within the network; ‘Loneliness, Worrying & Burnout’ was the most influential. We further grouped the domains into three distinct syndromes labelled ‘Diabetes Distress’, ‘Treatment Burden’ and ‘Impact of Diabetes on Life’. These syndromes reflect the most relevant pillars of the psychosocial burden in PwT1D.
We observed that ‘Loneliness, Worrying & Burnout’ is the most influential psychosocial burden network domain to prioritise for type 1 diabetes care. This new network-based approach opens the path to defining personalised interventions targeting the most critical burden parameters to expect the most significant overall beneficial impact on PwT1D’s health.
To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).
Observational study.
14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.
Eight systematic reviews were rated by all reviewers using AMSTAR-PF.
Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.
Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.
Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.
The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.
This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.
The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.
This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.
The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.
Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.
This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.
This study has ethical, Health Research Authority and participating NHS Trust approvals.
Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.
Few studies have examined how psychosocial risk and protective factors in adolescence shape mental health outcomes and other multimorbid conditions in adulthood, particularly among Canadian youth. The Research on Eating and Adolescent Lifestyle (REAL) 2.0 study was a 15-year follow-up cohort study designed to investigate how early etiological factors, including body image and disordered eating symptoms in adolescence, contribute to the development of eating, weight-related concerns, mental health and substance use health problems in early adulthood. In this paper, we describe the REAL 2.0 cohort’s demographic and clinical characteristics alongside an overview of the study procedures, laying the groundwork for collaboration on future learnings with this unique data.
The cross-sectional REAL study initially surveyed middle and high school students from 2004 to 2010 (n=3043) across 43 schools in the Ottawa, Canada region. Of those, respondents in grade 7 or 9 (n=1197 from 25 of the 43 original schools) were asked to participate in a longitudinal arm of the study that consisted of yearly follow-ups. From the longitudinal cohort, there were 278 participants (29.1% male; Mage=28.6) from those who consented to be re-contacted (n=912), who completed the REAL 2.0 survey electronically (30.4%), providing comprehensive data on demographic, clinical, eating and weight-related behaviour, psychological, social, environmental and substance use health factors in adulthood.
9.4% of REAL 2.0 participants met DSM-5 criteria for an eating disorder, while 17.6% met criteria for disordered eating. Moderate to severe anxiety was reported by 28% of participants, while 21.6% experienced moderate to severe depressive symptoms. Regarding substance use, 16.9% engaged in hazardous drinking, 16.9% used cannabis daily or almost daily, and 4.3% reported daily tobacco use.
REAL 2.0 has the potential to answer multiple research questions about several mental health outcomes, but its priority focus is to answer questions related to risk and protective factors of multimorbidity in adulthood. Additionally, profiling work, linked to health service utilisation data for systems planning work and predictive modelling studies are secondary goals. By leveraging the Health Data Nexus (HDN) platform, we welcome collaboration with interested researchers who would like to utilise the breadth of data both in adolescence and adulthood to answer other pertinent aetiological questions in mental health and substance use health outcomes. Future plans to conduct additional follow-ups remain feasible.
Primary aldosteronism (PA) is a highly prevalent but underdiagnosed cause of hypertension, characterised by renin-independent aldosterone production. PA is associated with a higher incidence of cardiovascular and kidney complications, independent of blood pressure. Although mineralocorticoid receptor antagonists (MRAs) are the standard treatment when surgical adrenalectomy is not clinically indicated or possible, response is typically monitored using indirect clinical markers such as blood pressure and potassium. Emerging evidence suggests that achieving renin unsuppression may result in better outcomes, yet this hypothesis has not been tested in a randomised controlled trial. The objective of this trial is to evaluate whether a renin-guided MRA titration strategy improves biochemical efficacy compared with standard titration in patients with PA.
This is a multicentre, open-label, pragmatic randomised controlled trial in four academic centres in Canada. 58 adults with confirmed PA, suppressed renin at baseline, and an indication for long-term MRA therapy will be enrolled. Key exclusion criteria include prior MRA use, estimated glomerular filtration rate 4.8 mmol/L and pregnancy. The primary endpoint is the proportion of participants with unsuppressed renin at 12 months. Secondary outcomes include blood pressure, left ventricular mass, kidney function, MRA dose, quality of life and various safety outcomes. Participants will be randomised 1:1 to a renin-guided titration strategy or standard care. In the intervention arm, MRAs will be titrated to achieve unsuppressed renin (>10 ng/L, >15 mIU/L or >1.0 ng/mL/hour). The control arm follows usual clinical practice, without serial renin measurements during dose titration. All participants will be followed for 12 months, with visits at 1, 3, 6, 9 and 12 months. Analysis will follow the intention-to-treat principle and use Fisher’s exact test for proportions, mixed-effects models for continuous outcomes and Kaplan-Meier estimates for time-to-event data. The trial is powered to detect a 42% absolute difference in the primary outcome (40% in the control groups vs 82% in the experimental group; alpha 0.05, 80% power, 15% loss to follow-up). This trial will be the first to prospectively assess the biochemical efficacy of a renin-guided MRA titration strategy in PA. If successful, the next phase will be to assess the efficacy of this strategy on important surrogate outcomes and patient-reported outcome measures.
This study was approved by the Research and Ethics Board of the Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal (project number 2024-2727). All the participating sites have received the ethics approval. The findings will be disseminated through national and international presentations and peer-reviewed publications.
Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.
This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.
The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.
Several antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.
We will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.
The Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.
In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.
We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.
This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.
NCT06719245. Dutch trial registry: NL87196.058.24
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