Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.
A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol
The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.
EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.
To identify profiles of compositional movement behaviour patterns among children and examine cross-sectional and 12-month associations with adiposity markers and health-related quality of life (HRQoL).
Secondary analysis of data from the TransformUs cluster randomised controlled trial with cross-sectional and 12-month follow-up analyses.
Primary schools in metropolitan and regional areas of Victoria, Australia.
Children aged 7–11 years with valid accelerometer at baseline, regardless of demographic, adiposity and HRQoL data available (n=792), were included in the analytical sample for the latent profile analysis.
Sedentary time, light-intensity physical activity (LPA) and moderate- to vigorous-intensity physical activity (MVPA) along with their respective mean bout lengths were derived from raw acceleration data. Latent profile analysis used these measures (total times, as isometric log ratios and mean bout lengths) as input variables to classify distinct profiles for us as a categorical exposure variable in regression models. Primary outcomes were age- and sex-standardised body mass index, waist circumference and parent-reported HRQoL at baseline. Secondary outcomes were the same measures assessed at 12-month follow-up.
Four distinct profiles were identified. The high MVPA-short sedentary bout profile (n=184) was characterised by the highest levels of MVPA, moderate sedentary time and the shortest mean sedentary bout duration. The low sedentary-high LPA profile (n=54) had the lowest sedentary time, the highest LPA and the longest mean LPA bout duration. Two profiles were characterised by high sedentary time: the high sedentary-long sedentary bout profile (n=149), which had the longest mean sedentary bout durations, and the high sedentary-shorter bouts profile (n=405), which also had high sedentary time but shorter bout durations for all intensities. While the omnibus Wald test for differences across profiles indicated uncertainty in the overall profile effect, the high MVPA-short sedentary bout profile had favourable adiposity levels cross-sectionally compared with the high sedentary-long sedentary bout reference profile in pairwise comparisons. No longitudinal associations were detected.
Four distinct movement profiles were identified. Few pairwise differences between health outcomes were observed. While MVPA remains a key factor for promoting healthy body weight, our findings suggest that a variety of movement patterns - including those characterised by lower sedentary time and higher LPA - may also support health in children.
This study is a secondary analysis of the TransformUs effectiveness-implementation trial, registered with the Australian Clinical Trials Registry (ACTRN12617000204347; 1 April 2017).
To examine gender-based disparities across each link of the American Heart Association's Chain of Survival for women experiencing out-of-hospital cardiac arrest, highlighting systemic, cultural and educational barriers that compromise equitable outcomes.
A discursive review synthesizing epidemiological studies, public health data and qualitative research on cardiac arrest and gender disparities.
A comprehensive search of databases including PubMed and CINAHL identified studies on gender differences in out-of-hospital cardiac arrest recognition, bystander intervention, emergency response and post-arrest care. Literature was critically analyzed using constant comparative analysis and organized according to the five links of the American Heart Association's Chain of Survival to identify recurring themes and evidence of disparity.
Significant disparities were identified at every link in the Chain of Survival. Women are less likely to have cardiac symptoms recognized, receive bystander cardiopulmonary resuscitation or defibrillation and experience timely or guideline-concordant advanced life support and post-resuscitation care. Contributing factors include implicit bias, underrepresentation of women in resuscitation training materials and social norms that hinder rapid intervention.
Gender disparities in cardiac arrest survival are systemic and multifactorial, resulting in ‘broken links’ across emergency response systems, public perceptions and healthcare education. Addressing these inequities requires reforms in public education, resuscitation training and clinical protocols that prioritize gender-sensitive and inclusive care.
Nurses, as educators, advocates and caregivers, are uniquely positioned to drive transformational change in emergency and cardiac care. By championing women-centered and gender-sensitive resuscitation education, implementing inclusive practices and addressing intersectional barriers, nurses can help ensure equitable, responsive and just care. Advancing these priorities is essential for improving survival and neurological outcomes for women and advancing health equity in global healthcare.
We adhered to the principles of the EQUATOR guidelines. This discursive paper did not meet the criteria for a specific standardized checklist.
No patient or public involvement. This study did not include patient or public involvement in its design, conduct or reporting.
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.
To identify whether patients with arrhythmia, heart failure or ischaemic heart disease presenting with anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) have identifiable anxiety according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) and, if so, which type of anxiety disorder based on the SCID.
Initial screening data from the Heart and Mind randomised clinical trial.
Patients with arrhythmia, heart failure or ischaemic heart disease were screened using HADS, and patients with a HADS-anxiety (HADS-A) score≥8 were invited to participate. Participants were interviewed by trained cardiac nurses using the SCID to determine whether they met the criteria for anxiety and, if so, the type of anxiety disorder.
Of the 7816 patients who completed the HADS questionnaire, 1803 (23%) had a HADS-A score≥8. Among these, 398 (22%) agreed to the SCID interview, and 336 (84%) met the diagnostic criteria for an anxiety disorder. The mean age was 61 years, with 40% being female. The mean HADS-A score was 11.3 (SD=2.7). The most common types of anxiety were generalised anxiety disorder (61%), panic disorder (23%) and specific phobia (8%).
The majority of individuals identified by the instrument also met the diagnostic criteria for an anxiety disorder. Generalised anxiety disorder and panic disorder were the most prevalent subtypes. Anxiety was common across the cardiac population, underscoring the need for routine assessment and targeted intervention in clinical practice.
Healthcare contributes considerably to greenhouse gas emissions, particularly from operating theatres. The global demand for total hip replacements (THR) is rising, highlighting the need to understand its impact on the environment. The study aims to assess the environmental impact of THRs using life cycle assessment (LCA) and to identify key contributors.
A process-based LCA focusing on the surgical procedure was conducted in accordance with global standards (ISO 14040:2006 and ISO 14044:2006). Eleven sensitivity scenarios were performed to assess the robustness of the results.
A Danish University Hospital.
The empirical data involved the quantity and type of surgical equipment, material composition, energy usage and clinical infrastructure. There were no study participants.
No study interventions were performed.
18 environmental impact scores, such as global warming, human toxicity and water consumption, were assessed.
The carbon footprint of a THR was 62.0 kg CO2e, with major contributors being single-use disposable utensils (54 %), implants (22 %), and sterilisation of non-disposable utensils (18 %). Operating theatre energy usage, non-disposable utensils and clinical infrastructure contributed less, at 3 %, 2 % and 1 % each. Although the results of the other 17 environmental impact scores varied, they were predominantly influenced by the same factors as the carbon footprint. The sensitivity analysis showed that the overall carbon footprint varied by no more than 6 % unless the energy system shifted to less renewable energy, potentially increasing the footprint by 47 %.
THRs impose a substantial environmental burden, and sustainable solutions should focus on the primary drivers of this impact: disposable utensils, implants and the sterilisation process. In contrast, clinical infrastructure and non-disposable utensils appear to have a relatively minimal environmental impact.
Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.
REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.
The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.
by Michelle Lauge Quaade, Mikael Leijon, Mikhayil Hakhverdyan, Thomas Bruun Rasmussen, Charlotte Kristiane Hjulsager, Lars Andresen, Karin Mundbjerg, Anne Sofie Vedsted Hammer
Diarrhea outbreaks significantly affect the health and growth of farmed mink, posing economic and welfare challenges. While various pathogens have been linked to mink diarrhea, the causes during the weaning period remain unclear. Sporadic associations of mink coronavirus (MCoV), Campylobacter, and gastrointestinal disease in mink have been suggested. This study investigates the occurrence and levels of MCoV and Campylobacter in fecal samples from Danish farm mink (Neogale vison) and their potential association with post-weaning anorexia diarrhea syndrome (PADS), growth-period diarrhea (GPD), or pre-weaning diarrhea (PWD). The focus of the study is on PADS, studied through two case-control setups where case farms had known problems with PADS and control farms without such problems. Animals were also diagnosed based on necropsy pathological findings. Seventeen MCoV genomes were determined from five Danish farms. This data facilitated the development of an MCoV RT-qPCR and was applied across three study groups. Results showed high prevalence of both MCoV and Campylobacter spp. in all groups. No link was found between MCoV presence or levels and PADS diagnosis on the individual level; however, farm-level analysis revealed that MCoV was 2.35 times more likely (95% CI 1.027; 5.056) on PADS case farms than controls. Mink with PWD exhibited higher MCoV levels compared to GPD cases, suggesting a role at this developmental stage. Phylogenetic analysis revealed diverse and farm-specific MCoV strains, with sequences from healthy controls forming a distinct subclade, hinting at strain-specific pathogenicity. Campylobacter spp. presence was not significantly associated with PADS, but higher levels were observed in mink with PADS versus those without (not tested for PWD). These findings highlight the importance of surveillance and rigorous hygiene practices on mink farms to address risks from MCoV and Campylobacter spp., calling for further research to clarify their roles in PADS and overall mink health.Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.
This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.
This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.
Patients with total hip arthroplasties and hemiarthroplasties are both subject to hip dislocations. Although the incidence of complications differs, both patient groups suffer immediate high pain and need acute treatment. The purpose of this study is to design a fast-track pathway for patients with a dislocated hip prosthesis primarily to reduce the time from arrival to reduction and the total hospitalisation time. The secondary aim is to investigate whether quicker prosthesis reduction influences subsequent hip function and quality of life, reduces pain experience immediately and in the long term, and increases patient satisfaction.
This is a prospective observational cohort study, initiated on 1 December 2024 and continuing for 2 years. During the first year, patients admitted to the University Hospital of Southern Denmark, Esbjerg, will follow the current standard treatment pathway. After 1 December 2025, a newly developed treatment pathway (fast-track) will be adhered to. Based on a sample size calculation, 120 patients will be included. The main clinical outcomes (time to reduction (primary outcome), total hospitalisation) are registered from patient files. The patients are followed up for 1 year to measure patient-reported outcomes.
The study is conducted as a treatment quality study and is locally approved by the Executive Board at the University Hospital of Southern Denmark. The results will be published in relevant national and/or international journals and presented at relevant congresses.