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.

Area-based measures of socioeconomic status (SES) are increasingly used to study health disparities among people living with HIV (PLWH), with wide variation in how they are defined and applied across studies and settings. This study synthesises the types of area-based measures of SES used in Canada and the USA, the domains captured and their associations with health outcomes among PLWH.

A scoping review of studies published in English between 2012 and 2025 was conducted using PubMed and Web of Science. The search combined ‘HIV’ with terms related to area-based SES measures. Eligible studies included PLWH, were based in Canada or the USA, used area-based SES measures and assessed health outcomes.

We screened 3470 studies: 56 met inclusion criteria. Most were US-based (n=53) and focused solely on PLWH (n=46). Area-based SES was measured using composite (n=34), single (n=16) or both types of indicators (n=6), all drawn from census data. The most common SES domain was income/poverty (n=56), the most common geographic unit was census tract (n=19) and the most common health outcome assessed was viral load/suppression (n=29). Most studies linked lower area-based SES with poorer health outcomes among PLWH (n=46).

Our findings highlight the utility of area-based SES as an individual-level SES proxy and tool for capturing broader social determinants of health when assessing a range of health outcomes across studies including PLWH. This review contributes to strengthening methodological approaches and supports future work focused on addressing social determinants and advancing health equity for PLWH.

Asthma is one of the most prevalent long-term health conditions affecting pregnant women. Poorly controlled asthma during pregnancy is associated with adverse maternal and fetal outcomes and may predispose offspring to long-term respiratory morbidity. The current ‘one size fits all’ approach to asthma management during pregnancy is not optimally effective for approximately half of the pregnant women with asthma. A personalised medicine approach to managing airways disease is required. The treatable traits approach focuses on the identification and treatment of traits in the pulmonary, extra-pulmonary and behavioural domains, which are identifiable, measurable, clinically relevant (linked to exacerbation risk or poor asthma control) and treatable. This manuscript outlines the protocol for the Treatable Traits for Asthma Management in Pregnancy (TTAP) study. The purpose of the TTAP study is to prospectively determine the prevalence of a range of treatable traits from these three domains in pregnant women with asthma and determine which traits are associated with exacerbation risk, poor asthma control and poor asthma-related quality of life. Additionally, this study will assess differences in trait prevalence and clinical relevance in pregnant women from regional versus metropolitan hospitals in Australia and in different antenatal models of care.

The TTAP study is a multicentre, prospective observational cohort study. Study participants are pregnant women with asthma attending antenatal clinics at 10 metropolitan and regional hospitals (public and private) in NSW and Victoria, Australia. Assessment of traits from the pulmonary, extrapulmonary and behavioural domains as well as asthma outcomes is conducted at three gestational timepoints: 12–16 weeks, 22–26 weeks and 32–36 weeks of pregnancy. A follow-up assessment of asthma outcomes is conducted at 2–4 weeks postpartum. The outcomes assessed are asthma exacerbations requiring medical intervention (primary outcome), asthma symptom control and asthma-related quality of life. Traits and outcomes will be assessed using questionnaires, direct questioning, measurement of biomarkers, physical measurements and assessment of routinely collected data from medical records.

The Hunter New England Human Ethics Committee (2024/ETH01289) has approved the TTAP study protocol. Outcomes will be published in peer-reviewed journals, presented at scientific conferences and disseminated online to participants, clinicians and other pregnant women with asthma and their families via the Asthma in Pregnancy Toolkit website https://asthmapregnancytoolkit.org.au/.

Data on medication concentrations in human milk and their potential effects on the breastfed infant remain limited, leaving clinicians with insufficient evidence to guide women who require medication while breastfeeding. The MedMilk study aims to systematically measure medication concentrations in human milk, calculate the relative infant dose (RID) and evaluate infant outcomes.

This observational clinical study will recruit breastfeeding women using prescription and over-the-counter medications. Women will provide milk and urine samples along with self-reported maternal and infant health data. The primary outcome is quantification of medication concentrations in human milk. Secondary outcomes include estimation of the RID based on measured milk concentrations, maternally reported infant symptoms and adverse events potentially related to medication exposure, and pharmacokinetically simulated infant plasma exposure. Analytical methods include solid-phase extraction liquid chromatography-tandem mass spectrometry for quantification combined with descriptive statistics and pharmacokinetic modelling. The study aims to recruit approximately 250 women across medication groups. For the most frequently used medications, we aim to include 20 participants per medication, with each participant contributing four milk samples and a urine sample. Biological samples will be stored in a biobank, and data in a secure database.

The study has been approved by the Regional Research Ethics Committee of the Capital Region of Denmark (Journal no. H-23062687) and the Danish Data Protection Agency (Ref. P-2023-14627). All participants will provide written informed consent before enrolment. Findings will be disseminated through peer-reviewed journal publications and presentations at relevant national and international scientific conferences.

NCT07346716.

In many countries, a high or increasing rate of sickness absence is challenging the sustainability of present sickness absence benefit schemes. Most sickness absence is certified on the grounds of common mental disorders or musculoskeletal disorders, and substantial effort has been invested in developing interventions promoting return to work for these patients. In Norway, the Health in Work ((HelseIArbeid), HIA) clinics were established as outpatients’ services within the specialised healthcare system, with the aim of improving health and supporting return to work. The HIA service admits patients with low-to-moderate anxiety/depression and/or musculoskeletal disorders. In this protocol, we describe the naturalistic multicentre randomised controlled trial Norwegian Sickness Absence Clinic Efficacy study, which aims to determine the effect of HIA on work participation and health.

The HIA outpatient service is staffed by clinical psychologists, physiotherapists, medical specialists in physical medicine and rehabilitation and employment support supervisors from the Norwegian Labour and Welfare Administration. Patients admitted to HIA have access to multidisciplinary assessment and treatment. The trial recruits’ patients from five HIA outpatient clinics in Northern Norway. Patients are randomised in equal proportions to either (1) rapid HIA (assessment within 4 weeks), (2) delayed HIA (assessment within 10–14 weeks) or (3) active control, which consists of a monodisciplinary examination at HIA close to diagnosis-specific deadline for examination as suggested by guidelines (8–26 weeks). The trial commenced recruitment on 16 January 2023 and will recruit 2500 patients. The aim is to assess the effect of the HIA service, with the hypothesis that the HIA concept is superior to what resembles treatment as usual, in improving employment and preventing long-term welfare dependency. Secondary outcomes include self-reported symptoms of health problems. We also examine the effect the service has on other healthcare utilisation. To date, no research has been conducted to assess the efficacy of the HIA service. If proven efficacious, and if there is an economic case for this investment in tailored healthcare delivery, the policy implication may be implementation of the service at scale. If not, adaptations or investments into other viable paths of treatment may be considered.

The study is approved by the Regional Committee for Medical Research Ethics (REC North, #122770). Results from the study will be disseminated at national and international scientific conferences, to funders and participating outpatient clinics in seminars and in peer-reviewed scientific journals.

NCT05310695.

This scoping review intended to map the existing literature on chronic stroke rehabilitation interventions in primary healthcare (PHC) settings, with a particular focus on intervention dosage—frequency, intensity, type and duration—as well as the mode of delivery, which encompasses intervention location, format and provider.

A scoping review was conducted following the guidelines outlined in the Joanna Briggs Institute Manual for Evidence Synthesis.

A comprehensive search of 16 databases was conducted on the EBSCOhost platform on 10 February 2022. A supplementary Google search was conducted to identify grey literature up to 19 November 2022.

Sources published in English between 2010 and 2022 with full-text availability, addressing interventions for chronic stroke survivors delivered by various stakeholders in PHC, community or home-based settings.

Two reviewers independently screened the identified sources to determine eligibility for inclusion. Data were extracted independently, compared between reviewers, analysed and synthesised narratively with descriptive statistics.

In total 34 sources are included in the review, with most (n=28) originating from high-income countries. Interventions predominantly targeted the body function and structure component of the International Classification of Functioning, Disability and Health framework (n=29) through physical exercise (n=21). However, few interventions addressed the activity (n=17) and participation (n=11) components. Contextual factors (n=9) were seldom considered in intervention design. Intervention dosage varied widely. Most interventions were delivered by the multidisciplinary team (n=9) and were provided either at home (n=16) or in the community (n=13). Individual sessions (n=18) were more commonly offered than group sessions (n=8).

The optimal dosage for chronic stroke interventions remains uncertain, and current interventions, along with their modes of delivery, are often misaligned with PHC settings. Further research is essential to establish best practices in both well-resourced and under-resourced environments to address the current evidence gap and to enable the development of effective rehabilitation protocols that meet the needs of chronic stroke survivors and their families in PHC settings.

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.

NCT06922630.

Microbiome composition across multiple body sites, including the vagina, gut, urinary tract and semen, has been implicated in reproductive health and infertility. Vaginal dysbiosis and reduced Lactobacillus abundance have previously been associated with poorer outcomes in assisted reproductive technologies, yet few studies have simultaneously characterised microbiomes of both partners or compared infertile couples with healthy population controls. The BIOME study, a prospective cohort study, aims to characterise multisite microbiomes in infertile and healthy Danish couples and examine their association with long-term fertility outcomes.

The BIOME study is a multicentre, prospective observational cohort study including 100 couples undergoing fertility treatment following ≥12 months of unsuccessful pregnancy attempts and 100 healthy control couples. Participants provide biological samples from multiple body sites (vaginal swab or semen, faeces, urine and blood) prior to initiation of fertility treatment. Samples will undergo microbial sequencing, quantitative PCR, culture-based analyses, proteomics, metabolomics and microRNA profiling. Questionnaire data, clinical information and electronic medical record data will be collected. Participants will be followed for 5 years after sample collection to assess fertility outcomes. No intervention, randomisation or blinding is performed. Recruitment is planned over 24 months.

The study has been approved by the Danish Ethics Committee (#SJ-1033), and all participants provide written informed consent. Data are processed according to the General Data Protection Regulation and the Danish Data Protection Act, with pseudonymisation and restricted-access procedures. Results will be disseminated through peer-reviewed publications and scientific conferences. Sequencing data will be deposited in a public repository (eg, European Nucleotide Archive) with personal identifiers removed, and curated metadata will be available on reasonable request.

Vision reduction is linked to reduced quality of life, self-care capacity, increased fall risk, cognitive decline and depression. Prevalence increases with age. In response, WHO recommends regular vision assessment at primary care level, such as general practice (GP), for adults +50 years. However, research on detection of age-related vision reduction in GP is limited. The objective is to assess the feasibility and clinical utility of implementing vision screening in Danish general practice following an annual control consultation for patients aged ≥70 years with minimum one chronic condition.

Complex health intervention in a Danish general practice setting. Testing a patient baseline questionnaire with 18 items on self-reported vision and quality of life in combination with three vision tests: Colenbrander Mixed Contrast Card Test for near vision, Amsler Grid test and Confrontational Visual Field Test. 18–20 GP clinics and 450 patients are planned to be included. After GP consultation, all patients visit a collaborating optometrist for a comprehensive vision assessment including refraction, intraocular pressure measurement, fundus photography and optical coherence tomography (OCT). Data and pictures from the optometrist are evaluated by an ophthalmologist, who refers to further follow-up and/or treatment if deemed necessary.

Feasibility outcomes: patient recruitment rate, patient adherence, as well as patients’ and health providers’ experiences with the intervention. Clinical outcomes: GP staff assessment of patient vision and patient-reported assessment compared with ophthalmologic assessment. This includes identifying the need for new glasses and detecting eye diseases that require further evaluation, monitoring or treatment. This study will provide evidence on the feasibility of integrating vision screening into routine general practice, potentially helping expedient referrals and improving detection and access to primary eye-health care for older adults.

The study is registered and approved by Danish Research Ethics and Data Protection, VEK F-23070033 and in ClinicalTrials.gov: NCT07015034. Findings will be disseminated in peer-review journals, academic conferences and with the public through patient organisations and public health events.

ClinicalTrials.gov; identifier: NCT07015034.

Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.

LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m² with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.

Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.

NCT06321458.

To describe how video support is used in telephone triage at Norwegian Local Emergency Medical Communication Centres (LEMCs), including frequency, call duration, patterns of video use and associations with urgency and response assessments.

An observational study using national-level operational data and prospectively collected triage data from the Watchtower Project.

Norwegian LEMCs, which provide 24/7 nurse-managed telephone triage within the municipal emergency primary healthcare system, handling a broad range of medical inquiries.

79 LEMCs using the Norwegian Air Ambulance video solution in 2024 and six LEMCs participating in the Watchtower Project in 2022–2023.

Frequency of video use and call duration with and without video support. Video use across caller and patient characteristics and reasons for contact. Changes in urgency level and intended response following video use.

The national-level dataset included 2 242 522 calls and the Watchtower dataset included 109 281 calls. Nationally, video was used in 4.9% of answered calls. Median call duration was 7:13 min (IQR: 5:09–10:02) with video and 3:58 min (IQR: 2:18–6:16) without video (p

Video-supported calls were longer than non-video calls. Video is used selectively and is associated with bidirectional adjustments in urgency and response assessments in a substantial share of calls.

Excessive gestational weight gain increases the risk of complications in pregnancy, childbirth and later in life among pregnant women living with overweight and their offspring. Therefore, this study aimed to develop and examine the feasibility of a digital intervention supporting recommended gestational weight gain and the recommended level of physical activity, targeting pregnant women with a body mass index (BMI) of 27 or above.

Intervention development was guided by the Medical Research Council guideline on the development and evaluation of complex interventions, and subsequent feasibility testing was conducted in a non-randomised design.

The obstetric department at Copenhagen University Hospital—North Zealand, Denmark.

98 pregnant women living with overweight participated in feasibility testing.

The intervention developed in this study was a mobile phone application with a digital care guide containing text and video information supporting recommended gestational weight gain and physical activity levels. The video material featured multiple healthcare professionals and a pregnant woman from the target group.

The main feasibility measures were participant recruitment and engagement with the digital care guide throughout pregnancy.

Recruitment rates were satisfactory, with 69% of eligible pregnant women consenting to participation. The participants used the application and engaged with the digital care guide; however, use of the care guide diminished as pregnancy progressed.

We developed a digital care guide supporting recommended gestational weight gain and physical activity levels for pregnant women with a BMI of 27 or higher. Feasibility testing indicated that there is sufficient interest in participating in a study promoting recommended weight gain and physical activity to warrant a larger effectiveness trial.

Weight loss through combined lifestyle interventions (CLIs) can slow down knee osteoarthritis (OA) progression. However, gender-related factors may influence both the implementation of and participation in CLIs. Therefore, the aims were to identify gender-related facilitators and barriers to CLI implementation among healthcare professionals (HCPs) and uptake and adherence among individuals with early-stage knee OA and overweight or obesity.

Semi-structured interviews were conducted in this qualitative study. Thematic analysis, combining inductive and deductive approaches, was performed according to the Consolidated Framework for Implementation Research (CFIR) domains.

HCPs and individuals with knee OA and overweight or obesity were interviewed in Dutch between December 2023 and May 2024.

16 HCPs who referred or delivered a CLI and 23 individuals with knee OA and overweight or obesity who participated in a CLI were purposively recruited. 16 participants identified themselves as women and 7 as men; no other gender identities were reported.

HCPs experienced resistance to CLIs of both men and women. Additionally, HCPs perceived that women were more open and available to participate in CLIs, tended to prioritise others over themselves and often lacked familial support compared with men. Women valued trust, preferred female HCPs and struggled with self-prioritisation. Men were motivated by female HCPs and participants due to their empathy and interaction. Across men and women, barriers included conflicting HCP advice, work stress, caregiving tasks and lack of discipline, while social environment support was a key facilitator.

Addressing gender-related facilitators and barriers in the design and implementation of the CLI may improve long-term engagement and efficacy in individuals with knee OA and overweight or obesity.

Overview of Medical Research in the Netherlands (OMON), managed by the CCMO: NL75367.078.20

Frailty is a clinical syndrome characterised by impaired homeostatic mechanisms and reduced physiological reserve. Hospital admissions for ambulatory care sensitive conditions (ACSCs) are commonly used as indicators of quality in primary healthcare. We aimed to examine the association between frailty and the use of healthcare resources, including unplanned hospital visits due to ACSCs and non-ACSCs and visits to general practitioners (GPs) and medical specialists (MSs) in primary care. We hypothesised that frail individuals would have similar odds of hospital visits due to ACSCs and non-ACSCs.

Registry-based epidemiological study.

Data from the Danish Lolland-Falster Health Study and national health registers. Data were collected in a rural region of Denmark between February 2016 and February 2020.

10 154 randomly selected individuals aged ≥50 years participating in the Lolland-Falster Health Study with valid frailty measurements.

Hospital visits due to any diagnosis, hospital visits due to ACSCs and non-ACSCs, and visits to GPs and MSs in the primary care sector.

After adjustment for age, sex, comorbidity and socioeconomic factors, frail participants had higher odds of hospital visits due to any diagnosis (OR 1.27, 95% CI 1.02 to 1.57; p=0.03). The odds of hospital visits due to ACSCs (OR 1.42, 95% CI 0.97 to 2.08; p=0.07) and non-ACSCs (OR 1.16, 95% CI 0.91 to 1.47; p=0.22) were not significantly different. Frail individuals had higher odds of visiting their GP (OR 1.21, 95% CI 1.00 to 1.46; p=0.047) but not a medical specialist (OR 0.82, 95% CI 0.62 to 1.07; p=0.15).

Among frail individuals, the distinction between unplanned hospital visits due to ACSCs and non-ACSCs is not meaningful. This finding is consistent with the understanding of frailty as a state of reduced physiological reserve, in which minor stressors may lead to hospital care regardless of diagnostic category.

Socioeconomic inequalities exist in infectious diseases and sepsis in high-income countries. We investigated the association between income and mortality among patients with sepsis, overall and among those treated in the intensive care unit (ICU) versus general wards.

A retrospective register-based cohort study.

The Region of Southern Denmark (RSD).

All adult patients with an unplanned contact with a hospital in the RSD from 1 January 2016 to 20 March 2018. Patients with sepsis were identified based on the following criteria: (1) blood culture(s) performed within 48 hours of arrival, (2) antibiotic(s) administered within 48 hours of arrival, (3) a discharge diagnosis of infection and (4) a SOFA (Sequential Organ Failure Assessment) score of ≥2. The cohort was divided into quartiles according to household income.

Cox proportional hazards models were used to estimate the association between income groups and mortality. The primary outcome was 90-day mortality with 7-day and 365-day mortality as secondary outcomes. All outcomes were calculated overall and stratified by general ward treatment only and ICU admission.

We identified 7813 first-time visits with community-acquired sepsis, including 886 ICU admissions (11.3%). Among patients in the lowest income group, sepsis was associated with a HR of 1.16 (95% CI 1.01 to 1.34) for 90-day mortality compared with the highest income group. This association was particularly pronounced at 365-day follow-up: HR=1.24 (95% CI 1.10 to 1.39). No difference was observed in 7-day all-cause mortality, HR=1.13 (95% CI 0.89 to 1.45). The association was not observed among patients admitted to the ICU.

Low income was associated with increased mortality in patients with sepsis, particularly during long-term follow-up. The impact of income disparities was not observed among patient admitted to the ICU.

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.

NCT04582734.