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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 and synthesise qualitative evidence on nurses' perceptions of reasons for missed nursing care in hospitals.
Systematic review of qualitative evidence.
An extensive search of all relevant databases was conducted. Study selection, quality assessment, data extraction and meta-aggregation were performed independently by two reviewers according to the JBI guidelines for systematic reviews of qualitative evidence. Confidence in the findings was assessed using the ConQual approach.
The electronic databases CINAHL, PubMed, Embase, PsychInfo, and Scopus were searched in January 2024 and repeated in May 2025.
Thirty-one studies from hospital settings worldwide were included following critical appraisal, with overall quality rated moderate to high. The studies contributed 168 findings, which were organised into 10 categories and three synthesised findings: Organisational and system-level factors influencing missed nursing care, Teamwork and cultural factors influencing missed nursing care, and Individual nurse- and patient-related factors influencing missed nursing care.
Reasons for missed nursing care represent an interplay of systemic, organisational, and individual factors within complex resource-constrained contexts.
Healthcare organisations are recommended to implement system-level interventions, rather than relying solely on behaviour-focused solutions. Healthcare leaders should ensure flexible staffing, strong managerial support, and adequate resources to enable fundamental care. Building collaborative, interprofessional cultures that value relational and fundamental care as well as technical tasks is essential, together with education and mentorship that support nurses' decision-making, resilience, and clinical competence.
Hospital leaders, policymakers, and nurse managers can use the recommendations to reduce missed nursing care and promote a safe person-centred practice. Implementing systemic changes will improve nurses' working conditions and capacity to deliver comprehensive care, ultimately enhancing patient satisfaction and outcomes.
The ‘enhancing transparency in reporting the synthesis of qualitative research statement’.
No patient or public involvement.
The review is registered in the International Prospective Register of Systematic Reviews. PROSPERO CRD42023438198 (https://www.crd.york.ac.uk/PROSPERO/search)
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.
To describe the development and refinement of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice through stakeholder feedback. The tool, based on the Fundamentals of Care Framework, supports healthcare leaders and clinicians in assessing fundamental care in a practical and user-friendly manner that embraces rather than minimises the inherent complexity of this care delivery as it occurs in practice.
Multi-method study informed by participatory action principles.
Data collection involved an anonymous online survey and cognitive interviews with key stakeholders internationally to gauge perspectives on the clarity, usability, and acceptability of the tool. Data were collected between October–December 2023. Quantitative, categorical data were analysed using descriptive statistics. Qualitative data were analysed via content analysis.
Participants described the Tool as Comprehensive, Practical, and Useful. Participants liked the visual representation of results in the form of bar and radar diagrams, which aided in interpreting the outcomes. The main suggestions for improvement were: (1) Simplifying items relating to the ‘Context of Care’ dimension of the Fundamentals of Care Framework; (2) Reducing similarity between some items; (3) Separating or simplifying items with multiple components; and (4) Clarifying terminology.
Based on stakeholder feedback, the Flinders Fundamentals of Care Assessment Tool for Clinical Practice is now digitised and includes a comprehensive instruction manual and definitions for each element of the Fundamentals of Care Framework assessed within the tool. The tool supports healthcare leaders and clinicians to assess fundamental care delivery at multiple levels—individual, team, unit/ward, organisational—identifying areas of strength and improvement to inform decision-making, planning, and quality improvement. The tool offers a way of assessing fundamental care holistically as a multi-dimensional construct rather than as a series of disaggregated tasks, better reflecting and capturing the complex reality of fundamental care delivery.
The Flinders Fundamentals of Care Assessment Tool for Clinical Practice supports real-time feedback (i.e., immediate visualisation of results), facilitating its integration in clinical practice to support enhanced fundamental care delivery.
Seeking stakeholder feedback has enhanced the relevance, acceptability, and feasibility of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice, facilitating its use as a decision-making and planning tool to support improved fundamental care delivery across clinical settings.
This study is reported using the CROSS and SRQR guidelines.
No Patient or Public Contribution.
To evaluate the impact of video use in out-of-hours primary care (OOH-PC) telephone triage by examining how triage outcomes (ie, ended by telephone, clinic consultation or home visit) changed during a period with video service failure.
Observational register-based study, using periods of video service failure as a randomisation mechanism for a controlled study.
OOH-PC in four of the five Danish regions.
All telephone triage contacts to the OOH-PC call centres between April 2020 and December 2021.
Video service failures resulted in a subset of telephone triage contacts without the option of using video as a triage tool. Video service failures were identified algorithmically based on observed periods without video use.
Proportion of telephone triage contacts with clinic consultations or home visits as triage outcome during a period of video service failure compared with matched reference telephone triage contacts taking place during normal service (1:10), presented as risk ratios (RR) with 95% CI).
The algorithm identified 6605 telephone triage contacts during video service failure. Compared with matched contacts during normal service, these had a 15% higher risk of resulting in a clinic consultation (RR: 1.15, 95% CI 1.09 to 1.20). This effect was primarily isolated to the year 2021 (RR: 1.23, 95% CI 1.16 to 1.31) compared with 2020 (RR: 1.05%, 95% CI 0.97 to 1.13). Video service failure did not significantly affect the risk of a home visit.
Results strongly suggest that the unavailability of the video service is likely to significantly increase the number of clinic consultations in OOH-PC as a triage outcome. Whether this effect is likely to persist in the long term remains unclear.
Early-life exposures, such as nutritional deficiencies, stress, smoking, toxins, medications, diseases, infections and inflammation may affect multiple physiological and metabolic systems in the offspring, including hormonal regulation, bone metabolism and mineralisation, and body composition. Moreover, the effect of these early-life exposures on later health may potentially be mediated through adverse neonatal epigenetic reprogramming of bone-related genes affecting health later in life, especially skeletal development and bone density. Thus, to advance this research further, the overall aim of the project is to investigate if (a) neonatal epigenetic and genetic signature; (b) maternal risk factors during preconception and pregnancy, such as medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle; (c) risk factors at birth, such as instrumental delivery, mode of delivery, medicine use, injuries, diseases, weight, size for gestational age, ponderal index, gestational age; and (d) childhood risk factors, such as diseases, medicine use, major life events, weight, growth and lifestyle are associated with hormonal status, lipids, bone turnover markers, bone mineral density, fat mass and lean body mass at age 18–19 years.
Population-based, nationwide, cross-sectional clinical study with potential for longitudinal reassessment. Danish women and men aged 18–19 years old will be selected at random from the Danish National Population Registry and invited if they have available neonatal dried blood spot cards. A total of 2000 individuals will be enrolled. The study combines register data, and neonatal epigenetic and genetic analyses from stored blood with clinical and survey data. Body composition will be measured using dual-energy X-ray absorptiometry. Adult blood and hair samples will be obtained to assess hormonal status, lipids and bone turnover markers. Height, weight, waist and hip circumference, and blood pressure will be measured. Questionnaires on well-being, sleep patterns, dietary and exercise habits, onset of puberty, use of cannabis, nicotine, alcohol and pain medication will be included. Information on medicine use, diseases, socioeconomic status, major life events, weight, growth and lifestyle will be obtained from the national administrative and health registers at the time of conception and during pregnancy for the parents, as well as from the participants throughout their lifetime. Health registries include the Danish Medical Birth Register, the National Patient Register, the Danish National Prescription Register, the National Child Health Register and Statistics Denmark. Multivariate regression analyses will be performed.
This nationwide study has been approved by the Regional Committees on Health Research Ethics for Southern Denmark (S-20230105). The study participants will be enrolled in the study following their informed written consent. Results will be submitted for publication. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guidelines will be used for reporting.
Parkinson’s disease is a neurological disease with a rising incidence and prevalence. Patients with Parkinson’s disease may receive antipsychotics, for example, due to Parkinson’s disease psychosis. Parkinson’s disease psychosis is characterised by visual hallucinations and other psychotic symptoms. To date, no systematic review has evaluated the effects of antipsychotics in patients with Parkinson’s disease. Therefore, this review aims to assess the beneficial and harmful effects of antipsychotics for Parkinson’s disease.
This is a protocol for a systematic review. A search specialist will perform a search in major medical databases (eg, MEDLINE (Medical Literature Analysis and Retrieval System Online), EMBASE (Excerpta Medica database), CENTRAL (Cochrane Central Register of Controlled Trials)) and clinical trial registries. Published and unpublished randomised clinical trials comparing antipsychotics to any control (placebo, standard care or other antipsychotics) in patients with Parkinson’s disease will be included. Two review authors will independently extract data and conduct risk of bias assessments with the Cochrane Risk of Bias tool—V.2. Primary outcomes will be all-cause mortality, serious adverse events and significant falls. Secondary outcomes will be hospitalisations, non-serious adverse events, Unified Parkinson’s Disease Rating Scale total score and psychotic symptoms using any valid symptom scale. Data will be synthesised by aggregate meta-analysis, trial sequential analysis and network meta-analysis. Several subgroup analyses are planned. An eight-step procedure will be used to assess if the thresholds for clinical significance are crossed, and the certainty of the evidence will be assessed by GRADE (Grading of Recommendations Assessment, Development and Evaluations) and CiNeMA (Confidence in Network Meta-Analysis) approach.
This protocol does not include results, and ethics approval is not required for the project. The findings from the systematic review will be published in international peer-reviewed scientific journals.
PROSPERO ID: CRD42025633985. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD42025633985.
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
To explore nursing students' experience of how the COVID-19 pandemic influenced the learning environment in clinical setting and how they responded to the change.
Qualitative descriptive interview study.
Eleven third-year baccalaureate nursing students from a University College in Northern Denmark participated in individual semi-structured interviews conducted in the spring 2021. Data analysis was guided by Braun and Clarke's thematic analysis.
Two themes were generated: ‘A compromised learning environment’ and ‘Adjusting to circumstances and making things work’.
Students perceived that their learning became secondary and was influenced negatively. Some students' focus shifted from an attention to learning opportunities to managing daily patient care and became hesitant to pose questions that were relevant to their learning. Students faced a dilemma between helping with daily tasks and prioritising their learning needs. Some students adjusted to the circumstances by taking the lead. Others reacted more passively and prioritised helping nurses in managing the daily workload.
The study highlights that changes in the work environment impact students. Institutions must ensure that students feel a sense of belonging and prioritise time with clinical supervisors for questions and reflection, avoiding situations where practical tasks take priority over learning. Since students manage changes differently, they require tailored support.
The study addressed changes in the clinical learning environment caused by the COVID-19 pandemic. The changes within the environment influenced the students learning negatively. The findings are of relevance to lecturers, supervisors, and academic decision-makers within nursing education and may guide the planning of clinical placements to better accommodate individual learning needs.
The study adheres to the COREQ guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
Continuous glucose monitoring (CGM) provides real-time glucose data for people with diabetes. However, detailed knowledge of its use in daily life remains limited. We aim to investigate the interaction between people with type 1 diabetes (T1D) and their CGM data and the impact of the interaction on glycaemia and diabetes distress.
This is a two-centre observational study of adults (n=500) with T1D using FreeStyle Libre 2. Over a period of 14 days, participants will continue their regular CGM use, record insulin doses and timing with smart insulin pens, track activity and sleep with an activity tracker, log all food intake in the LibreLink app and answer questions about quality of life and hypoglycaemia two times per day. Before the study period, the participants will complete a survey of 11 validated questionnaires assessing diabetes distress, hypoglycaemia awareness and other patient-reported outcomes (PROs). After the study period, the participants will complete two additional questionnaires assessing diabetes distress and health literacy.
The collected data will be used in two substudies with the overall aims of:
Substudy 1: to investigate how CGM is used in practice and the impact of the interaction on diabetes distress and glycaemia.
Substudy 2: to investigate whether and how CGM functions as a technological substitute for impaired awareness of hypoglycaemia, focusing on alarm data.
Endpoints will include CGM metrics, alarm data and PROs.
The Danish Data Protection Agency approved the study (P-2024–15985), and the regional committee on health research ethics has granted an ethical waiver (H-24014662). All participants have signed written informed consent forms before participating. The results will be published in an international peer-reviewed scientific journal by the study investigators and shared via www.clinicaltrials.gov. Participants who agreed to receive information about the study will be sent the results after publication.
ClinicalTrials.gov (NCT06453434).
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