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Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).
The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.
The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.
To identify the prevalence and types of missed nursing care in a Danish hospital context from patients' perspectives and to examine associations between missed nursing care, patient demographics, and patient-reported adverse events.
Cross-sectional study.
A total of 284 medical and surgical patients from 21 wards at a Danish university hospital completed the Danish version of the MISSCARE Survey–Patient. Descriptive statistics and analyses of associations between missed nursing care and patient demographics and adverse events were conducted.
Patients reported an overall prevalence of missed nursing care of 15%, with most omissions occurring in the physical care domain (22%), followed by psychosocial care (13%) and timeliness (6%). The most frequently missed activities included oral care, clarity about which nurse was responsible for their care, repositioning in bed, and help with eating. Medication errors were significantly associated with higher missed nursing care scores across all domains, while associations with other adverse events and demographics were inconsistent.
Patients generally perceived a low prevalence of missed nursing care, although notable variations were observed across care domains and specific activities. Incorporating patient perspectives alongside nurse perspectives offers a more complete understanding of missed nursing care.
Continuous assessment of missed nursing care from patients' perspectives could serve as a valuable complement to nurse-reported assessments, helping to identify specific areas for improvement. Targeted interventions addressing activities with higher patient-reported missed nursing care may enhance both care quality and patient outcomes.
STROBE guidelines were followed.
Patients were not involved in the study's design, conduct, or reporting.
This study highlights missed nursing care from patients' perspectives, revealing key care gaps. The findings can inform hospital administrators, nursing leaders, nursing educators, and policymakers in developing strategies to improve care quality and patient satisfaction.
To investigate the context of separations among mother, father and infant after childbirth, with a focus on the psychological, social and physical implications of these separations.
A short-term ethnographic study, which included participant observations and informal interviews. Data were analysed by a partly deductive content analysis inspired by Graneheim and Lundman.
A ‘27-bed’ Danish neonatal intensive care unit.
The study included parents (n=19) who had an infant in need of intensive care and were separated after childbirth.
The study identified an overarching theme of navigating family dynamics, caregiving and emotional challenges during separation. Three interconnected subthemes—Physical and virtual bonding as a necessity, Nurturing and caregiving shifts and Collective emotional impact of separation—shed light on the disjointed and emotional nature of parent-infant separation in neonatal care.
The findings revealed that the first hours in the neonatal intensive care unit were often characterised by disjointed rather than unified care, as nurses balanced their focus across the family while parents navigated the emotional strain of separation. Organisational and structural barriers further challenged reunification, highlighting the need for care models prioritising proximity, family bonding and minimised separation.
To explore the lived experience of the trusting nurse–patient relationship among patients admitted to internal medicine wards.
A qualitative study guided by van Manen's hermeneutic phenomenological approach.
Semi-structured interviews were conducted with fourteen hospitalised patients in a Danish University hospital in 2024. Data were analysed through thematic reflection.
The analysis revealed one overarching theme—the journey towards trust: bridging the need to feel safe with the pathways to wellbeing—supported by five subthemes. Trust developed through a dynamic and interpersonal process shaped by the patient's vulnerability, the nurse's actions and their mutual understanding. When trust was present, care was experienced as coherent, meaningful and safe; when absent, it felt disconnected and inadequate.
Trust within the nurse–patient relationship is experienced as a dynamic process shaped by the nurse's presence, authenticity and responsiveness. Rather than a static state, trust unfolds gradually, influencing how patients feel safe, understood and cared for. Relational competence should be recognised as a clinical skill, requiring the same support as technical competencies. Education, leadership and policies must protect interpersonal care. Further research should examine nurses' experiences and interventions that sustain trust.
The findings emphasise the need to recognise relational care as a professional and clinical competence. Supportive environments, relational training and organisational awareness are essential to enable nurses to prioritise trust-based relationships.
This study addresses the challenge of sustaining relational care in time-constrained hospital settings. It offers insight into patients' experiences of trust and highlights key relational behaviours. The findings are relevant for nurses, educators and healthcare leaders aiming to strengthen relational competence and improve patient care quality.
The study adheres to the COREQ reporting guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
Cardiovascular autonomic neuropathy (CAN) is a serious, untreatable complication of diabetes that contributes to excess cardiovascular mortality and morbidity. CAN is associated with increased fibrosis and inflammation, possibly driven by increased sympathetic activity and overactive mineralocorticoid receptors (MRs). These may represent a potential therapeutic target. MR antagonists (MRAs) improve autonomic function in non-diabetic diseases, and finerenone, a non-steroidal MRA, has demonstrated promising results in managing diabetic kidney disease and cardiovascular complications, suggesting its potential as a novel therapy for early-stage CAN. This trial aims to evaluate whether daily administration of finerenone can modify the disease progression of early-stage CAN.
This trial is a two-centre, double-blind, parallel-group, 1:1 randomised, placebo-controlled study evaluating the effect of 78 weeks of intervention with finerenone or placebo on early-stage CAN in 100 individuals with type 2 diabetes in Denmark. The primary endpoint is the between-group difference in the expiration:inspiration ratio of the cardiovascular autonomic reflex tests (CARTs). Secondary endpoints are the between-group differences in the remaining CARTs, heart rate variability measures and fibrosis markers. Treatment effects on other forms of neuropathy and related pathological mechanisms will be explored.
The study complies with the Declaration of Helsinki and the International Counsil for Harmonisation good clinical practice guidelines, with ethics approval obtained from the Danish Medical Research Ethics Committee. All participants will provide written informed consent. Due to the risk of hyperkalaemia associated with finerenone, safety will be closely monitored throughout the study. Findings will be disseminated through peer-reviewed publications, conference presentations and clinical trial registries. A lay summary will be provided to participants on study completion.
ClinicalTrials.gov: NCT06906081; registration date: 25 March 2025. Clinical Trials Information System: EUCT no. 2024-516597-30-00; registration date: 3 September 2024.
To translate, cross-culturally adapt, validate and psychometrically test the MISSCARE Survey–Patient for assessing patients' perspectives on missed nursing care (MNC) in a Danish hospital setting.
A two-phase cross-cultural adaptation and psychometric validation study.
The study was conducted in two phases. First, the MISSCARE Survey–Patient was cross-culturally adapted to ensure its relevance in a Danish hospital context. This phase involved translation and back-translation, expert committee reviews and cognitive interviews with 18 inpatients to establish content validity. Second, a convenience sample of 284 patients from surgical and medical departments completed the adapted survey. Psychometric properties were evaluated using structural equation modelling to test a second-order formative model.
The cross-cultural adaptation phase led to minor and substantial revisions, including the addition of six new items to enhance content validity. These items addressed aspects of nursing care relevant to patients in the contemporary hospital setting that were not captured by the original survey. Structural equation modelling confirmed the second-order formative model and demonstrated robust psychometric properties.
The MISSCARE Survey–Patient was successfully adapted and validated for use in Danish hospitals, ensuring strong content validity and psychometric robustness.
The Danish version of the survey provides a valuable tool for assessing MNC from patients' perspectives in hospital settings. Its use can help identify specific areas where nursing care falls short, guiding targeted initiatives to enhance care quality and patient safety. By integrating patients' experiences into quality improvement initiatives, the survey supports the development of more person-centred care practices.
The study adhered to the COnsensus-based Standards for the selection of health Measurement INstruments reporting guideline for studies on measurement properties of patient-reported outcome measures.
Patients were not involved in the study's design, conduct, or reporting.
The Danish version of the survey facilitates data collection on patients' perspectives of MNC in contemporary hospital settings, providing valuable insights into care quality. By offering a validated tool to assess MNC from patients' perspectives, the survey helps hospitals identify care gaps, prioritise improvement efforts and enhance person-centred care.
The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.
An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).
The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.
CRD42024612840.
The use of natural environments and nature activities as elements in the treatment and rehabilitation of mental health challenges is gaining international attention. The objective of the present review was to summarise the knowledge on the effects of nature-based health interventions (NBHIs) targeting individuals diagnosed with anxiety, depression and/or experiencing stress.
Systematic review and meta-analyses. The quality and certainty of evidence were assessed using the SIGN and GRADE.
Searches were performed in Embase, MEDLINE, PsycINFO, CINAHL, Cochrane and Web of Science.
(1) NBHIs, (2) Individuals with a diagnosis of mild to moderate anxiety, depression and/or experiencing stress, (3) Age of participating individuals: 18–84 years, (4) Study designs: randomised controlled trials, cohort studies, case-control studies and case-series studies and (5) Publication date: 2000–2024.
Screening, quality appraisal and certainty of evidence, assessed using SIGN and GRADE, were performed by two independent reviewers, except title screening. Meta-analyses were performed using random-effect models.
Nineteen articles were included, of which 14 were included in the meta-analyses. The articles showed substantial variation in design, interventions, settings and risk of bias, limiting the certainty of evidence according to GRADE. Participating in NBHIs led to a small to large effect in mental health with standardised mean changes of –0.80 (95% CI= (–1.56; –0.04)), –0.87 (95% CI= (–1.18; –0.56)), –0.32 (95% CI= (–0.74; 0.09)) and 0.58 (95% CI= (0.39; 0.77)) for anxiety, depression and stress scores and overall mental health scores, respectively.
This is the first systematic review examining the effect of NBHIs exclusively on individuals diagnosed with anxiety, depression and/or experiencing stress. Our findings suggest small to large improvements after participating in NBHIs. However, methodological limitations to the included articles necessitate cautious interpretation.
CRD42024516270.
FreshRSS 