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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)
To identify: (1) current evidence and gaps of PhD program components influencing PhD students' career outcomes; and (2) methods and tools used to assess the relationships between PhD program components and career outcomes.
PRISMA scoping review.
Search terms included PhD nursing students, PhD education, PhD-prepared nurse, PhD in nursing, nursing faculty, and assistant professor. Studies empirically assessing PhD program components and career outcomes (e.g., desires, attitudes, actual employment) were included. Two researchers conducted screening, data extraction, and inductive content analysis.
PubMed, Scopus, and CINAHL in October 2025, without year and geographic location restrictions.
The search yielded 379 studies. After title, abstract, and full-text screening, 13 studies were included. Analysis resulted in 10 factors spanning four categories: program preparation, readiness and satisfaction, impressions of the faculty role, and program support.
Experiences in the PhD program likely influence students' desire to pursue academia. While this review synthesized influential factors, given significant gaps in the literature, there are likely more factors influencing student career desires. A more robust understanding of the factors during the PhD program which influence career outcomes is needed.
This study did not include patient/public involvement in design, conduct, or reporting.
To examine the associations between socioeconomic position (SEP) and the incidence of serious hand infections—pyogenic flexor tenosynovitis (PFT) and septic arthritis (SA)—as well as risks of opioid overuse following diagnosis using nation-level data.
In a registry-based nationwide retrospective cohort study, (1) associations between SEP and incidence of PFT/SA; (2) SEP and infection-type effects on opioid overuse in the general population and (3) SEP and clinical predictors of opioid overuse among individuals diagnosed with PFT/SA were examined.
Using linked Swedish national registers (2010–2015), (1) a multinomial regression to assess SEP and infection risk (n=5 697 865); (2) logistic regression on opioid overuse (≥2 dispensations within 3 months) related to SEP and infection status and (3) a restricted analysis among diagnosed individuals (n=3701) to isolate clinical determinants of opioid overuse was conducted.
Among the study population, 0.04% had PFT and 0.02% had SA. In the general population, 0.31% received two or more opioid prescriptions, compared with 4.5% of those with PFT and 6.8% of those with SA. Male sex, older age, being native, low occupational qualification, comorbidity and—specifically for SA—low income were associated with higher infection risk. Both infections independently predicted opioid overuse (adjusted OR for PFT: 13.23 (95% CI 10.92 to 16.02); adjusted OR for SA: 15.16 (11.99 to 19.17)). Additional predictors of overuse included low SEP, female sex, older age, native birth, living alone and comorbidity. Infected individuals with SA were more likely to overuse opioids than those with PFT, but SEP had limited predictive power within this subgroup.
Despite universal healthcare, socioeconomic disparities exist in hand infection incidence and opioid prescribing. PFT and SA increase the risk of opioid overuse, but SE inequalities, except comorbidity, are less relevant among individuals. Targeted, equitable pain management strategies that reduce unnecessary opioid exposure while ensuring adequate care are needed.
To examine the distribution and frequency of International Classification of Diseases, 10th Revision (ICD-10), codes in emergency departments (EDs) across Malaysia, providing insights into the most common diagnoses. The aim is to support the development of a principal diagnosis short list for implementing ED-specific diagnosis-related groups (DRGs) to enhance resource allocation and healthcare efficiency.
A cross-sectional study conducted as part of a functional exercise by the Ministry of Health Malaysia, with systematic retrospective data collection over a 6-week period in 2022.
13 public emergency hospitals across Malaysia, representing state, major specialist, minor specialist and non-specialist hospitals, including facilities from Sabah and Sarawak for geographical diversity.
10 247 ED visit records were collected through systematic random sampling, of which 9942 complete and valid records were retained for analysis after the exclusion of incomplete or erroneous entries.
The study included 9942 ED patient records from 13 public hospitals across Malaysia over a 6-week period. Of these, 54.4% were male, and 45.5% were female. Malaysian citizens comprised 96.1% of the study population. The most frequently reported diagnoses were respiratory diseases (21.2%), followed by injuries and poisoning (13.2%) and digestive system disorders (8.4%). A total of 946 unique ICD-10 codes were identified, with 73.7% used fewer than five times. The top 20 diagnoses accounted for 42.9% of all records. Acute upper respiratory infection (J06.9) was the most commonly reported diagnosis (961 cases), followed by COVID-19 (U07.1, 608 cases) and gastroenteritis of unspecified origin (A09.9, 313 cases). The data demonstrated variation in the distribution of ICD-10 diagnoses across participating hospitals, highlighting key diagnostic categories relevant for future DRG development.
This study highlights the diversity of diagnoses in Malaysian EDs and underscores the need for tailored DRGs to optimise healthcare resource allocation. The findings suggest that a principal diagnosis short list may support future efforts to improve classification consistency and inform resource planning, although its effect warrants empirical evaluation. Given the concentration of diagnoses within a limited number of ICD-10 codes, implementing DRGs in emergency care is both feasible and necessary. Future research should expand data collection to capture seasonal trends and refine the principal diagnosis list to further support DRG categorisation and ensure its applicability across varying healthcare demands.
To evaluate the acceptability, mechanisms of impact, and contextual factors affecting a 9-month, nurse-led self-management intervention specifically designed for newly diagnosed patients with inflammatory arthritis, from both the patient and healthcare professional (HPs) perspectives.
A qualitative longitudinal study.
Individual baseline and follow-up interviews were conducted with 12 patients (baseline n = 12; follow-up n = 10) and four focus group interviews were conducted with 4 HPs at key intervention stages. Interview guides were drafted with open-ended questions and iteratively refined across interviews to match the evolving stages of the intervention. Data analysis was conducted using template analysis. This study adhered to the Consolidated Criteria for Reporting Qualitative Studies (COREQ): 32-item checklist.
Patients valued the tailored individual sessions, which provided emotional support and improved their understanding of IA. Group sessions received mixed feedback, with some patients suggesting a need for more organisation. The intervention fostered a sense of community, reducing isolation and empowering patients to navigate the healthcare system better. HPs praised the patient-centred approach and emphasised the importance of training and organisational support.
Both patients and HPs highly accepted our nurse-led self-management intervention, though group sessions received mixed feedback. Key impact mechanisms were the proactive management of symptoms and lifestyle, and the intervention's tailored support and emotional guidance. The HPs experienced professional growth but scheduling occasionally conflicted with regular work.
This study has provided valuable information in understanding intervention mechanisms. Findings from the evaluation will be used to refine the intervention.
Two patients contributed to the development of the intervention, and a patient research partner was actively engaged in all phases of this study.
To develop and validate the Internalised Stigma Scale for Gestational Diabetes Mellitus (ISS-GDM), a questionnaire measuring self-reported internalised stigma among women with prior gestational diabetes mellitus (GDM). We hypothesised that internalised GDM stigma could be reliably and validly assessed through a short psychometric instrument.
Cross-sectional validation study.
Follow-up data from the Danish, multicentre Face-it trial for women with prior GDM and their families.
In total, 248 women completed the ISS-GDM approximately 1 year after their GDM affected pregnancy.
The primary outcome was psychometric properties of the ISS-GDM, assessed using Cronbach’s alpha, confirmatory factor analysis (CFA) and Rasch analysis (RA). Secondary outcomes included identification of item anomalies (local response dependence, differential item functioning).
A large proportion of respondents endorsed statements reflecting self-disappointment, self-blame and an altered self-perception. Less endorsed statements included feeling inferior to other mothers or guilt towards family members due to GDM. The ISS-GDM demonstrated satisfactory psychometric properties. CFA indicated that item 2 assessing self-perceived capabilities as a mother did not load onto the main factor, while CFA and RA identified local response dependence and differential item functioning by body mass index. After adjustments, a two-factor solution supported calculating a sum score of items 1 and 3–11, with item 2 retained as a stand-alone indicator of perceived parenting capabilities. The 10-item scale demonstrated acceptable reliability (Cronbach’s alpha=0.78).
The ISS-GDM is a reliable and valid tool for assessing internalised stigma among women with prior GDM. Our findings further suggest that a substantial proportion of women with prior GDM experience self-blame and an altered self-perception due to their diagnosis. The ISS-GDM scale enables research into its prevalence, severity and consequences.
As people age, frailty becomes increasingly prevalent and is associated with adverse outcomes, including higher risks of hospitalisation, institutionalisation and mortality. Early identification of frailty in ambulance and emergency department (ED) settings may support clinical decision-making and help predict outcomes for older patients. However, there is currently no consensus on how frailty should be assessed in these settings, and the clinical usefulness of available tools remains uncertain. This protocol outlines the methods for a planned scoping review that aims to identify frailty screening tools used for older adults (age ≥65 years) in the ambulance and ED settings and to evaluate existing evidence on their clinical usefulness.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Protocols, and the final review will follow the Joanna Briggs Institute methodology and is reported in accordance with the PRISMA extension for Scoping Reviews guidelines. Studies will be included if they examine the use of frailty screening or assessment tools in individuals aged 65 years or older in ambulance and/or ED settings and report on aspects of clinical usefulness, such as feasibility, predictive validity or influence on clinical decisions. A comprehensive literature search will be conducted in PubMed, Embase, CINAHL, Scopus and Web of Science for studies published in English between January 2014 and December 2025. To refine the search strategy, an initial systematic pre-search was performed in PubMed using Medical Subject Headings terms, followed by a pilot study. A sample pilot screening of 101 references identified in the pre-search was conducted as a support for finalising the search. Ten of the papers in the pre-screening were furthermore used as a support for testing and validating the data extraction variables and quality assessment procedures. In the full scoping review, study selection and data extraction will be independently conducted by two reviewers using the Covidence software (Veritas Health Innovation, Melbourne, Australia), with any discrepancies resolved by a third reviewer. Extracted data will be summarised in tabular format and analysed through narrative synthesis. The methodological quality of included studies will be evaluated using the quality assessment tool of the National Heart, Lung, and Blood Institute for cohort studies.
Ethical approval is not required as no primary data will be collected. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and summaries shared with relevant clinical and research-related stakeholders.
To describe the point prevalence of major ECG abnormalities, their coexistence with screen-detected cardiovascular disease (CVD) and the proportion requiring referral for cardiac work-up and interventions.
A population-based cohort study.
Primary and secondary care settings in Denmark.
Since 2014, all 67-year-old Danish men and women from Viborg municipality were invited to the ‘Viborg Screening Programme’ (VISP).
VISP includes screening for lower extremity artery disease (LEAD), carotid plaque (CP), abdominal aortic aneurysm (AAA), hypertension, diabetes mellitus and cardiac conditions.
A single resting 12-lead ECG was recorded and coded using the Minnesota criteria. Major ECG abnormalities were divided into rhythm and rate disorders, signs of myocardial damage and conduction disorders.
Over the first 5 years, 4612 (83.8% of those invited) were screened, with 4437 (96.4%) undergoing an ECG. We found major ECG abnormalities in 152 (3.4%), including 92 (2.1%) rhythm and rate disorders, 28 (0.6%) with signs of myocardial damage and 32 (0.7%) with conduction disorders. Fifty-nine (1.3%) had newly screen-detected ECG abnormalities, and 34 (0.8%) required intervention after cardiac consultation (32 medication adjustments and/or 11 advanced treatments). Participants with major ECG abnormalities had a higher frequency of coexisting CVD, including CP (46.4% vs 38.1%; p=0.040), LEAD (9.5% vs 5.3%; p=0.026) and AAA (2.7% vs 0.9%; p=0.032) and were also more common in men than in women (4.7% vs 2.2%; p
This study provides a detailed overview of major ECG abnormalities in a population-based cardiovascular screening context. Although the yield of ECG screening was low, ECG may still add value as a simple and low-cost tool within multimodal programmes, enabling timely detection and treatment.
Digital documentation in patients’ electronic medical records (EMRs) places new demands on perioperative nurses, increasing workload and cognitive strain, with subsequent technostress. While new EMR systems are implemented, they are not always adapted to users’ needs.
This study aimed to explore how perioperative nurses and nursing assistants describe their experiences with electronic documentation during surgery and its impact on their work environment. Additionally, it examined the emotional reactions these experiences triggered, and the adaptive strategies used to manage their effects.
A qualitative study was conducted. Data were analysed using Braun and Clarke’s thematic analysis.
Two university hospitals and one county hospital in Sweden were included.
15 women and 5 men, including 9 specialist nurses in anaesthesia care, 9 nurses in operating room (OR) care and 2 nursing assistants in OR care in Sweden participated.
Two main themes emerged: A—Introducing digital systems without a clear aim undermines work performance and B—Digital systems were embraced when automation and comfort were present. Subthemes included leadership and management, possibilities to develop and influence digital systems and EMRs not adapted to clinical needs. Automation from digital systems made work easier, and digital systems within one’s comfort zone were appreciated. However, frustration and stress arose when aforementioned preconditions were not fulfilled, leading to adjustments to manage these challenges.
Digital documentation is appreciated when fundamental conditions are met. A lack of clarity on how, what and why to document, along with insufficient training and limited ability to have an influence, triggers negative emotional reactions and unhealthy coping strategies. To enhance digital literacy, a standardised process of digital systems including digital documentation through educational efforts in which knowledge control in educational purposes is included could be tested as a potential solution.
Commentary on: Szymczak JE, Hayes AA, Labellarte P, et al. Parent and clinician views on not using antibiotics for mild community-acquired pneumonia. Pediatrics. 2024 Jan 1;153(2):e2023063782.
Implications for practice and research Awareness of the possibility to abstain from antibiotic treatment in mild community-acquired pneumonia in young children has to increase. Not only is research needed on improvement of diagnostics and safety of the ‘no antibiotic’ strategy, but also on how to address social, emotional and logistical barriers.
Mild community-acquired pneumonia (CAP) in children under 5 years is often viral in origin. Because of this, routine antibiotic treatment of mild CAP is discouraged in the 2011 Pediatric Infectious Diseases Society (PIDS)/Infectious Diseases Society of America (IDSA) guideline.
Atrial fibrillation is a common arrhythmia in patients with ischaemic heart disease. New-onset atrial fibrillation after coronary revascularisation is associated with adverse cardiovascular outcomes. This study aimed to determine the long-term cumulative incidence of new-onset atrial fibrillation after percutaneous coronary intervention or coronary artery bypass grafting surgery.
A prospective observational cohort study in a real-world population setting, conducted at three tertiary centres, on new-onset atrial fibrillation incidence after percutaneous coronary intervention (N=123) or coronary artery bypass grafting (N=123). Heart rhythm was monitored the first 30 days in hospital by telemetry and on discharge using a handheld thumb ECG device three times a day, and thereafter for 2-week periods at 3, 12 and 24 months. The primary endpoint was the cumulative incidence of new-onset atrial fibrillation 24 months after the index procedure. Secondary objectives were to describe the incidence of cerebral ischaemic stroke and bleeding, myocardial infarction and major bleeding events during 24 months follow-up.
Mean age was 67 years, and male sex was more prevalent. At 30 days, the cumulative incidence of atrial fibrillation was 56% (69/123) in the coronary artery bypass graft group and 2% (3/123) in the percutaneous coronary intervention group. At 24 months, the cumulative incidence of atrial fibrillation was 58% (71/123) in the coronary artery bypass graft group and 6% (7/123) in the percutaneous coronary intervention group. Stroke, myocardial infarction and major bleeding were infrequent during follow-up.
Over 24 months of follow-up, incident new-onset atrial fibrillation mainly occurred during the first 30 days after coronary artery bypass grafting but was more evenly distributed during 24 months after percutaneous coronary intervention.
To understand nurses' personal and professional experiences with the heat dome, drought and forest fires of 2021 and how those events impacted their perspectives on climate action.
A naturalistic inquiry using qualitative description.
Twelve nurses from the interior of British Columbia, Canada, were interviewed using a semi-structured interview guide. Thematic analysis was employed. No patient or public involvement.
Data analysis yielded three themes to describe nurses' perspective on climate change: health impacts; climate action and system influences. These experiences contributed to nurses' beliefs about climate change, how to take climate action in their personal lives and their challenges enacting climate action in their workplace settings.
Nurses' challenges with enacting environmentally responsible practices in their workplace highlight the need for engagement throughout institutions in supporting environmentally friendly initiatives.
The importance of system-level changes in healthcare institutions for planetary health.
Osteoarthritis (OA) commonly affects the ageing population, particularly the hip joint. Total hip arthroplasty (THA) is a frequent procedure that relieves pain and improves mobility, though some patients experience persistent postoperative pain. With rising numbers of THA, optimising perioperative care and pain management is crucial to address the growing clinical burden and improve patient outcomes. Positive treatment expectations have shown promise in enhancing outcomes, especially in pain management. This study implements two strategies to optimise the patient’s treatment expectations, comprising enhanced physician communication and digital social observational learning. We will examine their separate and combined effects on preoperative expectations, negative emotions, postoperative pain, inflammation and function during recovery up to 12 months postoperatively.
This randomised controlled trial (RCT) investigates the impact of augmented physician communication and observational learning on treatment expectations and recovery. Participants (n=200) will be randomised into four groups: treatment as usual (TAU), augmented doctor conversation (aDOC), observational learning video (Video) and a combination of both (aDOC+Video). The aDOC group receives empathic communication and targeted information to strengthen self-efficacy. The Video group watches a model patient demonstrating successful recovery. The combined group receives both interventions. Outcomes will be assessed at multiple time points (4 days preoperatively; 1 and 4 days, 4 weeks and 3, 6 and 12 months postoperatively), including subjective pain ratings, mobility and objective physical function. The primary analysis will compare changes in pain intensity across groups. Secondary outcomes will include functional status, self-efficacy, recovery and systemic inflammatory markers. Statistical analysis involves repeated measures ANOVA and post hoc tests for between-group and within-group comparisons.
German Clinical Trials Register: DRKS00033212.
by Moayad Subahi, Fahda Alshaikh, Eyad Dahlawi, Feras Zafar, Tamim Alsulimany, Nawaf Alnefaie, Abdulrahman Almalki
Knee osteoarthritis (KOA) is a prevalent condition that reduces physical function and quality of life. Physical activity is foundational to KOA management; however, patient engagement and perceptions of treatment remain underexplored, particularly in Middle Eastern populations. This study evaluated physical activity (PA) levels among individuals with KOA and explored their perceptions, awareness, and experiences with management strategies, especially physical therapy. A sequential explanatory mixed-methods design was employed. Quantitative data were collected using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) from 60 adults with physician-diagnosed KOA (mean age 55.5 ± 6.4 years; 50% female) recruited from clinics and community programs in Saudi Arabia. Semi-structured interviews with 24 purposively selected participants further explored experiences and perceptions. Descriptive statistics summarized quantitative data, and thematic analysis guided qualitative interpretation. Ninety percent of participants recorded low PA levels (≤600 MET-min/week), with only 10% achieving moderate or high activity levels. Qualitative themes revealed multiple barriers including emotional distress, logistical difficulties, and misconceptions about KOA as well as facilitators such as family support and patient education. Integration of findings highlighted how contextual and psychosocial factors influence PA engagement. Adults with KOA in this study reported markedly low levels of PA, shaped by cultural, psychological, and environmental factors. Our findings highlight the importance of addressing these barriers through patient-centred education and improved access to physical therapy.To describe the variation in nurse educators' conceptions of how they facilitate critical thinking in bachelor nursing students.
Qualitative study with a phenomenographic approach.
Data was collected through twenty-six semi-structured interviews with nurse educators conducted in Sweden between March and June 2024.
The result of this study can be understood as five descriptive categories: Creating a safe and trustful relationship with the students, Encouraging a dialogue with the students, Using space as a tool, Using artefacts as a tool, and Using oneself as a tool.
The conclusion is that the facilitation of critical thinking needs to be based on a safe and trustful relationship between educators and students. Without this relationship, it is not possible to establish the central dialogue, where the educator can facilitate critical thinking through asking counterquestions and provoking the students.
To become critical thinkers, the students need to put their knowledge and assumptions in a new light and question them. Here, the educator has a vital role in being the guide and facilitator.
The result indicated that it is vital for the educators to build a safe relationship with the students. The relationship is a precondition for the facilitative dialogue where the educators can ask reflective and provoking questions to stimulate critical thinking. Future nurses need to be prepared with critical thinking to enable evidence-based clinical decisions both during clinical practice as well as when being registered nurses.
SRQR guidelines.
This study did not include patient or public involvement in its design, conduct, or reporting.
To identify and address ethical challenges in doctoral supervision within nursing and health sciences and propose strategies to overcome them.
Following PRISMA guidelines, this mixed-method systematic review synthesises findings from quantitative, qualitative and mixed-methods studies published in English between 2014 and 2025. Studies were included if they examined ethical challenges in doctoral supervision and strategies to address them within nursing and health sciences. Exclusion criteria encompassed reviews, books, editorials, opinion papers, conference papers, studies unrelated to nursing or health sciences or published before 2014.
A systematic search was conducted in CINAHL, Education Source, ERIC, PubMed, Scopus and Web of Science Core Collection, yielding 1100 citations.
The methodological quality of included studies was assessed using the STROBE checklist for quantitative studies and the COREQ framework for qualitative studies. The findings were then synthesised and thematically organised.
Eleven studies met the inclusion criteria: four quantitative, four qualitative and three mixed methods. Ethical challenges in doctoral supervision emerged at three levels: individual (e.g., misaligned expectations, inadequate feedback, student adjustment difficulties), institutional (e.g., high student–supervisor ratios, limited support structures), and cultural (e.g., differing norms around autonomy and academic authority). Supervisors also reported role conflicts. Strategies to address these challenges included improved communication, supervision agreements, institutional support and targeted training.
Ethical challenges in supervision are shaped by individual, institutional and cultural factors. Addressing them requires multi-level strategies, including clear expectations, feedback mechanisms, structured training and culturally sensitive supervision practices. Applying ethical principles fosters a transparent and supportive academic environment that enhances doctoral outcomes.
Universities should adopt multi-level strategies, including supervisor training, mentorship structures and culturally informed policies, to strengthen the ethical integrity and effectiveness of doctoral supervision.
What problem did the study address?: This study synthesises ethical challenges in doctoral supervision within nursing and health sciences, focusing on communication barriers, institutional constraints and the transition from clinical practice to academia. What were the main Findings?: Misaligned expectations between supervisors and students, inadequate feedback and structural limitations, negatively impact the quality of supervision. Doctoral students struggle to adapt to academic expectations, while supervisors face challenges in balancing multiple roles. Effective communication, institutional support and targeted training programmes are essential for improving supervisory experience. Where and on whom will the research have an impact?: The research will inform universities and institutions offering doctoral education in nursing and health sciences. It will benefit doctoral students, supervisors and academic administrators by providing insights and strategies to enhance supervision quality and promote ethical practices.
This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
No patient or public involvement.
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.
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.
Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.
Observational study based on prospectively collected registry data analysed retrospectively.
Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.
The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.
Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).
The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.
Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.
The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.
As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.
FreshRSS 