The home-based primary care cohort was set up to identify the characteristics of Home-Based Primary Care (HBPC) users across three domains: health-related information, utility of healthcare service and care-related information.

A total of 407 patients enrolled in five HBPC centres were recruited between January 2023 and March 2024. The baseline survey was conducted among 332 participants who provided informed consent for both study participation and home visits. The second wave of data collection is scheduled to take place 6 months after enrolment, while the third wave will be conducted 12 months post-enrolment. During each home visit, trained interviewers administered structured survey questionnaires. On completion of the 12-month follow-up period, the dataset will include survey data, intervention records from the five participating HBPC centres, home mortality status and institutionalisation risk linked to each participant.

This study examines HBPC in Korea, integrating the Widely Integrated Services in Home model with the long-term care insurance system. Among participants, 30.1% lived alone, and 74.1% were homebound, showing similarities to findings from a US HBPC study. Analysing cohort data, this study evaluates the impact of HBPC on healthcare utilisation, aligning with international findings on reduced hospitalisations and costs. As the first HBPC effectiveness study in Korea, it highlights its role in enhancing care for homebound older adults and shaping national health policies.

Data on the number of interventions by profession, institutionalisation and hospitalisation status and duration, and death at home occurrence are being separately collected from five HBPC centres and will be included in the analysis. The analysis will examine associations between these variables to identify risk factors influencing institutionalisation. Additionally, this study plans to link the dataset with the National Health Insurance Service-Senior (NHIS-Senior) customised cohort for further analysis.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.

Epidermolysis bullosa (EB) is a group of rare genetic skin disorders characterised by skin and mucosal fragility, leading to painful blisters and erosions. Among its subtypes, the severe form of EB simplex (EBS-sev, OMIM 131760) is associated with widespread blistering from birth, mucosal involvement and increased neonatal mortality due to infections. EBS is primarily caused by dominant mutations in the KRT5 or KRT14 genes.

There is currently no curative treatment for EBS; management is symptomatic and multidisciplinary. Our recent data indicate that EBS-sev is associated with an inflammatory profile involving elevated levels of Th17-polarising cytokines (TGF-β, IL-6, IL-21), suggesting a role for the Th17 immune response in disease pathogenesis.

EBULO is an open-label, multicentre phase 2 study, over a 20-week period, to evaluate the oral daily intake of apremilast (dosage depending on the age and the weight of patients) based on a challenge/dechallenge/rechallenge design. Patients are evaluated during five on-site visits, and apremilast is administered for 16 weeks during two treatment periods, with a 4-week treatment interruption in between. The primary outcome will be to assess the efficacy of apremilast in the treatment of patients with EBS-sev evaluated by counting the number of new blisters, a method specifically developed for this protocol to overcome the lack of reliable assessment tools in EBS-sev. The secondary outcome will include assessing the safety and tolerability of apremilast treatment through the description of the specific events occurring during the treatment periods of the study.

The French Ethical Review Authority has approved the EBULO trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.

NCT06509984.

Despite substantial research investments aiming to prevent cancer and develop therapeutic interventions, cancer remains a formidable challenge. In view of the persistent rise in cancer prevalence, the condition should also be recognised as a chronic disease. Such an approach can enhance the quality of life of patients with cancer, inhibit treatment-related adverse events and prevent recurrence via comprehensive post-treatment management. The core objective of this study is to investigate the association between dietary factors and treatment-related adverse events in patients with cancer, with the aim of providing individualised dietary recommendations to reduce adverse events and enhance quality of life.

The study cohort will include 600 participants aged ≥20 years. The participants will be assessed for dietary intake, cancer therapy-related adverse events and single-nucleotide polymorphisms using genomic DNA extracted from saliva. In addition, general and clinical information, lifestyle patterns and general/biochemical data of the blood will also be collected. The primary outcome is dietary factors that mitigate chemotherapeutic adverse events, and the secondary outcome is the association between nutritional status and survival in Korean patients with cancer. Considering the potential impact of dietary habits on the adverse events of cancer treatment, the findings of this study can be used as a basis for the establishment of new dietary guidelines for patients with cancer.

The Institutional Review Board of Severance Hospital, Yonsei University Health System, Seoul, Korea, approved the study protocol (4-2021-1110). Further, all participants provided a written informed consent prior to the study. The findings will be shared via publications.

Despite efforts to implement lesbian, gay, bisexual, transgender, queer or questioning, and other sexual and gender diverse (LGBTQ+) inclusive practices to address health disparities faced by LGBTQ+ individuals, factors that facilitate the uptake of these practices remain underexplored. Informed by the Consolidated Framework for Implementation Research (CFIR), this study explores nurse leaders’ perspectives across diverse US healthcare systems regarding the facilitators and barriers to implementing LGBTQ+ inclusive practices.

We used a qualitative descriptive design. Semistructured interviews guided by the CFIR framework were conducted from October to December 2023. The data were analysed using thematic analysis.

Diverse healthcare settings (eg, acute care hospitals and public health centres) across the USA.

We purposively recruited 21 nurse leaders, such as chief nursing officers or chief nurse executives, who oversee nursing strategy, staffing and quality across their organisations.

Consistent with prior frontline-focused studies, nurse leaders confirmed key inner setting and individuals facilitators (eg, LGBTQ+ specific training, electronic health record adaptation, visible executive engagement). Our findings add system-level detail from an executive perspective. Leaders identified actionable levers such as establishing LGBTQ+ clinical and social services, allocating protected time and budgets, and deploying dedicated implementation teams. We also identified a cross-cutting barrier: a reactive, crisis-driven organisational culture that hinders proactive inclusion efforts. Beyond the organisation, sociopolitical and legal climates shaped readiness and resourcing, with anti-LGBTQ+ laws influencing inclusion initiatives. Finally, nurse leaders highlighted the need for rigorous multilevel evaluation (eg, patient, staff, institution) and noted that common surveys inadequately capture LGBTQ+ inclusion, revealing measurement gaps that impede continuous improvement.

Implementing LGBTQ+ inclusive practices in healthcare is essential for optimal health outcomes and social justice. Understanding the context of implementation at multiple levels is crucial. Future research should focus on testing implementation strategies, developing inclusive healthcare surveys, and supporting the role of organisational culture and leadership in promoting LGBTQ+ inclusivity.

High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

NCT04499859.

To assess the association of normal systolic blood pressure maintenance (SBP_maintain) with coronary artery calcification (CAC) progression in non-diabetic and diabetic subjects at low to intermediate cardiovascular risk.

Retrospective cohort study with a mean follow-up of 3.3 years.

Data from the Korea Initiatives on Coronary Artery Calcification registry were analysed.

10 754 asymptomatic Korean adults (51.5±8.6 years; 84.5% male; 14.2% diabetes) were enrolled. Participants were divided into two groups: normal SBP_maintain (maintain (≥120 mmHg) at the time of follow-up CAC scan.

CAC progression was defined as a difference of ≥2.5 between the square roots () of the baseline and follow-up coronary artery calcium score (CACS) (transformed CACS). Annualised transformed CACS was defined as transformed CACS divided by the interscan period.

Compared with non-diabetics, the incidence of CAC progression was higher in diabetics (28.4% vs 47.3%, pmaintain was inversely associated with an annualised transformed CACS (β: –0.18, 95% CI: –0.25 to –0.12, pmaintain showed a lower risk of CAC progression than ≥elevated SBP_maintain in non-diabetics; however, this association was not observed in patients with diabetes.

Maintaining normal systolic blood pressure was associated with a significantly attenuated CAC progression, especially in clinical conditions without established diabetes.

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

DRKS00033284.

The primary objective was to determine peritraumatic distress among orthodontic patients during the COVID-19 lockdown. And the secondary objective was to determine the relationship between peritraumatic distress in relation to different appliance types.

Cross-sectional study.

Primary hospital between May and June 2022.

Patients in the process of orthodontic treatment, able to read Mandarin online, provided informed consent for the use of the data recorded and completed the questionnaire within a reasonable time.

None.

The demographic information and orthodontic urgencies were collected using online questionnaires. The peritraumatic distress symptoms were assessed by the COVID-19 Peritraumatic Distress Index (CPDI). The temporomandibular joint (TMJ) pain was evaluated using a Visual Analogue Scale.

A total of 480 participants were enrolled, including 331 with fixed appliances, 131 with clear aligners and 18 with removable appliances. For all participants, the median CPDI score was 12 (4, 19). Higher CPDI scores were observed in participants with urgency (14 (6, 21) vs 8 (2, 15), p18 years (β=0.271, p

The study suggested that during catastrophic events such as the COVID-19 lockdown, orthodontic urgencies may exacerbate patients’ peritraumatic distress, especially among adult patients and those who suffer from TMJ pain.

Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life (QoL). Up to 80% of patients with dermatological conditions experience severe itch and poor sleep, as well as related mental health challenges such as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics, such as mindfulness training, cognitive behavioural therapy and acceptance and commitment therapy, are widely used and effective in the treatment of mental health illnesses. However, there is limited evidence on the application of such interventions in dermatology, and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.

English-speaking patients aged 16 years and older with psoriasis, eczema or chronic urticaria will be recruited and randomised into the intervention arm (psychotherapeutic application) or active control group (Healthy365 app, a general wellness application managed by the Singapore Health Promotion Board). This allows a comparative assessment of app-usage-specific outcomes while preserving the blinding of all participants. The primary outcome is the change in the Dermatology Life Quality Index (DLQI) score from baseline to week 8. Secondary outcomes include physician-assessed disease severity at weeks 8 and 16 relative to baseline, differences in other patient-reported measures at weeks 8, 16 and 32, self-reported treatment adherence and initiation/escalation of systemic medications. To understand how patients engage with the app, we will evaluate the implementation process, focusing on key measures such as engagement, satisfaction and willingness to pay. Statistical analysis will be carried out on an intention-to-treat basis, and missing data will be analysed using last observation carried forward.

All participants will receive both verbal and written study information that aligns with Good Clinical Practice guidelines. Ethical approval has been obtained from the National Healthcare Group’s Domain Specific Review Board (reference number: 2022/00751). Results will be disseminated via publication in a relevant journal. Data will be available from the corresponding author on reasonable request.

NCT06702293.

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.

This study assessed changes in the prevalence of malnutrition and obesity in children from North Korean (NK) refugee families resettling in South Korea (SK).

A longitudinal cohort study.

This study, conducted between 2017 and 2023, recruited participants through snowball sampling using local Hana Centres, alternative schools, religious organisations, civic groups, and other community-based networks.

Of the 441 children initially recruited, 406 participated in the baseline survey after excluding 35 with missing height or weight data. Among them, 187 (46.1%) completed a follow-up survey conducted at least 1 year later.

The prevalences of stunting, underweight, wasting and obesity were defined according to the 2017 Korean National Growth Chart: stunting as height-for-age below the third percentile, underweight as weight-for-age below the fifth percentile, wasting as weight-for-height below the fifth percentile for ages 0–23 months or body mass index (BMI)-for-age below the fifth percentile for ages 2–18 years and obesity as BMI-for-age at or above the 95th percentile for ages 2–18 years.

The prevalence of stunting was 7.5% at baseline and 5.4% at follow-up, while those of underweight and wasting were 6.4% vs 5.4% and 11.2% vs 5.9%, respectively; however, none of these changes were statistically significant. In contrast, the prevalence of obesity increased significantly from 11.1% at baseline to 18.8% at follow-up (p=0.045).

Despite residing in SK for an extended period, children from NK refugee families continue to experience malnutrition, while the prevalence of obesity is rising significantly.