Staphylococcus aureus (S. aureus) bacteraemia is a common and severe infection. With mortality rates ranging from 20–30% and long-term impairments in over a third of survivors, better treatments are urgently needed. Linezolid, a well-established treatment for pneumonia and complicated skin infections, has been shown in preclinical studies to strongly suppress S. aureus virulence factors critical to bacterial persistence and tissue damage. Hence, we aim to investigate whether the addition of linezolid to standard therapy in patients with S. aureus bacteraemia leads to an overall improvement in patient-relevant outcomes.

We will conduct a two-arm, parallel-group, multicentre, randomised controlled trial (Linezolid Plus Standard of Care) in 12 hospitals in Switzerland with blinded treating physicians, patients and outcome assessors. Hospitalised patients aged ≥18 years with S. aureus bacteraemia will be eligible. Patients will receive standard antibiotic treatment as prescribed by the treating physician. Within 72 hours of collection of the blood sample yielding the first positive blood culture, patients will be enrolled and randomised 1:1 to receive either adjunctive linezolid (600 mg orally two times per day for 5 days) or placebo. To determine patient-relevant outcomes, we implemented a comprehensive patient-representative consultation process. Consequently, we will use the desirability of outcome ranking (DOOR) established for S. aureus bacteraemia as the primary outcome at 90 days. The hierarchical composite DOOR outcome includes the following four components, ranked from most to least important: (1) survival, (2) return to level of function before S. aureus infection, (3) complications leading to treatment changes and serious adverse reactions; and (4) hospital length of stay. This approach will allow us to analyse the win ratio, that is, whether patients receiving linezolid have a better DOOR rank compared to patients in the placebo group. We calculated a target sample size of 606 patients providing 90% power at a two-sided significance level of 0.05.

Ethical approval was received from the Ethics committee for Northern and Central Switzerland (BASEC number 2025-00655). Eligible patients will be informed about the study by the local study team and asked for written consent if they wish to participate. For patients unable to provide informed consent, an appropriate substitute (ie, a close relative or a physician not involved in the research project) may make decisions based on the presumed wishes and the best interest of the patient. The patient’s own consent will be obtained as soon as their condition permits. Results will be published in peer-reviewed journals and in laymen's terms through various channels (social media, Swiss national portal HumRes).

NCT06958835.

Visual impairment is reported to affect 40%–50% of children with cerebral palsy (CP). Vision difficulties in the context of rehabilitation are often under-recognised, under-treated and therefore under-studied, pointing to an urgent need for the development of evidence-based vision interventions for infants and toddlers with cerebral vision impairment (CVI). We present the protocol of a multisite pragmatic pilot randomised controlled trial (RCT) of feasibility, acceptability and preliminary efficacy of an early vision-awareness and parent-directed environmental enrichment programme for infants with or at risk of CP under 7 months corrected age (CA) with vision impairment.

The main objective is to determine the feasibility and acceptability of the Vision Intervention for Seeing Impaired Babies: Learning through Enrichment (VISIBLE) intervention. We will estimate the preliminary effects of the programme on infants’ visual functions and early development, as compared with standard community-based care (SCC).

A two-group RCT will be conducted. Infants at 3–6 months at entry, with severe visual impairment and at high risk of CP, will be enrolled and randomised (n=16 per group) to receive the VISIBLE intervention compared to SCC. Randomisation will be completed through an independent automated process (Research Electronic Data Capture). VISIBLE intervention will be delivered by a therapist through home visits (90–120 min) once every 2 weeks. Completion of 10 visits (80% of the intervention target dose) within 6 months is required for adherence to the VISIBLE trial. Outcome will be assessed at 12 months CA. Visual function will be evaluated with the Infant Battery for Vision, motor outcomes with the Peabody Developmental Motor Scales, Second Edition. Developmental quotients, infant quality of life, parent well-being and parent-infant relationship will be also monitored through standardised tools.

The enrolling sites have historically demonstrated rapid and effective translation of successful evidence-based interventions into routine clinical practice, as well as the dissemination of the findings through local, national and international scientific meetings.

ACTRN12618000932268.

Deprescribing is important because inappropriate polypharmacy increases the risk of adverse drug events, treatment burden, reduced adherence and healthcare costs, while potentially compromising patient safety and quality of life. This study aimed to investigate the perceived barriers and enablers experienced by healthcare professionals (HCPs) in Indonesia regarding deprescribing in patients with type 2 diabetes (T2D) and polypharmacy.

A qualitative study using focus group discussions (FGDs) and thematic analysis.

Four FGDs were conducted with general practitioners, specialists (internists) and pharmacists from healthcare facilities in West Java Province, Indonesia. Each group included 3–4 participants from the same discipline, with one mixed group that included one participant of each profession. In total, 13 participants were included in the study.

HCPs across disciplines recognised the goals of deprescribing as optimising treatment, reducing polypharmacy risks and preserving treatment outcomes. However, implementation was hindered by the lack of clear guidelines, hierarchical dynamics, limited training and resource constraints, particularly in rural and high-volume settings. Enablers included clinical competence, effective communication, access to comprehensive clinical data and interprofessional collaboration. Patient education level, family support and community engagement were also key, underscoring the need for system-level support and shared decision-making to achieve effective deprescribing.

Deprescribing in T2D with polypharmacy is shaped by clinical competence, interprofessional collaboration, patient engagement and system-level resources. Improving practice in Indonesia requires clear guidelines, targeted HCP training, stronger interprofessional communication, better access to patient data and active involvement of patients and families. These strategies could provide context-specific insights to guide practice and policy on deprescribing initiatives.

766/UN6.KEP/EC/2024

To develop an empirically grounded, activity-based tariff framework for Hospital at Home (HaH) services using time-driven activity-based costing (TDABC) and micro-costing to support transparent and equitable reimbursement for acute elderly care delivered at home.

Microcosting study embedded within a randomised controlled trial (RCT) comparing HaH with conventional hospital admission in Denmark.

Three municipalities in the Central Denmark Region in collaboration with emergency department physicians at a regional hospital.

A consecutive subsample of 107 elderly acute patients enrolled in the RCT between June 2022 and February 2024. Resource use for HaH activities was measured prospectively using microcosting logs, time-motion observations and administrative records.

Empirically derived tariffs per HaH visit (first and subsequent) calculated using an eight-step TDABC framework incorporating process mapping, resource identification, capacity cost rates and time equations. Sensitivity analyses tested robustness to variation in key cost drivers.

The mean total tariff was 338.89 (95% CI 310.94 to 351.49) for first visits and 207.81 (95% CI 200.70 to 215.69) for subsequent visits, including treatment and transport components. Staff time was the principal cost driver, while equipment, overhead and travel reimbursement had smaller effects. The framework accommodates variation in staffing, geography and visit intensity and can be used to estimate total costs across diverse HaH pathways.

A transparent and reproducible tariff-development framework for HaH services was established using TDABC and microcosting. The model aligns reimbursement with actual resource use and care complexity and provides a transferable template for economic evaluation and operational planning.

NCT05360914.

Self-injurious behaviour (SIB) consists of persistent, repetitive movements that can result in serious injury without suicidal intent. These behaviours are prevalent among children with neurodevelopmental disorders, including profound autism. Although many individuals benefit from currently available therapies, some exhibit treatment-refractory SIB that necessitates ongoing use of personal protective equipment and restraint, presumably due to stronger neurobiological drivers. We recently completed a phase I, open-label clinical trial demonstrating the safety, feasibility and preliminary efficacy of bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS) in children with profound autism and severe, refractory SIB. The objective of the proposed study is to characterise the effectiveness of NAc-DBS in treating severe, refractory SIB in this unique and vulnerable population.

A single-centre, randomised double-blinded, crossover trial is proposed. Informed by the results of our pilot study, 25 subjects with autism spectrum disorder and severe, refractory SIB will undergo bilateral NAc-DBS. Following a 4-week recovery period, participants will be randomised to either group A (stimulation ON then OFF) or group B (stimulation OFF then ON). Each block will last 12 weeks, separated by a 2-week washout period. Following completion of the second block, all participants will enter a 6-month open-label phase with stimulation ON. The primary outcome is the difference in the Repetitive Behaviour Scale–Revised total score, between DBS-ON and DBS-OFF conditions. Secondary outcomes include measures of quality of life, caregiver burden, daily logs of SIB events and direct observation of SIB under structured analogues.

The proposed trial has been approved by the institutional Research Ethics Board (1000081171). Trial results will be disseminated through peer-reviewed publications and conference presentations.

NCT06529380

Guided by Straussian Grounded Theory, this study aimed to explore patients’ dynamic trade-off processes in evaluating bariatric surgery outcomes and to construct a patient-centred theoretical framework to inform clinical assessment and intervention.

Qualitative study using Straussian Grounded Theory, semi-structured, in-depth interviews were conducted. Data were analysed using open, axial and selective coding. Reporting followed the Standards for Reporting Qualitative Research guidelines.

This study was conducted at a tertiary hospital in China between June 2023 and August 2023.

A total of 11 patients who had undergone bariatric surgery were enrolled, aged 21–54 years, with postoperative follow-up durations ranging from 1 to 10 years.

A core category—Dynamic Trade-off Evaluation of Bariatric Surgery Outcomes—was identified, characterised by dynamism, trade-off and subjectivity. The framework comprises four inter-related components: trade-off basis, trade-off moderation, trade-off process and comprehensive evaluation. Outcome evaluation emerged as a non-linear process progressing through four stages: burden-dominant, contradiction-coexistence, contradiction-persistence and meaning-reconstruction stages. Individual goal orientation and psychological resilience served as key moderating factors shaping evaluative trajectories.

This study proposes a novel theoretical framework elucidating how patients dynamically evaluate bariatric surgery outcomes. By revealing stage-specific mechanisms and moderating factors, the framework provides a theoretical basis for improving preoperative expectation management and postoperative support.

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Multicentre observational cohort study.

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

NCT04749212

We compared the cost-effectiveness of alternative fracture risk assessment strategies for people with intellectual disabilities (ID) aged ≥40 years from a UK National Health Services perspective over a lifetime horizon.

Cost-effectiveness analysis using a lifetime decision-analytical model.

UK primary care, with data from literature and national databases.

People with ID.

Three strategies were assessed: (S1) Risk assessment using the UK QFracture score; (S2) use of IDFracture (a fracture risk prediction tool specifically developed for adults with ID); and (S3) conducting a one-time dual-energy X-ray absorptiometry (DXA) scan in all. S1 and S2 were followed by DXA scan for those at risk. At-risk individuals received treatment according to UK practice (bisphosphonates plus vitamin D and calcium for osteoporosis, and vitamin D and calcium alone for osteopenia).

Direct healthcare costs and quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).

In the base case, S2 (ICER: –£2568/QALY) was dominant (ie, less costly and more effective) and S3 (ICER: £1678/QALY) was cost-effective relative to S1 for major osteoporotic fracture (MOF). For hip fracture, S2 (ICER: £32 116/QALY) and S3 (ICER: £49 536/QALY) were not cost-effective relative to S1 under the National Institute for Health and Care Excellence-recommended cost-effectiveness thresholds. Findings from the sensitivity analyses were predominantly consistent with the base-case results. Subgroup analyses showed that age-specific and gender-specific strategies could be used.

For people with ID aged ≥40 years, a proactive approach to risk assessment for MOF is not only clinically beneficial, but also cost-effective.

Patients discharged from intensive care units (ICUs) are at high risk of adverse long-term outcomes including cardiovascular and/or renal events and a 1-year mortality of approximately 22%. Plasma biomarkers measured at ICU discharge have demonstrated strong prognostic value, with elevated cardiac or renal biomarkers identifying patients at particularly high risk of poor outcomes. Sodium-glucose cotransporter 2 inhibitors are now widely recognised for their cardioprotective and nephroprotective effects in chronic conditions such as type 2 diabetes, heart failure or chronic kidney disease. These agents improve both morbidity and mortality across a range of high-risk populations. We hypothesise that a therapeutic strategy aimed at preventing the progression of cardiovascular and/or renal injury following ICU discharge may improve long-term outcomes in ICU survivors.

This is a multicentre, double-blind, randomised, placebo-controlled clinical trial conducted across 16 teaching and non-teaching ICUs in France. We will enrol 600 adult patients (18 years of age or older) who have received mechanical ventilation and/or vasopressors for at least 24 hours during their ICU stay, and who meet at least one of the following criteria at ICU discharge: N-terminal pro-B-type natriuretic peptide (NT-proBNP) >800 pg/mL or BNP >90 ng/L, an estimated glomerular filtration rate between 25 and 90 mL/min/m². Eligible patients will be randomised in a 1:1 ratio to receive either dapagliflozin (10 mg once daily) or a matching placebo for a duration of 1 year. The primary outcome is a composite endpoint assessed at 1 year after randomisation, comprising: all-cause mortality, unscheduled hospitalisation for acute heart failure and decrease in renal function. Feasibility will be assessed based on patient and clinical acceptability and recruitment performance, including enrolment rates across participating centres.

This study has been approved by the Institutional Review Board (CPP Ile-de-France 5). Written informed consent will be obtained from all participants prior to enrolment and the initiation of any study-related procedures. Dapagliflozin is a widely available medication with an established safety profile. If proven effective, it would represent a readily deployable strategy to improve long-term outcomes in ICU survivors. The study is described in accordance with the Standard Protocol Items: Recommendations for Interventional Trials framework, and key design features and methodological decisions are outlined accordingly. DAPA-ICU aims to evaluate the efficacy of dapagliflozin in cardiorenal protection among critically ill patients following ICU discharge. The main trial results will be submitted for publication in a peer-reviewed journal as soon as they become available after final analysis.

NCT07025629.

Co-design of the PREDICT-Kidney online tool by patients, members of the public and healthcare professionals (HCPs), to support the communication of the risk of recurrence following surgical treatment for kidney cancer.

Qualitative co-design study. Using an iterative process, feedback was collected (via workshops), prioritised and implemented.

Online workshops with participants from across the UK were conducted between December 2023 and November 2024.

18 adult participants, including patients surgically treated for kidney cancer, members of the public without a history of kidney cancer and HCPs involved in kidney cancer care.

To produce an online tool to support the communication of risk of kidney cancer recurrence that is easy to use, easy to understand and acceptable to stakeholders. Secondary outcomes are the properties of the feedback collected, including volume and type.

Across nine workshops, 99 discrete feedback items were collected, resulting in 71 actionable changes to the initial prototype tool. Differences in priorities were observed between participant groups, especially around the inclusion of information about competing risks of death. Participants valued the tool for improving consistency of follow-up information, supporting shared decision-making and providing multiple visual formats to communicate risk. Iterative feedback led to refinements in terminology, design, content and delivery, including adjustments to the presentation of recurrence and mortality risk.

A co-design approach was used to improve the PREDICT-Kidney online tool to align with the needs of patients and HCPs. A feasibility study is required to evaluate its use and impact in clinical practice.

Liver tumours are a leading cause of global morbidity and mortality. Current diagnostic tools, including computed tomography (CT), magnetic resonance imaging (MRI) and intraoperative ultrasound (IOUS), have limitations in detecting liver neoplasms. Indocyanine green (ICG) has emerged as a promising tool for improving liver tumour detection. This study aims to assess the impact of preoperative ICG on intraoperative tumour detection in minimally invasive surgery and develop a machine-learning algorithm to enhance tumour detection using ICG fluorescence.

This prospective, multicentre, phase IV clinical trial adheres to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Patients with liver tumours eligible for minimally invasive surgery and a preoperative imaging test will be included. ICG will be administered intravenously 24 hours before surgery. Intraoperative procedures will include IOUS, ICG mapping and photographic documentation. Patients will be followed for 90 days to assess tumour progression, morbidity and mortality. The photographic analysis will enable the development of an artificial intelligence algorithm using machine learning and neural networks to identify lesions based on ICG fluorescence. The estimated sample size is 173 patients and the trial is predicted to accrue in 3 years.

The trial will be conducted in accordance with the Declaration of Helsinki and the Spanish Agency of Medicines and Medical Devices (AEMPS) guidelines. Approved by the local institutional Ethics Committee and the AEMPS, the results will be shared with the scientific community through publications and conferences.

2023–5 08 316-27-00.

NCT06398028.

V.12, 18 March 2025

Heart failure (HF) is a major public health issue due to its high morbidity, mortality and healthcare burden. This study aimed to provide estimates of HF incidence, survival rates, outcome changes and their predictive factors in a central Italian population over the decade 2014–2023.

Population-based retrospective cohort study.

Hospital discharge records from all hospitals in L'Aquila Province of Italy were analysed.

All residents who experienced a HF index hospitalisation between 2014 and 2023 were included. HF index hospitalisation was defined as the first hospitalisation for HF in patients with no prior hospitalisation from the same diagnosis for at least 4 years.

The primary outcomes were age-standardised and sex-standardised incidence rates of HF index hospitalisations and all-cause mortality following index hospitalisation. Incidence rate ratios (IRRs), survival and their associated factors were analysed with negative binomial regression models, Kaplan-Meier analysis and Cox proportional hazards models, respectively.

A total of 6965 incident cases from 17 588 HF hospitalisations in the decade under study were analysed. The overall standardised incidence rate was 1.73 per 1000 person-years, with significant differences by age and sex. Incidence rates decreased by 17% from 2014–2018 to 2019–2023 (IRR: 0.834; 95% CI 0.743 to 0.936). Cumulative 1-year and 5-year survival were 70.05% and 36.38%, respectively, with a progressively higher mortality risk in older people. Compared with the 2014–2018 cohort, the 2019–2022 cohort showed improved survival at 30 and 90 days and at 1 year overall and by age groups, with

HF incidence declined, particularly in older populations, and remained higher in men, while survival rates improved. Despite these trends, HF continues to represent a substantial clinical and public health burden.

Ear, nose and throat (ENT) conditions are highly prevalent in primary and secondary care, yet patients frequently face prolonged waits for specialist review. In England, over half of ENT patients wait beyond the NHS 18-week referral-to-treatment target. Many of these cases can be effectively managed with advice and non-surgical interventions, presenting an opportunity for remote service innovation.

This study aims to evaluate the clinical effectiveness, cost-effectiveness, acceptability and environmental sustainability of a digitally enabled remote ENT clinic model compared with traditional face-to-face pathways.

This single-centre, mixed-methods, prospective cohort study will be conducted at University Hospitals Birmingham NHS Foundation Trust. Remote clinics will use trained staff to collect diagnostic data (including endoscopic imaging and boothless hearing tests) for consultant review via secure cloud-based software. Quantitative analysis will assess patient outcomes, costs, waiting times, carbon footprint and satisfaction. Qualitative data from semi-structured interviews with patients, clinicians and managers will explore acceptability, scalability and barriers to implementation. The qualitative data will be analysed using the framework methodology, according to the non-adoption, abandonment, scale-up, spread and sustainability framework, while the strengthening the reporting of observational studies in epidemiology framework will be used to guide the reporting of quantitative data. Cost-effectiveness analyses will follow NICE guidelines, while environmental impact will be measurement will be informed by the sustainability in quality improvement framework. Recruitment will be aiming for 300 completed datasets and 30–35 interviews.

Ethical approval has been granted (IRAS 350908; REC 25/SW/0116). Findings will be disseminated via conferences, peer-reviewed journals and institutional communication channels.

To evaluate the feasibility and relevance of the LIFE-UP Day audit, a simple, 1-day benchmarking tool based on the multidisciplinary LIFE-UP bundle (Limit sedation, optimise nutritional Intakes, engage Families, promote Exercise and follow-UP the patients after discharge) and assessing the implementation of postintensive care syndrome (PICS) prevention strategies in daily practice.

Exploratory multicentre cross-sectional audit study.

Eight Belgian adult intensive care units (ICUs), between April and July 2024.

All patients present at 08:00 on the audit day and hospitalised for ≥24 hours.

An independent nurse collected data on sedation, analgesia, nutrition, family empowerment, physical exercise and post-ICU follow-up. A multidimensional LIFE-UP composite score (raw 0–10 points), normalised to a 5-point scale, was created to quantify adherence to PICS prevention practices based on current recommendations. Feasibility was evaluated through data accessibility, resource needs, cooperation of ICU teams and the ability to complete the audit within 1 day. Relevance was evaluated through adherence to the bundle, assessed by comparing LIFE-UP scores between ICUs. Quantitative results were expressed as median and IQR.

The audit was tested in 87 patients aged 68 (59–74) years, 9 (5–15.5) days after their admission. The audit was feasible across all ICUs: necessary data were available, resources required were minimal and cooperation was excellent. The LIFE-UP score highlighted significant variability between ICUs (2.5 (1.75–2.75), p

The LIFE-UP Day audit proved feasible and provides a first structured framework for benchmarking. Broader implementation will be essential to validate the LIFE-UP score, refine the model and ultimately determine whether it can translate into improved patient and family outcomes.

This study aimed to determine the prevalence of fetal malnutrition (FM) among term singleton newborns at birth using clinical assessment of nutritional status (CAN) score. The study also compared the CAN score with selected anthropometric indices to describe their ability to identify FM. Furthermore, it sought to identify maternal and neonatal factors linked with FM among term infants delivered in four public hospitals in South Ethiopia.

Cross-sectional study.

The study was conducted at four public hospitals in South Ethiopia Regional State.

480 live-born full-term babies and their mothers delivered at four public hospitals between 6 June 2021 and 19 April 2022.

FM status at birth was the outcome variable. FM was assessed using both the CAN score and selected anthropometric indices. At birth, measurements of height, weight, head circumference (HC) and mid-arm circumference (MAC) were taken. The MAC/HC ratio, body mass index (BMI) and ponderal index (PI) were computed and contrasted with reference curves. By examining and calculating subcutaneous tissue and muscle loss, the CAN score was used to determine the newborn’s CAN status. A CAN score of

This study of 480 newborns found varying rates of FM depending on the diagnostic criteria used. The prevalence of FM was highest when assessed by CAN score (26.04%), followed by PI (17.29%), BMI (16.25%), MAC/HC ratio (13.54%) and birth size-for-gestational-age (11.25%). Not attending formal education (AOR 3.31 95% CI 1.14 to 9.64), age between 25–29 years (AOR 2.66 95% CI 1.19 to 5.98), primi-parity (AOR 9.63 95% CI 1.42 to 65.46), having

FM was prevalent among term neonates, with the CAN score showing higher prevalence than anthropometric indices. Education level of the mother, primi-parity, fewer ANC visits, maternal age between 25–29 years and PIH were significant risk factors. FM might be most effectively recognised using the CAN score, which can be done without advanced tools.

Early-stage mycosis fungoides (MF) is diagnostically challenging due to overlap with inflammatory dermatoses. Age-related immunological and cutaneous changes may modify histopathological presentation. We aimed to compare clinical, histopathological and immunophenotypic features of early-stage MF between geriatric and non-geriatric patients.

Multicentre retrospective cross-sectional study.

Dermatology departments of tertiary centres in Türkiye.

A total of 541 patients diagnosed with early-stage MF were included and stratified into geriatric (≥65 years) and non-geriatric (18–64 years) groups.

The primary outcomes were age-related differences in histopathological and immunohistochemical features. Secondary outcomes included clinical characteristics and quality of life measures. Primary endpoints were prespecified a priori (epidermotropism, basilar lymphocytes, epidermal atrophy, dermal lymphocytic infiltration, papillary dermal fibrosis and CD4-dominant versus CD8(+)/CD4(–) phenotypes); all other comparisons were considered exploratory.

The geriatric group had a higher proportion of males (59.5% vs 47.1%; p=0.004), while lesion type, duration, surface involvement and Dermatology Life Quality Index scores did not differ between groups. Histopathologically, epidermotropism (81.3% vs 63.3%), basilar lymphocytes (57.1% vs 45.7%), epidermal atrophy (26.6% vs 13.8%), dermal lymphocytic infiltration (75.8% vs 58.5%) and papillary dermal fibrosis (55.2% vs 38.4%) were more frequent in geriatric patients (all p

Although clinical characteristics were comparable across age groups, geriatric patients showed differences in reported histopathological and immunophenotypic features; these observations may facilitate clinicopathological recognition of early-stage MF in older individuals. However, some features (particularly epidermal atrophy and superficial/papillary fibrosis) are not MF-specific and may partly reflect background age- and site-related changes.

Cadmium is a metal that poses significant health risks, particularly in occupational environments where exposure can happen. The main objective of this scoping review is to review the cadmium exposure levels in the different occupational settings in the European Union (EU), considering the regulatory measures currently in place. The secondary objectives, depending on the availability of data, are (a) to identify the occupational settings where higher exposure levels occur, (b) to identify any geographical and temporal differences and trends within the EU and (c) to identify the most relevant co-exposures reported.

A scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews reporting guidelines. Studies reporting quantitative occupational data on cadmium exposure obtained through human biomonitoring and/or air monitoring will be included. A descriptive analysis of the findings will be performed.

This protocol for a scoping review does not require ethical approval as it is based on secondary data. The dissemination plan of the scoping review includes its publication in a scientific journal of reference, as it is expected that it will provide important knowledge to support ongoing and future occupational health interventions in the EU, at the technical and regulatory levels.

This study is registered at the Open Science Framework (OSF), 7 April osf.f2w3h.

Haemorrhoidal disease affects 25–40% of adults worldwide and constitutes a primary reason for outpatient colorectal consultations. Surgical management is essential for grade III–IV or treatment-refractory cases. Numerous procedures have emerged, including Milligan-Morgan open haemorrhoidectomy, Ferguson closed haemorrhoidectomy, stapled haemorrhoidopexy, Doppler-guided haemorrhoidal artery ligation, transanal haemorrhoidal dearterialisation and laser haemorrhoidoplasty. However, randomised controlled trials and conventional meta-analyses report conflicting results on efficacy, postoperative pain, recurrence rates and complications such as bleeding, stenosis and incontinence. Although network meta-analyses exist, an updated synthesis is needed because outcomes and follow-up vary across trials. This protocol aims to determine the most effective and safest haemorrhoid interventions (office-based and operative) through systematic review and network meta-analysis, providing evidence-based guidance for clinical practice and guideline development.

The Cochrane Library, Web of Science, MEDLINE, Embase, China National Knowledge Infrastructure, VIP, SinoMed and Wanfang databases will be searched from inception to January 2025, limited to English or Chinese publications. Randomised controlled trials evaluating haemorrhoid interventions/procedures for haemorrhoidal disease will be included, with outcomes encompassing cure rate, recurrence, complications, postoperative pain, wound-healing time, anal function and operative duration. Risk of bias will be assessed using RoB 2. Pairwise meta-analyses will be conducted in RevMan; network meta-analysis will employ Bayesian frameworks in GeMTC or R, incorporating consistency evaluation, node-splitting and surface under the cumulative ranking curve for treatment ranking. Subgroup analyses (haemorrhoid grade, follow-up duration), sensitivity analyses and publication bias assessments will be performed. Evidence certainty will be graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Confidence in Network Meta-Analysis (CINeMA) framework.

As only published data will be used, ethical approval is not required. Results will be disseminated via peer-reviewed publication and conference presentations.

CRD420251053697.