Surgical margins are crucial in determining postoperative local recurrence (LR) in patients with colorectal liver metastasis (CRLM) and hepatocellular carcinoma (HCC). Achieving a margin greater than 1 cm can be challenging due to constraints related to remnant liver reserve, proximity to major vascular structures and tumour depth. We previously published findings from a retrospective study suggesting that additional margin coagulation (AMC) using radiofrequency may reduce LR, and this multicentre randomised clinical trial aims to further assess this hypothesis.

The LIVERATION trial is an international, multicentre, single-blind, randomised, parallel-group, controlled clinical trial involving 698 patients undergoing liver resection for CRLM or HCC. Participants will be randomly assigned in a 1:1 ratio to either AMC (study group) or conventional liver resection (control group) to assess oncological outcomes for both CRLM and HCC. The primary outcome is the incidence of LR. Secondary endpoints include overall survival, disease-free survival, cancer-specific survival, surgical complications and quality of life. Follow-ups occur at 30 days, 90 days, and 1, 2 and 3 years postoperatively.

The LIVERATION trial has been approved by the Ethics Committee at the sponsor site Hospital del Mar de Barcelona, CEIM-PSMAR (Comité de Ética de la Investigación con Medicamentos – Parc de Salut Mar), as well as by the Institutional Ethics Committees in all participating countries. The results of the main trial, along with each of the secondary endpoints, will be submitted for publication in a peer-reviewed journal. The study adheres to national and international guidelines, including the Declaration of Helsinki, and complies with regulations for studies involving biological samples under Law 14/2007 on Biomedical Research. A dissemination strategy has been developed to engage stakeholders and facilitate knowledge transfer to support the use of the findings of the study. LIVERATION is funded by the European Union under the Horizon Europe Framework Programme (Project Number: 101104360).

NCT05492136.

This study aims at documenting the frequency of reported abuse, stigma and discrimination and exploring the perspectives for improving the quality of maternal-newborn care (QMNC) of migrant mothers’ reporting abuse, stigma or discrimination.

Mixed methods multicentre cross-sectional study.

All maternal facilities (tertiary and secondary levels of care, n=9) from Friuli-Venezia Giulia region, Northeast Italy, between November 2019 and January 2022 in Northeast Italy.

874 migrant and 3968 non-migrant women answering a validated WHO Standard-based questionnaire after birth.

Frequency of reported abuse, stigma and discrimination during facility-based childbirth was calculated and compared with those of non-migrant mothers. Thematic analysis was conducted on eight open questions, using WHO Standards as a framework for the analysis.

Among migrant women, 84 (9.6%) reported some type of abuse, stigma and discrimination, a frequency similar to non-migrant women (9.8%, p=0.880). The most frequently reported was verbal abuse (87.7%), followed by stigma and discrimination (15.1%). Most women (86.9%) provided at least one comment, with a frequency comparable to non-migrant women (p=0.076). Among a total of 327 comments, 104 (31.8%) were practical suggestions for improving QMNC. Experience of care was the domain with the highest frequency both of negative (64.9% of negative comments) and positive comments (51.7% of positive comments) and with the highest frequency of suggestions for improving QMNC (52.9% of suggestions). Overall, suggestions mainly focused on strengthening healthcare professionals’ communication skills, allowing companionship during childbirth, increasing healthcare professionals’ availability and timely support.

This study shows that both migrant and non-migrant mothers are exposed to abuse, stigma and discrimination during childbirth, and that both are willing to provide practical suggestions, which should be used for planning actions to improve QMNC.

The study aims to assess the associated influencing oncology nurses’ perceptions of managers’ empowering leadership style and to examine the influence of sex, work experience, shift work, membership of an oncology nursing association or a scientific society, nursing educational level and specialised nursing training in oncology on oncology nurses’ perceptions of managers’ empowering leadership style and its subdimensions.

Descriptive cross-sectional study.

In March 2024, oncology nurses employed in oncology settings were invited to participate.

All Italian oncology nurses who were currently employed were eligible to participate.

The Italian version of the Empowering Leadership Questionnaire was used to assess nurses’ perceptions of managers’ performance in leading by example, participative decision-making, coaching, informing and demonstrating concern/interacting with the team.

A total of 298 nurses agreed to participate. The associated factors for an empowered leadership style across all subdimensions were sex (p=0.006) and the educational level in nursing (p=0.004). Participative decision-making, coaching, informing and demonstrating concern/interacting with the team subdimensions were associated with shift work. Participation in scientific associations (p=0.005) was also influential.

Exploring the data according to the nursing specialisation appeared intriguing, since it could be a more indicative suggestion for future interventions to implement an empowering leadership style in clinical nursing practice and better inform health policymakers to achieve the right solution in their health organisations.

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.

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

ISRCTN12377415.

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

clinicaltrials.gov (NCT06021288).

While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.

A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.

TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.

NCT06245135.

Point-of-care lung ultrasound (LUS) can assist in diagnosing acute respiratory diseases for its high accuracy and immediate availability at the bedside, including older patients with frailty. Delirium represents a frequent complication of hospitalisation in this setting, frequently triggered by acute respiratory diseases. LUS may therefore help identify individuals at risk of delirium, but the association between LUS abnormalities and delirium remains unexplored.

This study is a prospective, observational, multicentre study, with the main objective of assessing the correlation between LUS abnormalities and incident delirium during hospitalisation (primary outcome). The secondary objectives are to assess correlations between lung and diaphragm ultrasound parameters and clinical outcomes including duration of delirium, severity of respiratory failure and mortality. 480 patients aged ≥65 years old, urgently hospitalised after an emergency department visit for acute respiratory complaints, will be recruited in eleven acute geriatric wards located in eight teaching hospitals across Italy. LUS examinations will be performed by skilled clinicians prior to treatment whenever feasible, and in any case within 48 hours from admission. They will also undergo comprehensive geriatric assessment, and daily delirium assessment through the 4-AT tool. The association between LUS abnormalities, related parameters (LUS score, Pleural Effusion Score) and outcomes will be assessed by linear and logistic regression models.

Ethics Committee approval of the coordinating centre (Comitato Etico Territoriale Lombardia 3, reference ID 4369_20.03.2024_M) and collaborative centres has been obtained. All participants will provide written informed consent. Study results will be publicly available following peer-reviewed publication in international scientific journals.

NCT06670118.