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

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 examine Australian General Practitioners’ (GPs) confidence in initiating oral anticoagulants (OACs) for patients with atrial fibrillation (AF), and their practices for monitoring treatment adherence.

Cross-sectional online survey.

GPs practising in metropolitan, regional and rural/remote locations in Australia.

1765 Australian GPs recruited through professional GP networks.

GPs’ self-reported confidence initiating OACs; practices monitoring patient adherence and persistence; and perceived barriers to adherence. Demographic data including clinical experience and geographic location were collected. ² analyses were used to examine associations between the key outcome variables and GP location and clinical experience.

Of 1765 respondents, 83.1% had practised for >10 years and 27.6% worked in regional or rural/remote areas. Overall, only 50.2% reported high confidence initiating OACs in patients with CHA₂DS₂-VA score ≥2 (a cumulative stroke risk score with a score of 1 for: congestive heart failure, hypertension, diabetes, vascular disease and age 65-74 years and 2 for: stroke/transient ischaemic attack, age ≥ 75 years). Unsurprisingly, confidence was higher among GPs with >10 years experience (51.5%) compared with 5–10 years (44.9%) and

Only half of GPs reported high confidence initiating OAC treatment, and approximately a quarter do not routinely monitor medication adherence or persistence. Targeted strategies to improve confidence and align practices with guideline recommendations are required. Appropriate education should be developed targeting the specific issues underlying lack of confidence in initiating OAC and the practice of referring newly diagnosed patients to cardiology. Further research into implementing systems for monitoring and improving adherence and persistence would be worthwhile in the context of these findings.

Climate change has led to extreme heat events, disproportionately affecting vulnerable populations. Heat stress during pregnancy is linked to adverse health outcomes, yet the biological mechanisms remain poorly understood. This research study aims to investigate the effect of environmental heat on maternal, fetal and infant health and examine the biological pathways linking heat stress to adverse pregnancy outcomes.

This prospective cohort study will recruit 6000 pregnant women from three districts in Sindh, Pakistan. Eligible participants ≥18 years old, will have a minimum of five scheduled visits from

The study has received ethical approval from the Aga Khan University (AKU) (Ref: 26249) and the Pakistan National Bioethics Committee (Ref: 1065/23/1736). Written informed consent will be obtained from all participants before enrolment. Referral pathways to healthcare facilities will be established to ensure timely management of pregnancy complications. Findings will be disseminated through peer-reviewed publications, scientific conferences, and engagement with policymakers and public health stakeholders to inform climate-resilient maternal health strategies. Results will also be shared with participants and communities through meetings and informal sessions to raise awareness and support evidence-based heat adaptation.

NCT01234567.

Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model—a structured, integrative psychedelic ketamine therapy developed for severe TRD.

This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.

This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.

NCT06620276.

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Preimplementation qualitative study using semistructured interviews.

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

To identify and prioritise research uncertainties regarding the assessment, management and rehabilitation of patients with problematic hip replacements through a national Priority Setting Partnership (PSP).

A national PSP using the James Lind Alliance (JLA) methodology.

UK.

Patients, carers and healthcare professionals (HCPs) involved in the care of patients with problematic hip replacements.

A steering group was established. The James Lind Alliance methodology was followed throughout. A nationwide survey was conducted to collect unanswered questions. These were refined, prioritised through an interim survey and ranked at a final consensus workshop.

The initial survey yielded 201 questions, refined to 32. The interim survey had 191 respondents, leading to 19 questions at the final workshop. The top 10 research priorities were agreed on.

This PSP identified key research priorities for problematic hip replacements, focusing on diagnosis, pain management, perioperative optimisation and infection. These priorities can inform researchers and funders to improve outcomes for affected patients.

A neglected area of patient safety research is how the characteristics of mental health staff and teams may influence incidents, specifically, through unintended and harmful consequences of clinical care. While the research literature into patient safety has increased, there is still a need to further consider safety on mental health wards, for example, the role of the staff team in containment and conflict. This review aims to explore the question, ‘How do staff and team characteristics relate to safety incidents in adult inpatient mental health settings?’.

The review will follow Whittemore and Knafl’s integrative review framework. CINAHL, Cochrane, Embase, MEDLINE, PsycINFO, Web of Science will be searched. Literature published after 1999, that includes extractable quantitative, qualitative and mixed methods data exploring the relationship between staff and team characteristics on incidents in adult inpatient mental health settings, will be suitable for inclusion. The Mixed Methods Appraisal Tool will be used for quality appraisal and data analysis and will comprise data reduction, display and comparison.

No new data or access to participants will be involved in this review. As such, ethical review will not be required. Dissemination will include publication in peer-reviewed journals and presentations at national and international conferences.

This review has been registered on PROSPERO (ref. CRD420251119981; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251119981).

Enabling the reuse of participant-level health data is central to advancing public health and clinical practice. Measuring knowledge, attitudes and practices (KAP) related to data sharing is essential for understanding how stakeholders perceive data reuse and where further investment is needed. We conducted a measurement systematic review to identify and describe the development, scope and measurement properties of quantitative surveys assessing data-sharing-related KAP in biomedical research.

Systematic review using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) approach.

Ovid (MEDLINE), EMBASE, CINAHL, PsycINFO and HaPI were searched for relevant surveys from 1 January 2000 to 7 April 2021. The Ovid (MEDLINE) search was updated on 30 May 2022 and 15 April 2024.

Quantitative surveys measuring knowledge, attitudes, behaviours or practices related to sharing or reusing participant-level health data were included.

Two independent reviewers screened studies, extracted data and, where possible, applied the COSMIN Risk of Bias checklist to assess survey measurement properties. We summarised survey scope, target populations, data types, development and measurement properties narratively. Due to substantial heterogeneity, survey findings were not compared across studies.

We screened 3684 title-abstracts, reviewed 104 full texts and extracted data from 72 publications representing 60 independent surveys. Most surveys originated from high-income countries and were used only once. Fewer than one-third reported pilot testing. Only six surveys provided sufficient information to apply COSMIN, and only three reported measurement properties, indicating low certainty in the available evidence.

This is the first systematic comparison of the development and measurement properties of quantitative survey instruments assessing data-reuse KAP. Most surveys lacked rigorous development and reporting, limiting their utility for comparing KAP related to data sharing across stakeholders and settings. The review findings will inform the creation of a cross-country, cross-disciplinary question bank to support future tool development.

CRD42021243926.

The COVID-19 pandemic threatened global HIV Test and Treat Efforts. We assessed whether it affected (1) the number of antiretroviral therapy (ART) initiations and (2) the proportion of timely ART initiations in people living with HIV (PLWH) globally.

Quasi-experimental, regression discontinuity design using routinely collected data from HIV clinics.

360 HIV care clinics across primary and secondary levels of care, participating in the International epidemiology Databases to Evaluate AIDS consortium, in 31 countries in Asia, Africa and the Americas.

177 391 PLWH (≥18 years old) who initiated ART 2 years before and 1 year after the onset of the COVID-19 pandemic in their country.

The primary outcome was the number of ART initiations per week; the secondary outcome was the proportion of timely ART initiations (ie, ART initiated within 7 days of enrolment). We assessed changes in these outcomes in the 52 weeks after compared to the 104 weeks before the pandemic onset, defined using each country’s peak Oxford Stringency Index score between January and June 2020.

Among 177 391 newly enrolled PLWH, 129 743 initiated during the pre-pandemic and 47 648 post-pandemic onset. 72.5% of ART initiations were timely pre-pandemic whereas 82.3% were during the pandemic. Absolute number of ART initiations remained stable during the pandemic period in 25 of 31 countries but decreased significantly in six countries: India (–5.0 p, 95% CI –9.2 to –0.7), Rwanda (–10.0 p, –18.6 to –1.4), Malawi (–33.4 p, –54.1 to –12.3), South Africa (–130.8 p, –188.6 to –73.1), Zimbabwe (–12.9 p, –20.0 to –5.8) and Togo (–19.6 p, –39.1 to –0.1). The proportion of timely initiations was stable in all countries except in Kenya (+4.2 pp, 95% CI +0.3 to +8.1) and in Mozambique (+2.7 pp, +0.5 to +4.9), where it increased significantly.

A deeper understanding of the factors that contributed to sustaining ART initiations, particularly in settings with stringent public health and social measures, is needed. These insights should inform preparedness strategies, resource allocation and policy development to ensure continuity of HIV services during future health emergencies, in line with World Health Organisation recommendations.