Cytoreductive surgery (CRS) with heated intraperitoneal chemotherapy (HIPEC) is a treatment for peritonitis carcinomatosa. These procedures often involve significant blood and fluid loss, leading to hyperdynamic circulation and vasodilation, necessitating intraoperative fluids and vasoconstrictors such as catecholamines. Excessive fluid administration to counteract vasodilation can cause intraoperative fluid overload, which is linked to increased postoperative complications. Vasopressin has emerged as a potential alternative to catecholamines, restoring vascular tone via non-adrenergic pathways and supporting perfusion pressure, potentially reducing the need for compensatory fluids solely administered to compensate for vasodilation. We hypothesise that compared with norepinephrine, vasopressin reduces cumulative intraoperative fluid administration during CRS-HIPEC within a goal-directed fluid therapy (GDFT) protocol, ultimately leading to a lowering of postoperative complications.

HiPress is a two-centre, two-arm randomised clinical trial with blinding of both patients and outcome assessors. A total of 70 adult patients undergoing CRS-HIPEC will be included. Patients will be randomised to receive either continuous low-dose argipressin or continuous low-dose norepinephrine. Both groups will receive standardised GDFT during the procedure. The primary endpoint is cumulative intraoperative fluid administration (mL). Secondary endpoints include direct fluid-related outcomes (eg, cumulative intraoperative fluid (ml/kg/hour), postoperative fluid balance until day five and ultrasound-assessed pulmonary oedema and venous congestion) and indirect fluid-associated outcomes (eg, quality of recovery, surgical and abdominal complications, acute kidney injury (AKI), pulmonary complications, length of ICU and hospital stay and 30-day mortality).

The study is enrolling patients since February 2025. The trial is approved by the Medical Research Ethics Committee (hereinafter: MREC) NedMec, The Netherlands (Ref: D-25-500202). Results of the trial will be published in an international peer-reviewed journal and announced at national and international scientific meetings.

Clinical Trials Information System (CTIS): European Union clinical trials register (EUCT) number: 2024–5 13 598-33-00

To explore the feasibility of the confidante methodology to measure past-year intimate partner violence (IPV) experiences in Burkina Faso and the Democratic Republic of the Congo (DRC) through (1) comparison of direct assessment with indirect estimation via the confidante method and (2) assessment of the performance of each confidante method assumption.

Cross-sectional study with nationally and subnationally representative data collected from December 2020 to March 2021 in Burkina Faso (national) and from December 2021 to April 2022 in Kinshasa and Kongo Central, DRC (subnational).

Burkina Faso; Kinshasa, DRC; Kongo Central, DRC.

Partnered women (married or cohabiting) aged 15–49 in Burkina Faso (N=3047), Kinshasa, DRC (N=702) and Kongo Central, DRC (N=688) and their partnered confidantes aged 15–49 (N=2064 in Burkina Faso, N=304 in Kinshasa, DRC, N=393 women in Kongo Central, DRC).

Past-year IPV (emotional, physical, sexual, any) comparing differences in prevalence between the direct respondent sample and the indirect confidante sample, adjusting for confidante method assumptions.

The confidante method produced comparable IPV estimates to respondents’ direct reports across sites (35.3% respondent vs 36.1% confidante in Kinshasa, DRC; 29.7% respondent vs 39.0% confidante in Kongo Central, DRC; 25.7% respondent vs 26.0% confidante in Burkina Faso, differences not statistically significant). Of note, there were differences in IPV estimates between respondents and confidantes by IPV subtype, with physical IPV consistently lower among respondents across sites and sexual IPV lower among confidantes in Kinshasa, DRC and Burkina Faso, though generally not statistically significant.

The confidante methodology did not afford advantages over standard, direct assessment for IPV. Overall, findings indicate the reliability of population-based surveys with direct IPV questions when implemented under recommended ethical guidelines, though direct reports are likely undercounts.

Diabetes is a chronic disease characterised by elevated blood sugar levels, which can lead to damage across various body systems. Bangladesh has the second highest number of adults with diabetes in South Asia and faces a significant economic burden from this condition. The objective of this study was to investigate the economic burden of diabetes and its associated factors among patients with diabetes registered at a tertiary-level diabetes hospital in the Rajshahi region of Bangladesh.

This was a cross-sectional hospital-based study.

Primary data were collected from patients with diabetes at a tertiary-level diabetes hospital in Bangladesh.

The study recruited 400 patientswith diabetes, who were randomly selected. The economic burden was assessed using the Catastrophic Health Expenditure (CHE) threshold of ≥10% of household income. Descriptive statistics, 2 tests, t-tests, linear regression and binary logistic regression were employed for analysis, with statistical significance set at p

The proportion of diabetes-related burden among patients with diabetes was 50.7%. 95.8% of patients had type 2 diabetes, and over half (52.5%) were overweight or obese. Treatment costs were significantly associated with diabetes duration, insulin use and age (35–55 vs ≥56 years). The economic burden was strongly associated with lower income levels (poor income and middle income vs high income) and longer diabetes duration. Participants not adhering to a healthy diet had 43% lower odds of experiencing economic burden than those following a healthy diet.

Approximately half of the patients experienced catastrophic health expenditure due to diabetes, indicating a substantial economic burden in the Rajshahi region of Bangladesh. This burden was significantly higher among lower-income and middle-income groups and patients with longer disease duration, and treatment-related factors such as insulin use were associated with greater financial strain. These findings emphasise the need for targeted financial protection strategies, including subsidised care and preventive interventions.

Accessible, person-centred, non-pharmacologic modalities are needed to address chronic pain and health-related quality of life (HRQoL) among individuals with sickle cell disease (SCD). Building off prior single-site pilot studies of music therapy (MT) in SCD, the purpose of this study is to (1) examine the data collection processes and intervention implementation overall and across two sites and (2) evaluate the implementation of the MT and health education interventions using quantitative and qualitative data.

This three-arm, two-site, feasibility randomised controlled trial will include 90 individuals ≥14 years who have SCD, chronic pain and access to a mobile device who are not currently engaged in mind-body pain management interventions under the supervision of a healthcare professional. Participants will be randomised to six sessions over 8 weeks of either: (1) in-person MT, (2) hybrid (one in-person, five virtual) MT or (3) hybrid health education. Patient-reported outcome measures of HRQoL and self-efficacy will be assessed at baseline, post-intervention and 6 weeks post-intervention. 24 participants (eight per arm) and 20 stakeholders (eg, haematologists, music therapists, nurses) will be invited to complete semi-structured interviews to further examine intervention acceptability, perceived benefits and implementation. Sessions will be monitored for fidelity, and participants lacking access to home internet or videoconferencing technology will be provided tablets to engage in virtual sessions. Feasibility will be determined by rates of data completion, recruitment, retention, session attendance and home practice.

This study was approved by the University Hospitals Cleveland Medical Center Institutional Review Board (STUDY20231055). The dissemination plan includes presenting findings at national and international scientific conferences and publishing in peer-reviewed journals. All activities will be conducted in collaboration with SCD community stakeholders.

NCT06853158.

More than 300 million major surgical procedures are carried out under general anaesthesia each year worldwide, and advanced airway management remains one of the leading daily challenges for clinicians. Data from large international prospective cohort studies on adverse events such as cardiovascular collapse, cardiac arrest and severe hypoxaemia during advanced airway management to facilitate anaesthesia are lacking.

The International obServational sTudy on AiRway manaGement in operAting room and non-operaTing room anaEsthesia (STARGATE) study will be an international prospective observational cohort study describing the incidence of major adverse events associated with advanced airway management (tracheal intubation or supraglottic airway device placement) for general anaesthesia in the operating and non-operating room for surgery and medical procedures. The secondary aim will be to describe the practice of airway management in a large international cohort. Critically ill patients will be excluded from this study. Data on patients’ characteristics, type of procedure and the adopted airway management strategy, post-procedure adverse events, operator characteristics and in-hospital mortality will be prospectively collected. The study aims to enrol 10 500 patients.

The study has been approved by the Ethics Committee of the coordinating centre (Comitato Etico Interaziendale AOU San Luigi Gonzaga, N° 25/2023). Each of the participating centres will then seek approval of their local Ethics Committee before enrolment. Data will be disseminated to the scientific community by original articles submitted to international peer-reviewed journals.

NCT05759299.

Type 2 diabetes mellitus (T2D) and metabolic syndrome (MetS) have reached epidemic proportions for Indigenous populations globally. In Australia, disproportionate rates of T2D and MetS are inextricably tied to the experience of colonisation. As part of a growing shift towards strengths-based, Aboriginal-led initiatives, this project sought to co-design and assess the feasibility of a metabolic remission initiative, whereby Aboriginal people living on Ngarrindjeri Ruwe (Country) are supported to adopt a low-carbohydrate diet.

This 28-week pilot takes the form of a non-randomised stepped-wedge design. Aboriginal adults (≥18 years) living on Ngarrindjeri Ruwe with T2D or MetS will be recruited to two sites in rural South Australia. Participants will transition through three phases (control phase, remission phase and maintenance phase) with repeated measures taken across five key time points (T1–T5). While centring on the adoption of a low-carbohydrate diet, participants will be equipped with continuous glucose and ketone monitors and meal boxes and offered ongoing support through weekly to fortnightly check-ins. The primary outcome is to assess the feasibility of Nra:gi Ya:yun in preparation for a large-scale clinical trial of similar design. Feasibility will be assessed through recruitment, retention and adherence rates. Self-reported dietary recall, out-of-pocket food costs and national pharmaceutical and medical benefits scheme data will also be examined. Qualitative data obtained using the Aboriginal research method of yarning will aid analysis and interpretation of results. Clinical measures (such as blood pressure, weight, waist circumference, capillary ketones and capillary glucose) and venous blood draws will assist in the evaluation of our secondary outcome, namely the initiatives’ preliminary effect on participant metabolic health.

Findings will be disseminated to Community, participants and policymakers in the form of digital posters, manuals, infographics and peer-reviewed publications. Lessons from this study have the potential to provide insights and benefits to Australian public health policy and research, as well as Indigenous populations globally who face similar metabolic challenges. Findings will be used to advise on an implementation strategy for a large-scale clinical trial. Pilot trial approved by the Aboriginal Health Research Ethics Committee (HREC), Flinders University HREC and Southern Adelaide Local Health Network HREC.

Pilot prospectively registered with the Australian and New Zealand Clinical Trials Registry ACTRN12624001019594.

Existing psychological and pharmacological interventions for young people at ultra-high risk (UHR) for psychosis have shown benefit in at least delaying the transition to psychosis, but they have limited benefit for comorbid disorders or social dysfunction, which are prominent for those at UHR. We developed a moderated online social therapy platform (named Momentum) including: (1) transdiagnostic therapeutic interventions targeting social functioning, depression, generalised anxiety and social anxiety; (2) a moderated, peer-led online community and (3) specialised human support from clinicians, career consultants and peer workers. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Momentum, a 12-month digital intervention, informed by the complex intervention framework, is superior to 12 months of TAU in improving social functioning in UHR young people.

The study design is a prospective, parallel group, rater-masked randomised controlled trial. We will recruit young people aged 14–27 years, meeting one or more UHR for psychosis criteria. Participants are randomly assigned to the condition using randomly permutated blocks with a 1:1 allocation ratio. Participants are stratified by age (

Melbourne Health Human Research Ethics Committee (HREC/42964/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website. De-identified individual participant data will be available after publication for 3 years via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Supplementary material including study protocol, informed consent material and statistical analysis plan will also be available.

Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619001411134.

This paper examines the challenges frontline health workers face, as well as their coping practices following district splitting. It also has ramifications for the need to take into account the nexus between district splitting and subnational health system functioning.

A qualitative cross-sectional study employing an exploratory design. Data were collected using an in-depth interview guide for individual interviews. We used a deductive thematic analysis to identify and structure challenges faced and coping mechanisms by health workers in new districts. The data were analysed deductively using Braun and Clarke’s six-step thematic analysis.

Frontline health workers from four randomly selected regions with one parent district selected randomly from each region and a respective child district that had been split from it between 2005 and 2015. Interviews were conducted between June and November 2018.

In-depth interviews were conducted with 24 frontline health workers whose age ranged from 33 to 51 years and these had changed locations between districts after district splitting occurred.

The challenges frontline health workers faced included work-related role changes, social demands, team integration and health system inadequacies. Health workers switched roles across districts, adapting to leadership while balancing clinical and administrative duties. Overall, five themes emerged during analysis. Newly promoted staff faced knowledge gaps in facility management. Social demands included accommodation issues and family/community pressures. Team integration impacted daily work, requiring newcomers to navigate hierarchy and culture. Health system issues, such as understaffing, poor infrastructure, drug shortages and strained work relations, worsened working conditions. Coping practices included induction, leadership training, staff appraisals, duty rosters, supervision, team building, partner support and financial/community planning.

District splitting worsens challenges for frontline health workers. While they show resilience through coping strategies, systemic improvements remain essential. Addressing root causes like better resource distribution, expanded training and stronger administrative support is crucial to achieving the district splitting goal of improving healthcare delivery in newly formed districts in Uganda.

This proof-of-concept study explored the feasibility and acceptability of research cafés as a community-based model to engage racially minoritised communities in health research, with a focus on mental health.

Adopting a community peer research approach, a research team led by researchers from racially minoritised backgrounds, partnered with four voluntary organisations to conduct four research cafés. A mixed-methods feasibility design combined descriptive quantitative questionnaire data with thematic analysis of discussion notes to evaluate the impact of these cafés in South West London.

The study took place in Wandsworth, Kingston, Croydon and Sutton, in community venues provided by the voluntary organisations.

A total of 75 participants from racially minoritised backgrounds attended the sessions. Participants were intentionally selected based on age, ethnicity, location, mental well-being experiences and willingness to engage in mental health research.

Quantitative data were collected on participant attendance, demographics and feedback. Qualitative data captured participant perceptions and experiences related to healthcare and research.

The study took place between October 2023 and March 2024. Out of the 112 individuals who registered, 75 people attended with 74 contributing to the analysis (excluding one on the day sign-up). Participants were predominantly Asian/Asian British (62%) and Black/Black British (31%). All participants reported feeling comfortable and respected. Understanding of research improved for 96% and 95% expressed interest in further research involvement, most commonly the idea of joining a peer research network (64%). Participants also highlighted a need for training in research methods and communication skills for ongoing involvement. Five main themes emerged from the café discussions: (1) systemic barriers to accessing safe healthcare and mistrust of UK healthcare systems; (2) the need for cultural competence and sensitivity in healthcare and research; (3) research as a positive step for change; (4) barriers to research participation and (5) the importance of incentives and feedback for research participation.

Preliminary findings suggest that diverse and inclusive community-based partnerships are the basis for developing research cafés as a feasible and acceptable model for engaging racially minoritised communities in health research. They complement existing participatory approaches by creating inclusive, peer-facilitated spaces that build trust, improve awareness and generate high intention for future involvement and participation. Future studies are needed to test the model’s scalability across different geographic and demographic contexts and evaluate its long-term impact on research literacy, participation and equity.

The use of data science for health research produces complex ethical, legal and social challenges that traditional ethical oversight mechanisms struggle to address. In Nigeria, the current ethical guidelines were not designed for these challenges which include pervasive data environments, consent for secondary data use, algorithmic decision-making and bias, privacy risks, involvement of commercial entities, data colonisation, inequitable benefit-sharing and commercial data holdings. To address these gaps, we developed a draft guideline incorporating principles like trust, veracity, global justice and alternative ethical approval mechanisms. Here, we describe the protocol for a study aimed at validating the guideline through stakeholder consensus on the content, feasibility and acceptability of this subcode for national implementation.

We describe the use of a modified e-Delphi approach to iteratively synthesize expert opinions about ethical oversight for data science health research (DSHR) led by a multidisciplinary working group from the Bridging Gaps in the ELSI of Data Science Health Research in Nigeria (BridgELSI) team. We will invite 65 experts, including health researchers, ethics committee members, data scientists, health policymakers, funders and key opinion leaders in Nigeria to participate. Participants will rate 13 core principles, including global justice, algorithmic bias, data governance and related governance provisions on importance, desirability for inclusion in national guidelines, feasibility and confidence in implementation, using 5-point Likert scales, with optional free-text comments. We will summarise responses using descriptive statistics, assess consensus and polarity using pre-specified thresholds for the mean and IQR, and iteratively refine statements between rounds using qualitative content analysis of comments.

Ethical approval was obtained from the Nigerian National Health Research Ethics Committee and the University of Maryland IRB, and participants will provide informed consent. Results will be shared with the expert panel and national regulators and disseminated via publications and conferences.

Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.

To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.

Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.

Electronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.

Eligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.

Search results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.

A total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.

This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.

The protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of lungs to noxious particles and gases. The inflammatory and reparative processes occurring in the lungs induce a ‘spill-over’ of inflammatory mediators into the circulation, resulting in an increase in systemic inflammation, which is further increased during acute exacerbations of COPD (AECOPD), leading to the development of extra-pulmonary comorbidities, such as cognitive impairment. Cognitive impairment affects up to 61% of people living with COPD. Heightened levels of inflammation have been linked to increased risk of cognitive impairments; however, the exact mechanisms remain unclear, thus hampering the development of therapeutics. This study aims to determine whether patients hospitalised with an acute COPD exacerbation show impaired cognitive function compared with recovery (~day 45), and whether such dysfunction is associated with systemic inflammation and oxidative stress.

A prospective, observational study will be conducted at Austin Health in Victoria, Australia. Eligible participants will be assessed during admission for AECOPD and following stabilisation (approximately day 45). The primary outcome is the difference in cognitive function between admission for AECOPD to recovery using non-verbal cognitive tests. Secondary outcomes are changes in systemic markers of inflammation, oxidative stress and ACE2 catalytic activity. Tertiary outcomes are anxiety and depression scores.

Ethical approval has been granted in Australia by Austin Health Human Research Ethics Committee (HREC 56099) with governance approval at Austin Hospital. The results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. Findings will be disseminated to consumers in publications for lay audiences.

Video games have been linked to a range of positive and negative effects on the mental health of adolescents and young adults. However, to better understand how games affect the mental health of young people, their use and experiences must be situated in the sociocultural and personal life contexts of individuals. Drawing from a cultural-ecosocial approach, this study combines cross-sectional and digital phenotyping measures to examine the effects of video games on the mental health of youth.

Participants will be young people aged 16–25 years from the community and living in the province of Quebec, Canada. An initial sample of 1000 youth will complete a cross-sectional survey online, including measures of socio-demographic context, gaming practices and experiences, streaming practices and experiences, as well as personality and well-being. Qualitative questions will explore personal views on games and mental health. A subsample of 100 participants will be selected for digital phenotyping, including daily surveys of well-being, gaming, streaming and social experiences, combined with passive mobile sensing (eg, geolocation). Analyses will include regression and mixed models for quantitative data, reflexive thematic analysis for qualitative data, and an integration of quantitative and qualitative results using participatory methods.

The study received ethical approval from the Institutional Review Board of McGill University (24-02-015). The dissemination of results will be conducted in partnership with a multi-stakeholder advisory committee, including youth who play video games, and will involve peer-reviewed publications, presentations to policymakers in Quebec, and workshops for clinicians and researchers.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).

Globally, about 74% of deaths are attributed to non-communicable diseases (NCDs). Tobacco use is one of the key risk factors of NCDs. Tobacco taxes can discourage the use of tobacco. However, how increasing tobacco taxation may reduce the burden of NCDs is not well studied.

This study examines whether higher cigarette taxes are associated with reduced premature deaths—death before the age of 70—from NCDs using multicountry panel data.

The study analysed country-level panel data of 152 countries from 2008 to 2020 collected from various sources. The annual burden of NCDs was measured by the proportion of deaths due to NCDs before age 70 in each country. The tax rate on cigarettes—both specific and total—was used as a key explanatory variable. Other covariates include MPOWER score net of taxes, tobacco prevalence and other country-level characteristics. Panel data regressions with various combinations of country and year fixed effects were used to estimate the association between tobacco taxation and the burden of NCDs.

Cigarette tax was significantly (p

The study provides important evidence that increasing tobacco taxation could be an effective tool in reducing the burden of NCDs. Countries aiming to curb the burden of NCDs could consider raising tobacco taxes.