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Geographic barriers to gynaecological cancer care in Indonesia: a geospatial and infrastructure analysis

Por: Tjokroprawiro · B. A. · Sulistya · H. A. · Rahma · A. A. · Novitasari · K. · Ulhaq · R. A. · Yuliati · I. · Utami · T. W. · Anggraeni · T. D.
Objective

This study aimed to identify underserved regions and evaluate the population coverage based on travel time and distance to hospitals with gynaecologic oncologists in Indonesia.

Methods

The travel time and distance to hospitals with gynaecologic oncologists were evaluated using the Quantum Geographic Information System. Data from 139 gynaecologic oncologists and their affiliated hospitals were obtained from the Indonesian Society of Gynecologic Oncologists (November 2024) and cross-referenced with the Ministry of Health records. The female population density data were sourced from Facebook’s high-resolution settlement layer. Isochrones were generated to estimate travel times and distances using zonal statistics, which facilitated the calculation of population coverage.

Results

A total of 139 gynaecologic oncologists were identified nationwide, practising in 243 hospitals (7.6% of the 3202 hospitals in Indonesia), with a concentration in Java (60.4%). 11 of the 38 provinces lack sub-specialists. Population coverage varies sharply: the travel time to a hospital with gynaecologic oncologists is ≤2 hours for 79.1% of women in Java, compared with 4.9% in Papua; overall, 34.4% reside more than 100 km away from hospitals with gynaecologic oncologists. Hospitals with gynaecologic oncologists are predominantly urban class B general hospitals, and 83.1% participate in the National Health Insurance Schemes. Exploratory district-level correlations showed positive associations between the number of such hospitals and total female population (r=0.44, p

Conclusions

Gynaecological oncology services in Indonesia remain heavily concentrated in Java, leaving nearly one-fifth of women residing more than 100 km away. The travel time is greater than 2 hours for many. Targeted expansion of the gynaecologic oncologists workforce, diagnostic and treatment infrastructure, and sustainable financing mechanisms are required to close these gaps.

Barriers and facilitators to implementing a shared decision-making tool for anticoagulant-related drug-drug interactions: a qualitative study across three academic medical centres in the USA

Por: Becker · R. A. · Bonnet · K. · Shah · M. V. · Dang · E. · Ancker · J. S. · Malone · D. C. · Trinkley · K. E. · Gomez-Lumbreras · A. · Del Fiol · G. · Kawamoto · K. · Tawfik · A. G. · Cornia · R. · Jones · A. E. · Mitchell · J. · Reese · T. J.
Objectives

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.

Design

Preimplementation qualitative study using semistructured interviews.

Setting

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

Participants

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

Results

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.

Conclusions

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.

Feasibility of an adjunctive INtervention for Debilitating symptom complexes attributed to ticks (FIND): study protocol for a randomised, waitlist-controlled feasibility trial

Por: Kanaan · R. A. A. · Macdonell · R. · Long · M. · Richardson · R. J. · Rogers · C. · Mcmanus · M. · Braat · S. · Zaloumis · S. · Mihalopoulos · C. · Chatterton · M. L. · Gibney · K. B. · Oliver · G. · Wilson · S. J. · Chalder · T.
Background

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

Methods

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

Ethics and dissemination

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

Trial registration number

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placebo-controlled trial

Por: Stotts · C. · Corrales-Medina · V. F. · deKemp · R. A. · Wells · G. A. · Beanlands · R. · Raggi · P. · Ferrara · G. · Sligl · W. · A Connelly · K. · Paul · N. · Brouwers · M. · Contreras-Dominguez · V. · Yadav · K. · Torres · C. · Tavoosi · A. · Wiefels · C. · Kirpalani · A. · Romsa · J.
Introduction

Inflammation plays a central role in atherosclerosis development and subsequent cardiovascular complications, including heart attack and stroke. Patients with inflammatory conditions such as community-acquired pneumonia (CAP) present with an elevated risk of cardiovascular events, which is likely driven by unresolved systemic inflammation. Targeting this heightened inflammatory burden may present a novel therapeutic strategy to attenuate heart attack risk in CAP survivors. Icosapent ethyl (IPE), an omega-3 fatty acid, demonstrates both pro-resolving and cardioprotective properties. The Targeting Vascular Inflammation In Patients with CAP (TIN-CAP) trial aims to evaluate the efficacy of IPE in mitigating vascular inflammation in CAP survivors.

Methods and analysis

TIN-CAP is a multicentre, randomised, double-blind, placebo-controlled trial. Eligible adults diagnosed with CAP in hospital or the emergency department will complete baseline assessments within 14 days of diagnosis including 18F-fluorodeoxyglucose (FDG) positron emission tomography/CT angiography, bloodwork and quality of life evaluation (EuroQol – 5 Dimensions (EQ-5D)). Participants will then be randomised 1:1 to receive IPE (4 g/day) or placebo for 6 months. Follow-up visits will occur at 30 days (bloodwork and EQ-5D only) and 6 months. The primary endpoint is the change in FDG uptake in the ascending aorta from baseline to 6 months between IPE and placebo groups. Secondary endpoints include FDG uptake in the bone marrow, spleen, lungs and other vasculature, in addition to major adverse cardiac events and quality of life assessments. An initial lead-in cohort of 18 patients will be enrolled to assess recruitment, imaging feasibility and IPE tolerability prior to full trial enrolment. These patients will remain blinded and will be included in the final analysis (Vanguard design).

Ethics and dissemination

The TIN-CAP trial has been approved provincially by the Clinical Trials Ontario Research Ethics Board (approval number: 5045). Participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

NCT06710080.

Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients

Por: van Herwerden · M. C. · Scholte · N. T. B. · Mkrtchjan · A. · Feyz · L. · Mol · A. P. · Aitken · J. · de Boer · R. A. · Chandoesing · P. P. · Gommers · D. A. M. P. J. · De Haan · B. · Den Hoed · C. M. · van den Hoogen · M. W. F. · Peeters · R. P. · Wlazlo · N. · Van Der Boon · R. M.
Introduction

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

Methods and analysis

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

Ethics and dissemination

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

Trial registration number

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial

Por: Coudroy · R. · Telias · I. · Jonkman · A. · Thille · A. W. · Diehl · J.-L. · Peron · N. · Ko · M. · Bourion · A.-A. · Tiribelli · N. · Fredes · S. · Gutierrez · M. · Manchado Bruno · A. · Vasquez · D. N. · Pratto · R. A. · Plotnikow · G. A. · Bianchini · F. · Accoce · M. · Dorado · J. · Sp
Introduction

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

Methods and analysis

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics and dissemination

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

Trial registration number

NCT03963622.

Determining the burden of falls amongst community-dwelling older people in Ireland to inform falls care delivery: secondary data analysis from the Irish longitudinal study on ageing - the defined study

Por: Briggs · R. · Ward · M. · Scarlett · S. · van der Velde · N. · Hernandez · B. · Romero-Ortuno · R. · Tysinger · B. · May · P. · Ahern · E. · Kenny · R. A.
Objective

Falls represent the most frequent reason older people are admitted to hospital and significantly increase the likelihood of functional decline, healthcare utilisation and early mortality. The aim of this study is to comprehensively delineate the burden of falls amongst community-dwelling older people in Ireland.

Design

Population-representative analysis of Wave 6 of the Irish Longitudinal Study on Ageing (TILDA) estimating incidence of falls requiring medical attention and emergency department (ED) attendance, fractures and fear of falling over 12 months. Additional data detailing falls-risk increasing drugs (FRIDs) and prior falls were also analysed.

Using Central Statistics Office Census 2022, the population of older people in Ireland was multiplied by the proportion of TILDA participants with each outcome of interest to yield population-level estimates.

Participants/Setting

Population-representative sample of 2299 (55% female) community-dwelling people in Ireland aged ≥70 years.

Results

Almost 12% (proportion 0.12 (95% CI 0.10 to 0.13)) of participants, corresponding to almost 62 000 older people in Ireland, reported a fall requiring medical attention in 12 months, with 6% (proportion 0.06 (95% CI 0.05 to 0.07)), or over 32 000 people, attending ED due to a fall. Over 3% (proportion 0.03 (95% CI 0.03 to 0.04)) reported sustaining a fracture. Almost half of participants reporting a fall requiring medical attention were prescribed FRIDs, and over half had also reported a fall when assessed at the prior wave of the study (ie, 2 years ago).

Conclusions

The burden of falls amongst community-dwelling older people is considerable; 1 in 8 required medical attention for a fall and 1 in 16 attended the ED with falls over 12 months.

Currently, there is no national falls strategy in Ireland. These findings, alongside our ageing population, underscore the need for strengthened falls-prevention strategies to reduce avoidable morbidity and healthcare utilisation.

Factors associated with early initiation of antenatal care in Bangladesh: a survival analysis using Bangladesh Demographic and Health Survey 2022

Por: Islam · M. S. · Noor · S. T. A. · Asha · R. A. · Islam · R. B. · Rahman · F.
Objectives

This study aims to identify factors associated with early antenatal care (ANC) initiation using a survival analysis approach applied to nationally representative data.

Design, setting and participants

This study used a cross-sectional design based on data from the nationally representative 2022 Bangladesh Demographic and Health Survey. The survey was conducted at the community level across all administrative divisions of Bangladesh. A total of 5128 ever-married women aged 15–49 years who had a live birth within 5 years prior to the survey were included in the analysis. Women with missing or incomplete information regarding the timing of their first ANC visit were excluded from the study.

Outcome

The primary outcome was early initiation of ANC, defined as the first ANC contact within the first trimester.

Materials and methods

The study applied survival analysis methods, including Kaplan-Meier survival curves, log-rank tests and an Accelerated Failure Time model, to assess the determinants of early ANC initiation.

Findings

Only 37.9% (95% CI 36.0% to 39.9%) of women in Bangladesh initiated ANC within the first trimester. Early ANC initiation was associated with higher maternal age, education, skilled employment, wealthier households, media exposure, higher decision-making autonomy, higher husband’s education and urban residence. Women who reported that distance to a health facility was not a big problem had initiated ANC earlier than those who considered distance a major barrier. Regional disparities were also evident, with women from Barishal, Chattogram, Rajshahi, Khulna and Rangpur accessing ANC later than those in Dhaka.

Conclusions

Persistent inequalities in early ANC initiation highlight the need for targeted policies to reduce financial barriers, improve healthcare accessibility and strengthen awareness campaigns to ensure equitable maternal healthcare in Bangladesh.

STEM-PD trial protocol: a multi-centre, single-arm, first-in-human, dose-escalation trial, investigating the safety and tolerability of intraputamenal transplantation of human embryonic stem cell-derived dopaminergic cells for Parkinsons disease

Por: Paul · G. · Bjartmarz · H. · Björklund · A. · Cutting · E. · Evans · A. · Harry · B. · Hansson · O. · Kayhanian · S. · Kirkeby · A. · Lao-Kim · N. · Lindvall · O. · Nelander · J. · Piccini · P. · Smith · R. · Ullen · S. · Van Vliet · T. · Widner · H. · Parmar · M. · Barker · R. A.
Introduction

Parkinson’s disease (PD) is a common neurodegenerative disease, which has extensive pathology that critically includes the loss of midbrain dopaminergic neurons. This loss leads to debilitating motor features such as bradykinesia and rigidity, as well as some non-motor symptoms. Intracerebral dopamine cell transplants have been explored for many years as a new approach to treating PD and initially used human fetal ventral mesencephalic tissue with inconsistent results, related in part to major logistical challenges in sourcing enough tissue of the right quality and the limited possibilities for quality control and standardisation. Dopaminergic neurons can now be derived reliably from human stem cell sources, which may overcome some of the challenges associated with fetal tissue transplantations.

Methods and analysis

STEM-PD is a multi-centre, single-arm, dose-escalation, first-in-human advanced therapy investigational medicinal product (ATIMP) trial in Europe using a cell product that consists of dopaminergic neural progenitors derived from the RC17 human embryonic stem cell line. The aim of the study is to assess the safety, tolerability and feasibility of intraputamenal transplantation of this cell product in patients with moderately advanced PD. Eight participants will be recruited from two sites, Skånes University Hospital (Lund, Sweden) and Cambridge University Hospital (Cambridge, UK). The primary outcome of the trial is safety and tolerability, assessed by the number and nature of adverse events and serious adverse events, and the absence of space-occupying lesions on cranial MRI, in the first 12 months following transplantation. Secondary and exploratory outcomes, including clinical measures, changes in anti-Parkinson’s medication and measures of graft survival using positron emission tomography imaging, will be assessed at both 12 and 36 months post-grafting.

Ethics and dissemination

Ethical approval was obtained from the Swedish Ethical Review Authority (EPM dnr 2021-06945-01) and South Central - Oxford A Research Ethics Committee (reference 23/SC/0243). Clinical Trial Authorisation was given by the Swedish Medical Products Agency (Dnr: 5.1-2022-57953) and the Medicines and Healthcare products Regulatory Agency for clinical trials authorisation (reference CTA 40773/0001/001-0001). Authorisation for transfer to Clinical Trial Regulation (EU) 536/2014 was given by the Swedish Medical Products Agency (Dnr: 5.1.1-2024-100773). Potential participants will receive verbal and written information about the trial and written informed consent will be obtained prior to enrolment. A lay summary of the results of the trial will be uploaded to the trial website which is publicly accessible. Trial results will be published in peer-reviewed journals.

Trial registration numbers

NCT05635409.

Protocol for a cervical screening implementation trial comparing two approaches for delivering HPV self-collection in low-resource settings in India: a type 3 hybrid cluster randomised controlled trial (SHE-CAN)

Por: Oommen · A. M. · Ashfaq · M. · Tonsing · M. V. · Cherian · A. G. · Singarayar · P. · Viswanathan · V. · Muniswamy · V. · Hawkes · D. · Abraham · P. · Pricilla · R. A. · Manoharan · R. · Zomawia · E. · Oldenburg · B. · Saville · M. · Krishnaraj · K. · T S · S. · Basu · P. · Brotherton · J.
Background

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

Methods

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

Analysis

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics and dissemination

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

Trial registration number

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

Insights from critical care clinicians, patients and families from culturally and linguistically diverse backgrounds about end-of-life care in the intensive care unit: a scoping review

Por: Sundararajan · K. · Aziz · S. · Anderson · N. · Damarell · R. A. · Raith · E. · Phelan · C. · Subramaniam · A.
Background

Patients and families from culturally and linguistically diverse (CALD) backgrounds face distinct challenges during end-of-life care (EOLC) in intensive care unit (ICU) settings, where communication, cultural expectations and decision-making may conflict with clinical norms. These complexities have important implications for intensive and palliative care teams.

Objectives

To map literature on clinician, patient and family perspectives on end-of-life communication with CALD populations in ICUs, and identify barriers and facilitators to culturally responsive care.

Design

This scoping review followed Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. The protocol was registered with the Open Science Framework and published in BMJ Open. Screening, review and data extraction were conducted by multiple reviewers using Covidence and the Joanna Briggs Institute tool, with findings synthesised through inductive thematic analysis.

Primary and secondary outcome measures

The primary outcome was to identify barriers and facilitators to communication between clinicians, patients and families from CALD backgrounds during EOLC. Secondary outcomes were to map the scope of evidence, describe study characteristics and participant demographics, and summarise themes on cultural sensitivity, clinician awareness, family involvement, decision-making and integration of support services.

Results

Thirty of 766 screened studies were included. Three themes emerged: communication challenges; cultural sensitivity and humility and decision-making and support. Barriers included limited access to palliative care, language discordance, underuse of interpreters, clinician discomfort and conflicting care expectations. Facilitators included structured meetings, inclusive practices and interdisciplinary collaboration.

Conclusions

Structural, communicative and cultural barriers undermine equitable EOLC for CALD patients. Embedding palliative care principles, cultural responsiveness and shared decision-making into ICU practice requires coordinated input from a multidisciplinary team involving physicians, nurses, social workers, spiritual care, psychologists and interpreters. System-level reforms in training, service delivery and research are needed to ensure person-centred care.

Protocol registration

Registered with BMJ Open DOI: 10.1136/bmjopen-2024-090168

Examining the associations between the food environment and dietary intake in British Columbia: a cross-sectional study

Por: Zhao · B. · Cohen · T. R. · Sutherland · J. · Meza · R. · Bhatti · P. · Murphy · R. A.
Objectives

To characterise neighbourhood food environments in British Columbia (BC) and determine whether food environment characteristics are associated with fruit and vegetable (FV) intake.

Design

A cross-sectional study using geospatial linkage of food environment measures within 1 km residential buffers, analysed with mixed-effects models

Setting

Urban neighbourhoods in BC, Canada.

Participants

Approximately 25 000 adults aged 35–69 years from the BC Generations Project cohort.

Outcome measures

FV intake as a continuous variable (servings/day) and as a binary measure (

Results

Approximately 50% of participants lived in neighbourhoods without chain grocery stores, fast-food outlets or convenience stores within walking distance. Neighbourhoods in the highest density category for fast-food outlets were associated with lower odds of consuming ≥5 servings of FV per day (OR=0.89, 95% CI 0.80 to 0.98). Associations between chain grocery stores, convenience stores and FV intake were attenuated after adjusting for neighbourhood characteristics including walkability, and material and social deprivation.

Conclusions

The findings suggest limited neighbourhood access to retail food outlets across urban areas in BC. Participants living in neighbourhoods with greater density of fast-food restaurants were less likely to consume >5 servings of FV per day. Further studies are needed to better understand the null findings and additional factors that may be associated with dietary intake.

Epidemiology and disease burden of connective tissue disease-associated interstitial lung disease (CTD-ILD) in Asia: a systematic review and meta-analysis protocol

Por: Chua · F. · Subramaniam · S. · Lai · W. H. · Tan · S. H. · Yean · H. R. A. · Kho · S. S. · Yew · J. S. Y. · Hong · H. C. · Ng · C. C. M. · Sirol Aflah · S. S. · Mohd Zaidi · N. A. · Ong · V. H. · Chai · G. T. · Ang · S. H. · Maamor · H. · Muhamad · N. A.
Introduction

Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.

Methods and analysis

This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.

PROSPERO registration number

The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).

Student paramedic experiences of group-based simulation activities used in assessment: a qualitative UK study

Por: Colthup · R. A. · Johnson · G. N. · Jenkins · R. J. · Runacres · J.
Objectives

This research aimed to explore student paramedics’ experiences of participating in group-based simulation activities used as part of their summative assessment. It sought to understand their perceptions of the effectiveness of group-based simulation in fostering learning and informing future assessment design.

Design

A qualitative questionnaire-based study.

Setting

A UK higher education institution.

Participants

A total of 34 first-year (level 4) student paramedics from the September 2022 to September 2023 cohorts.

Intervention

Following the completion of a summative assessment for the introduction to non-technical skills and simulation module, students were invited to reflect on their experiences of group-based simulation through an online questionnaire. The assessment incorporated team-based simulation scenarios intended to evaluate non-technical competencies within a realistic and supportive environment.

Results

Four key themes emerged through thematic analysis of the responses: experiential learning; autonomous learning; reflective learning; and support and learning. These themes provide insights into the pedagogical value of group-based simulation, with students identifying both individual and collective benefits in developing non-technical skills within a group assessment framework.

Conclusion

Group-based simulation assessments enhance student engagement and promote collaborative decision-making in a context that mimics real paramedic practice. While students often associate realism with increased confidence, their experiences highlight complex interactions between perceived fidelity, assessment pressure and learning. This underscores the need to further investigate how group dynamics and authenticity influence learning outcomes in assessment-focused simulations.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Large cohort study of postnatal events over 18 months in a not-for-profit referral centre in Vellore, South India

Por: Abraham · N. A. · Nagasamudra Devendrappa · V. · Mano R · G. · Pricilla · R. A. · Rathore · S. · Yenuberi · H. · Tirkey · R. S. · Shabeer · M. · Kumar · M. · Abraham · A. · Vijayaselvi · R. · George · A. · Abraham · K. · Prasanthi · A. · Minz · S. · Abraham · S. · Kurian · S. · Premkumar
Objective

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

Design

A prospective cohort study.

Setting

A large tertiary care centre.

Participants

12 245 women who delivered after 22 weeks gestation in the year 2022.

Interventions

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary and secondary outcome measures

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Results

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Conclusion

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

Trial registration number

CTRI/2022/03/041343.

Epidemiological assessment of mental health screening protocols for high school athlete participation in the USA, 2021

Por: Generoso · R. A. · Vasudevan · V. · Hamade · H. · Sylvester-Omorodion · P. · Wolohan · M.
Objectives

To examine state-level variation in mental health screening practices for high school athletes in the USA and evaluate associations between screening protocols and adolescent depression-related and suicide-related outcomes.

Design

Cross-sectional study of preparticipation examination (PPE) forms and Youth Risk Behaviour Surveillance System (YRBSS) data.

Setting

High school athletics across all 50 US states and the District of Columbia.

Participants

732 676 high school students who completed the 2021 YRBSS survey (grades 9–12).

Primary and secondary outcome measures

Prevalence of depressive symptoms and suicide-related behaviours, measured using YRBSS items on sadness/hopelessness, suicide ideation, planning, attempts and suicide attempts resulting in injury. State-level PPE forms were reviewed for presence and depth of mental health screening, including Patient Health Questionnaire-4 (PHQ-4) and eating disorder (ED) risk questions.

Results

Screening practices varied widely, ranging from no mention of mental health in some states to required evaluations with formal referral protocols in others. Of 732 676 students, 503 861 (68.7%) reported feeling sad or hopeless, 608 416 (83.0%) seriously considered suicide and 64 072 (8.8%) attempted suicide in the past year. States with required screening protocols had higher reported rates of depressive symptoms (71.0% vs 68.7%, p

Conclusions

High school athletes represent a vulnerable group in need of structured and standardised mental health screening. State-level screening policies were associated with lower suicide attempt rates, though causal inference is limited by the cross-sectional design. Standardised use of validated mental health tools may support early identification and intervention for at-risk adolescents.

Aetiological clustering of newly diagnosed type 2 diabetes using machine learning: a retrospective cross-sectional study in Dubai, UAE

Por: Dsouza · S. M. · Sulaiman · F. · Abdul · F. · Mulla · F. · Ahmed · F. S. · AlSharhan · M. · AlOlama · A. · Ali · N. · Abdulaziz · A. · Rafie · A. M. · Alnuaimi · S. · Goswami · N. · Khamis · A. H. · Bayoumi · R. A. L.
Objectives

Type 2 diabetes (T2D) is a complex disease with a heterogeneous clinical presentation. Recently, five distinct clusters of T2D have been identified in the Emirati population of long-standing T2D with complications. This study aimed to validate these clusters in newly diagnosed T2D patients without any complications and determine whether severe and mild phenotypes are detectable early in the disease course.

Design

Retrospective, cross-sectional, non-interventional study.

Setting

Primary healthcare centres in Dubai, UAE.

Participants

A total of 451 adults, including both Emiratis and expatriates, diagnosed with T2D in the last 5 years and without T2D-related complications at the time of visit, were enrolled. Patients with complications, incomplete clinical data or higher duration of T2D were excluded from the study.

Outcome measures

Identification of distinct T2D clusters using machine learning-based clustering analysis. Five clinical variables: age at diagnosis, body mass index, glycated haemoglobin, fasting serum insulin and fasting blood glucose served as predictors. Overlap between clusters was assessed via the Silhouette Index and Bayesian probability.

Results

Five clusters were identified, replicating prior findings: severe insulin-resistant diabetes (SIRD), severe insulin-deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity-related diabetes (MOD) and mild early-onset diabetes (MEOD). As confirmed by a Silhouette Index and Bayesian probability of 1, 55.43% of the patients showed cluster-exclusiveness, while 44.56% of the cohort showed overlap between clusters. The highest overlap was recorded for mild forms of T2D in the order MOD>MARD>MEOD.

Conclusions

The study confirms that both severe and mild T2D phenotypes are present in newly diagnosed, complication-free patients, supporting the applicability of cluster-based classification early in disease. These results highlight the potential for personalised treatment strategies to optimise management and prevent complications. Future studies should investigate longitudinal outcomes and therapeutic response across clusters.

Early childhood exposure to skin-lightening products in Nigeria: prevalence, maternal perspectives and predictors from a cross-sectional study

Por: Ajani · A. A. · Omokanye · C. · Adebayo · A. · Adejumobi · R. A. · Ijiyode · B. · Ogundiran · M. O. · Torimiro · A. · Raheem · O. · Ijadunola · M.
Background

Increasing reports of life-threatening complications in young children exposed to skin-lightening products present a significant public health concern, yet this issue remains under-researched.

Objectives

To determine the prevalence, maternal perceptions and predictors of early childhood exposure to skin-lightening products among mothers in Southwestern Nigeria.

Design

A cross-sectional, questionnaire-based study.

Setting

Three randomly selected government-owned primary healthcare facilities in Ile-Ife, Nigeria.

Participants

Three hundred and sixty-nine mothers aged ≥18 years, each with at least one child under 5, recruited by simple random sampling. Data were collected between May and July 2024 using pretested, interviewer–administer semistructured questionnaires. Mothers with acutely ill children were excluded.

Primary outcome and secondary outcome measures

Primary outcome was the use of skin lightening products on children while secondary outcomes included maternal use, perceptions and sociodemographic/familial predictors.

Results

Participants’ ages ranged from 18 to 54 years (mean: 30.92±6.11 years). Overall, 19.5% (n=72) mothers practised early childhood skin lightening, with 80.6% of exposed children

Conclusion

This study highlights a high prevalence of early childhood exposure to lightening products in a semiurban Nigerian community, with maternal use emerging as a key associated factor. Although awareness of potential health risks was common, aesthetic preferences for lighter skin tones appeared to outweigh safety concerns. These findings highlight the need for culturally sensitive interventions and further research to inform strategies that promote safer childhood skin-care practices.

How prevalent are modifiable dementia risk factors in Ireland? A 12-year observational study in community-dwelling older adults

Por: McGarvey · C. · Kenny · R. A. · Kennelly · S. · Sexton · D. · Briggs · R.
Objectives

Dementia is potentially preventable and deferrable yet remains a major cause of disability, dependency and mortality worldwide. The 2024 Lancet Commission on dementia identified 14 modifiable dementia risk factors and estimated that addressing these could reduce dementia cases by up to 45%. The aim of this study is to assess dementia risk factor prevalence in adults ≥50 years participating in a nationally representative longitudinal study on ageing, providing crucial context for the delivery of dementia prevention.

Design and setting

The Irish Longitudinal Study on Ageing (TILDA) is a population-based prospective cohort study, representative of community-dwelling adults ≥50 years living in Ireland.

Participants

All participants from waves 1 (2009–2010): n=8171, 3 (2014–2015): n=6615 and 6 (2021–2023): n=4318 of TILDA were analysed over a 10.93 (±0.37) years of follow-up.

Results

70.6%, 61.1% and 54.2% of the population had ≥4 modifiable risk factors for dementia at consecutive waves, amounting to over 500 000 people with ≥4 modifiable risk factors for dementia on weighted population analysis at wave 6. 77% of those with severe decline in cognitive performance during follow-up had ≥4 risk factors at baseline. An estimated 32 480 cases of severe decline in cognitive performance during follow-up were potentially preventable if risk factors were addressed.

Conclusions

In a nationally representative sample of older European adults, there is a high prevalence of modifiable dementia risk factors. This highlights the need for greater attention on educating people on the concept of brain health through public health messaging as well as the development of a clinical framework focused on delivering on the opportunity of dementia prevention. Preventing and delaying dementia onset can have a significant impact on the compression of morbidity and increasing healthy lifespan in older age.

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