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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Development and internal validation of an intrapartum caesarean risk prediction model to guide rural obstetric transfer decisions: a population-based study using BORN Ontario data

Por: Jolin-Dahel · K. · Hawken · S. · Bruce · L.
Objective

To develop and internally validate a clinical prediction model estimating the probability of emergency caesarean delivery among low-risk pregnancies using routinely available intrapartum variables. The model is intended to support clinicians in recommending transfer decisions in rural obstetric settings without onsite caesarean capacity.

Design

Retrospective cohort study with multivariable logistic regression and internal validation using bootstrap resampling.

Setting

Province-wide birth registry in Ontario, Canada.

Participants

Singleton, hospital births from low-risk pregnancies between 1 April 2012 and 31 March 2020, captured in the Better Outcomes Registry and Network Ontario. Exclusions included previous caesarean, major comorbidities and other high-risk conditions.

Primary outcome

Emergency caesarean delivery during labour.

Results

Among 611 644 low-risk pregnancies, 66 482 (10.9%) resulted in emergency caesarean delivery. Key predictors included abnormal fetal health surveillance, nulliparity, gestational hypertension, polyhydramnios area under the receiver operating characteristic curve (AUC) and oxytocin augmentation. The optimism-corrected AUC was 0.86, indicating strong discrimination. Calibration was generally good, though the model underestimated caesarean risk in patients first admitted to level I hospitals.

Conclusions

This study presents a proof-of-concept prototype with strong discrimination, though calibration of the full model was suboptimal in level I hospitals, the intended setting for application. While not clinically deployable in its current form, the model lays the groundwork for a translational pathway that will require local recalibration, external validation and contextual adaptation before implementation. Threshold-based clinical utility (eg, positive/negative predictive value or net benefit) was not assessed and will be evaluated during external validation and local recalibration.

Antibacterial consumption in four paediatric inpatient facilities in Sri Lanka in 2023: a cross-sectional descriptive study

Objective

To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.

Design

Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.

Settings

Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.

Data

Data on antibacterials for systemic use, J01 in the Anatomical Therapeutic Chemical (ATC) classification issued to these paediatric inpatient facilities in 2023 by their respective hospital pharmacies.

Outcome measures

(1) ABC at ATC third and fifth levels expressed as defined daily doses (DDDs)/100 admissions, (2) ABC as per WHO ‘Access, Watch and Reserve’ category, (3) choice of antibacterials within a class, (4) DU 75% for oral and parenteral dosage forms, (5) quality indicators such as amoxicillin index and broad:narrow spectrum ratio.

Results

In 2023, total antibacterial (J01) consumption across the four paediatric inpatient facilities was 94.49 DDDs/100 admissions. Together, non-penicillin beta-lactams, penicillins and macrolides/lincosamides/streptogramins accounted for 90–98%. Co-amoxiclav was the most consumed antibacterial, and six agents (co-amoxiclav, cefotaxime, clarithromycin, azithromycin, cefuroxime and meropenem) collectively accounted for 70–90%. Aminoglycosides, tetracyclines, sulfonamides and trimethoprim, and quinolones contributed minimally. Access and Watch group antibacterials accounted for 34 and 65%. Quality indicators demonstrated disproportionately higher use of broad-spectrum and Watch group antibacterials.

Conclusion

High use of broad-spectrum and Watch-group antibacterials was observed across the four paediatric inpatient facilities. The findings highlight targets for antibacterial stewardship programmes and demonstrate the feasibility of ABC surveillance in Sri Lanka.

Brain and behavioural responses to food viewing in women during pregnancy and their relationship with metabolic health: study protocol for the FOODY Play Study - a prospective observational study

Por: Trevino Montemayor · M. · Hamam-Mechkour · A. · Eisler · J. J. · Murray · M. M. · Spierer · L. · Schenk · S. · Halter · R. J. · Toepel · U. · Horsch · A. · Retsa · C. · Arhab · A. · Quansah · D. Y. · Puder · J. J.
Introduction

During pregnancy, physiological and psychological factors influence eating behaviour and food preferences. Food cravings are common in pregnancy and contribute to excessive gestational weight gain (GWG). Excessive GWG is present across all body mass index (BMI) categories and is associated with adverse outcomes. Outside of pregnancy, highly palatable food cues activate brain regions involved in reward and attention, which may influence eating behaviour and behavioural responses. However, brain and behavioural responses to food cues across pregnancy, and their association with psychological and metabolic factors, remain poorly understood. This study aims to investigate spatiotemporal brain responses to visual food cues across individuals with different BMI categories and their associations with behavioural, psychological and metabolic outcomes during pregnancy.

Methods and analysis

This is a prospective observational cohort study conducted at the Lausanne University Hospital, Switzerland. 94 pregnant individuals (47 healthy normal weight and 47 with overweight/obesity) will be assessed at 12–16 and 31–36 weeks of gestational age from November 2024 to September 2026. Data collected for the primary outcomes include electroencephalography-based brain responses to validated visual food cues varying in fat and carbohydrate content, behavioural responses to the same cues using a gamified smartphone Go/NoGo task. Secondary validated outcomes include heart rate variability (Actiheart), body composition (InBody S10), glycated haemoglobin (Afinion), cardiorespiratory fitness (The Chester step test), snack intake, eating behaviour (Intuitive Eating Scale-2, Three-Factor Eating Questionnaire-Revised), food cravings (Food Craving Questionnaire-state), mood and depressive symptoms (Edinburgh Postnatal Depression Scale). Statistical analyses include group comparisons, longitudinal analyses and regression models adjusted for potential sociodemographic/medical confounders.

Ethics and dissemination

All participants will provide written informed consent. The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (CER-VD 2023-01462). Findings will be disseminated through peer-reviewed publications, (inter)national conferences and shared with healthcare professionals and stakeholders to inform strategies for improving maternal health.

Intercultural interpreters perspectives on the provision of sexual and reproductive healthcare to Eritrean and Somali forced immigrant women in Switzerland: a qualitative exploration

Por: Zepro · N. B. · Erhardt · R. M. · Abongomera · C. · Paris · D. H. · Bohlius · J. · Chernet · A. · Merten · S.
Objectives

This study aimed to explore and synthesise interpreters’ perspectives on the provision of sexual and reproductive health (SRH) care to Eritrean and Somali migrant women in Switzerland, and to identify and analyse the professional and ethical challenges they encounter in this context.

Design

An exploratory qualitative study from a social constructionist perspective. The interviews were recorded, transcribed, categorised and analysed through thematic analysis.

Setting and participants

The study was conducted in the canton of Basel-Stadt, northwestern Switzerland. We have purposively selected 10 Eritrean and Somali intercultural interpreters serving as crucial intermediaries in assisting immigrant women to access SRH services.

Results

Our analysis of the interpreters’ perspectives revealed three key thematic areas that they identified as central challenges for their Eritrean and Somali immigrant women: (1) perceived limited health literacy among patients, (2) sociocultural barriers that interpreters observed hindering patient provider communication and (3) structural difficulties that interpreters reported their patients faced in navigating the Swiss healthcare system. These challenges have now persisted for a long time, and research findings and recommendations do not appear to have changed practices. For example, while abortion services are fully covered by Swiss health insurance, contraceptive methods often require out-of-pocket payments. This financial disparity may discourage appropriate use of SRH services among immigrant women. The lack of culturally competent care and the limited availability of funding for intercultural interpreters were among important bottlenecks identified.

Conclusions

This study explored interpreters’ perspectives on the provision of SRH care to Eritrean and Somali immigrant women in Switzerland. Despite the outstanding Swiss healthcare system, a majority of Eritrean and Somali refugee women struggle to benefit from SRH services due to limited health literacy, language barriers and challenges in navigating the Swiss healthcare system. Partnerships and integration of community entities, such as the Swisso-Kalmo association for Somali women and different Eritrean communities, could contribute via facilitating entry points for access to SRH healthcare.

FinnDiane LifeOne Study: influence of ageing on people with type 1 diabetes - a prospective observational cohort study protocol

Por: Nicklen · J. · Satuli-Autere · S. · Rimpeläinen · K. · Dufva · A. · Ylinen · A. · Franzen · E. M. · Eriksson · M. I. · Jansson Sigfrids · F. · Öhman · H. · Thorn · L. M.
Introduction

Life expectancy for people with type 1 diabetes has increased due to improved treatment of diabetes and its comorbidities, allowing many to reach old age. Still, we lack knowledge of how individuals with type 1 diabetes age. On one hand, those who reach older age can be considered survivors, but on the other hand their long-standing diabetes might still exhibit negative impacts on their health and functional ability. Healthy ageing is the WHO’s priority for this decade. The focus has shifted from chronological age to functional ability, which reflects the ability of individuals to perform meaningful activities. Functional ability is shaped by intrinsic capacity, the environment and their interaction. Intrinsic capacity encompasses five main domains: cognition, vitality, sensory function, locomotion and psychological domain. This observational study aims to assess how this vulnerable group of individuals with type 1 diabetes age and to identify factors that contribute to their healthy ageing, intrinsic capacity and its domains.

Methods and analysis

The FinnDiane LifeOne Study is a prospective observational cohort study. We aim to recruit a minimum of 300 individuals with type 1 diabetes from the FinnDiane Study, aged >65 and a minimum of 100 matched controls without insulin-dependent diabetes. The cohort will be comprehensively characterised, including clinical assessment, laboratory tests, questionnaires and a geriatric assessment of different aspects of functioning ability, with 5 years intervals. We will compare the individuals with type 1 diabetes to their matched controls. For those with type 1 diabetes, we will further assess which factors from the FinnDiane baseline and trajectories during follow-up predict healthy ageing in above 65-year-olds.

Ethics and dissemination

The LifeOne Study protocol is approved by the Ethics Committee of HUS Helsinki University Hospital (HUS/4387/2023) and the study adheres to the Declaration of Helsinki. Written informed consent is obtained from each participant. Findings will be published in international peer-reviewed journals with an open access choice.

Trial registration number

NCT07289204.

Health system interventions to floods and heatwaves for maternal and child health services: a realist-informed systematic review protocol

Por: Debele · S. E. · Bozzani · F. M. · Mushinda-Musonda · G. · Kovats · S. · Bonnet · G. · Chama-Chiliba · C. M. · Foss · A. M. · da Silva · E. N. · Borghi · J.
Introduction

Floods and heatwaves are becoming more frequent and intense and can disrupt routine maternal and child health (MCH) services. Previous reviews have not systematically examined how context and mechanisms may shape adaptation outcomes. This realist-informed systematic review examines how, why and under what conditions interventions support access to, utilisation of and continuity of routine MCH services during flood and heat events.

Methods and analysis

The search strategy was developed by integrating terms from 17 related reviews, refined with the author team and checked by an experienced London School of Hygiene & Tropical Medicine librarian. The initial database search was conducted on 16 May 2025 and the search was updated on 30 April 2026. Eight databases were searched: Web of Science, Ovid MEDLINE, EMBASE, Global Health, EconLit, GreenFILE, CINAHL and ProQuest Environmental Science & Public Policy. Records published between January 2000 and April 2026 were eligible. Search results were imported into EndNote and deduplicated. Title-and-abstract screening and full-text assessment were conducted independently by two reviewers for the initial search and are ongoing for the updated search, with ASReview being used to prioritise records during title-and-abstract screening. Data extraction across the full review evidence base remains ongoing using a structured template covering study context, intervention characteristics, mechanisms, outcomes, costs and implementation conditions. Study settings will be classified by country income group, health system context and Köppen–Geiger climate zone to compare evidence across settings and, where appropriate, to identify possible climate analogues for exploratory, context-specific assessment. Climate-zone similarity will not be used to infer intervention transferability or future effectiveness. The synthesis will be guided by the WHO Climate-Resilient Health Systems framework, Meadows’ leverage-points framework and realist-informed C–M–O reasoning. Interventions will be grouped to identify where they operate within the health system and which health system components and vulnerabilities they address. Findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance.

Ethics and dissemination

Ethical approval is not required because the review uses published literature and does not involve human participants. The findings will be disseminated through a peer-reviewed systematic review publication. They will inform the design, improvement and scaling of interventions intended to maintain routine MCH services and strengthen health system resilience to floods and heatwaves across diverse settings.

Registration details

The review was not prospectively registered with PROSPERO.

Impact of menopausal status on human papillomavirus detection and cervical neoplasia in middle-aged Senegalese women

by Emily R. Spencer, Rachel L. Winer, Selly Ba, Marie Pierre Sy, John Lin, Qinghua Feng, Geoffrey S. Gottlieb, Papa Salif Sow, Nancy B. Kiviat, Stephen E. Hawes

Hormonal and immunologic changes related to menopause may play a role in human papillomavirus (HPV) and cervical neoplasia detection, yet this relationship has not been examined in West African populations, where cervical cancer remains a leading cause of cancer-related death. The purpose of this study was to assess whether menopausal status is associated with HPV and cervical neoplasia detection in Senegalese women aged 40–60. We conducted a secondary analysis of three prospective cervical cancer studies in Dakar, Senegal (1998–2011). Participants with known menopausal status and a satisfactory HPV test (N = 3,118) and/or Pap smear (N = 2,907) were included, excluding those with cervical cancer or pregnancy; participants without known HIV status were additionally excluded from the cervical neoplasia analysis. Multivariable logistic regression and generalized estimating equations were used to estimate adjusted odds ratios and 95% confidence intervals, adjusting for age, gravidity, and HIV status. Compared with premenopausal women, postmenopausal women had significantly higher odds of HPV detection (OR = 1.48; 95% CI: 1.18, 1.85), including both high-risk (OR = 1.55; 95% CI: 1.25, 1.93) and low-risk types (OR = 1.64; 95% CI: 1.30, 2.08). Odds of cervical neoplasia were elevated, but non-significant, among postmenopausal women (OR = 1.36; 95% CI: 0.97, 1.90), with increased odds for both high-grade (OR = 1.43; 95% CI: 0.90, 2.28) and low-grade lesions (OR = 1.30; 95% CI: 0.84, 2.02). However, in a sensitivity analysis restricted to participants with known HIV status, these cervical neoplasia odds were attenuated, suggesting caution in interpreting the magnitude of these findings. These findings suggest menopause may contribute to HPV persistence or reactivation, and development of cervical neoplasia. Our results highlight the importance of continued surveillance for HPV and cervical neoplasia among older women, particularly in low-resource settings with disproportionately high cervical cancer burden.

Physiotherapist-led education and exercise for patients with MRI-verified hip abductor tendon pathology: a prospective cohort study

Por: Hogsholt · M. · Kierkegaard-Brochner · S. · Lange · J. · Lund · B. · Langgard Jorgensen · S. · Thorborg · K. · Bagger Bohn · M.
Objectives

To investigate changes in lateral hip pain following a 3-month, physiotherapist-led, education and exercise programme in patients with clinically and MRI-verified hip abductor tendon pathology.

Design

Prospective cohort study.

Setting

Secondary care, Danish public teaching hospital.

Participants

From May 2024 to July 2025, 60 patients (100% women) with lateral hip pain duration of >6 months, aged 18–75 years (mean age 58.2), MRI-verified hip abductor tendon pathology were included; 55 patients completed the intervention.

Interventions

Patient education on load management and modification of daily activity was provided through seven physiotherapist-led sessions over 3 months. Additionally, patients followed an individually progressed daily home-based exercise programme.

Primary and secondary outcome measures

The primary outcome was change in the subscale pain of the revised Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes included hip-related patient-reported outcomes and health-related quality of life, isometric hip muscle strength and a 30-second Chair Stand Test (30s-CST).

Results

Adherence to the exercise protocol was 85%. The mean (95% CI) score in the revised HAGOS pain improved from 46.4 (41.5 to 51.2) to 60.1 (54.4 to 65.7) at 3 months follow-up. Clinically relevant improvements were observed in secondary hip-related patient-reported outcomes, alongside improvements in generic patient-reported outcomes. Minor strength improvements were observed, while the 30s-CST improved from 11.7 (10.6 to 12.9) to 14.2 (12.8 to 15.6) repetitions.

Conclusions

Following 3 months of physiotherapist-led, combined patient education and exercise therapy, patients with clinically and MRI-verified hip abductor tendon pathology, seen in secondary care, experienced clinically relevant changes in lateral hip pain measured by the revised HAGOS pain.

Trial registration number

NCT06418217.

Considerations of equity in the development of tools that identify and respond to end-of-life carer support needs: a scoping review

Por: Long · H. A. · Rowland · C. · Higgerson · J. · Hall · A. · Urwin · S. · Brooks · J.
Objectives

To (1) systematically identify tools developed to assess and address the support needs of informal carers in palliative or end-of-life care and (2) examine the extent to which socially stratifying sample characteristics have been reported following tool use.

Design

A systematic scoping review was conducted.

Methods

Medline, CINAHL, PsycINFO, ASSIA, ProQuest Central and Web of Science databases were searched from inception to May 2024 and again in May 2025. Primary studies using any methodology reporting the development and/or use of tools to assess informal carer support needs in end-of-life care were included. Consistent with scoping review methodology, we did not conduct a quality appraisal of included studies. We extracted tool characteristics, frequency of use and sample characteristics according to PROGRESS+.

Results

A total of 74 articles were included. From these, 24 unique tools were identified. Nine tools were used in ≥2 articles, while 15 were used only once. The most commonly used tools were the Carer Support Needs Assessment Tool (35 articles), the Family Inventory of Needs (6 articles), the Carer Alert Thermometer (5 articles) and the Spiritual Needs Inventory (4 articles). There was limited evaluation of tools beyond psychometric validation. There were substantial gaps in equity-informed caregiver sample reporting. While gender, age and country of participants were commonly reported, most other PROGRESS+characteristics were inconsistently or minimally reported.

Conclusions

While numerous tools exist to assess and address informal caregiver support needs, there is considerable variation in tool uptake, evaluation and the extent to which tools consider equity factors. There is a need for equity-informed tool development and clearer conceptualisation of caregiver needs, alongside efforts to evaluate tool implementation, impact and sustainability in palliative care settings.

The ChUSE trial - improving access to psychological therapies for children with distressing sensory experiences in NHS CAMHS: a randomised controlled feasibility trial protocol

Por: Parry · S. · Carr · S. · Carter · L.-A. · Kirk · S. · Petrussa · C. · Malpass · F. · Shields · G. E. · Thompson · A. · Morrision · A. · Varese · F.
Introduction

Distressing sensory experiences (DSEs) are commonly reported by children and young people accessing Child and Adolescent Mental Health Services (CAMHS) in the UK. Despite their prevalence, evidence-based tailored interventions for this population are scarce. The ChUSE trial aims to address this gap by evaluating the feasibility and acceptability of a novel brief talking therapy for children aged 8–16 years and an accompanying parent coaching programme.

Methods and analysis

A single-blind, two-arm randomised controlled feasibility trial will be conducted across three National Health Service trusts in Greater Manchester, UK. Sixty young people under the care of CAMHS experiencing DSEs and their parents/caregivers will be randomised 1:1 to receive either treatment as usual (TAU) or TAU plus the ChUSE intervention. The intervention involves four child therapy sessions and three optional parent sessions. Primary feasibility outcomes include recruitment and retention rates, treatment adherence and intervention safety. Secondary objectives assess the feasibility of data collection procedures and gather qualitative insights into trial acceptability and the influence of the intervention on young people’s well-being.

Ethics and dissemination

The ChUSE Trial has received ethical approval through the Health Research Authority following review by the West Midlands – South Birmingham Research Ethics Committee specialising in paediatric research (ID 327343). The feasibility trial addresses a significant clinical gap in CAMHS provision and will also capture information as to current TAU practices, contributing novel data to guide future service provision as TAU is currently understood to be heterogeneous. The information gathered through this trial will inform the design of a definitive trial evaluating the clinical effectiveness and cost-consequences of an early, age-appropriate intervention for DSEs. Findings and translational outputs will be shared through scientific and public forums to reach a variety of audiences.

Trial registration number

ISRCTN12245618.

Variations in geographical accessibility: a cross-sectional nationwide study of travel times in Swedish primary care

Por: Isaksson · D. · Vengberg · S. · Fredriksson · M.
Objectives

To examine geographical accessibility to primary care in Sweden by estimating driving distances and travel times to primary care centres, assessing the availability of alternative providers within predefined travel-time thresholds and describing variation by municipality type.

Design

Descriptive cross-sectional nationwide study.

Setting

Primary care in Sweden, including all primary care centres operating nationally during 2019–2020.

Participants

Individual-level residential grid coordinates for all residents of Sweden as of 31 December 2019 were obtained. After exclusion of observations with missing coordinate data, the final analytical sample comprised 9 946 509 individuals. A total of 1167 primary care centres were included after merging duplicate administrative units at the same physical location.

Outcome measures

Outcomes were driving distance and driving travel time by car from place of residence to the nearest primary care centre. Furthermore, driving distance and travel time to the second- to fifth-nearest centres, and the number of centres reachable within 5, 10, 20 and 30 min by car were used as outcomes.

Results

Nationally, the mean travel distance and time to the nearest primary care centre were 3.84 km (SD=5.8) and 5.6 min (SD 6.3), respectively (median distance 1.63 km, IQR 0.90–3.67; median time 3.3 min, IQR 2.0–6.2). Overall, 15.8% of residents could not reach a primary care centre within 10 min by car while 0.9% had travel times exceeding 30 min. Mean travel time to the nearest centre was 15.1 min (SD 18.9) in very rural municipalities compared with 3.0 min (SD 2.5) in large cities.

Conclusions

Geographical accessibility to Swedish primary care is high on average but substantial urban–rural disparities remain. Residents of sparsely populated areas face markedly longer travel times and more limited practical provider choice. Future studies should complement geographical measures with indicators of staffing, waiting times and multimodal transport to better assess medical deserts and effective access.

Baseline and longitudinal measures of continuity of primary care and COPD-related service utilisation: a cohort study using Korean National Health Insurance Service claims data

Por: Jo · A. J. · Kim · S. · Choo · E. · Je · N. K. · Jang · E. J. · Lee · I.-H.
Objectives

To compare baseline, cluster-based and trajectory-based classifications of continuity of primary care (COC) and to examine their associations with chronic obstructive pulmonary disease (COPD)-related hospitalisation and emergency department (ED) visits.

Design

Population-based retrospective cohort study.

Setting

National Health Insurance claims data from South Korea (Korean National Health Insurance Service), 2014–2021.

Participants

92 977 patients aged ≥40 years newly diagnosed with COPD between 2015 and 2016, with at least four ambulatory primary care visits during the exposure period.

Primary and secondary outcome measures: The primary outcome was the incidence of COPD-related hospitalisation; the secondary outcome was the incidence of COPD-related ED visits. Continuity of primary care was quantified using the Continuity of Care Index (COCI) and classified using three approaches: (1) a baseline COCI-based method, (2) a cluster-based method using K-means clustering and (3) a trajectory-based method using group-based trajectory modelling. Fine-Gray subdistribution hazard models, accounting for death as a competing risk, were used to estimate adjusted HRs (aHRs).

Results

Across all three classification approaches, low continuity of care was consistently associated with an increased risk of COPD-related hospitalisation (aHR 2.43, 95% CI 2.22 to 2.66 for baseline COCI; 2.26, 95% CI 2.06 to 2.47 for cluster-based; 2.73, 95% CI 2.49 to 2.99 for trajectory-based) and ED visits (aHR 2.32, 95% CI 2.04 to 2.63 for baseline COCI; 2.55, 95% CI 2.25 to 2.88 for cluster-based; 3.48, 95% CI 3.05 to 3.96 for trajectory-based). Effect estimates were consistently strongest for the trajectory-based approach and weakest for the baseline COCI approach. Agreement among the three classification methods was substantial (overall 87.2%; Fleiss’ kappa 0.78).

Conclusions

Baseline COCI classification offers a pragmatic and robust measure of COC, producing effect estimates directionally consistent with those derived from more complex longitudinal approaches; however, observed transitions between continuity groups over time indicate that reliance on baseline classification alone may attenuate effect estimates when continuity patterns change. Trajectory-based methods may yield additional insight in populations with greater temporal variability in care patterns but entail substantially higher data and modelling requirements.

Comparison of an ensemble machine learning model to a Cox regression model to predict colorectal cancer risk among people with HIV using retrospective nationwide cohort data in Sweden: a study protocol

Por: Nilsson · J. · Deng · Y. · Elvstam · O. · Killander-Möller · I. · Lei · J. · Mansson · F. · Naucler · P. · Nygren · J. · Ruhe-van der Werff · S. · Wagner · P. · Yilmaz · A. · Brännström · J. · Boman · M. · Carlander · C.
Introduction

There are currently no colorectal cancer (CRC) screening recommendations specifically outlined for people with HIV (PWH). Screening measures used for people without HIV (PWoH) have been previously discussed as sufficient for use among PWH, despite observations of higher CRC prevalence and CRC reportedly appearing at earlier ages among PWH in comparison to PWoH. Machine learning (ML) methods are regarded as robust approaches that may enhance predictive performance, particularly in the context of complex or high-dimensional data. This study aims to develop an ensemble ML model to predict CRC risk in PWH using comprehensive nationwide datasets. The model’s predictive performance will be evaluated and compared with a baseline Cox proportional regression model. The better-performing method will be implemented to develop a CRC risk prediction model with the aim of personalising screening recommendations for PWH.

Methods and analysis

The study population will include all PWH and PWoH born between 1940 and 2008, aged 18 or older and living in Sweden sometime between 1983 and 2024. The study population will be linked to six nationwide demographic and healthcare registers. Follow-up will continue until the first incident of CRC, emigration or death. The outcome of interest is CRC. PWH will be matched to negative controls 1:10. A Cox regression analysis will be completed first, and the results will be used as a baseline comparison to the ensemble ML results. A range of ML methods will be used to develop the ensemble model using stacking.

Ethics and dissemination

This study has ethical approval from the Regional Ethical Committee in Sweden (Dnr: 2024-04185-02, 2024-06783-02, 2023-00191-01, 2022-02897-02, 2022-05624-01, 2018/11-31/2). Given that the study is retrospective and register-based, using only pseudonymised data, there are minimal physical, psychological or privacy risks to included individuals. All results will be presented at the population level with no possibility of identification. The results of this study will be submitted for publication in a peer-reviewed journal.

Health-related quality of life in patients with cancer in Lubumbashi/Democratic Republic of the Congo: a semi-structured qualitative and quantitative prospective cross-sectional study

Por: Pilz · M. J. · Giesinger · J. M. · Mutoke · S. · Kavira · G. · Kaseba · A. N. · Epule · N. · Kitenge · P. · Basema · M.-F. · Shabani · F. M. · Arraras · J. I. · Mitterlehner · S. B. · Hallsson · L. R. · Tambwe-A-Nkoy · A. M.
Objectives

Health-related quality of life (HRQoL) assessments are a cornerstone of outcome evaluations for patients with cancer. The aim of this project was to assess patients with cancer in Lubumbashi/Democratic Republic of the Congo and: (1) evaluate what constitutes a clinically important health problem, (2) evaluate HRQoL and (3) compare HRQoL to controls.

Design

Cross-sectional, prospective study.

Setting

Patient recruitment took place in 12 hospitals in Lubumbashi.

Participants

Inclusion criteria were a secured diagnosis of cancer, aged 18 years and above, no serious cognitive impairments.

Primary and secondary outcome measures

(1) Semi-structured interviews with patients and healthcare professionals were conducted to investigate aspects of clinical importance. (2) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was employed to quantitatively assess HRQoL; (3) an exploratory comparison of HRQoL data to Spanish controls, multinational reference data and the European general population data is performed.

Results

(1) 20 patients (x-age=55.0 years; 70.0% female) and 10 healthcare professionals were interviewed. Social isolation, need for help/care and worries were frequently mentioned aspects making a health problem clinically important. (2) 103 patients (x-age=54.0 years; 67.0% female) with various cancer types were assessed. The prevalence of clinically important problems ranged from 26.2 % for fatigue to 94.1% for financial problems. (3) Compared to matched Spanish controls (n=207), symptom burden was more pervasive (OR 1.18 for insomnia to 28.0 for financial problems) than functional health limitations (max. OR 2.12 for role function). While adjusting HRQoL scores for age, sex, comorbidities and treatment intention decreased effect sizes of score difference across countries for 14 out of 16 scales, statistically significant differences across countries (p<0.05) remained for ten scales even after adjusting for covariates.

Conclusion

Clinical characteristics, aspects of clinical importance and HRQoL profiles of patients with cancer in Lubumbashi were reported. Aspects of clinical importance were identified, whereas a high symptom burden was reported by patients with cancer in Lubumbashi. Enhancing symptom management in Lubumbashi may alleviate symptom burden of patients with cancer.

Physiological-behavioural discordance in paediatric perioperative anxiety assessment: a scoping review protocol

Por: Guo · S. · Liu · H. · Wang · L. · Zhang · H.
Introduction

Preoperative anxiety in children is a common problem in paediatric surgical care. In current practice, anxiety is assessed mainly by behavioural rating scales, of which the modified Yale Preoperative Anxiety Scale (mYPAS) is the most widely used. However, behavioural observation may not capture children whose outward behaviour stays calm while their autonomic stress response is still high. This mismatch between visible behaviour and underlying physiology can lead to under-recognition of anxiety and may explain the modest correlations reported between behavioural scores and physiological markers in children. The aim of this scoping review is to map the published evidence on physiological–behavioural discordance during paediatric perioperative anxiety and to identify methodological gaps that future multimodal assessment research will need to address.

Methods and analysis

The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews reporting guideline and the Joanna Briggs Institute methodology for scoping reviews. We will search PubMed/MEDLINE, Embase, Web of Science Core Collection, CINAHL Complete and PsycINFO from database inception to 31 December 2025. Eligible studies will recruit children aged 0 to 18 years in perioperative or analogous procedural settings, and will report both a behavioural anxiety measure (such as mYPAS, mYPAS-SF, State–Trait Anxiety Inventory for Children (STAI-C)) and at least one concurrent physiological stress indicator (heart rate variability, salivary cortisol, salivary alpha-amylase, electrodermal activity, heart rate or intraoperative nociception indices). The primary analysis will focus on perioperative anaesthesia induction. Procedural sedation, venipuncture and dental contexts will be analysed as a separate secondary stratum because their stress profile is not the same as anaesthesia induction. Two reviewers will screen and extract data independently. Premedication exposure, regular home psychoactive medication use (including cannabinoids) and the time gap between behavioural and physiological sampling will be extracted as prespecified confounders. Findings will be synthesised narratively following the Synthesis Without Meta-analysis reporting guideline.

Ethics and dissemination

Ethical approval is not required because the review uses only published literature. Results will be submitted to a peer-reviewed journal and presented at paediatric anaesthesia conferences. A plain-language summary will be co-produced with parent advisors.

Ebetsu Active Future Study (EAFS): cognitive function and physical and mental health in elderly residents of Ebetsu City, Japan - cohort profile

Por: Kagami-Katsuyama · H. · Ito · N. · Hazama · M. · Toya · N. · Wataya · T. · Satoh · K. · Toda · N. · Kinoshita · K. · Honma · N. · Nishibe · T. · Satoh · H. · Koshino · K. · Saito · S. · Chiba · F. · Hattori · H. · Ogata · A. · Tanaka · N. · Maeda-Yamamoto · M. · Kimoto · H. · Kim · M. · Kumano
Purpose

Ebetsu Active Future Study (EAFS) conducts comprehensive annual surveys of individuals who are independent in activities of daily living (ADLs) to track age-related physical and mental changes. These surveys include a variety of assessments such as cognitive function tests, physical function tests, blood tests, self-administered questionnaires about lifestyle and health, and interviews regarding medical and family history. In addition, serum, plasma and DNA samples from these assessments are stored at –80°C to facilitate future analyses and accommodate the potential addition of new measurement items. The purposes of this study are: (1) to identify potential blood-based biomarkers applicable to the detection of various types of mild cognitive impairment (MCI), (2) to explore diet-based strategies for preventing MCI and the progression of dementia, (3) to examine the relationship between urban characteristics, individual attributes and healthy life expectancy in Ebetsu City and (4) to return the research findings to the city.

Participants

From August to October 2023, EAFS invited Ebetsu residents to participate in the study. As a result, 1340 individuals applied and 1189 residents aged between 55 and 75 years who were independent in ADLs participated in the baseline survey for the first year.

Findings to date

EAFS initiated a follow-up of 1189 participants (38.9% male; 64.5±5.6 years) in the baseline year of 2023 and maintained a high follow-up rate of 98.5% by wave 3 (2025). The Montreal Cognitive Assessment-Japanese demonstrated that 53.6% of the participants had operational MCI. The proportion of participants with operational MCI increased with ageing. Regarding the APOE4 gene, which is associated with an increased risk of Alzheimer’s disease, 1.2% of the total population were homozygous carriers and 22.1% were heterozygous carriers.

Future plans

EAFS will conduct annual follow-up surveys until 2032. In addition to analysing data for each objective, we also plan to perform further analysis of the stored specimens.

Sexual victimisation in college and university settings: a scoping review of student experiences, disclosure pathways, coping strategies and family-related evidence

Por: Chan · L. K. · Mohd Zain · N. · Solihin Sulaiman · N. A. · Bakar · R. S. · Hamid · S. H. A. · Othman · S.
Objectives

To map empirical evidence on sexual victimisation among higher education students, focusing on disclosure pathways, coping strategies and the extent and nature of family-related evidence.

Design

Scoping review.

Data sources

Scopus, Web of Science Core Collection, MEDLINE via EBSCOhost, ERIC via EBSCOhost, ProQuest Dissertations & Theses Citation Index, Google Scholar and citation tracking. The most recent search was conducted in June 2026.

Eligibility criteria

Primary empirical quantitative, qualitative and mixed-methods studies published between 1 January 2015 and 31 December 2025 were eligible if they included higher education students and/or family members and reported on at least one focal domain: disclosure, reporting, help-seeking, coping, recovery, social support or family involvement after sexual victimisation.

Data extraction and synthesis

Two reviewers screened records and extracted data using a standardised form. Quantitative findings were summarised descriptively; qualitative and mixed-methods findings were charted by focal domain and integrated narratively. Equity-relevant characteristics were mapped using PROGRESS-Plus.

Results

After screening and eligibility verification, 86 studies met the Population-Concept-Context criteria. These comprised 70 journal articles, 11 theses/dissertations and 5 conference proceedings papers. Most studies were conducted in North America and employed cross-sectional survey designs. Definitions and measures of sexual victimisation varied widely. When disclosure occurred, it was most often directed to peers and other informal supporters, whereas formal reporting to campus, legal or healthcare systems was less common. Coping responses ranged from social support, counselling, safety planning and advocacy to avoidance, self-blame, substance use and academic withdrawal. Family members were rarely sampled directly; family-related evidence was usually indirect, derived from students’ accounts of disclosure recipients or perceived reactions.

Conclusions

The evidence indicates persistent gaps in non-US contexts, distance-learning settings, research on male and gender-diverse students’ experiences and direct family-level research. Campus responses should be trauma-informed and equity-informed, while recognising that evidence for family-inclusive interventions remains preliminary and requires further empirical development.

Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial

Por: Rouleau · G. W. · Smith · A. W. · Parrish · C. G. · Allen · L. J. · Jayaram · J. E. · Ruble · S. R. · Adkins · C. M. · Eden · S. · Shotwell · M. S. · Yaghmour · E. T. · Statzer · N. J. · Wanderer · J. P. · Henson · C. P. · Shams · D. · Kertai · M. D. · Investigators · I. · IMPALA Inves
Introduction

Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery.

Methods and analysis

The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index–adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record.

Ethics and dissemination

This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients.

Trial registration number

NCT07224711.

Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol

Por: Werner · O. · Ferchaud-Roucher · V. · Karakachoff · M. · Bourgoin · P. · Chauvire-Drouard · A. · Galy · J. · Cosse · M. · Chaffiraud · M. · Boivin · M. · Gauvard · E. · Egron · S. · Romefort · B. · Benbrik · N. · Padovani · P. · Prigent · S. · Tagorti · M. · Demonceaux · M. · Gronier · C.
Introduction

Critical congenital heart disease (CHD) is associated with neurodevelopmental disorders, recognised as the most common long-term morbidity in affected children. In critical CHD, that is, CHD requiring cardiac surgery within the first 3 months of life, 30%–50% of children have lower developmental scores. Therefore, early identification of at-risk infants is crucial, yet there is no scientifically evaluated care programme in France. This study aims to evaluate early neurodevelopmental status in infants with prenatally diagnosed critical CHD and to determine how intrinsic susceptibility, prenatal and postnatal factors are functionally associated with developmental delay in this population.

Methods and analysis

Caractérisation et Accompagnement des Troubles du neurodéveloppement Associés aux MAlfoRmations cArdiaques coNgénitales (CATAMARAN) is a prospective, multicentre cohort study including 150 fetuses with critical CHD and their parents across eight French tertiary CHD centres. The primary objective will be to estimate the proportion of developmental delay at 6 months using the Bayley Scales of Infant and Toddler Development. Secondary objectives will include exploring potential prenatal, perinatal, perioperative determinants of developmental delay. Data collection will span pregnancy to 6 months of age including clinical assessments, maternal questionnaires (stress and nutrition), multimodal imaging and extensive biobanking (placenta, cord and peripheral blood, stool samples). To explore potential genetic and other multi-omic factors involved in the occurrence of a developmental delay, a case-control analysis will be conducted within the cohort.

Ethics and dissemination

Clinical and biological data will be collected through a secure system, with anonymised samples analysed in specialised facilities under collaborative agreements. Data confidentiality, traceability and long-term storage are ensured through controlled access and audit trails. Study results will be published and shared with families and the public through the patient association Petit Coeur de Beurre. This study received approval from a French ethics committee in November 2024 (no. 2024-A00425-42).

Trial registration number

NCT06690151.

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