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.

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’).

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.

Home-based primary care has been suggested to reduce emergency department visits among vulnerable older adults but how it should be organised to achieve this effect is unclear. This study aimed to increase the understanding of how older adults receiving home-based primary care and their family caregivers’ experience care during the period prior to an emergency department visit and to identify components of home-based primary care delivery that could help reduce such visits.

Qualitative study using semi-structured interviews with older adults receiving home-based primary care who had recently visited the emergency department, along with their family caregivers. Interviews were analysed using inductive thematic analysis.

Interviews were conducted in the homes of informants receiving home-based primary care in Region Stockholm, Sweden, 2022–2023.

Fourteen adults aged ≥65 years receiving home-based primary care who had visited an emergency department within the past 3 months were interviewed; seven interviews also included a family member.

An overarching theme, Trust as a prerequisite for timely emergency assessments in home-based primary care, describes how patient trust–in home-based primary care in general and in specific individual healthcare professionals–seems important in reducing emergency department visits, especially when patients experience symptoms of uncertain urgency or gradual onset. Four subthemes describe how primary care may build trust: through (1) access to care, (2) medical competence, (3) respect and relationship and (4) coordination and teamwork.

Trust in both home-based primary care in general and in individual healthcare professionals is crucial in reducing emergency department visits among older adults receiving home-based primary care. Trust may be strengthened by accessible and competent care, familiarity with both general practitioners and the responsible nurse and working as a collaborative team.

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

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

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

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.

(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.

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.

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.

Anastomotic leak is a major complication after anterior resection for rectal cancer, with reported rates of 10–15%. Recent evidence implicates the gut microbiome, where specific bacteria colonise the anastomotic site and secrete collagenase that weakens healing tissue. Preclinical studies demonstrate that tranexamic acid can inhibit this process when delivered rectally into the bowel lumen. This protocol outlines a feasibility trial of rectally administered tranexamic acid delivered via rectal catheter to the anastomotic site after anterior resection, accompanied by embedded microbiome and qualitative substudies.

This is an open-label, single-centre, randomised controlled feasibility trial. 45 patients undergoing anterior resection for rectal or sigmoid cancer will be randomised 2:1 to receive tranexamic acid or sterile water, administered intraoperatively and on postoperative days 1–3 via a rectal catheter. Feasibility outcomes include assessment of recruitment, intervention adherence, protocol compliance and safety. Exploratory clinical outcomes include anastomotic leak and other postoperative complications. A mandatory microbiome substudy will characterise changes in microbial composition and bacterial collagenase activity, providing mechanistic insight into treatment response. An optional qualitative substudy will explore acceptability of the intervention from the perspectives of patients and healthcare professionals.

The protocol was approved by the North West Liverpool Central Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency on 30 October 2024 (24/NW/0254). Recruitment commenced on 7 January 2025 following receipt of site-specific approvals. Feasibility, mechanistic and qualitative findings will be disseminated through peer-reviewed publications, academic conferences and stakeholder engagement activities. The results will inform progression to a definitive phase III trial and shape key elements of study design.

ISRCTN13727659.

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

NCT07560748.

Type 2 diabetes mellitus (T2DM) affects hundreds of millions of people worldwide. Self-management education is a cornerstone of diabetes care. Digital technology-based interventions have demonstrated short-term benefits; however, their medium-term to long-term effects remain unclear.

We will systematically search seven databases (PubMed, Embase, the Cochrane Library, the China National Knowledge Infrastructure [CNKI], the China Biomedical Literature Database [CBM], Wanfang and the China Science Journal Database [VIP]) and three clinical trial registries (ClinicalTrials.gov, Chinese Clinical Trial Registry [ChiCTR] and WHO International Clinical Trials Registry Platform [ICTRP]) from inception to March 2026. We will include randomised controlled trials that provide diabetes self-management education via digital technologies, such as mobile applications, websites, text messaging, remote monitoring or computer programmes. Interventions may be fully digital or hybrid, provided that digital technology is the core delivery method. Eligible studies will involve adults with T2DM or studies in which at least 80% of the participants have T2DM, with a minimum follow-up of 12 months. Primary outcomes will be mortality, diabetes-related complications, hospitalisations, severe hypoglycaemia, quality of life and glycated haemoglobin. Secondary outcomes include fasting plasma glucose, lipids, blood pressure, anthropometric measures and patient-reported outcomes such as self-management behaviours and diabetes distress. Two reviewers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias 2 (RoB 2) tool. Where data are sufficient and studies are adequately comparable in terms of participants, interventions, comparators, outcomes and study design, we will perform meta-analyses using Cochrane Review Manager (RevMan) V.5.3 and Stata V.19.0. Heterogeneity will be explored through subgroup analyses and meta-regression. The certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

As this study will synthesise the published data, ethical approval is not required.

CRD420251135023.

Studies have shown promising results using bone graft as a carrier for local administration of antibiotics to reduce the risk of prosthetic joint infection (PJI). The objective of this clinical trial is to determine if tobramycin and vancomycin-impregnated bone graft is safe and effective in reducing the rate of PJI after total hip arthroplasty (THA).

This study is an international, randomised, double-blinded, placebo-controlled clinical drug trial. Patients scheduled for THA (n=1100) requiring bone grafting (excluding revisions due to an ongoing infection) are randomised in a 1:1 ratio to prophylactic treatment with tobramycin and vancomycin or placebo-impregnated bone graft.

The primary outcome is the time to reoperation due to infection or diagnosis of PJI, expressed as a relative risk difference between the two groups. A risk reduction of at least 50% is considered clinically relevant. Secondary outcomes are time to and reason for reoperation and implant revision, type of micro-organism and antibiotic susceptibility pattern within 2 and 5 years after surgery. Safety outcomes are the number of adverse events and revision rate due to aseptic loosening. The primary analysis will be performed using proportional hazard models.

The study has been approved under the Clinical Trial Regulation No 536/2014 (EU CT; 2024-510921-25-00). Results will be published in open-access peer-reviewed journals and disseminated to patient organisations and the media, and de-identified individual participant data will be curated and shared on reasonable request in accordance with the Findability, Accessibility, Interoperability and Reuse principles, subject to the laws and regulations governing data protection in each participating country.

NCT05169229.

Frailty is a multidimensional syndrome of reduced physiological reserve and heightened vulnerability to stressors. Frailty is common among older adults and linked to adverse outcomes including disability, hospitalisation and death. Infections are common in older populations and remain a major cause of morbidity and death. Although it has been suggested that infections influence frailty development and progression (via inflammatory and functional mechanisms), evidence from longitudinal studies is inconsistent. Therefore, we aim to assess longitudinal associations between infections and frailty in adults.

We will conduct a systematic review of observational cohort and case-control studies examining associations between infections and frailty in adults. We will search MEDLINE, Embase and Global Health from 2001 to February 2026 without language restrictions. Two reviewers will independently screen titles and abstracts and subsequently assess full texts for eligibility. Data will be extracted using a standardised data extraction form. Risk of bias will be assessed using a customised domain-based tool based on the Risk Of Bias In Non-randomised Studies of Exposures (ROBINS-E) framework. We will initially narratively synthesise our findings. Where studies are sufficiently homogeneous, we will undertake random effects meta-analysis. We will assess the certainty of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethical approval is not required for a systematic review. Results of the review will be published in a peer-reviewed journal and disseminated through conferences.

CRD420261299590.

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [¹⁸F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

2024-512301-16-01

Parkinson’s disease (PD) is the second most common neurodegenerative disorder, its principal symptom being deterioration of motor function. Current treatment options are limited to symptom management but there is evidence that physical activity can provide motor benefits. More recently there is evidence to suggest that rhythmic auditory stimulation may improve gait and balance in PD. Sparky Samba is a community initiative in South Wales, UK, founded by a person living with PD. Sessions incorporate the following samba rhythms from a trained facilitator and are held weekly in a community setting.

The Sparky Samba trial is a multi-site, non-blinded, randomised controlled feasibility trial of Sparky Samba compared with activity as usual. A total of 60 people with PD will be randomised 1:1 to take part in a local Sparky Samba group for 12 weeks or continue their normal activities for the same length of time. The primary outcome is feasibility defined by recruitment, retention, data completeness and intervention adherence. Secondary outcomes relating to motor function, cognition, well-being and self-efficacy will also be assessed at baseline and at 12 weeks. Additionally, we will conduct a process evaluation to understand contextual mechanisms surrounding Sparky Samba. This will be achieved through qualitative interviews and structured participant questionnaires following individual trial completion and through structured questionnaires with intervention delivery staff, supplemented with qualitative interviews.

Feasibility outcomes will be assessed according to pre-defined criteria. For secondary outcomes, means and standard deviations (or medians and IQRs) will be calculated by arm, alongside 95% CIs for change from baseline to 12-week follow-up. Qualitative data will be subject to thematic analysis using NVivo software.

This study received a favourable ethical opinion from the North of Scotland Research Ethics Committee in April 2025 (REC reference 25/NS/0037). Study results will be disseminated through the peer-review literature, the ISRCTN registry and directly to participants, which will be facilitated by the study’s public and patient involvement steering group.

ISRCTN11861663

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.

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.

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 (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.

Cross-sectional, prospective study.

Patient recruitment took place in 12 hospitals in Lubumbashi.

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

(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.

(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.

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.

Chronic pain affects around 28 million adults in the UK and is associated with impaired work ability, reduced productivity and increased sickness absence. Access to work-focused support within healthcare services is limited, and most employers do not routinely provide structured assistance for employees living with chronic pain. The Pain-at-Work Toolkit is a co-created, web-based intervention designed to improve work ability, self-management, and workplace experiences for employees living with chronic pain. A feasibility trial demonstrated strong acceptability, exceptional recruitment and potential improvements in work ability, providing clear justification for progression to a fully powered evaluation. This paper describes the protocol for a definitive cluster randomised controlled trial to evaluate the effectiveness, cost-effectiveness and implementation of the Pain-at-Work Toolkit.

This two-arm, open-label cluster-randomised controlled trial will recruit at least 70 organisations (minimum 35 clusters per arm) and at least 685 participants. Organisations will be randomised 1:1 to (a) support-as-usual (SAU) or (b) SAU plus the Pain-at-Work Toolkit, and Pain-at-Work Manager’s Toolkit as an implementation-support component. The primary outcome is work ability at 3 months, measured using the Work Ability Index (three-item version). Secondary outcomes include work self-efficacy, sickness absence, presenteeism, productivity loss, job satisfaction, job stressfulness, turnover intentions, anxiety, depression and health-related quality of life. A mixed-methods process and implementation evaluation will assess fidelity, contextual influences and mechanisms of impact. A health economic evaluation will estimate cost-effectiveness from employer and societal perspectives. Analyses will follow intention-to-treat principles using multilevel modelling.

Ethical approval was granted by the University of Nottingham Faculty of Medicine and Health Sciences Research Ethics Committee (Ref: FMHS 1200226) and the UK Health Research Authority and Health and Care Wales (IRAS 367449). Findings will be disseminated through peer-reviewed publications, conference presentations, stakeholder reports and public summaries.

NCT07600892.

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.

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.

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.

NCT07224711.

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.

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.

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).

NCT06690151.

Engagement with the arts is advocated to reduce stigma and to increase the social inclusion of people living with dementia since the arts powerfully support non-verbal communication, affect and the opportunity to participate in activities that are meaningful to self and others. An example is Sharing Dance Older Adults (SDOA), an innovative, community dance programme that is offered by Canada’s National Ballet School (NBS) intended to support social inclusion by making dance accessible to older adults with a range of physical and cognitive abilities, including people living with dementia. Despite the benefits that SDOA offers people living with dementia and their carers, individuals from historically excluded populations, and more specifically those from racialised groups, have had only limited engagement with the programme. This study thus aims to co-develop with dance artists in the three largest racialised communities in Canada (Black, Chinese and South Asian) culturally relevant SDOA-informed dance opportunities for people living with dementia.

This 3-year study (2024–2027) is a multiple-case and intrinsic-case study design informed by critical participatory action research and the Critical Realism and the Arts Research Utilisation Model. For each of the three racialised communities, implementation and data collection will develop across five phases (preimplementation of professional development for dance artists; implementation of professional development for dance artists; postimplementation of professional development for dance artists; implementation of dance programming; and postimplementation of dance programming). Drawing on organisational partnerships in two Canadian provinces for three racialised communities, we plan to recruit older adults living with/without dementia who will attend the dance programming (n=90), formal/informal carers such as nurses and family (n=30), site managers such as directors of care (n=15), dance artists from the case communities (n=15) and NBS dance trainers who teach SDOA (n=2). Data collection strategies include: semistructured e-diary entries; active interviews; and video recordings of dance classes. All e-diary entries, transcriptions of interviews and video clips selected for full verbatim transcription will be analysed concurrently and recursively, using standard thematic analysis techniques.

All five phases of this study have been approved by the Clinical Trials Ontario (CTO Project ID: 4997, 11 June 2026), which is a streamlined ethics review system for multisite studies. All participants will provide written informed consent before taking part in the study. The outcomes will be shared through articles published in journals, presentations at academic and professional conferences, arts-based community events and other knowledge mobilisation forums that include all partners and collaborators.

We investigated the magnitude and correlates of modern contraceptive non-use among women of reproductive age (15–49 years) in Eswatini (formerly Swaziland).

Secondary analysis of a cross-sectional, nationally representative, population-based, household survey

Eswatini

Women of reproductive age in the Swaziland HIV Incidence Measurement Survey 3 2021 dataset

The primary outcome was non-use of modern contraceptive methods.

Of 3080 reproductive age women whose data were analysed in this study, 53% were aged 20–34 years, and the majority were from rural areas (66.8%). The weighted prevalence of non-use of modern contraceptives was 33%. The risk of non-use of modern contraceptives was lower among women: aged 20–34 (adjusted risk ratio (ARR)=0.85, 95% CI 0.75 to 0.97); from households of middle wealth quintile (ARR=0.82, 95% CI 0.68 to 0.97); who had given birth at least once (ARR=0.84, 95% CI 0.73 to 0.96); who were living with HIV (ARR=0.79, 95% CI 0.70 to 0.89); and among those who reported being sexually active in the past 12 months (ARR=0.54, 95% CI 0.48 to 0.61). On the other hand, adolescent girls aged 15–19 years (ARR=1.31, 95% CI 1.04 to 1.67) and women who lived in the Manzini (ARR=1.21, 95% CI 1.01 to 1.46) and Shiselweni regions (ARR=1.21, 95% CI 1.00 to 1.45) had a higher risk of not using modern contraceptives.

Given that a third of women in Eswatini did not use modern contraceptive methods, there is a need to promote modern contraceptive methods in Eswatini, particularly long-acting methods. The Eswatini Sexual and Reproductive Health Program should strengthen initiatives aimed at promoting modern contraceptive use among adolescent girls and those living in the Manzini and Shiselweni regions, who showed a higher risk of not using modern contraceptives.

Sickle cell disease places a significant burden on health systems in sub-Saharan Africa, including Ghana, where access to high-quality, patient-centred care remains limited. This study evaluated patient-perceived quality of sickle cell disease care at a tertiary-level facility in Ghana and explored process factors influencing perceived quality of care.

Cross-sectional, questionnaire-based study.

A tertiary-level healthcare facility in Accra, Ghana.

A total of 424 individuals with sickle cell disease were recruited using convenience sampling. Data were collected between 4 September and 16 October 2023 using pretested, interviewer-administered questionnaires. First-time clinic attendees and those requiring urgent medical intervention were excluded.

Primary outcome was patient-perceived quality of care. Secondary outcome measures included socio-demographic and process-related factors influencing patient-perceived care quality.

Participants’ ages ranged from 15 to 66 years, with a median (IQR) age of 32 (27–42) years. Most were female (67.4%), had the SS genotype (51.9%) and 68.6% were on hydroxyurea. Overall, 81.8% of respondents reported receiving good-quality care. Predictors of higher perceived care quality included age (adjusted OR (AOR)=8.9, (95% CI 3.3 to 24.3), p=0.001), hydroxyurea use (AOR=2.3, (95% CI 1.2 to 4.2), p=0.008), good health worker-patient communication (AOR=3.2, (95% CI 1.7 to 6.0), p=0.001), positive provider attitudes (AOR=3.1, (95% CI 1.7 to 5.7), p=0.001), receipt of health education (AOR=2.1, (95% CI 1.1 to 3.9), p=0.030) and shorter waiting times for emergency care (AOR=0.2, (95% CI 0.1 to 0.6), p=0.001).

This study provides context-specific evidence on process-level determinants of quality of sickle cell disease care in Ghana. Interventions to improve provider communication, enhance provider attitudes, strengthen patient education and reduce waiting times may improve patient experience and contribute to progress towards Universal Health Coverage in resource-limited settings.

Skeletal fractures are a leading cause of death and disability and a growing global public health concern. Internal fixation is a common surgical treatment indicated for several fractures, yet there are few comprehensive epidemiological studies describing mortality following the procedure.

Data were extracted from an England-wide administrative database (Hospital Episode Statistics, HES) and linked to mortality records from the Office for National Statistics (ONS). All records from patients aged 18 years or older who were admitted due to a non-polytrauma single fracture and underwent internal fixation between 2013 and 2023 were included. Crude and adjusted mortality rates were calculated as well as the restricted mean time lost.

A total of 630 758 admissions were included in the primary analysis. Of these, 55% were female, and the mean±SD age was 59±23 years. Primary open reduction internal fixation was the most common procedure (54% of cases), followed by closed reduction internal fixation (35%). Overall, mortality rates following internal fixation were 2% within 30 days, 5% within 90 days and 10% within 365 days. Mortality rates were described by fracture region and reduction procedure. Variation in mortality rates across fracture regions and procedures was attenuated in the case-mix-adjusted estimates.

This study described national crude and adjusted mortality rates following internal fixation for the treatment of skeletal fractures. These findings provide population-level descriptive benchmarks for clinical and epidemiological interpretation and may inform decision-making by clinicians and patients as well as the design of randomised controlled trials and other research studies.