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.

Type 2 diabetes (T2DM) and cognitive impairment are common long-term chronic conditions affecting older people in hospital. Cognitive impairment can complicate glucose monitoring and lead to diabetes-related emergencies in T2DM. Traditionally, point of care test measurements of capillary blood glucose are conducted in-hospital for T2DM while continuous glucose monitoring (CGM) is not widely used.

To understand the feasibility, acceptability and tolerability of using CGM in older inpatients with T2DM and cognitive impairment.

32 older people (mean age=78.7±6.7 years) with comorbid T2DM and cognitive impairment (Abbreviated Mini-Mental Test ≤8/10 and Mini-Addenbrooke’s Cognitive Examination ≤22/30) were recruited within a tertiary care hospital in the UK. All participants were naive to CGM and were asked to wear blinded Dexcom G7 sensors for up to 10 days. Participants were asked about feasibility, acceptability and tolerability questions at the point of sensor removal.

29 participants (96%) reported no pain during CGM fitting. All participants (100%) agreed that they did not notice wearing the sensor, and it did not affect their day-to-day hospital activities. All participants (100%) found it ‘very easy’ or ‘easy’ to have the sensor fitted and wearing it for 10 days, with 27 participants (90%) finding CGM convenient. 17 participants (57%) reported favourable perceptions of the subcutaneous sensor sensation.

CGM use in older inpatients with T2DM and cognitive impairment is highly feasible and acceptable for patients. Future studies and trials are now needed to evaluate the clinical use of CGM for glucose monitoring in hospitalised or community-dwelling older individuals with T2DM and cognitive impairment.

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.

Prospective cohort study.

Secondary care, Danish public teaching hospital.

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.

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.

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).

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.

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.

NCT06418217.

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.

A systematic scoping review was conducted.

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+.

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.

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.

Mailed smoking and vaping cessation support provided through the Which Way? Quit Pack programme has demonstrated acceptability and preliminary effectiveness in delivering culturally grounded support. However, there is no evidence of the effectiveness of mailed cessation programmes for Aboriginal and Torres Strait Islander people when implemented on a national scale. Building on previous work, this study aims to evaluate both the implementation effectiveness and cost-effectiveness analysis of the Which Way? Quit Pack mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander people.

A national single-group hybrid type 2 effectiveness-implementation study with 2000 Aboriginal and/or Torres Strait Islander people who use cigarettes and/or e-cigarettes (vapes) daily, want to quit and are aged ≥18 years. Participants will receive access to a culturally tailored mailed quit pack that includes up to a 12-week supply of nicotine replacement therapy, phone-based behavioural counselling and access to an online support forum. Cessation outcomes including 7-day point prevalence abstinence, prolonged abstinence and quit rates will be evaluated at 3, 6 and 12 months. An intention-to-treat approach will be used for cessation outcomes, with participants lost to follow-up classified as smokers or vapers. Exploratory logistic regression analyses will examine factors associated with quitting, and causal machine learning methods will be used to explore variation in intervention effectiveness across participant subgroups. The Reach-Effectiveness-Adoption-Implementation-Maintenance framework will guide evaluation of implementation and effectiveness outcomes. Analysis measures include cessation and quit attempt rates, number of participants recruited, representativeness and intervention uptake. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) will guide the cost-effectiveness analysis.

This study is governed by Aboriginal and Torres Strait Islander leadership and community-controlled partnerships and is conducted in line with Indigenous data sovereignty and Indigenous research ethics principles. The study has also received approval from the following human research ethics committees: Aboriginal Health & Medical Research Council of NSW (2493/25), Aboriginal Health Committee South Australia (04-25-1209), the Western Australian Aboriginal Health (HREC1474), the Victorian Aboriginal Community Controlled Health Organisation (2025/HREC0061) and the University of Newcastle Human Research (H-2025-0311). Findings will be disseminated in forms determined, governed and endorsed by Aboriginal and Torres Strait Islander people and communities through the project Governance, including peer-reviewed publications, policy briefs, community-led knowledge translation activities and presentations at local, national and international conferences.

ACTRN12626000459325.

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

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.

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.

Schools are key settings to intervene for the purpose of health promotion in children. However, the effectiveness of school-based interventions remains limited, potentially related to the obesogenic behaviours observed during holidays as posited by the structured days hypothesis. This study aims to evaluate the feasibility, process evaluation and preliminary efficacy of the keep moving in a structured summer (KEMOSS) intervention among Chinese children.

The KEMOSS intervention is an 8-week hybrid programme comprising two digitally supported home-based phases (weeks 1–2 and 7–8) and a structured school-based phase (weeks 3–6). The school-based phase will be a full-day scheduled programme that replicates the routine of regular school days, with a coach-led structured physical activity lesson and a free-play lesson embedded in the morning and afternoon, respectively. During the home-based phases, participants will be encouraged to complete prescribed exercises independently with support from mHealth reminders and instructional materials and to achieve a minimum of 10 000 steps per day. Feasibility, process evaluation and preliminary efficacy outcomes will be assessed using a mixed-methods approach. Quantitative data will be analysed using SPSS, while qualitative data from interviews and focus groups will be analysed thematically using NVivo.

Ethical approval has been obtained from the Ningbo University Ethics Committee (TY2026028). Findings will inform the refinement of the intervention and the design of a future definitive trial. Results will be disseminated through peer-reviewed publications and conference presentations.

ChiCTR2600126738.

Intraductal papillary mucinous neoplasms (IPMNs) are common pancreatic cystic neoplasms with malignant potential. Current evidence on IPMN management is derived largely from retrospective surgical cohorts that over-represent high-risk cases and provide limited insight into the long-term outcomes of conservatively managed lesions. Australia currently lacks a prospective national dataset to evaluate surveillance pathways, practice patterns, guideline adherence and long-term outcomes in individuals with IPMN. Variation between international guideline recommendations may also contribute to differences in surveillance intensity and thresholds for intervention. The Australian Pancreatic Cyst Registry (APCR) was established to address these evidence gaps.

The APCR is a prospective, multicentre clinical quality registry that collects clinical, imaging, management and outcome data for individuals with IPMN across public and private healthcare settings in Australia. Historical information is extracted from existing clinical documentation where available, with prospective data collection continuing during routine follow-up. The registry operates under an opt-out model and aims to enrol up to 10 000 participants over a 5-year recruitment period. Participants are followed through routine clinical care until discharge from surveillance, diagnosis of pancreatic cancer, withdrawal or death. Standardised electronic case report forms capture clinical and imaging variables aligned with risk features described in the 2024 Kyoto guidelines. This analysis will describe participant characteristics, cyst features, management and clinical outcomes, with comparative, time-to-event and multivariable analyses undertaken where appropriate. Guideline adherence and the predictive performance of established risk stratification frameworks will also be evaluated.

The study protocol was approved by the Monash Health Human Research Ethics Committee (Project ID: RES-24-0000-634A). Findings will be disseminated through peer-reviewed publications, conference presentations and updates to participating sites.

Lung ultrasound (LUS) is accurate for diagnosing pneumonia in the emergency department (ED), but standard training is time-intensive, limiting its widespread implementation. We evaluated LUS proficiency for pneumonia diagnosis and perceived adoption barriers after a short training programme.

This study was conducted in the frame of the PLUS-IS-LESS trial (Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments) (NCT05463406), a pragmatic stepped-wedge cluster-randomised clinical trial evaluating a clinical management algorithm combining LUS and procalcitonin to guide antibiotic use for lower respiratory tract infections (LRTIs) in 10 Swiss EDs.

All medical supervisors (senior registrars and senior physicians) from the participating EDs were invited to go through the PLUS-IS-LESS LUS training programme and all those who completed the training programme were included in this study.

The training programme included an e-learning course, followed by a half-day on-site training session with theory and hands-on practice. For proficiency evaluation, a validated structured assessment of LUS skills (LUS-OSAUS) was adapted into a 32-question online quiz and five bedside LUS examinations. Success was defined as achieving a score ≥80% on both the online quiz and supervised practical assessment. Success rates were compared between physicians according to their characteristics (age, sex, medical experience, previous use of ultrasound or LUS, linguistic region of work and type of hospital) using a ² test. A 6-month follow-up survey identified factors associated with non-certification and barriers to the clinical use of LUS for managing LRTIs.

Of 122 trained physicians, 83 (68 %) completed both quiz and supervised LUS and 61 (50%) achieved certification. The most challenging items were pleural line assessment (83% success), recognition of consolidations (83%) and decision-making based on LUS findings (72%). Physicians <40 years had a higher success rate (p=0.009). Among those without complete certification, limited access to an ultrasound machine and low perceived added value of LUS were the main identified reasons. Lack of time was the most frequently reported barrier overall to LUS integration into ED workflows (77%).

After receiving short training and focused proficiency testing, only half of physicians achieved certification, underscoring the challenges of broad LUS implementation. Limited time, equipment access and low perceived clinical value were key barriers, and integrating LUS findings into decision-making remained difficult. Ongoing support, supervision and protected time may be needed to enhance LUS adoption in EDs.

NCT05463406.