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.

General statements that vaccinations are among the most important preventive measures in medicine are common in public health guidance. While the efficacy of individual vaccines is well established through randomised controlled trials and observational studies, ecological studies at the population level can provide complementary insights into the relative historical contributions of different childhood vaccinations to reductions in morbidity and mortality. To date, there has been a lack of systematic reviews of such comparative studies, especially with a focus on Germany. The aim of this scoping review is to map the state of research on ecological studies that compare the relative contribution of different childhood vaccinations to reducing morbidity and mortality, with a focus on reported data from Germany in an international comparison. A more precise scientific and public communication about vaccinations strengthens confidence in evidence-based vaccination recommendations.

This scoping review follows the Joanna Briggs Institute methodology for scoping reviews. Reporting will be in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR). A comprehensive search will be conducted in MEDLINE via PubMed, Embase via Elsevier, Web of Science, Scopus via Elsevier and Google Scholar, supplemented by grey literature sources. Studies will be selected and data charted by at least two independent reviewers using the Population/Concept/Context (PCC) framework. Results will be synthesised descriptively and presented thematically.

No ethical approval is required as this is a secondary analysis of published data. The findings will be disseminated through publication in a peer-reviewed journal and as part of the first author’s doctoral thesis. The protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4FH3X).

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.

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.

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.

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.

This study assessed the feasibility of both the delivery and evaluation of ‘enhanced’ (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening.

A pilot randomised controlled trial (RCT).

13 General Practice (GP) practices in London were recruited.

GP practices identified people with SMI aged 24–64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials.

In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.

18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).

Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not.

Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group.

ISRCTN12558681.

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.

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

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.

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.

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.

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.

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.

Descriptive cross-sectional nationwide study.

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

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.

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.

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.

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.

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

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.

Intravenous thrombolysis is the standard early treatment for acute ischaemic stroke (AIS), yet a substantial proportion of patients, particularly those with mild disabling deficits, do not achieve favourable functional recovery. Tenecteplase (TNK), a fibrin-specific thrombolytic agent administered as a single bolus, and butylphthalide (NBP), a multi-mechanism neuroprotective agent, have each shown benefit in AIS. However, whether their combination confers additional benefit in mild disabling AIS remains unknown. This trial aims to determine whether adding NBP to TNK improves functional outcomes in patients with mild disabling ischaemic stroke treated within 4.5 hours of symptom onset.

BENEFIT-2 is a prospective, multicentre, randomised, double-blind, active-controlled trial. Eligible patients will be randomised 1:1 to receive either TNK plus NBP (combination group) or TNK plus placebo (control group) via block randomisation. The intervention comprises intravenous NBP 25 mg/100 mL two times per day for 7 days, followed by oral NBP 0.2 g three times per day up to day 14, with matching placebos for the control group. Key eligibility criteria include age 18–80 years, symptom onset within 4.5 hours, baseline National Institutes of Health Stroke Scale (NIHSS) score 2–5 with persistent unilateral weakness or speech impairment, and prestroke modified Rankin Scale (mRS) score 0 or 1. The primary outcome is the proportion of patients achieving mRS 0–1 at 90 days (allowable window ±7 days). Secondary endpoints include change in NIHSS, stroke recurrence, major vascular events, quality of life measured by EQ-5D and penumbral salvage on imaging. Safety endpoints comprise symptomatic intracranial haemorrhage, vascular death, all-cause mortality and other adverse events within 90 days. The primary analysis will follow the intention-to-treat principle.

Ethics approval has been obtained from the Independent Ethics Committee of Xiangya Hospital (No. 2026020399), Central South University. Results will be published in peer-reviewed journals and presented at academic conferences.

NCT07369999

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.

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.

More than half of older adults living with Alzheimer’s disease and related dementias (ADRD) never receive a formal diagnosis, and when a diagnosis occurs, it is often years after symptom onset. Primary care clinicians are ideally positioned to detect ADRD early; however, current workflows lack scalable tools that support systematic identification and follow-up. The Passive Digital Marker (PDM), a machine learning model that uses structured electronic health record (EHR) data, can identify patients at elevated risk for ADRD without adding burden to clinicians. This protocol outlines a feasibility study to develop and evaluate a patient-informed secure messaging intervention paired with PDM-based risk stratification to enhance patient engagement in cognitive assessment in primary care settings.

This will be a non-randomised pilot study conducted across 12 single health system primary care clinics. The PDM will be applied to EHR data to identify patients aged ≥65 years who are at high risk for ADRD. High-risk patients will receive a co-designed secure message prior to and after upcoming primary care visits encouraging follow-up evaluation with a trained nurse, the Brain Health Navigator (BHN). The primary objectives are to: (1) determine the feasibility of applying the PDM to EHR data across 12 primary care clinics; (2) assess the feasibility of engaging patients identified as positive on the PDM through secure text messaging prior to a primary care encounter and (3) evaluate engagement with the BHN following secure text messaging. Study outcomes will assess the feasibility of implementing the PDM and secure messaging workflow, including identification of high-risk patients using the PDM, message delivery and patient engagement measured through message open rates, completion of cognitive concern questions and appointments scheduled with the BHN. Quantitative data will be analysed using descriptive statistics.

This study was deemed exempt as part of enhanced patient care. The findings will be disseminated through peer-reviewed publications, professional conferences, health system reports and public-facing communications.

NCT07016178.

Adverse event reporting is critical for evaluating the safety of interventions in sleep disorders. Inconsistent reporting between trial registries and publications may alter clinical decision-making and patient safety. We assessed the concordance of adverse event reporting between ClinicalTrials.gov and peer-reviewed publications for interventional trials in sleep disorders. Primary outcomes included the consistency of reporting serious adverse events, other adverse events and patient/event counts. The location and detail of adverse event reporting within publications were also evaluated.

Among 168 trials, 143 (85.1%) showed discrepancies in serious adverse event counts between registry and publication. Patient count variations occurred in 73.2% and 35.1% of publications reported no adverse event data. Post-Final Rule trials demonstrated improved registry-based reporting, though discordance remained.

Substantial inconsistencies in adverse event reporting between registries and publications persist in sleep disorder trials. Improved standardisation and adherence to reporting guidelines are necessary to protect patient safety.

Registered on Open Science Framework.