Individuals with incomplete spinal cord injury (iSCI) often experience impaired balance control and turning-while-walking ability, which increase the risk of falls and limit their community mobility. While overground exoskeleton training has shown promise in improving gait and balance, evidence from randomised controlled trials (RCTs) on ambulation of individuals with iSCI remains limited. This protocol outlines a cluster RCT investigating the effectiveness of overground exoskeleton-assisted gait training compared with conventional training and usual care in improving turning-while-walking performence, balance control, and functional mobility in individuals with iSCI.

This multicentre, cluster RCT will compare 12-week interventions across three groups: (1) overground exoskeleton training group, (2) conventional training group and (3) usual care group. Participants with ambulatory iSCI will be recruited from three centres in Hong Kong SAR and mainland China. Primary outcomes include turning duration and number of steps during a 2-m turning-while-walking test. Secondary outcomes include static and dynamic balance, sensorimotor integration, gait performance, muscle strength, spasticity, quality of life, self-efficacy and fall incidence. Assessments will be conducted at baseline, mid-intervention, postintervention and at the 1-month follow-up.

This study has received approval from the Research Ethics Committees of Hong Kong Metropolitan University, the Affiliated BenQ Hospital of Nanjing Medical University, and Changzhou Sunshine Rehabilitation Hospital. Written informed consent will be obtained from all participants before enrolment. Study findings will be shared through peer-reviewed publications, conference presentations and summaries available to participants upon request.

NCT06971510.

Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.

A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.

This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.

Research has increasingly underscored the impact of factors such as socioeconomic status, education, healthcare access, housing and environmental conditions in shaping population health outcomes. These factors, collectively called social determinants of health (SDOH), provide crucial context for understanding drivers of health outcomes. In sub-Saharan Africa (SSA), the study of SDOH is critical due to the region’s unique sociocultural and economic conditions. Understanding how SDOH interacts with health systems and capturing SDOH in data is crucial for informing modelling efforts and policies improving population health more effectively. This scoping review aims to map the types of data used to capture SDOH in research conducted in SSA, to identify research gaps and to summarise key findings.

This scoping review will follow the Arksey and O’Malley methodological framework, enhanced by Levac et al, providing best practices for identifying, selecting and analysing eligible studies. Key steps include (1) identifying the research question, (2) identifying relevant studies, (3) selecting eligible studies via a locally curated search, (4) extracting information, (5) collating, summarising and reporting results and (6) consultation with stakeholders.

Ethical approval is not required, as this review relies solely on published literature. Findings will be disseminated across academic channels (journals, conferences) and through targeted stakeholder engagement efforts, such as policy briefs and public health workshops, to reach policymakers, healthcare practitioners and community health organisations. This dissemination strategy aims to inform health policy and drive programme development in SSA.

To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.

A descriptive qualitative study using in-depth interviews and thematic analysis.

The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.

17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.

Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.

Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.

Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.

Previous meta-analysis only focused on the safety and effectiveness of vagus nerve stimulation (VNS) in upper extremities motor function in stroke patients. The aim of this study was to systematically evaluate the efficacy and safety of VNS for more comprehensive functional rehabilitation in stroke patients.

This systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. The study protocol was registered in PROSPERO (CRD42024552624) and included randomised controlled trials (RCTs) investigating VNS-assisted rehabilitation in patients with stroke.

Searches were conducted in PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang Database, covering the period up to October 2025.

We included studies in which the intervention group received VNS, while the control group received either sham stimulation or conventional rehabilitation alone. Studies were required to report efficacy outcomes (such as upper extremity motor function and swallowing function) as well as safety outcomes.

Two researchers independently performed literature screening, data extraction and quality assessment. A meta-analysis was conducted using RevMan V.5.4 (The Cochrane Collaboration, London, United Kingdom) and STATA V.18.0(StataCorp LLC, College Station, TX, USA), using the standardised mean difference (SMD) for continuous outcomes and applying a random-effects model. To explore potential sources of heterogeneity, sensitivity and subgroup analyses were performed, while publication bias was assessed using funnel plots and Egger's test.

Overall, 18 RCTs involving 954 participants were included in this study. This meta-analysis indicated that VNS could improve Fugl-Meyer Assessment of Upper Extremity (SMD=0.89, 95% CI 0.59 to 1.20, I²=64%, pI²=81%, p=0.005), Motor Activity Log (SMD=0.44, 95% CI 0.18 to 0.70, I²=0%, p=0.0008), swallowing function (SMD=0.62, 95% CI 0.12 to 1.11, I²=0%, p=0.01), extensor carpi radialis muscle strength (SMD=1.07, 95% CI 0.67 to 1.47, I²=0%, pI²=48%, p≤0.0006), Modified Barthel Index (SMD=0.95, 95% CI 0.48 to 1.42, I²=75%, pI²=0%, p=0.00009) in stroke patients compared with the control group. Quality assessment using the Cochrane Risk of Bias tool indicated that most studies had a low risk of bias. Publication bias was low, as indicated by symmetric funnel plots and Egger's test results (p>0.05 for all key outcomes). According to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, five outcomes (eg, swallowing function) were rated as high quality, while two (WMFT and spasticity) were rated as low quality. Sensitivity analysis confirmed that no single study significantly influenced the pooled results. Subgroup analysis identified stimulation modality, treatment duration, region and age as the main sources of heterogeneity in this study.

The evidence supporting the use of VNS to improve function in stroke patients demonstrates reasonable reliability, a satisfactory degree of consistency and applicability, and suggests a potentially favourable clinical impact.

To investigate, in a prospective cohort study, the association between cognitive impairment and cardiovascular disease (CVD), to quantify the extent to which uncontrolled risk factors mediate this association, and to explore whether the mediation effect varies across sex and age groups.

Prospective cohort study.

UK Biobank, a large population-based cohort study in the UK.

A total of 152 155 participants without prevalent CVD or dementia at baseline were included. The mean age was 56.3±8.2 years, and 44.0% were male.

Cardiovascular death and composite cardiovascular outcomes, assessed using Cox proportional-hazards models and mediation analyses.

During a median follow-up of 13.03–13.87 years, 1474 cardiovascular deaths and 21 518 composite cardiovascular outcomes were recorded. Participants with cognitive impairment (n=23 146; 15.2%) exhibited higher proportions of lifestyle, metabolic and psychological risks (p

Cognitive impairment is associated with increased risks of cardiovascular death and composite cardiovascular outcomes. Uncontrolled lifestyle, cardiometabolic and psychological risk factors partially mediate this association, highlighting the importance of comprehensive management to improve cardiovascular prognosis in this population.

Osteogenesis imperfecta (OI) is the most common inherited cause of bone fragility (approximately 1 in 16 000). People with OI suffer bone fragility causing fractures, pain and deformity; sarcopenia causing fatigue and poor endurance; aortic root dilatation and hearing loss. No drug currently has market authorisation to treat OI in Europe. Current standard-of-care is multidisciplinary, with pharmacological interventions—primarily bisphosphonates—directed at increasing bone mass; however, such interventions are of equivocal efficacy. The structural damage that can accumulate as a result of repeated fractures over time may not be reversible. The lack of a treatment with clearly defined efficacy in terms of reducing fracture frequency or the sarcopenia, that is increasingly recognised in this condition, leads to the consideration of alternatives based on what is known about the molecular pathophysiology of the condition. For reasons that are currently unclear, transforming growth factor beta (TGFβ) pathway signalling is increased in OI, and both studies in mouse models and more recently also in humans suggest that reducing TGFβ pathway signalling could be of benefit in OI. This demonstrator project tests the hypothesis that losartan, an antihypertensive agent known to reduce circulating TGFβ, will reduce bone turnover and bone loss and have a positive effect on muscle function and quality of life in adults and older adolescents with OI.

This is a phase 2/pilot, open-label, dose-escalating study. This study aims to identify the effective dose for losartan in this population to inform the design of a pivotal phase III study. The study aims to recruit 30 adolescents and adults aged 16 years and above with OI across secondary care study sites in the UK and Italy. Participants will be recruited from the patient populations attending for treatment of OI at the participating hospital sites or referred by clinicians at the Participant Identification Centres (PIC sites). Participants will be randomised to one of three ‘final doses’—25, 50 or 75 mg losartan once daily. All participants will start on 25 mg once daily. Those assigned to higher ‘final doses’ will increase in 25 mg once daily increments on day 8 and day 15 following safety assessments. The primary outcome measures are to establish the effective dose of losartan in OI patients, based on maximal reduction in the bone resorption marker carboxy-terminal crosslink of type I collagen telopeptide (CTX) over the 24-week period of the study.

Secondary outcome measures are to determine the changes in proxy efficacy outcomes for bone (turnover, mass, architecture and strength) using blood tests, high-resolution peripheral quantitative CT (HRpQCT), dual-energy X-ray absorptiometry (DXA) and muscle (strength) using the ‘Timed Up and Go’ test. In addition, the changes in quality of life, including pain and fatigue, will be evaluated by using a disease-specific tool (OI-QOL) and a validated generic tool (EQ-5D-5L-VAS).

In the UK, the study protocol and amendments have been approved by the London Bridge Research Ethics Committee (REC reference: 23/LO/015) and by the Medicines and Healthcare products Regulatory Agency (MHRA). In Italy, the study protocol and amendments have been approved by the Italian and European ethics and regulatory authorities (Clinical Trials Information System European Union (CTIS EU) portal according to EU Regulation 536/2014). Final version of study protocol: Version 3.2, 05.03.2025. Final results will be disseminated in peer-reviewed journals through local OI, orthopaedic and other relevant clinical networks and at national and international meetings. Sheffield Children’s National Health Service Foundation Trust (UK) and Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Rizzoli (Italy) are the joint study sponsors.

ISRCTN (ISRCTN13317811).

Next-generation imaging (NGI), particularly with prostate-specific membrane antigen positron emission tomography (PSMA PET) tracers, enables earlier and more accurate detection of metastases. However, conventional imaging (CT and bone scan) remains more affordable and widely accessible and was the standard used in most pivotal trials that established current survival outcomes. As PSMA PET becomes more widely adopted, a stage migration effect is emerging. However, key uncertainties persist regarding the actual proportional employment of NGI in clinical practice, main indications for its use and the mid-term and long-term effects of an NGI-driven treatment pathway. Furthermore, when or whether CI alone might remain enough informative for the treatment decision-making is still unclear.

The European Registry of Next-Generation Imaging in Advanced Prostate Cancer is a non-profit, non-interventional, multi-centre, international, prospective, investigator-initiated registry that is intended to collect real-world data on how patients with prostate cancer at risk of harbouring metastasis (high-risk at initial diagnosis, or after primary treatment) are managed according to the type of imaging used for the systemic work-up. The registry is conducted in two phases: (1) cross-sectional analysis of imaging choices and their effect on clinical decision-making and (2) longitudinal follow-up evaluating survival outcomes such as progression-free survival (PFS), disease-specific survival (DSS) and skeletal-related events (SSEs). Statistical analyses will include descriptive analysis of demographic and clinical variables, comparative analysis between different imaging pathways, survival and prognostic analyses using Kaplan–Meier tests. The expected minimum sample size of the registry is 600 patients, and the planned follow-up duration is 24 months for the longitudinal follow-up.

The study protocol was approved by the ethics committee of Fundació Puigvert (#C2024/30), and ethics approval is required at all participating sites. All patients will provide written informed consent. The results will be disseminated widely and transparently to maximise their effect on clinical practice, research and patient care through peer-reviewed publications, presentations at international conferences as well as through patient advocacy groups and relevant patient websites.

NCT06866782.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.