Conectar
Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.
This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.
The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.
Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.
The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.
The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.
The study has been registered in the Clinical Trials database (NCT06887634).
The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery.
Prospective, two-arm, randomised, double-blind pilot trial.
Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery.
32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age
Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care.
Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes.
In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p>0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups.
This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial.
CliniacalTrials.gov NCT05391412.
To investigate the association between loneliness and all-cause mortality and inpatient hospitalisation among adults with atherosclerotic cardiovascular disease (ASCVD) in a real-world setting, and to explore the potential implications of routine loneliness screening. The primary hypothesis was that loneliness is associated with increased all-cause mortality.
Observational retrospective cohort study.
Analysis of linked administrative claims and routinely collected loneliness screening data from a large health plan.
7484 adult health plan members with documented ASCVD and ≥10 months of continuous enrolment around the screening date. Selection criteria included ASCVD diagnosis and sufficient enrolment for baseline assessment.
The primary outcome measure was 365-day all-cause mortality. The secondary outcome measure was the 365-day all-cause inpatient hospitalisation rate.
881 deaths occurred during follow-up (18% in the lonely group vs 11% in the non-lonely group). The lonely group had a lower proportion of men (54% vs 65%, p
Our findings corroborate the association between loneliness and morbidity and mortality among those with known ASCVD. The effect for loneliness was similar in magnitude to clinical comorbidities and smoking, suggesting that routine screening for loneliness may provide valuable information for assessing and managing the risk of death among patients with ASCVD.
To quantify and describe the use of real-world data (RWD) in National Institute for Health and Care Excellence (NICE) oncology technology appraisal (TA) final appraisal determination documents.
A systematic literature review was conducted on pharmaceutical NICE oncology TAs published between April 2000 and March 2024 (covering financial years 2000/2001 to 2023/2024 inclusive) extracted on 22 August 2023 (2000/2001 - 2022/2023) and 8 August 2024 (2023/2024).
NICE TA final appraisal determination documents.
All pharmaceutical oncology TAs published between April 2000 and March 2024 (financial years 2000/2001 to 2023/2024) that did not go on to be terminated.
The data required for eligibility screening was extracted from an Excel file directly from the NICE website, where data related to each TA was extracted using an automated script derived from published sources. TAs were assessed based on prespecified review criteria covering whether an RWD submission was reported by the committee, and if so, which RWD sources were used, alongside the methods reported and any feedback from the committee regarding the use of RWD. Bias was not assessed as part of the study.
Of 310 TAs identified, 135 (48.0%) used RWD. A variety of RWD types were used, mostly from UK or US data sources. 47 TAs (34.8%) leveraged RWD from multiple sources. RWD was mostly used in comparisons of survival (41.5%), to inform utility values (26.7%) and to compare baseline characteristics (19.3%), with matched adjusted indirect comparisons (MAICs) and external control arms (ECAs), seen from 2015 and 2018, respectively. The committee expressed concerns around the RWD presented by the company in 53 TAs (39.2%), the most common being a lack of generalisability to the UK population and/or National Health Service practice and comprehensiveness of the RWD.
This study quantifies the increasing use of diverse RWD sources in NICE oncology TAs, as well as the shift towards more complex methods like MAICs and ECAs. The feedback of the NICE committee highlights key areas of improvement as the generalisability and maturity of the RWD presented.
A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
Wound care remains a high-priority area for improvement in the Canadian health care system. Older adults aged 65 and older are disproportionately affected by chronic and non-healing wounds and often experience multiple co-morbid conditions, challenges which can be further complicated by living in rural and northern areas. A workshop-based multi-methods study was conducted to describe rural and northern perspectives on opportunities and feasibility to implement innovative wound care technologies. Each workshop included pre- and post- workshop surveys, a live demonstration of Swift Skin and Wound, a Q&A session, and facilitated discussion exploring the technology's feasibility, usability, and accessibility in northern and rural care contexts. Participants who volunteered for the study included care staff and healthcare executives (N = 11), described their perspectives on implementing AI-driven digital wound care management solutions with a focus on integration into health care settings. Three themes were identified including: confidence and optimism in improving wound care management, recognition of the superiority of AI-driven digital wound care solutions over current practices, and the importance of adaptable change processes for successful adoption. While generalizability may be limited, findings suggest that adopting AI-driven wound care tools could improve wound assessment accuracy and streamline care for aging populations in rural and northern areas.
This paper examines the impact of India’s National Publicly Funded Health Assurance Scheme, Ayushman Bharat Pradhan Mantri Jan Aarogya Yojana (PM-JAY), in Haryana on out-of-pocket (OOP) expenses and catastrophic health expenditure (CHE).
We conducted a case-control study using a stratified random sampling approach.
Six districts in Haryana, based on utilisation, were selected: Mewat, Faridabad, Sonipat, Ambala, Kurukshetra and Karnal.
A total sample size of 772 individuals, that is, 386 PM-JAY beneficiaries (cases) and non-beneficiaries (controls) each.
Data were collected using a semistructured questionnaire covering household demographics and expenditure details. The interview gathered information on hospitalisation within the past year, types of ailments, the type of empanelled facility visited, expenditure details and borrowing/selling of assets for treatment.
Mean OOP expenditure was calculated for beneficiaries and non-beneficiaries based on the type of healthcare provider. The impact of PM-JAY on OOP expenditure was analysed using a generalised linear model controlling for religion, caste, type of house, type of family, morbidity patterns, type of disease, type of health facility, hospital stay duration, average distance to the facility and travel time. CHE was defined as OOP payments ≥30% of household income. Logistic regression was used to assess the determinants of CHE.
We found that direct medical expenses incurred for hospitalisations were 65% lower for beneficiaries (11 131 rupees) compared with non-beneficiaries (31 675 rupees). While OOP expenditures are similar for both groups in public empanelled hospitals, non-beneficiaries incur OOP costs three times higher than PM-JAY beneficiaries in private empanelled hospitals. Factors, including the disease type, average distance from home to the facility, average travel time and type of hospital, significantly influence these expenses. Furthermore, the prevalence of CHE is significantly lower among PM-JAY beneficiaries (13.3%) compared with non-beneficiaries (45.9%), with an OR of 7.15 (95% CI: 4.74 to 10.80; p
Our analysis shows the scheme’s impact on decreasing OOP expenditure and CHE. To enhance the scheme’s effectiveness, the study highlights the necessity of addressing non-medical expenses and expanding coverage for indirect costs, such as food, accommodation and transportation. Additionally, strengthening the supply side through improved drug availability at healthcare facilities is crucial for enhancing financial protection and access to care.
Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany.
This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care.
SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians.
Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians.
Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care.
Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening.
Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were 2175 lower (bias-corrected bootstrap CIs (BCI): 527 to 3734), and LCI-associated costs were reduced by 1218 (BCI: 296 to 2164). Comparing the savings to the additional costs of diagnosis (range: 1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs.
SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs.
The SEAL registration number is DRKS00013460. This study relates to its results.
Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.
This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.
This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.
Children with limited access to dental care can be negatively impacted by reduced frequency of oral health monitoring, delays in diagnosis of dental disease and increased waits for dental care, resulting in them experiencing more disease (extent and amount). Smartphone-based intraoral photography has been cited as having the potential to improve oral health monitoring for children through screening; however, it has not been well evaluated, and its limitations are unclear. The picture-perfect study aims to assess diagnostic accuracy, feasibility and acceptability to determine whether remote photographic monitoring can be effectively integrated into pathways of dental care for children aged 6-16 years.
Observational, cross-sectional, mixed-methods study with three workflows: Workflow 1: development of user-friendly, comprehensive guidance to help parent/carers (parents) take high-quality intraoral photographs of their children’s mouths. The guidance will be codesigned with parents and healthcare professionals. Workflow 2: diagnostic accuracy using intraoral photographs taken by a parent of their children will be evaluated by comparing clinicians' diagnoses from the photographs to gold-standard clinical visual-tactile examinations. Parent–child dyads (n=110) will be recruited to capture intraoral photographs using positioning aids, guidance and smartphones provided by the research team. The diagnoses will focus on plaque accumulation, gingival health, restoration status and dental caries. Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value, negative predictive value and area under the curve. Workflow 3: assessment of feasibility and acceptability will be through task completion rates, photograph quality and participant feedback. Qualitative interviews and an online survey will capture parents’ and children’s experiences. Observational data will provide insights into practical challenges.
This study, approved by the National Health Service (NHS) Research Ethics Committee (Integrated Research Application System [IRAS]: 24/EE0137), will be conducted in adherence to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participating parents, with age-appropriate assent from children prior to enrolment. Participants have the right to withdraw at any time without explanation, and their data will be anonymised to ensure privacy and confidentiality. Study findings will be disseminated through peer-reviewed journals, conference presentations and reports to relevant stakeholders.
The study protocol has been registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/WX29D.
Palliative cancer care is comprehensive, specialised medical care of patients that aims to alleviate physical, mental and emotional distress based on patients’ needs rather than on prognosis. In Ethiopia, the federal ministry of health started palliative care (PC) in 2016. Since then, services have been developed and integrated as important components of the Health Sector Transformation Plan II. However, there is a scarcity of nationally summarised data regarding PC service utilisation in Ethiopia. Therefore, this protocol describes a planned systematic review and meta-analysis that will evaluate utilisation of PC services and its predictors among adult cancer patients in Ethiopia.
The online databases of PubMed, Hinari, EMBASE, CINHAL, Science Direct, Scopus and Google Scholar will be comprehensively searched from inception to 31 February 2025. To assess the quality of included studies, the Joanna Briggs Institute critical appraisal tools will be used. The statistical software STATA V.17 will be used for data analyses. To examine the heterogeneity between studies, inverse variance (I2) will be used. To calculate the pooled prevalence of PC service utilisation, a fixed or random effects meta-analyses model will be used with a 95% CI, depending on the presence or absence of heterogeneity between included studies. To look for publication bias, a visual inspection of the funnel plot and Egger and Begg’s regression test and a 5% level of significance will be used.
Ethical approval is not applicable. The results will be disseminated to academic beneficiaries and the public.
Guideline-based strategies to prevent chronic kidney disease (CKD) progression and complications are available, yet their implementation in clinical practice is uncertain. We aimed to synthesise the available evidence on the concordance of CKD care with clinical guidelines to identify gaps and inform future CKD care.
Systematic review and meta-analysis.
We systematically searched MEDLINE (OVID), EMBASE (OVID) and CINAHL (EBSCOhost) (to 18 July 2025) for observational studies of adults with CKD reporting data on the quality of CKD care. We assessed data on quality indicators of CKD care across domains that related to patient monitoring (glomerular filtration rate and albuminuria), medications use (ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), statins) and treatment targets (blood pressure (BP) and HbA1c). Pooled estimates (95% CI) of the percentage of patients who met the quality indicators for CKD care were estimated using random effects model.
59 studies across 24 countries, including a total of 3 003 641 patients with CKD, were included. Across studies, 81.3% (95% CI: 75% to 87.6%) of patients received eGFR monitoring, 47.4% (95% CI: 40.0% to 54.7%) had albuminuria testing, and 90% (95% CI: 84.3% to 95.9%) had BP measured. ACEIs/ARBs were prescribed among 56.7% (95% CI: 51.5% to 62%), and statins among 56.6% (95% CI: 48.9% to 64.3%) of patients. BP (systolic BP ≤140/90 mm Hg) and HbA1c (
Current evidence shows substantial variation in CKD care quality globally. Guideline-concordant care varied according to quality measures and across patient groups, with gaps in indicators like albuminuria testing. These findings underscore the need for effective quality improvement strategies to address gaps in CKD care, including increased albuminuria testing for risk stratification, together with systematic measures for monitoring care quality.
CRD42023391749.
To map, summarise and analyse the methodologies of corneal nerve fibre imaging in studies using in vivo confocal microscopy (IVCM) in diabetes and assess the potential for standardising methods and reporting.
A scoping review was conducted using five databases, MEDLINE, Embase, Cochrane, Web of Science and Scopus, with search terms related to IVCM, diabetes and corneal nerves. Two researchers independently screened the studies for eligibility. Relevant data were extracted and systematically analysed.
Out of 1533 screened articles, 195 met the inclusion criteria. Spanning from 2000 to 2024, the studies showed high variability in image acquisition, image processing, image analysis and reporting detail. Most studies used laser scanning confocal microscopy, examining the central cornea in both eyes in patients with type 2 diabetes, manually selecting 3–6 images from each eye, and using ACCMetrics and CCMetrics for quantifying corneal nerve fibre length in mm/mm2. Many studies lacked sufficient methodological details for reproducibility.
IVCM studies of corneal nerve fibres in diabetes show substantial methodological heterogeneity and inconsistent reporting, limiting reproducibility. We propose a guideline to support standardisation and improve the reliability of future research.
This study aimed to assess eye check-up practice and associated factors among patients with diabetes attending primary hospitals in the Central Gondar Zone, Northwest Ethiopia.
A multicentre hospital-based cross-sectional study.
This study was conducted at primary hospitals in Central Gondar Zone, Northwest Ethiopia, from 10 June 2024 to 10 July 2024.
The study included 689 consecutive adult patients with diabetes who met the inclusion criteria.
Participants were diagnosed with diabetes mellitus by a general practitioner. Optometrists conducted interviews, reviewed medical records and administered a pretested, structured questionnaire. Binary logistic regression was performed to identify associated factors, with significance considered at a p
A total of 689 participants were involved in this study, with a response rate of 98.4%. The proportion of good eye check-up practice was 20.6% (95% CI: 17.6% to 23.8%). Factors associated with good eye check-up practice included urban residence (adjusted OR, AOR=4.10, 95% CI: 1.72 to 9.82), diabetes duration of 12+ years (AOR=4.98, 95% CI: 1.43 to 17.38), previous eye disease (AOR=3.78, 95% CI: 1.79 to 7.95), good knowledge of diabetic retinopathy (AOR=3.22, 95% CI: 1.42 to 7.29), higher family income (AOR=3.80, 95% CI: 1.27 to 11.36), referral from a diabetic clinic (AOR=3.48, 95% CI: 1.58 to 7.67) and a favourable attitude (AOR=3.75, 95% CI: 1.46 to 9.65).
This study revealed a low proportion of good eye check-up practices among patients with diabetes. Urban residency, longer duration of diabetes, higher income, clinic referrals, history of eye disease, knowledge of diabetic retinopathy and a favourable attitude were significantly associated with good eye check-up practices. Therefore, targeted health education and strengthened referral systems are recommended to improve regular eye check-up practices among individuals with diabetes.
A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET’s impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET’s effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.
This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (
This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.
Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
Early childhood development (ECD) lays the foundation for lifelong health, academic success and social well-being, yet over 250 million children in low- and middle-income countries are at risk of not reaching their developmental potential. Traditional measures fail to fully capture the risks associated with a child’s development outcomes. Artificial intelligence techniques, particularly machine learning (ML), offer an innovative approach by analysing complex datasets to detect subtle developmental patterns.
To map the existing literature on the use of ML in ECD research, including its geographical distribution, to identify research gaps and inform future directions. The review focuses on applied ML techniques, data types, feature sets, outcomes, data splitting and validation strategies, model performance, model explainability, key themes, clinical relevance and reported limitations.
Scoping review using the Arksey and O‘Malley framework with enhancements by Levac et al.
A systematic search was conducted on 16 June 2024 across PubMed, Web of Science, IEEE Xplore and PsycINFO, supplemented by grey literature (OpenGrey) and reference hand-searching. No publication date limits were applied.
Included studies applied ML or its variants (eg, deep learning (DL), natural language processing) to developmental outcomes in children aged 0–8 years. Studies were in English and addressed cognitive, language, motor or social-emotional development. Excluded were studies focusing on robotics; neurodevelopmental disorders such as autism spectrum disorder, attention-deficit/hyperactivity disorder and communication disorders; disease or medical conditions; and review articles.
Three reviewers independently extracted data using a structured MS Excel template, covering study ML techniques, data types, feature sets, outcomes, outcome measures, data splitting and validation strategies, model performance, model explainability, key themes, clinical relevance and limitations. A narrative synthesis was conducted, supported by descriptive statistics and visualisations.
Of the 759 articles retrieved, 27 met the inclusion criteria. Most studies (78%) originated from high-income countries, with none from sub-Saharan Africa. Supervised ML classifiers (40.7%) and DL techniques (22.2%) were the most used approaches. Cognitive development was the most frequently targeted outcome (33.3%), often measured using the Bayley Scales of Infant and Toddler Development-III (33.3%). Data types varied, with image, video and sensor-based data being most prevalent. Key predictive features were grouped into six categories: brain features; anthropometric and clinical/biological markers; socio-demographic and environmental factors; medical history and nutritional indicators; linguistic and expressive features; and motor indicators. Most studies (74.1%) focused solely on prediction, with the majority conducting predictions at age 2 years and above. Only 41% of studies employed explainability methods, and validation strategies varied widely. Few studies (7.4%) conducted external validation, and only one had progressed to a clinical trial. Common limitations included small sample sizes, lack of external validation and imbalanced datasets.
There is growing interest in using ML for ECD research, but current research lacks geographical diversity, external validation, explainability and practical implementation. Future work should focus on developing inclusive, interpretable and externally validated models that are integrated into real-world implementation.
Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.
The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.
Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.
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