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This systematic review aims to synthesise current evidence on gut microbiome profiles among children with sickle cell disease (SCD), assess the influence of analgesic and antibiotic use, and explore the contributions of environmental factors on their gut microbiota diversity. Through identification of consistent microbial patterns and gaps in the existing literature, this review will provide vital insight into potential microbiome-targeted strategies for improving health outcomes in paediatric SCD care.
Studies describing the gut microbiota among paediatric SCD human subjects (
Ethical approval will not be required as this is a systematic review of published data. The findings will be disseminated through publications in peer-reviewed journals and presentations at relevant scientific conferences.
CRD420251102736.
Pre-exposure prophylaxis (PrEP) use among cisgender female sex workers (FSWs), a population at disproportionately high HIV acquisition risk in Uganda, remains suboptimal. Uptake and continued use are constrained by barriers, such as limited clinical hours, long distances to access facility-based PrEP services, and high mobility among FSWs. Community pharmacies may offer a more accessible PrEP delivery model due to extended operating hours and convenient locations. This study aims to evaluate the accessibility and capacity of pharmacies in Kampala, Uganda, to serve as potential sites for PrEP delivery.
We will conduct a concurrent mixed-methods study combining geospatial mapping, structured surveys, a discrete choice experiment (DCE), and in-depth interviews (IDIs). First, the study will compare the reach and accessibility of PrEP services through community pharmacies versus public healthcare facilities. To highlight PrEP service reach, we will use geospatial analysis to map pharmacies, PrEP clinics, FSW hotspots (i.e., areas where sex is exchanged), and HIV incidence. We will also calculate a PrEP facility needs ratio (number of PrEP facilities/HIV incidence) for each of Kampala’s administrative divisions and estimate travel distance and time to access PrEP services using cost–distance analysis. Perceived accessibility of PrEP services will be assessed through FSW surveys (n=50) and IDIs (n=20–30), guided by Levesque’s framework. Then, we will evaluate pharmacy capacity via surveys (n=274) and IDIs (n=20–30), exploring infrastructure, resources, and staff perspectives, informed by the Consolidated Framework for Implementation Research. Additionally, a DCE will be embedded in the pharmacy survey to elicit staff preferences for delivery approaches and analysed using mixed logit models. Finally, we will integrate quantitative and qualitative findings to provide a broad assessment of whether pharmacies are suitable venues for PrEP delivery to FSWs in Kampala. Enrolment will begin by April 2026 for FSWs and July 2026 for pharmacy staff.
Ethical approval has been obtained from the Infectious Diseases Institute Research Ethics Committee (IDI-REC-2025-175) and the Uganda National Council for Science and Technology (HS6178ES). Written informed consent will be obtained from all participants. We will disseminate study findings through stakeholder meetings, scientific conferences, and peer-reviewed publications.
While needs assessment is the starting point of good quality care, there is anecdotal evidence of patients receiving different care in similar circumstances. This study aims to investigate whether practice variation exists in needs assessments conducted by home care nurses and to identify the factors influencing these assessments.
A cross-sectional, quantitative retrospective study.
Primary care; home care nursing in the Netherlands in 2023.
Sampling was based on criterion sampling. Home care organisations were approached based on the following inclusion criteria: organisations providing home care nursing in the Netherlands, organisations from various regions of the country and organisations offering different types of home care nursing (eg, paediatric or palliative care), funded under the Dutch Health Insurance Act (Zvw). Organisations were excluded if they provided home care nursing funded by sources other than the Dutch Health Insurance Act. Home care nurses were recruited from participating organisations, each of whom had recently assessed the care needs of at least five patients. In total, 28 organisations and 258 home care nurses participated in this study, thereby yielding data from 1615 patients.
Assessed and delivered minutes of home care per patient per week.
Variation was primarily associated with patient-related factors. After accounting for these factors, 83% (assessed minutes) and 88% (delivered minutes) of the total variation was attributed to the patient level, 8% (assessed minutes) and 10% (delivered minutes) to the home care nurses’ level and 9% (assessed minutes) and 2% (delivered minutes) to the organisational level. Due to inadequate documentation in electronic health records, many missing values were identified.
The lack of nursing documentation suggests that missing factors may have contributed to variations in needs assessments. Thus, further research should comprehensively explore the patient-related factors currently absent from nursing documentation.
Health cadres, who assist midwives in supporting pregnant women in community settings, need to enhance their competencies in identifying risk factors and referring high-risk pregnant women to midwives for further care. Since the capabilities of these health cadres are influenced by maternal complications, an educational programme was implemented to strengthen their skills. Therefore, this study aimed to evaluate the competency of health cadres by providing a researcher-developed educational programme.
An open-label, cluster non-randomised controlled trial.
Health cadres with at least 1 year of work experience were recruited at six public health centres (PHCs) in Banjarnegara Regency, Indonesia.
Six PHCs were selected and allocated into intervention group (IG=3 PHCs) and control group (CG=3 PHCs) groups. A total of 133 female health cadres were enrolled across the selected PHCs. At each PHC, a systematic random sampling method was used to select the participants. The researchers and health professionals provided a 3-week period of theoretical and scenario-based simulations to the IG, while the CG received no education.
Researcher-developed questionnaires and checklists were used to assess the knowledge, skills (health assessment, communication, attitude) and confidence. The primary endpoint was competency, a total score of knowledge and skills. The outcome domains were compared between the two groups, and a linear mixed-effect model was used to account for cluster-level variation.
A total of 130 (97.7%) completed the study (IG:64, CG:66). The competency score showed significant improvement at endline (CG=49.5 and IG=52.5; p=0.002). The median scores for health assessment skills (CG=12 vs IG=14; p
Education effectively increased the competency of health cadres. A well-structured education programme is necessary for health cadres to improve and maintain their competencies in monitoring high-risk pregnant women.
Epilepsy prevalence varies widely across Nigeria, with rates ranging from 3.1 to 37.0/1000 population. There have been no studies on epilepsy prevalence and treatment gap in the Northeast Region of Nigeria. This study aimed to study epilepsy prevalence and the epilepsy treatment gap (ETG) in an urban and a rural community in Northeast Nigeria.
Cross-sectional, community-based survey.
Epilepsy screening of residents in two communities in Northeast Nigeria using a WHO screening tool and a validated study questionnaire from 1 March to 10 June 2022.
8599 community residents aged ≥2 years.
Prevalence of epilepsy, active epilepsy, ETG and associated factors.
We screened 8599 residents, of whom 88 had epilepsy. Crude epilepsy prevalence was 10.2 per 1000 and was three times higher in the rural than in the urban community (18.5 vs 6.4; 2=26.79, p2=0.087, p=0.768). Logistic regression analysis showed that the ETG was associated with a lack of counselling (OR 15.8, 95% CI 3.5 to 70.7, p
The prevalence of epilepsy in Bauchi State was within the range reported in Nigeria but three times higher in the rural than in the urban community. A high ETG was associated with poor counselling of people with epilepsy. Epilepsy counselling, health education and wider access to neurology services could reduce the burden of epilepsy in Northeast Nigeria.
Neurogranin (Ng) has a role in synaptic plasticity and is considered a biomarker of synaptic dysfunction, a process hypothesised to be important in delirium. Few studies examining Ng in delirium exist, with mixed findings. This study aimed to investigate associations between cerebrospinal fluid (CSF) Ng concentrations and delirium in acutely admitted hip fracture patients.
Cross-sectional study.
Acutely admitted orthopaedic patients with hip fracture recruited from four participating hospitals in eastern Norway, representing secondary and tertiary care settings.
This study included 392 hip fracture patients. All admitted hip fracture patients operated in spinal anaesthesia were, regardless of age, considered for inclusion.
An in-house ELISA was used to measure CSF Ng concentration in patients acutely admitted with a hip fracture (n=392). Delirium status was evaluated daily according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Editions criteria independently by two experienced geriatricians. A value
180 patients (46 %) developed delirium and 70% of these had dementia. CSF Ng concentration did not differ significantly between those with and without delirium (176 pg/mL vs 164 pg/mL), with an estimated difference in medians of 12 (95% CI –5.8 to 29.8), p=0.185. Analyses adjusted for age, gender and dementia status did not show a statistically significant difference in Ng concentrations between the patients.
We did not find an association between delirium and CSF concentrations of Ng. This could imply that synaptic dysfunction and degeneration, involving Ng, are not key processes in the development of delirium. Further studies on other synaptic proteins are warranted to better explore synaptic dysfunction’s potential role in the pathophysiology of delirium.
To understand the regulatory landscape in the UK and globally before the introduction of the Medicines and Healthcare Products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP). This paper aims to inform on the IRP’s potential impact on access to innovative medicines, by comparing medicines approval in the UK with other international regulatory agencies.
A retrospective analysis of 154 technologies (medicine(s) + studied indication(s)) was conducted based on the National Institute for Health and Care Research Innovation Observatory technology briefings submitted to the National Institute for Health and Care Excellence (NICE) in 2020. These briefings serve as the trigger for the NICE Technology Assessment process. Data on the medicines’ submission and approval dates were extracted across five IRP reference regulators, which are the regulators from the US (Food and Drug Administration (FDA)), European Union (EU) (European Medicines Agency (EMA)), Japan (Pharmaceuticals and Medical Devices Agency (PMDA)), Australia (Therapeutic Goods Administration (TGA)) and Singapore (Health Science Authority (HSA)). The dates were compared with data from the UK (MHRA).
95 (62%) medicines were approved by at least one regulatory agency, while 59 (38%) medicines were not approved by any regulatory agency. The number of medicines approved by the following regulatory agencies is FDA (n=84, 55%), EMA (n=80, 52%), MHRA (n=71, 46%), TGA (n=51, 33%), HSA (n=41, 27%) and PMDA (n=38, 25%). The first submissions were primarily to the FDA (n=64) or the EMA (n=24). The FDA had the highest number of first approvals (n=70), followed by the EMA (n=17), PMDA (n=5) and the MHRA (n=1). The FDA used more expedited pathways than other regulators (n=61). Compared with the MHRA, FDA approvals were on average 360 days faster and EMA approvals 86 days faster.
There were significant differences in market access timelines across the five reference regulators, with the FDA and EMA having the highest number of approved medicines, first submissions and first approvals. IRP applications with the FDA or EMA as reference regulators may expedite access to innovative medicines in the UK by reducing the approval dates gap between the FDA/EMA and the MHRA. This understanding of the regulatory landscape will help inform future planning to accommodate the disruption that the IRP may cause.
Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.
This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.
Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.
This study aimed to assess the prevalence and determinants of vaccine hesitancy among pregnant women in South-West Nigeria.
An explanatory sequential mixed-methods study was conducted between January and March 2023. Participants for the quantitative phase were selected using a systematic sampling technique, while those for the qualitative phase were purposively selected. A modified parent attitude about childhood vaccines questionnaire was used for data collection and analysed using IBM SPSS V.25.0. Qualitative data were collected through focus group discussions and analysed using NVivo V.14. Univariable, bivariable and multivariable logistic regression analysis was done. A p
A tertiary health facility in South-West Nigeria.
Three hundred and forty-five pregnant women participated in the quantitative phase, while 24 pregnant women were involved in the qualitative phase.
The overall prevalence of vaccine hesitancy was 32%. Based on the domains, only 15.4% of the respondents were hesitant due to vaccination behaviour, 38.6% for safety and efficacy, and 49.6% were hesitant due to general attitude and trust for healthcare providers. Maternal age, number of children, religion and occupation showed significant association with vaccine hesitancy. Regarding the predictors of vaccine hesitancy, employed pregnant women (adjusted OR (aOR), 4.33; 95% CI: 1.60 to 9.70) and younger pregnant women (aOR, 2.53; 95% CI: 1.04 to 7.70) had a significantly higher odds of being vaccine-hesitant. The qualitative analyses revealed several major themes that contributed to vaccine hesitancy, including concerns about vaccine safety and efficacy, distrust of healthcare providers and the government, and the spread of misinformation through social networks and peers.
A significant proportion of pregnant women in this study were vaccine-hesitant. The major reasons for vaccine hesitancy are concerns about the safety of vaccines and lack of trust for healthcare providers. Policies and programmes should be aimed at improving vaccination behaviour, addressing safety concerns and building trust in vaccination systems.
Gestational diabetes mellitus (GDM) is an emerging public health concern in low and middle-income countries, including Nigeria, because of the associated pregnancy complications, increased healthcare costs and long-term health sequelae among women of reproductive age and their offspring. We determined the cumulative incidence, risk factors and pregnancy outcomes of GDM in Ibadan, Nigeria.
Prospective cohort study.
Ibadan, Southwest Nigeria.
721 pregnant women from the Ibadan Pregnancy Cohort Study participated in the one-step 75 g-oral glucose tolerance test at 24–28 weeks’ gestation.
The primary outcome of the study is the cumulative incidence of GDM. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups criteria. Secondary outcomes were pregnancy outcomes, which included modes of delivery (CS, spontaneous vaginal delivery), macrosomia (birth weight ≥4.0 kg), gestational age at delivery and birth asphyxia. The risk factors (exposures) examined included sociodemographic, obstetric, clinical, behavioural and lifestyle factors. Bivariate and multivariate Log-binomial regression models were used to identify the independent risk factors of GDM (adjusted for maternal age ≥35 years, income, maternal body mass index, history of pregnancy loss and congenital anomaly) and the associated pregnancy outcomes of GDM (adjusted for maternal age, income and maternal body mass index). Adjusted relative risk (aRR) and 95% CI, used to assess the strength of associations, were reported.
The cumulative incidence of GDM was 20.7%, 95% CI (17.9% to 23.9%). The mean time for the diagnosis of GDM is 25.4±1.42 weeks of gestation. After adjusting for other variables, maternal age ≥35 years: (aRR: 1.48). 95% CI (1.07 to 1.97) p=0.016), maternal obesity (aRR: 1.85, 95% CI (1.26 to 2.30) p=0.002) and a previous history of congenital anomaly (aRR: 2.83, 95% CI (1.97 to 4.07) p
The cumulative incidence of GDM is high among pregnant women in Ibadan. Maternal age ≥35 years, maternal obesity and a history of congenital anomaly were significant independent risk factors for GDM. These factors should be targeted for public health interventions, including lifestyle modification among pregnant women with obesity and early screening and diagnosis of GDM.
To examine the knowledge and attitudes regarding cardiopulmonary resuscitation (CPR) among Jordanian physical education (PE) students with and without CPR training, and the association between knowledge and attitudes.
Cross-sectional survey-based study.
Private and public universities in Jordan.
A convenience sample of 372 full-time second, third and fourth-year PE students.
Primary outcomes were levels of knowledge and attitudes towards CPR, measured using a validated questionnaire. Secondary outcomes included group comparisons (trained vs untrained) and the correlation between knowledge and attitude scores.
Of the 372 participants (mean age: 22.0±1.6 years; 51% female), 189 (51%) reported prior CPR training. Only 3% of students demonstrated high knowledge (>80% of correct answers), while 56% had low knowledge (
CPR knowledge among Jordanian PE students was low regardless of training. Attitudes were positive, mainly among trained students. There is a need for a structured CPR education in PE that addresses cultural and psychological barriers to improve preparedness for emergency response in athletic settings.
Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.
PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.
We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.
We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.
Primary and secondary outcomes will be published on trial completion.
This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.
Predictive scoring systems support clinicians in decision-making by estimating the prognosis of patients in intensive care units (ICUs). However, there is limited evidence on the accuracy of these systems in predicting mortality and organ dysfunction in special populations. The aim of this review is to assess the performance of predictive scoring systems in forecasting mortality in adult ICU patients in relation to baseline kidney function. It is anticipated that the assessment of predictive scoring systems’ performance and patient outcomes in this review may reveal information that will contribute to improve the quality of care and outcomes for special or under-represented ICU patient populations. It might also inform future research and contribute to the development of novel risk prediction models to address identified gaps or unanswered questions.
This review will include only observational studies, as these allow us to assess the real-world performance of predictive scoring systems in ICU settings by examining the original validation studies. By excluding randomised trials, paediatric studies, case reports and machine learning-derived models, this review focuses on the direct practical use of the scoring systems in adult ICU patients. A comprehensive search of MEDLINE, Embase and Scopus was conducted from database inception to 10 October 2024. The data will be extracted on study characteristics, patient outcomes and performance metrics.
This review will analyse data from previously published studies; no ethical approval is required. All data that will be included in the analysis will be publicly available and will be included in the final manuscript. Results will be disseminated through publication in a peer-reviewed journal and will also be presented at seminars and conferences.
CRD42024611547.
FreshRSS 