Socioeconomic inequalities in neonatal mortality are observed globally but gaps remain in the evidence from current reviews, specifically: a wider range of socioeconomic indicators at the individual, household and area level than previous reviews, and alternative time frames to define neonatal mortality. Thus, a comprehensive updated review of the literature is required, focusing on multiple measures of socioeconomic status and alternative time frames, to assess the relationship between maternal socioeconomic status and neonatal mortality in high-income countries.
Three different search approaches will be used: electronic searching of three databases, grey literature searching and reference list checking. First, the three databases Medline, Scopus and Web of Science will be searched using relevant synonyms and adapted terms from medical subject heading terms (MeSH) in Medline for maternal socioeconomic status and neonatal mortality identified from previous systematic reviews on inequalities in adverse pregnancy outcomes. Second, grey literature will be searched by entering the relevant terms into Google. Title, abstract and full text screening will be conducted by the review team against the inclusion and exclusion criteria, with at least 10% checked by a second reviewer to assess for any bias and errors. We will also conduct the kappa statistic for inter-rater reliability. Third, the reference lists of included studies will be reviewed for any additional studies that meet the criteria. Data will be extracted using a data extraction form and extracted studies will be assessed using the Liverpool Quality Assessment Tool. A narrative synthesis will be conducted and, where appropriate, meta-analysis will be performed. If the data allow, subgroup analysis by neonatal care population and specific gestational ages will be performed.
Ethical approval is not required as all studies in this systematic review will be publicly available. The findings of this review will be presented at conferences and disseminated in peer-reviewed publications.
CRD42022315407.
This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.
Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.
Conde, Bahia, Brazil, from December 2024 to January 2025.
Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.
The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.
A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.
This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.
Brazilian Clinical Trials Registry; RBR-86kcy37.
Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening.
Cross-sectional, retrospective.
Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies.
The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy.
87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p
Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes.
A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.
A multicentre retrospective study.
The data were collected from electronic health records of two academic hospitals located in the Netherlands.
Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.
Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p
This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.
The mental health of people living with HIV (PLWH) is a growing concern globally, particularly in sub-Saharan Africa (SSA), where there is limited access to mental healthcare, with evidence showing high levels of depression, anxiety and neurocognitive disorders among this population. While Mental Health Disorders (MHDs) can impede HIV care and promote adverse health outcomes, there is limited literature on MHDs among PLWH. This scoping review will explore the existing literature on the burden and factors associated with MHDs among adults living with HIV in SSA.
Arksey and O’Malley’s methodological framework will guide the search of this scoping review. Relevant original research articles published in English from 1 January 2000 to 31 May 2025 on MHDs among PLWH in SSA will be identified through searches in the African Index Medicus, African Journal Online, PubMed and Embase databases. Four independent reviewers, working in pairs (one reviewer and one verifier), will screen the titles, abstracts and later the full texts, adopting the population, concept and context framework. Other coauthors will serve as tiebreakers whenever there is disagreement on the eligibility. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews flowchart will be presented. We will perform a narrative synthesis to report our findings.
This scoping review protocol does not require ethical approval, as it relies solely on publicly available existing data and does not involve human participants. We will disseminate the findings from this review through peer-reviewed publications and presentations at local and international conferences.
The protocol was registered in the Open Science Framework (https://osf.io/8ymqu).
To assess the relation of exposure to cement dust and heavy metal (aluminium, cadmium and lead) exposures to pulmonary function among male cement plant workers. The study also aimed to evaluate dose–response relationships and prevalence and severity of respiratory symptoms among exposure categories compared with a control group.
Cross-sectional study.
Secondary-level occupational health clinic in Ankara, Türkiye.
461 male non-smoking cement plant employees were included in total. Participants were categorised into packaging (n=101), milling (n=162) and office unexposed workers (n=198). Inclusion criteria were more than 70% work history in the cement industry and exclusion of pre-existing respiratory disease and missing data from the participants.
Not applicable.
Pulmonary function tests (forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), FEV1/FVC and peak expiratory flow (PEF)) and urinary, cadmium and blood lead concentrations were measured. Lung function impairment was the primary outcome measure; secondary outcomes included metal exposure—pulmonary measure correlations.
Significant negative correlations existed between FEV1 and urine aluminium (r=–0.622, p
Occupational cement dust and heavy metal exposure is closely linked to impaired pulmonary function in cement plant employees, particularly those who work in higher exposure jobs. The implications are robust endorsement of targeted monitoring and preventive interventions. Long-term longitudinal research is necessary to identify long-term outcome and efficacy of exposure reduction approaches.