The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.
Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.
Primary healthcare in rural China.
27 health practitioners from township health centres assigned to the intervention arm.
A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.
Not applicable.
Data were analysed using thematic analysis.
The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.
The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.
ISRCTN30652037 (01/12/2020).
To identify behavioural and household factors associated with poor oral hygiene among Japanese kindergarten children in a population with high health awareness, using the Debris Index-Simplified (DI-S) as a clinical proxy for early oral hygiene deterioration.
Cross-sectional study.
Seven kindergartens in Sapporo city, Japan.
Of the 1229 kindergarten children invited, 871 provided parental consent (consent rate: 70.9%). Among them, 675 children aged 1–6 years who completed both the questionnaire and oral examination (completion rate: 54.9%). Most post-consent losses were due to logistical and staffing constraints. Children were stratified into ≤3 year and ≥4 year academic classes.
The primary outcome was oral hygiene status based on the DI-S scores (categorised as good (DI-S=0) or poor (DI-S>0). The secondary outcome was the presence of dental caries, defined as decayed, missing and filled primary teeth: dmft≥1. Multivariable logistic regression was used to estimate associations between poor oral hygiene and behavioural and household factors.
Among the 675 children, 168 children (24.9%) exhibited poor oral hygiene (DI-S>0) and 89 children (13.2%) had dental caries (dmft≥1). In multivariable analysis adjusted for demographic, dental and dietary variables, poor oral hygiene was significantly associated with being from a multiple-child household (OR 1.67, 95% CI 1.16 to 2.42) and irregular juice consumption (OR 1.60, 95% CI 1.07 to 2.38). Age-stratified analysis revealed that these associations persisted among those in the ≥4 year class, with additional significance for infrequent tooth brushing (
In a high health awareness Japanese preschool population, poor oral hygiene was independently associated with household composition and juice consumption, rather than traditional dental behaviours. These findings suggest the need to broaden preventive strategies beyond routine dental guidance to include family structure and dietary patterns, particularly in low-prevalence settings. Differential associations between DI-S and caries experience emphasise the utility of early clinical indices in oral health promotion.
Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.
To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.
The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.
MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.
MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.
MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.
This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.
To describe the prevalence and characteristics of traditional, complementary and integrative medicine (TCIM) practice and product use by the population of the UK providing up-to-date data on the landscape of TCIM use in the UK.
A cross-sectional online survey, administered using the Qualtrics platform, among adults (aged 18 years and over) residing in the UK (England, Wales, Scotland or Northern Ireland). Data were collected between May and October 2024. The 40-item instrument covered four domains: demographics, health status, use of health products and practices, and use of health services. Descriptive statistics were used to summarise survey responses, and ² tests were applied to assess associations between participant characteristics and TCIM use. Backwards stepwise logistic regression was conducted to identify predictors of TCIM use across four outcome categories (p≤0.05).
The sample (n=1559) was broadly representative of the UK population. Prevalence of any TCIM use over a 12-month period was 65.9% with 19.1% consulting a TCIM practitioner and 63.3% using any TCIM product or practice. Bodywork therapists (massage therapists 9.4%, chiropractors 7.9%, yoga teachers 5.0%) and homeopaths (4.1%) were the most commonly consulted TCIM practitioners and Anthroposophic doctors were the least commonly consulted (2.1%). Among TCIM products, vitamin and mineral supplements were the most commonly used (37.3%) and relaxation or meditation practices were reported by 19.4% of respondents. TCIM users were more likely to be female, identify as Asian or Black, have a chronic disease diagnosis, report good health, possess private health insurance, have a higher education level, be employed (or seeking employment) and sometimes experience financial management difficulties.
There is substantial use of TCIM across the UK adult population and there is a need for more research on integrating TCIM into mainstream healthcare and the National Health Service. Clear strategies are necessary to enhance communication between TCIM and conventional healthcare providers, ensure patient safety and promote person-centred, coordinated models of care.
Postoperative pain is common, with approximately one-third of surgical patients experiencing severe acute pain and 10–20% developing chronic post-surgical pain (CPSP). Evidence shows that female patients are at higher risk of pain after sex non-specific surgery, thus sex- or gender-specific differences in pain treatment efficacy with potential consequences for perioperative pain management are to be expected. Considering the clinical and societal burden of poorly managed postoperative pain, the GEPard project comprises two systematic reviews, GEPard 1: sex- and/or gender-specific differences in efficacy of perioperative pain management for certain (major) surgical procedures in adult patients; and GEPard 2: sex- and/or gender-specific differences in the dosing, efficacy and adverse effects of the most common systemic perioperative non-opioid- and co-analgesics across all sex non-specific surgical procedures in adult patients.
The reviews will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook. MEDLINE, Embase, Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov and PsycINFO will be searched. We will include randomised controlled trials (RCTs) and systematic reviews/meta-analyses reporting outcomes disaggregated by sex and/or gender in adult surgical patients. For GEPard 1, this applies to selected major surgical procedures; for GEPard 2, to all non-sex-specific surgical procedures. Interventions include regional anaesthesia, systemic analgesics and psychological strategies for GEPard 1 and non-opioid- as well as co-analgesics for GEPard 2. Two reviewers will independently screen and extract the data. Cochrane Risk of Bias Tool 2.0 (RoB 2) and AMSTAR 2 tools will assess study quality. Random-effects or Bayesian meta-analyses will be performed where possible; otherwise, narrative synthesis will be applied. GRADE methodology will assess evidence certainty.
No ethical approval is required for these reviews. Findings will be disseminated via peer-reviewed publications, patient organisations and professional societies. Data will be shared via Zenodo or Open Science Framework (OSF), following FAIR principles.
The systematic review protocols for both reviews have been registered in PROSPERO on 29 August 2025 (Registration-ID: CRD420251121393 (GEPard1), CRD420251121536 (GEPard2).
Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.
A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.
Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.
PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.
Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.
PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.
PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.
To describe obstacles and ideas for improvement for the delivery of cardiopulmonary resuscitation and basic life support to wheelchair users.
A descriptive qualitative study underpinned by constructivism was conducted.
Semi structured interviews were completed with 26 participants from three cohorts: formal and informal carers, wheelchair users and healthcare professionals. Data were collected via online and in person interviews between February and June 2024. All participants were located in Australia, with the exception of one who was located in the United Kingdom. Data were analysed using thematic analysis.
Two major themes were identified: (1) obstacles to providing cardiopulmonary resuscitation and basic life support to a wheelchair user and (2) aspirations for improving cardiopulmonary resuscitation and basic life support for wheelchair users.
Participants shared ideas for how to improve emergency care for wheelchair users, highlighting a need for further research, testing and development of an education intervention.
Improving knowledge about providing emergency care to a wheelchair user could improve outcomes, save lives and reduce the life expectancy gap experienced by people with disability.
Approximately 2% of the global population use a wheelchair. Wheelchair use complicates the delivery of cardiopulmonary resuscitation and basic life support. There are currently no guidelines informing emergency care for wheelchair users available globally. Recognition of common symptoms of distress exhibited by wheelchair users, and options for the delivery of practical emergency care are required for wheelchair users.
The paper adheres to the EQUATOR reporting guidelines utilising the SRQR checklist.
Patients and the public were the driving force in recognising the gap in knowledge regarding the delivery of CPR to wheelchair users. Questions from patients and the public shaped the aims and methodological choices for this study.
To explore the experiences of and reasons for midwives leaving practice.
A qualitative approach applying a social constructivism interpretative framework.
Twenty participants were selected for interviews based on reasons for leaving midwifery practice between October 2022 and April 2023. Thematic analysis was used to identify themes, and results were checked for trustworthiness through a third coder, community engagement and member checking with two participants.
One overarching theme with six subthemes characterised the experience of leaving midwifery practice. All participants reported the overarching theme: Caring for myself and my close community became incompatible with the work of midwifery. Five subthemes reflected negative aspects of midwifery work: value incongruence; racism in midwifery; not feeling respected/valued (+compensation); high workload leading to low quality of care; negative practice climate and psychosocial safety climate. The theme of strong professional commitment and identity weighed into their decision to leave. Negative experiences working in birth centres were prominent across themes.
Participants reported leaving the profession of midwifery when they reached an unsustainable balance between the demands of work life and personal life. The decision to leave midwifery was emotional; participants maintained a strong connection to midwifery. The leaving process supports a theoretical premise for midwifery turnover behaviour. The work life of midwives is a complex composite of challenges that are reflective of identified problems with maternity care in the United States.
Midwives are not leaving practice because they want to leave midwifery but because they are unable to meet non-work-related caring demands. Family-friendly policies, such as flexible schedules and leave policies, could help retain the midwifery workforce.
Based on recommendations from representatives of historically marginalised groups within the midwifery community, we offered participants to be interviewed by a midwife of colour.
Acute kidney injury (AKI) is a significant challenge in hospital settings, and accurately differentiating between intrinsic and prerenal AKI is crucial for effective management. The fractional excretion of urea (FEUN) has been proposed as a potential biomarker for this purpose, offering an alternative to traditional markers such as fractional excretion of sodium. This study aimed to assess the diagnostic accuracy of FEUN for differentiating intrinsic from prerenal AKI in hospitalised patients.
We conducted a systematic review and bivariate random effects meta-analysis of diagnostic accuracy studies. The study followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
PubMed, Embase and Cochrane databases were searched from inception to 1 November 2023.
We included observational studies that focused on patient with AKI and reported FEUN data sufficient to reconstruct a complete 2x2 contingency table (true positives, true negatives, false positives and false negatives) for evaluating its diagnostic accuracy.
Two reviewers extracted data, assessed risk of bias with Quality Assessment of Diagnostic Accuracy Studies-2 and graded certainty of evidence using the GRADE approach. Pooled sensitivity, specificity, positive and negative likelihood ratios, and the area under the summary receiver operating characteristic curve (SROC) were calculated; heterogeneity was measured with I². A prespecified subgroup restricted to patients receiving diuretics served as a sensitivity analysis.
12 studies involving 1240 patients were included, with an overall occurrence rate of intrinsic AKI of 38.8%. FEUN had a pooled sensitivity of 0.74 (95% CI 0.60 to 0.84) and specificity of 0.78 (95% CI 0.66 to 0.87), with positive predictive value and negative predictive value of 0.76 (95% CI 0.68 to 0.83) and 0.74 (95% CI 0.66 to 0.81), respectively. The SROC curve showed a pooled diagnostic accuracy of 0.83. Heterogeneity was substantial (I²>90%) for sensitivity and specificity. In a diuretic-only subgroup (six studies) specificity rose to0.87 and heterogeneity declined (I²=56%). Overall certainty of evidence was low owing to inconsistency.
FEUN is a biomarker with moderate diagnostic accuracy for differentiating between intrinsic and prerenal AKI in hospitalised patients. Its application could enhance AKI management; however, the high heterogeneity observed in our study highlights the need for further research to evaluate its utility across diverse patient populations and clinical settings.
CRD42024496083.
This study aimed to determine the prevalence and factors associated with pre-diabetes and undiagnosed type 2 diabetes (UDD) in Cambodia.
This analysis used data from the WHO World Health Survey Plus, which was collected using a cross-sectional design with a GIS-based, three-stage sampling approach. Multiple logistic regression was used to identify key associated factors, based on a significance level of p
Data were collected from all 25 provinces in Cambodia between 12 March 2023 and 31 May 2023.
4427 individuals aged 18 years or older, residing in the selected household for at least 6 months in the past year.
Pre-diabetes (Haemoglobin A1c (HbA1c) 5.7%–6.4%) and UDD (HbA1c≥6.5%), without prior knowledge of having type 2 diabetes (T2D).
The weighted prevalences of pre-diabetes and UDD were 26.4% (95% CI 24.0% to 29.0%) and 9.3% (95% CI 7.9% to 11.0%). Pre-diabetes prevalence was higher in urban areas compared with rural areas (adjusted OR, aOR=1.2, 95% CI 1.0 to 1.4), males (aOR=1.7, 95% CI 1.3 to 2.3), individuals aged 40–49 (aOR=1.8, 95% CI 1.4 to 2.4), individuals aged 50+ years group (aOR=2.9, 95% CI 2.3 to 3.6) compared with the 18–39 years group, overweight individuals (aOR=1.7, 95% CI 1.4 to 2.0), obese (aOR=2.1, 95% CI 1.5 to 3.0) and those with elevated total triglycerides (aOR=1.3, 95% CI 1.1 to 1.5). Similar risk factors were identified for UDD, with the addition of hypertension (aOR=1.6, 95% CI 1.3 to 2.0) and high waist circumference (aOR=2.0, 95% CI 1.5 to 2.7).
The high prevalence of pre-diabetes and UDD in Cambodia is a pressing public health concern. Urgent and intensive interventions are needed to effectively prevent and manage T2D, particularly among urban residents, older persons and individuals with metabolic risk factors.
To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).
Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]
A single NHS hospital in the UK.
The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.
CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).
CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.
Although neurofilament light chain (NfL) is used as a biomarker of neurodegenerative decline, its application in surgery- and anaesthesia-induced acute cognitive dysfunction remains uncertain. We aimed to synthesise existing evidence to evaluate the potential of NfL as a biomarker for perioperative neurocognitive disorder (PND).
Systematic review and meta-analysis.
PubMed, EMBASE, MEDLINE, the Cochrane Library and the Cochrane Central Register of Clinical Trials were systematically searched up to March 2024.
Observational studies—including cohort, case-control and cross-sectional designs—were included if they reported cerebrospinal fluid (CSF) or blood NfL levels in individuals with and without PND.
Three independent reviewers assessed each article. Quality scoring was conducted, and the extracted data were analysed using STATA. Risk of bias was evaluated using the Newcastle–Ottawa Scale. Meta-analytical model selection was guided by the I2 statistic, with I2≤40% indicating low heterogeneity and the use of a fixed-effect model; random-effects models were used when this threshold was exceeded.
Within-group analyses showed significant postoperative increases in blood NfL levels in both the postoperative delirium (POD) group (standardised mean difference (SMD) = 0.49; 95% CI 0.34 to 0.64) and the no-POD group (SMD=0.67, 95% CI 0.53 to 0.81). Between-group comparisons revealed significantly higher preoperative CSF NfL levels in the POD group (SMD=0.27, 95% CI 0.07 to 0.47). Both preoperative and postoperative blood NfL levels were also significantly elevated in the POD group (SMD=0.53, 95% CI 0.40 to 0.66, and SMD=0.58, 95% CI 0.43 to 0.73, respectively).
This meta-analysis suggests that NfL may be a potential biomarker for POD. Further research is needed to clarify the association between CSF and blood NfL levels and other forms of PND.
CRD42024516907.
To assess nutrition-related knowledge, attitudes and practices among pregnant women, and identify socioeconomic and healthcare determinants.
A cross-sectional study on maternal nutrition during pregnancy.
Pregnant women attending primary healthcare centres in the south of Tehran from December 2022 to March 2024.
1535 pregnant women of all ages living in the south of Tehran (both Iranian and non-Iranian).
Pregnant women were systematically selected from primary healthcare centres. Data were collected via validated questionnaires and electronic health records. Statistical analyses included multivariate logistic regression (adjusted ORs (aORs) with 95% CIs) and generalised linear mixed models.
The findings revealed that a majority of pregnant women (83.3%; 95% CI 81.2% to 85.3%) exhibited low levels of nutritional knowledge (scores below 12), whereas 14% demonstrated moderate knowledge (scores between 12 and 17), and only 2.7% (95% CI 1.9% to 3.8%) possessed high nutritional knowledge (scores above 18). In terms of attitudes, 36.9% of respondents expressed positive views toward nutrition, with higher education significantly associated with positive attitudes (aOR=1.8; 95% CI 1.3 to 2.5, comparing higher vs lower education levels). Dietary variety was consistently reported by 65.4% of participants, while 8.5% lacked dietary variety. Statistically significant associations were observed between educational attainment, socioeconomic status and nutrition-related practices (p
As a cross-sectional study, these findings highlight substantial gaps in nutrition knowledge among pregnant women in Tehran, with socioeconomic status and education playing crucial roles in shaping dietary behaviours. Improving nutritional education through healthcare interventions is essential for enhancing maternal and fetal health outcomes.
Long-term healthcare utilisation (HCU) among mothers of infants with neonatal, invasive group B Streptococcus disease (iGBS) remains understudied; identifying these patterns could provide better support for affected families and address the iGBS public health burden.
Cohort study.
Population of Denmark.
1565 mothers of infants with iGBS and 44 976 matched comparators from 1997 through 2021, with follow-up until 2022, using national health and social registry data.
HCU including primary, inpatient, outpatient, psychiatric and surgical care was evaluated as period prevalence ratio (PPR) and rate ratios compared across three time periods (0–6 years, 7–13 years and 14–20 years) using a modified Poisson regression model and negative binomial regression with 95% CIs.
Mothers of newborns with iGBS had higher PPRs of psychiatric care contacts in the first 0–6 years and 14–20 years following iGBS compared with the comparison cohort (RR0–61.12 (95% CI 0.93 to 1.35), RR14–201.24 (95% CI 0.97 to 1.58)). Exposed mothers had similar PPRs of primary, inpatient and outpatient care use as comparators, except for a slightly higher inpatient care use 7–13 years following iGBS. Exposed mothers had higher RRs for primary, inpatient, outpatient and psychiatric care contacts than mothers in the comparison cohort.
Mothers of iGBS-exposed infants had elevated psychiatric healthcare use and increased primary, and outpatient care visits compared with matched comparators, suggesting heightened healthcare needs and psychosocial burden of caregiving up to 20 years post-iGBS.
Treatment failure remains a major challenge in tuberculosis (TB) management. Rapid and objective assessment of treatment response is essential, as existing tools have limited accuracy and slow turnaround times. The PATHFAST TB LAM Ag assay (PATHFAST-LAM), an automated chemiluminescent enzyme immunoassay, was developed to quantify lipoarabinomannan (LAM) in sputum within 1 hour. Previous studies have shown a strong correlation between sputum LAM concentration and culture-based bacterial load. However, its clinical utility for predicting poor outcomes during treatment has not been prospectively evaluated.
We will conduct a prospective longitudinal study enrolling newly diagnosed, bacteriologically confirmed patients with pulmonary TB at Rhodes Chest Clinic and Mbagathi County Referral Hospital in Nairobi, Kenya. We will follow participants throughout the 6-month treatment course, attempting to collect sputum weekly during weeks 1–4, biweekly during weeks 5–12 and monthly during months 3–6. We will measure LAM concentrations at these time points using the PATHFAST-LAM assay. The primary outcome is to assess whether changes in sputum LAM concentration during the intensive phase (baseline to week 4 and/or week 8) predict a composite poor outcome, defined as positive sputum culture at month 6, treatment failure, death during treatment or relapse within 3 months after treatment completion. The primary endpoint is the area under the curve from the receiver operating characteristic analysis, representing the predictive performance of changes in sputum LAM concentration for the composite poor outcome. We will identify the optimal cut-off value for LAM change and estimate sensitivity and specificity with 95% CIs using 2x2 tables. We will apply an adaptive design that allows sample-size re-estimation after interim analysis.
The study was approved by the Kenya Medical Research Institute (KEMRI/SERU/CRDR/124/5241) and Nagasaki University (250619327). Findings will be disseminated through peer-reviewed publications and scientific meetings.
Published clinical trials offer valuable insights into the clinical research landscape in Portuguese-speaking African countries (PSAC)—Angola, Cabo Verde, Guinea-Bissau, São Tomé and Príncipe and Mozambique. The objective of this comprehensive scoping review is to systematically map and analyse randomised clinical trials (RCTs) evaluating pharmacological interventions conducted in PSAC from 1995 to 2024, in order to identify research trends, targeted diseases, geographic distribution and evidence gaps to better understand the development and evolution of clinical trials in the region. This is the first comprehensive scoping review to examine the clinical trials landscape in PSAC.
This scoping review adheres to the Joanna Briggs Institute methodology for scoping reviews, which builds on the Arksey and O’Malley methodological framework (refined by Levac et al) and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A dual-search strategy will be used, consulting 4 electronic databases (MEDLINE, EMBASE, African Index Medicus, Cochrane Central Register of Clinical Trials) and 3 clinical trials registries platforms (Clinicaltrials.gov, International Clinical Trials Registry Platform, Pan African Clinical Trials Registry). Eligible studies will include RCTs conducted in at least one of the PSAC. Extracted data will include trial characteristics, targeted diseases, phases and designs, funding and ethical compliance. Risk of bias (RoB) will be assessed using the Cochrane RoB tool V.2.0 to evaluate the quality of the evidence included in the scoping review. Conclusions will be drawn upon the comparison between countries and their scope of clinical research, together with comparison with countries from other geographies, considering disease profiles.
Ethical approval is not required. Results will be disseminated through a peer-reviewed publication, conference presentation and in plain language in social media, both in Portuguese and in English.
This protocol is registered in the Open Science Framework https://osf.io/5nhc9.
Outcome from large vessel occlusion stroke can be significantly improved by time-critical thrombectomy but treatment is only available in regional comprehensive stroke centres (CSCs). Many patients are first admitted to a local primary stroke centre (PSC) and require transfer to a CSC, which delays treatment and decreases the chance of a good outcome. Access to thrombectomy might be improved if eligible patients could be identified in the prehospital setting and selectively redirected to a CSC. This study is evaluating a new specialist prehospital redirection pathway intended to facilitate access to thrombectomy.
This study is a multicentre cluster randomised controlled trial with included health economic and process evaluations. Clusters are ambulance stations (or teams) which are work bases for ambulance practitioners. Intervention allocated ambulance practitioners use the Specialist PrE-hospital rEDirection for ischaemic stroke thrombectomY (‘SPEEDY’) pathway which comprises initiation according to specific criteria followed by contact with CSC staff who undertake a remote assessment to select patients for direct CSC admission. Control allocated ambulance practitioners continue to provide standard care which comprises admission to a local PSC and transfer to a CSC for thrombectomy if required. A co-primary outcome of thrombectomy treatment rate and time from stroke symptom onset to thrombectomy treatment will evaluate the impact of the pathway. Secondary outcomes include key aspects of emergency care including prehospital/hospital time intervals, receipt of other treatments including thrombolysis, and performance characteristics of the pathway. A broad population of all ambulance practitioner suspected and confirmed stroke patients across participating regions is being enrolled with a consent waiver. Data about SPEEDY pathway delivery are captured onto a study case record form, but all other data are obtained from routine healthcare records. Powered on a ‘primary analysis population’ (ischaemic stroke patients with pathway initiation criteria), 894 participants will detect an 8.4% difference in rate and data from 564 thrombectomy procedures will detect a 30 minute difference in time to treatment. The full study population is estimated to be approximately 80 000. Regression modelling will be used to examine primary and secondary outcomes in several analysis populations. The economic analyses will include cost-effectiveness and cost–utility analyses, and calculation of willingness to pay at a range of accepted threshold values. The process evaluation involves semi-structured interviews with professionals and patient/family members to explore views and experiences about the SPEEDY pathway.
This study has ethical, Health Research Authority and participating NHS Trust approvals.
Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities.
Type 2 diabetes is a growing global health challenge that requires effective prevention strategies. Public health and community-based approaches play an essential role in reaching vulnerable populations and addressing broader determinants of health. This protocol outlines a scoping review aimed at systematically mapping the existing evidence on lifestyle-based diabetes prevention interventions implemented in public health and community contexts.
A systematic literature search will be conducted to identify relevant studies published in English or German from 1 January 2014 onwards. The following databases will be searched: PubMed, Web of Science Core Collection, CINAHL (via EBSCO), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews (via OVID) and ClinicalTrials.gov. Relevant websites and grey literature sources will be searched to identify further eligible studies. (Cluster-)randomised controlled trials, non-randomised controlled trials and clinical trials will be included. These must examine nutrition-based, physical activity-based or lifestyle-based interventions aimed at preventing type 2 diabetes in healthy adults or individuals with pre-diabetes, implemented in public health or community settings. Case reports and studies involving medical therapies or pharmacological interventions will be excluded. The literature search started in May 2025 and is expected to be completed by the end of December 2025.
As this scoping review is based on the secondary analysis of publicly available data, no ethical approval is required. Our dissemination strategy includes publication in peer-reviewed journals, presentations at academic conferences and targeted dissemination to relevant interest holders.
This project has been registered at Open Science Framework (https://osf.io/zafg5/), as PROSPERO does not accept registrations for scoping reviews.
Understanding the epidemiological shifts of respiratory syncytial virus (RSV) is essential to inform public health interventions, particularly given its increased burden on healthcare systems post-COVID-19 pandemic. This study aimed to examine age-specific trends and seasonal variations in RSV incidence, considering the recent introduction of a newborn RSV immunisation programme in Ireland.
A surveillance time series study analysing routinely collected RSV notification data.
National-level weekly RSV notifications collected by the Health Service Executive-Health Protection Surveillance Centre in Ireland from 2012 to 2024.
Infants (
Annual trends in RSV epidemiology with special reference to the pre- and post-COVID-19 winter surges, and the time lag in age-related transmission to peak incidence among the various age groups. Data were analysed to evaluate incidence rates, peak timing, age-related transmission trends and lag times before and after the COVID-19 pandemic.
The study examined the increasing incidence of RSV post-COVID-19 and a significant shift toward earlier RSV peaks in recent years (2021/2022, 2022/2023 and 2023/2024 seasons) in Ireland, with the onset and peak of the season nearly 2 months earlier than in pre-COVID-19 pandemic seasons (p
This analysis highlights an early seasonal onset and intensified RSV burden among infants in recent winters (2021/2022, 2022/2023 and 2023/2024 seasons). Quantifying the time lag for the community-level RSV transmission from infants and young children to older adults will offer insights to optimise RSV intervention strategies as a ‘life-course approach’ to alleviate healthcare system pressures during peak seasons.
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterised by impairments in social interaction, communication and the presence of repetitive behaviours. Recent advancements in brain-computer interface (BCI) technologies have demonstrated potential benefits in enhancing cognitive, social and communication skills in individuals with ASD. However, the effectiveness of BCI-based interventions in ASD rehabilitation remains inconsistent across studies. Therefore, this protocol outlines a systematic review and meta-analysis to synthesise the evidence on the effectiveness of BCI-based interventions for ASD rehabilitation.
We will conduct a comprehensive literature search across multiple databases, including MEDLINE Ovid, Embase Ovid, Cochrane Central Register of Controlled Trials (CENTRAL), Conference Proceedings Citation Index-Science (CPCI-S), Science Citation Index Expanded (SCI-EXPANDED) and so on, to identify relevant studies published from inception to the present. The search will be supplemented by screening the reference lists of included studies and relevant systematic reviews. Two independent reviewers will screen the titles, abstracts and full texts of identified studies for eligibility based on predefined criteria. Data extraction will be performed using a standardised form, and the risk of bias (RoB) will be assessed using the Cochrane RoB tool. Heterogeneity will be evaluated using the I² statistic, and a random-effects or fixed-effects model will be selected for meta-analysis based on the degree of heterogeneity. Subgroup analyses will be conducted to explore potential sources of heterogeneity, including participant age, ASD severity, type of BCI intervention and duration of the intervention. The review will be conducted from January 2026 to April 2026.
Ethical approval is not required for this study, as it does not involve the collection of primary data from individual patients. Findings will be disseminated through peer-reviewed publication and conference presentations.
CRD420251010496.