This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.

Secondary analysis of prospectively collected cohort data.

Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.

From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.

Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.

Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).

Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma.

TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient’s home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months.

The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences.

NCT06682962.

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

NCT07156552.

Few artificial intelligence (AI) clinical decision support systems (CDSSs) are ever evaluated in practice. Although some signal of clinical effectiveness may be needed to justify AI deployment and testing, such data are typically unavailable in early-stage research. This conundrum is especially relevant in the intensive care unit (ICU), where conditions like sepsis and acute respiratory distress syndrome (ARDS) require high-stakes decisions. Our group developed the AI ventilator assistant (AVA), a novel AI CDSS for patients with sepsis ARDS receiving invasive mechanical ventilation. But the promising results of predictive performance estimates are not sufficient to assess AVA’s clinical safety and appropriateness prior to future evaluation and deployment. Therefore, we propose a Clinician Turing Test as a novel validation approach to determine whether clinicians can distinguish AVA-generated treatment recommendations from those enacted by real human clinicians. If AVA’s recommendations are consistently indistinguishable from those of real clinicians, thereby ‘passing’ this Turing test, this would provide a strong preclinical signal of safety and appropriateness.

This multisite, randomised, electronic, vignette-based Phase 1b study will use a Clinician Turing Test design. We aim to recruit 350 critical care clinicians, including physicians and advanced practice providers from six US hospitals. Participants will review nine clinical vignettes of patients with sepsis and ARDS derived from the Molecular Epidemiology of Severe Sepsis in the ICU cohort and an associated profile of a suggested treatment plan. For each participant–vignette combination, the source of the treatment profile will be randomly assigned (AI-generated by AVA vs the actually enacted treatment from real human clinicians) in a 1:1 allocation. The primary endpoint is the participants’ accuracy in identifying whether a treatment profile was AI-generated or human-generated, assessed using equivalence testing through a mixed-effects logistic regression model with random effects for participants and vignettes. Secondarily, a fitted binary classifier will assess discrimination ability using the C-statistic. Secondary endpoints include clinicians’ perceptions of the safety and appropriateness of the treatment profiles, confidence in distinguishing AI-generated and human-generated recommendations, interest in AI CDSSs for sepsis and ventilator management and the time to complete the survey. This novel Phase 1b design provides preliminary but essential information about an AI CDSS’s clinical appropriateness without the risk or cost of actual deployment, thereby informing decisions about future clinical implementation and evaluation in real clinical environments.

This protocol was approved by the Institutional Review Board of the University of Pennsylvania (Protocol #858201). Results are expected in 2026 and will be submitted for publication in peer-reviewed journals and presented at scientific conferences.

NCT07025096.

Intermittent theta-burst stimulation (iTBS) is a non-invasive brain stimulation technique that has been shown to improve cognition and mood when applied to certain brain structures and regions. Despite research demonstrating that iTBS may have clinical utility in treating cognitive and mood changes, no study has yet been conducted to explore the potential to modulate the neurophysiological changes that can underpin cognitive and mood changes during the menopause transition. Cognitive and psychological symptoms are commonly reported by females experiencing the menopause transition, and it is thought that these symptoms arise due to various neurophysiological, metabolic and endocrinological changes. Despite being common, there is a lack of treatments available for managing these symptoms and a scarcity of data regarding the mechanisms by which they occur.

The aim of this 5-week randomised, sham-controlled, double-blinded pilot clinical trial (n=72) is to assess the underlying mechanisms of action of iTBS in females in the late menopause transition and the relationship with cognition and mood. Data will be analysed using Stata^TM. Normality checks will guide the choice between parametric and non-parametric tests. Generalised linear models will assess within-subject and between-subject effects across timepoints, with additional regression analyses exploring associations between biomarkers, cognition and mood. Effect sizes, CIs and relevant test statistics will be reported, with significance set at p

The study protocol has been reviewed and ethically approved by the Western Sydney University Human Research Ethics Committee (H16200; 8 November 2024). All participants will provide written informed consent prior to enrolment. Results from this trial will be disseminated via peer-reviewed publications and conference presentations, with findings shared in accordance with open science and data transparency principles.

ACTRN12625000030471, Australian New Zealand Clinical Trials Registry

Rheumatoid arthritis (RA) is a heterogeneous disease, which current treatment guidelines insufficiently accommodate, as they predominantly emphasise the suppression of disease activity. However, a step towards personalised medicine is preferred to further optimise treatment and requires homogeneous subgroups with similarities in pathophysiological mechanisms and treatment responses. Prior research has already demonstrated notable differences in the pathophysiology of patients with autoantibody-positive and autoantibody-negative RA, as well as differences in treatment responses, which may serve as a strong basis for personalised medicine. Additionally, there is evidence suggesting that an early treatment response is indicative of future courses. Based on these findings, we designed a personalised medicine trial in RA that compares the effectiveness and cost-effectiveness of a tailor-made approach with routine care.

The PeRsonalIsed Medicine in RA (PRIMERA) trial is a multicentre, open-label, randomised controlled trial that includes 300 adult patients with newly diagnosed, DMARD-naïve RA, according to 2010 American College of Rheumatology/EULAR criteria. Patients are randomised into either routine care or a tailor-made approach. Both management approaches use a treat-to-target strategy, aiming for low disease activity (LDA, Disease Activity Score using 44 joints (DAS) ≤2.4). In routine care, initial treatment consists of methotrexate along with a single intramuscular dose of glucocorticoids (GCs) and treatment can be intensified after 3, 7 and 10 months if LDA is not reached. Conversely, initial treatment in the tailor-made approach depends on the presence of autoantibodies, with patients with autoantibody-positive and autoantibody-negative RA starting with hydroxychloroquine or methotrexate together with a single intramuscular dose of GCs, respectively. Medication intensifications will be allowed at months 1, 3, 4, 7 and 10. Intensifications at months 1 and 4 depend on whether patients have an early sufficient response to GCs and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively. The tailor-made approach is superior to routine care if no more biological DMARDs (bDMARDs) or tsDMARDs are used after 10 months of treatment, while the mean DAS over time is lower. Our primary outcome is the proportional difference in bDMARD or tsDMARD usage after 10 months of treatment between routine care and the tailor-made approach. Secondary outcomes are DAS over time, time to achieve LDA, cost-effectiveness and patient-reported outcome measurements over time.

Ethical approval has been granted by Erasmus MC Medical Ethics Review Committee (MEC-2020-0825). The results will be disseminated through peer-review journals and medical congresses.

ISRCTN16170070.

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

CTIS EU 2024-514620-17-00

Post-COVID syndrome manifests with a diverse array of symptoms for which no standard care plan currently exists. Many questions were raised by patients, which underscored the need for a validated patient-reported outcome measure (PROM). Therefore, a post-COVID module was developed to be included in the Assessment of Burden of Chronic Conditions (ABCC-) tool. The ABCC-tool evaluates and visualises the perceived physical, emotional and social burden of one or multiple chronic disease(s) using a balloon diagram and aims to facilitate person-centred care and structured discussions between patients and healthcare professionals. This study explores the patients’ perspective on the content of the ABCC-tool for post-COVID and the tool’s usability in a home-based setting.

All patients who completed the ABCC-tool for post-COVID were invited for an online semi-structured interview. We selected post-COVID patients who had used the tool in the past three months. Interviews were audio recorded and analysed using a thematic approach with Atlas.ti version 23.

Nineteen post-COVID patients (10 males, mean age 56) were interviewed between May and August 2024. The tool was regarded as user-friendly, and patients indicated they would use the tool again in the future. Patients valued the tool’s broad range of topics, some of which are often overlooked in standard healthcare consultations. The tool was comprehensible and relevant according to all patients. The balloon diagram was easy to understand, but a legend explaining the colours of the balloons was preferred. Other suggestions for improvement included adding open-text fields and periodic reminders to increase usability and adding long-term data.

The ABCC-tool is a promising instrument for post-COVID patients, offering a structured way to monitor and communicate experienced burden in addition to standard healthcare consultations. Refinements addressing usability and comprehensiveness are recommended to facilitate its integration into clinical practices.

Cognitive impairment is considered a challenge in medication management for both the affected patient as well as their caregiver. Numerous studies have investigated interventions aiming to improve medication therapy safety in this population; however, there is insufficient knowledge on interventions which support patients and caregivers effectively. The aim of this systematic review is to (1) identify interventions to improve medication therapy safety in older patients with cognitive impairment, and (2) to evaluate their effectiveness.

We will conduct a systematic review of literature with participatory elements of public involvement in every step of the process. Five literature databases (PubMed, CENTRAL, Embase, PsycINFO and CINAHL) will be screened to identify interventions to improve medication therapy safety in older (≥65 years of age) adults with cognitive impairment. To support methodology and evidence synthesis, we will conduct expert panel discussions as well as focus group discussions of caregivers and healthcare professionals. Study selection, data extraction and bias assessment will be conducted independently by two reviewers. For data synthesis, studies will be organised by setting (eg, community setting, hospital setting, nursing home setting).

The responsible Ethics Committee of the Medical Faculty of Heidelberg granted approval for the public involvement strategies in this project (S-562/2024). Results will be presented by publication in an academic journal and at scientific conferences.

CRD42024623352.

Racialised older adults living with dementia face various challenges and barriers in receiving culturally sensitive care in hospital settings. Stigma, discrimination and healthcare provider bias toward racialised older adults living with dementia infringe on their right to access quality care services in acute hospital settings and can negatively affect their quality of life. Despite the growing need to integrate culturally sensitive dementia care into acute hospital care, little research has been done in this area. Therefore, the aim of this scoping review is to summarise and map what is known about the hospitalisation experience of racialised older adults with dementia in receiving care and identify research gaps.

We will use Arksey and O’Malley’s framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist to conduct and write the review. The search strategy will use keywords and index terms across selected databases: Google Scholar, PubMed, Scopus, Medline, PsycINFO and Cumulative Index for Nursing and Allied Health Literature, and hand-searching the reference lists from chosen literature. Grey literature will be searched using Google and the Alzheimer Society websites to find further evidence and literature. Two researchers will screen the titles and abstracts independently by referring to the inclusion criteria. Data from the extracted studies will be reported in tabular and narrative form that answer the scoping review’s questions. Research gaps and recommendations for future research will be identified and summarised. The review’s results will be shared with stakeholders, policymakers, healthcare professionals and community organisations working with the racialised community and dementia care.

This scoping review does not require ethics approval because it collects data from publicly available resources. The results will be disseminated through peer-reviewed scientific journals, professional conferences and with community organisations and healthcare providers.

This review is registered in the Open Science Framework registration link: osf.io/7rfje

This study aimed to describe the experiences of chemotherapy-induced oral mucositis among patients with breast cancer. Its primary focus is on how chemotherapy-induced oral mucositis affects day-to-day functioning, psychological wellness and overall quality of life.

12 Jordanian women who had been diagnosed with breast cancer and had presented with chemotherapy-induced oral mucositis were the purposive sample for this qualitative study, which employed in-depth, semistructured interviews. The verbatim transcriptions of the interviews were subjected to thematic analysis.

The thematic analysis of the 12 participants’ reviews revealed five main themes: distressing physical manifestations, eating and nutritional struggles, mouth care difficulties, psychological strain, social and emotional consequences, and coping and adaptation strategies.

Breast cancer patients’ daily routines, mental health and quality of life are all significantly impacted by chemotherapy-induced oral mucositis. According to the study, individuals with breast cancer who experience chemotherapy-induced oral mucositis should get patient-centred care and address their emotional, psychological, social and physical discomfort to maximise their outcomes.

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

ClinicalTrials.gov, NCT06619223.

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

The ventilatory ratio (VR) is a simple and accessible index that reflects ventilatory efficiency in critically ill patients. Although several studies have examined its potential as a prognostic marker in acute respiratory distress syndrome (ARDS), the results remain inconsistent and inconclusive. This systematic review and Bayesian meta-analysis aimed to evaluate the association between VR and mortality in adult patients with ARDS.

Two investigators will independently conduct systematic literature searches in the PubMed, Embase, Scopus, Cochrane Library and Latin American and Caribbean Health Sciences Literature / Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS) databases, covering all publications from database inception to July 2025.

This systematic review and meta-analysis will include prospective and retrospective cohort studies evaluating the association between the VR and mortality in adult patients with ARDS. Specifically, we aim to answer the following Patient, Population or Problem, Intervention, Comparison, and Outcome (PICO) question: In adult patients with ARDS (Population), is an elevated VR (Exposure), compared to lower or normal VR values (Comparison), associated with an increased risk of mortality (Outcome)?

The primary outcome will be mortality, as defined in each included study. Outcomes will be analysed according to the characteristics and reporting of the original publications.

The methodological quality of the included studies will be assessed using the Quality In Prognosis Studies tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A hierarchical Bayesian random-effects model will be used to synthesise the data, with effect sizes expressed as ORs and 95% credible intervals. Weakly informative priors will be applied to model parameters.

Between-study heterogeneity will be assessed through the estimation of the between-study variance (²) and the I² statistic. Subgroup analyses will be conducted based on study design and ARDS aetiology, and a bivariate meta-regression will explore potential effect modifiers. A leave-one-out sensitivity analysis will also be performed to assess the robustness of the findings.

Publication bias will be evaluated using a Bayesian funnel plot and an adapted version of Egger’s test.

This systematic review does not require ethics approval. The results will be published in scientific journals, presented at national and international conferences and shared on social media in accessible language.

CRD420251008773

Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.

This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.

No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

This study aimed to investigate the characteristics and management of influenza-like illnesses (ILIs) in the outpatient and inpatient settings in Vietnam.

A cross-sectional, observational study.

We conducted a questionnaire survey of 407 individuals with ILI symptoms who presented to public community health centres and the paediatric ward of a public hospital in the city of Nha Trang, Khanh Hoa Province, Vietnam, from December 2022 to March 2023.

Not applicable.

No primary and secondary outcomes were pre-specified because this study was an explanatory study. The basic characteristics of the participants are presented using descriptive statistics. We conducted multivariable logistic regression analysis to examine the factors associated with the prescription of antibiotics to outpatients with ILIs.

A total of 198 outpatients and 200 inpatients were enrolled in the study. Most inpatients were children under 5 years of age and experienced longer illness durations and higher costs, with almost all patients receiving antibiotics. The rate of antimicrobial prescription for ILIs was 79.3% for outpatients and 99.5% for inpatients. The median health-related quality of life score of participants aged ≥18 years during illness was 0.796 (IQR 0.674–0.922). Logistic regression analysis indicated a negative association between a definite diagnosis of viral infection by rapid diagnostic test and outpatient antibiotic prescription (OR: 0.20, p=0.006).

This study underscores the widespread inappropriate antimicrobial use for ILIs in a community in Vietnam, which contributes to an avoidable economic and health burden. The results of this study suggest that implementing diagnostic tools may support antimicrobial stewardship efforts.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.