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Educational Attainment and Diabetic Foot Ulceration: Outcomes From the Barbados Diabetic Foot Study

ABSTRACT

Diabetic foot ulceration (DFU) contributes significantly to diabetes-related morbidity and amputation. In Barbados, where amputation rates are among the highest globally, the influence of socioeconomic factors on ulceration outcomes remains underexplored. Educational attainment, a social determinant of health, may influence health behaviours, engagement with healthcare services, and ultimately clinical outcomes. This study examines whether educational attainment is associated with diabetic foot ulcer severity, as measured by the SINBAD scoring system, and six-week healing outcomes among inpatients with DFU. A prospective observational study was conducted over 6 months at Barbados' sole public hospital. A total of 176 participants admitted with a diagnosis of DFU were recruited. Baseline demographics, comorbidities, and ulcer characteristics were collected, and SINBAD scores were determined. Random forest modelling was employed to evaluate predictors of complete healing at 6 weeks and to assess ulcer severity stratified by educational attainment. Of the cohort, 17.5% reported primary education as their highest attainment level, compared with 2.9% of the general adult population. The mean SINBAD score was 2.45 among those with primary education and 2.51 among those with secondary education (p > 0.05). No statistically significant association was found between educational attainment and healing outcomes at 6 weeks. Educational attainment in this inpatient DFU cohort was lower than that of the general Barbadian population; however, it was not significantly associated with ulcer severity or six-week healing outcomes. In a universal healthcare setting, equitable access to care may attenuate the effect of educational attainment on clinical outcomes. These null findings highlight the need for future adequately powered studies incorporating health literacy assessment and key clinical confounders. Nonetheless, the observed disparity in educational attainment among DFU inpatients suggests that foot health education initiatives should be designed to be accessible to individuals across all educational levels.

Clinical performance of the BioFire Blood Culture Identification 2 panel for microorganism species identification and resistance gene detection in blood culture-positive specimens

by Haruki Naruse, Noriyuki Watanabe, Sachie Koyama, Sachi Tanaka, Yoshitada Taji, Yasuhiro Ebihara

Introduction

Bloodstream infections are life-threatening, and the rapid identification of pathogens and resistance genes is essential for the administration of appropriate antimicrobial agents. The BioFire Blood Culture Identification 2 (BCID2) panel on the FilmArray multi-parameter genetic analyzer is a fully automated PCR test that rapidly identifies species and resistance genes. Here, we compared the performance of the Filmarray BCID2 panel (BCID2 method) with the conventional method.

Methods

Among the blood culture-positive specimens submitted between January 2023 and November 2024, this study analyzed 201 specimens that contained the target microorganisms of the BCID2 panel. In our laboratory, after subculturing the culture medium obtained from a positive blood-culture bottle, we perform species identification using mass spectrometry and drug susceptibility testing (the conventional method). We compared the results of the BCID2 method with those of the conventional method.

Results

Concordance between the BCID2 and conventional methods was found in 152 of the 161 monomicrobial specimens (94.4%) and in 31 of the 40 polymicrobial specimens (77.5%). The 18 specimens that were discordant were mostly matched at the genus level, but the BCID2 method also detected other microorganisms that were not identified by the conventional method. Resistance genes were identified in 57 of the 61 matched specimens (93.4%).

Conclusion

The BCID2 method exhibits excellent identification results and resistance gene detection rates, suggesting that it is a reliable and rapid diagnostic test system for bloodstream infections.

Association between venous access-site closure device use and postoperative nausea and vomiting after atrial fibrillation ablation under propofol sedation: a single-centre retrospective observational study in Okayama, Japan

Por: Sakanoue · H. · Yamaji · H. · Okamoto · S. · Okano · K. · Fujita · Y. · Higashiya · S. · Murakami · T. · Hirohata · S. · Kusachi · S.
Objectives

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Design

Observational study.

Setting

A single-centre retrospective observational study in Okayama, Japan.

Participants

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Interventions

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

Primary outcome measure

The primary outcome was the occurrence of PONV following AF ablation.

Results

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

Conclusions

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

Assessing the Outcomes and Complications of Skin Allografts in Healing Diabetic Foot and Venous Leg Ulcers: A Systematic Review of Randomised Controlled Trials

ABSTRACT

Chronic diabetic foot ulcers and venous leg ulcers remain difficult to treat due to delayed healing and high complication rates. Biologic skin allografts derived from living or amniotic tissue provide extracellular matrix components, cytokines, growth factors and viable cells that facilitate tissue repair. This investigation systematically reviewed randomised controlled trials comparing Apligraf, Theraskin, Amnioband, Amnioexcel, EpiCord and Epifix for chronic lower extremity wounds. Searches were conducted in PubMed, Embase and Cochrane databases. Primary outcomes included complete wound closure at 12 weeks, time to healing and percent area reduction. Secondary outcomes included infection, amputation and recurrence rates. Nineteen trials with a total of 1303 participants met inclusion criteria. Analysis demonstrated statistical significance in 12-week wound closure (p = 0.0394), with Theraskin achieving the highest mean closure (84.7%) and Amnioexcel the lowest (37.5%). Epifix and Amnioband showed faster healing trends and greater closure advantages compared with standard care. Reported complications were uncommon and inconsistently defined. While no single graft demonstrated statistically superior outcomes, descriptive trends suggest Theraskin, Epifix and Amnioband may offer greater clinical benefit. These findings provide comparative insight to guide clinical selection of skin substitutes and highlight the need for large-scale head-to-head trials to establish relative efficacy.

Feasibility and acceptability of therapist-guided, asynchronous, internet-delivered trauma-focused CBT for adolescents with PTSD: a single-group feasibility trial in Sweden

Por: Mattelin · E. · Weyler · H. · Andersson · R. · Paulsen · J. · Tielman · S. · Vikgren · A. · Bondjers · K. · Serlachius · E. · Mataix-Cols · D. · Bragesjö · M.
Objectives

Trauma-focused cognitive behavioural therapy (TF-CBT) is the established first-line treatment for paediatric post-traumatic stress disorder (PTSD), but access to evidence-based care remains limited. This study aimed to evaluate the feasibility and acceptability of a therapist-guided, 12 week, internet-delivered TF-CBT (iTF-CBT) programme for adolescents with PTSD and to explore preliminary changes in PTSD symptoms.

Design

Single-group feasibility trial.

Setting

Save the Children, Sweden.

Participants

Twenty-two adolescents (13–17 years, 82% female) with primary PTSD.

Interventions

A 12 week, therapist-guided, asynchronous, internet-delivered TF-CBT comprising eight modules and parallel caregiver modules with joint adolescent–caregiver activities.

Outcomes

Feasibility measures included recruitment pace, participant retention, treatment adherence (module completion) and therapist time. Acceptability was evaluated through satisfaction, credibility, negative effects and reported adverse events. Within-group changes in PTSD severity using independent evaluator-rated Clinician-Administered PTSD Scale (CAPS-CA-5) and the self-reported Child and Adolescent Trauma Screen 2 (CATS-2) were used as indicators of potential clinical change. Assessments occurred at baseline, during treatment, post-treatment and at 1 month follow-up (primary endpoint).

Results

Recruitment was completed after 7 months of active enrolment. Retention and adherence were high, satisfaction and credibility ratings were favourable, and no intervention-related serious adverse events occurred. Within-group improvements were observed at the primary endpoint, with large reductions on CAPS-CA-5 (Cohen’s d=1.27) and CATS-2 (Cohen’s d=1.51). At follow-up, 47.6% of participants no longer met criteria for PTSD.

Conclusions

Therapist-guided iTF-CBT for adolescents with PTSD was safe, feasible, acceptable and associated with potentially meaningful symptom improvements. These findings support further evaluation in larger, controlled trials to determine efficacy, cost-effectiveness and long-term outcomes.

Trial registration number

NCT06185244.

Who gets to deliver in a health facility? An investigation of wealth-based inequities in institutional delivery in Ghana

Por: Atta-Doku · J. F. · Achiam · W. K. A.
Objectives

Institutional delivery under skilled care is essential for reducing maternal mortality. Ghana has expanded maternal health services through policies such as the National Health Insurance Scheme and the free maternal healthcare policy. Inequalities in access to facility-based delivery, however, remain across socioeconomic groups. This study examined wealth-based inequities in institutional delivery and identified maternal and socioeconomic factors associated with facility delivery in Ghana.

Design

A cross-sectional analysis of nationally representative survey data.

Setting

Ghana.

Participants

Data were drawn from the 2022 Ghana Demographic and Health Survey. The analysis included 5855 women aged 15–49 years who had at least one live birth in the 5 years preceding the survey.

Methods

Descriptive statistics were used to summarise participant characteristics, and weighted logistic regression models were applied to identify factors associated with institutional delivery.

Results

84.3% of women delivered in a health facility. Wealth showed a strong gradient effect. Women in the richest wealth quintile had significantly higher odds of institutional delivery compared with those in the poorest quintile (odds ratio (OR) 2.71, p

Conclusion

Socioeconomic and geographic disparities in institutional delivery remain evident in Ghana. Wealth, education, antenatal care attendance and health insurance coverage influence access to facility-based childbirth. Targeted interventions are needed to improve equitable access to skilled delivery services.

Efficacy and Safety of a Defined Two‐Dose Protocol of Autologous Platelet‐Rich Plasma (PRP) Injection for Refractory Chronic Non‐Healing Wounds: A Prospective Clinical Study

ABSTRACT

Chronic non-healing wounds represent a major global public health challenge. Their persistence is frequently attributed to localized biological deficits that cause them unresponsive to conventional therapeutic modalities. While Platelet-Rich Plasma (PRP) has demonstrated promising results as an adjunctive treatment by delivering highly concentrated growth factors, its clinical application is currently impeded by a lack of clinical standardization, particularly optimal injection frequency, interval, and dosage. The aim of this study is to rigorously evaluate the efficacy and safety of a specific, non-intensive two-dose PRP injection protocol for accelerating the reduction of wound area in patients with various types of refractory chronic wounds. We conducted a prospective, single-arm, pretest-posttest study enrolling 18 patients with refractory non-healing wounds, defined as lesions persisting for a minimum period of 4 weeks which had failed to achieve definitive closure under optimized standard care. Autologous high-concentration PRP was injected intradermally around the wound margin at baseline (Day 0) and again 3 weeks later (Day 21). Wound area was digitally measured at baseline and subsequently at 7, 11 and 15 weeks. The primary outcome was the mean reduction in wound area (cm2) at the 15-week follow-up, assessed using a Paired Samples t-test. The mean patient age was 57.89 ± 15.64 years, and wounds had a mean chronicity of 15.83 ± 19.05 months. The PRP preparation achieved a mean platelet concentration 8.5 times greater than the peripheral blood threshold (first injection) and 7.0 times greater than the threshold (second injection), confirming high therapeutic quality. Analysis of the total cohort demonstrated a statistically significant reduction in mean wound area from baseline 27.41 ± 70.38 cm2 to 15 weeks 21.5 ± 68.96 cm2. Three patients (16.67%) achieved complete epithelialization. Subgroup trends suggested diabetic and venous ulcers responded more favourably than radiation-induced ulcers. The protocol was safe, with no systemic or severe localized adverse events observed among participants. The defined two-dose PRP injection protocol provides a clinically effective and safe adjunctive therapy that significantly promotes wound area reduction in challenging chronic non-healing wounds. This reproducible, low-frequency protocol offers a rationale for standardization in advanced wound care, warranting validation through future large-scale Randomized Controlled Trials (RCTs).

Association between discharge planning department staffing levels and the average length of stay in acute care wards: a nationwide cross-sectional study in Japan

Por: Machida · A. · Kashiwagi · M.
Objectives

To investigate the association between staffing levels, particularly the number and combination of nurses and medical social workers (MSWs) in the discharge planning department, and the average length of stay (LOS) at the ward level in acute care hospitals in Japan.

Design

Cross-sectional study.

Methods

We used nationwide administrative hospital-level and ward-level data from fiscal year 2021, encompassing 4989 acute care wards in 923 hospitals across 216 secondary medical areas.

Participants

A total of 1036 wards in designated special function hospitals, 3398 general acute care wards with a 7:1 patient-to-nurse ratio (7:1 acute care wards) and 555 general acute care wards with a 10:1 patient-to-nurse ratio (10:1 acute care wards) were included in the analysis.

Primary outcome measure

Average LOS per ward.

Methods

Two-level multilevel linear regression models with random intercepts were stratified by ward type. The analysis was adjusted for ward-level, hospital-level and region-level covariates. We examined both the total staffing level (the total number of nurses and MSWs per 100 hospital beds) and the staffing combinations (high/low numbers of nurses and MSWs) in the discharge planning department.

Results

In multilevel models, no statistically significant associations were observed between discharge planning department staffing and ward-level average LOS across any ward type. In special function wards, wards with high nurse/low MSW staffing (coefficient: –1.07; 95% CI –2.39 to 0.25; p=0.11) and high nurse/high MSW staffing (coefficient: –1.16; 95% CI –2.45 to 0.13; p=0.08) tended to have shorter LOS than did those with low nurse/low MSW staffing. In 7:1 acute care wards, higher total staffing was not significantly associated with LOS (coefficient: –0.14; 95% CI –0.30 to 0.03; p=0.10). No clear associations were observed for 10:1 acute care wards.

Conclusions

This nationwide cross-sectional study found no statistically significant association between discharge planning department staffing levels and ward-level LOS in Japanese acute care hospitals. While LOS alone may not adequately capture the discharge planning relationship, the findings may inform staffing policies in healthcare systems facing population ageing.

Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension assoc

Por: Yoshida · K. · Hosokawa · K. · Hiraide · T. · Akagi · S. · Ejiri · K. · Taniguchi · Y. · Adachi · S. · Inami · T. · Nakanishi · N. · Kataoka · M. · Satoh · T. · Tatebe · S. · Shinke · T. · Tomita · H. · Akazawa · Y. · Higaki · T. · Tagawa · K. · Ishikita · A. · Asakawa · S. · Abe · K.
Introduction

Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.

Methods and analysis

The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.

Ethics and dissemination

The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.

Trial registration number

Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025

Randomised, double-blind, parallel group, placebo-controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants in the UK: BALLOON study - study protocol

Por: Kotecha · S. J. · Lowe · J. · Gillespie · D. · Perez-Alijas · M. · Aboklaish · A. F. · Mahachi · T. L. · Cumming · O. S. · Harris · D. · Hubbard · M. · Thomas-Jones · E. · Jones · T. · Ladell · K. · Moore · C. · Humpreys · I. · Grigg · J. · Berrington · J. · Kotecha · S.
Introduction

A significant proportion of infants born at ≤29+6 weeks’ gestation develop lung disease during the neonatal period, thus putting them at risk of developing prematurity-associated lung disease in childhood and adulthood. After discharge from the neonatal unit, pre-existing lung disease in preterm-born infants is exacerbated by (often frequent) respiratory viral infections requiring greater health utilisation, including hospital admissions, than their term-born equivalents. Opportunities to prevent viral infections in infancy are largely limited to anti-respiratory syncytial virus (RSV) antibody prophylaxis and recently maternal RSV immunisation, but in term-born infants, trained immunity-based vaccines such as Bactek (MV130, Inmunotek, Spain) are increasingly used. Bactek provides a promising therapeutic avenue for preterm-born infants to target postdischarge respiratory viral infection in this vulnerable group of infants. The BALLOON study aims to assess this treatment in a very/extremely preterm-born population and determine if treatment with the trained immunity-based vaccine Bactek decreases the risk of unscheduled visits to healthcare professionals for lower respiratory tract infections, when compared with placebo. Included infants are born at ≤29+6 weeks’ gestation and treated daily from term-equivalent (37–43 weeks’ postmenstrual age, PMA) or from discharge, if earlier, up to 1 year of corrected age.

Methods and analysis

542 infants are being recruited prior to discharge by neonatal units in the UK. They are being randomised to receive Bactek or placebo, once daily dose of 2 sprays (each 0.1 mL) of IMP (300 Formazin Turbidity Units), from 37 to 43 weeks’ PMA or discharge if earlier up to 1 year of corrected age. The primary objective is to assess if sublingual Bactek spray decreases the risk of health professional diagnosed lower respiratory tract infections (LRTIs) (unscheduled visits to general practitioners, accident and emergency departments and hospital admissions) between enrolment and 1 year of corrected age. Secondary outcomes include the number of parent-reported, health professional-confirmed unscheduled visits for LRTIs, the time to first parent-reported, health professional-confirmed unscheduled visit for LRTI, parent-reported wheeze episodes (identification aided by WheezeScan (Omron, Japan)), parent-reported use of respiratory medications, growth (weight, length and head circumference), parent(s)/guardian(s) reported time missed from work and/or nursery time missed for the infant and volume of adverse reactions. Viruses associated with LRTIs will also be identified.

Ethics and dissemination

Ethics permission has been granted by the Wales Research Ethics Committee 3 (Ref 24/WA/0181), and regulatory permission by the Medicines and Healthcare Products Regulatory Agency (CTA reference 21323/0063/001-0004). The study is registered on ISRCTN (ISRCTN14019493). Findings will be disseminated via national and international peer-reviewed journals, and conferences. Oversight of the study is being provided by an Independent Data Monitoring Committee and an independent Trial Steering Committee (TSC). The Trial Management Group (TMG) meets every month.

Trial registration number

ISRCTN14019493.

Detection of spike protein in term placentas of COVID-19 vaccinated and/or SARS-CoV-2 infected women

by Catharina Bartmann, Vanessa Schmidt, Michael Mörz, Michael Schwab, Monika Rehn, Bettina Blau-Schneider, Achim Wöckel, Ulrike Kämmerer

Introduction

COVID-19 (Corona Virus Induced Disease-19) caused by the SARS-CoV-2 coronavirus can be a serious in pregnancy. Therefore, vaccination with modRNA vaccines was recommended depending on the immunity status for women of reproductive age and pregnant women since 2022. However, there are only preliminary data on transplacental transmission of the virus and modRNA from genetic vaccines so far.

Methods

The study population included 106 women who have given birth at the Department of Obstetrics and Gynecology, University Hospital of Würzburg during November 2020 to October 2022. In addition to medical data and vaccination history, immunohistochemical examination of the placenta was performed with antibodies against SARS-CoV-2 spike and nucleocapsid proteins. RNAscope in situ Hybridization was used to show RNA detection in positive placental tissues as a proof of concept.

Results

Altogether, 87% of participants received at least one vaccine dose against SARS-CoV-2 and 56 women (42 vaccinated, 14 not vaccinated) contracted COVID-19. In total, 31 placentas were found positive for the spike protein. Spike positive cells were predominantly Hofbauer cells and trophoblasts. In three cases of vaccinated and then infected woman, an additional nucleocapsid staining was detected, but there was no significant difference in staining pattern in correlation to the vaccine/COVID-19 status. Interestingly, we did not find viral RNA in the investigated samples, but we could show a positive in situ Hybridization of BNT162b2 and S-encoding mRNA-1273 in two individual samples.

Discussion

The spike protein of SARS-CoV-2 has been be detected in placental Hofbauer and Trophoblast cells as well as villous endothelia after infection and vaccination indicating a possible transplacental transfer or uptake. These findings may suggest a potential for transplacental transfer or cellular uptake; however, the extent, mechanisms, and clinical significance of this phenomenon remain to be fully understood.Clinical trial registration: DRKS00022506.

Effectiveness and cost-effectiveness of a 9 week multi-component cycling programme versus an existing single cycling training session: protocol for the Cycle Nation Communities randomised controlled trial

Por: Lawlor · E. R. · Gabler Trisotti · M. F. · McIntosh · E. · McConnachie · A. · Gill · J. M. R. · Gray · C. M.
Introduction

Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

Methods and analysis

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethics and dissemination

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

Trial registration number

NCT07005674.

Cohort profile: Infant Gut Bacterial Study in Nigeria (INBUGS-NG)

Por: Akpulu · C. P. · Maikudi Sada · H. · Ahmed · H. · Idris · H. B. · Yakubu · R. · Aminu · A. · Iregbu · K. · Oduwo · J. · Owinoh · E. · Lankapalli · A. K. · De Nies · L. · Achi · C. R. · Thomson · K. · Stracy · M. · Walsh · T. R. · Sands · K.
Purpose

The Infant Gut Bacterial Study in Nigeria (INBUGS-NG) investigates how delivery mode, antibiotic exposure, feeding practices and environmental factors shape gut microbiome development and acquisition of antibiotic resistance genes (ARGs) during the first year of life in northern Nigeria.

Participants

Between February and July 2024, 90 mother–infant dyads were enrolled at a tertiary hospital in Kano city, Nigeria. This was a prospective longitudinal cohort with follow-ups at 10 scheduled time points: days 0, 1, 3, 5, 7, 14, 28, 90, 180 and 365. We also intensified stool sampling after infant antibiotic administration, enabling dense early-life sampling. To date, the cohort has contributed 480 infant stool samples, 232 maternal rectal swabs, 254 breast milk samples and 806 environmental samples (total 1772). In parallel, socio-demographic, clinical and cultural data were collected using Research Electronic Data Capture (REDCap) and household visit diaries.

Findings to date

Baseline data show that 84/90 mothers (93.3%) received postpartum antibiotics, and 26/90 infants (28.9%) received antibiotics within the first 3 months of life. Only 8% of infants were exclusively breastfed, with early water supplementation common. Caesarean deliveries accounted for 25% of births, and the mean gestational age was 38.5 weeks. Across the cohort, high retention was achieved, and the study has generated a unique long-read metagenomic resource from an African infant population, with analyses ongoing.

Future plans

Shotgun long-read metagenomic sequencing (Oxford Nanopore) will enable strain-level and plasmid-level profiling of microbial communities and ARGs. Planned analyses include associations between early-life exposures and resistome dynamics, as well as cross-cohort comparisons with a parallel study in Pakistan. Follow-up will continue through 12 months.

MetaMind: A multi-agent transformer-driven framework for automated network meta-analyses

by Achilleas Livieratos, Maria Kudela, Yuxi Zhao, All-shine Chen, Xin Luo, Junjing Lin, Di Zhang, Sai Dharmarajan, Sotirios Tsiodras, Vivek Rudrapatna, Margaret Gamalo

Background

Network meta-analysis (NMA) can compare several interventions at once by combining head-to-head and indirect trial evidence. However, identifying, extracting, and modelling these often takes months, delaying updates in many therapeutic areas.

Objective

To develop and validate MetaMind, an end-to-end, transformer-driven framework that automates NMA processes—including study retrieval, structured data extraction, and meta-analysis execution—while minimizing human input.

Methods

MetaMind integrates Promptriever, a fine-tuned retrieval model, to semantically retrieve high-impact clinical trials from PubMed; a multi-agent LLM architecture--Mixture of Agents (MoA)-- pipeline to extract PICO-structured (Population, Intervention, Comparison, Outcome) endpoints; and GPT-4o–generated Python and R scripts to perform Bayesian random-effects NMA and other NMA designs within a unified workflow. Validation was conducted by comparing MetaMind’s outputs against manually performed NMAs in ulcerative colitis (UC) and Crohn’s disease (CD).

Results

Promptriever outperformed baseline SentenceTransformer with higher similarity scores (0.7403 vs. 0.7049 for UC; 0.7142 vs. 0.7049 for CD) and narrower relevance ranges. Promptriever performance achieved 82.1% recall, 91.1% precision and an F1 score of 86.4% when compared to a previously published NMA. MetaMind achieved 100% accuracy on a limited set of remission endpoints regarding PICO (Population, Intervention, Comparator, Outcome) element extraction and produced comparative effect estimates and credible intervals closely matching manual analyses.

Conclusions

In our validation studies, MetaMind reduced the end-to-end NMA process to less than a week, compared with the several months typically needed for manual workflows, while preserving statistical rigor. This suggests its potential for future scaling of evidence synthesis to additional therapeutic areas.

Relationship Between Weight Loss and Problems With Oral Intake in Institutionalised Older Adults: A Japanese Multi‐Institutional 1‐Year Follow‐Up Study

ABSTRACT

Aim

To examine the relationship between weight loss and problems with oral intake in institutionalised older adults.

Design

A 1-year longitudinal observational study.

Methods

Data were obtained from a prospective study conducted in three nursing homes and two long-term care facilities in Japan. Participants' problems with oral intake were assessed using items published in 2021 by the Japanese Ministry of Health, Labour and Welfare. Baseline and follow-up factors were compared between individuals who experienced a weight loss of 5% or more and those who did not. Separate multivariable logistic regression models were constructed for each oral intake assessment item to examine its independent association with weight loss of 5% or more, accounting for transitions in each item between baseline and the 1-year follow-up.

Results

In total, 172 institutionalised older adults were included in the analysis. Among them, 57 (33.1%) participants experienced a weight decrease of 5% or more. The emergence of somnolence or clouding of consciousness during meals at the 1-year follow-up in participants without these signs at baseline was independently associated with a weight loss of 5% or more, after adjustment for baseline characteristics.

Conclusion

Recognising signs of somnolence or clouding of consciousness during meals may be useful for the early detection and prevention of weight loss in institutionalised older adults.

Implications for the Profession and/or Patient Care

Early detection of individuals at risk is essential to prevent significant weight loss and its associated adverse outcomes. Recognising somnolence or clouding of consciousness during meals may enable earlier detection and intervention to prevent weight loss and improve the quality of care for older adults.

Reporting Method

Strengthening the Reporting of Observational Studies in Epidemiology.

Patient or Public Contribution

No patient or public contribution.

Defining Wound Care Learning Objectives for Medical Students: A Multidisciplinary Comparison of Expert and Practitioner Perspectives

ABSTRACT

Assessing and treating a patient's wound is something that every medical student may be faced with from day one of their postgraduate clinical career, regardless of their chosen field of specialisation. This includes acute or post-surgical wounds as well as chronic wounds. In contrast, learning content concerning wound care is currently underrepresented in medical school curricula, although there are many possible topics and options to incorporate this subject into medical teaching. As a first step in curriculum development, this study provides a comprehensive yet clinically relevant catalogue of possible learning objectives for medical students in wound care. An interprofessional and interdisciplinary group of wound care experts collected a first draft of learning objectives. Then a group of clinicians from 16 different medical specialties was consulted to additionally rate the relevance of each proposed learning objective. By this approach, a consensus catalogue of 32 relevant learning objectives in wound care for medical students was developed. Furthermore, varying perspectives of experts and clinicians on wound care topics and their relevance for medical students were identified. The findings of this study will facilitate future discussions about implementation of wound care content into medical curricula.

Climate change, transactional sex, HIV/AIDS and sustainable livelihoods among fishing communities around Lake Victoria: a scoping review protocol

Por: Were · L. P. O. · Kachingwe · O. N. · Goldman · T. · Ma · Y. · Awuor · F. J. · Nyamweya · C. · Okechi · J. · Kaufman · L. · Gopal · S.
Background

The objective of this scoping review is to map out what has been published in the scientific literature on the relationship between climate change-related events and how these overlap with associated changes in resource availability, transactional sex and HIV incidence and prevalence, within fishing communities in the Lake Victoria basin. This objective is informed by the fact that climate change and the associated natural resource strains in the Lake Victoria region have exacerbated existing inequities within fishing communities. Vulnerable populations, especially women, engage in strategies such as transactional sex to cope with the uncertainty of natural resource-dependent livelihoods. This practice greatly increases women’s risk of contracting HIV in this region, with prevalence rates four to five times the national averages. This scoping review will thus show how the existing empirical literature reports on climate change, transformation in natural resources and livelihoods, and transactional sex and HIV in the Lake Victoria region.

Methods

Studies that meet the following inclusion criteria will be included: align with at least two of the major concepts of interest, including climate change, transactional sex, HIV/AIDS, Lake Victoria Basin and/or empirical studies; are published in English and after 2012; and focus on the Lake Victoria basin. The scoping review will be guided by the JBI Manual for Evidence Synthesis: Scoping Reviews, supported by the standard principles of Arksey and O’Malley. The specific search strategies to be implemented were developed with guidance from an experienced research librarian to align with the inclusion criteria. The search will be conducted in relevant global databases, with two reviewers screening the results and extracting relevant data points. Finally, results will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews flow diagram, and summarised in figures, tables and text.

Discussion

The scoping review is designed to comprehensively scope the existing literature and document the coverage of linkages between transactional sex, HIV/AIDS and sustainable livelihoods in the context of climate change with a view to informing health systems responses to human health specific to the HIV epidemic.

Scoping review registration

The proposed scoping review is registered with the Open Science Foundation (OSF), registration number:https://doi.org/10.17605/OSF.IO/9DTW4.

Anal HPV shedding assessed by self-sampling and multiplex real-time PCR among men who have sex with men in N’Djamena, Chad: a feasibility and acceptability study

by Donato Koyalta, Zita Aleyo Nodjikouambaye, Jonathan Muwonga Tukisadila, Hachim Djamal Abdoulaye Bargo, Suitombaye Noubaramadji Yamti, Amine Akouya, Ralph-Sydney Mboumba Bouassa, Laurent Belec

Background

High-risk (HR) human papillomavirus (HPV) infection remains a great concern in sub-Saharan Africa in men who have sex with men (MSM). The prevalence of anal shedding of HPV and associated risk factors was estimated for the first time in a cross-sectional observational study covering MSM living in N’Djamena, the capital city of Chad.

Methods

MSM were recruited from the community in 21 sites in neighborhoods of 5 districts randomly selected in N’Djamena by respondent-driven sampling (RDS) method. Anal Collector V-Veil UP2™ device was used for anal canal self-sampling. Manual silica-extracted DNA was subjected for HPV detection and genotyping using BMRT Human Papillomavirus Genotyping Real Time PCR assay (Jiangsu Bioperfectus Technologies Co., Ltd., Taizhou, China). HIV serostatus was assessed using two rapid tests in series.

Results

A total of 70 MSM (mean age: 29.9 years; range, 18–50) were included. The overall acceptability to practice veil-based anal self-sampling was 95.9%. The usability of the veil collector device was high (92.3%), with easy understandable instructions for use and correct placement in the anal canal. Satisfaction questionnaire reported high overall feeling, intimacy respect and lack of shame. The majority of MSM (44/70, 62.8%) showed anal shedding of HPV DNA, with HR-HPV frequently detected (38,70, 54.3%), including HPV-33 (30/70, 42.9%) HPV-68 (16/70, 22.9%), HPV-18 (4/70, 5.7%), HPV-35 (3/70, 4.3%), HPV-58 (2/70, 2.9%), and HPV-45 (1/70, 1.4%). The distribution of genotypes in HR-HPV DNA-positive MSM revealed that HPV-33 (30/70; 42.9%) was the predominant genotype, followed by the HPV-68 (16/70; 22.9%), HPV-18 (4/70; 5.7%), HPV-35 (3/70; 4.3%), HPV-58 (2/70; 2.9%), and HPV-45, HPV-51 and HPV-56 (each type, 1/70;1.4%).Among all HPV detected, only 42 HPV (36.8%) were covered by Gardasil-9® vaccine, including the HR-HPV-33, −18, −58 and −45, and the low risk-HPV-6 (5.7%) and HPV-11 (1.4%). The majority of detected HPV were non-covered by Gardasil-9® vaccine (63.1%). Overall HIV prevalence was 5.7%.

Conclusions

Taken together, these observations point the MSM population in N’Djamena as a very particular core group of HIV and HPV transmission. HIV prevalence was higher than that of general adult population, but limited to only one MSM of twenty. The RDS method of recruitment allowed to include MSM likely belonging to the same sexual network of HPV transmission leading to the selection of an atypical and specific profile of anal HPV distribution. The potential efficacy of HPV prophylactic vaccination in this population can be estimated at relatively weak.

Developing an Evidence‐Based and Patient‐Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project

ABSTRACT

Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.

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