bluuebunny/crossref_metadata_2025_split huggingface dataset:
Optimization and analytical validation of the Allplex HPV28 genotyping assay for use in first-void urine samples
Authors: Bell Margo , Baussano Iacopo , Rol MaryLuz , Tenet Vanessa , Heideman Daniëlle A. M. , Gheit Tarik , Van Caesbroeck Anne , Vorsters Alex , Clifford Gary 
Published: December 2024

ABSTRACT

Despite first-void urine (FVU) being increasingly recognized as a credible specimen for human papillomavirus (HPV) detection, there is a lack of well-validated testing methods providing full quantitative genotyping required for vaccine impact monitoring from FVU samples. The Allplex HPV28 assay, capable of individually detecting 28 HPV genotypes, presents a promising method. We aimed to evaluate its genotype-specific performance on FVU samples, following optimization of FVU preanalytics. We selected 701 FVU samples collected using a Colli-Pee device (20 mL, with UCM), enriched for HPV-positivity (
n
= 630) based on previous testing with GP5+/6+-PCR-based reverse line blot (GP5+/6+ RLB) and E7-MPG after Amicon filtration (AF). We first evaluated the comparability and agreement of Allplex HPV28 genotype-specific positivity according to different preanalytics. Subsequently, we conducted the genotype-specific comparison of Allplex HPV28 with GP5+/6+ RLB AF and E7-MPG AF. No significant differences in HPV positivity by Allplex HPV28 testing were observed when comparing pre-centrifuged versus non-centrifuged DNA extraction, nor when comparing manual versus automated DNA extraction. Good genotype-specific agreement was observed between Allplex HPV28 and GP5+/6+ RLB AF, with Allplex HPV28 being slightly more sensitive for all 28 HPV genotypes (average Allplex HPV28:GP5+/6+ RLB AF ratio 1.729). Compared to E7-MPG AF, Allplex HPV28 exhibited lower sensitivity for all 21 overlapping HPV genotypes (average Allplex HPV28:E7-MPG AF ratio 0.588). The findings of this study, combined with practical considerations for real-world implementation, support the use of Allplex HPV28 testing after automated or manual DNA extraction without the requirement for pre-centrifugation, for HPV studies based on FVU samples, most notably those for vaccine impact monitoring on HPV prevalence.

IMPORTANCE
This study provides the first analytical validation of the Allplex HPV28 genotyping assay for use in first-void urine samples, offering a reliable, non-invasive, and practical alternative to cervical samples for human papillomavirus (HPV) detection. It demonstrates a validated approach that supports the assay’s potential application in real-world settings, including low- and middle-income countries, where non-invasive and widely acceptable sampling methods are crucial for maximizing population coverage and representativity. Given the urgent need for accurate and practical tools to monitor HPV vaccination impact, these findings offer a timely and impactful contribution to the field.
Predictors of cytomegalovirus corneal endotheliitis postcorneal transplantation
Authors: Watanabe Mako , Kitazawa Koji , Fukuoka Hideki , Wakimasu Koichi , Inatomi Tsutomu , Yoshii Kengo , Koizumi Noriko , Kinoshita Shigeru , Sotozono Chie 
Published: December 2024

PurposeThis study was designed to investigate risk factors for the development of cytomegalovirus (CMV) corneal endotheliitis following corneal transplantation.MethodsWe retrospectively analysed 1225 corneal transplants for bullous keratopathy between 2011 and 2021. 31 cases who were administered the treatment of CMV corneal endotheliitis preoperatively were excluded, and 1194 cases were analysed for risk factors for the development of CMV corneal endotheliitis following corneal transplantation.ResultsAmong 1194 cases, 15 cases (1.26%) occurred CMV corneal endotheliitis after corneal transplantation. Coin-shaped lesion or keratoprecipitates were observed in 100% of cases. Postoperatively, the mean onset of CMV corneal endotheliitis was 9.9±12.2 months, with 12 eyes (80.0%) within the first 12 months. Multivariate analysis adjusted for potential confounding factors revealed a gender (male, OR (8.42, 95% CI: 2.19 to 56.00), the previous history of anterior uveitis (OR: 25.31, 95% CI: 8.22 to 95.19) and the previous history of glaucoma (OR: 6.25, 95% CI: 1.17 to 115.90) were significantly associated with the development of postoperative CMV corneal endotheliitis. The maternal proportion Ryan multiple comparison tests revealed that dual previous history with glaucoma and anterior uveitis significantly enhanced the development of postoperative CMV corneal endotheliitis (p<0.001).ConclusionsCMV corneal endotheliitis developed postcorneal transplantation with coin-shaped lesions. Careful postoperative follow-up, especially within the first 12 months after surgery, is necessary for patients with a history of glaucoma or anterior uveitis.
Living with pain and Parkinson’s developing an understanding of the impact, trajectory and pain management needs: a qualitative interview study protocol
Authors: Naisby Jenni , Avery Leah , Baker Katherine , Parkinson Mark , Hand Annette , Rochester Lynn , Yarnall Alison , Walker Richard , Flynn Darren , Ryan Cormac , Finch Tracy 
Published: December 2024

IntroductionPain is reported as one of the most troubling symptoms for people with Parkinson’s (PwP); however, the literature exploring their lived experience of pain and how to manage it is limited. Pain affects PwP at all stages of their condition and can fluctuate and change over time. Therefore, it is pertinent to speak to PwP to understand their experiences of pain to inform the development of tailored behavioural interventions to manage pain. How pain interacts with other Parkinson’s symptoms lacks consensus. Gaining a better understanding of this from the perspective of PwP is important to inform interventions. Exploring the behavioural determinants, including the barriers and enablers to pain management from the perspective of PwP, the role of healthcare professionals and impact of other symptoms alongside pain will inform the development of a fit for purpose, pain management toolkit for PwP.Methods and analysisA longitudinal qualitative study using semi structured interviews at two time points within an 18-month period will be conducted. PwP living with pain will be purposefully sampled from four NHS sites in the North of England. Data will be thematically analysed with reference to the Theoretical Domains Framework.Ethics and disseminationA favourable ethical opinion has been granted by the National Health Service East Midlands-Derby Research Ethics Committee (22/EM/0176) and the NHS Health Research Authority (IRAS ID 316403). Findings will be disseminated via scientific conferences, academic journals, lay summaries and public engagement events.
Night shift work and prostate cancer: a large cohort study from UK Biobank and Mendelian randomisation study
Authors: Yang Guorong , Yang Yingzi , Lv Kaikai , Wu Yangyang , Song Tao , Yuan Qing 
Published: December 2024

ObjectiveThe global concern regarding the health implications of night shift work has escalated. Nevertheless, variations exist in the observed association between night shift work and prostate cancer (PCa). This study aims to systematically explore the association between night shift work and the risk of PCa.DesignCohort study and Mendelian randomisation (MR) study were used.SettingCohort study data was from the UK Biobank (UKB). MR study using data was from the Finngen study and UKB through the Integrative Epidemiology Unit (IEU) Open Genome-Wide Association Study Project.ParticipantsParticipants without prior PCa in paid employment or self-employment were include in the current work schedule cohort, participants without PCa who provided employment history formed the lifetime night shift work cohort.Main outcome measuresThe outcome, incident PCa, was obtained from cancer register through linkage to national cancer databases. National cancer registries centralised information received from separate regional cancer centres around the UK.ResultsA total of 130 853 participants were included in the current work schedule cohort, while the lifetime night shift work cohort comprised 49 511 participants. Over a median follow-up duration of 13.9 years, the current work schedule cohort witnessed 4993 incident cases of PCa, while the lifetime night shift work cohort recorded 2022 PCa cases. In the analysis of the current work schedule, final model showed that no significant association was found between shift work and PCa risk, whether it involved shift but no night shifts (HR 0.96, 95% CI 0.85 to 1.08), some night shifts (HR 1.16, 95% CI 0.99 to 1.33) and usual night shifts (HR 1.01, 95% CI 0.85 to 1.19). In the analysis of the average frequency of night shift work, final model showed no significant impact of different night shift frequencies (<3/month: HR 0.97, 95% CI 0.73 to 1.29; 3–8/month: HR 0.99, 95% CI 0.83 to 1.19; >8/month: HR 0.89, 95% CI 0.73 to 1.07) on the risk of PCa. No significant association was found for either <10 years (HR 0.89, 95% CI 0.72 to 1.09) or ≥10 years (HR 1.00, 95% CI 0.86 to 1.16) of night shift work. Subsequent subgroup and sensitivity analyses demonstrated consistent results without significant alterations. Furthermore, in the two-sample MR analysis, no statistically significant causal relationship was identified between night shift work and the incidence of PCa.ConclusionIn both the cohort studies and MR analysis, our investigation did not find any association between night shift work and PCa.
Efficacy in predicting mortality of patients with heart failure using heart rate before intensive care unit discharge: a retrospective cohort study from MIMIC-IV Database
Authors: Hsiao Chia-Ying , Su Min-I , Chang Yu-Cheng , Lee Ying-Hsiang , Lin Po-Lin , Chiou Wei-Ru 
Published: December 2024

ObjectiveHeart rate serves as a critical prognostic factor in heart failure (HF) patients. We hypothesise that elevated heart rate in critically ill HF patients on discharge from the intensive care unit (ICU) could be linked to adverse outcomes.DesignA single-centre retrospective cohort study.SettingThis study used data collected between 2008 and 2019 from the Medical Information Mart for Intensive Care IV (V.2.0) Database.ParticipantsFrom the 76 943 ICU stays, we enrolled 2365 patients in this study.Primary and secondary outcome measuresWe observed correlations between in-hospital mortality and ICU discharge heart rate of 83.56±15.81 beats per minute (bpm) (survivors) vs 93.84±17.28 bpm (non-survivors, p<0.001). Total mortality showed similar trends, with 83.67±15.36 bpm (survivors) vs 85.23±17.25 bpm (non-survivors, p=0.027), as did ICU readmissions at 83.55±15.77 bpm (non-readmitted) vs 88.64±17.49 bpm (readmitted, p<0.001).ResultsGiven multivariate analysis, the ICU discharge heart rate strongly predicted in-hospital mortality (HR 1.032 (95% CI 1.022 to 1.041), p<0.001), total mortality (HR 1.008 (95% CI 1.004 to 1.013), p<0.001) and ICU readmission (HR 1.018 (95% CI 1.010 to 1.025), p<0.001). Patients with an ICU discharge heart rate>90 bpm demonstrated significantly higher in-hospital mortality (HR 2.639 (95% CI 1.898 to 3.669), p<0.001), total mortality (HR 1.342 (95% CI 1.163 to 1.550), p<0.001) and ICU readmission rates (HR 1.781 (95% CI 1.413 to 2.243), p<0.001).ConclusionThe findings suggest that HF patients with an elevated heart rate (>90 bpm) at ICU discharge are more likely to experience increased in-hospital mortality, total mortality and ICU readmissions, indicating potential negative outcomes.
Implementation and impact of NHS-funded tobacco dependence services in England: a mixed-method evaluation protocol
Authors: Aquino Maria Raisa Jessica , Brennan-Tovey Kerry , Fong Mackenzie , Wearn Angela , Bigirumurame Theophile , Robinson Tomos , Trevor Miranda , Feeney Joanna , Rutter Ailsa , Sharrock Ruth , West Jane , Bridges Sally , Attwood Angela S , Jolly Kate , Damery Sarah , Flanagan Sarah , Armitage Chris , Russell Samantha , Strong Steve , Ramsay Sheena E , Kaner Eileen F S 
Published: December 2024

IntroductionTobacco smoking remains a leading cause of ill-health, premature mortality and a driver of health inequalities. To support smokers in England, a comprehensive approach to treating tobacco dependence is being implemented. This includes offering support to all people admitted to hospitals, as well as women and pregnant people within NHS settings. We aim to describe the protocol for an evaluation of this tobacco-dependence service.Methods and analysisThis is a national evaluation across five regions in England (i.e., South West, West Midlands, Greater Manchester, North East and North Cumbria, Yorkshire and Humber) including 11 NHS Foundation Trusts. It is funded from September 2021 to September 2025. Evaluation settings are acute hospital, maternity and inpatient mental health.Work package (WP) 1 involves qualitative key informant interviews to characterise the policy implementation context. WP 2 involves an online survey to assess the routinisation of the service in practice and staff attitudes regarding tobacco dependence, plus in-depth interviews with relevant practitioners to explore survey findings and interviews with smokers to investigate its usefulness and impact. WP 3 involves descriptive statistical analysis of routinely collected data to assess service uptake and impact on health and care outcomes (e.g., smoking status). WP 4 involves an economic analysis of routinely collected data to determine the financial impact of the service. Qualitative data (WP 1, WP 2) will be analysed using Thematic Analysis and Framework Analysis, respectively. WP 2 survey data will be analysed using descriptive statistics.Ethics and disseminationThis evaluation received favourable ethical opinion from Newcastle University (17756/2021) and NHS Wales Research Ethics Committee (22/WA/0203). It has also received Confidentiality Advisory Group support (22CAG0103).
Derivation and validation of the simplified BleedingAudit Triage Trauma (sBATT) score: a simplified trauma score for major trauma patients injured in motor vehicle collisions
Authors: Nutbeam Tim , Stassen Willem , Foote Emily , Ageron Francois-Xavier 
Published: December 2024

ObjectivesTo develop and validate a simplified Bleeding Audit Triage Trauma (sBATT) score for use by lay persons, or in areas and environments where physiological monitoring equipment may be unavailable or inappropriate.DesignThe sBATT was derived from the original BATT, which included prehospital systolic blood pressure (SBP), heart rate, respiratory rate, Glasgow Coma Scale (GCS), age and trauma mechanism. Variables suitable for lay interpretation without monitoring equipment were included (age, level of consciousness, absence of radial pulse, tachycardia and trapped status). The sBATT was validated using data from the UK Trauma Audit Research Network (TARN) registry.SettingData sourced from prehospital observations from multiple trauma systems in the UK.Participants70 027 motor vehicle collision (MVC) patients from the TARN registry (2012–2019). Participants included were those involved in MVCs, with exclusion criteria being incomplete data or non-trauma-related admissions.InterventionsNot applicable.Primary and secondary outcome measuresDeath within 24 hours of MVC. Secondary: need for trauma intervention.ResultsIn a cohort of 70 027 MVC patients, 1976 (3%) died within 24 hours. The sBATT showed an area under receiver operating characteristic curve of 0.90 (95% CI: 0.90 to 0.91) for predicting 24-hour mortality, surpassing other trauma scores such as the Shock Index and Assessment of Blood Consumption score. Sensitivity was 96% and specificity 72%, with a negative likelihood ratio below 0.1, indicating strong rule-out capability. Sensitivity analyses confirmed consistent performance across varying SBP and GCS thresholds. The sBATT was equally effective across sexes with no significant predictive discrepancies.ConclusionsThe sBATT is a novel, simplified tool that performs well at predicting early death in the TARN dataset. It demonstrates high predictive accuracy for 24-hour mortality and need for trauma intervention. Further research should validate sBATT in diverse populations and real-world scenarios to confirm its utility and applicability.
“Effect of post-kidney transplant diabetes mellitus on long-term outcomes in a cohort of pediatric kidney transplant recipients from 2005 to 2022.” Survival analysis
Authors: Calvo-Herrera Maria Alejandra , Serna-Campuzano Angelica Maria , Isaza-Lopez María Carolina , Villegas-Arbeláez Esteban , Rojas-Rosas Luisa Fernanda , Serna-Higuita Lina Maria , Ochoa-García Carolina Lucia 
Published: December 2024

BackgroundPost-transplantation diabetes mellitus and carbohydrate intolerance (PTDM/iCHO) are complications following solid organ transplantation, which significantly increases the risk of graft loss and mortality. However, data concerning long-term outcomes in paediatric kidney transplant recipients with PTDM/iCHO are scarce. This study aimed to evaluate the risk of graft loss in paediatric kidney transplant recipients with PTDM or iCHO compared with non-PTDM/iCHO.MethodsThe study cohort included patients aged <18 who underwent a kidney transplant in a transplant centre from 2005 to 2022. The primary outcome was graft survival loss; secondary outcomes were acute rejection, renal function and mortality. Cumulative incidence of graft loss and acute rejection was estimated, considering death a competing risk. Fine and Gray’s proportional subdistribution hazard model was used to analyse the effect of PTDM/iCHO status on the event.ResultsSeventy-six paediatric kidney transplant recipients were included. The incidence of PTDM and iCHO was 6.6% and 9.2%, respectively. Patients with PTDM/iCHO had a significantly higher cumulative graft loss incidence than those without (34.4% vs 13.9% at 36 months, p<0.008). Multivariable analysis revealed a threefold increased risk of graft loss in patients with PTDM/iCHO (HRadjusted3.33, 95% CI 1.19 to 9.30, p=0.022). PTDM/iCHO was associated with a higher incidence of acute rejection (33.3% vs 14.5% at 1 year, p=0.025). Patients with PTDM/iCHO also exhibited significantly worse eGFR at all time points compared with patients without PTDM/iCHO (p=0.036)ConclusionPatients with PTDM and iCHO had a higher risk of graft loss and lower renal function in paediatric kidney transplant recipients. This justifies close monitoring of metabolic complications in these patients.
Impact of maternal antenatal nutrition and infection treatment interventions on Longitudinal Infant Development and Growth in rural Ethiopia: protocol of the LIDG child follow-up study
Authors: Workneh Firehiwot , Chin Theresa I , Yibeltal Kalkidan , Fasil Nebiyou , North Krysten , Jensen Sarah K G , Kidane Workagegnhu Tarekegn , Melese Mulatu , Tsegaye Sitota , Berhane Yoseph Yemane , Roy Paladhi Unmesha , Abate Betelhem Haimanot , Teklehaimanot Atsede , Melka Tizita Lemma , Pihl Stephen , An Winko W , Van Dyk Fred , Mullany Luke C , Folger Lian V , Cherkerzian Sara , Troller-Renfree Sonya V , Thomason Moriah E , Andersson Maria , Inder Terrie , Nelson Charles A , Grant P Ellen , Christian Parul , Worku Alemayehu , Berhane Yemane , Lee Anne CC 
Published: December 2024

IntroductionMaternal undernutrition and inflammation in utero may significantly impact the neurodevelopmental potential of offspring. However, few studies have investigated the effects of pregnancy interventions on long-term child growth and development. This study will examine the effects of prenatal nutrition and infection management interventions on long-term growth and neurodevelopmental outcomes of offspring.MethodsThe Enhancing Nutrition and Antenatal Infection Treatment (‘ENAT’) study (ISRCTN15116516) was a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. The study enrolled 2399 pregnant women who were randomised to receive routine care, an enhanced nutrition package (iron and folic acid, monthly household supply of iodised salt, and micronutrient-fortified balanced energy protein supplement for undernourished women), an enhanced infection management package (genitourinary tract infection screening and treatment, and enhanced deworming), or both packages. In the present Longitudinal Infant Development and Growth study, a subset of 480 children of mothers from ENAT will be recruited equally from each of the four study arms and visited at 12, 18, and 24 months of postnatal age. We will evaluate a range of domains and deploy multiple measures to assess child neurodevelopment, including resting electroencephalography and visual evoked potentials, Hammersmith Infant Neurological Examination, eye-tracking, Bayley Scales of Infant and Toddler Development (Bayley-III), and Magnetic Resonance Imaging (MRI).DiscussionThis study will advance understanding of the impact of nutrition and inflammation in pregnancy on long-term offspring neurodevelopment. This study aims to fill a critical knowledge gap on the benefits of prenatal interventions to promote the health of mothers and their offspring.Ethics and disseminationThis study was approved by the Institutional Review Boards of Addis Continental Institute of Public Health (ACIPH/IRB/002/2022) and Mass General Brigham (2023P000461). Results will be disseminated to local and international stakeholders.Trial registration numberNCT06296238.
Effects of non-invasive brain stimulation on impulsivity in patients with mental disorders: a systematic review and meta-analysis of randomised clinical trials
Authors: Machado Yuri de Castro , Oliveira Mariana , Mundoca Mateus Pereira , Viana Bernardo , Marques de Miranda Debora , Romano-Silva Marco Aurélio 
Published: December 2024

BackgroundNon-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), may offer an alternative treatment strategy for impulsive behaviour. By modulating brain activity, these techniques could potentially enhance impulse control and mitigate impulsivity.AimsTo provide a comprehensive analysis of the correlation between NIBS parameters, targeted brain regions and impulsivity.MethodsWe systematically searched PubMed, Scopus and Embase on 5 April 2023 for randomised controlled trials (RCTs) of NIBS on impulsivity. Unbiased Hedges’ g with 95% CIs was used to define the effect size. Cochran Q test and I² statistics were used to assess for heterogeneity; p values inferior to 0.10 and I²>25% were considered significant for heterogeneity. Publication bias was investigated by funnel plot analysis of point estimates according to study weights, by Egger’s regression test and by non-parametric rank correlation (Begg) test.ResultsA total of 18 studies were included, comprising 655 patients from 14 RCTs and four randomised crossover studies. The meta-analysis of effect sizes from 9 tDCS studies on impulsivity did not show a significant effect (g=−0.18; 95% CI −0.46 to 0.10; p=0.210) and from 9 repetitive TMS (rTMS) studies also did not yield a statistically significant effect (g=0.21; 95% CI −0.38 to 0.80; p=0.490). When analysing active tDCS using Barratt Impulsiveness Scale version 11, the scores showed a trend towards improvement with active tDCS over placebo (g=−0.54; 95% CI −0.97 to −0.12; p<0.05; I²=0%).ConclusionsThere is currently insufficient evidence to support the clinical use of rTMS or tDCS as a means of reducing impulsivity in individuals with mental disorders. The main limitations of this study are the lack of available patient-level data, a limited number of studies, the lack of consensus on the structure of impulsivity and variability in how impulsivity is measured and conceptualised.PROSPERO registration numberCRD42023413684.