bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review
Authors: Madi Karima , Flumian Clara , Olivier Pascale , Sommet Agnès , Montastruc François 
Published: September 2023

ObjectiveTo assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov.DesignSystematic review.Data sourcesPubMed and ClinicalTrials.gov registries were searched from 1 December 2019 to 17 February 2022.Eligibility criteria for selecting studiesRandomised clinical trials evaluating the efficacy and safety of drugs used to treat covid-19 disease in participants of all ages with suspected, probable, or confirmed SARS-CoV-2 infection were included. Clinical trials were screened on title, abstract, and text by two authors independently. Only articles published in French and English were selected. The Cochrane risk of bias tool for randomised trials (RoB 2) was used to assess risk of bias.ResultsThe search strategy identified 1962 randomised clinical trials assessing the efficacy and safety of drugs used to treat covid-19, published in the PubMed database; 1906 articles were excluded after screening and 56 clinical trials were included in the review. Among the 56 clinical trials, no study had a high score for quality of reporting of adverse events, 60.7% had a moderate score, 33.9% had a low score, and 5.4% had a very low score. All clinical trials with a very low score for quality of reporting of adverse events were randomised open label trials. For reporting of serious adverse events, journal articles published on PubMed under-reported 51% of serious adverse events compared with clinical trial summaries published on ClinicalTrials.gov.ConclusionsIn one in three published clinical trials on covid-19 drugs, the quality of reporting of adverse events was low or very low. Differences were found in the number of serious adverse events reported in journal articles versus clinical trial summaries. During the covid-19 pandemic, risk assessment of drugs in clinical trials of covid-19 drugs did not comply with good practice recommendations for publication of results.Systematic review registrationEuropean Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) EUPAS45959.
What are the perspectives of adults aged 18–40 living with type 2 diabetes in urban settings towards barriers and opportunities for better health and well-being: a mixed-methods study
Authors: Croke Sarah , Volkmann Anna-Maria , Perry Catherine , Atkinson Ross A , Pruneddu Alessio , Morris Lydia , Bower Peter 
Published: September 2023

ObjectivesDelivered as part of the global assessment of diabetes in urban settings, this study explores different aspects of living with type 2 diabetes, for adults aged 18–40. Primary questions were as follows: (1) can we identify subgroups of adults under 40 years old sharing specific perspectives towards health, well-being and living with type 2 diabetes and (2) do these perspectives reveal specific barriers to and opportunities for better type 2 diabetes prevention and management and improved well-being?DesignThe study employed a mixed-method design with data collected through demographic questionnaires, Q-sort statement sorting exercises, focus groups discussions and individual interviews.SettingPrimary care across Greater Manchester, UK.ParticipantsThose aged between 18 and 40, with a confirmed type 2 diabetes diagnosis, and living in Greater Manchester were eligible to participate. A total of 46 people completed the Q-sort exercise and 43 were included in the final analysis. Of those, 29 (67%) identified as female and 32 (75%) as white. Most common time since diagnosis was between 5 and 10 years.ResultsThe Q-sort analysis categorised 35 of the 43 participants (81%) into five subgroups. Based on average statement sorts for each subgroup, perspectives were characterised as: (1) stressed and calamity coping (n=13), (2) financially disadvantaged and poorly supported (n=12), (3) well-intentioned but not succeeding (n=5), (4) withdrawn and worried (n=2) and (5) young and stigmatised (n=3). Holistic analysis of our qualitative data also identified some common issues across these subgroups.ConclusionsAdults under 40 with type 2 diabetes are not a homogeneous group, but fall into five identifiable subgroups. They also experience issues specific to this age group that make it particularly difficult for them to focus on their own health. More tailored support could help them to make the necessary lifestyle changes and manage their type 2 diabetes better.
Comparing the accuracy of positive and negative indocyanine green staining in guiding laparoscopic anatomical liver resection: protocol for a randomised controlled trial
Authors: Alomari Malek Abdallah Muflih , Wakabayashi Taiga , Colella Marco , Mishima Kohei , Fujiyama Yoshiki , Ababneh Ebaa , Wakabayashi Go 
Published: September 2023

IntroductionKnowledge of the clinical liver anatomy has evolved with advanced imaging modalities and laparoscopic surgery. Therefore, precise anatomical resection knowledge has become the standard treatment for primary and secondary liver cancer. Segmentectomy, a parenchymal-preserving approach, is regarded as an option for anatomical resections in patients with impaired liver. Indocyanine green (ICG) staining is a promising method for understanding the anatomical borders of the liver segments. There are two methods of ICG staining (positive and negative), and the superiority of either approach has not been determined to date.Methods and analysisThis is a prospective randomised controlled superiority clinical trial performed in a single centre tertiary hospital in Japan. A comparison between the accuracy of positive and negative ICG staining in guiding laparoscopic anatomical liver resection is planned in this study. Possible candidates are patients with liver malignant tumours in whom laparoscopic monosegmentectomy or subsegmentectomy is planned. Fifty patients will be prospectively allocated into the following two groups: group A, ICG-negative staining group, and group B, ICG-positive staining group. The optimal dose of ICG for positive staining will be determined during the preparation phase. To assess the ability of the ICG fluorescence guidance in anatomical resection, the primary endpoint is the success rate of ICG staining, which consists of a subjective optical scoring (SOS) based on three components: superficial demarcation in the liver surface, visualisation of the parenchymal borders and consistency with the preoperative three-dimensional simulation. The secondary endpoints are the evaluation of short-term surgical outcomes and recurrence-free survival.Ethics and disseminationThe study was approved by Ageo Central General Hospital Clinical Research Ethical Committee (No: 1044) and it carried out following the Declaration of Helsinki (2013 revision). Informed consent will be taken from the patients before participating. The findings will be disseminated through peer-reviewed publications, scientific meetings and conferences.Trial registration numberUMIN000049815.
Obstetric referrals, complications and health outcomes in maternity wards of large hospitals during the COVID-19 pandemic: a mixed methods study of six hospitals in Guinea, Nigeria, Uganda and Tanzania
Authors: Beňová Lenka , Semaan Aline , Afolabi Bosede Bukola , Amongin Dinah , Babah Ochuwa Adiketu , Dioubate Nafissatou , Harissatou Niane , Kikula Amani Idris , Nakubulwa Sarah , Ogein Olubunmi , Adroma Moses , Anzo Adiga William , Diallo Abdourahmane , Diallo Ibrahima Sory , Diallo Lamine , Cellou Diallo Mamadou , Maomou Cécé , Mtinangi Nathanael , Sy Telly , Delvaux Thérèse , Delamou Alexandre , Nakimuli Annettee , Pembe Andrea Barnabas , Banke-Thomas Aduragbemi Oluwabusayo 
Published: September 2023

ObjectivesThe COVID-19 pandemic affected provision and use of maternal health services. This study describes changes in obstetric complications, referrals, stillbirths and maternal deaths during the first year of the pandemic and elucidates pathways to these changes.DesignProspective observational mixed-methods study, combining monthly routine data (March 2019–February 2021) and qualitative data from prospective semi-structured interviews. Data were analysed separately, triangulated during synthesis and presented along three country-specific pandemic periods: first wave, slow period and second wave.SettingSix referral maternities in four sub-Saharan African countries: Guinea, Nigeria, Tanzania and Uganda.Participants22 skilled health personnel (SHP) working in the maternity wards of various cadres and seniority levels.ResultsPercentages of obstetric complications were constant in four of the six hospitals. The percentage of obstetric referrals received was stable in Guinea and increased at various times in other hospitals. SHP reported unpredictability in the number of referrals due to changing referral networks. All six hospitals registered a slight increase in stillbirths during the study period, the highest increase (by 30%–40%) was observed in Uganda. Four hospitals registered increases in facility maternal mortality ratio; the highest increase was in Guinea (by 158%), which had a relatively mild COVID-19 epidemic. These increases were not due to mortality among women with COVID-19. The main pathways leading to these trends were delayed care utilisation and disruptions in accessing care, including sub-optimal referral linkages and health service closures.ConclusionsMaternal and perinatal survival was negatively affected in referral hospitals in sub-Saharan Africa during COVID-19. Routine data systems in referral hospitals must be fully used as they hold potential in informing adaptations of maternal care services. If combined with information on women’s and care providers’ needs, this can contribute to ensuring continuation of essential care provision during emergency.
CheckPOINT: a simple tool to measure Surgical Safety Checklist implementation fidelity
Authors: Moyal-Smith Rachel , Etheridge James C , Turley Nathan , Lim Shu Rong , Sonnay Yves , Payne Sarah , Smid-Nanninga Henriette , Kothari Rishabh , Berry William , Havens Joaquim , Brindle Mary E 
Published: September 2023

IntroductionThe WHO Surgical Safety Checklist (SSC) is a communication tool that improves teamwork and patient outcomes. SSC effectiveness is dependent on implementation fidelity. Administrative audits fail to capture most aspects of SSC implementation fidelity (ie, team communication and engagement). Existing research tools assess behaviours during checklist performance, but were not designed for routine quality assurance and improvement. We aimed to create a simple tool to assess SSC implementation fidelity, and to test its reliability using video simulations, and usability in clinical practice.MethodsThe Checklist Performance Observation for Improvement (CheckPOINT) tool underwent two rounds of face validity testing with surgical safety experts, clinicians and quality improvement specialists. Four categories were developed: checklist adherence, communication effectiveness, attitude and engagement. We created a 90 min training programme, and four trained raters independently scored 37 video simulations using the tool. We calculated intraclass correlation coefficients (ICC) to assess inter-rater reliability (ICC>0.75 indicating excellent reliability). We then trained two observers, who tested the tool in the operating room. We interviewed the observers to determine tool usability.ResultsThe CheckPOINT tool had excellent inter-rater reliability across SSC phases. The ICC was 0.83 (95% CI 0.67 to 0.98) for the sign-in, 0.77 (95% CI 0.63 to 0.92) for the time-out and 0.79 (95% CI 0.59 to 0.99) for the sign-out. During field testing, observers reported CheckPOINT was easy to use. In 98 operating room observations, the total median (IQR) score was 25 (23–28), checklist adherence was 7 (6–7), communication effectiveness was 6 (6–7), attitude was 6 (6–7) and engagement was 6 (5–7).ConclusionsCheckPOINT is a simple and reliable tool to assess SSC implementation fidelity and identify areas of focus for improvement efforts. Although CheckPOINT would benefit from further testing, it offers a low-resource alternative to existing research tools and captures elements of adherence and team behaviours.
Single-lead arrhythmia detection through machine learning: cross-sectional evaluation of a novel algorithm using real-world data
Authors: Mitchell Henry , Rosario Nicole , Hernandez Carme , Lipsitz Stuart R , Levine David M 
Published: September 2023

BackgroundComputer-assisted interpretation of single-lead ECG is the preliminary method for clinicians to flag and further evaluate an arrhythmia of clinical importance for acutely ill patients. Critical scrutiny of novel detection algorithms is lacking, particularly in external real-world data sets. This study’s objective was to evaluate a hybrid machine learning model’s ability to classify eight arrhythmias from a single-lead ECG signal from acutely ill patients.MethodsThis cross-sectional external retrospective evaluation of a previously trained hybrid machine learning model against an ECG reading team in the setting of home hospital care (acute care delivered at home substituting for traditional hospital care) draws from patients admitted at two hospitals in Boston, Massachusetts, USA between 12 June 2017 and 23 November 2019. We calculated classifier statistics for each arrhythmia, all arrhythmias and strips where the model identified normal sinus rhythm.ResultsThe model analysed 2 680 162 min of single-lead ECG data from 423 patients and identified 691 478 arrhythmias. Patients had a mean age of 70 years (SD, 18), 60% were female and 45% were white. For any arrhythmia, the model had a sensitivity of 98%, a specificity of 100%, an accuracy of 98%, a positive predictive value of 100%, a negative predictive value of 93% and an F1Score of 99%. Performance was best for pause (F1Score, 99%) and worst for paroxysmal supraventricular tachycardia (F1Score, 92%). The model’s false positive rate for any arrhythmia was 0.2%, ranging from 0.4% for pause to 7.2% for paroxysmal supraventricular tachycardia. The false negative rate for any arrhythmia was 1.9%.ConclusionsA hybrid machine learning model was effective at classifying common cardiac arrhythmias from a single-lead ECG in real-world data.
Exploring Structure Incentive Domain Adversarial Learning for Generalizable Sleep Stage Classification
Authors: Ma Shuo , Zhang Yingwei , Chen Yiqiang , Xie Tao , Song Shuchao , Jia Ziyu 
Published: September 2023

Sleep stage classification is crucial for sleep state monitoring and health interventions. In accordance with the standards prescribed by the American Academy of Sleep Medicine, a sleep episode follows a specific structure comprising five distinctive sleep stages that collectively form a sleep cycle. Typically, this cycle repeats about five times, providing an insightful portrayal of the subject’s physiological attributes. The progress of deep learning and advanced domain generalization methods allows automatic and even adaptive sleep stage classification. However, applying models trained with visible subject data to invisible subject data remains challenging due to significant individual differences among subjects. Motivated by the periodic category-complete structure of sleep stage classification, we propose a Structure Incentive Domain Adversarial learning (SIDA) method that combines the sleep stage classification method with domain generalization to enable cross-subject sleep stage classification. SIDA includes individual domain discriminators for each sleep stage category to decouple subject dependence differences among different categories and fine-grained learning of domain-invariant features. Furthermore, SIDA directly connects the label classifier and domain discriminators to promote the training process. Experiments on three benchmark sleep stage classification datasets demonstrate that the proposed SIDA method outperforms other state-of-the-art sleep stage classification and domain generalization methods and achieves the best cross-subject sleep stage classification results.
Simultaneous Targeting of IL-1–Signaling and IL-6–Trans-Signaling Preserves Human Pulmonary Endothelial Barrier Function During a Cytokine Storm—Brief Report
Authors: Colás-Algora Natalia , Muñoz-Pinillos Pablo , Cacho-Navas Cristina , Avendaño-Ortiz José , de Rivas Gema , Barroso Susana , López-Collazo Eduardo , Millán Jaime 
Published: September 2023

BACKGROUND:
Systemic inflammatory diseases, such as sepsis and severe COVID-19, provoke acute respiratory distress syndrome in which the pathological hyperpermeability of the microvasculature, induced by uncontrolled inflammatory stimulation, causes pulmonary edema. Identifying the inflammatory mediators that induce human lung microvascular endothelial cell barrier dysfunction is essential to find the best anti-inflammatory treatments for critically ill acute respiratory distress syndrome patients.

METHODS:
We have compared the responses of primary human lung microvascular endothelial cells to the main inflammatory mediators involved in cytokine storms induced by sepsis and SARS-CoV2 pulmonary infection and to sera from healthy donors and severely ill patients with sepsis. Endothelial barrier function was measured by electric cell-substrate impedance sensing, quantitative confocal microscopy, and Western blot.

RESULTS:
The human lung microvascular endothelial cell barrier was completely disrupted by IL (interleukin)-6 conjugated with soluble IL-6R (IL-6 receptor) and by IL-1β (interleukin-1beta), moderately affected by TNF (tumor necrosis factor)-α and IFN (interferon)-γ and unaffected by other cytokines and chemokines, such as IL-6, IL-8, MCP (monocyte chemoattractant protein)-1 and MCP-3. The inhibition of IL-1 and IL-6R simultaneously, but not separately, significantly reduced endothelial hyperpermeability on exposing human lung microvascular endothelial cells to a cytokine storm consisting of 8 inflammatory mediators or to sera from patients with sepsis. Simultaneous inhibition of IL-1 and JAK (Janus kinase)-STAT (signal transducer and activator of transcription protein), a signaling node downstream IL-6 and IFN-γ, also prevented septic serum-induced endothelial barrier disruption.

CONCLUSIONS:
These findings strongly suggest a major role for both IL-6 trans-signaling and IL-1β signaling in the pathological increase in permeability of the human lung microvasculature and reveal combinatorial strategies that enable the gradual control of pulmonary endothelial barrier function in response to a cytokine storm.
Eli’s “Heavy Eyes” in LXX 1 Kingdoms 3:2 and Euripides’ Alcestis
Authors: Wessels Samuel Hendrick 
Published: September 2023

Abstract
Septuagint Kingdoms, the Greek translation of Samuel-Kings, has an ambiguous linguistic reputation. While scholars sometimes note natural linguistic features, its isomorphic and literal translation style is typically emphasised. This ambiguity has apparently caused several scholars to misinterpret LXX 1 Kgdms 3:2, which uses the verb βαρύνω in reference to the failing eyesight of the priest Eli. When examined against other evidence, notably Euripides’ Alcestis, Kingdoms is shown to use a natural though poorly attested Greek expression meaning “go blind.” This paper demonstrates the natural idiomatic use of βαρύνω in 1 Kgdms 3:2 and shows its value in refining our understanding of “heavy eyes” in other non-translation Greek texts. More broadly, it promotes the reading of the LXX against the wider history of the Greek language.
Esoteric Publishing in the 1920s
Authors: Vogel Lukas 
Published: September 2023

Abstract
Two texts by Marian Dockerill (1878–1972) are often consulted as sources in research on occultism in the early twentieth century. A source-critical reading casts doubt on their authenticity. Based on clear evidence, the journalist and book author William Seabrook may be considered the author. The Dockerill texts fit seamlessly into his work but should be used with great caution as sources on the life dates of the persons described as well as contributions to female confessional literature in the environment of new religious movements.
A Method to the Madness?
Authors: Randolph Jacob 
Published: September 2023

Abstract
This article assesses the 1534–1535 Anabaptist kingdom of Münster and how its leader, Jan of Leiden, asserted the legitimacy of his divinely anointed kingship. Rather than dismiss Jan of Leiden’s displays of supremacy as arbitrary, radical, or mere delusions of grandeur, I seek to contextualize the spectacle of Münster through an appeal to the power of cultural memory and chivalry. At least three applications of chivalric power are narrated in contemporary accounts of Münster. These relate to clothing, royal entries, and tournament events. By paying particular attention to these applications of chivalric power, we can surmise with more clarity just what Jan of Leiden and his advisors envisioned for the city and themselves and how that vision made sense within the social imaginary of late medieval Europe from which chivalry drew its symbolic power.
Algorithmic Hallucinations of Near-Surface Winds: Statistical Downscaling with Generative Adversarial Networks to Convection-Permitting Scales
Authors: Annau Nicolaas J. , Cannon Alex J. , Monahan Adam H. 
Published: September 2023

Abstract
This paper explores the application of emerging machine learning methods from image super resolution (SR) to the task of statistical downscaling. We specifically focus on convolutional neural network–based generative adversarial networks (GANs). Our GANs are conditioned on low-resolution (LR) inputs to generate high-resolution (HR) surface winds emulating Weather Research and Forecasting (WRF) Model simulations over North America. Unlike traditional SR models, where LR inputs are idealized coarsened versions of the HR images, WRF emulation involves using nonidealized LR and HR pairs, resulting in shared-scale mismatches due to internal variability. Our study builds upon current SR-based statistical downscaling by experimenting with a novel frequency-separation (FS) approach from the computer vision field. To assess the skill of SR models, we carefully select evaluation metrics and focus on performance measures based on spatial power spectra. Our analyses reveal how GAN configurations influence spatial structures in the generated fields, particularly biases in spatial variability spectra. Using power spectra to evaluate the FS experiments reveals that successful applications of FS in computer vision do not translate to climate fields. However, the FS experiments demonstrate the sensitivity of power spectra to a commonly used GAN-based SR objective function, which helps interpret and understand its role in determining spatial structures. This result motivates the development of a novel partial frequency-separation scheme as a promising configuration option. We also quantify the influence on GAN performance of nonidealized LR fields resulting from internal variability. Furthermore, we conduct a spectrum-based feature-importance experiment, allowing us to explore the dependence of the spatial structure of generated fields on different physically relevant LR covariates.

Significance Statement
We use artificial intelligence algorithms to mimic wind patterns from high-resolution climate models, offering a faster alternative to running these models directly. Unlike many similar approaches, we use datasets that acknowledge the essentially stochastic nature of the downscaling problem. Drawing inspiration from computer vision studies, we design several experiments to explore how different configurations impact our results. We find evaluation methods based on spatial frequencies in the climate fields to be quite effective at understanding how algorithms behave. Our results provide valuable insights into and interpretations of the methods for future research in this field.