bluuebunny/crossref_metadata_2025_split huggingface dataset:
An adaptation of the SAE J4000/2021 standard for assessing lean maturity in Brazilian hospitals
Authors: Fernandes June Marques , Reis Luciana Paula , Mansk Raphael 
Published: August 2023

PurposeThis study aims to validate a model to assess the level of lean maturity of Brazilian hospitals based on the adaptation of the SAE J4000/2021 standard.Design/methodology/approachThe methodology was divided: (1) adaptation of the standard to the health context, (2) application of the questionnaire through a survey, and (3) comparison of the results of the level of maturity in the standard and by the clustering technique, using Minitab.FindingsThe research presents two contributions: (1) validation of a model to assess the level of lean maturity based on the SAE J4000/2021; (2) insights into the level of maturity of Brazilian hospitals. It was observed that only 10% of the sample was classified at maturity level 3 and 75% at level 2. Private and large hospitals showed greater maturity compared to the others.Research limitations/implicationsThis includes the limited number of hospitals that participated in the survey, given the difficulty of adherence to due constraints of time and staffing from hospitals, during the COVID-19 pandemic.Practical implicationsThis article presents a lean maturity assessment proposal, adapting a consolidated standard in the automobile industry to the health context. Insights on the lean maturity of Brazilian hospitals can contribute to the development of policies to encourage the implementation of the lean philosophy directed to each specific environment.Social implicationsThis study serves as a guide for public agents interested in monitoring the quality of hospital indicators through the SAE J4000/2021 standard. From this lean maturity analysis, hospital managers can understand their opportunities for improvement in both human and organizational aspects. This favors the improvement of service delivery to society that depends on health services.Originality/valueDue to the lack of research that validates lean maturity level assessment models in Brazilian hospitals, this study can be considered a pioneer in this Brazilian research by validating the SAE J4000/2021 standard in its updated version in the health context.
Remimazolam for sedation: A protocol for a systematic review with meta‐analysis, trial sequential analysis, and GRADE approach
Authors: Stehr‐Pingel Lasse , Maagaard Mathias , Tvarnø Casper Duevang , Andersen Lars Peter Kloster , Andersen Jakob Hessel , Mathiesen Ole 
Published: August 2023

AbstractBackgroundProcedural sedation aims to facilitate a successful diagnostic or therapeutic procedure. The pharmacokinetic properties and pharmacodynamic effects need to be taken into consideration when choosing the ideal sedative. Midazolam and propofol are frequently employed. However, they are associated with respiratory depression with increasing dosage. Also, midazolam has a potentially unpredictable pharmacodynamic response and propofol may cause hypotension and injection site pain. Remimazolam may provide a superior alternative due to its rapid pharmacodynamic profile and insignificant circulatory effects.MethodsThis protocol employs the Preferred Reporting Items for Systematic Reviews and Meta‐Analysis guidelines. The review aims to assess the beneficial and harmful clinical effects of remimazolam versus placebo or other sedatives in adult patients requiring sedation in relation to a diagnostic or therapeutic procedure, or due to other circumstances. Three primary outcomes are identified: Sedation success rate, respiratory complications, and hemodynamic complications. Six secondary outcomes are identified: among these are quality of recovery and serious adverse events. All randomized trials are included. The search strategy includes six major biomedical databases. Literature screening and data extraction will be performed independently by two authors. Risk of systemic error will be assessed with Risk of Bias 2 Tool. Risk of random error will be assessed with trial sequential analysis. Heterogeneity will be evaluated by appropriate statistical tests. The certainty of the evidence will be judged using Grading of Recommendations Assessment, Development, and Evaluation. Meta‐analysis will be carried out with Rstudio. A “Summary of Findings” table will be presented with our primary and secondary outcome results.DiscussionThe systematic review with up‐to‐date methodology outlined in this protocol investigates the clinical effects of remimazolam in relation to procedural sedation. The results may guide clinicians in the clinical use of remimazolam.
Pharmacological characterisation of erenumab, Aimovig, at two calcitonin gene‐related peptide responsive receptors
Authors: Garelja Michael L. , Alexander Tyla I. , Bennie Amy , Nimick Mhairi , Petersen Jakeb , Walker Christopher S. , Hay Debbie L. 
Published: August 2023

AbstractBackground and PurposeCalcitonin gene‐related peptide (CGRP) is involved in migraine pathophysiology. CGRP can signal through two receptors. The canonical CGRP receptor comprises the calcitonin receptor‐like receptor and receptor activity‐modifying protein 1 (RAMP1); the AMY1 receptor comprises the calcitonin receptor with RAMP1. Drugs that reduce CGRP activity, such as receptor antagonists, are approved for the treatment and prevention of migraine. Despite being designed to target the canonical CGRP receptor, emerging evidence suggests that these antagonists, including erenumab (a monoclonal antibody antagonist) can also antagonise the AMY1 receptor. However, it is difficult to estimate its selectivity because direct comparisons between receptors under matched conditions have not been made. We therefore characterised erenumab at both CGRP‐responsive receptors with multiple ligands, including αCGRP and βCGRP.Experimental ApproachErenumab antagonism was quantified through IC50 and pKB experiments, measuring cAMP production. We used SK‐N‐MC cells which endogenously express the human CGRP receptor, and HEK293S and Cos7 cells transiently transfected to express either human CGRP or AMY1 receptors.Key ResultsErenumab antagonised both the CGRP and AMY1 receptors with an ~20–120‐fold preference for the CGRP receptor, depending on the cells, agonist, analytical approach and/or assay format. Erenumab antagonised both forms of CGRP equally, and appeared to act as a competitive reversible antagonist at both receptors.Conclusion and ImplicationsDespite being designed to target the CGRP receptor, erenumab can antagonise the AMY1 receptor. Its ability to antagonise CGRP activity at both receptors may be useful in better understanding the clinical profile of erenumab.
Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial
Authors: McInnes Natalia , Hall Stephanie , Lochnan Heather A. , Harris Stewart B. , Punthakee Zubin , Sigal Ronald J. , Hramiak Irene , Azharuddin Mohammed , Liutkus Joanne F. , Yale Jean‐François , Sultan Farah , Smith Ada , Otto Rose E. , Sherifali Diana , Liu Yan Yun , Gerstein Hertzel C. ,   the REMIT‐iGlarLixi Collaborative Group
Published: August 2023

AbstractAimNon‐surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short‐term intensive glucose‐lowering therapy.MethodsIn this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks. The primary outcome was diabetes relapse defined as HbA1c ≥6.5% (48 mmol/mol) at 24 weeks or thereafter, capillary glucose ≥10 mmol/L on ≥50% of readings, or use of diabetes medications, analysed as time‐to‐event. Main secondary outcomes included complete or partial diabetes remission at 24, 36, 48 and 64 weeks defined as HbA1c <6.5% (48 mmol/mol) off diabetes medications since 12 weeks after randomisation. A hierarchical testing strategy was applied.ResultsThe intervention significantly reduced the hazard of diabetes relapse by 43% (adjusted hazard ratio 0.57, 95% confidence interval 0.40‐0.81; p = .002). Complete or partial diabetes remission was achieved in 30 (38.0%) intervention group participants versus 16 (19.8%) controls at 24 weeks and 25 (31.6%) versus 14 (17.3%) at 36 weeks [relative risk 1.92 (95% confidence interval 1.14‐3.24) and 1.83 (1.03‐3.26), respectively]. The relative risk of diabetes remission in the intervention versus control group was 1.88 (1.00‐3.53) at 48 weeks and 2.05 (0.98‐4.29) at 64 weeks.ConclusionsA 12‐week intensive intervention comprising insulin glargine/lixisenatide, metformin and lifestyle approaches can induce remission of diabetes.
Subclonal p53 immunostaining in the diagnosis of endometrial carcinoma molecular subtype
Authors: Huvila Jutta , Thompson Emily F , Vanden Broek Jamie , Lum Amy , Senz Janine , Leung Samuel , Gilks C Blake , Köbel Martin , McAlpine Jessica N , Jamieson Amy 
Published: August 2023

AimsThe significance of subclonal expression of p53 (abrupt transition from wild‐type to mutant‐pattern staining) is not well understood, and the arbitrary diagnostic cut‐off of 10% between NSMP and p53abn molecular subtypes of endometrial carcinoma (EC) has not been critically assessed. Our aim was to characterise subclonal p53 and discrepant p53 expression/TP53 sequencing results in EC and assess their clinical significance.Methods and resultsSubclonal p53 immuostaining on whole sections from 957 ECs was recorded. Agreement between TP53 mutational assessment and p53 immunostaining was evaluated. Subclonal p53 IHC staining was seen in 4.0% (38 of 957) of cases, with 23 of 957 (2.4%) showing mutant‐pattern p53 staining in ≥10% of tumour cells. It was most commonly seen in POLEmut (nine of 65, 14%) and MMRd (13 of 274, 4.7%) EC (‘multiple classifier’ ECs), where subclonal p53 staining does not impact the molecular subtype diagnosis. Excluding POLEmut and MMRd EC, 11 of 957 (1.1%) showed ≥10% subclonal p53 from which four patients died of disease, while there were no deaths due to disease in the five patients with <10% mutant‐pattern p53 staining. Agreement between p53 immunostaining and TP53 sequencing was 92.6%; most of the discrepant results were in the ultramutated POLEmut or hypermutated MMRd ECs. In NSMP and p53abn EC the agreement between IHC and sequencing was 95.8%.ConclusionsSubclonal p53 staining ≥10% is present in only 1.1% of EC after excluding ‘multiple classifier’ ECs. The cut‐off of ≥10% subclonal p53 staining identified patients at increased risk of dying from EC, supporting its use to diagnose p53abn molecular subtype.
Impact of tissue sampling on detection of venous invasion in colorectal cancer: a prospective analysis
Authors: Duan Kai , Chow Brian , Tsui William , Elliot Colin , Sari Aysegul , Shivji Sameer , Kirsch Richard , Conner James R 
Published: August 2023

AimsVenous invasion (VI) is a powerful yet under‐reported prognostic factor in colorectal cancer (CRC). Efforts to improve its detection have largely focused upon histological assessment, with less attention paid to tissue‐sampling strategies. This study aimed to prospectively determine the number of tumour blocks required to optimise VI detection in CRC resections. In addition, the relationship between linear spiculation (LS) and extramural venous invasion (EMVI) was investigated.Methods and resultsA standardised tissue sampling protocol was developed and applied prospectively to 217 CRC resections [AJCC 8th edition, stage 1 (n = 32); stage 2 (n = 84); stage 3 (n = 87); stage 4 (n = 14); and post‐neoadjuvant therapy (n = 46)]. Elastin stains were performed on all tumour blocks. VI was identified in 55% of cases (EMVI = 37%; IMVI alone = 18%). The sensitivity of VI detection increased with increasing numbers of tumour blocks submitted [one block (35%), three blocks (66%), five blocks (84%), six blocks (95%) and seven blocks (97%)]. Similar findings were observed for EMVI [one block (35%), three blocks (73%), five blocks (89%), six blocks (96%) and seven blocks (96%)]. LS was identified macroscopically in 22% of specimens. In cases where no neoadjuvant therapy had been given, EMVI was significantly associated with LS (71% in LS+ cases versus 29% in LS– cases; P < 0.001). In addition, tumour blocks targeting LS were associated with a fivefold higher rate of EMVI compared with blocks that did not (P < 0.001).ConclusionsOur findings demonstrate the impact of tissue sampling and quality of gross examination on VI detection and may inform practices in future CRC protocols.
Mn2+/Pr3+/Tb3+ single‐doped Mg4Ga4Ge3O16 persistent luminescence materials for optical information storage application
Authors: Jiang Chen , Zhang Rui , Han Lidan , Chen Yanhui 
Published: August 2023

AbstractPersistent luminescence (PersL) phosphors are considered as promising candidates for the next generation of information storage medium. Mg4Ga4Ge3O16 (MGG) is an electron trapping material which exhibits defect luminescence, and the luminescent properties are easily tuned via doping various activated ions. In this work, undoped and Mn2+/Pr3+/Tb3+ single‐doped MGG phosphors were synthesized via high temperature solid phase reactions. X‐ray diffraction and scanning electron microscope results confirm that the activated ions tend to occupy Mg2+ sites. Excited at 265 nm, the MGG host exhibits a defect emission band peaked at 450 nm. Red, pink and green emissions are observed in the Mn2+/Pr3+/Tb3+ single‐doped MGG samples, which are ascribed to the Mn2+: 4T1(G) → 6A1(S), Pr3+: 1D2 → 3H4 and Tb3+: 5D4 → 7F5 transitions, respectively. All the samples exhibit bright PersL for minutes after the cessation of excitation. The energy transfer, concentration quenching, luminescence decay and afterglow mechanisms are also discussed in detail. The phosphors exhibit efficient thermal and optical stimuli response, showing great potentials in the optical information storage.
Further psychometric validation and test–retest reproducibility of the WOUND‐Q
Authors: Simonsen Nina Vestergaard , Klassen Anne F. , Rae Charlene , Dalaei Farima , Cano Stefan , Poulsen Lotte , Pusic Andrea L. , Sørensen Jens Ahm 
Published: August 2023

AbstractWOUND‐Q is a condition‐specific patient‐reported outcome measure developed for all types of chronic wounds, located anywhere on the body. To establish reliability and validity of a patient‐reported outcome measure, multiple pieces of evidence are required. The purpose of this study was to examine the measurement properties of 9 of the 13 WOUND‐Q scales and perform a test–retest reproducibility study in an international sample. In August 2022, we invited members of an international online community (Prolific.com) with any type of chronic wound to complete a survey containing the WOUND‐Q scales, the Wound‐QoL and EQ‐5D. A test–retest survey was performed 7 days after the first survey. It was possible to examine the reliability and validity of eight of the nine WOUND‐Q scales by Rasch Measurement Theory (RMT). To examine test–retest reproducibility intraclass correlation coefficients (ICCs), the standard error of the measurement and the smallest detectable change were calculated. In total, 421 patients from 22 different countries with 11 different types of chronic wounds took part in this study. Our analyses provided further evidence of the reliability and validity of the scales measuring wound characteristics (assessment, drainage, smell), health‐related quality of life (life impact, psychological, sleep, social) and wound treatment (dressing).
Effects of dietary supplementation of Achyranthes aspera extract on growth performance, digestibility, innate immunity, antioxidant capacity, and disease resistance of juvenile Pacific white shrimp, Penaeus vannamei
Authors: Ko Daehyun , Medagoda Nalin , Yun Kawn‐Sik , Lee Kyeong‐Jun 
Published: August 2023

AbstractA supplemental effect of Achyranthes aspera extract (200 mg/kg phytosterol) in diets was evaluated for Pacific white shrimp (Penaeus vannamei) on growth performance, digestibility, innate immunity, antioxidant capacity, and disease resistance against Vibrio parahaemolyticus. A fish meal and soybean meal‐based control diet (Con; protein 38.0% and lipid 8.7%) was formulated and five other diets were prepared by adding A. aspera extract into Con diet to be 0.05, 0.1, 0.2, 0.4, and 0.8 mg phytosterol/kg concentration (designated as P05, P10, P20, P40, and P80, respectively). Three replicate groups of 30 shrimp (initial body weight, 0.40 ± 0.001 g) per diet were randomly assigned into 18 acrylic tanks (240 L) and fed one of the diets for 53 days. The growth performance and feed utilization efficiency were significantly higher in shrimp fed P20 and P80 diets than in shrimp fed Con and P10 diets. The dietary phytosterol supplementation improved non‐specific immune response, antioxidant capacity, and apparent digestibility coefficients of dry matter and protein of shrimp. The IGF‐binding protein gene expression was also upregulated with dietary phytosterol supplementation. During the challenge test, the disease resistance of shrimp was significantly enhanced against V. parahaemolyticus when shrimp were fed P20 diet. These results indicate that A. aspera extract could be used as a functional feed additive for the improvements in the growth performance, feed efficiency, innate immunity, antioxidant capacity, digestibility, and disease resistance of the shrimp. The optimum dietary inclusion level of the phytosterol seems to be 0.2–0.4 mg/kg diet.
Using Interactive Fiction to Stimulate Metalinguistic Talk in the English Classroom
Authors: Holdstock Sam 
Published: August 2023

AbstractInteractive Fiction (IF)—a digital form of non‐linear narrative writing—requires readers to respond, to make choices that shape their reading experience. I argue that such choices can be put to use in the classroom, helping teachers to facilitate metalinguistic talk. In this article, I offer a clear conceptualisation of metalinguistic talk, drawing upon existing research to create a useful framework comprised of four characteristics. Using this framework, and with reference to interview data and field notes, I analyse and consider two transcripts of classroom talk in order to explore the extent to which a particular work of IF enabled me to facilitate metalinguistic talk with a class of 16–17‐year‐old English Literature students. The lesson in question formed part of an action research project exploring the possibilities for IF in the secondary school English classroom. I argue that the choices contained withinA Great Gatsby, a work of IF which I designed via a process of critical‐creative textual intervention and using Fitzgerald'sThe Great Gatsbyas my source material, can help to scaffold metalinguistic talk—conversationsaboutlanguage.
The analysis of reliability and validity of a competency evaluation model for front‐line nursing staff during the outbreak of major infectious diseases
Authors: Bai Xue , Gan Xiuni , Yang Ruiqi , Gao Ruqi , Zhou Wen , Zheng Qiulan , Shi Yan 
Published: August 2023

AbstractBackgroundOutbreaks of major infectious diseases represent a tremendous threat to people's health, safety and property, yet little is known about the competence of front‐line caregivers in such situations.AimTo construct a model for evaluating the competency of front‐line nursing staff during major infectious disease outbreaks and to test the model's reliability and validity.Study DesignThis was a cross‐sectional study that took place between November and December 2021, in Chinese hospitals. The model was constructed through literature reviews, descriptive qualitative research, the Delphi method and the analytic hierarchy process. To evaluate the model's validity and reliability, 550 front‐line nurses were selected to complete a questionnaire survey, and six experts were invited to conduct a content validity evaluation. Cronbach's α coefficient was used to test the model's reliability, while an exploratory factor analysis was used to measure the structural validity of the model.ResultsThe model included 57 items. The Cronbach's α coefficient of the model was 0.983, and the content validity index was 0.958. Six common factors were produced by exploratory factor analysis. The cumulative variance contribution rate was 66.718%. After discussion, the original four dimensions were maintained.ConclusionThe model for evaluating the competency of front‐line nursing staff during an outbreak of major infectious diseases has strong reliability and validity and can be used as a tool to assess the competency level of front‐line nursing staff.Relevance to clinical practiceThis model can provide a useful reference for care managers to accurately evaluate, train and select caregivers during an epidemic.
Association between vaginal bleeding in pregnancy that resulted in delivery and risk of cancer: A Danish registry‐based cohort study
Authors: Dudukina Elena , Horváth‐Puhó Erzsébet , Sørensen Henrik Toft , Ehrenstein Vera 
Published: August 2023

AbstractBackgroundVaginal bleeding (VB) before 20 gestational weeks of a viable pregnancy is a manifestation of a threatened miscarriage. VB is associated with increased levels of pro‐inflammatory cytokines such as interferon‐gamma, tumour necrosis factor‐alpha and interleukin‐6. Increased levels of these cytokines and oxidative stress are risk factors for cancer. The risk of cancer following a VB‐affected pregnancy that ended in childbirth is unknown.ObjectivesTo investigate the associations between VB in pregnancy that resulted in delivery and risk of incident cancer.MethodsWe conducted a cohort study (1995–2018) in Denmark using administrative and healthcare registries. We included 37,082 VB‐affected deliveries, 1,363,614 VB‐unaffected deliveries, 324,328 pregnancies ending in terminations, and 137,104 miscarriages. We computed the absolute risk of cancer and hazard ratios (HR) with 95% confidence intervals (CI) adjusted for age, calendar year, morbidities, and socio‐economic factors using Cox proportional hazards regression. Multiple pregnancies to the same woman were accounted for in the analysis.ResultsThe median (25th–75th percentile) follow‐up in the study was 12.6 (6.9, 18.2) years. The prevalence of VB in the present study was 3%. At the end of the follow‐up, there were 1320 cancer cases among the VB‐affected delivery cohort, 40,420 among the VB‐unaffected delivery cohort, 10,300 among the termination cohort and 4790 among the miscarriage cohort. HRs for any cancer among VB‐affected deliveries were 1.03 (95% CI 0.97, 1.08) compared with VB‐unaffected deliveries, 1.03 (95% CI 0.97, 1.09) compared with terminations and 0.90 (95% CI 0.84, 0.95) compared with miscarriages. There were no increased risks of premenopausal breast cancer, cervical cancer, ovary and fallopian tube cancer or uterine cancer following VB‐affected deliveries vs. comparison cohorts.ConclusionsWe found no evidence of an association between vaginal bleeding in pregnancy and an increased risk of cancer.