bluuebunny/crossref_metadata_2025_split huggingface dataset:
Successful Implementation of an Increased Viral Risk Donor Waiting List for Preconsented Kidney Transplant Candidates in Victoria, Australia
Authors: Lee Darren , Gramnea Indra , Seng Nina , Bruns Meaghan , Hudson Fiona , D’Costa Rohit , McEvoy Leanne , Sasadeusz Joe , O’Leary Michael J. , Basu Gopal , Kausman Joshua Y. , Masterson Rosemary , Paizis Kathy , Kanellis John , Hughes Peter D. , Goodman David J. , Whitlam John B. 
Published: September 2021

Background.
Increased viral risk donors (IVRDs) with increased risk behaviors for blood-borne virus infection and negative nucleic acid testing have a low absolute risk of “window period” infection. Utilization and allocation of IVRD organs differ between jurisdictions.

Methods.
We examined the characteristics and utilization of deceased donor IVRD kidneys and recipient outcomes within a 2-y period (July 31, 2018–July 31, 2020) postimplementation of a new opt-in allocation pathway for preconsented recipients in Victoria, Australia.

Results.
Fifty-six kidneys from 31 IVRDs were utilized, comprising 13% of donors. Preconsent rate to accept IVRD kidneys increased to 41% of the waitlist in the 2 y postimplementation, and IVRDs having no kidneys utilized reduced to 0%. Compared with non-IVRD kidneys, kidney offer declines >10 per donor were less likely from IVRDs (3% vs 19%; P < 0.05). IVRDs were younger (median age 36 [IQR 30–44] vs 51 [35–60] y; P < 0.0001), with lower kidney donor profile index (25% [13–40%] vs 57% [29–75%]; P < 0.0001), and less hypertension (0% vs 22%; P < 0.01). Estimated glomerular filtration rate 3 mo post-transplant was superior (P < 0.01). Injecting drug use (61%) was the most common increased risk behavior. 29% of IVRDs were hepatitis C antibody positive but nucleic acid testing negative. No active infection was detected in any recipient post-transplant.

Conclusions.
The described opt-in system permits efficient allocation and utilization of kidneys from IVRDs, with superior quality and graft function. Education is crucial to facilitate informed consent and equity of access to this donor pool.
How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov
Authors: Hutchinson Nora , Klas Katarzyna , Carlisle Benjamin G. , Kimmelman Jonathan , Waligora Marcin 
Published: September 2021

AbstractBackgroundEarly in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.MethodsWe created a cohort of SARS-CoV-2 treatment and prevention efficacy trials that were initiated from 2020-01-01 to 2020-06-30 using ClinicalTrials.gov registration records. We evaluated trials on 3 criteria of informativeness: potential redundancy, design quality and feasibility of patient-participant recruitment. The study protocol was prospectively registered with the Open Science Framework (https://osf.io/fp726/).ResultsWe included 500 trials in our cohort, 58% of which were Phase 2 and 84.8% were directed towards the treatment of SARS-CoV-2. Close to one third of trials met all three criteria and were deemed informative (29.9% (95% Confidence Interval 23.7 – 36.9)). The proportion of potentially redundant trials in our cohort was 4.1%. Over half of the trials in our cohort (56.2%) did not meet our criteria for high quality trial design. The proportion of trials with infeasible patient-participant recruitment was 22.6%.ConclusionsLess than one third of COVID-19 trials registered on ClinicalTrials.gov during the first six months met all three criteria for informativeness. Shortcomings in trial design, recruitment feasibility and redundancy reflect longstanding weaknesses in the clinical research enterprise that were likely amplified by the exceptional circumstances of a pandemic.
The comparability of Anti-Spike SARS-CoV-2 antibody tests is time-dependent: a prospective observational study
Authors: Perkmann Thomas , Mucher Patrick , Perkmann-Nagele Nicole , Radakovics Astrid , Repl Manuela , Koller Thomas , Schmetterer Klaus G , Bigenzahn Johannes W , Leitner Florentina , Jordakieva Galateja , Wagner Oswald F , Binder Christoph J , Haslacher Helmuth 
Published: September 2021

AbstractObjectivesVarious commercial anti-Spike SARS-CoV-2 antibody tests are used for studies and in clinical settings after vaccination. An international standard for SARS-CoV-2 antibodies has been established to achieve comparability of such tests, allowing conversions to BAU/ml. This study aimed to investigate the comparability of antibody tests regarding the timing of blood collection after vaccination.MethodsFor this prospective observational study, antibody levels of 50 participants with homologous AZD1222 vaccination were evaluated at 3 and 11 weeks after the first dose and 3 weeks after the second dose using two commercial anti-Spike binding antibody assays (Roche and Abbott) and a surrogate neutralization assay.ResultsThe correlation between Roche and Abbott changed significantly depending on the time point studied. Although 3 weeks after the first dose, Abbott provided values three times higher than Roche, 11 weeks after the first dose, the values for Roche were twice as high as for Abbott, and 3 weeks after the second dose even 5-6 times higher.ConclusionsThe comparability of quantitative anti-Spike SARS-CoV-2 antibody tests is highly dependent on the timing of blood collection after vaccination. Therefore, standardization of the timing of blood collection might be necessary for the comparability of different quantitative SARS-COV-2 antibody assays.Abstract Figure
Comparative quantitative analysis of SARS- CoV-2 Spike neutralizing antibody titers following two anti COVID-19 vaccines in India
Authors: Chanukya GV , Srikantam Aparna 
Published: September 2021

AbstractIn COVID 19 Pandemic,first line of defence is effective vaccination program.Because of multiple platforms available for vaccine production we tested relative immunogenicity of two vaccines available in India, Covaxin® and Covishield® We performed quantitative analysis of neutralizing antibodies to SARS Cov2 spike (receptor binding domain) protein, from sera of 53 subjects who completed vaccines schedules.There was significantly higher immunogenic response with Covishield® as compared to Covaxin® and are independent of age. Studies on a large scale with long term follow up are needed to further advance the knowledge in this domain.
National Population-Level Disparities in COVID-19 Mortality Across the Intersection of Race/Ethnicity and Sex in the United States
Authors: Xu Jay J. , Chen Jarvis T. , Belin Thomas R. , Brookmeyer Ronald S. , Suchard Marc A. , Ramirez Christina M. 
Published: September 2021

ABSTRACTMales and certain racial/ethnic minority groups have borne a disproportionate burden of COVID-19 mortality in the United States, and substantial scientific research has sought to quantify and characterize population-level disparities in COVID-19 mortality outcomes by sex and across categories of race/ethnicity. However, there has not yet been a national population-level study to quantify disparities in COVID-19 mortality outcomes across the intersection of these demographic dimensions. Here, we analyze a publicly available dataset from the National Center for Health Statistics comprising COVID-19 death counts stratified by race/ethnicity, sex, and age for the year 2020, calculating mortality rates for each race/ethnicity-sex-age stratum and age-adjusted mortality rates for each race/ethnicity-sex stratum, quantifying disparities in terms of mortality rate ratios and rate differences. Our results reveal persistently higher COVID-19 age-adjusted mortality rates for males compared to females within every racial/ethnic group, with notable variation in the magnitudes of the sex disparity by race/ethnicity. However, non-Hispanic Black, Hispanic, and non-Hispanic American Indian or Alaska Native females have higher age-adjusted mortality rates than non-Hispanic White and non-Hispanic Asian/Pacific Islander males. Moreover, persistent racial/ethnic disparities are observed among both males and females, with higher COVID-19 age-adjusted mortality rates observed for non-Hispanic Blacks, Hispanics, and non-Hispanic American Indian or Alaska Natives relative to non-Hispanic Whites.
Validation of HER2 status in whole genome sequencing data of breast cancers with AI-driven, ploidy-corrected approach
Authors: Marzena Wojtaszewska , Rafał Stępień , Alicja Woźna , Maciej Piernik , Maciej Dąbrowski , Michał Gniot , Sławomir Szymański , Maciej Socha , Piotr Kasprzak , Rafał Matkowski , Paweł Zawadzki 
Published: September 2021

AbstractThe HER2 protein overexpression is one of the most significant biomarkers for breast cancer diagnostics, prediction, and prognostics. The availability of HER2-inhibitors in routine clinical practice directly translates into the diagnostic need for precise and robust marker identification.At the brink of the genomic era, multigene next-generation sequencing methodologies slowly take over the field of single-biomarker molecular and cytogenetic tests. However, copy number alterations such as amplification of the HER2-coding ERBB2 gene, are certainly harder to validate as an NGS biomarker than simple SNV mutations. They are characterized by several compound genomic factors i.a. structural heterogeneity, dependence on chromosome count and genomic context of ploidy. In our study, we tested the approach of using whole genome sequencing instead of NGS panels to robustly and accurately determine HER2 status in clinical setup. Based on the large dataset of 877 breast cancer patients’ genomes with curated clinical data and a machine learning approach for optimization of an unbiased diagnostic classifier, we provide a reliable algorithm of HER2 status assessment.
Impact of Stratified Interventions in University Reopenings
Authors: Zhang Yiwei , Yu Zhuoting , Fujimoto Akane , Keskinocak Pinar , Swann Julie L. 
Published: September 2021

AbstractMore than 4,000 colleges and universities in the U.S. are scheduled to start a new semester in August or September, 2021. Many colleges require Covid-19 vaccination, as well as some combination of face coverings or diagnostic testing, while others do not (in some cases due to governance structure). Large state universities may especially have limitations and are not requiring vaccination, testing, or indoor face coverings, nor offering hybrid classes (to promote physical distancing). Group living quarters or classrooms with densely packed students are among the riskiest settings for infectious disease spread.
Differences in Skilled Nursing Facility Characteristics and Quality Ratings by Long-Term Care Pharmacy Provider
Authors: Zullo Andrew R. , Riester Melissa R. , Goldberg Elizabeth M. , Cupp Meghan A. , Berry Sarah D. , Beaudoin Francesca L. 
Published: September 2021

ABSTRACTObjectivesLimited data exist on the U.S. long-term care (LTC) pharmacy market and how skilled nursing facilities (SNFs) may differ by LTC pharmacy provider. We estimated the market shares of two major LTC pharmacies (Omnicare and PharMerica) and assessed if SNF characteristics differ by pharmacy.DesignCross-sectional.Setting and ParticipantsSeventy-five Rhode Island (RI) SNFs that provided post-acute care (PAC) services in 2019.MethodsSNF location, structure, staffing measures, and quality ratings were ascertained from publicly available data sources. The LTC pharmacy used by each SNF was compiled by case managers at a RI health system.ResultsAmong 75 SNFs, 32 (43%) were served by Omnicare and 36 (48%) by PharMerica. LASSO logistic regression and random forest models identified 5 key predictors of SNFs selecting PharMerica over Omnicare: number of skilled beds, total number of beds, nursing hours per resident per day, five-star health inspection rating, and average number of residents per day. In a multivariable regression model including 4 predictors (total number of beds excluded due to collinearity), SNFs had a 6% higher prevalence of using Omnicare over PharMerica for every additional 10 skilled beds (Prevalence Ratio 1.06, 95% CI 1.02-1.10).Conclusions and ImplicationsOmnicare and PharMerica comprised over 90% of the SNF PAC market in RI, with Omnicare covering larger facilities. Understanding if these companies serve a similar proportion of SNFs in other U.S. states is necessary to advance future research initiatives and examine how collaborations between SNFs and LTC pharmacy chains may improve medication management in SNFs.Brief SummaryTwo pharmacies may comprise over 90% of the skilled nursing facility post-acute care market. This market concentration may represent a prime opportunity to efficiently improve medication management.
Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring
Authors: Abara Winston E. , Gee Julianne , Mu Yi , Deloray Mark , Ye Tun , Shay David K. , Shimabukuro Tom 
Published: September 2021

AbstractBackgroundKnowledge of expected rates of potential adverse events of special interest (AESI) that may occur coincidentally following COVID-19 vaccination is essential for vaccine safety surveillance and assessment. We calculated the expected rates of 21 potential AESI following COVID-19 vaccination among vaccinated persons within 1 day, 7 days, and 42 days of vaccination.MethodsWe used meta-analytic methods to estimate background rates of 21 medical conditions considered potential AESI and calculated expected rates of each potential AESI within 1 day, 7 days, and 42 days of vaccination.ResultsBackground rates of three commonly monitored AESI, Guillain-Barre syndrome (GBS), myopericarditis, and all-cause deaths were 2.0 GBS cases/100,000 person-years, 1.3 myopericarditis cases/100,000 person-years, and 863.8 all-cause deaths/100,000 person-years, respectively. Based on these background rates, if 10,000,000 persons are vaccinated, we would expect 0.5, 3.7, and 22.5 GBS cases; 0.3, 2.4, and 14.3 myopericarditis cases; and 236.5, 1655.5, and 9932.8 all-cause deaths to occur in coincident temporal association (i.e., as a result of background incidence) within 1 day, 7 days, and 42 days of vaccination, respectively.ConclusionKnowledge of expected rates of potential AESI can help contextualize adverse health events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine public health communication, and inform benefit-risk assessments of COVID-19 vaccines.
Effects of Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas on Cognitive and Physical Function in Nursing Home Residents
Authors: Zullo Andrew R. , Duprey Matthew S. , Smith Robert J. , Gutman Roee , Berry Sarah D. , Munshi Medha N. , Dore David D. 
Published: September 2021

ABSTRACTAimsDipeptidyl peptidase-4 inhibitors (DPP4Is) may mitigate hypoglycemia-mediated declines in cognitive and physical functioning compared to sulfonylureas (SUs), yet comparative studies are unavailable among older adults, especially nursing home (NH) residents. We evaluated the effects of DPP4Is versus SUs on cognitive and physical functioning among NH residents.Materials and MethodsThis new-user cohort study included long-stay NH residents aged ≥65 years from the 2007-2010 national US Minimum Data Set (MDS) clinical assessments and linked Medicare claims. We measured cognitive decline from the validated 6-point MDS Cognitive Performance Scale, functional decline from the validated 28-point MDS Activities of Daily Living scale, and hospitalizations or emergency department visits for altered mental status from Medicare claims. We compared 180-day outcomes in residents who initiated a DPP4I versus SU after propensity score matching using Cox regression models.ResultsThe cohort (N=1,784) had a mean (SD) age of 80 (8) years and was 73% female. Approximately 46% had no or mild cognitive impairment and 35% had no or mild functional impairment before treatment initiation. Compared to SU users, DPP4I users had statistically similar 180-day rates of cognitive decline (HR=0.61, 95%CI 0.31-1.19), altered mental status events (HR=0.71, 95%CI 0.39-1.27), and functional decline (HR=0.89, 95%CI 0.51-1.56).ConclusionsRates of cognitive and functional decline were not markedly reduced among DPP4I users compared to SU users, but the point estimates and lower 95% confidence bounds do not rule out the possibility that DPP4Is result in reduced rates. Larger studies with greater statistical power should resolve this remaining uncertainty.
Classification of Functional Movement Disorders with Resting State fMRI
Authors: Waugh Rebecca E. , Parker Jacob A. , Hallett Mark , Horovitz Silvina G. 
Published: September 2021

AbstractFunctional movement disorder (FMD) is a type of functional neurological disorder characterized by abnormal movements that patients do not recognize as self-generated. Prior imaging studies show a complex pattern of altered activity, linking regions of the brain involved in emotional responses, motor control, and agency. This study aimed to better characterize these relationships by building a classifier via support vector machine (SVM) to accurately classify 61 FMD patients from 59 healthy controls using features derived from resting state functional MRI (rs-fMRI). First, we selected 66 seed regions based on prior related studies, then calculated the full correlation matrix between them, before performing recursive feature elimination to winnow the feature set to the most predictive features and building the classifier. We identified 29 features of interest that were highly predictive of FMD condition, classifying patients from controls with 80% accuracy. The features selected by the model highlight the importance of the interconnected relationship between areas associated with emotion, reward and sensorimotor integration, potentially mediating relationships between regions associated with motor function, attention and executive function. Exploratory machine learning was able to identify this distinctive, abnormal pattern, suggesting that alterations in functional linkages between these regions may be a consistent feature of the condition in many FMD patients.
Taking a participatory research approach within workplace health promotion research to improve physical activity levels in office-based workers: a scoping review protocol
Authors: Buffey Aidan , Carson Brian P , Donnelly Alan , Salsberg Jon 
Published: September 2021

AbstractIntroductionPhysical activity (PA) workplace health promotion (WHP) interventions have traditionally utilised a top-down research approach at an individual level where participants are considered as passive subjects. Whereas participatory research involves the participants and relevant stakeholders within the research process utilising a bottom-up approach which focuses on the health priorities of the participants and allows the integration of the researcher’s expertise and the end-users lived experiences, which has been shown to aid in the acceptability and relevance of the research.This protocol describes a scoping review which will explore, identify and map participatory research techniques and their impact when utilised in office based WHP interventions designed to improve PA levels and/or decrease sitting time. Providing an overview of key characteristics of WHP interventions which took a participatory research approach.Methods and analysisThis scoping review will follow the guidelines and framework from the PRISMA-ScR. Articles will be retrieved via five databases: Web of Science, PubMED, Scopus, Google Scholar and OpenGrey. A search strategy was piloted, and relevant review articles search strategies were explored, to identify appropriate key words and MeSH terms. Two independent reviewers will screen retrieved articles based on our inclusion and exclusion criteria by title and abstract first, followed by the full text. Any discrepancies will be discussed until a consensus is reached. Data will be extracted, charted and summarised via a narrative synthesis and qualitative analyses.Ethics and disseminationEthical approval was not required or obtained for this scoping review. The completed scoping review findings will be disseminated in a peer-reviewed journal which has a research scope that encompasses participatory research and health promotion. The findings will be presented at appropriate academic conferences and to project partners to inform the design of a WHP intervention.Strengths and limitations of this studyThe proposed scoping review will explore and map the current participatory research techniques and approaches taken when completing an office-based workplace health promotion intervention designed to increase physical activity.The scoping review by nature and the search strategy proposed will allow for a wide breadth of literature to be explored.There is no critical appraisal or quality assessment of the included studies which is typical of a systematic review but not of a scoping review or the aim of this review article.This scoping review has a narrow focus on physical activity and may limit/exclude articles aiming to improve psychological wellbeing or work performance.
Long-term Stored Platelets Coupled to Thrombospondin-1 Detection for Rapid and Accurate Identification of Pathogenic HIT Antibodies
Authors: Kanack A , Jones C , Singh B , Leger R , Heikal NM , Chen D , Pruthi RK , Padmanabhan A 
Published: September 2021

AbstractHeparin-induced thrombocytopenia (HIT) is a potentially life-threatening disorder characterized by antibodies to Platelet Factor 4 (PF4)-polyanion complexes which cause thrombocytopenia and thrombosis. Currently used technically-simple frontline assays such as the PF4-polyanion enzyme-linked immunosorbent assays (ELISAs) lack specificity, and more accurate functional assays such as the serotonin release assay (SRA) and PF4-dependent P-selectin expression assay (PEA) have long turnaround times due to technical complexity and availability only in the reference laboratory setting. There is a critical need for accurate near-patient functional testing to guide patient management, but a key barrier to attaining this goal is the short-term viability of platelets. Here, we detail a process of platelet cryopreservation that renders them viable for at least one year and show that PF4-treated cryopreserved platelets, when coupled with ELISA-based measurement of thrombospondin-1 release (a platelet α-granule protein), detects pathogenic HIT antibodies with high accuracy. Furthermore, testing of a cohort of non-pathogenic HIT antibodies that were strongly reactive in PF4/polyanion ELISA but negative in functional assays demonstrated negative results in the thrombospondin-1 release assay, confirming high specificity of this technique. These findings have the potential to transform the diagnostic testing paradigm in HIT by making in-hospital functional testing available for rapid and accurate diagnosis.