bluuebunny/crossref_metadata_2025_split huggingface dataset:
Orbital Implants Receiving Food and Drug Administration Premarket Notification
Authors: Corcoran Ruiz Kiara M. , Vaishnav Yash J. , Desautels Jordan , Schaefer Jamie L. , Migliori Michael E. , Yilmaz Taygan 
Published: June 2022

Purpose:
This perspective explores the Food and Drug Administration (FDA) 510(k) program, occasionally referred to as premarket notification, which facilitates faster marketing of Class II medical devices, such as orbital implants by demonstrating “substantial equivalence” to previously approved devices. This allows for FDA clearance, rather than FDA approval of orbital implants via comparison to currently marketed implants rather than clinically proven safety standards.

Methods:
Utilizing the FDA’s publicly available 510(k) Premarket Notification database, we conducted a thorough search of FDA-cleared orbital implants dating back to the inception of the 510(k) process in 1976.

Results:
We found that 29 orbital implants received 510(k) FDA clearance between 1987 and 2022. Four of the 29 implants were recalled. Only 9 of 29 implants had available data on their predicate or comparison devices; of these 9, 3 implants received clearance based on devices that were subsequently recalled.

Conclusions:
This investigation into premarket approval of orbital implants identifies a shortcoming in the FDA 510(k) approval process. Long-term implant-associated morbidity is difficult to predict during premarket analysis but is further complicated for 510(k) cleared implants since devices approved based on substantial equivalence to recalled devices may not be automatically recalled. Clinicians should be aware of the approval process for the devices they select, and review of the 510(k) process, especially as it applies to substantial equivalence to devices subsequently recalled is warranted.
Phase 1 Single Ascending and Multiple Ascending Dose Studies of Phosphodiesterase-9 Inhibitor E2027
Authors: Landry Ishani S. , Aluri Jagadeesh , Schuck Edgar , Ino Mitsuhiro , Horie Kanta , Boyd Peter , Reyderman Larisa , Lai Robert 
Published: June 2022

Background:
E2027 is a novel, highly selective and potent inhibitor of phosphodiesterase9 (PDE9) being evaluated as a treatment for dementia with Lewy bodies.

Methods:
Phase 1, randomized, double-blind, single ascending dose (SAD, n=96) and multiple ascending dose (MAD, n=68) studies evaluated E2027 doses (5 to 1200 mg) in healthy subjects. The impact of age, race (Japanese/non-Japanese), and food on pharmacokinetics (PK)/pharmacodynamics were evaluated. Serial cerebrospinal fluid (CSF) samples were collected to assess the target engagement.

Results:
E2027 PK profiles were biphasic (elimination half-life: ~30 hours. Approximately 3-fold accumulation was observed following multiple once-daily dosing. E2027 single doses of 50 to 400 mg resulted in mean maximum increases in CSF cyclic guanosine monophosphate ranging from 293% to 461% within 5.37 to 12.9 hours after dose administration to assess target engagement. Dose-response modelling of steady-state predose CSF cyclic guanosine monophosphate concentrations showed ≥200% increase from baseline is maintained with doses of ≥50 mg QD. The most common adverse events with E2027 were post-LP syndrome and back pain. PK profiles were similar between Japanese and non-Japanese. Higher exposure observed in fed versus fasted state was not considered clinically significant. PK exposure was higher in elderly subjects.

Conclusions:
S.E2027 was well-tolerated following single and multiple administration. E2027 achieved maximal and sustained target engagement at 50 mg QD, the dose selected for the phase 2 clinical trial.
How Many Hours Do Internal Medicine Residents At University Of Toronto Spend Onboarding At Hospitals Each Year? A Cross-sectional Survey Study
Authors: Hodzic-Santor Benazir , Prakash Varuna , Raudanskis Ashley , Lorens Edmund , Detsky Allan S. , Fralick Michael 
Published: June 2022

ABSTRACTBackgroundBurnout among medical residents is common. One source of burnout is the need to complete redundant administrative tasks such as onboarding processes at various hospitals.ObjectivesTo quantify the time residents at the University of Toronto spend onboarding at teaching hospitals, to identify areas of redundancy in onboarding processes, and to identify trainee perceptions of onboarding processes.MethodsWe conducted a quality improvement survey of core internal medicine residents at the University of Toronto where residents rotate through multiple different teaching hospitals. The primary outcome was time spent onboarding. Secondary outcomes included perceptions of the onboarding process, and impact on well-being.Results41% (N=93) of all Internal Medicine residents completed the survey. Most (n=81, 87%) rotated through at least four hospitals and 24 (26%) rotated through more than 5 in the preceding year. The median number of hours spent on the onboarding process was 5 hours per hospital (IQR 1-8) and these tasks were often completed when trainees were post-call (82%, n=76) or outside of work hours (97%, n= 90). The cumulative number of hours spent each year on onboarding tasks by the 93 trainees was 2325 hours (97 days) which extrapolates to 5625 hours (234 days) for all 225 trainees in the core internal medicine program. Most residents reported high levels of redundancy across hospital sites (n=79, 85%) and felt that their well-being was negatively affected (73%, n=68).ConclusionsThe median internal medicine resident at the University of Toronto spent 5 hours onboarding for each hospital. There is considerable redundancy and the process contributes to self-reported burnout.
Serotypes and Serogroups implicated in Bacterial meningitis across Ghana
Authors: Weyori Enoch Weikem , Abdul-Karim Abass , Eleeza John Bertson , Bernard Nkrumah , Abubakari Braimah Baba , Kosi Abiwu Hilarius Asiwome , Eugene Kuugbee Dogkotenge , Yidaana Adadow , Nuertey Benjamin , Kojo Adatsi Richard , Azure Stebleson , Mensah Sylvester , Yakubu Etowi Boye , Cheba Valentine Koyiri , Dombadoh Alentis Aba-ifaa 
Published: June 2022

AbstractBackgroundBacterial meningitis is a dangerous infection that can kill children and adults alike. An estimated 1.2 million instances of bacterial meningitis are anticipated to occur globally each year, despite the discovery of polysaccharide and conjugate vaccines in recent years [1]. The study aimed to find out which bacteria isolates are linked to meningitis and to compare the culture method to the rT-PCR method.MethodThis study examined data on bacterial meningitis from the Ghana Health Service’s Public Health Division from 2015 to 2019. Patients’ information was collected from case-based forms held at the Tamale Public Health and Reference Laboratory. The data from the case-based forms was transcribed into a pre-designed Microsoft Excel template. For analysis, the data was cleaned and loaded into Minitab version 18.ResultsThere were 2,446 CSM cases documented in all, 34.4 percent were confirmed. Males (52.7%) were more suspected than females (47.3%). Age group 15-44 were affected most (37.5%). The predominant pathogens were Neisseria meningitidis (W135) and Streptococcus pneumoniae (St.1) with NMX, St.14, St.19, and St. 12F/12A/12b as new emerging strains.Notwithstanding that, low NPV (72.6%), NLR (0.69), and sensitivity (31.8%) of culture method for detected pathogens of bacterial meningitis were found to produce a statistically significant false negatives compared to the gold standard (rT-PCR).ConclusionEmergence of new strains of bacterial meningitis and the false negative results chained out by the culture method is alarming.
School bullying and social adaptation in Chinese adolescents: A multiple mediation model of self-disclosure and school connectedness
Authors: Xiang Guo-Xing , Gan Xiong , Wang Pin-Yi , Zhang Rui-Jin , Jin Xin , Li Hao 
Published: June 2022

AbstractBackgroundWhen it comes to the occurrence place of bullying behavior, school can never be ignored because adolescents spend a lot of time in school. School bullying has become a significant social issue among young generations, which influences their healthy growth. However, our understanding of the effects of school bullying is still limited. So, the present study aims to investigate how school bullying affects adolescent social adaptation.MethodsA sample of 434 Chinese adolescents (56.9% females; Mage=13.07 years, SD=0.93) participated in the survey. Structural equation modeling was adopted to assess the hypothesized model.ResultsThe results indicated that school bullying had a direct effect on negative social adaptation rather than positive social adaptation. Moreover, self-disclosure and school connectedness mediated the relationship between school bullying and social adaptation, separately and sequentially.ConclusionsThe present study combines self-disclosure and school connectedness into a multiple mediation model, highlighting the importance of individual and environmental factors in the effects of school bullying on adolescents’ social adaptation. Practically, the current findings may provide some guidance for the prevention and intervention of school bullying and the promotion of social adaptation in adolescents.
Baseline Peripheral Blood Counts and Outcomes in Patients Presenting with COVID-19
Authors: Jeyaraman Preethi , Borah Pronamee , Singh Omender , Dewan Arun , Dayal Nitin , Naithani Rahul 
Published: June 2022

AbstractBackgroundSARS-CoV-2 pandemic has significant impact on hematopoietic system.ObjectiveTo report the incidence and pattern of baseline hematological parameters in patients with COVID-19 and their association with severity of disease and outcome.MethodsRetrospective observational study.ResultsA total of 440 patients were included in the study. The mean age of the study cohort was 47.5 ±15.8 years. Fifty percent of patients had at least 1 comorbidity. ICU stay was required in 125 (39.6%) patients. Overall mortality in the study cohort was 3.52%. The average age of patients who died was significantly higher than that of patients who were alive (65.1 years vs 46.5 years; p= 0.000). DM, HTN, CAD and CKD were all associated with higher incidence of ICU stay and mortality. Lymphopenia < 1×109/μl was observed in 24.3% and eosinopenia was noted in 44.3% patients. Leukocytosis>11×109/μl was seen in 8.2 % of patients. The median neutrophil lymphocyte ratio (NLR) of whole cohort was 2.63. NLR, Lymphopenia, eosinopenia, leucocytosis, D dimer, lactate dehydrogenase (LDH), ferritin and IL6 levels all were associated with need for ICU transfer and mortality. Hemoglobin, red cell distribution width (RDW), PT and aPTT correlated with need for ICU transfer but not with mortality. Ferritin cutoff ≥751 ng/ml and IL6 levels ≥64pg/ml was able to identify all deaths. Ferritin (0.989) and IL-6 (0.985) had very high negative predictive value.ConclusionsPeripheral blood counts at time of hospitalization is a simple tool to predict outcomes in patients admitted with Covid-19.
Do children evaluated for maltreatment have higher subsequent emergency department and inpatient care utilization compared to a general pediatric sample?
Authors: Liu Yuerong , Shepherd-Banigan Megan , Evans Kelly , Stilwell Laura , Terrell Lindsay , Hurst Jillian , Gifford Elizabeth J. 
Published: June 2022

AbstractBackgroundChild maltreatment leads to substantial adverse health outcomes, but little is known about acute health care utilization patterns after children are evaluated for a concern of maltreatment at a child abuse and neglect medical evaluation clinic.ObjectiveTo quantify the association of having a child maltreatment evaluation with subsequent acute health care utilization among children from birth to age three.Participants and SettingChildren who received a maltreatment evaluation (N = 367) at a child abuse and neglect subspecialty clinic in an academic health system in the United States and the general pediatric population (N = 21,231).MethodsWe conducted a retrospective cohort study that compared acute health care utilization over 18 months between the two samples using data from electronic health records. Outcomes were time to first emergency department (ED) visit or inpatient hospitalization, maltreatment-related ED use or inpatient hospitalization, and ED use or inpatient hospitalization for ambulatory care sensitive conditions (ACSCs). Multilevel survival analyses were performed.ResultsChildren who received a maltreatment evaluation had an increased hazard for a subsequent ED visit or inpatient hospitalization (hazard ratio [HR]: 1.3, 95% confidence interval [CI]: 1.1, 1.5) and a maltreatment-related visit (HR: 4.4, 95% CI: 2.3, 8.2) relative to the general pediatric population. A maltreatment evaluation was not associated with a higher hazard of health care use for ACSCs (HR: 1.0, 95% CI: 0.7, 1.3).ConclusionThis work can inform targeted anticipatory guidance to aid high-risk families in preventing future harm or minimizing complications from previous maltreatment.
A systems approach to enhance Lynch syndrome diagnosis through tumor testing
Authors: Singh Vinit , Mezzacappa Catherine , Gershkovich Peter , Di Giovanna Jessica , Ganzak Amanda , Gibson Joanna , Sinard John , Xicola Rosa M. , Llor Xavier 
Published: June 2022

ABSTRACTBackgroundGuidelines recommend universal mismatch repair tumor (MMR) testing of colorectal adenocarcinomas (CRC) to screen for Lynch syndrome (LS). However, its implementation remains disjointed and referral for genetic testing dismal, particularly among minorities. We aimed to increase referral, cancer genetic testing, and eventually LS diagnosis by developing a systems approach which, in the second phase was automated.MethodsThis is a cohort study of all patients diagnosed with CRC at an academic center between 1/1/2012 and 1/31/2021. Tumor testing included MMR immunohistochemistry, followed by BRAF V600E/MLH1 promoter methylation testing when indicated. The intervention included a manual phase, which systematized Pathology screening and cancer genetics (CG) referral mechanisms, and an automated phase utilizing computer programming.ResultsA total of 249/1,541 CRC (17.38%) had MMR loss of expression and 129 (8.37%) qualified for CG evaluation. Referral was 27.58% in the original cohort and 92.1% in the intervention (p<0.001). Patients seen by CG among referred were 27.58% in the original cohort and 74.3 % in the intervention (P two-sided <0.001). The distribution of race/ethnicity among patients qualifying and referred for CG evaluation was not significantly different across cohorts. LS diagnosis increased from 0.56% (original cohort) to 1.43% (intervention). Cost per new diagnosis of LS decreased from $173,675 to $87,960 from original cohort to intervention.ConclusionImplementation of systematic case identification and referral support mechanisms significantly increased the proportion of patients undergoing genetic testing and doubled the percentage of patients diagnosed with Lynch syndrome with no referral differences across racial/ethnic groups.
Surface anchoring of the Kingella kingae galactan is dependent on the lipopolysaccharide O-antigen
Authors: Montoya Nina R. , Porsch Eric A. , Muñoz Vanessa L. , Muszyński Artur , Vlach Jiri , Hahn David K. , Azadi Parastoo , Sherman Matthew , Yang Hyojik , Chandler Courtney E. , Ernst Robert K. , St. Geme Joseph W. 
Published: June 2022

AbstractKingella kingae is a leading cause of bone and joint infections and other invasive diseases in young children. A key K. kingae virulence determinant is a secreted exopolysaccharide that mediates resistance to serum complement and neutrophils and is required for full pathogenicity. The K. kingae exopolysaccharide is a galactofuranose homopolymer called galactan and is encoded by the pamABC genes in the pamABCDE locus. In this study, we sought to define the mechanism by which galactan is tethered on the bacterial surface, a prerequisite for mediating evasion of host immune mechanisms. We found that the pamD and pamE genes are glycosyltransferases and are required for synthesis of an atypical lipopolysaccharide (LPS) O-antigen. The LPS O-antigen in turn is required for anchoring of galactan, a novel mechanism for association of an exopolysaccharide with the bacterial surface.SignificanceKingella kingae is an emerging pediatric pathogen and produces invasive disease by colonizing the oropharynx, invading the bloodstream, and disseminating to distant sites. This organism produces a uniquely multifunctional exopolysaccharide called galactan that is critical for virulence and promotes intravascular survival by mediating resistance to serum and neutrophils. In this study, we established that at least some galactan is anchored to the bacterial surface via a novel structural interaction with an atypical lipopolysaccharide O-antigen. Additionally, we demonstrated that the atypical O-antigen is synthesized by the pamD and pamE genes, located downstream of the gene cluster responsible for galactan biosynthesis. This work addresses how the K. kingae exopolysaccharide can mediate innate immune resistance and advances understanding of bacterial exopolysaccharides and lipopolysaccharides.
Human resource development and turnover intention: organizational commitment's role as a mediating variable
Authors: Rawashdeh Adnan M. , Elayan Malek Bakheet , Shamout Mohamed Dawood , Hamouche Salima 
Published: June 2022

PurposeThe purpose of this paper is to examine the effect of human resource development on turnover intention through the mediating role of organizational commitment.Design/methodology/approachThis paper used a quantitative research design. Data were collected from 204 flight attendants employees working at Royal Jordanian Airlines Company using an email survey questionnaire. Structural equation modeling (SEM) was adopted to test the hypothesized model.FindingsThe results assure positive effect of human resource development (HRD) on organizational commitment. Negative effect of both HRD and organizational commitment to turnover intention is observed. The results also confirm that the effect of HRD on turnover intention is negatively mediated by organizational commitment.Originality/valueThis research paper extends the literature by empirically adducing evidence that organizational commitment negatively mediated the effect of human resource development on turnover intention of the airlines in Jordan.
Introduction: innovation in qualitative research in HRD
Authors: Cho Yonjoo , Grenier Robin , Williams Peter 
Published: June 2022

PurposeThe purpose of this paper is to offer a collection of articles that explore some of the many innovative approaches to qualitative inquiry and to challenge HRD scholars and practitioners to consider using innovative approaches in their work. In doing so, qualitative research in HRD can better capture and honour voices, experiences and meaning making of individuals, teams, organizations and communities.Design/methodology/approachUsing Lê and Schmid’s (2022) definition of innovation in qualitative research, the authors selected four innovative approaches to qualitative research that have the potential to enhance HRD research and practice: use of multiple-case study designs in case study research in HRD, a new take on critical incident technique, a narrative approach of testimonio and a visual approach of participant photography.FindingsInnovative approaches to qualitative research in this special issue include a review of case study research in HRD by Tkachenkoet al., a new take on the familiar critical incident technique of Watkinset al., a narrative approach to testimonio by Salcedoet al.and a visual approach to participant photography by Hurtienneet al.The last article, by Grenieret al., addresses the implications of these articles to the field of HRD and points to additional directions for innovative qualitative approaches that can help to understand and create more inclusive, democratic and just organizations.Research limitations/implicationsThe articles in this special issue are intended to spark a dialogue about the meaning of innovation in qualitative research in HRD. It also can serve as an impetus for considering how innovative approaches to qualitative research can better tackle questions that come from the new normal of the workplace, society and diverse contexts.Practical implicationsThis special issue will give HRD scholars and practitioners a realistic, practical view on how innovation in qualitative research can help in exploring specific problems in the workplace. The articles will offer a glimpse into how specific social complex issues can be explored and addressed through innovative approaches, new and tried/modified, to qualitative inquiry.Originality/valueFour articles introduce new and tried/modified qualitative methods, and their value is in prompting HRD scholars and practitioners to consider some of the innovative approaches in exploring, understanding and transforming the workplace. The final article is a review of more innovative qualitative approaches for HRD scholars and practitioners to understand complex organizational phenomena and promote positive and inclusive change accordingly.
Asymmetric effects of global uncertainty: the socioeconomic and environmental vulnerability of developing countries
Authors: Nguyen Canh Phuc , Schinckus Christophe , Su Thanh Dinh 
Published: June 2022

PurposeThis study aims to investigate the influences of global uncertainty indicators volatility on the domestic socioeconomic and environmental vulnerability in a sample of 54 developing countries.Design/methodology/approachThe two-step system generalized method of moments estimator is recruited to deal with autoregression and endogeneity matter in our dynamic panel data. Seven different global uncertainty indicators (US trade uncertainty; world trade uncertainty; economic policy uncertainty; world commodities and oil prices; the geopolitical risk index and the world uncertainty index) have been mobilized and compared for their empirical impact on the economic (growth and GDP), social (the misery index and income inequality) and environmental (CO2 emissions) vulnerabilities of nations.FindingsOur empirical estimations suggest that the socioeconomic and environmental vulnerability cannot be solved through the same pattern: all decrease of a particular aspect will necessarily have a cost and an opposite influence on at least one of the other aspects of the nations' vulnerability.Originality/valueThe originality of this article is to combine these three dimensions of vulnerability in the same investigation. To our knowledge, our research is one of the few providing a joint analysis of the influence of global uncertainty on the economic and socioenvironmental countries' vulnerabilities – given the fact social, economic and environmental aspects are at the heart of the UN sustainable goals, our study can be seen as an investigation of the nations' capabilities to work proactively on meaningful sustainable goals in an increasingly uncertain world.