bluuebunny/crossref_metadata_2025_split huggingface dataset:
Modeling Obesity in Norway (The MOON Study): A Decision-Analytic Approach—Prevalence, Costs, and Years of Life Lost
Authors: Bjørnelv Gudrun M. W. , Halsteinli Vidar , Kulseng Bård E. , Sonntag Diana , Ødegaard Rønnaug A. 
Published: December 2020

Background Limited knowledge exists on the expected long-term effects and cost-effectiveness of initiatives aiming to reduce the burden of obesity. Aim To develop a Norwegian obesity-focused disease-simulation model: the MOON model. Material and Methods We developed a Markov model and simulated a Norwegian birth cohort’s movement between the health states “normal weight,”“overweight,”“obese 1,”“obese 2,” and “dead” using a lifetime perspective. Model input was estimated using longitudinal data from health surveys and real-world data (RWD) from local and national registers ( N = 99,348). The model is deterministic and probabilistic and stratified by gender. Model validity was assessed by estimating the cohort’s expected prevalence, health care costs, and mortality related to overweight and obesity. Results Throughout the cohort’s life, the prevalence of overweight increased steadily and stabilized at 45% at 45 y of age. The number of obese 1 and 2 individuals peaked at age 75 y, when 44% of women and 35% of men were obese. The incremental costs per person associated with obesity was highest in older ages and, when accumulated over the lifetime, higher among women (€12,118, €9,495–€15,047) than men (€6,646, €5,252–€10,900). On average, obesity shortened the life expectancy of women/men in the whole cohort by 1.31/1.08 y. The life expectancy for normal-weight women/men at age 30 was 83.31/80.31. The life expectancy was reduced by 1.05/0.65 y if the individual was overweight, obese (2.87/2.71 y), or obese 2 (4.06/4.83 y). Conclusion The high expected prevalence of obesity in the future will lead to substantial health care costs and large losses in life-years. This underscores the need to implement interventions to reduce the burden of obesity; the MOON model will enable economic evaluations for a wide range of interventions.
Informal caregiver burden and influencing factors in gynaecological oncology patients hospitalized for chemotherapy: a cross-sectional study
Authors: Zuo Yan , Luo Bi-Ru , Peng Wen-Tao , Liu Xin-Ru , He Ya-Lin , Zhang Jian-Jun 
Published: December 2020

Objective To determine the level and influencing factors of informal caregiver burden in gynaecological oncology inpatients receiving chemotherapy. Methods This cross-sectional study enrolled gynaecological oncology patients and their informal caregivers between May 2018 and November 2018 and measured the caregivers’ burden using the Caregiver Burden Inventory. The influencing factors were evaluated with univariate regression analysis and multivariate linear stepwise regression analysis. Results A total of 138 patients and their informal caregivers completed the questionnaire. The mean ± SD total informal caregiver burden score was 53.18 ± 10.97. The highest mean ± SD score was recorded in the dimension of time-dependent burden (14.28 ± 2.74), followed by developmental burden (13.65 ± 2.15), physical burden (10.52 ± 2.07), social burden (7.61 ± 2.58) and emotional burden (7.12 ± 1.43). Multivariate analysis showed that the informal caregiver’s sex, relationship to the patient, daily duration of care, presence of chronic health problems and the duration of the patient’s disease were factors influencing the level of caregiver burden. Conclusions The informal caregivers of gynaecological cancer patients hospitalized for chemotherapy experience a moderate level of burden. Nursing measures should be considered to reduce informal caregiver burden and improve the quality of lives of both patients and their caregivers.
The effect of downsizing on innovation outputs: The role of resource slack and constraints
Authors: Ramdani Boumediene , Guermat Cherif , Mellahi Kamel 
Published: December 2020

Although the practice of downsizing is prevalent, its effects on organisational outcomes remain poorly understood. This article examines how and when downsizing affects organisational innovation. Using a unique data set of UK firms over a period of 22 years, we test the effect of downsizing on innovation outputs by considering the moderating role of resource slack and constraints. We argue and empirically demonstrate that downsizing has a dual effect on innovation, contingent on the firm’s level of resources. Our results reveal that downsizing affects innovation outputs positively in firms experiencing resource slack and negatively in firms experiencing resource constraints. We also show that the effect is more immediate in resource-constrained firms. Theoretical and managerial implications of these results are discussed. JEL Classification: J63, L25, M51, O32
African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial
Authors: Stockdill Macy L. , Dionne-Odom J. Nicholas , Wells Rachel , Ejem Deborah , Azuero Andres , Keebler Konda , Sockwell Elizabeth , Tims Sheri , Burgio Kathryn L. , Engler Sally , Durant Raegan , Pamboukian Salpy V. , Tallaj Jose , Swetz Keith M. , Kvale Elizabeth , Tucker Rodney , Bakitas Marie 
Published: December 2020

Background: Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge. Objectives: Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs. Methods: This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials. Results: Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; PFDR = .03), were more likely to be single ( P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more “denial” coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores. Conclusion: ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs. Trial Registration: ClinicalTrials.gov Identifier: NCT02505425
Reviewing the Effects of Miltefosine and Suggesting It for the Treatment of Coronavirus Disease (COVID-19)
Authors: Latifi Alireza 
Published: December 2020

Objective: Miltefosine is an anti-cancer drug used to treat leishmaniasis and deadly opportunistic free-living amoeba and other deadly pathogenic microorganisms. Several studies have demonstrated its antiviral effect. In this study, we discuss the effectiveness of this drug on pathogenic microorganisms, and according to the functional system of the medicine, we present this drug as a therapeutic proposal to treat Coronavirus disease (COVID-19) Methods: A literature search was conducted in electronic databases, including Pubmed, Science Direct, Elsevier, and Google Scholar, and articles published from 2006 to 2020 (the last decade) were selected. The search keywords included Miltefosine, microorganism, pathogen, and treatment. Results: The studies indicated that Miltefosine had therapeutic effects on leishmaniasis and deadly opportunistic free-living amoeba and other deadly pathogenic microorganisms. Several studies have proven its antiviral effect. Conclusion: Owing to the beneficial effects of this drug on pathogenic and deadly microorganisms and antiviral effects, and due to the epidemic of Coronavirus and the lack of effective treatment and vaccine, this drug is recommended as one of the treatment options for this disease.
Lying to patients: Ethics of deception in nursing
Authors: Curtis Drew A , Braziel Jennifer M , Redfearn Robert A , Hall Jaimee 
Published: December 2020

While the ethical use of deception has been discussed in literature, the ethics and acceptability of nursing deception has yet to be studied. The current study examined nurses’ and nursing students’ ratings of the ethics and acceptability of nursing deception. We predicted that nurses and nursing students would rate a truthful vignette as more ethical than a deceptive vignette. We also predicted that participants would rate nursing deception as unethical and unacceptable. A mixed design was used to examine ethics scores as a within-subjects factor and order as a between-groups design factor. A total of 131 nurses and nursing students were recruited from university nursing programs and hospitals in Texas. Participants were provided with a truthful vignette and deceptive vignette and used the Multidimensional Ethics Scale-Revised 1 to rate each vignette. Participants also completed the Lies in Nursing Ethics Questionnaire. The truthful nursing vignette was rated as more ethical than the deceptive vignette. Results indicated that most participants rated nursing deception as unethical, unacceptable, and a violation of the ANA ethical code. Some participants deemed that nursing deception may be acceptable within some cases. Age and years of experience were not related to the perceived ethics and acceptability of nursing deception. Nurses and nursing students believe that using deception with patients is unethical and unacceptable. However, some participants believed that deception may be warranted within some cases. These findings may reflect nurses’ placing the patient at the core of their values and viewing honesty as important for the nurse-patient relationship. Further implications and directions are discussed.
Data management in substance use disorder treatment research: Implications from data harmonization of National Institute on Drug Abuse-funded randomized controlled trials
Authors: Susukida Ryoko , Amin-Esmaeili Masoumeh , Mayo-Wilson Evan , Mojtabai Ramin 
Published: December 2020

Background: Secondary analysis of data from completed randomized controlled trials is a critical and efficient way to maximize the potential benefits from past research. De-identified primary data from completed randomized controlled trials have been increasingly available in recent years; however, the lack of standardized data products is a major barrier to further use of these valuable data. Pre-statistical harmonization of data structure, variables, and codebooks across randomized controlled trials would facilitate secondary data analysis, including meta-analyses and comparative effectiveness studies. We describe a pre-statistical data harmonization initiative to standardize de-identified primary data from substance use disorder treatment randomized controlled trials funded by the National Institute on Drug Abuse available on the National Institute on Drug Abuse Data Share website. Methods: Standardized datasets and codebooks with consistent data structures, variable names, labels, and definitions were developed for 36 completed randomized controlled trials. Common data domains were identified to bundle data files from individual randomized controlled trials according to relevant concepts. Variables were harmonized if at least two randomized controlled trials used the same instruments. The structures of the harmonized data were determined based on the feedback from clinical trialists and substance use disorder research experts. Results: We have created a harmonized database of variables across 36 randomized controlled trials with a build-in label and a brief definition for each variable. Data files from the randomized controlled trials have been consistently categorized into eight domains (enrollment, demographics, adherence, adverse events, physical health measures, mental-behavioral-cognitive health measures, self-reported substance use measures, and biologic substance use measures). Standardized codebooks and concordance tables have also been developed to help identify instruments and variables of interest more easily. Conclusion: The harmonized data of randomized controlled trials of substance use disorder treatments can potentially promote future secondary data analysis of completed randomized controlled trials, allowing combining data from multiple randomized controlled trials and provide guidance for future randomized controlled trials in substance use disorder treatment research.
Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Authors: Basch Ethan , Becker Claus , Rogak Lauren J , Schrag Deborah , Reeve Bryce B , Spears Patricia , Smith Mary Lou , Gounder Mrinal M , Mahoney Michelle R , Schwartz Gary K , Bennett Antonia V , Mendoza Tito R , Cleeland Charles S , Sloan Jeff A , Bruner Deborah Watkins , Schwab Gisela , Atkinson Thomas M , Thanarajasingam Gita , Bertagnolli Monica M , Dueck Amylou C 
Published: December 2020

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested. Methods: A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443). Results: In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation. Conclusion: A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.
Plate fixation versus titanium elastic nailing in midshaft clavicle fractures based on fracture classifications
Authors: Park Jun Sung , Ko Sang Hyun , Hong Taek Ho , Ryu Dong Jin , Kwon Dae Gyu , Kim Myung-Ku , Jeon Yoon Sang 
Published: December 2020

Background: The best strategy for implant selection in midshaft clavicular fractures (MCF) remains controversial. The present study aims to determine the optimal strategy for implant selection by comparing plate and Titanium Elastic Nail (TEN) with respect to outcomes and related complications and analyze the results based on fracture patterns. Methods: A total of 97 patients with MCF who underwent plate (48 patients) or TEN (49 patients) fixation were retrospectively reviewed. Both groups were divided into three subgroups by fracture type using the AO Foundation/Orthopaedic Trauma Association classification: simple fracture (type A), wedge fracture (type B), and multi-fragmentary fracture (type C). The observed outcome measures were bone union rate, related complications, functional scores, and patient satisfaction score. These outcomes were analyzed based on the fracture classification. Results: Both groups demonstrated excellent union rates (p = 0.495) and similar functional scores (p > 0.05). Visual analog scale (VAS) for satisfaction was better in TEN than plate fixation (p < 0.001). In type A and B subgroups, there were no significant difference in functional scores between plate and TEN fixation (p > 0.05). In type C subgroup, however, both VAS for pain and DASH score in TEN fixation were significantly worse than in plate fixation at 2 and 6 weeks postoperatively (p < 0.05). The incidences of clavicle shortening and skin irritation are higher especially in type C subgroup of TEN fixation (p < 0.05). Conclusion: Patient satisfaction of TEN fixation was higher than that of plate fixation, but TEN fixation had a higher incidence of early postoperative pain and migration in type C fractures. Therefore, type A and B fractures can successfully be treated with plate or TEN fixation, but type C fractures should be treated with plate fixation.
Employee selection, education, and firm-provided training
Authors: Barrenechea-Méndez Marco , Ortín-Ángel Pedro , Rodes Eduardo C. 
Published: December 2020

Theoretical debate suggests at least three strategies for firms to provide training to employees in the same job position: individualized and egalitarian with or without adaptation to the abilities of the recruited employees. The article provides a formal framework for deriving distinctive empirical implications regarding the relationship of these strategies with the firms’ selection policies, which are tested using a dataset of blue-collar workers in Spanish industrial plants. The evidence is consistent with the empirical implications of the egalitarian strategy with adaptation. This strategy entails providing the same level of training to all workers in the same job position and setting this level according to the average ability of recruited workers. Paradoxically, this strategy has not been used to interpret the results of the existing empirical literature. JEL CLASSIFICATION M53; M54; M21; J24
Phase 2 study of the safety and efficacy of umbralisib in patients with CLL who are intolerant to BTK or PI3Kδ inhibitor therapy
Authors: Mato Anthony R. , Ghosh Nilanjan , Schuster Stephen J. , Lamanna Nicole , Pagel John M. , Flinn Ian W. , Barrientos Jacqueline C. , Rai Kanti R. , Reeves James A. , Cheson Bruce D. , Barr Paul M. , Kambhampati Suman , Lansigan Frederick , Pu Jeffrey J. , Skarbnik Alan P. , Roeker Lindsey , Fonseca Gustavo A. , Sitlinger Andrea , Hamadeh Issam S. , Dorsey Colleen , LaRatta Nicole , Weissbrot Hanna , Luning Prak Eline T. , Tsao Patricia , Paskalis Dana , Sportelli Peter , Miskin Hari P. , Weiss Michael S. , Svoboda Jakub , Brander Danielle M. 
Published: December 2020

AbstractIntolerance is the most common reason for kinase inhibitor (KI) discontinuation in chronic lymphocytic leukemia (CLL). Umbralisib, a novel highly selective phosphatidylinositol 3-kinase δ (PI3Kδ)/CK1ε inhibitor, is active and well tolerated in CLL patients. In this phase 2 trial (NCT02742090), umbralisib was initiated at 800 mg/d in CLL patients requiring therapy, who were intolerant to prior BTK inhibitor (BTKi) or PI3K inhibitor (PI3Ki) therapy, until progression or toxicity. Primary end point was progression-free survival (PFS). Secondary end points included time to treatment failure and safety. DNA was genotyped for CYP3A4, CYP3A5, and CYP2D6 polymorphisms. Fifty-one patients were enrolled (44 BTKi intolerant and 7 PI3Kδi intolerant); median age was 70 years (range, 48-96), with a median of 2 prior lines of therapy (range, 1-7), 24% had del17p and/or TP53 mutation, and 65% had unmutated IGHV. Most common adverse events (AEs) leading to prior KI discontinuation were rash (27%), arthralgia (18%), and atrial fibrillation (16%). Median PFS was 23.5 months (95% CI, 13.1–not estimable), with 58% of patients on umbralisib for a longer duration than prior KI. Most common (≥5%) grade ≥3 AEs on umbralisib (all causality) were neutropenia (18%), leukocytosis (14%), thrombocytopenia (12%), pneumonia (12%), and diarrhea (8%). Six patients (12%) discontinued umbralisib because of an AE. Eight patients (16%) had dose reductions and were successfully rechallenged. These are the first prospective data to confirm that switching from a BTKi or alternate PI3Ki to umbralisib in this BTKi- and PI3Ki–intolerant CLL population can result in durable well-tolerated responses.
Large-scale circular RNA deregulation in T-ALL: unlocking unique ectopic expression of molecular subtypes
Authors: Buratin Alessia , Paganin Maddalena , Gaffo Enrico , Dal Molin Anna , Roels Juliette , Germano Giuseppe , Siddi Maria Teresa , Serafin Valentina , De Decker Matthias , Gachet Stéphanie , Durinck Kaat , Speleman Frank , Taghon Tom , te Kronnie Geertruij , Van Vlierberghe Pieter , Bortoluzzi Stefania 
Published: December 2020

AbstractCircular RNAs (circRNAs) are stable RNA molecules that can drive cancer through interactions with microRNAs and proteins and by the expression of circRNA encoded peptides. The aim of the study was to define the circRNA landscape and potential impact in T-cell acute lymphoblastic leukemia (T-ALL). Analysis by CirComPara of RNA-sequencing data from 25 T-ALL patients, immature, HOXA overexpressing, TLX1, TLX3, TAL1, or LMO2 rearranged, and from thymocyte populations of human healthy donors disclosed 68 554 circRNAs. Study of the top 3447 highly expressed circRNAs identified 944 circRNAs with significant differential expression between malignant T cells and normal counterparts, with most circRNAs displaying increased expression in T-ALL. Next, we defined subtype-specific circRNA signatures in molecular genetic subgroups of human T-ALL. In particular, circZNF609, circPSEN1, circKPNA5, and circCEP70 were upregulated in immature, circTASP1, circZBTB44, and circBACH1 in TLX3, circHACD1, and circSTAM in HOXA, circCAMSAP1 in TLX1, and circCASC15 in TAL-LMO. Backsplice sequences of 14 circRNAs ectopically expressed in T-ALL were confirmed, and overexpression of circRNAs in T-ALL with specific oncogenic lesions was substantiated by quantification in a panel of 13 human cell lines. An oncogenic role of circZNF609 in T-ALL was indicated by decreased cell viability upon silencing in vitro. Furthermore, functional predictions identified circRNA-microRNA gene axes informing modes of circRNA impact in molecular subtypes of human T-ALL.