bluuebunny/crossref_metadata_2025_split huggingface dataset:
An instrument for assessing the quality of informed consent documents for elective procedures: development and testing
Authors: Spatz Erica S , Suter Lisa G , George Elizabeth , Perez Mallory , Curry Leslie , Desai Vrunda , Bao Haikun , Geary Lori L , Herrin Jeph , Lin Zhenqiu , Bernheim Susannah M , Krumholz Harlan M 
Published: May 2020

ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.InterventionsWith stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.ConclusionsWe identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.
Global and regional geographical prevalence of depression in gastric cancer: a systematic review and meta-analysis
Authors: Kouhestani Mostafa , Ahmadi Gharaei Hasan , Fararouei Mohammad , Hosienpour Ghahremanloo Hasan , Ghaiasvand Reza , Dianatinasab Mostafa 
Published: May 2020

BackgroundSubstantial uncertainty exists about the prevalence of depression in patients with gastric cancer. We aimed to summarise the global and regional pooled prevalence of depression among patients with gastric cancer.MethodUp to February 2020, we searched PubMed/MEDLINE, Embase, Scopus, Web of science (ISI) and PsychINFO to identify published studies on the prevalence of depression among patients with gastric cancer. The study selection procedure was in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We estimated the prevalence of depression in gastric cancer patients using a random-effect pooled estimate analysis approach with subgroup analysis based on WHO regions, and methods of depression measurement.ResultsTotally, we retrieved 3781 studies from the previously mentioned databases, of which 18 (12 cross-sectional and 6 cohort studies in design) met the eligibility criteria, which were published from 2001 to 2017 in different regions. The total sample size of the included studied contained 4709 patients with gastric cancer, of which 1885 cases were diagnosed with depression. The pooled prevalence of depression among gastric cancer patients was 37%(95% CI: 26% to 48%). Subgroup analysis showed that the highest prevalence of depression was in Eastern Mediterranean (pooled prevalence=42%; 95% CI: 18% to 65%) followed by the Western Pacific region (pooled prevalence=40%;95% CI: 26% to 54%). The results indicated a significant heterogeneity (I2=98.8%,P<0.05).ConclusionOur findings indicated that depression is high among gastric cancer patients. The findings suggest health authorities to provide specially designed social and psychological supportive care services, including screening for depression, among such patients.PROSPERO registration numberCRD42020139836.
Chromosome 6p Amplification in Aqueous Humor Cell-Free DNA Is a Prognostic Biomarker for Retinoblastoma Ocular Survival
Authors: Xu Liya , Polski Ashley , Prabakar Rishvanth K. , Reid Mark W. , Chevez-Barrios Patricia , Jubran Rima , Kim Jonathan W. , Kuhn Peter , Cobrinik David , Hicks James , Berry Jesse L. 
Published: May 2020

AbstractAqueous humor contains tumor-derived cell-free DNA (cfDNA) and can serve as a liquid biopsy for retinoblastoma. We previously associated somatic copy-number alteration (SCNA) 6p gain with a 10-fold increased risk of enucleation. Here we provide a 2-year update to further explore 6p gain as a prognostic biomarker for ocular survival. Patients diagnosed with retinoblastoma from December 2014 to July 2019 from whom aqueous humor was sampled were included. cfDNA was extracted and shallow whole-genome sequencing performed to identify highly recurrent retinoblastoma SCNAs (gain of 1q, 2p, 6p, loss of 13q, 16q). 116 aqueous humor samples from 50 eyes of 46 patients were included: 27 eyes were salvaged, 23 were enucleated. Highly recurrent retinoblastoma SCNAs were found in 66% eyes. 6p gain was the most prevalent SCNA (50% eyes). It was particularly more prevalent in enucleated eyes (73.9%) than in salvaged eyes (29.6%; P = 0.004). 6p gain in aqueous humor cfDNA portended nearly 10-fold increased odds of enucleation (OR = 9.87; 95% confidence interval = 1.75–55.65; P = 0.009). In the enucleated eyes, 6p gain was associated with aggressive histopathologic features, including necrosis, higher degrees of anaplasia, and focal invasion of ocular structures. With extended follow-up and nearly double the aqueous humor samples, we continue to demonstrate 6p gain as a potential prognostic biomarker for retinoblastoma.Implications:Aqueous humor is a high-yield source of tumor-derived DNA in retinoblastoma eyes. Detection of 6p gain in the aqueous humor allows for targeted, patient-centered therapies based on this molecular prognostic marker. Prospective, multicenter studies with aqueous humor sampled from all eyes at diagnosis are warranted to validate these findings.
Fibroblast Growth Factor 21 is Related to Atherosclerosis Independent of Nonalcoholic Fatty Liver Disease and Predicts Atherosclerotic Cardiovascular Events
Authors: Wu Liang , Qian Lingling , Zhang Lei , Zhang Jing , Zhou Jia , Li Yuehua , Hou Xuhong , Fang Qichen , Li Huating , Jia Weiping 
Published: May 2020

Background

FGF21 (fibroblast growth factor 21), a novel hepatokine regulating lipid metabolism, has been linked to atherosclerotic disease. However, whether this relationship exists in patients without nonalcoholic fatty liver disease is unclear. We assessed the association between serum
FGF
21 levels and atherosclerosis in patients without nonalcoholic fatty liver disease, and investigated whether baseline
FGF
21 could predict incident atherosclerotic cardiovascular disease in a 7‐year prospective cohort.

Methods and Results

Baseline serum
FGF
21 was measured in a cross‐sectional cohort of 371 patients with type 2 diabetes mellitus without nonalcoholic fatty liver disease (determined by hepatic magnetic resonance spectroscopy), and in a population‐based prospective cohort of 705 patients from the Shanghai Diabetes Study. In the cross‐sectional study,
FGF
21 was significantly higher in patients with than in those without subclinical carotid atherosclerosis (
P
<0.01). The association remained significant after adjusting for demographic and traditional cardiovascular risk factors. In the prospective cohort, 80 patients developed atherosclerotic cardiovascular disease during follow‐up. Baseline
FGF
21 was significantly higher in those who developed ischemic heart disease or cerebral infarction than in those who did not. Using a cutoff serum concentration of 232.0 pg/mL, elevated baseline
FGF
21 independently predicted incident total atherosclerotic cardiovascular disease events, ischemic heart disease, and cerebral infarction in a nondiabetic population (all
P
<0.05), and significantly improved the discriminatory and reclassifying abilities of our prediction model after adjustment for established cardiovascular risk factors.

Conclusions

This study provides the first evidence that
FGF
21 levels are elevated in patients without nonalcoholic fatty liver disease with subclinical atherosclerosis. Baseline
FGF
21 is an independent predictor of atherosclerotic cardiovascular disease and represents a novel biomarker for primary prevention in the general population.
Morphological and molecular characterisation of Telotylenchus tamariscus n. sp. (Nematoda: Telotylenchinae) recovered from Khuzestan, south-western Iran
Authors: Hosseinvand Manouchehr , Eskandari Ali , Ghaderi Reza 
Published: May 2020

Summary
An undescribed species from the rhizosphere of tamarisk, Tamarix passerinoides, Telotylenchus tamariscus n. sp., is illustrated and described based on morphological, morphometric and molecular approaches. The new species is characterised by female characters including body size of ca 1 mm, areolated lateral fields, cephalic region rounded, distinctly set off from the body contour, stylet 19.5 (18.5-20.5) μm long with posteriorly directed basal knobs, pharyngeal glands overlapping intestine dorso-laterally, subcylindrical tail bearing 32 (25-37) cuticular annuli and ending in an annulated terminus, and male spicules and gubernaculum 27 (25-29) and 13 (12.5-14.5) μm long, respectively. Morphologically, our population comes close to several known species of the genus, including T. avaricus, T. aerolatus, T. indicus, T. ventralis, T. paaloofi and T. namibiensis. In the 18S rRNA phylogenetic tree, it occupied a phylogenetic position in close affinity with two sequences of T. ventralis. In the 28S rRNA tree, the genus Telotylenchus did not form a monophyletic group, our isolate clustering with an unknown population of Histotylenchus and four isolates of Tylenchorhynchus mediterraneus in a clade well separated from another clade that included three other isolates tentatively named as Telotylenchus sp.
The Role of the State in the Exercise of Transnational Public and Private Authority over Labour Standards
Authors: Diller Janelle M. 
Published: May 2020

Interdependence among States in an era of globalization exacerbates the increasing emphasis on competing claims of national interest in the global arena. Rising nationalism is a symptom of the weakness of conception of transnational governance that insufficiently coordinates public and private interactions across multiple systems of governance which overlap on matters of common interest such as labour standards. The State-centric system of world governance lacks effective structures to bridge the gap between transnational labour governance (‘TLG’) and national, interstate, and international governance. However, emerging evidence suggests that the State is capable of facilitating inclusive and consensual action with non-state bodies of collective interest at national and transnational levels that helps connect TLG with national and international governance. This review compares differing degrees and methods of State action in selected TLG prototypes and their outcomes relevant to public and private policy choices affecting decent work and equal opportunity for well-being. Particular focus is placed on the State’s role in attributing private authority to non-state bodies of collective interest, facilitating consensual decision-making and regulatory action, aligning TLG with international norms and relevant national law and institutions, and cooperating in TLG with other States, including with or through international organizations. Challenges to effective TLG, such as opting-out, competing structures, and difficulty in leveraging short-term initiatives for longer-term capacity, are examined within the context of the legitimacy and coherence of TLG systems and across phases of governance, including agenda setting, norm development, implementation, oversight, evaluation, correction and revision. Preliminary conclusions call for further theoretical and empirical research to evaluate factors that influence such innovations and the extent to which they lead to durable and effective TLG within and across States that advances decent work and equal opportunity for well-being in globalized markets.
Rethinking Play, Diversity and Belonging in Early Childhood Education
Authors: ARNDT Sonja 
Published: May 2020

We might say that children’s play is the foundation of all learning. Often play is recognized as integral to childhood, but children’s abilities to engage in play are complex and these complexities can be easily overlooked. This paper elevates children’s play as critical for their learning, particularly in support of their sense of belonging. The paper argues for an openness to the complexities of children’s play as a crucial practice of their cultural identity, through a critical conceptualization of some of the nuances and uncertainties of children’s subject formation.
Drawing on concerns of cultural difference in early childhood education, Julia Kristeva’s foreigner lens and her theory on the subject in process are used to theorise children’s play as an ongoing process of belonging. Through the notions of the semiotic, abjection, love and revolt, the notion of the subject in process is elaborated to reconceptualize play as also in-process and ongoing. Rethinking play as a vital process within the sometimes difficult, often unpredictable experiences of becoming part of a centre community is elevated as crucial for a sense of belonging in early childhood education.
Unpacking the Levels of Household and Individual Climate Change Adaptation: Empirical Evidence from Leeds, United Kingdom
Authors: Otum Ume Chukwuma , Onah Ogochukwu , Adeosun Kehinde Paul , Nnamdi Onyekwe Chris , Ihedioha Nice Nneoma , Onyia Chukwuemeka , Orie Idika Ezinne 
Published: May 2020

AbstractThis study set out to empirically determine the current state of individual and household adaptation to climate change in the United Kingdom and how policy makers can improve on it. The study utilized both qualitative and quantitative approaches (mixed method). For the quantitative aspect of the study, a quota-sampling technique was employed in the selection of 650 respondents for the study using a well-structured questionnaire. The quota representation was based on age and gender. Data were analyzed using descriptive statistics and binary logit regression. In addition, qualitative content/topic analysis of an in-depth interview of the respondents was employed in further analyzing why and how policy makers can improve climate change adaptation. Findings from the study indicate the dire need for continued government support in household and individual adaptation in Leeds, and this support should also be encouraged in other cities where government intervention is low. Interventions in the form of subsidies, direct regulations, and public awareness are needed. The implementation of these measures is expected to generate a wide range of additional benefits to most vulnerable groups who should be central to the rapidly expanding climate change research and policy agenda in the United Kingdom.
Early Integrated Palliative Care Bundle Impacts Location of Death in Interstitial Lung Disease: A Pilot Retrospective Study
Authors: Archibald Nathan , Bakal Jeffrey A. , Richman-Eisenstat Janice , Kalluri Meena 
Published: May 2020

Background: Interstitial lung diseases (ILDs) comprise a heterogeneous group of fibrotic, progressive pulmonary diseases characterized by poor end-of-life care and hospital deaths. In 2012, we launched our Multidisciplinary Collaborative (MDC) ILD clinic to deliver integrated palliative approach throughout disease trajectory to improve care. We sought to explore the effects of palliative care and other factors on location of death (LOD) of patients with ILD. Methods: The MDC-ILD clinic implemented a palliative care bundle including advance care planning (ACP), opiates use, allied health home care engagement, and use of supplemental oxygen and early caregiver engagement in care. Data from patients with ILD who attended the clinic and died between 2012 and 2019 were used to generate scores representing the components and duration of palliative care (palliative care bundle score) and caregiver involvement (caregiver engagement score). We examined the impact of these scores on patients’ LOD. Results: A total of 92 MDC-ILD clinic patients were included, 57 (62%) had home or hospice deaths. Patients who died at home or hospice had higher palliative care bundle scores (10.0 ± 4.0 vs 7.8 ± 3.9, P = .01) and caregiver engagement scores (1.7 ± 0.6 vs 1.3 ± 0.7, P = .01) compared to those who died in hospital. Patients were 1.13 times more likely to die at home or hospice following a 1-point increase in palliative care bundle score (95% CI: 1.01-1.29, P = .04) and 2.38 times more likely following a 1-point increase in caregiver engagement score (95% CI: 1.17-5.15, P = .02). Conclusions: Home and hospice deaths are feasible in ILD. Early initiation of palliative care bundle components such as ACP discussions, symptom self-management, caregiver engagement, and close collaboration with allied health home care supports can promote adherence to patient preference for home or hospice deaths.
Short-term outcomes of intravitreal dexamethasone in relation to biomarkers in diabetic macular edema
Authors: Narnaware Shilpi Harshal , Bawankule Prashant Keshao , Raje Dhananjay 
Published: May 2020

Purpose: The purpose of this study was to determine the effects of dexamethasone implant (0.7 mg) on biomarkers such as hyper-reflective dots, external limiting membrane integrity and disorganization of retinal inner layers in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases with diabetic macular edema and its effects on edema and visual acuity. Methods: This is a prospective study of treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder patients with diabetic macular edema, treated with single dexamethasone implant. Pre- and post-injection-based best-corrected visual acuity, central macular thickness, hyper-reflective dots, external limiting membrane integrity and disorganization of retinal inner layers were assessed. Results: A total of 27 diabetic macular edema eyes, including 9 non-responder eyes, 9 eyes which received less than three anti-vascular endothelial growth factor injections and 9 treatment-naïve eyes, were included in this study. Baseline hyper-reflective dots were 22.22 ± 11.76, 30 ± 7.91 and 19.44 ± 8.82 which reduced to 3.33 ± 1.32, 9 ± 8.35 and 8.78 ± 2.53 four months after implant in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases, respectively. Baseline central macular thickness was 589.44 ± 175.37, 537 ± 181.81 and 673.11 ± 138.24 and the central macular thickness after dexamethasone implant was 272.11 ± 39.00, 336.44 ± 132.88 and 524.00 ± 200.39 in treatment-naïve patients, patients who received less than three anti-vascular endothelial growth factor injections and non-responder cases, respectively. External limiting membrane integrity was restored in two patients in each group, whereas two patients with disorganization of retinal inner layers in treatment-naïve group showed reorganization of retinal structures after treatment with dexamethasone implant. Conclusion: Better response to dexamethasone implant in cases with more hyper-reflective dots shows that these hyper-reflective dots can be used as a predictive biomarker. Dexamethasone implant might help in restoring external limiting membrane integrity and resolution of disorganization of retinal inner layers.
Outcomes of comprehensive treatment for primary osteosarcoma
Authors: Hashimoto Kazuhiko , Nishimura Shunji , Oka Naohiro , Akagi Masao 
Published: May 2020

Purpose: This study aimed to evaluate the clinical features and outcomes of osteosarcoma to identify prognostic factors and determine new strategies to improve overall survival. Patients and Methods: We retrospectively analyzed 12 cases of osteosarcoma treated at our hospital from 2012 to 2017. Tumor site, tissue type, stage, treatments, adverse effects, postoperative limb function, surgical margin, and final outcomes were evaluated. Results: All patients received chemotherapy, and 10 underwent wide resection. The Musculoskeletal Tumor Society scores were more than good in all cases, and the 3-year survival rate was 73.3%. Two patients are alive with disease, eight have remained disease-free, and two died of the disease. Three of the four recurrent cases involved the pelvis. Conclusion: The treatment of primary osteosarcoma with wide resection in our department, therefore, yielded favorable outcomes. However, improved treatment strategies are needed for pelvic and advanced cases.
Something to Sweat About: Two Cases of Dupilumab-Induced Hyperhidrosis and Bromhidrosis
Authors: Rowane Marija , Valencia Reimus , Schend Jason , Jhaveri Devi , Hostoffer Robert 
Published: May 2020

Introduction Atopic dermatitis (AD, eczema) is familial chronic inflammatory skin disease of complex etiology and increasing prevalence. Dupilumab is an IL-4 receptor subunit alpha (IL-4Rα) antagonist that is the first Food and Drug Administration-approved biological therapy for moderate-to-severe adult AD inadequately controlled with topical therapies. Adverse effects reported in the literature include injection site reactions, conjunctivitis, headache, and nasopharyngitis. Objective We report the first cases of hyperhidrosis and bromhidrosis as side effects from dupilumab (Dupixent®) for the treatment of AD. Case Reports Case 1 is a 20-year-old woman with controlled allergic rhinitis and severe AD reported axillary hyperhidrosis with bromhidrosis, comparable to sweat from high-intensity exercise, with no relief from several different over-the-counter antiperspirants. Case 2 is a 61-year-old woman with history of chronic asthma, allergic contact dermatitis, allergic rhinitis, and AD noticed markedly increased sweating with bromhidrosis that was reminiscent of her menopausal symptomology, about 3 months after initiating dupilimab. Discussion Traditional immunosuppressive agents and corticosteroids have limited efficacy, numerous side effects, and increased risk of infection. The safety profile and efficacy of the newly approved IL-4Rα antagonist dupilumab may be favorable to oral immunosuppressants, but its use remains limited to severe recalcitrant cases, due to financial implications and lack of long-term safety data and comparative head-to-head trials. Conclusion We report improved outcomes with dupilumab, in addition to unpublished cases of bromhidrosis and hyperhidrosis in 2 patients with AD. This report of additional complications may inspire further clinical research and assist clinicians in considering the option of dupilumab for uncontrolled AD, despite aggressive traditional treatment.