bluuebunny/crossref_metadata_2025_split huggingface dataset:
Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study
Authors: Iflaifel Mais , Sprange Kirsty , Bell Jennifer , Cook Andrew , Gamble Carrol , Julious Steven A. , Juszczak Edmund , Linsell Louise , Montgomery Alan , Partlett Christopher 
Published: January 2023

Abstract
Background
Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, there remains substantial variation in practice between UK Clinical Trials Units (CTUs) when it comes to blinding statisticians. Therefore, the aim of this study was to develop guidance to advise CTUs on a risk-proportionate approach to blinding statisticians within clinical trials.

Methods
This study employed a mixed methods approach involving three stages: (I) a quantitative study using a cohort of 200 studies (from a major UK funder published between 2016 and 2020) to assess the impact of blinding statisticians on the proportion of trials reporting a statistically significant finding for the primary outcome(s); (II) a qualitative study using focus groups to determine the perspectives of key stakeholders on the practice of blinding trial statisticians; and (III) combining the results of stages I and II, along with a stakeholder meeting, to develop guidance for UK CTUs.

Results
After screening abstracts, 179 trials were included for review. The results of the primary analysis showed no evidence that involvement of an unblinded trial statistician was associated with the likelihood of statistically significant findings being reported, odds ratio (OR) 1.02 (95% confidence interval (CI) 0.49 to 2.13). Six focus groups were conducted, with 37 participants. The triangulation between stages I and II resulted in developing 40 provisional statements. These were rated independently by the stakeholder group prior to the meeting. Ten statements reached agreement with no agreement on 30 statements. At the meeting, various factors were identified that could influence the decision of blinding the statistician, including timing, study design, types of intervention and practicalities. Guidance including 21 recommendations/considerations was developed alongside a Risk Assessment Tool to provide CTUs with a framework for assessing the risks associated with blinding/not blinding statisticians and for identifying appropriate mitigation strategies.

Conclusions
This is the first study to develop a guidance document to enhance the understanding of blinding statisticians and to provide a framework for the decision-making process. The key finding was that the decision to blind statisticians should be based on the benefits and risks associated with a particular trial.
Transitions in Metabolic Health Status and Obesity Over Time and Risk of Diabetes: The Dongfeng–Tongji Cohort Study
Authors: Wei Yue , Wang Ruixin , Wang Jing , Han Xu , Wang Fei , Zhang Zefang , Xu Yali , Zhang Xiaomin , Guo Huan , Yang Handong , Li Xiulou , He Meian 
Published: January 2023

Abstract

Context
Evidence regarding the association between metabolically healthy overweight or obesity (MHOO) and diabetes is controversial, and mostly ignores the dynamic change of metabolic health status and obesity.

Objective
To explore the association between transitions of metabolic health status and obesity over 5 years and diabetes incidence.

Methods
We examined 17 309 participants derived from the Dongfeng–Tongji cohort and followed from 2008 to 2018 (median follow-up 9.9 years). All participants were categorized into 4 phenotypes based on body mass index (BMI) and metabolic health status: metabolically healthy normal weight (MHNW), metabolically unhealthy normal weight (MUNW), MHOO, and metabolically unhealthy overweight or obesity (MUOO). The associations of changes in BMI–metabolic health status (2008-2013) with diabetes incidence (2018) were performed among 12 206 individuals with 2 follow-up examinations.

Results
Compared with stable MHNW, stable MHOO (hazard ratio [HR] 1.76; 95% CI 1.26, 2.45) and transition from MHOO to metabolically unhealthy phenotypes were associated with higher risk for diabetes (HR 2.97; 95% CI 1.79, 4.93 in MHOO to MUNW group and HR 3.38; 95% CI 2.54, 4.49 in MHOO to MUOO group). Instead, improvements to metabolic healthy phenotypes or weight loss occurring in MUOO reduced the risk of diabetes compared with stable MUOO, changing from MUOO to MHNW, MUNW, and MHOO resulted in HRs of 0.57 (95% CI 0.37, 0.87), 0.68 (95% CI 0.50, 0.93), and 0.45 (95% CI 0.34, 0.60), respectively.

Conclusion
People with MHOO, even stable MHOO, or its transition to metabolically unhealthy phenotypes were at increased risk of diabetes. Metabolic improvements and weight control may reduce the risk of diabetes.
The genome sequence of the Brick, Agrochola circellaris (Hufnagel, 1766)
Authors: Boyes Douglas ,   University of Oxford and Wytham Woods Genome Acquisition Lab,   Darwin Tree of Life Barcoding collective,   Wellcome Sanger Institute Tree of Life programme,   Wellcome Sanger Institute Scientific Operations: DNA Pipelines collective,   Tree of Life Core Informatics collective, Hoile Asia ,   Darwin Tree of Life Consortium
Published: January 2023

We present a genome assembly from an individual male Agrochola circellaris (the Brick; Arthropoda; Insecta; Lepidoptera; Noctuidae). The genome sequence is 572 megabases in span. Most of the assembly is scaffolded into 30 chromosomal pseudomolecules, including the Z sex chromosome. The mitochondrial genome has also been assembled and is 15.5 kilobases in length. Gene annotation of this assembly on Ensembl has identified 18,319 protein coding genes.
Analytics Saves Lives During the COVID-19 Crisis in Chile
Authors: Basso Leonardo J. , Goic Marcel , Olivares Marcelo , Sauré Denis , Thraves Charles , Carranza Aldo , Weintraub Gabriel Y. , Covarrubia Julio , Escobedo Cristian , Jara Natalia , Moreno Antonio , Arancibia Demian , Fuenzalida Manuel , Uribe Juan Pablo , Zúñiga Felipe , Zúñiga Marcela , O’Ryan Miguel , Santelices Emilio , Torres Juan Pablo , Badal Magdalena , Bozanic Mirko , Cancino-Espinoza Sebastián , Lara Eduardo , Neira Ignasi 
Published: January 2023

During the COVID-19 crisis, the Chilean Ministry of Health and the Ministry of Sciences, Technology, Knowledge and Innovation partnered with the Instituto Sistemas Complejos de Ingeniería (ISCI) and the telecommunications company ENTEL, to develop innovative methodologies and tools that placed operations research (OR) and analytics at the forefront of the battle against the pandemic. These innovations have been used in key decision aspects that helped shape a comprehensive strategy against the virus, including tools that (1) provided data on the actual effects of lockdowns in different municipalities and over time; (2) helped allocate limited intensive care unit (ICU) capacity; (3) significantly increased the testing capacity and provided on-the-ground strategies for active screening of asymptomatic cases; and (4) implemented a nationwide serology surveillance program that significantly influenced Chile’s decisions regarding vaccine booster doses and that also provided information of global relevance. Significant challenges during the execution of the project included the coordination of large teams of engineers, data scientists, and healthcare professionals in the field; the effective communication of information to the population; and the handling and use of sensitive data. The initiatives generated significant press coverage and, by providing scientific evidence supporting the decision making behind the Chilean strategy to address the pandemic, they helped provide transparency and objectivity to decision makers and the general population. According to highly conservative estimates, the number of lives saved by all the initiatives combined is close to 3,000, equivalent to more than 5% of the total death toll in Chile associated with the pandemic until January 2022. The saved resources associated with testing, ICU beds, and working days amount to more than 300 million USD. Funding: This work was supported by the ANID PIA/APOYO [Grant AFB180003 and AFB220003], used to hire research assistants for developing solutions, information systems, data management, and training of field staff. Fieldwork was funded by the Ministry of Health of the Government of Chile. M. Goic acknowledges the financial support of Fondecyt [Project 1221711] and the Institute for Research in Market Imperfections and Public Policy [Grant IS130002 ANID]. D. Sauré acknowledges the financial support of Fondecyt [Project 1211407]. Finally, G. Weintraub and A. Carranza thank the Stanford RISE COVID-19 Crisis Response Faculty Seed Grant Program for helpful financial support.
Berberine inhibits RA-FLS cell proliferation and adhesion by regulating RAS/MAPK/FOXO/HIF-1 signal pathway in the treatment of rheumatoid arthritis
Authors: Li Zhiqi , Chen Meilin , Wang Zhaoyi , Fan Qiqi , Lin Zili , Tao Xiaoyu , Wu Jiarui , Liu Zhenquan , Lin Ruichao , Zhao Chongjun 
Published: January 2023

Aims Rheumatoid arthritis (RA) is a common chronic immune disease. Berberine, as its main active ingredient, was also contained in a variety of medicinal plants such as Berberaceae, Buttercup, and Rutaceae, which are widely used in digestive system diseases in traditional Chinese medicine with anti-inflammatory and antibacterial effects. The aims of this article were to explore the therapeutic effect and mechanism of berberine on rheumatoid arthritis. Methods Cell Counting Kit-8 was used to evaluate the effect of berberine on the proliferation of RA fibroblast-like synoviocyte (RA-FLS) cells. The effect of berberine on matrix metalloproteinase (MMP)-1, MMP-3, receptor activator of nuclear factor kappa-Β ligand (RANKL), tumour necrosis factor alpha (TNF-α), and other factors was determined by enzyme-linked immunoassay (ELISA) kit. Transcriptome technology was used to screen related pathways and the potential targets after berberine treatment, which were verified by reverse transcription-polymerase chain reaction (RT-qPCR) and Western blot (WB) technology. Results Berberine inhibited proliferation and adhesion of RA-FLS cells, and significantly reduced the expression of MMP-1, MMP-3, RANKL, and TNF-α. Transcriptional results suggested that berberine intervention mainly regulated forkhead box O (FOXO) signal pathway, prolactin signal pathway, neurotrophic factor signal pathway, and hypoxia-inducible factor 1 (HIF-1) signal pathway. Conclusion The effect of berberine on RA was related to the regulation of RAS/mitogen-activated protein kinase/FOXO/HIF-1 signal pathway in RA-FLS cells. Cite this article: Bone Joint Res 2023;12(2):91–102.
Pre-pandemic geographic access to hospital-based telehealth for cancer care in the United States
Authors: Shalowitz David I. , Hung Peiyin , Zahnd Whitney E. , Eberth Jan 
Published: January 2023

Importance
Little is known about US hospitals’ capacity to ensure equitable provision of cancer care through telehealth.

Objective
To conduct a national analysis of hospitals’ provision of telehealth and oncologic services prior to the SARS-CoV-2 pandemic, along with geographic and sociodemographic correlates of access.

Design, setting, and participants
Retrospective cross-sectional analysis with Geographic Information Systems mapping of 1) 2019 American Hospital Association (AHA) Annual Hospital Survey and IT Supplement, 2) 2013 Urban Influence Codes (UIC) from the United States Department of Agriculture, 3) 2018 Area Health Resources Files from the Health Services and Resources Administration (HRSA).

Interventions
Hospitals were categorized by telehealth and oncology services availability. Counties were classified as low-, moderate-, or high-access based on availability of hospital-based oncology and telehealth within their boundaries.

Main outcomes and measures
Geospatial mapping of access to hospital-based telehealth for cancer care. Generalized logistic mixed effects models identified associations between sociodemographic factors and county- and hospital-level access to telehealth and oncology care.

Results
2,054 out of 4,540 hospitals (45.2%) reported both telehealth and oncology services. 272 hospitals (6.0%) offered oncology without telehealth, 1,369 (30.2%) offered telehealth without oncology, and 845 (18.6%) hospitals offered neither. 1,288 out of 3,152 counties with 26.6 million residents across 41 states had no hospital-based access to either oncology or telehealth. After adjustment, rural hospitals were less likely than urban hospitals to offer telehealth alongside existing oncology care (OR 0.27; 95% CI 0.14–0.55; p < .001). No county-level factors were significantly associated with telehealth availability among hospitals with oncology.

Conclusions and relevance
Hospital-based cancer care and telehealth are widely available across the US; however, 8.4% of patients are at risk for geographic barriers to cancer care. Advocacy for adoption of telehealth is critical to ensuring equitable access to high-quality cancer care, ultimately reducing place-based outcomes disparities. Detailed, prospective, data collection on telehealth utilization for cancer care is also needed to ensure improvement in geographic access inequities.
An integrative literature review of kidney transplantation knowledge tools
Authors: Kang Chan Mi , Lee Hyejin 
Published: January 2023

PurposeThis study aimed to identify knowledge measurement tools for kidney transplantation (KT) and confirm their assessment methods, domains, and validity to provide useful information.DesignAn integrative review based on Whittemore and Knafl’s (2005) framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 guidelines.MethodsAn integrative search was conducted using four English databases (PubMed, Embase, CINAHL, and the Cochrane Library) and the top three Korean databases (RISS, DBpia, and KISS). Search terms and strategies included (“kidney transplant*” OR “renal transplant*” OR “kidney replace*” OR “renal replace*” OR “kidney graft” OR “renal graft”) & (knowledge OR awareness) & (scale OR tool OR instrument OR questionnaire OR inventory). The time limit was set to February 2022. The extracted data included the content of the tools, participants, and psychometrics. Quality of life was assessed using a psychometric grading framework.ResultsA total of 15 studies and 13 tools were reviewed. Of these, seven studies (46.7%) targeted KT patients, five (33.3%) targeted KT candidates, and three (20.0%) included both groups. The number of items in the tools ranged from five to 33 items. Furthermore, seven tools comprised true-false questions and eight multiple-choice questions. The domains of the KT knowledge measurement tool used in each study differed across study participants. Both reliability and validity were confirmed in six tools, and only two showed a grade of “adequate” or higher.ConclusionA validated tool is required to measure KT knowledge. These tools can be used to evaluate the effectiveness of educational interventions in promoting self-management after KT.Protocol registration numberCRD42022334559.
Gaming Masculinity: Trolls, Fake Geeks and the Gendered Battle for Online Culture, Megan Condis (2018)
Authors: Driessen Simone 
Published: January 2023

Review of: Gaming Masculinity: Trolls, Fake Geeks and the Gendered Battle for Online Culture, Megan Condis (2018)
Iowa City: Iowa University Press, 138 pp.,
ISBN 978-1-60938-565-1, p/bk, $65.00
Boys’ Love, Cosplay, and Androgynous Idols: Queer Fan Cultures in Mainland China, Hong Kong, and Taiwan, Maud Lavin, Ling Yang and Jing Jamie Zhao (Eds) (2017)
Authors: Yang Xiaofei 
Published: January 2023

Review of: Boys’ Love, Cosplay, and Androgynous Idols: Queer Fan Cultures in Mainland China, Hong Kong, and Taiwan, Maud Lavin, Ling Yang and Jing Jamie Zhao (Eds) (2017)
Hong Kong: Hong Kong University Press, 258 pp.,
ISBN 978-9-88839-080-9, h/bk, $60.00 / £47.00
Theme Park Fandom: Spatial Transmedia, Materiality and Participatory Cultures, Rebecca Williams (2020)
Authors: Dye-Reeves Amy 
Published: January 2023

Review of: Theme Park Fandom: Spatial Transmedia, Materiality and Participatory Cultures, Rebecca Williams (2020)
Amsterdam: Amsterdam University Press, 260 pp.,
ISBN 978-9-46298-257-4, h/bk, $127.00
Effect of Negative Pressure Wound Therapy on Diabetic Foot Ulcers
Authors: Prerana Raju Gudimetla  , Swarnadeepu Shabasu  , Akshay Duppelly  , Yadagiri Rao Jeripotula  
Published: January 2023

BACKGROUND
In this study, we wanted to evaluate the effect of negative pressure wound therapy on diabetic foot ulcers.
METHODS
This was a hospital based prospective comparative study, conducted among 40 patients who came for treatment of diabetic foot ulcers to the Department of General Surgery, Kamineni Academy of Medical Sciences and Research Centre, Hyderabad, Telangana, over a period of 2 years from September 2019 to September 2021, after obtaining clearance from Institutional Ethics Committee and written informed consent from the study participants.
RESULTS
The increase in amount of granulation tissue negative pressure wound therapy (NPWT) and saline-soaked gauzed dressing (SSGD groups were found to be statistically significant. Mean change (increase in granulation tissue in NPWT & SSGD groups) from day 0 to day 42 were 78.083 % and 66.103 % respectively. Whereas in NPWT and SSGD groups, the size of ulcer was decreased which was statistically significant. Mean decrease in ulcer size in NPWT & SSGD groups from day 0 to day 42 were 52 cm sq and 29.15 cm sq respectively. The mean duration of stay in hospital in NPWT & SSGD groups were 29.35 + 4.51 days and 32.75 + 4.75 days with p value of 0.02, which is statistically significant. Among patients with NPWT, response was present in 95 % (19) patients and among patients with SSGD, response was present in 85 % (17) patients. The association between the groups was found to be statistically not significant.
CONCLUSIONS
Length of stay was shorter in the NPWT group when compared with that of SSGD group. Rate of granulation tissue formation was faster in NPWT group when compared to SSGD group. Reduction in ulcer size was significantly better in the NPWT group. Patient compliance and satisfaction was better in NPWT group. Lesser number of changes of dressings were needed in the NPWT group. It could be concluded that negative pressure wound therapy helps in faster healing, better, safe, and convenient as compared to saline soaked gauzed dressing in the treatment of diabetic foot ulcers.
Study of Lung Function in COVID-19 Pneumonia Recovered Individuals
Authors: Mekala Kamala Priyadarshini  , Moravineni Usha Rani  
Published: January 2023

BACKGROUND
Corona virus disease 2019 (COVID-19) is an acute respiratory infectious disease caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). Pulmonary system is the most commonly affected organ system by COVID-19. SARS-CoV-2 results in disruption of ACE/ACE2 balance leading to RAAS activation. The present study was carried out to determine the lung function in the recovery phase of COVID -19 by spirometry in India.
METHODS
A prospective (Follow up) observational study was done on 100 patients from March 2021 to November 2021. COVID-19 patients with RT-PCR positive results aged between 25 to 60 years were enrolled in the study. All the subjects were health care workers working in King George Hospital, Visakhapatnam. They were followed for a period of 3 months.
RESULTS
The mean age was 48.35 ± 11.07 years. 71 % were males. The mean height was 162.85 ± 7.47 cm while the mean weight was 36.71 ± 1.12 kg. During enrolment, the mean forced vital capacity (FVC) was 2.22 ± 0.68 L, forced expiratory volume (FEV1) was 1.97 ± 0.63 L and FEV1/FVC% was 89.35 ± 13.27 %. There was no statistically significant difference in FVC between enrolment and various periods of follow up at 1 and 3 months. There was a statistically significant difference between FEV1 and FEV1/FVC% between enrolment and various periods of follow up at 1 and 3 months.
CONCLUSIONS
COVID-19 infection has an impact on the lung functions. PFT done 3 months later after clinical cure/discharge showed an improvement in FEV1 and FEV1/FVC% in the present study. Long-term follow-up of the lung function in post-COVID-19 survivors is recommended.
Nutrition Literacy Is Not Sufficient to Induce Needed Dietary Changes in Nonalcoholic Fatty Liver Disease
Authors: Carroll Allison M. , Rotman Yaron 
Published: January 2023

INTRODUCTION:
Dietary and lifestyle changes are the first line of therapy for nonalcoholic fatty liver disease (NAFLD), the most prevalent liver disease in the western world. Nutrition literacy is the ability to understand nutrition information and implement that knowledge. We aimed to compare indicators of nutrition literacy in subjects with and without NAFLD in a representative US cohort.

METHODS:
In a cross-sectional study using data from the National Health and Nutrition Examination Survey 2017–2018 cycle, we included 2,938 adult subjects with complete dietary and vibration-controlled transient elastography data and no alternative reason for hepatic steatosis. Nutrition literacy was assessed using questionnaires. Diet perception accuracy was assessed by comparing self-reported diet quality with objective diet quality scores—the Healthy Eating Index and alternative Mediterranean diet score—to assess real-world application of nutrition knowledge.

RESULTS:
Nutrition literacy was not different between subjects with or without NAFLD (P = 0.17): more than 90% of subjects reported using nutrition labels, and most of them correctly identified the meaning of daily value. Subjects with NAFLD had a lower-quality diet (Healthy Eating Index, P = 0.018; alternative Mediterranean diet, P = 0.013) and rated their diet as poorer (P < 0.001). On self-assessment, only 27.8% of subjects overestimated their diet quality, while 37.5% consumed more calories than their self-assessed needs. Both accuracy measures were similar between subjects with NAFLD and those without (P = 0.71 and 0.63, respectively). Subjects with NAFLD were more likely to report being advised to lose weight (42.1% vs 16.5%, P < 0.001) or to attempt losing weight (71.9% vs 60.9%, P < 0.001). Diet quality was not better in subjects with NAFLD who received dietary recommendations.

DISCUSSION:
Subjects with NAFLD have poor diet quality despite receiving medical recommendations to lose weight and having nutrition literacy and perception that are comparable with subjects without NAFLD. Educational approaches may not be sufficient to promote weight loss and improve diet quality in NAFLD.
It Can't Be a Coincidence: A Comparison of Cases of Autoimmune Hepatitis After Vaccination Against COVID-19
Authors: Gips Julia R. , Woreta Tinsay A. 
Published: January 2023

ABSTRACT
While rare, there is now a documented cohort of patients presenting with autoimmune hepatitis secondary to vaccination against COVID-19. With this case report, we aim to compare the published cases in order to discern any unifying characteristics among those affected, and share the story of a seventy-two-year old patient presenting with autoimmune hepatitis less than two weeks after receiving his first dose of the Pfizer COVID-19 vaccine.