bluuebunny/crossref_metadata_2025_split huggingface dataset:
Coagulopathy is a major extrapulmonary risk factor for mortality in hospitalized patients with COVID-19 with type 2 diabetes
Authors: Chen Xiaoyan , Chen Ying , Wu Chaomin , Wei Ming , Xu Jie , Chao Yen-cheng , Song Juan , Hou Dongni , Zhang Yuye , Du Chunling , Li Xiaoying , Song Yuanlin 
Published: November 2020

IntroductionTo investigate the risk factors for the death in patients with COVID-19 with type 2 diabetes mellitus (T2DM).Research design and methodsWe retrospectively enrolled inpatients with COVID-19 from Wuhan Jinyintan Hospital (Wuhan, China) between December 25, 2019, and March 3, 2020. The epidemiological and clinical data were compared between non-T2DM and T2DM or between survivors and non-survivors. Univariable and multivariable Cox regression analyses were used to explore the effect of T2DM and complications on in-hospital death.ResultsA total of 1105 inpatients with COVID-19, 967 subjects with without T2DM (n=522 male, 54.0%) and 138 subjects with pre-existing T2DM (n=82 male, 59.4%) were included for baseline characteristics analyses. The complications were also markedly increased in patients with pre-existing T2DM, including acute respiratory distress syndrome (ARDS) (48.6% vs 32.3%, p<0.001), acute cardiac injury (ACI) (36.2% vs 16.7%, p<0.001), acute kidney injury (AKI) (24.8% vs 9.5%, p<0.001), coagulopathy (24.8% vs 11.1%, p<0.001), and hypoproteinemia (21.2% vs 9.4%, p<0.001). The in-hospital mortality was significantly higher in patients with pre-existing T2DM compared with those without T2DM (35.3% vs 17.4%, p<0.001). Moreover, in hospitalized patients with COVID-19 with T2DM, ARDS and coagulopathy were the main causes of mortality, with an HR of 7.96 (95% CI 2.25 to 28.24, p=0.001) for ARDS and an HR of 2.37 (95% CI 1.08 to 5.21, p=0.032) for coagulopathy. This was different from inpatients with COVID-19 without T2DM, in whom ARDS and cardiac injury were the main causes of mortality, with an HR of 12.18 (95% CI 5.74 to 25.89, p<0.001) for ARDS and an HR of 4.42 (95% CI 2.73 to 7.15, p<0.001) for cardiac injury.ConclusionsCoagulopathy was a major extrapulmonary risk factor for death in inpatients with COVID-19 with T2DM rather than ACI and AKI, which were well associated with mortality in inpatients with COVID-19 without T2DM.
New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial
Authors: Illés Dóra , Ivány Emese , Holzinger Gábor , Kosár Klára , Adam M Gordian , Kamlage Beate , Zsóri Gábor , Tajti Máté , Svébis Márk M , Horváth Viktor , Oláh Ilona , Márta Katalin , Váncsa Szilárd , Zádori Noémi , Szentesi Andrea , Czakó Bálint , Hegyi Péter , Czakó László 
Published: November 2020

IntroductionPancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection and prevention programmes. Patients with new-onset diabetes mellitus (DM) represent a high-risk group for PDAC as they have an eightfold higher risk of PDAC than the general population. The proposed screening programme may allow the detection of PDAC in the early, operable stage. Diagnosing more patients in the curable stage might decrease the morbidity and mortality rates of PDAC and additionally reduce the burden of the healthcare.Methods and analysisThis is a prospective, multicentre observational cohort study. Patients ≥60 years old diagnosed with new-onset (≤6 months) diabetes will be included. Exclusion criteria are (1) Continuous alcohol abuse; (2) Chronic pancreatitis; (3) Previous pancreas operation/pancreatectomy; (4) Pregnancy; (5) Present malignant disease and (6) Type 1 DM. Follow-up visits are scheduled every 6 months for up to 36 months. Data collection is based on questionnaires. Clinical symptoms, body weight and fasting blood will be collected at each, carbohydrate antigen 19–9 and blood to biobank at every second visit. The blood samples will be processed to plasma and analysed with mass spectrometry (MS)-based metabolomics. The metabolomic data will be used for biomarker validation for early detection of PDAC in the high-risk group patients with new-onset diabetes. Patients with worrisome features will undergo MRI or endoscopic ultrasound investigation, and surgical referral depending on the radiological findings. One of the secondary end points is the incidence of PDAC in patients with newly diagnosed DM.Ethics and disseminationThe study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (41085-6/2019). We plan to disseminate the results to several members of the healthcare system includining medical doctors, dietitians, nurses, patients and so on. We plan to publish the results in a peer-reviewed high-quality journal for professionals. In addition, we also plan to publish it for lay readers in order to maximalise the dissemination and benefits of this trial.Trial registration numberClinicalTrials.govNCT04164602
Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol
Authors: Tang Lili , Pang Ying , He Yi , Shi Qiuling , Han Xinkun , Li Zimeng , Zhou Chengcheng , Zhou Yuhe , He Shuangzhi , Wang Yan , Zhang Yening , Song Lili , Wang Bingmei , Li Xiumin 
Published: November 2020

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.Methods and analysisThe study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.Ethics and disseminationThe study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.Trial registration numberChiCTR1900023560.
Mental health recovery for survivors of modern slavery: grounded theory study protocol
Authors: Wright Nicola , Hadziosmanovic Emina , Dang Minh , Bales Kevin , Brookes Caroline , Jordan Melanie , Slade Mike 
Published: November 2020

IntroductionSlavery and human trafficking are crimes involving the violation of human rights and refer to exploitative situations where an individual cannot refuse or leave due to threats, coercion or abuse of power. Activities involving slavery include forced labour exploitation, forced sexual exploitation, forced marriage and servitude. Epidemiological studies show high levels of mental health need and poor provision of appropriate support for survivors. What mental health recovery means to victims/survivors and how it could be promoted is under-researched.Methods and analysisA grounded theory study based on individual interviews will be undertaken. Survivors across the UK will be identified and recruited from non-governmental organisations and via social media. As per grounded theory methodology, data collection and analysis will be undertaken concurrently and recruitment will continue until theoretical saturation is reached. It is anticipated that approximately 30 participants will be recruited. Interviews will be audio recorded, transcribed verbatim and uploaded to NVivo V.11. The constant comparative method will be used to analyse the data, in order to produce a theoretical framework for mental health recovery that is grounded in the experiences of survivors.Ethics and disseminationEthical approval has been obtained from the Faculty of Medicine and Health Sciences Ethics Committee at the University of Nottingham. The findings of the study will be disseminated to academic, professional and survivor-based audiences to inform future policy developments and the provision of mental health recovery support to this population.
Effect of spironolactone on cardiovascular morbidity and mortality in patients with hypertension and glucose metabolism disorders (ESCAM): a study protocol for a pragmatic randomised controlled trial
Authors: Li Nanfang , Lin Mengyue , Heizhati Mulalibieke , Wang Lin , Luo Qin , Li Yuanyuan , Yili Jina , Hong Jing , Yao Xiaoguang , Zhu Qing 
Published: November 2020

IntroductionHypertension combined with diabetes and hypokalemia is more likely to develop hyperaldosteronism and is at higher risk of cardiovascular events. There is evidence that activation of aldosterone and mineralocorticoid receptors may play a significant role in the occurrence of cardiovascular events in patients with hypertension and diabetes. Clinical studies have demonstrated that spironolactone can reduce the incidence of cardiovascular events in patients with chronic kidney diseases or severe heart failure. However, the effect of spironolactone on cardiovascular risk in patients with hypertension and glucose metabolism disorders (GMD) and low potassium has been scarcely studied. Therefore, this study aims to evaluate whether add-on spironolactone (conventional antihypertensive drugs alone vs conventional antihypertensive drugs+spironolactone) can reduce the morbidity and mortality of cardiovascular events in this population.Methods and analysisIn this multicentre, randomised, parallel-controlled study, a total of 7140 hypertensive patients aged 45–75 years with GMD and low potassium will be randomised in a 1:1 manner to the control or the spironolactone group (20 mg/day or with a maximum dose of 40 mg). The primary objective is to estimate the difference in the HR of composite cardiovascular events between the two groups. We will also assess the effects of spironolactone on individual cardiovascular events and the progression of diabetes and renal dysfunction.Ethics and disseminationThis protocol was approved by the Independent Ethics Committee of People’s Hospital of Xinjiang Uygur Autonomous Region (no. 2020020618). The results will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberChiCTR2000028909.
Use of dating sites and applications by women and their risk of sexually transmitted infections: a systematic review and meta-analysis protocol
Authors: Queiroz Janice França , Medeiros Kleyton Santos , Sarmento Ayane Cristine Alves , Monteiro Michelly Nóbrega , Cobucci Ricardo Ney , Stransky Beatriz , Gonçalves Ana Katherine 
Published: November 2020

IntroductionThe use of social networks has been increasing worldwide. Mobile websites and applications (apps) allow people to network more quickly and have more partners for sex. This can facilitate risky sexual behaviours, such as having multiple partners and unprotected sex, which can lead to a higher incidence of sexually transmitted infections. This systematic review/meta-analysis will assess the effects of the use of dating sites and apps by women on their level of engagement in risky sexual behaviours and their incidence of sexually transmitted infections.Methods and analysisThe Cochrane Central Controlled Trials Registry, ClinicalTrials.gov, MEDLINE, Embase, SciELO, Web of Science, Scopus and Cumulative Index to Nursing & Allied Health Literature will be searched for cross-sectional studies, clinical trials and observational studies published between January 1990 and July 2020. This systematic review and meta-analysis will include studies investigating the use of mobile apps by women, risky sexual behaviour and sexually transmitted infections. The outcome will be an increase in new cases of sexually transmitted infections and HIV among women using dating sites and apps. Three independent reviewers will select the studies and extract data from the original articles. The risk of bias will be assessed using the Cochrane risk of bias tool and Risk Of Bias in Non-randomized Studies of Interventions. Data synthesis will be performed using Review Manager software (RevMan V.5.2.3). To assess heterogeneity, we will compute the I2statistic. In addition, a quantitative synthesis will be carried out if the included studies are sufficiently homogeneous.Ethics and disseminationThis study will be a review of the published data, and thus ethical approval is not required. The findings of this systematic review will be published in a peer-reviewed journal.PROSPERO registration numberCRD42019120494.
Active and passive work breaks during simulated laparoscopy among laparoscopic surgeons: study protocol for a controlled, randomised cross-over laboratory trial
Authors: Luger Tessy , Rieger Monika A , Bonsch Rosina , Krämer Bernhard , Seibt Robert , Steinhilber Benjamin 
Published: November 2020

IntroductionLaparoscopy has partially replaced open surgery due to the lower infection rate for the patient and hence better and shorter recovery. However, the surgeon’s physical load is higher due to longer duration static and awkward body postures, increasing the risk for developing work-related musculoskeletal disorders. Interventions of an organisational nature are work breaks, being either passive or active. The primary objectives of this study are to determine whether passive and active work breaks lead to less discomfort than no work breaks and whether active work breaks lead to less discomfort than passive work breaks.Methods and analysisA controlled, randomised cross-over trial will be performed in the laboratory, of which its protocol is described here according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. Recruitment of 21 laparoscopic surgeons started in April 2019 and the study is ongoing. The participating surgeons will perform three 1.5 hour experimental conditions, one without work breaks, one with 2.5 min passive work breaks including rest, and one with 2.5 min active work breaks including mobility and stretching exercises. The work breaks will be taken after 30 and 60 min of work. During the experiments, outcomes will be recorded. The primary outcome is rating of perceived discomfort measured on an 11-point numeric rating scale. The secondary outcomes are performance, muscle activity of selected muscles, upper body angles, heart rate, workload and subjective evaluation of both interventions. The collected data will be tested using a one-way or two-factorial repeated-measures analysis of variance.Ethics and disseminationEthical approval of the study protocol was received by the local medical ethical committee of the University of Tübingen in February 2019 (no 618/2018BO2). The results of this study will be presented at national and international conferences, submitted for publications in peer-reviewed journals and serve as the starting point for a feasibility study.Trial registration numberNCT03715816.
Valuing health-related quality of life among the Indian population: a protocol for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study
Authors: Jyani Gaurav , Prinja Shankar , Kar Sitanshu Sekhar , Trivedi Mayur , Patro Binod , Purba Fredrick , Pala Star , Raman Swati , Sharma Atul , Jain Shalu , Kaur Manmeet 
Published: November 2020

IntroductionQuality-adjusted life year (QALY) has been recommended by the government as preferred outcome measure for Health Technology Assessment (HTA) in India. As country-specific health-related quality of life tariff values are essential for accurate measurement of QALYs, the government of India has commissioned the present study. The aim of this paper is to describe the methods for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study. Additionally, this study aspires to establish if the design of 10-time trade-off (TTO) blocks is enough to generate valid value sets.Methods and analysisA cross-sectional survey using the EuroQol Group’s Valuation Technology (EQ-VT) will be undertaken in a sample of 2700 respondents selected from six different states of India using a multistage stratified random sampling technique. The participants will be interviewed using computer-assisted personal interviewing technique. The TTO valuation will be done using 10 composite TTO (c-TTO) tasks and 7 discrete choice experiment (DCE) tasks. Hybrid modelling approach using both c-TTO and DCE data to estimate the potential value set will be applied. Values of all 3125 health states will be predicted using both the conventional EQ-VT design of 10 blocks of 10 TTO tasks, and an extended design of 18 blocks of 10 TTO tasks. The potential added value of the eight additional blocks in overall validity will be tested. The study will deliver value set for India and assess the adequacy of existing 10-blocks design to be able to correctly predict the values of all 3125 health states.Ethics and disseminationThe ethical approval has been obtained from Institutional Ethics Committee of PGIMER, Chandigarh, India. The anonymised EQ-5D-5L value set will be available for general use and in the HTAs commissioned by India’s central HTA Agency.
Risk assessment and identification of HIV infection among men who have sex with men: a cross-sectional study in Southwest China
Authors: Zheng Min , He Jiayu , Yuan Zhi , Zhang Xinhui , Yao Yongming , Fang Xing , Fu Lin , Ding Yingying , He Na , Zhang Yuqiong 
Published: November 2020

ObjectivesThe HIV epidemic is around 7%–20% among men who have sex with men (MSM) in Southwest China. The low HIV-testing rate highlights the need for tools to identify high-risk MSM in resource-limited regions. Our aim was, therefore, to evaluate the HIV RISK Assessment Tool for HIV prediction and to characterise the primary infection among MSM in Southwest China.DesignA cross-sectional survey was conducted in Guizhou province between January and December 2018. Participants were recruited from gay communities, among whom the HIV RISK Assessment Tool was evaluated. Logistic regression was used to analyse items associated with HIV and the area under the curve (AUC) of the receiver operating curve was calculated to quantify discrimination performance.Participants1330 MSM participants, of which 83 (6.2%) tested as HIV positive.ResultsA higher composite score of the tool (adjusted OR (aOR) 9.33, 95% CI 4.57 to 19.05) was independently associated with HIV infection. Items positively associated with HIV infection included having 2–5 same sex partners (aOR 2.43, 95% CI 1.28 to 4.64), always (aOR 5.93, 95% CI 1.59 to 22.13) or sometimes (aOR 4.25, 95% CI 2.09 to 8.64) having unprotected anal intercourse, taking both insertive and receptive sex roles (aOR 4.95, 95% CI 2.57 to 9.53) or only the receptive sex role (aOR 2.26, 95% CI 1.21 to 4.24). The tool showed an optimal discrimination ability (AUC=0.827), with a specificity of 0.747 and sensitivity of 0.785. Five MSM were identified with primary infection and had similar sexual risk behaviors as HIV-positive participants.ConclusionsThe HIV RISK Assessment Tool showed an overall good performance in predicting HIV risk among MSM in Guizhou province where the prevalence is still severe. This tool also demonstrated a potential to identify primary infection and is worth being promoted in resource-limited regions.
Evaluating the impact of the Bolsa Familia conditional cash transfer program on premature cardiovascular and all-cause mortality using the 100 million Brazilian cohort: a natural experiment study protocol
Authors: Pescarini Julia M , Craig Peter , Allik Mirjam , Amorim Leila , Ali Sanni , Smeeth Liam , Barreto Mauricio L , Leyland Alastair H , Aquino Estela M L , Katikireddi Srinivasa Vittal 
Published: November 2020

IntroductionBrazil’s Bolsa Familia Program (BFP) is the world’s largest conditional cash transfer scheme. We shall use a large cohort of applicants for different social programmes to evaluate the effect of BFP receipt on premature all-cause and cardiovascular mortality.Methods and analysisWe will identify BFP recipients and non-recipients among new applicants from 2004 to 2015 in the 100 Million Brazilian Cohort, a database of 114 million individuals containing sociodemographic and mortality information of applicants to any Brazilian social programme. For individuals applying from 2011, when we have better recorded income data, we shall compare premature (age 30–69) cardiovascular and all-cause mortality among BFP recipients and non-recipients using regression discontinuity design (RDD) with household monthly per capita income as the forcing variable. Effects will be estimated using survival models accounting for individuals follow-up. To test the sensitivity of our findings, we will estimate models with different bandwidths, include potential confounders as covariates in the survival models, and restrict our data to locations with the most reliable data. In addition, we will estimate the effect of BFP on studied outcomes using propensity score risk-set matching, separately for individuals that applied ≤2010 and >2011, allowing comparability with RDD. Analyses will be stratified by geographical region, gender, race/ethnicity and socioeconomic position. We will investigate differential impacts of BFP and the presence of effect modification for a combination of characteristics, including gender and race/ethnicity.Ethics and disseminationThe study was approved by the ethics committees of Oswaldo Cruz Foundation and the University of Glasgow College of Medicine and Veterinary Life Sciences. The deidentified dataset will be provided to researchers, and data analysis will be performed in a safe computational environment without internet access. Study findings will be published in high quality peer-reviewed research articles. The published results will be disseminated in the social media and to policy-makers.