bluuebunny/crossref_metadata_2025_split huggingface dataset:
Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting
Authors: Lang Katharina M , Harrison Kathryn L. , Williamson Paula R. , Huntly Brian J.P. , Ossenkoppele Gert , Geissler Jan , Bereczky Tamàs , Hernández-Rivas Jesús M. , Chevrou-Séverac Hélène , Goodbody Rory , Schulze-Rath Renate , Bullinger Lars 
Published: July 2019

Abstract
Background

Acute myeloid leukemia is the most common acute leukemia in adults with an unacceptably low cure rate. In recent years a number of new treatment strategies and compounds were developed for the treatment of acute myeloid leukemia. There were several randomized, controlled clinical trials with the objective to improve patients’ management and patients’ outcome in acute myeloid leukemia. Unfortunately, these trials are not always directly comparable, as they do not measure the same outcomes and currently there are no core outcome sets that can be utilized to guide outcome selection and harmonization in this disease area.

The HARMONY Alliance is a public-private European Network established in 2017, which currently includes 53 partners and 32 associated members from 22 countries. Amongst many other goals of the HARMONY Alliance, Work Package 2 focuses on defining outcomes that are relevant to each hematological malignancy.

In accordance, a pilot study will be performed to define core outcome set in acute myeloid leukemia.

Methods

The pilot study will use a three-round Delphi survey and a final consensus meeting to define a core outcome set. Participants will be recruited from different stakeholder groups, including patients, clinicians, regulators and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). At the pre-Delphi stage a literature research was conducted followed by several semi-structured interviews of clinical public and private key opinion leaders. Subsequently the preliminary outcome list was discussed in several multi-stakeholder face-to-face meetings.

The Delphi survey will reduce the preliminary outcome list to essential core outcomes.

After completing the last Delphi round a final face-to-face meeting is planned to achieve consensus about core outcome set in acute myeloid leukemia.

Discussion

The pilot Delphi as part of HARMONY Alliance aims to define a core outcome set in acute myeloid leukemia based on a multi-stakeholder consensus. Such a core outcome set will help to allow consistent comparison of future clinical trials and real world evidence research and ensures that appropriate outcomes valued by a range of stakeholders are measured within future trials.
A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog Trial
Authors: Leroi Iracema , Armitage Christopher J. , Collin Fidéline , Frison Eric , Hann Mark , Hooper Emma , Reeves David , Simkin Zoe , Wolski Lucas 
Published: July 2019

Abstract
Background:
Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT.

Methods and analysis:
We will use a mixed method approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes.

Discussion:
This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received, across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment.

Trial registration number: ISRCTN17056211. Registered on 19 February 2018. http://www.isrctn.com/ISRCTN17056211
Neuromuscular shoulder activity during exercises with different combinations of stable and unstable weight mass
Authors: Baritello Omar , Khajooei Mina , Engel Tilman , Kopinski Stephan , Quarmby Andrew , Mueller Steffen , Mayer Frank 
Published: July 2019

Abstract
Background

Recent shoulder injury prevention programs have utilized resistance exercises combined with different forms of instability, with the goal of eliciting functional adaptations and thereby reducing the risk of injury. However, it is still unknown how an unstable weight mass affects the muscular activity of the shoulder stabilizers.

Aim of the study was to analyzed the neuromuscular activity of the dynamic shoulder stabilizers under four combinations of stable and unstable weight mass during three shoulder exercises. It was hypothesized that a combined condition of weight with unstable mass would elicit significantly greater activation due to the increased stabilization demand.

Methods

Sixteen participants (7 m/9 f) were included in this cross-sectional study and prepared with an EMG-setup for the: Mm. upper/lower trapezius (U.TA/L.TA), lateral deltoid (DE), latissimus dorsi (LD), serratus anterior (SA) and pectoralis major (PE). A maximal voluntary isometric contraction test (MVIC; 5 sec.) was performed on an isokinetic dynamometer. Next, internal/external rotation (In/Ex), abduction/adduction (Ab/Ad) and diagonal flexion/extension (F/E) exercises (5 reps.) were performed with four custom-made-pipes representing different training conditions. First, the empty-pipe (P; 0.5 kg) and then, randomly ordered, water-filled-pipe (PW; 1 kg), weight-pipe (PG; 4.5 kg) and weight + water-filled-pipe (PWG; 4.5 kg), while EMG was recorded. Raw root mean square values (RMS) were normalized to MVIC (%MVIC). Differences between conditions for RMS%MVIC, scapular stabilizer (SR: U.TA/L.TA; U.TA/SA) and contraction (CR: concentric/eccentric) ratios were analyzed (paired t-test; α=0.05; Bonferroni adjusted α=0.008)

Results

PWG showed significantly greater muscle activity for all exercises and all muscles except for PE compared to P and PW. Condition PG elicited muscular activity comparable to PWG (p>0.008) with significantly lower activation of L.TA and SA in the In/Ex rotation. The SR ratio was significantly higher in PWG compared to P and PW. No significant differences were found for the CR ratio in all exercises and for all muscles.

Conclusion

Higher weight generated greater muscle activation whereas an unstable weight mass behavior raised the neuromuscular activity, possibly due to increased stabilization demands. Application of an unstable weight mass may be beneficial to improve training effects in shoulder prevention and rehabilitation programs.
Recombinant Human Endostatin against the development of RIPF in a murine model
Authors: YING HANG JIE , ZHOU CHENG , CHEN MEI YA , CHEN YUAN MENG , DONG QIANG BAI , FANG MIN , CHEN MING 
Published: July 2019

Abstract
Abstract
Background: Recent evidence has demonstrated the role of angiogenesis in the pathogenesis of pulmonary fibrosis. This study aimed to assess the therapeutic effect of Recombinant Human Endostatin (Endostar) administration on histopathological markers of radiation-induced pulmonary fibrosis, and investigate the underlying mechanism.
Methods: 80 Inbred C57BL/6 female mice were randomly divided into four treatment groups: No treatment group(NT, normal saline control), Radiation treatment group (RT), Endostar treatment group(EN), Endostar plus radiation treatment group (RT+EN). RT and RT+EN mice were exposed to a single-fraction 16Gy of 6MV X-ray for thorax irradiation. Mice in EN and RT+EN groups were given a daily subcutaneous injection of Endostar at a dose of 20 mg/kg, and thorax irradiation was performed 3 days after the first subcutaneous injection. Mice were sacrificed at 12 and 24 weeks post-irradiation. Pulmonary tissue was used in hematoxylin-eosin (H&E) and Masson’s trichrome staining, as well as for immunohistochemical assessment of CD31, Collagen I and Collagen IV, and reverse transcription-polymerase chain reaction (RT-PCR) was used to detect the expression level of vascular endothelial growth factor (VEGF) and transforming growth factor-β1 (TGF-β1). The protein expression level of TGF-β1, α-smooth muscle actin (α-SMA), total drosophila mothers against decapentaplegic protein 3 (Smad3), phosphorylate Smad3 (p-Smad3), total extracellular signal-regulated kinase (ERK) and phosphorylate ERK (p-ERK), β-Actin were analyzed by western blot.
Results: During the observation period, the hair of irradiated groups showed whitening in the irradiated area and radiation induced body weight loss of mice was partially attenuated by Endostar treatment. Endostar treatment significantly reduced alveolar inflammation and pulmonary fibrosis in RT+EN group compared with RT group, as indicated by a decrease in the expression level of Collagen I, Collagen IV and CD31 in lung tissue. Thorax irradiation significantly increased the expression of TGF-β1 and VEGF mRNA as well as α-SMA, TGF-β1, p-Smad3, p-ERK protein in lung tissue of mice, however, those were attenuated after Endostar treatment.
Conclusion: Endostar could reduce radiation-induced plumonary fibrosis in mice, and this effect may be related to the inhibition of angiogenesis and TGF-β1/Smad3/ERK pathway.
Conventional Computed Tomographic Calcium Scoring vs Full Chest CTCS for Lung Cancer Screening: A Cost-Effectiveness Analysis
Authors: Jiang Boxiang , Linden Philip A. , Jarrett Craig , Worrell Stephanie G. , Ho Vanessa P. , Perry Yaron , Towe Christopher W. 
Published: July 2019

Abstract
Background
Conventional CTCS images the mid/lower chest for coronary artery disease (CAD). Because many CAD patients are also at risk for lung malignancy, CTCS often discovers incidental pulmonary nodules (IPN). CTCS excludes the upper chest, where malignancy is common. Full-chest CTCS (FCT) may be a cost-effective screening tool for IPN.
Methods
A decision tree was created to compare a FCT to CTCS in a hypothetical patient cohort with suspected CAD. (Figure) The design compares the effects of missed cancers on CTCS with the cost of working up non-malignant nodules on FCT. The model was informed by results of the National Lung Screening Trial and literature review, including the rate of malignancy among patients receiving CTCS and the rate of malignancy in upper vs lower portions of the lung. The analysis outcomes are Quality-Adjusted Life Year (QALY) and incremental cost-effectiveness ratio (ICER), which is generally considered beneficial when <$50,000/QALY.
Results
Literature review suggests that rate of IPNs in the upper portion of the lung varied from 47-76%. Our model assumed that IPNs occur in upper and lower portions of the lung with equal frequency. The model also assumes an equal malignancy potential in upper lung IPNs despite data that malignancy occurs 61-66% in upper lung fields.
In the base case analysis, a FCT will lead to an increase of 0.03 QALYs comparing to conventional CTCS (14.54 vs 14.51 QALY, respectively), which translates into an QALY increase of 16 days. The associated incremental cost for FCT is $278 ($1,027 vs $748, FCT vs CTCS respectively. The incremental cost-effectiveness ratio (ICER) is $10,289/QALY, suggesting significant benefit. Sensitivity analysis shows this benefit increases proportional to the rate of malignancy in upper lung fields.
Conclusion
Conventional CTCS may be a missed opportunity to screen for upper lung field cancers in high risk patients. The ICER of FCT is better than screening for breast cancer screening (mammograms $80k/QALY) and colon cancer (colonoscopy $6k/QALY). Prospective studies are appropriate to define protocols for FCT.
Turnover Intention and Burnout among Workers in Primary Care Institutions: Moderating Role of Job Satisfaction ——Based on A Cross-Sectional Survey
Authors: Chen Xuyu , Ran Li , Zhang Yuting , Yang Jinru , Yao Hui , Zhu Sirong , Tan Xiaodong 
Published: July 2019

Abstract
Background: Global countries are suffering from a shortage of health professionals, turnover intention is closely related to job satisfaction and burnout, making good use of these relationship could alleviate the crises.
Methods: This research was conducted in Huangpi, China. Convenience sampling methods and self-designed questionnaires was used. 1370 of valid samples were collected with 97.72% effective rate. Descriptive analyses were conducted to describe social demographic factors. The structural equation model (SEM) was performed to adjust model fitting, and the mediation effect test was carried out by using the bootstrap method. Sobel-Z test was used to verify the significance of mediation effect.
Results: The mean age was 36.98 (SD=9.84). The fitting indices of hypothetical model is not good. After the adjustments, for job satisfaction, turnover intention and burnout, the Cronbach’s is 0.976, 0.910, 0.879, respectively. 2/df =5.590, GFI=0.932, AGFI=0.901, CFI=0.977, NFI=0.973, IFI=0.977, TLI=0.970, RESEA=0.058. The revised model fitted well, and the SEM was put up by using the bootstrap method. The mediating effect is partial, and Soble-Z test indicates that the mediation effect is significant. Burnout is negatively correlated with job satisfaction (p<0.01) and the standardized path coefficient is -0.41. Job satisfaction is also negatively correlated with turnover intention (p<0.01) and the standardized path coefficient is -0.18. Burnout is positively correlated with turnover intention (p<0.01) and the standardized path coefficient is 0.83.
Conclusions: Job satisfaction is a mediating variable that affects the relationship between burnout and turnover intention. Turnover intention was negatively related to job satisfaction and positively related to burnout, job satisfaction was negative related to burnout. And the mediation effect has a low impact of 7.4%.
Keywords: Turnover Intention, Burnout, Job satisfaction, Workers in primary care institution, Structural equation model
Household food insecurity, copying strategies and its associated with parents food preference to children in Dabat Demographic and health surveillance system; North West Ethiopia, April 2019
Authors: tebeje nigusie birhan , Biks Gashaw Andargie , Abebe Solomon Mekonnen , Yesuf Melike Endris 
Published: July 2019

Abstract
Abstract
Introduction:- the association of household food insecurity with a physical health problem, quality of life, mental health problem and utilization of health service was reported by several studies. However, the association of household food insecurity with parent’s food preference to children is not assessed even though all of these factors may make parents to prefer inappropriate child food. Therefore this study was aimed to determine the association of food insecurity with parent's food preference.
Methods and materials: - A community-based cross-sectional survey was conducted among 6215 households in Dabat district. Data were collected and supervised by experienced data collectors and supervisors working for the surveillance site after five days of training on the tool. Data were entered into the epi data template then transported to Stata 14 software for analysis. An ordinal logistic regression model was fitted to identify predictor for household food insecurity.
Finding: About 21.77% of the households were food insecured in Dabat district. High wealth 61% (57-80%), and achieving college education 97%(74-99.6%) were associated with the less likelihood of household food insecurity. While mothers/caretakers preference to feed children always fruit and vegetable only 1.75(1.11-2.57) and, always milk and meat only 1.72(1.17-2.52) were associated were the more likelihood of experiencing the worst state of household food insecurity.
Conclusion: -A significant number of households in Dabat had experienced household food insecurity associated with wealth status of the household, and, parents/caretakers specific type of food preference for their children. Therefore we recommend counseling services on the importance of feeding a child with a balanced diet in the improvement of household food security.
Keywords: - food insecurity, household, Dabat, surveillance, Gondar and Ethiopia
Vaccination Coverage with the Pneumococcal and Influenza Vaccine Among Persons with Chronic Diseases in Shanghai, China, 2017
Authors: Wang Yuheng , Cheng Minna , Wang Siyuan , Wu Fei , Yan Qinghua , Yang Qinping , Li Yanyun , Guo Xiang , Fu Chen , Shi Yan , Wagner Abram L. , Boulton Matthew L. 
Published: July 2019

Abstract
Background

Adults with chronic conditions such as heart disease, diabetes, or lung disease are more likely to develop complications from a number of vaccine-preventable diseases, including influenza and pneumonia. In this study, we use the data from a chronic disease management information system in Shanghai to estimate vaccination coverage and characterize predictors of influenza and pneumococcal vaccination among people with chronic disease in Shanghai.

Methods

The Shanghai Centers for Disease Control and Prevention have information systems related to chronic disease management, hospital records, and immunizations. Data from individuals with chronic disease were abstracted during July 2017. The main outcome was coverage of pneumococcal and influenza vaccination. Vaccination coverage was calculated across demographic groups. Significance in bivariate associations was assessed through Pearson’s chi-square tests, and in multivariable models through logistic regression models with a forward stepwise method to select variables.

Results

In the sample of 2,531,227 individuals ≥15 years, 22.8% were vaccinated for pneumonia from January 2013 to July 2017, and the vaccination coverage of influenza in the 2016/17 influenza season was 0.4%. Vaccination coverage was highest in those 70-79 and lowest in those younger than 60. Compared to urban areas, uptake in rural areas was higher for pneumonia vaccination (OR: 2.43, 95% CI: 2.41, 2.45), but lower for influenza vaccination (OR: 0.55, 95% CI: 0.51, 0.59). Having a greater number of chronic diseases was associated with higher likelihood of pneumonia vaccination (3 vs 1: OR: 1.68, 95% CI: 1.64, 1.71), but this relationship was not statistically significant for influenza vaccination.

Conclusions

We found low levels with of pneumococcal vaccination, and extremely low uptake of influenza vaccination among individuals with high risk conditions in Shanghai who should be priority groups targeted for vaccination. Interventions could be designed to target groups with low uptake – like younger adults, and individuals who have not yet retired.
Screening for gestational diabetes mellitus in women with low BMI in an urban, Chinese, population: two retrospective cohorts study
Authors: Guo Fei , Yang Shuai , Zhang Yong , Yang Xi , Zhang Chen , Fan Jianxia 
Published: July 2019

Abstract
Background

We design this study to assess the utility of baseline characteristics in first trimester in the prediction of gestational diabetes mellitus (GDM) in non-obese, women in an urban, Chinese, antenatal population.

Methods

Multiple, logistic regression analysis was used to develop a predictive model for GDM, in a retrospective cohort of 3956 women (mean age 30.61, years, mean pre-pregnant BMI= 21.45 kg/m2) during 2015 in Shanghai. We refined the predictive model with t-distributed stochastic neighbor embedding (t-SNE) to attempt to distinguish GDM from non-GDM.

Results

GDM prevalence in the retrospective cohort was 16.7%. Advanced age, prepregnant obesity, high first-trimester, fasting, plasma glucose, and, a family history of diabetes were positively-related to the development of GDM. The simplified point scoring system yielded an AUC of 0.69. When the model was applied to a prospective cohort of 6572 women recruited in 2016 (mean age 30.80 years, mean prepregnant BMI = 21.18 kg/m2, incidence of GDM 10.8%), the AUC was 0.70. A score of ≥3 points was 91.3% specific and 25.4% sensitive for GDM. In both cohorts, the distinct regions of GDM and non-GDM were ideally separated in the t-SNE, generating transitional boundaries in the image found by different color.

Conclusions

Our low BMI, antenatal population now over-consumes a Western, diabetogenic diet during pregnancy though we attribute the declining incidence (2015, 16.7% vs 2016, 10.8%) to an improved antenatal education program. We propose a score system to screen for GDM in first trimester, and also, we should concentrate our efforts on prevention through antenatal education.
Anatomic features of mandibular second molars root canals in a Yemeni population: cone-beam computed tomography
Authors: Senan Elham M. , Alhadainy Hatem A. , Madfa Ahmed A. 
Published: July 2019

Abstract
Background: This study aimed to identify and characterize root and canal morphology and the prevalence of C-shaped canals of mandibular second molars (MSMs) in a Yemeni population using cone-beam computed tomography (CBCT).
Methods: CBCT images of 500 right and left MSMs with mature roots were taken from 250 Yemeni individuals and analyzed for the following features: number of roots, total number of canals orifices within the tooth and number of canals orifices in each root, type of roots, either fused or separated, shape of root in cross section, type of canal configuration in each root, presence of C-shaped canal, and primary variations in the morphology of root and canal systems.
Results: Molars with separated two roots predominated (89.6%), fused two roots were 9%, separated three roots were 0.6% and one root MSMs were 0.8%. Molars with three canals orifices were the most common. Mesial root was mainly ribbon-shaped (60.5%) and distal root was mainly kidney-shaped (50.7%). Type II and Type I canal configurations were the most frequent in mesial root (56.9%) and distal root (91.3%), respectively. C-shaped canals were found in 9%. Six variants were found with variant 3 was the most common (71%).
Conclusions: Yemeni permanent MSMs have mainly two separated roots. Mesial root is mostly ribbon-shaped and distal root is mainly kidney-shaped. Vertucci type II and I canal configurations showed the higher incidence in mesial and distal roots, respectively. C-shaped canals were found in 9%.
Keywords: Cone-beam computed tomography, C-shaped canal, mandibular second molar, morphology, root canal, Yemen