bluuebunny/crossref_metadata_2025 huggingface dataset:
Study of influential factors of provincial health expenditure -analysis of panel data after the 2009 healthcare reform in China
Authors: Hou Jifei , Tian Liqi , Zhang Yun , Liu Yanzheng , Li Jing , Wang Yue
Published: July 2020

Background

Total Healthcare Expenditure (THE) has increased substantially in all countries. Since the health system reform and health policy environment differ from each country, it is necessary to analyze the motivations of THE in a specific country.

Methods

The objective of this study was to analyze the influential factors of Provincial THE (PTHE) per capita in China by using spatiotemporal panel data across 31 provinces (including provinces, autonomous regions, and municipalities, all called provinces in here) from 2009 to 2016 at the provincial and annual level. Generalized Estimating Equation (GEE) was used to identify the influential factors of PTHE per capita.

Results

The number of beds per 10,000 population explained most of the variation of PTHE per capita. The results also showed that health expenditure in China reacts more to mortality compared with the Gross Domestic Product (GDP) per capita. But mortality and Out-Of-Pocket Payments (OOP) as a percentage of THE were associated with PTHE per capita negatively. The rate of infectious diseases and THE as a percentage of GDP had no statistical significance. And the Proportion of the Population Aged 65 and Over (POP65) impact PTHE per capita positively. But the coefficient was small.

Conclusions

In response to these findings, we conclude that the impact of the increasing percentage of OOP in THE diminishes the PTHE. Furthermore, we find that both the “baseline” health level and health provision are positively correlated with PTHE, which outweighs the effect of GDP.
sTREM-1 predicts mortality in hospitalized patients with infection in a tropical, middle-income country
Authors: Wright Shelton W. , Lovelace-Macon Lara , Hantrakun Viriya , Rudd Kristina E. , Teparrukkul Prapit , Kosamo Susanna , Liles W. Conrad , Limmathurotsakul Direk , West T. Eoin
Published: July 2020

Background

Few studies of biomarkers as predictors of outcome in infection have been performed in tropical, low- and middle-income countries where the burden of sepsis is highest. We evaluated whether selected biomarkers could predict 28-day mortality in infected patients in rural Thailand.

Methods

Four thousand nine hundred eighty-nine adult patients admitted with suspected infection to a referral hospital in northeast Thailand were prospectively enrolled within 24 h of admission. In a secondary analysis of 760 patients, interleukin-8 (IL-8), soluble tumor necrosis factor receptor 1 (sTNFR-1), angiopoietin-1 (Ang-1), angiopoietin-2 (Ang-2), and soluble triggering receptor expressed by myeloid cells 1 (sTREM-1) were measured in the plasma. Association with 28-day mortality was evaluated using regression; a parsimonious biomarker model was selected using the least absolute shrinkage and selection operator (LASSO) method. Discrimination of mortality was assessed by receiver operating characteristic curve analysis and verified by multiple methods.

Results

IL-8, sTNFR-1, Ang-2, and sTREM-1 concentrations were strongly associated with death. LASSO identified a three-biomarker model of sTREM-1, Ang-2, and IL-8, but sTREM-1 alone provided comparable mortality discrimination (p = 0.07). sTREM-1 alone was comparable to a model of clinical variables (area under receiver operating characteristic curve [AUC] 0.81, 95% confidence interval [CI] 0.77–0.85 vs AUC 0.79, 95% CI 0.74–0.84;p = 0.43). The combination of sTREM-1 and clinical variables yielded greater mortality discrimination than clinical variables alone (AUC 0.83, 95% CI 0.79–0.87;p = 0.004).

Conclusions

sTREM-1 predicts mortality from infection in a tropical, middle-income country comparably to a model derived from clinical variables and, when combined with clinical variables, can further augment mortality prediction.

Trial registration

The Ubon-sepsis study was registered onClinicalTrials.gov(NCT02217592), 2014.
Translational data analytics in exposure science and environmental health: a citizen science approach with high school students
Authors: Hyder Ayaz , May Andrew A.
Published: July 2020

Background

Translational data analytics aims to apply data analytics principles and techniques to bring about broader societal or human impact. Translational data analytics for environmental health is an emerging discipline and the objective of this study is to describe a real-world example of this emerging discipline.

Methods

We implemented a citizen-science project at a local high school. Multiple cohorts of citizen scientists, who were students, fabricated and deployed low-cost air quality sensors. A cloud-computing solution provided real-time air quality data for risk screening purposes, data analytics and curricular activities.

Results

The citizen-science project engaged with 14 high school students over a four-year period that is continuing to this day. The project led to the development of a website that displayed sensor-based measurements in local neighborhoods and a GitHub-like repository for open source code and instructions. Preliminary results showed a reasonable comparison between sensor-based and EPA land-based federal reference monitor data for CO and NOx.

Conclusions

Initial sensor-based data collection efforts showed reasonable agreement with land-based federal reference monitors but more work needs to be done to validate these results. Lessons learned were: 1) the need for sustained funding because citizen science-based project timelines are a function of community needs/capacity and building interdisciplinary rapport in academic settings and 2) the need for a dedicated staff to manage academic-community relationships.
Feasibility and accuracy of a novel automated three-dimensional ultrasonographic analysis system for abdominal aortic aneurysm: comparison with two-dimensional ultrasonography and computed tomography
Authors: Cho In-Jeong , Lee Jinyong , Park Jinki , Lee Sang-Eun , Ahn Chul-Min , Ko Young-Guk , Choi Donghoon , Chang Hyuk-Jae
Published: July 2020

Background

Accurate measurement of the maximum aortic diameter (Dmax) is crucial for patients with abdominal aortic aneurysm (AAA). Aortic computed tomography (CT) provides accurate Dmax values by three-dimensional (3-D) reconstruction but may cause nephrotoxicity because of contrast use and radiation hazard. We aimed to evaluate the accuracy of a novel semi-automated 3-D ultrasonography (3-D US) system compared with that of CT as a reference.

Methods

Patients with AAA (n = 59) or individuals with normal aorta (n = 18) were prospectively recruited in an outpatient setting. Two-dimensional ultrasonography (2-D US) and 3-D US images were acquired with a single-sweep volumetric transducer. The analysis was performed offline with a software. Dmax and the vessel area of the Dmax slice were measured with 2-D US, 3-D US, and CT. The lumen and thrombus areas of the Dmax slice were also measured in 40 patients with intraluminal thrombus. Vessel and thrombus volumes were measured using 3-D US and CT.

Results

The Dmax values from 3-D US demonstrated better agreement (R2 = 0.984) with the CT values than with the 2-D US values (R2 = 0.938). Overall, 2-D US underestimated Dmax compared with 3-D US (32.3 ± 12.1 mm vs. 35.1 ± 12.0 mm). The Bland-Altman analysis of the 3-D US values, revealed better agreement with the CT values (2 standard deviations [SD], 2.9 mm) than with the 2-D US values (2 SD, 5.4 mm). The vessel, lumen, and thrombus areas all demonstrated better agreement with CT than with 2-D US (R2 = 0.986 vs. 0.960 for the vessel, R2 = 0.891 vs. 0.837 for the lumen, and R2 = 0.977 vs. 0.872 for the thrombus). The thrombus volume assessed with 3-D US showed good correlation with the CT value (R2 = 0.981 and 2 SD in the Bland-Altman analysis: 13.6 cm3).

Conclusions

Our novel semi-automated 3-D US analysis system provides more accurate Dmax values than 2-D US and provides precise volumetric data, which were not evaluable with 2-D US. The application of the semi-automated 3-D US analysis system in abdominal aorta assessment is easy and accurate.
Rich at risk: socio-economic drivers of COVID-19 pandemic spread
Authors: Gangemi Sebastiano , Billeci Lucia , Tonacci Alessandro
Published: July 2020

COVID-19, the novel coronavirus affecting the most part of worldwide countries since early 2020, is fast increasing its prevalence around the world, representing a significant emergency for the population and the health systems at large. While proper treatments are being developed, in-depth studies concerning its way of diffusion are necessary, in order to understand how the virus is actually spreading, through the investigation on some socio-economic indicators for the various countries in the world, retrieved through open-access data publicly available. The correlation analysis displayed significant relationships between COVID-19 incidence with several of such indicators, including the Gross Domestic Product per capita and the number of flights per capita, whereas mortality is mainly related to the main age of the population. All such data displayed an interesting mean to understand the way the virus has diffused worldwide, possibly representing the basis for future preventive measures to effectively challenge a new COVID-19 pandemic wave, but also other, similar pandemics.
Prevalence and correlates of poor sleep quality among college students: a cross-sectional survey
Authors: Li Yuanyuan , Bai Wei , Zhu Bo , Duan Ruixin , Yu Xiao , Xu Wen , Wang Mohan , Hua Wanqing , Yu Weiying , Li Wenjun , Kou Changgui
Published: July 2020

Background

Sleep problems are widespread among college students around the globe, especially in China. This study was designed to investigate the prevalence of poor sleep quality and identify associated factors among college students in Jilin Province, China.

Methods

A total of 6284 participants were completely collected by stratified cluster sampling in 2016. Information on basic demographics, lifestyles, social and family support, and subjective sleep quality was collected by questionnaire. The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire used to assess sleep for one month.

Results

1951 (31.0%) participants were classified into poor sleep quality group, as defined by a PSQI score > 5. Males scored significantly higher than females on sleep duration and use of sleep medication, while females scored significantly higher than males on PSQI total and sleep disturbances. The results of the multivariate logistic regression show the following factors to be significant predictors of poor sleep quality: freshman (OR = 1.523, 95% CI: 1.168–1.987), alcohol use (OR = 1.634, 1.425–1.874), gambling behaviors (OR = 1.167, 95% CI: 1.005–1.356), exercised for more than 30 min a week on less than one day (OR = 1.234, 95% CI: 1.016–1.498), the feelings of satisfied with parental love (OR = 1.849, 95% CI: 1.244–2.749), and harmonious/neutral relationship with classmates (OR = 2.206, 95% CI: 1.312–3.708; OR = 1.700, 95% CI: 1.414–2.045),. No study pressure of this academic year (OR = 0.210, 95% CI: 0.159–0.276), no truancy in the past month (OR = 0.510, 95% CI: 0.354–0.735), never had self-injurious behaviors (OR = 0.413, 95% CI: 0.245–0.698), very harmonious family relationship (OR = 0.377, 95% CI: 0.219–0.650), frequent communication with parents (OR = 0.524, 95% CI: 0.312–0.880), the feelings of satisfied with maternal love (OR = 0.432, 95% CI: 0.257–0.725), and frequent excursions to gymnasium (OR = 0.770, 95% CI: 0.659–0.899) were the protective factors.

Conclusions

The implication of the present study may be that college students must be made aware of the consequences of inadequate sleep quality and risk factors could be improved if students tried to change their behavior and subjective consciousness.
Toxicity of particles emitted by fireworks
Authors: Hickey Christina , Gordon Christopher , Galdanes Karen , Blaustein Martin , Horton Lori , Chillrud Steven , Ross James , Yinon Lital , Chen Lung Chi , Gordon Terry
Published: July 2020

Background

Particle matter (PM) has been associated with increased morbidity and mortality rates across the world. This study was designed to test the hypotheses that pyrotechnic firework displays introduce significant amounts of toxic metals into the atmosphere and are hazardous to human health. Size-selective emissions from 10 different fireworks displays were collected during particle generation in a dynamic, stainless steel chamber and tested for toxicity in cells. A subset of 2 particle types were tested in vivo in mice. At doses that did not produce cytotoxicity in an LDH assay, in vitro reactive oxygen species (ROS) formation was measured in bronchial epithelial airway (BEAS-2B) and human pulmonary microvascular endothelial (HPMEC-ST1.6R) cell lines treated with size-fractionated particles from the emissions of fireworks.

Results

Significant increases in ROS, in both cell types, were dependent upon the type of firework but not particle size. The in vitro ROS activity was correlated with lung inflammation produced in groups of mice treated by oropharyngeal aspiration with 0, 50, or 100 μg fireworks PM10/mouse. Trace metal analyses of the PM10 samples showed significant differences in metal content among fireworks type. Interestingly, the PM10 sample for the fireworks type producing the greatest in vitro ROS response in BEAS-2B cells contained ~ 40,000 and ~ 12,000 ppm of lead and copper, respectively. This sample also produced the greatest inflammatory response (i.e., increased neutrophils in bronchoalveolar lavage fluid) in mice.

Conclusions

These findings demonstrate that pyrotechnic display particles can produce adverse effects in mammalian cells and lungs, thus suggesting that further research is needed to expand our understanding of the contribution of metal content to the adverse health effects of fireworks particles. This information will lead to the manufacture of safer fireworks.
Effectiveness of reminders to sustain practice change among direct care providers in residential care facilities: a cluster randomized controlled trial
Authors: Slaughter Susan E. , Eliasziw Misha , Ickert Carla , Jones C. Allyson , Estabrooks Carole A. , Wagg Adrian S.
Published: July 2020

Background

The study purpose was to compare the effectiveness of monthly or quarterly peer reminder knowledge translation interventions, with monthly or quarterly paper-based reminders, to sustain a mobility innovation, the sit-to-stand activity.

Method

A cluster RCT using a stratified 2 × 2 factorial design was conducted in 24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides. The 1-year intervention included two intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents’ rooms), at two frequencies (monthly; every 3 months). Intervention fidelity was assessed using questionnaires and observations. Monthly sustainability rate of the sit-to-stand activity was calculated as the percentage of opportunities that residents successfully completed the activity in 30 days. Residents’ sustainability rates were analyzed using a linear mixed model that mirrored the clustered repeated-measures factorial trial design. The model included a random intercept to account for clustering within sites. An unstructured covariance structure characterized the interdependence of repeated measures over time.

Results

Twenty-four sites were randomized. One site was excluded because of falsifying data, leaving 23 sites and 349 residents for intention-to-treat analysis. Paper reminders were implemented with high fidelity across all arms (91.5% per protocol), while the peer reminders were implemented with moderate fidelity in the monthly group (81.0% per protocol) and poor fidelity in the quarterly group (51.7% per protocol). At month 1, mean sustainability ranged from 40.7 to 47.2 per 100 opportunities, across the four intervention arms (p = 0.43). Mean rate of sustainability in the high intensity, high frequency group diverged after randomization, yielding statistically significant differences among the groups at 4 months which persisted for the remainder of the trial. After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001).

Conclusions

A monthly peer reminder intervention was more effective than a quarterly peer reminder intervention, a monthly paper-based reminder intervention, and a quarterly paper-based reminder intervention, in supporting care aides to sustain a mobility innovation in residential care facilities over 1 year.

Trial registration

ClinicalTrials.gov, NCT01746459. Registered 11 December 2012: https://clinicaltrials.gov/ct2/show/NCT01746459.
Fast computation of genome-metagenome interaction effects
Authors: Guinot Florent , Szafranski Marie , Chiquet Julien , Zancarini Anouk , Le Signor Christine , Mougel Christophe , Ambroise Christophe
Published: July 2020

Motivation

Association studies have been widely used to search for associations between common genetic variants observations and a given phenotype. However, it is now generally accepted that genes and environment must be examined jointly when estimating phenotypic variance. In this work we consider two types of biological markers: genotypic markers, which characterize an observation in terms of inherited genetic information, and metagenomic marker which are related to the environment. Both types of markers are available in their millions and can be used to characterize any observation uniquely.

Objective

Our focus is on detecting interactions between groups of genetic and metagenomic markers in order to gain a better understanding of the complex relationship between environment and genome in the expression of a given phenotype.

Contributions

We propose a novel approach for efficiently detecting interactions between complementary datasets in a high-dimensional setting with a reduced computational cost. The method, named SICOMORE, reduces the dimension of the search space by selecting a subset of supervariables in the two complementary datasets. These supervariables are given by a weighted group structure defined on sets of variables at different scales. A Lasso selection is then applied on each type of supervariable to obtain a subset of potential interactions that will be explored via linear model testing.

Results

We compare SICOMORE with other approaches in simulations, with varying sample sizes, noise, and numbers of true interactions. SICOMORE exhibits convincing results in terms of recall, as well as competitive performances with respect to running time. The method is also used to detect interaction between genomic markers inMedicago truncatulaand metagenomic markers in its rhizosphere bacterial community.

Software availability

An package is available [4], along with its documentation and associated scripts, allowing the reader to reproduce the results presented in the paper.
Thoracoscopic lobectomy for a 4-day-old neonate with a large congenital pulmonary airway malformation: a case report
Authors: Huang Jinxi , Zhou Chaoming , Chen Qiang , Wu Dianming , Hong Junjie , Hong Songming
Published: July 2020

Background: Congenital pulmonary airway malformation is a rare congenital lung lesion. Infants with large Congenital pulmonary airway malformation can present with a series of serious symptoms. Surgery is still the main treatment. Thoracoscopic lobectomy for neonates is rarely reported.

Case presentation

The authors report a case of a congenital pulmonary airway malformation located in the left lower lung of a 4-day-old female infant. Prenatally, the cystic adenomatoid malformation volume ratio was 2.99 according to ultrasound scan. After birth, thoracoscopic lobectomy was performed to alleviate respiratory failure and mediastinal hernia. The patient’s clinical symptoms and the X-ray re-examination showed good postoperative recovery.

Conclusions

The purpose of this study is to indicate that a safe and effective minimally invasive surgery for the giant congenital pulmonary airway malformation is feasible, even for infants only 4 days old.
Effect of a multi-citrus extract-based feed additive on the survival of rainbow trout (Oncorhynchus mykiss) following challenge with Lactococcus garvieae
Authors: Mora-Sánchez Brenda , Fuertes Héctor , Balcázar José Luis , Pérez-Sánchez Tania
Published: July 2020

Growing global concerns about antibiotic resistance have generated a considerable interest in the search for alternative environmental-friendly approaches. This study was aimed to assess the antimicrobial activity of a multi-citrus extract-based feed additive (Biocitro®) against some fish pathogens, as well as evaluate its capacity to protect rainbow trout (Oncorhynchus mykiss) to lactococcosis. A broth dilution method was used to determine the minimum inhibitory concentration (MIC) of Biocitro®, and the results showed a strong antibacterial activity against Aeromonas salmonicida, Lactococcus garvieae and Yersinia ruckeri with MIC values of 2.0 µg/mL. Afterwards, rainbow trout juveniles were fed a Biocitro®-enriched diet (750 mg/kg feed) at a daily rate of 1.5% body weight for 4 weeks, then they were challenged with L. garvieae by the cohabitation method. At the end of the experimental period, fish treated with Biocitro® showed significantly (P < 0.001) improved protection against L. garvieae compared to control fish. Although further studies are needed to understand how Biocitro® increases rainbow trout resistance to L. garvieae, this feed additive could be considered as a useful alternative to chemotherapeutic treatment in aquaculture.
Plantar pressure sensors indicate women to have a significantly higher peak pressure on the hallux, toes, forefoot, and medial of the foot compared to men
Authors: Yamamoto Tetsuya , Hoshino Yuichi , Kanzaki Noriyuki , Nukuto Koji , Yamashita Takahiro , Ibaraki Kazuyuki , Nagamune Kouki , Nagai Kanto , Araki Daisuke , Matsushita Takehiko , Kuroda Ryosuke
Published: July 2020

Background

Sex‐related differences of plantar pressure distribution during activities should be thoroughly inspected as it can help establish treatment and prevention strategies for foot and ankle problems. In‐shoe measurement systems are preferable without space and activity restrictions; however, previously reported systems are still heavy and bulky and induce unnatural movement. Therefore, a slim and light plantar pressure sensor was newly developed to detect the effect of sex difference on plantar pressure during standing and walking.

Methods

One‐hundred healthy adult volunteers (50 women and 50 men) were recruited. Ten plantar pressure sensors were implanted in a 1‐mm thick insole, with a total weight of 29 g. Plantar pressure was recorded with 200 Hz during 3 s of standing and while walking 10 steps. The maximum loads during standing and walking were analyzed in each sensor, and the results were compared between different areas of the foot in the antero‐posterior direction and the medio‐lateral direction and between different time points. The movement of the center of pressure (COP) during walking was also evaluated. Analyses were adjusted for body mass index and gait speed.

Results

The movement of COP was constant for both sexes. In all cases, the maximum load was observed on the medial of the foot. Women had a significantly higher peak pressure on the hallux, toes, forefoot, and medial aspect of the foot compared to men while standing and walking (p < .05).

Conclusions

A newly introduced in‐shoe plantar pressure sensor demonstrated a typical loading transition pattern of the foot. Furthermore, higher plantar pressure in the forefoot was detected in healthy women as compared to men during standing and walking activities.
Poorer prognosis of ovarian squamous cell carcinoma than serous carcinoma: a propensity score matching analysis based on the SEER database
Authors: Zhang Cheng , Ma Tai
Published: July 2020

Background

Ovarian squamous cell carcinoma (SCC) is a rare cancer with possible poor survival, however no direct evidence supports this viewpoint and the independent prognostic factors are controversial. Patients with ovarian SCC and serous carcinoma (SC) who were diagnosed between 2004 and 2016 were selected using the recent released SEER database. Propensity score matching was used to balance the characteristics of the two groups. The difference of survival between patients with ovarian SCC and SC was explored using Kaplan-Meier method. Cox regression analyses were performed to further identify the independent prognostic factors among patients with ovarian SCC.

Results

Of 15,286 patients (15,106 SC cases and 180 SCC cases), 304 were identified in the matched cohort (200 SC cases and 104 SCC cases). The overall survival and cause-specific survival for patients with SCC were significantly poorer (Plog-rank < 0.001). The median survival time was 21 months for SCC and 95 months for SC. Patients who underwent bilateral salpingo-oophorectomy with hysterectomy and omentectomy seemed to have a better outcome. In multivariate analysis, older age at diagnosis, larger tumor size, bilateral and FIGO stage IV malignancy were the independent risk factors for poor disease outcome.

Conclusions

The prognosis of ovarian SCC is worse than ovarian SC. Older age at diagnosis, advanced disease stage, larger tumor size and bilateral malignancy are the independent risk factors for poor survival.
The rate of short-term revisits after diagnosis of non-specific abdominal pain is similar for surgeons and emergency physicians - results from a single tertiary hospital emergency department
Authors: Saaristo Leena , Ukkonen Mika T. , Laukkarinen Johanna M. , Pauniaho Satu-Liisa K.
Published: July 2020

Background

Acute abdominal pain can be a diagnostic challenge even for experienced surgeons. Delayed diagnosis can lead to higher morbidity, mortality and increased costs. While readmission rate has been used to evaluate quality of surgical care, studies addressing the issue in emergency departments (ED) are rare. The role of emergency physicians in the care of patients with abdominal pain is increasing in many European countries, including Finland. It is not known whether this has an effect on the number of readmissions.

Here we evaluate whether the increasing role of emergency physicians in examining patients presenting with abdominal pain has affected the rate of short-term revisits among patients with non-specific abdominal pain (NSAP).

Methods

We identified consecutive ED patients receiving a diagnosis of NSAP 1.1. 2015–31.12.2016 in the ED of Tampere University Hospital. Those revisiting the ED within 48 h were selected for further analysis. Data were obtained from electronic medical records. We compared the outcomes of those initially examined by surgeons and by emergency physicians.

Results

During the study period, 173,630 patients visited our ED, of whom 6.1% (n = 10,609) were discharged with a diagnosis of NSAP. Only 3.0% of patients revisited the ED, 0.7% required hospitalization and 0.06% immediate surgery. The short-term revisit rates among those originally examined by surgeons and by emergency physicians were similar, 2.8 and 3.2% respectively (p = 0.193).

Conclusions

The rate of short-term revisits in patients with NSAP was altogether low. The increasing role of emergency physicians in the care of acute abdominal patients did not affect the revisit rate.
Effect of voluntary breathing exercises on stable coronary artery disease in heart rate variability and rate-pressure product: a study protocol for a single-blind, prospective, randomized controlled trial
Authors: Wu Qing , Liu Lin , Jiang Xin , Hu Yao-Yao , Liang Qiu-Shi , He Zhi-Song , Xue Yuan , Zhu Wei , Tang Zai-Xiang , Hou Yun-Ying , Zhao Qi , Wang Xiao-Hua
Published: July 2020

Background

At present, China has more than 11 million patients with stable coronary heart disease and this is becoming a major public health problem. The pathological changes of coronary heart disease can lead to dysfunction of the cardiac autonomic nervous system, which increases the risk of complications such as malignant arrhythmia (ventricular flutter, ventricular fibrillation, etc.), heart rate, systolic blood pressure, and rate-pressure product (RPP), which is highly correlated with myocardial oxygen consumption and indirectly reflects myocardial blood supply and oxygen consumption. Although the guidelines recommend that such patients take drugs to reduce heart rate and myocardial oxygen consumption, the clinical control of heart rate is still not ideal. Thus, in this trial, we will use voluntary breathing exercises as the strategy of exercise rehabilitation for patients with stable coronary artery disease (SCAD), in order to increase the vagus nerve activity and/or reduce the sympathetic nervous activity, help maintain or rebuild the balance of plant nerve system, improve the time-domain index of heart rate variability, reduce the burden on the heart, and relieve patients’ anxiety and other negative emotions.

Methods

This is a 6-month single-blind, randomized controlled clinical trial that will be conducted in the First Affiliated Hospital of Soochow University. A total of 140 patients who fill out the Informed Consent Form are registered and randomized 1:1 into the Voluntary Breathing Exercises (VBE)-based clinical trial monitoring group (n = 70) or the Routine follow-up group (n = 70). The VBE-based clinical trial monitoring group is given VBE training on the basis of conventional treatment and health education, while the control group received conventional health education and follow-up. The primary outcomes will be measured heart rate variability and RPP. Secondary outcomes will include changes in Self-rating Anxiety Scale, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, weight, and body mass index.

Discussion

This trial will carry out scientific respiratory exercise for patients with SCAD, which belongs to the category of active secondary prevention for patients, and changes from remedial to pre-protective. VBE is easy to operate and is not limited by time and place. It is important and meaningful to carry out VBE for patients with SCAD. This study will provide considerable evidence for further large-scale trials and alternative strategies for the rehabilitation nursing of patients with SCAD.

Trial registration

Chinese Clinical Trials Registry, 1900024043. Registered on 23 June 2019.
Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial)
Authors: Yang Yang , Su Yuchen , Zhang Xiaobin , Liu Jun , Zhang Hong , Li Bin , Hua Rong , Tan Lijie , Chen Hezhong , Li Zhigang
Published: July 2020

Background

Esophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial to compare the two treatments for patients with pT1b ESCC.

Methods

One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers and randomly assigned to the esophagectomy group or the dCRT group. The clinical lymph node status will be measured by image examination, including computer tomography and positron emission tomography–computed tomography. The pathological tumor status will be diagnosed after endoscopic submucosal dissection (ESD). All patients will be followed up for 60 months after randomization. The primary endpoint is 5-year overall survival. The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates.

Discussion

To the best of our knowledge, this is the first phase III randomized controlled trial to compare esophagectomy and dCRT for patients with cN0-pT1b ESCC after ESD. Based on the results of this study, we will show whether dCRT will benefit patients more than esophagectomy, which will contribute more high-quality evidence to the primary salvage treatment for these patients.

Trial registration

ClinicalTrials.gov, NCT04135664. Registered on Aug. 10, 2019.
Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol
Authors: Watson Sinead , McMullan Julie , Brocklehurst Paul , Tsakos Georgios , Watt Richard G. , Wassall Rebecca R. , Sherriff Andrea , Ramsay Sheena E. , Karki Anup J. , Tada Sayaka , Lappin Caroline , Donaldson Michael , McKenna Gerald
Published: July 2020

Background

Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a core outcome set for oral health services research involving dependent older adults.

Methods

A multi-step process involving consensus methods and including key stakeholders will be undertaken. This will involve identifying potentially relevant outcomes through a systematic review of previous studies examining the effectiveness of strategies to prevent oral disease in dependent older adults, combined with semi-structured interviews with key stakeholders. Stakeholders will include dependent older adults, family members, carers, care-home managers, health professionals, researchers, dental commissioners and policymakers. To condense and prioritise the long list of outcomes generated by the systematic review and semi-structured interviews, a Delphi survey consisting of several rounds with key stakeholders, as mentioned above, will be undertaken. The 9-point Likert scale proposed by the GRADE Working Group will facilitate this consensus process. Following the Delphi survey, a face-to-face consensus meeting with key stakeholders will be conducted where the stakeholders will anonymously vote and decide on what outcomes should be included in the finalised core outcome set.

Discussion

Developing a core set of outcomes that are clinically and patient-centred will help improve the design, conduct and reporting of oral health services research involving dependent older adults, and ultimately strengthen the evidence base for high-quality oral health care for dependent older adults.

Trial registration

The study was registered with the COMET initiative on 9 January 2018 http://www.cometinitiative.org/studies/details/1081?result=true.
TILT: Time-Lapse Imaging Trial—a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment
Authors: Bhide Priya , Srikantharajah Arasaratnam , Lanz Doris , Dodds Julie , Collins Bonnie , Zamora Javier , Chan David , Thangaratinam Shakila , Khan Khalid S.
Published: July 2020

Background

Subfertility is a common problem for which in vitro fertilisation (IVF) treatment is commonly recommended. Success rates following IVF are suboptimal and have remained static over the last few years. This imposes a considerable financial burden on overstretched healthcare resources. Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment. This may be either by providing undisturbed culture conditions or by improving the predictive accuracy for optimal embryo selection from a cohort of available embryos. However, the current best evidence for its effectiveness is inconclusive.

Methods

The time-lapse imaging trial is a pragmatic, multi-centre, three-arm parallel-group randomised controlled trial using re-randomisation. The primary objective of the trial is to determine if the use of TLI or undisturbed culture in IVF treatment results in a higher live birth rate when compared to current standard methods of embryo incubation and assessment. Secondary outcomes include measures of clinical efficacy and safety. The trial will randomise 1575 participants to detect an increase in live birth from 26.5 to 35.25%.

Discussion

In the absence of high-quality evidence, there is no current national guidance, recommendation or policy for the use of TLI. The use of TLI is not consistently incorporated into standard IVF care. A large, pragmatic, multi-centre, trial will provide much needed definitive evidence regarding the effectiveness of TLI. If proven to be effective, its incorporation into standard care would translate into significant clinical and economic benefits. If not, it would allow allocation of resources to more effective interventions.

Trial registration

ISRCTN registry ISRCTN17792989. Prospectively registered on 18 April 2018
The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial—study protocol for a randomized controlled trial
Authors: Legrand Matthieu , Oufella Hafid Ait , De Backer Daniel , Duranteau Jacques , Leone Marc , Levy Bruno , Rossignol Patrick , Vicaut Eric , Dépret François ,   for the I-MICRO trial investigators, Depret François , Constantin Jean-Michel , Ait Oufella Hafid , De Backer Daniel , Levy Bruno , Leone Marc , Dureanteau Jacques , Gaugain Samuel , Audart Jules , Lefrant Jean-Yves , Megarbane Bruno , Pottecher Julien , Sonneville Romain , Rimmele Thomas , Ichai Carole , Vieillard Antoine , Tran Dinh Alexy , Aubron Cécile , Mari Arnaud , Labbe Vincent , Plantefeve Gaetan , Fedou Anne Laure , Barraud Damien , Gaudry Stéphane , Nougue Helene
Published: July 2020

Background

Septic shock remains a significant cause of death in critically ill patients. During septic shock, some patients will retain microcirculatory disorders despite optimal hemodynamic support (i.e., fluid resuscitation, vasopressors, inotropes). Alterations in the microcirculation are a key pathophysiological factor of organ dysfunction and death in septic shock patients. Ilomedin is a prostacyclin analog with vasodilatory effect and anti-thrombotic properties (i.e., inhibition of platelet aggregation) preferentially at the microcirculatory level. We hypothesize that early utilization of intravenous Ilomedin in septic shock patients with clinical persistence of microperfusion disorders would improve the recovery of organ dysfunction.

Methods

The I-MICRO trial is a multicenter, prospective, randomized, double-blinded, placebo-controlled study. We plan to recruit 236 adult patients with septic shock and persistent microcirculatory disorders (i.e., skin mottling or increased capillary refill time) despite hemodynamic support. Participants will be randomized to receive a 48-h intravenous infusion of either Ilomedin or placebo starting at the earliest 6 h and later 24 h after septic shock. The primary outcome will be the change (delta) of sequential organ failure assessment (SOFA) score between randomization and day 7. Secondary outcomes will include mean SOFA score during the first 7 days after randomization, mortality at day 28 post-randomization, number of ventilation-free survival days in the 28 days post-randomization, number of renal replacement therapy-free survival days in the 28 days post-randomization, number of vasopressor-free survival days in the 28 days post-randomization, and mottling score at day 1 after randomization.

Discussion

The trial aims to provide evidence on the efficacy and safety of Ilomedin in patients with septic shock and persistent microcirculatory disorders.

Trial registration

NCT NCT03788837. Registered on 28 December 2018
Identifying Chagas disease vectors using elliptic Fourier descriptors of body contour: a case for the cryptic dimidiata complex
Authors: Cruz Daryl D. , Arellano Elizabeth , Denis Ávila Dennis , Ibarra-Cerdeña Carlos N.
Published: July 2020

Background

Triatoma dimidiata(Reduviidae: Triatominae) is an important vector of Chagas disease in various countries in the Americas. Phylogenetic studies have defined three lineages in Mexico and part of Central America. While there is a marked genetic differentiation, methods for identifying them using morphometric analyses with landmarks have not yet been fully resolutive. Elliptical Fourier descriptors (EFDs), which mathematically describe the shape of any closed two-dimensional contours, could be a potentially useful alternative method. Our objective was to validate the use of EFDs for the identification of three lineages of this species complex.

Method

A total of 84 dorsal view images of individuals of the three lineages were used. Body contours were described with EFDs using between 5 and 30 harmonics. The number of obtained coefficients was reduced by a principal components analysis and the first axis scores were used as shape variables. A linear discriminant function analysis and an ordination plot of the discriminant analysis were performed using the shape variables. A confusion matrix of the ordination plot of the discriminant analysis was obtained to estimate the classification errors, the first five PC scores were statistically compared, and a neural network were then performed using the shape variables.

Results

The first principal component explained 50% of the variability, regardless the number of harmonics used. The results of discriminant analysis get improved by increasing the number of harmonics and components considered. With 25 harmonics and 30 components, the identification of haplogroups was achieved with an overall efficiency greater than 97%. The ordering diagram showed the correct discrimination of haplogroups, with only one error of discrimination corroborated by the confusion matrix. When comparing the first five PC scores, significant differences were found among at least two haplogroups. The 30 multilayer perceptron neural networks were also efficient in identification, reaching 91% efficiency with the validation data.

Conclusions

The use of EFD is a simple and useful method for the identification of the main lineages ofTriatoma dimidiata, with high values of correct identification.
Biovar-related differences apparent in the flea foregut colonization phenotype of distinct Yersinia pestis strains do not impact transmission efficiency
Authors: Lemon Athena , Sagawa Janelle , Gravelle Kameron , Vadyvaloo Viveka
Published: July 2020

Background

Yersinia pestisis the flea-transmitted etiological agent of bubonic plague. Sylvatic plague consists of complex tripartite interactions between diverse flea and wild rodent species, and pathogen strains. Transmission by flea bite occurs primarily by theY. pestisbiofilm-mediated foregut blockage and regurgitation mechanism, which has been largely detailed by studies in the model interaction betweenY. pestisKIM6+ andXenopsylla cheopis. Here, we test if pathogen-specific traits influence this interaction by determining the dynamics of foregut blockage development inX. cheopisfleas among extant avirulent pCD1-Y. pestisstrains, KIM6+ and CO92, belonging to distinct biovars, and a non-circulating mutant CO92 strain (CO92gly), restored for glycerol fermentation; a key biochemical difference between the two biovars.

Methods

Separate flea cohorts infected with distinct strains were evaluated for (i) blockage development, bacterial burdens and flea foregut blockage pathology, and (ii) for the number of bacteria transmitted by regurgitation during membrane feeding. Strain burdens per flea was determined for fleas co-infected with CO92 and KIM6+ strains at a ratio of 1:1.

Results

Strains KIM6+ and CO92 developed foregut blockage at similar rates and peak temporal incidences, but the CO92gly strain showed significantly greater blockage rates that peak earlier post-infection. The KIM6+ strain, however, exhibited a distinctive foregut pathology wherein bacterial colonization extended the length of the esophagus up to the feeding mouthparts in ~65% of blocked fleas; in contrast to 32% and 26%, respectively, in fleas blocked with CO92 and CO92gly. The proximity of KIM6+ to the flea mouthparts in blocked fleas did not result in higher regurgitative transmission efficiencies as all strains transmitted variable numbers ofY. pestis, albeit slightly lower for CO92gly. During competitive co-infection, strains KIM6+ and CO92 were equally fit maintaining equivalent infection proportions in fleas over time.

Conclusions

We demonstrate that disparate foregut blockage pathologies exhibited by distinct extantY. pestisstrain genotypes do not influence transmission efficiency fromX. cheopisfleas. In fact, distinct extantY. pestisgenotypes maintain equivalently effective blockage and transmission efficiencies which is likely advantageous to maintaining continued successful plague spread and establishment of new plague foci.
HiCoP, a simple and robust method for detecting interactions of regulatory regions
Authors: Zhang Yan , Li Zhaoqiang , Bian Shasha , Zhao Hao , Feng Delong , Chen Yanhong , Hou Yuhe , Liu Qifa , Hao Bingtao
Published: July 2020

Background

Chromatin physical interactions provide essential information for understanding the regulation of cis-elements like enhancers, promoters, and insulators in cell development and differentiation. The Hi-C assay is a technique detecting chromatin structures of the whole genome, but not sensitive to interactions of regulatory elements. Several methods, like HiChIP, DNase-C, and OCEAN-C, have been developed for enriching interactions of regulatory regions, but all of them have some shortcomings. New simple, efficient, and robust methods are still in need for detecting interactions of regulatory regions.

Results

We developed a new, simple, and robust assay called CoP (Column Purified chromatin) for profiling of open chromatin regions by directly purifying fragmentized crosslinked chromatin with a DNA purification column. The accessible chromatin regions, including active enhancers, promoters, and insulators, were significantly enriched in CoP chromatin. The CoP-seq assay can efficiently detect open chromatin regions, especially active promoters, with a high signal-to-noise ratio. We integrated the CoP-seq and Hi-C technique (HiCoP) to detect interactions of accessible chromatin regions, which represent active cis-regulatory elements in cells. We observed that the HiCoP captured the peaks in the promoters-associated enhancer regions. HiCoP detected more promoter–enhancer (P–E), promoter–promoter (P–P), and enhancer–enhancer (E–E) interactions within 20 kb–5 Mb than Hi-C. Most of the loops identified by HiCoP are associated with the expressed genes.

Conclusion

CoP assay can efficiently enrich open chromatin regions. When CoP assay was integrated with Hi-C assay, it provides a simple, robust, alternative technique for profiling accessible chromatin regions and chromatin conformation simultaneously.