bluuebunny/crossref_metadata_2025 huggingface dataset:
Low FCMR mRNA expression in leukocytes of patients with Kawasaki disease six months after disease onset
Authors: Chang Ling‐Sai , Guo Mindy Ming‐Huey , Yan Jia‐Huei , Huang Ying‐Hsien , Lo Mao‐Hung , Kuo Ho‐Chang
Published: February 2020

Background

Immunoglobulin (Ig) M plays an important role in immune regulation. FCMR‐encoded FcμR is a receptor of IgM. Previous research has suggested that IgM levels may be involved in the coronary artery lesions of Kawasaki syndrome or Kawasaki disease (KD). In this study, we aimed to explore the roles of mRNA expressions of IgM receptors, particularly FCMR, in KD patients. FCMR encodes the Fc fragment of immunoglobulin M receptor.

Methods

We enrolled 60 KD patients and 55 non‐KD controls. Whole‐blood leukocytes were isolated, and the mRNA expression for FCMR was determined. Each mRNA consisted of a sample taken before intravenous immunoglobulin (IVIG) was administered (acute, KD1) and those taken at three weeks, six months, and one year later (KD3, KD4, KD5). Paired KD subjects were analyzed from both the acute and convalescent phases (n = 28).

Results

After six months and one year of treatment, KD patients still apparently have lower FCMR compared with controls (P = .004). FCMR expressions were downregulated in male patients with KD prior to IVIG administration (P = .044). The FCMR of paired KD patients who received IVIG treatments after six months was significantly lower than before undergoing IVIG treatment (P = .044). Expressions in the polymorphonuclear leukocytes were similar to those in the peripheral blood mononuclear cells.

Conclusion

The unique data supported that FCMR is expressed by granulocytes at RNA levels in humans and demonstrated lower FCMR six months after the onset of KD. The findings remind us of the need to track the health of children with KD over the long term, even if we think patients have fully recovered.
Implementation of Digital‐Era Governance: The Case of Open Data in U.S. Cities
Authors: Young Matthew M.
Published: February 2020

This article examines the institutional factors that influence the implementation of open data platforms in U.S. cities. Public management scholarship has argued that governance can be transformed by new information technologies that improve transparency and engagement, reduce administrative costs, and support performance management systems. However, this argument ignores key risks for administrators, as well as institutional and political obstacles that can thwart implementation. This article uses hierarchical negative binomial regression to analyze the organizational and institutional features influencing implementation in more than 1,500 departments across 60 cities. Department type and administrative capacity are strongly associated with the number of open data files available, while city‐level institutional characteristics and administrative capacity are not significant factors. Municipal demographics are also identified as a factor, suggesting a potential demand‐side influence from wealthy and technologically proficient residents.

Evidence for Practice

The implementation of open data policies benefits from targeted approaches at the department level rather than uniform, citywide objectives or requirements.

City executive‐level positions such as chief data or information officers are not necessarily associated with successful implementation, measured by the number of open data files made available.

Open data implementation involves additional administrative responsibilities and labor at the department level, so city administrators looking to expand the number and variety of data sets available through their open data platforms should devote time and resources to working directly with departments to facilitate and encourage data sharing.

Administrators looking to expand the number and variety of data sets available through their open data platforms should consider the costs associated with investing in increasing individual departments’ abilities to balance the additional administrative responsibilities and labor involved.
Comparison of tuberculin skin test and interferon gamma release assay in pediatric candidates of heart transplantation and a 2‐year follow‐up
Authors: Sayyahfar Shirin , Mahdavi Mohammad , Seyedi Arani Soodeh , Fotovati Zahra
Published: February 2020

Background

Currently, tuberculin skin test (TST) and interferon gamma release assay (IGRA) are used to find the latent tuberculosis infection (LTBI) cases in the candidates of heart transplantation. Therefore, this study aimed to compare TST and IGRA to diagnose LTBI in pediatric heart transplant candidates.

Methods

This cross‐sectional study was performed on 50 children, who were candidates for heart transplantation, of whom 42 cases underwent heart transplantation in Shahid Rajaie Cardiovascular, Medical, and Research center, Tehran, Iran, from 2016 to 2017.

Results

Participants of the study included 24 male patients (%48) (p‐value = 0.67). The mean age of the patients was 8.18 ± 4.27 years (1‐16 years). According to the results, IGRA was negative in all patients, and no indeterminate result was reported, while the purified derivative test (PPD) was positive in three (6%) cases. In comparison with QFT, an accuracy of 94% was achieved for TST to diagnose Mycobacterium tuberculosis infection.

Conclusions

It seems that TST can still be used as an accurate test for screening LTBI in pediatric candidates for heart transplantation.
Design of a Robotic Rehabilitation System for Mild Cognitive Impairment Based on Computer Vision
Authors: Chen Hao-dong , Zhu Hongbo , Teng Zhiqiang , Zhao Ping
Published: February 2020

This paper develops a robotic cognitive rehabilitation therapy (CRT) system to assist patients with mild cognitive impairment (MCI) in block design test (BDT) rehabilitation training. This system bridges the treatment gap that occurs when one physician has several patients to attend to. One physician can setup the BDT training task and simultaneously monitor the training progress of several patients with MCI, which forms an effective one-to-many rehabilitation model. A target information acquisition method is designed to realize target detection and position extraction in automatic rehabilitation. Two graphic user interfaces (GUIs) are developed to provide intuitive control and immediate visual feedback. Different BDTs are selected from the benchmark by the physician in an integrated GUI (I-GUI) and are assigned to several patient GUIs (P-GUIs), respectively. During training, automatic visual assistance can be triggered by the help button and the patients can be guided in finding the target block. Additionally, a robotic arm could be engaged to further help with teaching so that patients can follow the instructions given by the P-GUI and imitate the demonstration given by the robot arm to finish the training task. This system converts traditional MCI rehabilitation into an automatic process, creating an effective model of BDT training for MCI rehabilitation.
Lumped Parameter Modeling and Snap-Through Stability Analysis of Planar Hydraulically Amplified Dielectric Elastomer Actuators
Authors: Zamanian Amir Hosein , Son David Y. , Krueger Paul S. , Richer Edmond
Published: February 2020

In this paper, we established an analytical model that avoids extensive numerical computation for the analysis of a hydraulically amplified dielectric elastomer actuator. This actuator comprises a thin elastomer shell filled with an incompressible dielectric fluid coupled with a pair of electrodes placed in the central area. Application of high voltage on the electrodes inflates the actuator due to the induced Maxwell stress that pressurizes the incompressible dielectric fluid. The lumped parameter model predicts the stable functional region and the snap-through instability in the actuator. The model was compared with multi-physics finite element models that considered both linear elastic and nonlinear Mooney–Rivlin materials. The proposed model showed good agreement in the estimation of the actuation strain and the hydrostatic pressure as a function of voltage when compared to the finite element results. The average error in the axial and radial actuation using the proposed analytical model and nonlinear finite element method models was 1.62% and 3.42%, respectively. This shows the model strength in the estimation of the actuator states and the critical voltage to avoid snap-through instability, required in applications such as control algorithms.
Investigation of the Mechanical Behavior of Electroless Ni–P–Ti Composite Coatings
Authors: Li Zhi , Farhat Zoheir , Jarjoura George , Fayyad Eman , Abdullah Aboubakr , Hassan Mohammad
Published: February 2020

To improve the toughness of Ni–P coatings, NiTi superelastic particles were introduced into the Ni–P matrix through the electroless co-depositing of Ni–P and Ti particles and annealing Ni–P–Ti coatings. The mechanical properties of the coatings were determined through bend testing bilayer specimens and tensile testing the standalone coating. The effects of Ti content and annealing on Young’s modulus, toughness, and fracture strength were investigated. After annealing, the toughness and strength improved considerably. The formation of the superelastic NiTi phase after annealing led to the improvement of toughness and fracture strength of the composite coating through transformation toughening, crack deflection, bridging, and shielding. Different toughening mechanisms interacted with each other and operated together. This contributed to the enhancement of toughness and fracture strength.
Numerical and Experimental Analyses of Breakwater Designs for Turbulent Flow Characteristics and Sediment Transport Under Coastal Wave Actions
Authors: Wang Hairui , Foltz William , Zhang Ning , Dermisis Dimitrios
Published: February 2020

The goal of the study is to identify optimal breakwater designs to be placed on the banks of various water bodies in coastal Louisiana, to prevent the coastal erosion. Coastal erosion is a significant concern for Louisiana's wavy coastline. The loss of coastal wetlands is threatening the environment and the economic development. One of the ways to prevent coastal erosion and wetland losses is by using breakwaters designed to reduce the wave energy and change the transport of sediments brought by the waves. The objective of this research is to analyze the turbulent characteristics around specially designed three-dimensional (3D) breakwaters, and its impact on sediment deposition under coastal wave actions. Both computational fluid dynamics (CFD) simulations and experimental measurements were conducted. In order to validate the CFD models used for this study, the simulation results were compared to data measured from a scale-down experiment. Once the validity of the CFD models has been confirmed on three miniature panels, namely, a solid panel, a panel with three holes, and a panel with eight holes, the simulations were scaled up to the actual size of the designed breakwater panels for tests. The breakwater designs aim to allow sediment pass through the holes, to deposit sediment at target areas, and to reduce wave actions. There were three different panel-design cases simulated in this study. The results of 3D CFD simulations of these panels were compared and analyzed to determine the performance of each design in terms of wave reduction and sediment retention.
Thermodynamics Model for Stribeck Curve and Experiments: The Role of Interfacial Interaction
Authors: Zhang Xiangjun , Jing Haoda , Tian Yu , Meng Yonggang
Published: February 2020

A thermodynamics model was built to simulate and analyze the Stribeck curve of a lubrication system, focusing on the competition between the hydrodynamic effect of the lubricant and the lubricant–substrate interaction effect. For the first time, an entropy production model for a lubrication system was introduced by combining with interfacial disjoining pressure function and interfacial free energy. It reveals that as the film thickness of the lubricant decrease to nanometers, the friction force resulted from interfacial interaction becomes significant and dominant. Meanwhile, the Stribeck curve of the lubrication system presents transition lubrication regime with minimum friction coefficients, namely, valley zone. The Stribeck curve based on the thermodynamic model was simulated and experimentally confirmed by friction tests on silicon wafer substrates modified with different free energies. Test results revealed that a stronger interfacial interaction may cause a smaller friction coefficient within the valley zone on the Stribeck curve, and the corresponding transition regime could be tailored by modifying the interfacial interaction. The proposed thermodynamic model is inclusive and reasonable to reveal the multiscale and multidiscipline effects involved in the lubrication and friction system.
A liquid alkoxide precursor for the atomic layer deposition of aluminum oxide films
Authors: Cao LiAo , Mattelaer Felix , Sajavaara Timo , Dendooven Jolien , Detavernier Christophe
Published: February 2020

For large-scale atomic layer deposition (ALD) of alumina, the most commonly used alkyl precursor trimethylaluminum poses safety issues due to its pyrophoric nature. In this work, the authors have investigated a liquid alkoxide, aluminum tri-sec-butoxide (ATSB), as a precursor for ALD deposition of alumina. ATSB is thermally stable and the liquid nature facilitates handling in a bubbler and potentially enables liquid injection toward upscaling. Both thermal and plasma enhanced ALD processes are investigated in a vacuum type reactor by using water, oxygen plasma, and water plasma as coreactants. All processes achieved ALD deposition at a growth rate of 1–1.4 Å/cycle for substrate temperatures ranging from 100 to 200 °C. Film morphology, surface roughness, and composition have been studied with different characterization techniques.
Higher-order figure-8 sensors in a pair, skewed and collocated—Their azimuthal “spatial matched filter” beam-pattern
Authors: Nnonyelu Chibuzo Joseph , Wong Kainam Thomas , Lee Charles Hung
Published: February 2020

Two figure-8 sensors, differently oriented but collocated, can facilitate azimuth- elevation two-dimensional beamforming that is invariant of the frequency spectrum of the incident signal. For such a pair of identical figure-8 sensors of any arbitrary directivity-order, their spatial matched filter beam-pattern is characterized analytically here in this paper. This paper shows that the beamformer would suffer a high pointing bias if the figure-8 sensors' directivity-order exceeds one. Other characteristics of the beam-pattern are also analytically explained herein.
Combining partial information from speech and text
Authors: Fogerty Daniel , Iftikhar Irraj , Madorskiy Rachel
Published: February 2020

The current study investigated how partial speech and text information, distributed at various interruption rates, is combined to support sentence recognition in quiet. Speech and text stimuli were interrupted by silence and presented unimodally or combined in multimodal conditions. Across all conditions, performance was best at the highest interruption rates. Listeners were able to gain benefit from most multimodal presentations, even when the rate of interruption was mismatched between modalities. Supplementing partial speech with incomplete visual cues can improve sentence intelligibility and compensate for degraded speech in adverse listening conditions. However, individual variability in benefit depends on unimodal performance.
An
In Vitro
Pipeline for Screening and Selection of Citrus-Associated Microbiota with Potential Anti-“
Candidatus
Liberibacter asiaticus” Properties
Authors: Blacutt Alex , Ginnan Nichole , Dang Tyler , Bodaghi Sohrab , Vidalakis Georgios , Ruegger Paul , Peacock Beth , Viravathana Polrit , Vieira Flavia Campos , Drozd Christopher , Jablonska Barbara , Borneman James , McCollum Greg , Cordoza Jennifer , Meloch Jeremiah , Berry Victoria , Salazar Lia Lozano , Maloney Katherine N. , Rolshausen Philippe E. , Roper M. Caroline
Published: February 2020

Globally, citrus is threatened by huanglongbing (HLB), and the lack of effective control measures is a major concern of farmers, markets, and consumers. There is compelling evidence that plant health is a function of the activities of the plant's associated microbiome. Using
Liberibacter crescens
, a culturable surrogate for the unculturable HLB-associated bacterium “
Candidatus
Liberibacter asiaticus,” we tested the hypothesis that members of the citrus microbiome produce potential anti-“
Ca
. Liberibacter asiaticus” natural products with potential anti-“
Ca
. Liberibacter asiaticus” activity. A subset of isolates obtained from the microbiome inhibited
L. crescens
growth in an agar diffusion inhibition assay. Further fractionation experiments linked the inhibitory activity of the fungus
Cladosporium cladosporioides
to the fungus-produced natural products cladosporols A, C, and D, demonstrating dose-dependent antagonism to
L. crescens
.
Effectiveness of an innovative and comprehensive eye care model for individuals in residential care facilities: results of the residential ocular care (ROC) multicentred randomised controlled trial
Authors: Man Ryan Eyn Kidd , Gan Alfred Tau Liang , Constantinou Marios , Fenwick Eva K , Holloway Edith , Finkelstein Eric A , Coote Michael , Jackson Jonathan , Rees Gwyn , Lamoureux Ecosse Luc
Published: February 2020

Background

To assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care.

Methods

In this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015–2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms.

Results

At 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed.

Conclusion

Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted.
Maternal and fetal outcomes following exposure to duloxetine in pregnancy: cohort study
Authors: Huybrechts Krista F , Bateman Brian T , Pawar Ajinkya , Bessette Lily G , Mogun Helen , Levin Raisa , Li Hu , Motsko Stephen , Scantamburlo Fernandes Maria Fernanda , Upadhyaya Himanshu P , Hernandez-Diaz Sonia
Published: February 2020

Objective

To evaluate the risk of adverse maternal and infant outcomes following in utero exposure to duloxetine.

Design

Cohort study nested in the Medicaid Analytic eXtract for 2004-13.

Setting

Publicly insured pregnancies in the United States.

Participants

Pregnant women 18 to 55 years of age and their liveborn infants.

Interventions

Duloxetine exposure during the etiologically relevant time window, compared with no exposure to duloxetine, exposure to selective serotonin reuptake inhibitors, exposure to venlafaxine, and exposure to duloxetine before but not during pregnancy.

Main outcome measures

Congenital malformations overall, cardiac malformations, preterm birth, small for gestational age infant, pre-eclampsia, and postpartum hemorrhage.

Results

Cohort sizes ranged from 1.3 to 4.1 million, depending on the outcome. The number of women exposed to duloxetine varied by cohort and exposure contrast and was around 2500-3000 for early pregnancy exposure and 900-950 for late pregnancy exposure. The base risk per 1000 unexposed women was 36.6 (95% confidence interval 36.3 to 36.9) for congenital malformations overall, 13.7 (13.5 to 13.9) for cardiovascular malformations, 107.8 (107.3 to 108.3) for preterm birth, 20.4 (20.1 to 20.6) for small for gestational age infant, 33.6 (33.3 to 33.9) for pre-eclampsia, and 23.3 (23.1 to 23.4) for postpartum hemorrhage. After adjustment for measured potential confounding variables, all baseline characteristics were well balanced for all exposure contrasts. In propensity score adjusted analyses versus unexposed pregnancies, the relative risk was 1.11 (95% confidence interval 0.93 to 1.33) for congenital malformations overall and 1.29 (0.99 to 1.68) for cardiovascular malformations. For preterm birth, the relative risk was 1.01 (0.92 to 1.10) for early exposure and 1.19 (1.04 to 1.37) for late exposure. For small for gestational age infants the relative risks were 1.14 (0.92 to 1.41) and 1.20 (0.83 to 1.72) for early and late pregnancy exposure, respectively, and for pre-eclampsia they were 1.12 (0.96 to 1.31) and 1.04 (0.80 to 1.35). The relative risk for postpartum hemorrhage was 1.53 (1.08 to 2.18). Results from sensitivity analyses were generally consistent with the findings from the main analyses.

Conclusions

On the basis of the evidence available to date, duloxetine is unlikely to be a major teratogen but may be associated with an increased risk of postpartum hemorrhage and a small increased risk of cardiac malformations. While continuing to monitor the safety of duloxetine as data accumulate over time, these potential small increases in risk of relatively uncommon outcomes must be weighed against the benefits of treating depression and pain during pregnancy in a given patient.

Trial registration

EUPAS 15946.
Comparison of emergency department trauma triage performance of clinicians and clinical prediction models: a cohort study in India
Authors: Wärnberg Gerdin Ludvig , Khajanchi Monty , Kumar Vineet , Roy Nobhojit , Saha Makhan Lal , Soni Kapil Dev , Mishra Anurag , Kamble Jyoti , Borle Nitin , Verma Chandrika Prasad , Gerdin Wärnberg Martin
Published: February 2020

Objective

The aim of this study was to evaluate and compare the abilities of clinicians and clinical prediction models to accurately triage emergency department (ED) trauma patients. We compared the decisions made by clinicians with the Revised Trauma Score (RTS), the Glasgow Coma Scale, Age and Systolic Blood Pressure (GAP) score, the Kampala Trauma Score (KTS) and the Gerdin et al model.

Design

Prospective cohort study.

Setting

Three hospitals in urban India.

Participants

In total, 7697 adult patients who presented to participating hospitals with a history of trauma were approached for enrolment. The final study sample included 5155 patients. The majority (4023, 78.0%) were male.

Main outcome measure

The patient outcome was mortality within 30 days of arrival at the participating hospital. A grid search was used to identify model cut-off values. Clinicians and categorised models were evaluated and compared using the area under the receiver operating characteristics curve (AUROCC) and net reclassification improvement in non-survivors (NRI+) and survivors (NRI−) separately.

Results

The differences in AUROCC between each categorised model and the clinicians were 0.016 (95% CI −0.014 to 0.045) for RTS, 0.019 (95% CI −0.007 to 0.058) for GAP, 0.054 (95% CI 0.033 to 0.077) for KTS and −0.007 (95% CI −0.035 to 0.03) for Gerdin et al. The NRI+ for each model were −0.235 (−0.37 to −0.116), 0.17 (−0.042 to 0.405), 0.55 (0.47 to 0.65) and 0.22 (0.11 to 0.717), respectively. The NRI− were 0.385 (0.348 to 0.4), −0.059 (−0.476 to −0.005), −0.162 (−0.18 to −0.146) and 0.039 (−0.229 to 0.06), respectively.

Conclusion

The findings of this study suggest that there are no substantial differences in discrimination and net reclassification improvement between clinicians and all four clinical prediction models when using 30-day mortality as the outcome of ED trauma triage in adult patients.

Trial registration number

ClinicalTrials.gov Registry (NCT02838459).
Economic evaluation of the OSAC randomised controlled trial: oral corticosteroids for non-asthmatic adults with acute lower respiratory tract infection in primary care
Authors: Moure-Fernandez Aida , Hollinghurst Sandra , Carroll Fran E , Downing Harriet , Young Grace , Brookes Sara , May Margaret , El-Gohary Magdy , Harnden Anthony , Kendrick Denise , Lafond Natasher , Little Paul , Moore Michael , Orton Elizabeth , Thompson Matthew , Timmins David , Wang Kay , Hay Alastair D
Published: February 2020

Objective

To estimate the costs and outcomes associated with treating non-asthmatic adults (nor suffering from other lung-disease) presenting to primary care with acute lower respiratory tract infection (ALRTI) with oral corticosteroids compared with placebo.

Design

Cost-consequence analysis alongside a randomised controlled trial. Perspectives included the healthcare provider, patients and productivity losses associated with time off work.

Setting

Fifty-four National Health Service (NHS) general practices in England.

Participants

398 adults attending NHS primary practices with ALRTI but no asthma or other chronic lung disease, followed up for 28 days.

Interventions

2× 20 mg oral prednisolone per day for 5 days versus matching placebo tablets.

Outcome measures

Quality-adjusted life years using the 5-level EuroQol-5D version measured weekly; duration and severity of symptom. Direct and indirect resources related to the disease and its treatment were also collected. Outcomes were measured for the 28-day follow-up.

Results

198 (50%) patients received the intervention (prednisolone) and 200 (50%) received placebo. NHS costs were dominated by primary care contacts, higher with placebo than with prednisolone (£13.11 vs £10.38) but without evidence of a difference (95% CI £3.05 to £8.52). The trial medication cost of £1.96 per patient would have been recouped in prescription charges of £4.30 per patient overall (55% participants would have paid £7.85), giving an overall mean ‘profit’ to the NHS of £7.00 (95% CI £0.50 to £17.08) per patient. There was a quality adjusted life years gain of 0.03 (95% CI 0.01 to 0.05) equating to half a day of perfect health favouring the prednisolone patients; there was no difference in duration of cough or severity of symptoms.

Conclusions

The use of prednisolone for non-asthmatic adults with ALRTI, provided small gains in quality of life and cost savings driven by prescription charges. Considering the results of the economic evaluation and possible side effects of corticosteroids, the short-term benefits may not outweigh the long-term harms.

Trial registration numbers

EudraCT 2012-000851-15 and ISRCTN57309858; Pre-results.
Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands: study protocol for the retrospective ODYSSEUS study
Authors: Geraedts Anna Catharina Maria , de Mik Sylvana , Ubbink Dirk , Koelemay Mark , Balm Ron
Published: February 2020

Introduction

Strict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as ‘low risk’ for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance.

Methods and analysis

The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.

Ethics and dissemination

The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.

Trial registration number

The Netherlands Trial Registry, NL6953 (old: NTR28773).
Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial
Authors: Coteur Kristien , Van Nuland Marc , Vanmeerbeek Marc , Henrard Gilles , Anthierens Sibyl , Van den Broeck Kris , De Sutter An , Creupelandt Hanne , Devroey Dirk , Van Overmeire Roel , Offermans Anne-Marie , Kacenelenbogen Nadine , Laenen Annouschka , Mathei Catharina
Published: February 2020

Introduction

Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process.

Methods and analysis

This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study.

Ethics and dissemination

This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations.

Trial registration number

NCT03937180.
Trajectories of self-rated health in an older general population and their determinants: the Lifelines Cohort Study
Authors: Feenstra Marlies , van Munster Barbara C , MacNeil Vroomen Janet L , de Rooij Sophia E , Smidt Nynke
Published: February 2020

Objectives

Poor self-rated health (SRH) is a strong predictor of premature mortality in older adults. Trajectories of poor SRH are associated with multimorbidity and unhealthy behaviours. Whether trajectories of SRH are associated with deviating physiological markers is unclear. This study identified trajectories of SRH and investigated the associations of trajectory membership with chronic diseases, health risk behaviours and physiological markers in community-dwelling older adults.

Study design and setting

Prospective general population cohort.

Participants

Trajectories of SRH over 5 years were identified using data of 11 600 participants aged 65 years and older of the Lifelines Cohort Study.

Outcome measures

Trajectories of SRH were the main outcome. Covariates included demographics (age, gender, education), chronic diseases, health-risk behaviour (physical activity, smoking, drinking) and physiological markers (body mass index, cardiovascular function, lung function, glucose metabolism, haematological condition, endocrine function, renal function, liver function and cognitive function).

Results

Four stable trajectories were identified, including excellent (n=607, 6%), good (n=2111, 19%), moderate (n=7677, 65%) and poor SRH (n=1205, 10%). Being women (OR: 1.4; 95% CI: 1.0 to 1.9), low education (OR: 2.1; 95% CI: 1.5 to 3.0), one (OR: 10.4; 95% CI: 7.4 to 14.7) or multiple chronic diseases (OR: 37.8; 95% CI: 22.4 to 71.8), smoking (OR: 1.8; 95% CI: 1.0 to 3.2), physical inactivity (OR: 3.1; 95% CI: 1.8 to 5.2), alcohol abstinence (OR: 2.2; 95% CI: 1.4 to 3.2) and deviating physiological markers (OR: 1.5; 95% CI: 1.1 to 2.0) increase the odds for a higher probability of poor SRH trajectory membership compared with excellent SRH trajectory membership.

Conclusion

SRH of community-dwelling older adults is stable over time with the majority (65%) having moderate SRH. Older adults with higher probabilities of poor SRH often have unfavourable health status.
Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)
Authors: Liu Xiaoqian , Robbins Sarah , Eyles Jillian , Fedorova Tatyana , Virk Sonika , Deveza Leticia A , McLachlan Andrew , Hunter David
Published: February 2020

Introduction

Hand osteoarthritis (HOA) is a highly prevalent disabling joint disease. The current management regimens are limited. Potentially as a consequence, many people turn to complementary and alternative medicines for symptomatic relief. A combination of two or more supplements is common in clinical practice; however, evidence for the efficacy of this approach is lacking. The aim of this study is to investigate the efficacy of a supplement combination for treating symptomatic HOA in comparison to placebo.

Methods and analysis

The RADIANT study is an internet-based, parallel, superiority, double-blind, placebo-controlled, randomised, two-arm clinical trial. A participatory design is used to facilitate the study procedures. One hundred and six participants aged over 40 years with painful HOA and structural change on X-ray (Kellgren and Lawrence grade (KLG) ≥2) will be recruited from the community and randomly allocated to receive either a supplement combination composed of: (1) combined supplement containingBoswellia serrataextract, pine bark extract and methylsulfonylmethane and (2) curcumin or placebo for 12 weeks. The primary outcome will be 12-week change in hand pain on a visual analogue scale (VAS). Main secondary outcomes include adverse events, change in hand function, patient global assessment of disease activity and quality of life. A range of additional measures will be recorded, and an individual patient placebo response will be performed. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored weekly throughout the study.

Ethics and dissemination

This protocol has been approved by the University of Sydney Human Research Ethics Committee (HREC No. 2018/766). Dissemination will occur through conferences, social media, scientific publications and PhD thesis.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12619000835145); Pre-results
What do we really assess with organisational culture tools in healthcare? An interpretive systematic umbrella review of tools in healthcare
Authors: Malik Romana Fattimah , Buljac-Samardžić Martina , Akdemir Nesibe , Hilders Carina , Scheele Fedde
Published: February 2020

Introduction

A toxic organisational culture (OC) is a major contributing factor to serious failings in healthcare delivery. Poor OC with its consequences of unprofessional behaviour, unsafe attitudes of professionals and its impact on patient care still need to be addressed. Although various tools have been developed to determine OC and improve patient safety, it remains a challenge to decide on the suitability of tools for uncovering the underlying factors which truly impact OC, such as behavioural norms, or the unwritten rules. A better understanding of the underlying dimensions that these tools do and do not unravel is required.

Objectives

The aim of this study is to provide an overview of existing tools to assess OC and the tangible and intangible OC dimensions these tools address.

Methods

An interpretive umbrella review was conducted. Literature reviews were considered for inclusion if they described multiple tools and their dimensional characteristics in the context of OC, organisational climate, patient safety culture or climate. OC tools and the underlying dimensions were extracted from the reviews. A qualitative data analysis software program (MAX.QDA 2007) was used for coding the dimensions, which resulted in tangible and intangible themes.

Results

Fifteen reviews met our inclusion criteria. A total of 127 tools were identified, which were mainly quantitative questionnaires covering tangible key dimensions. Qualitative analyses distinguished nine intangible themes (commitment, trust, psychological safety, power, support, communication openness, blame and shame, morals and valuing ethics, and cohesion) and seven tangible themes (leadership, communication system, teamwork, training and development, organisational structures and processes, employee and job attributes, and patient orientation).

Conclusion

This umbrella review identifies the essential tangible and intangible themes of OC tools. OC tools in healthcare do not seem to be designed to determine deeper underlying dimensions of culture. We suggest approaching complex underlying OC problems by focusing on the intangible dimensions, rather than putting the tangible dimensions up front.
Glucose as an additional parameter to National Early Warning Score (NEWS) in prehospital setting enhances identification of patients at risk of death: an observational cohort study
Authors: Vihonen Hanna , Lääperi Mitja , Kuisma Markku , Pirneskoski Jussi , Nurmi Jouni
Published: February 2020

Background

To determine if prehospital blood glucose could be added to National Early Warning Score (NEWS) for improved identification of risk of short-term mortality.

Methods

Retrospective observational study (2008–2015) of adult patients seen by emergency medical services in Helsinki metropolitan area for whom all variables for calculation of NEWS and a blood glucose value were available. Survival of 24 hours and 30 days were determined. The NEWS parameters and glucose were tested by multivariate logistic regression model. Based on ORs we formed NEWSgluc model with hypoglycaemia (≤3.0 mmol/L) 3, normoglycaemia 0 and hyperglycaemia (≥11.1 mmol/L) 1 points. The scores from NEWS and NEWSgluc were compared using discrimination (area under the curve), calibration (Hosmer-Lemeshow test), likelihood ratio tests and reclassification (continuous net reclassification index (cNRI)).

Results

Data of 27 141 patients were included in the study. Multivariable regression model for NEWSgluc parameters revealed a strong association with glucose disturbances and 24-hour and 30-day mortality. Likelihood ratios (LRs) for mortality at 24 hours using a cut-off point of 15 were for NEWSgluc: LR+ 17.78 and LR− 0.96 and for NEWS: LR+ 13.50 and LR− 0.92. Results were similar at 30 days. Risks per score point estimation and calibration model showed glucose added benefit to NEWS at 24 hours and at 30 days. Although areas under the curve were similar, reclassification test (cNRI) showed overall improvement of classification of survivors and non-survivors at 24 days and 30 days with NEWSgluc.

Conclusions

Including glucose in NEWS in the prehospital setting seems to improve identification of patients at risk of death.
Angiotensin II for the emergency physician
Authors: Wallis Marianne C , Chow Jonathan H , Winters Michael E , McCurdy Michael T
Published: February 2020

Refractory hypotension is one of the most common and difficult clinical problems faced by acute care clinicians, and it poses a particularly large problem to the emergency physician when a patient in undifferentiated shock arrives in the department. Angiotensin II (Ang-2) has been previously used as a vasopressor to combat shock; the feasibility of its clinical use has been reinvigorated after approval of a human synthetic formulation of the medication by the US Food and Drug Administration in 2017 and the European Medicines Agency in 2019. A thorough literature search was completed, and in this review, we discuss the discovery and development of Ang-2, its complex mechanisms of vasoconstriction, its potential adverse effects and its potential role in clinical practice for emergency physicians.
Mediterranean diet intervention in overweight and obese subjects lowers plasma cholesterol and causes changes in the gut microbiome and metabolome independently of energy intake
Authors: Meslier Victoria , Laiola Manolo , Roager Henrik Munch , De Filippis Francesca , Roume Hugo , Quinquis Benoit , Giacco Rosalba , Mennella Ilario , Ferracane Rosalia , Pons Nicolas , Pasolli Edoardo , Rivellese Angela , Dragsted Lars Ove , Vitaglione Paola , Ehrlich Stanislav Dusko , Ercolini Danilo
Published: February 2020

Objectives

This study aimed to explore the effects of an isocaloric Mediterranean diet (MD) intervention on metabolic health, gut microbiome and systemic metabolome in subjects with lifestyle risk factors for metabolic disease.

Design

Eighty-two healthy overweight and obese subjects with a habitually low intake of fruit and vegetables and a sedentary lifestyle participated in a parallel 8-week randomised controlled trial. Forty-three participants consumed an MD tailored to their habitual energy intakes (MedD), and 39 maintained their regular diets (ConD). Dietary adherence, metabolic parameters, gut microbiome and systemic metabolome were monitored over the study period.

Results

Increased MD adherence in the MedD group successfully reprogrammed subjects’ intake of fibre and animal proteins. Compliance was confirmed by lowered levels of carnitine in plasma and urine. Significant reductions in plasma cholesterol (primary outcome) and faecal bile acids occurred in the MedD compared with the ConD group. Shotgun metagenomics showed gut microbiome changes that reflected individual MD adherence and increase in gene richness in participants who reduced systemic inflammation over the intervention. The MD intervention led to increased levels of the fibre-degradingFaecalibacterium prausnitziiand of genes for microbial carbohydrate degradation linked to butyrate metabolism. The dietary changes in the MedD group led to increased urinary urolithins, faecal bile acid degradation and insulin sensitivity that co-varied with specific microbial taxa.

Conclusion

Switching subjects to an MD while maintaining their energy intake reduced their blood cholesterol and caused multiple changes in their microbiome and metabolome that are relevant in future strategies for the improvement of metabolic health.
One health ethics: a response to pragmatism
Authors: Lederman Zohar , Capps Benjamin
Published: February 2020

Johnson and Degeling have recently enquired whether one health (OH) requires a comprehensive normative framework, concluding that such a framework, while not necessary, may be helpful. In this commentary, we provide a context for this debate, and describe how pragmatism has been predominant in the OH literature. We nevertheless argue that articulating a comprehensive normative theory to ground OH practice might clear existing vagueness and provide stronger guidance in relevant health dilemmas. A comprehensive theory will also be needed eventually to ground notions such as universal good. We, thus, call for the systematic articulation of a comprehensive, metaethical theory, concomitantly with already ongoing normative work.
Animal research nexus: a new approach to the connections between science, health and animal welfare
Authors: Davies Gail , Gorman Richard , Greenhough Beth , Hobson-West Pru , Kirk Robert G W , Message Reuben , Myelnikov Dmitriy , Palmer Alexandra , Roe Emma , Ashall Vanessa , Crudgington Bentley , McGlacken Renelle , Peres Sara , Skidmore Tess
Published: February 2020

Animals used in biological research and testing have become integrated into the trajectories of modern biomedicine, generating increased expectations for and connections between human and animal health. Animal research also remains controversial and its acceptability is contingent on a complex network of relations and assurances across science and society, which are both formally constituted through law and informal or assumed. In this paper, we propose these entanglements can be studied through an approach that understands animal research as a nexus spanning the domains of science, health and animal welfare. We introduce this argument through, first, outlining some key challenges in UK debates around animal research, and second, reviewing the way nexus concepts have been used to connect issues in environmental research. Third, we explore how existing social sciences and humanities scholarship on animal research tends to focus on different aspects of the connections between scientific research, human health and animal welfare, which we suggest can be combined in a nexus approach. In the fourth section, we introduce our collaborative research on the animal research nexus, indicating how this approach can be used to study the history, governance and changing sensibilities around UK laboratory animal research. We suggest the attention to complex connections in nexus approaches can be enriched through conversations with the social sciences and medical humanities in ways that deepen appreciation of the importance of path-dependency and contingency, inclusion and exclusion in governance and the affective dimension to research. In conclusion, we reflect on the value of nexus thinking for developing research that is interdisciplinary, interactive and reflexive in understanding how accounts of the histories and current relations of animal research have significant implications for how scientific practices, policy debates and broad social contracts around animal research are being remade today.