bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of lateral positioning on the bronchial cuff pressure of a left-sided double-lumen endotracheal tube during thoracic surgery: study protocol for a prospective observational study
Authors: Kim Eugene , Kim In-Young , Byun Sung-Hye 
Published: March 2019

IntroductionCorrect pressure is important when using a double-lumen endotracheal tube (DLT), especially in thoracic surgery. An inadequate bronchial cuff pressure (BCP) can cause air leak and interfere with visualisation of the surgical field, whereas an excessive pressure BCP can lead to cuff-related complications. Based on several reports that cuff pressure could alter after a positional change when using an endotracheal tube, we hypothesise that a change from the supine position to the lateral decubitus position, which is essential for thoracic surgery, would affect the BCP of the DLT.Methods and analysisThis prospective, single-centre, observational study will enrol 74 patients aged 18–70 years undergoing elective lung surgery from September 2018 to April 2019. The primary outcome will be the change in the ‘initially established BCP’ (maximum BCP not exceeding 40 cm H2O with no air leak in the supine position) after lateral decubitus positioning. BCP and air leak will be assessed in each patient position during inflation of the cuff with air in 0.5 mL increments from 0 to 3 mL. Secondary outcomes will include the incidence of BCP exceeding 40 cm H2O after the initial established value and that of a change in the smallest bronchial cuff volume without air leak after a change to the lateral position. The relationship between the change in BCP and airway pressure, compliance and body mass index after lateral positioning will be investigated.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki and supervised by the Daegu Catholic University Medical Center institutional review board (study approval number CR-18–111). All patients will receive information about the study and will need to provide written informed consent before enrolment. The results will be presented at an international meeting and published in a peer-reviewed journal.Trial registration numberNCT03656406; Pre-results.
Dose–response association between physical activity and non-alcoholic fatty liver disease: a case–control study in a Chinese population
Authors: Li YangFan , He Fei , He Yun , Pan XinTing , Wu YunLi , Hu ZhiJian , Lin Xu , Peng Xian-E , Xu ShangHua 
Published: March 2019

AimPhysical activity plays an important role in the development of non-alcoholic fatty liver disease (NAFLD).However, the optimal intensity and dose of physical activity for the treatment of NAFLD have yet to be found. In the present study, we aimed to provide a dose–response association between physical activity and NAFLD in a Chinese population.MethodsWe recruited 543 patients with NAFLD diagnosed by abdominal ultrasonography, and 543 age-matched and sex-matched controls. The amount of physical activity, sedentary time and energy intake was collected through a structured questionnaire. Logistic regression analyses were performed to investigate the association between physical activity and NAFLD.ResultsAfter adjusting for hypertension, diabetes, body mass index, fasting blood glucose, energy intake and sedentary time, the total amount of physical activity was found to be inversely associated with NAFLD in a dose-dependent manner in men (>3180 metabolic equivalent of energy [MET]-min/week vs ≤1440 MET-min/week: OR 0.60, 95% CI 0.40 to 0.91, p for trend=0.01). In addition, both moderate-intensity and vigorous-intensity physical activity were effective in reducing the risk of NAFLD, independent of confounding variables in men (moderate-intensity physical activity: >684 MET-min/week vs none: OR 0.58, 95% CI 0.40 to 0.86, p for trend=0.01; vigorous-intensity physical activity: >960 MET-min/week vs none: OR 0.63, 95% CI 0.41 to 0.95, p for trend=0.02).ConclusionsPhysical activity was inversely associated with risk of NAFLD in a dose-dependent manner in men. Vigorous-intensity and moderate-intensity physical activity were both beneficial to NAFLD, independent of sedentary time and energy intake.
Home-based Anti-Tuberculosis Treatment Adverse Reactions (HATTAR) study: a protocol for a prospective observational study
Authors: Yang Miaomiao , Pan Hongqiu , Lu Lihuan , He Xiaomin , Chen Hongbo , Tao Bilin , Liu Wenpei , Yi Honggang , Tang Shaowen 
Published: March 2019

IntroductionTuberculosis (TB) continues to be an important public health problem throughout much of the world. Drug treatment is the only effective treatment method, but adverse drug events (ADEs) and adverse drug reactions (ADRs) can affect medication adherence. As the number of drug-resistant TB patients and the number of anti-TB drugs have increased, it is necessary to explore the risk factors for ADEs/ADRs to reduce their occurrence. This study aims to build a home-based anti-TB treatment cohort and to recognise the incidences, prognosis and risk factors of anti-TB drug-induced ADEs/ADRs in real-world experiences.Methods and analysisThis study is a multicentre, prospective observational cohort study. The study population will consist of 3200 newly diagnosed TB patients between January 2019 and December 2020. After initiating the anti-TB treatment, all patients will be followed up until finishing treatment unless they withdraw, and we will record personal drug use and signs and/or symptoms of discomfort. Patients will receive scheduled laboratory tests in designated hospitals every 2 weeks during the first 2 months, and the residual blood sample after conducting the laboratory tests will be preserved. The ADEs/ADRs will be placed into eight categories: liver dysfunction, gastrointestinal reactions, drug allergy, arthralgia or muscle pain, nervous system disorders, haematological system disorders, renal impairment and others.Ethics and disseminationThis study protocol has been approved by the ethics committees of Nanjing Medical University. All patients will give written informed consent before enrollment. The findings of the study will be published in peer-reviewed journals and will be presented at national and international conferences.
Impact of using patient-reported outcome measures in routine clinical care of paediatric patients with chronic conditions: a systematic review protocol
Authors: Bele Sumedh , Mohamed Bijan , Chugh Ashton , Haverman Lotte , Santana Maria-Jose 
Published: March 2019

IntroductionChronic diseases among children are associated with lower health-related quality of life (HRQOL) and higher utilisation of healthcare services. Integrating Patient-Reported Outcomes Measures (PROMs) in routine clinical care has been shown to reduce utilisation of healthcare services while improving patient outcomes. The objectives of our study are to: (1) identify previously implemented and evaluated PROMs for chronic conditions in paediatric settings; (2) consolidate the evidence to evaluate the impact of using PROMs on HRQOL, healthcare utilisation, patient outcomes (eg, symptoms control) and quality of care among paediatric patients with chronic conditions. The findings from this review will inform the future integration of PROMs in paediatric clinical practice.Methods and analysisWe will systematically search the following electronic databases: MEDLINE, EMBASE, CINAHL, PsychINFO and Cochrane library. Reference lists of included studies will also be searched in Web of Science (Thomson Reuters) database to ensure more complete coverage. Two reviewers will independently screen the studies and abstract the data using standardised form. Extracted data will be analysed and synthesised. Finally, a narrative synthesis of summarised data will be presented.Ethics and disseminationEthical approval is not required, as the proposed systematic review will use data from published research articles. The results of this study will be disseminated through publication in peer-reviewed journals, scientific conferences and meetings, and the lead author’s doctoral dissertation.PROSPERO registration numberCRD42018109035.
The impact of different prostate-specific antigen (PSA) testing intervals on Gleason score at diagnosis and the risk of experiencing false-positive biopsy recommendations: a population-based cohort study
Authors: Palsdottir Thorgerdur , Nordstrom Tobias , Karlsson Andreas , Grönberg Henrik , Clements Mark , Eklund Martin 
Published: March 2019

ObjectiveGiven a man’s current prostate- specific antigen (PSA) level, age and family history of prostate cancer, what are the benefits (decreased risk of higher Gleason score [GS] cancer at diagnosis) and harms (increased risk of false-positive biopsy recommendation) of waiting 1, 2, 3, 4 or 5–8 years until the next PSA test?DesignProspective cohort.SettingAll PSA tested men in Stockholm, Sweden, between 2003 and 2015.ParticipantsMen aged 50–74 years with at least two PSA tests between 2003 and 2015 (n=174 636).Main outcome measuresLog-binomial regression to calculate the risk ratio (RR) of GS ≥7 and GS 6 versus benign outcome at prostate biopsy and 12-year cumulative probability of experiencing a false-positive biopsy by testing interval, age, PSA level and first-degree family history.ResultsMen with PSA ≤1 ng/mL had low risk of GS ≥7 prostate cancer irrespective of testing interval; <3% had a PSA >3 at the next testing occasion, and of the 663 men biopsied after the next PSA test only 32 (5%) had GS ≥7 cancer. Men with PSA >1 ng/mL had increased risk of being diagnosed with GS ≥7 prostate cancer when screened with longer than annual intervals (RRs ranged from 1.4 to 3.2 depending on PSA level and testing interval). The results were consistent across age groups and family history status. This benefit needs to be balanced against the increased risk for false-positive biopsy recommendation with shorter testing intervals (twofold for annual vs biennial and threefold for annual vs triennial).ConclusionsMen aged 50–74 years with PSA ≤1 ng/mL can wait 3–4 years before having a new PSA test. For men with PSA >1 ng/mL, we observed an increased risk of being diagnosed with GS ≥7 prostate cancer with longer than annual testing intervals. This benefit needs to be balanced against the markedly increased risks for false-positive biopsy recommendations with shorter testing intervals recommendations.
Protocol for a mixed methods realist evaluation of regional District Health Board groupings in New Zealand
Authors: Stokes Tim , Atmore Carol , Penno Erin , Richard Lauralie , Wyeth Emma , Richards Rosalina , Doolan-Noble Fiona , Gray Andrew R , Sullivan Trudy , Gauld Robin 
Published: March 2019

IntroductionAchieving effective integration of healthcare across primary, secondary and tertiary care is a key goal of the New Zealand (NZ) Health Strategy. NZ’s regional District Health Board (DHB) groupings are fundamental to delivering integration, bringing the country’s 20 DHBs together into four groups to collaboratively plan, fund and deliver health services within their defined geographical regions. This research aims to examine how, for whom and in what circumstances the regional DHB groupings work to improve health service integration, healthcare quality, health outcomes and health equity, particularly for Māori and Pacific peoples.Methods and analysisThis research uses a mixed methods realist evaluation design. It comprises three linked studies: (1) formulating initial programme theory (IPT) through developing programme logic models to describe regional DHB working; (2) empirically testing IPT through both a qualitative process evaluation of regional DHB working using a case study design; and (3) a quantitative analysis of the impact that DHB regional groupings may have on service integration, health outcomes, health equity and costs. The findings of these three studies will allow refinement of the IPT and should lead to a programme theory which will explain how, for whom and in what circumstances regional DHB groupings improve service integration, health outcomes and health equity in NZ.Ethics and disseminationThe University of Otago Human Ethics Committee has approved this study. The embedding of a clinician researcher within a participating regional DHB grouping has facilitated research coproduction, the research has been jointly conceived and designed and will be jointly evaluated and disseminated by researchers and practitioners. Uptake of the research findings by other key groups including policymakers, Māori providers and communities and Pacific providers and communities will be supported through key strategic relationships and dissemination activities. Academic dissemination will occur through publication and conference presentations.
Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study
Authors: Haslund-Krog Sissel Sundell , Hertel Steen , Dalhoff Kim , Poulsen Susanne , Christensen Ulla , Wilkins Diana , van den Anker John , Brink Henriksen Tine , Holst Helle 
Published: March 2019

IntroductionAnticipated or actual pain in neonates results in use of paracetamol for prolonged pain relief in many neonatal intensive care units. Clinical trials examining safety of paracetamol exposure in neonates have been of short duration (1–3 days) and hepatic biomarkers and paracetamol metabolism are rarely reported in the same studies.We aim to investigate the safety (hepatic tolerance) and effectiveness of prolonged paracetamol exposure in neonates by measuring hepatic biomarkers, plasma concentrations of paracetamol and its metabolites and pain scores. In addition, we study a possible interaction between ethanol and paracetamol.Methods and analysisA multicentre interventional cohort study.Neonates of any gestational age and up to 44 weeks postmenstrual age, treated with oral or intravenous paracetamol can be included.Alanine aminotransferase (ALT) and bilirubin are measured at baseline or within 24 hours after treatment initiation. P-paracetamol and metabolites are measured at steady state and every 2 days (opportunistically) together with ALT and bilirubin and lastly after discontinuation of treatment. COMFORT neo pain scores are collected longitudinally. COMFORT neo pain scores and population pharmacokinetic analysis of paracetamol samples will be analysed simultaneously using non-linear mixed effects models. One and two compartment models with first-order elimination will be tested for disposition. In addition, plasma ethanol is measured if the patient receives concomitant treatment with intravenous or oral phenobarbital containing ethanol as an excipient.Ethics and disseminationInclusion of patients can be postponed 24 hours after the first paracetamol dose. This is intended to make the inclusion process less stressful for parents. This study uses standard dosing strategies. The potential risks are additional blood samples, which are collected opportunistically to reduce additional heel pricks.Trial registrationnumberEthics Comittee: H-17027244, EudraCT no: 2017-002724-25, BFH-2017–106, 05952.
Platelet-bound C4d, low C3 and lupus anticoagulant associate with thrombosis in SLE
Authors: Petri Michelle A , Conklin John , O'Malley Tyler , Dervieux Thierry 
Published: March 2019

BackgroundLow C3 and lupus anticoagulant (LAC) are known risk factors for thrombosis in SLE. We evaluated the association between C4d products deposited on platelets (PC4d) and thrombosis in SLE. Antiphosphatidyl serine/prothrombin (PS/PT) complex antibody was also evaluated as an alternative to LAC.MethodsThis was a cross-sectional analysis of 149 consented patients with SLE (mean age: 47±1 years, 86% female) classified with (n=16) or without (n=133) thrombotic events in the past 5 years. Abnormal PC4d (≥20 units) was measured using flow cytometry. LAC and C3 were measured using dilute Russell’s viper venom time (>37 s) and immunoturbidimetry, respectively. Anti-PS/PT antibody status (IgG) was measured by immunoassay. Statistical analysis consisted of logistic regression and calculation of OR estimates with 95% CI.ResultsAbnormal PC4d (OR=8.4, 95% CI 2.8 to 24.8), low C3 (OR=9.5, 95% CI 3.0 to 30.3), LAC (OR=5.4, 95% CI 1.3 to 22.3) and anti-PS/PT IgG (OR=3.4, 95% CI 1.2 to 9.7) status associated with thrombosis (p<0.05). Cumulatively, the presence of PC4d, low C3 and LAC abnormalities as a composite risk score was higher in the presence of thrombosis (1.93±0.25) than in its absence (0.81±0.06) (p<0.01). Each unit of this composite risk score yielded an OR of 5.2 (95% CI 2.5 to 10.7) to have thrombosis (p<0.01). The composite risk score with anti-PS/PT antibody status instead of LAC also associated with thrombosis (p<0.01).ConclusionA composite risk score including PC4d, low C3 and LAC was associated with recent thrombosis and acknowledges the multifactorial nature of thrombosis in SLE.
Clinical features, anaesthetic management and perioperative complications seen in three horses with pheochromocytoma
Authors: Norgate Daisy Jessica , Foster Andrew , Dunkel Bettina , Spiro Simon , Veres‐Nyeki Kata 
Published: March 2019

Three horses presenting with colic signs to the Equine Referral Hospital at The Royal Veterinary College underwent general anaesthesia between September 2013 and November 2017 for emergency exploratory laparotomy. No obvious cause for the colic signs was identified in two horses, while a haemoperitoneum was identified in the third. All horses were euthanased within 12 hours of surgery due to deteriorating haemodynamic instability and/or intractable pain. Postmortem examination revealed an adrenal mass in each case, confirmed to be a pheochromocytoma on histopathology. In retrospect, each horse had some hallmark characteristics consistent with a functional pheochromocytoma, including hyperglycaemia and hyperlactataemia. Extremely high packed cell volume (PCV) (>65 per cent) was also identified in two horses, with a high‐normal PCV found in the haemoperitoneum case. Perioperative haemodynamic instability was predominantly characterised by episodes of intermittent hypertension and tachycardia.
Galectin‐3 Is Associated With Stage B Metabolic Heart Disease and Pulmonary Hypertension in Young Obese Patients
Authors: Gopal Deepa M. , Ayalon Nir , Wang Yi‐Chih , Siwik Deborah , Sverdlov Aaron , Donohue Courtney , Perez Alejandro , Downing Jill , Apovian Caroline , Silva Vanessa , Panagia Marcello , Kolachalama Vijaya , Ho Jennifer E. , Liang Chang‐seng , Gokce Noyan , Colucci Wilson S. 
Published: March 2019

Background

Obesity is a precursor to heart failure with preserved ejection fraction. Biomarkers that identify preclinical metabolic heart disease (
MHD
) in young obese patients would help identify high‐risk individuals for heart failure prevention strategies. We assessed the predictive value of GAL3 (galectin–3), FSTL3 (follistatin‐like 3 peptide), and NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide) to identify stage B
MHD
in young obese participants free of clinically evident cardiovascular disease.

Methods and Results

Asymptomatic obese patients (n=250) and non‐obese controls (n=21) underwent echocardiographic cardiac phenotyping. Obese patients were classified as
MHD
positive (
MHD
‐
POS
; n=94) if they had abnormal diastolic function or left ventricular hypertrophy and had estimated pulmonary artery systolic pressure ≥35 mm Hg. Obese patients without such abnormalities were classified as MHD negative (MHD‐NEG; n=52). Serum biomarkers timed with echocardiography.
MHD
‐
POS
and MHD‐NEG individuals were similarly obese, but
MHD
‐
POS
patients were older, with more diabetes mellitus and metabolic syndrome. Right ventricular coupling was worse in
MHD
‐
POS
patients (
P
<0.001).
GAL
3 levels were higher in
MHD
‐
POS
versus
MHD
‐NEG patients (7.7±2.3 versus 6.3±1.9 ng/mL, respectively;
P
<0.001). Both
GAL
3 and
FSTL
3 levels correlated with diastolic dysfunction and increased pulmonary artery systolic pressure but not with left ventricular mass. In multivariate models including all 3 biomarkers, only
GAL
3 remained associated with
MHD
(odds ratio: 1.30; 95%
CI
, 1.01–1.68;
P
=0.04).

Conclusions

In young obese individuals without known cardiovascular disease,
GAL
3 is associated with the presence of preclinical
MHD
.
GAL
3 may be useful in screening for preclinical
MHD
and identifying individuals with increased risk of progression to obesity‐related heart failure with preserved ejection fraction.
Impact of Treatment Modality on Vascular Function in Coarctation of the Aorta: The LOVE‐COARCT Study
Authors: Martins José D. , Zachariah Justin , Selamet Tierney Elif Seda , Truong Uyen , Morris Shaine A. , Kutty Shelby , de Ferranti Sarah D. , Guarino Maria , Thomas Boban , Oliveira Diana , Marinho António , António Marta , Gauvreau Kimberlee , Jalles Nuno , Geva Tal , Carmo Miguel M. , Prakash Ashwin ,   for the LOVE‐COARCT Study
Published: March 2019

Background
Optimally treated patients with coarctation of the aorta remain at risk for late vascular dysfunction. The effect of treatment modality on vascular function is unknown. The LOVE‐COARCT (Long‐term Outcomes and Vascular Evaluation After Successful Coarctation of the Aorta Treatment) study was done to compare vascular function in patients with coarctation of the aorta treated with surgery, balloon dilation (BD), or stent implantation.

Methods and Results

In treated coarctation of the aorta patients without residual coarctation, we prospectively compared aortic stiffness by applanation tonometry and cardiac magnetic resonance; endothelial function by endothelial pulse amplitude testing; blood pressure (
BP
) phenotype by office
BP
, ambulatory
BP
monitoring, and
BP
response to exercise; left ventricular mass by cardiac magnetic resonance; and blood biomarkers of endothelial function, inflammation, vascular wall function, and extracellular matrix. Participants included 75 patients treated with surgery (n=28),
BD
(n=23), or stent (n=24). Groups had similar age at enrollment, coarctation of the aorta severity, residual gradient, and metabolic profile, but differed by age at treatment. Prevalence of systemic hypertension, aortic stiffness, endothelial function, and left ventricular mass were similar among treatment groups. However,
BD
patients had more‐distensible ascending aortas, lower peak systolic
BP
during exercise, less impairment in diurnal
BP
variation, and lower inflammatory biomarkers. Results were unchanged after adjustment for potential confounders, including age at treatment.

Conclusions

In our cohort of patients without residual coarctation, treatment modality was not associated with major vascular outcomes, even though there were some favorable vascular characteristics in the
BD
patients. Although this suggests that choice of treatment modality should continue to be driven by likelihood of achieving a good anatomical result, more long‐term studies are required to assess the clinical significance of the more‐optimal results of secondary markers of vascular function in
BD
patients.

Clinical Trial Registration

URL
:
http://www.clinicaltrials.gov
. Unique identifier:
NCT
03262753.