bluuebunny/crossref_metadata_2025_split huggingface dataset:
Double blind, randomised, placebo-controlled trial to evaluate the efficacy of esomeprazole to treat early onset pre-eclampsia (PIE Trial): a study protocol
Authors: Cluver Catherine A , Walker Susan P , Mol Ben W , Theron Gerard B , Hall David R , Hiscock Richard , Hannan N , Tong S 
Published: October 2015

IntroductionPre-eclampsia is a major complication of pregnancy, globally responsible for 60 000 maternal deaths per year, and far greater numbers of fetal losses. There is no definitive treatment other than delivery. A drug that can quench the disease process could be useful to treat early onset pre-eclampsia, as it could allow pregnancies to safely continue to a gestation where fetal outcomes are significantly improved. We have generated preclinical data to show esomeprazole, a proton pump inhibitor used for gastric reflux, has potent biological effects that makes it a worthwhile therapeutic candidate. Esomeprazole potently decreases soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin secretion from placenta and endothelial cells, and has biological actions to mitigate endothelial dysfunction and oxidative stress.Methods and analysisWe propose undertaking a phase II, double blind, randomised controlled clinical trial to examine whether administering 40 mg esomeprazole daily may prolong gestation in women with early onset pre-eclampsia. We will recruit 120 women (gestational age of 26+0 to 31+6 weeks) who will be randomised to receive either esomeprazole or an identical placebo. The primary outcome will be the number of days from randomisation to delivery. Secondary outcomes include maternal, fetal and neonatal composite and individual outcomes. Maternal outcomes include maternal death, eclampsia, pulmonary oedema, severe renal impairment, cerebral vascular events and liver haematoma or rupture. Neonatal outcomes include neonatal death within 6 weeks after the due date, intraventricular haemorrhage, necrotising enterocolitis and bronchopulmonary dysplasia. We will examine whether esomeprazole can decrease serum sFlt-1 and soluble endoglin levels and we will record the safety of esomeprazole in these pregnancies.Ethics and disseminationThis study has ethical approval (Protocol V.2.4, M14/09/038, Federal Wide assurance Number 00001372, IRB0005239), and is registered with NHREC (ID 3649) and the Pan African Clinical Trial Registry (PACTR201504000771349). Data will be presented at international conferences and published in peer-reviewed journals.
Mental health in women 20–23 years after IVF treatment: a Swedish cross-sectional study
Authors: Vikström J , Josefsson A , Bladh M , Sydsjö G 
Published: October 2015

ObjectiveTo assess self-perceived mental health in women treated with in vitro fertilisation (IVF) 20–23 years previously, while comparing them to a reference group, and to determine any differences in mental health between those who had given birth, those who had adopted a child, those who had given birth and adopted a child and those who remained childless.DesignA cross-sectional study.SettingA Center of Reproductive Medicine (RMC) at a Swedish University hospital.Participants520 women who had undergone at least one IVF cycle at the University Hospital in Linköping between 1986 and 1989. 504 of 520 women (97%) were eligible for follow-up. While 34 women declined, 93 per cent (n=470) of the women agreed to participate. The reference group consisted of 150 women of the Swedish population included in a study that was used to validate the Symptom CheckList (SCL)-90.InterventionsFollow-up was conducted in 2008–2009. The SCL-90 was used to measure the women's self-perceived mental health and a questionnaire specific for this study was used to retain demographic information.Outcome measuresThe SCL-90 assesses 9 primary dimensions; somatisation, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. There is also a global index of distress.ResultsWomen who had previously undergone IVF treatment were at increased risk of symptoms of depression (p=0.017), obsessive-compulsion (p=0.02) and somatisation (p≤0.001) when compared to a reference group. In addition, the women who have remained childless are at increased risk of symptoms of depression (p=0.009) and phobic anxiety (p=0.017).ConclusionsThe majority of the women who have been treated with IVF 20–23 years previously appear to be in good mental health. However, women who remain childless and/or without partner after unsuccessful infertility treatment constitute a vulnerable group even later on in life.
Qualitative complaints and their relation to overall hospital rating using an H-CAHPS-derived instrument
Authors: Kemp Kyle , Warren Sarah , Chan Nancy , McCormack Brandi , Santana Maria , Quan Hude 
Published: October 2015

Background and objectivesDue to the multitude of questions in the Hospital-Consumer Assessment of Healthcare Providers and Systems (H-CAHPS) survey, it may be difficult to decide where quality improvement efforts should be focused. Our organisation has supplemented the survey with a ‘patient complaints’ section. The study objectives were to determine (1) the frequency of qualitative complaints and the demographic/clinical profile of patients lodging them, (2) the most frequent complaint themes and their association with overall experience scores and (3) whether overall experience scores varied based upon the complaint action taken by the patient or the degree of patient satisfaction in the handling of complaints.MethodsFrom April 2013 to March 2014, 8929 telephone surveys were completed by patients discharged from 93 acute care hospitals in Alberta, Canada. These were successfully linked with the corresponding inpatient record. Open-ended complaints were themed into categories. Mean differences in overall inpatient experience were assessed for each complaint theme, including overall and multiple complaints.Results1870 patients (20.9%) reported at least one open-ended complaint. Most frequent complaint themes were nursing (n=491; 5.5% of cohort), medications (n=219; 2.5%) and food (n=193; 2.2%). Increased odds of having a complaint were associated with younger age, being born in Canada and having no documented medical comorbidities. Protective factors were male gender, lower education level, urgent hospital admission, lower resource intensity and length of stay (LOS) <3 days.ConclusionsThis is the first investigation of its type using H-CAHPS-based data in a Canadian context. Through replication of this study, other healthcare organisations may determine the association between open-ended complaints and their own overall experience scores.
Assessing global risk factors for non-fatal injuries from road traffic accidents and falls in adults aged 35–70 years in 17 countries: a cross-sectional analysis of the Prospective Urban Rural Epidemiological (PURE) study
Authors: Raina Parminder , Sohel Nazmul , Oremus Mark , Shannon Harry , Mony Prem , Kumar Rajesh , Li Wei , Wang Yang , Wang Xingyu , Yusoff Khalid , Yusuf Rita , Iqbal Romaina , Szuba Andrzej , Oguz Aytekin , Rosengren Annika , Kruger Annamarie , Chifamba Jephat , Mohammadifard Noushin , Darwish Ebtihal Ahmad , Dagenais Gilles , Diaz Rafael , Avezum Alvaro , Lopez-Jaramillo Patricio , Seron Pamela , Rangarajan Sumathy , Teo Koon , Yusuf Salim 
Published: October 2015

ObjectivesTo assess risk factors associated with non-fatal injuries (NFIs) from road traffic accidents (RTAs) or falls.MethodsOur study included 151 609 participants from the Prospective Urban Rural Epidemiological study. Participants reported whether they experienced injuries within the past 12 months that limited normal activities. Additional questions elicited data on risk factors. We employed multivariable logistic regression to analyse data.ResultsOverall, 5979 participants (3.9% of 151 609) reported at least one NFI. Total number of NFIs was 6300: 1428 were caused by RTAs (22.7%), 1948 by falls (30.9%) and 2924 by other causes (46.4%). Married/common law status was associated with fewer falls, but not with RTA. Age 65–70 years was associated with fewer RTAs, but more falls; age 55–64 years was associated with more falls. Male versus female was associated with more RTAs and fewer falls. In lower-middle-income countries, rural residence was associated with more RTAs and falls; in low-income countries, rural residence was associated with fewer RTAs. Previous alcohol use was associated with more RTAs and falls; current alcohol use was associated with more falls. Education was not associated with either NFI type.ConclusionsThis study of persons aged 35–70 years found that some risk factors for NFI differ according to whether the injury is related to RTA or falls. Policymakers may use these differences to guide the design of prevention policies for RTA-related or fall-related NFI.
Improving outcomes in patients with Acute Kidney Injury: the impact of hospital based automated AKI alerts
Authors: Prendecki M , Blacker E , Sadeghi-Alavijeh O , Edwards R , Montgomery H , Gillis S , Harber M 
Published: October 2015

AbstractBackgroundAcute kidney injury (AKI) is a significant cause of morbidity and mortality. Early identification may improve the outcome and in 2012 our hospital introduced an automated AKI alert system for early detection and management of AKI.ObjectivesUsing an automated AKI alert system we analysed whether early review and intervention by the Critical Care and Outreach (CCOT) team improved patient outcomes in AKI and whether serum bicarbonate was useful in predicting outcomes in patients with AKI.MethodsIn a retrospective analysis we identified patients who triggered an AKI alert from 20 April 2012 to 20 September 2013 and collected data on mortality, length of stay, need for intensive care admission and renal replacement therapy (RRT).Results994 AKI alerts were generated and analysed. Patients with bicarbonate outside the normal range had significantly higher mortality. Bicarbonate &lt;22 mmol/L was associated with a mortality of 25.7% (49/191) compared with 16.9% (39/231) when 22–29 mmol/L (p=0.047, χ2). Those patients reviewed ≥1 day after AKI alert by CCOT compared with those seen on the day of the alert had a 2.4 times increase in mortality and were 7 times more likely to require RRT acutely.ConclusionsElectronically identified AKI alerts identify patients at high risk of morbidity and mortality. In this group AKI alerts preceded CCOT review by a mean of 2 days. This represents a window for supportive interventions, which may explain improved outcomes in those reviewed earlier. The addition of serum bicarbonate offers a further method of risk stratifying patients at greater risk of death.
Photoactive Layer of DSSCS Based on Natural Dyes: A Study of Experiment and Theory
Authors: Li Yuanzuo , Li Huixing , Song Peng , Sun Chaofan 
Published: October 2015

Three natural dyes (Forsythia suspensa, Herba Violae, and Corn leaf) have been investigated as potential sensitizers for dye‐sensitized solar cells. UV‐vis absorption spectra reveal that three natural dyes mainly contain the compound of pheophytin a. Among three DSSCs, the highest photo electronic conversion efficiency η is 0.96% with open circuit voltage (VOC) of 0.66 V, short circuit current density (ISC ) of 1.97 mA cm−2, and fill factor (ff) of 0.74. Theoretical time‐dependent density functional theory and charge difference density are used to explore the nature of excited states. Results demonstrate that the first state is an intramolecular charge transfer (ICT) state, and electron injection could occur owing to the thermodynamically driving force.
Risk of major bleeding in patients with venous thromboembolism treated with rivaroxaban or with heparin and vitamin K antagonists
Authors: Ageno Walter , Rutjes Anne W. S. , Pap Akos F. , Büller Harry R. , Nisio Marcello Di 
Published: October 2015

SummaryThe study aim was to identify predictive factors for major bleeding in patients receiving the novel oral factor Xa inhibitor rivaroxaban or enoxaparin-vitamin K antagonists (VKAs) for the treatment of acute symptomatic venous thromboembolism. We analysed data from patients included in the phase III EINSTEIN DVT and EINSTEIN PE studies. Factors associated with major bleeding events were assessed with best subset variable selection using Cox proportional hazards regression model. Three time windows were considered, i. e. the initial three weeks, after the third week onwards, and the entire duration of the anticoagulant treatment. Model discrimination was estimated using the C-statistic and validated internally by bootstrap techniques. Major bleeding occurred in 40 (1.0 %) of 4130 patients receiving rivaroxaban and in 72 (1.7 %) of 4116 receiving enoxaparin/VKAs, with 44 % of the major bleeding events occurring in the first three weeks of treatment. Significant risk factors for major bleeding were older age, black race, low haemoglobin concentrations, active cancer, and antiplatelet or non-steroidal anti-inflammatory drug therapy. The discrimination of the model for major bleeding was high for the first three weeks (C-statistic 0.73), from the fourth week onwards (C-statistic 0.68), and the entire period of anticoagulant treatment (C-statistic 0.74). This analysis identified risk factors for major bleeding in patients receiving the novel oral anticoagulant rivaroxaban or enoxaparin/VKAs for the treatment of acute venous thromboembolism. The prognostic model based on the combination of identified risk factors may be informative to estimate the risk of major bleeding both during the initial and later phases of anticoagulation.Supplementary Material to this article is available online at www.thrombosis-online.com.
Smoking Paradox in Patients Hospitalized With Coronary Artery Disease or Acute Ischemic Stroke
Authors: Ali Syed F. , Smith Eric E. , Reeves Mathew J. , Zhao Xin , Xian Ying , Hernandez Adrian F. , Bhatt Deepak L. , Fonarow Gregg C. , Schwamm Lee H. 
Published: October 2015

Background—
Smoking is a potent risk factor for coronary artery disease (CAD) and acute ischemic stroke (AIS), but there are numerous reports of lower in-hospital mortality among smokers versus nonsmokers hospitalized for these events.

Methods and Results—

We analyzed all consecutive patients hospitalized with a first index CAD (n=158 054) or AIS (n=899 295) event in Get With The Guidelines from 2002 to 2012; 20.4% of AIS and 30.4% of patients with CAD were past-year smokers. Multivariable models and age-stratified analyses were used to estimate the adjusted odds ratio of in-hospital mortality in smokers versus nonsmokers. Smokers were younger, more often male, with fewer vascular risk factors, and were more likely to be admitted to hospitals that were large, academic, or in the South. In-hospital mortality was significantly lower among smokers in both CAD (2.7% versus 5.2%;
P
<0.0001) and AIS (3.5% versus 5.8%;
P
<0.0001). The difference between unadjusted and adjusted odds ratios for smoking (0.57 versus 0.86 in CAD; 0.56 versus 0.86 in AIS) indicates the presence of substantial confounding by age and other covariates, but a significant association of past-year smoking remained.

Conclusions—
Among patients hospitalized with CAD and AIS, smoking is a risk factor for early age of onset, even among those with few vascular risk factors. The persistent association with lower in-hospital mortality after adjusted and stratified analyses probably represents residual unmeasured confounding, although a biological effect of smoking cannot be excluded. Further clinical and prospective population-based studies are needed to explore variables that contribute to outcomes in these patients.
Meta-Analysis of Randomized Controlled Trials Comparing the Long-Term Outcomes of Carotid Artery Stenting Versus Endarterectomy
Authors: Vincent Sophie , Eberg Maria , Eisenberg Mark J. , Filion Kristian B. 
Published: October 2015

Background—
Stenting is an endovascular alternative to endarterectomy for the management of carotid stenosis, but its long-term safety and efficacy relative to endarterectomy remain unclear. Our objective was to compare the safety and efficacy of stenting with those of endarterectomy, with a particular focus on long-term outcomes, via meta-analysis of randomized controlled trials (RCTs).

Methods and Results—
We systematically searched PubMed, EMBASE, MEDLINE, and the Cochrane Library for RCTs with ≥50 patients that compared stenting with endarterectomy in patients with carotid stenosis. Periprocedural and long-term outcomes were assessed, with data pooled across RCTs using random-effects models. Eight RCTs were included in our meta-analysis (n=7091), with follow-up ranging from 2.0 to 10.0 years. When compared with endarterectomy, stenting was associated with an increased risk of periprocedural stroke (relative risk, 1.49, 95% confidence interval [CI], 1.11 to 2.01; risk difference, 1.7%; 95% CI, 0.3 to 3.0) but a decreased risk of periprocedural myocardial infarction (relative risk, 0.47; 95% CI, 0.29 to 0.78; risk difference, −0.4%; 95% CI, −0.8% to 0.1%). During long-term follow-up, stenting was associated with an increased risk of stroke (relative risk, 1.36; 95% CI, 1.16 to 1.61) and a composite end point of ipsilateral stroke, periprocedural stroke, or periprocedural death (relative risk, 1.45; 95% CI, 1.20 to 1.75).

Conclusions—
Although stenting has more favorable periprocedural outcomes with respect to myocardial infarction, the observed increased risk of stroke and death throughout follow-up with stenting suggests that endarterectomy remains the treatment of choice for carotid stenosis.
Quality of Care and Ischemic Stroke Risk After Hospitalization for Transient Ischemic Attack
Authors: O’Brien Emily C. , Zhao Xin , Fonarow Gregg C. , Schulte Phillip J. , Dai David , Smith Eric E. , Schwamm Lee H. , Bhatt Deepak L. , Xian Ying , Saver Jeffrey L. , Reeves Mathew J. , Peterson Eric D. , Hernandez Adrian F. 
Published: October 2015

Background—
Patients with transient ischemic attack (TIA) are at increased risk for ischemic stroke. We derived a prediction rule for 1-year ischemic stroke risk post-TIA, examining estimated risk, receipt of inpatient quality of care measures for TIA, and the presence or absence of stroke at 1 year post discharge.

Methods and Results—
We linked 67 892 TIA Get With The Guidelines-Stroke patients >65 years (2003–2008) to Medicare inpatient claims to obtain longitudinal outcomes. Using Cox proportional hazards modeling in a split sample, we identified baseline demographics and clinical characteristics associated with ischemic stroke admission during the year post-TIA, and developed a Get With The Guidelines Ischemic Stroke after TIA Risk Score; performance was examined in the validation sample. Quality of care was estimated by a global defect-free care measure, and individual performance measures within estimated risk score quintiles. The overall hospital admission rate for ischemic stroke during the year post-TIA was 5.7%. Patients with ischemic stroke were more likely to be older, black, and have higher rates of smoking, previous stroke, diabetes mellitus, previous myocardial infarction, heart failure, and atrial fibrillation. The Risk Score showed moderate discriminative performance (c-statistic=0.606); highest quintile patients were less likely to receive statins, smoking cessation counseling, and defect-free care. Although not associated with 1-year ischemic stroke, DCF was associated with a significantly lower risk of all-cause mortality.

Conclusions—
TIA patients with high estimated ischemic stroke risk are less likely to receive defect-free care than low-risk patients. Standardized risk assessment and delivery of optimal inpatient care are needed to reduce this risk-treatment mismatch.
Mobile Phone–Based Questionnaire for Assessing 3 Months Modified Rankin Score After Acute Stroke
Authors: Cooray Charith , Matusevicius Marius , Wahlgren Nils , Ahmed Niaz 
Published: October 2015

Background—
In many countries, a majority of stroke patients are not assessed for long-term functional outcome owing to limited resources and time. We investigated whether automatic assessment of the modified Rankin Scale (mRS) based on a mobile phone questionnaire may serve as an alternative to mRS assessments at clinical visits after stroke.

Methods and Results—
We enrolled 62 acute stroke patients admitted to our stroke unit during March to May 2014. Forty-eight patients completed the study. During the stay, patients and/or caregivers were equipped with a mobile phone application in their personal mobile phones. The mobile phone application contained a set of 20 questions, based on the Rankin Focused Assessment, which we previously tested in a pilot study. Three months after inclusion, the mobile phone application automatically prompted the study participants to answer the mRS questionnaire in the mobile phones. Each question or a group of questions in the questionnaire corresponded to a certain mRS score. Using a predefined protocol, the highest mRS score question where the study participant had answered yes was deemed the final mobile mRS score. A few days later, a study personnel performed a clinical visit mRS assessment. The 2 assessments were compared using quadratic weighing κ-statistics. Mean age was 67 years (38% females), and median baseline National Institutes of Health Stroke Scale (NIHSS) score was 5 (interquartile range 2–10.5, range 0–23). Median and mean clinical visit mRS at 3 months was 2 and 2.3, respectively. We found a 62.5% agreement between clinical visit and mobile mRS assessment, weighted kappa 0.89 (95% confidence interval 0.82–0.96), and unweighted kappa 0.53 (95% confidence interval 0.36–0.70). Dichotomized mRS outcome separating functionally independent (mRS score 0–2) from dependent (mRS score 3–5) showed 83% agreement and unweighted kappa of 0.66 (95% confidence interval 0.45–0.87).

Conclusions—
Mobile phone–based automatic assessments of mRS performed well in comparison with clinical visit mRS and could be used as an alternative in stroke follow-up.
Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis
Authors: Anani Nadim , Mazya Michael V. , Bill Olivier , Chen Rong , Koch Sabine , Ahmed Niaz , Wahlgren Nils , Prazeres Moreira Tiago 
Published: October 2015

Background—
Intravenous thrombolysis (IVT) for acute ischemic stroke is subject to label and guideline contraindications. Updated European guidelines in 2008/2009 recommended IVT in selected patients aged >80 years and stroke onset-to-treatment time 3 to 4.5 hours, which the label still prohibited. Our aim was to compare contraindication nonadherence before and after the guideline update.

Methods and Results—

Data on IVT-treated patients with stroke at 232 European hospitals participating in the Safe Implementation of Treatments in Stroke registry during both periods 2006 to 2007 (n=6354) and 2010 to 2011 (n=12 046). After the 2008/2009 guideline update, the proportion of patients nonadherent to label increased from 23.6% to 51.1% (
P
<0.001). Specifically, nonadherence to onset-to-treatment time >3 hours increased from 8.2% to 27.9% and IVT in patients aged >80 years from 8.9% to 17.2% (both
P
<0.001). Nonadherence also increased to the contraindications severe stroke (National Institutes of Health Stroke Scale score >25), onset-to-treatment time >4.5 hours, blood pressure >185/110 mm Hg, and ongoing oral anticoagulation (all
P
≤0.001). Higher hospital IVT patient volumes were associated with higher nonadherence rates.

Conclusions—
After the European guideline update, new recommendations were promptly adopted and nonadherence to the unchanged label increased. Label contraindications should be updated.