bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real‐world experience with Grazoprevir/Elbasvir in the treatment of previously “difficult to treat” patients infected with hepatitis C virus genotype 1 and 4
Authors: Zarębska‐Michaluk Dorota , Jaroszewicz Jerzy , Buczyńska Iwona , Simon Krzysztof , Lorenc Beata , Tudrujek‐Zdunek Magdalena , Tomasiewicz Krzysztof , Sitko Marek , Garlicki Aleksander , Janczewska Ewa , Dybowska Dorota , Halota Waldemar , Pawłowska Małgorzata , Pabjan Paweł , Mazur Włodzimierz , Czauż‐Andrzejuk Agnieszka , Berak Hanna , Horban Andrzej , Socha Łukasz , Klapaczyński Jakub , Piekarska Anna , Blaszkowska Maria , Belica‐Wdowik Teresa , Dobracka Beata , Tronina Olga , Deroń Zbigniew , Białkowska‐Warzecha Jolanta , Laurans Łukasz , Flisiak Robert 
Published: November 2019

AbstractBackground and AimGrazoprevir/elbasvir (GZR/EBR) was approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 and 4 infected patients with or without compensated liver cirrhosis. The aim of this study was to assess GZR/EBR regimen in the real‐world experience, particularly in previously “difficult‐to‐treat” patients with chronic kidney diseases, human immunodeficiency virus‐coinfected, cirrhotics, and treatment‐experienced.MethodsThe analysis included patients treated with GZR/EBR selected from 10 152 individuals from the EpiTer‐2 database, large national real‐world study evaluating antiviral treatment in 22 Polish hepatology centers between 2015 and 2018. Data were completed retrospectively and submitted online.ResultsA total of 1615 patients who started GZR/EBR therapy in 2017 and 2018 with a female predominance (54%) and median age of 54 years were analyzed. The majority were infected with GT1b (89%) and treatment naïve (81%). Liver cirrhosis was diagnosed in 19%, and 70% of patients had comorbidities, of which chronic renal disease was present in 7% and HIV‐coinfection in 4%. Overall, a sustained virologic response (SVR) was achieved by 95% according to intent‐to‐treat (ITT) and 98% after exclusion of lost to follow up (modified ITT). No differences were found in cure rate between all included patients and subpopulations previously considered as difficult‐to‐treat. Majority of patients completed the treatment course as scheduled, adverse events were mostly mild and did not lead to therapy discontinuation.ConclusionsGZR/EBR treatment carried‐out in patients infected with HCV genotype 1 and 4 demonstrated good tolerability and an excellent SVR rate with no effectiveness reduction in so called difficult‐to‐treat populations.
A symptom severity questionnaire for patients suffering from functional gastrointestinal disorder: FGI‐Checklist
Authors: Chan Yawen , Cheong Pui Kuan , Fang Fanny Fan , Cheung Cynthia K Y , Lan Lin Lin , Yuen Kay Wing Ki , Ching Jessica Yuet Ling , Mak Arthur Dun Ping , Wu Justin Che‐yuen 
Published: November 2019

AbstractBackground and AimA well‐validated, comprehensive checklist of functional gastrointestinal (FGI) disorder (FGID) symptom severity for tracking symptom profile changes over time is lacking. We aim to develop and validate a comprehensive symptom severity checklist for FGID.MethodsA 20‐item scale, including both upper and lower gastrointestinal symptoms, was generated to measure the symptom severity commonly found in FGID. Patients who experienced at least monthly symptoms of FGID with negative endoscopy findings were invited to complete the FGI‐Checklist, Patient Health Questionaire‐9 for assessing depressive symptoms, and Patient Health Questionnaire‐15 for assessing somatic symptoms at baseline. A subset of patients who met Rome III diagnostic criteria of gastroesophageal reflux disease, functional dyspepsia, and irritable bowel syndrome received medication treatment for 8–12 weeks and completed the FGI‐Checklist again at a follow‐up visit. Exploratory factor analysis was performed for subscales formation and psychometric properties were measured.ResultsSix hundred and forty‐one patients were recruited for current study and 108 (16.8%) of them completed the FGI‐Checklist again at follow‐up. Exploratory factor analysis identified a five‐factor solution accounting for 66.8% of the total variance. The five factors are named esophageal syndrome, reflux syndrome, functional dyspepsia syndrome, nausea and vomiting syndrome, and abdominal and bowel syndrome. The FGI‐Checklist total score correlated with Patient Health Questionaire‐9 and Patient Health Questionnaire‐15 (all P < 0.001), which demonstrated good construct validity. Good item‐internal consistency was found (Cronbach's alphas: 0.69–0.87). Responsiveness for reflux syndrome subscale, functional dyspepsia syndrome subscale, and abdominal and bowel syndrome subscale after medication treatment was significant (paired‐t‐test: all P < 0.01).ConclusionThe instrument, Checklist, is valid and reliable.
Late Palaeozoic red beds elucidate fluvial architectures preserving large woody debris in the seasonal tropics of central Pangaea
Authors: Trümper Steffen , Gaitzsch Birgit , Schneider Jörg W. , Ehling Bodo‐Carlo , Kleeberg Reinhard , Rößler Ronny 
Published: November 2019

AbstractFluvial red beds containing anatomically preserved large woody debris shed new light on seasonally dry biomes of the Pennsylvanian–Permian transition and elucidate the concurrence of river depositional systems and vegetation. As a result, the occurrence, distribution and preservation of petrified large woody debris accumulations are considered crucial to understanding the role of arborescent vegetation in shaping fluvial environments. This study reports sizeable silicified trunks and corresponding fluvial architectures from the uppermost Pennsylvanian (upper Gzhelian) Siebigerode Formation (Kyffhäuser, central Germany). The origin, taphonomy and depositional environment of the fossil woods are elucidated by using a multidisciplinary approach including geological mapping, lithofacies analysis, sediment petrography, wood anatomical studies and microstructure analyses. Results reflect the gradual burial of a gentle basement elevation by sand‐bed to gravel‐bed braided rivers at the north‐western margin of the perimontane Saale Basin. Facies architectures resulted from a complex interplay of syndepositional tectonics, repeated palaeorelief rejuvenation, high‐frequency channel avulsion, seasonally dry climate and woody debris–sediment interactions. The alluvial influx and cut‐bank erosion recruited trunks from adjacent semi‐riparian slope habitats vegetated by up to 40 m tall cordaitaleans and conifers. High discharge in wide braids facilitated uncongested transport of large woody debris. Trunk entombment and initial preservation resulted from grounding on barforms, anchoring by attached roots and subsequent burial. The post‐depositional two‐phase silicification was influenced by hydrothermal hematite mineralization and determined a selective wood preservation pattern known as ‘pointstone’. Large woody debris‐induced sedimentary structures (‘LWDISS’) are introduced as a class of sediment structures formed by the biogenic impact on terrestrial deposition.
Effect of medical insurance and family financial risk on healthcare utilisation by patients with chronic diseases in China: a cross-sectional study
Authors: Shu Zhan , Han Yu , Xiao Jinguang , Li Jian 
Published: November 2019

ObjectiveTo assess the joint cumulative effects of medical insurance and family health financial risk on healthcare utilisation among patients with chronic conditions in China.DesignA nationwide population-based case–control study with multinomial logistic regression was conducted and used to estimate the ORs of healthcare utilisation against type of medical insurance and family health financial risk using the Anderson model as a theoretical framework.SettingChina Family Panel Studies (CFPS) database.ParticipantsThe study sample included 5260 patients with chronic conditions identified from the 2014 CFPS database.Main outcome measuresThe participants were classified by their health insurance coverage: urban employee basic medical insurance (UEBMI), Gong Fei Medical Insurance (GFMI), new rural cooperative medical scheme (NCMS) and urban residents basic medical insurance. Healthcare utilisation was measured by assessing the care level provided by the health institutions selected by patients when they were sick. Health financial risk was measured using the cost of medical expenditures and annual family income over the past year.ResultsPatients were more likely to choose hospital care than care from primary health centres. Patients with NCMS preferred primary healthcare, compared with patients with no medical insurance (OR 1.852, 95% CI 1.458 to 2.352). Patients with UEBMI and GFMI made use of hospital healthcare services (OR 2.654, 95% CI 1.85 to 3.81; OR 1.629, 95% CI 1.15 to 2.30, respectively). Patients who had medium or high financial risk were more likely to choose tertiary/specialised hospital care, compared with those at low financial risk (OR 1.629, 95% CI 1.15 to 2.30; OR 1.220, 95% CI 1.04 to 1.43, respectively).ConclusionsThe majority of patients chose hospital care in our sample. There was a joint effect and relationship between degree of family health financial risk and medical insurance on healthcare utilisation.
HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial
Authors: Baker Felicity Anne , Bloska Jodie , Braat Sabine , Bukowska Anna , Clark Imogen , Hsu Ming H , Kvamme Tone , Lautenschlager Nicola , Lee Young-Eun Claire , Smrokowska-Reichmann Agnieszka , Sousa Tanara Vieira , Stensaeth Karette A , Tamplin Jeanette , Wosch Thomas , Odell-Miller Helen 
Published: November 2019

IntroductionPharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.Methods and analysisA large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).Ethics and disseminationEthical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.Trial registration numbersACTRN12618001799246p;NCT03907748
Cohort profile: Mental Health Living Longer: a population-wide data linkage to understand and reduce premature mortality in mental health service users in New South Wales, Australia
Authors: Sara Grant , Arumuganathan Myu , Chen Wendy , Wu Fred , Currow David , Large Matthew , Mulder Cornelis , Ramanuj Parashar Pravin , Burgess Philip M 
Published: November 2019

PurposeHealth systems must move from recognition to action if we are to address premature mortality in people with mental illness. Population data registers are an essential tool for planning and monitoring improvement efforts. The Mental Health Living Longer (MHLL) programme establishes a population-wide data linkage to support research translation and service reform in New South Wales (NSW), Australia.ParticipantsA total of 8.6 million people who have had contact with NSW public and private health services between July 2001 and June 2018 are currently included in the study. Data include more than 120 million linked records from NSW data collections covering public and private hospital care, emergency departments, ambulance, community mental health services, cancer notifications and care, and death registrations. Linkage is occurring with population-wide breast and cervical cancer screening programmes. Data will be updated 6 monthly.Findings to dateThe cohort includes 970 145 people who have received mental healthcare: 79% have received community mental healthcare, 35% a general hospital admission with a primary mental health diagnosis and 25% have received specialist mental health inpatient care. The most frequent pattern of care is receipt of community mental healthcare only (50%). The median age of the mental health cohort is 34 years, and three-quarters are younger than 53 years. Eleven per cent of the mental health cohort had died during the observation period. Their median age at death was 69 years, which was younger than the median age at death for people accessing other health services.Future plansThe MHLL programme will examine (i) all-cause mortality, (ii) suicide, (iii) cancer mortality and (iv) medical mortality. Within each theme, the programme will quantify the problem in mental health service users compared with the NSW population, describe the people most affected, describe the care received, identify predictors of premature mortality, and identify variation and opportunities for change.
The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support
Authors: Amin Amit P. , Spertus John A. , Curtis Jeptha P. , Desai Nihar , Masoudi Frederick A. , Bach Richard G. , McNeely Christian , Al-Badarin Firas , House John A. , Kulkarni Hemant , Rao Sunil V. 
Published: November 2019

Background:
Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).

Methods:
From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).

Results:
Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13–1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00–1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00–1.17).

Conclusions:
Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.
Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age
Authors: Martinez Felipe A. , Serenelli Matteo , Nicolau Jose C. , Petrie Mark C. , Chiang Chern-En , Tereshchenko Sergey , Solomon Scott D. , Inzucchi Silvio E. , Køber Lars , Kosiborod Mikhail N. , Ponikowski Piotr , Sabatine Marc S. , DeMets David L. , Dutkiewicz-Piasecka Monika , Bengtsson Olof , Sjöstrand Mikaela , Langkilde Anna Maria , Jhund Pardeep S. , McMurray John J.V. 
Published: November 2019

Background:
The DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure) showed that dapagliflozin added to other guideline-recommended therapies reduced the risk of mortality and heart failure hospitalization and improved symptoms in patients with heart failure and reduced ejection fraction. We examined the effects of dapagliflozin according to age, given potential concerns about the efficacy and safety of therapies in the elderly.

Methods:

Patients in New York Heart Association functional class II or greater with a left ventricular ejection fraction ≤40% and a modest elevation of NT-proBNP (N-terminal pro-B-type natriuretic peptide) were eligible. Key exclusion criteria included systolic blood pressure <95 mm Hg and estimated glomerular filtration rate <30 mL·min
−1
·1.73 m
−2
. The primary outcome was the composite of an episode of worsening heart failure (heart failure hospitalization or urgent heart failure visit) or cardiovascular death, whichever occurred first.

Results:

A total of 4744 patients 22 to 94 years of age (mean age, 66.3 [SD 10.9] years) were randomized: 636 patients (13.4%) were <55 years of age, 1242 (26.2%) were 55 to 64 years of age, 1717 (36.2%) were 65 to 74 years of age, and 1149 (24.2%) were ≥75 years of age. The rate of the primary outcome (per 100 person-years, placebo arm) in each age group was 13.6 (95% CI, 10.4–17.9), 15.7 (95% CI, 13.2–18.7), 15.1 (95% CI, 13.1–17.5), and 18.0 (95% CI, 15.2–21.4) with corresponding dapagliflozin/placebo hazard ratios of 0.87 (95% CI, 0.60–1.28), 0.71 (95% CI, 0.55–0.93), 0.76 (95% CI, 0.61–0.95), and 0.68 (95% CI, 0.53–0.88;
P
for interaction=0.76). Consistent benefits were observed for the components of the primary outcome, all-cause mortality, and symptoms. Although adverse events and study drug discontinuation increased with age, neither was significantly more common with dapagliflozin in any age group.

Conclusions:
Dapagliflozin reduced the risk of death and worsening heart failure and improved symptoms across the broad spectrum of age studied in DAPA-HF. There was no significant imbalance in tolerability or safety events between dapagliflozin and placebo, even in elderly individuals.

Clinical Trial Registration:

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT03036124.
Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction
Authors: McMurray John J.V. , Jackson Alice M. , Lam Carolyn S.P. , Redfield Margaret M. , Anand Inder S. , Ge Junbo , Lefkowitz Marty P. , Maggioni Aldo P. , Martinez Felipe , Packer Milton , Pfeffer Marc A. , Pieske Burkert , Rizkala Adel R. , Sabarwal Shalini V. , Shah Amil M. , Shah Sanjiv J. , Shi Victor C. , van Veldhuisen Dirk J. , Zannad Faiez , Zile Michael R. , Cikes Maja , Goncalvesova Eva , Katova Tzvetana , Kosztin Anamaria , Lelonek Malgorzata , Sweitzer Nancy , Vardeny Orly , Claggett Brian , Jhund Pardeep S. , Solomon Scott D. 
Published: November 2019

Background:
Unlike heart failure with reduced ejection fraction, there is no approved treatment for heart failure with preserved ejection fraction, the predominant phenotype in women. Therefore, there is a greater heart failure therapeutic deficit in women compared with men.

Methods:
In a prespecified subgroup analysis, we examined outcomes according to sex in the PARAGON-HF trial (Prospective Comparison of ARNI With ARB Global Outcomes in Heart Failure With Preserved Ejection Fraction), which compared sacubitril-valsartan and valsartan in patients with heart failure with preserved ejection fraction. The primary outcome was a composite of first and recurrent hospitalizations for heart failure and death from cardiovascular causes. We also report secondary efficacy and safety outcomes.

Results:

Overall, 2479 women (51.7%) and 2317 men (48.3%) were randomized. Women were older and had more obesity, less coronary disease, and lower estimated glomerular filtration rate and NT-proBNP (N-terminal pro–B-type natriuretic peptide) levels than men. For the primary outcome, the rate ratio for sacubitril-valsartan versus valsartan was 0.73 (95% CI, 0.59–0.90) in women and 1.03 (95% CI, 0.84–1.25) in men (
P
interaction = 0.017). The benefit from sacubitril-valsartan was attributable to reduction in heart failure hospitalization. The improvement in New York Heart Association class and renal function with sacubitril-valsartan was similar in women and men, whereas the improvement in Kansas City Cardiomyopathy Questionnaire clinical summary score was less in women than in men. The difference in adverse events between sacubitril-valsartan and valsartan was similar in women and men.

Conclusions:
As compared with valsartan, sacubitril-valsartan seemed to reduce the risk of heart failure hospitalization more in women than in men. Whereas the possible sex-related modification of the effect of treatment has several potential explanations, the present study does not provide a definite mechanistic basis for this finding.

Clinical Trial Registration:

https://www.clinicaltrials.gov
. Unique identifier: NCT01920711.