bluuebunny/crossref_metadata_2025_split huggingface dataset:
IQOS labelling will mislead consumers
Authors: McKelvey Karma , Popova Lucy , Kim Minji , Lempert Lauren Kass , Chaffee Benjamin W , Vijayaraghavan Maya , Ling Pamela , Halpern-Felsher Bonnie 
Published: August 2018

BackgroundPhilip Morris International (PMI) continually expands and diversifies their nicotine product portfolio, which includes IQOS, a heated tobacco product. In December 2016, PMI filed a modified risk tobacco product (MRTP) application with the US Food and Drug Administration (FDA), seeking authorisation to market IQOS in USA with three claims of reduced harm: ‘switching completely from conventional cigarettes to theIQOSsystem…’ (1) ‘can reduce the risks of tobacco-related diseases;’ (2) ‘significantly reduce[s] your body’s exposure to harmful or potentially harmful chemicals;’ and (3) ‘presents less risk of harm than continuing to smoke cigarettes.’ Consumers may misunderstand what is meant by ‘switching completely'.MethodsWe critically reviewed study reports submitted to FDA by PMI in support of proposed marketing claims in its MRTP application for IQOS and focused on the statement that switching completely to IQOS reduces risk.ResultsWe found deficiencies with evidence provided by PMI supporting their assertions that: current smokers will understand what is meant by the phrase ‘switching completely'; the proposed claims will not decrease smokers’ intentions to quit; and IQOS users will in fact ‘switch completely’ from smoking cigarettes to using IQOS. The studies and measurement instruments employed by PMI suffer from design flaws and their reporting of associated findings is misleading.ConclusionConsumers will not understand the condition of the claims—that they must quit using cigarettes completely to achieve the inferred health benefits of IQOS. Rather, they are likely to misunderstand the unsupported claims of reduced risks to mean IQOS are harm-free.
Waterpipe tobacco package warning exposure’s impact on risk perceptions and use among young adults in the USA: a longitudinal analysis of the population assessment of tobacco and health study
Authors: King Jessica L , Reboussin Beth A , Cornacchione Ross Jennifer , Sutfin Erin L 
Published: August 2018

BackgroundAlthough Food and Drug Administration (FDA)-mandated waterpipe tobacco warnings were not required until August 2018, some waterpipe tobacco packaging (WTP) sold in the USA, contained warnings prior to this date. We examined the prevalence of WTP warning exposure and whether exposure influenced risk perceptions or use among young adult (aged 18–24 years) current waterpipe users.MethodsWe used data from waves 1 (2013–2014) and 2 (2014–2015) of the Population Assessment of Tobacco and Health Study, a nationally representative longitudinal study of US adults and youth. We conducted logistic regression analyses to identify factors associated with wave 1 warning exposure, and whether wave 1 WTP warning exposure predicted wave 2 relative risk perceptions and waterpipe use.ResultsMore than one-third of our sample (35.9%, 95% CI 33.5 to 38.4) reported past-month WTP warning exposure. Exposure was higher among males (adjusted OR (AOR)=1.34, 95% CI 1.04 to 1.72), those who usually do not share the waterpipe (AOR=3.10, 95% CI 1.45 to 6.60), those who purchased waterpipe tobacco (AOR=1.73, 95% CI 1.28 to 2.34), and those with a regular brand (AOR=1.84, 95% CI 1.26 to 2.68). Those exposed to WTP warnings at wave 1 were more likely than those not exposed to perceive waterpipe tobacco to be as or more harmful than cigarettes at wave 2 (AOR=1.35, 95% CI 1.02 to 1.78). There was no association between wave 1 WTP exposure and wave 2 waterpipe use.ConclusionsMore than one-third of US young adult current waterpipe users reported WTP warning exposure prior to FDA-mandated warning implementation. Findings suggest the mandated warning may result in high exposure among users; it will be critical to assess exposure’s impact on risk perceptions and behaviour after FDA-mandated warnings are implemented.
Uncertainty Quantification for Direct Aeroacoustic Simulations of Cavity Flows
Authors: Kuhn Thomas , Dürrwächter Jakob , Meyer Fabian , Beck Andrea , Rohde Christian , Munz Claus-Dieter 
Published: August 2018

We investigate the influence of uncertain input parameters on the aeroacoustic feedback of cavity flows. The so-called Rossiter feedback requires a direct numerical computation of the acoustic noise, which solves hydrodynamics and acoustics simultaneously, in order to capture the interaction of acoustic waves and the hydrodynamics of the flow. Due to the large bandwidth of spatial and temporal scales, a high-order numerical scheme with low dissipation and dispersion error is necessary to preserve important small scale information. Therefore, the open-source CFD solver FLEXI, which is based on a high-order discontinuous Galerkin spectral element method, is used to perform the aforementioned direct simulations of an open cavity configuration with a laminar upstream boundary layer. To analyze the precision of the deterministic cavity simulation with respect to random input parameters, we establish a framework for uncertainty quantification (UQ). In particular, a nonintrusive spectral projection method with Legendre and Hermite polynomial basis functions is employed in order to treat uniform and normal probability distributions of the random input. The results indicate a strong, nonlinear dependency of the acoustic feedback mechanism on the investigated uncertain input parameters. An analysis of the stochastic results offers new insights into the noise generation process of open cavity flows and reveals the strength of the implemented UQ framework.
Prepubertal and Pubertal Endocrine-Disrupting Chemical Exposure and Breast Density among Chilean Adolescents
Authors: Binder Alexandra M. , Corvalan Camila , Pereira Ana , Calafat Antonia M. , Ye Xiaoyun , Shepherd John , Michels Karin B. 
Published: August 2018

Abstract

Background:
During puberty, mammary tissue undergoes rapid development, which provides a window of heightened susceptibility of breast composition to the influence of endogenous and exogenous hormones. Exposure to endocrine-disrupting chemicals (EDC) may affect breast development and composition and the risk of developing breast cancer in adulthood.

Methods:
We evaluated the associations between breast density and urinary concentrations of phenols and phthalates collected at Tanner 1 (B1) and Tanner 4 (B4) in 200 Chilean girls. Total breast volume (BV), fibroglandular volume (FGV), and percent dense breast (%FGV) were evaluated at B4 using dual X-ray absorptiometry. Generalized estimating equations were used to analyze the association between concentrations of EDC biomarkers across puberty and breast density.

Results:
The geometric mean %FGV was 7% higher among girls in the highest relative to the lowest tertile of monocarboxyisooctyl phthalate [1.07; 95% confidence interval (CI), 1.01–1.14]. Monoethyl phthalate concentrations at B4 were positively associated with FGV (highest vs. lowest tertile: 1.22; 95% CI, 1.06–1.40). Bisphenol A displayed a U-shaped association with FGV; girls in the middle tertile had at least 10% lower FGV than girls in the lowest or highest tertiles. Monocarboxyisononyl phthalate showed a nonlinear association with BV. No other statistically significant associations were observed.

Conclusions:
Our results suggest that the developing breast tissue is susceptible to select EDCs during childhood and adolescence.

Impact:
This study may spur further investigations into environmental influences on breast development during puberty and how shifts in pubertal breast density track through the life course to modify breast cancer risk.
Validation of a Blood Biomarker for Identification of Individuals at High Risk for Gastric Cancer
Authors: Epplein Meira , Butt Julia , Zhang Yang , Hendrix Laura H. , Abnet Christian C. , Murphy Gwen , Zheng Wei , Shu Xiao-Ou , Tsugane Shoichiro , Qiao You-lin , Taylor Philip R. , Shimazu Taichi , Yoo Keun-Young , Park Sue K. , Kim Jeongseon , Jee Sun Ha , Waterboer Tim , Pawlita Michael , You Wei-cheng , Pan Kai-feng 
Published: August 2018

Abstract

Background:
Helicobacter pylori is the leading cause of gastric cancer, yet the majority of infected individuals will not develop neoplasia. Previously, we developed and replicated serologic H. pylori biomarkers for gastric cancer risk among prospective cohorts in East Asia and now seek to validate the performance of these biomarkers in identifying individuals with premalignant lesions.

Methods:
This cross-sectional study included 1,402 individuals from Linqu County screened by upper endoscopy. H. pylori protein-specific antibody levels were assessed using multiplex serology. Multivariable-adjusted logistic regression models were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for prevalent intestinal metaplasia, indefinite dysplasia, or dysplasia, compared with superficial or mild atrophic gastritis.

Results:
Compared with individuals seronegative to Omp and HP0305, individuals seropositive to both were seven times more likely to have precancerous lesions (OR, 7.43; 95% CI, 5.59–9.88). A classification model for precancerous lesions that includes age, smoking, and seropositivity to H. pylori, Omp, and HP0305 resulted in an area under the curve (AUC) of 0.751 (95% CI, 0.725–0.777), which is significantly better than the same model, including the established gastric cancer risk factor CagA (AUC, 0.718; 95% CI, 0.691–0.746, Pdifference = 0.0002).

Conclusions:
The present study of prevalent precancerous gastric lesions provides support for two new serum biomarkers of gastric cancer risk, Omp and HP 0305.

Impact:
Our results support further research into the serological biomarkers Omp and HP0305 as possible improvements over the established virulence marker CagA for identifying individuals with precancerous lesions in East Asia.
The Long Walk to Strasbourg: About the Insufficient Judicial Protection in Some Areas of the Common Foreign and Security Policy before the European Union’s Accession to the ECHR
Authors: Cortés-Martín José M. 
Published: August 2018

Abstract
It is likely that the European Court of Justice’s (ECJ) objection in Opinion 2/13 regarding the absence of judicial remedies in certain Common Foreign and Security Policy (CFSP) areas can hardly be accommodated in a future revised Accession Project to the European Convention on Human Rights (ECHR). This is basically due to obstacles to proceeding with reform of the EU Treaties or establishing an ECHR reservation clause. However, as a matter of fact, the exact dimension of this problem seems to be quite relative. First of all, this is because recent ECJ case-law is gradually eroding the Court’s lack of competence, in particular, after Rosneft. Next, this is because, in those cases where there is still an absence of effective judicial protection, national courts – as EU ordinary courts – could fill this gap. Finally, this gap could also be filled by creating accountability mechanisms in the area of human rights within the framework of Common Security and Defence Policy (CSDP) missions.
Magnetic Resonance Imaging of Ménière’s Disease After Intravenous Administration of Gadolinium
Authors: Shi Suming , Guo Ping , Wang Wuqing 
Published: August 2018

Objectives: A three-dimensional (3D) inversion-recovery (IR) sequence with real reconstruction (3D-real IR) sequence 4 hours after intravenous (IV) gadolinium injection has been used to visualize the endolymphatic hydrops (ELH) in Ménière’s disease (MD). This study was designed to investigate the ELH characteristics in clinically diagnosed definite MD and to explore the pathology of MD with magnetic resonance imaging (MRI). Methods: One hundred fifty-four patients with definite MD were included in this study. All patients underwent the IV method. The grades of ELH were analyzed on each image, regions of interest of the cochlear perilymph and the cerebellum white matter were determined, and the signal intensity ratio of the former to the latter (CC ratio) on both sides in patients with unilateral MD was subsequently evaluated. Results: Endolymphatic hydrops was observed in 148 patients (96.1%) on the clinically affected side; the remaining 6 patients (3.9%) had no apparent ELH. One hundred fifteen patients (74.7%) had unilateral ELH, and 33 patients (21.4%) had bilateral ELH. Eighteen patients (11.7%) had ELH on the clinically silent side. Patients with moderate and significant grades of ELH in the vestibule and cochlea accounted for 88.3% and 90.3%, respectively. The CC ratio of the affected side (1.39 ± 0.37) was higher than that of the unaffected side (1.18 ± 0.29) ( P < .01) in 115 patients with unilateral MD. Conclusions: Moderate and significant grades of ELH are common in MD; however, the proposed diagnostic criteria are not fully consistent with ELH. The elevated contrast effect in the affected side in patients with unilateral MD may better reflect the pathologic condition of MD.
Using peer research processes to understand strategies to support those with severe, multiple and complex health needs
Authors: Woodall James , Cross Ruth , Kinsella Karina , Bunyan Ann-Marie 
Published: August 2018

Objectives: There has been an increased focus in policy discourse on individuals with severe, multiple and complex needs. This paper seeks to understand how best to enable these individuals to take greater control over their health. Design: Qualitative, user-led, peer research. Setting: Large urban UK city. Method: Trained peer researchers with previous experience in contexts of severe and multiple disadvantage gathered data using a snowball sampling approach from 21 individuals engaged in a service specifically designed to provide for their needs. Results: The study identified enabling factors that create conditions for individuals with severe and multiple disadvantage to take greater control of factors impacting on their health and social situations. These included working holistically with individuals, understanding the interconnected issues impacting on health, developing trusting relationships with professionals and working within a positive framework that fosters self-belief and which is focused on salutogenesis rather than pathogenesis. Conclusion: There exists a set of enabling factors that may support individuals facing particular challenges in their lives. While derived from within a specific geographical context, findings have relevance to other settings in relation to ways of working. Peer research demonstrates itself to be a research approach well suited to understanding lived experiences.
Clostridium septicum arthroplasty infection: beware of occult aortitis and malignancy
Authors: Turnbull Gareth , Spierits Euan , Russell David , Clarke Jon , Picard Frédéric , Sarungi Martin 
Published: August 2018

Introduction The Clostridia species are responsible for life-threatening conditions such as tetanus, botulism and gas gangrene. Clostridium septicum is a rare cause of clinical infection, accounting for less than 1% of blood culture samples that test positive for Clostridia. However, C. septicum bacteraemia is associated with greater than 60% mortality and in over 80% of cases is associated with an underlying malignancy. Case presentation We present a review of the literature and the first case of an acute arthroplasty infection and concurrent infective aortitis caused by this organism in the absence of an identified underlying malignancy. Early diagnosis and multi-disciplinary input resulted in the patient surviving a rare and potentially fatal infective aortitis and septic arthritis. Conclusion This case demonstrates the importance of early systemic investigation to exclude occult infective aortitis in C. septicum infection. The key role of multi-disciplinary input into the management of this often fatal infection is also discussed along with the requirement to exclude occult gastrointestinal and haematological malignancy.
A Pilot Clinical Trial of Smoking Cessation Services Implemented in the Workplace for Service Industry Employees
Authors: Bold Krysten W. , Kimmel Lisa , Hanrahan Tess H. , Romano Denise , Rojewski Alana M. , Krishnan-Sarin Suchitra , Fucito Lisa M. , O’Malley Stephanie S. 
Published: August 2018

Purpose: Evaluate the feasibility and preliminary efficacy of implementing evidence-based tobacco treatment at the workplace for service industry employees. Design: Randomized trial using 6 paired worksites (3 test and 3 delayed intervention control sites). Setting: US Northeast city. Participants: Employees were recruited from university food service settings. Intervention: Comprehensive smoking treatment was provided at the workplace including individual counseling, free pharmacotherapy (dual nicotine replacement therapy or varenicline), and 5 weeks of contingency management that reinforced abstinence or reductions in smoking to encourage progress toward quitting. Measures: Primary measures included a smoking status survey administered at the end of treatment at the test sites and before treatment began at the delayed intervention control sites. Analysis: Analyses compared rates of quit attempts and successful abstinence for at least 24 hours between the test and delayed intervention control sites. Results: Twenty-five employees were enrolled in treatment. The majority were single (12/25), black (16/25), and reported their educational attainment as high school or less (18/25). Employees in the test (vs delayed intervention control) sites reported higher rates of quit attempts (66.7% vs 12.5%, P = .02) and success quitting for at least 24 hours (53.3% vs 12.5%, P = .08). Participants rated the treatment as very helpful overall. Conclusion: Findings support the feasibility and efficacy of providing workplace-based smoking cessation services and may inform strategies to increase access to treatment.
POLST Facilitation in Complex Care Management: A Feasibility Study
Authors: Torke Alexia M. , Hickman Susan E. , Hammes Bernard , Counsell Steven R. , Inger Lev , Slaven James E. , Butler Dawn 
Published: August 2018

Background: The Physician Orders for Life-Sustaining Treatment (POLST) form is an advance care planning tool designed for seriously ill patients. The discussions needed for high-quality POLST decision-making are time intensive and often do not occur in the outpatient setting. Objective: We conducted a single-arm feasibility study of POLST facilitation by nonphysicians using Respecting Choices Last Steps, a standardized, structured approach to facilitation of POLST conversations. Setting/Participants: Community-dwelling adults aged 65 and older enrolled in a complex care management program in a Midwestern urban hospital. Measurements: We assessed the feasibility and acceptability by determining the proportion of eligible patients who enrolled and completed the study, by adherence to the Respecting Choices protocol, and by responses to qualitative and quantitative survey items about the intervention. Results: We enrolled 18 (58.1%) of 31 eligible patients, with a mean age of 77.8 years (standard deviation: 6.95); 12 were African American. The POLST facilitation was delivered to all 18; 10 (55.6%) completed POLST forms. Direct observation of intervention delivery using a checklist found 85% of the required elements were performed by facilitators. We completed 6- to 8-week follow-up interviews in 16 of 18 patients (88.9%). We found 87.5% of decision makers agreed or strongly agreed that “Talking about the (POLST) form helped me think about what I really want.” Conclusions: The POLST facilitation can be successfully delivered to frail older adults in a complex care management setting, with high fidelity to protocol. Further research is needed to demonstrate the effects of this approach on decision quality and other patient-reported outcomes.
Patient-Perceived Barriers to Accessing Cleft Care at a Tertiary Referral Center in São Paulo, Brazil
Authors: Ise Ananda , Menezes Camila , Batista Neto Joao , Saluja Saurab , Amundson Julia R. , Jenny Hillary , Massenburg Ben , Citron Isabelle , Alonso Nivaldo 
Published: August 2018

Background: In low- and middle-income countries, poor access to care can result in delayed surgical repair of orofacial clefts leading to poor functional outcomes. Even in Brazil, an upper middle-income country with free comprehensive cleft care, delayed repair of orofacial clefts commonly occurs. This study aims to assess patient-perceived barriers to cleft care at a referral center in São Paulo. Methods: A 29-item questionnaire assessing the barriers to care was administered to 101 consecutive patients (or their guardians) undergoing orofacial cleft surgery in the Plastic Surgery Department in Hospital das Clínicas, in São Paulo, Brazil, between February 2016 and January 2017. Results: A total of 54.4% of patients had their first surgery beyond the recommended time frame of 6 months for a cleft lip or cleft lip and palate and 18 months for a cleft palate. There was a greater proportion of isolated cleft palates in the delayed group (66.7% vs 33.3%). Almost all patients had a timely diagnosis, but delays occurred from diagnosis to repair. The mean number of barriers reported for each patient was 3.8. The most frequently cited barriers related to lack of access to care include (1) lack of hospitals available to perform the surgery (54%) and (2) lack of availability of doctors (51%). Conclusion: Delays from diagnosis to treatment result in patients receiving delayed primary repairs. The commonest patient-perceived barriers are related to a lack of access to cleft care, which may represent a lack of awareness of available services.
Treating pediatric conjunctivitis without an exam: An evaluation of outcomes and antibiotic usage
Authors: Penza Kristine S , Murray Martha A , Myers Jane F , Maxson Julie , Furst Joseph W , Pecina Jennifer L 
Published: August 2018

Objective The objective of this research paper is to compare antibiotic treatment, follow-up rates, and types of follow-up encounters among eVisits, phone calls, and in-person encounters for pediatric conjunctivitis. Study design A retrospective chart review of pediatric patients evaluated for conjunctivitis between May 1, 2016 and May 1, 2017, was performed. A total of 101 eVisits, 202 in-person retail clinic visits, and 202 nurse phone calls for conjunctivitis were manually reviewed for outcomes. Exclusion criteria included previous encounter for conjunctivitis in the past 14 days, treatment with an oral antibiotic at the initial encounter, or patient outside Minnesota at the time of encounter. Comparison among the three encounter types with regard to follow-up rates, follow-up encounter type within 14 days of initial evaluation, and prescribing rates was performed. Results Patients completing non-face-to-face encounters were significantly more likely to have follow-up care (34.6% and 45.5%) than those who had a face-to-face visit at the retail clinic (7.4%), p ≤ 0.0001. Patients initially evaluated by eVisit were more likely to have follow-up at the retail clinic while patients initially evaluated by phone call were more likely to have follow-up in their primary care office. Treatment rates with antibiotics were significantly higher in phone call encounters (41.6%) than in eVisits (25.7%) or face-to-face encounters (19.8%), p < 0.0001. Conclusions Non-face-to-face visits have significantly higher rates of follow-up when compared to face-to-face encounters. Antibiotic prescribing is greater with phone call triage encounters; however, there was no significant difference in antibiotic prescribing rates between eVisits and face-to-face visits. Follow-up type varied according to site of initial encounter.