US Setting Research Articles

Adiposity, CVD risk factors and testosterone: Variation by partnering status and residence with children in US men.

Background and objectivesIn many settings, partnered, invested fathers have lower testosterone than single men or fathers who are not involved in caregiving. Reduced testosterone has been identified as a risk factor for multiple chronic diseases, and men’s health also commonly varies by life history status. There have been few tests of whether variation in testosterone based on partnering and parenting has implications for men’s health.MethodologyWe analysed data from a US population-representative sample (NHANES) of young-to-middle aged US men (n = 875; mean age: 29.8 years ± 6.0 [SD]). We tested for life history status differences in testosterone, adiposity levels and biomarkers of cardiovascular disease (CVD)-risk (HDL cholesterol; triglycerides; white blood cell count [WBC]).ResultsPartnered men residing with children (RC) had lower testosterone and elevated abdominal adiposity compared to never married men not residing with children. While they did not significantly differ for WBC or triglycerides, partnered RC men also had comparatively lower HDL. Partnered RC males’ lower testosterone accounted for their relatively elevated adiposity, but testosterone, adiposity, and health-related covariates did not explain their relatively reduced HDL.Conclusions and implicationsOur results linking life history status-based differences in testosterone and adiposity, alongside our complementary HDL findings, indicate that testosterone-related psychobiology might have implications for partnered RC men’s CVD risk in the US and other similar societal settings. These types of socially contextualized observations of men’s health and physiological function particularly merit incorporation in clinical discussions of fatherhood as a component of men’s health.

Exposing Students to Environmental Sustainability in Accounting: An Analysis of Its Impacts in a US Setting

ABSTRACTIn this study, we examine whether the introduction of two different forms of an environmental sustainability intervention into differing sections of an introductory-level managerial accounting course at a US university induces changes in students’ environmental intentions and behaviors. Based on attributes from Ajzen’s [1991. “The Theory of Planned Behavior.” Organizational Behavior and Human Decision Processes 50: 179–211; 2002. “Perceived Behavioral Control, Self-efficacy, Locus of Control, and the Theory of Planned Behavior.” Journal of Applied Social Psychology 32 (4): 665–683] theory of planned behaviour, results show that, in comparison to a control group with no intervention, students exhibited higher levels of attitude, perceived behavioural control, intentions, and behaviour following the interventions. However, the positive results were limited to students undergoing an experiential learning assignment beyond the basic reading, lecture, and discussion intervention. The findings provide some support for claims that bringing sustainability issues into the accounting curriculum can lead to positive student outcomes. But, given the increased efforts necessary to find and use experiential projects, they also suggest that inducing accounting faculty, at least in the US, to pursue such pedagogical approaches will require that more be done by those organisations calling for such efforts in terms of support, materials, and reward structures.

PRM99 - Sampling of Commonly used Population Characteristics: Is A Normal Approximation Valid?

Health economic models use a basecase that is generally representative of a subpopulation rather than the whole population. During sensitivity analysis, extrapolation of the model to other subpopulations or the whole population is estimated via sampling. Sampling is performed using summary statistics (e.g. mean and standard deviation) to inform generation of a distribution from which to draw values at random. Key population characteristics for healthcare include age, height, weight, and body mass index (BMI); all of which are commonly assumed to approximate to a normal distribution. Here the plausibility of this common assumption is tested. Full data (N=451,075) were obtained from the 2010 Behavioral Risk Factor Surveillance System (BRFSS), a national, US, health-related, telephone survey. Data collected include age, gender, height and weight, with BMI being a calculated variable. Summary statistics and distributions were produced from the whole population. A sample of 2,500 records were extracted for in-depth analysis. Of these, 2,365 had complete data for age, gender, height, and weight. Analyses performed in R and Microsoft Excel® included subsampling, normality and Cullen-Frey tests. None of the data assessed were normally distributed. Cullen-Frey plots indicate that the best distributions to approximate the data are Beta, Log-normal, Beta, Log-normal for age, weight, height and BMI, respectively. Taking 1,000 subsamples of 300 patients, 67% of samples had a mean age falling outside of the 99% confidence interval for the population. For BMI the percentage was 62%. The ability of progressively smaller subsamples to represent the population was progressively worse. Many population characteristics of interest to healthcare do not follow a normal distribution. In the BRFSS dataset, the most descriptive distributions are the log-normal for BMI and the Beta distribution with negative skew for age. Age distribution skew may represent the aging population in the US setting.

Cost-Effectiveness of Endovascular Stroke Therapy: A Patient Subgroup Analysis From a US Healthcare Perspective.

Endovascular therapy in addition to standard care (EVT+SC) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke. Our aim was to determine the cost-effectiveness of EVT+SC depending on patients' initial National Institutes of Health Stroke Scale (NIHSS) score, time from symptom onset, Alberta Stroke Program Early CT Score (ASPECTS), and occlusion location. A decision model based on Markov simulations estimated lifetime costs and quality-adjusted life years (QALYs) associated with both strategies applied in a US setting. Model input parameters were obtained from the literature, including recently pooled outcome data of 5 randomized controlled trials (ESCAPE [Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke], EXTEND-IA [Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial], MR CLEAN [Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands], REVASCAT [Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset], and SWIFT PRIME [Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment]). Probabilistic sensitivity analysis was performed to estimate uncertainty of the model results. Net monetary benefits, incremental costs, incremental effectiveness, and incremental cost-effectiveness ratios were derived from the probabilistic sensitivity analysis. The willingness-to-pay was set to $50 000/QALY. Overall, EVT+SC was cost-effective compared with SC (incremental cost: $4938, incremental effectiveness: 1.59 QALYs, and incremental cost-effectiveness ratio: $3110/QALY) in 100% of simulations. In all patient subgroups, EVT+SC led to gained QALYs (range: 0.47-2.12), and mean incremental cost-effectiveness ratios were considered cost-effective. However, subgroups with ASPECTS ≤5 or with M2 occlusions showed considerably higher incremental cost-effectiveness ratios ($14 273/QALY and $28 812/QALY, respectively) and only reached suboptimal acceptability in the probabilistic sensitivity analysis (75.5% and 59.4%, respectively). All other subgroups had acceptability rates of 90% to 100%. EVT+SC is cost-effective in most subgroups. In patients with ASPECTS ≤5 or with M2 occlusions, cost-effectiveness remains uncertain based on current data.

Recognition and management of perinatal depression and anxiety by general practitioners: a systematic review

Perinatal anxiety and depression are widespread, with up to 20% of women affected during pregnancy and after birth. In the UK, management of perinatal mental health falls under the remit of general practitioners (GPs). We reviewed the literature on GPs' routine recognition, diagnosis and management of anxiety and depression in the perinatal period. A systematic search of Embase, Medline, PsycInfo, Pubmed, Scopus and Web of Science was conducted. Studies were eligible if they reported quantitative measures of GPs' or Family Physicians' assessment, recognition and management of anxiety or depression in pregnancy or post-partum. Thirteen papers, reporting 10 studies, were identified from the United States, Australia, UK, Netherlands and Canada. All reported on depression; two included anxiety disorders. Reported awareness and ability to diagnose perinatal depression among GPs was high. GPs knew about and used screening tools in the UK but less so in US settings. Antidepressants were the first line of treatment, with various SSRIs considered safest. Counseling by GPs and referrals to specialists were common in the post-natal period, less so in pregnancy. Treatment choices were determined by resources, attitudes, knowledge and training. Data on GPs' awareness and management of perinatal depression were sparse and unlikely to be generalizable. Future directions for research are proposed; such as exploring the management of anxiety disorders which are largely missing from the literature, and understanding more about barriers to disclosure and recognition in primary care. More standardized training could help to improve recognition and management practices.

Preoperative short-course radiation therapy for rectal cancer provides excellent disease control and toxicity: Results from a single US institution

PurposePreoperative short-course radiation therapy (SCRT) has rarely been used for rectal cancer in the United States, although 2 randomized phase 3 trials demonstrate equivalence to conventional chemoradiation (CRT), and recent updates to national guidelines include this regimen as a treatment option. We sought to evaluate the efficacy and safety of preoperative SCRT followed by immediate surgery within 1 week to treat rectal cancer in the US setting. Methods and materialsAll patients treated with preoperative SCRT (4 Gy × 5 fractions for total 20 Gy) followed by planned surgery within 1 week at our institution were retrospectively evaluated. Censored cases with ≥2 years of follow-up were included along with any disease failure or death. Patients with cM1 disease were excluded. Patients with yp stage II/III disease typically received adjuvant chemotherapy from the 1990s onwards. The primary outcomes were actuarial (Kaplan-Meier) 5-year locoregional control (LC), disease-free survival (DFS), and overall survival (OS) as well as late severe (greater than or equal to grade 3) toxicity. ResultsOur analysis included 202 consecutive patients with clinical stage I-III disease treated from 1977 through 2011. Median follow-up was 6.5 years (range, 2-29.2). Five-year disease outcomes were 95.9% ± 1.5% for LC, 76.4% ± 3.1% for DFS, and 84.6% ± 2.6% for OS. For patients with locally advanced rectal cancer (cT3-4 and/or cN+), 5-year LC, DFS, and OS were 95.1% ± 2.1%, 73.3% ± 4.3%, and 80.6% ± 3.7%, respectively. The late severe toxicity rate was 11.4%. ConclusionsSCRT followed by immediate surgery is a safe and effective treatment for patients with rectal cancer in the United States. Though SCRT has not been widely adopted, recent updates to the national guidelines for rectal cancer as well as financial pressures to reduce healthcare costs may lead to increased utilization of this treatment regimen in the future.

US sets new fuel-efficiency standards for trucks

US sets new fuel-efficiency standards for trucks

Cardiometabolic Risk Factor Changes Observed in Diabetes Prevention Programs in US Settings: A Systematic Review and Meta-analysis.

BackgroundThe Diabetes Prevention Program (DPP) study showed that weight loss in high-risk adults lowered diabetes incidence and cardiovascular disease risk. No prior analyses have aggregated weight and cardiometabolic risk factor changes observed in studies implementing DPP interventions in nonresearch settings in the United States.Methods and FindingsIn this systematic review and meta-analysis, we pooled data from studies in the United States implementing DPP lifestyle modification programs (focused on modest [5%–7%] weight loss through ≥150 min of moderate physical activity per week and restriction of fat intake) in clinical, community, and online settings. We reported aggregated pre- and post-intervention weight and cardiometabolic risk factor changes (fasting blood glucose [FBG], glycosylated hemoglobin [HbA1c], systolic or diastolic blood pressure [SBP/DBP], total [TC] or HDL-cholesterol). We searched the MEDLINE, EMBASE, Cochrane Library, and Clinicaltrials.gov databases from January 1, 2003, to May 1, 2016. Two reviewers independently evaluated article eligibility and extracted data on study designs, populations enrolled, intervention program characteristics (duration, number of core and maintenance sessions), and outcomes. We used a random effects model to calculate summary estimates for each outcome and associated 95% confidence intervals (CI). To examine sources of heterogeneity, results were stratified according to the presence of maintenance sessions, risk level of participants (prediabetes or other), and intervention delivery personnel (lay or professional).Forty-four studies that enrolled 8,995 participants met eligibility criteria. Participants had an average age of 50.8 years and body mass index (BMI) of 34.8 kg/m2, and 25.2% were male. On average, study follow-up was 9.3 mo (median 12.0) with a range of 1.5 to 36 months; programs offered a mean of 12.6 sessions, with mean participant attendance of 11.0 core sessions. Sixty percent of programs offered some form of post-core maintenance (either email or in person). Mean absolute changes observed were: weight -3.77 kg (95% CI: -4.55; -2.99), HbA1c -0.21% (-0.29; -0.13), FBG -2.40 mg/dL (-3.59; -1.21), SBP -4.29 mmHg (-5.73, -2.84), DBP -2.56 mmHg (-3.40, 1.71), HDL +0.85 mg/dL (-0.10, 1.60), and TC -5.34 mg/dL (-9.72, -0.97). Programs with a maintenance component achieved greater reductions in weight (additional -1.66kg) and FBG (additional -3.14 mg/dl).Findings are subject to incomplete reporting and heterogeneity of studies included, and confounding because most included studies used pre-post study designs.ConclusionsDPP lifestyle modification programs achieved clinically meaningful weight and cardiometabolic health improvements. Together, these data suggest that additional value is gained from these programs, reinforcing that they are likely very cost-effective.

Carsharing’s life-cycle impacts on energy use and greenhouse gas emissions

This paper examines the life-cycle inventory impacts on energy use and greenhouse gas (GHG) emissions as a result of candidate travelers adopting carsharing in US settings. Here, households residing in relatively dense urban neighborhoods with good access to transit and traveling relatively few miles in private vehicles (roughly 10% of the U.S. population) are considered candidates for carsharing. This analysis recognizes cradle-to-grave impacts of carsharing on vehicle ownership levels, travel distances, fleet fuel economy (partly due to faster turnover), parking demand (and associated infrastructure), and alternative modes. Results suggest that current carsharing members reduce their average individual transportation energy use and GHG emissions by approximately 51% upon joining a carsharing organization. Collectively, these individual-level effects translate to roughly 5% savings in all household transport-related energy use and GHG emissions in the U.S. These energy and emissions savings can be primarily attributed to mode shifts and avoided travel, followed by savings in parking infrastructure demands and fuel consumption. When indirect rebound effects are accounted for (assuming travel-cost savings is then spent on other goods and services), net savings are expected to be 3% across all U.S. households.

Corporate Governance in Banks

AbstractManuscript TypeReviewResearch Question/IssueWe survey the literature on corporate governance in banks in the US and international settings. We discuss how the specialness of banks, deposit insurance, high bank leverage, and bank regulation interact with bank governance. We evaluate bank governance from three perspectives: (1) maximizing bank equity value, (2) maximizing total enterprise value, and (3) maximizing social objectives. Our survey includes evidence on how bank governance differs from that of manufacturing firms. We also survey studies on managerial incentives in banks and their implications for bank performance and risk taking before and during the 2007–2008 financial crisis.Research Findings/InsightsThe high leverage (usually above 90 percent) of banking institutions gives rise to a trade‐off between strengthening equity governance and maximizing enterprise value. Aligning managers very closely with shareholders can give rise to strong incentives for risk shifting to the detriment of firm value. The bank risk choices might also go against the societal objectives of a stable financial system.Theoretical/Academic ImplicationsWe provide a framework for the optimal design of bank governance and bank regulation, considering the objectives of both depositors and society‐at‐large in addition to those of bank shareholders. This framework could be especially important in determining risk choices by banks and the effects of such on the stability of the financial system.Practitioner/Policy ImplicationsOur analysis of the literature surveyed has policy implications for bank regulation, top‐management compensation in banks, and directives for design of governance in banks. We discuss implications for direct regulation of banks and regulation of bank governance. The findings surveyed provide guidance for board independence, board size, board composition, and incentive features in top‐management compensation.

Internal audit function quality and financial reporting: results of a survey on German listed companies

Most prior studies on internal audit function (IAF) quality and financial reporting have focused on the US setting and have found a positive association between IAF quality proxies and both financial reporting quality and audit efficiency. In this study, we apply the German setting that is characterized by a two-tier board system of corporate governance and different prerequisites for the serving-two-masters problem. This might weaken the IAF’s ability to monitor financial reporting-related processes. To analyze this, we use survey data to measure IAF quality in the German setting and run multiple regressions to examine the association of several IAF quality characteristics and a self-developed IAF quality score with financial reporting quality and audit efficiency. The results show that also in a two-tier system, a high-quality IAF is able to contribute to both financial reporting quality and audit efficiency. Our findings support the notion that the IAF serves as an essential element of effective corporate governance and plays an important role in financial reporting. Moreover, as a practical implication of interest to regulators and managers, we identify that the external certification of the IAF and internal audit-related certifications of IAF employees may contribute to higher financial reporting quality and lower audit fees.

Can a Bank Run Be Stopped? Government Guarantees and the Run on Continental Illinois

This paper analyzes the run on Continental Illinois in 1984. We find that the run slowed but did not stop following an extraordinary government intervention, which included the guarantee of all liabilities of the bank and a commitment to provide ongoing liquidity support. Continental’s outflows were driven by a broad set of US and foreign financial institutions. These were large, sophisticated creditors with holdings far in excess of the insurance limit. During the initial run, creditors with relatively liquid balance sheets nevertheless withdrew more than other creditors, likely reflecting low tolerance to hold illiquid assets. In addition, smaller and more- distant creditors were more likely to withdraw. In the second and more drawn out phase of the run, institutions with relative large exposures to Continental were more likely to withdraw, reflecting a general unwillingness to have an outsized exposure to a troubled institution even in the absence of credit r is k. Finally, we show that the concentration of holdings of Continental’s liabilities was a key dynamic in the run and was importantly linked to Continental’s systemic importance.

Searching for “Home” in Dixie: Identity and Education in the New Latin@ South

This study explores how 3 Latino male college students who attended rural, K–12 North Carolina schools use their conceptions of home to fight against oppressive forces in the southern United States. Specifically, through the use of life history data, I unpack both the challenges that they face and the agency-laden decisions that they make to navigate various tensions related to their Latin@ identities. This work extends current literature on men of color in schools, which largely omits the experiences of Latino male students that come of age in rural, southeastern, US settings.

Book Review: The Persistence of Polygamy: Fundamentalist Mormon Polygamy from 1890 to the Present (Bringhurst N.G. and Foster C.L. eds.)

The Persistence of Polygamy: Fundamentalist Mormon Polygamy from 1890 to the Present Newell G. Bringhurst and Craig L. Foster (Eds). Independence, Missouri. John Whitmer Books 2015, 629 pages.Polygamy is a fascinating topic for evolutionary anthropologists and psychologists alike because it is practiced by most primitive societies, meaning it was practiced in our own history. In these societies, females sexually select for the status of the males and thus the qualities that determine high status in such societies: physical health and, perhaps to a lesser extent, intelligence and certain personality traits. They do this because such a male provides them with healthier and more successful offspring and because the high status male will be able to invest in them and their offspring. In such societies, the headman might have 5 wives and many illegitimate children while around 40% of males will father no children at all. Indeed, Lynn (2011) has noted the persistence of polygyny among the British upper class right into Early Modern times, as it was effectively acceptable for them to father bastard children by mistresses.This volume is, therefore, significant because it explores, in painstaking detail, the only European-origin group which continues to practice polygamy in modern, Western society: the polygamous sects that have broken away from the mainline Church of Jesus Christ of Latter Day Saints (Mormons) in the USA. It is the third in a series of Persistence of Polygamy essay collections, with the same editors. The first looked at Joseph Smith and the origins of the practice (Bringhurst & Foster, 2010), while the second explored the practice in the early history of the church (Bringhurst & Foster, 2013).In the Introduction, the editors provide a readable history of the practice from 1890 onwards, when the official Mormon church banned it. It is appreciated that this is the third volume in a broader history of polygamy in the Mormon church, but it might have been useful to provide a little more background for the non-specialist on Mormon polygamy and the church in general. Joseph Smith, the first Mormon prophet, declared that all Mormons should be polygamous and himself had around 40 wives. The subject of intense persecution, the Mormons fled to Utah and established it as a state, but the persecution continued and the Mormon prophet in 1890 (a new prophet succeeds on the death of the last one, as with popes) banned polygamy. This led, eventually, to more fundamentalist Mormons deciding that the mainline church was disingenuous and establishing their own sects. One schism is known as the Apostolic United Brethren and is based in Utah. This split from the even more conservative, Fundamentalist Church of Jesus Christ of Latter Day Saints (FLDS) in the 1980s. This has established itself in Hildale-Colorado City on the Utah-Arizona border. It was in the news in 2008 as its dictatorial and puritanical prophet, Warren Jeffs, was jailed in Texas for child abuse. He remains in prison and is still regarded as the sect's prophet.Other chapters give various enlightening insights into the history of Mormon polygamy. Barbara Jones Brown explores how, in the 1880s, various Mormons fled to Mexico in order to avoid persecution by the US government and set up colonies there. …

Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs

PurposeIn patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective database analysis investigated clinical and economic outcomes associated with the timing of insulin initiation in patients with T2DM treated with ≥1 OAD in a real-world US setting. MethodsThis study linked data from the Truven Health MarketScan® Commercial database, Medicare Supplemental database, and Quintiles Electronic Medical Records database. A total of 1830 patients with T2DM were included. Patients were grouped according to their OAD use before basal insulin initiation (1, 2, or ≥3 OADs) as a proxy for the timing of insulin initiation. Clinical and economic outcomes were evaluated over 1 year of follow-up. FindingsDuring follow-up the 1 OAD group, compared with the 2 and ≥3 OADs groups, had a greater reduction in glycosylated hemoglobin A1c (−1.7% vs −1.0% vs −0.9%, respectively; P < 0.0001), greater achievement of glycemic target (38.2% vs 26.7% vs 19.6%, respectively; P < 0.0001), and a lower incidence of hypoglycemia (2.7% vs 6.6% vs 5.0%, respectively; P = 0.0002), with no difference in total health care costs ($21,167 vs $21,060 vs $20,133, respectively). ImplicationsThis study shows that early insulin initiation (represented by the 1 OAD group) may be clinically beneficial to patients with T2DM not controlled with OADs, without adding to costs. This supports the call for timely initiation of individualized insulin therapy in this population.

Disease and Clinical Characteristics of Patients with Polycythemia Vera: An Early View of the Reveal Study

Background: Patients with polycythemia vera (PV) have an increased symptom burden (eg, fatigue, pruritus, and splenomegaly-related symptoms) and an increased risk of mortality compared with the general population, often resulting from thrombotic events, disease transformation to myelofibrosis, or secondary malignancies. There are limited data regarding PV burden and treatment patterns in a contemporary, real-world US setting. REVEAL is an ongoing observational study being conducted to describe contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and healthcare resource utilization among patients with PV in the US. The objective of this assessment is to describe the clinical characteristics at enrollment among patients currently enrolled in REVEAL (enrollment from July 22, 2014 to June 9, 2015).Methods: REVEAL is a multicenter, noninterventional, nonrandomized, prospective, observational study. Eligible patients are ≥18 years of age with a PV diagnosis and currently under active management by a physician in the US. Data regarding disease and clinical characteristics, patient-reported outcomes, and health resource utilization are being collected at usual-care visits over a planned 36-month observation period. Analyses of these preliminary data were descriptive.Results: At data cutoff, 865 patients were enrolled (total planned enrollment, n=2000) from 174 sites (academic, n=27; community, n=147). Median (range) age at enrollment was 67 (22-95) years, 55.5% were male, 89.5% were white, and 45.4% had a history of smoking. Most patients (99.4%) had health insurance, including Medicare (56.0%), PPO (24.3%), or HMO (11.6%). Fifty-two percent were retired, 29.6% were employed, and 4.5% were unable to work or disabled. A total of 40.2% of patients completed a college/graduate degree, 19.9% had some college, and 32.5% completed high school or the equivalent.Documented major World Health Organization diagnostic criteria included JAK2V617F mutation in 50.9% of patients, elevated hemoglobin in 52.3%, and red cell mass in 5.5%. A bone marrow biopsy was conducted in 24.0% of patients, approximately half of whom (52.4% of the 24.0%) had trilineage myeloproliferation. Erythropoietin levels were abnormal in 19.7% of patients. Approximately half (46.6%) of patients had physician-reported PV-related symptoms at diagnosis, most frequently fatigue (25.2%) and pruritus (14.0%).At enrollment, median disease duration was 52.6 months; 42.3% of patients were diagnosed ≥5 years before enrollment. The most common comorbidities were hypertension (51.3%), obesity (14.2%), dyspnea (13.4%), myalgia (11.2%), and diabetes mellitus (11.1%). Mean hematocrit was 44.9%, hemoglobin was 14.5 g/dL, white blood cell count was 11.4×109/L, platelet count was 363.7×109/L, and absolute neutrophil count was 363.7×109/L. Twenty-one percent of patients had a history of thrombotic events, with 13.1% and 8.6% of patients experiencing ≥1 venous or arterial thromboembolic event, respectively. Of the 261 reported thrombotic events, 43.7% occurred after diagnosis of PV. The most common PV symptoms recorded at enrollment (using the Myeloproliferative Neoplasm Symptom Assessment Form) were fatigue (37.1%), pruritus (24.0%), headache (18.6%), insomnia (17.0%), dizziness (13.2%), bone pain (10.5%), and blurred vision (7.9%); 19.7% of 518 evaluable patients had palpable splenomegaly. Fewer than half of patients were receiving aspirin at enrollment (47.7%). The most common PV treatments ± aspirin were phlebotomy (PBT; 63.5%), hydroxyurea (HU; 42.2%), watchful waiting (5.3%), and ruxolitinib (3.1%); 23.0% of patients received PBT + HU.Conclusion: The REVEAL study is unique in that it captures data from both academic and community centers, and therefore includes a broader segment of the PV population typically not described in the literature. REVEAL can provide novel insights into questions related to the contemporary demographics of PV, practice patterns regarding diagnosis and therapy, and the real-world burden of PV and its impact on patients' quality of life and work productivity. Preliminary descriptive data from this early subset of patients suggest that a high proportion of patients report having PV-related symptoms at diagnosis, fewer patients are treated with aspirin than expected, and that thromboembolic event rates remain high after diagnosis. DisclosuresStein:Incyte Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moliterno:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees. Boccia:Incyte Corporation: Honoraria. Naim:Incyte Corporation: Employment, Equity Ownership. Cordaro:Incyte Corporation: Employment, Equity Ownership. Peng:Incyte Corporation: Employment, Equity Ownership. Sun:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Mesa:Promedior: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; NS Pharma: Research Funding; CTI Biopharma: Research Funding; Gilead: Research Funding; Pfizer: Research Funding; Incyte Corporation: Research Funding; Genentech: Research Funding.

Does market structure affect labour productivity and wages? Evidence from a smooth coefficient semiparametric panel model

This paper investigates the impact of market structure on labour productivity and wages using a panel data set of US manufacturing industries over the period 1958–2007. To account for nonlinear effects, we employ a smooth coefficient semiparametric model (SCSM). We find evidence in support of a nonlinear relationship between market concentration and labour productivity and wages. Lastly, our empirical findings shed new light on the competition–labour productivity nexus.

The Role of Directors’ and Officers’ Insurance in Securities Fraud Class Action Settlements

AbstractBecause of previous data unavailability, it is unclear how important directors’ and officers’ (D&O) insurance is in securities fraud class action settlements. Using a unique data set of US D&O policies, we find that D&O insurance coverage is a less significant determinant of settlement amounts than estimated damages and proxies for the merits of cases. Limits on D&O insurance are related to settlements in only the weakest cases (those without allegations of accounting violations or institutional lead plaintiffs) where proxies for cases’ merits play a minimal role. Our findings suggest that most securities fraud class action settlements are meritorious and that accounting-related cases are a reasonable proxy for fraud.

Great and Small Walls of China: Distance &amp; Chinese E-Commerce

Alibaba’s Taobao is China’s dominant C2C e-commerce platform. Relying on novel transaction level data from its electronics category, this paper examines the roles of distance as well as seller and buyer experience in Chinese e-commerce. Our estimate of a gravity model shows that the distance elasticity in our data is greater than US C2C e-commerce but smaller than that of South America. In addition, we document greater home bias in China than either of the US or South American Settings. Moreover, by estimating a “new-new” trade model using seller-level transaction data, this paper studies the link between seller experience and distance. Our results show that more experienced sellers tend to sell more and export their goods farther into the marketplace.

Bivalent rLP2086 Vaccine (Trumenba(®)): A Review in Active Immunization Against Invasive Meningococcal Group B Disease in Individuals Aged 10-25 Years.

Bivalent rLP2086 vaccine (Trumenba(®)) [hereafter referred to as rLP2086] is a Neisseria meningitidis serogroup B (MenB) vaccine recently licensed in the USA for active immunization to prevent invasive disease caused by MenB in individuals 10-25 years of age. rLP2086, which contains two variants of the meningococcal surface protein factor H-binding protein (fHBP), was approved by the FDA under the accelerated approval pathway after the immunogenicity of the vaccine was demonstrated in several phase II trials. This article reviews the immunogenicity and reactogenicity of rLP2086 as demonstrated in the trials with a focus on the US setting and on use of the vaccine as per FDA-approved labeling. rLP2086 is approved in the USA as a three-dose series administered in a 0-, 2-, and 6-month schedule. In the phase II trials, rLP2086 elicited a robust immune response against a panel of MenB test strains. A strong immune response was evident in a marked proportion of subjects after two vaccine doses, with a further increase after a third dose. The four primary test strains used were selected to be representative of MenB strains prevalent in the USA, with each expressing an fHBP variant heterologous to the vaccine antigens. rLP2086 was generally well tolerated in the trials, with most adverse reactions being mild to moderate in severity. Although some questions remain, including the duration of the protective response, rLP2086 vaccine has the potential to be a valuable tool for the prevention of invasive MenB disease.