Search

Introduction: Eribulin was approved by the FDA in 2010 for the treatment of metastatic breast cancer (MBC) in the United States (US). More recently, several immuno-oncology (IO) and antibody–drug conjugate (ADC) regimens have been approved for MBC. We assessed the treatment patterns and clinical outcomes in MBC patients treated with eribulin following treatment with an IO or ADC in US clinical practice.Materials and Methods: In a retrospective patient medical chart review study, patients with MBC, aged ≥ 18 years, who initiated eribulin therapy between March 1, 2019, and September 30, 2020, treated with either prior IO or ADC in the metastatic setting were included. Patient demographics, treatment characteristics, and clinical outcomes were analyzed descriptively. Real-world progression-free survival (rwPFS) and overall survival (OS) were estimated using Kaplan–Meier analyses.Results: In the study population (N=143), median age at eribulin initiation was 62 years; 64% were Caucasian, and 67% had triple-negative MBC (TNBC). Eribulin therapy was used in the second to fifth line of therapy in the metastatic setting; median treatment duration was 7.2 months. The overall response rate for eribulin was 59.4%. Median rwPFS and OS from eribulin initiation were 21.4 months (95% CI, 12.9-not estimable [NE]) and 24.2 months (95% CI, 17.5-NE), respectively. In patients with TNBC, median rwPFS and OS from eribulin initiation were 12.0 months (95% CI, 8.8-NE) and 18.3 months (95% CI, 14.9-NE), respectively.Conclusion: These real-world data provide evidence for the clinical effectiveness outcomes of eribulin treatment among MBC patients previously treated with an IO or ADC. [ABSTRACT FROM AUTHOR]

Background: Evidence on overall survival (OS) with cyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitors is generally limited to data from clinical trials or a few observational studies with limited generalizability to Medicare population. The aim of this study was to determine OS benefits associated with CDK4/6 inhibitors in older Medicare patients with hormone receptor (HR)–positive and human epidermal growth factor receptor‐2 overexpressing (HER2–) metastatic breast cancer (MBC). Methods: In a retrospective cohort design, female patients aged ≥65 years with diagnosis of HR+/HER2– MBC from 2015 to 2017 who initiated first‐line systemic therapy within 12 months of MBC diagnosis were selected from the Survey Epidemiology and End Results‐Medicare database. The effect of treatment type (endocrine therapy [ET]+CDK4/6 inhibitor vs. ET alone) on OS was analyzed using Kaplan–Meier methods and multivariable Cox regression models. Adjusted hazard ratio (aHR) and 95% CIs were estimated. Results: A total of 630 eligible patients were identified (169 patients treated with ET+CDK4/6 inhibitor and 461 patients treated with ET alone). In the Kaplan–Meier analysis, OS rate at 3 years after first‐line treatment initiation was 73.0% for ET+CDK4/6 inhibitor versus 49.1% for ET alone (log‐rank p <.0001). In Cox regression analysis, first‐line ET+CDK4/6 inhibitor therapy was associated with 41% lower rate of mortality versus ET alone (aHR, 0.590; 95% CI, 0.423–0.823). Conclusions: The findings of this real‐world study demonstrate significant OS benefit associated with ET+CDK4/6 inhibitor therapy over ET alone in an older Medicare population of patients with HR+/HER2– MBC, largely consistent with the evidence from clinical trials. In patients with metastatic breast cancer (MBC) receiving treatment with cyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitors, evidence on overall survival is generally limited to data from clinical trials or observational studies not generalizable to patients in the Medicare population. The findings of this real‐world analysis demonstrate that the addition of CDK4/6 inhibitors to endocrine therapy (ET) significantly improved survival among older Medicare beneficiaries, suggesting that treatment with ET alone should have a limited role in early lines of therapy for Medicare patients with HR+/HER2– MBC. [ABSTRACT FROM AUTHOR]

Background: Anticoagulation among patients with cancer and atrial fibrillation is challenging due to elevated risk of bleeding and stroke. We characterized use of oral anticoagulants among patients with cancer and non‐valvular atrial fibrillation (NVAF). Methods: We used Surveillance, Epidemiology, and End Results (SEER)‐Medicare data and included patients with cancer aged ≥66 years with an incident diagnosis of NVAF from 2010 to 2016. We used a Cox proportional hazard model and multivariable logistic regression to identify factors associated with anticoagulant use versus no use and direct oral anticoagulants (DOACs) versus warfarin use, respectively. Results: Of 27,702 patients with cancer and NVAF, 4469 (16.1%) used DOACs and 3577 (12.9%) used warfarin. Among 8046 anticoagulant users, DOACs use increased from 21.8% in 2011 to 76.2% in 2016, with a corresponding decline in warfarin use from 78.2% to 23.8%. Nearly 7 out of 10 patients with cancer and NVAF did not initiate anticoagulation in 2016. Anticoagulant use was more likely among those with higher CHA₂DS₂‐VASc scores (hazard ratio [HR] 1.55, 95% confidence interval [CI] 1.27–1.90 for score ≥6 vs. 1) or with lower HAS‐BLED scores (HR 1.96, 95% CI 1.67–2.30 for score 1 vs. ≥6). Among anticoagulant users, DOAC use was less likely than warfarin in those with higher CHA₂DS₂‐VASc scores (odds ratio [OR] 0.53, 95% CI 0.33–0.84 for score ≥6 vs. 1). Conclusions: Nearly 7 out of 10 patients with cancer and NVAF did not receive anticoagulation. Use of DOACs increased from 2010 to 2016, with a corresponding decline in warfarin use. DOACs are used less than warfarin among those at higher risk of stroke. [ABSTRACT FROM AUTHOR]

Background: Endocrine therapy (ET) remains a foundation of systemic therapy for HR+/ HER2- metastatic breast cancer (MBC), although chemotherapy (CT) is used in select patients. In this "real-world" study, we explored treatment patterns, health care resource use (HCRU), costs, adverse events (AEs) and overall survival (OS) in Medicare-enrolled, older patients with HR+/HER2- MBC. Methods: Patients with HR+/HER2- MBC (2007-2011) and aged >66 years were retrospectively analyzed using the SEER-Medicare data. Treatment patterns, HCRU, costs, AEs and OS after MBC diagnosis through end of study period (31 December 2013) were examined using descriptive and multivariable analyses. Results: Among 3622 eligible patients, ET was the most common treatment (77%), followed by CT (50%), radiation (48%) and surgery (19%). The proportion of patients treated with ET monotherapy decreased across therapy lines, from 74% in first line (1 L) to 35% in 4 L. The total number of unique therapy regimens used was 181 in 1 L, 171 in 2 L, 128 in 3 L, and 95 in 4 L. The median OS from MBC diagnosis was 25.3 months (95% CI, 24.0-26.7). In multivariable analyses, receipt of CT and combination CT + ET (versus ET monotherapy) in 1 L, metastatic disease at initial diagnosis, larger tumor size, and presence of visceral and brain metastases at MBC diagnosis significantly predicted receipt of 2 L therapy. Conclusions: ET was the most common first-line treatment for study patients, but its use decreased gradually in the subsequent lines. The heterogeneity in the treatment selection highlights a lack of consensus for the management of HR+/HER2- MBC in routine practice. [ABSTRACT FROM AUTHOR]

Introduction: Contemporary data describing treatment patterns, adverse events (AEs), and outcomes in patients with chronic lymphocytic leukemia (CLL) in clinical practice are lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health‐care resource use (HCRU), and costs in patients with diagnosis of CLL. Methods: Using a nationally representative population of privately insured patients in the US, adult patients with CLL diagnosis (July 2012‐June 2015) were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL‐directed treatment. Treatment patterns up to four lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per‐patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results: Of all patients meeting the selection criteria (n = 7,639; median age, 66 years), 18% (n = 1,379) received a systemic therapy during study follow‐up. Of these, bendamustine/rituximab (BR) was the most common first observed regimen (28.1%), while ibrutinib was the most common therapy in the second (20.8%) and third (25.5%) observed regimens. The mean monthly all‐cause and CLL‐related costs, among patients treated with a systemic therapy, were $7,943 (SD = $15,757) and $5,185 (SD = $9,935), respectively. Mean monthly all‐cause costs increased by the number of AEs (from $905 [SD = $1,865] among those with no AEs to $6,032 [SD = $13,290] among those with ≥6 AEs). Conclusions: Chemoimmunotherapy, particularly BR, was the most common first observed therapy for CLL, whereas ibrutinib was most preferred in the second and third observed lines of therapy during the study period. Findings demonstrate that the economic burden of AEs in CLL is substantial. [ABSTRACT FROM AUTHOR]

In view of recent therapeutic advances in mantle cell lymphoma (MCL), the aim of this retrospective cohort analysis was to assess treatment patterns, adverse events (AEs), resource utilization, and health care costs in patients with MCL in a US-based commercial claims database. A total of 783 patients with MCL (median age = 65 years) were selected. Among patients receiving systemic therapy (n = 457), the most common treatment regimens were bendamustine/rituximab (BR) (41.1%), rituximab/cyclophosphamide/doxorubicin/vincristine (RCHOP) (26.7%), rituximab monotherapy (20.4%), and ibrutinib monotherapy (14.2%). Mean monthly costs during treatments with BR, RCHOP, rituximab, and ibrutinib were $12,958, $24,719, $13,153, and $21,690, respectively. Mean monthly cost during follow-up was $13,650 among patients with ≥6 AEs versus $5131 among those without AEs. The costs of MCL varied considerably by treatment regimen and care setting. The overall economic burden of managing patients with MCL can be substantially affected by costs associated with managing AEs occurring during treatment. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study is to assess temporal trends in the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis and risk of febrile neutropenia (FN) among older women receiving adjuvant chemotherapy for early-stage breast cancer.Methods: Women aged ≥ 66 years with diagnosis of early-stage breast cancer who initiated selected adjuvant chemotherapy regimens were identified using the SEER-Medicare data from 2002 to 2012. Adjusted, calendar-year-specific proportions were estimated for use of G-CSF primary prophylaxis (PP) and secondary prophylaxis and FN risk in the first and the second/subsequent cycles during the first course of chemotherapy, using logistic regression models. calendar-year-specific mean probabilities were estimated with covariates set to modal values.Results: Among 11,107 eligible patients (mean age 71.7 years), 74% received G-CSF in the first course of chemotherapy. Of all patients, 5819 (52%) received G-CSF PP, and among those not receiving G-CSF PP, only 5% received G-CSF secondary prophylaxis. The adjusted proportion using G-CSF PP increased from 6% in 2002 to 71% in 2012. During the same period, the adjusted risk of FN in the first cycle increased from 2% to 3%; the adjusted risk increased from 1.5% to 2.9% among those receiving G-CSF PP and from 2.3% to 3.5% among those not receiving G-CSF PP.Conclusion: The use of G-CSF PP increased substantially during the study period. Although channeling of higher-risk patients to treatment with G-CSF PP is expected, the adjusted risk of FN among patients treated with G-CSF PP tended to be lower than among those not receiving G-CSF PP. [ABSTRACT FROM AUTHOR]

Current projections are that by 2050 the numbers of people aged 65 and older with Alzheimer’s disease (AD) in the US may increase threefold while dementia is projected to double every 20 years reaching ~115 million by 2050. AD is clinically characterized by progressive dementia and neuropathologically by neuronal and synapse loss, accumulation of amyloid plaques, and neurofibrillary tangles (NFTs) in specific brain regions. The preclinical or presymptomatic stage of AD-related brain changes may begin over 20 years before symptoms occur, making development of noninvasive biomarkers essential. Distinct from neuroimaging and cerebrospinal fluid biomarkers, plasma or serum biomarkers can be analyzed to assess (i) the presence/absence of AD, (ii) the risk of developing AD, (iii) the progression of AD, or (iv) AD response to treatment. No unifying theory fully explains the neurodegenerative brain lesions but neuroinflammation (a lethal stressor for healthy neurons) is universally present. Current consensus is that the earlier the diagnosis, the better the chance to develop treatments that influence disease progression. In this article we provide a detailed review and analysis of the role of the blood-brain barrier (BBB) and damage-associated molecular patterns (DAMPs) as well as coagulation molecules in the onset and progression of these neurodegenerative disorders. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether sphericity volume index (SVI), an indicator of left ventricular (LV) remodelling, predicts incident cardiovascular events (coronary heart disease, CHD; all cardiovascular disease, CVD; heart failure, HF; atrial fibrillation, AF) over 10 years of follow-up in a multiethnic population (Multi-Ethnic Study of Atherosclerosis).Methods: 5004 participants free of known CVD had magnetic resonance imaging (MRI) in 2000-2002. Cine images were analysed to compute, [Formula: see text] equivalent to LV volume/volume of sphere with length of LV as the diameter. The highest (greatest sphericity) and lowest (lowest sphericity) quintiles of SVI were compared against the reference group (2-4 quintiles combined). Risk-factor adjusted hazard's ratio (HR) from Cox regression assessed the predictive performance of SVI at end-diastole (ED) and end-systole (ES) to predict incident outcomes over 10 years in retrospective interpretation of prospective data.Results: At baseline, participants were aged 61±10 years; 52% men and 39%/13%/26%/22% Cauc/Chinese/Afr-Amer/Hispanic. Low sphericity was associated with higher Framingham CVD risk, greater coronary calcium score and higher N-terminal pro-brain natriuretic peptide (NT-proBNP); while increased sphericity was associated with higher NT-proBNP and lower ejection fraction. Low sphericity predicted incident CHD (HR: 1.48, 1.55-2.59 at ED) and CVD (HR: 1.82, 1.47-2.27 at ED). However, both low (HR: 1.81, 1.20-2.73 at ES) and high (HR: 2.21, 1.41-3.46 at ES) sphericity predicted incident HF. High sphericity also predicted AF.Conclusions: In a multiethnic population free of CVD at baseline, lowest sphericity was a predictor of incident CHD, CVD and HF over a 10-year follow-up period. Extreme sphericity was a strong predictor of incident HF and AF. SVI improved risk prediction models beyond established risk factors only for HF, but not for all CVD or CHD. [ABSTRACT FROM AUTHOR]

Objectives: In 2010, there were 2.5 million hospitalizations, emergency room visits, or deaths associated with concussions in the United States.[1] Knowledge deficits exist among physicians regarding concussion management, which can lead to severe repercussions, including poor patient outcomes, poor patient satisfaction, and potential medical-legal issues. While concussion is a prevalent condition evaluated in the medical field, medical students continue to have a knowledge deficit regarding concussion diagnosis, prognosis, medical management, and return to play guidelines. Methods: Medical students from a mid-western medical school completed a survey on concussion diagnosis, prognosis, medical management, and return to play guidelines. Results: The response rate was 40%. The data suggests that the vast majority of medical students are able to define concussion; however, most reported never having a lecture dedicated to concussion during medical school and also lacked clinical experience with acute concussion and post-concussive syndrome. There are clear areas of deficiency as noted by the inability of students to correctly identify symptoms and appropriate management of concussion. Conclusion: The current study indicates that at an individual, mid-western, top 50 medical school, current medical trainees may not be adequately educated to identify and manage concussion. Future research is warranted to determine the optimal guidelines to educate future physicians as it pertains to concussion diagnosis, management, prognosis, and return to play guidelines. [ABSTRACT FROM AUTHOR]

Background: The patient-centered medical home (PCMH) is increasingly being implemented in an effort to improve and coordinate primary care, but its effect on health care utilization among breast cancer patients remains unclear. The objective of this study was to examine health care utilization and expenditures as a function of PCMH enrollment among breast cancer patients in North Carolina's Medicaid program. Methods: North Carolina Medicaid claims linked to North Carolina Central Cancer Registry records (2003-2007) were used to examine monthly patterns of health care use and expenditures. Controlling for a selection bias for time-invariant characteristics, fixed effects regression models analyzed associations between PCMH enrollment and utilization of outpatient, inpatient, and emergency department (ED) services and Medicaid expenditures during the 15 months after the diagnosis of breast cancer. Results: Among 758 breast cancer patients, 381 (50%) were enrolled in a PCMH at some time in the 15 months after diagnosis. After controlling for individual fixed effects, PCMH enrollment was significantly associated with greater outpatient service use, but there was no difference in the probability of inpatient hospitalizations or ED visits. Enrollment in a PCMH was associated with increased average expenditures of $429 per month during the first 15 months. Conclusions: Greater outpatient care utilization and increased average expenditures among breast cancer patients enrolled in a PCMH may suggest that these women have improved access to primary and specialty care. Expanding PCMHs may change patterns of service utilization for Medicaid breast cancer patients but may not be associated with lower costs. [ABSTRACT FROM AUTHOR]

Objectives Despite advances in the treatment of nonsquamous non-small cell lung cancer (NSCLC), therapeutic choices and overall disease course for squamous NSCLC have remained relatively unchanged over the past several years. We provide a detailed account of current treatment patterns, healthcare use, and survival in real-world clinical settings for metastatic squamous NSCLC. Materials and methods Patients aged ≥65 years with metastatic squamous NSCLC diagnosed 2001–2009 were identified and followed through 2010 using the Surveillance, Epidemiology and End Results-Medicare database. Treatment patterns were descriptively analyzed. Multivariate logistic regressions were estimated to identify predictors of treatment pattern events; generalized linear models were estimated for total all-cause and NSCLC-related costs to assess cost drivers. Results Of 17,133 patients, 72% received cancer-directed therapy (surgery, radiation, chemotherapy, or biologic therapy), whereas 28% received only supportive care. Median survival was significantly longer in patients receiving cancer-directed therapy (8 months) than in patients receiving supportive care only (2 months) ( P < 0.0001). An agent-specific first-line chemotherapy regimen was identified for 91% of the 7700 patients who received chemotherapy. Among these, the most common first-line regimen was carboplatin-paclitaxel combination therapy (46%). Common second-line regimens were gemcitabine monotherapy (16%) and pemetrexed monotherapy (11%). Factors associated with decreased odds of receiving cancer-directed treatment were black versus white race (OR, 0.72; 95% CI, 0.64–0.82), residence in the West versus South (OR, 0.73; 95% CI, 0.66–0.81), and metastatic disease at initial diagnosis versus progression to metastatic disease (OR, 0.77; 95% CI, 0.70–0.84). Conclusions Our study shows that prognosis remains poor for patients with metastatic squamous NSCLC, even among those receiving treatment, but particularly for patients limited to supportive care only, highlighting the continuing unmet medical need in this population. Additionally, our analysis indicates that selections for second-line and third-line chemotherapies are not necessarily consistent with National Comprehensive Cancer Network guidelines. [ABSTRACT FROM AUTHOR]

Purpose: To identify the Obama administration's policy responsiveness to the (African) American LGBT communities. Methodology/approach: Theory development and content analysis. Findings: Civic universalism, as a theory, can explain President Obama's evolution on his support for marriage rights for same-sex couples. Obama employed the concept of e pluribus unum in his many approaches to LGBT responsive politics. Research limitations: To date, theoretical development within the social sciences of LGBT policy responsiveness is limited. Originality/value: Very little is written on the subject of LGBT (Lesbian, Gay, Bisexual, and Transgendered) politics in the 21st century. The study of the LGBT experience generally has been devoid of political variables because of a lack of attention toward LGBT issues, until recently, in national political party agendas. In this chapter, we review some of the contours of the LGBT community's fight for political recognition in the United States as a precursor to the election and reelection of President Obama. Drawing parallels with presidential responsiveness toward Blacks in their quest for rights, we examine the Obama administration's LGBT public policy initiatives as administrative policy and programs. We conclude by identifying new areas of research to explore on LGBT politics. [ABSTRACT FROM AUTHOR]

Firms outsource to achieve a marketplace position of competitive advantage. The trend to outsource has permeated into the health care industry because of skyrocketing health care costs. Concerned by the rising costs of health care and the growing number of underinsured and uninsured Americans, President Obama signed into law a sweeping health care reform known as the Affordable Care Act (ACA). Most experts agree that ACA has created uncertain times for global marketers of medical outsourcing. However, when faced with demand and market uncertainties, organizations form strategic global alliances to reduce such market uncertainties. Yet, the extant marketing and management literature reflects little effort to develop a framework for understanding medical outsourcing alliance success. This research draws from the explanatory power of resource advantage theory, alliance theory, and relationship marketing to develop a conceptual framework of medical outsourcing alliance success. Furthermore, the authors provide normative prescriptions for global marketers of medical outsourcing. [ABSTRACT FROM AUTHOR]

Introduction. Although lead paint and leaded gasoline have not been used in the US for thirty years, thousands of US children continue to have blood lead levels (BLLs) of concern. Methods.We investigated the potential association of modeled air lead levels and BLLs ⩾ 10 μg/dL using a large CDC database with BLLs on children aged 0-3 years. Percent of children with BLLs ⩾ 10 μg/dL (2000-2007) by county and proportion of pre-50 housing and SES variables were merged with the US EPA's National Air Toxics Assessment (NATA) modeled air lead data. Results.The proportion with BLL ⩾ 10 μg/dL was 1.24% in the highest air lead counties, and the proportion with BLL ⩾ 10 μg/dL was 0.36% in the lowest air lead counties, resulting in a crude prevalence ratio of 3.4. Further analysis using multivariate negative binomial regression revealed that NATA lead was a significant predictor of % BLL ⩾ 10 μg/dL after controlling for percent pre-l950 housing, percent rural, and percent black. A geospatial regression revealed that air lead, percent older housing, and poverty were all significant predictors of % BLL ⩾ 10 μg/dL. Conclusions. More emphasis should be given to potential sources of ambient air lead near residential areas. [ABSTRACT FROM AUTHOR]

Abstract: Objective: In order to increase transparency in the medical literature, the Food and Drug Administration (FDA) Modernization Act of 1997 and the FDA Amendment Act of 2007 required registration of all “applicable trials” with required “basic results” reporting. We evaluated the rate of compliance with the FDA mandatory results reporting in www.clinicaltrials.gov. Methods: All completed registered interventional studies that may be subject to FDA regulation, one year prior to required results reporting (October 2006 to September 2007, n=1097) and during the two years after required reporting (October 2007 to September 2008 (07–08), n=2231 and October 2008 to September 2009 (08–09), n=2923). Results: Downloading all 99,315 records from clinicaltrials.gov, we excluded all non-applicable studies. Results reporting increased from 6.8% (n=75) prior to mandatory reporting to 19.1% (n=427, p<.01) in 07–08 and 10.8% (n=316, p<.01) in 08–09. The odds ratio for results reporting using the 06–07 time period as the reference was 3.31 (95% CI 2.54–4.32) for 07–08 and 1.74 (1.33–2.28) for 08–09. Of the 818 trials with results in clinicaltrials.gov, the rate of published articles found decreased from 60% (n=45) in the year prior to required reporting to 33% (n=140, p<.001) for 07–08 and 20% (n=63, p<.001) for 08–09 time period. Conclusion: The majority of studies registered in clinicaltrials.gov are not required to report data. Of studies that may be required to report data, compliance with data reporting has improved. The clinicaltrials.gov website is not yet a comprehensive resource for study results. [Copyright &y& Elsevier]

Background: The purpose of this study was to investigate the association between Attention Deficit/Hyperactivity Disorder (ADHD) and various factors using a representative sample of US children in a comprehensive manner. This includes variables that have not been previously studied such as watching TV/playing video games, computer usage, family member's smoking, and participation in sports. Methods: This was a cross-sectional study of 68,634 children, 5-17 years old, from the National Survey of Children's Health (NSCH, 2007-2008). We performed bivariate and multivariate logistic regression analyses with ADHD classification as the response variable and the following explanatory variables: sex, race, depression, anxiety, body mass index, healthcare coverage, family structure, socio-economic status, family members' smoking status, education, computer usage, watching television (TV)/playing video games, participation in sports, and participation in clubs/organizations. Results: Approximately 10% of the sample was classified as having ADHD. We found depression, anxiety, healthcare coverage, and male sex of child to have increased odds of being diagnosed with ADHD. One of the salient features of this study was observing a significant association between ADHD and variables such as TV usage, participation in sports, two-parent family structure, and family members' smoking status. Obesity was not found to be significantly associated with ADHD, contrary to some previous studies. Conclusions: The current study uncovered several factors associated with ADHD at the national level, including some that have not been studied earlier in such a setting. However, we caution that due to the cross-sectional and observational nature of the data, a cause and effect relationship between ADHD and the associated factors can not be deduced from this study. Future research on ADHD should take into consideration these factors, preferably through a longitudinal study design. [ABSTRACT FROM AUTHOR]

ABSTRACT: This article examines the rhetorical strategies of black mayors Jack Ford and Rhine McLin and their efforts to represent black interests in majority-white cities and compares the strategies to those of President Obama. Using polling data, speech content analysis, and census data, the article identifies that all three black politicians were able to rhetorically advance policies and programs designed to represent black interests with majority-white constituencies. The results indicate that when black interest policy actions are framed utilizing a targeted universalistic rhetorical strategy, mayors Ford and McLin and President Obama each advanced black interests as they detailed how their proposed initiatives benefited all citizens. At the local and federal levels, the finding exposes the limits of the deracialization perspective and indicates how the advance of black interests can be achieved while maintaining significant white electoral and governing support. [ABSTRACT FROM AUTHOR]

Objective: This study identified factors in patients with diabetes associated with risk of developing dementia. Research Design and Methods: This retrospective, longitudinal study used a national cohort of US Veterans with diabetes 65 years or older to examine incidence of dementia over 2 years. A multivariable Cox regression model was used to estimate risk of developing dementia associated with sociodemographic factors, use of diabetes medications, and duration of diabetes. Results: In all, 377 838 patients (average age, 75.53 ±6.07 years) were studied. Over the 2 year follow-up, 14 580 (3.85%) were diagnosed with dementia. Major risk factors for dementia were age >75 years (75-85 years, hazard ratio [HR] 2.092, 95% confidence interval [CI] 2.017-2.169; ≥85 years, HR 3.468, CI 3.274-3.672), race black versus white, HR 1.218, CI 1.164-1.274), Southern residence (HR=1.181, CI 1.133-1.232), and diabetes duration (HR for 5 years or more, 1.428, CI 1.357-1.504). There was a reduced HR for dementia with use of an oral hypoglycemic agent (HR 0.940, CI 0.909-0.972) and HMG-CoA reductase inhibitors (HR, 0.875, CI 0.846-0.906). There was no change in HR with insulin use (HR 1.024, CI 0.983-1.067). Conclusions: Several important factors were identified that are associated with increased dementia risk, and two factors were identified that are associated with reduced risk. It will be important to ascertain whether risk-factor modification reduces the HR for dementia in persons with diabetes, and to further examine effects of medication use for comorbid conditions. [ABSTRACT FROM AUTHOR]

Both candidates and voters have increased their use of the Internet for political campaigns. Candidates have adopted many internet tools, including social networking websites, for the purposes of communicating with constituents and voters, collecting donations, fostering community, and organizing events. On the other side, voters have adopted Internet tools such as blogs and social networking sites to relate to candidates, engage in political dialogue, pursue activist causes, and share information. In this paper we examine two years of posts on the Facebook walls of the three major contenders for the U.S. Presidency in 2008: Barack Obama, Hillary Clinton, and John McCain. We analyze participation patterns of usage along dimensions of breadth and frequency, and interpret them in terms of the concept of the "public sphere". [ABSTRACT FROM AUTHOR]

The article examines the study on health services access and utilization patterns using nationally representative National Health Interview Survey (NHIS) data from 1999 to 2002 in the U.S. Study shows that Hispanic American children do better than non-Hispanic Whites with respect to certain health status measures such as school absence. It also shows that there is considerable heterogeneity in health status and health care utilization in the Hispanic subgroup.

Ammonium sulfate particles were generated by atomization and introduced into a smog chamber where they were coated with secondary organic aerosol from ozonolysis of limonene or α-pinene. These mixed particles were then sampled with a humidified Tandem-DMA system where a monodisperse aerosol population was selected, humidified, and dried to observe the relative humidity (RH) at which the particles returned to the original dry diameter. The volume fraction of secondary organic aerosol (SOA) in the mixed particles ranged from 0.59 to 0.94 for limonene SOA and 0.54 to 0.72 for α-pinene SOA. Efflorescence RHs for our mixed aerosols were in the range of 28–34%, similar to our observation of 32% ERH for pure ammonium sulfate nanoparticles. These findings indicate that the effect of SOA on the ERH of inorganic salts in the atmosphere may be negligible. [ABSTRACT FROM AUTHOR]

The article provides an overview of the mercury control technologies aimed at lessening the mercury emissions from coal-fired electric utility boilers in the U.S. The author stressed that mercury emissions from anthropogenic emission sources posed a global threat that needs to be subsided. In response, the U.S. Environmental Protection Agency proclaimed the Clean Air Mercury Rule to permanently cap and abridge emissions of mercury from coal-fired power plants. Another regulation promulgated is the Clean Air Interstate Rule, which compels further reduction of sulphur dioxide and nitrogen oxides from these power plants. Among the control technologies stressed include flue-gas desulfurization and limestone forced- oxidation.

Watermarking is the process that embeds data called a watermark, a tag, or a label into a multimedia object, such as images, video, or text, for their copyright protection. According to human perception, the digital watermarks can either be visible or invisible. A visible watermark is a secondary translucent image overlaid into the primary image and appears visible to a viewer on a careful inspection. The invisible watermark is embedded in such a way that the modifications made to the pixel value is perceptually not noticed, and it can be recovered only with an appropriate decoding mechanism. This paper presents a new very large scale integration (VLSI) architecture for implementing two visible digital image watermarking schemes. The proposed architecture is designed to aim at easy integration into any existing digital camera framework. To the authors' knowledge, this is the first VLSI architecture for implementing visible water-marking schemes. A prototype chip consisting of 28469 gates is implemented using 0.35-μm technology, which consumes 6.9-mW power while operating at 292 MHz. [ABSTRACT FROM AUTHOR]

The Bemidji aquifer in Minnesota, USA is a well-studied site of subsurface petroleum contamination. The site contains an anoxic groundwater plume where soluble petroleum constituents serve as an energy source for a region of methanogenesis near the source and bacterial Fe(III) reduction further down gradient. Methanogenesis apparently begins when bioavailable Fe(III) is exhausted within the sediment. Past studies indicate that Geobacter species and Geothrix fermentens-like organisms are the primary dissimilatory Fe-reducing bacteria at this site. The Fe mineralogy of the pristine aquifer sediments and samples from the methanogenic (source) and Fe(III) reducing zones were characterized in this study to identify microbiologic changes to Fe valence and mineral distribution, and to identify whether new biogenic mineral phases had formed. Methods applied included X-ray diffraction; X-ray fluorescence (XRF); and chemical extraction; optical, transmission, and scanning electron microscopy; and Mo¨ssbauer spectroscopy.All of the sediments were low in total Fe content (&ap; 1%) and exhibited complex Fe-mineralogy. The bulk pristine sediment and its sand, silt, and clay-sized fractions were studied in detail. The pristine sediments contained Fe(II) and Fe(III) mineral phases. Ferrous iron represented approximately 50% of FeTOT. The relative Fe(II) concentration increased in the sand fraction, and its primary mineralogic residence was clinochlore with minor concentrations found as a ferroan calcite grain cement in carbonate lithic fragments. Fe(III) existed in silicates (epidote, clinochlore, muscovite) and Fe(III) oxides of detrital and authigenic origin. The detrital Fe(III) oxides included hematite and goethite in the form of mm-sized nodular concretions and smaller-sized dispersed crystallites, and euhedral magnetite grains. Authigenic Fe(III) oxides increased in concentration with decreasing particle size through the silt and clay fraction. Chemical extraction and Mo¨ssbauer analysis indicated that this was a ferrihydrite like-phase. Quantitative mineralogic and Fe(II/III) ratio comparisons between the pristine and contaminated sediments were not possible because of textural differences. However, comparisons between the texturally-similar source (where bioavailable Fe(III) had been exhausted) and Fe(III) reducing zone sediments (where bioavailable Fe(III) remained) indicated that dispersed detrital, crystalline Fe(III) oxides and a portion of the authigenic, poorly crystalline Fe(III) oxide fraction had been depleted from the source zone sediment by microbiologic activity. Little or no effect of microbiologic activity was observed on silicate Fe(III). The presence of residual “ferrihydrite” in the most bioreduced, anoxic plume sediment (source) implied that a portion of the authigenic Fe(III) oxides were biologically inaccessible in weathered, lithic fragment interiors. Little evidence was found for the modern biogenesis of authigenic ferrous-containing mineral phases, perhaps with the exception of thin siderite or ferroan calcite surface precipitates on carbonate lithic fragments within source zone sediments. [Copyright &y& Elsevier]

This study aimed at investigating how income, culture, and language affect health care access. Data from a structured questionnaire administered to a random sample of 206 Latinos was analyzed using multivariate logistic regression. Qualitative data served to explain quantitative results. Point estimates for various access measures were similar to national data. In multivariate logistic regression, income and education determined having health insurance (OR 6.8 and 7.4; 95% CI 2.7-17.3 and 2.9-19.0, respectively). Time in the U.S. and health insurance determined having a regular source of care (OR 4.6 and 5.8; 95% CI 1.7-12.8 and 2.1-16.0, respectively). Having a source of care and being female determined visit to the doctor in the past year (OR 6.14 and 6.73; 95% CI 2.3-16.5 and 2.4-19.3, respectively). Language and culture showed no statistically significant effect on access measures, but qualitative data showed they were related to health care barriers. [ABSTRACT FROM AUTHOR]

An experimental and modeling study was conducted to investigate pertechnetate (Tc(VII)O4-) retardation, reduction, and rate scaling in three sediments from Ringold formation at U.S. Department of Energy's Hanford site, where 99Tc is a major contaminant in groundwater. Tc(VII) was reduced in all the sediments in both batch reactors and diffusion columns, with a faster rate in a sediment containing a higher concentration of HCl-extractable Fe(II). Tc(VII) migration in the diffusion columns was reductively retarded with retardation degrees correlated with Tc(VII) reduction rates. The reduction rates were faster in the diffusion columns than those in the batch reactors, apparently influenced by the spatial distribution of redox-reactive minerals along transport paths that supplied Tc(VII). X-ray computed tomography and autoradiography were performed to identify the spatial locations of Tc(VII) reduction and transport paths in the sediments, and results generally confirmed the newly found behavior of reaction rate changes from batch to column. The results from this study implied that Tc(VII) migration can be reductively retarded at Hanford site with a retardation degree dependent on reactive Fe(II) content and its distribution in sediments. This study also demonstrated that an effective reaction rate may be faster in transport systems than that in well-mixed reactors. [ABSTRACT FROM AUTHOR]

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder with few risk factors identified and no known cure. Gene-environment interaction is hypothesized especially for sporadic ALS cases (90–95%) which are of unknown etiology. We aimed to investigate risk factors for ALS including exposure to ambient air toxics. This population-based case-control study included 267 ALS cases (from the United States [U.S.] Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry National ALS Registry and Biorepository) and 267 age, sex, and county-matched controls identified via a commercial database. Exposure assessment for 34 ambient air toxicants was performed by assigning census tract-level U.S. Environmental Protection Agency (EPA) 2011 National Air Toxics Assessment (NATA) data to participants' residential ZIP codes. Conditional logistic regression was used to compute adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for individual compounds, chemical classes, and overall exposure. Sensitivity analyses using both conditional logistic regression and Bayesian grouped weighted quartile sum (GWQS) models were performed to assess the integrity of findings. Using the 2011 NATA, the highest exposure quartile (Q4) compared to the lowest (Q1) of vinyl chloride (aOR = 6.00, 95% CI: 1.87–19.25), 2,4-dinitrotoluene (aOR = 5.45, 95% CI: 1.53–19.36), cyanide (aOR = 4.34, 95% CI: 1.52–12.43), cadmium (aOR = 3.30, 95% CI: 1.11–9.77), and carbon disulfide (aOR = 2.98, 95% CI: 1.00–8.91) was associated with increased odds of ALS. Residential air selenium showed an inverse association with ALS (second quartile [Q2] vs. Q1: aOR = 0.38, 95% CI: 0.18–0.79). Additionally, residential exposure to organic/chlorinated solvents (Q4 vs Q1: aOR = 2.62, 95% CI: 1.003–6.85) was associated with ALS. Our findings using the 2011 NATA linked by census tract to residential area provide evidence of increased ALS risk in cases compared to controls for 2,4-dinitrotoluene, vinyl chloride, cyanide, and the organic/chlorinated solvents class. This underscores the importance of ongoing surveillance of potential exposures for at-risk populations. • A case control study was conducted using 267 cases from the National ALS Registry. • Case/control pairs drawn from a convenience sample of the 48 co-terminus US States. • We examined ambient air levels of 34 neurotoxicants and ALS risk using 2011 NATA. • Higher levels of 2,4-dinitrotoluene and vinyl chloride were related to ALS risk. • Increased risk of ALS was noted for cyanide, carbon disulfide and cadmium. [ABSTRACT FROM AUTHOR]

Background: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs.Methods: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing.Findings: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups.Interpretation: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves.Funding: Abbott. [ABSTRACT FROM AUTHOR]

Background and Objectives: Exposure to particulate matter (PM2.5) has been associated with increased cardiovascular outcomes, mediated by a hypothesized biological mechanism of systemic inflammation and oxidation. Although PM10 has been linked to inflammatory markers in a nationally representative sample (NHANES) using data from earlier cycles (1989-1994); no study has considered these relationships for PM2.5 in more recent time periods. We examined the association of ambient PM2.5 exposure and inflammatory markers in adult NHANES participants for cycles 2001-2008.Methods: We linked each of the adult NHANES participant's address with meteorological and modeled air pollution data for each census tract in conterminous United States. The effects of short and long term PM2.5 on C-reactive protein, white blood cells, fibrinogen and homocysteine were analyzed using multiple linear regression, adjusting for cardiovascular risk factors, temperature and ozone. SAS SURVEYREG was used to account for the complex survey design of NHANES.Results: In the overall population, no significant positive associations were noted for either short or long term PM2.5 exposures for any of the biomarkers after controlling for confounders. However, stronger associations were found among obese, diabetics, hypertensive and smokers. For every 10μg/m(3) increase in PM2.5, there was an increase of (a) 36.9% (95% CI: 0.1%, 87.2%) in CRP at annual average PM2.5 (adjusting for short term exposure) among diabetics (b) 2.6% (95% CI: 0.1%, 5.1%) in homocysteine at lag 0 among smokers.Conclusions: In a nationally representative sample of individuals we noted no overall association between PM2.5 and biomarkers of cardiovascular risk. However, sensitive subgroups manifested increases in these markers to PM2.5 exposure. Further studies should concentrate on the impact of PM2.5 on these biomarkers in those with multiple cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Abstract: In this paper, an attempt has been made to systematically organize the research investigations conducted on clad tube failure, so far. Before presenting the review on the clad failure studies, an introduction to different clad materials has been added, in which the effect of alloying elements on the material properties have been presented. The literature on clad failure has been broadly categorized under the headings LOCA and RIA. The failure mechanisms like creep, corrosion and pellet–clad interaction have been discussed in details. Each subsection of the review has been provided with summary table, in which the studies are arranged in the chronological order. A small section on acceptance criteria for ECCS has also been included. The last section of the review has been dedicated to the core-degradation phenomena. [Copyright &y& Elsevier]

One of the justifiable criticisms of human genetic studies is the underrepresentation of participants from diverse populations. Lack of inclusion must be addressed at-scale to identify causal disease factors and understand the genetic causes of health disparities. We present genome-wide associations for 2068 traits from 635,969 participants in the Department of Veterans Affairs Million Veteran Program, a longitudinal study of diverse United States Veterans. Systematic analysis revealed 13,672 genomic risk loci; 1608 were only significant after including non-European populations. Fine-mapping identified causal variants at 6318 signals across 613 traits. One-third ( n = 2069) were identified in participants from non-European populations. This reveals a broadly similar genetic architecture across populations, highlights genetic insights gained from underrepresented groups, and presents an extensive atlas of genetic associations.

Background: Choosing between a bioprosthetic and a mechanical mitral valve is an important decision for both patients and surgeons. We compared patient outcomes and readmission rates after bioprosthetic mitral valve replacement (Bio-MVR) vs mechanical mitral valve replacement (Mech-MVR)., Methods: The Nationwide Readmissions Database was queried to identify 31 474 patients who underwent isolated MVR (22 998 Bio-MVR, 8476 Mech-MVR) between January 1, 2016, and December 31, 2018. Propensity score matching by age, sex, elective status, and comorbidities was used to compare outcomes between matched cohorts by prosthesis type. Freedom from readmission within the first calendar year was estimated by Kaplan-Meier analysis and compared between matched cohorts., Results: Bio-MVR patients were older (median age, 69 vs 57 years; P < .001) and had more comorbidities (median Elixhauser score, 14 vs 11; P < .001) compared with Mech-MVR patients. After propensity score matching (n = 15 549), Bio-MVR patients had similar operative mortality (3.5% vs 3.4%; P = .97) and costs ($50 958 vs $49 782; P = .16) but shorter lengths of stay (8 vs 9 days; P < .001) and fewer 30-day (16.0% vs 18.1%; P = .04) and 90-day (23.8% vs 26.8%; P = .01) readmissions compared with Mech-MVR patients. The difference in readmissions persisted at 1 year (P = .045). Readmission for bleeding or coagulopathy complications was less common with Bio-MVR (5.7% vs 10.1%; P < .001)., Conclusions: Readmission was more common after Mech-MVR than after Bio-MVR. Identifying and closely observing patients at high risk for bleeding complications may bridge the readmissions gap between Bio-MVR and Mech-MVR., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Machine learning (ML) algorithms may enhance outcomes prediction and help guide clinical decision making. This study aimed to develop and validate a ML model that predicts postoperative outcomes and costs after cardiac surgery., Methods: The Society of Thoracic Surgeons registry data from 4874 patients who underwent cardiac surgery (56% coronary artery bypass grafting, 42% valve surgery, 19% aortic surgery) at our institution were divided into training (80%) and testing (20%) datasets. The Extreme Gradient Boosting decision-tree ML algorithms were trained to predict three outcomes: operative mortality, major morbidity or mortality, and Medicare outlier high hospitalization cost. Algorithm performance was determined using accuracy, F1 score, and area under the precision-recall curve (AUC-PR). The ML algorithms were validated in index surgery cases with The Society of Thoracic Surgeons risk scores for mortality and major morbidities and with logistic regression and were then applied to nonindex cases., Results: The ML algorithms with 25 input parameters predicted operative mortality (accuracy 95%; F1 0.31; AUC-PR 0.21), major morbidity or mortality (accuracy 71%, F1 0.47; AUC-PR 0.47), and high cost (accuracy 84%; F1 0.62; AUC-PR 0.65). Preoperative creatinine, complete blood count, patient height and weight, ventricular function, and liver dysfunction were important predictors for all outcomes. For patients undergoing nonindex cardiac operations, the ML model achieved an AUC-PR of 0.15 (95% CI, 0.05-0.32) for mortality and 0.59 (95% CI, 0.51-0.68) for major morbidity or mortality., Conclusions: The extreme gradient boosting ML algorithms can predict mortality, major morbidity, and high cost after cardiac surgery, including operations without established risk models. These ML algorithms may refine risk prediction after cardiac surgery for a wide range of procedures., (Copyright © 2023 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients with certain autoimmune conditions are at a reduced risk of developing breast cancer compared to the general population. Despite this, little is known about outcomes in patients with breast cancer who have a concurrent autoimmune diagnosis., Methods: This study compared differences in outcomes between women with breast cancer who had or did not have an autoimmune diagnosis. The SEER-Medicare databases (2007-2014) were used to identify patients with breast cancer and diagnosis codes were used to identify those with an autoimmune disorder., Results: The studied autoimmune diseases had a prevalence of 27% among the 137,324 patients with breast cancer. Autoimmune disease was associated with significantly longer overall survival (OS) and significantly lower cancer-specific mortality (CSM) among stage IV breast cancer patients (p < 0.0001). After controlling for the effects of age, race, chronic kideny disease, chemotherapy, and radiation therapy autoimmune disease was still predictive of improved OS (HR: 1.45, 95% CI: 1.35-1.55, p < 0.0001) and CSM (HR: 1.40, 95% CI: 1.29-1.5, p < 0.0001). By contrast, in patients with stage I-III breast cancer, the presence of an autoimmune diagnosis was associated with a lower OS (p < 0.0001, p < 0.0001, and p = 0.026, respectively), compared to patients without autoimmune disease., Conclusions: We found a higher prevalence of rheumatoid arthritis, Crohn's disease, ulcerative colitis, and systemic lupus erythematosus in patients with breast cancer compared to age matched cohorts in the general population. The presence of an autoimmune diagnosis was associated with a lower OS in stages I-III breast cancer and improved OS and CSM in patients with stage IV disease. These results suggest that anti-tumor immunity plays an important role in late stage breast cancer and could potentially be exploited to improve the effectiveness of immunotherapy., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: The self-expanding, intra-annular Navitor (Abbott Structural Heart) valve includes an outer cuff to reduce paravalvular leak (PVL) and large stent cells for future coronary access., Objectives: The purpose of the PORTICO NG (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis) study is to evaluate the safety and effectiveness of the Navitor valve in patients with symptomatic, severe aortic stenosis who are at high or extreme surgical risk., Methods: PORTICO NG is a prospective, multicenter, global study with follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoints are all-cause mortality and moderate or greater PVL at 30 days. Valve Academic Research Consortium-2 events and valve performance are assessed by an independent clinical events committee and echocardiographic core laboratory., Results: A total of 260 subjects were treated at 26 clinical sites across Europe, Australia, and the United States between September 2019 and August 2022. The mean age was 83.4 ± 5.4 years, 57.3% were female, and the average Society of Thoracic Surgeons score was 3.9% ± 2.1%. At 30 days, the rate of all-cause mortality was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%, life-threatening bleeding was 3.8%, stage 3 acute kidney injury was 0.8%, major vascular complications were 4.2%, and new permanent pacemaker implantation was 19.0%. Hemodynamic performance included a mean gradient of 7.4 ± 3.5 mm Hg and an effective orifice area of 2.00 ± 0.47 cm 2 ., Conclusions: The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery, which is supported by low rates of adverse events and PVL. (Evaluation of the Portico NG [Next Generation] Transcatheter Aortic Valve in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis [PORTICO NG]; NCT04011722)., Competing Interests: Funding Support and Author Disclosures Dr Reardon has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr Chehab has received speaker, consultancy, and proctor fees for Abbott, Edwards Lifesciences, Medtronic, and CSI. Dr Smith has received speaker and proctor fees for Abbott, Edwards Lifesciences, and Biosensors. Dr Walton is a proctor, on medical advisory boards, and has received grant support from Abbott, Medtronic, and Edwards Lifesciences. Dr Worthley has received speaker fees and proctorship from Abbott and HighLife Medical; and has received consultancy fees from Edwards Lifesciences. Dr Manoharan is a proctor for Abbott and Medtronic. Dr Sultan is a consultant for Abbott, Artivion, Medtronic, and Terumo Aortic. Dr Yong is a proctor for Abbott. Dr Harrington reports consultancy for Abbott and Boston Scientific; has received speaker fees for Boston Scientific, Artivion, and Edwards Lifesciences; and has received proctor fees for Edwards Lifesciences. Dr Mahoney has received speaker fees; and is a consultant and proctor for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Kleiman participated as an investigator for Abbott, Boston Scientific, and Edwards Lifesciences. Dr Makkar is a proctor for Edwards Lifescience; a consultant for Cordis and Medtronic; and has received research grants from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Fontana is a consultant, proctor, and speaker for Abbott and Medtronic. Dr DeLago has received speaker fees and is a consultant for Edwards Lifesciences and Boston Scientific; and is a proctor for Abbott, Edwards Lifesciences, and Boston Scientific. Dr Ramana is a consultant for Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Bates is an employee of Abbott. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Delaying chemotherapy remains a vital goal in therapeutic management of HR+/HER2- metastatic breast cancer (MBC). However, recent reports continue to highlight substantially high chemotherapy utilization in earlier therapy lines. In this study, we explored the impact of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy class, introduced in 2015, on early chemotherapy utilization in an older population of patients with HR+/HER2- MBC in the United States (US)., Methods: Using an interrupted time series design, patients with a confirmed diagnosis of MBC aged ≥ 65 years initiating systemic therapy during 2010-2019 were selected from the SEER-Medicare database. The proportion of chemotherapy use was summarized quarterly based on the date of treatment initiation separately in the first, second, and third lines. Segmented regression models adjusted for autocorrelation over time were fitted to estimate trends before and after the availability of CDK4/6 inhibitors in the first quarter of 2015., Results: Of the 3244 eligible women (median age at diagnosis: 74 years), all initiated first-line therapy; 47.9% (n = 1581) initiated second-line therapy, and 50.1% (n = 792) initiated third-line therapy. Overall utilization of chemotherapy (alone or in combination) during the study period was 15.7% for the first line, 19.6% for the second line, and 24.8% for the third line. Chemotherapy utilization in the period immediately after introduction of CDK4/6 inhibitor therapy decline by estimated 2.5% in the first line (P = 0.408), 15.5% in the second line (P = 0.005), and 16.3% in the third line (P = 0.003)., Conclusions: This population-based study illustrates that chemotherapy utilization in earlier therapy lines for HR+/HER2- MBC declined steadily between 2010 and 2019. These declines were significantly accelerated by the introduction of CDK4/6 therapy class in 2015, notably in the second- and third-line settings., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Teen dating violence (TDV) affects millions of youth in the United States and globally each year. A systematic review was conducted to examine the help-seeking intentions and behaviors of youth between the ages of 12 and 19 based on racial and ethnic differences. Considering the high prevalence of TDV among racially and ethnically diverse youth, previous systematic reviews have recommended that future scholarship address help-seeking intentions and behaviors among racially and ethnically diverse youth. The methodologies and results of TDV and help-seeking studies published since 2000 were reviewed and analyzed. A systematic search of peer-reviewed journal articles published in English was conducted using an electronic search. The rigorous search identified 10 studies that addressed help-seeking intentions and behaviors and racial and ethnic differences in youth meeting eligibility requirements. The search yielded few studies, indicating a need to conduct future research in this area. The strength of the studies' methodologies limited generalizability and external validity. The studies primarily addressed differences among African American and Latino youth. Youth relied on informal sources of support, with youth from both groups preferring to seek help from parents and friends. Mistrust, lack of closeness, and feelings of mistrust, shame, and embarrassment informed youths' help-seeking intentions and behaviors. Racially and ethnically specific factors such as negative perceptions of father figures, familism, acculturation, and traditional gender role notions were identified as barriers to help-seeking. As part of appraising and synthesizing the evidence, recommendations for research, practice, and policy are presented.

Background: We recently developed a multi-ancestry polygenic risk score (PRS) that effectively stratifies prostate cancer risk across populations. In this study, we validated the performance of the PRS in the multi-ancestry Million Veteran Program and additional independent studies., Methods: Within each ancestry population, the association of PRS with prostate cancer risk was evaluated separately in each case-control study and then combined in a fixed-effects inverse-variance-weighted meta-analysis. We further assessed the effect modification by age and estimated the age-specific absolute risk of prostate cancer for each ancestry population., Results: The PRS was evaluated in 31,925 cases and 490,507 controls, including men from European (22,049 cases, 414,249 controls), African (8794 cases, 55,657 controls), and Hispanic (1082 cases, 20,601 controls) populations. Comparing men in the top decile (90-100% of the PRS) to the average 40-60% PRS category, the prostate cancer odds ratio (OR) was 3.8-fold in European ancestry men (95% CI = 3.62-3.96), 2.8-fold in African ancestry men (95% CI = 2.59-3.03), and 3.2-fold in Hispanic men (95% CI = 2.64-3.92). The PRS did not discriminate risk of aggressive versus nonaggressive prostate cancer. However, the OR diminished with advancing age (European ancestry men in the top decile: ≤55 years, OR = 7.11; 55-60 years, OR = 4.26; >70 years, OR = 2.79). Men in the top PRS decile reached 5% absolute prostate cancer risk ~10 years younger than men in the 40-60% PRS category., Conclusions: Our findings validate the multi-ancestry PRS as an effective prostate cancer risk stratification tool across populations. A clinical study of PRS is warranted to determine whether the PRS could be used for risk-stratified screening and early detection., Funding: This work was supported by the National Cancer Institute at the National Institutes of Health (grant numbers U19 CA214253 to C.A.H., U01 CA257328 to C.A.H., U19 CA148537 to C.A.H., R01 CA165862 to C.A.H., K99 CA246063 to B.F.D, and T32CA229110 to F.C), the Prostate Cancer Foundation (grants 21YOUN11 to B.F.D. and 20CHAS03 to C.A.H.), the Achievement Rewards for College Scientists Foundation Los Angeles Founder Chapter to B.F.D, and the Million Veteran Program-MVP017. This research has been conducted using the UK Biobank Resource under application number 42195. This research is based on data from the Million Veteran Program, Office of Research and Development, and the Veterans Health Administration. This publication does not represent the views of the Department of Veteran Affairs or the United States Government., Competing Interests: FC, AR, XS, CR, CA, WT, AK, AP, KC, MJ, SG, LN, OO, OP, AA, OA, HA, MJ, OO, MN, BA, SM, AD, JM, AA, HD, JL, TR, SA, JG, AJ, DC, CH No competing interests declared, BD received honorarium for presentations at Society of Urology Oncology Annual Meeting (2021) and the Social Genomics Group at the University of Wisconsin, Madison (2021). The author has no other competing interests to declare, RM has stock or stock options in Navipoint Genomics LLC. The author has no other competing interests to declare

Background: Recruiting and promoting women and racial/ethnic minorities could help enhance diversity and inclusion in the academic cardiothoracic (CT) surgery workforce. However, the demographics of trainees and faculty at US training programs have not yet been studied., Methods: Traditional, integrated (I-6), and fast-track (4+3) programs listed in the Accreditation Council for Graduate Medical Education (ACGME) public database were analyzed. Demographics of trainees and surgeons, including gender, race/ethnicity, subspecialty, and academic appointment (if applicable), were obtained from ACGME Data Resource Books, institutional websites, and public profiles. Chi-square and Cochran-Armitage trend tests were performed., Results: In July 2020, 78 institutions had at least 1 CT surgery training program; 40 (51%) had only a traditional program, 20 (26%) traditional and I-6, 6 (8%) all 3 types of program, and 4 (5%) only I-6. The proportion of female trainees increased significantly from 2011 to 2019 (19% vs 24%, P < .001), with female I-6 trainees outnumbering female traditional trainees since 2018. Significant increases by race/ethnicity were observed overall and by program type, notably for Asian and Hispanic individuals in I-6 programs and Black individuals in traditional programs. Finally, of the 1175 CT surgeons identified, 633 (54%) were adult cardiac surgeons, 360 (37%) assistant professors, 116 (10%) women, and 33 (3%) Black., Conclusions: The demographic landscape of CT surgery trainees and faculty across multiple training pathways reflects increasing representation by gender and race/ethnicity. However, we must continue to work toward equitable representation in the workforce to benefit the diverse patients we treat., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Investigations into readmissions after surgical repair of acute Stanford type A aortic dissection (TAAD) remain scarce. We analyzed potential risk factors for readmission after TAAD., Methods: The 2013 to 2014 US Nationwide Readmissions Database was queried for TAAD index hospitalizations and 90-day readmissions indicated by diagnostic and procedural codes. Multivariable analysis was completed to identify risk factors and the most common reasons for readmission., Results: We identified 6975 patients (65% men; mean age, 60.0 ± 0.4 years) who underwent surgical repair for TAAD. Overall 2062 patients (29.6%) were readmitted within 90 days: 634 (30.7%) during the first 30 days and 1428 (69.3%) during days 31 through 90. Readmitted patients had a higher prevalence of chronic kidney disease at index admission (18.0% vs 11.6%, P = .002), greater overall index length of stay (17.8 ± 0.6 vs 15. 5 ± 0.4 days; P = .0003), and greater index hospitalization cost ($90,637 ± $2691 vs $80,082 ± $2091; P = .0003). Mortality during readmission was 3.6% (n = 74). Indications for readmission were most commonly cardiac (26.2%), infectious (17.8%), and pulmonary (11.7%). Multivariate analysis identified 2 independent risk factors for readmission: acute kidney injury (odds ratio, 1.49; 95% confidence interval, 1.24-1.78; P < .0001) and an Elixhauser comorbidity index > 4 (odds ratio, 1.26; 95% confidence interval, 1.06-1.49; P = .009)., Conclusions: After surgical repair of TAAD, approximately 30% of patients were readmitted within 90 days, two-thirds of them during the 31- to 90-day period. Targeted improvements in perioperative care and postdischarge follow-up of patients with multiple comorbidities could mitigate readmission rates. Efforts to reduce readmissions should be continued throughout the 90-day period., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Inferior vena cava (IVC) thrombosis is an uncommon complication associated with IVC filters (IVCFs), with studies reporting rates ranging from 1% to 31%. Few observational studies have described the risk factors associated with IVCF thrombosis, despite the significant clinical sequelae such as post-thrombotic syndrome, venous claudication, and venous ulceration. To better describe IVCF thrombosis and the risk factors, data were queried from Vascular Quality Initiative (VQI) participating centers., Methods: IVCF data were obtained from the international VQI database from 2013 to 2019. The patients included in the present analysis had 2 years of follow-up data available. The baseline demographics, medical comorbidities, medication, and procedural, anatomic, and postoperative variables were assessed using Kaplan-Meier survival curves with log-rank tests, Student's t tests, or Mann-Whitney U tests for IVCF thrombosis at 2 years. Cox regression analyses were used to identify independent predictors of IVCF thrombosis. A subgroup analysis of those who had presented with venous thromboembolism (VTE) was also performed., Results: A total of 62 U.S. and Canadian VQI-participating centers included 12,874 cases of IVCF placement. Of the 5780 cases with 2 years of follow-up available, 78 (1.3%) had developed IVCF thrombosis. Those who had experienced IVCF thrombosis had had significantly lower rates of diabetes, coronary artery disease, preoperative antiplatelet medications, preoperative statin use, and lower rates of discharge and follow-up antiplatelet medications. On univariable analysis, the cases of IVCF thrombosis also had higher rates of pulmonary embolism and VTE on admission, internal jugular venous access (vs femoral vein access), temporary IVCF use, follow-up anticoagulation, follow-up IVCF complication, follow-up access site thrombosis, and rates of new or propagated deep vein thrombosis at follow-up, and longer postoperative hospital stays. Multivariable analysis demonstrated that the independent predictors of IVCF thrombosis included new or propagated deep vein thrombosis at follow-up (hazard ratio [HR], 16.3; 95% confident interval [CI], 9.8-27.3; P < .001), no antiplatelet therapy at follow-up (HR, 4.8; 95% CI, 1.9-12.5; P = .001), internal jugular venous access (HR, 2.2; 95% CI, 1.4-3.5; P = .001), the presence of VTE on admission (HR, 2.7; 95% CI, 1.4-5.1; P = .002), and temporary IVCF placement (HR, 2.5; 95% CI, 1.1-5.6; P = .031). In an analysis of the subgroup of patients with VTE on admission, similar predictive factors were identified in a multivariable model. Massive pulmonary embolism was also predictive of IVCF thrombosis in this subgroup., Conclusions: The rate of IVCF thrombosis remained low in a contemporary international database. The results from the present study of >5000 patients with IVCFs suggest that antiplatelet therapy should be administered after IVCF placement to decreased the risk of IVCF thrombosis., (Copyright © 2021. Published by Elsevier Inc.)

For individuals experiencing intimate partner violence (IPV), formal services, including community agencies, health services, or the criminal justice system, are critical resources. Understanding the specific barriers that hinder or prevent survivors from seeking help from formal services could reveal important implications for the development of services for IPV as well as for members of other organizations who encounter survivors. The authors conducted a systematic review of the literature to identify barriers to help-seeking from formal services for survivors. Ten electronic databases were searched for key terms related to IPV, help seeking from formal services, and barriers to help seeking. Articles were included in the review if they were U.S.-based, contained samples that were adults who had experienced IPV, and discussed barriers to seeking help from formal services. An initial search yielded 1,155 articles and after screening, 29 articles were included in the review. Data were extracted to reveal the state of the literature regarding help-seeking barriers for survivors. Six barriers to help seeking were identified as follows: (1) lack of awareness, (2) access challenges, (3) consequences of disclosure, (4) lack of material resources, (5) personal barriers, and (6) system failures. These findings demonstrate the need for continued education surrounding available services for IPV as well as the continued development of resources that can mitigate personal barriers that survivors may face. Furthermore, these findings illuminate the necessity to increase the access of services, particularly for non-English speakers, immigrants and refugees, individuals with disabilities, men, and LGBTQIA identified individuals.

Background: Identification of clinical predictors of response to first-line therapies for EoE is needed to guide initial medical management., Study Design: A retrospective analysis of patients diagnosed with EoE from 2011 to 2018 was conducted. Clinical and diagnostic variables including demographics, endoscopic, and esophagram findings were compared between PPI responders and PPI nonresponders. All patients underwent a standard 8-week twice-daily PPI trial, with PPI responsiveness defined as < 15 eos/hpf on repeat EGD. Univariate and multivariable analyses were conducted to identify risk factors for nonresponse, and ROC curves were created to identify cutoff values., Results: A total of 223 EoE patients (135 male, median age 39 (29-51)) were identified, with PPI nonresponse (PPI-NR) in 71% of patients. PPI-NR was seen in all 10 patients with failure of scope passage, with an OR of 9.06 by univariate analysis (P = 0.1485). In a multivariable model, age per 10 years (OR 0.71; P = 0.007), BMI per 1 kg/m 2 (OR 0.94; P = 0.03), and peripheral eosinophil count per 100 per mm 3 (OR 1.37; P = 0.003) were independent risk factors. Dichotomization to maximize sensitivity and specificity identified age ≤ 36 years old, BMI ≤ 25.2 kg/m 2 , and peripheral eos > 460 per mm 3 as predictive thresholds for PPI-NR. The probability of PPI-NR was 72.4-84.5% with 1 risk factor, 87.9-93.8% with 2 risk factors, and 97.2% with all 3 risk factors., Conclusions: Young age, reduced BMI, elevated peripheral eosinophil count, and likely inability to pass an endoscope predict lack of response to PPIs in patients with EoE., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Real-world evidence specific to HR+/HER2- metastatic breast cancer (MBC) prior to introduction of CDK4/6 inhibitors is limited. In an effort to provide context for the introduction of new treatments, we assessed treatment patterns, adverse events, productivity loss, and direct/indirect economic burden in a privately insured population of patients with HR+/HER2- MBC., Research Design and Methods: Using a retrospective cohort design, patients aged 18-64 years, selected from MarketScan databases (2007-2014), were analyzed using descriptive and multivariable methods., Results: Among 5,563 eligible patients, endocrine therapy was the most common first-line (1L) therapy; its utilization trended downward from 63% (1L) to 23% (4L), with a simultaneous increase in chemotherapy use, 25% (1L) to 50% (4L). Two hundred and seventy-eight unique treatment regimens were used in the 1L setting. The average per patient monthly all-cause costs were $14,424. The 12-month indirect costs for short-term disability were substantially higher in MBC patients ($10,397) than in matched noncancer patients ($394)., Conclusion: The increasing use of chemotherapy as patients progressed to second and later lines and the substantial direct/indirect economic burden underscore an unmet need. The high number of 1L regimens highlights significant heterogeneity and a lack of consensus related to the management of HR+/HER2- MBC in routine practice.

Most data on overall survival (OS) and adverse events (AEs) in patients with mantle cell lymphoma (MCL) are from controlled trials; therefore, in this population-based study, we retrospectively assessed treatment patterns, OS, and AEs in MCL patients initiating systemic treatment during 2013-2015 using the United States Medicare claims database. Among 1390 eligible patients (median age = 74 years), chemoimmunotherapy with bendamustine/rituximab (BR) was the preferred choice in first-line (35.3%), followed by ibrutinib (33.5%), rituximab (9.1%), and rituximab/cyclophosphamide/doxorubicin/vincristine (R-CHOP) (6.8%). Twenty-four-month OS was 73% for BR; 47%, ibrutinib; 72%, rituximab; and 71%, R-CHOP. For the four most commonly used regimens, neutropenia, anemia, hypertension, and infection were the most frequent AEs. Patients with ≥3 AEs had nearly four times higher monthly costs than those with 0-2 AEs in the first observed therapy line. Findings demonstrate a substantial increase in the economic burden as the number of AEs increased among the Medicare MCL patients.

Background: Information on overall survival (OS) and adverse events (AEs) in patients with chronic lymphocytic leukemia (CLL) is mostly available from clinical trials. We therefore conducted a population-based retrospective cohort study to assess OS, incidence of AEs, and economic burden in real-world practice among Medicare patients treated for CLL., Methods: Patients with CLL receiving ≥1 systemic therapy from 2013 to 2015 were selected from the Medicare claims database and followed from the start of first observed systemic therapy (index date) through December 2016 or death. OS for patients receiving each of the most commonly observed treatments was estimated by the Kaplan-Meier method. AEs were assessed among patients receiving these treatments across all observed lines of therapy. All-cause direct medical costs were assessed from the Medicare system perspective., Results: Among 7,965 eligible patients across all observed therapy lines, ibrutinib monotherapy (Ibr; n = 2,708), chlorambucil monotherapy (Clb; n = 1,620), and bendamustine/rituximab (BR; n = 1,485) were the most common treatments. For first observed therapy, 24-month OS estimates for Ibr, Clb, and BR recipients were 69% (95% CI = 68%-71%), 68% (95% CI = 65%-71%), and 79% (95% CI = 77%-81%) respectively. The most frequently recorded AEs in patients receiving these treatments in any observed line of therapy were neutropenia, hypertension, anemia, and infection. For all patients, the mean monthly all-cause cost during the follow-up period was $8,974 (SD = $11,562); cost increased by the number of AEs, from $5,144 (SD = $5,409) among those with 1-2 AEs to $10,077 (SD = $12,542) among those with ≥6 AEs., Conclusion: Over two-thirds of patients survived at least 2 years after starting their first observed therapy for CLL. Our findings highlight considerable susceptibility to AEs and unmet medical need in Medicare patients with CLL treated in routine practice. Medicare incurred substantial economic burden following initiation of systemic therapy, and patients with greater numbers of AEs accounted disproportionately for the high overall cost of CLL management., (© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: Readmission after coronary artery bypass grafting (CABG) is used for quality metrics and may negatively affect hospital reimbursement. Our objective was to develop a risk score system from a national cohort that can predict 90-day readmission risk for CABG patients., Methods: Using the National Readmission Database between 2013 and 2014, we identified 104,930 patients discharged after CABG, for a total of 234,483 patients after weighted analysis. Using structured random sampling, patients were divided into a training set (60%) and test data set (40%). In the training data set, we used multivariable analysis to identify risk factors. A point system risk score was developed based on the odds ratios. Variables with odds ratio less than 1.3 were excluded from the final model to reduce noise. Performance was assessed in the test data set using receiver operator characteristics and accuracy., Results: In the United States, overall 90-day readmission rate after CABG was 19% (n = 44,559 of 234,483). Nine demographic and clinical variables were identified as important in the training data set. The final risk score ranged from 0 to 52; the 2 largest risks were associated with length of stay greater than 10 days (score = +10) and Medicaid insurance (score = +7). The final model's C-statistic was 0.67. Using an optimal cutoff of 18 points, the accuracy of the risk score was 77%., Conclusions: Ninety-day readmission after CABG surgery is frequent. A readmission risk score higher than 18 points predicts readmission in 77% of patients. Based on 9 demographic and clinical factors, this risk score can be used to target high-risk patients for additional postdischarge resources to reduce readmission., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)