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The purpose of this paper is to identify the special features of the governance structures of research universities in four western countries: the United States, Germany, the United Kingdom and France. Conceptual framework was laid out as groundwork of the paper. Scholarly work of known authors in higher education governance was reviewed with major features of the governance of the research universities of these countries identified and discussed with reflection of the conceptual framework. It was found in common that major research universities have (1) governance structure with responsibilities of components specifically defined; (2) distinct separation of business affairs and academic work; (3) good collaboration among the entities of their governance structure; and (4) great respect for academic freedom and independence.

Introduction: The Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, but whether adverse event (AE) information collected from these systems adequately captures experiences of the overall United States (US) population is unknown. Objective: To examine determinants of consumer AE reporting in the USA. Methods: Five-year AE reporting rate per 100,000 residents per US county were calculated, mapped, and quartiled for AE reports received directly from consumers between 2011 and 2015. Associations between county-level sociodemographic factors obtained from County Health Rankings and AE reporting rates were evaluated using negative binomial regression. Results: Reporting rates were variable across US counties with > 17.6 reports versus ≤ 5.5 reports/100,000 residents in the highest and lowest reporting quartile, respectively. Controlling for drug utilization, counties with higher reporting rates had higher proportions of individuals age ≥ 65 years (e.g., 2.4% reporting increase per 1% increase in individuals age > 65, incidence rate ratio (IRR): 1.024, 95% confidence interval (CI): 1.017–1.030), higher proportions of females (IRR: 1.027, 95% CI 1.012–1.043), uninsured (IRR: 1.009, 95% CI 1.005–1.013), higher median log household incomes (IRR: 1.897, 95% CI 1.644–2.189) and more mental health providers per 100,000 residents (IRR: 1.003, 95% CI 1.001–1.004). Lower reporting was observed in counties with higher proportions of individuals age ≤ 18 years (IRR: 0.966, 95% CI 0.959–0.974), American Indian or Alaska Native individuals (IRR: 0.991, 95% CI 0.986–0.996), individuals not proficient in English (IRR: 0.978, 95% CI 0.965–0.991), and individuals residing in rural areas within a county (IRR: 0.998, 95% CI 0.997–0.998). Conclusions: Observed variations in consumer AE reporting may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, voluntary AE reporting systems may be suboptimal for capturing emerging drug safety concerns among more vulnerable populations. [ABSTRACT FROM AUTHOR]

The genus Fuscoporia of the Hymenochaetaceae is characterized by resupinate to pileate basidiocarps, a dimitic hyphal system with fine crystal aggregates and encrusted generative hyphae in dissepiment edge and tube trama, the presence of hymenial setae, and hyaline, thin-walled, smooth basidiospores. Members of the F. contigua group are easy to distinguish from other species of Fuscoporia because of the moderately large pores, presence of mycelial setae, and large hymenial setae. Here, we explore phylogenetic relationships among 20 species of Fuscoporia based on examination of some 90 collections sampled worldwide. Seven new species are recognized in the F. contigua group--F. americana, F. centroamericana, F. costaricana, F. latispora, F. monticola, F. septiseta, and F. sinica--described from China, Costa Rica, Mexico, and the United States. Phylogenetic analyses inferred from DNA sequences of the nuc rDNA internal transcribed spacer (ITS1-5.8S-ITS2 = ITS), D1-D2 domains of nuc 28S rDNA (28S), and translation elongation factor EF-1 alpha (tef1) support the F. contigua group as one of two major clades within Fuscoporia comprising nine species worldwide. [ABSTRACT FROM AUTHOR]

Background: The selection of the most appropriate treatment combinations requires the balancing of benefits and harms of these treatment options as well as the patients' preferences for the resulting outcomes.Objective: This research aimed at estimating and comparing the utility weights between elderly women with early stage hormone receptor positive (HR+) breast cancer receiving a combination of radiotherapy and hormonal therapy after breast conserving surgery (BCS) and those receiving a combination of BCS and hormonal therapy.Methods: The Surveillance, Epidemiology, and End Results (SEER) linked with Medicare Health Outcomes Survey (MHOS) was used as the data source. Health utility weights were derived from the VR-12 health-related quality of life instrument using a mapping algorithm. Descriptive statistics of the sample were provided. Two sample t-tests were performed to determine potential differences in mean health utility weights between the two groups after propensity score matching.Results: The average age at diagnosis was 72 vs. 76 years for the treated and the untreated groups, respectively. The results showed an inverse relationship between the receipt of radiotherapy and age. Patients who received radiotherapy had, on average, a higher health utility weight (0.70; SD = 0.123) compared with those who did not receive radiotherapy (0.676; SD = 0.130). Only treated patients who had more than two comorbid conditions had significantly higher health utility weights compared with patients who were not treated.Conclusions: The mean health utility weights estimated for the radiotherapy and no radiotherapy groups can be used to inform a comparative cost-effectiveness analysis of the treatment options. However, the results of this study may not be generalizable to those who are outside a managed care plan because MHOS data is collected on managed care beneficiaries. [ABSTRACT FROM AUTHOR]

Comparative effectiveness research (CER) has received growing attention in the USA, and elsewhere, in recent years. CER aims to produce the best evidence to empower clinicians and other health-care providers to make rational decisions regarding what treatment is most effective at the individual and population level. However, unlike many other countries, the evidence generated by CER in the USA has traditionally been limited to the effectiveness, benefits and harms of health-care interventions, with cost being omitted from the analysis. The inclusion of economic evaluation as part of CER remains a debate. Based on other countries' experience, the inclusion of economic evaluation into CER would allow decision makers to make trade-off assessments between the benefits and opportunity costs associated with all the possible treatment options before making a decision. However, bridging economic evaluation and CER is not without pitfalls. This paper discusses the role of economic evaluation in improving health-care decision making in the USA through CER and proposes the establishment of an independent institution in each US state to generate the necessary data and make drug coverage recommendations. [ABSTRACT FROM AUTHOR]

A number of factors influence the disclosure of child sexual abuse by survivors. While the influence of race and ethnicity on disclosure patterns is getting more attention, little has been written on abused children of Pacific Islanders, due in part to both lack of relevant data and a relatively small Pacific Islander population in the United States. Drawing on interviews with Pacific Islander women who were sexually abused in childhood and who delayed revealing their victimization, we explore the reasons for delayed disclosure. Findings suggest that cultural norms and family dynamics affect disclosure decisions. Concerns for the family and self-blame were the most common reasons for delay and lack of disclosure. We discuss implications of the findings and make policy recommendations. [ABSTRACT FROM PUBLISHER]

Crown, root, and fruit rot caused by Phytophthora capsici is an increasing problem for vegetable growers in Michigan and the United States. The newly registered fungicide fluopicolide is effective to limit crop loss but the potential for P. capsici to develop resistance is not well known. A laboratory study assessed the risk of P. capsici developing resistance to fluopicolide. Baseline sensitivity to fluopicolide was determined using 126 P. capsici Michigan isolates. Values of effective concentrations for 50% inhibition of mycelial growth ranged from 0.08 to 0.24 μg/ml and were distributed as a unimodal curve, indicating that all isolates were sensitive to fluopicolide. Mutants resistant to fluopicolide were obtained from five isolates by screening zoospores on fluopicolide-amended (5 μg/ml) media at a mutation frequency above 1.0 × 10-7. The mutant isolates were clustered with either intermediate (resistance factor [RF] = 3.53 to 77.91) or high (RF = 2481.40 to 7034.79) resistance. Resistance was stable through 10 mycelial transfers on fungicide-free medium. All resistant mutants showed similar fitness in zoospore production, cyst germination, and virulence compared with their sensitive parents, with few exceptions. No cross-resistance was detected between fluopicolide and five other fungicides. There could be a moderately high risk of field populations of P. capsici developing resistance to fluopicolide, and populations should be monitored. [ABSTRACT FROM AUTHOR]

BACKGROUND: Hyperphosphatemia is very common in patients with end-stage renal disease (ESRD). Recently, a new phosphate binder, sevelamer, has become available in the US to treat this condition. The high cost of sevelamer has significantly impacted on third-party payors such as Florida Medicaid. Calcium acetate is a less expensive drug alternative; however, unlike sevelamer, it is associated with the adverse effect of hypercalcemia. There have been few cost analyses performed on either drug. Moreover, few studies have assessed the economic impact of ESRD with hyperphosphatemia. OBJECTIVES: The aims of this study were to: (i) describe the characteristics of ESRD patients with hyperphosphatemia in terms of demographics, comorbidities, and healthcare utilization; (ii) evaluate the primary cost drivers in the treatment of these patients; and (iii) assess the cost of illness associated with treating ESRD patients with hyperphosphatemia. METHODS: This retrospective study extracted data from the Florida Medicaid database. Healthcare costs were assessed from a third-party payor perspective. The patient inclusion criteria were current use of either sevelamer or calcium acetate and continuous eligibility to receive Florida Medicaid services from July 1, 1999 to December 31, 2002 with a run-in period from July 1, 1999 to December 31, 1999 to ensure that patients had been taking either of the two drugs for at least 6 months. The patient exclusion criteria were documented HIV and hemophilia. The specific direct costs included in the study were hospitalization costs, outpatient costs, emergency room costs, and prescription costs (only those for sevelamer and calcium acetate). The price year for the cost analysis was 2002. RESULTS: A total of 10 058 recipients constituted the study sample, of which 54.0% were male and 46.0% were female. African Americans represented the largest racial group (45.6%), followed by Caucasians (28.6%). The most frequent comorbidities were hypertension, anemia, and congestive heart failure. Healthcare was most often utilized through facility visits (78.1%), followed by pharmacy-related services (17.2%) and then medical services (4.7%). Based on medical claims, the ambulance service contributed the most to healthcare utilization (8.7%), followed by recipient home visits (3.3%) and inpatient visits (2.1%). Facility claims utilization was dominated by dialysis center visits (48.5%), followed by general hospital visits (43.3%) and nursing home visits (7.4%). The major cost driver for 2000–2 was dialysis center visits ($US95 million), followed by general hospital visits ($US92 million), and prescription medication ($US11 million). The cost analysis revealed that ESRD patients with hyperphosphatemia within Florida Medicaid imposed an economic burden (including facility, medical, and prescription claims) of $US228 million for the years 2000–2. CONCLUSIONS: This is the first study to report the economic impact of ESRD with hyperphosphatemia. Given the high economic burden of this population, efforts should be undertaken to enhance preventative measures for hyperphosphatemia as well as the treatment and recovery of these patients. [ABSTRACT FROM AUTHOR]

LGBTQ+ populations have been reported to have higher rates of depression compared with their heterosexual peers. Such data provided us the impetus to conduct a meta-analysis on the worldwide prevalence of major depressive disorder (MDD) in LGBTQ+ populations and moderating factors that contributed to differences in prevalence estimates between studies. A systematic literature search was performed in major international (PubMed, PsycINFO, Web of Science, EMBASE) and Chinese (Chinese Nation Knowledge Infrastructure (CNKI) and WANFANG) databases from dates of inception to 10 December 2021. 48 articles comprising 4,616,903 individuals were included in the meta-analysis. The overall prevalence of MDD was 32.2 % (95%CI: 30.8–33.6 %, I2 = 99.6 %, τ2 = 0.284). MDD prevalence was higher in the LGBTQ+ samples from the United States than other countries, though the difference was not significant in moderator analyses. Moderator analyses indicated point and lifetime prevalence of MDD were significantly higher than estimates based on the past year (Q = 6.270, p = 0.043). Furthermore, studies that relied on convenience sampling had a higher prevalence of MDD than those based on other sampling methods (Q = 8.159, p = 0.017). In meta-regression analyses, mean age (B = 0.03, z = 9.54, p < 0.001) and study quality assessment score (B = 0.24, z = 67.64, p < 0.001) were positively associated with pooled prevalence of MDD while mediation data of year of study (B = -0.08, z = −72.55, p < 0.001) and sample size (B = -1.46, z = −37.83, p < 0.001) were negatively associated with pooled prevalence of MDD in LGBTQ+ samples. MDD is common among in LGBTQ+ individuals. Considering the negative consequences MDD has on daily life and well-being, appropriate prevention and treatment measures should be provided to vulnerable members of these populations. The findings of this meta-analysis could facilitate identifying at-risk subgroups, developing relevant health policy for LGBTQ+ individuals and allocating health resources from an intersectionality perspective. • This meta-analysis examined the prevalence major depressive disorder (MDD) in LGBTQ+ populations and moderators. • In total, 48 articles comprising 4,618,787 individuals were included, and the overall prevalence of MDD was 32.2%. • The findings of this meta-analysis could facilitate identifying at-risk subgroups, developing relevant health policy for LGBTQ+ individuals. [ABSTRACT FROM AUTHOR]

Background and Aims: Acute liver failure is a multisystem disorder with a high mortality and frequent need for emergency liver transplantation. Following massive innate immune system activation, soluble markers of macrophage activation are released during liver damage and their association with disease severity and prognosis requires exploration., Methods: Patients ALF from the United States Acute Liver Failure Study Group (USALFSG, n = 224) and King's College Hospital (n = 40) together with healthy controls (HC, n = 50) were recruited. Serum from early (Days 1-3) and late (>Day 3) time points were analysed for MAMs by enzyme-linked immunosorbent assay correlated to markers of illness severity and 21-day spontaneous survival. Surface expression phenotyping was performed via Flow Cytometry on CD14 + monocytes., Results: All MAMs serum concentrations were significantly higher in ALF compared to controls (p < .0001). sCD206 concentration was higher in early and late stages of the disease in patients with bacteraemia (p = .002) and infection in general (p = .006). In MELD-adjusted multivariate modelling, sCD206 and sCD163 were independently associated with mortality. CD14 + monocyte expression of CD206 (p < .001) was higher in patients with ALF compared with controls and correlated with SOFA score (p = .018). sCD206 was independently validated as a predictor of infection in an external cohort., Conclusions: sCD206 is increased in serum of ALF patients with infections and poor outcome and is upregulated on CD14 + monocytes. Later measurements of sCD163 and sCD206 during the evolution of ALF have potential as mechanistic predictors of mortality. sCD206 should be explored as a biomarker of sepsis and mortality in ALF., (© 2024 The Authors. Liver International published by John Wiley & Sons Ltd.)

Purpose: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations., Methods: Trial eligibility criteria were abstracted from ClinicalTrials.gov for phase I-III US-based interventional clinical trials for patients with advanced breast, colorectal, lung, or melanoma cancers from January 2012 to December 2022. Trials were examined to determine whether patients with brain metastases were not excluded, conditionally excluded (ie, excluded in some circumstances), or wholly excluded. An interrupted time series analysis with multinomial logistic regression was used to determine whether the ASCO/FoCR/FDA recommendations were associated with changes in brain metastases criteria., Results: We evaluated N = 3,077 trials. Patients with brain metastases were not excluded in 506 trials (16.4%), conditionally excluded in 2,263 trials (73.5%), and wholly excluded in 308 trials (10.0%). In the postrecommendation period, we estimated a 68% increase in the odds of brain metastases not excluded compared with conditionally excluded (odds ratio, 1.68 [95% CI, 1.06 to 2.66], P = .03). The proportion of trials in which patients with brain metastases were not excluded increased (from 11.5% v 17.3%) and conditionally excluded decreased (from 82.3% to 75.2%, P = .03). We found no difference in the proportion of trials in which patients with brain metastases were wholly excluded (7.5% v 6.2%, P = .42)., Conclusion: The ASCO/FoCR/FDA task force recommendations were associated with a shift in patterns of brain metastases exclusion criteria from conditionally excluded to not excluded. These findings demonstrate that the cancer clinical trial community has begun to change the way trials are written to be more inclusive.

In 2019, the US Department of Health and Human Services launched the Ending the HIV Epidemic in the US initiative (EHE) with the goal of reducing new HIV infections by 90% by 2030. This initiative identifies 4 pillars (diagnose, treat, prevent, and respond) to address the HIV epidemic in the United States. To advance the EHE goals, the Federal Bureau of Prisons (FBOP) has implemented interventions at all points of the HIV care continuum. The FBOP has addressed the EHE pillar of prevention through implementing preexposure prophylaxis, developing a strategy to decrease the risk of new HIV infection, and providing guidance to FBOP healthcare providers. This article describes the implementation of programs to improve the HIV care continuum and end the epidemic of HIV within the FBOP including a review of methodology to implement an HIV preexposure prophylaxis program.

Importance: The Patient Protection and Affordable Care Act (ACA) Medicaid expansion resulted in increased use of Medicaid insurance nationwide. However, the association between Medicaid expansion and access to clinical trials has not been examined to date., Objective: To examine whether the implementation of ACA Medicaid expansion was associated with increased participation of patients with Medicaid insurance in cancer clinical trials., Design, Setting, and Participants: Data for this cohort study of 51 751 patients were from the SWOG Cancer Research Network. All patients aged 18 to 64 years and enrolled in treatment trials with Medicaid or private insurance between April 1, 1992, and February 29, 2020, were included. Interrupted time-series analysis with segmented logistic regression was used. The monthly unemployment rate and presidential administration were adjusted to reflect potential differences in Medicaid use associated with economic conditions and national administrative policies, respectively. Data analysis was conducted between June 22, 2021, and August 5, 2022., Exposure: Implementation of Medicaid expansion on January 1, 2014, was the independent exposure variable., Main Outcomes and Measures: The number and proportion of patients by insurance type enrolled in cancer clinical trials over time were analyzed., Results: Overall, data for 51 751 patients were analyzed. Mean (SD) age was 50.6 (9.8) years, 67.3% of patients were female, 41.1% were younger than 50 years, and 9.1% used Medicaid. A 19% annual increase (odds ratio [OR], 1.19; 95% CI, 1.11-1.28; P < .001) was identified in the odds of patients using Medicaid after the ACA Medicaid expansion, resulting in a 52% increase (OR, 1.52; 95% CI, 1.29-1.78; P < .001) compared with what was expected in the number of Medicaid patients enrolled over time. The association was greater in states that adopted Medicaid expansion in 2014 to 2015 (OR, 1.26; 95% CI, 1.15-1.38; P < .001) compared with other states (OR, 1.08; 95% CI, 0.96-1.21; P = .20; P = .04 for interaction). By February 2020, the proportion of patients with Medicaid insurance was 17.8% (95% CI, 15.0%-20.8%; P < .001), whereas the expected proportion had ACA Medicaid expansion not occurred was 6.9% (95% CI, 4.4%-10.3%; P < .001)., Conclusions and Relevance: Findings suggest that implementation of ACA Medicaid expansion was associated with increased participation of patients using Medicaid in cancer clinical trials. Improved participation in clinical trials for Medicaid-insured patients is critical for socioeconomically vulnerable patients seeking access to the newest treatments available in trials and for improving confidence that trial findings apply to patients of all backgrounds.

Background: Previous studies addressing the impact of environmental factors on TB prognosis are scarce, with only some studies examining the effect of particulate pollutants on TB mortality. Moreover, few studies have evaluated the effects of multiple gaseous pollutants and greenness exposures on newly treated TB patients on a large population scale., Methods: Through the Centers for Disease Control and Prevention, data were collected from January 1, 2015 to December 31, 2020 for newly treated TB patients in Anhui Province, China. Data on gaseous pollutants sulfur dioxide, nitrogen dioxide, carbon monoxide, and ozone were collected through the National Earth System Science Data Center of China. Normalized vegetation index data were obtained through NASA. The Cox proportional risk model was also applied to calculate the hazard ratios of SO 2 , NO 2 , CO, O 3 , and NDVI with 95% confidence intervals for mortality among newly treated TB patients., Results: Multifactorial Cox regression analysis showed that for every 0.10 μg/m 3 increase in SO 2 , the risk of death among newly treated TB patients increased by 13.2% (HR = 1.132, 95% CI: 1.045-1.1.225), for every 10 μg/m 3 increase in NO 2 , the risk of death among newly treated TB patients increased by 11.4%, and for each 0.1 mg/m 3 increase in CO, the risk of death among newly treated TB patients increased by 5.8%. For each 0.1 increase in NDVI 250m-buffer and 500m-buffer, the risk of death among newly treated TB patients decreased by 8.5% and 6.4%, respectively. The effect of gaseous pollutants on mortality decreased progressively with elevated greenness exposure when greenness exposure was grouped from low to high., Conclusion: Gaseous pollutants are a risk factor during the treatment of newly treated TB patients and greenness exposure is a protective factor. Higher greenness exposure reduces the risk of death due to exposure to gaseous pollutants., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

FDA's experience to date has shown that completion of stability data requirements is one of the most observed challenges for applicants of New Drug Applications (NDAs) with an expedited review designation. Since NDAs submitted under these expedited pathways often have limited available real-time stability data from the primary batches, Modeling Approaches to Reimagine Stability (MARS) have been proposed to support establishment of tentative retest periods of the drug substance and/or expiration dating period (shelf-life) of the drug product. MARS incorporate statistical principles and available tools as a part of the predictive models. In this study, a data mining exercise has been conducted with regulatory submissions of Investigational New Drug (IND) Applications, NDAs, and Abbreviated New Drug Applications (ANDAs) containing MARS data. The case studies presented herein demonstrate how MARS data has been applied to regulatory scenarios involving prediction of retest and/or shelf-life, bridging major development changes, and confirming that no degradation has been observed or predicted. Using the assumption of a linear time trend for those cases that do not display sufficient degradation to conduct MARS for projection of an expiration date, an analysis of covariance (ANCOVA) model is developed and described herein to test the hypothesis of zero slope by a p-value method. Our results show that the application of MARS adequately supported establishment of a tentative commercially viable retest date/shelf-life, thus enabling earlier access to critical drugs for patients with unmet medical needs., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Importance: Since the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials., Objective: To investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US., Data Sources: Identified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022., Study Selection: Included studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included., Data Extraction and Synthesis: Data on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19., Main Outcomes and Measures: Sex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19., Results: Overall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P < .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P < .001)., Conclusions and Relevance: In this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found. Strategies to better ensure diverse representation in COVID-19 studies are needed, especially for prevention trials.

Objective: The aim was to examine the real-world cost-effectiveness of breast-conserving surgery (BCS) plus hormonal therapy with radiotherapy, compared to hormonal therapy alone among women 66 and older with hormone receptor positive early-stage breast cancer in the United States (US)., Methods: This study was conducted from a U.S. Centers for Medicare and Medicaid Services perspective and an eight-year time horizon. Both costs (2020 US$) and health utilities (quality-adjusted life years, QALYs) were obtained from retrospective studies using the SEER linked with Medicare and Medicare Health Outcomes Survey, respectively. The incremental cost-effectiveness ratio (ICER) of the addition of radiotherapy to hormonal therapy versus hormonal therapy alone after BCS was estimated by an unbiased doubly robust estimator. Sensitivity analyses were conducted through bootstrapping to estimate credible intervals., Results: The addition of radiotherapy to hormonal therapy after BCS yielded the highest clinical benefits (2.66 QALYs) and costs ($19,424.27) compared to its hormonal therapy alone after BCS (0.77 QALYS; $2,028.58). The ICER was estimated to be $9,174.94/QALY. Sensitivity analyses did not change the direction of the findings., Conclusions: The results implicated that the combination of radiotherapy and hormonal therapy is cost-effective in the US.

Background: Hepatic encephalopathy (HE) is a complex and reversible neuropsychiatric syndrome that is associated with growing, substantial healthcare resource utilization. We aim to examine the predictors of 30-day readmission and hospitalization cost associated with HE., Research Design and Methods: We conducted a cross-sectional study using the Nationwide Readmissions Database from 2010 to 2014. We assessed the readmission rates using multivariate logistic regression and established temporal trends of readmission rates and hospitalization cost. Weighted hierarchical logistic regression and generalized linear mixed models were used to identify predictors for nationally representative readmissions and hospitalization costs, respectively., Results: The number of index hospitalizations with HE increased with a significant trend from 34,967 in 2010 to 44,791 in 2014. 16.8% of patients were readmitted within 30 days. Predictors increasing readmission risk included female sex, Elixhauser readmission score < 25, elective admission, patient's state residential status, privately insured, number of diagnoses >13, and length of stay >4 days., Conclusions: Our results indicate there is a need to implement better management strategies to improve outcomes in patients hospitalized with HE to curb the increase in the economic burden associated with the disease.

Background: Pregnant women are a vulnerable population exposed to opioids in the United States., Objective: To examine trends and factors associated with opioid prescribing to women proximal to pregnancy., Methods: The 2011 to 2015 Medical Expenditure Panel Survey (MEPS) was used to identify participants (n = 3020) with self-reported pregnancy or pregnancy-relevant events aged between 18 and 44 years old. To investigate factors associated with opioid prescriptions, we categorized participants into two subgroups: having one or more opioid prescription or having none during the observational period. We used survey multivariable logistic regression to identify factors associated with opioid prescribing accounting for the complex survey design in MEPS., Results: From 2011 to 2015, the prevalence of opioid prescribing among study participants was 31%. Opioids were more likely to be prescribed to women who had psychiatric conditions (odds ratio, 1,76, 95%CI: 1.27-2.44, p < 0.001). Other significant factors included being non-Hispanic white or black, living in the South, active tobacco users, and those with lower Physical Component Summary Scores., Conclusion: Receipt of an opioid prescription in the perinatal period is associated with maternal psychiatric disorders in the United States. Study findings add new data to the literature on opioid use among pregnant women and provide evidence for healthcare providers and policy makers to tailor treatment and educational programs to avoid opioid overuse among pregnant women., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Early age at menarche has been linked to many adverse health outcomes among women, including substance use. However, little is known on the association between age at menarche and nonmedical use of marijuana, and no study has assessed the potential racial/ethnic differences. In this study, the 2005-2016 National Health and Nutrition Examination Survey data were used to investigate the association between age at menarche and the risk of lifetime nonmedical use of marijuana. Logistic regression models were used to examine such association adjusting for sociodemographic factors. Interactions between age at menarche and race/ethnicity were also assessed. Among the 10,302 women included, 53.9% had lifetime nonmedical use of marijuana. The regression model shows that women with early menarche had 1.26 (95% CI 1.09, 1.45) times the odds of having lifetime nonmedical use of marijuana compared with women with normal age at menarche. When assessing the association by race/ethnicity, marginally positive associations were observed for both the early and late menarche groups among non-Hispanic White women. However, among women with race/ethnicity other than non-Hispanic White, early menarche is significantly associated with increased risks of lifetime nonmedical marijuana use, while late menarche is significantly associated with decreased risks. This study suggests that early menarche may be a risk factor of lifetime nonmedical use of marijuana, and racial/ethnic differences may exist in the association. Future studies are warranted to examine and confirm these findings.

On April 17, 2020, the FDA approved tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This was the first new molecular entity evaluated under Project Orbis, an FDA Oncology Center of Excellence initiative, which supports concurrent review of oncology drugs by multiple global health authorities. Approval was based on the HER2CLIMB trial, which randomized patients to receive tucatinib or placebo with trastuzumab and capecitabine. Tucatinib demonstrated efficacy compared with placebo in progression-free survival [PFS; HR: 0.54; 95% confidence interval (CI): 0.42-0.71; P < 0.00001] and overall survival (OS; HR: 0.66; 95% CI, 0.50-0.87; P = 0.00480). Patients with either treated and stable or active brain metastases made up 48% of the study population. PFS in patients with brain metastases confirmed benefit (HR: 0.48; 95% CI, 0.34-0.69; P < 0.00001). The benefit in patients with brain metastases allowed for inclusion of this specific population in the indication. Important safety signals included diarrhea and hepatotoxicity which are listed under Warnings and Precautions. This article summarizes the FDA thought process and data supporting the favorable benefit-risk profile and approval of tucatinib., (©2020 American Association for Cancer Research.)

Background: Hepatitis C virus (HCV) infection is associated with with an increased risk of non-hepatic cancers, but the impact of HCV treatment on non-hepatic cancer is unclear., Aims: To assess if HCV treatment reduced the incidence of non-hepatic cancers among patients with chronic HCV infection in the US., Methods: We conducted a retrospective cohort study in MarketScan Databases from January 2005 to December 2016. Multivariable, time-varying Cox proportional-hazards models were used to determine hazard ratios (HRs) of incident non-hepatic cancers in treated and untreated patients with HCV infection. We conduscted subgroup analyses for sex, age, and presence of cirrhosis or diabetes., Results: Among 62 078 patients with newly diagnosed HCV infection, 17 302 (28%) initiated HCV treatment, among whom 15 322 completed 8-16 weeks treatment (minimally effective treatment). Patients who initiated HCV treatment had an 11% decreased risk of developing an incident non-hepatic cancer compared to untreated patients (HR = 0.89, 95% confidence interval (Cl) = 0.82-0.96). The reduction was slightly higher when patients completed a minimally effective treatment (HR = 0.87; 95% Cl = 0.80 - 0.95). This was observed in most subgroup analyses for those who had a minimally effective treatment including patients with cirrhosis. When we stratified cancer or therapy subtypes, the association remained consistent for pancreatic and lung cancers, and dual HCV therapy., Conclusions: HCV treatment led to a significantly reduced incidence of non-hepatic cancers among patients with HCV infection. Despite discrepancies between cancer or HCV therapy subtypes, our findings suggest that treating HCV infection can decrease the extrahepatic cancer burden associated with chronic HCV infection., (© 2020 John Wiley & Sons Ltd.)

Introduction: The rapidly expanding size of the Food and Drug Administration's (FDA) Adverse Event Reporting System database requires modernized pharmacovigilance practices. Techniques to systematically identify high utility individual case safety reports (ICSRs) will support safety signal management., Objectives: The aim of this study was to develop and validate a model predictive of an ICSR's pharmacovigilance utility (PVU)., Methods: PVU was operationalized as an ICSR's inclusion in an FDA-authored pharmacovigilance review's case series supporting a recommendation to modify product labeling. Multivariable logistic regression models were used to examine the association between PVU and ICSR features. The best performing model was selected for bootstrapping validation. As a sensitivity analysis, we evaluated the model's performance across subgroups of safety issues., Results: We identified 10,381 ICSRs evaluated in 69 pharmacovigilance reviews, of which 2115 ICSRs were included in a case series. The strongest predictors of ICSR inclusion were reporting of a designated medical event (odds ratio (OR) 1.93, 95% CI 1.54-2.43) and positive dechallenge (OR 1.67, 95% CI 1.50-1.87). The strongest predictors of ICSR exclusion were death reported as the only outcome (OR 2.72, 95% CI 1.76-4.35), more than three suspect products (OR 2.69, 95% CI 2.23-3.24), and > 15 preferred terms reported (OR 2.69, 95% CI 1.90-3.82). The validated model showed modest discriminative ability (C-statistic of 0.71). Our sensitivity analysis demonstrated heterogeneity in model performance by safety issue (C-statistic range 0.58-0.74)., Conclusions: Our model demonstrated the feasibility of developing a tool predictive of ICSR utility. The model's modest discriminative ability highlights opportunities for further enhancement and suggests algorithms tailored to safety issues may be beneficial.

Backgroud: Breast cancer is a rampant disease and is highly prevalent among women in the United States. Two out of three breast cancers are hormone receptor positive and hormonal therapies (Tamoxifen and Aromatase Inhibitors) are used to treat this type of breast cancer. However, adherence to these efficacious therapies is relatively low., Purpose: The aim of this study was to identify factors that are associated with adherence to hormonal therapy among breast cancer patients, and the extent to which they influence adherence, by looking at data from a nationally representative database., Methods: A retrospective cross-sectional study was conducted using Medical Expenditure Panel Survey (MEPS) for 2011-2015. Individuals ≥18 years diagnosed with breast cancer utilizing Tamoxifen and Aromatase inhibitors were identified. The Proportion of Days Covered (PDC) adherence measure was used to classify individuals as adherent (PDC≥80%) or non-adherent (PDC<80%). Multivariable logistic regression was used to determine factors associated with adherence to hormonal therapy., Results: Out of the 354 breast cancer respondents utilizing hormonal therapy, 194 (54.8%) were adherent and 160 (45.20%) were non-adherent. From 2011 through 2015, an increase in the usage of hormonal therapy was observed. Individuals having at least a high school diploma or General Equivalency Diploma (GED) had 2.795 (1.081, 6.941) times the odds of being adherent when compared to those who did not have a high school diploma or GED. Race, insurance status, marital status, poverty level, class of drug (aromatase inhibitor/tamoxifen), age, comorbidities, out-of-pocket costs and region were not significantly associated with adherence to hormonal therapy among breast cancer patients., Conclusions: This study found an association between an individual's level of education and adherence to hormonal therapy among breast cancer patients. These results can be used to help optimize allocation of resources to promote knowledge designed to increase the adherence of breast cancer patients to hormonal therapy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Study Objective: Consumers and healthcare professionals can voluntarily report adverse experiences associated with drug products to the United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Consumers and healthcare professionals used the same general voluntary reporting form (GVR) until mid-2013, when a consumer voluntary reporting form (ConVR), written in plain language, was implemented. The objective of this study was to examine the effect of the ConVR on the quality and quantity of consumer reports submitted directly to FAERS., Design: Descriptive; quasi-experimental., Data Source: FAERS database., Measurements and Main Results: We identified all consumer and healthcare professional reports received directly by the FDA from January 1, 2011, through December 31, 2015. Report quality was defined by the completeness of 15 individual data fields and a structured tool measuring clinical documentation. An interrupted time series design was used to evaluate the impact on the quantity of consumer reports. Consumer reports submitted on the ConVR generally included more patient, product, and event data in the structured data fields than those submitted on the GVR. Fields with the greatest absolute percentage difference after the ConVR was introduced included race/ethnicity (+77.2%), product start and stop dates (+43% and +40.3%, respectively), dechallenge and rechallenge information (+19.1% and +29.4%, respectively), and medical history (+27%). Our structured assessment also classified more reports received on the ConVR as well documented relative to the GVR consumer reports (64.9% vs 37.8%, p<0.01). The time series model demonstrated an immediate increase of 499 consumer reports in the month following the ConVR's implementation (p<0.01)., Conclusion: Our findings suggest that the ConVR has contributed positively to both the quality and quantity of consumer reports in FAERS., (© 2019 Pharmacotherapy Publications, Inc.)

Aim: To examine disparities in opioid prescription between different races of prostate cancer patients. Materials & methods: We used the Medical Expenditure Panel Survey data (2013-2015) and developed a model based on covariates that may affect opioid prescription and based on this model, we carried out logistic regression, where our outcome of interest was prescription of at least one opioid among prostate cancer patients. Results: Compared with non-Hispanic whites, Hispanics had 0.490 (0.214-1.123), non-Hispanics blacks had 0.745 (0.429-1.293) and other ethnic groups had 2.550 (0.947-6.863) times the odds of receiving opioids than non-Hispanic whites. These differences were not statistically significant. Conclusion: There were no differences between races in terms of opioid prescription for patients with prostate cancer.

Our recent study revealed recurrent chromosomal losses and somatic mutations of genes in the Hippo pathway in mucinous tubular and spindle cell carcinoma (MTSCC). Here, we performed an integrative analysis of 907 renal cell carcinoma (RCC) samples (combined from The Cancer Genome Atlas and in-house studies) and the Knepper data set of microdissected rat nephrons. We identified VSTM2A and IRX5 as novel cancer-specific and lineage-specific biomarkers in MTSCC. We then assessed their expression by RNA in situ hybridization (ISH) in 113 tumors, including 33 MTSCC, 40 type 1 papillary RCC, 8 type 2 papillary RCC, 2 unclassified RCC, 15 clear cell RCC, and 15 chromophobe RCC. Sensitivity and specificity were calculated as the area under the receiver operating characteristics curve (AUC). All MTSCC tumors demonstrated moderate to high expression of VSTM2A (mean ISH score=255). VSTM2A gene expression assessed by RNA sequencing strongly correlated with VSTM2A ISH score (r(2)=0.81, P=0.00016). The majority of non-MTSCC tumors demonstrated negative or low expression of VSTM2A. IRX5, nominated as a lineage-specific biomarker, showed moderate to high expression in MTSCC tumors (mean ISH score=140). IRX5 gene expression assessed by RNA sequencing strongly correlated with IRX5 ISH score (r(2)=0.69, P=0.00291). VSTM2A (AUC: 99.2%) demonstrated better diagnostic efficacy than IRX5 (AUC: 87.5%), and may thus serve as a potential diagnostic marker to distinguish tumors with overlapping histology. Furthermore, our results suggest MTSCC displays an overlapping phenotypic expression pattern with the loop of Henle region of normal nephrons.

Variation in the use of inferior vena cava filters (IVCFs) across hospitals has been observed, suggesting differences in quality of care. Hospitalization metrics associated with venous thromboembolism (VTE) patients have not been compared based on IVCF utilization rates using a national sample. We conducted a descriptive retrospective study using the Nationwide Readmissions Database (NRD) to delineate the variability of hospitalization metrics across the hospital quartiles of IVCF utilization for VTE patients. The NRD included all-payer administrative inpatient records drawn from 22 states. Adult (≥ 18 years) patients with VTE hospitalizations with or without IVCF were identified from January 1, 2013 through December 31, 2014 and hospitals were divided into quartiles based on the IVCF utilization rate as a proportion of VTE patients. Primary outcome measures were observed rates of in-hospital mortality, 30-day all-cause readmissions and VTE-related readmissions, cost, and length of stay. Patient case-mix characteristics and hospital-level factors by hospital quartiles of IVCF utilization rates, were compared. Overall, 12.29% of VTE patients had IVCF placement, with IVCF utilization ranging from 0% to 46.84%. The highest quartile had fewer pulmonary embolism patients relative to deep vein thrombosis patients, and older patient ages were present in higher quartiles. The highest quartile of hospitals placing IVCFs were more often private, for-profit, and non-teaching. Patient and hospital characteristics and hospitalization metrics varied by IVCF utilization rates, but hospitalization outcomes for non-IVCF patients varied most between quartiles. Future work investigating the implications of IVCF utilization rates as a measure of quality of care for VTE patients is needed.

Palliative care focuses on improving the quality of life for patients and families facing life-threatening illness. Since its introduction in China,palliative care has developed rapidly with greater numbers of elderly adults and increasing chronic disease. However,palliative care education lags behind somehow,especially for undergraduate medical students. This article summarizes the history and status quo of palliative care education for undergraduate medical students in countries and regions including the United Kindom,the United States,Japan,and Taiwan Province,with an attempt to further promote the palliative care education for medical students in mainland China.

Purpose: Chronic obstructive pulmonary disease (COPD) is a leading and costly cause of readmissions to the hospital, with one of the highest rates reported in Florida. From 2009 to 2014, strategies such as readmission reduction programs, as well as updated guidelines for COPD management, were instituted to reduce readmission rates for patients with COPD. Thus, the question has been raised whether COPD-related 30-day hospital readmission rates in Florida have decreased and whether COPD-related readmission costs during this period have changed. In addition, we examined trends in length of stay, hospital charges, and in-hospital mortality associated with COPD, as well as identified patient-level risk factors associated with 30-day readmissions., Methods: A retrospective analysis of adult patients (≥18 years of age) with COPD was conducted by using the Healthcare Cost and Utilization Project Florida State Inpatient Database, 2009 to 2014. Weighted least squares regression was used to assess trends in the COPD readmission rate on a yearly basis, as well as other outcomes of interest. A multivariable logistic regression was used to identify patient characteristics that were associated with 30-day COPD readmissions., Findings: Overall, 268,084 adults were identified as having COPD. Between 2009 and 2014, more than half of patients aged 65-84 years, most were white, 55% were female, and 73% had Medicare. The unadjusted rate for COPD-related 30-day readmissions did not change (8.04% to 7.85%; P = 0.434). However, the mean total charge for 30-day COPD-related readmissions was significantly higher in 2014 ($40,611) compared with that in 2009 ($36,714) (P = 0.011). The overall unadjusted in-hospital mortality of COPD-related hospitalizations significantly decreased from 1.83% in 2009 to 1.34% in 2014 (P < 0.001). In a multivariable logistic regression model, patients with COPD were 2% less likely to be readmitted to the hospital for each additional year (odds ratio [OR], 0.98 [95% confidence interval (CI), 0.97-0.99]). Factors associated with significantly higher odds of COPD-related readmission were: older age (45 ≤ age ≤ 64 years; OR, 1.91 [95% CI, 1.70-2.14]), being male (OR, 1.14 [95% CI, 1.10-1.17]), and being a Medicaid beneficiary (OR, 1.28 [95% CI, 1.21-1.35])., Implications: Although the adjusted odds of COPD readmissions slightly decreased, as did the length of stay and all-cause in-patient mortality, the financial burden increased substantially. Future strategies to further reduce readmissions of patients with COPD and curb financial burden in Florida are needed., (Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.)

On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients randomized to palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg orally daily) or letrozole alone. The phase II portion of the trial was divided into two cohorts: cohort 1 enrolled 66 biomarker-unselected patients and cohort 2 enrolled 99 biomarker-positive patients. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). A large magnitude of improvement in PFS was observed in patients receiving palbociclib plus letrozole compared with patients receiving letrozole alone (HR, 0.488; 95% confidence interval, 0.319-0.748). Multiple sensitivity analyses were supportive of clinical benefit. The most common adverse reaction in patients receiving palbociclib plus letrozole was neutropenia. This article summarizes the FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMA-2., (©2015 American Association for Cancer Research.)

On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea., (©2015 American Association for Cancer Research.)

On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 patients with HER2-positive MBC that randomly allocated patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in patients receiving ado-trastuzumab emtansine compared with patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable., (©2014 American Association for Cancer Research.)

Objective: To examine recent national trends in psychotropic use for very young children at US outpatient medical visits., Methods: Data for 2- to 5-year-old children (N = 43 598) from the 1994-2009 National Ambulatory and National Hospital Ambulatory Medical Care Surveys were used to estimate the weighted percentage of visits with psychotropic prescriptions. Multivariable logistic regression was used to identify factors associated with psychotropic use. Time effects were examined in 4-year blocks (1994-1997, 1998-2001, 2002-2005, and 2006-2009)., Results: Psychotropic prescription rates were 0.98% from 1994-1997, 0.83% from 1998-2001, 1.45% from 2002-2005, and 1.00% from 2006-2009. The likelihood of preschool psychotropic use was highest in 2002-2005 (1994-1997 adjusted odds ratio [AOR] versus 2002-2005: 0.67; 1998-2001 AOR versus 2002-2005: 0.63; 2006-2009 AOR versus 2002-2005: 0.64), then diminished such that the 2006-2009 probability of use did not differ from 1994-1997 or from 1998-2001. Boys (AOR versus girls: 1.64), white children (AOR versus other race: 1.42), older children (AOR for 4 to 5 vs 2 to 3 year olds: 3.87), and those lacking private insurance (AOR versus privately insured: 2.38) were more likely than children from other groups to receive psychotropic prescriptions., Conclusions: Psychotropic prescription was notable for peak usage in 2002-2005 and sociodemographic disparities in use. Further study is needed to discern why psychotropic use in very young children stabilized in 2006-2009, as well as reasons for increased use in boys, white children, and those lacking private health insurance.

The U.S. Food and Drug Administration (FDA) describes the accelerated approval of brentuximab vedotin for patients with relapsed Hodgkin lymphoma and relapsed systemic anaplastic large-cell lymphoma (sALCL). FDA analyzed the results of two single-arm trials, enrolling 102 patients with Hodgkin lymphoma and 58 patients with sALCL. Both trials had primary endpoints of objective response rate (ORR) and key secondary endpoints of response duration and complete response (CR) rate. For patients with Hodgkin lymphoma, ORR was 73% (95% CI, 65-83%); median response duration was 6.7 months, and CR was 32% (95% CI, 23-42%). For patients with sALCL, ORR was 86% (95% CI, 77-95%), median response duration was 12.6 months, and CR was 57% (95% CI, 44-70%). The most common adverse reactions were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting. FDA granted accelerated approval of brentuximab vedotin for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplantation (ASCT) or after failure of at least two prior multiagent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with sALCL after failure of at least one prior multiagent chemotherapy regimen., (©2012 AACR.)

Objective: To examine the effect of perceived health status on three components of patient satisfaction., Methods: The Household Component of the 1999 Medical Expenditure Panel Survey for people 35-64 years of age was used to examine the effect of perceived health status on patient satisfaction measured in terms of access to care, provider quality and quality of care. Descriptive statistics and multivariate regression were used to describe the subjects and to examine the relationship between patient satisfaction and perceived health status controlling for patient demographic factors, health factors and provider characteristics. All analyses used STATA 8.0 which is designed to analyze weighted data., Results: A total of 4,417 patients (71% women) met the inclusion criteria for the study. Patients who rated their health excellent or good scored higher on the three dimensions of patient satisfaction. Higher scores on one or more components of patient satisfaction were associated with being older, married, better educated and having higher income, health insurance and good mental health. Seeing the health-care provider for an old problem resulted in lower levels of patient satisfaction. Provider characteristics significantly related to patient satisfaction were listening to the patient, being a specialist, seeing patients in an office setting and being located in the South., Conclusions: This study has shown that patient satisfaction is influenced by a person's self-perceived health status and other personal characteristics that are external to the delivery of health care. These findings suggest that patient satisfaction data should be used judiciously because a significant portion of the variation may be attributed to factors endogenous to the patient and therefore are not amenable to provider intervention.