The Federal Tort Claims Act - Absolute Liability, The Discretionary Function Exception, Sonic Booms; Laird v. Nelms

[A]lthough the legislative history of the FTCA lends great support for the argument that the doctrine of absolute liability is an acceptable theory to employ to seek recovery under the FTCA, the Supreme Court has chosen to rely on the Dalehite decision and completely overlook later Supreme Court interpretations. The legislative history of the FTCA also indicates that the discretionary function exception must always be confronted, regardless of the theory one proceeds under to seek recovery

Real-world Treatment Patterns and Adverse Events in Metastatic Renal Cell Carcinoma from a Large US Claims Database

Background: Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only ≈ 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC. Methods: US administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006–2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration. Results: Ten-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment–related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents. Conclusions: In the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions

Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database.

BACKGROUND: Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only ≈ 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC. METHODS: US administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006-2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration. RESULTS: Ten-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment-related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents. CONCLUSIONS: In the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions

The Assessment of Hydration Status and Renal Markers Associated with Acute Kidney Injury in NCAA Division I Female Soccer Players During Preseason Training in South Texas: A Pilot Study

Recent research suggest that recurrent heat-associated dehydration and strenuous physical exertion may be associated with the development of acute and potentially chronic renal dysfunction. Typical South Texas environmental conditions in August, during preseason, on NCAA female college athletes may warrant concerns for promoting acute kidney injury (AKI). PURPOSE: The purpose of this study is to investigate hydration status and renal biomarkers in NCAA Division I female soccer athletes in South Texas during the preseason. METHODS: (Mean ± SEM; n = 12; age: 19.5 ± 0.9 y; ht: 167.6 ± 6.24 cm; wt: 66.6 ± 10.15 kg). Each subject participated in Pre-and post-body composition measures via DXA (iDXA, Lunar Prodigy), pre-, post-practice, and game weight changes (SECA Model 769); provided 14-urine samples throughout the preseason for hydration via Urine Specific Gravity (USG) and renal function Creatinine (UCr) ELISA analyses. Urine samples were collected prior to preseason (PRE-PS), fitness testing days (FT1, FT2), regular practices (MidW1, MidW2, POST-PS) and exhibition games (PRE-BU, POST-BU,12HR-BU, 24HR-BU, PRE-UT, POST-UT, 12HR-UT, 24HR-UT). Heat index was assessed at each practice session and exhibition match (Kestrel 5000; Kestrel Meters). RESULTS: 1-way ANOVA for USG analysis, a difference was found at MidW2 prior to the end of the POST-PS 1.018 ± .001 (p = .03; CI: 1.017-1.025) and early fitness testing values (FT1: 1.022 ± 0.005; FT2: 1.022 ± 0.006) and the MidW1 of the pre-season 1.025 ±.001; (p = .004; CI: 1.022 - 1.027). The BU game USG pre-measure was lower than post (POST-BU, 12 h and 24 h) \u3c p = .02; 1.01 ± .001; CI: 1.008 - 1.016), a difference was found during the UT game pre-measure compared to POST-UT and 12 h post values 1.009 ± .0016 (p = .0009; CI: 1.006 - 1.013) and no different than the 24 h POST-UT 1.014 ± .001. 2-way ANOVA ( x heat index x time) for UCr (mg· dL-1· LBM-1), a difference was found between PRE-BU and POST-BU (p = .001; CI: .448 - 3.81) and comparing PRE-UT to POST-UT (p = \u3c .0001; CI: 2.57 - 6.31) and 12HR-UT (p = \u3c .0001; CI: 2.09 - 5.21). CONCLUSION: Our current analysis suggests, the subjects were euhydrated prior to the exhibition games and hypohydrated 12-hours post-exhibition game, prior to fitness assessments (FT1, FT2), and regular morning practice (MidW1). UCr increased above normative values post-exhibition games. The increases in UCr may be independent of hydration status and muscle mass as euhydration was maintained post-exhibition matches

2011-2012 UNLV McNair Journal

Journal articles based on research conducted by undergraduate students in the McNair Scholars Program Table of Contents Biography of Dr. Ronald E. McNair Statements: Dr. Neal J. Smatresk, UNLV President Dr. Juanita P. Fain, Vice President of Student Affairs Dr. William W. Sullivan, Associate Vice President for Retention and Outreach Mr. Keith Rogers, Deputy Executive Director of the Center for Academic Enrichment and Outreach McNair Scholars Institute Staf

Resident involvement and experience do not affect perioperative complications following robotic prostatectomy

Most urologic training programs use robotic prostatectomy (RP) as an introduction to teach residents appropriate robotic technique. However, concerns may exist regarding differences in RP outcomes with resident involvement. Our objective was therefore to evaluate whether resident involvement affects complications, operative time, or length of stay following RP

Large-scale association analyses identify host factors influencing human gut microbiome composition

To study the effect of host genetics on gut microbiome composition, the MiBioGen consortium curated and analyzed genome-wide genotypes and 16S fecal microbiome data from 18,340 individuals (24 cohorts). Microbial composition showed high variability across cohorts: only 9 of 410 genera were detected in more than 95% of samples. A genome-wide association study of host genetic variation regarding microbial taxa identified 31 loci affecting the microbiome at a genome-wide significant (P < 5 x 10(-8)) threshold. One locus, the lactase (LCT) gene locus, reached study-wide significance (genome-wide association study signal: P = 1.28 x 10(-20)), and it showed an age-dependent association with Bifidobacterium abundance. Other associations were suggestive (1.95 x 10(-10) < P < 5 x 10(-8)) but enriched for taxa showing high heritability and for genes expressed in the intestine and brain. A phenome-wide association study and Mendelian randomization identified enrichment of microbiome trait loci in the metabolic, nutrition and environment domains and suggested the microbiome might have causal effects in ulcerative colitis and rheumatoid arthritis

Roadmap for the development of the University of North Carolina at Chapel Hill Genitourinary OncoLogy Database—UNC GOLD

The management of genitourinary malignancies requires a multidisciplinary care team composed of urologists, medical oncologists and radiation oncologists. A genitourinary (GU) oncology clinical database is an invaluable resource for patient care and research. Although electronic medical records provide a single web-based record used for clinical care, billing and scheduling, information is typically stored in a discipline-specific manner and data extraction is often not applicable to a research setting. A GU oncology database may be used for the development of multidisciplinary treatment plans, analysis of disease-specific practice patterns, and identification of patients for research studies. Despite the potential utility, there are many important considerations that must be addressed when developing and implementing a discipline-specific database