International comparison of the quality of voluntary adverse event reports for cremophor-containing paclitaxel-associated anaphylaxis submitted to regulatory agencies in the United States, Europe, and Japan

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6589-6589
Author(s):  
E. Calhoun ◽  
D. Raisch ◽  
H. Luu ◽  
E. Carias ◽  
L. Irizarry ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Drug Events ◽  
Case Reports ◽  
The United States ◽  
Adverse Event Report ◽  
H2 Blockers ◽  
The Us ◽  
Drug Regimens ◽  
Prophylaxis Therapy

6589 Background: Serious adverse drug events (sADEs) are a significant cause of morbidity and mortality. The FDA's MedWatch program is a voluntary adverse drug reporting program. In Europe and Japan, sADE reports are rarely reimbursed. We evaluated the quality of adverse events reporting in the US, Europe, and Japan for paclitaxel-associated anaphylaxis. Hypersensitivity reactions (presumably due to the diluent cremophor) occur in up to 42% of patients receiving paclitaxel (cremophor- containing paclitaxel was licensed in 1992, a cremophor-free paclitaxel was licensed in 2005). Methods: We reviewed reports of anaphylactic reactions to paclitaxel reported between 1997–2007 contained in the FDA Adverse Event Report System (AERS). Results: Of 171 unique case reports, 34% resulted in death. Cases that resulted in death were mostly incomplete in reporting descriptions of anaphylaxis symptoms and prophylaxis/therapy drug regimens in the US, Europe and Japan. (Table) The median duration between date of event and regulatory notification was 27, 55, and 18 days for the US, Europe, and Japan respectively. Conclusions: Overall, the quality of case reports of serious anaphylaxis reactions to cremophor-containing paclitaxel was poor in the US, Europe, and Japan, despite a substantial number of these reports being associated with death. Surprisingly, among the patients receiving prophylaxis with corticosteroids, anti-histamines, and/or H2-blockers, 36% of patients still died. [Table: see text] No significant financial relationships to disclose.

Precarious Work and Young Workers in the United States

2018 ◽  
Author(s):  
Arne L. Kalleberg
Keyword(s):  
Labor Market ◽  
The United States ◽  
Young Workers ◽  
Severe Problem ◽  
Precarious Work ◽  
The Great Recession ◽  
The Us ◽  
Training Opportunities ◽  
And Training

This chapter discusses how the growth of precarious work and the polarization of the US labor market have produced major problems for the employment experiences of young workers. A prominent indicator of young workers’ difficulties in the labor market has been the sharp increase in their unemployment rates since the Great Recession. Another, equally if not more severe, problem faced by young workers today is the relatively low quality of the jobs that they were able to get. Other problems include the exclusion of young workers from the labor market and from education and training opportunities; the inability to find jobs that utilize their education, training, and skills; and the inability to obtain jobs that provide them with an opportunity to get a foothold in a career that would lead to progressively better jobs and thus be able to construct career narratives.

scholarly journals Quality of Modern Total Ankle Arthroplasty Research

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0016
Author(s):  
Daniel Bohl ◽  
Emily Vafek ◽  
Simon Lee ◽  
Johnny Lin ◽  
George Holmes ◽  
...  
Keyword(s):  
Cohort Studies ◽  
Case Reports ◽  
Case Series ◽  
The United States ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthritis ◽  
Level Of Evidence ◽  
Ankle Arthroplasty ◽  
End Stage

Category: Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) is gaining popularity as an alternative to ankle arthrodesis in the setting of end-stage ankle arthritis. However, compared to hip and knee arthroplasty, there is a relative dearth of evidence to support its use. This study assesses the quality of literature surrounding modern TAA designs. Methods: A search of all peer-reviewed, English-language journals was conducted to identify publications involving TAA. The initial search identified 444 articles published during 2006-2016. Of these, 182 were excluded because they were not clinical outcomes studies, 46 because the TAA implant was no longer available, and 15 because the primary outcome of the study was not related to TAA, leaving 201 articles for analysis. Results: No Level I studies were identified. Seventeen (8%) studies were Level II, 48 (24%) Level III, 128 (64%) Level IV, and 8 (4%) Level V. One hundred forty-three studies (71%) were retrospective in nature. Stratification by study design revealed 128 (64%) case series, 33 (16%) experimental cohort studies, 19 (10%) case-control studies, 13 (6%) observational cohort studies, and 8 (4%) case reports. The number of studies published each year steadily increased from 2006 to 2016. A total of 51% of TAA research was published in only two journals: Foot and Ankle International and the Journal of Bone and Joint Surgery. Publications from the United States accounted for 36% of total publications. The most published implant was the Scandinavian Total Ankle Replacement (Figure 1). Conclusion: While the number of TAA studies published each year has steadily increased since 2006, the quality of this research as measured by level of evidence remains suboptimal. This analysis highlights the need for continued improvement in methodology and development of robust prospective registries to advance our knowledge of TAA as a treatment for end-stage ankle arthritis.

United States of America

2021 ◽  
pp. 44-88
Author(s):  
Christian Leuprecht
Keyword(s):  
United States ◽  
Civil Liberties ◽  
The United States ◽  
Intelligence Community ◽  
Government Accountability ◽  
Select Committee ◽  
Accountability System ◽  
The Us ◽  
The Government

This chapter reviews the member organizations of the United States Intelligence Community, the strategic environment that has informed intelligence and accountability in the United States, including scandals as a key driver of innovation, and the current and future threat environment as seen by the United States. The chapter examines the US intelligence accountability architecture: the House of Representative Permanent Select Committee on Intelligence, the Senate Select Committee on Intelligence, the Foreign Intelligence Surveillance Court, the Inspectors General, the Government Accountability Office, the Privacy and Civil Liberties Oversight Office, and the President’s Intelligence Advisory Board. The sheer number and complexity of accountability bodies in the US gives rise to inefficiencies, ineffectiveness, and duplication. The accountability system is replete with gaps and vulnerabilities: partisanship, collective-action problems, resource allocation, and inconsistent quality of review in congressional accountability; GAO’s limited authority to review the USIC and sensitive operations; the adequacy of the FISA court in adequately protecting the rights of Americans; and Presidential discretion in appointing and removing IGs. These issues have implications not just for the United States, but for allies, partners as well as regional and global stability.

scholarly journals Assessing U.S. Landscape Architecture Faculty Research Contribution

Land ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 64
Author(s):  
Robert D. Brown ◽  
Tamanna Tasnum ◽  
YouJoung Kim
Keyword(s):  
Professional Education ◽  
Landscape Architecture ◽  
Social Issues ◽  
The United States ◽  
Scholarly Output ◽  
Wide Range ◽  
The Us ◽  
Available Information ◽  
Contribution Level

Landscape architecture programs in the United States are assessed based on the quality of the professional education received by their students. Research is becoming an increasingly important part of the profession as evidence-based landscape architecture grows, and it is critical that university faculty provide information that can be used in professional practice to resolve important environmental and social issues. In many universities, individual landscape architecture faculty are encouraged to conduct research and their performance is evaluated based largely on the quantity and quality of their scholarly output. This paper used publicly-available information to conduct a citation analysis for individual faculty and professionally accredited landscape architecture programs across the US. There was a wide range in the contribution level with some programs and some individuals who were very productive, while many others contributed very little. This might point to an attempt by programs to maintain a balance between scholarly contributions and the education of professional landscape architects. As research becomes an increasing important part of the profession, the productive programs and individuals identified in this study might provide models for others to emulate.

FDA at BIO 2011 – Weighing a hefty mission: Where is the balance?

1969 ◽  
Vol 17 (4) ◽  
Author(s):  
Suzanne Levy
Keyword(s):  
Nonprofit Sector ◽  
The United States ◽  
Biotechnology Industry ◽  
Washington Dc ◽  
Current State ◽  
Industry Organization ◽  
The Us ◽  
Quality Of Food ◽  
Biotechnology Industry Organization

The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year's annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission.The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC – the seat of the federal government and of BIO's headquarters – much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.

Charitable contributions and quality in the us hospice care setting

2014 ◽  
Vol 26 (4) ◽  
pp. 539-556 ◽  
Author(s):  
Kelly Noe ◽  
Dana A. Forgione
Keyword(s):  
Quality Of Care ◽  
Hospice Care ◽  
The United States ◽  
Charitable Contributions ◽  
The Us ◽  
Home Health Aide ◽  
Report Data ◽  
Worker Quality ◽  
Cost Report

This paper examines the association of charitable donations with quality of care proxies for nonprofit hospice providers in the United States (US). An estimated 1.45 million patients received hospice care in the US in 2008. Medicare hospice spending exceeded $10 billion in 2007 and is expected to more than double over the next 10 years. Using Guidestar and Medicare Hospice Cost Report data, we find donations are positively associated with proxies for nurse and social worker quality of care, but not with our home-health aide quality proxy. This research adds to our understanding of charitable contributions in hospice provider organizations.

Horizontal Mergers in the United States Health Field: Some Practical Realities

2000 ◽  
Vol 13 (3) ◽  
pp. 137-151 ◽  
Author(s):  
T. P. Weil
Keyword(s):  
The United States ◽  
Horizontal Mergers ◽  
Health Networks ◽  
General Management ◽  
The Past ◽  
Regulatory Strategies ◽  
The Us ◽  
Integration Of Services ◽  
Health Field

During the past decade, ‘merger mania’ has been a striking trend in the US health field as a strategy to improve the integration of services, to reduce expenses, and to increase the ability of providers to manage risk-based payment. However, during the past quarter of a century limited operational and fiscal evidence has been published in both the health and general management literature that strongly supports the efficacy of horizontal mergers. This article further argues that a likely scenario over the next decade, in spite of disappointments among these mergers in effecting significant cost reductions, is for the US health networks to continue acquiring additional providers and insurers. After these alliances gain significant market penetration, they are expected to behave as oligopolists. For these mergers to eventually achieve their earlier projected savings, the health field's leadership will be forced to implement cost-cutting measures such as: more vigorously coordinating the network's key clinical services to reduce competition for revenues among the partners within an alliance, closing superfluous hospitals and centralizing expensive tertiary services, encouraging surplus physicians to relocate to under-served areas, and providing direction to carefully integrate the best elements of what the competitive and regulatory strategies are able to offer to improve access, social equity, quality of care, and to reduce total health expenditures.

scholarly journals Military Interventions As Omitted Variable Of Inversed Democratic Peace: An Empirical Evidence

2020 ◽  
Vol 66 (4/2019) ◽  
pp. 77-97
Author(s):  
Srđan Korać ◽  
Nenad Stekić
Keyword(s):  
Foreign Policy ◽  
The United States ◽  
Political Regime ◽  
Democratic Peace ◽  
Military Interventions ◽  
Post Conflict ◽  
Policy Goals ◽  
The Us ◽  
The Relationship

The paper examines the relationship between military interventions and democratisation processes which took place in targeted states. While many researchers try to identify relationship between the regime type and countries’ war proneness, the authors of this paper put these two variables in a reversed order. To test this so-called “inversed democratic peace” thesis based on an argument that an ongoing war is likely to lead to democratisation, we focus our analysis on the US interventions in Afghanistan, Iraq, Libya, and FR Yugoslavia (Kosovo). We deploy three variables: 1) Foreign policy similarity, to determine whether the intervening actor (USA) had similar or different foreign policy goals at the beginning of interventions; 2) Political regime similarity, to indicate whether there were any deviations in the quality of political regime between the intervening state and the target country, as indicated by the democratic peace postulates; 3) military interventions (independent variable). Foreign policy score includes S score dataset developed by Curtis S. Signorino and Jeffrey M. Ritter (1999), while for the political regime quality, the authors deploy Polity IV data. Statistical analysis including Pearsonʼs correlation, logistic regression and descriptive statistics, will be presented for specific dyad level in three specifically designated models. The authors conclude that it is more likely that military interventions affect further democratisation of the targeted post-conflict societies, if observed in a short term rather than in longitudinal domain, while the foreign policy similarity (with the United States) positively correlates in cases with more successful democratisation process.

scholarly journals Pediatric Shock: An Uncommon and Underrecognized Etiology

2020 ◽  
Vol 09 (03) ◽  
pp. 210-212 ◽  
Author(s):  
Kim R. Derespina ◽  
Shubhi Kaushik ◽  
Shivanand S. Medar
Keyword(s):  
Case Reports ◽  
Multiorgan Failure ◽  
The United States ◽  
International Studies ◽  
Disease Entity ◽  
Mucocutaneous Lymph Node Syndrome ◽  
Toxic Shock ◽  
The Us ◽  
Critically Ill Child ◽  
Lymph Node Syndrome

AbstractKawasaki disease, also known as mucocutaneous lymph node syndrome, is a well-known disease entity. Kawasaki shock syndrome (KSS), on the other hand, is less well recognized and has been reported in small single-center international studies and case reports. We report a case in the United States of an 11-year-old male with multiorgan failure and shock, presumed to be secondary to toxic shock but later diagnosed with KSS, an underrecognized entity in the US and review the literature. KSS should be considered in a critically ill child with unexplained shock.

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