10 resultados para Post-registration changes to medicines
em Duke University
Resumo:
This study investigates the changes of the North Atlantic subtropical high (NASH) and its impact on summer precipitation over the southeastern (SE) United States using the 850-hPa geopotential height field in the National Centers forEnvironmental Prediction (NCEP) reanalysis, the 40-yr European Centre for Medium-Range Weather Forecasts (ECMWF) Re-Analysis (ERA-40), long-term rainfall data, and Intergovernmental Panel on Climate Change (IPCC) Fourth Assessment Report (AR4) model simulations during the past six decades (1948-2007). The results show that the NASH in the last 30 yr has become more intense, and its western ridge has displaced westward with an enhanced meridional movement compared to the previous 30 yr. When the NASH moved closer to the continental United States in the three most recent decades, the effect of the NASH on the interannual variation of SE U.S. precipitation is enhanced through the ridge's north-south movement. The study's attribution analysis suggested that the changes of the NASH are mainly due to anthropogenic warming. In the twenty-first century with an increase of the atmospheric CO2 concentration, the center of the NASH would be intensified and the western ridge of the NASH would shift farther westward. These changes would increase the likelihood of both strong anomalously wet and dry summers over the SEUnited States in the future, as suggested by the IPCC AR4 models. © 2011 American Meteorological Society.
Resumo:
This study assessed the sustained effect of a physical activity (PA) counseling intervention on PA one year after intervention, predictors of sustained PA participation, and three classes of post-intervention PA trajectories (improvers, maintainers, and decliners) in 238 older Veterans. Declines in minutes of PA from 12 to 24 months were observed for both the treatment and control arms of the study. PA at 12 months was the strongest predictor of post-intervention changes in PA. To our surprise, those who took up the intervention and increased PA levels the most, had significant declines in post-intervention PA. Analysis of the three post-intervention PA trajectories demonstrated that the maintenance group actually reflected a group of nonresponders to the intervention who had more comorbidities, lower self-efficacy, and worse physical function than the improvers or decliners. Results suggest that behavioral counseling/support must be ongoing to promote maintenance. Strategies to promote PA appropriately to subgroups of individuals are needed.
Resumo:
In April 2008, the Infectious Diseases Society of America (IDSA) entered into an agreement with Connecticut Attorney General Richard Blumenthal to voluntarily undertake a special review of its 2006 Lyme disease guidelines. This agreement ended the Attorney General's investigation into the process by which the guidelines were developed. The IDSA agreed to convene an independent panel to conduct a one-time review of the guidelines. The Review Panel members, vetted by an ombudsman for potential conflicts of interest, reviewed the entirety of the 2006 guidelines, with particular attention to the recommendations devoted to post-Lyme disease syndromes. After multiple meetings, a public hearing, and extensive review of research and other information, the Review Panel concluded that the recommendations contained in the 2006 guidelines were medically and scientifically justified on the basis of all of the available evidence and that no changes to the guidelines were necessary.
Resumo:
During the past 2 decades, significant advances in our understanding of the humoral immune response to human immunodeficiency virus type 1 (HIV-1) infection have been made, yet a tremendous amount of work lies ahead. Despite these advances, strategies to reliably induce antibodies that can control HIV-1 infection are still critically needed. However, recent advances in our understanding of the kinetics, specificity, and function of early humoral responses offer alternative new approaches to attain this goal. These results, along with the new broadly neutralizing antibody specificities, the role for other antibody functions, the increased understanding of HIV-1-induced changes to B cell biology, and results from the RV144 "Thai" trial showing potential modest sterilizing protection by nonneutralizing antibody responses, have renewed focus on the humoral system. In this review, recent advances in our understanding of the earliest humoral responses are discussed, highlighting presentations from the meeting on the Biology of Acute HIV Infection.
Resumo:
We investigated perceptions among overweight and obese state employees about changes to health insurance that were designed to reduce the scope of health benefits for employees who are obese or who smoke. Before implementation of health benefit plan changes, 658 state employees who were overweight (ie, those with a body mass index [BMI] of 25-29.9) or obese (ie, those with a BMI of > or = 30) enrolled in a weight-loss intervention study were asked about their attitudes and beliefs concerning the new benefit plan changes. Thirty-one percent of employees with a measured BMI of 40 or greater self-reported a BMI of less than 40, suggesting they were unaware that their current BMI would place them in a higher-risk benefit plan. More than half of all respondents reported that the new benefit changes would motivate them to make behavioral changes, but fewer than half felt confident in their ability to make changes. Respondents with a BMI of 40 or greater were more likely than respondents in lower BMI categories to oppose the new changes focused on obesity (P < .001). Current smokers were more likely than former smokers and nonsmokers to oppose the new benefit changes focused on tobacco use (P < .01). Participants represented a sample of employees enrolled in a weight-loss study, limiting generalizability to the larger population of state employees. Benefit plan changes that require employees who are obese and smoke to pay more for health care may motivate some, but not all, individuals to change their behaviors. Since confidence to lose weight was lowest among individuals in the highest BMI categories, more-intense intervention options may be needed to achieve desired health behavior changes.
Resumo:
Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was 56 million dollars (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that total spending on postapproval safety by the top twenty drug manufacturers was 800 million dollars in 2003. We also examined, using regression analysis, the relationship between the number of safety personnel and the number of initial adverse-event reports. This study offers information for the debate on proposed changes to safety surveillance.
Resumo:
We study how effectively information induces Bangladeshi households to avoid a health risk. The response to information is large and rapid; knowing that the household's well water has an unsafe concentration of arsenic raises the probability that the household changes to another well within one year by 0.37. Households who change wells increase the time spent obtaining water fifteen-fold. We identify a causal effect of information, since incidence of arsenic is uncorrelated with household characteristics. Our door-to-door information campaign provides well-specific arsenic levels without which behavior does not change. Media communicate general information about arsenic less expensively and no less effectively. © 2006 Elsevier B.V. All rights reserved.
Resumo:
The cascade that culminates in macrometastases is thought to be mediated by phenotypic plasticity, including epithelial-mesenchymal and mesenchymal-epithelial transitions (EMT and MET). Although there is substantial support for the role of EMT in driving cancer cell invasion and dissemination, much less is known about the importance of MET in the later steps of metastatic colonization. We created novel reporters, which integrate transcriptional and post-transcriptional regulation, to test whether MET is required for metastasis in multiple in vivo cancer models. In a model of carcinosarcoma, metastasis occurred via an MET-dependent pathway; however, in two prostate carcinoma models, metastatic colonization was MET independent. Our results provide evidence for both MET-dependent and MET-independent metastatic pathways.
Resumo:
Background: Since 2007, there has been an ongoing collaboration between Duke University and Mulago National Referral Hospital (NRH) in Kampala, Uganda to increase surgical capacity. This program is prepared to expand to other sites within Uganda to improve neurosurgery outside of Kampala as well. This study assessed the existing progress at Mulago NRH and the neurosurgical needs and assets at two potential sites for expansion. Methods: Three public hospitals were visited to assess needs and assets: Mulago NRH, Mbarara Regional Referral Hospital (RRH), and Gulu RRH. At each site, a surgical capacity tool was administered and healthcare workers were interviewed about perceived needs and assets. A total of 39 interviews were conducted between the three sites. Thematic analysis of the interviews was conducted to identify the reported needs and assets at each hospital. Results: Some improvements are needed to the Duke-Mulago Collaboration model prior to expansion; minor changes to the neurosurgery residency program as well as the method for supply donation and training provided during neurosurgery camps need to examined. Neurosurgery can be implemented at Mbarara RRH currently but the hospital needs a biomedical equipment technician on staff immediately. Gulu RRH is not well positioned for Neurosurgery until there is a CT Scanner somewhere in the Northern Region of Uganda or at the hospital. Conclusions: Neurosurgery is already present in Uganda on a small scale and needs rapid expansion to meet patient needs. This progression is possible with prudent allocation of resources on strategic equipment purchases, human resources including clinical staff and biomedical staff, and changes to the supply chain management system.
Resumo:
At the crux of health disparities for women of color lies a history of maltreatment based on racial difference from their white counterparts. It is their non-whiteness that limits their access to the ideologies of “woman” and “femininity” within dominant culture. As the result of this difference, the impact of the birth control movement varied among women based on race. This project explores how the ideology attributed to the black female body limited black women’s access to “womanhood” within dominant culture, and analyzes the manners in which their reproductive autonomy was compromised as the result of changes to that ideology through time. This project operates under the hypothesis that black women’s access to certain aspects of femininity such as domesticity and motherhood reflected their roles in slave society, that black women’s reproductive value was based on the value of black children within slave culture, and that both of these factors dictated the manner in which their reproductive autonomy was managed by health professionals. Black people’s worth as a free labor force within dominant culture diminished when the Reconstruction Amendments were added to the constitution and slavery was deemed unconstitutional—resulting in the paradigmatic shift from the promotion of black fertility to its recession. America’s transition to the medicosocial regulation of black fertility through Eugenics, the role of the black elite in the movement, and the negative impact of this agenda on the reproductive autonomy of black women from low socioeconomic backgrounds are enlisted as support. The paper goes on to draw connections between post-slavery ideology of black femininity and modern-day medicosocial occurrences within clinical settings in order to advocate for increased bias training for medical professionals as a means of combating current health disparities. It concludes with the possibility that this improvement in medical training could persuade people of color to seek out medical intervention at earlier stages of illness and obtain regular check-ups by actively countering physicians’ past transgressions against them.