Intense interest surrounds the recent expansion of US National Institutes of Health (NIH) budgets as part of economic stimulus legislation. However, the relationship between NIH funding and cardiovascular disease research is poorly understood, making the likely impact of this policy change unclear.

The impact and effectiveness of clinical trial data sharing initiatives may differ depending on the data sharing model used. We characterized outcomes associated with models previously used by the U.S. National Institutes of Health (NIH): National Heart, Lung, and Blood Institute's (NHLBI) centralized model and National Cancer Institute's (NCI) decentralized model. We identified trials completed in 2010-2013 that met NIH data sharing criteria and matched studies based on cost and/or size, determining whether trial data were shared, and for those that were, the frequency of secondary internal publications (authored by at least one author from the original research team) and shared data publications (authored by a team external to the original research team). We matched 77 NHLBI-funded trials to 77 NCI-funded trials; among these, 20 NHLBI-sponsored trials (26%) and 4 NCI-sponsored trials (5%) shared data (OR 6.4, 95% CI: 2.1, 19.8). From the 4 NCI-sponsored trials sharing data, we identified 65 secondary internal and 2 shared data publications. From the 20 NHLBI-sponsored trials sharing data, we identified 188 secondary internal and 53 shared data publications. The NHLBI's centralized data sharing model was associated with more trials sharing data and more shared data publications when compared with the NCI's decentralized model.

According to a wide variety of analyses and projections, the potential effects of global climate change on human health are large and diverse. The U.S. National Institutes of Health (NIH), through its basic, clinical, and population research portfolio of grants, has been increasing efforts to understand how the complex interrelationships among humans, ecosystems, climate, climate variability, and climate change affect domestic and global health.

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The Food and Drug Administration Amendments Act of 2007 mandated that sponsors of applicable studies must provide results within one year of study completion. We aimed to analyze the factors associated with reporting of results from interventional studies registered on ClinicalTrials.gov. On May 20, 2010, we retrieved 20 available fields from 57,233 closed studies on the website and identified 31,161 interventional studies that were required to post results. We compared the proportion of studies with results versus studies without results by age, gender, and disease status of participants, by interventions, sponsors, phase of clinical trials, and completion dates. The results of studies were reported for 4.7% of applicable studies, 8% of industry-sponsored studies, 7.5% of Phase II and 6.5% of Phase IV clinical trials, 4.9% of drug studies, and 0% of genetic studies. Withdrawn (n = 486) and suspended (n = 414) interventions did not provide results. The percentage of studies with results varied from 0% to 21% among different sponsors. The first studies with results were completed in 1992. The proportion of studies with results increased over time. Completion dates were not available for 7446 studies. The database does not have fields available to facilitate routine analysis of the rate of compliance with federal law for posting results. The analysis of accuracy of the protocols in relation to the results and publications is not possible without time-consuming evaluation of individual postings and individual publications.

Drug development is an expensive process that is marked by a high-failure rate. For this reason early stage bioequivalence and pharmacokinetic studies are essential in determining the fate of new drug products. In this study, we sought to systematically assess the current trends of ongoing and recently completed bioequivalence and bioavailability trials that have been registered within a national clinical trials registry. All bioequivalence and bioavailability studies registered in the United States ClinicalTrials.gov registry from late-2007 through 2011 were identified. Over this period, more than 2300 interventional bioequivalence and bioavailability trials were registered. As of 2013, the vast majority of studies (86%) have been completed, 10% are actively recruiting participants, and the remainder are engaged in data analysis (4%). When compared to completed trials, ongoing trials are in later phases of clinical development, recruiting larger numbers of participants, and more likely to recruit women and children (P<0.001 for all). These data suggest that the quality of bioequivalence and bioavailability studies has improved rapidly, even over the last five years. However, further work is needed to sustain - and accelerate - these improvements in the design of bioequivalence and bioavailability studies to ensure that safe and efficacious medicines swiftly reach healthcare providers and their patients.

To examine whether National Institutes of Health (NIH) funded articles that were archived in PubMed Central (PMC) after the release of the 2008 NIH Public Access Policy show greater scholarly impact than comparable articles not archived in PMC.

Hispanics/Latinos are expected to constitute 25% of the U.S. population by 2060. Differences in the prevalence of health risk factors, chronic diseases, and access to and utilization of health-care services between Hispanics/Latinos and other populations in the U.S. have been documented. This study aimed to describe and analyze the landscape of Research Program Grants (RPGs) funded by the National Institutes of Health (NIH) between 2008 and 2015 involving Hispanic/Latino health research in six health condition areas-asthma, cancer, dementia, diabetes, liver/gallbladder disease, and obesity-and to identify opportunities for continued research in these areas. Using an NIH internal search engine, we identified new and renewal Hispanic/Latino health RPGs searching for specific Hispanic/Latino identifiers in the Title, Abstract, and Specific Aims. We used descriptive statistics to examine the distribution of funded RPGs by NIH disease-based classification codes for the six health condition areas of interest, and other selected characteristics. The most prominent clusters of research subtopics were identified within each health condition area, and performance sites were mapped at the city level. Within the selected time frame, 3,221 Hispanic/Latino health-related unique RPGs were funded (constituting 4.4% of all funded RPGs), and of those 625 RPGs were eligible for review and coding in the present study. Cancer and obesity were the most commonly studied health condition areas (72%), while studies on mechanisms of disease-biological and non-biological-(72.6%), behavioral research (42.1%) and epidemiological studies (38.1%) were the most common types of research. Most of the primary performance sites were in California, Texas, the northeastern U.S., and Illinois. The predominance of mechanistic, behavioral, and epidemiological studies in our analysis poses opportunities to evaluate knowledge gained and their clinical application, explore new research questions, or to update some methods or instruments. The findings of the present study suggest opportunities to expand research in understudied mechanisms of disease that could explain differences in prevalence of conditions like diabetes and cancer among different heritage groups. In addition, our findings suggest that the impact of interventions or policies designed to reduce health disparities, innovative multi-level interventions, implementation and dissemination studies, the role of health information technology on health outcomes, and the intersectionality of individual, sociocultural, geographic, and other factors on health outcomes, among others, are understudied approaches, which could potentially advance research in Hispanic/Latino health and contribute to the achievement of better health outcomes in this diverse population.

Little is known about the association between cardiovascular (CV) health and health insurance status. We hypothesized that U.S. adults without health insurance coverage would have a lower likelihood of ideal cardiovascular health.

The interplay between sleep duration and inflammation on the baseline and incident cardiovascular (CV) risk is unknown. We sought to evaluate the association between sleep duration, C-reactive protein (CRP), baseline CV risk, and incident CV mortality.

Evaluating the impact of federally funded research with a broad, methodical, and objective approach is important to ensure that public funds advance the mission of federal agencies.

As Canada increases requirements for research data management and sharing, there is value in identifying how research data are shared and what has been done to make them findable and reusable. This study aimed to understand Canada's data-sharing landscape by reviewing how data funded by the Canadian Institutes of Health Research (CIHR) are shared and comparing researchers' data-sharing practices to best practices for research data management and sharing.

Background: Healthcare costs are increasing in the U.S. Healthcare market is fragmented and opaque. The Amazon, JP Morgan Chase, and Berkshire Hathaway partnered to form an independent healthcare company 'Haven', designed to support cost-containment in health care and to forge a better patient experience. Limited information is available in the public domain about Haven's strategy to deliver cost-effective healthcare for their employees. Objective: To describe the impact of Haven Health of modern healthcare. Methods: We reviewed literature in Pubmed (MEDLINE database of references and abstracts on life sciences and biomedical topics from the USA National Library of Medicine at the National Institutes of Health) and the public domain. Results: Amazon's expertise and abilities in e-commerce such as logistics, supply, and big data management will support Haven's quest to resolve inefficiencies in health care. Haven may attempt to directly negotiate with providers, bypassing insurance companies, to establish themselves as an independent payor. Additionally, Haven to establish themselves as a provider by building new low-cost primary care clinics, focusing on chronic disease prevention. The new healthcare system may leverage machine learning, artificial intelligence and big data analysis to support its initiatives and other 'big data' analytics to drive it all. Conclusions: Heaven Health may use its expertise to disrupt everything from the pharmaceutical supply chain to primary care and telehealth. More research is needed to evaluate the impact of Haven Healthcare on disease outcomes and healthcare costs.

Although workplace discrimination and mistreatment (WDM) has recently drawn widespread media attention, our understanding of the prevalence of these phenomena remains limited. In the current study, we generated national prevalence estimates of WDM from a community-based cohort of employed black and white men and women aged ≥48 years. Measures of WDM in the current job were obtained by computer-assisted telephone interview (2011-2013) involving dichotomous responses (yes or no) to five questions and deriving a composite measure of discrimination (yes to at least one). Prevalence estimates and age- and region-adjusted prevalence ratios were derived with use of SUDAAN software to account for the complex sample design. Analyses were stratified by race and sex subgroups. This sample represents over 40 million U.S. workers aged ≥48 years. The prevalence of workplace discrimination ranged from a high of 25% for black women to a low of 11% for white men. Blacks reported a 60% higher rate of discrimination compared to whites; women reported a 53% higher prevalence of discrimination, compared with men. The prevalence of workplace mistreatment ranged from 13% for black women to 8% for white men. Women reported a 52% higher prevalence of mistreatment compared to men, while differences by race were not significant. Mistreatment was 4-8 times more prevalent among those reporting discrimination than among those reporting none. Subgroup differences in mistreatment were confined to the wage-employed. Findings suggest that middle age and older wage-employed blacks and women experience the highest prevalence of WDM; moreover, discrimination is strongly associated with mistreatment. This study contributes to our understanding of at-risk segments of the U.S. labor market and the need for targeted interventions to reduce WDM.

Most US adults have limited health literacy skills. They struggle to understand complex health information and services and to make informed health decisions. The Internet has quickly become one of the most popular places for people to search for information about their health, thereby making access to quality information on the Web a priority. However, there are no standardized criteria for evaluating Web-based health information. Every 10 years, the US Department of Health and Human Services' Office of Disease Prevention and Health Promotion (ODPHP) develops a set of measurable objectives for improving the health of the nation over the coming decade, known as Healthy People. There are two objectives in Healthy People 2020 related to website quality. The first is objective Health Communication and Health Information Technology (HC/HIT) 8.1: increase the proportion of health-related websites that meet 3 or more evaluation criteria for disclosing information that can be used to assess information reliability. The second is objective HC/HIT-8.2: increase the proportion of health-related websites that follow established usability principles.

Nursing professional organizations and media sources indicated early in the pandemic that the physical and psychological effects of COVID-19 might be distinct and possibly greater in nurses than in other types of healthcare workers (HCWs).

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Introduction: Language concordance between patients and physicians is an important factor in providing safe and effective health care, with Spanish as the predominant and fastest growing non-English language in the United Sates. However, despite increasing demand for medical Spanish education, valid concerns about inadvertently increasing provider use of limited Spanish with patients, lack of knowledge of best practice in education and assessment, and lack of institutional support still present barriers to medical Spanish education in medical schools. Methods: The authors conducted a narrative review of existing literature that evaluates the link between medical Spanish education of physicians and language concordance. Results: Medical Spanish educational efforts, although increasing, are not consistently linked to learner assessment. The literature to date supports that for medical Spanish education to improve patient outcomes, it should be linked to assessment methodology that demonstrates improvement in language concordance with Spanish-speaking patients, and should include safety measures to prevent inadvertent communication errors. The authors review data for published medical Spanish postcourse language assessment strategies and provide recommendations to ensure responsible and competent use of medical Spanish skills. Conclusion: The authors propose three structural elements that should be considered when incorporating or enhancing medical Spanish education in medical schools: institutional endorsement of the role of medical Spanish education within a national health disparities context; precourse proficiency testing to establish student starting level; and learner postcourse communications skills and limitations assessment to provide individualized recommendations and assure patient safety.

The surveillance of influenza activity is critical to early detection of epidemics and pandemics and the design of disease control strategies. Case reporting through a voluntary network of sentinel physicians is a commonly used method of passive surveillance for monitoring rates of influenza-like illness (ILI) worldwide. Despite its ubiquity, little attention has been given to the processes underlying the observation, collection, and spatial aggregation of sentinel surveillance data, and its subsequent effects on epidemiological understanding. We harnessed the high specificity of diagnosis codes in medical claims from a database that represented 2.5 billion visits from upwards of 120,000 United States healthcare providers each year. Among influenza seasons from 2002-2009 and the 2009 pandemic, we simulated limitations of sentinel surveillance systems such as low coverage and coarse spatial resolution, and performed Bayesian inference to probe the robustness of ecological inference and spatial prediction of disease burden. Our models suggest that a number of socio-environmental factors, in addition to local population interactions, state-specific health policies, as well as sampling effort may be responsible for the spatial patterns in U.S. sentinel ILI surveillance. In addition, we find that biases related to spatial aggregation were accentuated among areas with more heterogeneous disease risk, and sentinel systems designed with fixed reporting locations across seasons provided robust inference and prediction. With the growing availability of health-associated big data worldwide, our results suggest mechanisms for optimizing digital data streams to complement traditional surveillance in developed settings and enhance surveillance opportunities in developing countries.