Cardiologists' Perspectives on BiDil and the Use of Race in Drug Prescribing.

OBJECTIVES: We explored cardiologists' attitudes and prescribing patterns specific to the use of generic isosorbide dinitrate and hydralazine hydrochloride, and the fixed-dose patented drug, BiDil. BACKGROUND: Since the Food and Drug Administration approved BiDil in 2005 with an indication for self-identified black patients, disagreement about the appropriateness of race-based drugs has intensified and led to calls for providers and researchers to abandon race-based delimitations. This paper reports empirical evidence of cardiologists' views on BiDil's race-based indication and their ongoing inertia with respect to the debate about BiDil. METHODS: We conducted a 2010 cross-sectional online survey of members of the Association of Black Cardiologists. RESULTS: Fifty-nine cardiologists responded to the survey. Most participants (62.7%) prescribed BiDil to their patients. More than 40% of respondents did not prescribe BiDil to any non-African Americans. When considering whether to prescribe BiDil, a patient's race determined by physician assessment was the third most important factor considered by participants. The majority of participants (72.7%) selected symptoms as the most important factor. Most participants (59.2%) perceived race as defining biologically distinct individuals. Respondents prescribed BiDil more often to African American patients than non-African American patients. However, they prescribed the generic components that makeup BiDil to African Americans and non-African American patients similarly. CONCLUSIONS: The survey provides useful findings that, when viewed within the context of ongoing debates about race-based medicine, show little progress toward appropriately utilizing BiDil to maximize health outcomes, yet, might inform the development of practical and effective guidelines concerning the use of race in medicine.

Uses and Limitations of Claims-based Performance Feedback Reports: Lessons From the Comprehensive Primary Care Initiative.

BACKGROUND: Performance feedback is central to data-driven models of quality improvement, but the use of claims-based data for feedback has received little attention. PURPOSE: To examine the challenges, uses, and limitations of quarterly Medicare claims-based performance feedback reports generated for practices participating in the Comprehensive Primary Care (CPC) initiative from 2012 to 2015. METHODS: Mixed methods study of nearly 500 CPC practices in seven regions, combining pilot testing; systematic monitoring; surveys; in-depth interviews; user feedback; and input from data feedback team. RESULTS: Designing reports required addressing issues about timing, data completeness and reliability, variations in patient risk across practices, and use of benchmarks and metrics understandable to users. Practices' ability to use reports constructively depended on their experience, analytic resources, expectations, and perceptions about the role of primary care in improving reported outcomes. CONCLUSIONS: Generating claims-based feedback reports that support practices' quality improvement efforts requires a significant investment of analytic expertise, time, resources, continuous improvement, and technical assistance. IMPLICATIONS: Claims-based performance feedback can provide insight into patterns of patients' care across provider settings and opportunities for improvement, but practices need data from other sources to manage patients in real time or assess the short-term effects of specific changes in care delivery.

Should the Affordable Care Act's preventive services coverage provision be used to widely disseminate whole genome sequencing to Americans?

I argue that the provision of the Patient Protection and Affordable Care Act (ACA) of 2010, which eliminates cost sharing for preventive services, should be utilized as a pathway for reimbursing whole genome sequencing (WGS) and making it widely available to most Americans. This act provides multiple routes for determining which preventive services receive this designation. Three of these routes should be considered as pathways for reimbursing WGS, including approval by the United States Preventive Services Task Force, inclusion in the guidelines of the American Academy of Pediatrics Bright Futures Project, and classification as a preventive service for women by the Institute of Medicine. There are valid arguments against the expansion of this technology, including inadequate national and state laws prohibiting genetic discrimination, informed consent limitations, and potentially expensive genome interpretations. These concerns should not inhibit the wide dissemination of this technology, as current efforts by the NIH and industry to expand the use of genome sequencing demonstrate. The ACA should be used as a tool to prevent disparities in access to genome information in the United States and avoid the development of a two-tiered health system based on those with and without genome sequence data.

Toward better Alzheimer's research information sources for the public.

The National Plan to Address Alzheimer's Disease calls for a new relationship between researchers and members of the public. This relationship is one that provides research information to patients and allows patients to provide ideas to researchers. One way to describe it is a "bidirectional translational relationship." Despite the numerous sources of online and offline information about Alzheimer's disease, there is no information source which currently provides this interaction. This article proposes the creation an Alzheimer's research information source dedicated to monitoring Alzheimer's research literature and providing user friendly, publicly accessible summaries of data written specifically for a lay audience. This information source should contain comprehensive, updated, user friendly, publicly available, reviews of Alzheimer's research and utilize existing online multimedia/social networking tools to provide information in useful formats that help patients, caregivers, and researchers learn rapidly from one another.

Increasing the efficiency of medical research with dynamic research summaries for researchers and consumers.

Literature reviews are usually the first step in conducting medical research projects. They often lead to the creation of a useful research question. However, this initial step in medical research contains inefficiencies, which if removed, could speed up the research process and thereby enhance development of innovative health related products. In addition, existing research article databases offer information which is inaccessible to most lay consumers. This article proposes an alternative approach for allowing researchers to assess the state of research in a particular area called "dynamic research summaries." These summaries would offer a regularly updated narrative of existing research in any given area. They could increase the speed at which researchers of all levels review literature and develop useful research questions. In addition, this article proposes translating this information into a consumer friendly form that enhances the ability of non-expert consumers to review existing research relevant to their illness or a loved one's illness. This consumer friendly version could also be translated into other languages, such as Spanish in the US, to increase accessibility for minority groups that speak other languages more proficiently. Finally, the article discusses the potential of either the public or private sector leading efforts to develop dynamic research summaries for experts and consumers.

Associations between genetic variants in vitamin D metabolism and asthma characteristics in young African Americans: a pilot study.

INTRODUCTION: Low vitamin D levels have been associated with asthma severity in children. Young, urban African Americans (AAs) have high rates of hypovitaminosis D and asthma. Our objective was to determine associations between variants in vitamin D metabolism genes and asthma characteristics in a pilot study of young urban AAs. MATERIALS AND METHODS: Two urban AA cohorts of subjects aged 6 to 20 years (139 subjects with asthma and 74 subjects without asthma) were genotyped for 12 single nucleotide polymorphisms (SNPs) in 3 vitamin D metabolism genes: VDR (vitamin D receptor), CYP24A1 (cytochrome P450 vitamin D 24-hydroxylase), and CYP2R1 (cytochrome P450 vitamin D 25-hydroxylase). In a case-control analysis, SNPs were studied for associations with an asthma diagnosis. Within the asthmatic cohort, SNPs were analyzed for associations with quantitative asthma characteristics. All analyses were adjusted for age, sex, and body mass index percentile. RESULTS: Only the CYP2R1 SNP rs10766197 homozygous minor genotype was associated with asthma (P = 0.044). CYP24A1 SNP rs2248137 was associated with lower vitamin D levels (P = 0.006). Within the asthma cohort, multiple significant associations between SNPs and asthma characteristics were identified; VDR SNP rs2228570 was associated with the higher nighttime asthma morbidity scores (P = 0.04), lower baseline spirometric measures (P < 0.05), 1 or more positive aeroallergen skin test (P = 0.003), and increased immunoglobulin E levels (P < 0.001). DISCUSSION: This pilot study demonstrates that variants in vitamin D metabolism genes are associated with quantitative asthma characteristics in young, urban AAs. The collection of these associations provides evidence for the need for a large population-based study of vitamin D-relevant SNPs in this cohort.

Regional differences in awareness and attitudes regarding genetic testing for disease risk and ancestry.

Little is known about the lay public's awareness and attitudes concerning genetic testing and what factors influence their perspectives. The existing literature focuses mainly on ethnic and socioeconomic differences; however, here we focus on how awareness and attitudes regarding genetic testing differ by geographical regions in the US. We compared awareness and attitudes concerning genetic testing for disease risk and ancestry among 452 adults (41% Black and 67% female) in four major US cities, Norman, OK; Cincinnati, OH; Harlem, NY; and Washington, DC; prior to their participation in genetic ancestry testing. The OK participants reported more detail about their personal ancestries (p = 0.02) and valued ancestry testing over disease testing more than all other sites (p < 0.01). The NY participants were more likely than other sites to seek genetic testing for disease (p = 0.01) and to see benefit in finding out more about one's ancestry (p = 0.02), while the DC participants reported reading and hearing more about genetic testing for African ancestry than all other sites (p < 0.01). These site differences were not better accounted for by sex, age, education, self-reported ethnicity, religion, or previous experience with genetic testing/counseling. Regional differences in awareness and attitudes transcend traditional demographic predictors, such as ethnicity, age and education. Local sociocultural factors, more than ethnicity and socioeconomic status, may influence the public's awareness and belief systems, particularly with respect to genetics.

Compulsory service programmes for recruiting health workers in remote and rural areas: do they work?

Compulsory service programmes have been used worldwide as a way to deploy and retain a professional health workforce within countries. Other names for these programmes include "obligatory", "mandatory", "required" and "requisite." All these different programme names refer to a country's law or policy that governs the mandatory deployment and retention of a heath worker in the underserved and/or rural areas of the country for a certain period of time. This study identified three different types of compulsory service programmes in 70 countries. These programmes are all governed by some type of regulation, ranging from a parliamentary law to a policy within the ministry of health. Depending on the country, doctors, nurses, midwives and all types of professional allied health workers are required to participate in the programme. Some of the compliance-enforcement measures include withholding full registration until obligations are completed, withholding degree and salary, or imposing large fines. This paper aims to explain these programmes more clearly, to identify countries that have or had such programmes, to develop a typology for the different kinds and to discuss the programmes in the light of important issues that are related to policy concepts and implementation. As governments consider the cost of investment in health professionals' education, the loss of health professionals to emigration and the lack of health workers in many geographic areas, they are using compulsory service requirements as a way to deploy and retain the health workforce.

The role of genetic and sociopolitical definitions of race in clinical trials.

Although the concept of race has been disputed for decades, race continues to be used as a variable in biomedical research. Public Law 103-43 calls on the National Institutes of Health to develop guidelines for defining "minority group" and "their subpopulations" for the purposes of ensuring that they are included in clinical trials. Current guidelines use census racial categories, even though these categories are labeled as not scientific by their creator, the Office of Management and Budget. Three policy options exist for improving the National Institutes of Health Policy on Reporting Race and Ethnicity: (1) using genetic ancestry instead of census racial categories;(2) developing a standardized definition of race using current science; and(3) redefining minority group populations and subpopulations using social environment variables rather than census racial categories.

Genetic and social environment interactions and their impact on health policy.

Genetic and social factors are not as separate as once thought. Researchers within the social sciences are beginning to realize that genetics and the social environment interact synergistically to affect health behaviors and outcomes. This way of thinking is leading to new research models and is influencing the development of research initiatives. The importance of this gene-social environment paradigm is evident in current and proposed health policies, and future research likely will spur further questions related to various areas of public policy.