Minority recruitment into clinical trials: experimental findings and practical implications.

Racial and ethnic minorities in the US suffer disproportionately from obesity and related comorbidities, yet remain underrepresented in health research. To date, research on practical strategies to improve minority reach and recruitment into clinical trials is primarily descriptive rather than experimental. Within a randomized behavioral weight management trial for obese women, this recruitment experiment examined whether two characteristics of direct mail letters, an ethnically-targeted statement and personalization, increased the response rate among minority women. The ethnically-targeted statement noted ethnic-specific information about health risks of obesity. Personalized letters included recipients' names/addresses in the salutation and a handwritten signature on high-quality letterhead. Of women sent direct mail letters (N=30,000), those sent letters with the ethnically-targeted statement were more likely to respond than women sent letters with the generic statement, 0.8% (n=121) vs. 0.6% (n=90) respectively, p=.03, a 34.4% increase. Women sent personalized letters were no more likely to respond than women sent non-personalized letters, p=.53. In the weight management trial itself, of 267 women randomized into the trial, 33.7% (n=90) were minorities. Of minority women randomized into the trial, 68.9% (n=62) were recruited by direct mail letters: 75.8% (n=47) of those were sent a letter and 24.2% (n=15) were referred by friends/family who were sent a letter. The results indicate that a simple modification to a standard recruitment letter can have a meaningful impact on minority reach and recruitment rates. Practical implications include using ethnically-targeted, non-personalized direct mail letters and recruiting through friends/family at no additional cost.

Are cancer registries unconstitutional?

Population-based cancer registration, mandated throughout the United States, is central to quantifying the breadth and impact of cancer. It facilitates research to learn what causes cancer to develop and, in many cases, lead to death. However, as concerns about privacy increase, cancer registration has come under question. Recently, its constitutionality was challenged on the basis of 1) the vagueness of statutory aims to pursue public health versus the individual privacy interests of cancer patients, and 2) the alleged indignity of one's individual medical information being transmitted to government authorities. Examining cancer registry statutes in states covered by the US National Cancer Institute's SEER Program and the US Centers for Disease Control and Prevention's National Program of Cancer Registries, we found that cancer registration laws do state specific public health benefits, and offer reasonable limits and safeguards on the government's possession of private medical information. Thus, we argue that cancer registration would survive constitutional review, is compatible with the civil liberties protected by privacy rights in the U.S., satisfies the conditions that justify public health expenditures, and serves human rights to enjoy the highest attainable standards of health, the advances of science, and the benefits of government efforts to prevent and control disease.

Research 2.0: social networking and direct-to-consumer (DTC) genomics.

The convergence of increasingly efficient high throughput sequencing technology and ubiquitous Internet use by the public has fueled the proliferation of companies that provide personal genetic information (PGI) direct-to-consumers. Companies such as 23andme (Mountain View, CA) and Navigenics (Foster City, CA) are emblematic of a growing market for PGI that some argue represents a paradigm shift in how the public values this information and incorporates it into how they behave and plan for their futures. This new class of social networking business ventures that market the science of the personal genome illustrates the new trend in collaborative science. In addition to fostering a consumer empowerment movement, it promotes the trend of democratizing information--openly sharing of data with all interested parties, not just the biomedical researcher--for the purposes of pooling data (increasing statistical power) and escalating the innovation process. This target article discusses the need for new approaches to studying DTC genomics using social network analysis to identify the impact of obtaining, sharing, and using PGI. As a locus of biosociality, DTC personal genomics forges social relationships based on beliefs of common genetic susceptibility that links risk, disease, and group identity. Ethical issues related to the reframing of DTC personal genomic consumers as advocates and research subjects and the creation of new social formations around health research may be identified through social network analysis.

Direct-to-consumer advertising in black and white: racial differences in placement patterns of print advertisements for health products and messages.

If direct-to-consumer advertising (DTCA) increases consumer participation in healthcare, then it may provide a useful strategy for addressing health disparities, in part, where patient-level barriers have contributed to such disparities. However, this presumes equitable access to DTCA. Using mixed methods, we explored advertisement patterns in matched African American and general audience magazines across a range of genres and ad types. Results suggest no significant differences in ad frequencies by race. However other meaningful categorical and qualitative differences were found, suggesting that advertisers may fall short in maximizing DTCA as an adjunctive strategy for empowering populations at risk for health disparities.

Creating a segregated medical profession: African American physicians and organized medicine, 1846-1910.

An independent panel of experts, convened by the American Medical Association (AMA) Institute for Ethics, analyzed the roots of the racial divide within American medical organizations. In this, the first of a 2-part report, we describe 2 watershed moments that helped institutionalize the racial divide. The first occurred in the 1870s, when 2 medical societies from Washington, DC, sent rival delegations to the AMA's national meetings: an all-white delegation from a medical society that the US courts and Congress had formally censured for discriminating against black physicians; and an integrated delegation from a medical society led by physicians from Howard University. Through parliamentary maneuvers and variable enforcement of credentialing standards, the integrated delegation was twice excluded from the AMA's meetings, while the all-white society's delegations were admitted. AMA leaders then voted to devolve the power to select delegates to state societies, thereby accepting segregation in constituent societies and forcing African American physicians to create their own, separate organizations. A second watershed involved AMA-promoted educational reforms, including the 1910 Flexner report. Straightforwardly applied, the report's population-based criterion for determining the need for phySicians would have recommended increased training of African American physicians to serve the approximately 9 million African Americans in the segregated south. Instead, the report recommended closing all but 2 African American medical schools, helping to cement in place an African American educational system that was separate, unequal, and destined to be insufficient to the needs of African Americans nationwide.

Segregation, civil rights, and health disparities: the legacy of African American physicians and organized medicine, 1910-1968.

Between 1910 and 1968, the National Medical Association (NMA) repeatedly clashed with the American Medical Association (AMA) over the latter organization's racial bars to membership and other health policy issues. The NMA, founded in 1895 as a nonexclusionary medical society to provide a voice for disenfranchised black physicians and patients, struggled in its early years, during which AMA leadership took scant notice of it. But skirmishes ensued over such actions as stigmatizing racial labels in the AMA's American Medical Directory, which, beginning in 1906, listed all U.S. physicians but designated African Americans with the notation col. The NMA also repeatedly asked the AMA to take action against overt racial bars on blacks' membership in its constituent state and county societies. During the civil rights era, African American physicians received no AMA support in seeking legal remedies to hospital segregation. And the NMA and AMA found themselves opposed on other policy issues, including Medicaid and Medicare. These differences eventually catalyzed a series of direct confrontations. The 1965 AMA meeting in New York City, for example, was protested by about 200 NMA-led picketers. The NMA's quest for racial equality in medicine was supported by some other medical organizations, such as the Medical Committee for Human Rights. In 1966, the AMA House voted to amend the AMA Constitution and Bylaws, giving its Judicial Council (now the Council on Ethical and Judicial Affairs) the authority to investigate allegations of discrimination. This paved the way for a subsequent era of increasing cooperation and understanding.

Use of neurodevelopmental delay in pediatric solid organ transplant listing decisions: inconsistencies in standards across major pediatric transplant centers.

Children with NDD present for organ transplant evaluation, but the role of NDD as a listing criterion itself is poorly described. Therefore, we sought to investigate how major pediatric solid organ transplant programs use NDD as a criterion in their listing decisions. We developed a survey that was sent via post to active pediatric solid organ transplant programs across the United States investigating transplant listing decision-making for neurodevelopmentally delayed children. Respondents were medical/surgical directors and transplant coordinators. Descriptive statistics summarize the findings. Programs inconsistently use NDD in listing decisions. Thirty-nine percent of programs stated that they "rarely" or "never" consider NDD in their decisions, whereas 43% of programs "always" or "usually" do. Sixty-two percent of programs report that informal processes guide their use of NDD, and no programs describe their process as "formal, explicit, and uniform." The degree of delay is an additional source of discordance among programs, with 14% of programs reporting mild or moderate NDD as a relative contraindication to listing and 22% reporting that NDD was "irrelevant" to the listing decision. The use of NDD in pediatric solid organ transplant listing decisions is varied and inconsistent across active programs.

Perceived medical discrimination and cancer screening behaviors of racial and ethnic minority adults.

BACKGROUND: Discrimination has been shown as a major causal factor in health disparities, yet little is known about the relationship between perceived medical discrimination (versus general discrimination outside of medical settings) and cancer screening behaviors. We examined whether perceived medical discrimination is associated with lower screening rates for colorectal and breast cancers among racial and ethnic minority adult Californians. METHODS: Pooled cross-sectional data from 2003 and 2005 California Health Interview Survey were examined for cancer screening trends among African American, American Indian/Alaskan Native, Asian, and Latino adult respondents reporting perceived medical discrimination compared with those not reporting discrimination (n = 11,245). Outcome measures were dichotomous screening variables for colorectal cancer among respondents ages 50 to 75 years and breast cancer among women ages 40 to 75 years. RESULTS: Women perceiving medical discrimination were less likely to be screened for colorectal [odds ratio (OR), 0.66; 95% confidence interval (95% CI), 0.64-0.69] or breast cancer (OR, 0.52; 95% CI, 0.51-0.54) compared with women not perceiving discrimination. Although men who perceived medical discrimination were no less likely to be screened for colorectal cancer than those who did not (OR, 1.02; 95% CI, 0.97-1.07), significantly lower screening rates were found among men who perceived discrimination and reported having a usual source of health care (OR, 0.30; 95% CI, 0.28-0.32). CONCLUSIONS: These findings of a significant association between perceived racial or ethnic-based medical discrimination and cancer screening behaviors have serious implications for cancer health disparities. Gender differences in patterns for screening and perceived medical discrimination warrant further investigation.

Racial, cultural, and ethnic factors influencing end-of-life care.

Past efforts in the palliative and end-of-life care field have been laudably directed at increasing the cultural competence of providers and institutions and improving outreach to multicultural communities. Today, however, we face new challenges with regard to racial, cultural, and ethnic factors at the end of life. We now have documented evidence of disparities in almost every area of health care. In addition, breakthroughs in genomics research, including "race-based therapeutics," have redefined the meaning of our human differences. These trends, unfolding in an increasingly polarized post-9/11 world, greatly challenge our understanding of concepts of race, culture, and ethnicity. By definition, when considering these concepts, our focus shifts from the individual to that of group membership. In turn, this suggests using a population-based or epidemiological approach, which at once reveals inequalities and inequities in mortality patterns across diverse groups. Understanding and serving the needs of specific populations requires us to apply a framework of equity and to consider strategies to eliminate disparities. These include identifying sources of bias and discrimination in health care; enhancing the collection of racial, ethnic, and other demographic data; and increasing the representation of a range of diverse population groups in well designed qualitative and quantitative research. Using an epidemiological framework does not suggest, however, that we lose sight of dying individuals and their families. At the end of life, an individualized approach to care with a focus on quality is paramount for any patient, regardless of racial, ethnic, or cultural background.

Qualitative methods in end-of-life research: recommendations to enhance the protection of human subjects.

Qualitative research has the potential to contribute important new knowledge to care near the end of life, but research is often hampered by questions about how best to protect dying patients and their family members who serve as research subjects. Due to lack of familiarity with the techniques of ethnographic or observational research, as well as concerns about the vulnerability of the dying, members of Institutional Review Boards (IRBs) are often unable to evaluate the benefits and potential harms of studies. In addition, policies derived from standards based on interventional medical research or clinical trials may be applied inappropriately. We offer comprehensive recommendations aimed at improving the translation of human subjects guidelines into meaningful protections for subjects in qualitative studies, including education for IRBs. Policies must be flexible and should be guided by empirical findings documenting the actual impact of research participation, rather than a priori assumptions about patient vulnerability. Sensitive topics, such as drug use, may require added protections.

Strategies for culturally effective end-of-life care.

As a result of profound worldwide demographic change, physicians will increasingly care for patients from cultural backgrounds other than their own. Differences in beliefs, values, and traditional health care practices are of particular relevance at the end of life. Health care providers and patients and families may not have shared understandings of the meaning of illness or death and may not agree on the best strategies to plan for the end of life or to alleviate pain and suffering. Good end-of-life care may be complicated by disagreements between physicians and patients, difficult interactions, or decisions the physician does not understand. Challenges may result from cultural differences between the patient's background and traditional medical practice. Values so ingrained in physicians as to be unquestioned may be alien to patients from different backgrounds. Physicians need to be sensitive to cultural differences and to develop the skills necessary to work with patients from diverse backgrounds. Community and cultural ties provide a source of great comfort as patients and families prepare for death. This paper describes two cases that raise issues about cross-cultural end-of-life practice and suggests strategies for negotiating common problems. Physicians should assess the cultural background of each patient and inquire about values that may affect care at the end of life. They should become aware of the specific beliefs and practices of the populations they serve, always remembering to inquire whether an individual patient adheres to these cultural beliefs. Attention to cultural difference enables the physician to provide comprehensive and compassionate palliative care at the end of life.