Selecting subjects for participation in clinical research: one sphere of justice.
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Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (+info)
Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association.
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PURPOSE: Minority accrual onto clinical trials is of significant interest to cooperative oncology study groups. The Eastern Cooperative Oncology Group (ECOG) conducted a study to identify barriers and solutions to African American accrual onto clinical trials. METHODS: We hypothesize that the National Medical Association (NMA) might provide insight into ways to increase minority participation and that ECOG might facilitate that participation. Four sites were selected in which NMA chapters existed and ECOG main institutions with less than half of the corresponding percentage of minorities in their communities entered trials for 1992. Fifteen workshops were conducted using discussions and open-ended, self-administered questionnaires. RESULTS: Seventy percent of NMA physicians cited mistrust of the research centers, fear of losing patients, and a lack of respect from ECOG institutions as the most important barriers to minority cancer patient referrals, compared with 30% for ECOG physicians. Sixty-nine percent of NMA and 43% of ECOG physicians cited a lack of information about specific trials. Nearly half of NMA physicians (47%) cited a lack of minority investigators as a barrier, compared with 4% of ECOG physicians. Solutions by both groups were improved communication (73%) and culturally relevant educational materials (40%). ECOG physicians cited more minority outreach staff as a potential solution (22% v 6%). NMA physicians cited increased involvement of referring physicians (44% v4%). CONCLUSION: NMA physicians who serve a significant sector of the African American population demonstrated a willingness to participate and work with a cooperative group effort to increase participation of minority patients and investigators. (+info)
Marijuana use among minority youths living in public housing developments.
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Youths residing in public housing developments appear to be at markedly heightened risk for drug use because of their constant exposure to violence, poverty, and drug-related activity. The purpose of this study was to develop and test a model of marijuana etiology with adolescents (N = 624) residing in public housing. African-American and Hispanic seventh graders completed questionnaires about their marijuana use, social influences to smoke marijuana, and sociodemographic and psychosocial characteristics. Results indicated that social influences, such as friends' marijuana use and perceived ease of availability of marijuana, significantly predicted both occasional and future use of marijuana. Individual characteristics such as antimarijuana attitudes and drug refusal skills also predicted marijuana use. The findings imply that effective prevention approaches that target urban youths residing in public housing developments should provide them with an awareness of social influences to use marijuana, correct misperceptions about the prevalence of marijuana smoking, and train adolescents in relevant psychosocial skills. (+info)
Library residencies and internships as indicators of success: evidence from three programs.
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This paper discusses post-master's degree internships in three very different organizations; the University of Illinois at Chicago, the National Library of Medicine, and the Library of Congress. It discusses the internships using several questions. Do the programs serve as a recruitment strategy? Do the programs develop key competencies needed by the participant or organization? Do the programs develop leaders and managers? Is acceptance into a program an indicator of future career success? A survey was mailed to 520 persons who had completed internships in one of the three programs. There was a 49.8% response rate. Responses to fifty-four questions were tabulated and analyzed for each program and for the total group. The results confirm the value of internships to the career of participants. (+info)
Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth.
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CONTEXT: Unintended pregnancy remains a major public health concern in the United States. Information on pregnancy rates among contraceptive users is needed to guide medical professionals' recommendations and individuals' choices of contraceptive methods. METHODS: Data were taken from the 1995 National Survey of Family Growth (NSFG) and the 1994-1995 Abortion Patient Survey (APS). Hazards models were used to estimate method-specific contraceptive failure rates during the first six months and during the first year of contraceptive use for all U.S. women. In addition, rates were corrected to take into account the underreporting of induced abortion in the NSFG. Corrected 12-month failure rates were also estimated for subgroups of women by age, union status, poverty level, race or ethnicity, and religion. RESULTS: When contraceptive methods are ranked by effectiveness over the first 12 months of use (corrected for abortion underreporting), the implant and injectables have the lowest failure rates (2-3%), followed by the pill (8%), the diaphragm and the cervical cap (12%), the male condom (14%), periodic abstinence (21%), withdrawal (24%) and spermicides (26%). In general, failure rates are highest among cohabiting and other unmarried women, among those with an annual family income below 200% of the federal poverty level, among black and Hispanic women, among adolescents and among women in their 20s. For example, adolescent women who are not married but are cohabiting experience a failure rate of about 31% in the first year of contraceptive use, while the 12-month failure rate among married women aged 30 and older is only 7%. Black women have a contraceptive failure rate of about 19%, and this rate does not vary by family income; in contrast, overall 12-month rates are lower among Hispanic women (15%) and white women (10%), but vary by income, with poorer women having substantially greater failure rates than more affluent women. CONCLUSIONS: Levels of contraceptive failure vary widely by method, as well as by personal and background characteristics. Income's strong influence on contraceptive failure suggests that access barriers and the general disadvantage associated with poverty seriously impede effective contraceptive practice in the United States. (+info)
Contraceptive failure, method-related discontinuation and resumption of use: results from the 1995 National Survey of Family Growth.
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CONTEXT: Half of all pregnancies in the United States are unintended. Of these, half occur to women who were practicing contraception in the month they conceived, and others occur when couples stop use because they find their method difficult or inconvenient to use. METHODS: Data from the 1995 National Survey of Family Growth were used to compute life-table probabilities of contraceptive failure for reversible methods of contraception, discontinuation of use for a method-related reason and resumption of contraceptive use. RESULTS: Within one year of starting to use a reversible method of contraception, 9% of women experience a contraceptive failure--7% of those using the pill, 9% of those relying on the male condom and 19% of those practicing withdrawal. During a lifetime of use of reversible methods, the typical woman will experience 1.8 contraceptive failures. Overall, 31% of women discontinue use of a reversible contraceptive for a method-related reason within six months of starting use, and 44% do so within 12 months; however, 68% resume use of a method within one month and 76% do so within three months. Multivariate analyses show that the risk of contraceptive failure is elevated among low-income women and Hispanic women. Low-income women are also less likely than other women to resume contraceptive use after discontinuation. CONCLUSIONS: The risks of pregnancy during typical use of reversible methods of contraception are considerably higher than risks of failure during clinical trials, reflecting imperfect use of these methods rather than lack of inherent efficacy. High rates of method-related discontinuation probably reflect dissatisfaction with available methods. (+info)
Risk for metabolic control problems in minority youth with diabetes.
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OBJECTIVE: We examined and quantified the degree of risk for poor glycemic control and hospitalizations for diabetic ketoacidosis (DKA) among black, Hispanic, and white children and adolescents with diabetes. RESEARCH DESIGN AND METHODS: We examined ethnic differences in metabolic control among 68 black, 145 Hispanic, and 44 white children and adolescents with type 1 diabetes (mean age 12.9 [range 1-21] years), who were primarily of low socioeconomic status. Clinical and demographic data were obtained by medical chart review. Glycohemoglobins were standardized and compared across ethnic groups. Odds ratios among the ethnic groups for poor glycemic control and hospitalizations for DKA were also calculated. RESULTS: The ethnic groups were not different with respect to age, BMI, insulin dose, or hospitalizations for DKA, but black children were older at the time of diagnosis than Hispanics (P < 0.05) and were less likely to have private health insurance than white and Hispanic children (P < 0.001). Black youths had higher glycohemoglobin levels than white and Hispanic youths (P < 0.001 after controlling for age at diagnosis). Black youths were also at greatest risk for poor glycemic control (OR = 3.9, relative to whites; OR = 2.5, relative to Hispanics). CONCLUSIONS: These results underscore and quantify the increased risk for glycemic control problems of lower-income, black children with diabetes. In the absence of effective intervention, these youths are likely to be overrepresented in the health care system as a result of increased health complications related to diabetes. (+info)
Racial bias in federal nutrition policy, Part II: Weak guidelines take a disproportionate toll.
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Many diet-related chronic diseases take a disproportionate toll among members of racial minorities. Research shows the prevalence of diabetes, hypertension, cancer, and heart disease is higher among various ethnic groups compared with whites. The Guidelines and the Food Guide Pyramid, however, promote the use of multiple servings of meats and dairy products each day and do not encourage replacing these foods with vegetables, legumes, fruits, and grains. The Dietary Guidelines for Americans encourage a 30% caloric reduction in fat intake and make no provision for further reductions for those who wish to minimize health risks. Abundant evidence has shown that regular exercise combined with diets lower in fat and richer in plant products than is encouraged by the Dietary Guidelines for Americans are associated with reduced risk of these chronic conditions. While ineffective Dietary Guidelines potentially put all Americans at unnecessary risk, this is particularly true for those groups hardest hit by chronic disease. (+info)