Summary

To develop a survey, the Bioethicai Issues in Biostatistical Consulting Questionnaire, for investigating bioethical issues in analysis, a comprehensive literature review was conducted to specify areas of bioethics. Through a focus group study and the evaluation by 10 biostatisticians, the questionnaire was constructed. Validation must involve a panel of experts. Now, test-retest reliability and factor analysis should be conducted on a group of eligible subjects.

The purpose of this community-based participatory study was to identify factors associated with colorectal cancer (CRC) screening compliance and non-compliance among Cambodians, Vietnamese, Koreans and Chinese men and women 50 years and older living in the United States. A cross-sectional design was used in the study. The completed sample included 815 Asian Americans which included Cambodians (N=215), Vietnamese (N=195), Koreans (N=94) and Chinese (N=311). A 95-item questionnaire was developed and pilot tested for content validity and reliability. An in-person data collection approach was utilized and participants were given choice in responding in English or their native language. Of the 815 participants, 79.1% (N=645) reported never-screened, 7.9% (N=64), non-compliance, and 13.0% (N=106) compliance. Education was significantly associated with never-screened for CRC for Vietnamese and Chinese; employment status for Cambodians and Koreans; lack of health insurance for Cambodians, Korean and Chinese; English fluency and years lived in the U.S. for Vietnamese, Koreans, and Chinese. Less acculturated Asian Americans were more likely to be never screened, but differentially across ethnic subgroups. Barriers to screening included lack of knowledge, language, transportation, and time. Increased culturally-targeted public awareness and education programs are needed to improve CRC screening and compliance among high risk Asian American ethnic subgroups.

Objective

Informatics applications have the potential to improve participation in clinical trials, but their design must be based on user-centered research. This research used a fully counterbalanced experimental design to investigate the effect of changes made to the original version of a website, http://BreastCancerTrials.org/, and confirm that the revised version addressed and reinforced patients' needs and expectations.

Design

Participants included women who had received a breast cancer diagnosis within the last 5 years (N=77). They were randomized into two groups: one group used and reviewed the original version first followed by the redesigned version, and the other group used and reviewed them in reverse order.

Measurements

The study used both quantitative and qualitative measures. During use, participants' click paths and general reactions were observed. After use, participants were asked to answer survey items and open-ended questions to indicate their reactions and which version they preferred and met their needs and expectations better.

Results

Overall, the revised version of the site was preferred and perceived to be clearer, easier to navigate, more trustworthy and credible, and more private and safe overall. However, users who viewed the original version last had similar attitudes toward both versions.

Conclusion

By applying research findings to the redesign of a website for clinical trial searching, it was possible to re-engineer the interface to better support patients' decisions to participate in clinical trials. The mechanisms of action in this case appeared to revolve around creating an environment that supported a sense of personal control and decisional autonomy.

This report explores the level of detailed knowledge about the Tuskegee Syphilis Study (TSS) among 848 Blacks and Whites in three U.S. cities across an array of demographic variables. The Tuskegee Legacy Project (TLP) Questionnaire was used, which was designed to explore the willingness of minorities to participate in biomedical studies. A component of the TLP Questionnaire, the TSS Facts & Myths Quiz, consisting of seven yes/no factual questions, was used to establish respondents’ level of detailed knowledge on the TSS. Both Blacks and Whites had similar very low mean quiz score on the 7-point scale, with Blacks’ scores being slightly higher than Whites (1.2 vs. 0.9, p = .003). When analyzing the level of knowledge between racial groups by various demographic variables, several patterns emerged: (a) higher education levels were associated with higher levels of detailed knowledge and (b) for both Blacks and Whites, 30 to 59 years old knew the most about TSS compared with younger and older adult age groups. The findings show that much of the information that circulates in the Black and White communities about the TSS is false, often minimizing or understating the most egregious injustices that occurred. Health promotion and educational implications of these findings are offered and conclude that the findings should be used as a catalyst to explore local realities and sentiments regarding participation in biomedical research within the research philosophy and framework of community-based participatory research.

Background

The relative effects of race/ethnicity and other sociodemographic factors, compared to those of attitudes and beliefs on willingness to have cancer screening, are not well understood.

Methods

We conducted telephone interviews with 1148 adults (31% African American, 27% Puerto Rican American, 43% white) from 3 cities in mainland United States and Puerto Rico. Respondents reported their sociodemographic characteristics, attitudes about barriers and facilitators of cancer screening, and willingness to have cancer screening under 4 scenarios: when done in the community vs one’s doctor’s office, and whether or not one had symptoms.

Results

Racial/ethnic minority status, age, and lower income were frequently associated with increased willingness to have cancer screening, even after including attitudes and beliefs about screening. Having screening nearby was important for community screening, and anticipation of embarrassment from screening for when there were no cancer symptoms. Associations varied across 4 screening scenarios, with the fewest predictors for screening by one’s doctor when there were symptoms.

Conclusions

Sociodemographic characteristics not only were related to willingness to have cancer screenings in almost all cases, but were generally much stronger factors than attitudinal barriers and facilitators. Cancer screening campaigns should affect attitudinal change where possible, but should also recognize that targeting screening to specific population groups may be necessary.

Purpose

To examine the influence of sex and race on the effects of strength training (ST) on thigh muscle volume (MV), midthigh subcutaneous fat (SCF), and intermuscular fat (IMF).

Methods

One hundred eighty-one previously inactive healthy Caucasian (N = 117) and African American (N = 54) men (N = 82) and women (N = 99), aged 50–85 yr, underwent about 10 wk of unilateral knee extension ST. Ten subjects were neither Caucasian nor African American and were, therefore, not included in the race analysis. Quadriceps MV and midthigh SCF and IMF cross-sectional area were measured with computed tomography before and after ST. Sex and race comparisons were made with a 2 × 2 (sex by race) analysis of covariance.

Results

Training-induced increases in absolute MV were significantly greater (P < 0.001) in men than in women, though both sex groups increased MV significantly with ST (P < 0.001), and the relative (%) increases were similar. There were significant increases in MV within race groups (P < 0.001), but no significant differences between races. There were no significant changes in SCF or IMF, whether sex and racial groups were separated or combined. In addition, there was no sex by race interaction for changes in MV, SCF, or IMF with ST.

Conclusion

Strength training does not alter subcutaneous or intermuscular fat, regardless of sex or racial differences. Although men exhibit a greater muscle hypertrophic response to strength training than do women, the difference is small. Race does not influence this response.

Abstract

Background

Given the history of vulnerability of women of childbearing age to medical treatments that have caused injury, for example, diethylstilbestrol (DES) and thalidomide, it is surprising that, to date, little research has directly examined attitudes of the general public regarding the vulnerability of women when they participate in biomedical research studies.

Methods

We asked three questions about beliefs of women as biomedical research subjects of 623 white, 353 black, and 157 Hispanic people in four U.S. cities: (1) Do you believe that women are more likely to be “taken advantage of” when they become subjects in a medical research project as compared to men? (2) Do you believe that women of childbearing age (15–45-year-olds) should become study participants in medical research projects? and, if the response was no or don't know/not sure, (3) Would you still say no or don't know/not sure to question 2 even if it meant that we would not know anything about the health and medical treatments for women aged 15–45 years?

Results

Overall, women were 60% more likely than men to state that women were more likely than men to be “taken advantage of,” even when controlling for potential confounders, and both black and Hispanic participants were much more likely than white participants to state that this was the case. The majority of respondents (57.4%) said that women of childbearing age should not be research subjects; among women, both black and Hispanic people were less likely than white people to change their minds when prompted that this might mean that “nothing would be known about the health and medical treatments for women aged 15–45 years.”

Conclusions

A substantial proportion of the participants reported knowledge of historical events, and this knowledge was related, particularly in black participants, to attitudes toward vulnerability of women as biomedical research subjects.

The purpose of this follow-up 2003 3-City Tuskegee Legacy Project (TLP) Study was to validate or refute our prior findings from the 1999–2000 4 City TLP Study, which found no evidence to support the widely acknowledged “legacy” of the Tuskegee Syphilis Study (TSS), ie, that blacks are reluctant to participate in biomedical studies due to their knowledge of the TSS. The TLP Questionnaire was administered in this random-digit-dial telephone survey to a stratified random sample of 1162 black, white, and Puerto Rican Hispanic adults in 3 different US cities. The findings from this current 3-City TLP Study fail to support the widely acknowledged “legacy” of the TSS, as awareness of the TSS was not statistically associated with the willingness to participate in biomedical studies. These findings, being in complete agreement with our previous findings from our 1999–2000 4-City TLP, validate those prior findings.

Background

In the United States, blacks and Hispanics have lower cancer screening rates than whites have. Studies on the screening behaviors of minorities are increasing, but few focus on the factors that contribute to this discrepancy. This study presents the self-reported willingness by blacks, Puerto Rican Hispanics, and non-Hispanic whites to participate in cancer screenings in differing cancer screening situations.

Methods

The Cancer Screening Questionnaire (CSQ), a 60-item questionnaire, was administered via random-digit-dial telephone interviews to adults in three cities: Baltimore, Maryland; New York, New York; and, San Juan, Puerto Rico.

Results

The 1,148 participants in the CSQ study sample consisted of 355 blacks, 311 Puerto Rican Hispanics, and 482 non-Hispanic whites. Response rates ranged from 45% to 58% by city. Multivariable logistic regression analyses revealed that blacks and Puerto Ricans were often more likely (OR 2.0-3.0) and never less likely than whites to self-report willingness to participate in cancer screenings regardless of who conducted the cancer screening, what one was asked to do in the cancer screening, or what type of cancer was involved (with the exception of skin cancer where blacks, compared with whites, had an OR of 0.5).

Conclusions

The findings from this study provide evidence that blacks and Hispanics self-report that they are either as willing or more willing than whites to participate in cancer screening programs.

Background

This analysis was conducted to determine whether there is a difference among blacks, Hispanics, and whites in their perception of risks associated with participating in either a biomedical study or a cancer screening.

Methods

The Tuskegee Legacy Project Questionnaire, which focused on research subject participation, was administered in two different surveys (1999-2000 and 2003) in seven cities. The Cancer Screening Questionnaire was administered in 2003 in three cities.

Results

The study sample across the three surveys consisted of 1,064 blacks, 781 Hispanics, and 1,598 non-Hispanic whites. Response rates ranged from 44% to 70% by city. Logistic regression analyses, adjusted for age, sex, education, income, and city, revealed that blacks and Hispanics each self-reported that minorities, compared with whites, are more likely to be “taken advantage of” in biomedical studies and much less likely to get a “thorough and careful examination” in a cancer screening (odds ratios ranged from 3.6 to 14.2).

Conclusions

Blacks and Hispanics perceive equally high levels of risk for participating in cancer screening examinations and for volunteering to become research subjects in biomedical studies. This perception provides a strong message about the need to overtly address this critical health disparities issue.

In endothelial cells, NF-κB is an important intracellular signaling molecule by which changes in wall shear stress are transduced into the nucleus to initiate downstream endothelial nitric oxide synthase (NOS3) gene expression. We investigated whether NF-κ light-chain gene enhancer in B cells 1 (NFKB1) promoter polymorphism (−94NFKB1 I/D, where I is the insertion allele and D is the deletion allele) was associated with 1) NOS3 gene expression in endothelial cells under physiological levels of unidirectional laminar shear stress (LSS) and 2) endothelial function in prehypertensive and stage I hypertensive individuals before and after a 6-mo supervised endurance exercise intervention. Competitive EMSAs revealed that proteins present in the nuclei of endothelial cells preferentially bound to the I allele NFKB1 promoter compared with the D allele. Reporter gene assays showed that the I allele promoter had significantly higher activity than the D allele. In agreement with these observations, homozygous II genotype cells had higher p50 expression levels than homozygous DD genotype cells. Cells with the homozygous II genotype showed a greater increase in NOS3 protein expression than did homozygous DD genotype cells under LSS. Functional experiments on volunteers confirmed higher baseline reactive hyperemic forearm blood flow, and, furthermore, the subgroup analysis revealed that DD homozygotes were significantly less prevalent in the exercise responder group compared with II and ID genotypes. We conclude that the −94NFKB1 I/D promoter variation contributes to the modulation of vascular function and adaptability to exercise-induced flow shear stress, most likely due to differences in NFKB1 gene transactivity.

Objectives

The specific aim of this study was to determine the self-reported likelihood of New York Puerto Ricans (NYPR) and San Juan Puerto Ricans (SJPR) to participate in: 10 site-specific cancer screenings, cancer-screenings conducted by different specific persons/agencies and cancer-screening under specific conditions of what one was asked to do as a part of cancer screening.

Methods

The Cancer Screening Questionnaire (CSQ) was administered via random-digit-dial telephone interviews to 154 adults living in San Juan, PR and 155 in New York, NY.

Results

Although the self-reported willingness to participate across the 10 site-specific cancer screening exams was consistently high in both cities, SJPR had higher rates, as compared to NYPR for all 10 site-specific cancer screening exams in the unadjusted analyses. A similar pattern was observed regarding the influence of both “who conducts the cancer-screening exam” and “what one is asked to do in a cancer-screening exam” as factors in the willingness to participate in such exams. Adjusted multivariate analysis showed that the odds of SJPR participating in skin cancer screening as compared to NYPR, were three-fold higher to participate in skin cancer screening and were two-fold higher to participate in a cancer screening where they have to be interviewed about their alcohol habits. These two observed differences might reflect the effect of acculturation in the NYPR.

Objectives

The purposes of this analysis were to compare the self-reported willingness of blacks, Puerto-Rican Hispanics and whites to participate as research subjects in biomedical studies, and to determine the reliability of the Tuskegee Legacy Project Questionnaire (TLP).

Methods

The TLP Questionnaire, initially used in a four-city study in 1999–2000, was administered in a follow-up study within a random-digit-dial telephone survey to a stratified random sample of adults in three different U.S. cities: Baltimore, MD; New York City; and San Juan, PR. The questionnaire, a 60-item instrument, contains two validated scales: the Likelihood of Participation (LOP) Scale and the Guinea Pig Fear Factor (GPFF) Scale.

Results

Adjusting for age, sex, education, income and city, the LOP Scale was not statistically significantly different for the racial/ethnic groups (ANCOVA, p=87). The GPFF Scale was statistically significantly higher for blacks and Hispanics as compared to whites (adjusted ANCOVA, p<0.001).

Conclusions

The of the findings from the current three-city study, as well as from our prior four-city study, are remarkably similar and reinforce the conclusion that blacks and Hispanics self-report that, despite having a higher fear of participation, they are just as likely as whites to participate in biomedical research.

OBJECTIVES: The present study aims to examine the relationship between substance use and HIV/sexually transmitted disease (STD)-related sexual risk behaviors among a national sample of sexually active adolescents in rural settings. METHODS: Participants included 9th-12th grade rural adolescents (N=5,745) who completed the 2003 national Youth Risk Behavior Survey. The independent variables were six substance use behaviors, including alcohol, marijuana, tobacco and cocaine use. The dependent variables were unprotected sex and the number of recent sexual partners. Univariate and multivariate logistic regression models were examined. RESULTS: Smoking > or =3 days during the past 30 days was associated with unprotected sex. Alcohol or drug use before last sexual intercourse, having ever used marijuana, having ever used cocaine and drinking alcohol during the past 30 days were associated with having multiple sexual partners. CONCLUSIONS: Results from the current study highlighted the need to provide youth with increased STD/HIV prevention knowledge in rural areas. Our finding confirmed that in order to achieve more effective STD/HIV prevention among high-risk substance-abusing youth, more intensive and better-tailored efforts will be needed to promote sexual risk reduction.

OBJECTIVES: The purposes of this analysis were to compare the self-reported willingness of blacks, Puerto-Rican Hispanics and whites to participate as research subjects in biomedical studies, and to determine the reliability of the Tuskegee Legacy Project Questionnaire (TLP). METHODS: The TLP Questionnaire, initially used in a four-city study in 1999-2000, was administered in a follow-up study within a random-digit-dial telephone survey to a stratified random sample of adults in three different U.S. cities: Baltimore, MD; New York City; and San Juan, PR. The questionnaire, a 60-item instrument, contains two validated scales: the Likelihood of Participation (LOP) Scale and the Guinea Pig Fear Factor (GPFF) Scale. RESULTS: Adjusting for age, sex, education, income and city, the LOP Scale was not statistically significantly different for the racial/ethnic groups (ANCOVA, p=87). The GPFF Scale was statistically significantly higher for blacks and Hispanics as compared to whites (adjusted ANCOVA, p<0.001). CONCLUSIONS: The of the findings from the current three-city study, as well as from our prior four-city study, are remarkably similar and reinforce the conclusion that blacks and Hispanics self-report that, despite having a higher fear of participation, they are just as likely as whites to participate in biomedical research.

This 6-week study was conducted to evaluate the effects of seven different levels of dietary chromium (Cr) (0, 75, 150, 300, 450, 600, and 1 200 ppb Cr) in the form of Cr nanoparticle (CrNano) on growth, body composition, serum hormones and tissue Cr in Sprague-Dawley (SD) rats. Seventy male SD rats (average initial body weight of (83.2±4.4) g) were randomly assigned to seven dietary treatments (n=10). At the end of the trial, body composition was assessed via dual energy X-ray absorptiometry (DEXA). All rats were then sacrificed to collect samples of blood, organs and tissues for determination of serum hormones and tissue Cr contents. The results indicated that lean body mass was significantly increased (P<0.05) due to the addition of 300 and 450 ppb Cr from CrNano. Supplementation of 150, 300, 450, and 600 ppb Cr decreased (P<0.05) percent body fat significantly. Average daily gain was increased (P<0.05) by addition of 75, 150, and 300 ppb Cr and feed efficiency was increased (P<0.05) by supplementation of 75, 300, and 450 ppb Cr. Addition of 300 and 450 ppb Cr decreased (P<0.05) the insulin level in serum greatly. Cr contents in liver and kidney were greatly increased (P<0.05) by the addition of Cr as CrNano in the dosage of from 150 ppb to 1 200 ppb. In addition, Supplementation of 300, 450, and 600 ppb Cr significantly increased (P<0.05) Cr content in the hind leg muscle. These results suggest that supplemental CrNano has beneficial effects on growth performance and body composition, and increases tissue Cr concentration in selected muscles.

OBJECTIVES: The specific aim of this study was to determine the self-reported likelihood of New York Puerto Ricans (NYPR) and San Juan Puerto Ricans (SJPR) to participate in: 10 site-specific cancer screenings, cancer-screenings conducted by different specific persons/agencies and cancer-screening under specific conditions of what one was asked to do as a part of cancer screening. METHODS: The Cancer Screening Questionnaire (CSQ) was administered via random-digit-dial telephone interviews to 154 adults living in San Juan, PR and 155 in New York, NY. RESULTS: Although the self-reported willingness to participate across the 10 site-specific cancer screening exams was consistently high in both cities, SJPR had higher rates, as compared to NYPR for all 10 site-specific cancer screening exams in the unadjusted analyses. A similar pattern was observed regarding the influence of both "who conducts the cancer-screening exam" and "what one is asked to do in a cancer-screening exam" as factors in the willingness to participate in such exams. Adjusted multivariate analysis showed that the odds of SJPR participating in skin cancer screening as compared to NYPR, were three-fold higher to participate in skin cancer screening and were two-fold higher to participate in a cancer screening where they have to be interviewed about their alcohol habits. These two observed differences might reflect the effect of acculturation in the NYPR.

Objective

To test the Sociocultural Health Behavior Model in relation to the health behavior of prostate cancer (PCa) screening among Chinese American men.

Methods

Confirmatory factor analysis and structural equation model analyses were conducted among Chinese American men.

Results

The path analysis supported the components of the sociocultural model and indicated a positive and significant relationship between PCa screening and the enabling factors; between cultural factors and predisposing, enabling, and access/satisfaction with health care factors; and between enabling factors and access/satisfaction with health care.

Conclusions

The model highlights the significance that sociocultural factors play in relation to PCa screening.

Objectives

We compared the influence of awareness of the Tuskegee Syphilis Study and the presidential apology for that study on the willingness of Blacks, non-Hispanic Whites, and Hispanics to participate in biomedical research.

Methods

The Tuskegee Legacy Project Questionnaire was administered to 1133 adults in 4 US cities. This 60-item questionnaire addressed issues related to the recruitment of minorities into biomedical studies.

Results

Adjusted multivariate analysis showed that, compared with Whites, Blacks were nearly 4 times as likely to have heard of the Tuskegee Syphilis Study, more than twice as likely to have correctly named Clinton as the president who made the apology, and 2 to 3 times more likely to have been willing to participate in biomedical studies despite having heard about the Tuskegee Syphilis Study (odds ratio [OR]=2.9; 95% confidence interval [CI]=1.4, 6.2) or the presidential apology (OR=2.3; 95% CI=1.4, 3.9).

Conclusions

These marked differences likely reflect the cultural reality in the Black community, which has been accustomed to increased risks in many activities. For Whites, this type of information may have been more shocking and at odds with their expectations and, thus, led to a stronger negative impact.

The phrase, legacy of the Tuskegee Syphilis Study, is sometimes used to denote the belief that Blacks are more reluctant than Whites to participate in biomedical research studies because of the infamous study of syphilis in men run by the U.S. Public Health Service from 1932-72. This paper is the first to attempt to assess directly the accuracy of this belief within a multi-city, multi-racial, large-scale, detailed random survey. We administered the Tuskegee Legacy Project (TLP) Questionnaire to 826 Blacks and non-Hispanic White adults in three U.S. cities. While Blacks had higher levels of general awareness of the Tuskegee Syphilis Study, there was no association between either awareness or detailed knowledge of the Tuskegee Syphilis Study and willingness to participate in biomedical research, either for Blacks or Whites observed in our survey. While this study refutes the notion that there is a direct connection between detailed knowledge of the Tuskegee Syphilis Study and willingness to participate in biomedical research, it does not assess the broader question of whether and how historical events influence people's willingness to participate in research. Future studies should explore this.

The broad goal of the Tuskegee Legacy Project (TLP) study was to address, and understand, a range of issues related to the recruitment and retention of Blacks and other minorities in biomedical research studies. The specific aim of this analysis was to compare the self-reported willingness of Blacks, Hispanics, and Whites to participate as research subjects in biomedical studies, as measured by the Likelihood of Participation (LOP) Scale and the Guinea Pig Fear Factor (GPFF) Scale. The Tuskegee Legacy Project Questionnaire, a 60 item instrument, was administered to 1,133 adult Blacks, Hispanics, and non-Hispanic Whites in 4 U.S. cities. The findings revealed no difference in self-reported willingness to participate in biomedical research, as measured by the LOP Scale, between Blacks, Hispanics, and Whites, despite Blacks being 1.8 times as likely as Whites to have a higher fear of participation in biomedical research on the GPFF Scale.