Statewide Tuskegee Alliance for clinical trials. A community coalition to enhance minority participation in medical research.

BACKGROUND: Cancer mortality rates for all sites are nearly 2.5 times greater for African-Americans compared with whites. In addition, there are data implying that cancer treatment outcomes for minorities are unfavorable compared with whites. Whether this is due to poor access to health care or a biologic property of malignancies occurring in specific populations remains to be determined. Because of these unknown factors, targeting minorities for clinical trials may contribute toward the reduction of the overall morbidity and mortality associated with specific cancers. METHODS: The current study describes the establishment of a genuine collaborative partnership between the targeted minority community and clinical investigators at the University of Alabama at Birmingham. This partnership was formed for the purpose of identifying strategies that would enhance the accrual and retention of minority participants into current and future cancer prevention and control trials. Focus groups and key informant interviews were conducted to ascertain the community's perception of participating in clinical trials. RESULTS: The majority of focus group participants were unclear regarding the nature of clinical trials. Participants indicated that they would participate in research studies if they received adequate information regarding the purpose and benefits of the study, and if the charge came from a pastor or physician. Barriers to participation included time commitments, family obligations, whether blood was involved, and past experiences. The majority of the participants indicated that their knowledge of the Tuskegee Syphilis Study did not influence their decision to participate in research. A major outcome of the conference was the formation of the Statewide Tuskegee Alliance Coalition. The planning coalition decided to continue their efforts to work with communities and promote cancer awareness among minorities. After the conference, the coalition conducted several meetings and in July 1998, 1 year after the conference, the coalition selected a chair, co-chair, and a formal name for the organized group. CONCLUSIONS: The planning, development, and implementation of this conference provided a valuable experience for researchers and community members. It was discovered that community involvement in the early phase of this project contributed to its success. Furthermore, the partnership that developed between researchers (academic institutions) and communities successfully provided an infrastructure that supported the interest of both groups.

African-American attitudes regarding cancer clinical trials and research studies: results from focus group methodology.

Despite federal recommendations highlighting the need to include special population groups (mainly minorities and women) in clinical research, recruitment and retention of these groups present a great challenge to researchers. This paper describes a focus group study that was conducted to examine factors related to minority participation and retention in cancer clinical research studies. In 1996, the National Cancer Institute submitted a request for applicants to receive support for regional conferences. The purpose of the proposed conferences was to share current information and strategies to aid cancer clinical investigators in recruiting and retaining minority participants in clinical cancer research and to stimulate local/regional adaptations of these strategies. The University of Alabama at Birmingham (UAB), The University of Alabama, and Tuskegee University collaborated to respond to the request. Funding was granted by NCI for the regional conference in Alabama. The conference was held in Tuskegee, Alabama, the site of the infamous US Public Health Syphilis Study at Tuskegee. In planning for the conference, focus group sessions were conducted with African-American men and women who represented all regions of Alabama. The focus group information was used to identify important issues to be addressed at the conference.

Recruitment and retention of minority women in cancer screening, prevention, and treatment trials.

Researchers are giving greater attention to the recruitment and retention of minority women in clinical studies because of their historical underrepresentation, despite their greater morbidity and mortality for many conditions. Using findings from four studies, this article examines documented barriers to the recruitment and retention of minority women to clinical cancer research and discusses effective recruitment strategies. Among the major barriers to recruitment were lack of awareness, lack of transportation, interference with work/family responsibilities, financial costs, negative side effects, and burdensome procedures. Effective recruitment strategies focused on using culturally targeted mass mailings and media presentations based on acquiring an understanding of the minority community. Recommendations are made for further study and implementation.

Minority recruitment in clinical trials: a conference at Tuskegee, researchers and the community.

PURPOSE: This article describes the planning, implementation, and evaluation of a 2-day conference designed to examine the factors related to the participation of African Americans in cancer clinical trials. METHODS: Pre-conference formative evaluations (e.g., focus group discussions and key informant interviews with community leaders and health providers) were conducted in several rural and urban counties in the state of Alabama to determine African Americans' perceptions of participation in clinical research. The findings from these evaluations were used to develop a conference format and agenda. The 2-day conference included: (i) a pretest of African Americans' perceptions of cancer research, participation factors, and communication and recruitment issues; (ii) individual presentations high-lighting community leaders, church leaders, and researchers' perspectives regarding minority participation in research; (iii) working group discussions regarding the barriers and solutions to minority participation in research; and (iv) a posttest evaluation to measure changes in African Americans' perceptions of research. RESULTS: Several recruitment barriers and solutions were identified and reported by the working groups. Comparisons of the pretest and posttest measures showed significant (p > .05) and favorable shifts in the areas of perceptions of cancer research, participation factors, communication issues, and recruitment issues. Participation in the conference reflected a positive change in attitudes on these measures. However, the theme, "barriers that contributed to nonparticipation," did not show any significant changes during the two testing periods. The most critical lesson that resulted from this conference was the need for researchers and community members to have open dialogue about participation in research. CONCLUSIONS: This conference demonstrated that progress can be made when all parties are at the "table" and can be heard. In this model, community members proved to be valuable resources in providing researchers with information that was vital to the success of recruitment and retention studies and trials.

Compliance with mammography guidelines: physician recommendation and patient adherence.

BACKGROUND: Guidelines recommend that women ages 50-75 years receive screening mammography every 1-2 years. We related receipt of physician recommendations for mammography and patient adherence to such recommendations to several patient characteristics. METHODS: We retrospectively reviewed medical records of 1,111 women ages 50-75 attending three clinics in an urban university medical center. We ascertained overall compliance with mammography guidelines and two components of compliance: receipt of a physician recommendation and adherence to a recommendation. Outcome measures were the proportion of patients demonstrating each type of compliance and adjusted odds ratios, according to several patient-related characteristics. RESULTS: Overall, 66% of women received a recommendation. Of women receiving a documented recommendation, 75% adhered. Factors showing significant positive associations with receiving a recommendation included being a patient in the general internal medicine clinic, having private insurance, visiting the clinic more often, and having a recent Pap smear. Patient adherence was positively associated with private insurance and Pap smear history, negatively associated with internal medicine, and not associated with visit frequency. CONCLUSIONS: Patient factors influencing physician mammography recommendations may be different from those associated with patient adherence, except for having private health insurance, which was a predictor of both.

Chronic disease as a barrier to breast and cervical cancer screening.

OBJECTIVE: To assess whether chronic disease is a barrier to screening for breast and cervical cancer. DESIGN: Structured medical record review of a retrospectively defined cohort. SETTING: Two primary care clinics of one academic medical center. PATIENTS: All eligible women at least 43 years of age seen during a 6-month period in each of the two study clinics (n = 1,764). MEASUREMENTS AND MAIN RESULTS: Study outcomes were whether women had been screened: for mammogram, every 2 years for ages 50-74; for clinical breast examinations (CBEs), every year for all ages; and for Pap smears, every 3 years for ages under 65. An index of comorbidity, adapted from Charlson (0 for no disease, maximum index of 8 among our patients), and specific chronic diseases were the main independent variables. Demographics, clinic use, insurance, and clinical data were covariates. In the appropriate age groups for each test, 58% of women had a mammogram, 43% had a CBE, and 66% had a Pap smear. As comorbidity increased, screening rates decreased (p < .05 for linear trend). After adjustment, each unit increase in the comorbidity index corresponded to a 17% decrease in the likelihood of mammography (p = .005), 13% decrease in CBE (p = .006), and 20% decrease in Pap smears (p = .002). The rate of mammography in women with stable angina was only two fifths of that in women without. CONCLUSIONS: Among women who sought outpatient care, screening rates decreased as comorbidity increased. Whether clinicians and patients are making appropriate decisions about screening is not known.

A hypertension control program tailored to unskilled and minority workers.

PURPOSE: A comprehensive worksite health promotion program designed to reduce risk factors for cardiovascular disease among 4000 city of Birmingham employees was used to develop and implement a tailored antihypertensive educational intervention. The mean age of the underlying population was 36 years, 89% were blue-collar or unskilled workers, 50% were African Americans and 20% were female. METHODS: First, we identified barriers to hypertension control: low literacy, difficulty understanding the need for treatment of asymptomatic disease, and wide variability of health beliefs and priorities. We then tailored an educational program, which offered employees health education sessions on a variety of different topics, including heart disease, cancer, sleep disorders and back injury. All program materials focused on lifestyle changes and the need to seek medical care. This program was offered to all hypertensive workers; 130 chose to enroll, and 81 completed the program. These 81 participants were matched by age, sex, race and baseline BP with nonparticipating hypertensive workers (controls). Changes in SBP and DBP from before to after the educational program were used to evaluate the program. RESULTS: Overall, intervention participants had a decrease of 4.5 mm Hg in mean SBP (different from zero, [p = 0.03]). African American participants showed a significant decrease (7.4 mm Hg, [p = 0.004]), as did unskilled intervention participants (SBP changes = 7.7 mm Hg, [p = 0.004]). Although not statistically significant, controls showed decreases in BP in the same direction. CONCLUSION: An educational intervention tailored to the specific health perceptions and working conditions of a low literacy population is feasible, and may have a significant effect on hypertension control.