MINORITIES AND EVIDENCE BASED MEDICINE, DO RANDOMIZED CONTROLLED TRIALS PROVIDE THE ANSWER? S. Malhi 1 , S.M. Sandhu 1 , H.S. Gurm 2 ; 1 Fairview Hospital, Fairview Park, OH; 2 Cleveland Clinic Foundation, Cleveland, OH PURPOSE: Race has a significant impact on prevalence, presentation and outcome of disease. While the randomized controlled trials (RCTs) have become the gold standard for evidence based medicine, there is a paucity of data on representation of minorities in RCTs. The purpose of this study was to review minority enrollment in RCTs published in a major medical journal. METHODS: We conducted a systematic search of all articles published in the original articles section of the New England Journal of Medicine from 1993 ± 2000. All randomized control trials done in North America were included for abstraction. We excluded all studies limited to certain ethnic groups, subset analysis of other trials and meta-analyses. Trials were characterized by primary speciality and source of funding. Data were analyzed using Students t test and ANOVA. RESULTS: 1799 original articles were published in the period between 1993 ± 2000 including 535 Randomized controlled trials. Of the 302 RCTs done in North America, only 106 specified the percentage of minorities enrolled. A total of 180,364 patients were enrolled in these 106 trials of which 37,653 were minorities (20.8%) . The maximum number of trials (80) were in cardiovascular medicine. The minority enrollment was specified in only 24, (30%) and in these the minorities constituted only 14% of the enrollees. (4766/34,132) . In contrast to cardiovascular medicine, 15 out of 22 trials (68%) in pregnancy related disorders and 12 out of 27 RCTs (44%) related to pediatric population specified minority enrollment. Similarly, the trials in these groups enrolled a larger percentage of minorities: 40.7% (13928/34220) in pregnancy related trials and 51.3% (3253/6343) in the pediatric trials. After trials in pregnant women and children are excluded only 6% (20,472/293,297) of enrolled subjects were minorities. CONCLUSION: Although minorities now make up almost one third of the American population, they are significantly underrepresented in randomized controlled trials. Most studies fail to specify the ethnic or racial mix of the population and thereby significantly limit the generalizability of the results. At a time when all research is held up to the gold standard of the RCTs, the RCTs fail to provide data on a significant segment of the population. Our data underscores the importance of an ongoing effort to improve minority enrollment and ethnic specific analysis in clinical trials. PURPOSE: Among the rehabilitation options for persons with substance abuse disorders are the prevalent and increasingly publicized faith-based programs. We sought to describe key structural aspects of substance abuse recovery programs within one major national Christian organization. METHODS: A convenience sample of 7 administrators, clinical directors, and counselors from 4 New England-based residential recovery programs was identified. Each subject was interviewed for 60 minutes using a semi-structured protocol. Using qualitative methods, key words and phrases were derived from all instances where aspects of the program structure were mentioned. The key words were placed into groups that categorized the major structural elements of the program RESULTS: The programs in this study provide long-term free services for men and women of all faiths. All programs are self-supporting and receive no governmental funding. Religious (or spiritual) components mentioned were Bible studies, worship and devotional services, vespers and prayer meetings, spiritual growth classes, retreats, and Alcoholics Anonymous or Narcotics Anonymous meetings. Individual and group therapy sessions also included spiritual references and themes. Secular components were medical and dental services, mental health services, Graduate Equivalency Diploma classes and job skills training, work therapy, sponsorship, access to physical fitness facilities, recreational activities, and aftercare program planning. CONCLUSION: Activities relating to religious study, worship, and spiritual growth are critical components of the faith-based recovery programs studied. However, the religious aspects of these programs appear to complement rather than replace the elements seen in secular programs. Further analyses of how their philosophy of faith is translated into practice are needed. PURPOSE: Tamoxifen was FDA approved for breast cancer risk reduction in 1998 for women who have a 5 year risk > 1.7% (average risk of a 60 year old white woman). Healthy women deciding whether to take it for prevention must weigh its potential benefits and adverse effects. Purpose: To develop an understanding of how ethnically diverse risk-eligible women weigh risks and benefits regarding tamoxifen prophylaxis. METHODS: We undertook a qualitative intervention study using a focus group-format to provide general information about the risks and benefits of tamoxifen for breast cancer risk reduction and to assess the concerns of ethnically diverse (Caucasian, African-American, and Latina) women about the use of tamoxifen prophylaxis. Group facilitators were matched to the ethnicity of participants. Focus group discussions involved: (1) exploration of knowledge of the risks and benefits of tamoxifen as a preventive therapy; (2) a standardized educational intervention about tamoxifen's risks and benefits based on findings from the Breast Cancer Prevention Trial; and 3) discussion about participant decision-making and tamoxifen's overall value in prevention. All participants completed a brief questionnaire to assess the impact of the intervention on their understanding of tamoxifen as preventive therapy. Focus groups were audiotaped and later transcribed for analysis. A multi-disciplinary team of investigators identified prominent themes related to health beliefs that emerged from iterative review of focus group transcripts. RESULTS: 27women (age range 61 ± 78) participated in the focus groups. Most reported that they felt more informed after the group. In general, fear of breast cancer was not prominent, and participants were not inclined to take tamoxifen as preventive therapy. Decisions about tamoxifen were based on participants' assessment of the balance of competing risks and competing benefits. Specifically, participants expressed limited willingness to take medication with serious side effects for breast cancer risk reduction, uncertainty about its interaction with other medications, and concern about the need to discontinue hormone replacement therapy. Caucasian and Latina groups expressed concerns about reliability of scientific studies. African ± American women described faith as important to prevention. CONCLUSION: Women were wary of taking a drug for a disease they might not develop. Women felt they had options other than Tamoxifen to reduce risk of breast cancer, including early detection, diet, faith, and alternative medicine. Information about tamoxifen decreased interest in use for breast cancer prevention. PURPOSE: Although shared decision-making has been advocated for screening mammography for women under age 50, little is known about how women decide whether to get screened, what are their preferred sources of information and what are their preferences for involvement in screening decisions. This study explored these issues in patient decision-making. METHODS: We conducted in-depth, semi-structured telephone interviews with 16 randomly selected English-speaking women ages 38-45 who were enrolled at a large New England HMO, and had no prior history of breast cancer. Interviews were transcribed and coded into major themes using QSR NUD*IST. RESULTS: Thirteen participants were aged 41 ± 45 and 3 were aged 38 ± 40. Nine were white and seven were African ± American. The majority (10/13) of women over age 40 had prior mammograms and all intended to have a screening mammogram before age 50. Factors in women's decisions to undergo screening included knowledge of the``recommendation to begin screening at age 40'' obtained either from their physicians or the media and``having a friend or acquaintance with breast cancer.'' Most women stated that screening has a number of benefits, including``early detection,''``peace of mind'' and``it's better knowing.'' Possible risks of mammography, although not considered important, included radiation, pain, and``not being able to catch everything.'' None of the women who heard of or experienced false positive mammograms (8/16) were or would be deterred from future screenings. While all women stated that the physician should be the primary source of information about screening, 11/16 had no discussions with their own physicians regarding the mammography procedure, its risks and/or benefits. Many (12/16) learned such information from the media. Preferences for involvement in decision making varied; 4/16 preferred to leave screening decisions mostly to the physician, 9/16 preferred to make them mostly themselves, and the rest were uncertain. We found no major thematic differences among the white and the African ± American women. CONCLUSION: Our results suggest that in this setting the decisions of women under 50 to undergo screening mammography are based on their own perceptions of risks/benefits or on the recommendation of their physicians. However, in these recommendations, discussion of specific information relating to screening rarely occurs, and shared decision-making is limited. These findings can guide future research and lead to the development of policy that facilitates patient ± physician communication in this area.