Diabetes, metformin and cancer risk in myotonic dystrophy type I.

Myotonic dystrophy type I (DM1) is an autosomal dominant multisystem disorder characterized by myotonia and muscle weakness. Type 2 diabetes (T2D) and cancer have been shown to be part of the DM1 phenotype. Metformin, a well-established agent for the management of T2D, is thought to have cancer-preventive effects in the general population. In our study, we aimed to assess the association between T2D, metformin use and the risk of cancer in DM1 patients. We identified a cohort of 913 DM1 patients and an age-, sex- and clinic-matched cohort of 12,318 DM1-free controls from the UK Clinical Practice Research Datalink, a large primary care records database. We used Cox regression models to assess cancer risk in T2D patients who were metformin users or nonusers compared to patients without T2D. Separate analyses were conducted for DM1 patients and controls. T2D was more prevalent in DM1 than in controls (8% vs. 3%, p < 0.0001). DM1 patients with T2D, compared to those without T2D, were more likely to develop cancer (hazard ratio [HR] = 3.60, 95% confidence interval [CI] = 1.18-10.97; p = 0.02), but not if they were treated with metformin (HR = 0.43, 95% CI = 0.06-3.35; p = 0.42). Among controls, we observed no significant associations between T2D and cancer risk in either users or nonusers of Metformin (HR = 1.28, 95% CI = 0.91-1.79; p = 0.16 and HR = 1.13, 95% CI = 0.72-1.79; p = 0.59, respectively). These results show an association between T2D and cancer risk in DM1 patients and may provide new insights into the possible benefits of Metformin use in DM1.

Body mass index modifies bladder cancer risk associated with low estrogen exposure among Egyptian women after menopause.

PURPOSE: Investigators have reported inconsistent findings regarding associations between body mass index (BMI) and bladder cancer risk, and they have postulated that sex steroids mediate such associations. We assessed the impact of BMI on the relationship between bladder cancer risk and combinations of age at first childbirth, parity, and age at menopause, among Egyptian women. METHODS: We used data from our multicenter case-control study of 419 cases and 786 controls in logistic regression models to estimate adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of such associations. RESULTS: Age > 18 years at first childbirth and parity ≤ 6 were significantly associated with bladder cancer risk, which was higher when both factors (AOR = 2.31, 95% CI = 1.55-3.43) and age at menopause < 45 years (AOR = 3.51, 95% CI = 1.88-6.55) were present. Early menopause was associated with higher bladder cancer risk in obese (AOR = 2.90, 95% CI = 1.40-5.98) but not normal weight women (AOR = 0.98, 95% CI = 0.58-1.65; Pinteraction = 0.11), and the risk was greatest when both first childbirth at age > 18 years and parity ≤ 6 were present (AOR = 7.60, 95% CI = 1.84-31.35); however, overweight and obesity were associated with significantly lower bladder cancer risk (AOR = 0.59, 95% CI = 0.43-0.81, and AOR = 0.26, 95% CI = 0.18-0.38, respectively). CONCLUSION: Body mass index appears to modify bladder cancer risk in Egyptian women after menopause by slightly enhancing the risk associated with low estrogen exposure among the obese only. Longitudinal studies of the BMI role in bladder malignancy in this distinctive population are required.

Training Teachers to Teach Epidemiology in Middle and High Schools.

Objective The purpose of this study was to evaluate the outcomes of a workshop which was designed to prepare teachers to teach epidemiology to middle and high school students. Methods The workshop introduced the fundamental enduring understandings of epidemiology as well as a pedagogical framework for teaching it. Using an online questionnaire and telephone interviews, we assessed post-workshop outcomes. Results The majority (80%) of workshop alumni had taught epidemiology with the most common approach (52%) being the inclusion of epidemiologic concepts into other courses. Teachers felt that learning epidemiology was a valuable experience for their students and reported that students found it engaging and relevant to their lives. Conclusions These preliminary findings suggest that there may be benefit to teaching epidemiology in middle and high schools. Further research should directly evaluate public health-related outcomes among students, such as improvements in health literacy and health behavior.

Evaluation of the Balanced Menus Challenge: a healthy food and sustainability programme in hospitals in Maryland.

OBJECTIVE: The Balanced Menus Challenge (BMC) is a national effort to bring the healthiest, most sustainably produced meat available into health-care settings to preserve antibiotic effectiveness and promote good nutrition. The present study evaluated the outcomes of the BMC in the Maryland/Washington, DC region. DESIGN: The BMC is a cost-effective programme whereby participating hospitals reduce meat purchases by 20 % of their budget, then invest the savings into purchasing sustainably produced meat. A mixed-methods retrospective assessment was conducted to assess (i) utilization of the BMC 'implementation toolkit' and (ii) achievement of the 20 % reduction in meat purchases. Previous survey data were reviewed and semi-structured interviews were conducted. SETTING: Hospitals located in the Maryland/Washington, DC region, USA, that adopted the BMC. SUBJECTS: Twelve hospitals signed the BMC in the Maryland/Washington, DC region and six were available for interview. RESULTS: Three hospitals in the Maryland/Washington, DC region that signed the BMC tracked their progress and two achieved a reduction in meat procurement by ≥20 %. One hospital demonstrated that the final outcome goal of switching to a local and sustainable source for meat is possible to achieve, at least for a portion of the meal budget. The three hospitals that reduced meat purchases also received and used the highest number of BMC implementation tools. There was a positive correlation between receipt and usage of implementation tools (r=0·93, P=0·005). CONCLUSIONS: The study demonstrates that hospitals in the Maryland/Washington, DC region that sign the BMC can increase the amount of sustainably produced meat purchased and served.

Examining Sexual and Dating Violence by Gender Identity Among High School Students.

PURPOSE: This study examined the reporting of sexual and dating violence among high school students using a standard gender identity question. METHODS: Using data from the 2017 and 2019 Youth Risk Behavior Surveys, multivariable regression models estimated the association between gender identity and four measures of sexual and dating violence, adjusted for confounding by race/ethnicity, grade, and reported sex. RESULTS: Of the 198,900 teenagers, 1.8% identified as transgender, 1.6% were not sure, and 1.9% responded that they did not know what question was being asked. Across all measures of violence, transgender, "unsure" and "don't understand" students were significantly more likely than cisgender students to report having been victimized. DISCUSSION: Standard analysis practices of eliminating unsure and/or don't understand responses to gender identity questions may underestimate at-risk youth. Researchers seeking to understand disparities in youth violence by gender identity will need to ensure that they employ inclusive measures.

Mini-Medical school empowers community members to advocate for their and others health.

PURPOSE: Over the past three decades, the term Mini-Medical School (MMS) has been used to describe programs offered by schools of medicine, which provide health education to the lay public and health career exposure to youth. The University of Maryland School of Medicine has operated an MMS program since 2001. The purpose of this study was to assess the sociodemographic characteristics of MMS participants and the impacts of this program on their health. METHODS: We analyzed anonymous post-completion program evaluation survey responses and we conducted focus groups with some of the participants who had attended the program for ≥10 years. RESULTS: Most of the MMS participants were women (84%, n = 72), ≥55 years of age (88%), and well-educated (58% with college degree and higher); and 59% had attended the program for ≥5 years. The focus group discussions revealed acquisition of medical knowledge and community outreach as recurring themes; the former leading to empowerment of the participants for better self-care and care for others, while the latter driving them to health education and advocacy. Most of the participants showed interest in becoming "ambassadors" in their respective communities. CONCLUSION: The health information provided by the MMS program is well-received and even anticipated by its participants. It has empowered them to care for themselves and for others by making them educated consumers and health advocates in their community. The MMS program should work with the School's community partners to make this resource more widely accessible, particularly to populations experiencing the most health disparities.

Empowering students with cultural competence knowledge: randomized controlled trial of a cultural competence curriculum for third-year medical students.

BACKGROUND: Formal training in cultural competence for health care providers has become vital as the US population continues to become increasingly culturally diverse. However, a low percentage of medical schools offer formal training in this area, and there is a lack of curriculum evaluation reported in the literature. PURPOSE: To determine the impact of formal cultural competence teaching on third-year medical students' knowledge of cultural competence. METHOD: Data from 109 third-year medical students during the period of November 2001 to February 2004 were analyzed in the study. The intervention was a comprehensive cultural competence curriculum, and the primary outcome measure was the change score in cultural competence knowledge demonstrated by the medical students after completing a precourse and postcourse 40-item multiple-choice questionnaire. RESULTS: Forty-seven medical students in the control group and 62 medical students in the intervention group completed both the pretest and posttest. The overall knowledge scores in the intervention group increased by 19%, compared to a 4% increase in the controls (p < .01). CONCLUSIONS: Third-year medical students in the intervention group were significantly empowered with cultural competence knowledge when compared to the control group.

Health Savings Account Ownership and Financial Barriers to Health Care: What Social Workers Should Know.

Over a decade ago, Health Savings Accounts (HSAs) were deemed contrary to social work values, leading to greater inequality in access to health care. Using data from the 2015 National Health Interview Survey (NHIS) (n= 12,265), we examine whether HSA ownership is associated with unmet need for health care due to cost (financial barrier). HSA ownership was significantly associated with reduced financial barriers to health care (p< .001) in the regression model. Owning an HSA may be related to reducing financial barriers to health care access, which could inform improvements in HSA policy provisions for social work practice.

Benign tumors in myotonic dystrophy type I target disease-related cancer sites.

OBJECTIVES: Recent evidence showed that myotonic dystrophy type I (DM1) patients are at increased risk of certain cancers, but the risk of benign tumors is unknown. We compared the risk of benign tumors in DM1 patients with matched DM1-free individuals and assessed the association between benign tumors and subsequent cancers. METHODS: We identified 927 DM1 patients and 13,085 DM1-free individuals matched on gender, birth-year, clinic, and clinic-registration year from the UK Clinical Practice Research Datalink, a primary care records database. We used Cox regression models for statistical analyses. RESULTS: DM1 patients had elevated risks of thyroid nodules (Hazard Ratio [HR] = 10.4; 95% Confidence Interval [CI] = 3.91-27.52; P < 0.001), benign tumors of the brain or nervous system (HR = 8.4; 95% CI = 2.48-28.47; P < 0.001), colorectal polyps (HR = 4.3; 95% CI = 1.76-10.41; P = 0.001), and possibly uterine fibroids (HR = 2.7; 95% CI = 1.22-5.88; P = 0.01). Pilomatricomas and salivary gland adenomas occurred almost exclusively in DM1 patients (Fisher's exact P < 0.001). The HR for colorectal polyps was elevated in DM1 males but not in females (HR = 8.2 vs. 1.3, respectively; P-heterogeneity < 0.001), whereas endocrine and brain tumors occurred exclusively in females. The data suggested an association between benign tumors and subsequent cancer in classic DM1 patients (HR = 2.7; 95% CI = 0.93-7.59; P = 0.07). INTERPRETATION: Our study showed a similar site-specific benign tumor profile to that previously reported for DM1-associated cancers. The possible association between benign tumors and subsequent cancer in classic DM1 patients warrants further investigation as it may guide identifying patients at elevated risk of cancer. Our findings underscore the importance of following population-based screening recommendations in DM1 patients, for example, for colorectal cancer.

Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles.

Cancer Risk in Myotonic Dystrophy Type I: Evidence of a Role for Disease Severity.

BACKGROUND: Myotonic dystrophy type 1 (DM1) is an inherited trinucleotide repeat disorder in which specific cancers have been implicated as part of the disease phenotype. This study aimed to assess whether cancer risk in DM1 patients is modified by disease severity. METHODS: Using the United Kingdom Clinical Practice Research Datalink (primary care electronic medical records), we identified a cohort of 927 DM1 and a matched cohort of 13 085 DM1-free individuals between January 1, 1988 and February 29, 2016. We used Cox regression models to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) of organ-specific cancer risks. Analyses were stratified by age at DM1 diagnosis as a surrogate for disease severity. Statistical tests were two-sided. RESULTS: Patients with classic DM1 (age at diagnosis: 11-40 years) were at elevated risk of cancer overall (HR = 1.81; 95% CI = 1.12 to 2.93); cancers of the thyroid (HR = 15.93; 95% CI = 2.45 to 103.64), uterus (HR = 26.76; 95% CI = 2.32 to 309.26), and cutaneous melanoma (HR = 5.98; 95% CI = 1.24 to 28.79) accounted for the excess. In late-onset DM1 patients (age at diagnosis >40 years), a reduced overall cancer risk was observed (HR = 0.53; 95% CI = 0.32 to 0.85), possibly driven by the deficit in hematological malignancies (DM1 = 0 cases, DM1-free = 54 cases; P = .02). The difference between the observed HR for classic and late-onset DM1 was statistically significant (P < .001). CONCLUSIONS: The observed difference in relative cancer risk between classic and late-onset DM1 patients compared with their DM1-free counterparts provides the first evidence that disease severity modifies DM1-related cancer susceptibility. This novel finding may guide clinical management and scientific investigations for the underlying molecular mechanisms in DM-related carcinogenesis.

Racial and Ethnic Differences in the Relationship between Aspirin Use and Non-Small Cell Lung Cancer Risk and Survival.

BACKGROUND: African Americans (AA) experience higher incidence and mortality of lung cancer as compared with European Americans (EA). Inflammation is associated with lung cancer, many aspects of which differ between AA and EA. We investigated whether use, frequency, and duration of the anti-inflammatory drug aspirin were associated with lung cancer risk and survival, separately among AA and EA populations. METHODS: Using data from the Maryland Non-Small Cell Lung Cancer (NSCLC) Case-Control Study (1,220 cases [404 AA and 816 EA] and 1,634 controls [1,004 EA and 630 AA]), we estimated the adjusted odds ratios (OR) and hazard ratios (HR) with 95% confidence intervals (CI) of the associations between aspirin use and NSCLC risk and survival, respectively. RESULTS: Any aspirin use (OR: 0.66; 95% CI, 0.49-0.89), daily use of ≥ 1 tablet (OR: 0.68; 95% CI, 0.50-0.90), and use for ≥ 3 years (OR: 0.61; 95% CI, 0.44-0.85) was associated with lower NSCLC risk only among men, even after adjustment for covariates including body mass index and global genetic ancestry. These variables were also associated with improved survival, but only among AA (HR: 0.64; 95% CI, 0.46-0.91; HR: 0.61; 95% CI, 0.42-0.90; and HR: 0.60; 95% CI, 0.39-0.92, respectively). Tylenol and other NSAIDs were either associated with elevated or no NSCLC risk. CONCLUSIONS: Aspirin use is associated with lower risk of NSCLC among men and improved survival among AA. IMPACT: Preventive regular aspirin use could be considered among men and AA.

Participation in research studies: factors associated with failing to meet minority recruitment goals.

PURPOSE: To determine the recruitment goals that investigators set for racial/ethnic minorities and the factors associated with failure to meet those goals. METHODS: Four hundred forty principal investigators (PIs) conducting clinical research funded by the National Heart, Lung, and Blood Institute (NHLBI) in 2001 completed a mailed survey providing their minority recruitment goals and enrollment data for their most recent NHLBI-funded study. RESULTS: Ninety-two percent of PIs set goals for African Americans, 68% for Hispanics, 55% for Asian Americans, 35% for Native Hawaiians/Pacific Islanders, and 23% of PIs set recruitment goals for American Indians/Native Alaskans. Among those PIs who did set minority recruitment goals, the mean goal for the recruitment of African Americans was 31%, 16% for Hispanics, and 9% for Asian Americans. Twenty-seven percent of PIs failed to meet their recruitment goals for African Americans, 23% for Asian Americans, and 23% for Hispanics. After adjusting for multiple investigator and trial characteristics, the type of study (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.2, 3.4 for observational vs. phase III trial) completion of study enrollment (OR 2.0; 95% CI 1.2, 3.4), and PI identification of a larger number of major barriers to participation (OR 1.8; 95% CI 1.1, 3.0) were all associated with failure to meet recruitment goals for African Americans. However, no factors were consistently associated with failure to meet recruitment goals across different racial/ethnic groups. CONCLUSIONS: Investigators often do not set recruitment goals for some racial/ethnic groups. Factors associated with failure to meet recruitment goals vary in the recruitment of different minority groups.

Nonoccupational exposure to agricultural work and risk of urinary bladder cancer among Egyptian women.

This study examined the associations between nonoccupational exposure to agricultural work, through husband or head of household (H/HH) occupation, and urinary bladder cancer risk among Egyptian women. A total of 1,167 women (388 bladder cases and 779 age- and residence-matched, population-based controls) from a multicenter case-control study were included in the analysis. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression. Among married women, those who reported H/HH to be an agricultural worker were at increased risk for bladder cancer as compared to those with H/HH in other occupations, AOR = 1.54, 95% CI [1.09, 2.18]; among unmarried women the risk was not increased, AOR = 0.77, 95% CI [0.45, 1.32]. Nonoccupational exposure to agricultural work, defined as living with an agricultural worker, increased the risk for bladder cancer among married Egyptian women.

Investigators' assessment of NIH mandated inclusion of women and minorities in research.

BACKGROUND: While investigators were concerned about the impact of mandated inclusion of minorities and women on the conduct of research, there has been little subsequent assessment of investigator views on the effectiveness of the mandate in achieving gender and racial/ethnic research diversity. We describe investigators' assessment of the impact of the mandate on inclusion of women and minorities in research. METHODS: 440 principal investigators (PIs) surveyed between August 2002 and December 2002. RESULTS: Most PIs (69%) felt the mandate has been successful in increasing gender diversity, 7% felt that the mandate had failed to increase females and 24% were unsure. Fifty-five percent of PIs felt the mandate had been successful in increasing minorities; 12% felt it had failed and 32% were unsure. Those who felt that failure to include women makes it hard to draw conclusions about treatment/prevention strategies (P=0.05), white PIs (P=0.05), and those who ascribed importance to female inclusion (P=0.03) were more positive about the mandate's success for women. Similarly, those who felt more strongly that diversity in study samples ensures generalizability (P=0.03), white PIs (P=0.01), and those who ascribed importance to minority inclusion (P<0.01) were more positive about the mandate's success for minorities. CONCLUSION: While the majority of PIs were positive in their assessment of the mandate on increasing diversity in research, many were ambivalent. Greater clarity on the criteria the scientific community should use in assessing the effectiveness of the mandate would allow us to reach the mandate goals.

Effect of relationship factors on safer sex decisions in older inner-city women.

OBJECTIVES: Heterosexual transmission of the human immunodeficiency virus (HIV) in older women is on the rise, yet little is known about safer sex practices in these women. We sought to determine the prevalence of and effect of relationship factors on safer sex practices among older women living in a high HIV incidence region. METHODS: In a cross-sectional study at an ambulatory medicine clinic of a large inner-city hospital, participants were women over age 50 seeking medical services at the study site. Measurements included (1) partner trust, (2) dependence on partner, (3) personally obtaining condoms, (4) safer sex (frequent condom use or abstinence), (5) knowledge of condom efficacy, and (6) perceived HIV risk. RESULTS: Of 155 participants in a current relationship, 81% were sexually active; however, only 13% of these women used condoms frequently. No significant differences were found between participants who did and did not practice safer sex with respect to their age, race, employment, marital status, knowledge of condom efficacy, or perceived HIV risk. Trust in partner was independently associated with lower odds of safer sex (OR 0.3, 95% CI 0.08-1.06). Personally obtaining condoms (OR 9.2, 95% CI 1.9-44.2) and dependence on partner for condoms (OR 12.3, 95% CI 3.0-50.3) were independently associated with higher odds of safer sex. CONCLUSIONS. Few older women in high HIV incidence areas practice safer sex. Relationship factors impact the risk of acquiring HIV through safer sex decisions. HIV prevention messages geared to older women should incorporate references to the role these factors can play in reducing their HIV risk.

Distrust, race, and research.

BACKGROUND: Investigators have voiced concerns that distrust of research and the medical community impedes successful recruitment of African Americans into clinical research. OBJECTIVES: To examine possible differences in distrust by race and to determine to what extent other sociodemographic factors explain any racial differences in distrust. METHODS: We analyzed data from 527 African American and 382 white respondents of a national telephone survey on participation in clinical research. Our main outcome measure was a 7-item index of distrust. RESULTS: African American respondents were more likely than white respondents not to trust that their physicians would fully explain research participation (41.7% vs 23.4%, P<.01) and to state that they believed their physicians exposed them to unnecessary risks (45.5% vs 34.8%, P<.01). African American respondents had a significantly higher mean distrust index score than white respondents (3.1 vs 1.8, P<.01). After controlling for other sociodemographic variables in a logistic regression model, race remained strongly associated with a higher distrust score (prevalence odds ratio, 4.7; 95% confidence interval, 2.9-7.7). CONCLUSIONS: Even after controlling for markers of social class, African Americans were less trusting than white Americans. Racial differences in distrust have important implications for investigators as they engage African Americans in research.

Knowledge of cultural competence among third-year medical students.

An increasingly diverse population and ongoing health disparities have brought national attention to cultural competence training in medical schools. However, few data exist on medical students' knowledge in cultural competence. The purpose of this study is to assess medical students' knowledge in cultural competence to identify training areas for curriculum development. All third-year medical students at a single institution during the period of November 2001 to February 2004 completed a questionnaire to assess their knowledge of cultural competence during their medicine clerkship. The 40-item questionnaire measured several domains of cultural competence: health disparities, stereotyping, exploring culture, perceptions of health and illness, and communication/language. The mean knowledge score was 55%, and no student scored >80%. Race and prior cultural training were not predictors of overall performance.

Pesticides, gene polymorphisms, and bladder cancer among Egyptian agricultural workers.

This study examined the associations between pesticide exposure, genetic polymorphisms for NAD(P)H: quinone oxidoreductase I (NQO1) and superoxide dismutase 2 (SOD2), and urinary bladder cancer risk among male agricultural workers in Egypt. Logistic regression was used to analyze data from a multicenter case-control study and estimate adjusted odds ratio (OR) and 95% confidence interval (CI). Exposure to pesticides was associated with increased bladder cancer risk (odds ratio (95% confidence interval): 1.68 (1.23-2.29)) in a dose-dependent manner. The association was slightly stronger for urothelial (1.79 (1.25-2.56)) than for squamous cell (1.55 (1.03-2.31)), and among participants with combined genotypes for low NQO1 and high SOD2 (2.14 (1.19-3.85)) activities as compared with those with high NQO1 and low SOD2 genotypes (1.53 (0.73-3.25)). In conclusion, among male agricultural workers in Egypt, pesticide exposure is associated with bladder cancer risk and possibly modulated by genetic polymorphism.

Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities.

Although federal initiatives have mandated broader inclusion of minorities in clinical research on diseases that have disparities in health by race and ethnicity, it is not clear whether these initiatives have affected reporting of trial results. The objective of this study was to examine the reporting of race/ethnicity in clinical trials reports in areas of known disparities in health (i.e., diabetes, cardiovascular disease, HIV/AIDS, and cancer) and to determine what factors were associated with reporting of race/ethnicity in results. We performed a Medline search covering the period January 1989 to Oct 2000 to identify clinical trials of diabetes, cardiovascular disease, HIV/AIDS, and cancer published in the Annals of Internal Medicine, JAMA, and New England Journal of Medicine. The main outcome measure was the reporting of participation and of results by race/ethnicity of trial participants. Of 253 eligible trials, 40% (n=102) were non race-focused yet did not report race, while 2% (n=4) were non gender-focused and did not report gender. Forty-six percent of trials that reported the race/ethnicity of the sample reported only one or two racial/ethnic categories, and in 43% of these trials the total number of individuals reported in each race/ethnicity category did not equal the total reported sample size. Analysis of results by race/ethnicity was reported in only two trials, and by gender in only three trials. In diseases with known racial and ethnic disparities, many clinical trials do not report the race/ethnicity of the study participants, and almost none report analyses by race/ethnicity. Although federal initiatives mandate inclusion of minority groups in research, that inclusion has not translated to reporting of results that might guide therapeutic decisions.