Diversity in clinical research: public health and social justice imperatives.

It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical research is important. This article aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise.

Preventing Cardiovascular Disease Among Urban African Americans With a Mobile Health App (the MOYO App): Protocol for a Usability Study.

BACKGROUND: Cardiovascular disease (CVD) disparities are a particularly devastating manifestation of health inequity. Despite advancements in prevention and treatment, CVD is still the leading cause of death in the United States. Additionally, research indicates that African American (AA) and other ethnic-minority populations are affected by CVD at earlier ages than white Americans. Given that AAs are the fastest-growing population of smartphone owners and users, mobile health (mHealth) technologies offer the unparalleled potential to prevent or improve self-management of chronic disease among this population. OBJECTIVE: To address the unmet need for culturally tailored primordial prevention CVD-focused mHealth interventions, the MOYO app was cocreated with the involvement of young people from this priority community. The overall project aims to develop and evaluate the effectiveness of a novel smartphone app designed to reduce CVD risk factors among urban-AAs, 18-29 years of age. METHODS: The theoretical underpinning will combine the principles of community-based participatory research and the agile software development framework. The primary outcome goals of the study will be to determine the usability, acceptability, and functionality of the MOYO app, and to build a cloud-based data collection infrastructure suitable for digital epidemiology in a disparity population. Changes in health-related parameters over a 24-week period as determined by both passive (eg, physical activity levels, sleep duration, social networking) and active (eg, use of mood measures, surveys, uploading pictures of meals and blood pressure readings) measures will be the secondary outcome. Participants will be recruited from a majority AA "large city" school district, 2 historically black colleges or universities, and 1 urban undergraduate college. Following baseline screening for inclusion (administered in person), participants will receive the beta version of the MOYO app. Participants will be monitored during a 24-week pilot period. Analyses of varying data including social network dynamics, standard metrics of activity, percentage of time away from a given radius of home, circadian rhythm metrics, and proxies for sleep will be performed. Together with external variables (eg, weather, pollution, and socioeconomic indicators such as food access), these metrics will be used to train machine-learning frameworks to regress them on the self-reported quality of life indicators. RESULTS: This 5-year study (2015-2020) is currently in the implementation phase. We believe that MOYO can build upon findings of classical epidemiology and longitudinal studies like the Jackson Heart Study by adding greater granularity to our knowledge of the exposures and behaviors that affect health and disease, and creating a channel for outreach capable of launching interventions, clinical trials, and enhancements of health literacy. CONCLUSIONS: The results of this pilot will provide valuable information about community cocreation of mHealth programs, efficacious design features, and essential infrastructure for digital epidemiology among young AA adults. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16699.

Strategies for Achieving Health Equity: Concern about the Whole Plus Concern about the Hole.

Health equity is a process, assurance of the conditions for optimal health for all people, which requires valuing all individuals and populations equally, recognizing and rectifying historical injustices, and providing resources according to need. At the heart of health equity is concern about the whole of society, not just a single individual or group. Also, at the heart of health equity is concern about the holes in society, about gaps of opportunity and gaps of being valued that are experienced by many. Strategies to achieve health equity that reflect concern about the w(hole) require the examination of a practical roadmap that combines citizenship (WHOLE) with a gap analysis (HOLE). This shorthand of operationalizing health equity as concern about the (w)hole may prove to be useful in generating further strategies for achieving health equity.

Systems of power, axes of inequity: parallels, intersections, braiding the strands.

This commentary builds on work examining the impacts of racism on health to identify parallels and intersections with regard to able-ism and health. The "Cliff Analogy" framework for distinguishing between five levels of health intervention is used to sort the Healthy People 2020 goals on Disability and Health along an array from medical care to addressing the social determinants of equity. Parallels between racism and able-ism as systems of power, similarities and differences between "race" and disability status as axes of inequity, intersections of "race" and disability status in individuals and in communities, and the promise of convergent strength between the anti-racism community and the disability rights community are highlighted. With health equity defined as assurance of the conditions for optimal health for all people, it is noted that achieving health equity requires valuing all individuals and populations equally, recognizing and rectifying historical injustices, and providing resources according to need.

Effects of full-day kindergarten on the long-term health prospects of children in low-income and racial/ethnic-minority populations: a community guide systematic review.

CONTEXT: Children from low-income and minority families are often behind higher-income and majority children in language, cognitive, and social development even before they enter school. Because educational achievement has been shown to improve long-term health, addressing these delays may foster greater health equity. This systematic review assesses the extent to which full-day kindergarten (FDK), compared with half-day kindergarten (HDK), prepares children, particularly those from low-income and minority families, to succeed in primary and secondary school and improve lifelong health. EVIDENCE ACQUISITION: A meta-analysis (2010) on the effects of FDK versus HDK among U.S. children measured educational achievement at the end of kindergarten. The meta-analysis was concordant with Community Guide criteria. Findings on the longer-term effects of FDK suggested "fade-out" by third grade. The present review used evidence on the longer-term effects of pre-K education to explore the loss of FDK effects over time. EVIDENCE SYNTHESIS: FDK improved academic achievement by an average of 0.35 SDs (Cohen's d; 95% CI=0.23, 0.46). The effect on verbal achievement was 0.46 (Cohen's d; 95% CI=0.32, 0.61) and that on math achievement was 0.24 (Cohen's d; 95% CI=0.06, 0.43). Evidence of "fade-out" from pre-K education found that better-designed studies indicated both residual benefits over multiple years and the utility of educational boosters to maintain benefits, suggesting analogous longer-term effects of FDK. CONCLUSIONS: There is strong evidence that FDK improves academic achievement, a predictor of longer-term health benefits. To sustain early benefits, intensive elementary school education is needed. If targeted to low-income and minority communities, FDK can advance health equity.

Association of race consciousness with the patient-physician relationship, medication adherence, and blood pressure in urban primary care patients.

BACKGROUND: Race consciousness (the frequency with which one thinks about his or her own race) is a measure that may be useful in assessing whether racial discrimination negatively impacts blood pressure (BP). However, the relation between race consciousness and BP has yet to be empirically tested, especially within the context of the patient-physician relationship and medication adherence. METHODS: Race-stratified generalized estimating equations were used to assess the relationship of race consciousness on BP, measures of the patient-physician relationship, and self-reported medication adherence, controlling for patients being nested within physicians and for patient age and sex. RESULTS: The mean age of the patients was 61.3 years, 62% were black, and 65% were women. Black patients were more likely to ever think about race than were white patients (49% vs. 21%; P < 0.001). Race-conscious blacks had significantly higher diastolic BP (79.4 vs. 74.5 mm Hg; P = 0.004) and somewhat higher systolic BP (138.8 vs. 134.7 mm Hg; P = 0.13) than blacks who were not race conscious. Race-conscious whites were more likely to perceive respect from their physician (57.1% vs. 25.8%; P = 0.01) but had lower medication adherence (62.4% vs. 82.9%; P = 0.05) than whites who were not race-conscious. CONCLUSIONS: Among blacks, race consciousness was associated with higher diastolic BP. In contrast, among whites, there was no association between race consciousness and BP, but race consciousness was associated with poor ratings of adherence, despite more favorable ratings of the patient-physician relationship. Future work should explore disparities in race consciousness and its impact on health and health-care disparities.

Understanding racial and ethnic disparities in colorectal cancer screening: Behavioral Risk Factor Surveillance System, 2002 and 2004.

INTRODUCTION: Racial/ethnic disparities in colorectal cancer (CRC) screening exist. The literature suggests that differential treatment by race may influence health behaviors and health outcomes. OBJECTIVE: We examined the impact of Reactions to Race-based treatment on being up-to-date with colorectal cancer screening with endoscopy or fecal occult blood testing (FOBT) among non-Hispanic White, non-Hispanic Black, and Hispanic men and women aged > or = 50 years. DESIGN: Secondary data analysis of the Reactions to Race Module on the 2002 and 2004 Behavioral Risk Factor Surveillance System (BRFSS) was performed. Using logistic regression, we examined the strength of association between Reactions to Race-based treatment variables with up-to-date CRC screening tests after adjusting for demographic and access variables. MAIN OUTCOME MEASURES: CRC screening tests were analyzed independently as FOBT within 2 years (n = 30,134) and endoscopy (colonoscopy or sigmoidoscopy) within 5 years (n = 30,210). RESULTS: Among Whites, 34% reported FOBT, compared with 30.6% of Blacks and 15.3% of Hispanics (P < .05). Forty-five percent of Whites reported endoscopy, compared with 40.7% of Blacks and 32.1% of Hispanics (P < .05). After adjusting for sociodemographic characteristics, Hispanics who always thought about their race were 73% (OR = .27; 95% CI: .13-.57) less likely to receive FOBT. CONCLUSIONS: While screening disparities were largest among persons without insurance and a usual source of care, more research is needed to understand the influence of Reactions to Race-based treatment as an additional barrier to CRC screening.

"It's the skin you're in": African-American women talk about their experiences of racism. an exploratory study to develop measures of racism for birth outcome studies.

OBJECTIVES: Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. METHODS: Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. RESULTS: Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. CONCLUSIONS: This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested.

Understanding the role of reactions to race-based treatment in breast and cervical cancer screening.

Racial and ethnic disparities in breast and cervical cancer mortality persist despite effective screening methods. We examined associations between race/ethnicity and Pap testing within three years or mammography within two years, controlling for a composite reactions-to-race-based-treatment variable created using data from the 2002 and 2004 Behavioral Risk Factor Surveillance System Reactions to Race module, which assessed respondents experiences based on one's race. We calculated prevalence of Pap testing (for women aged > or = 18) and mammography (for women aged > or = 40) by race, and fit logistic regression models to estimate the strength of association of reactions to race-based treatment with screening and race--before and after controlling for demographics, socioeconomic status, health status, smoking and healthcare access. In the reduced model, black women were more likely (2.03: 95% CI: 1.55-2.65) to be screened for cervical cancer than whites. Reactions to race-based treatment did not impact the odds of black women receiving Pap tests or mammograms. Given current racial and ethnic disparities in breast and cervical cancer mortality, we suggest that more attention needs to be focused on follow-up of abnormal results and state-of-the art treatment for black and Hispanic women.

Employment status, social ties, and caregivers' mental health.

The purpose of this study of mid-life and older women was to assess the relation between informal care provision and depressive symptoms, taking into account concurrent demands on women's time (including multiple caregiving roles and employment outside the home) as well as participants' access to potentially supportive social ties. This cross-sectional study included women ages 46-71, free from major disease, who provided complete health and social information in the 1992 Nurses' Health Study follow-up survey (n = 61,383). In logistic regression models predicting depressive symptoms, we examined the interaction between employment outside the home and informal care provision for a disabled or ill spouse or parent. We also investigated level of social ties, measured with the Berkman-Syme Social Network Index, as a potential modifier of the association between informal care provision and depressive symptoms. In all analyses, higher weekly time commitment to informal care for a spouse or parent was associated with increased risk of depressive symptoms. This relationship persisted whether women were not employed outside the home, were employed full-time, or were employed part-time. Higher weekly time commitment to informal care provision was associated with increased risk of depressive symptoms whether women were socially integrated or socially isolated. However, both informal care provision and social ties were potent independent correlates of depressive symptoms. Therefore, women who reported high spousal care time commitment and few social ties experienced a dramatic elevation in depressive symptoms, compared to women with no spousal care responsibilities and many social ties (OR for depressive symptoms=11.8; 95% CI 4.8, 28.9). We observed the same pattern among socially isolated women who cared for their parent(s) many hours per week, but the association was not as strong (OR for depressive symptoms=6.5; 95% CI 3.4, 12.7). In this cross-sectional study, employment status did not seem to confer additional mental health risk or benefit to informal caregivers, while access to extensive social ties was associated with more favorable caregiver health outcomes.

Microalbuminuria in the US population: third National Health and Nutrition Examination Survey.

Microalbuminuria (MA) is associated with adverse health outcomes in diabetic and hypertensive adults. The prevalence and clinical significance of MA in nondiabetic populations is less clear. The purpose of this study was to generate national estimates of the prevalence of MA in the US population. Untimed urinary albumin concentrations (UACs) and creatinine concentrations were evaluated in a nationally representative sample of 22,244 participants aged 6 years and older. Persons with hematuria and menstruating or pregnant women were excluded from analysis. The percent prevalence of clinical proteinuria (UAC > or = 300 mg/L) was similar for males and females. However, the prevalence of MA (urinary albumin-creatinine ratio [ACR], 30 to 299 mg/g) was significantly lower in males (6.1%) compared with females (9.7%). MA prevalence was greater in children than young adults and increased continuously starting at 40 years of age. MA prevalence was greater in non-Hispanic blacks and Mexican Americans aged 40 to 79 years compared with similar-aged non-Hispanic whites. MA prevalence was 28.8% in persons with previously diagnosed diabetes, 16.0% in those with hypertension, and 5.1% in those without diabetes, hypertension, cardiovascular disease, or elevated serum creatinine levels. In adults aged 40+ years, after excluding persons with clinical proteinuria, albuminuria (defined as ACR > or = 30 mg/g) was independently associated with older age, non-Hispanic black and Mexican American ethnicity, diabetes, hypertension, and elevated serum creatinine concentration. MA is common, even among persons without diabetes or hypertension. Age, sex, race/ethnicity, and concomitant disease contribute to the variability of MA prevalence estimates.