The Impact of COVID-19 on the All of Us Research Program.

The All of Us Research Program, a health and genetics epidemiologic data collection program, has been substantially affected by the coronavirus disease 2019 (COVID-19) pandemic. Although the program is highly digital in nature, certain aspects of the data collection require in-person interaction between staff and participants. Before the pandemic, the program was enrolling approximately 12,500 participants per month at more than 400 clinical sites. In March 2020, because of the pandemic, all in-person activity at program sites and by engagement partners was paused to develop processes and procedures for in-person activities that incorporated strict safety protocols. In addition, the program adopted new data collection methodologies to reduce the need for in-person activities. Through February 2022, a total of 224 clinical sites had reactivated in-person activity, and all enrollment and engagement partners have adopted new data collection methods that can be used remotely. As the COVID-19 pandemic persists, the program continues to require safety procedures for in-person activity and continues to generate and pilot methodologies that reduce risk and make it easier for participants to provide information.

Development of the Initial Surveys for the All of Us Research Program.

BACKGROUND: The All of Us Research Program is building a national longitudinal cohort and collecting data from multiple information sources (e.g., biospecimens, electronic health records, and mobile/wearable technologies) to advance precision medicine. Participant-provided information, collected via surveys, will complement and augment these information sources. We report the process used to develop and refine the initial three surveys for this program. METHODS: The All of Us survey development process included: (1) prioritization of domains for scientific needs, (2) examination of existing validated instruments, (3) content creation, (4) evaluation and refinement via cognitive interviews and online testing, (5) content review by key stakeholders, and (6) launch in the All of Us electronic participant portal. All content was translated into Spanish. RESULTS: We conducted cognitive interviews in English and Spanish with 169 participants, and 573 individuals completed online testing. Feedback led to over 40 item content changes. Lessons learned included: (1) validated survey instruments performed well in diverse populations reflective of All of Us; (2) parallel evaluation of multiple languages can ensure optimal survey deployment; (3) recruitment challenges in diverse populations required multiple strategies; and (4) key stakeholders improved integration of surveys into larger Program context. CONCLUSIONS: This efficient, iterative process led to successful testing, refinement, and launch of three All of Us surveys. Reuse of All of Us surveys, available at http://researchallofus.org, may facilitate large consortia targeting diverse populations in English and Spanish to capture participant-provided information to supplement other data, such as genetic, physical measurements, or data from electronic health records.

Extra-familial social factors and obesity in the Hispanic Community Children's Health Study/Study of Latino Youth.

Hispanic/Latino youth are disproportionately affected by obesity. However, how social factors outside of the family relate to Hispanic/Latino youth obesity is not well understood. We examined associations of extra-familial social factors with overweight/obesity prevalence, and their variation by sex and age, in 1444 Study of Latino Youth participants [48.6% female; 43.4% children (8-11 years); 56.6% adolescents (12-16 years)], who were offspring of the Hispanic Community Health Study/Study of Latinos participants. Youth self-reported general social support from friends, dietary-, and physical activity (PA)-specific support from peers, and awareness/internalization of thinness ideals. Overweight/obesity was defined as body mass index ≥ 85th percentile. Logistic regression models assessed effects of social factors and their interactions with age-group and sex, adjusting for potential confounders. Social support from friends interacted with both age and sex in relation to overweight/obesity. Female children who reported lesser (OR 0.60; 95% CI [0.39, 0.91]) and female adolescents who reported greater (OR 1.35; 95% CI [1.06, 1.74]) social support from friends had higher odds of overweight/obesity. Among males, greater awareness/internalization of thinness ideals related to higher odds of overweight/obesity (OR 2.30; 95% CI [1.59, 3.31]). Awareness/internalization of thinness ideals was not associated with overweight/obesity among females. Dietary and PA-specific peer support did not relate to overweight/obesity. Social support from friends and awareness/internalization of thinness ideals were significantly related to odds of overweight/obesity in Hispanic/Latino youth; associations varied by age and sex, and persisted after control for intra-familial factors (overall family support/function; diet and activity specific support).

A Strategic Framework for Utilizing Late-Stage (T4) Translation Research to Address Health Inequities.

Achieving health equity requires that every person has the opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances. Inequity experienced by populations of lower socioeconomic status is reflected in differences in health status and mortality rates, as well as in the distribution of disease, disability and illness across these population groups. This article gives an overview of the health inequities literature associated with heart, lung, blood and sleep (HLBS) disorders. We present an ecological framework that provides a theoretical foundation to study late-stage T4 translation research that studies implementation strategies for proven effective interventions to address health inequities.

A Global Perspective on Using Implementation Research to Address Hypertension-Associated Target Organ Damage.

Hypertension, a major risk factor for cardiovascular disease, imposes a significant public health burden and challenge to address it worldwide. Scaling up delivery of proven, effective interventions for hypertension could significantly advance the goal of reducing the global burden. Although significant progress has been made in many countries, some lament that large-scale initiatives focused on reducing blood pressure in global populations have not effectively addressed this challenge. Late-stage implementation research plays a critical role in determining effective and sustainable scale-up of these initiatives. In this article, we briefly discuss some of the global initiatives that have been funded by the National Heart, Lung, and Blood Institute of the US National Institutes of Health. Intervention delivery strategies in low resource settings must have demonstrated effectiveness and consideration for the social, cultural and physical context (eg, access, affordability, and availability of medications) in which a program is being delivered in order to be sustainable nationally and globally. Hence, the use of implementation research is central to determining sustainable delivery of evidence-based and tailored interventions focused on hypertension control. The sustained control of hypertension in global populations holds tremendous potential for reducing morbidity, premature mortality, and the adverse economic impact of cardiovascular disease in all regions.

Working to Eliminate Cancer Health Disparities from Tobacco: A Review of the National Cancer Institute's Community Networks Program.

INTRODUCTION: In 2005, the National Cancer Institute funded the Community Networks Program (CNP), which aimed to reduce cancer health disparities in minority racial/ethnic and underserved groups through community-based participatory research, education, and training. The purpose of this study was to describe the CNP model and their tobacco-related work in community-based research, education, and training using a tobacco disparities research framework. METHODS: We conducted a comprehensive review of the CNP tobacco-related activities including publications, published abstracts, research activities, trainee pilot studies, policy-related activities, educational outreach, and reports produced from 2005-2009. Two authors categorized the tobacco-related activities and publications within the framework. RESULTS: Although there was no mandate to address tobacco, the CNPs produced 103 tobacco-related peer-reviewed publications, which reflects the largest proportion (12%) of all CNP cancer-related publications. Selected publications and research activities were most numerous under the framework areas "Psychosocial Research," "Surveillance," "Epidemiology," and "Treatment of Nicotine Addiction." Thirteen CNPs participated in tobacco control policymaking in mainstream efforts that affected their local community and populations, and 24 CNPs conducted 1147 tobacco-related educational outreach activities. CNP activities that aimed to build research and infrastructure capacity included nine tobacco-related pilot projects representing 16% of all CNP cancer-related pilot projects, and 17 publications acknowledging leveraged partnerships with other organizations, a strategy encouraged by the CNP. CONCLUSIONS: The CNP is a promising academic-community model for working to eliminate tobacco-related health disparities. Future efforts may address scientific gaps, consider collaboration across groups, assess the extent of operationalizing community-based participatory research, and improve common tracking measures.

Measuring social determinants of health in the All of Us Research Program.

To accelerate medical breakthroughs, the All of Us Research Program aims to collect data from over one million participants. This report outlines processes used to construct the All of Us Social Determinants of Health (SDOH) survey and presents the psychometric characteristics of SDOH survey measures in All of Us. A consensus process was used to select SDOH measures, prioritizing concepts validated in diverse populations and other national cohort surveys. Survey item non-response was calculated, and Cronbach's alpha was used to analyze psychometric properties of scales. Multivariable logistic regression models were used to examine associations between demographic categories and item non-response. Twenty-nine percent (N = 117,783) of eligible All of Us participants submitted SDOH survey data for these analyses. Most scales had less than 5% incalculable scores due to item non-response. Patterns of item non-response were seen by racial identity, educational attainment, income level, survey language, and age. Internal consistency reliability was greater than 0.80 for almost all scales and most demographic groups. The SDOH survey demonstrated good to excellent reliability across several measures and within multiple populations underrepresented in biomedical research. Bias due to survey non-response and item non-response will be monitored and addressed as the survey is fielded more completely.

A contextual approach to understanding breast cancer survivorship among Latinas.

OBJECTIVES: The purpose of this review is to describe the empirical literature on the health-related quality of life (HRQOL) in Latina breast cancer survivors by exploring the social determinants of health. In framing the key domains of survivors' quality of life within a ecological-contextual model that evaluates individual and societal contributions to health outcomes, we provide a comprehensive landscape of the diverse factors constituting Latina survivors' lived experiences and their resultant quality of life outcomes. METHODS: We retrieved 244 studies via search engines and reference lists, of which 37 studies met the inclusion criteria. RESULTS: Findings document the importance of the social determinants of HRQOL, with studies documenting ecological and contextual factors accounting for significant variance in HRQOL outcomes. Our review identifies a dearth of research examining community-, institutional-, and policy-level factors, such as health care access, legal and immigration factors, physical and built environments, and health care affordability and policies affecting Latina breast cancer survivors' HRQOL. CONCLUSIONS: Overall research on Latina breast cancer survivorship is sparse, with even greater underrepresentation within longitudinal and intervention studies. Results highlight a need for clear documentation of the comprehensive care needs of underserved cancer survivors and interventions considering integrated systems of care to address the medical and ecological factors known to impact the HRQOL of breast cancer survivors.

Assessing the awareness of and willingness to participate in cancer clinical trials among immigrant Latinos.

Clinical trials are considered the gold standard of evidence about the efficacy of cancer prevention, early detection, and treatment interventions. A paucity of data exists on determinants of clinical trial participation in the growing US Latino population despite poor cancer outcomes in this group. This study seeks to describe correlates of awareness of and willingness to participate in clinical trials among largely Central, North, and South American Latinos using safety-net clinics. Between June 2007 and November 2008, we conducted an interviewer-administered, Spanish-language cross-sectional survey (n = 944). Logistic regression was used to assess effects of health information sources and psychosocial variables on awareness of and intention to participate in clinical trials. Analyses were completed in spring 2010. While only 48% knew what a clinical trial was, when explained, 65% indicated a willingness to participate. Providers were the most common source of health information. Use of Internet for health information, trust in health information, and higher education each independently increased the odds of clinical trial awareness, but obtaining information from providers did not. Contacting the Cancer Information Service and psychosocial factors were each independently associated with intent to join a clinical trial, while demographic factors were not. Information channels such as the Internet may be effective in conveying clinical trial information to Latinos. Providers being cited as the most common source of health information but not being associated with knowledge about or intent to participate in trials suggests a missed opportunity for communication to this population.

Quality of life among immigrant Latina breast cancer survivors: realities of culture and enhancing cancer care.

Breast cancer is the most common cancer among Latinas. This study examined social, cultural, and health care system factors that impact the quality of life and survivorship experiences of Latina immigrant breast cancer survivors. We interviewed Latina breast cancer survivors (n = 19) and, based on the interview findings, conducted two focus groups (n = 9). Research staff translated transcripts from Spanish into English. Two trained raters reviewed the content and identified themes. Thematic content analysis was used to categorize and organize data. Participants were largely monolingual in Spanish, predominantly from Central and South America and most (68%) had lived in the U.S. for ten or more years. All women were diagnosed and treated in the U.S. and were an average of 3.1 years from diagnosis. Women's survivorship experiences appeared to be shaped by cultural beliefs and experiences as immigrants such as secrecy/shame about a breast cancer diagnosis, feelings of isolation, importance of family support (familism), challenges with developing social relationships in the U.S. (less personalismo), and, for some, their partner's difficulty with showing emotional support (machismo). Navigating the U.S. medical system and language barriers were additional challenges in the participants' health care interactions. Latina breast cancer survivors adhere to certain cultural values and face unique issues as immigrants, potentially influencing overall quality of life and doctor-patient communication. Efforts to improve Latina immigrant breast cancer survivors' quality of life could include increased assessment of psychosocial functioning and referral to social support services, culturally sensitive navigation programs, and consistent use of appropriately trained interpreters.

The Limits of Self-Management: Community and Health Care System Barriers Among Latinos With Diabetes.

Although numerous studies examine diabetes self-care, few regard ecological framework correlates such as community and institutional level factors as fundamental for understanding diabetes management for Latinos. This article addresses the dearth of research that exists regarding social contextual forces and diabetes management for Latinos. Given the scarcity of research on this topic, studies of non-Latino groups were reviewed to illustrate the importance of community and institutional influences on diabetes care. Consideration of fundamental correlates within the ecological framework may better discern the underlying rationale for inadequate diabetes self-management for individuals who live in impoverished communities.

Diversity and inclusion for the All of Us research program: A scoping review.

The All of Us Research Program (All of Us) is a national effort to accelerate health research by exploring the relationship between lifestyle, environment, and genetics. It is set to become one of the largest research efforts in U.S. history, aiming to build a national resource of data from at least one million participants. All of Us aims to address the need for more diversity in research and set the stage for that diversity to be leveraged in precision medicine research to come. This paper describes how the program assessed demographic characteristics of participants who have enrolled in other U.S. biomedical research cohorts to better understand which groups are traditionally represented or underrepresented in biomedical research. We 1) reviewed the enrollment characteristics of national cohort studies like All of Us, and 2) surveyed the literature, focusing on key diversity categories essential to the program's enrollment aims. Based on these efforts, All of Us emphasizes enrollment of racial and ethnic minorities, and has formally designated the following additional groups as historically underrepresented: individuals-with inadequate access to medical care; under the age of 18 or over 65; with an annual household income at or below 200% of the federal poverty level; who have a cognitive or physical disability; have less than a high school education or equivalent; are intersex; identify as a sexual or gender minority; or live in rural or non-metropolitan areas. Research accounting for wider demographic variability is critical. Only by ensuring diversity and by addressing the very barriers that limit it, can we position All of Us to better understand and tackle health disparities.

Effectiveness of community outreach and engagement in recruitment success for a prebirth cohort.

INTRODUCTION: We describe the effectiveness of community outreach and engagement in supporting recruitment for the US National Children's Vanguard Study between 2009 and 2012. METHODS: Thirty-seven study locations used 1 of 4 strategies to recruit 18-49-year-old pregnant or trying to conceive women: (1) Initial Vanguard Study used household-based recruitment; (2) Direct Outreach emphasized self-referral; (3) Enhanced Household-Based Recruitment enhanced Initial Vanguard Study strategies; and (4) Provider-Based Recruitment recruited through healthcare providers. Outreach and engagement included advance letters, interactions with healthcare providers, participation in community events, contacts with community organizations, and media outreach. RESULTS: After 1-2 years, 41%-74% of 9844 study-eligible women had heard about the National Children's Vanguard Study when first approached. Women who heard were 1.5-3 times more likely to consent. Hearing via word-of-mouth or the media most frequently predicted consent. The more sources women heard from the higher the odds of consent. CONCLUSIONS: We conclude that tailored outreach and engagement facilitate recruitment in cohort studies.

A Systematic Review of Obesity Disparities Research.

CONTEXT: A review of interventions addressing obesity disparities could reveal gaps in the literature and provide guidance on future research, particularly for populations with a high prevalence of obesity and obesity-related cardiometabolic risk. EVIDENCE ACQUISITION: A systematic review of clinical trials in obesity disparities research that were published in 2011-2016 in PubMed/MEDLINE resulted in 328 peer-reviewed articles. Articles were excluded if they had no BMI, weight, or body composition measure as primary outcome or were foreign (n=201); were epidemiologic or secondary data analyses of clinical trials (n=12); design or protocol papers (n=54); systematic reviews (n=3); or retracted or duplicates (n=9). Forty-nine published trials were summarized and supplemented with a review of ongoing obesity disparities grants being funded by the National, Heart, Lung and Blood Institute. EVIDENCE SYNTHESIS: Of the 49 peer-reviewed trials, 27 targeted adults and 22 children only or parent-child dyads (5 of 22). Interventions were individually focused; mostly in single settings (e.g., school or community); of short duration (mostly ≤12 months); and primarily used behavioral modification (e.g., self-monitoring) strategies. Many of the trials had small sample sizes and moderate to high attrition rates. A meta-analysis of 13 adult trials obtained a pooled intervention effect of BMI -1.31 (95% CI=-2.11, -0.52, p=0.0012). Institutional review identified 140 ongoing obesity-related health disparities grants, but only 19% (n=27) were clinical trials. CONCLUSIONS: The reviews call for cardiovascular-related obesity disparities research that is long term and includes population research, and multilevel, policy, and environmental, or "whole of community," interventions.

Considerations of Methodological Approaches in the Recruitment and Retention of Immigrant Participants.

OBJECTIVE: This study aims to identify effective strategies related to recruitment and retention of immigrant survey participants. METHODOLOGY: The study used a multi-mode approach in, first, conducting a literature review of recent articles on surveys that either targeted immigrants or included large numbers of immigrants in their samples. Next, six surveys were reviewed that either targeted or included large numbers of immigrants. Finally, expert opinions on immigration were gathered regarding recruitment and retention of immigrant survey participants. RESULTS: Although immigrants may be difficult to recruit due to limited English proficiency, mistrust of strangers, and/or high mobility, many of these challenges can be overcome by adopting the same strategies used when surveying ethnically diverse populations (e.g., snowballing versus advertisement, establishing a personal connection with data collectors). Nonetheless, a few practices were identified as most relevant for recruitment and retention of immigrant populations, including involving local community organizations relevant to immigrants, translation of materials tailored to the vernacular language of the various ethnicities, and customizing non-monetary incentives to the specific ethnicity. CONCLUSIONS: Based on the reviews and expert interviews, multiple strategies have been shown to be effective in recruiting and retaining immigrant participants.

Patient and provider factors associated with colorectal cancer screening in safety net clinics serving low-income, urban immigrant Latinos.

BACKGROUND: Latinos have lower colorectal cancer screening rates than Whites. METHODS: We reviewed a random sample of charts between July 2009 and February 2010 of safety-net clinic of 840 immigrants (50 years and older) from Central and South America receiving care. Logistic regression evaluated associations of ever vs. never screening, patient and physician factors. RESULTS: Ever screening rates were 24.5%, and only 17% of charts noted a physician screening recommendation. However, the odds of screening were 9.89 times higher (95% CI: 6.25-15.64, p<.001) among patients with a physician recommendation vs. those without, considering covariates. The odds of screening were 0.61 times lower (95% CI: 0.40-0.92, p=.02) in patients with a body mass index ≥ 30 vs. <30. CONCLUSIONS: While rates were low, determinants of screening were similar in this Latino subgroup to those reported in other Latino and non-Latino populations. Low rates of documented physician screening recommendations may indicate a potential missed opportunity for cancer control in safety-net clinics.

Conceptions of acculturation: a review and statement of critical issues.

This article reviews evidence for re-conceptualizing acculturation status and acculturation process in health care research with United States (U.S.) Latino populations. Prior literature on acculturation has focused on: (a) acculturative change towards the dominant culture, (b) acculturation as it occurs with Mexican Americans, and (c) language as the principal component of acculturation. We review empirically based health research on acculturation and propose an ecodevelopmental framework for better understanding the process of acculturation. We then offer recommendations that may assist public health researchers, policymakers and program developers in better understanding "real world" acculturation. This includes understanding acculturation within this ecodevelopmental context for a more complete understanding of the acculturation process and its influences on health-related behaviors, with aims of reducing or eliminating health disparities in Latino populations.

Efficiency and cost-effectiveness of recruitment methods for male Latino smokers.

Little is known about the most effective strategies to recruit male Latino smokers to cessation research studies. The purpose of this study was to identify efficient and cost-effective research recruitment strategies for this priority population.

Assessment of community food resources: A Latino neighborhood study in upstate New York.

This study aims to assess availability, affordability, and accessibility of food items in a low-income Latino neighborhood within a small city using an on-site food store survey. Store locations were identified by on-site GPS. Results showed the Latino neighborhood had limited availability and above average cost of high-fiber bread. Fresh vegetables were more expensive compared to the non-Latino neighborhood, and more stores in the Latino neighborhood participated in Supplemental Nutrition Assistance Food Program. The lack of supermarkets, fewer stores with disability access, and the lack of public transportation left Latino residents without a vehicle or with physical disabilities with few food shopping options.