Implementation of social needs screening for minoritized patients newly diagnosed with breast cancer: a mixed methods evaluation in a pragmatic patient navigation trial.

BACKGROUND: Social needs inhibit receipt of timely medical care. Social needs screening is a vital part of comprehensive cancer care, and patient navigators are well-positioned to screen for and address social needs. This mixed methods project describes social needs screening implementation in a prospective pragmatic patient navigation intervention trial for minoritized women newly diagnosed with breast cancer. METHODS: Translating Research Into Practice (TRIP) was conducted at five cancer care sites in Boston, MA from 2018 to 2022. The patient navigation intervention protocol included completion of a social needs screening survey covering 9 domains (e.g., food, transportation) within 90 days of intake. We estimated the proportion of patients who received a social needs screening within 90 days of navigation intake. A multivariable log binomial regression model estimated the adjusted rate ratios (aRR) and 95% confidence intervals (CI) of patient socio-demographic characteristics and screening delivery. Key informant interviews with navigators (n = 8) and patients (n = 21) assessed screening acceptability and factors that facilitate and impede implementation. Using a convergent, parallel mixed methods approach, findings from each data source were integrated to interpret study results. RESULTS: Patients' (n = 588) mean age was 59 (SD = 13); 45% were non-Hispanic Black and 27% were Hispanic. Sixty-nine percent of patients in the navigators' caseloads received social needs screening. Patients of non-Hispanic Black race/ethnicity (aRR = 1.25; 95% CI = 1.06-1.48) and those with Medicare insurance (aRR = 1.13; 95% CI = 1.04-1.23) were more likely to be screened. Screening was universally acceptable to navigators and generally acceptable to patients. Systems-based supports for improving implementation were identified. CONCLUSIONS: Social needs screening was acceptable, yet with modest implementation. Continued systems-based efforts to integrate social needs screening in medical care are needed.

Clinician-perceived barriers to cervical cancer screening before and during the COVID-19 pandemic at three US healthcare systems.

Introduction: The COVID-19 pandemic posed serious challenges to cancer screening delivery, including cervical cancer. While the impact of the pandemic on deferred screening has been documented, less is known about how clinicians experienced barriers to screening delivery, and, in particular, the role of pre-pandemic barriers to changes reported during the pandemic. Methods: Survey of clinicians who performed ≥ 10 cervical cancer screening tests in 2019 from Mass General Brigham, Kaiser Permanente Washington, and Parkland Health, the healthcare systems participating in the Population-based Research to Optimize the Screening Process (PROSPR II) consortium (administered 10/2020-12/2020, response rate 53.7 %). Results: Prior to the pandemic, clinicians commonly noted barriers to the delivery of cervical cancer screening including lack of staff support (57.6%), interpreters (32.5%), resources to support patients with social barriers to care (61.3%), and discrimination or bias in interactions between staff and patients (31.2%). Clinicians who reported experiencing a given barrier to care before the pandemic were more likely than those who did not experience one to report worsening during the pandemic: lack of staff support (odds ratio 4.70, 95% confidence interval 2.94-7.52); lack of interpreters (8.23, 4.46-15.18); lack of resources to support patients in overcoming social barriers (7.65, 4.41-13.27); and discrimination or bias (6.73, 3.03-14.97). Conclusions: Clinicians from three health systems who deliver cervical cancer screening commonly reported barriers to care. Barriers prior to the pandemic were associated with worsening of barriers during the pandemic. Addressing barriers to cervical cancer screening may promote resilience of care delivery during the next public health emergency.

Association of food insecurity with changes in diet quality, weight, and glycemia over two years in adults with prediabetes and type 2 diabetes on medicaid.

Little is known about longitudinal associations between food insecurity (FI) and diet, weight, and glycemia in people with prediabetes and type 2 diabetes (T2D). In a secondary analysis of Medicaid-enrolled health center patients with prediabetes or T2D in Boston, Massachusetts (N = 188), we examined associations between food security (FS) and measures of diet quality, weight, and hyperglycemia. FS (10-item USDA FS module) was ascertained at baseline, 1-year, and 2-year follow-up and categorized as persistently secure, intermittently insecure, or persistently insecure. Associations between FS category and changes in Healthy Eating Index-2020 (HEI-20), body mass index (BMI), and hemoglobin A1c (A1c) from baseline to year 2 were assessed using multivariate generalized linear models. Participants had median (p25, p75) age of 52 (42, 57); 71.8% were female and 62.8% Hispanic. Over follow-up, 32.4% were persistently food secure, 33.0% intermittently insecure, and 34.5% persistently insecure. Baseline mean (SD) HEI-20, BMI, and A1c were 55.8 (14.5), 35.9 (8.7) kg/m2, 7.1% (1.6) and did not differ by FS category. FS category was not associated with changes in HEI-20, BMI, and A1c at 2 years (all p > 0.05). Results suggest that Medicaid-enrolled adults with prediabetes or T2D, regardless of FS status, would benefit from dietary and weight management interventions.

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.

Screening for Financial Hardship: Comparing Patient Survey Responses Using Two Different Screening Tools.

BACKGROUND: Healthcare delivery organizations are increasingly screening patients for social risks using tools that vary in content and length. OBJECTIVES: To compare two screening tools both containing questions related to financial hardship. DESIGN: Cross-sectional survey. PARTICIPANTS: Convenience sample of adult patients (n = 471) in three primary care clinics. MAIN MEASURES: Participants randomly assigned to self-complete either: (1) a screening tool developed by the Centers for Medicare & Medicaid Services (CMS) consisting of six questions on financial hardship (housing stability, housing quality, food security, transportation security, utilities security); or (2) social and behavioral risk measures recommended by the National Academy of Medicine (NAM), including one question on financial hardship (financial strain). We compared patient acceptability of screening, positive screening rates for financial hardship, patient interest in assistance, and self-rated health. RESULTS: Ninety-one percent of eligible/interested patients completed the relevant survey questions to be included in the study (N = 471/516). Patient acceptability was high for both tools, though more participants reported screening was appropriate when answering the CMS versus NAM questions (87% vs. 79%, p = 0.02). Of respondents completing the CMS tool, 57% (132/232) reported at least one type of financial hardship; on the NAM survey, 52% (125/239) reported financial hardship (p = 0.36). Nearly twice as many respondents indicated interest in assistance related to financial hardship after completing items on the CMS tool than on the NAM question (39% vs. 21%, p < 0.01). CONCLUSIONS: Patients reported high acceptability of both social risk assessment tools. While rates of positive screens for financial hardship were similar across the two measures, more patients indicated interest in assistance after answering questions about financial hardship on the CMS tool. This might be because the screening questions on the CMS tool help patients to appreciate the types of assistance related to financial hardship that may be available after screening. Future research should assess the validity and comparative validity of individual measures and measure sets. Tool selection should be based on setting and population served, screening goals, and resources available.

Association of Food Insecurity with Changes in Diet Quality, Weight, and Glycemia Over Two Years in Adults with Prediabetes and Type 2 Diabetes on Medicaid.

Little is known about longitudinal associations between food insecurity (FI) and diet, weight, and glycemia in people with prediabetes and type 2 diabetes (T2D). In a secondary analysis of Medicaid-enrolled health center patients with prediabetes or T2D in Boston, Massachusetts (N = 188), we examined associations between food security (FS) and measures of diet quality, weight, and hyperglycemia. FS (10-item USDA FS module) was ascertained at baseline, 1-year, and 2-year follow-up and categorized as persistently secure, intermittently insecure, or persistently insecure. Associations between FS category and changes in Healthy Eating Index-2020 (HEI-20), body mass index (BMI), and hemoglobin A1c (A1c) from baseline to year 2 were assessed using multivariate generalized linear models. Participants had median (p25, p75) age of 52 (42, 57); 71.8% were female and 62.8% Hispanic. Over follow-up, 32.4% were persistently food secure, 33.0% intermittently insecure, and 34.5% persistently insecure. Baseline mean (SD) HEI-20, BMI, and A1c were 55.8 (14.5), 35.9 (8.7) kg/m2, 7.1% (1.6) and did not differ by FS category. FS category was not associated with changes in HEI-20, BMI, and A1c at 2 years (all p > 0.05). Results suggest that Medicaid-enrolled adults with prediabetes or T2D, regardless of FS status, would benefit from dietary and weight management interventions.

Examining sociodemographic correlates of opioid use, misuse, and use disorders in the All of Us Research Program.

BACKGROUND: The All of Us Research Program enrolls diverse US participants which provide a unique opportunity to better understand the problem of opioid use. This study aims to estimate the prevalence of opioid use and its association with sociodemographic characteristics from survey data and electronic health record (EHR). METHODS: A total of 214,206 participants were included in this study who competed survey modules and shared EHR data. Adjusted logistic regressions were used to explore the associations between sociodemographic characteristics and opioid use. RESULTS: The lifetime prevalence of street opioids was 4%, and the nonmedical use of prescription opioids was 9%. Men had higher odds of lifetime opioid use (aOR: 1.4 to 3.1) but reduced odds of current nonmedical use of prescription opioids (aOR: 0.6). Participants from other racial and ethnic groups were at reduced odds of lifetime use (aOR: 0.2 to 0.9) but increased odds of current use (aOR: 1.9 to 9.9) compared with non-Hispanic White participants. Foreign-born participants were at reduced risks of opioid use and diagnosed with opioid use disorders (OUD) compared with US-born participants (aOR: 0.36 to 0.67). Men, Younger, White, and US-born participants are more likely to have OUD. CONCLUSIONS: All of Us research data can be used as an indicator of national trends for monitoring the prevalence of receiving prescription opioids, diagnosis of OUD, and non-medical use of opioids in the US. The program employs a longitudinal design for routinely collecting health-related data including EHR data, that will contribute to the literature by providing important clinical information related to opioids over time. Additionally, this data will enhance the estimates of the prevalence of OUD among diverse populations, including groups that are underrepresented in the national survey data.

Assessment of the Massachusetts Flexible Services Program to Address Food and Housing Insecurity in a Medicaid Accountable Care Organization.

Importance: Health systems are increasingly addressing health-related social needs. The Massachusetts Flexible Services program (Flex) is a 3-year pilot program to address food insecurity and housing insecurity by connecting Medicaid accountable care organization (ACO) enrollees to community resources. Objective: To understand barriers and facilitators of Flex implementation in 1 Medicaid ACO during the first 17 months of the program. Design, Setting, and Participants: This mixed-methods qualitative evaluation study from March 2020 to July 2021 used the Reach, Efficacy, Adoption, Implementation, Maintenance/Practical, Robust Implementation, and Sustainability Model (RE-AIM/PRISM) framework. Two Mass General Brigham (MGB) hospitals and affiliated community health centers were included in the analysis. Quantitative data included all MGB Medicaid ACO enrollees. Qualitative interviews were conducted with 15 members of ACO staff and 17 Flex enrollees. Main Outcomes and Measures: Reach was assessed by the proportion of ACO enrollees who completed annual social needs screening (eg, food insecurity and housing insecurity) and the proportion and demographics of Flex enrollees. Qualitative interviews examined other RE-AIM/PRISM constructs (eg, implementation challenges, facilitators, and perceived effectiveness). Results: Of 67 098 Medicaid ACO enrollees from March 2020 to July 2021 (mean [SD] age, 28.8 [18.7] years), 38 442 (57.3%) completed at least 1 social needs screening; 10 730 (16.0%) screened positive for food insecurity, and 7401 (11.0%) screened positive for housing insecurity. There were 658 (1.6%) adults (mean [SD] age, 46.6 [11.8] years) and 173 (0.7%) children (<21 years; mean [SD] age, 10.1 [5.5]) enrolled in Flex; of these 831 people, 613 (73.8%) were female, 444 (53.4%) were Hispanic/Latinx, and 172 (20.7%) were Black. Most Flex enrollees (584 [88.8%] adults; 143 [82.7%] children) received the intended nutrition or housing services. Implementation challenges identified by staff interviewed included administrative burden, coordination with community organizations, data-sharing and information-sharing, and COVID-19 factors (eg, reduced clinical visits). Implementation facilitators included administrative funding for enrollment staff, bidirectional communication with community partners, adaptive strategies to identify eligible patients, and raising clinician awareness of Flex. In Flex enrollee interviews, those receiving nutrition services reported increased healthy eating and food security; they also reported higher program satisfaction than Flex enrollees receiving housing services. Enrollees who received nutrition services that allowed for selecting food based on preferences reported higher satisfaction than those not able to select food. Conclusions and Relevance: This mixed-methods qualitative evaluation study found that to improve implementation, Medicaid and health system programs that address social needs may benefit from providing funding for administrative costs, developing bidirectional data-sharing platforms, and tailoring support to patient preferences.

Food Insecurity and Diet Quality Among Adults on Medicaid With and Without a Mental Illness Diagnosis.

BACKGROUND: Adults with mental illnesses are more likely to have low income and diet-related chronic diseases. OBJECTIVE: This study examined associations of mental illness diagnosis status with food insecurity and diet quality and whether the relationship between food security status and diet quality differed by mental illness diagnosis status in adult Medicaid beneficiaries. DESIGN: This was a secondary cross-sectional analysis of baseline (2019-2020) data collected as part of the LiveWell study, a longitudinal study evaluating a Medicaid food and housing program. PARTICIPANTS/SETTING: Participants were 846 adult Medicaid beneficiaries from an eastern Massachusetts health system. MAIN OUTCOME MEASURES: Food security was measured with the 10-item US Adult Food Security survey module (0 = high food security, 1-2 = marginal food security, 3-10 = low/very low food security). Mental illness diagnoses included health record-documented anxiety, depression, or serious mental illness (eg, schizophrenia, bipolar disorder). Healthy Eating Index (HEI-2015) scores were calculated from 24-hour dietary recalls. STATISTICAL ANALYSES: Multivariable regression analyses adjusted for demographics, income, and survey date. RESULTS: Participants' mean (standard deviation) age was 43.1 (11.3) years, and 75% were female, 54% Hispanic, 33% non-Hispanic White, and 9% non-Hispanic Black. Fewer than half (43%) of participants reported high food security, with almost one third (32%) reporting low or very low food security. The 341 (40%) participants with one or more mental illness diagnosis had greater odds of low/very low food security (adjusted odds ratio [OR], 1.94; 95% confidence interval [CI], 1.38-2.70) and had similar mean HEI-2015 scores (53.1 vs 56.0; P = 0.12) compared with participants with no mental illness diagnosis. Mean adjusted HEI-2015 scores did not significantly differ by high vs low/very low food security for those without a mental illness diagnosis (57.9 vs 54.9; P = 0.052) or those with a mental illness diagnosis (53.0 vs 52.9; P = 0.99). CONCLUSION: In a cohort of adults with Medicaid, those with mental illness diagnoses had higher odds of experiencing food insecurity. Overall, diet quality among adults in this sample was low but did not differ by mental illness diagnosis or food security status. These results highlight the importance of augmenting efforts to improve both food security and diet quality among all Medicaid participants.

Racial and Ethnic Disparities in Opioid Access and Urine Drug Screening Among Older Patients With Poor-Prognosis Cancer Near the End of Life.

PURPOSE: To characterize racial and ethnic disparities and trends in opioid access and urine drug screening (UDS) among patients dying of cancer, and to explore potential mechanisms. METHODS: Among 318,549 non-Hispanic White (White), Black, and Hispanic Medicare decedents older than 65 years with poor-prognosis cancers, we examined 2007-2019 trends in opioid prescription fills and potency (morphine milligram equivalents [MMEs] per day [MMEDs]) near the end of life (EOL), defined as 30 days before death or hospice enrollment. We estimated the effects of race and ethnicity on opioid access, controlling for demographic and clinical factors. Models were further adjusted for socioeconomic factors including dual-eligibility status, community-level deprivation, and rurality. We similarly explored disparities in UDS. RESULTS: Between 2007 and 2019, White, Black, and Hispanic decedents experienced steady declines in EOL opioid access and rapid expansion of UDS. Compared with White patients, Black and Hispanic patients were less likely to receive any opioid (Black, -4.3 percentage points, 95% CI, -4.8 to -3.6; Hispanic, -3.6 percentage points, 95% CI, -4.4 to -2.9) and long-acting opioids (Black, -3.1 percentage points, 95% CI, -3.6 to -2.8; Hispanic, -2.2 percentage points, 95% CI, -2.7 to -1.7). They also received lower daily doses (Black, -10.5 MMED, 95% CI, -12.8 to -8.2; Hispanic, -9.1 MMED, 95% CI, -12.1 to -6.1) and lower total doses (Black, -210 MMEs, 95% CI, -293 to -207; Hispanic, -179 MMEs, 95% CI, -217 to -142); Black patients were also more likely to undergo UDS (0.5 percentage points; 95% CI, 0.3 to 0.8). Disparities in EOL opioid access and UDS disproportionately affected Black men. Adjustment for socioeconomic factors did not attenuate the EOL opioid access disparities. CONCLUSION: There are substantial and persistent racial and ethnic inequities in opioid access among older patients dying of cancer, which are not mediated by socioeconomic variables.

Achieving a Representative Sample of Asian Americans in Biomedical Research Through Community-Based Approaches: Comparing Demographic Data in the All of Us Research Program With the American Community Survey.

BACKGROUND: Underrepresented persons are often not included in biomedical research. It is unknown if the general Asian American population is being represented in All of Us. The purpose of this study was to compare the Asian demographic data in the All of Us cohort with the Asian nationally representative data from the American Community Survey. METHOD: Demographic characteristics and health literacy of Asians in All of Us were examined. Findings were qualitatively compared with the Asian data in the 2019 American Community Survey 1-year estimate. RESULTS: Compared with the national composition of Asians, less All of Us participants were born outside the United States (64% vs 79%), were younger, and had higher levels of education (76% vs 52%). Over 60% of All of Us participants reported high levels of health literacy. CONCLUSION: This study had implications for the development of strategies that ensure diverse populations are represented in biomedical research.

Contributors to Early Mortality in African Americans, the Jackson Heart Study.

Introduction: In recent years, premature "deaths of despair" (ie, due to alcohol, drug use, and suicide) among middle-aged White Americans have received increased attention in the popular press, yet there has been less discussion on what explains premature deaths among young African Americans. In this study, we examined factors related to deaths of despair (alcohol use, drug use, smoking) and contextual factors (perceived discrimination, socioeconomic status, neighborhood conditions) as predictors of premature deaths before the age of 65 years among African Americans. Methods: The Jackson Heart Study (JHS) is a longitudinal cohort study of African Americans in the Jackson, Mississippi, metropolitan statistical area. We included participants younger than 65 years at baseline (n=4000). Participant enrollment began in 2000 and data for these analyses were collected through 2019. To examine predictors of mortality, we calculated multivariable adjusted hazard ratios (HRs; 95% CI), using Cox proportional hazard models adjusted for age, sex, ideal cardiovascular health metrics, drug use, alcohol intake, functional status, cancer, chronic kidney disease, asthma, waist circumference, depression, income, education, health insurance status, perceived neighborhood safety, and exposure to lifetime discrimination. Results: There were 230 deaths in our cohort, which spanned from 2001-2019. After adjusting for all covariates, males (HR, 1.50; 95% CI, 1.11-2.03), participants who used drugs (HR, 1.53; 95% CI, 1.13-2.08), had a heavy alcohol drinking episode (HR, 1.71; 95% CI, 1.22-2.41), reported 0-1 ideal cardiovascular health metrics (HR, 1.78; 95% CI, 1.06-3.02), had cancer (HR, 2.38; 95% CI, 1.41-4.01), had poor functional status (HR, 1.68; 95% CI, 1.19-2.37), or with annual family income less than $25,000 (HR, 1.63; 95% CI, 1.02-2.62) were more likely to die before 65 years of age. Conclusions: In our large cohort of African American men and women, clinical predictors of premature death included poor cardiovascular health and cancer, and social predictors included low income, drug use, heavy alcohol use, and being a current smoker. Clinical and social interventions are warranted to prevent premature mortality in African Americans.

Social Determinants of Health and Hypertension Control in Adults with Medicaid.

BACKGROUND: Social determinants of health (SDOH) are associated with cardiovascular disease, but little is known about mechanisms underlying those relationships. We hypothesized that SDOH would be associated with uncontrolled hypertension (HTN) in adults with Medicaid. METHODS: This was a retrospective analysis of adults in a Medicaid accountable care organization who had HTN diagnoses, received regular care at community health centers, and enrolled in a cohort study between December 2019 and December 2020. Baseline surveys collected demographics and SDOH, including food insecurity, unstable housing, cost-related medication underuse, and financial stress. Blood pressure (BP) measurements over 12 months after survey completion were obtained from the electronic health record. Participants were categorized as: uncontrolled HTN (mean systolic BP ≥ 140 mm Hg and/or mean diastolic BP ≥ 90 mm Hg), controlled HTN, or unknown HTN control (no BP documented). We examined the association of individual and cumulative (count, 0-4) SDOH with uncontrolled HTN and unknown HTN control using multivariable logistic regression adjusting for demographics, smoking, diabetes, and HTN medication. RESULTS: Participants (n = 245) were mean (SD) age 51.3 (8.6) years, 66.1% female, 43.7% Hispanic, 34.3% White, and 18.0% Black. Overall, 58.0% had food insecurity, 38.0% had unstable housing, 29.4% had financial stress, and 20.0% reported cost-related medication underuse. BP was documented for 180 participants; 44 (24.4%) had uncontrolled HTN. In multivariable models, neither individual nor cumulative SDOH were associated with uncontrolled HTN or unknown HTN control. CONCLUSIONS: In a Medicaid-insured population receiving care at community health centers, adverse SDOH were prevalent but were not associated with HTN control.

Investigation of hypertension and type 2 diabetes as risk factors for dementia in the All of Us cohort.

The World Health Organization recently defined hypertension and type 2 diabetes (T2D) as modifiable comorbidities leading to dementia and Alzheimer's disease. In the United States (US), hypertension and T2D are health disparities, with higher prevalence seen for Black and Hispanic minority groups compared to the majority White population. We hypothesized that elevated prevalence of hypertension and T2D risk factors in Black and Hispanic groups may be associated with dementia disparities. We interrogated this hypothesis using a cross-sectional analysis of participant data from the All of Us (AoU) Research Program, a large observational cohort study of US residents. The specific objectives of our study were: (1) to compare the prevalence of dementia, hypertension, and T2D in the AoU cohort to previously reported prevalence values for the US population, (2) to investigate the association of hypertension, T2D, and race/ethnicity with dementia, and (3) to investigate whether race/ethnicity modify the association of hypertension and T2D with dementia. AoU participants were recruited from 2018 to 2019 as part of the initial project cohort (R2019Q4R3). Participants aged 40-80 with electronic health records and demographic data (age, sex, race, and ethnicity) were included for analysis, yielding a final cohort of 125,637 individuals. AoU participants show similar prevalence of hypertension (32.1%) and T2D (13.9%) compared to the US population (32.0% and 10.5%, respectively); however, the prevalence of dementia for AoU participants (0.44%) is an order of magnitude lower than seen for the US population (5%). AoU participants with dementia show a higher prevalence of hypertension (81.6% vs. 31.9%) and T2D (45.9% vs. 11.4%) compared to non-dementia participants. Dominance analysis of a multivariable logistic regression model with dementia as the outcome shows that hypertension, age, and T2D have the strongest associations with dementia. Hispanic was the only race/ethnicity group that showed a significant association with dementia, and the association of sex with dementia was non-significant. The association of T2D with dementia is likely explained by concurrent hypertension, since > 90% of participants with T2D also had hypertension. Black race and Hispanic ethnicity interact with hypertension, but not T2D, to increase the odds of dementia. This study underscores the utility of the AoU participant cohort to study disease prevalence and risk factors. We do notice a lower participation of aged minorities and participants with dementia, revealing an opportunity for targeted engagement. Our results indicate that targeting hypertension should be a priority for risk factor modifications to reduce dementia incidence.

An Overview of Cancer in the First 315,000 All of Us Participants.

INTRODUCTION: The NIH All of Us Research Program will have the scale and scope to enable research for a wide range of diseases, including cancer. The program's focus on diversity and inclusion promises a better understanding of the unequal burden of cancer. Preliminary cancer ascertainment in the All of Us cohort from two data sources (self-reported versus electronic health records (EHR)) is considered. MATERIALS AND METHODS: This work was performed on data collected from the All of Us Research Program's 315,297 enrolled participants to date using the Researcher Workbench, where approved researchers can access and analyze All of Us data on cancer and other diseases. Cancer case ascertainment was performed using data from EHR and self-reported surveys across key factors. Distribution of cancer types and concordance of data sources by cancer site and demographics is analyzed. RESULTS AND DISCUSSION: Data collected from 315,297 participants resulted in 13,298 cancer cases detected in the survey (in 89,261 participants), 23,520 cancer cases detected in the EHR (in 203,813 participants), and 7,123 cancer cases detected across both sources (in 62,497 participants). Key differences in survey completion by race/ethnicity impacted the makeup of cohorts when compared to cancer in the EHR and national NCI SEER data. CONCLUSIONS: This study provides key insight into cancer detection in the All of Us Research Program and points to the existing strengths and limitations of All of Us as a platform for cancer research now and in the future.

The All of Us Research Program: Data quality, utility, and diversity.

The All of Us Research Program seeks to engage at least one million diverse participants to advance precision medicine and improve human health. We describe here the cloud-based Researcher Workbench that uses a data passport model to democratize access to analytical tools and participant information including survey, physical measurement, and electronic health record (EHR) data. We also present validation study findings for several common complex diseases to demonstrate use of this novel platform in 315,000 participants, 78% of whom are from groups historically underrepresented in biomedical research, including 49% self-reporting non-White races. Replication findings include medication usage pattern differences by race in depression and type 2 diabetes, validation of known cancer associations with smoking, and calculation of cardiovascular risk scores by reported race effects. The cloud-based Researcher Workbench represents an important advance in enabling secure access for a broad range of researchers to this large resource and analytical tools.

Association of Everyday Discrimination With Depressive Symptoms and Suicidal Ideation During the COVID-19 Pandemic in the All of Us Research Program.

Importance: The COVID-19 pandemic has coincided with an increase in depressive symptoms as well as a growing awareness of health inequities and structural racism in the United States. Objective: To examine the association of mental health with everyday discrimination during the pandemic in a large and diverse cohort of the All of Us Research Program. Design, Setting, and Participants: Using repeated assessments in the early months of the pandemic, mixed-effects models were fitted to assess the associations of discrimination with depressive symptoms and suicidal ideation, and inverse probability weights were applied to account for nonrandom probabilities of completing the voluntary survey. Main Outcomes and Measures: The exposure and outcome measures were ascertained using the Everyday Discrimination Scale and the 9-item Patient Health Questionnaire (PHQ-9), respectively. Scores for PHQ-9 that were greater than or equal to 10 were classified as moderate to severe depressive symptoms, and any positive response to the ninth item of the PHQ-9 scale was considered as presenting suicidal ideation. Results: A total of 62 651 individuals (mean [SD] age, 59.3 [15.9] years; female sex at birth, 41 084 [65.6%]) completed at least 1 assessment between May and July 2020. An association with significantly increased likelihood of moderate to severe depressive symptoms and suicidal ideation was observed as the levels of discrimination increased. There was a dose-response association, with 17.68-fold (95% CI, 13.49-23.17; P < .001) and 10.76-fold (95% CI, 7.82-14.80; P < .001) increases in the odds of moderate to severe depressive symptoms and suicidal ideation, respectively, on experiencing discrimination more than once a week. In addition, the association with depressive symptoms was greater when the main reason for discrimination was race, ancestry, or national origins among Hispanic or Latino participants at all 3 time points and among non-Hispanic Asian participants in May and June 2020. Furthermore, high levels of discrimination were as strongly associated with moderate to severe depressive symptoms as was history of prepandemic mood disorder diagnosis. Conclusions and Relevance: In this large and diverse sample, increased levels of discrimination were associated with higher odds of experiencing moderate to severe depressive symptoms. This association was particularly evident when the main reason for discrimination was race, ancestry, or national origins among Hispanic or Latino participants and, early in the pandemic, among non-Hispanic Asian participants.

Effects of social support on depression risk during the COVID-19 pandemic: What support types and for whom?

Background: Rates of depression have increased worldwide during the COVID-19 pandemic. One known protective factor for depression is social support, but more work is needed to quantify the extent to which social support could reduce depression risk during a global crisis, and specifically to identify which types of support are most helpful, and who might benefit most. Methods: Data were obtained from participants in the All of Us Research Program who responded to the COVID-19 Participant Experience (COPE) survey administered monthly from May 2020 to July 2020 (N=69,066, 66% female). Social support was assessed using 10 items measuring emotional/informational support (e.g., someone to confide in or talk to about yourself or your problems), positive social interaction support (e.g., someone to do things with to help you get your mind off things), and tangible support (e.g., someone to help with daily chores if sick). Elevated depression symptoms were defined based on having a moderate-to-severe (≥10) score on the Patient Health Questionnaire (PHQ-9). Mixed-effects logistic regression models were used to test associations across time between overall social support and its subtypes with depression, adjusting for age, sex, race, ethnicity, and socioeconomic factors. We then assessed interactions between social support and potential effect modifiers: age, sex, pre-pandemic mood disorder, and pandemic-related stressors (e.g., financial insecurity). Results: Approximately 16% of the sample experienced elevated depressive symptoms. Overall social support was associated with significantly reduced odds of depression (adjusted odds ratio, aOR [95% CI]=0.44 [0.42-0.45]). Among subtypes, emotional/informational support (aOR=0.42 [0.41-0.43]) and positive social interactions (aOR=0.43 [0.41-0.44]) showed the largest protective associations with depression, followed by tangible support (aOR=0.63 [0.61-0.65]). Sex, age, and pandemic-related financial stressors were statistically significant modifiers of the association between social support and depression. Conclusions: Individuals reporting higher levels of social support were at reduced risk of depression during the early COVID-19 pandemic. The perceived availability of emotional support and positive social interactions, more so than tangible support, was key. Individuals more vulnerable to depression (e.g., women, younger individuals, and those experiencing financial stressors) may particularly benefit from enhanced social support, supporting a precision prevention approach.

Epidemiology of atrial fibrillation in the All of Us Research Program.

BACKGROUND: The prevalence, incidence and risk factors of atrial fibrillation (AF) in a large, geographically and ethnically diverse cohort in the United States have not been fully described. METHODS: We analyzed data from 173,099 participants of the All of Us Research Program recruited in the period 2017-2019, with 92,318 of them having electronic health records (EHR) data available, and 35,483 having completed a medical history survey. Presence of AF at baseline was identified from self-report and EHR records. Incident AF was obtained from EHR. Demographic, anthropometric and clinical risk factors were obtained from questionnaires, baseline physical measurements and EHR. RESULTS: At enrollment, mean age was 52 years old (range 18-89). Females and males accounted for 61% and 39% respectively. Non-Hispanic Whites accounted for 67% of participants, with non-Hispanic Blacks, non-Hispanic Asians and Hispanics accounting for 26%, 4% and 3% of participants, respectively. Among 92,318 participants with available EHR data, 3,885 (4.2%) had AF at the time of study enrollment, while the corresponding figure among 35,483 with medical history data was 2,084 (5.9%). During a median follow-up of 16 months, 354 new cases of AF were identified among 88,433 eligible participants. Individuals who were older, male, non-Hispanic white, had higher body mass index, or a prior history of heart failure or coronary heart disease had higher prevalence and incidence of AF. CONCLUSION: The epidemiology of AF in the All of Us Research Program is similar to that reported in smaller studies with careful phenotyping, highlighting the value of this new resource for the study of AF and, potentially, other cardiovascular diseases.

COVID-19 stressors and one-year changes in depression and anxiety in a longitudinal cohort of low-income adults in the United States.

Emerging data suggest that adults with low income are at highest risk for COVID-19-related stressors and mental health disorders. This study aimed to determine if COVID-19-related stressors were associated with worsening depression and anxiety in a cohort of low-income adults one year after the start of the pandemic. Participants included 253 Medicaid and commercial accountable care organization recipients from 5 community health centers around Boston, MA who enrolled December 2019-March 2020 in a larger longitudinal study of a Medicaid program. Participants completed surveys at baseline and one-year follow-up that measured depression (Patient Health Questionnaire-8 [PHQ-8]) and anxiety (Generalized Anxiety Disorder-7 [GAD-7]) symptoms. Follow-up surveys assessed COVID-19-related stressors experienced over the prior 12 months. A stressor score included COVID-19-related infectious, social, and economic stressors categorized into tertiles (low, 0-3; medium, 4-6; high, 7-19). Mean age (SD) was 45.2 (11.5) years; 71.2% were female, 42.3% Hispanic and 14.6% Black. At baseline, 126 (49.8%) had moderate or severe depression (PHQ-8 ≥ 10), and 109 (43.1%) had moderate or severe anxiety (GAD-7 ≥ 10). The mean (SD) number of COVID-19 stressors was 4.9 (3.1); the most frequent were food insecurity (52.2%) and job or income loss (43.9%). Compared to the low tertile, those in high and medium tertiles had significantly greater one-year increases in depression and anxiety symptoms. Low-income adults facing multiple COVID-19-related stressors, particularly health-related social needs, had worsening mental health symptoms over one year. Interventions are urgently needed to address the dual burden of health-related social needs and poor mental health exacerbated by COVID-19.