US Census Research Articles

Prevalence of menthol cigarette use among adults who smoke from the United States by census division and demographic subgroup, 2002–2020: findings from the International Tobacco Control (ITC) project

BackgroundTargeted marketing of menthol cigarettes in the US influences disparities in the prevalence of menthol smoking. There has been no analysis of sub-national data documenting differences in use across demographic subgroups. This study estimated trends in the prevalence of menthol use among adults who smoke in the nine US census divisions by sex, age, and race/ethnicity from 2002 to 2020.MethodsData from 12 waves of the US ITC Survey were used to estimate the prevalence of menthol cigarette use across census divisions and demographic subgroups using multilevel regression and post-stratification (n = 12,020). Multilevel logistic regression was used to predict the prevalence of menthol cigarette use in 72 cross-classified groups of adults who smoke defined by sex, age, race/ethnicity, and socioeconomic status; division-level effects were fit with a random intercept. Predicted prevalence was weighted by the total number of adults who smoke in each cross-classified group and aggregated to divisions within demographic subgroup. Estimates were validated against the Tobacco Use Supplement to the Current Population Survey (TUS-CPS).ResultsOverall modeled prevalence of menthol cigarette use was similar to TUS-CPS estimates. Prevalence among adults who smoke increased in each division from 2002 to 2020. By 2020, prevalence was highest in the Middle (46.3%) and South Atlantic (42.7%) and lowest in the Pacific (25.9%) and Mountain (24.2%) divisions. Prevalence was higher among adults aged 18–29 (vs. 50+) and females (vs. males). Prevalence among non-Hispanic Black people exceeded 80% in the Middle Atlantic, East North Central, West North Central, and South Atlantic in all years and varied most among Hispanic people in 2020 (Pacific: 26.5%, New England: 55.1%).ConclusionsSignificant geographic variation in the prevalence of menthol cigarette use among adults who smoke suggests the proposed US Food and Drug Administration (FDA) menthol cigarette ban will exert differential public health benefits and challenges across geographic and demographic subgroups.

Impact of the COVID-19 Pandemic on Blood Lead Testing in Children in the United States.

The study objective was to evaluate the impact of the coronavirus disease (COVID-19) pandemic on pediatric blood lead testing in the United States. Clinical laboratory pediatric (ages <6 years) blood lead level (BLL) tests performed by Quest Diagnostics, January 2019-March 2022, were analyzed. Patients were categorized by age, by sex, and, through matching by ZIP code with US Census data, for race, ethnicity, pre-1950 housing, and poverty estimates. Over 2.8 million results from children (<6 years old) from all 50 states and the District of Columbia were included. Compared to March-May 2019, BLL testing was lower by 53.6% in March-May 2020 and lower by 14.6% in March-May 2021. Testing rebounded more for children in predominantly White non-Hispanic communities and among children living in communities, based on ZIP codes, with the least pre-1950 housing stock and lowest poverty rates. The proportion of children with BLL at or above the United States Centers for Disease Control and Prevention reference values of 3.5 and 5.0 µg/dL fell by 19% and 24%, respectively, in 2021 versus 2019. In conclusion, pediatric BLL testing has rebounded from sharp declines during the early pandemic period but unevenly. Declines in the proportion of children with elevated BLL should be interpreted with caution, as testing rebounds were less robust among communities with the highest risk of lead poisoning, notably communities with the oldest housing stock and higher poverty rates. More public health efforts are needed to address lead toxicity throughout the United States, especially in communities that did not experience a full rebound subsequent to the early COVID-19 pandemic period.

Disparities in Mentorship and Implications for US Surgical Resident Education and Wellness

Many surgeons cite mentorship as a critical component of training. However, little evidence exists regarding factors associated with mentorship and the influence of mentorship on trainee education or wellness. To evaluate factors associated with surgical trainees' perceptions of meaningful mentorship, assess associations of mentorship with resident education and wellness, and evaluate programmatic variation in mentorship. A voluntary, anonymous survey was administered to clinically active residents in all accredited US general surgery residency programs following the 2019 American Board of Surgery In-Service Training Examination. Data were analyzed from July 2019 to July 2022. Residents were asked, "Do you have a mentor who genuinely cares about you and your career?" Resident characteristics associated with report of meaningful mentorship were evaluated with multivariable logistic regression. Associations of mentorship with education (clinical and operative autonomy) and wellness (career satisfaction, burnout, thoughts of attrition, suicidality) were examined using cluster-adjusted multivariable logistic regression controlling for resident and program factors. Residents' race and ethnicity were self-identified using US census categories (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White), which were combined and dichotomized as non-Hispanic White vs non-White or Hispanic. A total of 6956 residents from 301 programs completed the survey (85.6% response rate); 6373 responded to all relevant questions (2572 [40.3%] female; 2539 [39.8%] non-White or Hispanic). Of these, 4256 (66.8%) reported meaningful mentorship. Non-White or Hispanic residents were less likely than non-Hispanic White residents to report meaningful mentorship (odds ratio [OR], 0.81, 95% CI, 0.71-0.91). Senior residents (postgraduate year 4/5) were more likely to report meaningful mentorship than interns (OR, 3.06; 95% CI, 2.59-3.62). Residents with meaningful mentorship were more likely to endorse operative autonomy (OR, 3.87; 95% CI, 3.35-4.46) and less likely to report burnout (OR, 0.52; 95% CI, 0.46-0.58), thoughts of attrition (OR, 0.42; 95% CI, 0.36-0.50), and suicidality (OR, 0.47; 95% CI, 0.37-0.60) compared with residents without meaningful mentorship. One-third of trainees reported lack of meaningful mentorship, particularly non-White or Hispanic trainees. Although education and wellness are multifactorial issues, mentorship was associated with improvement; thus, efforts to facilitate mentorship are needed, especially for minoritized residents.

Race and ethnicity reporting and representation in hemophilia clinical trials

AbstractRacial and ethnic representativeness in clinical trials is crucial to mitigate disparities in outcomes; however, diversity among hemophilia trials is unknown. The aim of this study is to examine the reporting and representation of race and ethnicity in trials of people with hemophilia (PwH). In this cross-sectional study, the ClinicalTrials.gov database was queried in April 2023 for interventional clinical trials involving PwH between 2007 and 2022. The distribution of participants (observed) was compared with expected proportions based on US Hemophilia Treatment Center (HTC) and country-specific census data with observed-to-expected ratios (OERs). Of 129 trials included, 94.6% were industry sponsored, with a mean of 62 participants and mean age of 26.8 years. Overall, 52.0% (n = 66) of trials reported data on race and ethnicity, increasing from 13.9% in 2007-2012 to 22.5% in 2013-2016 to 100% in 2017-2022 (P = .001). Among these 66 trials, 65.8%, 22.8%, 5.1%, 3.9% of participants were White, Asian, Hispanic, and Black, respectively. OERs were 10% to 20% lower for White participants vs US HTC, and US, UK, and Canadian census populations and ∼75% lower for Black or Hispanic participants when compared with US HTC and US census population. OERs for Asian participants were 1.6 to 3 times higher than Canada, US, and UK census populations. The reporting of race and ethnicity in hemophilia trials has drastically improved; however, Black and Hispanic PwH remain especially underrepresented. To address these disparities, stakeholders across the clinical trial enterprise need to implement strategies to ensure equitable participation.

Counting question 20 on the 1870 census, the denial of the right to vote: Different tallies by the Census Office; the Minnesota Population Center; and Ancestry.com

Question 20 on the 1870 US Census asked respondents if they had been denied the right to vote. The Census Office told Congress in 1871 that 40,800 men answered yes to the question. The Minnesota Population Center (MPC) one percent sample of the 1870 entries projected 29,900 affirmative answers. By contrast, Ancestry.com counted more than 125,000 ‘yes’ answers. The three tallies stem from different assumptions about how to enter data from the manuscript pages. Researchers using the MPC 1% sample and the Ancestry.com full count sample should be aware of the different assumptions about how to enter data. The differences also indicate a need for a fourth count that captures the complexity of the asking and answering of question 20.

Racial Diversity of Patient Population Represented on United States Plastic Surgeons' Webpages.

Current literature demonstrates a lack of racial diversity in plastic surgery media. However, to our knowledge, no study has yet examined the racial diversity of Webpage content as if from a patient-search perspective. The objective of this study is to determine if there is a racial discrepancy between the US Census, American Society of Plastic Surgeons (ASPS) statistics, and the media featuring implied patients on US plastic surgeons' Webpages from a patient-focused approach. A Google search was completed using the term "(state) plastic surgeon." The first 10 relevant Web sites were collected for each state, and homepages were analyzed. In line with previous studies, the implied patients in media were classified into 1 of 6 skin tone categories: I, ivory; II, beige; III, light brown; IV, olive; V, brown; and VI, dark brown. These correlate to Fitzpatrick phototypes; however, the Fitzpatrick scale measures skin's response to UV exposure. Skin tone was used as a guide to measure racial representation in the media, with the caveat that skin tone does not absolutely correlate to racial identity. Categories I-III were further classified as "white" and IV-VI as "nonwhite." These data were compared with the 2020 ASPS demographics report and US Census. Four thousand eighty individuals were analyzed from 504 Webpages, the majority of which were those of private practice physicians. A total of 91.62% of individuals were classified as "white" and 8.38% "nonwhite." The distribution by category was as follows: I = 265, II = 847, III = 2626, IV = 266, V = 71, and VI = 5. Using χ2 analyses, a statistically significant difference was found between the racial representation within this sample and that of the 2020 US Census nationally (P < 0.001), regionally (P < 0.001), and subregionally (P < 0.001); the 2020 ASPS Cosmetic Summary Data (P < 0.001); and the 2020 ASPS Reconstructive Summary Data (P < 0.001). This study highlights the significant difference between racial representation on plastic surgeons' Webpages and the demographics of patients they serve. Further analyses should identify the impact of these representational disparities on patient care and clinical outcomes, as well as examine how best to measure racial diversity and disparities in patient-oriented media.

505 Use of Expanded Access at Michigan Medicine and Associations with Neighborhood Factors

OBJECTIVES/GOALS: Socioeconomic status (SES) affects risk of disease and access to therapies. The expanded access (EA) pathway allows for the clinical use of investigational products for patients who have serious illness but no Food and Drug Administration (FDA)-approved therapeutic options. The SES of patients who receive EA is unknown. METHODS/STUDY POPULATION: We reviewed the patients who were approved for treatment through a single-patient EA pathway between 2018 and 2023. Using Michigan Medicine (MM) DataDirect software linked to the MM electronic medical record system, we linked the EA pathway patients to neighborhood data from the National Neighborhood Data Archive (NaNDA) to compare neighborhood related markers of affluence among EA patients and others treated at MM. We used descriptive statistics to compare variables between EA pathway patients and residents of the state of Michigan or the local county surrounding MM (Washtenaw County), using US Census tract data to provide context for these findings. RESULTS/ANTICIPATED RESULTS: MM patients who received EA treatments were more likely to come from neighborhoods that showed markers of high SES compared to residents of the state of Michigan but not Washtenaw County. This includes the proportion of persons living in poverty (12.5% EA / 13.4% Michigan / 12.4% Washtenaw) and education in the form of a bachelor’s degree or higher (32.2% / 30.6% / 57.2%). This varied by the disease being treated. Oncology patients were more likely to be from areas with less poverty and more education (12.4% / 76.8%) than the EA average. EA patients being treated for infectious diseases were from areas with more poverty and less education (13.5% / 26.7%). DISCUSSION/SIGNIFICANCE: Patients treated at Michigan Medicine using treatments obtained through the EA pathway came from areas that were, on average, more affluent than residents of the state of Michigan as a whole. This finding warrants more research to ensure equitable access to these therapies for patients in disadvantaged neighborhoods.

325 The Economic Impact of Pediatric and Adolescent Gunshot Wound Mortality

INTRODUCTION: Gunshot wounds (GSW) are the leading cause of pediatric/adolescent mortality in the United States. The total economic impact of lost productivity has not been previously quantified. METHODS: The CDC WONDER database was utilized to document GSW fatalities of individuals 19 years and younger between 2001-2021. The weighted net present value (NPV) of potential future lost income for each child was calculated based on the Social Security Administration’s estimated NPV of lifetime earnings at age 20, using a 4% discount rate, and factoring in updated US census data on education status, graduation rates, and wage-gaps. Each year’s total lost income was adjusted to 2022 USD using the CPI-W. Sensitivity analysis tested the robustness of our model parameters’ variability on our model results. RESULTS: 64,503 total pediatric/adolescent GSW mortalities have occurred since 2001. Total estimated NPV income loss in 2022 USD is $58.78 Billion. This correlates with an estimated loss to Social Security of $7.29 Billion. Sensitivity analyses found that changes in salary had the highest potential impact on the final outcomes. Overall, the worst-case income scenario (-20% change in base salary) showed an estimated $47 Billion economic loss in 2022 USD. A similar analysis for total pediatric mortality due to neurological disease showed an economic loss of $18.86 Billion. CONCLUSIONS: The economic impact of income lost due to pediatric GSW fatalities between 2001-2021 is estimated to be $58.78 billion, with minimum value of $47 billion after sensitivity analysis. This estimate likely undervalues the total economic impact of pediatric gun violence since it is based on median salaries and excludes medical treatment, long-term disability/morbidity, multiplier effects, or future offspring productivity. The total cost to society of pediatric GSW mortality significantly exceeds all neurologic-related mortality and is too high for physicians and policymakers to ignore.

16 Sociodemographic and Hospital-Level Characteristics Associated with Hospital-Onset Bacteremia in the Neonatal Intensive Care Unit

OBJECTIVES/GOALS: The primary objective is to measure the independent association of hospital-level and sociodemographic variables on the rate of hospital-onset bacteremia among infants admitted to the neonatal intensive care unit in a United States of America retrospective cohort. The secondary outcome will be relative blood culture collection rate. METHODS/STUDY POPULATION: The study is an analysis of a retrospective cohort comprised of infants admitted to 322 neonatal intensive care units (NICUs) in the United States of America between 2016-2021. The primary outcome will be hospital-onset bacteremia (HOB), defined as a positive blood culture with a bacteria or fungi after day 3 of admission. Independent risk factors will include birthweight, postnatal age, central venous catheter presence, sociodemographic variables (race, ethnicity, insurance status and ZIP code-level demographic data from the US Census American Community Survey (ACS), and hospital-level variables. Infants will be stratified by sociodemographic groups and a Poisson model will be utilized to measure the adjusted association between risk of HOB and clinical and hospital-level variables. RESULTS/ANTICIPATED RESULTS: I anticipate that infants in sociodemographic groups with a history of socioeconomic marginalization will have a higher unadjusted rate of HOB; however, sociodemographic variables will not be independently associated with HOB risk after adjusting for markers of hospital quality and acuity, such as quartiles of the following: mean admissions per year, percentage of infants born &lt;1500g, annual blood culture contamination rate, and percentage infants born at another facility. DISCUSSION/SIGNIFICANCE: Neonatal bacteremia has high morbidity and mortality; however, its contribution to known infant mortality inequities is unknown. This study will estimate the burden of infant HOB stratified by sociodemographic groups and measure the independent association of sociodemographic and hospital-level variables on the adjusted rate of HOB.

Trends in medical device company payments in neurosurgery: a nationwide, multidatabase, geospatial analysis.

Industry partnerships help advance the field of neurosurgery. Given the nature of the field and its close relationship with innovation, neurosurgeons frequently partner with the medical device industry to advance technology and improve outcomes. However, this can create important ethical concerns for patients. In this paper, the authors sought to comprehensively study how physician payments from medical device companies have changed and what geographic parameters influence the trends observed over the years. The authors queried and merged several large databases, including Medicare and Medicaid provider usage data and databases from the Open Payments Program, National Plan and Provider Enumeration System, and US Census Bureau. Geospatial analysis was performed using Moran's I and II clustering. Univariate and multivariable analyses were performed using the Mann-Whitney U-test and geospatially weighted multivariable regression for hot spot and cold spot membership. Data for 952 counties across the continental United States were analyzed. Ninety-seven counties constituted geographic hot spots. These hot spots were primarily concentrated in Florida, the New York-Pennsylvania region, central Colorado, and southwestern United States. Independent predictors of hot spot membership included greater unemployment rates, the percentage of White patients, the presence of mobile homes, and the percentage of county Hispanic and Black populations. Company-based differences were examined. The vast majority of Medtronic's payments were in the form of royalties and licensing (86.6%). Royalties and licensing accounted for the majority of payments for DePuy (69.4%), Globus Medical (62%), and NuVasive (77.1%). In contrast, other companies, such as Boston Scientific, opted to pay physicians in the form of ownership and investment interests (42.1%). The impact of the COVID-19 pandemic was also assessed. During the onset of the pandemic in 2020, physician payments fell or remained the same across all regions with the exception of the South Atlantic region. However, it was observed that nearly all regions rebounded, with stark elevations in physician payments immediately in 2021. This analysis demonstrates that there are national hot spots and cold spots of physician payments, and offers some social, economic, and company-dependent predictors that may influence the magnitude of payments. Further analysis is needed to better understand this clinical-commercial partnership in healthcare, specifically within neurosurgical practice.

Combining zip code-based population data and pharmacy administrative claims data to create measures of social determinants of health.

Social determinants of health (SDoH) are key factors that impact health outcomes. However, there are many barriers to collecting SDoH data (eg, cost of data collection, technological barriers, and lack of standardized measures). Population data may provide an accessible alternative to collecting SDoH data for patients. To explain how population data can be leveraged to create SDoH measures, assess the association of population SDoH measures with diabetic medication adherence, and discuss how understanding a patient's SDoH can inform care plans and patient engagement. A nationally representative commercial sample of patients who were aged 18 years and older and met Pharmacy Quality Alliance inclusion criteria for diabetes mellitus were analyzed (N = 37,789). US Census and North American Industry Classification System data were combined with pharmacy administrative claims data to create SDoH measures. Derived measures represent 2 SDoH domains: (1) economic stability (housing density, housing relocation, jobs per resident, and average salary) and (2) health care access and quality (urban/rural classification, distance traveled to prescriber and pharmacy, use of a primary care provider [PCP], and residents per PCP). The association of population SDoH measures with diabetic medication adherence (proportion of days covered) was assessed via logistic regression, which included covariates (eg, sex, age, comorbidities, and prescription plan attributes). As housing density (houses per resident) increased, so did the likelihood of adherence (odds ratio = 1.54, 95% CI = 1.21-1.97, P = 0.001). Relative to patients who did not move, patients who moved once had 0.87 (95% CI = 0.81-0.93, P < 0.001) the odds of being adherent, and patients who moved 2 or more times had 0.82 (95% CI = 0.71-0.95, P = 0.008) the odds of being adherent. Compared with areas with fewer jobs per resident, patients living within a zip code with 0.16 to 0.26 jobs per resident were 1.12 (95% CI = 1.04-1.20, P = 0.002) times more likely to be adherent. Patients who lived in an urban cluster were 1.11 (95% CI = 1.01-1.22, P = 0.037) times more likely to be adherent than patients living in a rural area. Patients who travel at least 25 miles to their prescriber had 0.82 (95% CI = 0.77-0.86, P < 0.001) the odds of being adherent. Community pharmacy users had 0.65 (95% CI = 0.59-0.71, P < 0.001) the odds of being adherent compared with mail order pharmacy users. Patients who had a PCP were 1.26 (95% CI = 1.18-1.34, P < 0.001) times more likely to be adherent to their medication. Leveraging publicly available population data to create SDoH measures is an accessible option to overcome barriers to SDoH data collection. Derived measures can be used to increase equity in care received by identifying patients who could benefit from assistance with medication adherence.

Quantifying Disparities in Per- and Polyfluoroalkyl Substances (PFAS) Levels in Drinking Water from Overburdened Communities in New Jersey, 2019-2021.

Policymakers have become increasingly concerned regarding the widespread exposure and toxicity of per- and polyfluoroalkyl substances (PFAS). While concerns exist about unequal distribution of PFAS contamination in drinking water, research is lacking. We assess the scope of PFAS contamination in drinking water in New Jersey (NJ), the first US state to develop regulatory levels for PFAS in drinking water. We test for inequities in PFAS concentrations by community sociodemographic characteristics. We use PFAS testing data for community water systems (CWS) () from the NJ Department of Environmental Protection (NJDEP) from 2019 to 2021 and demographic data at the block group level from the US Census to estimate the demographics of the NJ population served by CWS. We use difference in means tests to determine whether CWSs serving "overburdened communities" (OBCs) have a statistically significant difference in likelihood of PFAS detections. OBCs are defined by the NJDEP to be census block groups in which: a) at least 35% of the households qualify as low-income, b) at least 40% of the residents identify as people of color, or c) at least 40% of the households have limited English proficiency. We calculate statewide summary statistics to approximate the relative proportions of sociodemographic groups that are served by CWSs with PFAS detections. We find that 63% of all CWSs tested by NJDEP from 2019 to 2021 had PFAS detections in public drinking water, collectively serving 84% of NJ's population receiving water from CWSs. Additionally, CWSs serving OBCs had a statistically significant higher likelihood of PFAS detection and a higher likelihood of exposure above state MCLs. We also find that a larger proportion of people of color lived in CWS service areas with PFAS detections compared to the non-Hispanic white population. These findings quantitatively identify disparities in PFAS contamination of drinking water by CWS service area and highlight the extent of PFAS drinking water contamination and the importance of PFAS remediation efforts for protecting environmental health and justice. https://doi.org/10.1289/EHP12787.

Patient Out-of-Pocket Costs for Biologic Drugs After Biosimilar Competition

Biologic drugs account for a growing share of US pharmaceutical spending. Competition from follow-on biosimilar products (subsequent versions that have no clinically meaningful differences from the original biologic) has led to modest reductions in US health care spending, but these savings may not translate to lower out-of-pocket (OOP) costs for patients. To investigate whether biosimilar competition is associated with lower OOP spending for patients using biologics. This cohort study used a national commercial claims database (Optum Clinformatics Data Mart) to identify outpatient claims for 1 of 7 clinician-administered biologics (filgrastim, infliximab, pegfilgrastim, epoetin alfa, bevacizumab, rituximab, and trastuzumab) from January 2009 through March 2022. Claims by commercially insured patients younger than 65 years were included. Year relative to first biosimilar availability and use of original or biosimilar version. Patients' annual OOP spending on biologics for each calendar year was determined, and OOP spending per claim between reference biologic and biosimilar versions was compared. Two-part regression models assessed for differences in OOP spending, adjusting for patient and clinical characteristics (age, sex, US Census region, health plan type, diagnosis, and place of service) and year relative to initial biosimilar entry. Over 1.7 million claims from 190 364 individuals (median [IQR] age, 53 [42-59] years; 58.3% females) who used at least 1 of the 7 biologics between 2009 and 2022 were included in the analysis. Over 251 566 patient-years of observation, annual OOP costs increased before and after biosimilar availability. Two years after the start of biosimilar competition, the adjusted odds ratio of nonzero annual OOP spending was 1.08 (95% CI, 1.04-1.12; P < .001) and average nonzero annual spending was 12% higher (95% CI, 10%-14%; P < .001) compared with the year before biosimilar competition. After biosimilars became available, claims for biosimilars were more likely than reference biologics to have nonzero OOP costs (adjusted odds ratio, 1.13 [95% CI, 1.11-1.16]; P < .001) but had 8% lower mean nonzero OOP costs (adjusted mean ratio, 0.92 [95% CI, 0.90-0.93; P < .001). Findings varied by drug. Findings of this cohort study suggest that biosimilar competition was not consistently associated with lower OOP costs for commercially insured outpatients, highlighting the need for targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability for patients who need biologics.

Trends and Disparities in Cardiovascular Death in Sarcoidosis: A Population-Based Retrospective Study in the United States From 1999 to 2020.

Despite significant cardiac involvement in sarcoidosis, real-world data on death due to cardiovascular disease among patients with sarcoidosis is not well established. We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database for data on patients with sarcoidosis aged ≥25 years from 1999 to 2020. Diseases of the circulatory system except ischemic heart disease were listed as the underlying cause of death, and sarcoidosis was stated as a contributing cause of death. We calculated age-adjusted mortality rate (AAMR) per 1 million individuals and determined the trends over time by estimating the annual percentage change using the Joinpoint Regression Program. Subgroup analyses were performed on the basis of demographic and geographic factors. In the 22-year study period, 3301 cardiovascular deaths with comorbid sarcoidosis were identified. The AAMR from cardiovascular deaths with comorbid sarcoidosis increased from 0.53 (95% CI, 0.43-0.65) per 1 million individuals in 1999 to 0.87 (95% CI, 0.75-0.98) per 1 million individuals in 2020. Overall, women recorded a higher AAMR compared with men (0.77 [95% CI, 0.74-0.81] versus 0.58 [95% CI, 0.55-0.62]). People with Black ancestry had higher AAMR than people with White ancestry (3.23 [95% CI, 3.07-3.39] versus 0.39 [95% CI, 0.37-0.41]). A higher percentage of death was seen in the age groups of 55 to 64 years in men (23.11%) and women (21.81%), respectively. In terms of US census regions, the South region has the highest AAMR from cardiovascular deaths with comorbid sarcoidosis compared with other regions (0.78 [95% CI, 0.74-0.82]). The increase of AAMR from cardiovascular deaths with comorbid sarcoidosis and higher cardiovascular mortality rates among adults aged 55 to 64 years highlight the importance of early screening for cardiovascular diseases among patients with sarcoidosis.

Abstract 2160: Utilizing geospatial analytics to identify neighborhood cancer hot spots for recruitment of underserved populations in clinical prevention research

Abstract Background: The term “precision public health” has increasingly been used in literature to describe public health practices that utilize new technologies and big data to precisely target the most vulnerable populations for disease control. Following the principles of precision public health, we used geospatial technologies and population-based health data to identify the locations and socioeconomic status of neighborhoods with high cancer incidences for recruitment of participants in prevention research. Methods: Using Florida cancer registry data, geospatial hot spot analyses were carried out to identify statistically significant clusters of census tracts with high incidences of prostate, gastric, and oral cancers within the catchment area of the Sylvester Comprehensive Cancer Center in South Florida. The locations, social determinants of health (US Census’ American Community Survey), and behavioral risk factor data (CDC’s Behavioral Risk Factor Surveillance System) of these hot spots were analyzed to identify the locations of underserved communities facing high risk for these three cancers. Results: Hot spots with high incidences for each of these three cancers overlap in many neighborhoods with high proportions of Hispanic and Non-Hispanic Black populations and high levels of socioeconomic disparities, such as low income, low education level, rental housing, no vehicles, and no access to health insurance. These neighborhoods also have high rates for behavioral risk factors in smoking, lack of physical activity, obesity, and high incidence of cervical cancer (high risk areas for HPV-associated oral cancers). Mobile screening units called the Game Changer Vehicles have been deployed to the locations to recruit participants who were tested on-site for prostate specific antigen (prostate cancer), H. pylori (gastric cancer), or solCD44 (a soluble tumor marker for squamous cell carcinoma) and total protein levels in oral rinse specimens, which can distinguish individuals with molecular features at risk for oral cancers due to tobacco, alcohol use, and human HPV infection. Conclusions: Geospatial analyses of population health data can be used to produce metrics that precisely target neighborhoods with high cancer risk and health disparities to recruit research participants. The same precision approach can also be applied for cancer screening purposes, such as offering cervical self-sample and fecal blood test kits in disadvantaged communities facing heightened risk for cervical and colorectal cancers. Citation Format: Ming S. Lee, Rebecca Kaiser, Ridhi Vyas, Amando Vera, Daniela Flores Quetant, Nancy Elliott, Valerie Bethel, Amanda Rivera, Shria Kumar, Brandon Mahal, Elizabeth Franzmann, Erin Kobetz. Utilizing geospatial analytics to identify neighborhood cancer hot spots for recruitment of underserved populations in clinical prevention research [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2160.

Abstract 3943: Refined race and ethnicity categories for an EHR-based cohort to study disparities in liver cancer risk

Abstract Purpose: To develop a schema for harmonized, detailed characterization of race and ethnicity data for an electronic health record (EHR)-based cohort linked to cancer registry data to assess disparities in hepatocellular carcinoma (HCC) risk. Methods: We assembled an cohort of adults with 1+ encounter in 2000-2017 by pooling EHR data from three healthcare systems (Kaiser Permanente Hawai’i, Sutter Health, San Francisco Health Network). EHR data to define sociodemographic and clinical factors were linked to population-based state cancer registries for data on incident HCC (ICD-03 site/histology C22.0/8170-8175) through 2017. We extracted, harmonized and developed schemas to characterize multiple response race and ethnicity data across systems. We used Cox proportional hazards regression to examine disparities in HCC risk across racial and ethnic groups, comparing observations across categorization schema. Results: The cohort included 4,248,553 adults; 2,916 had incident HCC. A race and ethnicity schema that prioritized small populations and disaggregation of heterogenous groups defined 16 categories and was used to analyze pooled data from Kaiser Permanente Hawai’i and Sutter Health. With this schema, we observed variation in HCC risk across ethnic groups that are typically aggregated into larger ethno-racial categories (e.g., Asian American). Compared to non-Hispanic (NH) White males, Vietnamese American males had greater risk of HCC (hazard ratio (HR): 7.42; 95% CI: 4.25, 12.96) as did American Indian/Alaska Native, Black, Chinese American, Hispanic, Native Hawaiian, and Pacific Islander males; Asian Indian, Filipino, Japanese, and Korean American males did not. Among females, every group except American Indian/Alaska Native, Asian Indian American, and Pacific Islander females had greater risk of HCC than the NH White group. Due to less granular data from San Francisco Health Network during our study period, we developed a second, grouped schema aggregating categories from the detailed schema; it resulted in seven race and ethnicity categories and was used to analyze pooled data from all three healthcare systems. Compared to the categorization of race and ethnicity used by the US Census, which also has seven categories, we observed different patterns in HCC risk disparities for the smallest groups (i.e., American Indian/Alaska Native and Native Hawaiian). Conclusions: Analysis of a large EHR-based cohort linked to cancer registry data using a race and ethnicity characterization schema that prioritizes small populations yields valuable knowledge on disparities in HCC risk. Thus, to advance research on health disparities using EHR data, researchers must critically assess racial and ethnic categories typically available from healthcare system data repositories. We offer recommendations to operationalize EHR data on race and ethnicity to facilitate its meaningful use in research. Citation Format: Mindy C. DeRouen, Caroline A. Thompson, Alison J. Canchola, Alyssa Cortella, Pushkar Inamdar, Janet Chu, Sixiang Nie, Mai Vu, Ma Somsouk, Michele M. Tana, Anna D. Rubinsky, Iona Cheng, Mi-Ok KIm, Mark Segal, Chanda Ho, Yihe G. Daida, Su-Ying Liang, Hashem B. El-Serag, Scarlett L. Gomez, Salma Shriff-Marco. Refined race and ethnicity categories for an EHR-based cohort to study disparities in liver cancer risk [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3943.

Abstract 4824: Multi-level intervention to increase minority cancer patient enrollment to clinical treatment trials- Study design considerations and baseline characteristics from the ACTWONDER2S Study

Abstract Introduction: Black/African American (AA) and Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs). Disparities stem from multiple factors, thus, comprehensive, multi-level interventions (MLI) are needed. Presented here is a conceptual framework for selecting the appropriate study design for MLIs using ACTWONDER2S, a multi-level intervention (MLI) aimed to increase Black/AA and Hispanic patient participation into CCTs, as an illustrative example. Baseline characteristics of the ACTWONDER2S target populations are also provided. Methods: ACTWONDER2S integrates community health educator and digital tools into an MLI targeting community residents and physicians in the Moffitt Cancer Center (MCC) catchment area, as well as MCC patients, physicians and CCT coordinators. A literature review of the relative strengths and weakness of 5 candidate designs for MLIs was conducted, and a cluster stratified randomized design was selected. Geospatial analytics were used to identify clusters of census tracts (“priority zones”) with high Black/AA and Hispanic populations for intervention deployment. Baseline characteristics of the priority zones were described using US Census data and other sources. Results: 14 priority zones were identified, which were matched on population characteristics and randomized into intervention (n=7) and control (n=7) zones. There were no statistically significant differences between the intervention and control priority zones in total population size (paired t-test p-value=0.63), proportions of Black/AA (p=0.133) and Hispanic populations p=0.17), and distance (in miles) from MCC (p=0.64). Approximately 35.8% and 16.5% of the intervention priority zones were Hispanic or Black/AA, respectively. Average distance to MCC, cancer cases, referral and CCT enrollment rates were also similar between groups. Conclusion: Decision frameworks for MLI study design selection are lacking. The framework provided here for ACTWONDER2S can be applied to other studies seeking to evaluate MLIs. Furthermore, the randomization of the priority zones produced optimal target populations for testing the efficacy of the MIL within ACTWONDER2S. Citation Format: Dana E. Rollison, Rossybelle P. Amorrortu, Lindsay N. Fuzzell, Melany A. Garcia, Elliott S. Tapia-Kwan, Yayi Zhao, Steven A. Eschrich, Bob R. Gore, Brian S. Mittman, Nathanael B. Stanley, Susan T. Vadaparampil. Multi-level intervention to increase minority cancer patient enrollment to clinical treatment trials- Study design considerations and baseline characteristics from the ACTWONDER2S Study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4824.

Abstract 1311: Planning for health equity in oncology trials: Expectations and feasibility

Abstract Achieving diverse representation in oncology studies is an ongoing challenge., Responding to calls to advance health equity in clinical trials, Congress amended the Food Drug and Cosmetic Act to require trial sponsors to submit a “diversity action plan” to the FDA with a study’s protocol. This requirement to plan for diverse trial recruitment drives a need to innovate approaches for site selection and trial recruitment that go beyond mirroring race-ethnicity distributions from the US Census or disease prevalence. We present a novel framework that nests clinical trials in a longitudinal patient registry to achieve diverse representation across multiple domains, evaluate site-selection and recruitment strategies, and examine health equity across the cancer patient journey. Implementing a registry to support longitudinal data collection (i.e., a cohort study), we establish a continuous view of participant characteristics including demographic and social determinants of health, treatment received, and relevant outcomes. Nesting clinical trials within the structure of the cohort, we can select sites and recruit for diverse representation to achieve equity goals. This framework involves a multi-layer analysis of external population statistics and internal reference registry to gauge the pool of eligible participants and calibrate the sampling strategy and recruitment expectations to the realities of clinical representation. Moreover, where clinical representation differs from population statistics, the registry offers an opportunity to report benchmarks for diversity and compare to site-level and study-level realized enrollment and feasibility. In conclusion, the path to health equity in oncology trials depends on a capacity to ask and answer the right questions in planning. What specific aspects of diversity are we aiming to capture? How do these aspects impact outcomes? We advocate for a dynamic planning process that continuously reevaluates goals and strategies in the face of enrollment data and evolving population demographics. By utilizing a registry with longitudinal follow-up, we can set forth clear expectations, transparently report on the progress of inclusion efforts, and candidly address feasibility challenges. We present a structured framework for trial sponsors to not only comply with the forthcoming requirement for diversity action plans, but ultimately to advance the goal of equitable cancer care through research that truly reflects the complex intersectional diversity of those impacted by the disease. Citation Format: Halcyon G. Skinner, Caroline Marra, April I. Alexandrow, Hamsa L. Subramaniam, Nathan C. Nussbaum, Joseph B. Franklin, Edgar P. Simard, Amy P. Abernethy. Planning for health equity in oncology trials: Expectations and feasibility [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1311.

Abstract 4784: PATHFINDER 2: A prospective study to evaluate safety and performance of a multi-cancer early detection test in a population setting

Abstract Background: Multi-cancer early detection (MCED) tests are being established as a novel approach to screen for multiple cancer types with one test. A blood-based MCED test using cell-free DNA targeted methylation patterns to detect a shared cancer signal and predict a cancer signal origin (CSO) has demonstrated feasibility. An initial return of results study (PATHFINDER; NCT04241796) reported performance of a refined version of the MCED test, including a 43.1% positive predictive value (PPV), 98.5% negative predictive value (NPV), 99.5% specificity, and 88.0% CSO accuracy. To build on this work, the PATHFINDER 2 study (NCT05155605) will evaluate safety and performance of the MCED test in larger, more diverse populations. Methods: PATHFINDER 2 is a prospective, multicenter, interventional study. Participants ≥50 years of age will be enrolled, with specific targets to improve diversity (age, sex, race/ethnicity) and few exclusions due to comorbid conditions. Exclusion criteria include current clinical suspicion of cancer or recent cancer/treatment (within 3 years). Participants will undergo blood draw for MCED testing, followed by return of results (cancer signal detection and CSO) to the investigator and diagnostic evaluations if a cancer signal is detected. A confirmatory PET-CT scan will be performed when CSO-directed workups do not result in a cancer diagnosis. Participants will be followed for approximately 3 years. Primary endpoints include 1) MCED test safety in terms of diagnostic testing triggered by a positive result (number/type of procedures and adverse events) and 2) test performance (PPV, NPV, specificity, sensitivity, CSO accuracy, cancer detection rate and number needed to screen). Secondary endpoints include participant reported outcomes (eg, anxiety), utilization of guideline-recommended cancer screening, and cancer detection rate of confirmatory PET-CT, amongst others. The study plans to enroll approximately 35,000 participants across North America. Sites were selected based on geographic location, catchment area demographics, and practice setting (academic vs non-academic). Enrollment targets for age, sex and race/ethnicity (White [non-Hispanic] 72%; Hispanic or Latino 11%; African American or Black 11%; Asian, Native Hawaiian or Other Pacific Islander 6%; American Indian/Alaska Native 1%) were derived from US Census data. Strategies to promote diverse recruitment include translation of participant-facing documents across multiple languages, participant and healthcare provider educational material, and site-led community outreach campaigns. MCED testing is an emerging, potentially paradigm-changing strategy in cancer screening, and PATHFINDER 2 is designed to characterize the safety, performance, and clinical implementation of the MCED test as a screening tool in a broad and representative population. Citation Format: Karthik V. Giridhar, Michael J. Demeure, Raymond H. Kim, Justin A. Chen, Shirish Gadgeel, Dax Kurbegov, Margarita Lopatin, Roland Matthews, Marc Matrana, Charles McDonnell, Donald Richards, Benjamin Rybicki, Gretchen Stipec, Nima Nabavizadeh. PATHFINDER 2: A prospective study to evaluate safety and performance of a multi-cancer early detection test in a population setting [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4784.

Abstract P483: Food Purchase Priorities and Healthy Food Purchase Supports and Barriers for U.S. General and Low-Income Consumers: A Quantitative Survey

Introduction: Identifying priorities and attributes that influence food purchase decisions will inform interventions and strategies to promote healthy eating. Aim: This study aimed to identify food purchase priorities and healthy food purchase supports and barriers for the general population and those with limited household income. Methods: Participants were recruited by a market research company in May 2023 and were required to be ≥ 18 years old, not work in healthcare/medical/nutrition or advertising/public relations/marketing/market research and be the primary/shared food decision maker for the household. Recruitment quotas ensured age, income, gender and geographic region approximated 2022 US census data (n=1,182) (Census-representative group, CRG). A sample with limited income and participation in federal food or healthcare programs (low-income group, LIG) was also recruited (n=506). The survey was administered online in May and June 2023. Differences between LIG and CRG were assessed using z-tests (p &lt; 0.05). Results: Taste was most commonly rated by CRG as very or extremely important in household food purchasing (87%). Availability, price, ingredients and nutritional value were also important to at least two-thirds of CRG. Taste was similarly important to LIG (85%), but they were more likely to rate price and less likely to rate availability, nutritional value and ingredients as important. When prompted to choose the most important factor, price and taste were the most common responses, chosen by similar proportions of CRG, while price was the most important factor for LIG, followed by taste. CRG versus LIG were more likely to prioritize personal taste over cost, health and nutrition information on labels, buying local and selecting according to nutrition, brand and origin/sourcing information. CRG were less likely than LIG to prefer a lower cost and usually select according to price. LIG were more likely than CRG to state that nothing supports them in selecting healthier foods and less likely to have found support from good-tasting recipes, advance meal or grocery list preparation, cooking equipment access, following influencers, recommendations from organizations or consulting a dietitian/nutritionist. Conversely, LIG were more likely to identify price and availability as barriers to selecting healthier foods, and less likely to see long preparation time, small servings sizes or nothing as barriers. Conclusions: Cost is a strong barrier to healthy eating, especially with limited income, along with taste, while nutrition is not a leading influence on food choice. Strategies to enable healthy eating among low-income households must prioritize taste and cost.