Differences in Metabolomic Profiles Between Black and White Women and Risk of Coronary Heart Disease: an Observational Study of Women From Four US Cohorts.

BACKGROUND: Racial differences in metabolomic profiles may reflect underlying differences in social determinants of health by self-reported race and may be related to racial disparities in coronary heart disease (CHD) among women in the United States. However, the magnitude of differences in metabolomic profiles between Black and White women in the United States has not been well-described. It also remains unknown whether such differences are related to differences in CHD risk. METHODS: Plasma metabolomic profiles were analyzed using liquid chromatography-tandem mass spectrometry in the WHI-OS (Women's Health Initiative-Observational Study; 138 Black and 696 White women), WHI-HT trials (WHI-Hormone Therapy; 156 Black and 1138 White women), MESA (Multi-Ethnic Study of Atherosclerosis; 114 Black and 219 White women), JHS (Jackson Heart Study; 1465 Black women with 107 incident CHD cases), and NHS (Nurses' Health Study; 2506 White women with 136 incident CHD cases). First, linear regression models were used to estimate associations between self-reported race and 472 metabolites in WHI-OS (discovery); findings were replicated in WHI-HT and validated in MESA. Second, we used elastic net regression to construct a racial difference metabolomic pattern (RDMP) representing differences in the metabolomic patterns between Black and White women in the WHI-OS; the RDMP was validated in the WHI-HT and MESA. Third, using conditional logistic regressions in the WHI (717 CHD cases and 719 matched controls), we examined associations of metabolites with large differences in levels by race and the RDMP with risk of CHD, and the results were replicated in Black women from the JHS and White women from the NHS. RESULTS: Of the 472 tested metabolites, levels of 259 (54.9%) metabolites, mostly lipid metabolites and amino acids, significantly differed between Black and White women in both WHI-OS and WHI-HT after adjusting for baseline characteristics, socioeconomic status, lifestyle factors, baseline health conditions, and medication use (false discovery rate <0.05); similar trends were observed in MESA. The RDMP, composed of 152 metabolites, was identified in the WHI-OS and showed significantly different distributions between Black and White women in the WHI-HT and MESA. Higher RDMP quartiles were associated with an increased risk of incident CHD (odds ratio=1.51 [0.97-2.37] for the highest quartile comparing to the lowest; Ptrend=0.02), independent of self-reported race and known CHD risk factors. In race-stratified analyses, the RDMP-CHD associations were more pronounced in White women. Similar patterns were observed in Black women from the JHS and White women from the NHS. CONCLUSIONS: Metabolomic profiles significantly and substantially differ between Black and White women and may be associated with CHD risk and racial disparities in US women.

Ten-Year Differences in Women's Awareness Related to Coronary Heart Disease: Results of the 2019 American Heart Association National Survey: A Special Report From the American Heart Association.

BACKGROUND: High awareness that cardiovascular disease is the leading cause of death (LCOD) among women is critical to prevention. This study evaluated longitudinal trends in this awareness among women. METHODS AND RESULTS: Online surveys of US women (≥25 years of age) were conducted in January 2009 and January 2019. Data were weighted to the US population distribution of sociodemographic characteristics. Multivariable logistic regression was used to evaluate knowledge of the LCOD. In 2009, awareness of heart disease as the LCOD was 65%, decreasing to 44% in 2019. In 2019, awareness was greater with older age and increasing education and lower among non-White women and women with hypertension. The 10-year awareness decline was observed in all races/ethnicities and ages except women ≥65 years of age. The greatest declines were among Hispanic women (odds ratio of awareness comparing 2019 to 2009, 0.14 [95% CI, 0.07-0.28]), non-Hispanic Black women (odds ratio, 0.31 [95% CI, 0.19-0.49]), and 25- to 34-year-olds (odds ratio, 0.19 [95% CI, 0.10-0.34]). In 2019, women were more likely than in 2009 to incorrectly identify breast cancer as the LCOD (odds ratio, 2.59 [95% CI, 1.86-3.67]), an association that was greater in younger women. Awareness of heart attack symptoms also declined. CONCLUSIONS: Awareness that heart disease is the LCOD among women declined from 2009 to 2019, particularly among Hispanic and non-Hispanic Black women and in younger women (in whom primordial/primary prevention may be most effective). An urgent redoubling of efforts by organizations interested in women's health is required to reverse these trends.

Plasma Estradiol and Testosterone Levels and Ischemic Stroke in Postmenopausal Women.

Background and Purpose- Although exogenous hormone therapy (HT) use has been associated with increased risk of ischemic stroke in postmenopausal women, it remains unknown whether sex hormone levels contribute to ischemic stroke risk. We aimed to estimate associations between plasma sex hormone levels and ischemic stroke risk, by HT status, in a nested case-control study of postmenopausal women from the NHS (Nurses' Health Study). Methods- Women with confirmed incident ischemic stroke (n=419) were matched with controls (n=419) by age, HT use, and other factors. Plasma estradiol and testosterone levels were measured using liquid chromatography tandem mass spectrometry; SHBG (sex hormone-binding globulin) was assayed by electrochemiluminescence immunoassay. Associations of total and free estradiol and testosterone, the estradiol/testosterone ratio, and SHBG with ischemic stroke were estimated using conditional logistic regressions stratified by HT status with adjustment for matching and cardiovascular risk factors. Results- Current HT users had different hormone profiles from never/past users. No clear linear trends were observed between estradiol (total or free) levels or the estradiol/testosterone ratio and ischemic stroke risk among either current users (Ptrend>0.1) or never/past users (Ptrend>0.6). For both current and never/past users, the associations between some of the sex hormones and ischemic stroke differed by body mass index categories (Pinteraction≤0.04). For women with a body mass index <25 kg/m2, a higher estradiol/testosterone ratio was associated with significantly elevated ischemic stroke risk among current users (Ptrend=0.01), and higher levels of total and free estradiol were significantly associated with higher ischemic stroke risk among never/past users (Ptrend≤0.04). Testosterone and SHBG were not associated with ischemic stroke in either current or never/past users. Conclusions- Our findings do not support a role of sex hormone levels in mediating ischemic stroke risk among postmenopausal women. Replications in additional larger studies are required.

Racial Variation in Stroke Risk Among Women by Stroke Risk Factors.

Background and Purpose- In the United States, black Americans exhibit a greater risk of stroke and burden of stroke risk factors than whites; however, it is unclear whether these stroke risk factors influence stroke risk differently across racial groups. Methods- In total, 126 018 participants of the Women's Health Initiative (11 389 black and 114 629 white women), free of stroke and coronary heart disease at baseline (1994-1998), were followed through 2010. Participants completed baseline clinical exams with standardized measurements of blood pressure and anthropometrics, medication inventory and self-reported questionnaires on sociodemographics, behaviors/lifestyle, and medical history. Incident total, ischemic and hemorrhagic strokes were updated annually through questionnaires with medical record confirmation. Rate differences (per 100 000 person-years) and hazard ratios (HR) based on multivariable Cox models and were estimated. Results- Over a median of 13 years, 4344 stroke events were observed. Absolute incidence rates were higher in black than white women in each age group. In age-adjusted analyses, the risk of stroke was significantly higher among black compared with white women (HR=1.47, 95% CI, 1.33-1.63); adjustment for stroke risk factors, which may be on the causal pathway, attenuated the estimate. Racial disparities were greatest among women 50 to <60 years (HR=3.48; 95% CI, 2.31-5.26; rate difference =99) and diminished with increasing age (60 to <70 HR=1.80; 95% CI, 1.50-2.16; rate difference =107; ≥70 years: HR=1.26; 95% CI, 1.10-1.43; rate difference =87; Pinteraction <0.001). Black women 50 to <60 years remained at significantly higher risk than white women after adjustment for stroke risk factors (HR=1.76; 95% CI, 1.09-2.83). Conclusions- There was a moderately greater risk of total stroke among black compared with white women; however, racial disparities were greatest among women aged 50 to <60 years. Interventions targeted at younger black women may provide the greatest benefit in reducing disparities.

Plasma Retinol-Binding Protein 4 Levels and the Risk of Ischemic Stroke among Women.

BACKGROUND: Plasma retinol-binding protein 4 (RBP4) levels have been associated with cardiovascular risk factors and risk of coronary heart disease, but little is known about the association between RBP4 and the risk of ischemic stroke. We hypothesized that elevated RBP4 levels would be associated with an increased risk of ischemic stroke among women. METHODS: We performed a nested case-control study among women enrolled in the Nurses' Health Study who provided blood samples between 1989 and 1990 and were free of prior stroke and cancer. We measured prediagnostic RBP4 levels in 471 ischemic stroke cases who were confirmed by medical record review and in 471 controls who were matched 1:1 to the cases on age, race, blood collection date, menopausal status, postmenopausal hormone use, and smoking status. We analyzed the association between RBP4 levels and ischemic stroke using multivariable conditional logistic regression conditional on the matching factors and adjusted for physical activity, body mass index, aspirin use, alcohol consumption, diet, history of diabetes, high cholesterol, high blood pressure, or heart disease, and cholesterol and hemoglobin A1C levels. RESULTS: Median levels of RBP4 were similar in cases (31.1 µg/mL) and controls (31.0 µg/mL; P value from the Wilcoxon rank-sum test = .82). Quartiles of RBP4 were not associated with an increased risk of ischemic stroke (highest quartile compared to lowest quartile: multivariate-adjusted odds ratio, .75; 95% confidence interval, .48, 1.17). We also did not observe associations between RBP4 and ischemic stroke of thrombotic or embolic origin. CONCLUSIONS: Elevated levels of RBP4 were not associated with an increased risk of ischemic stroke.

Association between alcohol consumption and plasma fetuin-A and its contribution to incident type 2 diabetes in women.

AIMS/HYPOTHESIS: The benefits of moderate alcohol consumption for type 2 diabetes have been postulated to involve a mechanism of improved insulin sensitivity. Fetuin-A, which is known to inhibit insulin signalling, has emerged as a biomarker for diabetes risk. Alcohol consumption may influence circulating fetuin-A concentrations and subsequently diabetes risk by altering the insulin signal. We therefore hypothesised that moderate alcohol consumption would be associated with lower fetuin-A concentration and that fetuin-A would partly explain the association between alcohol consumption and incident type 2 diabetes. METHODS: Among diabetes-free female participants in the Nurses' Health Study (n = 1,331), multiple linear regression was conducted to assess the association between alcohol consumption and plasma fetuin-A. Least-squares means (lsmeans) of fetuin-A were estimated in categories of alcohol consumption (0, 0.1-4.9, 5-14.9 and ≥ 15 g/day). The proportion of alcohol consumption and diabetes association explained by baseline fetuin-A was assessed in 470 matched incident diabetes case-control pairs with follow-up 2000-2006. RESULTS: Higher alcohol consumption was associated with lower plasma fetuin-A (p for trend = 0.009): lsmean ± SE 476.5 ± 5.9 µg/ml for abstainers, 468.9 ± 5.2 µg/ml for 0.1-4.9 g/day consumers, 455.9 ± 7.0 µg/ml for 5.0-14.9 g/day consumers, and 450.0 ± 9.4 µg/ml for ≥ 15.0 g/day consumers. Fetuin-A and fasting insulin explained 18.4% and 54.8%, respectively, of the inverse association between alcohol consumption and diabetes after multiple adjustment (both p for contribution <0.04). CONCLUSIONS/INTERPRETATION: Moderate alcohol consumption is associated with lower plasma fetuin-A in diabetes-free women. Fetuin-A and insulin explain a significant proportion of the association between alcohol consumption and incident type 2 diabetes. Further studies are needed to examine potential biological mechanisms underlying this association.

Plasma magnesium and risk of ischemic stroke among women.

BACKGROUND AND PURPOSE: Lower plasma magnesium levels may be associated with higher blood pressure and endothelial dysfunction, but sparse prospective data are available for stroke. METHODS: Among 32,826 participants in the Nurses' Health Study who provided blood samples in 1989 to 1990, incident ischemic strokes were identified and confirmed by medical records through 2006. We conducted a nested case-control analysis of 459 cases, matched 1:1 to controls on age, race/ethnicity, smoking status, date of blood draw, fasting status, menopausal status, and hormone use. We used conditional logistic regression models to estimate the multivariable adjusted association of plasma magnesium and the risk of ischemic stroke and ischemic stroke subtypes. RESULTS: Median magnesium levels did not differ between ischemic stroke cases and controls (median, 0.86 mmol/L for both; P=0.14). Conditional on matching factors, women in the lowest magnesium quintile had a relative risk of 1.34 (95% confidence interval, 0.86-2.10; P trend=0.13) for total ischemic stroke compared with women in the highest quintile. Additional adjustment for risk factors and confounders did not substantially alter the risk estimates for total ischemic stroke. Women with magnesium levels<0.82 mmol/L had significantly greater risk of total ischemic stroke (multivariable relative risk, 1.57; 95% confidence interval, 1.09-2.27; P=0.01) and thrombotic stroke (multivariable relative risk, 1.66; 95% confidence interval, 1.03-2.65; P=0.03) compared with women with magnesium levels≥0.82 mmol/L. No significant effect modification was observed by age, body mass index, hypertension, or diabetes mellitus. CONCLUSIONS: Lower plasma magnesium levels may contribute to higher risk of ischemic stroke among women.

Circulating fetuin-A and risk of ischemic stroke in women.

BACKGROUND: Fetuin-A, a protein secreted primarily by the liver, has been associated with nonalcoholic fatty liver disease and insulin resistance. In a recent study, higher circulating fetuin-A was associated with cardiovascular events, particularly ischemic stroke. However, these data have not been replicated. METHODS: A nested case control design was used to examine the relationship between fetuin-A and ischemic stroke among female participants of the Nurses' Health Study. Fetuin-A was measured in blood samples collected and stored between 1989 and 1990. A total of 459 incident cases of ischemic stroke were identified and confirmed by medical records according to the National Survey of Stroke criteria between 1990 and 2006 and matched to 459 controls by age, race/ethnicity, date of sample collection, menopausal status, postmenopausal hormone use, and smoking status. The association between fetuin-A and ischemic stroke was modeled using conditional logistic regression. RESULTS: Circulating fetuin-A was higher in women (P < 0.01) who reported increased body mass index (BMI) of ≥25 kg/m(2), total cholesterol ≥200 mg/dL, high-sensitivity C-reactive protein ≥3 mg/L, and current hormone use at baseline. Significant partial Spearman correlations (P < 0.001), adjusted for matching factors, were found between measured concentrations of fetuin-A and triglycerides (r = 0.20), C-reactive protein (r = 0.14), and BMI (r = 0.15). Fetuin-A quartiles were not significantly associated with increased risk of incident ischemic stroke when adjusted for matching factors (relative risk, 1.03; 95% CI, 0.69-1.54, extreme quartiles); additional adjustment for lifestyle factors or cardiovascular disease risk factors and biomarkers did not alter results. CONCLUSIONS: In this sample of women, fetuin-A was not significantly associated with risk of ischemic stroke. Further research is needed to explore this association.

Predicted vitamin D status and incidence of tooth loss and periodontitis.

OBJECTIVE: Vitamin D insufficiency is highly prevalent, with particular subgroups at greater risk (e.g. the elderly and those with darker skin). Vitamin D insufficiency may partly explain US racial/ethnic disparities in the prevalence of periodontitis and tooth loss. We evaluated the association between a predictor score of plasma 25-hydroxyvitamin D (25(OH)D) and incidence of periodontitis and tooth loss. DESIGN: Detailed biennial questionnaires were collected on medical history, lifestyle practices and incident periodontitis and tooth loss. The predictor score was derived from variables known to influence circulating concentrations of plasma 25(OH)D and validated against plasma concentrations among a sub-sample. Multivariable Cox proportional-hazards models with time-varying covariates estimated the association between the predicted 25(OH)D score and time until first tooth loss. SUBJECTS: A total of 42,730 participants of the Health Professionals Follow-Up Study aged 40-75 years at baseline were followed from 1986 to 2006. SETTING: USA, representing all fifty states and the District of Columbia. RESULTS: We observed 13,581 incident tooth loss events from 539,335 person-years. There was a dose-dependent significant inverse association across quintiles of the predicted 25(OH)D score and incidence of tooth loss. In multivariable analyses, the highest quintile of the updated predicted 25(OH)D score compared with the lowest was associated with a 20% lower incidence of tooth loss (hazard ratio = 0.80, 95 % CI 0.76, 0.85; P value for trend <0.001); UV-B was also independently associated. Results for the predicted 25(OH)D score and periodontitis were similar. CONCLUSIONS: These results are suggestive of an association between predictors of vitamin D and lower incidence of tooth loss and periodontitis.

Mental health, chronic and infectious conditions among pregnant persons in US state prisons and local jails 2016-2017.

BACKGROUND: Pregnant individuals in incarcerated settings have unique healthcare needs. Rates of mental health, infectious diseases, and chronic disease are higher among nonpregnant incarcerated women compared with those who are not, but the prevalence of these conditions among pregnant people in custody has not been documented. OBJECTIVES: The objective of this study is to describe the prevalence of metabolic, infectious, and mental health conditions in pregnant people to identify the medical needs of high-risk pregnancies in US state prisons and local jails. STUDY DESIGN: This was a prospective epidemiologic surveillance of a convenience sample of state prisons (n = 20) and local jails (n = 3). METHODS: We used purposive and snowball sampling to recruit a national sample of prisons and jails of a range of sizes and geographies. Reporters submitted to our study database monthly data on selected pregnancy comorbidities for 6 months between 2016 and 2017. Screening, diagnosis, and tracking of these conditions are derived from each facility's medical record and health care delivery systems. RESULTS: Of the 445 newly admitted pregnant people in prisons and 243 in jails, the most prevalent conditions were mental health conditions and hepatitis C. Specifically, 34.1% (n = 152) in prison and 23.5% (n = 57) in jail had a substance use disorder, and 27.4% (n = 122) of those in prison and 17.7% (n = 43) in jail had a psychiatric diagnosis. Finally, 20.2% (n = 91) in prison and 6.6% (n = 16) in jail had hepatitis C. CONCLUSIONS: This study demonstrates that chronic medical and mental health conditions are prevalent among pregnant people in US prisons and jails. However, significant variability in the reported number of cases of these conditions from state to state and between facility types implies a lack of or inadequate screening practices. These data indicate the need for comprehensive screening and appropriate care for the complex needs of pregnant incarcerated people.

OBJECTIVES: The objective of this study is to describe the prevalence of these conditions in pregnant people to identify the medical needs of high-risk pregnancies in US state prisons and local jails. STUDY DESIGN: The study involved ongoing systematic data collection, analysis and interpretation of pregnancy data from a convenience sample of state prisons (n = 20) and local jails (n = 3). METHODS: We intentionally recruited a national sample of prisons and jails of a range of sizes and geographies that house pregnant individuals. Some study facilities were referred from others. Reporters submitted to our study database monthly data on selected pregnancy comorbidities for 6 months between 2016 and 2017. Screening, diagnosis, and tracking of these conditions derived from each facility's medical record and health care delivery systems. RESULTS: Of the 445 newly admitted pregnant people in prisons and 243 in jails, the most prevalent conditions were mental health conditions and hepatitis C. Specifically, 34.1% (n = 152) in prison and 23.5% (n = 57) in jail had a substance use disorder and 27.4% (n = 122) of those in prison and 17.7% (n = 43) in jail had a psychiatric diagnosis. Finally, 20.2% (n = 91) in prison and 6.6% (n = 16) in jail had hepatitisc. CONCLUSIONS: This study demonstrates that chronic medical and mental health conditions are prevalent among pregnant people in US prisons and jails. However, significant variability in the reported number of cases of these conditions from state to state and between facility types implies a lack of or inadequate screening practices. These data indicate the need for comprehensive screening and appropriate care for the complex needs of pregnant incarcerated people.

Health care conditions among pregnant persons in US state prisons and local jails 2016­2017Background: Pregnant individuals in incarcerated settings have unique health care needs. Rates of mental health, infectious diseases, and chronic disease are higher among nonpregnant incarcerated women compared with those who are not, but the prevalence of these conditions among pregnant people in custody has not been documented.

The PhenX Toolkit: Recommended Measurement Protocols for Social Determinants of Health Research.

Health disparities are driven by unequal conditions in the environments in which people are born, live, learn, work, play, worship, and age, commonly termed the Social Determinants of Health (SDoH). The availability of recommended measurement protocols for SDoH will enable investigators to consistently collect data for SDoH constructs. The PhenX (consensus measures for Phenotypes and eXposures) Toolkit is a web-based catalog of recommended measurement protocols for use in research studies with human participants. Using standard protocols from the PhenX Toolkit makes it easier to compare and combine studies, potentially increasing the impact of individual studies, and aids in comparability across literature. In 2018, the National Institute on Minority Health and Health Disparities provided support for an initial expert Working Group to identify and recommend established SDoH protocols for inclusion in the PhenX Toolkit. In 2022, a second expert Working Group was convened to build on the work of the first SDoH Working Group and address gaps in the SDoH Toolkit Collections. The SDoH Collections consist of a Core Collection and Individual and Structural Specialty Collections. This article describes a Basic Protocol for using the PhenX Toolkit to select and implement SDoH measurement protocols for use in research studies. © 2024 The Authors. Current Protocols published by Wiley Periodicals LLC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. Basic Protocol: Using the PhenX Toolkit to select and implement SDoH protocols.

Low dehydroepiandrosterone sulfate is associated with increased risk of ischemic stroke among women.

BACKGROUND AND PURPOSE: Previous research suggests greater risk of coronary heart disease with lower levels of the adrenal steroid dehydroepiandrosterone sulfate (DHEAS). No studies have examined the association between DHEAS and risk of ischemic stroke. DHEAS may influence ischemic stroke risk through atherosclerotic-related mechanisms (endothelial function and smooth muscle cell proliferation) or insulin resistance. METHODS: Between 1989 and 1990, 32 826 women without prior stroke in the Nurses' Health Study, an observational cohort, provided blood samples and were followed up for cardiovascular events. Among this sample, using a nested case-control design, 461 ischemic strokes were confirmed by medical records by 2006. Cases were matched to controls free of stroke at the time of the index case and by age, race, menopausal status, postmenopausal hormone use, smoking status, and date of sample collection. Multivariable conditional logistic regression was used. RESULTS: Median DHEAS levels did not differ between cases (median=58.7) and controls (median=66.0; P=0.10). Conditional on matching factors, the lowest DHEAS quartile exhibited a relative risk of 1.30 for ischemic stroke (95% confidence interval, 0.88-1.94), compared with the highest quartile and marginally unchanged when adjusted for confounders (relative risk=1.33; 95% confidence interval, 0.87-2.02). When modeled as a binary variable dichotomized at the lowest quartile, women with low DHEAS (≤the lowest quartile) had a significantly increased multivariable adjusted risk of ischemic stroke compared with those with higher levels (relative risk=1.41; 95% confidence interval, 1.03-1.92). CONCLUSIONS: Lower DHEAS levels were associated with a greater risk of ischemic stroke, even after adjustment for potential confounders. These novel observations warrant confirmation in other populations.

Economic burden related to fistulas or strictures among commercially insured patients with Crohn's disease in the United States.

BACKGROUND: Crohn's disease (CD) is a chronic, progressive, immune-mediated gastrointestinal condition that can lead to fistulizing or stricturing complications. OBJECTIVE: To quantify the burden of illness related to fistulas and/or strictures in patients with CD. METHODS: Using the Optum Research Database from October 2015 to December 2019, patients with CD were classified according to 1 of 3 condition cohorts: CD with fistula (CD-F), CD with stricture (CD-S), or CD with fistula and stricture (CD-FS). Each cohort was matched to a nonfistula, nonstricture CD cohort. Postdiagnosis per patient per year (PPPY) costs and health care resource utilization were assessed, accounting for variable lengths of follow-up periods. Multivariable generalized linear models were used to estimate the adjusted mean costs in each cohort. RESULTS: The CD-F, CD-S, and CD-FS cohorts included 1,317; 4,650; and 894 patients, respectively. The mean age of patients within the CD-S and their comparator cohorts was higher than in the CD-F or CD-FS cohorts (59.9 vs 49.5 vs 49.6 years). At baseline, cardiovascular disease was the most common comorbidity across all condition and comparator cohorts. Condition cohorts had 2-4 times more inpatient visits, 5-8 times more surgical visits, and 2-3 times more endoscopies PPPY than comparator cohorts. Compared with their respective comparator cohort, patients in the 3 condition cohorts had higher medication, medical, and total health care costs. CONCLUSIONS: This study demonstrates a significant economic burden related to fistulas and/or strictures among patients with CD, highlighting the importance of prevention, early recognition, and appropriate management of CD-related complications. DISCLOSURES: Yanni Fan, Ling Zhang, Jennifer S Thompson, and Kimberly G Brodovicz are employees of Boehringer Ingelheim. Rhonda L Bohn, Monik C Jiménez, and Stephani Gray (Bohn Epidemiology, LLC) are paid consultants to Boehringer Ingelheim. Gil Y Melmed reports receiving grants from Pfizer; consulting fees from Boehringer Ingelheim, AbbVie, Arena, BMS, Celgene, Entasis, Ferring Lilly, Fresenius Kabi, Medtronic, Samsung Bioepis, Janssen, Takeda, Pfizer, Prometheus Labs, and TechLab. We conducted a retrospective study using administrative claims data from the Optum Research Database, a database of a commercially insured population in the United States. All patient data were anonymized and deidentified; therefore, informed consent was not necessary. Restrictions apply to the availability of these data because of a contract between Optum and Boehringer Ingelheim, and data are thus unavailable to the public. For enquiries on the dataset analyzed in this study, please contact Optum (https://www.optum.com).

Conditions of Confinement in U.S. Carceral Facilities During COVID-19: Individuals Speak-Incarcerated During the COVID-19 Epidemic.

Objectives: We aimed to describe conditions of confinement among people incarcerated in the United States during the coronavirus disease 2019 (COVID-19) pandemic using a community-science data collection approach. Methods: We developed a web-based survey with community partners to collect information on confinement conditions (COVID-19 safety, basic needs, support). Formerly incarcerated adults released after March 1, 2020, or nonincarcerated adults in communication with an incarcerated person (proxy) were recruited through social media from July 25, 2020 to March 27, 2021. Descriptive statistics were estimated in aggregate and separately by proxy or formerly incarcerated status. Responses between proxy and formerly incarcerated respondents were compared using Chi-square or Fisher's exact tests based on α=0.05. Results: Of 378 responses, 94% were by proxy, and 76% reflected state prison conditions. Participants reported inability to physically distance (≥6 ft at all times; 92%), inadequate access to soap (89%), water (46%), toilet paper (49%), and showers (68%) for incarcerated people. Among those receiving prepandemic mental health care, 75% reported reduced care for incarcerated people. Responses were consistent between formerly incarcerated and proxy respondents, although responses by formerly incarcerated people were limited. Conclusions: Our findings suggest that a web-based community-science data collection approach through nonincarcerated community members is feasible; however, recruitment of recently released individuals may require additional resources. Our data obtained primarily through individuals in communication with an incarcerated person suggest COVID-19 safety and basic needs were not sufficiently addressed within some carceral settings in 2020-2021. The perspectives of incarcerated individuals should be leveraged in assessing crisis-response strategies.

Excess mortality in U.S. prisons during the COVID-19 pandemic.

U.S. prisons were especially susceptible to COVID-19 infection and death; however, data limitations have precluded a national accounting of prison mortality (including but not limited to COVID-19 mortality) during the pandemic. Our analysis of mortality data collected from public records requests (supplemented with publicly available data) from 48 Departments of Corrections provides the most comprehensive understanding to date of in-custody mortality during 2020. We find that total mortality increased by 77% in 2020 relative to 2019, corresponding to 3.4 times the mortality increase in the general population, and that mortality in prisons increased across all age groups (49 and under, 50 to 64, and 65 and older). COVID-19 was the primary driver for increases in mortality due to natural causes; some states also experienced substantial increases due to unnatural causes. These findings provide critical information about the pandemic's toll on some of the country's most vulnerable individuals while underscoring the need for data transparency and standardized reporting in carceral settings.

Quantifying structural racism in cohort studies to advance prospective evidence.

Calls-to-action in health research have described a need to improve research on race, ethnicity, and structural racism. Well-established cohort studies typically lack access to novel structural and social determinants of health (SSDOH) or precise race and ethnicity categorization, contributing to a loss of rigor to conduct informative analyses and a gap in prospective evidence on the role of structural racism in health outcomes. We propose and implement methods that prospective cohort studies can use to begin to rectify this, using the Women's Health Initiative (WHI) cohort as a case study. To do so, we evaluated the quality, precision, and representativeness of race, ethnicity, and SSDOH data compared with the target US population and operationalized methods to quantify structural determinants in cohort studies. Harmonizing racial and ethnic categorization to the current standards set by the Office of Management and Budget improved measurement precision, aligned with published recommendations, disaggregated groups, decreased missing data, and decreased participants reporting "some other race". Disaggregation revealed sub-group disparities in SSDOH, including a greater proportion of Black-Latina (35.2%) and AIAN-Latina (33.3%) WHI participants with income below the US median compared with White-Latina (42.5%) participants. We found similarities in the racial and ethnic patterning of SSDOH disparities between WHI and US women but less disparity overall in WHI. Despite higher individual-level advantage in WHI, racial disparities in neighborhood resources were similar to the US, reflecting structural racism. Median neighborhood income was comparable between Black WHI ($39,000) and US ($34,700) women. WHI SSDOH-associated outcomes may be generalizable on the basis of comparing across race and ethnicity but may quantitatively (but not qualitatively) underestimate US effect sizes. This paper takes steps towards data justice by implementing methods to make visible hidden health disparity groups and operationalizing structural-level determinants in prospective cohort studies, a first step to establishing causality in health disparities research.