Behaviors Related to Medication Safety and Use During Pregnancy.

Background: Most women take medication during pregnancy despite limited scientific evidence on safety. We investigated medication use, including changes in and reasons for changes in use during pregnancy, with attention to medication use in pregnant women with chronic conditions. Materials and Methods: We conducted an online survey of pregnant women aged ≥18 years (n = 1,226). We calculated descriptive statistics for aspects of medication use and performed multivariable logistic regression to examine associations between change in use and chronic conditions. Results: Seventy-nine percent of women took at least one medication during pregnancy. Among those, 63.2% made at least one medication change: 42.0% started, 34.9% stopped, 30.0% missed dose(s), and 18.1% lowered dose(s) from that originally prescribed or recommended. More than a third (36.5%) of women who stopped, lowered, or missed medication did so independent of health care provider advice; 54.0% cited concern about birth or developmental defects as reasons for change. Odds of medication change were higher for women with chronic conditions: digestive conditions-starting (adjusted odds ratio [AOR] = 1.8, 95% confidence interval [CI] = 1.1-2.7), stopping (AOR = 2.1, 95% CI = 1.4-3.3), and lowering (AOR = 2.4, 95% CI = 1.7-3.3) medication; mental health conditions-starting (AOR = 1.6, 95% CI = 1.2-2.2), stopping (AOR = 3.0, 95% CI = 2.3-4.0), or missing (AOR = 2.1, 95% CI = 1.6-2.8) medication; pain conditions-stopping (AOR = 2.9, 95% CI = 2.0-4.2); and respiratory conditions-starting (AOR = 2.0, 95% CI = 1.3-3.1), stopping (AOR = 1.7, 95% CI = 1.1-2.6), and missing (AOR = 2.2, 95% CI = 1.4-3.4) medication. Conclusions: Most pregnant women take medication and many, including those with chronic conditions, change their medication use during pregnancy. Medication change may occur independent of health care provider advice and due to women's safety concerns.

Determinants of Hormone Replacement Therapy Knowledge and Current Hormone Replacement Therapy Use.

Background: The use of hormone replacement therapy (HRT) to treat menopausal symptoms has declined since the early 2000s, and little is known about the contemporary determinants of use in the United States. We aim to understand women's knowledge of HRT as a treatment of menopausal symptoms and to assess the factors associated with HRT use. Materials and Methods: Weighted multivariate logistic regression models evaluated the correlates of high HRT knowledge and current HRT use among a sample of 2,548 women aged ≥45 years who participated in an online survey between August 2019 and May 2020. Results: In total, 82% of the women surveyed reported experiencing one or more menopausal symptoms, yet only 10.5% reported using HRT. Only 33% reported high HRT knowledge. The odds of reporting high HRT knowledge increased with increasing age. Racial, ethnic minority women were less likely to report high HRT knowledge (adjusted odds ratio [AOR] = 0.69; 95% confidence interval [CI] = 0.5-0.9). Hispanic and non-Hispanic women of other racial and ethnic groups were less likely to use HRT compared with non-Hispanic White women (AOR = 0.3; 95% CI = 0.1-0.6) (AOR = 0.4; CI = 0.2-0.9), respectively. Women experiencing irregular periods were less likely to report current HRT use (AOR = 0.1, 95% CI = 0.4-0.7). Compared with past users, never users appeared to be more risk averse, and reported concern over HRT risks and side effects as reasons for nonuse. Conclusions: Many factors impact women's perceived HRT knowledge level and to a lesser extent HRT use. Future research should better define the most important factors influencing decisions to use HRT for symptom relief.

Nativity and Cardiovascular Dysregulation: Evidence from the 2001-2016 National Health and Nutrition Examination Survey.

OBJECTIVES: To examine nativity-based differences in 3 cardiovascular biomarkers commonly used to assess cardiovascular dysregulation. METHODS: Data was pooled from the 2001-2016 National Health and Nutrition Examination Survey to compare biomarker risk scores for the US-born (n = 4693) and foreign-born (n = 2968) Black adults. We used multivariable-adjusted logistic regression to assess the association between nativity and cardiovascular biomarkers, controlling for gender, age, health behaviors, and socioeconomic status. RESULTS: In the full model, a foreign-born health advantage was not observed in all 3 cardiovascular biomarkers. In fact, foreign-born Blacks were almost twice as likely to have high mean diastolic blood pressure compared with the US-born individuals (OR = 1.82; 95% CI = 1.15, 2.88) and had an increased risk of high 60-s pulse. Foreign-born individuals living in the USA for less than 5 years were 62% less likely to have high mean systolic blood pressure than individuals living in the USA for 20 years or more. CONCLUSIONS: The foreign-born health advantage among Blacks was not observed in the cardiovascular biomarkers under study, suggesting that the commonly cited Healthy Immigrant Effect may need to be reassessed.

The role of prenatal food insecurity on breastfeeding behaviors: findings from the United States pregnancy risk assessment monitoring system.

BACKGROUND: In addition to its health and nutritional benefits, breastfeeding can save low-income, food insecure mothers the cost of infant formula so that money can be spent on food and other necessities. Yet breastfeeding may exacerbate food insecurity by negatively affecting maternal employment. The relationship between food insecurity and breastfeeding has been explored previously, with varying results. The purpose of this study was to determine the relationship between prenatal food insecurity and breastfeeding initiation and early cessation (< 10 weeks) among U.S. mothers. METHODS: Data were pooled from 2012 to 2013 (Phase 7) of the Pregnancy Risk Assessment Monitoring System, a population-based cross-sectional survey of postpartum women administered 2-4 months after delivery. The analytic sample was drawn from Colorado, Maine, New Mexico, Oregon, Pennsylvania, and Vermont, and limited to mothers aged 20 years and older whose infants were alive and living with them at the time of the survey (n = 10,159). We used binomial and multinomial logistic models to assess the predictive association between food insecurity and breastfeeding initiation and early cessation, respectively, while controlling for confounders. RESULTS: Most women reported prenatal food security (90.5%) and breastfeeding initiation (91.0%). Of those who initiated breastfeeding, 72.7% breastfed for > 10 weeks. A larger proportion of food secure women compared to food insecure women, initiated breastfeeding (91.4% vs. 87.6%, P < 0.01), and patterns of early breastfeeding cessation differed significantly between the two groups (P < 0.01). In the final models, prenatal food insecurity was not associated with breastfeeding initiation or early cessation, with one exception. Compared to food secure mothers, mothers reporting food insecurity had a lower risk of breastfeeding for 4-6 weeks than for > 10 weeks, independent of covariates (relative risk ratio 0.65; 95% CI 0.50, 0.85; P < 0.01). Women who were married, had a college degree, and did not smoke were more likely to initiate breastfeeding and breastfeed for a longer time, regardless of food security status (P < 0.01). CONCLUSIONS: Socioeconomic, psychosocial, and physiological factors explain the association between prenatal food insecurity and breastfeeding outcomes among this U.S. SAMPLE: More targeted and effective interventions and policies are needed to encourage the initiation and duration of breastfeeding, regardless of food security status.

Cardiovascular Disease in the Nation's Capital: How Policy and the Built Environment Contribute to Disparities in CVD Risk Factors in Washington, D.C.

On average, Washington D.C. residents experience low levels of cardiovascular disease (CVD) behavioral risk factors compared to the rest of the country. Despite presenting as a city of low risk, CVD mortality is higher than the national average. Driving this inconsistency are vast racial disparities as Black D.C. residents die from CVD at a much higher rate than their White counterparts. A closer examination of the data also reveals significant disparities between White and Black populations with regard to behavioral risk factors. Segregation and the built environments of sections of the city with large Black populations may be contributing to risk factor disparities. We examine factors in those built environments that contribute to disparities and assess the intentionality and effectiveness of policies focused on food access, physical activity, and tobacco use implemented between 2003 and 2014. We found that D.C. enacted few policies intentionally designed to reduce barriers in the physical environment that contributed to disparate outcomes, and the few that were implemented showed mixed results in their levels of effectiveness. Our findings demonstrated that both racial and geographical disparities have persisted for more than a decade and half. It is possible that the formation of intentional policies may help reduce barriers in the physical environment and disparate CVD outcomes.

Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?

Policy Points: A 1993 law required the National Institutes of Health to include women and racial and ethnic minorities in relevant research studies. Most federal health agencies adopted the same policy, but the US Food and Drug Administration (FDA) did not. A 2012 law encouraged the FDA to ensure that new medical products be analyzed for safety and effectiveness for key demographic patient groups. Our study of high-risk medical devices reviewed by the FDA in 2014-2017 found that due to lack of patient diversity and publicly available data, clinicians and patients often cannot determine which devices are safe and effective for specific demographic groups. CONTEXT: Demographic differences can influence the safety and effectiveness of medical devices; however, clinical trials of devices for adults have historically underrepresented women, people of color, and patients over age 65. The US Food and Drug Administration (FDA) Safety and Innovation Act became law in 2012, encouraging greater diversity and subgroup analyses. In 2013, the FDA reported that there was diversity in clinical trials considered "pivotal" for approval decisions and that subgroup analyses were conducted for most applications for the highest-risk medical devices. However, the FDA's report did not specify whether analyses included sufficient numbers to be meaningful, whether analyses were conducted for most major subgroups, or whether analyses included safety, effectiveness, or accuracy. METHODS: We examined publicly available documents for all 22 medical devices that the FDA designated "highest risk" or "novel," were reviewed through the premarket approval pathway, and were scrutinized at FDA public meetings from 2014 to 2017. We evaluated patient demographics and subgroup analyses for all pivotal trials. FINDINGS: Only 3 (14%) of the devices provided subgroup analyses for both effectiveness and safety or both sensitivity and selectivity for gender, race, and age. However, 55% of the devices reported both of those subgroup analyses for at least 1 of the 3 subgroups. Whether analyses were reported or not, the number of patients in most subgroups was too small to draw meaningful conclusions. Subgroup analyses were more likely to be reported to the FDA's Advisory Committees than in the FDA's public reviews or labeling. CONCLUSIONS: Despite a law encouraging more diversity and subgroup analyses in pivotal trials used as the basis for FDA approval, the results of our study indicate relatively few subgroup analyses are publicly available for the highest-risk and novel medical devices. The lack of subgroup analyses makes it impossible to inform patients or physicians as to whether many newly approved medical devices are safe and effective for specific demographic subgroups defined by gender, race, and age.

Health Policy Responsiveness: Lessons Learned from Maryland and Prince George's County.

Effective, timely, and intentional policy efforts can significantly impact and improve the public's health and reduce racial and ethnic health disparities across the nation. Creating and implementing responsive policies at the state and county level is essential to supporting community efforts to improve health behaviors and health outcomes, particularly for communities of color who bear the brunt of disease risk and negative health outcomes. Using policy examples from the State of Maryland and Prince George's County, the largest and wealthiest predominately African-American county in the USA, this case study highlights the importance of state and county policy action when presented with opportunities to affect long-lasting, positive change. We examine each jurisdiction's policy response through the lens of timeliness, intentionality, and effectiveness. At first glance, it would appear that Maryland responded effectively to the rise in tobacco use. Similarly, at face value, it appears that Prince George's County's unchecked rise in obesity rates among African-Americans is an example of nonresponsiveness among local policymakers in the face of an obesity epidemic. However-guided by a more nuanced understanding of "policy responsiveness"-this analysis uncovers a more revealing picture, with important strengths and limitations seen in both policy situations. This analysis raises critical questions about the determinants of jurisdictions' health policy capacity and how policymakers might best be supported in their efforts to build an arsenal of health policies that are timely, effective, and intentional in meeting the needs of vulnerable communities.

An Examination of the Sociodemographic and Health Determinants of Major Depressive Disorder Among Black Women.

OBJECTIVES: Black women disproportionately share the distribution of risk factors for physical and mental illnesses. The goal of this study was to examine the sociodemographic and health correlates of major depressive disorder (MDD) symptoms among black women. METHODS: Pooled data from the 2005-2010 National Health and Nutrition Examination Survey (NHANES) were used to assess the sociodemographic and health correlates of MDD symptoms among black women (n = 227). Multivariate logistic regression techniques assessed the association between MDD symptoms and age, socioeconomic status, health status, and health behaviors. RESULTS: Poverty income ratio and smoking status were significantly associated with the likelihood of having MDD symptoms. Black women who were smokers were also more likely to have MDD symptoms compared to non-smokers [OR = 8.05, 95% CI = (4.56, 14.23)]. After controlling for all other socioeconomic and health variables, this association remained statistically significant. In addition, after controlling for all other variables, the multivariate analyses showed that black women below 299% federal poverty level (FPL) were nearly three times more likely to have MDD symptoms compared to women above 300% FPL [OR = 2.82, 95% CI = (1.02, 7.96)]. CONCLUSIONS: These analyses suggest that poverty and smoking status are associated with MDD symptoms among black women. A deeper understanding of the underlying mechanisms and key factors which influence MDD symptoms are needed in order to develop and create mental health programs targeting women of color.

The Impact of Educational Attainment on Observed Race/Ethnic Disparities in Inflammatory Risk in the 2001-2008 National Health and Nutrition Examination Survey.

Inflammation has shown to be an independent predictor of cardiovascular disease (CVD) and growing evidence suggests Non-Hispanic Blacks (NHBs) and certain Hispanic subgroups have higher inflammation burden compared to Non-Hispanic Whites (NHWs). Socioeconomic status (SES) is a hypothesized pathway that may account for the higher inflammation burden for race/ethnic groups yet little is known about the biological processes by which SES "gets under the skin" to affect health and whether income and education have similar or distinct influences on elevated inflammation levels. The current study examines SES (income and education) associations with multiple levels of C-Reactive Protein (CRP), an important biomarker of inflammation, in a sample of 13,362 NHWs, 7696 NHBs and 4545 Mexican Americans (MAs) in the United States from the 2001 to 2008 National Health and Nutrition Examination Survey. After adjusting for age, sex, and statin use, NHBs and MAs had higher intermediate and high CRP levels compared to NHWs. Income lessened the magnitude of the association for both race/ethnic groups. The greater intermediate and high CRP burden for NHBs and MAs was strongly explained by educational attainment. MAs were more vulnerable to high CRP levels for the lowest (i.e., less than nine years) and post high school (i.e., associates degree) educational levels. After additional adjustment for smoking, heavy drinking, high waist circumference, high blood pressure, diabetes and statin use, the strength of the association between race/ethnicity and inflammation was reduced for NHBs with elevated intermediate (RR = 1.31; p ≤ 0.001) and high CRP levels (RR = 1.14; p ≤ 0.001) compared to NHWs but the effect attenuated for MAs for both intermediate (RR = 0.74; p ≤ 0.001) and high CRP levels (RR = 0.38; p ≤ 0.001). These findings suggest educational attainment is a powerful predictor of elevated CRP levels in race/ethnic populations and challenges studies to move beyond examining income as a better predictor in the SES-inflammation pathway.

Allostatic load in foreign-born and US-born blacks: evidence from the 2001-2010 National Health and Nutrition Examination Survey.

OBJECTIVES: We tested whether the immigrant health advantage applies to non-Hispanic Black immigrants and examined whether nativity-based differences in allostatic load exist among non-Hispanic Blacks. METHODS: We used pooled data from the 2001-2010 National Health and Nutrition Examination Survey to compare allostatic load scores for US-born (n = 2745) and foreign-born (n = 152) Black adults. We used multivariate logistic regression techniques to assess the association between nativity and high allostatic load scores, controlling for gender, age, health behaviors, and socioeconomic status. RESULTS: For foreign-born Blacks, length of stay and age were powerful predictors of allostatic load scores. For older US-born Blacks and those who were widowed, divorced, or separated, the risk of high allostatic load was greater. CONCLUSIONS: Foreign-born Blacks have a health advantage in allostatic load. Further research is needed that underscores a deeper understanding of the mechanisms driving this health differential to create programs that target these populations differently.

Fathers matter: the role of paternal age in infant mortality.

Infant mortality is the most widely used indicator of a nation's health status and is associated with a plethora of maternal and socioeconomic factors. Although the association between young and old maternal age and the risk of infant mortality is well established, the link between paternal age and birth outcomes has received far less attention. This study seeks to examine the added impact of paternal age on infant mortality, above and beyond that of maternal age among married couples. Using the 2002 linked birth and infant death data set (N = 63,754), hazard odds ratios for the association between combined adolescent and adult maternal and paternal age and the risk of infant mortality were estimated. Maternal demographic characteristics, such as education and race/ethnicity were controlled. The findings indicate that, independent of maternal education and race/ethnicity, adolescent father adds additional risk, above and beyond that of maternal age, only when the mother is older (21-45 years; hazard ratio = 2.7). This study highlights that for married couples, adolescent fathers add to the risk of infant mortality when the mothers are older, providing insight into the role of paternal age in infant mortality. Implications for additional research are discussed.

The human endogenous circadian system causes greatest platelet activation during the biological morning independent of behaviors.

BACKGROUND: Platelets are involved in the thromboses that are central to myocardial infarctions and ischemic strokes. Such adverse cardiovascular events have day/night patterns with peaks in the morning (~9 AM), potentially related to endogenous circadian clock control of platelet activation. The objective was to test if the human endogenous circadian system influences (1) platelet function and (2) platelet response to standardized behavioral stressors. We also aimed to compare the magnitude of any effects on platelet function caused by the circadian system with that caused by varied standardized behavioral stressors, including mental arithmetic, passive postural tilt and mild cycling exercise. METHODOLOGY/PRINCIPAL FINDINGS: We studied 12 healthy adults (6 female) who lived in individual laboratory suites in dim light for 240 h, with all behaviors scheduled on a 20-h recurring cycle to permit assessment of endogenous circadian function independent from environmental and behavioral effects including the sleep/wake cycle. Circadian phase was assessed from core body temperature. There were highly significant endogenous circadian rhythms in platelet surface activated glycoprotein (GP) IIb-IIIa, GPIb and P-selectin (6-17% peak-trough amplitudes; p ≤ 0.01). These circadian peaks occurred at a circadian phase corresponding to 8-9 AM. Platelet count, ATP release, aggregability, and plasma epinephrine also had significant circadian rhythms but with later peaks (corresponding to 3-8 PM). The circadian effects on the platelet activation markers were always larger than that of any of the three behavioral stressors. CONCLUSIONS/SIGNIFICANCE: These data demonstrate robust effects of the endogenous circadian system on platelet activation in humans--independent of the sleep/wake cycle, other behavioral influences and the environment. The 9 AM timing of the circadian peaks of the three platelet surface markers, including platelet surface activated GPIIb-IIIa, the final common pathway of platelet aggregation, suggests that endogenous circadian influences on platelet function could contribute to the morning peak in adverse cardiovascular events as seen in many epidemiological studies.