Safety of intravenous lacosamide in hospitalized children and neonates.

OBJECTIVE: Seizures are common in critically ill children and neonates, and these patients would benefit from intravenous (IV) antiseizure medications with few adverse effects. We aimed to assess the safety profile of IV lacosamide (LCM) among children and neonates. METHODS: This retrospective multicenter cohort study examined the safety of IV LCM use in 686 children and 28 neonates who received care between January 2009 and February 2020. RESULTS: Adverse events (AEs) were attributed to LCM in only 1.5% (10 of 686) of children, including rash (n = 3, .4%), somnolence (n = 2, .3%), and bradycardia, prolonged QT interval, pancreatitis, vomiting, and nystagmus (n = 1, .1% each). There were no AEs attributed to LCM in the neonates. Across all 714 pediatric patients, treatment-emergent AEs occurring in >1% of patients included rash, bradycardia, somnolence, tachycardia, vomiting, feeling agitated, cardiac arrest, tachyarrhythmia, low blood pressure, hypertension, decreased appetite, diarrhea, delirium, and gait disturbance. There were no reports of PR interval prolongation or severe cutaneous adverse reactions. When comparing children who received a recommended versus a higher than recommended initial dose of IV LCM, there was a twofold increase in the risk of rash in the higher dose cohort (adjusted incidence rate ratio = 2.11, 95% confidence interval = 1.02-4.38). SIGNIFICANCE: This large observational study provides novel evidence demonstrating the tolerability of IV LCM in children and neonates.

Intrafamilial Characteristics Are Important Predictors of Children's Diets in New Mexico's Border Colonias.

INTRODUCTION: We assessed selected nutritional indicators in Mexican-origin children in two low-income, rural colonias in New Mexico on the U.S.-Mexico border. These children are at higher risk for obesity and other chronic diseases linked to poor nutrition in childhood, but little is known about their diets. METHOD: We surveyed mothers of 202 children 6 to 10 years old about sociodemographic characteristics, family and child attitudes and behaviors, and the child's diet. We compared diet with dietary recommendations and used regression trees to identify significant predictors of recommended intake. RESULTS: Among families, 89.1% participated in Medicaid, and 52.5% participated in a Supplemental Nutrition Program. More children met recommendations for fruit (36.1%) than vegetables (1.5%). Greater vegetable intake was associated with a child's not thinking healthy food tasted bad, greater family activity, and younger maternal age. Only 5.0% of children met the recommendation for <10% of energy from added sugar, with the average child consuming 2.4 times that from sugar-sweetened beverages and snacks. Lower sugar intake was associated with less screen time, not having TV on during meals, and playing team sports. Family access to healthy food and child use of mobile food vendors, vending and convenience stores were not predictive of diet. CONCLUSION: Hispanic children in border colonias have poor diets that put them at risk for obesity and numerous chronic diseases. Addressing this problem will require changing family norms and attitudes toward healthy food, screen time behavior, and physical activity levels within families.

Pre-diagnosis alcohol consumption and mortality risk among black women and white women with invasive breast cancer.

BACKGROUND: Alcohol consumption is associated with increased risk of breast cancer; however, its association with subsequent risk of breast cancer death is unclear. METHODS: We followed 4523 women with complete information on relevant risk factors for mortality; these women were 35 to 64 years of age when diagnosed with incident invasive breast cancer between 1994 and 1998. During follow up (median, 8.6 years), 1055 women died; 824 died from breast cancer. The information on alcohol consumption before diagnosis was collected shortly after breast cancer diagnosis (average: 5.1 months) during an in-person interview which used a structured questionnaire. Multivariable Cox proportional hazards regression models provided hazard ratios (HRs) and 95% confidence intervals (CIs) for breast cancer-specific mortality, mortality due to causes other than breast cancer, and all-cause mortality associated with alcohol consumption from age 15 years until breast cancer diagnosis and during recent periods of time prior to breast cancer diagnosis. RESULTS: Average weekly alcohol consumption from age 15 years until breast cancer diagnosis was inversely associated with breast cancer-specific mortality (Ptrend = 0.01). Compared to non-drinkers, women in the highest average weekly alcohol consumption category (≥7 drinks/week) had 25% lower risk of breast cancer-specific mortality (HR = 0.75, 95% CI = 0.56-1.00). Breast cancer mortality risk was also reduced among women in the highest average weekly alcohol consumption category in two recent time periods (5-year period ending 2-years prior to breast cancer diagnosis, HR = 0.74, 95% CI = 0.57-0.95; 2-year period immediately prior to breast cancer diagnosis: HR = 0.73, 95% CI = 0.56-0.95). Furthermore, analyses of average weekly alcohol consumption by beverage type from age 15 years until breast cancer diagnosis suggested that wine consumption was inversely associated with breast cancer-specific mortality risk (wine Ptrend = 0.06, beer Ptrend = 0.24, liquor Ptrend = 0.74). No association with any of these alcohol consumption variables was observed for mortality risk due to causes other than breast cancer. CONCLUSIONS: Overall, we found no evidence that alcohol consumption before breast cancer diagnosis increases subsequent risk of death from breast cancer.

Body mass index at age 18 years and recent body mass index in relation to risk of breast cancer overall and ER/PR/HER2-defined subtypes in white women and African-American women: a pooled analysis.

BACKGROUND: Although it has been well-documented that obesity is associated with decreased risk of premenopausal breast cancer and increased risk of postmenopausal breast cancer, it is unclear whether these associations differ among breast cancer subtypes defined by the tumor protein expression status of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). METHODS: We evaluated the associations of body mass index (BMI) at age 18 years and recent BMI in relation to risk of breast cancer overall and ER/PR/HER2-defined subtypes, in 6320 women (3934 case-patient participants, 2386 control participants) aged 35-64 years, who participated in one of three population-based case-control studies. We estimated multivariable-adjusted odd ratios (ORs) and corresponding 95% confidence intervals (CIs) using polychotomous unconditional logistic regression methods for case-control comparisons in premenopausal women and postmenopausal women. RESULTS: BMI at age 18 years was inversely associated with risk of breast cancer, particularly among premenopausal women (≥ 25 vs. < 20 kg/m2, OR = 0.72, 95% CI = 0.53-0.96; per 5 kg/m2 increase, OR = 0.83, 95% CI = 0.73-0.95). This inverse association did not differ across ER/PR/HER2-defined subtypes or by race (white women, African-American women). Recent BMI was not associated with risk of premenopausal breast cancer after adjustment for BMI at age 18 years; nevertheless, the analysis for the joint effects of BMI at age 18 years and recent BMI showed that premenopausal women in the highest categories of the two BMI measures (≥ 25 kg/m2 at age 18 years and ≥ 30 kg/m2 for recent BMI) had 46% lower risk of breast cancer than premenopausal women in the lowest categories of the two BMI measures (< 20 kg/m2 at age 18 years and < 25 kg/m2 for recent BMI; OR = 0.54, 95% CI = 0.38-0.78). Neither measure of BMI was statistically significantly associated with risk of postmenopausal breast cancer. CONCLUSION: Our findings indicate that high BMI near the end of adolescence decreases risk of all ER/PR/HER2-defined subtypes of premenopausal breast cancer and also suggest that this benefit could be maximized among premenopausal women who consistently have high BMI during their premenopausal years.

Scope of Knowledge About Zika Among Women in US-Mexico Border Communities.

Maternal Zika virus infection (ZIKV) has serious health consequences for unborn offspring. Knowledge about prevention is critical to reducing risk, yet what women in the high-risk US-Mexico border region know about protecting themselves and their babies from ZIKV is mostly unknown. This study aimed to assess knowledge of ZIKV among pregnant and inter-conception women and to identify sources of information that might address knowledge gaps. Clients in five federally-funded, border region Healthy Start programs (N = 326) were interviewed in late 2016 about their knowledge of ZIKV prevention methods and whether they believed themselves or their babies to be at risk. Sources of information about ZIKV and demographic characteristics were also measured. Chi square tests identified important associations between variables; adjusted odds ratios (AOR) and 95% confidence intervals for knowledge and beliefs were calculated. Among the 305 women aware of ZIKV, 69.5% could name two ways to prevent infection. Only 16.1% of women named using condoms or abstaining from sex as a prevention method. While 75.3% heard about ZIKV first from TV/radio, just 9.5% found the information helpful. Women who received helpful information from health care providers had greater odds of knowing two prevention methods (AOR = 2.0; 1.1-3.7), when to test for ZIKV (AOR = 5.2; 2.1-13.2), and how long to delay pregnancy after infection in a male partner (AOR = 1.9; 1.1-3.2). Those who said web-based and social media sources were helpful had greater odds of knowing when to test for ZIKV (AOR = 2.8; 1.3-6.3). Results can inform messaging for safe pregnancy and ZIKV prevention.

Patterns of Screen Time Among Rural Mexican-American Children on the New Mexico-Mexico Border.

INTRODUCTION: The prevalence of obesity is 26% among Hispanic children and teenagers and 47% among Hispanic adults. One contributor to obesity is sedentary behavior, such as using electronic screen devices (ie, screens). Low-income and Hispanic youths spend more time using such devices than other youths. METHODS: We interviewed 202 parents of Mexican-origin children aged 6 to 10 years in 2 rural communities near the US-Mexico border to determine screen use among children. We tested for associations between covariates and heavy screen use (≥4 hours/day) and calculated adjusted odds ratios (AORs) to identify independent, modifiable risk factors for such use. RESULTS: More than two-thirds (68.3%) of households had an annual income of less than $24,000, 89.1% spoke primarily Spanish, and 92.1% had internet access. The percentage of children with heavy screen use was 14.9% on weekdays and 25.2% on weekends. Smartphones were used by 62.4% of children, desktops or laptops by 60.9%; homework was the most common reason for use of these devices. One in 3 children used them for social media. Increased odds of heavy screen use were associated with having a television on while the child ate (weekday AOR = 3.02; 95% confidence interval [CI], 1.08-8.45 and weekend AOR = 2.38; 95% CI, 1.04-5.40) and using electronics to entertain (weekend AOR = 2.94; 95% CI, 1.15-7.51). More than 3 family meals per week (AOR = 0.40; 95% CI, 0.17-0.94 compared with ≤3 meals) and 2 or 3 family activities per week (AOR = 0.33; 95% CI, 0.12-0.87 compared with ≤1 activity) were associated with decreased odds of heavy weekend use. CONCLUSION: Even in low-income, Spanish-speaking communities, children have access to electronic devices, social media, and the internet, and a substantial fraction of them are heavy users. Efforts to reduce screen time might focus on understanding and changing the social norms that promote it.

Reproductive factors and the risk of triple-negative breast cancer in white women and African-American women: a pooled analysis.

BACKGROUND: Early age at menarche, nulliparity, late age at first completed pregnancy, and never having breastfed, are established breast cancer risk factors. However, among breast cancer subtypes, it remains unclear whether all of these are risk factors for triple-negative breast cancer (TNBC). METHODS: We evaluated the associations of these reproductive factors with TNBC, in 2658 patients with breast cancer (including 554 with TNBC) and 2448 controls aged 20-64 years, who participated in one of the three population-based case-control studies: the Women's Contraceptive and Reproductive Experiences Study, the Women's Breast Carcinoma in situ Study, or the Women's Learning the Influence of Family and Environment Study. We used multivariable polychotomous unconditional logistic regression methods to conduct case-control comparisons among breast cancer subtypes defined by estrogen receptor, progesterone receptor, and human epidermal growth factor receptor-2 expression status. RESULTS: TNBC risk decreased with increasing duration of breastfeeding (P trend = 0.006), but age at menarche, age at first completed pregnancy, and nulliparity were not associated with risk of TNBC. Parous women who breastfed for at least one year had a 31% lower risk of TNBC than parous women who had never breastfed (odds ratio, OR = 0.69; 95% confidence interval, CI = 0.50-0.96). The association between breastfeeding and risk of TNBC was modified by age and race. Parous African-American women aged 20-44 years who breastfed for 6 months or longer had an 82% lower risk of TNBC than their counterparts who had never breastfed (OR = 0.18, 95% CI = 0.07-0.46). CONCLUSIONS: Our data indicate that breastfeeding decreases the risk of TNBC, especially for younger African-American women.

Decision Making About Method of Delivery on the U.S.-Mexico Border.

We explored how low-risk, nulliparous pregnant women and their doctors in two contiguous U.S.-Mexico border communities communicate about methods of delivery and how they perceive that the delivery method decision is made. We recruited 18 women through obstetricians in El Paso, Texas (n = 10), and prenatal care providers in Ciudad Juárez, Mexico (n = 8). We observed prenatal care visits, interviewed women prenatally and postpartum, and interviewed the El Paso obstetricians. Qualitative analysis demonstrated that birthing decisions are complex and involve multiple influences, including women's level of knowledge about birth, doctor-patient communication, and women's participation in decision making.

First trimester initiation of prenatal care in the US-Mexico border region.

OBJECTIVES: To systematically examine prevalence of first trimester prenatal care (FTPNC) in the 44 US counties and 80 Mexican municipios of the binational border region; and to describe disparities between border and nonborder areas within states, border states, and countries. METHODS: We combined 2009 records of singleton live births from the 10 US-Mexico border states (N=1,370,206) into a single file. We included FTPNC; county/municipio, state, and country of maternal residence; and demographic variables common to all records. We computed prevalence of FTPNC for border and nonborder residents by state and country. Using multivariable regression, we computed adjusted prevalence ratios (aPR) for FTPNC in border relative to nonborder residents, states relative to one another, and the US relative to Mexico. RESULTS: In 2009, 68.8% of US-Mexico border mothers and 72.9% of nonborder mothers received FTPNC. After adjustment, nonborder residents had higher prevalence of FTPNC than border residents in Sonora, New Mexico, Arizona, Coahuila, and Chihuahua (aPR=1.09-124). In US states, prevalence was 13%-36% higher in New Mexico, Arizona, and California than Texas. In Mexico, when compared with Coahuila, adjusted prevalence was 12%-20% higher in neighboring states. Between countries, FTPNC prevalence in border counties/municipios was higher in Mexico among women with low parity/low education and in the United States among women with high parity/high education. CONCLUSIONS: In the US and Mexico, women in border counties/municipios receive less timely prenatal care than their nonborder counterparts, but the magnitude of the disparity varies by state. Lack of a consistent, binational approach to birth data collection requires cautious interpretation of findings.

Unintended birth among Hispanic women in Texas: a descriptive analysis.

Unintended birth is associated with adverse maternal and infant outcomes. In 2006, US Hispanics had the highest unintended birth rate (45 births/1,000 women) compared to other groups. One-fifth of US Hispanic women reside in Texas, yet unintended birth among Texas Hispanics has not been studied. The goal of this study was to describe the prevalence and characteristics of unintended birth in this population. Using data from Hispanic participants in the Texas Pregnancy Risk Assessment Monitoring System 2009-2010, we studied unintended birth in relation to demographic, lifestyle and partner characteristics. Adjusted prevalence odds ratios (POR) were computed for each characteristic and the analysis was stratified by maternal nativity (US vs foreign born). The weighted proportion of unintended birth was 49.5 % (CI = 45.9-52.6). In adjusted analyses, women aged 12-19 had a higher prevalence of unintended birth compared to ≥20 years (POR = 2.1, CI = 1.3-3.7). Unmarried (POR = 1.5, CI = 1.1-2.1), uninsured (POR = 1.7, CI = 1.2-2.3), and US-born (POR = 1.6, CI = 1.0-2.6) women had higher prevalence compared to married, insured and foreign-born women, respectively. Among US-born Hispanic women, higher prevalence of unintended birth was associated with being young, unmarried and experiencing psychological stressors within 12 months of giving birth; among foreign-born Hispanic women, higher prevalence was associated with lack of insurance. Efforts to reduce unintended birth in Texas might focus on young, single, uninsured and US-born Hispanic women. Analyses of other pre-pregnancy factors and health outcomes among Texas Hispanics could increase understanding of the differences we observed in unintended birth between US and foreign-born Hispanics.

Cesarean birth in the border region: a descriptive analysis based on US Hispanic and Mexican birth certificates.

Cesarean birth (CB) is more prevalent in the US-Mexico border region than among all US Hispanics. Comparable data from US and Mexican birth certificates can be used to compare prevalence and identify risk factors on either side of the border. Using 2009 US and Mexican birth certificates, we compared the characteristics of US Hispanic and Mexican CBs in six geographic subgroups: US and Mexican border counties/municipios, US and Mexican non-border counties/municipios and the US and Mexico overall. We also explored cesarean prevalence over time. During 2000-2009, CB rates increased from 22.1 to 31.6 % among US Hispanics and from 25.9 to 37.9 % among Hispanics in the US border region. 2009 rates were 44.5 % in Mexico and 43.1 % in the Mexican border region. In both countries, CB rates were similar for primiparas and multiparas. Higher education, being married and parity >4 were associated with CB in Mexico; being married was associated in the US. Hispanic rates were higher in the US border than non-border region for all age groups. Along the border, cesarean rates for Hispanics were highest in Texas (43.5 %) and neighboring Tamaulipas (49.8 %). Higher cesarean prevalence in Mexico than in US Hispanics, while unexplained, is consistent with high prevalence in some Latin American countries. Higher cesarean prevalence among Hispanics in the US border region than among Hispanics nationwide cannot be explained by maternal age or parity. Medical indications are also unlikely to explain such high rates, which are undesirable for mothers and infants.

Adolescent births in the border region: a descriptive analysis based on US Hispanic and Mexican birth certificates.

Adolescent childbearing adversely affects both mothers and infants. The birth rate for US adolescent women of Hispanic origin is higher than that for US adolescents overall. Birth rates among US Hispanic adolescents in the border region are higher than rates among other US Hispanic adolescents, and rates among Mexican border adolescents are higher than rates among other Mexican adolescents. We used binational birth certificate data for US Hispanic and Mexican adolescent women living inside the border region, elsewhere within the border states, and in the US and Mexico overall to compare birth rates and other health indicators among these groups. From 2000 to 2009, birth rates for 15-19 year-olds declined 19-28 % among US Hispanic geographic subgroups and 8-13 % among Mexican geographic subgroups; rates in the border region in 2009 were 73.8/1,000 women ages 15-19 for US Hispanics and 87.2/1,000 for Mexicans and were higher than rates in other US and Mexican subgroups, respectively. Less than one in five US Hispanic and Mexican adolescent mothers in the border region was married. About one in three delivered by cesarean. Late or no prenatal care was more prevalent among US Hispanic (17.6 %) than Mexican (14.3 %) border adolescents. Birth weight and gestational age outcomes were generally poorest in Texas border counties compared with border counties in other US states and in municipios of Mexican states bordering Texas. High birth rates and low prenatal care utilization among adolescents are problems along the US-Mexico border.

Obstetric emergencies at the United States-Mexico border crossings in El Paso, Texas.

OBJECTIVE: To describe the frequency, characteristics, and patient outcomes for women who accessed Emergency Medical Services (EMS) for obstetric emergencies at the ports of entry (POE) between El Paso, Texas, United States of America, and Ciudad Juárez, Chihuahua, Mexico. METHODS: A descriptive study of women 12-49 years of age for whom an EMS ambulance was called to an El Paso POE location from December 2008-April 2011 was conducted. Women were identified through surveillance of EMS records. EMS and emergency department (ED) records were abstracted for all women through December 2009 and for women with an obstetric emergency through April 2011. For obstetric patients admitted to the hospital, additional prenatal and birth characteristics were collected. Frequencies and proportions were estimated for each variable; differences between residents of the United States and Mexico were tested. RESULTS: During December 2008-December 2009, 47.6% (68/143) of women receiving EMS assistance at an El Paso POE had an obstetric emergency, nearly 20 times the proportion for Texas overall. During December 2008-April 2011, 60.1% (66/109) of obstetric patients with ED records were admitted to hospital and 52 gave birth before discharge. Preterm birth (23.1%; No. = 12), low birth weight (9.6%; No. = 5), birth in transit (7.7%; No. = 4), and postpartum hemorrhage (5.8%; No. = 3) were common; fewer than one-half the women (46.2%; No. = 24) had evidence of prenatal care. CONCLUSIONS: The high proportion of obstetric EMS transports and high prevalence of complications in this population suggest a need for binational risk reduction efforts.

Retrospective Multicenter Cohort Study on Safety and Electroencephalographic Response to Lacosamide for Neonatal Seizures.

BACKGROUND: There is growing evidence supporting the safety and effectiveness of lacosamide in older children. However, minimal data are available for neonates. We aimed to determine the incidence of adverse events associated with lacosamide use and explore the electroencephalographic seizure response to lacosamide in neonates. METHODS: A retrospective cohort study was conducted using data from seven pediatric hospitals from January 2009 to February 2020. For safety outcomes, neonates were followed for ≤30 days from index date. Electroencephalographic response of lacosamide was evaluated based on electroencephalographic reports for ≤3 days. RESULTS: Among 47 neonates, 98% received the first lacosamide dose in the intensive care units. During the median follow-up of 12 days, 19% of neonates died, and the crude incidence rate per 1000 patient-days (95% confidence interval) of the adverse events by diagnostic categories ranged from 2.8 (0.3, 10.2) for blood or lymphatic system disorders and nervous system disorders to 10.5 (4.2, 21.6) for cardiac disorders. Electroencephalographic seizures were observed in 31 of 34 patients with available electroencephalographic data on the index date. There was seizure improvement in 29% of neonates on day 1 and also in 29% of neonates on day 2. On day 3, there was no change in 50% of neonates and unknown change in 50% of neonates. CONCLUSIONS: The results are reassuring regarding the safety of lacosamide in neonates. Although some neonates had fewer seizures after lacosamide administration, the lack of a comparator arm and reliance on qualitative statements in electroencephalographic reports limit the preliminary efficacy results.

Quantitative measures of estrogen receptor expression in relation to breast cancer-specific mortality risk among white women and black women.

INTRODUCTION: The association of breast cancer patients' mortality with estrogen receptor (ER) status (ER + versus ER-) has been well studied. However, little attention has been paid to the relationship between the quantitative measures of ER expression and mortality. METHODS: We evaluated the association between semi-quantitative, immunohistochemical staining of ER in formalin-fixed paraffin-embedded breast carcinomas and breast cancer-specific mortality risk in an observational cohort of invasive breast cancer in 681 white women and 523 black women ages 35-64 years at first diagnosis of invasive breast cancer, who were followed for a median of 10 years. The quantitative measures of ER examined here included the percentage of tumor cell nuclei positively stained for ER, ER Histo (H)-score, and a score based on an adaptation of an equation presented by Cuzick and colleagues, which combines weighted values of ER H-score, percentage of tumor cell nuclei positively stained for the progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) results. This is referred to as the ER/PR/HER2 score. RESULTS: After controlling for age at diagnosis, race, study site, tumor stage, and histologic grade in multivariable Cox proportional hazards regression models, both percentage of tumor cell nuclei positively stained for ER (Ptrend = 0.0003) and the ER H-score (Ptrend = 0.0004) were inversely associated with breast cancer-specific mortality risk. The ER/PR/HER2 score was positively associated with breast cancer-specific mortality risk in women with ER + tumor (Ptrend = 0.001). Analyses by race revealed that ER positivity was associated with reduced risk of breast cancer-specific mortality in white women and black women. The two quantitative measures for ER alone provided additional discrimination in breast cancer-specific mortality risk only among white women with ER + tumors (both Ptrend ≤ 0.01) while the ER/PR/HER2 score provided additional discrimination for both white women (Ptrend = 0.01) and black women (Ptrend = 0.03) with ER + tumors. CONCLUSIONS: Our data support quantitative immunohistochemical measures of ER, especially the ER/PR/HER2 score, as a more precise predictor for breast cancer-specific mortality risk than a simple determination of ER positivity.

Mortality risk of black women and white women with invasive breast cancer by hormone receptors, HER2, and p53 status.

BACKGROUND: Black women are more likely than white women to have an aggressive subtype of breast cancer that is associated with higher mortality and this may contribute to the observed black-white difference in mortality. However, few studies have investigated the black-white disparity in mortality risk stratified by breast cancer subtype, defined by estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status. Furthermore, it is not known whether additional consideration of p53 protein status influences black-white differences in mortality risk observed when considering subtypes defined by ER, PR and HER2 status. METHODS: Four biomarkers were assessed by immunohistochemistry in paraffin-embedded breast tumor tissue from 1,204 (523 black, 681 white) women with invasive breast cancer, aged 35-64 years at diagnosis, who accrued a median of 10 years' follow-up. Multivariable Cox proportional hazards regression models were fit to assess subtype-specific black-white differences in mortality risk. RESULTS: No black-white differences in mortality risk were observed for women with triple negative (ER-negative [ER-], PR-, and HER2-) subtype. However, older (50-64 years) black women had greater overall mortality risk than older white women if they had been diagnosed with luminal A (ER-positive [ER+] or PR+ plus HER2-) breast cancer (all-cause hazard ratio, HR, 1.88; 95% confidence interval, CI, 1.18 to 2.99; breast cancer-specific HR, 1.51; 95% CI, 0.83 to 2.74). This black-white difference among older women was further confined to those with luminal A/p53- tumors (all-cause HR, 2.22; 95% CI, 1.30 to 3.79; breast cancer-specific HR, 1.89; 95% CI, 0.93 to 3.86). Tests for homogeneity of race-specific HRs comparing luminal A to triple negative subtype and luminal A/p53- to luminal A/p53+ subtype did not achieve statistical significance, although statistical power was limited. CONCLUSIONS: Our findings suggest that the subtype-specific black-white difference in mortality risk occurs mainly among older women diagnosed with luminal A/p53- breast cancer, which is most likely treatable. These results further suggest that factors other than subtype may be relatively more important in explaining the increased mortality risk seen in older black women.

A binational overview of reproductive health outcomes among US Hispanic and Mexican women in the border region.

INTRODUCTION: The US-Mexico border region has 15 million residents and 300,000 births annually. Reproductive health concerns have been identified on both sides of the border, but comparable information about reproductive health is not available. The objective of this study was to compare reproductive health indicators among populations in this region. METHODS: We used 2009 US Hispanic and Mexican birth certificate data to compare births inside the border region, elsewhere within the border states, and in the United States and Mexico overall. We examined trends in total fertility and birth rates using birth data from 2000 through 2009 and intercensal population estimates. RESULTS: Among women in the border region, US women had more lifetime births than Mexican women in 2009 (2.69 births vs 2.15 births) and throughout the decade. Birth rates in the group aged 15 to 19 years were high in both the US (73.8/1,000) and Mexican (86.7/1,000) border regions. Late or no prenatal care was nearly twice as prevalent in the border regions as in the nonborder regions of border states. Low birth weight and preterm and early-term birth were more prevalent in the US border than in the Mexican border region; US border rates were higher and Mexican rates were lower than their corresponding nonborder and national rates. We found some variations within border states. CONCLUSION: These findings constitute the first population-based information on the reproductive health of the entire Hispanic US-Mexico border population. Evidence of disparities warrants exploration at state and local levels. Teen pregnancy and inadequate prenatal care are shared problems in US-Mexico border communities and suggest an area for binational cooperation.

Evaluating Kidney Function Decline in Children with Chronic Kidney Disease Using a Multi-Institutional Electronic Health Record Database.

BACKGROUND: The objectives of this study were to use electronic health record data from a US national multicenter pediatric network to identify a large cohort of children with CKD, evaluate CKD progression, and examine clinical risk factors for kidney function decline. METHODS: This retrospective cohort study identified children seen between January 1, 2009, to February 28, 2022. Data were from six pediatric health systems in PEDSnet. We identified children aged 18 months to 18 years who met criteria for CKD: two eGFR values <90 and ≥15 ml/min per 1.73 m2 separated by ≥90 days without an intervening value ≥90. CKD progression was defined as a composite outcome: eGFR <15 ml/min per 1.73 m2, ≥50% eGFR decline, long-term dialysis, or kidney transplant. Subcohorts were defined based on CKD etiology: glomerular, nonglomerular, or malignancy. We assessed the association of hypertension (≥2 visits with hypertension diagnosis code) and proteinuria (≥1 urinalysis with ≥1+ protein) within 2 years of cohort entrance on the composite outcome. RESULTS: Among 7,148,875 children, we identified 11,240 (15.7 per 10,000) with CKD (median age 11 years, 50% female). The median follow-up was 5.1 (interquartile range 2.8-8.3) years, the median initial eGFR was 75.3 (interquartile range 61-83) ml/min per 1.73 m2, 37% had proteinuria, and 35% had hypertension. The following were associated with CKD progression: lower eGFR category (adjusted hazard ratio [aHR] 1.44 [95% confidence interval (95% CI), 1.23 to 1.69], aHR 2.38 [95% CI, 2.02 to 2.79], aHR 5.75 [95% CI, 5.05 to 6.55] for eGFR 45-59 ml/min per 1.73 m2, 30-44 ml/min per 1.73 m2, 15-29 ml/min per 1.73 m2 at cohort entrance, respectively, when compared with eGFR 60-89 ml/min per 1.73 m2), glomerular disease (aHR 2.01 [95% CI, 1.78 to 2.28]), malignancy (aHR 1.79 [95% CI, 1.52 to 2.11]), proteinuria (aHR 2.23 [95% CI, 1.89 to 2.62]), hypertension (aHR 1.49 [95% CI, 1.22 to 1.82]), proteinuria and hypertension together (aHR 3.98 [95% CI, 3.40 to 4.68]), count of complex chronic comorbidities (aHR 1.07 [95% CI, 1.05 to 1.10] per additional comorbid body system), male sex (aHR 1.16 [95% CI, 1.05 to 1.28]), and younger age at cohort entrance (aHR 0.95 [95% CI, 0.94 to 0.96] per year older). CONCLUSIONS: In large-scale real-world data for children with CKD, disease etiology, albuminuria, hypertension, age, male sex, lower eGFR, and greater medical complexity at start of follow-up were associated with more rapid decline in kidney function.

The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods.

Rationale & Objective: PRESERVE seeks to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE will compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expand the National Patient-Centered Clinical Research Network (PCORnet) common data model by adding pediatric- and kidney-specific variables and linking electronic health record data to other kidney disease databases; and assess the lived experiences of patients related to BP management. Study Design: Multicenter retrospective cohort study (clinical outcomes) and cross-sectional study (patient-reported outcomes [PROs]). Setting & Participants: PRESERVE will include approximately 20,000 children between January 2009-December 2022 with mild-moderate CKD from 15 health care institutions that participate in 6 PCORnet Clinical Research Networks (PEDSnet, STAR, GPC, PaTH, CAPRiCORN, and OneFlorida+). The inclusion criteria were ≥1 nephrologist visit and ≥2 estimated glomerular filtration rate (eGFR) values in the range of 30 to <90 mL/min/1.73 m2 separated by ≥90 days without an intervening value ≥90 mL/min/1.73 m2 and no prior dialysis or kidney transplant. Exposures: BP measurements (clinic-based and 24-hour ambulatory BP); urine protein; and antihypertensive treatment by therapeutic class. Outcomes: The primary outcome is a composite event of a 50% reduction in eGFR, eGFR of <15 mL/min/1.73 m2, long-term dialysis or kidney transplant. Secondary outcomes include change in eGFR, adverse events, and PROs. Analytical Approach: Longitudinal models for dichotomous (proportional hazards or accelerated failure time) and continuous (generalized linear mixed models) clinical outcomes; multivariable linear regression for PROs. We will evaluate heterogeneity of treatment effect by CKD etiology and degree of proteinuria and will examine variation in hypertension management and outcomes based on socio-demographics. Limitations: Causal inference limited by observational analyses. Conclusions: PRESERVE will leverage the PCORnet infrastructure to conduct large-scale observational studies that address BP management knowledge gaps for pediatric CKD, focusing on outcomes that are meaningful to patients. Plain-Language Summary: Hypertension is a major modifiable contributor to loss of kidney function in chronic kidney disease (CKD). The purpose of PRESERVE is to provide evidence to inform shared decision-making regarding blood pressure management for children with CKD. PRESERVE is a consortium of 16 health care institutions in PCORnet, the National Patient-Centered Clinical Research Network, and includes electronic health record data for >19,000 children with CKD. PRESERVE will (1) expand the PCORnet infrastructure for research in pediatric CKD by adding kidney-specific variables and linking electronic health record data to other kidney disease databases; (2) compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; and (3) assess the lived experiences of patients and caregivers related to blood pressure management.

Examination of ancestral informative markers and self-reported race with tumor characteristics of breast cancer among Black and White women.

African American (AA) women have a higher mortality from breast cancer (BC) compared to European American (EA) women. This may be due to the higher proportion of AA women with tumors that are diagnosed at more advanced stages and are characterized as being estrogen receptor negative (ER-)/progesterone receptor negative (PR-). Our study sought to determine whether self-reported race and percent African ancestry were associated with BC tumor characteristics. In a multi-center, population-based case-control study of BC, we determined percent African ancestry using ancestry informative markers (AIM) among women self-reporting race as AA or Black. BC tumor characteristics were associated with self-reported race (including a 30 % reduction in ER+/PR+ tumors [95 % confidence interval [CI]: 0.6-0.9] and a 1.5-fold increased risk of high grade [95 % CI: 1.2-1.9] for AA women compared to EA women). AIMs among AA women were not associated with BC tumor characteristics (AA women with ≥95 % versus <80 % African ancestry, odds ratio [OR] = 1.0 for ER+/PR+ [95 % CI: 0.6-1.8] and OR = 0.9 for high-grade tumors [95 % CI: 0.6-1.4]). Similar findings were observed for BC stage. While BC subtypes were associated with self-reported race, BC subtypes were not associated with percent African ancestry. These study results suggest that subtle differences in percent African ancestry are less important than the overall presence of African ancestry in relation to BC tumor characteristics.