Effectiveness and safety in non-valvular atrial fibrillation patients switching from warfarin to direct oral anticoagulants in US healthcare claims.

INTRODUCTION: There is a paucity of real-world studies examining the risks of stroke/systemic embolism (SE) and major bleeding (MB) among non-valvular atrial fibrillation (NVAF) patients switching from warfarin to a direct oral anticoagulant (DOAC). This retrospective study was conducted to compare the stroke/SE and MB risks between patients switched from warfarin to apixaban, dabigatran, or rivaroxaban in real-world clinical practice. MATERIALS AND METHODS: This study used data from four United States commercial claims databases from January 1, 2012 to June 30, 2019. The study population included NVAF patients initially treated with warfarin and switched to apixaban, dabigatran, or rivaroxaban within 90 days of their warfarin prescription ending. Patients were matched 1:1 between the DOACs in each database using propensity scores and then pooled for the final analysis. Cox proportional hazards models were used to calculate the risk of stroke/SE and MB. RESULTS AND CONCLUSIONS: The final population consisted of 2,611 apixaban-dabigatran, 12,165 apixaban-rivaroxaban, and 2,672 dabigatran-rivaroxaban pairs. Apixaban vs. dabigatran was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.39-0.96) and MB (HR: 0.67; 95% CI: 0.50-0.91). Apixaban vs. rivaroxaban was associated with a similar risk of stroke/SE (HR: 0.88; 95% CI: 0.73-1.07) and a lower risk of MB (HR: 0.60; 95% CI: 0.52-0.68). There was no significant difference in either risk between dabigatran and rivaroxaban. These results provide important insights into how the risks of stroke/SE and MB for NVAF patients vary when switching from warfarin to different DOACs.

Pre- and Perinatal Risk Factors for Child Maltreatment in Military Families Across the First Two Years of Life.

Military families are exposed to a unique constellation of risk factors, which may impact maltreatment outcomes. The present study examined prospective relationships between demographic, health, birth-related, and military-specific risk factors identified prior to a child's birth on their risk for maltreatment in the first two years of life. Data from the Millennium Cohort Study, Department of Defense (DoD) operational records and Family Advocacy Program data on met-criteria maltreatment, and Birth and Infant Health Research program data on suspected maltreatment were linked for 9076 service member parents. Discrete time survival analysis showed that preterm birth increased risk of maltreatment while parents' older age, physical health, and service in the Navy or Air Force decreased risk. Building on DoD's New Parent Support Program, findings suggest the need for universal and targeted prevention efforts, beginning during pregnancy, which limit or eliminate risk factors for maltreatment in military families.

Pregnancy and posttraumatic stress disorder: associations with infant outcomes and prenatal care utilization.

BACKGROUND: Posttraumatic stress disorder (PTSD) affects 3.6-9.7% of women, and has been associated with adverse outcomes in pregnancy; however, associations with prenatal care (PNC) utilization are not clear. OBJECTIVE: To evaluate associations of PTSD in pregnancy with PNC utilization and adverse infant outcomes in an active-duty military population (a population with universal health insurance). METHODS: This was a retrospective cohort study of pregnant active-duty service members in Department of Defense Birth and Infant Health Research program data from 2007 to 2014. Administrative medical encounter data were used to define PTSD cases and outcomes of interest. Descriptive statistics and multivariable log-binomial regression compared PNC utilization and adverse infant outcomes (preterm birth, small for gestational age [SGA], major birth defects) among service members with current PTSD (defined as PTSD in the year prior to pregnancy or during pregnancy) to those without current PTSD. RESULTS: Of the 103,221 singleton live births identified, 1657 (1.6%) were born to active-duty service members diagnosed with current PTSD. Service members with PTSD were more likely to initiate PNC in the first trimester (93.5% vs. 90.2%) and score adequate plus on the Adequacy of Prenatal Care Utilization Index (63.2% vs. 40.0%) compared to service members without PTSD. PTSD case status was not associated with preterm birth, SGA, or major birth defects, regardless of the adjustment set used (fully adjusted RR 0.96, 95% CI 0.82-1.13; RR 1.08, 95% CI 0.79-1.48; and RR 1.03, 95% CI 0.79-1.34, respectively). CONCLUSION: For pregnant service members with current PTSD, no associations with adverse infant outcomes were noted, and these patients initiated care earlier and had higher PNC utilization scores compared to pregnant service members without current PTSD. Universal health care coverage and utilization of PNC in this population may mitigate adverse pregnancy outcomes observed in civilian populations of patients with PTSD.

Posttraumatic Stress Disorder in a Cohort of Pregnant Active Duty U.S. Military Servicewomen.

The present study aimed to describe the demographic and occupational characteristics, comorbidities, and psychotropic medication receipt associated with posttraumatic stress disorder (PTSD) diagnosis during pregnancy among a sample of active duty U.S. military servicewomen. Data from the U.S. Department of Defense Birth and Infant Health Research program were used to identify pregnancies in active duty servicewomen from 2007 through 2014. Demographic and occupational data were linked with electronic medical and pharmacy records to capture mental health diagnoses and medication receipt dates. Cases of PTSD were identified by the presence of ICD-9-CM Diagnostic Code 309.81 on maternal records from 1 year before the date of the last menstrual period through the end of pregnancy. Of 134,244 identified pregnancies among active duty servicewomen, 2,240 (1.7%) met the case criteria for PTSD. Women with a PTSD diagnosis compared to those without a PTSD diagnosis were more likely to be White non-Hispanic (51.3% vs. 47.4%), unmarried (33.3% vs. 28.2%), in the Army (49.6% vs. 35.8%) or Marine Corps (10.9% vs. 8.0%), in a service and supply occupation (18.2% vs. 13.6%), and to have a junior enlisted rank (56.3% vs. 50.1%) and have been previously deployed (51.2% vs. 39.6%), RRs = 1.15-1.75. Among PTSD cases, the most common mental health comorbidities were depressive disorder (60.9%), adjustment disorder (43.4%), and anxiety disorder (39.3%). During pregnancy, 44.2% of PTSD cases and 7.2% of noncases received psychotropic medications. Demographic and occupational characteristics, comorbidities, and psychotropic medication use differed substantially among PTSD cases and noncases in this large records-based study.

Safety of tetanus, diphtheria, and acellular pertussis vaccination among pregnant active duty U.S. military women.

BACKGROUND: The tetanus, diphtheria, and acellular pertussis (Tdap) vaccine was approved for U.S. adults in 2005 and recommended for administration in every pregnancy in 2012, with optimal timing between 27 and 36 weeks' gestation. In the military, however, a current Tdap vaccination status is compulsory for service, and active duty women may be inadvertently exposed in early pregnancy. Safety data in this population are limited. OBJECTIVES: To assess safety of inadvertent (0-13 weeks' gestation) and recommended (27-36 weeks' gestation) exposure to the Tdap vaccine in pregnancy. METHODS: Pregnancies and live births from Department of Defense Birth and Infant Health Research program data were linked with military personnel immunization records to determine pregnancy Tdap vaccine exposure among active duty women, 2006-2014. Multivariable Cox and generalized linear regression models estimated associations between Tdap vaccine exposure and adverse pregnancy or infant outcomes. RESULTS: Of 145,883 pregnancies, 1272 were exposed to the Tdap vaccine in the first trimester and 9438 between 27 and 36 weeks' gestation. Neither inadvertent nor recommended vaccine exposure were associated with spontaneous abortion, preeclampsia, or preterm labor. Among 117,724 live born infants, 984 were exposed to the Tdap vaccine in the first trimester and 9352 between 27 and 36 weeks' gestation. First trimester exposure was not associated with birth defects, growth problems in utero, growth problems in infancy, preterm birth, or low birth weight. Tdap vaccine exposure between 27 and 36 weeks' gestation was not associated with any adverse infant outcome. CONCLUSIONS: Among a population of active duty women in the U.S. military who received the Tdap vaccine during pregnancy, we detected no increased risks for adverse maternal, fetal, or infant outcomes. Our findings corroborate existing literature on the safety of exposure to the Tdap vaccine in pregnancy.

Epidemiology of Sarcoidosis in a Prospective Cohort Study of U.S. Women.

RATIONALE: Sarcoidosis is a systemic granulomatous and inflammatory disorder that most often involves the lungs but also affects many other organs. Data on sarcoidosis from large epidemiological studies remain scarce. OBJECTIVES: To evaluate the baseline prevalence and 22-year incidence of sarcoidosis and their associations with demographic and geographic characteristics in a large cohort of U.S. women. METHODS: The Nurses' Health Study II is a prospective cohort study of U.S. female nurses enrolled in 1989 (aged 25-44 yr, n = 116,430). Data on major illnesses were collected through biennial questionnaires (1989-2011). Cases were identified by the nurses' self-report of physician-diagnosed sarcoidosis. Associations of demographic and geographic characteristics with sarcoidosis were evaluated by logistic regression and Cox models. MEASUREMENTS AND MAIN RESULTS: A total of 377 sarcoidosis cases were identified. The baseline prevalence was 100/100,000 women. The average annual incidence rate was 11/100,000 during 2,275,028 person-years of follow up. Incidence rate increased with age (P = 0.003), from 9 to 15/100,000 in women aged less than 35 to 55 or more years, respectively. Black women had a higher prevalence (odds ratio, 5.24; 95% confidence interval, 2.87-9.55) and incidence (hazard ratio, 3.80; 95% confidence interval, 2.31-6.24) than white women. Across U.S. regions, more than twofold differences were observed in sarcoidosis prevalence and incidence, with consistently higher rates in the Northeast. CONCLUSIONS: We provide recent national data on the epidemiology of sarcoidosis among U.S. women. Important differences in prevalence and incidence were observed across U.S. regions. Large epidemiological studies are needed to better understand the causes of the observed demographic and geographic differences in sarcoidosis.