IMPORTANCE Recommendations concerning the appropriate age threshold for respiratory syncytial virus (RSV) prophylaxis in moderate-preterm infants are highly debated. OBJECTIVE To determine the age at which moderate-preterm infants' risk of RSV hospitalization has decreased to the risk observed in low-risk term infants. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of Florida and Texas Medicaid fee-for-service billing records matched to birth certificates from Medicaid beneficiaries aged 0 to 12 months with a sibling younger than 5 years and without other indications for RSV prophylaxis between January 1, 1999, and December 31, 2004. EXPOSURES For each state, we used discrete time survival analysis to develop age trend models for RSV hospitalizations for 2 groups: moderate-preterm infants (32-34 weeks' gestational age) and term infants (37-41 weeks' gestational age). MAIN OUTCOMES AND MEASURES Age at which preterm infants' risk of RSV hospitalization equaled the risk for term infants at age 1 month. RESULTS Our cohort included 247,566 eligible infants with 5322 RSV hospitalizations. Preterm status doubled the risk for RSV hospitalization in both Florida (odds ratio = 2.41; 95% CI, 1.85-3.12) and Texas (odds ratio = 1.94; 95% CI, 1.64-2.30). Preterm infants' risk of RSV hospitalization was similar to that for 1-month-old term infants at ages 4.2 months (95% CI, 2.5-5.7) in Florida and 4.5 months (95% CI, 2.8-6.4) in Texas. CONCLUSIONS AND RELEVANCE The age at which moderate-preterm infants showed RSV hospitalization risk similar to their healthy term counterparts supports the more restrictive age thresholds in RSV immunoprophylaxis recommendations. Further studies are warranted to investigate the age-dependent risk of RSV hospitalization in other RSV risk groups.

Purpose-When a Medication Guide (MG) is part of Risk Evaluation and Mitigation Strategy (REMS), manufacturers assess the effectiveness of MGs through patient surveys, which have not undergone systematic evaluation. We aimed to characterize knowledge rates from these patient surveys, describe their design and respondent characteristics, and explore predictors of acceptable knowledge rates.Methods-We analyzed MG assessments submitted to the Food and Drug Administration from September 2008 through June 2012. We evaluated the prevalence of specific characteristics, and calculated knowledge rates, whereby we defined "acceptable knowledge" when ≥ 80% of respondents correctly answered questions about the primary drug risk. Univariate logistic models were used to investigate the predictors of acceptable knowledge rates.Results-We analyzed the first completed MG assessment for each drug with a patient survey, resulting in 66 unique MG assessments. The mean knowledge rate was 63.8%, with 20 MG assessments (30.3%) achieving the 80% threshold. Compared to assessments that did not reach acceptable knowledge rates, those that did were more likely associated with additional REMS Conclusions-Most MG assessments did not reach the 80% knowledge threshold, but those associated with additional interventions were more likely to achieve it. Our study highlights the need to improve patient-directed information and the methods of assessing it. HHS Public Access

Purpose The state‐assigned Case ID number in the Medicaid Analytic eXtract (MAX) allows for potential linkage of mothers to infants. No validation of respective linkage algorithms is available. We established and validated an algorithm within MAX that links mothers to infants and to identify factors influencing successful mother‐infant linkage. Methods We identified all mother‐infant pairs in FL and TX birth certificates records (BCR) that could be linked individually to MAX records (1999‐2005 for FL and 1999‐2010 for TX) based on Social Security Number (gold standard pairs). Case ID linkage performance was evaluated as the proportion of gold standard mother‐infant pairs that were identified by the algorithm (sensitivity) and the proportion of algorithm defined mother‐infant pairs that were correctly linked. Generalized estimating equations were used to calculate the probability for successful Case ID algorithm linkage versus non‐linkage using maternal and infant characteristics. Results We identified 323,160 gold standard pairs in FL BCR and MAX and 1,025,350 in TX BCR and MAX. Depending on Medicaid enrollment the algorithm sensitivity ranged from 85.51% to 87.96% in FL and 19.60% to 35.75% in TX. In both states, positive predictive value exceeded 99%, regardless of enrollment periods. Determinants for successful linkage varied across states, but suggested better results for younger mothers, minority women, and those with lower educational achievement. Conclusions Our algorithm can correctly link liveborn infants to their mothers. The algorithm's sensitivity in identifying pairs varied across states, but PPV was consistently high. Linkage performance was associated with certain characteristics that may affect representativeness of successfully linked pairs.

BackgroundWith the increasing prevalence of type 2 diabetes in young adulthood, treatment of diabetes in pregnancy faces new challenges. Anti-diabetic drug utilization patterns of pregnant women with pre-existing diabetes are poorly described. We aim to describe anti-diabetic (AD) agent utilization among diabetic pregnant women.MethodsWe utilized IMS LifeLink, including administrative claims data of patients in US managed care plans, to establish a retrospective cohort of women, age 18–46 years (N = 96,740) with billed procedures for a live birth, and a 12 month eligibility period before and 3 month after delivery. Diabetes mellitus was identified from ≥2 in- or outpatient claims with diagnoses (ICD-9-CM 250.XX) before pregnancy. We estimated the prevalence of AD drugs before, during and after pregnancy, and secular trends across the study period (1999–2009), using linear regression. A sensitivity analysis was conducted to identify the extent of misclassification of trimesters.ResultsAlmost six percent (n = 5,581) of the live birth cohort had diabetes mellitus. Throughout the study, 48% (1999) and 78% (2009) (p < 0.0001) of diabetic women received AD drugs during pregnancy. The most common AD drugs during pregnancy were insulin, metformin, sulfonylureas, thiazolidinediones (TZD), and combination AD. The annual prevalence of insulin use increased by only 1% from 39% (1999) to 40% (2009) (p = 0.589) during pregnancy, while use of sulfonylureas and metformin increased from 2.5% and 4.2% (1999) to 17.3% and 15.3% (2009) (p < 0.0001), respectively. Insulin and sulfonylurea use steadily increased in prevalence from the 1st to 3rd trimester (16.5% and 3.3% to 33.0% and 7.5%), while metformin and TZD use decreased (11.4% and 1.6% to 3.8% and 0.2%).ConclusionsAD use during pregnancy demonstrates the need for additional investigation regarding safety and efficacy of AD drugs on maternal outcomes.

Introduction: The United States (US) Food and Drug Administration (FDA) required a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics on 09 July 2012. Methods: This study compared the incidence of opioid overdose before (July 2010-June 2012) and after (July 2013-September 2016) the initiation of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. We identified patients with ≥1 ER/LA opioid dispensing in either time period in national data from the HealthCore Integrated Research Database SM (HIRD) and in United States (US) Medicaid claims data from four states. We described each population, calculated the incidence rate (IR) of opioid overdose, and assessed crude and propensity score adjusted incidence rate ratios (IRR) comparing the overdose rate after vs before implementation of the REMS. Results: A total of 121,229 commercially insured and 11,488 Medicaid patients were included in the analysis. Rates of overdose were substantially higher in Medicaid patients than in the commercially insured patients (IR 192.0, 95% confidence interval [CI] 162.60-225.18 versus 102.60, 95% CI 93.0-112.93 in the active period). The IRRs for opioid overdose were 1.01 (95% CI 0.87-1.17) in the commercially insured population and 0.70 (95% CI 0.52-0.93) in Medicaid. Conclusion: This leveling off of overdose rates among commercially insured patients and decline among Medicaid patients is encouraging, but it is difficult to disentangle the specific impact of the REMS from many other ongoing initiatives with similar goals.