Purpose Estimating drug effectiveness and safety among older adults in population-based studies using administrative healthcare claims can be hampered by unmeasured confounding due to frailty. A claims-based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding control. Our objective was to develop an algorithm to predict dependency in activities of daily living (ADL) in a sample of Medicare beneficiaries. Methods Community-dwelling respondents to the 2006 Medicare Current Beneficiary Survey, >65 years old, with Medicare Part A, B, home health, and hospice claims were included. ADL dependency was defined as needing help with bathing, eating, walking, dressing, toileting, or transferring. Potential predictors were demographics, ICD-9 diagnosis/procedure and durable medical equipment codes for frailty-associated conditions. Multivariable logistic regression was to predict ADL dependency. Cox models estimated hazard ratios for death as a function of observed and predicted ADL dependency. Results Of 6391 respondents, 57% were female, 88% white, and 38% were ≥80. The prevalence of ADL dependency was 9.5%. Strong predictors of ADL dependency were charges for a home hospital bed (OR=5.44, 95% CI=3.28–9.03) and wheelchair (OR=3.91, 95% CI=2.78–5.51). The c-statistic of the final model was 0.845. Model-predicted ADL dependency of 20% or greater was associated with a hazard ratio for death of 3.19 (95% CI: 2.78, 3.68). Conclusions An algorithm for predicting ADL dependency using healthcare claims was developed to measure some aspects of frailty. Accounting for variation in frailty among older adults could lead to more valid conclusions about treatment use, safety, and effectiveness.
IMPORTANCE Glyburide is thought to be safe for use during pregnancy for treatment of gestational diabetes mellitus (GDM). However, there are limited data on the effectiveness of glyburide when compared with insulin as used in a real-world setting.OBJECTIVE To estimate the risk of adverse maternal and neonatal outcomes in women with GDM treated with glyburide compared with insulin. DESIGN, SETTING, AND PARTICIPANTSRetrospective cohort study of a population-based cohort from a nationwide US employer-based insurance claims database from January 1, 2000, to December 31, 2011. We identified women with GDM and their newborns. We excluded those with type 1 or 2 diabetes and those younger than 15 years or older than 45 years.EXPOSURES Treatment with glyburide or insulin during pregnancy within 150 days before delivery. MAIN OUTCOMES AND MEASURESWe used binomial regression to estimate risk ratios (RRs) and risk differences with 95% confidence intervals for the association of glyburide with diagnosis codes for obstetric trauma, cesarean delivery, birth injury, preterm birth, hypoglycemia, respiratory distress, jaundice, large for gestational age, and hospitalization in the neonatal intensive care unit. Inverse probability of treatment weights were used to adjust for maternal characteristics that differed between the treatment groups.RESULTS Among 110 879 women with GDM, 9173 women (8.3%) were treated with glyburide (n = 4982) or insulin (n = 4191). After adjusting for differences at baseline, newborns of women treated with glyburide were at increased risk for neonatal intensive care unit admission (RR = 1.41; 95% CI, 1.23-1.62), respiratory distress (RR = 1.63; 95% CI, 1.23-2.15), hypoglycemia (RR = 1.40; 95% CI, 1.00-1.95), birth injury (RR = 1.35; 95% CI, 1.00-1.82), and large for gestational age (RR = 1.43; 95% CI, 1.16-1.76) compared with those treated with insulin; they were not at increased risk for obstetric trauma (RR = 0.92; 95% CI, 0.71-1.20), preterm birth (RR = 1.06; 95% CI, 0.93-1.21), or jaundice (RR = 0.96; 95% CI, 0.48-1.91). The risk of cesarean delivery was 3% lower in the glyburide group (adjusted RR = 0.97; 95% CI, 0.93-1.00). The risk difference associated with glyburide was 2.97% (95% CI, 1.82-4.12) for neonatal intensive care unit admission, 1.41% (95% CI, 0.61-2.20) for large for gestational age, and 1.11% (95% CI, 0.50-1.72) for respiratory distress.CONCLUSIONS AND RELEVANCE Newborns from privately insured mothers treated with glyburide were more likely to experience adverse outcomes than those from mothers treated with insulin. Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority.
Objective To describe trends and identify factors associated with choice of pharmacotherapy for gestational diabetes (GDM) from 2000–2011 using a healthcare claims database. Methods This was a retrospective cohort study of a large nationwide population of commercially insured women with GDM and pharmacy claims for glyburide or insulin prior to delivery, 2000–2011. We excluded women younger than 15 years or older than 50 years, those with prior type 2 diabetes, or those who had multiple gestations. We estimated trends over time in the use of glyburide compared with insulin and prevalence ratios (PR) and 95% confidence intervals (CI) for the association between covariates of interest and treatment with glyburide compared with insulin. Results We identified 10,778 women with GDM treated with glyburide (n=5,873) or insulin (n=4,905). From 2000–2011, glyburide use increased from 7.4% to 64.5%, becoming the more common treatment in 2007. Women less likely to be treated with glyburide were those with metabolic syndrome (PR=0.71, 95%CI: 0.50– 0.99), hyperandrogenism (PR=0.77, 95%CI: 0.62–0.97), polycystic ovarian syndrome (PR=0.88, 95%CI: 0.78–0.99), hypothyroidism (PR=0.89, 95%CI: 0.83–0.96) or undergoing infertility treatment (PR=0.93, 95%CI: 0.86–1.02). The probability of receiving glyburide decreased by 5% for every 10-year increase in maternal age (PR=0.95, 95%CI: 0.91–0.99). Among women prescribed with glyburide, 7.8% switched or augmented to a different drug class compared with 1.1% of insulin initiators. Conclusion Glyburide has replaced insulin as the more common pharmacotherapy for GDM over the last decade among those privately insured. Given its rapid uptake and the potential implications of suboptimal glucose control on maternal and neonatal health, robust evaluation of glyburide’s relative effectiveness is warranted to inform treatment decisions for women with gestational diabetes.
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