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Hines, IL, United States

Dong D.Y.,Emory University | Dong D.Y.,Center for Medication Safety | Binongo J.N.,Emory University | Kancherla V.,Emory University
Maternal and Child Health Journal | Year: 2016

Objectives: Genital Chlamydia is a common bacterial sexually-transmitted infection among reproductive aged women, particularly younger populations. Cyanotic congenital heart defects (CCHDs) constitute about one quarter of all cardiac malformations at birth, and are associated with high rate of morbidity and mortality. Epidemiological research on the association between maternal Chlamydia during pregnancy and CCHDs in the offspring is lacking. Methods: Using data from the 2012 United States birth certificates, we examined the association between CCHDs and prenatal exposure to Chlamydia among live singleton births with CCHDs (n = 2487) and unaffected singleton births (n = 3,334,424). We estimated adjusted odds ratios (aORs) and 95 % confidence intervals (CIs) using unconditional logistic regression analysis for all CCHDs combined, and isolated CCHDs (without other major congenital malformations). Results: Overall 1.7 % of case and 1.7 % of control women reported having Chlamydia during their pregnancies. After controlling for potential confounders, we found a weak positive association between maternal Chlamydia during pregnancy and all CCHDs combined (aOR = 1.39; 95 % CI 1.02–1.90). The positive association persisted for isolated CCHD cases, but with marginal significance (aOR = 1.34; 95 % CI 0.96–1.74). Subgroup analyses for younger women showed an increased risk for CCHDs; however, the associations were not statistically significant. Conclusions: Maternal exposure to Chlamydia during pregnancy was weakly associated with a higher risk of CCHDs in the offspring. The finding should be interpreted with caution due to limitations of birth certificate data. Future studies using more robust data sources are warranted to further study the association between maternal Chlamydia during pregnancy and CCHDs in the offspring. © 2015, Springer Science+Business Media New York.

Chidi A.P.,University of Pittsburgh | Chidi A.P.,Center for Health Equity Research and Promotion | Rogal S.,University of Pittsburgh | Rogal S.,Center for Health Equity Research and Promotion | And 12 more authors.
Hepatology | Year: 2016

Recently approved, interferon-free medication regimens for treating hepatitis C are highly effective, but extremely costly. We aimed to identify cost-effective strategies for managing treatment-naïve U.S. veterans with new hepatitis C medication regimens. We developed a Markov model with 1-year cycle length for a cohort of 60-year-old veterans with untreated genotype 1 hepatitis C seeking treatment in a typical year. We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprevir/dasabuvir to treat: (1) any patient seeking treatment; (2) only patients with advanced fibrosis or cirrhosis; or (3) patients with advanced disease first and healthier patients 1 year later. The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included for comparison. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die. Complications were less likely after sustained virological response. We calculated the incremental cost per quality-adjusted life year (QALY) and varied model inputs in one-way and probabilistic sensitivity analyses. We used the Veterans Health Administration perspective with a lifetime time horizon and 3% annual discounting. Treating any patient with ombitasvir-based therapy was the preferred strategy ($35,560; 14.0 QALYs). All other strategies were dominated (greater costs/QALY gained than more effective strategies). Varying treatment efficacy, price, and/or duration changed the preferred strategy. In probabilistic sensitivity analysis, treating any patient with ombitasvir-based therapy was cost-effective in 70% of iterations at a $50,000/QALY threshold and 65% of iterations at a $100,000/QALY threshold. Conclusion: Managing any treatment-naïve genotype 1 hepatitis C patient with ombitasvir-based therapy is the most economically efficient strategy, although price and efficacy can impact cost-effectiveness. It is economically unfavorable to restrict treatment to patients with advanced disease or use a staged treatment strategy. © 2016 by the American Association for the Study of Liver Diseases.

Gellad W.F.,Center for Health Equity Research and Promotion | Gellad W.F.,University of Pittsburgh | Gellad W.F.,RAND Corporation | Good C.B.,Center for Medication Safety | And 3 more authors.
American Journal of Managed Care | Year: 2010

Objectives: To examine variation in outpatient prescription use and spending for hyperlipidemia and diabetes mellitus in the Veterans Affairs Healthcare System (VA) and its association with quality measures for these conditions. Study Design: Cross-sectional. Methods: We compared outpatient prescription use, spending, and quality of care across 135 VA medical centers (VAMCs) in fiscal year 2008, including 2.3 million patients dispensed lipid-lowering medications and 981,031 patients dispensed diabetes medications. At each facility, we calculated VAMC-level cost per patient for these medications, the proportion of patients taking brand-name drugs, and Healthcare Effectiveness Data and Information Set (HEDIS) scores for hyperlipidemia (low-density lipoprotein cholesterol level <100 mg/dL) and for diabetes (glyco sylated hemoglobin level >9% or not measured). Results: The median cost per patient for lipid-lowering agents in fiscal year 2008 was $49.60 and varied from $39.68 in the least expensive quartile of VAMCs to $69.57 in the most expensive quartile (P < .001). For diabetes agents, the median cost per patient was $158.34 and varied from $123.34 in the least expensive quartile to $198.31 in the most expensive quartile (P < .001). The proportion of patients dispensed brand-name oral drugs among these classes in the most expensive quartile of VAMCs was twice that in the least expensive quartile (P < .001). There was no correlation between VAMC-level prescription spending and performance on HEDIS measures for lipid-lowering drugs (r = 0.12 and r = 0.07) or for diabetes agents (r = -0.10). Conclusions: Despite the existence of a closely managed formulary, significant variation in prescription spending and use of brand-name drugs exists in the VA. Although we could not explicitly risk-adjust, there appears to be no relationship between prescription spending and quality of care.

Kapur K.,Harvard University | Bhaumik R.,University of Illinois at Chicago | Charlene Tang X.,Hines Veterans Administration Hospital | Hur K.,Center for Medication Safety | And 3 more authors.
Statistics in Medicine | Year: 2014

In this article, we develop appropriate statistical methods for determining the required sample size while comparing the efficacy of an intervention to a control with repeated binary response outcomes. Our proposed methodology incorporates the complexity of the hierarchical nature of underlying designs and provides solutions when varying attrition rates are present over time. We explore how the between-subject variability and attrition rates jointly influence the computation of sample size formula. Our procedure also shows how efficient estimation methods play a crucial role in power analysis. A practical guideline is provided when information regarding individual variance component is unavailable. The validity of our methods is established by extensive simulation studies. Results are illustrated with the help of two randomized clinical trials in the areas of contraception and insomnia. © 2014 John Wiley & Sons, Ltd.

London M.J.,University of California at San Francisco | Hur K.,Center for Medication Safety | Schwartz G.G.,University of Colorado at Denver | Henderson W.G.,Health Outcomes Program
JAMA - Journal of the American Medical Association | Year: 2013

Importance: The effectiveness of perioperative β-blockade in patients undergoing noncardiac surgery remains controversial. Objective: To determine the associations of early perioperative exposure to β-blockers with 30-day postoperative outcome in patients undergoing noncardiac surgery. Design, Setting, and Patients: A retrospective cohort analysis evaluating exposure to β-blockers on the day of or following major noncardiac surgery among a population-based sample of 136 745 patients who were 1:1 matched on propensity scores (37 805 matched pairs) treated at 104 VA medical centers from January 2005 through August 2010. Main Outcomes and Measures: All cause 30-day mortality and cardiac morbidity (cardiac arrest or Q-wave myocardial infarction). Results: Overall 55 138 patients (40.3%) were exposed to β-blockers. Exposure was higher in the 66.7% of 13 863 patients undergoing vascular surgery (95% CI, 65.9%-67.5%) than in the 37.4% of 122 882 patients undergoing nonvascular surgery (95% CI, 37.1%-37.6%; P < .001). Exposure increased as Revised Cardiac Risk Index factors increased, with 25.3% (95% CI, 24.9%-25.6%) of those with no risk vs 71.3% (95% CI, 69.5%-73.2%) of those with 4 risk factors or more exposed to β-blockers (P < .001). Death occurred among 1.1% (95% CI, 1.1%-1.2%) and cardiac morbidity occurred among 0.9% (95% CI, 0.8%-0.9%) of patients. In the propensity matched cohort, exposure was associated with lower mortality (relative risk [RR], 0.73; 95% CI, 0.65-0.83; P < .001; number need to treat [NNT], 241; 95% CI, 173-397). When stratified by cumulative numbers of Revised Cardiac Risk Index factors, β-blocker exposure was associated with significantly lower mortality among patients with 2 factors (RR, 0.63 [95% CI, 0.50-0.80]; P < .001; NNT, 105 [95% CI, 69-212]), 3 factors (RR, 0.54 [95% CI, 0.39-0.73]; P < .001; NNT, 41 [95% CI, 28-80]), or 4 factors or more (RR, 0.40 [95% CI, 0.25-0.73]; P < .001; NNT, 18 [95% CI, 12-34]). This association was limited to patients undergoing nonvascular surgery. β-Blocker exposure was also associated with a lower rate of nonfatal Q-wave infarction or cardiac arrest (RR, 0.67 [95% CI, 0.57-0.79]; P < .001; NNT, 339 [95% CI, 240-582]), again limited to patients undergoing nonvascular surgery. Conclusions and Relevance: Among propensity-matched patients undergoing noncardiac, nonvascular surgery, perioperative β-blocker exposure was associated with lower rates of 30-day all-cause mortality in patients with 2 or more Revised Cardiac Risk Index factors. Our findings support use of a cumulative number of Revised Cardiac Risk Index predictors in decision making regarding institution and continuation of perioperative β-blockade. A multicenter randomized trial involving patients at a low to intermediate risk by these factors would be of interest to validate these observational findings. ©2013 American Medical Association. All rights reserved.

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