Hines, IL, United States
Hines, IL, United States

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London M.J.,University of California at San Francisco | Schwartz G.G.,Cardiology Section | Hur K.,Center for Medication Safety | Henderson W.G.,University of Colorado at Denver | Henderson W.G.,Health Outcomes Sciences
JAMA Internal Medicine | Year: 2017

IMPORTANCE The efficacy of statins in reducing perioperative cardiovascular and other organ system complications in patients undergoing noncardiac surgery remains controversial. Owing to a paucity of randomized clinical trials, analyses of large databasesmay facilitate informed hypothesis generation and more efficient trial design. OBJECTIVE To evaluate associations of early perioperative statin use with outcomes in a national cohort of veterans undergoing noncardiac surgery. DESIGN, SETTING, AND PARTICIPANTS This retrospective, observational cohort analysis included 180 478 veterans undergoing elective or emergent noncardiac surgery (including vascular, general, neurosurgery, orthopedic, thoracic, urologic, and otolaryngologic) who were admitted within 7 days of surgery and sampled by the Veterans Affairs Surgical Quality Improvement Program (VASQIP). Patients were admitted to Department of Veterans Affairs hospitals and underwent 30-day postoperative follow-up. Data were collected from October 1, 2005, to September 30, 2010, and analyzed from November 28, 2013, to October 31, 2016. EXPOSURE Statin use on the day of or the day after surgery. MAIN OUTCOMES AND MEASURES All-cause 30-day mortality (primary outcome) and standardized 30-day cardiovascular and noncardiovascular outcomes captured by VASQIP. Use of statins and other perioperative cardiovascular medications was ascertained from the Veterans Affairs Pharmacy Benefits Management research database. RESULTS A total of 180 478 eligible patients (95.6%men and 4.4%women; mean [SD] age, 63.8 [11.6] years) underwent analysis, and 96 486 were included in the propensity score-matched cohort (96.3%men; 3.7%women; mean [SD] age, 65.9 [10.6] years). At the time of hospital admission, 37.8%of patients had an active outpatient prescription for a statin, of whom 80.8%were prescribed simvastatin and 59.5%used moderate-intensity dosing. Exposure to a statin on the day of or the day after surgery based on an inpatient prescription was noted in 31.5%of the cohort. Among 48 243 propensity score-matched pairs of early perioperative statin-exposed and nonexposed patients, 30-day all-cause mortality was significantly reduced in exposed patients (relative risk, 0.82; 95%CI, 0.75-0.89; P < .001; number needed to treat, 244; 95%CI, 170-432). Of the secondary outcomes, a significant association with reduced risk of any complication was noted (relative risk, 0.82; 95%CI, 0.79-0.86; P < .001; number needed to treat, 67; 95%CI, 55-87); all were significant except for the central nervous system and thrombosis categories, with the greatest risk reduction (relative risk, 0.73; 95%CI, 0.64-0.83) for cardiac complications. CONCLUSIONS AND RELEVANCE Early perioperative exposure to a statin was associated with a significant reduction in all-cause perioperative mortality and several cardiovascular and noncardiovascular complications. However, the potential for selection biases in these results must be considered.


Robb M.A.,U.S. Food and Drug Administration | Racoosin J.A.,U.S. Food and Drug Administration | Worrall C.,MediCaid | Chapman S.,Center for Medication Safety | And 2 more authors.
Medical Care | Year: 2012

After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups. Copyright © 2012 by Lippincott Williams & Wilkins.


London M.J.,University of California at San Francisco | Hur K.,Center for Medication Safety | Schwartz G.G.,University of Colorado at Denver
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.


PubMed | Boston University, U.S. Food and Drug Administration and Center for Medication Safety
Type: Journal Article | Journal: Addiction (Abingdon, England) | Year: 2016

We compared the risk of mental health episodes requiring hospitalization (primary aim) or out-patient clinic visits (secondary aim) associated with varenicline versus the nicotine patch (NP) in an era prior to psychiatric boxed warnings.Retrospective cohort.Department of Veterans Affairs (VA), USA.VA patients with or without psychiatric comorbidities and a new prescription for varenicline (15255) were propensity score-matched (1:2) to new users of NP (123054) between 1May 2006 and 30September 2007, resulting in 11774 and 23548 patients in the varenicline and NP groups, respectively.The primary outcomes were hospitalizations with a primary discharge diagnosis of a range of mental health disorders: depression, schizophrenia, bipolar disorder, suicide attempt, post-traumatic stress disorder, other psychosis and drug-induced mental disorders. Secondary outcomes were out-patient clinic visits with a primary diagnosis of the above list of mental health disorders.Background characteristics of the treatment groups were similar after matching. There was no statistically significant difference in risk of hospitalization for any of the studied mental health disorders with varenicline compared with NP. Among secondary outcomes there was an increased risk of out-patient clinic visits for schizophrenia among patients who received varenicline [hazard ratio (HR)=1.27; 95% confidence interval (CI)=1.07, 1.51], this increase being evident only in those with a pre-existing mental health disorder.In US VA patients studied prior to the boxed warning being implemented, use of varenicline for smoking cessation was not associated with a detectable increase compared with nicotine patches in hospitalization for any mental health outcomes. There was an increased rate of out-patient attendances with a primary diagnosis of schizophrenia amounting to five per 100 person years of treatment. This increase was found only in patients with a pre-existing mental health disorder.


Shore S.,Emory University | Ho P.M.,Emory University | Ho P.M.,Veterans Affairs Eastern Colorado Health Care System | Ho P.M.,Aurora University | And 16 more authors.
JAMA - Journal of the American Medical Association | Year: 2015

IMPORTANCE: Unlike warfarin, which requires routine laboratory testing and dose adjustment, target-specific oral anticoagulants like dabigatran do not. However, optimal follow-up infrastructure and modifiable site-level factors associated with improved adherence to dabigatran are unknown. OBJECTIVES: To assess site-level variation in dabigatran adherence and to identify site-level practices associated with higher dabigatran adherence. DESIGN, SETTING, AND PARTICIPANTS: Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data. A total of 67 Veterans Health Administration sites with 20 or more patients filling dabigatran prescriptions between 2010 and 2012 for nonvalvular atrial fibrillation were sampled (4863 total patients; median, 51 patients per site). Forty-seven pharmacists from 41 eligible sites participated in the qualitative inquiry. EXPOSURE: Site-level practices identified included appropriate patient selection, pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring. MAIN OUTCOMES AND MEASURES: Dabigatran adherence (intensity of drug use during therapy) defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more. RESULTS: The median proportion of patients adherent to dabigatran was 74% (interquartile range [IQR], 66%-80%). After multivariable adjustment, dabigatran adherence across sites varied by a median odds ratio of 1.57. Review of practices across participating sites showed that appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. The proportion of adherent patients was higher at sites performing appropriate selection (75%vs 69%), education (76% vs 66%), and monitoring (77% vs 65%). Following multivariable adjustment, association between pharmacist-led education and dabigatran adherence was not statistically significant (relative risk [RR], 0.94; 95%CI, 0.83-1.06). Appropriate patient selection (RR, 1.14; 95%CI, 1.05-1.25), and provision of pharmacist-led monitoring (RR, 1.25; 95%CI, 1.11-1.41) were associated with better patient adherence. Additionally, longer duration of monitoring and providing more intensive care to nonadherent patients in collaboration with the clinician improved adherence. CONCLUSIONS AND RELEVANCE: Among nonvalvular atrial fibrillation patients treated with dabigatran, there was variability in patient medication adherence across Veterans Health Administration sites. Specific pharmacist-based activities were associated with greater patient adherence to dabigatran. Copyright 2015 American Medical Association. All rights reserved.


PubMed | University of California at San Francisco, Center for Medication Safety, Health Outcomes Sciences and Cardiology Section
Type: | Journal: JAMA internal medicine | Year: 2016

The efficacy of statins in reducing perioperative cardiovascular and other organ system complications in patients undergoing noncardiac surgery remains controversial. Owing to a paucity of randomized clinical trials, analyses of large databases may facilitate informed hypothesis generation and more efficient trial design.To evaluate associations of early perioperative statin use with outcomes in a national cohort of veterans undergoing noncardiac surgery.This retrospective, observational cohort analysis included 180478 veterans undergoing elective or emergent noncardiac surgery (including vascular, general, neurosurgery, orthopedic, thoracic, urologic, and otolaryngologic) who were admitted within 7 days of surgery and sampled by the Veterans Affairs Surgical Quality Improvement Program (VASQIP). Patients were admitted to Department of Veterans Affairs hospitals and underwent 30-day postoperative follow-up. Data were collected from October 1, 2005, to September 30, 2010, and analyzed from November 28, 2013, to October 31, 2016.Statin use on the day of or the day after surgery.All-cause 30-day mortality (primary outcome) and standardized 30-day cardiovascular and noncardiovascular outcomes captured by VASQIP. Use of statins and other perioperative cardiovascular medications was ascertained from the Veterans Affairs Pharmacy Benefits Management research database.A total of 180478 eligible patients (95.6% men and 4.4% women; mean [SD] age, 63.8 [11.6] years) underwent analysis, and 96 486 were included in the propensity score-matched cohort (96.3% men; 3.7% women; mean [SD] age, 65.9 [10.6] years). At the time of hospital admission, 37.8% of patients had an active outpatient prescription for a statin, of whom 80.8% were prescribed simvastatin and 59.5% used moderate-intensity dosing. Exposure to a statin on the day of or the day after surgery based on an inpatient prescription was noted in 31.5% of the cohort. Among 48243 propensity score-matched pairs of early perioperative statin-exposed and nonexposed patients, 30-day all-cause mortality was significantly reduced in exposed patients (relative risk, 0.82; 95% CI, 0.75-0.89; P<.001; number needed to treat, 244; 95% CI, 170-432). Of the secondary outcomes, a significant association with reduced risk of any complication was noted (relative risk, 0.82; 95% CI, 0.79-0.86; P<.001; number needed to treat, 67; 95% CI, 55-87); all were significant except for the central nervous system and thrombosis categories, with the greatest risk reduction (relative risk, 0.73; 95% CI, 0.64-0.83) for cardiac complications.Early perioperative exposure to a statin was associated with a significant reduction in all-cause perioperative mortality and several cardiovascular and noncardiovascular complications. However, the potential for selection biases in these results must be considered.


Spina J.R.,University of California at Los Angeles | Glassman P.A.,University of California at Los Angeles | Glassman P.A.,andD Center for the Study of Healthcare Provider Behavior | Glassman P.A.,Center for Medication Safety | And 9 more authors.
Medical Care | Year: 2011

OBJECTIVE: Understanding provider perceptions of and experiences with order entry and order checks (drug alerts) in an electronic prescribing system may help improve medication safety technology. DESIGN: Cross-sectional, national survey of Veterans Administration physicians practicing in various specialties. MEASUREMENT: Thirty-five question instrument was divided into 4 content domains. Response options included dichotomous, numeric, multiple choices, and Likert-like scales. Statistical methods included logistic regression. RESULTS: The adjusted response rate was 1543 of 3588 (43%). Almost all providers (90%) felt that the VA electronic prescribing system, including its order checks, improved prescribing safety to some degree. Most respondents (72%) reported that they always or almost always document outside medications in a clinic note, although only 44% always or almost always entered outside medications in the non-VA medication data field. Most physicians (88%) who encountered serious allergic or adverse drug reactions reported either notifying a pharmacist or entering the information in the allergies/adverse reactions field. Generalists and physicians with higher numbers of prescriptions were more likely to enter relevant data into the electronic medical record (or notify a pharmacist, in the case of adverse reactions). In addition, 48% of providers described critical drug-drug interaction alerts as very useful; medical specialists found these less useful, whereas surgical specialists found these more useful when compared with generalists. LIMITATIONS: Survey was conducted within a single healthcare system. CONCLUSION: Computerized provider order entry and related order checks are perceived to improve prescribing safety; however, provider entry of some relevant information into the appropriate electronic fields may not be optimal. Copyright © 2011 by Lippincott Williams & Wilkins.


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 4 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.


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.


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.

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