Veterans Affairs Cooperative Studies Program Coordinating Center

Hines, IL, United States

Veterans Affairs Cooperative Studies Program Coordinating Center

Hines, IL, United States

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Maron D.J.,Vanderbilt University | Boden W.E.,State University of New York at Buffalo | O'Rourke R.A.,South Texas Veterans Health Care System Audie Murphy Campus | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | And 20 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: This paper describes the medical therapy used in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial and its effect on risk factors. Background: Most cardiovascular clinical trials test a single intervention. The COURAGE trial tested multiple lifestyle and pharmacologic interventions (optimal medical therapy) with or without percutaneous coronary intervention in patients with stable coronary disease. Methods: All patients, regardless of treatment assignment, received equivalent lifestyle and pharmacologic interventions for secondary prevention. Most medications were provided at no cost. Therapy was administered by nurse case managers according to protocols designed to achieve predefined lifestyle and risk factor goals. Results: The patients (n = 2,287) were followed for 4.6 years. There were no significant differences between treatment groups in proportion of patients achieving therapeutic goals. The proportion of smokers decreased from 23% to 19% (p = 0.025), those who reported <7% of calories from saturated fat increased from 46% to 80% (p < 0.001), and those who walked ≥150 min/week increased from 58% to 66% (p < 0.001). Body mass index increased from 28.8 ± 0.13 kg/m2 to 29.3 ± 0.23 kg/m2 (p < 0.001). Appropriate medication use increased from pre-randomization to 5 years as follows: antiplatelets 87% to 96%; beta-blockers 69% to 85%; renin-angiotensin-aldosterone system inhibitors 46% to 72%; and statins 64% to 93%. Systolic blood pressure decreased from a median of 131 ± 0.49 mm Hg to 123 ± 0.88 mm Hg. Low-density lipoprotein cholesterol decreased from a median of 101 ± 0.83 mg/dl to 72 ± 0.88 mg/dl. Conclusions: Secondary prevention was applied equally and intensively to both treatment groups in the COURAGE trial by nurse case managers with treatment protocols and resulted in significant improvement in risk factors. Optimal medical therapy in the COURAGE trial provides an effective model for secondary prevention among patients with chronic coronary disease. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; NCT00007657). © 2010 American College of Cardiology Foundation.


Pan Y.,Stanford University | Sonn G.A.,Stanford University | Sin M.L.Y.,University of Arizona | Mach K.E.,Stanford University | And 6 more authors.
Biosensors and Bioelectronics | Year: 2010

Urine is the most abundant and easily accessible of all body fluids and provides an ideal route for non-invasive diagnosis of human diseases, particularly of the urinary tract. Electrochemical biosensors are well suited for urinary diagnostics due to their excellent sensitivity, low-cost, and ability to detect a wide variety of target molecules including nucleic acids and protein biomarkers. We report the development of an electrochemical immunosensor for direct detection of the urinary tract infection (UTI) biomarker lactoferrin from infected clinical samples. An electrochemical biosensor array with alkanethiolate self-assembled monolayer (SAM) was used. Electrochemical impedance spectroscopy was used to characterize the mixed SAM, consisted of 11-mercaptoundecanoic acid and 6-mercapto-1-hexanol. A sandwich amperometric immunoassay was developed for detection of lactoferrin from urine, with a detection limit of 145. pg/ml. We validated lactoferrin as a biomarker of pyuria (presence of white blood cells in urine), an important hallmark of UTI, in 111 patient-derived urine samples. Finally, we demonstrated multiplex detection of urinary pathogens and lactoferrin through simultaneous detection of bacterial nucleic acid (16S rRNA) and host immune response protein (lactoferrin) on a single sensor array. Our results represent first integrated sensor platform capable of quantitative pathogen identification and measurement of host immune response, potentially providing clinical diagnosis that is not only more expeditious but also more informative than the current standard. © 2010.


Crane B.A.,University of Hartford | Wininger M.,University of Hartford | Wininger M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Kunsman M.,University of Hartford
Advances in Skin and Wound Care | Year: 2015

Bed positioning poses a subtle, yet important, tradeoff in the competing needs of hospitalized patients, particularly those susceptible to lower respiratory tract infections and/or pressure ulcers. Although it is widely held that a minimum 30° incline is necessary to mitigate risk of ventilator-acquired pneumonia, it is unclear what effect semirecumbent positioning has on the risk of pressure ulcerations. The authors test several hypotheses with the objective of elucidating the relationship between bed incline, posture, and incline, pursuant to a more evidence-based recommendation for practice in clinical care. To this end, interfacial pressures from 40 healthy subjects were analyzed following observation in both supine and sidelying positions, at shallow (30°) and moderate (45°) bed-angle incline. Summarily, the authors report that supine postures reduce pressure signatures associated with pressure ulceration versus sidelying position: 15% increase area of contact (P = 1.3×10-5), and 17% decrease in ratio of peak to average pressure (P = 3.1×10-3). Within supine posture, the authors found significant increases in 4 measures of local pressure, including average pressure (10.4% decrease, P =.005) and coefficient of pressure variation (22.1%, P = 2.2×10-4) at moderate incline. The authors conclude that supine bed positionings at moderate incline appear to reduce predictors of pressure ulceration. © 2015 Wolters Kluwer Health, Inc. All rights reserved.


Maron D.J.,Vanderbilt University | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Neff D.R.,Sharp Corporation | Weintraub W.S.,Christiana Care Health System | Boden W.E.,Samuel ratton Veterans Affairs Medical Center
American Journal of Cardiology | Year: 2013

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) study, a revascularization strategy trial with optimal medical therapy in both arms, the low-density lipoprotein (LDL) cholesterol goal was 60 to 85 mg/dl; this was revised to <70 mg/dl in 2004. COURAGE patients (n = 2,287) were titrated with increasing statin doses to achieve the initial LDL cholesterol goal using a prespecified protocol. Ezetimibe was not available when study enrollment began in 1999 but became available after approval in 2003. After maximizing statin dose, ezetimibe was added to reach the LDL cholesterol goal in 34% of patients (n = 734). Median baseline LDL cholesterol was higher in patients who received ezetimibe than in those who did not (109 vs 96 mg/dl). At baseline, 18% of patients who would later receive ezetimibe had LDL cholesterol <85 mg/dl, and 8% had LDL cholesterol <70 mg/dl. On maximum tolerated statin (with or without other lipid-lowering drugs), 40% had LDL cholesterol <85 mg/dl and 23% had LDL cholesterol <70 mg/dl before starting ezetimibe. At the final study visit, 68% of ezetimibe patients achieved LDL cholesterol <85 mg/dl, and 46% achieved LDL cholesterol <70 mg/dl. Using Cox regression analysis, the most significant factors associated with achieving LDL cholesterol goals were lower baseline LDL cholesterol, average statin dose, and ezetimibe use. In conclusion, after maximizing statin dose, the addition of ezetimibe results in a substantial increase in the percentage of patients who reach LDL cholesterol goal, a key component of optimal medical therapy. © 2013 Published by Elsevier Inc. All rights.


Alegria M.,Center for Multicultural Mental Health Research | Alegria M.,Harvard University | Lin J.Y.,Veterans Affairs Cooperative Studies Program Coordinating Center | Green J.G.,Boston University | And 3 more authors.
Journal of the American Academy of Child and Adolescent Psychiatry | Year: 2012

To investigate racial/ethnic differences in teachers' and other adults' identification and/or encouragement of parents to seek treatment for psychiatric problems in their children and to evaluate if and whether identification/ encouragement is associated with service use. Data on identification/ encouragement to seek treatment for externalizing disorders (i.e., attention-deficit/hyperactivity disorder, oppositional-defiant disorder, and/or conduct disorder) and internalizing disorders (i.e., major depressive episode/dysthymia and/or separation anxiety disorder) and services used were obtained for 6,112 adolescents (13-17 years of age) in the National Comorbidity Survey Adolescent Supplement. Racial/ethnic differences were examined for Latinos, non-Latino blacks, and non-Latino whites. There were few racial/ethnic differences in rates of youth identification/encouragement and how identification/encouragement related to service use. Only non-Latino black youth with low severity internalizing disorders were less likely to be identified/encouraged to seek services compared with non-Latino white youth with the same characteristics (odds ratio [OR] = 0.4, 95% confidence interval [CI] = [0.2-0.7]). Identification/encouragement increased the likelihood of seeking services for externalizing and internalizing disorders for all youth. However, compared with their non-Latino white counterparts, non-Latino black youth who met criteria for internalizing disorders appeared less likely to have used any services (OR = 0.4, 95%, CI = 0.2-0.7), after adjusting for identification/ encouragement, clinical, and sociodemographic characteristics. Non-Latino black youth with internalizing disorders and without identification/encouragement were less likely to use the specialty care sector than their non-Latino white counterparts. In this study of a nationally representative sample of adolescents, almost no ethnic/racial differences in identification/encouragement were found. However, identification/encouragement may increase service use for all youth. © 2012 American Academy of Child and Adolescent Psychiatry.


Peloso G.M.,Boston University | Demissie S.,Boston University | Collins D.,Veterans Affairs Cooperative Studies Program Coordinating Center | Mirel D.B.,Cambridge Broad Institute | And 7 more authors.
Journal of Lipid Research | Year: 2010

A low level of HDL-C is the most common plasma lipid abnormality observed in men with established coronary heart disease (CHD). To identify allelic variants associated with susceptibility to low HDL-C and CHD, we examined 60 candidate genes with key roles in HDL metabolism, insulin resistance, and inflammation using samples from the Veterans Affairs HDL Intervention Trial (VA-HIT; cases, n = 699) and the Framingham Offspring Study (FOS; controls, n = 705). VA-HIT was designed to examine the benefits of HDL-raising with gemfibrozil in men with low HDL-C (≤40 mg/dl) and established CHD. After adjustment for multiple testing within each gene, single-nucleotide polymorphisms (SNP) significantly associated with case status were identified in the genes encoding LIPC (rs4775065, P < 0.0001); CETP (rs5882, P = 0.0002); RXRA (rs11185660, P = 0.0021); ABCA1 (rs2249891, P = 0.0126); ABCC6 (rs150468, P = 0.0206; rs212077, P = 0.0443); CUBN (rs7893395, P = 0.0246); APOA2 (rs3813627, P = 0.0324); SELP (rs732314, P = 0.0376); and APOC4 (rs10413089, P = 0.0425). Included among the novel findings of this study are the identification of susceptibility alleles for low HDL-C/CHD risk in the genes encoding CUBN and RXRA, and the observation that genetic variation in SELP may influence CHD risk through its effects on HDL.


Kaafarani H.M.A.,Tufts Medical Center | Kaufman D.,Veterans Affairs Cooperative Studies Program Coordinating Center | Reda D.,Veterans Affairs Cooperative Studies Program Coordinating Center | Itani K.M.F.,Veterans Affairs Boston Healthcare System | And 2 more authors.
Journal of Surgical Research | Year: 2010

Background: Surgical site infection (SSI) after ventral incisional hernia repair (VIH) can result in serious consequences. We sought to identify patient, procedure, and/or hernia characteristics that are associated with SSI in VIH. Methods: Between 2004 and 2006, patients were randomized in four Veteran Affairs (VA) hospitals to undergo laparoscopic or open VIH. Patients who developed SSI within eight weeks postoperatively were compared to those who did not. A bivariate analysis for each factor and a multiple logistic regression analysis were performed to determine factors associated with SSI. The variables studied included patient characteristics and co-morbidities (e.g., age, gender, race, ethnicity, body mass index, ASA classification, diabetes, steroid use), hernia characteristics (e.g., size, duration, number of previous incisions), procedure characteristics (e.g., open versus laparoscopic, blood loss, use of postoperative drains, operating room temperature) and surgeons' experience (resident training level, number of open VIH previously performed by the attending surgeon). Antibiotic prophylaxis, anticoagulation protocols, preparation of the skin, draping of the wound, body temperature control, and closure of the surgical site were all standardized and monitored throughout the study period. Results: Out of 145 patients who underwent VIH, 21 developed a SSI (14.5%). Patients who underwent open VIH had significantly more SSIs than those who underwent laparoscopic VIH (22.1% versus 3.4%; P = 0.002). Among patients who underwent open VIH, those who developed SSI had a recorded intraoperative blood loss greater than 25 mL (68.4% versus 40.3%; P = 0.030), were more likely to have a drain placed (79.0% versus 49.3%; P = 0.021) and were more likey to be operated on by surgeons with less than 75 open VIH case experience (52.6% versus 28.4%; P = 0.048). Patient and hernia characteristics were similar between the two groups. In a multiple logistic regression analysis, the open surgical technique was associated with SSI (OR 8.03, 95% CI 2.03, 31.72; P = 0.003) while controlling for the VA medical center where the procedure was performed (P = 0.041). Conclusion: Open surgical technique and the medical center rather than patient co-morbidities or hernia characteristics are associated with the formation of postoperative SSI in VIH. © 2010 Elsevier Inc. All rights reserved.


Maron D.J.,Vanderbilt University | Maron D.J.,Vanderbilt Heart and Vascular Institute | Boden W.E.,State University of New York at Buffalo | Spertus J.A.,University of Missouri - Kansas City | And 11 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: Our purpose was to clarify the clinical utility of identifying metabolic syndrome (MetS) in patients with coronary artery disease (CAD). Background: It is uncertain whether MetS influences prognosis in patients with CAD and whether the risk associated with MetS exceeds the risk associated with the sum of its individual components. Methods: In a post hoc analysis, we compared the incidence of death or myocardial infarction (MI) in stable CAD patients in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial according to the presence (+) or absence (-) of MetS and diabetes: Group A, -MetS/-diabetes; Group B, +MetS/-diabetes; Group C, -MetS/+diabetes; and Group D, +MetS/+diabetes. We explored which MetS components best predicted adverse outcomes and whether MetS had independent prognostic significance beyond its individual components. Results: Of 2,248 patients, 61% had MetS and 34% diabetes. Risk for death or MI increased from Group A (14%) to Group D (25%, p < 0.001). Hypertension (hazard ratio [HR]: 1.30; 95% confidence interval [CI]: 0.98 to 1.71; p = 0.07), low high-density lipoprotein cholesterol (HR: 1.26; 95% CI: 1.03 to 1.55; p = 0.03), and elevated glucose (HR: 1.17; 95% CI: 0.96 to 1.47; p = 0.11) most strongly predicted death or MI. MetS was associated with an increased risk of death or MI (unadjusted HR: 1.41; 95% CI: 1.15 to 1.73; p = 0.001). However, after adjusting for its individual components, MetS was no longer significantly associated with outcome (HR: 1.15; 95% CI: 0.79 to 1.68; p = 0.46). Allocation to initial percutaneous coronary intervention did not affect the incidence of death or MI within any group. Conclusions: Among stable CAD patients in the COURAGE trial, the presence of MetS identified increased risk for death or MI, but MetS did not have independent prognostic significance after adjusting for its constituent components. The addition of early percutaneous coronary intervention to optimal medical therapy did not significantly reduce the risk of death or MI regardless of MetS or diabetes status. (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE]; NCT00007657) © 2011 American College of Cardiology Foundation.


Mancini G.B.J.,University of British Columbia | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Shaw L.J.,Emory University | Berman D.S.,University of California at Los Angeles | And 12 more authors.
JACC: Cardiovascular Interventions | Year: 2014

Objectives The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes. Background Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions. When both measures are available, their relative utility for prognostication and management choice is controversial. Methods A total of 621 patients enrolled in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial with baseline quantitative nuclear single-photon emission computed tomography (SPECT) and quantitative coronary angiography were studied. Several multiple regression models were constructed to determine independent predictors of the endpoint of death, myocardial infarction (MI) (excluding periprocedural MI) and non-ST-segment elevation acute coronary syndromes (NSTE-ACS). Ischemic burden during stress SPECT, anatomic burden derived from angiography, left ventricular ejection fraction, and assignment to either optimal medical therapy (OMT) + percutaneous coronary intervention (PCI) or OMT alone were analyzed. Results In nonadjusted and adjusted regression models, anatomic burden and left ventricular ejection fraction were consistent predictors of death, MI, and NSTE-ACS, whereas ischemic burden and treatment assignment were not. There was a marginal (p = 0.03) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome, but separately or in combination, neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome. Conclusions In a cohort of patients treated with OMT, anatomic burden was a consistent predictor of death, MI, and NSTE-ACS, whereas ischemic burden was not. Importantly, neither determination, even in combination, identified a patient profile benefiting preferentially from an invasive therapeutic strategy. © 2014 by the American College of Cardiology Foundation.


Mancini G.B.J.,University of British Columbia | Hartigan P.M.,Veterans Affairs Cooperative Studies Program Coordinating Center | Bates E.R.,University of Michigan | Sedlis S.P.,New York University | And 11 more authors.
Circulation: Cardiovascular Interventions | Year: 2011

Background-The extent to which recurrent events in patients with stable coronary artery disease is attributable to progression of an index lesion originally ≥50% diameter stenosis (DS) but not revascularized or originally <50% DS is unknown during optimal medical therapy (OMT). Methods and Results-In the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial, 205 patients assigned to OMT plus percutaneous coronary intervention (PCI) and 284 patients assigned to OMT only had symptom-driven angiograms suitable for analysis. Percentages of patients in the OMT+PCI and OMT-only cohorts with index lesions originally <50% DS were 30% and 32%, respectively; 20% and 68% had index lesions originally ≥50% DS. In both groups, index lesions originally <50% or ≥50% DS represented <4% and <25% of all such lesions, respectively. The only angiographic predictor of myocardial infarction or acute coronary syndrome was the number of lesions originally ≥50% DS that had not been revascularized (odds ratio, 1.15; confidence limits, 1.01-1.31; P<0.04). Conclusions-Lesions originally <50% DS were index lesions in one third of patients referred for symptom-driven repeat angiography, but represented <4% of all such lesions. Nonrevascularized lesions originally ≥50% DS were more often index lesions in OMT-only patients, but still represented a minority (<25%) of all such lesions. These findings underscore the need for improved therapies to arrest plaque progression and reliable strategies for selecting stenoses warranting PCI. © 2011 American Heart Association, Inc.

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