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Society for Vascular Surgery/Vascular Quality Initiative Research Application Research Project Title: Variation and intensity of medical therapy in patients undergoing vascular surgery procedures Principal Investigator: Randall R. DeMartino, M.D., M.S. Co-Investigators: Philip P. Goodney, MD, MS Jack L. Cronenwett, MD Yuanyuan Zhao, MS Specific Aims: Peripheral arterial disease (PAD) affects millions worldwide, approaching 20% of those over 70 years of 1 age. Additionally, abdominal aortic aneurysms (AAA) are present in nearly 7% of older men.2 Both PAD and AAA patients have a high prevalence of concomitant cardiovascular disease and approximately 75% of patients with PAD will ultimately die of cardiovascular causes.1, 3 Despite the benefits and recommendations for use of antiplatelet, statin, and beta blocker medications for patients with PAD and coronary artery disease (CAD),1, 4-6 these patients remains undertreated. Up to half of patients with PAD are not on antiplatelet or statin medication.7, 8 Given that vascular surgery practice centers around treatment for symptomatic PAD and aneurysmal disease, vascular surgeons are situated to ensure proper medical care is provided to these patients. This proposal will seek to understand the variation of appropriate medical care among patients undergoing vascular procedures, seek to understand the determinants to medical care, and to identify the effect of medication on peri-operative and long term outcomes for patients with PAD and AAA. Specific Aim 1. To describe of the variation of medication utilization among providers of vascular care -Using the Vascular Quality Initiative (VQI) dataset, I will analyze the utilization of medications including aspirin, statins and beta blockers among patients undergoing vascular surgical procedures within centers in the VQI. The intensity of vascular care will be measured in two ways. 1) The proportion of patients on aspirin and statins and beta blockers on the procedural level. 2) The proportion of patients in aspirin, statin and beta blocker on the center and regional level. Hypothesis: There is wide variation within the number of patients on appropriate cardiovascular medications surrounding and following their vascular procedures Specific Aim 2. To explore the determinates of medication treatment intensity during vascular surgical procedures -Using the VQI dataset, I will determine the characteristics of patients receiving appropriate medical management. Covariates that will be explored will include age, gender, race, and comorbidities. Additionally, systems-level covariates, including provider, hospital, and region, will be included to understand the influence of system factors on medical treatment. Hypothesis: In addition to specific patient characteristics, systems-based factors such as provider and center will have an impact on medication utilization Specific Aim 3. To demonstrate the association of medication utilization and intensity with both short and long term outcomes following vascular surgical procedures. -Using the VQI dataset with long term follow up data and mortality status from the SSDI, I will demonstrate the association of medication utilization with both post-operative outcomes as well as long term survival. Hypothesis: Increased systems-based utilization of cardiovascular medications will correlate with improved post-operative outcomes as well as long term survival. Significance: Peripheral arterial disease (PAD) includes atherosclerotic occlusive disease of the cerebral, visceral, and lower extremity arterial vascular beds. PAD affects millions worldwide, approaching 20% of those over 70 years of age.1 In addition, abdominal aortic aneurysms (AAA) remain a prevalent disease present in nearly 7% of older men undergoing population based screening.2 Both PAD and AAA patients have a high rate of associated cardiovascular disease. In fact, only 8% of patients undergoing major vascular surgical procedures may have normal coronary.9 This is translated into a high incidence of clinical coronary and cerebrovascular disease burdens among those with PAD and AAA.1, 10 A recent epidemiological study has also shown that patients with AAA have a two-fold higher risk of heart attack and 1.8-fold higher risk of stroke compared with population based controls.11 Lastly, cardiovascular comorbidities remain a long term complication, where approximately 75% of those with PAD will ultimately die from cardiovascular causes.1, 3 The most commonly recognized medical treatment for patients with PAD and coronary artery disease (CAD) is acetylsalicylic acid (aspirin). Numerous studies have consistently demonstrated the benefit of aspirin in high risk cohorts. In a meta-analysis of 195 randomized studies of antiplatelet therapy versus placebo, there is a 25% reduction in cardiovascular events, including stroke, among those with PAD on aspirin therapy. This has lead multiple organizations to recommend aspirin therapy to patients with symptomatic PAD.1, 3, 5, 12 In addition, the CAPRIE trial demonstrated that clopidogrel is as effective as aspirin in patients with PAD in reducing cardiovascular events.13 Due to its effect on patient with cerebrovascular disease,13, 14 antiplatelet therapy is also recommended for all patients with extracranial cerebrovascular disease. This has lead to a National Quality Forum measure for antiplatelet use surrounding carotid revascularization.15 Although no specific recommendations for aspirin therapy in patients with AAA exist at present, epidemiologic data demonstrate patients with AAA are at elevated risk for cardiovascular events and carry high rates of cardiac comorbidities.11 Aspirin is widely accepted as basic medical therapy for those with CAD.6 In addition to aspirin therapy, the use of HGM-CoA reductase inhibitors (statins) is standard practice for patients with PAD16, 17 and those undergoing major vascular surgery.18 The POISE III trial demonstrated a 9% absolute risk reduction and 55% relative risk reduction in myocardial ischemic events with a similar effect on all cardiovascular death after AAA repair, carotid endarterectomy, and arterial reconstruction for occlusive disease.18 For this reason, statin usage is recommended for symptomatic PAD patients and those with coronary disease by multiple guidelines.1, 3, 4, 6 Despite these benefits, some evidence has suggested statin use is associated with insulin resistance and risk of diabetes. However, the benefit of statins on cardiac events far outweighs the risks of diabetes.19 Beta-blocker therapy has been shown to be effective in reducing cardiac related morbidity among patient undergoing non-cardiac and vascular surgery.20, 21 However, this has been meet with conflicting results, making the net benefit of beta-blocker therapy a topic of debate.22, 23 Despite this, beta-blocker therapy remains a prominent measure of care quality and it is recommended for patients at intermediate to high cardiac risk, or known stress induced ischemia in the peri-operative period.24, 25 Although work within the Vascular Study Group of New England has shown that overall increases in beta blocker usage did not decrease cardiac morbidity, we have also increased out ability to better risk stratify patients at high cardiac risk.26, 27 Thus, the opportunity exists to understand and describe the variation in beta blocker usage and its relation to high risk vascular surgery patients and their outcomes. Many patients with PAD remain undertreated. Of all PAD patients, 40-60% of patients are not on antiplatelet agents and 40-70% are not on statins.7, 8 This is correlated with increased risk of mortality, even in those with no known associated CAD.7 This has prompted the Department of Health and Humans Services to initiate the Million Hearts Campaign to promote proper medical management to prevent strokes and death from cardiovascular causes.28 Date from the VSGNE has shown similar trends of medication use. We have recently studied the use of antiplatelet medication and statin use among patients undergoing carotid interventions (CAS and CEA), infra and suprainguinal bypass, and aneurysm repair (open and EVAR). Within New England, many patients on not on antiplatelet (AP) and statin medication in the perioperative period who should be treated (Figure 1, unpublished data). From 2005 to 2012, we have improved the number of patients on both AP and statin medications at pre-op and discharge (54% in 2005 to 67% in 2012, p<0.001). However our overall rate of AP and statin use pre-op and discharge has not improved over the past few years, averaging 65-70% of eligible patients. Despite this modest improvement, the ability to place patients on AP and statin medications before their operation and at discharge varies significantly by center and by procedure (Figure 2, unpublished data). This demonstrates that there are likely center effects that relate to the ability to ensure that patients are placed on appropriate therapy. This may be due to surgeon preference or processes of care within each center. Finally, our analysis has shown that optimal AP and statin therapy has a significant effect on per-operative and longterm mortality. Pre-operative AP and statin use was associated with lower 30-day mortality (0.97 vs 1.58%, RR 0.61, p<0.01). This remained significant after adjustment for patient factors (OR 0.66, 95% CI 0.5-0.9, p=0.01). Additionally, optimal medical therapy with AP and statin was also associated with improved 5-year survival, with the effect additive for both AP and statin use (Figure 3, unpublished data). This effect remained significant after adjustment for patient characteristics. Figure 1. Proportion of patients on Antiplatelet, Statin or Beta-blocker within the VSGNE by Procedure Pre-operative Discharge Intolerant and missing excluded Innovation: As discussed, despite their benefits, many patients remain on suboptimal medical regimens. This results from complex interactions between providers, patients and the systems of care that they interact within. Understanding these dynamic forces can help to improve the quality of care delivered, as well as improve outcomes. In this effort, the Society for Vascular Surgery Patient Safety Organization (SVS-PSO) and the Vascular Quality Initiative (VQI) were established.29 Based on regional quality efforts in New England, the VQI has established itself as a national, multi-institutional collaborative to improve the care of patients with vascular disease. The VQI is uniquely detailed to study the association of medical management surrounding vascular operations in ways not possible by other means. First, the VQI records aspirin use. Apart from chart review, tracking aspirin use is difficult, given its over-the-counter availability. Administrative databases, Medicare Part D, or other databases are unable to correctly track its use. This makes the VQI valuable to understanding its use surrounding vascular surgical procedures across centers. Second, the VQI tracks the use of aspirin, statin, and beta-blocker usage pre-operatively, at discharge, and at one year follow up. This permits the ability to study how effective medications are utilized during the peri-operative period and if they are maintained long term. Finally, by linking with the Social Security Death Index (SSDI), we can establish vital status of post-operative patients. Since the vast majority of PAD patients will die of cardiovascular causes, this is an ideal outcome for assessment since these medications are known to prevent cardiovascular events. This analysis establishes a novel approach to analyzing medication utilization. While our group has confirmed that many patients remain undertreated, understanding the overall effect on suboptimal medical care following vascular operations remains unknown. In addition, little is know about the contributing factors, such as regional variation and other determinants of optimal medical care. Once the drivers for suboptimal care are identified, quality improvement initiatives can be focused to improve these measures and improve the medical care provided. Work within the Vascular Study Group of New England has shown that use of these data can be used to augment physician practice for process improvement, making this analysis a step towards providing better medical care.26 Research Strategy Methods Overall approach: To conduct our analysis, we will utilize the Vascular Quality Initiative (VQI) national dataset from inception to present. We will analyze all elective procedures, including patients undergoing carotid endarterectomy, carotid artery stenting, infra-inguinal bypass, supra-inguinal bypass, peripheral vascular interventions, and open and endovascular aneurysm repair (infrarenal and thoracic). Only patients with CAD or PAD history who underwent aneurysm repair will be included, as aortic aneurysmal disease alone carries no endorsed medication recommendations. Patients will be censored after their first operation into the VQI dataset. Thus, patients cannot be analyzed twice if they undergo a second operation in the dataset. This will help understand the processes of care present within each center and region for all patients at their initial presentation. Patients undergoing multiple procedures may have medication changes not reflective of the standard practice, potentially due to complications or procedural failures. This may bias the findings in ways not easily accounted for within the dataset. Fortunately, our group has extensive experience with the VQI dataset from the Vascular Study Group of New England.26, 30-33 Aim 1. To describe of the variation of medication utilization among providers of vascular care. First, to understand the variation present in medication utilization, I will characterize the centers present within the VQI. As noted above, I will create my study population, a cohort based on patients undergoing their first procedure within the VQI. The unit of analysis will be the patient, aggregated at the center and regional level. The main outcome measure will be the intensity of medical treatment surrounding the patient’s procedure. Intensity will be characterized in three ways. 1) The number of patients on antiplatelet medications (defined as aspirin or clopidogrel), statin, or beta blockers before their surgery, at discharge, and at the most recent long term follow up. 2) Higher intensity care will be defined as at least antiplatelet and statin usage at pre-operatively and discharge for those undergoing operations for PAD, carotid revascularization or aneurysm repair with cardiovascular risk factors (defined as those with any coronary disease, prior coronary revascularization, prior bypass or stenting or prior carotid endarterectomy). 3) Beta blocker usage will be assessed as proportion of high cardiac risk patients27 on chronic or pre-operative beta-blocker therapy undergoing major vascular surgery procedures (open AAA, lower extremity bypass). Data will be aggregated at the center level into tertiles on intensity of care. This will be utilized for further analysis on outcomes to ensure the anonymity of any one center. Potential Problems with Aim 1: One potential problem will be centers with low case volumes. Centers with only a few cases will increase the potential for measurement error in understanding their practice patterns for medical management. I will limit my center analyses to only those centers with >100 cases to limit this problem. Another potential problem will involve medication intolerance. In my analysis, I will exclude patients that are intolerant of both medications. For composite endpoints (such as being on AP and statin), patients will be credited for optimal therapy if they are one medication, but intolerant of the other medication. This will ensure centers and providers are credited for proper “intention to treat” with respect to optimal medical management. I will also run my analysis with all patients who have medication intolerance removed to see how this affects our findings. Aim 2. To explore the determinates of medication treatment intensity during vascular surgical procedures To understand the determinates in the intensity medical management surrounding vascular surgical procedures, I will use available data within the VQI dataset to associate specific variables with medical treatment. For this, the unit of analysis will be the patient and the outcome of interest (dependent variable) will be pre-operative and discharge antiplatelet and statin medication usage following carotid interventions, procedures for PAD and aneurysm repair. Beta blocker usage will be assessed on pre-operative and discharge for high risk procedures as noted above. The exposure (independent variables) will include medical co-morbidities, race, gender, age, surgeon, center and region. The later two will remain anonymous. I will look to understand and identify potential interactions among surgeon and center, as these may be related by system factors. I will use multivariable logistic regression analyses to explore the relationships between my exposures and the intensity of medical treatment. Potential Problems with Aim 2: There may be missing data for patients within the VQI. Since at this time, we do not understand if these data are missing at random, all logistical analyses will be based on patients with no missing data for significant variables. Additionally, to ensure that medication use is recorded correctly, we will perform site specific random audits to verify the VQI medication data. Aim 3. To demonstrate the association of medication utilization and intensity with both short and long term outcomes following vascular surgical procedures. Once terciles of medication intensity are created, they can then be applied to understand what effect both center level contextual variables and patient level medication use have on outcomes. Three outcomes will be identified. 1) First, strata of medication intensity use will be evaluated on thirty-day mortality following each operation. Thirty day or in hospital death will be defined as a combination of a discharge status of death within the VQI and by death <30 days following a patient’s operation by SSDI (the outcome). I will explore patient demographics, center, and medication use (exposures) on 30-day mortality while adjustments are done for patient covariates using logistic regression techniques. This will include hierarchical modeling techniques (center level terciles medication intensity) to understand what effect center intensity of care has on outcomes. 2) Similar techniques will be employed to understand the effect of optimal medication usage on cardiovascular morbidity, defined as post-operative death, myocardial infarction, dysrhythmia, or congestive heart failure. 3) Finally, the effect of medication utilization on long term mortality (outcome) will be analyzed. Using life table methods with Cox proportional hazards techniques, the association of patient demographics, optimal medication utilization, and center intensity of care (exposures) will be described. Potential Problems with Aim 3: As in Aim 2, there may be missing data for patients within the VQI. For logistic and survival analyses, I will limit the multivariate models to patients without missing data on significant variables. Timeline: Data Management Data Analysis Presentation of Findings Publication of Findings 1-3 months X X 3-6 months 6-12 months X X Budget: Analyst Support: $2,000 Presentation and Dissemination of findings at Regional/National Academic Vascular Meeting: $1,000 Funds for the above budget will be provided by grant support for Philip Goodney, MD, via support from exiting grant funding mechanisms. References: 1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5-67. 2. Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ, et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. Bmj. 2004;329(7477):1259. 3. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006;113(11):e463-654. 4. Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011;124(4):489-532. 5. Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery. J Vasc Surg. 2011;54(5):e32-58. 6. Smith SC, Jr., Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation. 2011;124(22):2458-73. 7. Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011;124(1):17-23. 8. Subherwal S, Patel MR, Kober L, Peterson ED, Jones WS, Gislason GH, et al. Missed opportunities: despite improvement in use of cardioprotective medications among patients with lower-extremity peripheral artery disease, underuse remains. Circulation. 2012;126(11):1345-54. 9. Hertzer NR, Beven EG, Young JR, O'Hara PJ, Ruschhaupt WF, 3rd, Graor RA, et al. Coronary artery disease in peripheral vascular patients. A classification of 1000 coronary angiograms and results of surgical management. Ann Surg. 1984;199(2):223-33. 10. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. Jama. 2001;286(11):1317-24. 11. Eldrup N, Budtz-Lilly J, Laustsen J, Bibby BM, Paaske WP. Long-term incidence of myocardial infarct, stroke, and mortality in patients operated on for abdominal aortic aneurysms. J Vasc Surg. 2012;55(2):311-7. 12. Sobel M, Verhaeghe R. Antithrombotic therapy for peripheral artery occlusive disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):815S-43S. 13. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996;348(9038):1329-39. 14. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Bmj. 2002;324(7329):71-86. 15. NQF Measure 0465-Perioperative Anti-platelet Therapy for Patients undergoing Carotid Endarterectomy. [November 26, 2012]; Available from: http://www.qualityforum.org. 16. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-81. 17. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002;360(9326):7-22. 18. Schouten O, Boersma E, Hoeks SE, Benner R, van Urk H, van Sambeek MR, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-9. 19. Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375(9716):735-42. 20. Poldermans D, Boersma E, Bax JJ, Thomson IR, van de Ven LL, Blankensteijn JD, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med. 1999;341(24):1789-94. 21. Lindenauer PK, Pekow P, Wang K, Mamidi DK, Gutierrez B, Benjamin EM. Perioperative beta-blocker therapy and mortality after major noncardiac surgery. N Engl J Med. 2005;353(4):349-61. 22. Brady AR, Gibbs JS, Greenhalgh RM, Powell JT, Sydes MR. Perioperative beta-blockade (POBBLE) for patients undergoing infrarenal vascular surgery: results of a randomized double-blind controlled trial. J Vasc Surg. 2005;41(4):602-9. 23. Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008;371(9627):1839-47. 24. Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation. 2007;116(17):e418-99. 25. Schouten O, Sillesen H, Poldermans D. New guidelines from the European Society of Cardiology for perioperative cardiac care: a summary of implications for elective vascular surgery patients. Eur J Vasc Endovasc Surg. 2010;39(1):1-4. 26. Goodney PP, Eldrup-Jorgensen J, Nolan BW, Bertges DJ, Likosky DS, Cronenwett JL. A regional quality improvement effort to increase beta blocker administration before vascular surgery. J Vasc Surg. 2011;53(5):1316-28 e1; discussion 27-8. 27. Bertges DJ, Goodney PP, Zhao Y, Schanzer A, Nolan BW, Likosky DS, et al. The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients. J Vasc Surg. 2010;52(3):674-83, 83 e1-83 e3. 28. Million Hearts Initiative. [January 20, 2013]; Available from: http://millionhearts.hhs.gov/index.html. 29. Cronenwett JL, Kraiss LW, Cambria RP. The Society for Vascular Surgery Vascular Quality Initiative. J Vasc Surg. 2012;55(5):1529-37. 30. De Martino RR, Nolan BW, Goodney PP, Chang CK, Schanzer A, Cambria R, et al. Outcomes of symptomatic abdominal aortic aneurysm repair. J Vasc Surg. 2010;52(1):5-12 e1. 31. Nolan BW, De Martino RR, Goodney PP, Schanzer A, Stone DH, Butzel D, et al. Comparison of carotid endarterectomy and stenting in real world practice using a regional quality improvement registry. J Vasc Surg. 2012;56(4):990-6. 32. Goodney PP, Likosky DS, Cronenwett JL. Factors associated with stroke or death after carotid endarterectomy in Northern New England. J Vasc Surg. 2008;48(5):1139-45. 33. Beck AW, Goodney PP, Nolan BW, Likosky DS, Eldrup-Jorgensen J, Cronenwett JL. Predicting 1-year mortality after elective abdominal aortic aneurysm repair. J Vasc Surg. 2009;49(4):838-43; discussion 43-4. BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Randall De Martino Chief Resident Section of Vascular Surgery Dartmouth-Hitchcock Medical Center eRA COMMONS USER NAME (credential, e.g., agency login) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE (if applicable) YEAR(s) University of Richmond Virginia Commonwealth Univ. School of Med. BS MD 2003 2007 Dartmouth College MS 2011 - 2007-P INSTITUTION AND LOCATION Dartmouth-Hitchcock Medical Center FIELD OF STUDY Biology Medicine Clinical & Health Services Research Vascular Surgery A: Personal Statement I am a vascular surgery resident at Dartmouth-Hitchcock Medical Center. I am also a health services researcher interested in comparative effectiveness and quality of care. In addition to my surgical training, I completed a Master's degree in Clinical and Health Services Research at The Dartmouth Institute. My prior work with the Vascular Study Group of New England has focused on improving patient selection and has enabled me to become facile with the Vascular Quality Initiative dataset. The aim of this proposal is to understand the variation and effect of medication utilization across centers within the Vascular Quality Initiative. In addition, this proposal is well aligned with my long-term research goal, which is to better characterize the effect of quality vascular care and understand the barriers to providing such care in an effort to improve outcomes. B. Positions Vascular Surgery Resident Dartmouth-Hitchcock Medical Center (Mark F. Fillinger, M.D.) 2007 - 2013 Masters Degree Clinical and Health Services Research The Dartmouth Institute, Dartmouth College (Philip P Goodney, MD, MS) 2010 - 2011 Honors: Joint Surgical Advocacy Conference Scholarship, Society for Vascular Surgery Chairman’s Scholarship, Dartmouth-Hitchcock Medical Center Gold Foundation Humanism and Excellence in Teaching Award Society for Vascular Surgery Annual Meeting Scholarship Society for Vascular Surgery Dean’s Merit Scholarship Award, VCU School of Medicine Willie M. Reams Award in Biology, University of Richmond University of Richmond Summer Research Fellowship, University of Richmond Merck/AAAS Fellowship for Biochemical Research, University of Richmond 2011 2010 2010 2007 2003-2007 2003 2001-2003 2001-2002 B: Peer-Reviewed Publications 1. Gillespie SR, De Martino RR, Zhu J, Chong HJ, Ramirez C, Shelburne CP, Bouton LA, Bailey DP, Gharse A, Mirmonsef P, Odom S, Gomez G, Rivera J, Fischer-Stenger K, and Ryan JJ. IL-10 Inhibits Fc epsilon RI Expression in Mouse Mast Cells. J. Immunol. Mar 2004; 172: 3181 - 3188. PMID 14978125. 2. De Martino RR, Stone DH. Repair of Multiple Right Renal Artery Aneurysms with Associated Fibromuscular Dysplasia in a Solitary Kidney. J Vasc Surg. 2009; 49:497. PMID 19216969. 3. De Martino RR, Stone DH, Beck AW, Walsh DW. Thoracic Outlet Syndrome Associated With a Large Cervical Rib. Vasc Endovascular Surg. 2009;43:393-4. PMID 19556226. 4. De Martino RR, Nolan BW, Powell RP, Walsh DW, Stone DH. Stent Graft Repair of Iatrogenic Femoral Arteriovenous Fistula; A Useful Therapeutic Approach in a Hostile Groin. Vasc Endovascular Surg. 2010;44:40-3. PMID 19917562. 5. Beck AW, Nolan BW, De Martino RR, Tanski W, Stone DH, Walsh DB, Powell RP. Predicting Blood Pressure Response after Renal Artery Stenting. J Vasc Surg. 2010;51:380-5. PMID 19939607. 6. Scali ST, Beck AW, De Martino RR, Duxbury A, Walsh DB. Endovascular Management of Congenital Atresia of the Infrarenal IVC. Vasc Endovascular Surg. 2010;44:234-6. PMID 20308176. 7. De Martino RR, Nolan BW, Goodney PP, Chang CK, Schanzer A, Cambria R, Bertges DJ, Cronenwett LJ. Outcomes of Symptomatic Abdominal Aortic Aneurysm Repair. J Vasc Surg. 2010;52:5-12. PMID 20471771. 8. Goodney PP, Schanzer A, De Martino RR, Nolan BW, Hevelone ND, Conte MS, Powell RJ, Cronenwett JL. Validation of the Society for Vascular Surgery’s Objective Performance Goals (OPGs) for Critical Limb Ischemia in Everyday Vascular Surgery Practice. J Vasc Surg. 2011;54:100-8. PMID 21334173. 9. Brewster LP, Glass C, De Martino RR, Hall H, Kauvar DS, Kokkosis AA, Kreishman P, Boros M, Kalata E, Farber A. The Formal Response of Vascular Surgery Trainees to ACGME Recommendations. 2010. Published in Vascularweb.org. Accessed October 2010. 10. Nolan BW, De Martino RR, Beck AW, Schanzer A, Goodney PP, Walsh DW, Cronenwett JL. Prior Failed Ipsilateral Percutaneous Vascular Intervention (PVI) in Patients with Critical Limb Ischemia Predicts Poor Outcome after Lower Extremity Bypass. J Vasc Surg. 2011;54(3):730-5. PMID 21802888. 11. Scali ST, Beck AW, Nolan BW, De Martino RR, Rzucidlo E, Walsh DB. Completion Duplex Ultrasound Predicts Graft Performance after Crural Bypass. J Vasc Surg. 2011;54:1006-10. PMID 21820833. 12. Ashe KM, Chiu W, Khalifa AM, Nicolas AN, Brown BL, De Martino RR, Alexander CP, Waggener CT, FischerStenger K, Stewart JK. Vesicular Monoamine Transporter-1 (VMAT-1) mRNA and Immunoreactive Proteins in Mouse Brain. Neuro Endocrinol Lett. 2011;32(3):253-8. PMID 21712771. 13. De Martino RR, Brewster LP, Kokkosis AA, Class C, Boros M, Kreishman P, Kauver DS, Farber A. The Perspective of the Vascular Surgery Trainee on New ACGME Regulations, Fatigue, Resident Training and Patient Safety. Vasc Endovascular Surg. 2011;45(8):697-702. PMID 22262113. 14. De Martino RR, Wallaert JB, Rossi A, Zbehlik A, Suckow B, Walsh DW. A Meta-Analysis of Anticoagulation for Calf Deep Venous Thrombosis. J Vasc Surg. 2012;56(1):228-37. PMID 22209612. 15. De Martino RR, Goodney PP, Spangler EL, Wallaert JB, Corriere M, Rzucidlo EM, Walsh DB, Stone DH. Variation in Thromboembolic Complications Among Patients Undergoing Commonly Performed Cancer Operations. J Vasc Surg. 2012;55(4):1035-41. PMID 22409858. 16. Wallaert JB, De Martino RR, Finlayson SR, Walsh DB, Corriere M, Edwards M, Stone DH, Goodney PP. Carotid Endarterectomy in Asymptomatic Patients with Limited Life Expectancy. Stroke. 2012;43:17811787. PMID 22550053. 17. Brooke BS, De Martino RR, Girotti M, Dimick JB, Goodney PP. Developing Strategies for Predicting and Preventing Readmissions in Vascular Surgery. J Vasc Surg. 2012;56(2):556-62. PMID 22743022. 18. Nolan BW, De Martino RR, Goodney PP, Butzel D, Schanzer A, Stone DH, Kwolek CJ, Powell RJ, Cronenwett JL. Comparison of Carotid Endarterectomy and Stenting in Real World Practice Using A Regional Quality Improvement Registry. J Vasc Surg. 2012;56(4):990-6. PMID 22579135. 19. De Martino RR, Edwards MS, Corriere M, Beck AW, Stone DH, Finlayson SR, Cronenwett JL, Goodney PP. Impact of Screening versus Symptomatic Measurement of Deep Venous Thrombosis in a National Quality Improvement Registry. J Vasc Surg. 2012;56(4):1045-51. PMID 22832263. 20. Wallaert JB, De Martino RR, Marsicovetere PS, Goodney PP, Finlayson SR, Murray JJ, Holubar SD. Venous Thromboembolism after Surgery for Inflammatory Bowel Disease: Are There Modifiable Risk Factors? Data from ACS-NSQIP. Dis Colon Rectum. 2012;55(11):1138-44. PMID 23044674. 21. Wallaert JB, Cronenwett JL, Bertges DJ, Schanzer A, De Martino RR, Nolan BW, Eldrup-Jorgensen, Goodney PP. Optimal selection of asymptomatic patients for carotid endarterectomy based on predicted 5-year survival. J Vasc Surg. Accepted. BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Philip Goodney Assistant Professor Section of Vascular Surgery Dartmouth-Hitchcock Medical Center eRA COMMONS USER NAME (credential, e.g., agency login) PGOODNEY EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) DEGREE (if applicable) YEAR(s) University of Connecticut University of Connecticut School of Medicine BS MD 1995 1999 Dartmouth Medical School MS 2003 - 2006 2008 INSTITUTION AND LOCATION Dartmouth-Hitchcock Medical Center Dartmouth-Hitchcock Medical Center FIELD OF STUDY Chemistry Medicine Evaluative Clinical Science General Surgery Vascular Surgery A: Personal Statement I am a vascular surgeon and health services researcher at Dartmouth. During surgical training, I completed a Master's degree in Evaluative Clinical Sciences during a two-year research fellowship at The Dartmouth Institute. After joining the faculty at Dartmouth in 2008, I received a Career Development Award from the NHLBI in 2010, as well as the Lifeline Research Award from the Society for Vascular Surgery in 2011. In my research, I've enjoyed studying ways to determine which patients are most likely to benefit from surgical treatments (References 3, 4, 5-8, and 14), and examining variation in the use and effectiveness of revascularization for peripheral arterial disease (PAD) (References 1, 2, 6, and 13). The aim of this proposal is to understand variation and effectiveness of medication utilization within the Vascular Quality Initiative. My innovative research approaches have combined administrative claims with granular detail about patients, procedures, and prevention, and advanced analytic tools such as hierarchical and econometric models. We will utilize some of these methods for this proposal. Our results will impact the quality of care for patients undergoing vascular surgery, by informing patients and physicians of the relative importance of medical management. This proposal is well aligned with my long-term research goal, which is to better inform, patients, physicians, and policymakers about quality of care in vascular surgery. B. Positions General Surgery Residency 1999 - 2001 Dartmouth-Hitchcock Medical Center (Richard W. Dow, M.D.) 2003 - 2006 VA Special Fellowship in Outcomes Research VA Outcomes Group, White River Junction, Vermont (John D. Birkmeyer, M.D.) 2001 - 2003 Masters Degree in Evaluative Clinical Sciences Center for Evaluative Clinical Sciences, Dartmouth (Elliott S. Fisher, MD, MPH) 2001 - 2003 Vascular Surgery Fellowship Dartmouth-Hitchcock Medical Center (Jack L. Cronenwett, M.D.) 2006 - 2008 Assistant Professor, Section of Vascular Surgery Dartmouth-Hitchcock Medical Center Lebanon, NH 2008-current Assistant Professor The Dartmouth Institute for Health Policy and Clinical Practice 2008-current Director (Interim), Surgical Outcomes Research The Department of Surgery Dartmouth Hitchcock Medical Center 2012-current Honors: Distinguished Fellow, Society for Vascular Surgery NIH Loan Repayment Program Faculty Loan Repayment Award, DHHS Harmes Research Award, Department of Surgery, DHMC Darling Award, New England Society for Vascular Surgery Thomas P. Almy Housestaff Teaching Award Jobst Award, Frederick A. Coller Surgical Society Peripheral Vascular Surgery Society Academic Award Dartmouth Medical School Class of 2007 Teaching Award 2012 2010 2009 2009 2008 2006 2007 2007 2007 B: Selected Peer-Reviewed Publications (of a total of 80) Most Relevant to Current Proposal 1. Goodney PP, Travis LA, Lucas FL, Cronenwett JL, Goodman DC. Variation in the use of vascular procedures in the year prior to amputation. Circulation: Cardiovascular Quality and Outcomes 2012 Jan; 5(1): 94-102. PMID 22147886. 2. Goodney PP, Holman KL, Travis LA, Henke PS, Birkmeyer JD, Cronenwett JL, Fisher ES. Regional use of revascularization and amputation rates. J. Vasc Surg (in press), Sept . 2012. 3. Goodney PP, Travis LA, Lucas FL, Cronenwett JL, Goodman DC, Stone DH. Survival following open and endovascular thoracic aneurysm repair in the Medicare population Circulation 2011 Dec 13; 124 (24): 2661-9. PMID 22104552. 4. Goldberg J, Baker FB, Cronenwett, JL, Goodney PP. The effect of risk and race on lower extremity amputation among Medicare diabetics. J Vasc Surg 2012 Sept 7(epub ahead of print) PMID 22963815. 5. Nallamothu BK, Gurm HS, Ting HH, Goodney PP, Rogers MA, Curtis JP, Dimick JB, Bates ER, Krumholz HM, Birkmeyer JD. Operator experience and outcomes with carotid stenting in Medicare beneficiaries. JAMA 2011 Sept 28; 306 (12) 1338-43 PMID 21954477. Additional Publications of Importance 6. Goodney PP, Travis LL, Malenka D, Bronner KK, Lucas FL, Cronenwett JL, Goodman DC, Fisher ES. Regional variation in carotid artery stenting and endarterectomy in the Medicare population. Circulation: Cardiovascular Quality and Outcomes 2010 (3): 15-24. PMID 20123667. 7. Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP et al. Surgeon volume and operative mortality in the United States. New England Journal of Medicine. Nov 27 2003;349(22):2117-2127. PMID: 14645640. 8. Goodney PP, Lucas FL, Birkmeyer JD. Should volume standards for cardiovascular surgery focus only on high-risk patients? Circulation. Jan 28 2003;107(3):384-387. PMID: 12551859. 9. Goodney PP, O'Connor GT, Wennberg DE, et al. Do hospitals with low mortality rates in coronary artery bypass also perform well in valve replacement? Annals of Thoracic Surgery. Oct 2003;76(4):1131-1136; discussion 1136-1137. PMID: 14529999. 10. Goodney PP, Stukel TA, Lucas FL, et al. Hospital volume, length of stay, and readmission rates in high-risk surgery. Annals of Surgery. Aug 2003;238(2):161-167. PMID: 12894006. 11. Birkmeyer NJO, Goodney PP, Stukel TA, et al. Do cancer centers designated by the National Cancer Institute have better surgical outcomes? Cancer. Feb 1 2005;103(3):435-441. PMID: 15622523. 12. Goodney PP, Lucas FL, Stukel TA, et al. Surgeon specialty and operative mortality with lung resection. Annals of Surgery. Jan 2005;241(1):179-184. PMID: 15622006. 13. Goodney PP, A Dartmouth Atlas Report: Trends and regional variation in the use of carotid revascularization. Dartmouth College Publishing, The Dartmouth Atlas (www.dartmouthatlas.org). 14. Goodney PP, Likosky DS, Cronenwett JL, et al. Factors associated with amputation or graft occlusion after lower extremity bypass in Northern New England. Annals of Vascular Surgery 2009. Sept 10 (Epub ahead of print) PMID: 19748222. 15. Goodney PP, Lucas FL, Travis LL, Fisher ES. Changes in the use of carotid revascularization among the medicare population.Archives of Surgery. Feb 2008;143(2):170-173. PMID: 18283142. C: Research Support Current: Dartmouth SYNERGY Award: Toward Understanding the Cost and Cost-Effectiveness of Carotid Stenting and Endarterectomy. Principal Investigator $50,000 2012-2014 NHLBI K08 Career Development Award (1K08HL05676-01) Understanding Regional Variation in Treatment Intensity with PAD Principal Investigator (Mentor = Elliott S. Fisher, MD, MPH) $699,570 2010-2015 American Vascular Association / American College of Surgeons Lifeline Award Supplemental Funding Award. Understanding Regional Variation in Treatment Intensity with PAD. $250,000 2011-2015 Department of Health and Human Services Faculty Loan Repayment Award Regional Variation in Treatment Intensity with Lower Extremity PAD Principal Investigator $35,451 2010-2012 National Institutes of Health Loan Repayment Award Understanding Regional Variation in Treatment Intensity with PAD $34,576 2011-2013 Peripheral Vascular Surgery Society Academic Award Development of a disease-specific quality of life measure for patients 2011-2012 with critical limb ischemia (Co-Investigator with Bjoern Suckow, MD) $14,500 Hitchcock Foundation Seed Grant Development of a Glucose Management Service for Vascular Surgery Patients Co-Investigator with Jessica Wallaert, MD $10,500 2011-2012 Completed Peripheral Vascular Surgery Society Academic Award (Goodney, PI) 2007-2008 Peripheral Vascular Surgery Society Risk Prediction Model for Complications Following Lower Extremity Revascularization Using data from the Vascular Study Group of Northern New England, this project entails constructing a risk prediction model to allow surgeons to select optimal candidates for lower extremity revascularization. $14,500 Society for Vascular Surgery Clinical Seed Grant (Goodney, PI) 2007-2008 Society for Vascular Surgery Development of a Risk Prediction Model for Complications and Functional Outcomes Following Lower Extremity Revascularization Using a Prospective Regional Database Using data from the Vascular Study Group of Northern New England, this project entails constructing a risk prediction model to identify and examine the incidence of functional outcomes after lower extremity revascularization. $15,000 Hitchcock Foundation Grant (Goodney, PI) Hitchcock Foundation, Dartmouth-Hitchcock Medical Center Has Carotid Stenting Affected the Incidence of Carotid Endarterectomy? This project examined the utilization of carotid revascularization in Medicare patients, and examines regional variation in this procedure as well as its effect on outcomes. $10,000 2006-2007 Quality Research Grant Program (Chang, Goodney, PIs) Hitchcock Foundation, Dartmouth-Hitchcock Medical Center Percutaneous arterial closure – Can we decrease morbidity? In this quality improvement project we designed, implemented, and measured the effects of a clinical pathway used to obtain hemostasis after percutaneous endovascular procedures. $8,000 2006-2007 Abbott Vascular, Inc. (Cronenwett, Goodney, PIs) Standardizing Arterial Closure Technique following Percutaneous Arterial Intervention: A Feasibility Study This project was an industry-sponsored study examining the indications, use and results of different methods of obtaining arterial closure following endovascular procedures. $6,000 2006-2008 BIOGRAPHICAL SKETCH Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME Jack L. Cronenwett, M.D. POSITION TITLE Professor, Department of Surgery, Community and Family Medicine and The Dartmouth Institute for Health Policy and Clinical Practice eRA COMMONS USER NAME JCronenwett INSTITUTION AND LOCATION University of Michigan, Ann Arbor, MI Stanford University Medical School, Stanford, CA University of Michigan, Ann Arbor, MI University of Michigan, Ann Arbor, MI University of Michigan University of Tennessee A. DEGREE (if applicable) B.S. M.D. Residency Fellowship Residency Fellowship YEAR(s) 1965-1969 1969-1973 1973-1975 1975-1977 1977-1979 1979-1980 FIELD OF STUDY Medicine General Surgery Vascular Research General Surgery Vascular Surgery Personal Statement. I strongly support Dr. De Martino’s application to understand variation and the effectiveness of medical management surrounding vascular surgery. This has high probability of improving care as well as reducing variation and cardiovascular complications following vascular surgical operations. I am in a unique position to support this activity as a co-investigator. During the past 10 years, I founded and serve as Medical Director of the Vascular Study Group of New England (VSGNE). This effort has demonstrated improvement in processes and outcomes associated with vascular procedures, and has directly led to the current national Vascular Quality Initiative (VQI) of the Society for Vascular Surgery (SVS). I led the development of the SVS Patient Safety Organization (SVS PSO), and now serve as the Medical Director of this effort, which began this year, and already involves > 100 hospitals in 30 states. I am appropriately positioned to work with Dr. De Martino in understanding variation in medical management. This project is in alignment with efforts by the Vascular Quality Initiative to reduce variation and improve the quality of care provided to improve outcomes. B. Positions and Honors. Academic Appointments: 1980 - 1983 Research Associate, Veterans Administration, Medical Center, Ann Arbor, Michigan 1980 - 1984 Assistant Professor, Department of Surgery, University of Michigan, Ann Arbor, Michigan 1984 - 1989 Associate Professor, Department of Surgery, Dartmouth Medical School, Hanover, NH 1989 Professor, Department of Surgery, Dartmouth Medical School, Hanover, NH 2002 Professor, Department of Community and Family Medicine, Dartmouth Medical School, Hanover, NH 2009 Professor, The Dartmouth Institute for Health Policy and Clinical Practice, Hanover, NH Professional Positions: 1980 - 1984 Director, Vascular Diagnostic Unit, Veterans Administration, Medical Center, Ann Arbor, Michigan 1980 - 1984 Attending Surgeon, University of Michigan Hospitals 1980 - 1984 Staff Surgeon, Veterans Administration, Medical Center, Ann Arbor, Michigan 1984 - 1987 Director, Vascular Laboratory, Dartmouth-Hitchcock Medical Center 1984 - 2007 Chair, Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center 1988 - 2007 1996 - 2002 1997 - 1998 2000 - 2002 2002 - 2003 2003 - 2011 2003 - 2008 2002 2011 - Program Director, Vascular Surgery Residency, Dartmouth-Hitchcock Medical Center Residency Review Committee for Surgery, Member President, New England Society for Vascular Surgery President, Association of Program Directors in Vascular Surgery President, Society for Vascular Surgery Senior Examiner, Vascular Surgery, American Board of Surgery Editor-in-Chief, Journal of Vascular Surgery Medical Director, Vascular Study Group of New England Medical Director, Society for Vascular Surgery Patient Safety Organization Honors: 1973 1977 1977 1977 1987 - 2011 1991 1994 - 2011 1994 - 2011 1996 - 2011 1998 2001 - 2011 2002 2003 2010 Senior Surgical Award, Stanford Medical School Frederick A. Coller Award for Research by Surgical Residents Conrad Jobst Award for outstanding contributions in vascular research Resident Research Award, Association for Academic Surgery 48 Visiting professorships Traveling Fellow, Australia and New Zealand Chapter of the ACS 27 Honorary lectures Listed in "The Best Doctors in America” Listed in "Who's Who in America," Marquis The Chairman's Award, Department of Surgery, Dartmouth Medical School Listed in Castle Connolly "America’s Top Doctors" Honorary Member, Canadian Society for Vascular Surgery Honorary Member, Southern Association for Vascular Surgery Julius H. Jacobson Physician Excellence Award, Vascular Disease Foundation C. Selected peer-reviewed publications (from a total of 180): Most Relevant to Current Proposal 1. Cronenwett JL, Birkmeyer JD, Nackman GB, Fillinger MF, Bech FR, Zwolak RM, Walsh DB. Costeffectiveness of carotid endarterectomy in asymptomatic patients. J Vasc Surg 1997;25:298-309; discussion 10-1, 9052564. 2. Cronenwett JL, Likosky DS, Russell MT, Eldrup-Jorgensen J, Stanley AC, Nolan BW. A regional registry for quality assurance and improvement: the Vascular Study Group of Northern New England (VSGNNE). J Vasc Surg 2007;46:1093-101; discussion 101-2, 17950568. 3. Goodney PP, Likosky DS, Cronenwett JL. Factors associated with stroke or death after carotid endarterectomy in Northern New England. J Vasc Surg 2008;48:1139-45, 18586446. 4. Beck AW, Goodney PP, Nolan BW, Likosky DS, Eldrup-Jorgensen J, Cronenwett JL. Predicting 1-year mortality after elective abdominal aortic aneurysm repair. J Vasc Surg 2009;49:838-43; discussion 43-4, 19341875. 5. Stone DH, Nolan BW, Schanzer A, Goodney PP, Cambria RA, Likosky DS, Walsh DB, Cronenwett JL. Protamine reduces bleeding complications associated with carotid endarterectomy without increasing the risk of stroke. J Vasc Surg 2010;51:559-64, 64 e1, 20045609. 6. Goodney PP, Travis LL, Malenka D, Bronner KK, Lucas FL, Cronenwett JL, Goodman DC, Fisher ES. Regional variation in carotid artery stenting and endarterectomy in the Medicare population. Circ Cardiovasc Qual Outcomes 2010;3:15-24, 20123667. 7. Goodney PP, Nolan BW, Eldrup-Jorgensen J, Likosky DS, Cronenwett JL. Restenosis after carotid endarterectomy in a multicenter regional registry. J Vasc Surg 2010;52:897-904, 5 e1-2; discussion -5, 20620001. 8. Wallaert JB, Goodney PP, Vignati JJ, Stone DH, Nolan BW, Bertges DJ, Walsh DB, Cronenwett JL. Completion imaging after carotid endarterectomy in the Vascular Study Group of New England. J Vasc Surg 2011;54:376-85, 85 e1-3, 21458209. Additional Publications of Importance (in chronological order) 9. Cronenwett JL, Johnston W. Rutherford’s Vascular Surgery. 7th ed: Saunders; 2010. 10. Schanzer A, Goodney PP, Li Y, Eslami M, Cronenwett J, Messina L, Conte MS. Validation of the PIII CLI risk score for the prediction of amputation-free survival in patients undergoing infrainguinal autogenous vein bypass for critical limb ischemia. J Vasc Surg 2009;50:769-75; discussion 75, 19628361. 11. Goodney PP, Likosky DS, Cronenwett JL. Predicting ambulation status one year after lower extremity bypass. J Vasc Surg 2009;49:1431-9 e1, 19497502. 12. Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Bertges DJ, Stanley AC, Stone DH, Walsh DB, Powell RJ, Likosky DS, Cronenwett JL. Factors associated with amputation or graft occlusion one year after lower extremity bypass in northern New England. Ann Vasc Surg 2010;24:57-68, 19748222. 13. Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Stanley AC, Stone DH, Likosky DS, Cronenwett JL. Factors associated with death 1 year after lower extremity bypass in Northern New England. J Vasc Surg 2010;51:71-8, 19939615. 14. Bertges DJ, Goodney PP, Zhao Y, Schanzer A, Nolan BW, Likosky DS, Eldrup-Jorgensen J, Cronenwett JL. The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) predicts cardiac complications more accurately than the Revised Cardiac Risk Index in vascular surgery patients. J Vasc Surg 2010;52:674-83, 83 e1-83 e3, 20570467. 15. Goodney PP, Eldrup-Jorgensen J, Nolan BW, Bertges DJ, Likosky DS, Cronenwett JL. A regional quality improvement effort to increase beta blocker administration before vascular surgery. J Vasc Surg 2011;53:1316-28 e1; discussion 27-8, 21334166. D. Research Support: Ongoing Research Support: Vascular Study Group of New England Cronenwett (PI) 2009 This is an ongoing quality improvement project funded by a consortium of 28 hospitals in New England to generate benchmarked, risk-adjusted outcomes reports, with derivative quality research designed to improve clinical care. Completed Research Support Centers for Medicare and Medicaid Cronenwett (PI) 2001 - 2009 "Northern New England Vascular Surgery Quality Improvement Initiative" This is a regional quality improvement initiative comprised of 13 hospitals in 3 states collecting data about vascular surgery procedures in order to identify process induced variation and improve outcomes. I am the PI of this project. Centers for Medicare and Medicaid Cronenwett (PI) “Aortic Aneurysm Screening in Medicare Beneficiaries” 2001- 2003 This was a study to determine the prevalence of AAAs in Medicare patients in 3 sites to calculate the costeffectiveness of screening in the general population. I was the PI in this multicenter study. Society for Vascular Surgery Cronenwett (PI) 1998 - 2000 "Dartmouth Atlas of Vascular Healthcare" This was a study of all vascular surgical procedures performed in the US based on small area analysis to identify variation in provider type, rates of intervention, and variation in outcome by hospital referral region. I was the PI. National Institutes of Health, NHLBI (R01-HL35102) Cronenwett (PI) "Pharmacologic modification of vascular graft patency." This was one of multiple basic research studies performed in my early career. 1985 - 1988 BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES. NAME POSITION TITLE Yuanyuan Zhao Statistical Research Analyst Section of Vascular Surgery Dartmouth-Hitchcock Medical Center eRA COMMONS USER NAME (credential, e.g., agency login) EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.) DEGREE INSTITUTION AND LOCATION MM/YY FIELD OF STUDY (if applicable) A. Eastern Michigan University, Ypsilanti, MI MA 09/04-12/06 Tianjin Institute of Technology, Tianjin, China BE 09/93-07/97 Math Department, Applied Statistics Telecommunications Engineering Personal Statement I am a Statistical Research Analyst at Section of Vascular Surgery, DHMC. I have a strong background in statistical theory and excellent experiences in medical data analysis. As a Statistical Research Analyst at Section of Vascular Surgery, I conduct statistical analysis in clinical research in Section of Vascular Surgery and Vascular Study Group of New England (VSGNE); assist data cleaning and management; coauthor research paper published and abstracts presented in academic conferences; review manuscript and abstracts before submission. I have rich experiences in multivariate linear regression analysis, categorical data analysis, survival analysis and longitudinal data analysis in medical and health science and programming in SAS 9.2. In the past I have demonstrated the ability to collaborate with colleagues in all kinds of projects. My expertise and experience have prepared me to participating in this proposed project. B. Positions and Honors Positions and Employment 01/2009-present Statistical Research Analyst Section of Vascular Surgery, Dartmouth- Hitchcock Medical Center, NH 07/2006-08/2006 Statistical Data Analyst Tobacco Research Center, University of Minnesota, Minneapolis, MN 01/2005-12/2006 Computing Consultant and Graduate Assistant Eastern Michigan University, Ypsilanti, MI 04/1998-07/2001 Senior Electrical Engineer Personal Communication Sector (PCS), Motorola (China) Electronics Ltd., Tianjin, China 07/1997-04/1998 Electrical Engineer Samsung Optical Electronics Ltd., Tianjin, China Honors 2005-2006 Outstanding Graduate Assistant, Eastern Michigan University, MI 1999-2001 Excellent Performance Award, Motorola (China) Electronics Ltd. 1993-1994 Distinguished Student Fellowship, Tianjin Institute of Technology, China C. Selected Peer-reviewed Publications 1. The Vascular Study Group of New England Cardiac Risk Index (VSG-CRI) Predicts Cardiac Complications More Accurately Than the Revised Cardiac Risk Index in Vascular Surgery Patients, Daniel J. Bertges, Philip P. Goodney, Yuanyuan Zhao, Andres Schanzer, Brian W. Nolan, Donald S. Likosky, Jens Eldrup-Jorgensen, Jack L. Cronenwett, Journal of Vascular Surgery, 2010 Sep; 52(3):674-83 2. Variation in smoking cessation after vascular operations, Andrew W. Hoel, Brian W. Nolan, Philip P. Goodney, Yuanyuan Zhao, Andres Schanzer, Andrew C. Stanley, Jens Eldrup-Jorgensen, Jack L. Cronenwett, Vascular Study Group of New England, Journal of Vascular Surgery, 2013 Jan 30