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Risks, Outcomes, and Costs in Neurosurgery – the New RISKS, OUTCOMES, AND COSTS IN NEUROSURGERY – THE NEW FRONTIER IN HEALTH SERVICES RESEARCH by ANDREEA SEICEAN MPH Submitted in partial fulfillment of the requirements For the degree of Doctor of Philosophy Dissertation Adviser: Dr. Duncan Neuhauser Department of Epidemiology and Biostatistics CASE WESTERN RESERVE UNIVERSITY May, 2013 CASE WESTERN RESERVE UNIVERSITY SCHOOL OF GRADUATE STUDIES We hereby approve the thesis/dissertation of Andreea Ana-Maria Seicean candidate for the Doctor of Philosophy degree *. Duncan Neuhauser PhD (chair of the committee) Paul K. Jones PhD Michael W. Kattan PhD Robert J. Weil MD MBA (date) February 12, 2013 *We also certify that written approval has been obtained for any proprietary material contained therein. 1 Dedication This work is dedicated to my wonderful uncle, George Manole, and my loving grandfather, Nicolae Seicean, who made my childhood magical. Both passed away from brain tumors. 2 Table of Contents List of Tables 5 Acknowledgements 7 Abstract 9 Chapter 1: Introduction 11 Chapter 2: Use and Utility of Preoperative Hemostatic Screening and Patient History in Adult Neurosurgical Patients 22 Chapter 3: Short Term Outcomes of Craniotomy for Malignant Brain Tumors in the Elderly 51 Chapter 4: Effect of Smoking on the Perioperative Outcomes of Patients who Undergo Elective Spine Surgery 71 Chapter 5: Pre-operative Anemia and Peri-operative Outcomes in Patients who Undergo Elective Spine Surgery 93 Chapter 6: Conclusion 119 Appendix 123 Bibliography 135 3 List of Tables: Chapter 2 Tables: Table 1: Summary of characteristics, history variables, and outcomes of interest for all 11,804 neurosurgery patients in the 2006–2009 NSQIP database 43 Table 2: Outcomes stratified by INR values, aPTT values, and platelet count in the 11,804 neurosurgery patients screened 45 Table 3: Outcome odds ratios by number of abnormal hemostasis test results in 6,787 neurosurgery patients who underwent all 3 hemostasis tests 46 Table 4: Outcome odds ratios by patient history indicative of potentially abnormal hemostasis in all 11,804 neurosurgery patients 47 Table 5: Abnormal screening test odds ratios by patient history indicative of potentially abnormal hemostasis in neurosurgery patients screened with all 3 hemostatic tests 48 Table 6: Predictive value of patient history indicating potentially abnormal coagulation, abnormal hemostatic test results, both, or neither in 6,787 patients screened with all 3 hemostatic tests 49 Table 7: Cost and rate of preoperative hemostasis screening in 11,804 neurosurgery patients between 2006 and 2009 50 Chapter 3 Tables Table 1: P Values for covariate balance between age groups, before and after stratification on propensity score 67 Table 2: 30-Day post-operative outcomes, stratified by age groups 69 4 Table 3: Age group comparisons for adverse outcomes using different analysis methods 70 Chapter 4 Tables Table 1: Patient demographics, comorbidities, preoperative lab values, and intraoperative factors by smoking status 88 Table 2: 30-day post-operative outcomes, stratified by smoking status 89 Table 3: Pre- and intraoperative factors by smoking status after stratification on propensity score and age 90 Table 4: Smoking status comparisons for adverse outcomes using different analysis methods 92 Chapter 5 Tables Table 1: Patient demographics, comorbidities, preoperative lab values, and intraoperative factors by anemia status 109 Table 2: 30-day post-operative outcomes, stratified by anemia status 111 Tables 3: Pre- and intraoperative factors by anemia status after stratification on propensity score 112 Table 4: Anemia status comparisons for adverse outcomes using different analysis methods 115 Table 5: Cost of excess length of hospitalization attributed to preoperative anemia in elective spine surgery patients in the USA per year, assuming our sample is representative of the 644,721 elective spine surgery cases done in the USA per year and that the average cost per day in the USA is $3,949 118 5 Appendix: Supplementary Chapter 4 Tables Table 1: P Values for pack-years by smoking status at baseline 128 Table 2: Pack-years comparison for adverse outcomes using logistic regression at baseline prior to stratification on propensity scores 129 Table 3A: Pack-years comparison for adverse outcomes after stratification on propensity score and age in current and never smokers 130 Table 3B: Pack-years comparison for adverse outcomes after stratification on propensity score and age in prior and never smokers 131 Appendix: Supplementary Chapter 5 Tables Table 1: Anemia status comparisons for total length of hospital stay after matching on propensity scores 134 6 Acknowledgement: We are very grateful for the funding opportunities that were utilized by each author during the course of working on this dissertation. Andreea Seicean: Agency for Healthcare Research and Quality (AHRQ) institutional training grant T32—HS00059-14 and the U.S. Department of Defense Breast Cancer Research Program grant W81XWH-062-0033. Robert Weil: Melvin Burkhardt chair in neurosurgical oncology and the Karen Colina Wilson research endowment within the Brain Tumor and Neuro-oncology Center at the Cleveland Clinic Foundation (RJW). None of the authors have any conflict of interest. I would like to thank the following people for their mentorship, help, and support over the years: • My wonderful committee members: Drs. Duncan Neuahuser PhD, Paul K. Jones PhD, Michael W. Kattan PhD, and Robert J. Weil MD MBA • My mother and lifelong mentor, Dr. Sinziana Seicean MD MPH PhD • Nicholas K. Schiltz • Nima Alan • Dr. Benjamin P. Rosenbaum MD • Dr. Susan Redline MD MPH 7 • Dr. Kathleen Smyth PhD • Dr. Alfred Rimm PhD • Dr. Ralph O'Brien PhD • Dr. Robert Elston PhD • Dr. Siran Koroukian PhD • Epi/Biostats department staff: Cynthia Moore, Joan Langan, Victor Courtney, Alberto H. Santana • Allan Chiunda MD MPH PhD • My family and friends 8 Risk, Outcomes, and Costs in Neurosurgery – The New Frontier in Health Services Research Abstract By ANDREEA SEICEAN Introduction: Health services research driven from within neurosurgery can be used to improve access to and quality of care, while helping to control costs. Aim: To answer clinically relevant questions that make a difference in patient care. Methods: We chose to use the American College of Surgeons National Safety and Quality Improvement Project as the database for all components of this dissertation, which contains prospective, blinded, multi-institutional information about patients undergoing surgery. Results: Hemostasis history was as predictive as laboratory testing for all outcomes, with higher sensitivity. Advanced age does not increase the risk of poor outcomes after surgical resection of primary or metastatic intracranial tumors, after controlling for other risk factors. We not find smoking to be associated with early (30-day) peri-operative morbidity or mortality. All levels of anemia were significantly associated with prolonged length of hospitalization and poorer operative or 30-day outcomes in patients undergoing elective spine surgery. Conclusions: Routine hemostatic laboratory screening appears to have limited utility. Testing limited to neurosurgical patients with a positive history would save an estimated $81,942,000 annually. Age should not be used, in isolation, as an a priori factor to 9 discourage pursuing craniotomy. Smoking cessation can be considered prior to spine surgery for reasons other then early (30-day) peri-operative morbidity or mortality. Anemia should be regarded as an independent risk factor for peri-operative and post- operative complications that deserves attention prior to elective spine surgery. 10 Chapter 1: Introduction Health services research (HSR) examines how people get access to health care, how much care costs, and what happens to patients as a result of this care. The main goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care; reduce medical errors; and improve patient safety. - Agency for Healthcare Research and Quality, June 2000 The field of HSR was officially recognized in 1966, through the establishment of a section of the United States federal government for the review of HSR grants proposals1. Over the past 60 years, the vast majority of HSR has been focused on primary care. It is only recently that interest has expanded to pursue HSR in surgical specialties. Surgical subspecialties provide specialized care at high cost, with limited evidence-based practice. HSR research driven from within each specialty can be used to improve access to and quality of care, while helping to control costs. The application of HSR to neurosurgery is in its infancy. Over 2 million neurosurgical procedures are done in the United States each year2 by approximately 3,500 practicing neurosurgeons3. Continued trends toward an aging population, combined with the increased incidence in tumors of all kinds with advancing age, suggest that the patient volume for neurosurgery may increase. The goal of this dissertation was to answer clinically relevant questions that make a difference in patient care. The first step in achieving our goal was to identify an appropriate data source that could be used to conduct health services research in surgery. The number of national or 11 multicenter databases that contain information of surgical procedures and outcomes is quite limited. Administrative datasets that rely of billing data, such as Medicare and Medicaid, lack of preoperative
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