Bio


Dr. Schulman was appointed as Professor of Medicine, Associate Chair of Business Development and Strategy in the Department of Medicine, Director of Industry Partnerships and Education for the Clinical Excellence Research Center (CERC) at the Stanford University School of Medicine, and, by courtesy, Professor of Economics at Stanford’s Graduate School of Business in June, 2018.

Dr. Schulman’s research interests include organizational innovation in health care, health care policy and health economics. With 300 original articles, 80 review articles/commentaries, and 40 case studies/book chapters, Kevin Schulman has had a broad impact on health policy (h-index = 61). His peer-reviewed articles have appeared in the New England Journal of Medicine, JAMA, and Annals of Internal Medicine. He is a member of the editorial/advisory boards of the American Heart Journal, Health Policy, Management and Innovation (www.HMPI.Org), and Senior Associate Editor of Health Services Research.

At Duke’s Fuqua School of Business, Dr. Schulman oversaw the growth of the health sector management program, graduating almost 1500 students. He is the Founding Director of the unique Master of Management in Clinical Informatics program (MMCi), originally offered through the Fuqua School of Business and now housed in the Duke University School of Medicine. He has served as a Visiting Professor in General Management at Harvard Business School from 2013-2016, and a visiting scholar from 2016-2018.

He is the Founding President of the Business School Alliance for Health Management (http://www.BAHM-Alliance.Org), which is a consortium of the leading business schools offering health management programs.

He is an elected member of ASCI and AAP.

Clinical Focus


  • Internal Medicine

Academic Appointments


  • Professor, Medicine
  • Professor (By courtesy), Economics

Professional Education


  • Board Certification: Internal Medicine, American Board of Internal Medicine (1991)
  • Residency:Hospital of the University of Pennsylvania Dept of Internal Medicine (1991) PA
  • Medical Education:New York University School of Medicine (1988) NY

All Publications


  • Toward an Effective Innovation Agenda. The New England journal of medicine Schulman, K. A., Richman, B. D. 2019

    View details for PubMedID 30673357

  • Evaluating the quality of antihypertensive drugs in Lagos State, Nigeria. PloS one Ndichu, E. T., Ohiri, K., Sekoni, O., Makinde, O., Schulman, K. 2019; 14 (2): e0211567

    Abstract

    BACKGROUND: As the burden of noncommunicable diseases grows, access to safe medical therapy is increasing in importance. The aim of this study was to develop a method for evaluating the quality of antihypertensive drugs and to examine whether this prevalence varies by socioeconomic variables.METHODS: We conducted a cross-sectional survey of registered pharmacies in 6 local government areas (LGAs) in Lagos State, Nigeria. In each LGA, we sampled 17 pharmacies from a list of all registered pharmacies derived from the Pharmacists Council of Nigeria. We assessed drug quality based on (1) the level of active pharmaceutical ingredients (APIs), which identified falsely labeled drug samples; and (2) the amount of impurities, which revealed substandard drug samples in accordance with the international pharmacopoeia guidelines. Good-quality drugs met specifications for both API and impurity.RESULTS: Of the 102 drug samples collected, 30 (29.3%) were falsely labeled, 76 (74.5%) were substandard,78 (76.5%) were of poor quality and 24 (23.5%) were of good quality.Among the falsely labeled drugs, 2 samples met standards set for purity while 28 did not. Among the 76 substandard drug samples, 28 were also falsely labeled. Of the falsely labeled drugs, 17 (56.7%) came from LGAs with low socioeconomic status, and 40 (52.6%) of the substandard drug samples came from LGAs with high socioeconomic status. Most of the good-quality drug samples, 14 (58.3%), were from LGAs with low socioeconomic status. Eighteen (60%) of the falsely labeled samples, 37 (48.7%) of the substandard samples, and 15 (62.5%) of the good-quality drug samples were from manufacturers based in Asia. The average price was 375.67 Nigerian naira (NGN) for falsely labeled drugs, 383.33 NGN for substandard drugs, and 375.67 NGN for good-quality drugs. The prevalence of falsely labeled and substandard drug samples did not differ by LGA-level socioeconomic status (P = .39) or region of manufacturer (P = .24); however, there was a trend for a difference by price (P = .06).CONCLUSION: The prevalence of falsely labeled and substandard drug samples was high in Lagos. Treatment of noncommunicable diseases in this setting will require efforts to monitor and assure drug quality.

    View details for PubMedID 30759124

  • The relationship between pharmacy benefit managers (PBMs) and the cost of therapies in the US pharmaceutical market: A policy primer for clinicians. American heart journal Schulman, K. A., Dabora, M. 2018; 206: 113–22

    Abstract

    Pharmaceutical benefit managers (PBMs) are playing an increasingly important role in establishing access to pharmaceutical products for patients. PBMs set retail prices for pharmaceutical products, negotiate "rebates" from manufacturers based on total sales volume of products, and achieve several types of postsale price concessions and payments from pharmacies. All of these activities describe a complex flow of funds that has not been transparent to clinicians or to patients. In this article, we describe these terms and processes to better understand how pharmaceutical products are financed in the United States. In 2016, US pharmaceutical manufacturers reported gross pharmaceutical sales of $462 billion and net pharmaceutical sales of $318 billion. The difference between gross and net sales is largely due to the different "payments" from manufacturers to PBMs and other intermediaries in the marketplace. We examine the flow of funds through the US pharmaceutical distribution system over time using data from the annual reports of 13 major pharmaceutical manufacturers for the period 2011-2016. Overall, we find that net revenues for our sample of firms grew by an average of 2.7% annually between 2011 and 2016, whereas rebates and other payments increased by 15% annually over the same period. Our examination of the pharmaceutical market reveals the enormous scale of payments from pharmaceutical manufacturers to intermediaries. We observed that these payments have been growing disproportionally to manufacturer net income over the past 5 years. We also found a lack of transparency regarding the flow of funds through intermediaries. This entire marketplace is now the subject of intense public debate.

    View details for PubMedID 30447542

  • The Evolving Pharmaceutical Benefits Market. JAMA Schulman, K. A., Richman, B. D. 2018; 319 (22): 2269–70

    View details for PubMedID 29625496

  • Administrative Costs Associated With Physician Billing and Insurance-Related Activities at an Academic Health Care System JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Tseng, P., Kaplan, R. S., Richman, B. D., Shah, M. A., Schulman, K. A. 2018; 319 (7): 691–97

    Abstract

    Administrative costs in the US health care system are an important component of total health care spending, and a substantial proportion of these costs are attributable to billing and insurance-related activities.To examine and estimate the administrative costs associated with physician billing activities in a large academic health care system with a certified electronic health record system.This study used time-driven activity-based costing. Interviews were conducted with 27 health system administrators and 34 physicians in 2016 and 2017 to construct a process map charting the path of an insurance claim through the revenue cycle management process. These data were used to calculate the cost for each major billing and insurance-related activity and were aggregated to estimate the health system's total cost of processing an insurance claim.Estimated time required to perform billing and insurance-related activities, based on interviews with management personnel and physicians.Estimated billing and insurance-related costs for 5 types of patient encounters: primary care visits, discharged emergency department visits, general medicine inpatient stays, ambulatory surgical procedures, and inpatient surgical procedures.Estimated processing time and total costs for billing and insurance-related activities were 13 minutes and $20.49 for a primary care visit, 32 minutes and $61.54 for a discharged emergency department visit, 73 minutes and $124.26 for a general inpatient stay, 75 minutes and $170.40 for an ambulatory surgical procedure, and 100 minutes and $215.10 for an inpatient surgical procedure. Of these totals, time and costs for activities carried out by physicians were estimated at a median of 3 minutes or $6.36 for a primary care visit, 3 minutes or $10.97 for an emergency department visit, 5 minutes or $13.29 for a general inpatient stay, 15 minutes or $51.20 for an ambulatory surgical procedure, and 15 minutes or $51.20 for an inpatient surgical procedure. Of professional revenue, professional billing costs were estimated to represent 14.5% for primary care visits, 25.2% for emergency department visits, 8.0% for general medicine inpatient stays, 13.4% for ambulatory surgical procedures, and 3.1% for inpatient surgical procedures.In a time-driven activity-based costing study in a large academic health care system with a certified electronic health record system, the estimated costs of billing and insurance-related activities ranged from $20 for a primary care visit to $215 for an inpatient surgical procedure. Knowledge of how specific billing and insurance-related activities contribute to administrative costs may help inform policy solutions to reduce these expenses.

    View details for PubMedID 29466590

    View details for PubMedCentralID PMC5839285

  • Understanding Frequent Emergency Department Use Among Primary Care Patients POPULATION HEALTH MANAGEMENT Hardy, M., Cho, A., Stavig, A., Bratcher, M., Dillard, J., Greenblatt, L., Schulman, K. 2018; 21 (1): 24–31

    Abstract

    Patients with high emergency department (ED) utilization are an important focus in population health management. This retrospective cohort study analyzed patterns of frequent ED use for 4087 patients enrolled at an academically-affiliated primary care clinic. For all ED visits (n = 4776), the chief complaints, admission rates, number of complaints per patient, and median time between return visits were assessed. Chart reviews were conducted for the 10 highest utilizers from each of the 3 leading complaints to help explain repeated ED use for the same complaints. Results showed that chief complaints for high utilizers were statistically similar to other patients. Nearly half (49.8%) of all ED visits among high utilizers were repeat visits for the same complaint. However, most high utilizers (85%) had 4 or more separate complaints. Their visits clustered temporally, with 55% occurring less than 30 days apart. Visits for psychiatric symptoms demonstrated the shortest time to repeat visit (median 17.5 days, interquartile range: 39.5). Abdominal pain, chest pain, and shortness of breath were the leading complaints and the leading sources of hospital admissions and repeat visits. Chart review revealed that these 3 chief complaints often were associated with a wide range of ongoing chronic conditions, confounded by substance abuse, anxiety, and treatment nonadherence. This study demonstrates an integrative method for examining patterns of ED use among high utilizers. It also highlights the complex nature of high utilization and the inherent difficulty in predicting and addressing the needs of high-utilizer patients.

    View details for PubMedID 28609191

  • Modeling the Potential Economic Impact of the Medicare Comprehensive Care for Joint Replacement Episode-Based Payment Model JOURNAL OF ARTHROPLASTY Maniya, O. Z., Mather, R. C., Attarian, D. E., Mistry, B., Chopra, A., Strickland, M., Schulman, K. A. 2017; 32 (11): 3268-+

    Abstract

    The Medicare program has initiated Comprehensive Care for Joint Replacement (CJR), a bundled payment mandate for lower extremity joint replacements. We sought to determine the degree to which hospitals will invest in care redesign in response to CJR, and to project its economic impacts.We defined 4 potential hospital management strategies to address CJR: no action, light care management, heavy care management, and heavy care management with contracting. For each of 798 hospitals included in CJR, we used hospital-specific volume, cost, and quality data to determine the hospital's economically dominant strategy. We aggregated data to assess the percentage of hospitals pursuing each strategy; savings to the health care system; and costs and percentages of CJR-derived revenues gained or lost for Medicare, hospitals, and postacute care facilities.In the model, 83.1% of hospitals (range 55.0%-100.0%) were expected to take no action in response to CJR, and 16.1% of hospitals (range 0.0%-45.0%) were expected to pursue heavy care management with contracting. Overall, CJR is projected to reduce health care expenditures by 0.5% (range 0.0%-4.1%) or $14 million (range $0-$119 million). Medicare is expected to save 2.2% (range 2.2%-2.2%), hospitals are projected to lose 3.7% (range 4.7% loss to 3.8% gain), and postacute care facilities are expected to lose 6.5% (range 0.0%-12.8%). Hospital administrative costs are projected to increase by $63 million (range $0-$148 million).CJR is projected to have a negligible impact on total health care expenditures for lower extremity joint replacements. Further research will be required to assess the actual care management strategies adopted by CJR hospitals.

    View details for PubMedID 28669568

  • Trends in Hospital-Physician Integration in Medical Oncology AMERICAN JOURNAL OF MANAGED CARE Clough, J. D., Dinan, M. A., Schulman, K. A. 2017; 23 (10): 624–27

    Abstract

    Hospitals have rapidly acquired medical oncology practices in recent years. Experts disagree as to whether these trends are related to oncology-specific market factors or reflect a general trend of hospital-physician integration. The objective of this study was to compare the prevalence, geographic variation, and trends in physicians billing from hospital outpatient departments in medical oncology with other specialties.Retrospective analysis of Medicare claims data for 2012 and 2013.We calculated the proportion of physicians and practitioners in the 15 highest-volume specialties who billed the majority of evaluation and management visits from hospital outpatient departments in each year, nationally and by state.We included 338,998 and 352,321 providers in 2012 and 2013, respectively, of whom 9715 and 9969 were medical oncologists. Among the 15 specialties examined, medical oncology had the highest proportion of hospital outpatient department billing in 2012 and 2013 (35.0% and 38.3%, respectively). Medical oncology also experienced the greatest absolute change (3.3%) between the years, followed by thoracic surgery (2.4%) and cardiology (2.0%). There was marked state-level variation, with the proportion of medical oncologists based in hospital outpatient departments ranging from 0% in Nevada to 100% in Idaho.Hospital-physician integration has been more pronounced in medical oncology than in other high-volume specialties and is increasing at a faster rate. Policy makers should take these findings into consideration, particularly with respect to recent proposals that may continue to fuel these trends.

    View details for Web of Science ID 000413945000010

    View details for PubMedID 29087634

  • PCSK9 Inhibitors and the Choice Between Innovation, Efficiency, and Affordability JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mark, D. B., Schulman, K. A. 2017; 318 (8): 711–12

    View details for PubMedID 28829851

  • Financing and Distribution of Pharmaceuticals in the United States JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dabora, M. C., Turaga, N., Schulman, K. 2017; 318 (1): 21–22

    View details for PubMedID 28505252

  • The economics of PCSK-9 inhibitors. American heart journal Schulman, K. A., Reed, S. D. 2017; 189: 200–201

    View details for PubMedID 28625378

  • Battling the Chargemaster: A Simple Remedy to Balance Billing for Unavoidable Out-of-Network Care AMERICAN JOURNAL OF MANAGED CARE Richman, B. D., Kitzman, N., Milstein, A., Schulman, K. A. 2017; 23 (4): E100-+

    Abstract

    To develop an effective legal mechanism to combat chargemaster abuses and to facilitate price transparency.Applying legal doctrines to out-of-network (OON) billing disputes.We reviewed rudimentary contract law and examined the law's handling of contracts where prices have not been specified in advance. These cases are the controlling authority to guide courts, handling of surprise and OON billing problems. We then compared legal remedies that correct OON billing abuses to prevailing legislative and regulatory approaches.Our analysis suggests that providers have no legal authority to collect chargemaster rates from surprise and OON billing abuses. A proper application of contract law can end such abuses and would facilitate superior pricing incentives to other strategies designed to end balance billing disputes.Chargemaster rates on uninsured and OON patients impose significant financial burdens on the vulnerable, distort medical prices, and inflate healthcare costs. Applying rudimentary contract law to these practices offers a solution that is simpler and more effective than other administrative and legislative schemes recently adopted in several states. It will prevent providers from hiding behind a convoluted hospital pricing system, encourage the development of attractive narrow-network insurance products, and shield urgently sick individuals from the dread of medical predation. Patients and payers should know that they are under no obligation to pay surprise bills containing chargemaster rates, and state attorneys general can use the law to prevent providers from pursuing chargemaster-related collection efforts against patients.

    View details for PubMedID 28554214

  • Barriers to Achieving Economies of Scale in Analysis of EHR Data A Cautionary Tale APPLIED CLINICAL INFORMATICS Sendak, M. P., Balu, S., Schulman, K. A. 2017; 8 (3): 826–31

    Abstract

    Signed in 2009, the Health Information Technology for Economic and Clinical Health Act infused $28 billion of federal funds to accelerate adoption of electronic health records (EHRs). Yet, EHRs have produced mixed results and have even raised concern that the current technology ecosystem stifles innovation. We describe the development process and report initial outcomes of a chronic kidney disease analytics application that identifies high-risk patients for nephrology referral. The cost to validate and integrate the analytics application into clinical workflow was $217,138. Despite the success of the program, redundant development and validation efforts will require $38.8 million to scale the application across all multihospital systems in the nation. We address the shortcomings of current technology investments and distill insights from the technology industry. To yield a return on technology investments, we propose policy changes that address the underlying issues now being imposed on the system by an ineffective technology business model.

    View details for DOI 10.4338/ACI-2017-03-CR-0046

    View details for Web of Science ID 000413010400005

    View details for PubMedID 28837212

  • Extreme Home Makeover - The Role of Intensive Home Health Care NEW ENGLAND JOURNAL OF MEDICINE Ticona, L., Schulman, K. A. 2016; 375 (18): 1707–9

    View details for PubMedID 27806216

  • A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department. Journal of patient safety Glickman, S. W., Mehrotra, A., Shea, C. M., Mayer, C., Strickler, J., Pabers, S., Larson, J., Goldstein, B., Mandelkehr, L., Cairns, C. B., Pines, J. M., Schulman, K. A. 2016

    Abstract

    OBJECTIVE: Medical errors in the emergency department (ED) occur frequently. Yet, common adverse event detection methods, such as voluntary reporting, miss 90% of adverse events. Our objective was to demonstrate the use of patient-reported data in the ED to assess patient safety, including medical errors.METHODS: Analysis of patient-reported survey data collected over a 1-year period in a large, academic emergency department. All patients who provided a valid e-mail or cell phone number received a brief electronic survey within 24 hours of their ED encounter by e-mail or text message with Web link. Patients were asked about ED safety-related processes.RESULTS: From Aug 2012 to July 2013, we sent 52,693 surveys and received 7103 responses (e-mail response rate 25.8%), including 2836 free-text comments (44% of respondents). Approximately 242 (8.5%) of 2836 comments were classified as potential safety issues, including 12 adverse events, 40 near-misses, 23 errors with minimal risk of harm, and 167 general safety issues (eg, gaps in care transitions). Of the 40 near misses, 35 (75.0%) of 40 were preventable. Of the 52 adverse events or near misses, 5 (9.6%) were also identified via an existing patient occurrence reporting system.CONCLUSIONS: A patient-reported approach to assess ED-patient safety yields important, complementary, and potentially actionable safety information.

    View details for PubMedID 27811598

  • Reassessing ACOs and Health Care Reform JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Schulman, K. A., Richman, B. D. 2016; 316 (7): 707–8

    View details for PubMedID 27533151

  • Patient Preferences for Features of Health Care Delivery Systems: A Discrete Choice Experiment HEALTH SERVICES RESEARCH Muehlbacher, A. C., Bethge, S., Reed, S. D., Schulman, K. A. 2016; 51 (2): 704–27

    Abstract

    To estimate the relative importance of organizational-, procedural-, and interpersonal-level features of health care delivery systems from the patient perspective.We designed four discrete choice experiments (DCEs) to measure patient preferences for 21 health system attributes. Participants were recruited through the online patient portal of a large health system. We analyzed the DCE data using random effects logit models.DCEs were performed in which respondents were provided with descriptions of alternative scenarios and asked to indicate which scenario they prefer. Respondents were randomly assigned to one of the three possible health scenarios (current health, new lung cancer diagnosis, or diabetes) and asked to complete 15 choice tasks. Each choice task included an annual out-of-pocket cost attribute.A total of 3,900 respondents completed the survey. The out-of-pocket cost attribute was considered the most important across the four different DCEs. Following the cost attribute, trust and respect, multidisciplinary care, and shared decision making were judged as most important. The relative importance of out-of-pocket cost was consistently lower in the hypothetical context of a new lung cancer diagnosis compared with diabetes or the patient's current health.This study demonstrates the complexity of patient decision making processes regarding features of health care delivery systems. Our findings suggest the importance of these features may change as a function of an individual's medical conditions.

    View details for PubMedID 26255998

    View details for PubMedCentralID PMC4799904

  • Health Care Tax Inversions - Robbing Both Peter and Paul NEW ENGLAND JOURNAL OF MEDICINE Warraich, H., Schulman, K. A. 2016; 374 (11): 1005–7

    View details for PubMedID 26981932

  • Options to Promote Competitive Generics Markets in the United States JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Wiske, C. P., Ogbechie, O. A., Schulman, K. A. 2015; 314 (20): 2129–30

    View details for PubMedID 26513309

  • Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model: A Web-based program designed to evaluate the cost-effectiveness of disease management programs in heart failure AMERICAN HEART JOURNAL Reed, S. D., Neilson, M. P., Gardner, M., Li, Y., Briggs, A. H., Polsky, D. E., Graham, F. L., Bowers, M. T., Paul, S. C., Granger, B. B., Schulman, K. A., Whellan, D. J., Riegel, B., Levy, W. C. 2015; 170 (5): 951–60

    Abstract

    Heart failure disease management programs can influence medical resource use and quality-adjusted survival. Because projecting long-term costs and survival is challenging, a consistent and valid approach to extrapolating short-term outcomes would be valuable.We developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, a Web-based simulation tool designed to integrate data on demographic, clinical, and laboratory characteristics; use of evidence-based medications; and costs to generate predicted outcomes. Survival projections are based on a modified Seattle Heart Failure Model. Projections of resource use and quality of life are modeled using relationships with time-varying Seattle Heart Failure Model scores. The model can be used to evaluate parallel-group and single-cohort study designs and hypothetical programs. Simulations consist of 10,000 pairs of virtual cohorts used to generate estimates of resource use, costs, survival, and incremental cost-effectiveness ratios from user inputs.The model demonstrated acceptable internal and external validity in replicating resource use, costs, and survival estimates from 3 clinical trials. Simulations to evaluate the cost-effectiveness of heart failure disease management programs across 3 scenarios demonstrate how the model can be used to design a program in which short-term improvements in functioning and use of evidence-based treatments are sufficient to demonstrate good long-term value to the health care system.The Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model provides researchers and providers with a tool for conducting long-term cost-effectiveness analyses of disease management programs in heart failure.

    View details for PubMedID 26542504

    View details for PubMedCentralID PMC4638158

  • Specialty Pharmaceuticals for Hyperlipidemia - Impact on Insurance Premiums NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Balu, S., Reed, S. D. 2015; 373 (17): 1591–93

    View details for PubMedID 26444460

  • Organizational Characteristics and Patient Experiences With Hospital Care: A Survey Study of Hospital Chief Patient Experience Officers AMERICAN JOURNAL OF MEDICAL QUALITY Manary, M., Staelin, R., Kosel, K., Schulman, K. A., Glickman, S. W. 2015; 30 (5): 432–40

    Abstract

    Beginning in fiscal year 2013, scores based on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) constitute 30% of incentive-based payments from Medicare's Value-Based Purchasing (VBP) initiative. Yet there is little empirical work to understand hospital approaches to improving the patient experience. In this study, chief patient experience officers at 416 VHA hospitals were surveyed to assess the relationship between organizational characteristics and publicly reported HCAHPS scores. Of 416 institutions, 143 (34.4%) participated. Respondents reported that boards (68%) and chief executive officers (81%) viewed the patient experience as extremely important. In contrast, they reported that in only 15% and 34% of hospitals, respectively, physicians and nurses were supportive of efforts to improve the patient experience. Hospitals with collaborative cultures and higher physician engagement had higher VBP total HCAHPS scores (6.9 points and 8.2 points higher, respectively; both P < .05). These areas should be addressed to improve the patient experience in provider organizations.

    View details for PubMedID 24951105

  • Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure JOURNAL OF HEART AND LUNG TRANSPLANTATION Dardas, T., Li, Y., Reed, S. D., O'Connor, C. M., Whellan, D. J., Ellis, S. J., Schulman, K. A., Kraus, W. E., Forman, D. E., Levy, W. C. 2015; 34 (8): 1017–23

    Abstract

    Multivariable risk scores and exercise measures are well-validated risk prediction methods. Combining information from a functional evaluation and a risk model may improve accuracy of risk predictions. We analyzed whether adding exercise measures to the Seattle Heart Failure Model (SHFM) improves risk prediction accuracy in systolic heart failure.We used a sample of patients from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) study (http://www.clinicaltrials.gov; unique identifier: NCT00047437) to examine the addition of peak oxygen consumption, expired volume per unit time/volume of carbon dioxide slope, 6-minute walk distance, or cardiopulmonary exercise duration to the SHFM. Multivariable Cox proportional hazards models were used to test the association between the combined end point (death, left ventricular assist device, or cardiac transplantation) and the addition of exercise variables to the SHFM.The sample included 2,152 patients. The SHFM and all exercise measures were associated with events (all p < 0.0001) in proportional hazards models. There was statistically significant improvement in risk estimation when exercise measures were added to the SHFM. However, the improvement in the C index for the addition of peak volume of oxygen consumption (+0.01), expired volume per unit time/volume of carbon dioxide slope (+0.02), 6-minute walk distance (-0.001), and cardiopulmonary exercise duration (+0.001) to the SHFM was small or slightly worse than the SHFM alone. Changes in risk assignment with the addition of exercise variables were minimal for patients above or below a 15% 1-year mortality.Exercise performance measures and the SHFM are independently useful for predicting risk in systolic heart failure. Adding cardiopulmonary exercise testing measures and 6MWD to the SHFM offers only minimal improvement in risk reassignment at clinically meaningful cut points.

    View details for DOI 10.1016/j.healun.2015.03.017

    View details for Web of Science ID 000358183600003

    View details for PubMedID 25940075

    View details for PubMedCentralID PMC4795804

  • Market-Based Solutions to Antitrust Threats - The Rejection of the Partners Settlement NEW ENGLAND JOURNAL OF MEDICINE Herzlinger, R. E., Richman, B. D., Schulman, K. A. 2015; 372 (14): 1287–89

    View details for PubMedID 25738542

  • Review: In adult outpatients, nurse-managed protocols improve hemoglobin A(1c) levels and blood pressure Commentary ANNALS OF INTERNAL MEDICINE Schulman, K. A. 2014; 161 (12): JC6
  • Exploring Variation in Care: Alternative Conceptual Models ANNALS OF INTERNAL MEDICINE Dinan, M. A., Schulman, K. A. 2014; 161 (11): 835–U130

    View details for DOI 10.7326/M14-2382

    View details for Web of Science ID 000347247200016

    View details for PubMedID 25437412

  • Predicting Nursing Home Placement Among Home- and Community-Based Services Program Participants AMERICAN JOURNAL OF MANAGED CARE Greiner, M. A., Qualls, L. G., Iwata, I., White, H. K., Molony, S. L., Sullivan, M., Burke, B., Schulman, K. A., Setoguchi, S. 2014; 20 (12): E535-+

    Abstract

    Several states offer publicly funded-care management programs to prevent long-term care placement of high-risk Medicaid beneficiaries. Understanding participant risk factors and services that may prevent long-term care placement can facilitate efficient allocation of program resources.To develop a practical prediction model to identify participants in a home- and community-based services program who are at highest risk for long-term nursing home placement, and to examine participant-level and program-level predictors of nursing home placement.In a retrospective observational study, we used deidentified data for participants in the Connecticut Home Care Program for Elders who completed an annual assessment survey between 2005 and 2010.We analyzed data on patient characteristics, use of program services, and short-term facility admissions in the previous year. We used logistic regression models with random effects to predict nursing home placement. The main outcome measures were long-term nursing home placement within 180 days or 1 year of assessment.Among 10,975 study participants, 1249 (11.4%) had nursing home placement within 1 year of annual assessment. Risk factors included Alzheimer's disease (odds ratio [OR], 1.30; 95% CI, 1.18-1.43), money management dependency (OR, 1.33; 95% CI, 1.18-1.51), living alone (OR, 1.53; 95% CI, 1.31-1.80), and number of prior short-term skilled nursing facility stays (OR, 1.46; 95% CI, 1.31-1.62). Use of a personal care assistance service was associated with 46% lower odds of nursing home placement. The model C statistic was 0.76 in the validation cohort.A model using information from a home- and community-based service program had strong discrimination to predict risk of long-term nursing home placement and can be used to identify high-risk participants for targeted interventions.

    View details for Web of Science ID 000351005400001

    View details for PubMedID 25741870

  • The Impact Of Specialty Pharmaceuticals As Drivers Of Health Care Costs HEALTH AFFAIRS Hirsch, B. R., Balu, S., Schulman, K. A. 2014; 33 (10): 1714–20

    Abstract

    The pharmaceutical industry is shifting its focus from blockbuster small molecules to specialty pharmaceuticals. Specialty pharmaceuticals are novel drugs and biologic agents that require special handling and ongoing monitoring, are administered by injection or infusion, and are sold in the marketplace by a small number of distributors. They are frequently identified by having a cost to payers and patients of $600 or more per treatment. The total costs of the new agents are likely to have a substantial impact on overall health care costs and on patients during the next decade, unless steps are taken to align competing interests. We examine the economic and policy issues related to specialty pharmaceuticals, taking care to consider the impact on patients. We assess the role of cost-sharing provisions, legislation that is promoting realignment within the market, the role of biosimilars in price competition, and the potential for novel drug development paradigms to help bend the cost curve. The economic aspects of this analysis highlight the need for a far-reaching discussion of potential novel approaches to innovation pathways in our quest for both affordability and new technology.

    View details for PubMedID 25288414

  • Associations Between Seattle Heart Failure Model Scores and Medical Resource Use and Costs: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Li, Y., Levy, W. C., Neilson, M. P., Ellis, S. J., Whellan, D. J., Schulman, K. A., O'Connor, C. M., Reed, S. D. 2014; 20 (8): 541–47

    Abstract

    Prognostic models, such as the Seattle Heart Failure Model (SHFM), have been developed to predict patient survival. The extent to which they predict medical resource use and costs has not been explored. In this study, we evaluated relationships between baseline SHFM scores and 1-year resource use and costs using data from a clinical trial.We applied generalized linear models to examine the relative impact of a 1-unit increase in SHFM scores on counts of medical resource use and direct medical costs at 1 year of follow-up. Of 2331 randomized patients, 2288 (98%) had a rounded integer SHFM score between -1 and 2, consistent with predicted 1-year survival of 98% and 74%, respectively. At baseline, median age was 59 years, 28% of patients were women, and nearly two-thirds of the cohort had New York Heart Association class II heart failure and one-third had class III heart failure. Higher SHFM scores were associated with more hospitalizations (rate ratio per 1-unit increase, 1.86; P < .001), more inpatient days (2.30; P < .001), and higher inpatient costs (2.28; P < .001), outpatient costs (1.54; P < .001), and total medical costs (2.13; P < .001).Although developed to predict all-cause mortality, SHFM scores also predict medical resource use and costs.

    View details for PubMedID 24887579

    View details for PubMedCentralID PMC4138128

  • Can Team-Based Care Improve Patient Satisfaction? A Systematic Review of Randomized Controlled Trials PLOS ONE Wen, J., Schulman, K. A. 2014; 9 (7): e100603

    Abstract

    Team-based approaches to patient care are a relatively recent innovation in health care delivery. The effectiveness of these approaches on patient outcomes has not been well documented. This paper reports a systematic review of the relationship between team-based care and patient satisfaction.We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, and PSYCHOINFO for eligible studies dating from inception to October 8, 2012. Eligible studies reported (1) a randomized controlled trial, (2) interventions including both team-based care and non-team-based care (or usual care), and (3) outcomes including an assessment of patient satisfaction. Articles with different settings between intervention and control were excluded, as were trial protocols. The reference lists of retrieved papers were also evaluated for inclusion.The literature search yielded 319 citations, of which 77 were screened for further full-text evaluation. Of these, 27 articles were included in the systematic review. The 26 trials with a total of 15,526 participants were included in this systematic review. The pooling result of dichotomous data (number of studies: 10) showed that team-based care had a positive effect on patient satisfaction compared with usual care (odds ratio, 2.09; 95% confidence interval, 1.54 to 2.84); however, combined continuous data (number of studies: 7) demonstrated that there was no significant difference in patient satisfaction between team-based care and usual care (standardized mean difference, -0.02; 95% confidence interval, -0.40 to 0.36).Some evidence showed that team-based care is better than usual care in improving patient satisfaction. However, considering the pooling result of continuous data, along with the suboptimal quality of included trials, further large-scale and high-quality randomized controlled trials comparing team-based care and usual care are needed.

    View details for PubMedID 25014674

  • Shifting toward Defined Contributions - Predicting the Effects NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Richman, B. D., Herzlinger, R. E. 2014; 370 (26): 2462–65

    View details for PubMedID 24963565

  • Removing a Constraint on Hospital Utilization: A Natural Experiment in Maryland AMERICAN JOURNAL OF MANAGED CARE Kalman, N. S., Hammill, B. G., Murray, R. B., Schulman, K. A. 2014; 20 (6): E191–E199

    Abstract

    To limit growth in hospital utilization in the 1990s, Maryland required payers to reimburse excess hospital volume at lower case rates. In 2001, this policy changed and excess volume was paid at full case rates. We investigated the impact of this policy change on hospital utilization and finances.We conducted interrupted time-series analyses of hospital-level annual inpatient admissions, outpatient equivalent volume, equivalent admissions, operating revenue, operating costs, and operating profit.We analyzed each time series for 45 acute care hospitals in Maryland using a segmented regression model, allowing for changes in level and slope of the trend in 2001, when the payment policy was changed. To incorporate trends for all hospitals, we fit these models as hierarchical generalized linear models.We observed significant changes in inpatient admissions, outpatient equivalent volume, and operating costs. Following the policy change, trends in inpatient admissions and outpatient equivalent volume had significant 1-year increases of 7.7% and 17.1%, respectively. The annual growth rate for inpatient admissions increased significantly, from 0.8% to 2.4%. The growth rate for outpatient equivalent volume increased from 3.2% to 4.7%, but this change was not statistically significant. Trends in operating costs had significant 1-year increases of 7.6% and an annual growth rate that increased significantly from 4.8% to 8.4%, exceeding the annual growth rate for utilization.Hospitals responded to changes in payment by accelerating the increase in service volume. The observed increase in utilization coincided with substantial inflation in operating costs that cannot be easily eliminated.

    View details for Web of Science ID 000342973500008

    View details for PubMedID 25180502

  • Health City Cayman Islands and the globalization of health services delivery AMERICAN HEART JOURNAL Shah, B. R., Narayan, M., Seth, A., Schulman, K. A. 2014; 167 (5): 770–74

    Abstract

    We describe a new health care campus under development in the Cayman Islands, Health City, based on the low-cost "focused factory" model. The construction of a multispecialty hospital opening in February 2014 less than a 4-hour flight away from the United States and convenient to both Central and South America for patients who already travel to the United States for clinical care could reshape the US health care marketplace and enhance access to affordable specialty health care in the region.

    View details for PubMedID 24766989

  • Redistribution of Health Care Costs after the Adoption of Positron Emission Tomography among Medicare Beneficiaries with Non-Small-Cell Lung Cancer, 1998-2005 JOURNAL OF THORACIC ONCOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2014; 9 (4): 512–18

    Abstract

    Treatment patterns and cost implications of increased positron emission tomography imaging use since Medicare approval in 1998 are not well understood. We examined rates of surgery, radiotherapy, and chemotherapy and inpatient and total health care costs between 1998 and 2005 among Medicare beneficiaries with non-small-cell lung cancer.Patients in this retrospective cohort study were 51,374 Medicare beneficiaries diagnosed with non-small-cell lung cancer between 1996 and 2005. The main outcome measures were receipt of surgical resection, radiotherapy, and chemotherapy and inpatient and total health care costs within 1 year of diagnosis.Between 1996-1997 and 2004-2005, the proportion of patients undergoing surgical resection decreased from 29% to 25%, the proportion receiving radiation therapy decreased from 49% to 43%, and inpatient costs decreased from $28,900 to $26,900. The proportion of patients receiving chemotherapy increased from 25% to 40% and total costs increased from $47,300 to $52,200 (p < 0.001 for all comparisons). Changes in use and costs remained after adjustment for shifting demographic characteristics during the study period.Adoption of positron emission tomography between 1998 and 2005 was accompanied by decreases in rates of surgery and radiotherapy and in short-term inpatient costs among Medicare beneficiaries with non-small-cell lung cancer, although there was an increase in chemotherapy and overall costs.

    View details for PubMedID 24736074

  • An Evaluation of Mobile Health Application Tools JMIR MHEALTH AND UHEALTH Sama, P. R., Eapen, Z. J., Weinfurt, K. P., Shah, B. R., Schulman, K. A. 2014; 2 (2): e19

    Abstract

    The rapid growth in the number of mobile health applications could have profound significance in the prevention of disease or in the treatment of patients with chronic disease such as diabetes.The objective of this study was to describe the characteristics of the most common mobile health care applications available in the Apple iTunes marketplace.We undertook a descriptive analysis of a sample of applications in the "health and wellness" category of the Apple iTunes Store. We characterized each application in terms of its health factor and primary method of user engagement. The main outcome measures of the analysis were price, health factors, and methods of user engagement.Among the 400 applications that met the inclusion criteria, the mean price of the most frequently downloaded paid applications was US $2.24 (SD $1.30), and the mean price of the most currently available paid applications was US $2.27 (SD $1.60). Fitness/training applications were the most popular (43.5%, 174/400). The next two most common categories were health resource (15.0%, 60/400) and diet/caloric intake (14.3%, 57/400). Applications in the health resource category constituted 5.5% (22/400) of the applications reviewed. Self-monitoring was the most common primary user engagement method (74.8%, 299/400). A total of 20.8% (83/400) of the applications used two or more user engagement approaches, with self-monitoring and progress tracking being the most frequent.Most of the popular mobile health applications focus on fitness and self-monitoring. The approaches to user engagement utilized by these applications are limited and present an opportunity to improve the effectiveness of the technology.

    View details for PubMedID 25099179

  • Impact of Cardiovascular Events on Change in Quality of Life and Utilities in Patients After Myocardial Infarction A VALIANT Study (Valsartan In Acute Myocardial Infarction) JACC-HEART FAILURE Lewis, E. F., Li, Y., Pfeffer, M. A., Solomon, S. D., Weinfurt, K. P., Velazquez, E. J., Califf, R. M., Rouleau, J., Kober, L., White, H. D., Schulman, K. A., Reed, S. D. 2014; 2 (2): 159–65

    Abstract

    The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL).There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial infarction (MI).The VALIANT (Valsartan In Acute Myocardial Infarction) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher (scale measuring heart failure severity post-MI ranging from class I to IV) and/or reduced ejection fraction. The HRQL substudy included 2,556 (17.4%) patients who completed the EQ-5D with 5 questions, with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale (VAS) ranging from 0 (worst) to 100 (best) imaginable health state. EQ-5D was administered at baseline and 6, 12, 20, and 24 months. The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events. Patients who died before the next EQ-5D assessment were excluded.Over a 2-year period, 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment. Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event (VAS 61.0 ± 19 vs 68.2 ± 18 [p < 0.001] and US-based utility score 0.76 ± 0.22 vs 0.83 ± 0.17 [p < 0.001]). These patients with CV events experienced a trajectory-adjusted 6.6 point decrease (p < 0.001) in VAS scores and a 0.07 decrease (p < 0.001) in utility score after the nonfatal CV event.MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory, suggesting that generic instruments can be responsive to nonfatal events. Reduction in nonfatal CV events may affect longitudinal changes in HRQL.

    View details for PubMedID 24720924

  • Hemoglobin, Exercise Training, and Health Status in Patients With Chronic Heart Failure (from the HF-ACTION Randomized Controlled Trial) AMERICAN JOURNAL OF CARDIOLOGY Pina, I. L., Lin, L., Weinfurt, K. P., Isitt, J. J., Whellan, D. J., Schulman, K. A., Flynn, K. E., HF-ACTION Investigators 2013; 112 (7): 971–76

    Abstract

    Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb.

    View details for DOI 10.1016/j.amjcard.2013.05.033

    View details for Web of Science ID 000325384500012

    View details for PubMedID 23809621

  • Who Enrolls in the Medicare Part D Prescription Drug Benefit Program? Medication Use Among Patients With Heart Failure JOURNAL OF THE AMERICAN HEART ASSOCIATION Eapen, Z. J., Hammill, B. G., Setoguchi, S., Schulman, K. A., Peterson, E. D., Hernandez, A. F., Curtis, L. H. 2013; 2 (5): e000242

    Abstract

    Dispensing data from Medicare Part D standalone prescription drug plans are now available, but characteristics of enrollees with heart failure have not been well described.We identified 81 874 patients with prevalent heart failure as of January 1, 2010, in a nationally representative 5% sample of Medicare beneficiaries. We classified patients according to enrollment in a Medicare Part D plan as of January 1, 2010. Demographic characteristics, comorbid conditions, and prescriptions were compared by enrollment status. A total of 49 252 (60.2%) were enrolled in a Medicare Part D plan as of January 1. Enrollees were more often women, black, and of lower socioeconomic status. Enrollees with heart failure more often filled prescriptions for loop diuretics than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, or aldosterone antagonists. During the first 4 months of 2010, 5444 (12.3%) reached the coverage gap, and 566 (1.3%) required catastrophic coverage beyond the gap.Medicare beneficiaries with heart failure differ significantly according to enrollment in Part D prescription drug plans and represent a population underrepresented in clinical efficacy trials. Many face the coverage gap, and few select Medicare Part D plans that provide coverage during the gap. Linking Medicare Part D event data with clinical registries could help to determine whether eligible enrollees are undertreated for heart failure.

    View details for PubMedID 24025363

  • The Mis-Measure of Physician Performance AMERICAN JOURNAL OF MANAGED CARE Glickman, S. W., Schulman, K. A. 2013; 19 (10): 782–85

    Abstract

    The Affordable Care Act directs the Secretary of Health and Human Services to compare individual physicians using patient experience measures. This policy initiative will utilize the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey program. It will impact over 700,000 eligible physicians and will be tied to reimbursement and the Centers for Medicare and Medicaid Services' Physician Compare reporting feature starting in 2015. We believe that the relevance of this framework to today's clinical environment is a critical issue to address before implementing this regulatory mandate. In this article we discuss our concerns about tying individual physician performance to CG-CAHPS scores, including: 1) intrinsic versus extrinsic approaches to assessing the patient experience, 2) measurement issues, and 3) unintended consequences. We also suggest an alternative pathway and opt-out mechanism to facilitate more rapid translation of service excellence into clinical practice.

    View details for Web of Science ID 000326420300002

    View details for PubMedID 24304157

  • Financial Incentives in Primary Care Practice The Struggle to Achieve Population Health Goals JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dolor, R. J., Schulman, K. A. 2013; 310 (10): 1031–32

    View details for DOI 10.1001/jama.2013.277575

    View details for Web of Science ID 000324133400019

    View details for PubMedID 24026597

  • Medical Resource Use, Costs, and Quality of Life in Patients With Acute Decompensated Heart Failure: Findings From ASCEND-HF JOURNAL OF CARDIAC FAILURE Reed, S. D., Kaul, P., Li, Y., Eapen, Z. J., Davidson-Ray, L., Schulman, K. A., Massie, B. M., Armstrong, P. W., Starling, R. C., O'Connor, C. M., Hernandez, A. F., Califf, R. M. 2013; 19 (9): 611–20

    Abstract

    The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) randomly assigned 7,141 participants to nesiritide or placebo. Dyspnea improvement was more often reported in the nesiritide group, but there were no differences in 30-day all-cause mortality or heart failure readmission rates. We compared medical resource use, costs, and health utilities between the treatment groups.There were no significant differences in inpatient days, procedures, and emergency department visits reported for the first 30 days or for readmissions to day 180. EQ-5D health utilities and visual analog scale ratings were similar at 24 hours, discharge, and 30 days. Billing data and regression models were used to generate inpatient costs. Mean length of stay from randomization to discharge was 8.5 days in the nesiritide group and 8.6 days in the placebo group (P = .33). Cumulative mean costs at 30 days were $16,922 (SD $16,191) for nesiritide and $16,063 (SD $15,572) for placebo (P = .03). At 180 days, cumulative costs were $25,590 (SD $30,344) for nesiritide and $25,339 (SD $29,613) for placebo (P = .58).The addition of nesiritide contributed to higher short-term costs and did not significantly influence medical resource use or health utilities compared with standard care alone.

    View details for PubMedID 24054337

  • Characteristics of Oncology Clinical Trials Insights From a Systematic Analysis of ClinicalTrials.gov JAMA INTERNAL MEDICINE Hirsch, B. R., Califf, R. M., Cheng, S. K., Tasneem, A., Horton, J., Chiswell, K., Schulman, K. A., Dilts, D. M., Abernethy, A. P. 2013; 173 (11): 972–79

    Abstract

    Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement.To perform a comprehensive analysis of the national oncology clinical research portfolio.All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; P < .001), open label (87.8% vs 47.3%; P < .001), and nonrandomized (63.9% vs 22.7%; P < .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P = .04] and 0.77 [P = .001], respectively). More than one-third of all oncology trials were conducted solely outside North America.There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.

    View details for DOI 10.1001/jamainternmed.2013.627

    View details for Web of Science ID 000320050200008

    View details for PubMedID 23699837

  • Variations in Use of PET among Medicare Beneficiaries with Non-Small Cell Lung Cancer, 1998-2007 RADIOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2013; 267 (3): 807–17

    Abstract

    To explore demographic and regional factors associated with the use of positron emission tomography (PET) in patients with non-small cell lung cancer (NSCLC) and to determine whether their associations with PET use has changed over time.The Office of Human Research Ethics at the University of North Carolina and the institutional review board of the Duke University Health System approved (with waiver of informed consent) this retrospective analysis of Surveillance Epidemiology and End Results Medicare data for Medicare beneficiaries given a diagnosis of NSCLC between 1998 and 2007. The primary outcome was change in the number of PET examinations 2 months before to 4 months after diagnosis, examined according to year and sociodemographic subgroup. PET use was compared between demographic and geographic subgroups and between early (1998-2000) and late (2005-2007) cohorts by using χ(2) tests. Factors associated with use of PET during the study period were further examined by using logit and linear probability multivariable regression analyses.The final cohort included 46 544 patients with 46 935 cases of NSCLC. By 2005, more than half of patients underwent one or more PET examinations, regardless of demographic subgroup. In multivariable logistic regression analysis, patients who underwent PET were more likely to be married, nonblack, and younger than 80 years and to live in census tracts with higher education levels or in the Northeast (P < .001 for all). Living within 40 miles of a PET facility was initially associated with undergoing PET (P < .001), but this association disappeared by 2007. Imaging rates increased more rapidly in patients who were nonblack (P ≤ .01), patients who were younger than 81 years (P < .001), and patients who lived in the Northeast and South (P < .001).PET imaging among Medicare beneficiaries with NSCLC was initially concentrated among nonblack patients younger than 81 years. Despite widespread adoption among all subgroups, differences within demographic subgroups remained.

    View details for DOI 10.1148/radiol.12120174

    View details for Web of Science ID 000319445400017

    View details for PubMedID 23418003

  • Associations Between Seattle Heart Failure Model Scores and Health Utilities: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Li, Y., Neilson, M. P., Whellan, D. J., Schulman, K. A., Levy, W. C., Reed, S. D. 2013; 19 (5): 311–16

    Abstract

    The Seattle Heart Failure Model (SHFM) is a well validated prediction model of all-cause mortality in patients with heart failure, but its relationship with generic health status measures has not been evaluated. We sought to investigate relationships between SHFM scores and health utility weights, which are necessary to estimate quality-adjusted life-years in cost-effectiveness analyses.We applied mixed linear regression to examine relationships between baseline SHFM scores and EQ-5D-derived health utilities collected longitudinally in a large clinical trial. A 1-unit increase in SHFM score (higher predicted mortality) was associated with a 0.030 decrease in utility (P < .001) and an additional 0.006 decrease per year (P < .001). With SHFM score modeled as a categorical variable, EQ-5D utilities for patients with rounded SHFM scores of 1 or 2 were significantly lower (-0.041 and -0.053, respectively; both P < .001) and declined more rapidly over time (-0.011 and -0.020, respectively; both P ≤ .004) than for patients with scores of -1.Patients with higher SHFM-predicted mortality had significantly lower health utilities at baseline and greater rates of decline over time, compared with patients with lower SHFM-predicted mortality. These relationships can be applied when examining the cost-effectiveness of heart failure interventions.

    View details for PubMedID 23663813

    View details for PubMedCentralID PMC3709866

  • A Web-based communication aid for patients with cancer CANCER Meropol, N. J., Egleston, B. L., Buzaglo, J. S., Balshem, A., Benson, A. B., Cegala, D. J., Cohen, R. B., Collins, M., Diefenbach, M. A., Miller, S. M., Fleisher, L., Millard, J. L., Ross, E. A., Schulman, K. A., Silver, A., Slater, E., Solarino, N., Sulmasy, D. P., Trinastic, J., Weinfurt, K. P. 2013; 119 (7): 1437–45

    Abstract

    Cancer patients and their oncologists often report differing perceptions of consultation discussions and discordant expectations regarding treatment outcomes. CONNECT, a computer-based communication aid, was developed to improve communication between patients and oncologists.CONNECT includes assessment of patient values, goals, and communication preferences; patient communication skills training; and a preconsultation physician summary report. CONNECT was tested in a 3-arm, prospective, randomized clinical trial. Prior to the initial medical oncology consultation, adult patients with advanced cancer were randomized to the following arms: 1) control; 2) CONNECT with physician summary; or 3) CONNECT without physician summary. Outcomes were assessed with postconsultation surveys.Of 743 patients randomized, 629 completed postconsultation surveys. Patients in the intervention arms (versus control) felt that the CONNECT program made treatment decisions easier to reach (P = .003) and helped them to be more satisfied with these decisions (P < .001). In addition, patients in the intervention arms reported higher levels of satisfaction with physician communication format (P = .026) and discussion regarding support services (P = .029) and quality of life concerns (P = .042). The physician summary did not impact outcomes. Patients with higher levels of education and poorer physical functioning experienced greater benefit from CONNECT.This prospective randomized clinical trial demonstrates that computer-based communication skills training can positively affect patient satisfaction with communication and decision-making. Measurable patient characteristics may be used to identify subgroups most likely to benefit from an intervention such as CONNECT.

    View details for DOI 10.1002/cncr.27874

    View details for Web of Science ID 000316811900021

    View details for PubMedID 23335150

    View details for PubMedCentralID PMC3604078

  • COSTS OF NEWLY DIAGNOSED NEOVASCULAR AGE-RELATED MACULAR DEGENERATION AMONG MEDICARE BENEFICIARIES, 2004-2008 RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES Qualls, L. G., Hammill, B. G., Wang, F., Lad, E. M., Schulman, K. A., Cousins, S. W., Curtis, L. H. 2013; 33 (4): 854–61

    Abstract

    To examine associations between newly diagnosed neovascular age-related macular degeneration and direct medical costs.This retrospective observational study matched 23,133 Medicare beneficiaries diagnosed with neovascular age-related macular degeneration between 2004 and 2008 with a control group of 92,532 beneficiaries on the basis of age, sex, and race. The index date for each case-control set corresponded to the first diagnosis for the case. Main outcome measures were total costs per patient and age-related macular degeneration-related costs per case 1 year before and after the index date.Mean cost per case in the year after diagnosis was $12,422, $4,884 higher than the year before diagnosis. Postindex costs were 41% higher for cases than controls after adjustment for preindex costs and comorbid conditions. Age-related macular degeneration-related costs represented 27% of total costs among cases in the postindex period and were 50% higher for patients diagnosed in 2008 than in 2004. This increase was attributable primarily to the introduction of intravitreous injections of vascular endothelial growth factor antagonists. Intravitreous injections averaged $203 for patients diagnosed in 2004 and $2,749 for patients diagnosed in 2008.Newly diagnosed neovascular age-related macular degeneration was associated with a substantial increase in total medical costs. Costs increased over time, reflecting growing use of anti-vascular endothelial growth factor therapies.

    View details for PubMedID 23296047

  • Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer GENETICS IN MEDICINE Reed, S. D., Dinan, M. A., Schulman, K. A., Lyman, G. H. 2013; 15 (3): 203–11

    Abstract

    New evidence is available regarding the utility of the 21-gene recurrence score assay in guiding chemotherapy use for node-negative, estrogen receptor-positive breast cancer. We applied this evidence in a decision-analytic model to re-evaluate the cost-effectiveness of the assay.We cross-classified patients by clinicopathologic characteristics from the Adjuvant! risk index and by recurrence score risk group. For non-recurrence score-guided treatment, we assumed patients receiving hormonal therapy alone had low-risk characteristics and patients receiving chemotherapy and hormonal therapy had higher-risk characteristics. For recurrence score-guided treatment, we assigned chemotherapy probabilities conditional on recurrence score risk group and clinicopathologic characteristics.An estimated 40.4% of patients in the recurrence score-guided strategy and 47.3% in the non-recurrence score-guided strategy were expected to receive chemotherapy. The incremental gain in quality-adjusted life-years was 0.16 (95% confidence interval, 0.08-0.28) with the recurrence score-guided strategy. Lifetime medical costs to the health system were $2,692 ($1,546-$3,821) higher with the recurrence score-guided strategy, for an incremental cost-effectiveness ratio of $16,677/quality-adjusted life-year ($7,613-$37,219). From a societal perspective, the incremental cost-effectiveness was $10,788/quality-adjusted life-year ($6,840-$30,265).The findings provide supportive evidence for the economic value of the 21-gene recurrence score assay in node-negative, estrogen receptor-positive breast cancer.

    View details for PubMedID 22975761

  • Let's Get SEERious: More Accurate Staging With Consequent High Management Impact Is Not Just Stage Migration Reply JOURNAL OF CLINICAL ONCOLOGY Dinan, M. A., Carpenter, W. R., Patz, E. F., Abernethy, A. P., Biddle, A. K., Schulman, K. A., Curtis, L. H. 2013; 31 (6): 820

    View details for DOI 10.1200/JCO.2012.46.7373

    View details for Web of Science ID 000315086400039

    View details for PubMedID 23544205

  • Patient Time Costs Associated with Sensor-Augmented Insulin Pump Therapy for Type 1 Diabetes: Results from the STAR 3 Randomized Trial MEDICAL DECISION MAKING Kamble, S., Weinfurt, K. P., Schulman, K. A., Reed, S. D. 2013; 33 (2): 215–24

    Abstract

    Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known.We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care.Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation.At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDI patients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDI patients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638).Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities.Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.

    View details for PubMedID 23128579

  • Comparative Effectiveness of Nonbiologic versus Biologic Disease-modifying Antirheumatic Drugs for Rheumatoid Arthritis JOURNAL OF RHEUMATOLOGY DeWitt, E., Li, Y., Curtis, J. R., Glick, H. A., Greenberg, J. D., Anstrom, K. J., Kremer, J. M., Reed, G., Schulman, K. A., Reed, S. D. 2013; 40 (2): 127–36

    Abstract

    To evaluate the comparative effectiveness of nonbiologic disease-modifying antirheumatic drugs (DMARD) versus biologic DMARD (bDMARD) for treatment of rheumatoid arthritis (RA), using 2 common analytic approaches.We analyzed change in Clinical Disease Activity Index (CDAI) scores in patients with RA enrolled in a US-based observational registry from 2001 to 2008 using multivariable (MV) regression and propensity score (PS) matching. Among patients who initiated treatment with a nonbiologic DMARD (n = 1729), we compared patients who switched to, or added, another nonbiologic (n = 182) or a bDMARD (n = 342) at 5, 9, and 24 months after treatment change.Both analytic approaches showed that patients switching to or adding another nonbiologic DMARD demonstrated improvement across 9 and 24 months (both p < 0.001). Both approaches also demonstrated greater improvement in CDAI among recipients of bDMARD relative to a second nonbiologic DMARD at 5 months (p < 0.02). The MV regression approach upheld these results at 9 and 24 months (p < 0.03). In contrast, the PS-matching approach did not show a sustained advantage with bDMARD at these later timepoints, possibly because of lower statistical power and/or lower baseline disease activity in the PS-matched cohort.Patients in both treatment groups generally experienced lower CDAI scores across time. Patients switching to bDMARD demonstrated greater improvement than patients switching to nonbiologic DMARD with both analytic approaches at 5 months. Relative advantages with bDMARD were observed at 9 and 24 months only with MV regression. These analyses provide a practical example of how findings in comparative effectiveness research can diverge with different methodological approaches.

    View details for DOI 10.3899/jrheum.120400

    View details for Web of Science ID 000314619500004

    View details for PubMedID 23322461

  • The economics of new drugs: can we afford to make progress in a common disease? American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Meeting Hirsch, B. R., Schulman, K. A. 2013

    Abstract

    The concept of personalized medicine is beginning to come to fruition, but the cost of drug development is untenable today. To identify new initiatives that would support a more sustainable business model, the economics of drug development are analyzed, including the cost of drug development, cost of capital, target market size, returns to innovators at the product and firm levels, and, finally, product pricing. We argue that a quick fix is not available. Instead, a rethinking of the entire pharmaceutical development process is needed from the way that clinical trials are conducted, to the role of biomarkers in segmenting markets, to the use of grant support, and conditional approval to decrease the cost of capital. In aggregate, the opportunities abound.

    View details for DOI 10.1200/EdBook_AM.2013.33.e126

    View details for PubMedID 23714477

  • Patient-Centered Health Care Delivery Systems: A Framework Muehlbacher, A. C., Bethge, S., Schulman, K. A. IGITUR, UTRECHT PUBLISHING & ARCHIVING SERVICES. 2013
  • Urinary Diversion in Patients With Spinal Cord Injury in the United States UROLOGY Peterson, A. C., Curtis, L. H., Shea, A. M., Borawski, K. M., Schulman, K. A., Scales, C. D. 2012; 80 (6): 1247–51

    Abstract

    To describe the patterns in the use of bladder augmentation and urinary diversion to manage urologic sequelae among patients with spinal cord injury in the United States.Discharge estimates were derived from the Nationwide Inpatient Sample. All patients underwent bladder augmentation or ileal conduit diversion from 1998 to 2005 and had a diagnosis of spinal cord injury.Ileal loop diversion was performed in an estimated 1919 patients and bladder augmentation in 1132 patients with spinal cord injury from 1998 to 2005. Patients undergoing urinary diversion tended to be older (mean age 46 vs 34 years; P <.001) and to have Medicare as the primary payer (55.0% vs 30.8%; P <.001). Patients who underwent urinary diversion appeared to use more healthcare resources, with a longer length of stay (15 vs 9 days), higher hospital charges ($58,626 vs $37,222), and a greater use of home healthcare services after discharge (all P <.001). Patients at teaching institutions were more likely to undergo bladder augmentation (42%) than those at nonteaching institutions (23%; P <.001).Bladder augmentation is used in approximately one-third of cases to manage the urologic complications of spinal cord injury. These patients likely constitute a clinically distinct population that uses fewer healthcare resources. The lower augmentation rates at nonteaching institutions may indicate an opportunity for quality improvement.

    View details for PubMedID 23206770

  • A model for the adoption of ICT by health workers in Africa INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS Jimoh, L., Pate, M. A., Lin, L., Schulman, K. A. 2012; 81 (11): 773–81

    Abstract

    To investigate the potential of information and communication technology (ICT) adoption among maternal and child health workers in rural Nigeria.A prospective, quantitative survey design was used to collect data from quasi-randomly selected clusters of 25 rural health facilities in 5 of the 36 states in Nigeria over a 2-month period from June to July 2010. A total of 200 maternal and child health workers were included in the survey, and the data were analyzed using a modified theory of acceptance model (TAM).There was no significant difference between ICT knowledge and attitude scores across states. There were significant differences in perceived ease of use (P<.001) and perceived usefulness scores (P=.001) across states. Midwives reported higher scores on all the constructs but a lower score on endemic barriers (which is a more positive outcome). However, the differences were only statistically significant for perceived usefulness (P=.05) and endemic barriers (P<.001). Regression analysis revealed that there was no interaction between worker group and age. Older workers were likely to have lower scores on knowledge and attitude but higher scores on perceived ease of use and perceived usefulness. Lastly, we found that worker preference for ICT application in health varied across worker groups and conflicted with government/employer priorities.Although the objective of this study was exploratory, the results provide insight into the intricacies involved in the deployment of ICT in low-resource settings. Use of an expanded TAM should be considered as a mandatory part of any pre-implementation study of ICT among health workers in sub-Saharan Africa.

    View details for PubMedID 22986218

  • Proposed 'Grant-And-Access' Program With Price Caps Could Stimulate Development Of Drugs For Very Rare Diseases HEALTH AFFAIRS Valverde, A. M., Reed, S. D., Schulman, K. A. 2012; 31 (11): 2528–35

    Abstract

    The 1983 Orphan Drug Act created incentives for the development of orphan drugs. Despite its successes, including a substantial increase in new drugs, approved orphan drugs still treat fewer than 5 percent of registered rare diseases. In addition, concerns have arisen about the high prices of many of these therapies, which can cost hundreds of thousands of dollars per patient each year. In this article, we propose a new "grant-and-access pathway," in which drug developers could opt to compete for federal grants to subsidize the costs of clinical testing. In return for the grant funding, companies would no longer claim orphan drug tax credits and would agree to price caps for marketed products based on the duration and costs associated with drug development, expected market size, and target rate of return. We identify scenarios in which such a policy could provide a net benefit to society.

    View details for PubMedID 23129684

  • In-Hospital Resource Use and Medical Costs in the Last Year of Life by Mode of Death (from the HF-ACTION Randomized Controlled Trial) AMERICAN JOURNAL OF CARDIOLOGY Reed, S. D., Li, Y., Dunlap, M. E., Kraus, W. E., Samsa, G. P., Schulman, K. A., Zile, M. R., Whellan, D. J. 2012; 110 (8): 1150–55

    Abstract

    Patterns of medical resource use near the end of life may differ across modes of death. The aim of this study was to characterize patterns of inpatient resource use and direct costs for patients with heart failure (HF) who died of sudden cardiac death (SCD), HF, other cardiovascular causes, or noncardiovascular causes during the last year of life. Data were from a randomized trial of exercise training in patients with HF. Mode of death was adjudicated by an end point committee. Generalized estimating equations were used to compare hospitalizations, inpatient days, and inpatient costs incurred during the final year of life in patients who died of different causes, adjusting for clinical and treatment characteristics. Of 2,331 patients enrolled in the trial, 231 died after ≥1 year of follow-up with an adjudicated mode of death, including 72 of SCD, 80 of HF, 34 of other cardiovascular causes, and 45 of noncardiovascular causes. Patients who died of SCD were younger, had less severe HF, and incurred fewer hospitalizations, fewer inpatient days, and lower inpatient costs than patients who died of other causes. After adjustment for patient characteristics, inpatient resource use varied by 2 to 4 times across modes of death, suggesting that cost-effectiveness analyses of interventions that reduce mortality from SCD compared to other causes should incorporate mode-specific end-of-life costs. In conclusion, resource use and associated medical costs in the last year of life differed markedly in patients with HF who experienced SCD and patients who died of other causes.

    View details for PubMedID 22762718

  • Associations Between Hemoglobin Level, Resource Use, and Medical Costs in Patients With Heart Failure: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Reed, S. D., Li, Y., Ellis, S. J., Isitt, J. J., Cheng, S., Schulman, K. A., Whellan, D. J. 2012; 18 (10): 784–91

    Abstract

    Reports that patients with heart failure and anemia incur greater costs and medical resource use have relied largely on data with limited clinical detail.HF-ACTION, a large trial of exercise training in heart failure, recorded hemoglobin at baseline. Medical resource use and hospital bills for inpatient and emergency department visits were collected throughout the study. We analyzed hemoglobin as a continuous variable to evaluate relationships with medical resource use and costs over 1 year.Among 1,763 patients with baseline hemoglobin levels, those with lower hemoglobin levels tended to be older, African American, and women and to have more severe heart failure. Lower hemoglobin was significantly associated with more hospital admissions, inpatient days, outpatient visits, and urgent care or emergency department visits (all P < .005, unadjusted). Although cost outliers influenced estimates, these observations were distributed across hemoglobin levels. Mean 1-year costs across hemoglobin levels defined as ≤ 11, >11-12, >12-13, >13-14, >14-15, and >15 g/dL were $21,106, $20,189, $16,249, $17,989, $13,216, and $12,492, respectively (P < .001, unadjusted). Significant associations remained after multivariable adjustment.Patients with lower baseline hemoglobin levels experienced progressively greater resource use and higher costs.

    View details for PubMedID 23040114

  • Cost-Effectiveness of Truncated Therapy for Hepatitis C Based on Rapid Virologic Response VALUE IN HEALTH Gellad, Z. F., Muir, A. J., McHutchison, J. G., Sievert, W., Sharara, A. I., Brown, K. A., Flisiak, R., Jacobson, I. M., Kershenobich, D., Manns, M. P., Schulman, K. A., Reed, S. D. 2012; 15 (6): 876–86

    Abstract

    Shortened courses of treatment with pegylated interferon alfa and ribavirin for patients with hepatitis C virus infection who experience rapid virologic response can be effective in appropriately selected patients. The cost-effectiveness of truncated therapy is not known.To assess the cost-effectiveness of response-guided therapy versus standard-duration therapy on the basis of best available evidence.We developed a decision model for chronic hepatitis C virus infection representing two treatment strategies: 1) standard-duration therapy with pegylated interferon alfa and ribavirin for 48 weeks in patients with genotype 1 or 4 and for 24 weeks in patients with genotype 2 or 3 and 2) truncated therapy (i.e., 50% decrease in treatment duration) in patients with rapid virologic response. Patients for whom truncated therapy failed began standard-duration therapy guided by genotype. We used a Markov model to estimate lifetime costs and quality-adjusted life-years.In the base-case analysis, mean lifetime costs were $46,623 ± $2,483 with standard-duration therapy and $42,354 ± $2,489 with truncated therapy. Mean lifetime quality-adjusted life-years were similar between the groups (17.1 ± 0.7 with standard therapy; 17.2 ± 0.7 with truncated therapy). Across model simulations, the probability of truncated therapy being economically dominant (i.e., both cost saving and more effective) was 78.6%. The results were consistent when we stratified the data by genotype. In one-way sensitivity analyses, the results were sensitive only to changes in treatment efficacy.Truncated therapy based on rapid virologic response is likely to be cost saving for treatment-naive patients with chronic hepatitis C virus infection. Cost-effectiveness varied with small changes in relative treatment efficacy.

    View details for PubMedID 22999138

  • Overbilling and Informed Financial Consent - A Contractual Solution NEW ENGLAND JOURNAL OF MEDICINE Richman, B. D., Hall, M. A., Schulman, K. A. 2012; 367 (5): 396–97

    View details for PubMedID 22853013

  • Seattle Heart Failure Model Scores are Significantly Predictive of Health Utilities and Their Change Over Time Li, Y., Neilson, M., Whellan, D. J., Schulman, K. A., Levy, W. C., Reed, S. D. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2012: S81
  • Can the Seattle Proportional Risk Model Identify Patients With a Greater ICD Benefit in HF-ACTION? Levy, W. C., Li, Y., Zile, M., Shadman, R., Dardas, T., Whellan, D., Schulman, K., Ellis, S., Neilson, M., O'Connor, C. M., Reed, S. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2012: S50
  • Stage Migration, Selection Bias, and Survival Associated With the Adoption of Positron Emission Tomography Among Medicare Beneficiaries With Non-Small-Cell Lung Cancer, 1998-2003 JOURNAL OF CLINICAL ONCOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2012; 30 (22): 2725–30

    Abstract

    Previous studies have linked the use of positron emission tomography (PET) with improved outcomes among patients with non-small-cell lung cancer (NSCLC). However, this association may be confounded by PET-induced stage migration and selection bias. We examined the association between PET use and overall survival among Medicare beneficiaries with NSCLC.Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER) -Medicare data was used to characterize changes in overall survival, stage-specific survival, and stage distribution among Medicare beneficiaries with NSCLC between 1998 and 2003.A total of 97,007 patients with NSCLC diagnosed between 1998 and 2003 met the study criteria. Two-year and 4-year survival remained unchanged, despite widespread adoption of PET. The proportion of patients staged with advanced disease increased from 44% to 50%. Upstaging of disease was accompanied by stage-specific improved survival, with 2-year survival of stage IV disease increasing from 8% to 11% between 1998 and 2003. PET was more likely to be administered to patients with less advanced disease (stages I through IIIA) and greater overall survival.Overall survival among Medicare beneficiaries with NSCLC was unchanged between 1998 and 2003, despite widespread adoption of PET. The association between PET use and increased survival likely reflects an artifact of selection bias and consequent stage migration.

    View details for DOI 10.1200/JCO.2011.40.4392

    View details for Web of Science ID 000306952100009

    View details for PubMedID 22753917

  • Cost-Effectiveness of Sensor-Augmented Pump Therapy in Adults with Type 1 Diabetes in the United States VALUE IN HEALTH Kamble, S., Schulman, K. A., Reed, S. D. 2012; 15 (5): 632–38

    Abstract

    A recent randomized trial demonstrated significant reductions in hemoglobin A(1c) levels with sensor-augmented pump therapy (SAPT) compared with multiple daily injections of insulin (MDI) in type 1 diabetes. We analyzed resource use in the trial and estimated the long-term cost-effectiveness of SAPT from the perspective of the US health care system.We undertook a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors, as in the trial, and 6-day sensors, approved in most markets but not yet approved in the United States.Within-trial hospital days, emergency department visits, and outpatient visits did not differ significantly between the treatment groups. Assuming 65% use of 3-day sensors, treatment-related costs in year 1 were an estimated $10,760 for SAPT and $5072 for MDI. Discounted lifetime estimates were $253,493 in direct medical costs and 10.794 quality-adjusted life-years (QALYs) for SAPT and $167,170 in direct medical costs and 10.418 QALYs for MDI. For 3-day and 6-day sensors, the incremental cost-effectiveness ratios were $229,675 per QALY (95% confidence interval $139,071-$720,865) and $168,104 per QALY (95% confidence interval $102,819-$523,161), respectively. The ratios ranged from $69,837 to $211,113 per QALY with different strategies for incorporating utility benefits resulting from less fear of hypoglycemia with SAPT.Despite superior clinical benefits of SAPT compared with MDI, SAPT does not appear to be economically attractive in the United States for adults with type 1 diabetes in its current state of development. However, further clinical developments reducing disposable costs of the system could significantly improve its economic attractiveness.

    View details for PubMedID 22867771

  • Systemic and Ocular Risks Associated With Therapies for Macular Degeneration: Clarification vs Confusion reply ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2012; 130 (6): 807
  • Treatment Patterns for Neovascular Age-Related Macular Degeneration: Analysis of 284 380 Medicare Beneficiaries AMERICAN JOURNAL OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Qualls, L. G., Dimartino, L. D., Wang, F., Schulman, K. A., Cousins, S. W. 2012; 153 (6): 1116–24

    Abstract

    To examine trends in the treatment of newly diagnosed neovascular age-related macular degeneration (AMD).Retrospective cohort study.Among 284 380 Medicare beneficiaries with a new diagnosis between 2006 and 2008, we used the cumulative incidence function to estimate procedure rates and the mean frequency function to estimate the cumulative mean number of intravitreous injections. We used Cox log-binomial regression to estimate predictors of the use of vascular endothelial growth factor (VEGF) antagonists within 1 year after diagnosis. Discontinuation of anti-VEGF therapy was defined by absence of treatment for 12 months. Discontinuation rates were calculated using the Kaplan-Meier method.The proportion of patients receiving anti-VEGF therapy increased from 60.3% to 72.7%, photodynamic therapy decreased from 12.8% to 5.3%, and thermal laser treatment decreased from 5.5% to 3.2%. Black patients (hazard ratio, 0.77; 95% confidence interval, 0.75-0.79) and patients of other/unknown race (0.83; 0.81-0.84) were less likely than white patients to receive anti-VEGF therapy. Patients with dementia were less likely to receive anti-VEGF therapy (0.88; 0.88-0.89). Among patients who received anti-VEGF therapy, the mean number of injections within 1 year of the first injection was 4.3 per treated eye. Anti-VEGF therapy was discontinued in 53.6% of eyes within 1 year, and in 61.7% of eyes within 18 months.Treatment of new neovascular AMD changed significantly between 2006 and 2008, most notably in the increasing use of anti-VEGF therapies. However, few patients treated with anti-VEGF medications received monthly injections, and discontinuation rates were high.

    View details for PubMedID 22321802

  • Improving the impact of clinical research: A systematic analysis of kidney cancer trials. Hirsch, B., Mitchell, A., Cheng, S., Tasneem, A., Schulman, K. A., Dilts, D. M., Abernethy, A. AMER SOC CLINICAL ONCOLOGY. 2012
  • Cost-effectiveness of the 21-gene recurrence score assay in the setting of multifactorial decision making for chemotherapy in early-stage breast cancer Reed, S. D., Dinan, M. A., Schulman, K. A., Lyman, G. H. AMER SOC CLINICAL ONCOLOGY. 2012
  • Geographic and network analysis of oncology trials: Portfolio assessment of ClinicalTrials.gov. Cheng, S., Hirsch, B., Califf, R. M., Tasneem, A., Schulman, K. A., Abernethy, A., Dilts, D. M. AMER SOC CLINICAL ONCOLOGY. 2012
  • Drug development risk and the cost of capital NATURE REVIEWS DRUG DISCOVERY Baras, A. I., Baras, A. S., Schulman, K. A. 2012; 11 (5): 347–48

    View details for DOI 10.1038/nrd3722

    View details for Web of Science ID 000303460000009

    View details for PubMedID 22498751

  • Can We Begin With the End in Mind? End-of-Life Care Preferences Before Long-term Dialysis ARCHIVES OF INTERNAL MEDICINE Patel, U. D., Schulman, K. A. 2012; 172 (8): 663–64

    View details for Web of Science ID 000303128700016

    View details for PubMedID 23446995

  • Changes in Initial Treatment for Prostate Cancer Among Medicare Beneficiaries, 1999-2007 INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS Dinan, M. A., Robinson, T. J., Zagar, T. M., Scales, C. D., Curtis, L. H., Reed, S. D., Lee, W., Schulman, K. A. 2012; 82 (5): E781–E786

    Abstract

    In the absence of evidence from large clinical trials, optimal therapy for localized prostate cancer remains unclear; however, treatment patterns continue to change. We examined changes in the management of patients with prostate cancer in the Medicare population.We conducted a retrospective claims-based analysis of the use of radiation therapy, surgery, and androgen deprivation therapy in the 12 months after diagnosis of prostate cancer in a nationally representative 5% sample of Medicare claims. Patients were Medicare beneficiaries 67 years or older with incident prostate cancer diagnosed between 1999 and 2007.There were 20,918 incident cases of prostate cancer between 1999 and 2007. The proportion of patients receiving androgen deprivation therapy decreased from 55% to 36%, and the proportion of patients receiving no active therapy increased from 16% to 23%. Intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the most common method of radiation therapy, accounting for 77% of external beam radiotherapy by 2007. Minimally invasive radical prostatectomy began to replace open surgical approaches, being used in 49% of radical prostatectomies by 2007.Between 2002 and 2007, the use of androgen deprivation therapy decreased, open surgical approaches were largely replaced by minimally invasive radical prostatectomy, and intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the predominant method of radiation therapy in the Medicare population. The aging of the population and the increasing use of newer, higher-cost technologies in the treatment of patients with prostate cancer may have important implications for nationwide health care costs.

    View details for PubMedID 22331001

  • Resource Use, Costs, and Utility Estimates for Patients with Cystic Fibrosis with Mild Impairment in Lung Function: Analysis of Data Collected Alongside a 48-Week Multicenter Clinical Trial VALUE IN HEALTH DeWitt, E., Grussemeyer, C. A., Friedman, J. Y., Dinan, M. A., Lin, L., Schulman, K. A., Reed, S. D. 2012; 15 (2): 277–83

    Abstract

    Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates.Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured on study case report forms. Sources for unit costs included the Medicare Physician Fee Schedule, the Nationwide Inpatient Sample, and the Red Book. Health utilities were derived from the Health Utilities Index Mark 2/3. We used multivariable regression to evaluate the impact of baseline covariates on costs.Characteristics of the 352 participants at enrollment included mean age of 14.6 years, history of Pseudomonas aeruginosa colonization in 45.2%, use of dornase alfa in 77.0%, and long-term use of inhaled antibiotics in 37.2%. Over 48 weeks, 22.4% of participants were hospitalized and, on average, participants missed 7.4 days of school or work. Mean total costs (excluding denufosol) were $39,673 (SD $26,842), of which 85% were attributable to medications. Female sex and P. aeruginosa colonization were independently associated with higher costs.Prospective economic data collection alongside a clinical trial allows for robust estimates of cost of illness. The mean annual cost of care for patients with cystic fibrosis with mild impairment in lung function exceeds $43,000 and is driven by medication costs.

    View details for DOI 10.1016/j.jval.2011.11.027

    View details for Web of Science ID 000301930600009

    View details for PubMedID 22433759

  • THE POTENTIAL INFLUENCE OF INTERNET-BASED SOCIAL NETWORKING ON THE CONDUCT OF CLINICAL RESEARCH STUDIES JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS Glickman, S. W., Galhenage, S., McNair, L., Barber, Z., Patel, K., Schulman, K. A., McHutchison, J. G. 2012; 7 (1): 71–80

    Abstract

    The rapid growth of internet usage has led to an explosion of social networking sites for discussion of health issues. This provides a forum for subjects to communicate with one another during the course of the studies. Previous studies have raised concerns about the quality of health information on social networking sites, although none have evaluated content related to ongoing clinical trials. We reviewed material posted in virtual communities by self-identified clinical trial participants. We identified material posted in online health forums that could introduce bias into clinical research studies; we believe that this issue warrants further study and discussion. Physicians and others who conduct clinical trials should be aware of this issue. Study investigators and research teams should also talk to their study subjects about where and how they are obtaining information in order to prevent behaviors and correct misinformation that could put a subject's safety or the study objectives at risk. Given the rapid increase in Internet use for health care, a broader evaluation of both the benefits and potential risks of social networking among research participants during the course of a clinical trial appears warranted.

    View details for DOI 10.1525/jer.2012.7.1.71

    View details for Web of Science ID 000301209000008

    View details for PubMedID 22378136

  • Introduction of the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Costing Tool A User-Friendly Spreadsheet Program to Estimate Costs of Providing Patient-Centered Interventions CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Reed, S. D., Li, Y., Kamble, S., Polsky, D., Graham, F. L., Bowers, M. T., Samsa, G. P., Paul, S., Schulman, K. A., Whellan, D. J., Riegel, B. J. 2012; 5 (1): 113–19

    Abstract

    Patient-centered health care interventions, such as heart failure disease management programs, are under increasing pressure to demonstrate good value. Variability in costing methods and assumptions in economic evaluations of such interventions limit the comparability of cost estimates across studies. Valid cost estimation is critical to conducting economic evaluations and for program budgeting and reimbursement negotiations.Using sound economic principles, we developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure (TEAM-HF) Costing Tool, a spreadsheet program that can be used by researchers and health care managers to systematically generate cost estimates for economic evaluations and to inform budgetary decisions. The tool guides users on data collection and cost assignment for associated personnel, facilities, equipment, supplies, patient incentives, miscellaneous items, and start-up activities. The tool generates estimates of total program costs, cost per patient, and cost per week and presents results using both standardized and customized unit costs for side-by-side comparisons. Results from pilot testing indicated that the tool was well-formatted, easy to use, and followed a logical order. Cost estimates of a 12-week exercise training program in patients with heart failure were generated with the costing tool and were found to be consistent with estimates published in a recent study.The TEAM-HF Costing Tool could prove to be a valuable resource for researchers and health care managers to generate comprehensive cost estimates of patient-centered interventions in heart failure or other conditions for conducting high-quality economic evaluations and making well-informed health care management decisions.

    View details for PubMedID 22147884

  • Risks of Adverse Events With Therapies for Age-Related Macular Degeneration: A Response ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2012; 130 (1): 125–26
  • Medical Resource Use, Costs and Quality of Life are Similar Between Patients with Acute Decompensated Heart Failure Treated with Nesiritide Versus Placebo Reed, S. D., Kaul, P., Hernandez, A. F., Li, Y., Eapen, Z. J., Schulman, K. A., Whellan, D. J., Westerhout, C. M., Massie, B., Howlett, J. G., Armstrong, P. W., Starling, R., O'Connor, C. M., Califf, R. M. LIPPINCOTT WILLIAMS & WILKINS. 2011
  • End Point Selection in Acute Decompensated Heart Failure Clinical Trials: Economic End Points HEART FAILURE CLINICS Reed, S. D., Eapen, Z. J., Schulman, K. A. 2011; 7 (4): 529-+

    Abstract

    The selection of economic end points in acute decompensated heart failure (ADHF) clinical trials requires prospectively planned evaluations that are developed in tandem with clinical end points. Integrating economic end points with concrete clinical outcomes postdischarge will provide meaningful data to evaluate a treatment's incremental value in the setting of ADHF.

    View details for PubMedID 21925436

  • THE COST-EFFECTIVENESS OF A TELAPREVIR-INCLUSIVE REGIMEN AS INITIAL THERAPY FOR GENOTYPE 1 HEPATITIS C INFECTION IN INDIVIDUALS WITH THE CC IL-28B POLYMORPHISM Gellad, Z. F., Naggie, S., Reed, S. D., Clark, P. J., Thompson, A. J., Schulman, K. A., Muir, A. J. WILEY-BLACKWELL. 2011: 417A–418A
  • Delivering affordable cancer care in high-income countries LANCET ONCOLOGY Sullivan, R., Peppercorn, J., Sikora, K., Zalcberg, J., Meropol, N. J., Amir, E., Khayat, D., Boyle, P., Autier, P., Tannock, I. F., Fojo, T., Siderov, J., Williamson, S., Camporesi, S., McVie, J. G., Purushotham, A. D., Naredi, P., Eggermont, A., Brennan, M. F., Steinberg, M. L., De Ridder, M., McCloskey, S. A., Verellen, D., Roberts, T., Storme, G., Hicks, R. J., Ell, P. J., Hirsch, B. R., Carbone, D. P., Schulman, K. A., Catchpole, P., Taylor, D., Geissler, J., Brinker, N. G., Meltzer, D., Kerr, D., Aapro, M. 2011; 12 (10): 933-980

    Abstract

    The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies.

    View details for Web of Science ID 000295787900008

    View details for PubMedID 21958503

  • Implications of Definitions of Simultaneous and Staged Bilateral Total Knee Replacement (TKR) in Device Epidemiology for Medicare Beneficiaries Setoguchi, S., Greiner, M. A., Pietrobon, R., Attarian, D., Kelley, S., Wellman, S., Schulman, K. A., Bolognesi, M. WILEY-BLACKWELL. 2011: S234–S235
  • Resource Use and Medical Costs by Cause of Death in HF-ACTION Li, Y., Whellan, D. J., Dunlap, M. E., Kraus, W. E., Samsa, G., Schulman, K. A., Zile, M., Reed, S. D. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2011: S78
  • Our failure to advance new treatments for glioma to market JOURNAL OF NEUROSURGERY Sampson, J. H., Kaminski, T. J., Schulman, K. A. 2011; 115 (2): 245–47

    View details for DOI 10.3171/2010.11.JNS101436

    View details for Web of Science ID 000293145100012

    View details for PubMedID 21568655

  • Seattle Heart Failure Model Scores Significantly Predict Medical Resource Use and Costs in HF-ACTION Reed, S. D., Li, Y., Ellis, S. J., Whellan, D. J., Schulman, K. A., O'Connor, C. M., Levy, W. C. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2011: S80
  • Bladder Augmentation Versus Urinary Diversion in Patients With Spina Bifida in the United States JOURNAL OF UROLOGY Wiener, J. S., Antonelli, J., Shea, A. M., Curtis, L. H., Schulman, K. A., Krupski, T. L., Scales, C. D. 2011; 186 (1): 161–65

    Abstract

    Augmentation cystoplasty has replaced urinary diversion as the cornerstone of surgical management of refractory neurogenic bladder in patients with spina bifida. Other than single institution series little is known about practice patterns of bladder augmentation vs diversion. Therefore, we characterized the use of bladder augmentation and urinary diversion in patients with spina bifida in a nationally representative, all payer, all ages data set.Discharge estimates were derived from the Nationwide Inpatient Sample. All patients who underwent bladder augmentation or ileal conduit diversion between 1998 and 2005 with a diagnosis consistent with spina bifida were included in the study.Bladder augmentation was performed in an estimated 3,403 patients and ileal loop diversion in 772 with spina bifida between 1998 and 2005. Patients fell into 2 clinically distinct populations. Those patients undergoing bladder augmentation tended to be younger (mean age 16 vs 36 years, p <0.001) and male (52% of bladder augmentations vs 43% of urinary diversions, p = 0.02), and to have private insurance (46% vs 29%, p <0.001) compared to those undergoing urinary diversion. Furthermore, patients undergoing urinary diversion required more health care resources, with significantly longer hospital stays, higher total charges and more use of home health care after discharge home.Augmentation cystoplasty is widely used in the surgical management of neurogenic bladder in patients with spina bifida, although ileal loop diversion is still performed in a substantial proportion with clinically distinct characteristics.

    View details for PubMedID 21575969

  • Training the Next Generation of Physician-Executives: An Innovative Residency Pathway in Management and Leadership ACADEMIC MEDICINE Ackerly, D. C., Sangvai, D. G., Udayakumar, K., Shah, B. R., Kalman, N. S., Cho, A. H., Schulman, K. A., Fulkerson, W. J., Dzau, V. J. 2011; 86 (5): 575-579

    Abstract

    The rapidly changing field of medicine demands that future physician-leaders excel not only in clinical medicine but also in the management of complex health care enterprises. However, many physicians have become leaders "by accident," and the active cultivation of future leaders is required. Addressing this need will require multiple approaches, targeting trainees at various stages of their careers, such as degree-granting programs, residency and fellowship training, and career and leadership development programs. Here, the authors describe a first-of-its-kind graduate medical education pathway at Duke Medicine, the Management and Leadership Pathway for Residents (MLPR). This program was developed for residents with both a medical degree and management training. Created in 2009, with its first cohort enrolled in the summer of 2010, the MLPR is intended to help catalyze the emergence of a new generation of physician-leaders. The program will provide physicians-in-training with rigorous clinical exposure along with mentorship and rotational opportunities in management to accelerate the development of critical leadership and management skills in all facets of medicine, including care delivery, research, and education. To achieve this, the MLPR includes 15 to 18 months of project-based rotations under the guidance of senior leaders in many disciplines including finance, patient safety, health system operations, strategy, and others. Developing both clinical and management skill sets during graduate medical education holds the promise of engaging future leaders of health care at an early career stage, keeping more MD-MBA graduates within health care, and creating a bench of talented future physician-executives.

    View details for DOI 10.1097/ACM.0b013e318212e51b

    View details for Web of Science ID 000289971300016

    View details for PubMedID 21436663

  • Use of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials MEDICAL CARE Dinan, M. A., Compton, K. L., Dhillon, J. K., Hammill, B. G., DeWitt, E., Weinfurt, K. P., Schulman, K. A. 2011; 49 (4): 415–19

    Abstract

    To optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations.To investigate current patterns of use of PROs in clinical trials.We conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials.The 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P<0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials.PRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas.

    View details for PubMedID 21368680

  • Perspective: The Case for Research Justice: Inclusion of Patients With Limited English Proficiency in Clinical Research ACADEMIC MEDICINE Glickman, S. W., Ndubuizu, A., Weinfurt, K. P., Hamilton, C. D., Glickman, L. T., Schulman, K. A., Cairns, C. B. 2011; 86 (3): 389–93

    Abstract

    Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

    View details for DOI 10.1097/ACM.0b013e318208289a

    View details for Web of Science ID 000287690700031

    View details for PubMedID 21248607

  • When experiments travel: Clinical trials and the global search for human subjects (Book Review) JOURNAL OF BIOETHICAL INQUIRY Book Review Authored by: Schulman, K. A. 2011; 8 (1): 95–96
  • Effects of Family History and Genetic Polymorphism on the Cost-Effectiveness of Chemoprevention With Finasteride for Prostate Cancer JOURNAL OF UROLOGY Reed, S. D., Scales, C. D., Stewart, S. B., Sun, J., Moul, J. W., Schulman, K. A., Xu, J. 2011; 185 (3): 841–47

    Abstract

    Improvement in the cost-effectiveness of chemoprevention for prostate cancer could be realized through the identification of patients at higher risk. We estimated the cost-effectiveness of prostate cancer chemoprevention across risk groups defined by family history and number of risk alleles, and the cost-effectiveness of targeting chemoprevention to higher risk groups.We developed a probabilistic Markov model to estimate costs, survival and quality adjusted survival across risk groups for patients receiving or not receiving chemoprevention with finasteride. The model uses data from national cancer registries, online sources and the medical literature.The incremental cost-effectiveness of 25 years of chemoprevention with finasteride in patients 50 years old was an estimated $89,300 per quality adjusted life-year (95% CI $58,800-$149,800), assuming finasteride decreased all grades of prostate cancer by 24.8%. Among patients with a positive family history (without genetic testing) chemoprevention provided 1 additional quality adjusted life-year at a cost of $64,200. Among patients with a negative family history at $400 per person tested, the cost-effectiveness of genetically targeted chemoprevention ranged from $98,100 per quality adjusted life-year when limiting finasteride to individuals with 14 or more risk alleles, to $103,200 per quality adjusted life-year when including those with 8 or more risk alleles.Although there are small differences in the cost-effectiveness of genetically targeted chemoprevention strategies in patients with a negative family history, genetic testing could reduce total expenditures if used to target chemoprevention for higher risk groups.

    View details for PubMedID 21239023

  • Resource Use in the Last 6 Months of Life Among Medicare Beneficiaries With Heart Failure, 2000-2007 ARCHIVES OF INTERNAL MEDICINE Unroe, K. T., Greiner, M. A., Hernandez, A. F., Whellan, D. J., Kaul, P., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2011; 171 (3): 196–203

    Abstract

    Heart failure is a common cause of death among Medicare beneficiaries, but little is known about health care resource use at the end of life.In a retrospective cohort study of 229,543 Medicare beneficiaries with heart failure who died between January 1, 2000, and December 31, 2007, we examined resource use in the last 180 days of life, including all-cause hospitalizations, intensive care unit days, skilled nursing facility stays, home health, hospice, durable medical equipment, outpatient physician visits, and cardiac procedures. We calculated overall costs to Medicare and predictors of costs.Approximately 80% of patients were hospitalized in the last 6 months of life; days in intensive care increased from 3.5 to 4.6 (P<.001). Use of hospice increased from 19% to nearly 40% of patients (P<.001). Unadjusted mean costs to Medicare per patient rose 26% from $28,766 to $36,216 (P<.001). After adjustment for age, sex, race, comorbid conditions, and geographic region, costs increased by 11% (cost ratio, 1.11; 95% confidence interval, 1.10-1.13). Increasing age was strongly and independently associated with lower costs. Renal disease, chronic obstructive pulmonary disease, and black race were independent predictors of higher costs.Among Medicare beneficiaries with heart failure, health care resource use at the end of life increased over time with higher rates of intensive care and higher costs. However, the use of hospice services also increased markedly, representing a shift in patterns of care at the end of life.

    View details for DOI 10.1001/archinternmed.2010.371

    View details for Web of Science ID 000287328700003

    View details for PubMedID 20937916

  • A Cautious Path Forward on Accountable Care Organizations JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Richman, B. D., Schulman, K. A. 2011; 305 (6): 602–3

    View details for PubMedID 21304085

  • Relationship Between Patient Satisfaction With Inpatient Care and Hospital Readmission Within 30 Days AMERICAN JOURNAL OF MANAGED CARE Boulding, W., Glickman, S. W., Manary, M. P., Schulman, K. A., Staelin, R. 2011; 17 (1): 41–48

    Abstract

    To determine whether hospitals where patients report higher overall satisfaction with their interactions among the hospital and staff and specifically their experience with the discharge process are more likely to have lower 30-day readmission rates after adjustment for hospital clinical performance.Among patients 18 years or older, an observational analysis was conducted using Hospital Compare data on clinical performance, patient satisfaction, and 30-day risk-standardized readmission rates for acute myocardial infarction, heart failure, and pneumonia for the period July 2005 through June 2008.A hospital-level multivariable logistic regression analysis was performed for each of 3 clinical conditions to determine the relationship between patient-reported measures of their satisfaction with the hospital stay and staff and the discharge process and 30-day readmission rates, while controlling for clinical performance.In samples ranging from 1798 hospitals for acute myocardial infarction to 2562 hospitals for pneumonia, higher hospital-level patient satisfaction scores (overall and for discharge planning) were independently associated with lower 30-day readmission rates for acute myocardial infarction (odds ratio [OR] for readmission per interquartile improvement in hospital score, 0.97; 95% confidence interval [CI], 0.94-0.99), heart failure (OR, 0.96; 95% CI, 0.95-0.97), and pneumonia (OR, 0.97; 95% CI, 0.96-0.99). These improvements were between 1.6 and 4.9 times higher than those for the 3 clinical performance measures.Higher overall patient satisfaction and satisfaction with discharge planning are associated with lower 30-day risk-standardized hospital readmission rates after adjusting for clinical quality. This finding suggests that patient-centered information can have an important role in the evaluation and management of hospital performance.

    View details for PubMedID 21348567

  • Usability evaluation of a personal health record. AMIA ... Annual Symposium proceedings. AMIA Symposium Segall, N., Saville, J. G., L'Engle, P., Carlson, B., Wright, M. C., Schulman, K., Tcheng, J. E. 2011; 2011: 1233–42

    Abstract

    The electronic personal health record (PHR) has been championed as a mediator of patient-centered care, yet its usability and utility to patients, key predictors of success, have received little attention. Human-centered design (HCD) offers validated methods for studying systems effects on users and their cognitive tasks. In HCD, user-centered activities allow potential users to shape the design of the end product and enhance its usability. We sought to evaluate the usability and functionality of HealthView, the PHR of the Duke University Health System, using HCD methods. Study participants were asked to think aloud as they carried out tasks in HealthView. They then completed surveys and interviews eliciting their reactions to the web portal. Findings were analyzed to generate redesign recommendations, which will be incorporated in a future release of HealthView.

    View details for PubMedID 22195184

  • Assessment of Left Ventricular Function in Older Medicare Beneficiaries With Newly Diagnosed Heart Failure CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Curtis, L. H., Greiner, M. A., Shea, A. M., Whellan, D. J., Hammill, B. G., Schulman, K. A., Douglas, P. S. 2011; 4 (1): 85–91

    Abstract

    Assessment of left ventricular function is a recommended performance measure for the care of patients with newly diagnosed heart failure. Little is known about the extent to which left ventricular function is assessed in real-world settings.We analyzed a 5% national sample of data from the Centers for Medicare and Medicaid Services from 1991 through 2008. Patients were 65 years or older, with incident heart failure in 1995, 1999, 2003, or 2007. We searched for evidence of tests of left ventricular function from 30 days before through 60 days after an incident heart failure diagnosis. We used logistic regression to identify patient characteristics associated with assessment of left ventricular function. There were 45 005 patients with incident heart failure in 1995, 38 425 in 1999, 39 529 in 2003, and 32 629 in 2007. Assessment of left ventricular function increased from 46% to 60%, with rest echocardiography being the predominant mode. Patients diagnosed with heart failure during a hospitalization had the highest assessment rates (58% in 1995, 64% in 1999, 69% in 2003, and 73% in 2007). After adjustment for other patient characteristics, odds of assessment were 4 times higher among patients diagnosed in inpatient settings.Nearly 40% of Medicare beneficiaries do not undergo assessment of left ventricular function when newly diagnosed with heart failure. Quality-improvement strategies are needed to optimize the care of these patients, especially in outpatient settings.

    View details for PubMedID 21098783

  • A policy approach to the development of molecular diagnostic tests NATURE BIOTECHNOLOGY Schulman, K. A., Tunis, S. R. 2010; 28 (11): 1157–59

    Abstract

    Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.

    View details for PubMedID 21057480

  • Geographic Variation and Trends in Carotid Imaging Among Medicare Beneficiaries, 2001 to 2006 CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Curtis, L. H., Greiner, M. A., Patel, M. R., Duncan, P. W., Schulman, K. A., Matchar, D. B. 2010; 3 (6): 599–606

    Abstract

    Diagnostic imaging among Medicare beneficiaries is an important contributor to rising health care costs. We examined temporal trends and geographic variation in the use of carotid ultrasound, carotid magnetic resonance angiography (MRA), and carotid x-ray angiography.Analysis of a 5% national sample of claims from the Centers for Medicare and Medicaid Services for 1999 through 2006. Patients were 65 years or older and underwent carotid ultrasound, carotid MRA, carotid x-ray angiography, or a carotid intervention. The main outcome measures were annual age-adjusted rates of carotid imaging and interventions and factors associated with the use of carotid imaging. Rates of imaging increased by 27%, from 98.2 per 1000 person-years in 2001 to 124.3 per 1000 in 2006. Rates of carotid ultrasound increased by 23%, and rates of MRA increased by 66%. Carotid intervention rates decreased from 3.6 per 1000 person-years in 2001 to 3.1 per 1000 person-years in 2006. In 2006, rates of carotid ultrasound were lowest in the New England, Mountain, and West North Central regions and highest in the Middle Atlantic and South Atlantic regions. Regional differences persisted after adjustment for patient demographic characteristics, history of vascular disease and other comorbid conditions, and study year.From 2001 through 2006, there was substantial growth and variation in the use of carotid imaging, including a marked increase in the use of MRA, and a decrease in the overall rate of carotid intervention.

    View details for PubMedID 20940248

  • Risks of Mortality, Myocardial Infarction, Bleeding, and Stroke Associated With Therapies for Age-Related Macular Degeneration ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2010; 128 (10): 1273–79

    Abstract

    To examine associations between therapies for age-related macular degeneration and risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.We conducted a retrospective cohort study of 146,942 Medicare beneficiaries 65 years or older with a claim for age-related macular degeneration between January 1, 2005, and December 31, 2006. On the basis of claims for the initial treatment, we assigned beneficiaries to 1 of 4 groups. The active control group included patients who received photodynamic therapy. The other groups included patients who received intravitreous pegaptanib octasodium, bevacizumab, or ranibizumab. We censored data from patients when they received a therapy different from the initial therapy. The main outcome measures were associations between photodynamic, pegaptanib, bevacizumab, and ranibizumab therapies and the risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.After adjustment for baseline characteristics and comorbid conditions, we found significant differences in the rates of mortality and myocardial infarction by treatment group. Specifically, the hazard of mortality was significantly lower with ranibizumab therapy than with photodynamic therapy (hazard ratio, 0.85; 99% confidence interval, 0.75-0.95) or pegaptanib use (0.84; 0.74-0.95), and the hazard of myocardial infarction was significantly lower with ranibizumab use than with photodynamic therapy (0.73; 0.58-0.92). There were no significant differences in the hazard of mortality or myocardial infarction between bevacizumab use and the other therapies. We found no statistically significant relationship between treatment group and bleeding events or stroke.Bevacizumab and ranibizumab use was not associated with increased risks of mortality, myocardial infarction, bleeding, or stroke compared with photodynamic therapy or pegaptanib use.

    View details for PubMedID 20937996

  • Commentary: Per Capita Payments in Clinical Trials: Reasonable Costs Versus Bounty Hunting ACADEMIC MEDICINE Hall, M. A., Friedman, J. Y., King, N. P., Weinfurt, K. P., Schulman, K. A., Sugarman, J. 2010; 85 (10): 1554–56

    Abstract

    Paying more for clinical research than the cost of doing the work may create a conflict of interest that could lead to overzealous recruitment, putting participants and scientific integrity at risk. Thus, although various policies prohibit "finder's fees" simply for recruiting patients, paying the actual costs for research is permissible. Whereas industry-sponsored research routinely pays for the costs of each patient enrolled, the line between reasonable and excessive costs merits more attention. In academic medical centers (AMCs), institutional review boards and conflict of interest committees usually are not involved in reviewing research budgets to determine whether per capita payments are excessive. Also, the costs for clinical services in research are not standardized. Instead, budgets are negotiated both internally, among departments within research institutions, and externally, between researchers and sponsors. Sometimes, rates paid by sponsors exceed what researchers usually receive or are actually paid for particular services, generating a surplus. Nevertheless, the authors see only limited cause for concern because, at the AMCs with which the authors are familiar, any monetary surplus generally remains within the research enterprise to cover unanticipated budget shortfalls or to support research staff in the future during lean times. In addition, the surplus from research budgets is not shared directly with individual investigators. However, further investigation is needed to determine whether practices outside AMCs pose greater concerns.

    View details for DOI 10.1097/ACM.0b013e3181ef9cc6

    View details for Web of Science ID 000282365000007

    View details for PubMedID 20881671

  • Animal, Vegetable, or ... Clinical Trial? ANNALS OF INTERNAL MEDICINE Yancy, W. S., Maciejewski, M. L., Schulman, K. A. 2010; 153 (5): 337–U93
  • Costs of Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage NEUROSURGERY Chou, C., Reed, S. D., Allsbrook, J. S., Steele, J. L., Schulman, K. A., Alexander, M. J. 2010; 67 (2): 345–51

    Abstract

    To assess the impact of vasospasm on costs, length of stay, and mortality among inpatients with aneurysmal subarachnoid hemorrhage.We combined hospital accounting and physician billing data for a consecutive cohort of 198 patients who underwent surgical clipping or endovascular coiling for subarachnoid hemorrhage repair. We considered patients with transcranial Doppler (TCD) velocity of 120 cm/s or greater in the middle cerebral artery to have TCD-defined vasospasm and patients with delayed ischemic neurological deficit to have symptomatic vasospasm. We compared outcomes of patients with TCD-defined vasospasm (n = 116) and those without (n = 73) and patients with symptomatic vasospasm (n = 62) and those without (n = 127), adjusting for demographic and clinical characteristics.In adjusted analyses, the incremental cost attributable to TCD-defined vasospasm was 1.20 times higher (95% confidence interval, 1.06-1.36; P = .004) than for patients without TCD-defined vasospasm. Length of stay was an estimated 1.22 times longer for patients with TCD-defined vasospasm (95% CI, 1.07-1.39; P < .01). For symptomatic vasospasm, adjusted costs were 1.27 times higher (95% CI, 1.12-1.43; P < .001) and length of stay was an estimated 1.24 times longer (95% CI, 1.09-1.40; P < .01) for patients with vasospasm than for those without. There was no significant relationship between either type of vasospasm and in-hospital mortality.Patients with subarachnoid hemorrhage and TCD-defined or symptomatic vasospasm incur higher inpatient costs and longer hospital stays than those without vasospasm.

    View details for PubMedID 20644420

  • Geographic Variation in Carotid Revascularization Among Medicare Beneficiaries, 2003-2006 ARCHIVES OF INTERNAL MEDICINE Patel, M. R., Greiner, M. A., DiMartino, L. D., Schulman, K. A., Duncan, P. W., Matchar, D. B., Curtis, L. H. 2010; 170 (14): 1218–25

    Abstract

    Little is known about patterns in the use of carotid revascularization since a 2004 Medicare national coverage decision supporting carotid artery stenting. We examined geographic variation in and predictors of carotid endarterectomy and carotid stenting.Analysis of claims from the Centers for Medicare & Medicaid Services from January 1, 2003, through December 31, 2006. Patients were 65 years or older and had undergone carotid endarterectomy or carotid stenting. The main outcome measures were annual age-adjusted rates of carotid endarterectomy and carotid stenting, factors associated with the use of carotid revascularization, and mortality rate at 30 days and 1 year.The rate of endarterectomy decreased from 3.2 per 1000 person-years in 2003 to 2.6 per 1000 person-years in 2006. After adjustment for demographic and clinical characteristics, there was significant geographic variation in the odds of carotid revascularization, with the East North Central region having the greatest odds of endarterectomy (odds ratio, 1.60; 95% confidence interval, 1.55-1.65) and stenting (1.61; 1.46-1.78) compared with New England. Prior endarterectomy (odds ratio, 3.06; 95% confidence interval, 2.65-3.53) and coronary artery disease (2.12; 2.03-2.21) were strong predictors of carotid stenting. In 2005, mortality was 1.2% at 30 days and 6.8% at 1 year for endarterectomy and 2.3% at 30 days and 10.3% at 1 year for stenting.Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.

    View details for Web of Science ID 000280347400006

    View details for PubMedID 20660840

  • Economic Evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) Randomized Controlled Trial An Exercise Training Study of Patients With Chronic Heart Failure CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Reed, S. D., Whellan, D. J., Li, Y., Friedman, J. Y., Ellis, S. J., Pina, I. L., Settles, S. J., Davidson-Ray, L., Johnson, J. L., Cooper, L. S., O'Connor, C. M., Schulman, K. A., HF-ACTIOn Investigators 2010; 3 (4): 374–81

    Abstract

    Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) assigned 2331 outpatients with medically stable heart failure to exercise training or usual care. We compared medical resource use and costs incurred by these patients during follow-up.Extensive data on medical resource use and hospital bills were collected throughout the trial for estimates of direct medical costs. Intervention costs were estimated using patient-level trial data, administrative records, and published unit costs. Mean follow-up was 2.5 years. There were 2297 hospitalizations in the exercise group and 2332 in the usual care group (P=0.92). The mean number of inpatient days was 13.6 (standard deviation [SD], 27.0) in the exercise group and 15.0 (SD, 31.4) in the usual care group (P=0.23). Other measures of resource use were similar between groups, except for trends indicating that fewer patients in the exercise group underwent high-cost inpatient procedures. Total direct medical costs per participant were an estimated $50,857 (SD, $81,488) in the exercise group and $56,177 (SD, $92,749) in the usual care group (95% confidence interval for the difference, $-12,755 to $1547; P=0.10). The direct cost of exercise training was an estimated $1006 (SD, $337). Patient time costs were an estimated $5018 (SD, $4600).The cost of exercise training was relatively low for the health care system, but patients incurred significant time costs. In this economic evaluation, there was little systematic benefit in terms of overall medical resource use with this intervention.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047437.

    View details for PubMedID 20551371

  • Oversight of Financial Conflicts of Interest in Commercially Sponsored Research in Academic and Nonacademic Settings Weinfurt, K. P., Hall, M. A., Hardy, N., Friedman, J. Y., Schulman, K. A., Sugarman, J. SPRINGER. 2010: 460–64

    Abstract

    Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings.Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007.Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001).Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

    View details for PubMedID 20186498

  • Can We Close The Income And Wealth Gap Between Specialists And Primary Care Physicians? HEALTH AFFAIRS Vaughn, B. T., DeVrieze, S. R., Reed, S. D., Schulman, K. A. 2010; 29 (5): 933–40

    Abstract

    Over their lifetimes, primary care physicians earn lower incomes--and accumulate considerably less wealth--than their specialist counterparts. This gap influences medical students, who are choosing careers in primary care in declining numbers. We estimated career wealth accumulation across specialists, primary care physicians, physician assistants, business school graduates, and college graduates. We then compared specialists, represented by cardiologists, to primary care physicians in four scenarios. The wealth gap is substantial; narrowing it would require substantial reductions in specialists' practice income or increases in primary care physicians' practice income, or both, of more than $100,000 a year. Current proposals for increasing primary care physician supply would do little to lessen these differences.

    View details for PubMedID 20439883

  • Changes in the Use and Costs of Diagnostic Imaging Among Medicare Beneficiaries With Cancer, 1999-2006 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dinan, M. A., Curtis, L. H., Hammill, B. G., Patz, E. F., Abernethy, A. P., Shea, A. M., Schulman, K. A. 2010; 303 (16): 1625–31

    Abstract

    Emerging technologies, changing diagnostic and treatment patterns, and changes in Medicare reimbursement are contributing to increasing use of imaging in cancer. Imaging is the fastest growing expense for Medicare but has not been examined among beneficiaries with cancer.To examine changes in the use of imaging and how those changes contribute to the overall cost of cancer care.Analysis of a nationally representative 5% sample of claims from the US Centers for Medicare & Medicaid Services from 1999 through 2008. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, or prostate cancer.Use and cost of imaging by modality, year, and cancer type.There were 100,954 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, and prostate cancer from 1999 through 2006. Significant mean annual increases in imaging use occurred among all cancer types for positron emission tomography (35.9%-53.6%), bone density studies (6.3%-20.0%), echocardiograms (5.0%-7.8%), magnetic resonance imaging (4.4%-11.5%), and ultrasound (0.7%-7.4%). Conventional radiograph rates decreased or stayed the same. As of 2006, beneficiaries with lung cancer and beneficiaries with lymphoma incurred the largest overall imaging costs, exceeding a mean of $3000 per beneficiary within 2 years of diagnosis. By 2005, one-third of beneficiaries with breast cancer underwent bone scans and half of beneficiaries with lung cancer or lymphoma underwent positron emission tomography scans. Mean 2-year imaging costs per beneficiary increased at a rate greater than the increase in mean total costs per beneficiary for all cancer types.Imaging costs among Medicare beneficiaries with cancer increased from 1999 through 2006, outpacing the rate of increase in total costs among Medicare beneficiaries with cancer.

    View details for DOI 10.1001/jama.2010.460

    View details for Web of Science ID 000277085200026

    View details for PubMedID 20424253

  • STAR 3 Randomized Controlled Trial to Compare Sensor-Augmented Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 1 Diabetes: Research Design, Methods, and Baseline Characteristics of Enrolled Subjects DIABETES TECHNOLOGY & THERAPEUTICS Davis, S. N., Horton, E. S., Battelino, T., Rubin, R. R., Schulman, K. A., Tamborlane, W. V. 2010; 12 (4): 249–55

    Abstract

    Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes.Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments.A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010.Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.

    View details for DOI 10.1089/dia.2009.0145

    View details for Web of Science ID 000275301700001

    View details for PubMedID 20210562

    View details for PubMedCentralID PMC2883476

  • Clopidogrel use and clinical events after drug-eluting stent implantation: Findings from the HealthCore Integrated Research Database AMERICAN HEART JOURNAL Petersen, J. L., Barron, J. J., Hammill, B. G., Cziraky, M. J., Anstrom, K. J., Wahl, P. M., Eisenstein, E. L., Krucoff, M. W., Califf, R. M., Schulman, K. A., Curtis, L. H. 2010; 159 (3): 462–U167

    Abstract

    Relationships between long-term use and level of dual antiplatelet therapy and outcomes after drug-eluting stent implantation are not well established.This is a retrospective cohort study of 9,256 patients receiving drug-eluting stents between January 2003 and August 2006. We classified patients according to tertiles of clopidogrel use during the 12 months after stent implantation. We used inverse probability weighting to account for differential selection into levels of clopidogrel use and logistic regression to estimate propensity scores for levels of clopidogrel use. We used Cox proportional hazards models to estimate effects of level of clopidogrel use on risk of bleeding events, death, and death or nonfatal myocardial infarction.There were 3,102 patients in the high-use group, 3,069 in the medium-use group, and 3,085 in the low-use group. Compared with the high-use group, risk of death or nonfatal myocardial infarction was greater in the medium-use group (hazard ratio [HR] 1.46, 95% CI 1.09-1.99, P = .01) and the low-use group (HR 1.59, 95% CI 1.18-2.14, P = .002). The risk of bleeding events was lower in the medium-use group (HR 0.84, 95% CI 0.71-0.98, P = .03) and the low-use group (HR 0.77, 95% CI 0.65-0.90, P = .002).Higher clopidogrel use 12 months after drug-eluting stent implantation was associated with a greater risk of subsequent bleeding events. Lower use was associated with a greater risk of death or nonfatal myocardial infarction.

    View details for PubMedID 20211310

  • Patient Reactions to Confidentiality, Liability, and Financial Aspects of Informed Consent in Cardiology Research CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Fortune-Greeley, A. K., Hardy, N., Lin, L., Friedman, J. Y., Lawlor, J. S., Muhlbaier, L. H., Hall, M. A., Schulman, K. A., Sugarman, J., Weinfurt, K. P. 2010; 3 (2): 151–U90

    Abstract

    Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001).Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

    View details for PubMedID 20233979

  • Relationships between emerging measures of heart failure processes of care and clinical outcomes AMERICAN HEART JOURNAL Hernandez, A. F., Hammill, B. G., Peterson, E. D., Yancy, C. W., Schulman, K. A., Curtis, L. H., Fonarow, G. C. 2010; 159 (3): 406–13

    Abstract

    Previous studies have not confirmed associations between some current performance measures for inpatient heart failure processes of care and postdischarge outcomes. It is unknown if alternative measures are associated with outcomes.Using data for 20,441 Medicare beneficiaries in OPTIMIZE-HF from March 2003 through December 2004, which we linked to Medicare claims data, we examined associations between hospital-level processes of care and patient outcomes. Performance measures included any beta-blocker for patients with left ventricular systolic dysfunction (LVSD); evidence-based beta-blocker for patients with LVSD; warfarin for patients with atrial fibrillation; aldosterone antagonist for patients with LVSD; implantable cardioverter-defibrillator for patients with ejection fraction < or =35%; and referral to disease management. Outcome measures were unadjusted and adjusted associations of each process measure with 60-day and 1-year mortality and cardiovascular readmission at the hospital level.Adjusted hazard ratios for 1-year mortality with a 10% increase in hospital- level adherence were 0.94 for any beta-blocker (95% CI, 0.90-0.98; P = .004), 0.95 for evidence-based beta-blocker (95% CI, 0.92-0.98; P = .004); 0.97 for warfarin (95% CI, 0.92-1.03; P = .33); 0.94 for aldosterone antagonists (95% CI, 0.91-0.98; P = .006); 0.92 for implantable cardioverter-defibrillator (95% CI, 0.87-0.98; P = .007); and 1.01 for referral to disease management (95% CI, 0.99-1.03; P = .21).Several evidence-based processes of care are associated with improved outcomes, can discriminate hospital-level quality of care, and could be considered as clinical performance measures.

    View details for PubMedID 20211302

  • Patient Satisfaction and Its Relationship With Clinical Quality and Inpatient Mortality in Acute Myocardial Infarction CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Glickman, S. W., Boulding, W., Manary, M., Staelin, R., Roe, M. T., Wolosin, R. J., Ohman, E., Peterson, E. D., Schulman, K. A. 2010; 3 (2): 188–95

    Abstract

    Hospitals use patient satisfaction surveys to assess their quality of care. A key question is whether these data provide valid information about the medically related quality of hospital care. The objective of this study was to determine whether patient satisfaction is associated with adherence to practice guidelines and outcomes for acute myocardial infarction and to identify the key drivers of patient satisfaction.We examined clinical data on 6467 patients with acute myocardial infarction treated at 25 US hospitals participating in the CRUSADE initiative from 2001 to 2006. Press Ganey patient satisfaction surveys for cardiac admissions were also available from 3562 patients treated at these same 25 centers over this period. Patient satisfaction was positively correlated with 13 of 14 acute myocardial infarction performance measures. After controlling for a hospital's overall guideline adherence score, higher patient satisfaction scores were associated with lower risk-adjusted inpatient mortality (P=0.025). One-quartile changes in both patient satisfaction and guideline adherence scores produced similar changes in predicted survival. For example, a 1-quartile change (75th to 100th) in either the patient satisfaction score or the guideline adherence score yielded the same change in predicted survival (odds ratio, 1.24; 95% CI, 1.02 to 1.49; and odds ratio, 1.24; 95% CI, 1.08 to 1.41, respectively). Satisfaction with nursing care was the most important determinant of overall patient satisfaction (P<0.001).Higher patient satisfaction is associated with improved guideline adherence and lower inpatient mortality rates, suggesting that patients are good discriminators of the type of care they receive. Thus, patients' satisfaction with their care provides important incremental information on the quality of acute myocardial infarction care.

    View details for PubMedID 20179265

  • Process of Care Performance Measures and Long-Term Outcomes in Patients Hospitalized With Heart Failure MEDICAL CARE Patterson, M. E., Hernandez, A. F., Hammill, B. G., Fonarow, G. C., Peterson, E. D., Schulman, K. A., Curtis, L. H. 2010; 48 (3): 210–16

    Abstract

    Recent efforts to improve care for patients hospitalized with heart failure have focused on process-based performance measures. Data supporting the link between current process measures and patient outcomes are sparse.To examine the relationship between adherence to hospital-level process measures and long-term patient-level mortality and readmission.Analysis of data from a national clinical registry linked to outcome data from the Centers for Medicare and Medicaid Services (CMS).A total of 22,750 Medicare fee-for-service beneficiaries enrolled in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure between March 2003 and December 2004.Mortality at 1 year; cardiovascular readmission at 1 year; and adherence to hospital-level process measures, including discharge instructions, assessment of left ventricular function, prescription of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker at discharge, prescription of beta-blockers at discharge, and smoking cessation counseling for eligible patients.Hospital conformity rates ranged from 52% to 86% across the 5 process measures. Unadjusted overall 1-year mortality and cardiovascular readmission rates were 33% and 40%, respectively. In covariate-adjusted analyses, the CMS composite score was not associated with 1-year mortality (hazard ratio, 1.00; 95% confidence interval, 0.98-1.03; P = 0.91) or readmission (hazard ratio, 1.01; 95% confidence interval, 0.99-1.04; P = 0.37). Current CMS process measures were not independently associated with mortality, though prescription of beta-blockers at discharge was independently associated with lower mortality (hazard ratio, 0.94; 95% confidence interval, 0.90-098; P = 0.004).Hospital process performance for heart failure as judged by current CMS measures is not associated with patient outcomes within 1 year of discharge, calling into question whether existing CMS metrics can accurately discriminate hospital quality of care for heart failure.

    View details for PubMedID 20125043

  • Increased rate of central venous catheterization procedures in community EDs AMERICAN JOURNAL OF EMERGENCY MEDICINE Glickman, S. W., Krubert, C., Koppenhaver, J., Glickman, L. T., Schulman, K. A., Cairns, C. B. 2010; 28 (2): 208–12

    Abstract

    Central venous catheterization (CVC) is integral to the emergency department (ED) treatment of critically ill patients, such as those receiving early goal-directed therapy for severe sepsis. No previous studies have described the overall use of CVC in community EDs. The objective of this study was to estimate the overall frequency and temporal trends in CVC use in a sample of patients visiting community EDs.This was a retrospective observational study of 2.97 million patient visits at 28 community EDs (range of annual visits, 10 837-110 136) from January 2004 to February 2008. Data were obtained from a community-based research consortium. Central venous catheterization procedures were aggregated at the hospital level for each study year. Trends in CVC use were evaluated using linear regression.Three thousand four hundred eighty-nine patient visits (0.12% of all ED patient visits) had a CVC procedure performed in the ED. The overall rate of CVC procedures per 1000 ED patient visits increased from 0.87 (95% confidence interval [CI(95%)], 0.80-0.95) in 2004 to 1.62 (CI(95%), 1.38-1.91) procedures in 2008 (P value for trend = .003). There was wide variability in the frequency of CVC procedures performed among EDs, ranging from a low of 0.27 (CI(95%), 0.18-0.42) to a high of 7.58 (CI(95%), 6.27-9.17) procedures per 1000 ED visits. The CVC procedure rates were lower in the 8 rural EDs (0.99 CVCs per 1000 ED patient visits [CI(95%), 0.91-1.07] compared with the 20 urban EDs (1.22 CVCs [CI(95%), 1.18-1.27]; P < .001). An increasing rate of CVC procedures during the study period was observed in urban EDs (0.84-1.94 CVCs per 1000 ED patient visits; P value for trend = .005) but not in rural EDs (1.1-0.93; P value for trend = .41) during the study period.The overall rate of CVC increased from 2004 to 2008. However, there was a wide variation among Eds, and the CVC rate was lower in rural compared with urban EDs. The increase in CVC use in urban EDs may reflect more intensive therapy in the management of ED patients with acute illness or injury. Future efforts are needed to optimize best practices for the use of CVC in community ED practices and to characterize factors responsible for urban rural differences in the rate of CVC procedures.

    View details for PubMedID 20159392

  • Relationship Between Cardiac Rehabilitation and Long-Term Risks of Death and Myocardial Infarction Among Elderly Medicare Beneficiaries CIRCULATION Hammill, B. G., Curtis, L. H., Schulman, K. A., Whellan, D. J. 2010; 121 (1): 63–70

    Abstract

    For patients with coronary heart disease, exercise-based cardiac rehabilitation improves survival rate and has beneficial effects on risk factors for coronary artery disease. The relationship between the number of sessions attended and long-term outcomes is unknown.In a national 5% sample of Medicare beneficiaries, we identified 30 161 elderly patients who attended at least 1 cardiac rehabilitation session between January 1, 2000, and December 31, 2005. We used a Cox proportional hazards model to estimate the relationship between the number of sessions attended and death and myocardial infarction (MI) at 4 years. The cumulative number of sessions was a time-dependent covariate. After adjustment for demographic characteristics, comorbid conditions, and subsequent hospitalization, patients who attended 36 sessions had a 14% lower risk of death (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.77 to 0.97) and a 12% lower risk of MI (HR, 0.88; 95% CI, 0.83 to 0.93) than those who attended 24 sessions; a 22% lower risk of death (HR, 0.78; 95% CI, 0.71 to 0.87) and a 23% lower risk of MI (HR, 0.77; 95% CI, 0.69 to 0.87) than those who attended 12 sessions; and a 47% lower risk of death (HR, 0.53; 95% CI, 0.48 to 0.59) and a 31% lower risk of MI (HR, 0.69; 95% CI, 0.58 to 0.81) than those who attended 1 session.Among Medicare beneficiaries, a strong dose-response relationship existed between the number of cardiac rehabilitation sessions and long-term outcomes. Attending all 36 sessions reimbursed by Medicare was associated with lower risks of death and MI at 4 years compared with attending fewer sessions.

    View details for DOI 10.1161/CIRCULATIONAHA.109.876383

    View details for Web of Science ID 000273267700010

    View details for PubMedID 20026778

    View details for PubMedCentralID PMC2829871

  • Clinical Effectiveness of Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries With Heart Failure CIRCULATION-HEART FAILURE Hernandez, A. F., Fonarow, G. C., Hammill, B. G., Al-Khatib, S. M., Yancy, C. W., O'Connor, C. M., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2010; 3 (1): 7–13

    Abstract

    The clinical effectiveness of implantable cardioverter-defibrillators (ICDs) in older patients with heart failure has not been established, and older patients have been underrepresented in previous studies.We identified patients with heart failure who were aged 65 years or older and were eligible for an ICD, had left ventricular ejection fraction of 35% or less, and were discharged alive from hospitals participating in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure and the Get With the Guidelines-Heart Failure quality-improvement programs during the period January 1, 2003, through December 31, 2006. We matched the patients to Medicare claims to examine long-term outcomes. The main outcome measure was all-cause mortality over 3 years. The study population included 4685 patients who were discharged alive and were eligible for an ICD. Mean age was 75.2 years, 60% of the patients were women, mean ejection fraction was 25%, and 376 (8.0%) patients received an ICD before discharge. Mortality was significantly lower among patients who received an ICD compared with those who did not (19.8% versus 27.6% at 1 year, 30.9% versus 41.9% at 2 years, and 38.1% versus 52.3% at 3 years; P<0.001 for all comparisons). The inverse probability-weighted adjusted hazard of mortality at 3 years for patients receiving an ICD was 0.71 (95% CI, 0.56 to 0.91).Medicare beneficiaries hospitalized with heart failure and left ventricular ejection fraction of 35% or less who were selected for ICD therapy had lower risk-adjusted long-term mortality compared with those who did not receive an ICD. Clinical Trial Registration- clinicaltrials.gov. Identifier: NCT00344513.

    View details for PubMedID 20009044

  • Costs of Inpatient Care Among Medicare Beneficiaries With Heart Failure, 2001 to 2004 CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Whellan, D. J., Greiner, M. A., Schulman, K. A., Curtis, L. H. 2010; 3 (1): 33–40

    Abstract

    Inpatient care is the primary driver of costs for patients with heart failure. It is unclear whether recent advances in heart failure care have reduced the costs to Medicare for the care of inpatients with heart failure.In a retrospective cohort study of 1 363 977 elderly Medicare beneficiaries hospitalized with heart failure between January 1, 2001, and December 31, 2004, we examined costs to Medicare for all inpatient care, inpatient cardiovascular care, and inpatient heart failure care and the adjusted relationships between patient characteristics and costs. Among 1 363 977 Medicare beneficiaries with an index heart failure hospitalization, 901 885 (66%) had a subsequent inpatient claim during the following year. Noncardiovascular costs accounted for 57% of total inpatient costs, and costs associated with heart failure hospitalizations accounted for 15% of total inpatient costs. No significant changes occurred in total, cardiovascular, and heart failure inpatient costs over time.The costs of inpatient care for patients with heart failure are high, but most subsequent inpatient costs are attributable to noncardiovascular and non-heart failure admissions. Further research is needed to identify predictors of costs, so that patients can be stratified according to risk, and to evaluate strategies that target primary cost drivers for patients with heart failure.

    View details for PubMedID 20123669

  • Addressing the systems-based practice requirement with health policy content and educational technology MEDICAL TEACHER Nagler, A., Andolsek, K., Dossary, K., Schlueter, J., Schulman, K. 2010; 32 (12): E559–E565

    Abstract

    Duke University Hospital Office of Graduate Medical Education and Duke University's Fuqua School of Business collaborated to offer a Health Policy lecture series to residents and fellows across the institution, addressing the "Systems-based Practice" competency.During the first year, content was offered in two formats: live lecture and web/podcast. Participants could elect the modality which was most convenient for them. In Year Two, the format was changed so that all content was web/podcast and a quarterly live panel discussion was led by module presenters or content experts. Lecture evaluations, qualitative focus group feedback, and post-test data were analyzed.A total of 77 residents and fellows from 8 (of 12) Duke Graduate Medical Education departments participated. In the first year, post-test results were the same for those who attended the live lectures and those who participated via web/podcast. A greater number of individuals participated in Year Two. Participants from both years expressed the need for health policy content in their training programs. Participants in both years valued a hybrid format for content delivery, recognizing a desire for live interaction with the convenience of accessing web/podcasts at times and locations convenient for them. A positive unintended consequence of the project was participant networking with residents and fellows from other specialties.

    View details for PubMedID 21090944

  • Economic Content in Medical Journal Advertisements for Medical Devices and Prescription Drugs PHARMACOECONOMICS Ackerly, D., Glickman, S. W., Schulman, K. A. 2010; 28 (5): 429–38

    Abstract

    Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

    View details for PubMedID 20402543

  • Resource use and costs of branch and central retinal vein occlusion in the elderly CURRENT MEDICAL RESEARCH AND OPINION Fekrat, S., Shea, A. M., Hammill, B. G., Nguyen, H., Kowalski, J. W., Schulman, K. A., Curtis, L. H. 2010; 26 (1): 223–30

    Abstract

    To examine the incidence, prevalence, resource use, and costs associated with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) in elderly patients.In a retrospective cohort study of a nationally representative sample of Medicare beneficiaries from 2001 through 2006, the authors identified patients with BRVO (n = 10,682) and CRVO (n = 6236) and controls with hypertension (n = 49,524) and glaucoma (n = 49,569) but no retinal vein occlusion. Incident cases were those with no claims listing a diagnosis for the same type of retinal vein occlusion in the previous 12 months. Prevalence was defined as the number of beneficiaries with a diagnosis of BRVO or CRVO. The authors summed Medicare reimbursements for all claims and used generalized linear models to estimate the effects of BRVO and CRVO on 1-year and 3-year costs compared with hypertension and glaucoma control groups. The authors also examined trends in the use of diagnostic and treatment modalities.Resource use (fluorescein angiography, optical coherence tomography, intravitreal injection, laser photocoagulation, and vitrectomy) and direct medical costs (total Medicare reimbursement amounts as recorded on each inpatient, outpatient, home health, skilled nursing, hospice, durable medical equipment, and professional service claim) at 1 year and 3 years.After adjustment for baseline characteristics, BRVO was associated with 16% higher 1-year costs and 12% higher 3-year costs compared with hypertension and 18% higher 1-year costs and 13% higher 3-year costs compared with glaucoma. CRVO was associated with 22% higher 1-year costs and 15% higher 3-year costs compared with hypertension and 24% higher 1-year costs and 16% higher 3-year costs compared with glaucoma. Use of fluorescein angiography and optical coherence tomography increased during the study. Use of intravitreal injections increased from less than 1% of patients overall to greater than 13% for BRVO and 16% for CRVO. The incidence of BRVO declined slightly during the study period, whereas the incidence of CRVO remained relatively flat. Prevalence increased in both groups.The results may not be generalizable to younger patients or managed-care beneficiaries. The study included only direct costs to Medicare, not nonmedical expenditures or outpatient prescription medications. Diagnosis and procedure codes may not have been complete. The study could not account for clinical variables, such as the amount of vision loss. It was not feasible to adjust for whether one or both eyes were affected or treated.Although not common in the Medicare population, BRVO and CRVO are important independent predictors of total medical costs. Diagnostic and treatment modalities have changed over time.

    View details for PubMedID 19921963

  • Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation. Journal of cardiac failure Patterson, M. E., Grant, W. C., Glickman, S. W., Massie, B. M., Ammon, S. E., Armstrong, P. W., Cleland, J. G., Collins, J. F., Teo, K. K., Schulman, K. A., Reed, S. D. 2009; 15 (10): 819–27

    Abstract

    BACKGROUND: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial revealed no significant differences among 1587 symptomatic heart failure patients randomized to warfarin, clopidogrel, or aspirin in time to all-cause death, nonfatal myocardial infarction, or nonfatal stroke. We compared within-trial medical resource use and costs between treatments.METHODS AND RESULTS: We assigned country-specific costs to medical resources incurred during follow-up. Annualized rates of hospitalizations, inpatient and outpatient procedures, and emergency department visits did not differ significantly between groups. Annualized total costs averaged $5901 (95% confidence interval [CI], $4776-$7520) for the aspirin group, $5646 (95% CI, $4903-$6584) for the clopidogrel group, and $5830 (95% CI, $4838-$7400) for the warfarin group.CONCLUSIONS: Consistent with clinical findings, our analyses did not identify significant cost differences between treatments.

    View details for PubMedID 19944357

  • Response to Letter Regarding Article, "Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial" CIRCULATION Massie, B. M., Ammon, S. E., Collins, J. F., Krol, W. F., Armstrong, P. W., Cleland, J. F., Ezekowitz, M., Jafri, S. M., O'Connor, C. M., Schulman, K. A., Teo, K., Warren, S. 2009; 120 (20): E165
  • Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures AMERICAN JOURNAL OF HEMATOLOGY Dinan, M. A., Chou, C., Hammill, B. G., Graham, F. L., Schulman, K. A., Telen, M. J., Reed, S. D. 2009; 84 (11): 703–9

    Abstract

    In this study, we examined differences in inpatient costs, length of stay, and in-hospital mortality between hospitalizations for patients with and without sickle cell disease (SCD) undergoing high-volume surgical procedures. We used Clinical Classification Software (CCS) codes to identify discharges in the 2002-2005 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project for patients who had undergone either cholecystectomy or hip replacement. We limited the non-SCD cohort to hospitals where patients with SCD had undergone the same procedure. We compared inpatient outcomes using summary statistics and generalized linear regression analysis to adjust for patient, hospital, and procedural characteristics. Overall, the median age of surgical patients with SCD was more than three decades less than the median age of patients without SCD undergoing the same procedure. In recognition of the age disparity, we limited the analyses to patients aged 18 to 64 years. Nonetheless, patients with SCD undergoing cholecystectomy or hip replacement were 12.1 and 14.4 years younger, had inpatient stays that were 73% and 82% longer, and incurred costs that were 46% and 40% higher per discharge than patients without SCD, respectively. Inpatient mortality for these procedures was low, approximately 0.6% for cholecystectomy and 0.2% for hip replacement and did not differ significantly between patients with and without SCD. Multivariable regression analyses revealed that higher inpatient costs among patients with SCD were primarily attributable to longer hospital stays. Patients with SCD who underwent cholecystectomy or hip replacement required more health care resources than patients without SCD. Am. J. Hematol. 2009. (c) 2009 Wiley-Liss, Inc.

    View details for PubMedID 19787790

  • Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure AMERICAN HEART JOURNAL Flynn, K. E., Lin, L., Ellis, S. J., Russell, S. D., Spertus, J. A., Whellan, D. J., Pina, I. L., Fine, L. J., Schulman, K. A., Weinfurt, K. P., HF-ACTION Investigators 2009; 158 (4): S64–S71

    Abstract

    Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure.Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions.The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II.These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

    View details for PubMedID 19782791

    View details for PubMedCentralID PMC2805910

  • New York Heart Association functional class predicts exercise parameters in the current era AMERICAN HEART JOURNAL Russell, S. D., Saval, M. A., Robbins, J. L., Ellestad, M. H., Gottlieb, S. S., Handberg, E. M., Zhou, Y., Chandler, B., HF-ACTION Investigators 2009; 158 (4): S24–S30

    Abstract

    The New York Heart Association (NYHA) functional class is a subjective estimate of a patient's functional ability based on symptoms that do not always correlate with the objective estimate of functional capacity, peak oxygen consumption (peak V(O2)). In addition, relationships between these 2 measurements have not been examined in the current medical era when patients are using beta-blockers, aldosterone antagonists, and cardiac resynchronization therapy (CRT). Using baseline data from the HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing) study, we examined this relationship.One thousand seven hundred fifty-eight patients underwent a symptom-limited metabolic stress test and stopped exercise due to dyspnea or fatigue. The relationship between NYHA functional class and peak V(O2) was examined. In addition, the effects of beta-blockers, aldosterone antagonists, and CRT therapy on these relationships were compared.The NYHA II patients have a significantly higher peak Vo(2) (16.1 +/- 4.6 vs 13.0 +/- 4.2 mL/kg per minute), a lower ventilation (Ve)/V(CO2) slope (32.8 +/- 7.7 vs 36.8 +/- 10.4), and a longer duration of exercise (11.0 +/- 3.9 vs 8.0 +/- 3.4 minutes) than NYHA III/IV patients. Within each functional class, there was no difference in any of the exercise parameters between patients on or off of beta-blockers, aldosterone antagonists, or CRT therapy. Finally, with increasing age, a significant difference in peak Vo(2), Ve/V(CO2) slope, and exercise time was found.For patients being treated with current medical therapy, there still is a difference in true functional capacity between NYHA functional class II and III/IV patients. However, within each NYHA functional class, the presence or absence or contemporary heart failure therapies does not alter exercise parameters.

    View details for DOI 10.1016/j.ahj.2009.07.017

    View details for Web of Science ID 000270705800004

    View details for PubMedID 19782785

    View details for PubMedCentralID PMC2762947

  • Relationship of age and exercise performance in patients with heart failure: The HF-ACTION study AMERICAN HEART JOURNAL Forman, D. E., Clare, R., Kitzman, D. W., Ellis, S. J., Fleg, J. L., Chiara, T., Fletcher, G., Kraus, W. E., HF-ACTION Investigators 2009; 158 (4): S6–S15

    Abstract

    More than three fourths of patients with heart failure (HF) are 65 years and older, and older age is associated with worse symptoms and prognoses than is younger age. Reduced exercise capacity is a chief HF complaint and indicates poorer prognosis, especially among elderly persons, but the mechanisms underlying functional decline in older patients with HF are largely unknown.Baseline cardiopulmonary exercise testing data from the HF-ACTION trial were assessed to clarify age effects on peak oxygen consumption (VO(2)) and ventilation-carbon dioxide production (VE/VCO(2)) slope.Among 2,331 New York Heart Association class II-IV patients with HF, increased age corresponded to decreased peak VO(2) (-0.14 mL kg(-1) min(-1) per year >40 years; P < .0001) and increased VE/VCO(2) slope (0.30 U/y >70 years; P < .0001). In a multivariable model with 34 other potential determinants, age was the strongest independent predictor of peak VO(2) (partial R(2) 0.130, total R(2) 0.392; P < .001) and a significant but relatively weaker predictor of VE/VCO(2) slope (partial R(2) 0.037, total R(2) 0.199; P < .001). Blunted peak heart rate was also a strong predictor of peak VO(2). Although peak heart rate and age were strongly correlated, both were significant independent predictors of peak VO(2) when analyzed simultaneously in a model. Aggregate comorbidity increased significantly with age but did not account for age effects on peak VO(2).Age is the strongest predictor of peak VO(2) and a significant predictor of VE/VCO(2) slope in the HF-ACTION population. Age-dependent comorbidities do not explain changes in peak VO(2). Age-related changes in cardiovascular physiology, potentially magnified by the HF disease state, should be considered a contributor to the pathophysiology and a target for more effective therapy in older patients with HF.

    View details for DOI 10.1016/j.ahj.2009.07.018

    View details for Web of Science ID 000270705800002

    View details for PubMedID 19782790

    View details for PubMedCentralID PMC2762946

  • Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction AMERICAN HEART JOURNAL Keteyian, S. J., Isaac, D., Thadani, U., Roy, B. A., Bensimhon, D. R., McKelvie, R., Russell, S. D., Hellkamp, A. S., Kraus, W. E., HF-ACTION Investigators 2009; 158 (4): S72–S77

    Abstract

    To assess the safety of symptom-limited exercise testing in patients with New York Heart Association class II-IV heart failure symptoms due to left ventricular systolic dysfunction, we investigated the frequency of all-cause fatal and nonfatal major cardiovascular (CV) events among subjects enrolled in a prospective clinical trial (HF-ACTION). We hypothesized that exercise testing would be safe, as defined by a rate for all-cause death of <0.1 per 1,000 tests and a rate of nonfatal CV events <1.0 per 1,000 tests.Before enrollment and at 3, 12, and 24 months after randomization, subjects were scheduled to complete a symptom-limited graded exercise test with open-circuit spirometry for analysis of expired gases. To ensure the accurate reporting of exercise test-related events, we report deaths and nonfatal major CV events per 1,000 tests at months 3, 12, or 24 after randomization.A total of 2,331 subjects were randomized into HF-ACTION. After randomization, 2,037 subjects completed 4,411 exercise tests. There were no test-related deaths, exacerbation of heart failure or angina requiring hospitalization, myocardial infarctions, strokes, or transient ischemic attacks. There was one episode each of ventricular fibrillation and sustained ventricular tachycardia. There were no exercise test-related implantable cardioverter defibrillator discharges requiring hospitalization. These findings correspond to zero deaths per 1,000 exercise tests and 0.45 nonfatal major CV events per 1,000 exercise tests (95% CI 0.11-1.81).In New York Heart Association class II-IV patients with severe left ventricular systolic dysfunction, we observed that symptom-limited exercise testing is safe based on no deaths and a rate of nonfatal major CV events that is <0.5 per 1,000 tests.

    View details for DOI 10.1016/j.ahj.2009.07.014

    View details for Web of Science ID 000270705800010

    View details for PubMedID 19782792

    View details for PubMedCentralID PMC2762951

  • Understanding heart failure through the HF-ACTION baseline characteristics AMERICAN HEART JOURNAL O'Connor, C. M., Whellan, D. J., HF-ACTION Investigators 2009; 158 (4): S1–S5

    View details for DOI 10.1016/j.ahj.2009.07.013

    View details for Web of Science ID 000270705800001

    View details for PubMedID 19782783

  • Alternative Pay-for-Performance Scoring Methods Implications for Quality Improvement and Patient Outcomes MEDICAL CARE Glickman, S. W., Boulding, W., Roos, J. T., Staelin, R., Peterson, E. D., Schulman, K. A. 2009; 47 (10): 1062–68

    Abstract

    Pay-for-performance programs typically rate hospitals using a composite summary score in which process measures are weighted by the total number of treatment opportunities. Alternative methods that weight process measures according to how hospitals organize care and the range for possible improvement may be more closely related to patient outcomes.To develop a hospital-level summary process measure adherence score that reflects how hospitals organize cardiac care and the range for possible improvement; and to compare associations of hospital adherence to this score and adherence to a composite score based on the Centers for Medicare and Medicaid Services scoring system with inpatient mortality.Hospital-level analysis of 7 process measures for acute myocardial infarction (AMI) and 4 process measures for heart failure at 4226 hospitals, and inpatient mortality after AMI at 1351 hospitals in the United States. Data are from the Hospital Compare and Joint Commission Core Measures databases for October 2004 through September 2006.Associations between composite scores based on Centers for Medicare and Medicaid Services methodology and alternative adherence scores with inpatient survival after AMI.In principal components analysis, hospital cardiac care varied between hospitals largely along the lines of "clinical" (ie, pharmacologic interventions) and "administrative" (ie, patient instructions or counseling) activities. A scoring system reflecting this organization was strongly associated with inpatient survival and fit the mortality data better than the composite score. Higher administrative activities scores, holding the clinical activities score fixed, were associated with lower survival.In-hospital cardiac care is organized by clinical and administrative processes of care. Pay-for-performance schemes that incentivize hospitals to focus on administrative process measures may be associated with decreased adherence to clinical processes. A pay-for-performance scheme that acknowledges these factors may be associated with improved inpatient mortality.

    View details for PubMedID 19648833

  • Myocardial perfusion, function, and dyssynchrony in patients with heart failure: Baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial AMERICAN HEART JOURNAL Atchley, A. E., Kitzman, D. W., Whellan, D. J., Iskandrian, A. E., Ellis, S. J., Pagnanelli, R. A., Kao, A., Abdul-Nour, K., O'Connor, C. M., Ewald, G., Kraus, W. E., Borges-Neto, S., HF-ACTION Investigators 2009; 158 (4): S53–S63

    Abstract

    There are currently limited data on the relationships between resting perfusion abnormalities, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class, and exercise capacity as defined by peak VO(2) and 6-minute walk test in patients with heart failure (HF) and reduced LVEF. Furthermore, the association between resting perfusion abnormalities and left ventricular dyssynchrony is currently unknown. This article addresses the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) gated SPECT imaging (gSPECT) substudy baseline results.HF-ACTION was a multicenter, randomized controlled trial of aerobic exercise training versus usual care in 2,331 stable patients with LVEF of < or = 35% and NYHA class II to IV HF symptoms treated with optimal medical therapy. Subjects enrolled in the HF-ACTION substudy underwent resting Tc-99m tetrofosmin gSPECT at baseline (n = 240). Images were evaluated for extent and severity of perfusion abnormalities using a 17-segment and a 5-degree gradation severity score (summed rest score [SRS]). Left ventricular function and dyssynchrony were assessed using validated available commercial software.The average age of patients enrolled was 59, 69% were male, 63% were white, and 33% were African American. Of the 240 participants, 129 (54%) were ischemic and 111 (46%) were nonischemic in etiology. The median LVEF by gSPECT for the entire cohort was 26%. Among the nuclear variables, there was a modest correlation between LVEF and SRS (r = -0.31, P < .0001) and there were stronger correlations between phase SD and SRS (r = 0.66, P < .0001) as well as phase SD and LVEF (r = -0.50, P < .0001). Patients with NYHA class III symptoms had more severe and significant degrees of dyssynchrony (median phase SD 54 degrees ) than those with NYHA class II symptoms (median phase SD 39 degrees, P = .001). Patients with an ischemic etiology had a higher SRS (P < .0001) and significantly more dyssynchrony (P < .0001) than those who were nonischemic. However, there was no difference in LVEF or objective measures of exercise capacity between these groups. With respect to peak VO(2), there was a weak correlation with LVEF (r = 0.18, P = .006) and no correlation with SRS (r = -0.04, P = 0.59) or with dyssynchrony (r = -0.13, P = .09). A weak but statistically significant correlation between SRS and 6-minute walk was observed (r = -0.15, P = .047).Gated SPECT imaging can provide important information in patients with HF due to severe LV dysfunction including quantitative measures of global systolic function, perfusion, and dyssynchrony. These measurements are modestly but significantly related to symptom severity and objective measures of exercise capacity.

    View details for DOI 10.1016/j.ahj.2009.07.009

    View details for Web of Science ID 000270705800008

    View details for PubMedID 19782789

    View details for PubMedCentralID PMC2908486

  • Baseline differences in the HF-ACTION trial by sex AMERICAN HEART JOURNAL Pina, I. L., Kokkinos, P., Kao, A., Bittner, V., Saval, M., Clare, B., Goldberg, L., Johnson, M., Swank, A., Ventura, H., Moe, G., Fitz-Gerald, M., Ellis, S. J., Vest, M., Cooper, L., Whellan, D., HF-ACTION Investigators 2009; 158 (4): S16–S23

    Abstract

    In patients with heart failure (HF), assessment of functional capacity plays an important prognostic role. Both 6-minute walk and cardiopulmonary exercise testing have been used to determine physical function and to determine prognosis and even listing for transplantation. However, as in HF trials, the number of women reported has been small, and the cutoffs for transplantation have been representative of male populations and extrapolated to women. It is also well known that peak VO(2) as a determinant of fitness is inherently lower in women than in men and potentially much lower in the presence of HF. Values for a female population from which to draw for this important determination are lacking.The HF-ACTION trial randomized 2,331 patients (28% women) with New York Heart Association class II-IV HF due to systolic dysfunction to either a formal exercise program in addition to optimal medical therapy or to optimal medical therapy alone without any formal exercise training. To characterize differences between men and women in the interpretation of final cardiopulmonary exercise testing models, the interaction of individual covariates with sex was investigated in the models of (1) VE/VCO(2), (2) VO(2) at ventilatory threshold (VT), (3) distance on the 6-minute walk, and (4) peak VO(2).The women were younger than the men and more likely to have a nonischemic etiology and a higher ejection fraction. Dose of angiotensin converting enzyme inhibitor (ACEI) was lower in the women, on average. The lower ACEI dose may reflect the higher use of angiotensin II receptor blocker (ARB) in women. Both the peak VO(2) and the 6-minute walk distance were significantly lower in the women than in the men. Perhaps the most significant finding in this dataset of baseline characteristics is that the peak VO(2) for women was significantly lower than that for men with similar ventricular function and health status.Therefore, in a well-medicated, stable, class II-IV HF cohort of patients who are able to exercise, women have statistically significantly lower peak VO(2) and 6-minute walk distance than men with similar health status and ventricular function. These data should prompt careful thought when considering prognostic markers for women and listing for cardiac transplant.

    View details for DOI 10.1016/j.ahj.2009.07.012

    View details for Web of Science ID 000270705800003

    View details for PubMedID 19782784

    View details for PubMedCentralID PMC3748941

  • N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: Data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study AMERICAN HEART JOURNAL Felker, G., Whellan, D., Kraus, W. E., Clare, R., Zannad, F., Donahue, M., Adams, K., McKelvie, R., Pina, I. L., O'Connor, C. M., HF-ACTION Investigators 2009; 158 (4): S37–S44

    Abstract

    To examine the relationship between N-terminal pro-brain natriuretic peptide (NT-proBNP) and exercise capacity in a large contemporary cohort of patients with chronic heart failure.Natriuretic peptides such as NT-proBNP are important biomarkers in heart failure. The relationship between NT-proBNP and exercise capacity has not been well studied.We analyzed the relationship between baseline NT-proBNP and peak oxygen uptake (peak VO(2)) or distance in the 6-minute walk test in 1383 subjects enrolled in the HF-ACTION study. Linear regression models were used to analyze the relationship between NT-proBNP and peak Vo(2) or distance in the 6-minute walk test in the context of other clinical variables. Receiver operator curve analysis was used to evaluate the ability of NT-proBNP to accurately predict a peak VO(2) <12 mL/kg per minute.NT-proBNP was the most powerful predictor of peak VO(2) (partial R(2) = 0.13, P < .0001) of 35 candidate variables. Although NT-proBNP was also a predictor of distance in the 6-minute walk test, this relationship was weaker than that for peak VO(2) (partial R(2) = 0.02, P < .0001). For both peak VO(2) and distance in the 6-minute walk test, much of the variability in exercise capacity remained unexplained by the variables tested. Receiver operator curve analysis suggested NT-proBNP had moderate ability to identify patients with peak VO(2) <12 mL/kg per minute (c-index, 0.69).In this analysis of baseline data from HF-ACTION, NT-proBNP was the strongest predictor of peak VO(2) and a significant predictor of distance in the 6-minute walk test. Despite these associations, NT-proBNP demonstrated only modest performance in identifying patients with a low peak VO(2) who might be considered for cardiac transplantation. These data suggest that, although hemodynamic factors are important determinants of exercise capacity, much of the variability in exercise performance in heart failure remains unexplained by traditional clinical and demographic variables.

    View details for DOI 10.1016/j.ahj.2009.07.011

    View details for Web of Science ID 000270705800006

    View details for PubMedID 19782787

    View details for PubMedCentralID PMC3748954

  • Relationship of Doppler-Echocardiographic left ventricular diastolic function to exercise performance in systolic heart failure: The HF-ACTION study AMERICAN HEART JOURNAL Gardin, J. M., Leifer, E. S., Fleg, J. L., Whellan, D., Kokkinos, P., LeBlanc, M., Wolfel, E., Kitzman, D. W., HF-ACTION Investigators 2009; 158 (4): S45–S52

    Abstract

    Patients with systolic heart failure often have concomitant left ventricular (LV) diastolic dysfunction. Although in animal models diastolic dysfunction is associated with worsening exercise capacity and prognosis, information regarding these relationships in patients with established systolic heart failure (HF) is sparse.HF-ACTION was a large, multicenter National Institutes of Health-funded trial of exercise training in systolic HF (LV ejection fraction [LVEF] < or = 35%) and included detailed Doppler-echocardiographic (echo) and cardiopulmonary exercise testing at baseline. We tested the hypothesis that echo measures of LV diastolic function predict key cardiopulmonary exercise outcomes, including aerobic exercise capacity (peak exercise oxygen consumption, VO(2)), distance in the 6-minute walk test (6MWD), and ventilatory efficiency (VE/VCO(2) slope) in patients with systolic HF.Overall, 2,331 patients (28% women, median age 59 years, median LVEF 25%) were enrolled. There were significant bivariate correlations between echo diastolic function variables and peak VO(2) (inverse) and VE/VCO(2) slope (direct) that were strongest for ratio of early diastolic peak transmitral (MV) to myocardial tissue velocity (E/E'), peak MV early-to-late diastolic velocity ratio (E/A), and left atrial dimension (range of absolute r = 0.16-0.28). Both MV E/A and E/E' were more strongly related to all 3 exercise variables than was LVEF. The relationships of E/A and E/E' with 6MWD were weaker than with peak VO(2) or VE/VCO(2) slope. A multivariable model with peak VO(2) as the dependent variable, which included MV E/A and 9 demographic predictors including age, sex, race, body mass index, and New York Heart Association class, explained 40% of the variation in peak VO(2), with MV E/A explaining 6% of the variation. Including LVEF in the model explained less than an additional 1% of the variance in peak VO(2). In a multivariable model for VE/VCO(2) slope, MV E/A was the strongest independent echo predictor, explaining 10% of the variance. The relationship of LV diastolic function variables with 6MWD was weaker than with peak VO(2) or VE/VCO(2) slope.In patients with systolic HF, LV early diastolic function is a modest independent predictor of aerobic exercise capacity and appears to be a better predictor than LVEF.

    View details for DOI 10.1016/j.ahj.2009.07.015

    View details for Web of Science ID 000270705800007

    View details for PubMedID 19782788

    View details for PubMedCentralID PMC2950162

  • Disclosure of Financial Relationships to Participants in Clinical Research. NEW ENGLAND JOURNAL OF MEDICINE Weinfurt, K. P., Hall, M. A., King, N. P., Friedman, J. Y., Schulman, K. A., Sugarman, J. 2009; 361 (9): 916–21

    View details for PubMedID 19710491

  • Effect of Cardiac Rehabilitation Visits on Mortality among Elderly Medicare Beneficiaries with Heart Failure Whellan, D. J., Hammill, B. G., Schulman, K. A., Curtis, L. H. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2009: S99
  • Personalized medicine and disruptive innovation: Implications for technology assessment GENETICS IN MEDICINE Schulman, K. A., Vidal, A., Ackerly, D. 2009; 11 (8): 577–81

    View details for DOI 10.1097/GIM.0b013e3181ae0935

    View details for Web of Science ID 000269273900005

    View details for PubMedID 19606052

  • External Validity of the Cardiovascular Health Study A Comparison With the Medicare Population MEDICAL CARE DiMartino, L. D., Hammill, B. G., Curtis, L. H., Gottdiener, J. S., Manolio, T. A., Powe, N. R., Schulman, K. A. 2009; 47 (8): 916–23

    Abstract

    The Cardiovascular Health Study (CHS), a population-based prospective cohort study, has been used to identify major risk factors associated with cardiovascular disease and stroke in the elderly.To assess the external validity of the CHS.Comparison of the CHS cohort to a national cohort of Medicare beneficiaries and to Medicare beneficiaries residing in the CHS geographic regions.CHS participants and a 5% sample of Medicare beneficiaries.Demographic and administrative characteristics, comorbid conditions, resource use, and mortality.Compared with both Medicare cohorts, the CHS cohort was older and included more men and African American participants. CHS participants were more likely to be enrolled in Medicare managed care than beneficiaries in the national Medicare cohort. Compared with the Medicare cohorts, mortality in the CHS was more than 40% lower at 1 year, approximately 25% lower at 5 years, and approximately 15% lower at 10 years. There were minimal differences in comorbid conditions and health care resource use.The CHS cohort is comparable with the Medicare population, particularly with regard to comorbid conditions and resource use, but had lower mortality. The difference in mortality may reflect the CHS recruitment strategy or volunteer bias. These findings suggest it may not be appropriate to project absolute rates of disease and outcomes based on CHS data to the entire Medicare population. However, there is no reason to expect that the relative risks associated with physiologic processes identified by CHS data would differ for nonparticipants.

    View details for PubMedID 19597373

  • Pattern and Predictors of the Initiation of Biologic Agents for the Treatment of Rheumatoid Arthritis in the United States: An Analysis Using a Large Observational Data Bank CLINICAL THERAPEUTICS DeWitt, E., Lin, L., Glick, H. A., Anstrom, K. J., Schulman, K. A., Reed, S. D. 2009; 31 (8): 1871–80

    Abstract

    The aim of this study was to identify factors associated with the initiation of biologic agents for the treatment of rheumatoid arthritis (RA) in a large US observational cohort.Semiannual patient-reported data in the ARAMIS (Arthritis, Rheumatism and Aging Medical Information System) data bank from January 1998 to January 2006 were analyzed retrospectively using pooled logistic regression (with adjustment for center-level and temporal effects) to identify patient-, disease-, and treatment-related characteristics associated with the initiation of biologics for the treatment of RA.The analysis included 1545 patients from 7 US centers. By 2006, 41.4% of 679 patients remaining in the sample had received biologics. Initiation of biologics was significantly associated with greater disability in the previous 6-month period (per 1-unit increase in Health Assessment Questionnaire score: odds ratio [OR] = 1.45; 95% CI, 1.22-1.72; P < 0.01) and treatment in the previous period with steroids (OR = 2.24; 95% CI, 1.76-2.85; P < 0.01) or nonbiologic disease-modifying antirheumatic drugs (OR = 2.43; 95% CI, 1.71-3.46; P < 0.01). Two sociodemographic factors were significant predictors of decreased use of biologics: older age (per 10 years: OR = 0.74; 95% CI, 0.660.82; P < 0.01) and lower annual income (per $10,000 reduction: OR = 0.95; 95% CI, 0.91-1.00; P = 0.04). There were no significant differences with respect to sex, race, employment status, comorbidity, previous NSAID use, or treatment center.Disease- and treatment-related factors were significant predictors of the initiation of biologics for RA. Independent of these factors, however, biologics were less often used in patients who were older and those with lower incomes. Use of biologics increased steadily over the period studied.

    View details for PubMedID 19808146

    View details for PubMedCentralID PMC3518838

  • Cost of Exercise Training and Its Impact on Medical Resource Use and Costs: Results of HF-ACTION Reed, S. D., Whellan, D. J., Li, Y., Friedman, J. Y., Pina, I. L., Settles, S. J., Davidson-Ray, L., Johnson, J., Cooper, L. S., O'Connor, C. M., Schulman, K. A. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2009: S93
  • Cost Utility of Sequential Adjuvant Trastuzumab for HER2/Neu-Positive Breast Cancer VALUE IN HEALTH Reed, S. D., Schulman, K. A. 2009; 12 (5): 637–40

    View details for PubMedID 19473336

  • Ethical and Scientific Implications of the Globalization of Clinical Research REPLY NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., Cairns, C. B., Schulman, K. A. 2009; 360 (26): 2793
  • Linking inpatient clinical registry data to Medicare claims data using indirect identifiers AMERICAN HEART JOURNAL Hammill, B. G., Hernandez, A. F., Peterson, E. D., Fonarow, G. C., Schulman, K. A., Curtis, L. H. 2009; 157 (6): 995–1000

    Abstract

    Inpatient clinical registries generally have limited ability to provide a longitudinal perspective on care beyond the acute episode. We present a method to link hospitalization records from registries with Medicare inpatient claims data, without using direct identifiers, to create a unique data source that pairs rich clinical data with long-term outcome data.The method takes advantage of the hospital clustering observed in each database by demonstrating that different combinations of indirect identifiers within hospitals yield a large proportion of unique patient records. This high level of uniqueness also allows linking without advance knowledge of the Medicare provider number of each registry hospital. We applied this method to 2 inpatient databases and were able to identify 81% of 39,178 records in a large clinical registry of patients with heart failure and 91% of 6,581 heart failure records from a hospital inpatient database. The quality of the link is high, and reasons for incomplete linkage are explored. Finally, we discuss the unique opportunities afforded by combining claims and clinical data for specific analyses.In the absence of direct identifiers, it is possible to create a high-quality link between inpatient clinical registry data and Medicare claims data. The method will allow researchers to use existing data to create a linked claims-clinical database that capitalizes on the strengths of both types of data sources.

    View details for PubMedID 19464409

  • Cost Effectiveness of Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment JOURNAL OF CLINICAL ONCOLOGY Reed, S. D., Li, Y., Anstrom, K. J., Schulman, K. A. 2009; 27 (13): 2185–91

    Abstract

    Using data from a recent randomized trial, we evaluated the cost effectiveness of ixabepilone plus capecitabine versus capecitabine alone in patients with predominantly metastatic breast cancer considered to be taxane-resistant and previously treated with or resistant to an anthracycline.We developed a stochastic decision-analytic model to represent data collected in the trial on medical resource use, health-related quality of life, and clinical outcomes. Estimates of overall survival were conditional on level of tumor response. We assigned monthly costs and utility weights according to periods defined by the duration of study treatment, time from discontinuation of the study drug until disease progression, and from progression until death and were specific to the level of response and receipt of subsequent therapy. Medical resources were valued in 2008 US dollars. We performed Monte Carlo simulations and sensitivity analyses to evaluate model uncertainty.Overall survival was significantly associated with level of tumor response (P < .001). Total costs were estimated at $60,900 for patients receiving ixabepilone plus capecitabine and $30,000 for patients receiving capecitabine alone. The estimated gain in life expectancy with ixabepilone was 1.96 months (95% CI, 1.36 to 2.64 months); the estimated gain in quality-adjusted survival was 1.06 months (95% CI, 0.09 to 2.03 months). The resulting incremental cost-effectiveness ratio was $359,000 per quality-adjusted life-year (95% CI, $183,000 to $4,030,000). In sensitivity analyses, the results were robust to changes in numerous inputs and assumptions.Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.

    View details for DOI 10.1200/JCO.2008.19.6352

    View details for Web of Science ID 000266195000014

    View details for PubMedID 19332722

  • Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure HF-ACTION Randomized Controlled Trial 81st Annual Scientific Session of the American-Heart-Association O'Connor, C. M., Whellan, D. J., Lee, K. L., Keteyian, S. J., Cooper, L. S., Ellis, S. J., Leifer, E. S., Kraus, W. E., Kitzman, D. W., Blumenthal, J. A., Rendall, D. S., Miller, N. H., Fleg, J. L., Schulman, K. A., McKelvie, R. S., Zannad, F., Pina, I. L. AMER MEDICAL ASSOC. 2009: 1439–50

    Abstract

    Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes.To test the efficacy and safety of exercise training among patients with heart failure.Multicenter, randomized controlled trial of 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months.Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone.Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization.The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Heart failure etiology was ischemic in 51%, and median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 patients (65%) in the exercise training group died or were hospitalized compared with 796 patients (68%) in the usual care group (hazard ratio [HR], 0.93 [95% confidence interval {CI}, 0.84-1.02]; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 patients [16%] in the exercise training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83-1.03]; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI, 0.75-1.00]; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81-0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82-1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74-0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups.In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization.clinicaltrials.gov Identifier: NCT00047437.

    View details for Web of Science ID 000264924900024

    View details for PubMedID 19351941

  • Effects of Exercise Training on Health Status in Patients With Chronic Heart Failure HF-ACTION Randomized Controlled Trial 81st Annual Scientific Session of the American-Heart-Association Flynn, K. E., Pina, I. L., Whellan, D. J., Lin, L., Blumenthal, J. A., Ellis, S. J., Fine, L. J., Howlett, J. G., Keteyian, S. J., Kitzman, D. W., Kraus, W. E., Miller, N. H., Schulman, K. A., Spertus, J. A., O'Connor, C. M., Weinfurt, K. P. AMER MEDICAL ASSOC. 2009: 1451–59

    Abstract

    Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent.To test the effects of exercise training on health status among patients with heart failure.Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007.Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models.Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle.Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected.Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time.clinicaltrials.gov Identifier: NCT00047437.

    View details for Web of Science ID 000264924900025

    View details for PubMedID 19351942

  • Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial CIRCULATION Massie, B. M., Collins, J. F., Ammon, S. E., Armstrong, P. W., Cleland, J. F., Ezekowitz, M., Jafri, S. M., Krol, W. F., O'Connor, C. M., Schulman, K. A., Teo, K., Warren, S. R., WATCH Trial Investigators 2009; 119 (12): 1616–24

    Abstract

    Chronic heart failure remains a major cause of mortality and morbidity. The role of antithrombotic therapy in patients with chronic heart failure has long been debated. The objective of this study was to determine the optimal antithrombotic agent for heart failure patients with reduced ejection fractions who are in sinus rhythm.This prospective, randomized clinical trial of open-label warfarin (target international normalized ratio of 2.5 to 3.0) and double-blind treatment with either aspirin (162 mg once daily) or clopidogrel (75 mg once daily) had a 30-month enrollment period and a minimum of 12 months of treatment. We enrolled 1587 men and women >/=18 years of age with symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of

    View details for DOI 10.1161/CIRCULATIONAHA.108.801753

    View details for Web of Science ID 000264709400009

    View details for PubMedID 19289640

  • Ownership of Medical Information JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Hall, M. A., Schulman, K. A. 2009; 301 (12): 1282–84

    View details for DOI 10.1001/jama.2009.389

    View details for Web of Science ID 000264492800030

    View details for PubMedID 19318657

  • Clopidogrel Use and Clinical Events After Drug-Eluting Stent Implantation: Findings From the HealthCore Integrated Research Database Petersen, J. L., Barron, J. D., Hammill, B. G., Cziraky, M. J., Anstrom, K. J., Wahl, P. M., Eisenstein, E. J., Krucoff, M. W., Califf, R. M., Schulman, K. A., Curtis, L. H. ELSEVIER SCIENCE INC. 2009: A11–A12
  • Ethical and Scientific Implications of the Globalization of Clinical Research NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., Schulman, K. A. 2009; 360 (8): 816–23

    View details for PubMedID 19228627

  • Outcomes of Staphylococcus aureus Infection in Hemodialysis-Dependent Patients CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Li, Y., Friedman, J. Y., O'Neal, B. F., Hohenboken, M. J., Griffiths, R. I., Stryjewski, M. E., Middleton, J. P., Schulman, K. A., Inrig, J. K., Fowler, V. G., Reed, S. D. 2009; 4 (2): 428–34

    Abstract

    Staphylococcus aureus is a leading cause of infection in patients with ESRD. Clinical and economic outcomes associated with S. aureus bacteremia and other S. aureus infections in patients with ESRD were examined.Laboratory, clinical, and hospital billing data from a randomized trial of 3359 hemodialysis-dependent patients hospitalized with S. aureus infection in the United States whose vascular access type was fistula or graft and who were hospitalized with S. aureus infection to evaluate inpatient costs, hospital days, and mortality over 12 wk were used. Generalized linear regression was used to identify independent predictors of 12-wk costs, inpatient days, and mortality.Of the 279 patients (8.3%) who developed S. aureus infection during approximately 1 yr of follow-up, 25.4% were treated as outpatients. Among patients for whom billing data were available, 89 patients hospitalized with S. aureus bacteremia incurred mean 12-wk inpatient costs of $19,454 and 11.9 inpatient days. Among the 70 patients hospitalized with non-bloodstream S. aureus infections, mean inpatient costs were $19,222 and the mean number of inpatient days was 11.3. Twelve-week mortality was 20.2 and 15.7% for patients with S. aureus bloodstream and non-bloodstream infections, respectively. Older age was independently associated with higher risk of death among patients with S. aureus bacteremia and with higher inpatient costs and more hospital days among patients with non-bloodstream infections.Hemodialysis-dependent patients with fistula or graft access incur high costs and long inpatient stays when hospitalized for S. aureus infection.

    View details for PubMedID 19118117

    View details for PubMedCentralID PMC2637588

  • Decision making and quality of life in the treatment of cancer: a review SUPPORTIVE CARE IN CANCER Zafar, S., Alexander, S. C., Weinfurt, K. P., Schulman, K. A., Abernethy, A. P. 2009; 17 (2): 117–27

    Abstract

    Complexity in decision making for cancer treatment arises from many factors. When considering how to treat patients, physicians prioritize factors such as stage of disease, patient age, and comorbid illnesses. However, physicians must balance these priorities with the patient's preferences, quality of life, social responsibilities, and fear of uncertainty. Although these factors are important, physicians are often unable to effectively judge their patients' preferences. Patients are often unable to fully understand their prognoses and the treatment intent.These differences influence how patients and physicians make treatment-related decisions. Partially due to these differences, patients are initially more likely than their physicians to accept greater risk for lesser benefit from treatment. As time progresses and as they experience treatment, a patient's preference changes, yet little is known about this process since few studies have examined it in a prospective longitudinal manner. We present an overview of the literature related to patient and physician decision making and quality of life in patients with advanced cancer, and we propose approaches to future decision-making models in cancer treatment.

    View details for PubMedID 18802727

  • Clinical Effectiveness of Beta-Blockers in Heart Failure Findings From the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) Registry JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Hernandez, A. F., Hammill, B. G., O'Connor, C. M., Schulman, K. A., Curtis, L. H., Fonarow, G. C. 2009; 53 (2): 184–92

    Abstract

    We sought to examine associations between initiation of beta-blocker therapy and outcomes among elderly patients hospitalized for heart failure.Beta-blockers are guideline-recommended therapy for heart failure, but their clinical effectiveness is not well understood, especially in elderly patients.We merged Medicare claims data with OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) records to examine long-term outcomes of eligible patients newly initiated on beta-blocker therapy. We used inverse probability-weighted Cox proportional hazards models to determine the relationships among treatment and mortality, rehospitalization, and a combined mortality-rehospitalization end point.Observed 1-year mortality was 33%, and all-cause rehospitalization was 64%. Among 7,154 patients hospitalized with heart failure and eligible for beta-blockers, 3,421 (49%) were newly initiated on beta-blocker therapy. Among patients with left ventricular systolic dysfunction (LVSD) (n = 3,001), beta-blockers were associated with adjusted hazard ratios of 0.77 (95% confidence interval [CI]: 0.68 to 0.87) for mortality, 0.89 (95% CI: 0.80 to 0.99) for rehospitalization, and 0.87 (95% CI: 0.79 to 0.96) for mortality-rehospitalization. Among patients with preserved systolic function (n = 4,153), beta-blockers were associated with adjusted hazard ratios of 0.94 (95% CI: 0.84 to 1.07) for mortality, 0.98 (95% CI: 0.90 to 1.06) for rehospitalization, and 0.98 (95% CI: 0.91 to 1.06) for mortality-rehospitalization.In elderly patients hospitalized with heart failure and LVSD, incident beta-blocker use was clinically effective and independently associated with lower risks of death and rehospitalization. Patients with preserved systolic function had poor outcomes, and beta-blockers did not significantly influence the mortality and rehospitalization risks for these patients.

    View details for DOI 10.1016/j.jacc.2008.09.031

    View details for Web of Science ID 000262418500006

    View details for PubMedID 19130987

    View details for PubMedCentralID PMC3513266

  • Fueling Innovation In Medical Devices (And Beyond): Venture Capital In Health Care HEALTH AFFAIRS Ackerly, D., Valverde, A. M., Diener, L. W., Dossary, K. L., Schulman, K. A. 2009; 28 (1): W68–W75

    Abstract

    Innovation in health care requires new ideas and the capital to develop and commercialize those ideas into products or services. The necessary capital is often "venture capital," but the link between public policy and the venture capital industry has not been well examined. In this paper we explore the link between venture capital and innovation in health care, and we present new descriptive data from a survey of health care venture capital fund managers. Respondents generally viewed policy levers (for example, reimbursement and regulations) as important risks to venture capital investments, potentially affecting their ability to raise capital for early-stage investment funds.

    View details for PubMedID 19049999

  • A Health Services Research Agenda for Cellular, Molecular and Genomic Technologies in Cancer Care PUBLIC HEALTH GENOMICS Wideroff, L., Phillips, K. A., Randhawa, G., Ambs, A., Armstrong, K., Bennett, C. L., Brown, M. L., Donaldson, M. S., Follen, M., Goldie, S. J., Hiatt, R. A., Khoury, M. J., Lewis, G., McLeod, H. L., Piper, M., Powell, I., Schrag, D., Schulman, K. A., Scott, J. 2009; 12 (4): 233–44

    Abstract

    In recent decades, extensive resources have been invested to develop cellular, molecular and genomic technologies with clinical applications that span the continuum of cancer care.In December 2006, the National Cancer Institute sponsored the first workshop to uniquely examine the state of health services research on cancer-related cellular, molecular and genomic technologies and identify challenges and priorities for expanding the evidence base on their effectiveness in routine care.This article summarizes the workshop outcomes, which included development of a comprehensive research agenda that incorporates health and safety endpoints, utilization patterns, patient and provider preferences, quality of care and access, disparities, economics and decision modeling, trends in cancer outcomes, and health-related quality of life among target populations.Ultimately, the successful adoption of useful technologies will depend on understanding and influencing the patient, provider, health care system and societal factors that contribute to their uptake and effectiveness in 'real-world' settings.

    View details for DOI 10.1159/000203779

    View details for Web of Science ID 000265136600004

    View details for PubMedID 19367091

    View details for PubMedCentralID PMC2844634

  • Cancer Patient Preferences for Quality and Length of Life CANCER Meropol, N. J., Egleston, B. L., Buzaglo, J. S., Benson, A. B., Cegala, D. J., Diefenbach, M. A., Fleisher, L., Miller, S. M., Sulmasy, D. R., Weinfurt, K. P., CONNECT Study Res Grp 2008; 113 (12): 3459–66

    Abstract

    Optimal patient decision making requires integration of patient values, goals, and preferences with information received from the physician. In the case of a life-threatening illness such as cancer, the weights placed on quality of life (QOL) and length of life (LOL) represent critical values. The objective of the current study was to describe cancer patient values regarding QOL and LOL and explore associations with communication preferences.Patients with advanced cancer completed a computer-based survey before the initial consultation with a medical oncologist. Assessments included sociodemographics, physical and mental health state, values regarding quality and length of life, communication preferences, and cancer-related distress.Among 459 patients with advanced cancer, 55% placed equal valued on QOL and LOL, 27% preferred QOL, and 18% preferred LOL. Patients with a QOL preference had lower levels of cancer-related distress (P < .001). A QOL preference was also associated with older age (P = .001), male sex (P = .003), and higher educational level (P = .062). Patients who preferred LOL over QOL desired a more supportive and less pessimistic communication style from their oncologists.These data indicate that a values preference for LOL versus QOL may be simply measured, and is associated with wishes regarding the nature of oncologist communication. Awareness of these values during the clinical encounter could improve decision making by influencing the style and content of the communication between oncologists and their patients.

    View details for DOI 10.1002/cncr.23968

    View details for Web of Science ID 000261665100022

    View details for PubMedID 18988231

    View details for PubMedCentralID PMC2606934

  • Early and Long-term Outcomes of Heart Failure in Elderly Persons, 2001-2005 ARCHIVES OF INTERNAL MEDICINE Curtis, L. H., Greiner, M. A., Hammill, B. G., Kramer, J. M., Whellan, D. J., Schulman, K. A., Hernandez, A. F. 2008; 168 (22): 2481–88

    Abstract

    The treatment of chronic heart failure has improved during the past 2 decades, but little is known about whether the improvements are reflected in trends in early and long-term mortality and hospital readmission.In a retrospective cohort study of 2 540 838 elderly Medicare beneficiaries hospitalized with heart failure between January 1, 2001, and December 31, 2005, we examined early and long-term all-cause mortality and hospital readmission and patient- and hospital-level predictors of these outcomes.Unadjusted in-hospital mortality declined from 5.1% to 4.2% during the study (P < .001), but 30-day, 180-day, and 1-year all-cause mortality remained fairly constant at 11%, 26%, and 37%, respectively. Nearly 1 in 4 patients were readmitted within 30 days of the index hospitalization, and two-thirds were readmitted within 1 year. Controlling for patient- and hospital-level covariates, the hazard of all-cause mortality at 1 year was slightly lower in 2005 than in 2001 (hazard ratio, 0.98; 95% confidence interval, 0.97-0.99). The hazard of readmission did not decline significantly from 2001 to 2005 (hazard ratio, 0.99; 95% confidence interval, 0.98-1.00).Early and long-term all-cause mortality and hospital readmission rates remain high and have improved little with time. The need to identify optimal management strategies for these clinically complex patients is urgent.

    View details for DOI 10.1001/archinte.168.22.2481

    View details for Web of Science ID 000261486600015

    View details for PubMedID 19064833

    View details for PubMedCentralID PMC2629051

  • Resource Use and Costs Associated With Diabetic Macular Edema in Elderly Persons ARCHIVES OF OPHTHALMOLOGY Shea, A. M., Curtis, L. H., Hammill, B. G., Kowalski, J. W., Ravelo, A., Lee, P. P., Sloan, F. A., Schulman, K. A. 2008; 126 (12): 1748–54

    Abstract

    To examine trends in resource use and the effect of incident diabetic macular edema (DME) on 1- and 3-year total direct medical costs in elderly patients.We used a nationally representative 5% sample of Medicare beneficiaries from 2000 through 2004 to identify patients with incident DME and a control cohort of patients with diabetes mellitus but no history of retinal disease. We summed Medicare reimbursement amounts for all claims and applied generalized linear models to estimate the effect of DME on 1- and 3-year costs. We also examined the use of select imaging techniques and treatments.After adjusting for demographic characteristics and baseline comorbid conditions, DME was associated with 31% higher 1-year costs and 29% higher 3-year costs. There were significant shifts in the use of testing and treatment modalities. From 2000 to 2004, use of intravitreal injection increased from 1% to 13% of patients; use of optical coherence tomography increased from 2.5% to more than 40%. Use of laser photocoagulation decreased over time.After adjusting for demographic variables and baseline comorbid conditions, new-onset DME was a significant independent predictor of total medical costs after 1 and 3 years. Diagnostic and treatment modalities used for DME have changed significantly.

    View details for DOI 10.1001/archopht.126.12.1748

    View details for Web of Science ID 000261481700019

    View details for PubMedID 19064859

    View details for PubMedCentralID PMC2630411

  • Long-term Outcomes and Costs of Ventricular Assist Devices Among Medicare Beneficiaries JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Hernandez, A. F., Shea, A. M., Milano, C. A., Rogers, J. G., Hammill, B. G., O'Connor, C. M., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2008; 300 (20): 2398–2406

    Abstract

    In 2003, Medicare expanded coverage of ventricular assist devices as destination, or permanent, therapy for end-stage heart failure. Little is known about the long-term outcomes and costs associated with these devices.To examine the acute and long-term outcomes of Medicare beneficiaries receiving ventricular assist devices alone or after open-heart surgery.Analysis of inpatient claims from the Centers for Medicare & Medicaid Services for the period 2000 through 2006. Patients were Medicare fee-for-service beneficiaries who received a ventricular assist device between February 2000 and June 2006 alone as primary therapy (primary device group; n = 1476) or after cardiotomy in the previous 30 days (postcardiotomy group; n = 1467).Cumulative incidence of device replacement, device removal, heart transplantation, readmission, and death, accounting for censoring and competing risks. Patients were followed up for at least 6 months and factors independently associated with long-term survival were identified. Medicare payments were used to calculate total inpatient costs and costs per day outside the hospital.Overall 1-year survival was 51.6% (n = 669) in the primary device group and 30.8% (n = 424) in the postcardiotomy group. Among primary device patients, 815 (55.2%) were discharged alive with a device. Of those, 450 (55.6%) were readmitted within 6 months and 504 (73.2%) were alive at 1 year. Of the 493 (33.6%) postcardiotomy patients discharged alive with a device, 237 (48.3%) were readmitted within 6 months and 355 (76.6%) were alive at 1 year. Mean 1-year Medicare payments for inpatient care for patients in the 2000-2005 cohorts were $178,714 (SD, $142,549) in the primary device group and $111,769 (SD, $95,413) in the postcardiotomy group.Among Medicare beneficiaries receiving a ventricular assist device, early mortality, morbidity, and costs remain high. Improving patient selection and reducing perioperative mortality are critical for improving overall outcomes.

    View details for DOI 10.1001/jama.2008.716

    View details for Web of Science ID 000261150800022

    View details for PubMedID 19033590

    View details for PubMedCentralID PMC2629048

  • Physician-Industry Cooperation In The Medical Device Industry HEALTH AFFAIRS Chatterji, A. K., Fabrizio, K. R., Mitchell, W., Schulman, K. A. 2008; 27 (6): 1532–43

    Abstract

    Anecdotal evidence suggests that innovative medical devices often arise from physicians' inventive activity, but no studies have documented the extent of such physician-engaged innovation. This paper uses patent data and the American Medical Association Physician Masterfile to provide evidence that physicians contribute to medical device innovation, accounting for almost 20 percent of approximately 26,000 medical device patents filed in the United States during 1990-1996. Moreover, two measures indicate that physician patents had more influence on subsequent inventive activity than nonphysician patents. This finding supports the maintenance of an open environment for physician-industry collaboration in the medical device discovery process.

    View details for PubMedID 18997209

  • Considerations of net present value in policy making regarding diagnostic and therapeutic technologies AMERICAN HEART JOURNAL Califf, R. M., Rasiel, E. B., Schuhnan, K. A. 2008; 156 (5): 879–85

    Abstract

    The pharmaceutical and medical device industries function in a business environment in which shareholders expect companies to optimize profit within legal and ethical standards. A fundamental tool used to optimize decision making is the net present value calculation, which estimates the current value of cash flows relating to an investment.We examined 3 prototypical research investment decisions that have been the source of public scrutiny to illustrate how policy decisions can be better understood when their impact on societally desirable investments by industry are viewed from the standpoint of their impact on net present value.In the case of direct, comparative clinical trials, a simple net present value calculation provides insight into why companies eschew such investments. In the case of pediatric clinical trials, the Pediatric Extension Rule changed the net present value calculation from unattractive to potentially very attractive by allowing patent extensions; thus, the dramatic increase in pediatric clinical trials can be explained by the financial return on investment. In the case of products for small markets, the fixed costs of development make this option financially unattractive.Policy decisions can be better understood when their impact on societally desirable investments by the pharmaceutical and medical device industries are viewed from the standpoint of their impact on net present value.

    View details for PubMedID 19061701

  • Cost of Inpatient Care for Medicare Heart Failure Patients, 2001-2004:More Than Just Heart Failure Whellan, D. J., Greiner, M. A., Schulman, K. A., Curtis, L. H. LIPPINCOTT WILLIAMS & WILKINS. 2008: S713
  • Long-term Outcomes and Costs of Ventricular Assist Devices among United States Medicare Beneficiaries Hernandez, A. F., Shea, A., Milano, C. A., Rogers, J. G., Hammill, B. G., Schulman, K. A., Peterson, E. D., Curtis, L. H. LIPPINCOTT WILLIAMS & WILKINS. 2008: S1016–S1017
  • Factors influencing the participation of gastroenterologists and hepatologists in clinical research BMC HEALTH SERVICES RESEARCH Dev, A. T., Kauf, T. L., Zekry, A., Patel, K., Heller, K., Schulman, K. A., McHutchison, J. G. 2008; 8: 1–11

    Abstract

    Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses by specialty and level of clinical trial experience.A majority of the respondents (71.6%) reported involvement in research activities. Factors most influential in clinical trial participation included funding and compensation (88.3%) and intellectual pursuit (87.8%). Barriers to participation were similar between gastroenterologists (n = 160) and hepatologists (n = 189) and between highly experienced (n = 62) and less experienced (n = 159) clinical researchers. These barriers included uncompensated research costs and lack of specialized support. Industry marketing was a greater influence among respondents with less trial experience, compared to those with extensive experience (15.7% vs 1.6%; P < .01). Hepatologists and respondents with extensive clinical trial experience tended to be more interested in phase 1 and 2 studies, whereas gastroenterologists and less experienced investigators were more interested in phase 4 studies.This study suggests that the greatest barrier to participation in clinical research is lack of adequate resources. Respondents also favored industry-sponsored research with less complex trial protocols and studies of relatively short duration.

    View details for DOI 10.1186/1472-6963-8-208

    View details for Web of Science ID 000260681400001

    View details for PubMedID 18842135

    View details for PubMedCentralID PMC2572062

  • Patient and Implanting Physician Factors Associated With Mortality and Complications After Implantable Cardioverter-Defibrillator Implantation, 2002-2005 CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Al-Khatib, S. M., Greiner, M. A., Peterson, E. D., Hernandez, A. F., Schulman, K. A., Curtis, L. H. 2008; 1 (4): 240–49

    Abstract

    Little is known about factors that influence survival and complications after implantable cardioverter-defibrillator (ICD) implantation in routine clinical practice. We examined patient and implanting physician factors associated with outcomes of ICD therapy in Medicare beneficiaries from 2002 through 2005.We limited this analysis to patients aged >or=65 with Medicare fee-for-service coverage who received an ICD between January 2002 and September 2005. The main outcome measures are time to postprocedural complications within 90 days and 1-year mortality. During the study period, 8581 patients had an ICD implanted by 1959 physicians. The number of procedures increased from 1644 in 2002 to 2374 in the first 3 quarters of 2005. The overall complication rate declined from 18.8% in 2002 to 14.2% in 2005 (P<0.001). Factors independently associated with an increased hazard of complications include chronic lung disease, dementia, renal disease, implantation by a thoracic surgeon, and implantation with removal/replacement. History of congestive heart failure, outpatient implantation, and more recent years of ICD implantation were associated with a lower risk of complications (P<0.05 for all factors). From 2002 to 2005, we observed a decline in 1-year mortality (P<0.001).We observed an appreciable increase in the number of ICD implants, which was associated with a significant decrease in the rate of complications and 1-year mortality. We identified factors associated with an increased risk of mortality and postprocedural complications that may support more nuanced treatment decisions than are currently possible.

    View details for PubMedID 19169382

  • Effects of disclosing financial interests on participation in medical research: A randomized vignette trial AMERICAN HEART JOURNAL Weinfurt, K. P., Hall, M. A., Friedman, J. Y., Hardy, N., Fortune-Greeley, A. K., Lawlor, J. S., Allsbrook, J. S., Lin, L., Schulman, K. A., Sugarman, J. 2008; 156 (4): 689–97

    Abstract

    Little is known about the effects of investigators' financial disclosures on potential research participants.We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial.Participants in the equity group reported less willingness to participate than participants in the per capita payments group (P = .01) and the no disclosure group (P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group (P < .001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group (P = .04) but did not differ significantly from trust among participants in the per capita payments group (P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups.Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.

    View details for PubMedID 18946893

  • Prostate-specific antigen screening among young men in the United States CANCER Scales, C. D., Antonelli, J., Curtis, L. H., Schulman, K. A., Moul, J. W. 2008; 113 (6): 1315–23

    Abstract

    Disagreement exists on the use of prostate-specific antigen (PSA) tests for cancer-risk stratification in young men in the United States. Little is known about the use of PSA testing in these men. To understand policy implications of risk stratification, the authors sought to characterize PSA use among young men.The authors used the 2002 Behavioral Risk Factor Surveillance System to study prostate-cancer screening in a representative sample of men aged 40 years and older (n = 58,511). The primary outcome was self-report of a PSA test in the previous year.Among men aged 40 to 49 years, 22.5% (95% confidence interval [CI], 21.5-23.5) reported having had a PSA test in the previous year, compared with 53.7% (95% CI, 52.8-54.7; P < .001) of men aged >or=50 years. When sociodemographic characteristics were statistically controlled, young, black, non-Hispanic men were more likely than young, white, non-Hispanic men to report having had a PSA test in the previous year (odds ratio [OR], 2.42; 95% CI, 1.95-3.01; P < .001). In young men, annual household income >or=USD 35,000 (OR, 1.50; 95% CI, 1.26-1.78; P < .001) and an ongoing relationship with a physician (OR, 2.52; 95% CI, 2.06-3.07; P < .001) were associated with PSA testing.One-fifth of young men reported having had a PSA test within the previous year. Young, black, non-Hispanic men are more likely than young, white, non-Hispanic men to report having had a PSA test, although screening in this high-risk group remains suboptimal.

    View details for PubMedID 18696715

  • Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs HEALTH AFFAIRS Reed, S. D., Anstrom, K. J., Seils, D. M., Califf, R. M., Schulman, K. A. 2008; 27 (5): W360–W370

    Abstract

    Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations.

    View details for PubMedID 18682441

  • DECISIONAL CONFLICT AMONG PATIENTS WHO ACCEPT OR DECLINE PARTICIPATION IN PHASE I ONCOLOGY STUDIES JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS Flynn, K. E., Weinfurt, K. P., Seils, D. M., Lin, L., Burnett, C. B., Schulman, K. A., Meropol, N. J. 2008; 3 (3): 69–77

    Abstract

    WE COMPARED DECISIONAL CONFLICT among adults with advanced cancer who had accepted or declined participation in phase I cancer clinical trials. Respondents completed a 121-item questionnaire that included the Decisional Conflict Scale (DCS), which was designed to measure uncertainty in making health decisions. We used standardized effect sizes to compare the DCS scores of accepters (n = 250) and decliners (n = 65). Accepters had lower decisional conflict than decliners overall (d = 0.42; 95% confidence interval, 0.17--0.68) and on all subscales. Whether greater decisional conflict among decliners represents suboptimal decision-making and is reason for bioethical concern depends on how the results are interpreted. We offer three scenarios to explain the differences and describe opportunities for future empirical work.

    View details for PubMedID 19122780

  • Lessons From India In Organizational Innovation: A Tale Of Two Heart Hospitals HEALTH AFFAIRS Richman, B. D., Udayakumar, K., Mitchell, W., Schulman, K. A. 2008; 27 (5): 1260–70

    Abstract

    Recent discussions in health reform circles have pinned great hopes on the prospect of innovation as the solution to the high-cost, inadequate-quality U.S. health system. But U.S. health care institutions-insurers, providers, and specialists-have ceded leadership in innovation to Indian hospitals such as Care Hospital in Hyderabad and the Fortis Hospitals around New Delhi, which have U.S.-trained doctors and can perform open heart surgery for $6,000 (compared to $100,000 in the United States). The Indian success is a window into America's stalemate with inflating costs and stagnant innovation.

    View details for PubMedID 18780909

  • Does reimportation reduce price differences for prescription drugs? Lessons from the European Union HEALTH SERVICES RESEARCH Kyle, M. K., Allsbrook, J. S., Schulman, K. A. 2008; 43 (4): 1308–24

    Abstract

    To examine the effect of parallel trade on patterns of price dispersion for prescription drugs in the European Union.Longitudinal data from an IMS Midas database of prices and units sold for drugs in 36 categories in 30 countries from 1993 through 2004.The main outcome measures were mean price differentials and other measures of price dispersion within European Union countries compared with within non-European Union countries.We identified drugs subject to parallel trade using information provided by IMS and by checking membership lists of parallel import trade associations and lists of approved parallel imports.Parallel trade was not associated with substantial reductions in price dispersion in European Union countries. In descriptive and regression analyses, about half of the price differentials exceeded 50 percent in both European Union and non-European Union countries over time, and price distributions among European Union countries did not show a dramatic change concurrent with the adoption of parallel trade. In regression analysis, we found that although price differentials decreased after 1995 in most countries, they decreased less in the European Union than elsewhere.Parallel trade for prescription drugs does not automatically reduce international price differences. Future research should explore how other regulatory schemes might lead to different results elsewhere.

    View details for PubMedID 18355258

  • Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease NEPHROLOGY Takahashi, T., Reed, S. D., Schulman, K. A. 2008; 13 (5): 419–27

    Abstract

    This study was designed to evaluate the cost-effectiveness of AST-120, an oral adsorbent that attenuates the progression of chronic kidney disease.We developed a Markov model with six health states, including four levels of serum creatinine, haemodialysis and death, using data from a randomized clinical trial conducted in Japan. Direct costs relevant to chronic kidney disease were calculated from a Japanese reimbursement perspective. Projected quality-adjusted life years (QALY) and costs were compared between the AST-120 and placebo groups. The target population was nondiabetic patients with serum creatinine levels from 5.0 to 8.0 mg/dL (442-707 micromol/L) at baseline. Probabilistic sensitivity analysis was performed to evaluate the stability of the results.At 3 years, mean total costs per patient were estimated at 6.67 million yen (US$56,982) in the AST-120 group and 9.38 million yen (US$80,196) in the placebo group. Mean total costs were 2.72 million yen (US$23,205) lower among patients receiving AST-120. QALY per patient were 0.295 (approximately 3.5 months) greater for patients receiving AST-120 than for those receiving placebo over 3 years. The finding that treatment with AST-120 dominated placebo (i.e. was less costly and resulted in more QALY) was upheld in sensitivity analyses.The use of AST-120 in patients with advanced chronic kidney disease may help to slow the rate of growth in expenditures for kidney disease.

    View details for PubMedID 18518936

  • Association between the medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Shea, A. M., Curtis, L. H., Hammill, B. G., DiMartino, L. D., Abernethy, A. P., Schulman, K. A. 2008; 300 (2): 189–96

    Abstract

    The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) altered reimbursements for outpatient chemotherapy drugs and drug administration services. Anecdotal reports suggest that these adjustments may have negatively affected access to chemotherapy for Medicare beneficiaries.To compare patient wait times and travel distances for chemotherapy before and after the enactment of the MMA.Analysis of a nationally representative 5% sample of claims from the Centers for Medicare & Medicaid Services for the period 2003 through 2006. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma who received chemotherapy in inpatient hospital, institutional outpatient, or physician office settings.Days from incident diagnosis to first chemotherapy visit and distance traveled for treatment, controlling for age, sex, race/ethnicity, cancer type, geographic region, comorbid conditions, and year of diagnosis and treatment.There were 5082 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma in 2003; 5379 cases in 2004; 5116 cases in 2005; and 5288 cases in 2006. Approximately 70% of patients received treatment in physician office settings in each year. Although the distribution of treatment settings in 2004 and 2005 was not significantly different from 2003 (P = .24 and P = .72, respectively), there was a small but significant change from 2003 to 2006 (P = .02). The proportion of patients receiving chemotherapy in inpatient settings decreased from 10.2% in 2003 to 8.8% in 2006 (P = .03), and the proportion in institutional outpatient settings increased from 21.1% to 22.5% (P = .004). The proportion in physician offices remained at 68.7% (P = .29). The median time from diagnosis to initial chemotherapy visit was 28 days in 2003, 27 days in 2004, 29 days in 2005, and 28 days in 2006. In multivariate analyses, average wait times for chemotherapy were 1.96 days longer in 2005 than in 2003 (95% confidence interval [CI], 0.11-3.80 days; P = .04) but not significantly different in 2006 (0.88 days; 95% CI, -0.96 to 2.71 days; P = .35). Median travel distance was 7 miles (11.2 km) in 2003 and 8 miles (12.8 km) in 2004 through 2006. After adjustment, average travel distance remained slightly longer in 2004 (1.47 miles [2.35 km]; 95% CI, 0.87-2.07 miles [1.39-3.31 km]; P < .001), 2005 (1.19 miles [1.90 km]; 95% CI, 0.58-1.80 miles [0.93-2.88 km]; P < .001), and 2006 (1.30 miles [2.08 km]; 95% CI, 0.69-1.90 miles [1.10-3.04 km]; P < .001) compared with 2003.There have not been major changes in travel distance and patient wait times for chemotherapy in the Medicare population since 2003, the year before MMA-related changes in reimbursement.

    View details for DOI 10.1001/jama.300.2.189

    View details for Web of Science ID 000257435500023

    View details for PubMedID 18612116

  • Identification of patients with diabetic macular edema from claims data - A validation study ARCHIVES OF OPHTHALMOLOGY Bearelly, S., Mruthyunjaya, P., Tzeng, J. P., Suner, I. J., Shea, A. M., Lee, J. T., Kowalski, J. W., Curtis, L. H., Schulman, K. A., Lee, P. P. 2008; 126 (7): 986-989

    Abstract

    To assess the validity of an algorithm for identifying patients with diabetic macular edema (DME) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes in administrative billing data from a convenience sample of physician offices.A convenience sample of 12 general ophthalmologists and 10 retina specialists applied prespecified algorithms based on ICD-9-CM diagnosis codes to the billing claims of their practices and selected the associated medical records. Four ophthalmologists abstracted data from the medical records, which were then compared with the coded diagnoses. Main outcome measures were sensitivity, specificity, and the kappa statistic for the DME algorithm (a combination of codes 250.xx and 362.53), treating medical record documentation of DME as the standard criterion.The DME algorithm had a sensitivity of 0.88 and a specificity of 0.96 for identifying DME. Excellent agreement was noted between the algorithm and the medical records (kappa = 0.84). The algorithm performed less well in identifying patients with a diagnosis of clinically significant DME (sensitivity, 0.86; specificity, 0.84; kappa = 0.64).The results of this pilot study suggest that patients with DME can be identified accurately in claims data using ICD-9-CM diagnosis codes. Application of this algorithm could improve investigations of disease prevalence and disease burden and provide an efficient means of assessing care and interventions.

    View details for Web of Science ID 000257511300016

    View details for PubMedID 18625948

  • Expectations of benefit in early-phase clinical trials: Implications for assessing the adequacy of informed consent MEDICAL DECISION MAKING Weinfurt, K. P., Seils, D. M., Tzeng, J. P., Compton, K. L., Sulmasy, D. P., Astrow, A. B., Solarino, N. A., Schulman, K. A., Meropol, N. J. 2008; 28 (4): 575–81

    Abstract

    Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit.Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions.Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]).The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

    View details for DOI 10.1177/0272989X08315242

    View details for Web of Science ID 000257836200013

    View details for PubMedID 18378940

    View details for PubMedCentralID PMC2630499

  • Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research ANNALS OF EMERGENCY MEDICINE Glickman, S. W., Anstrom, K. J., Lin, L., Chandra, A., Laskowitz, D. T., Woods, C. W., Freeman, D. H., Kraft, M., Beskow, L. M., Weinfurt, K. P., Schulman, K. A., Cairns, C. B. 2008; 51 (6): 775–80

    Abstract

    Emergency department (ED) -based clinical research has the potential to include patient populations that are typically underrepresented in clinical research. The objective of this study is to assess how emergency clinical care and research processes, informed consent, and patient demographic factors (age, sex, and ethnicity/race) affect enrollment and consent in clinical research in the ED.This was an analysis of prospectively collected data of all patients (aged 2 to 101 years) eligible for one of 7 clinical research studies from February 2005 to April 2007 in an academic ED. We measured rates of enrollment and consent in the clinical studies.One thousand two hundred two of the 4418 patients screened for participation in 7 clinical studies were clinically eligible for enrollment. Of the 868 patients who were able to provide a voluntary decision regarding consent, 639 (73.6%) agreed to participate; an overall enrollment rate of 53.2%. The mean age of patients enrolled was 51.8 years (range 3 to 98 years). Black patients (49.2% enrollment) and Latino patients (18.4% enrollment) were less likely to be enrolled in comparison with white patients (58.3% enrollment) (adjusted odds ratio [OR] of enrollment for blacks=0.64; 95% confidence interval [CI] 0.50 to 0.82; adjusted OR of enrollment for Latinos=0.16; 95% CI 0.08 to 0.33). Enrollment rates were lower among pediatric (40.0%) and geriatric patients (49.1%) in comparison with adult patients ages 18 to 64 years (55.5%) (adjusted OR of enrollment for pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of enrollment for geriatric patients=0.69, 95% CI 0.53 to 0.90). Unique issues contributing to underenrollment included challenges in consent among pediatric and elderly patients, language issues in Latino patients, reduced voluntary consent rates among black patients, and perhaps underuse of minimal risk waivers.In a large academic ED, minority, pediatric, and geriatric patients were less likely to be enrolled in acute care clinical research studies than middle-aged whites. Enrollment and consent strategies designed to enhance research participation in these important patient populations may be necessary to address disparities in the development and application of evidence-based emergency and acute care.

    View details for PubMedID 18191297

  • Using health communication best practices to develop a web-based provider-patient communication aid: The CONNECT (TM) study Fleisher, L., Buzaglo, J., Collins, M., Millard, J., Miller, S. M., Egleston, B. L., Solarino, N., Trinastic, J., Cegala, D. J., Benson, A. B., Schulma, K. A., Weinfurt, K. P., Sulmasy, D., Diefenbach, M. A., Meropol, N. J. ELSEVIER IRELAND LTD. 2008: 378–87

    Abstract

    Although there is broad consensus that careful content vetting and user testing is important in the development of technology-based educational interventions, often these steps are overlooked. This paper highlights the development of a theory-guided, web-based communication aid (CONNECT), designed to facilitate treatment decision-making among patients with advanced cancer.The communication aid included an on-line survey, patient skills training module and an automated physician report. Development steps included: (1) evidence-based content development; (2) usability testing; (3) pilot testing; and (4) patient utilization and satisfaction.Usability testing identified some confusing directions and navigation for the on-line survey and validated the relevance of the "patient testimonials" in the skills module. Preliminary satisfaction from the implementation of the communication aid showed that 66% found the survey length reasonable and 70% found it helpful in talking with the physician. Seventy percent reported the skills module helpful and about half found it affected the consultation.Designing patient education interventions for translation into practice requires the integration of health communication best practice including user feedback along the developmental process.This developmental process can be translated to a broad array of community-based patient and provider educational interventions.

    View details for DOI 10.1016/j.pec.2008.02.017

    View details for Web of Science ID 000256846100010

    View details for PubMedID 18417312

    View details for PubMedCentralID PMC2509582

  • The relationship between care patterns and receipt of ICDs among medicare beneficiaries Curtis, L. H., Greiner, M. A., Hernandez, A. F., Schulman, K. A. LIPPINCOTT WILLIAMS & WILKINS. 2008: E429
  • Effect of cardiac rehabilitation visits on survival among medicare beneficiaries Hammill, B. G., Curtis, L. H., Schulman, K. A., Whellan, D. LIPPINCOTT WILLIAMS & WILKINS. 2008: E417
  • Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents PLOS ONE Weinfurt, K. P., Seils, D. M., Tzeng, J. P., Lin, L., Schulman, K. A., Califf, R. M. 2008; 3 (5): e2128

    Abstract

    Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote.In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

    View details for PubMedID 18461146

  • Evidence-based perspectives on pay for performance and quality of patient care and outcomes in emergency medicine ANNALS OF EMERGENCY MEDICINE Glickman, S. W., Schulman, K. A., Peterson, E. D., Hocker, M. B., Cairns, C. B. 2008; 51 (5): 622–31

    Abstract

    Pay for performance is gaining momentum as a means to improve the quality of clinical care. Recently, the Centers for Medicare & Medicaid Services has expanded pay for performance initiatives to incorporate 9 emergency care metrics, including indicators for cardiac, pneumonia, and stroke care. The American College of Cardiology and American Heart Association (ACC/AHA) have published methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care. The purpose of this study is to grade each of the 9 Physician Quality Reporting Initiative emergency medicine process measures according to the ACC/AHA criteria related to clinical evidence (yes, no, indeterminate). Five of the 9 recently selected metrics in emergency medicine do not appear to meet all of the ACC/AHA criteria for measurement selection. Several of the metrics, including aspirin for acute myocardial infarction (mean hospital adherence 94.7%; SD 6.7%) and pulse oximetry for community-acquired pneumonia (mean 99.4%; SD 2.0%), already have high levels of performance nationally, which raises uncertainty about the overall cost-effectiveness of quality improvement interventions for these measures. Formal methodology needs to be established for future selection of performance measures for quality improvement programs in emergency care. These performance measures should focus on unique aspects of emergency and acute care, including recognition and treatment of time-sensitive life-threatening conditions, assessment of patients with undifferentiated signs and symptoms, and care of all-inclusive geographically based patient populations. In key emergency therapeutic areas, the evidence linking treatment and improved patient outcomes will require additional study before inclusion in pay for performance programs. New research initiatives are needed to assess the effect of timely administration of emergency department interventions on patient outcomes.

    View details for DOI 10.1016/j.annemergmed.2008.01.010

    View details for Web of Science ID 000255487200010

    View details for PubMedID 18358566

  • Primary PCI in ST-segment elevation myocardial infarction NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., Schulman, K. A., Cairns, C. B. 2008; 358 (16): 1751–52

    View details for Web of Science ID 000254966600020

    View details for PubMedID 18426001

  • Medical costs of abnormal serum sodium levels JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Shea, A. M., Hammill, B. G., Curtis, L. H., Szczech, L. A., Schulman, K. A. 2008; 19 (4): 764–70

    Abstract

    An abnormal serum sodium level is the most common electrolyte disorder in the United States and can have a significant impact on morbidity and mortality. The direct medical costs of abnormal serum sodium levels are not well understood. The impact of hyponatremia and hypernatremia on 6-mo and 1-yr direct medical costs was examined by analyzing data from the Integrated HealthCare Information Services National Managed Care Benchmark Database. During the period analyzed, there were 1274 patients (0.8%) with hyponatremia (serum sodium <135 mmol/L), 162,829 (97.3%) with normal serum sodium levels, and 3196 (1.9%) with hypernatremia (>145 mmol/L). Controlling for age, sex, region, and comorbidities, hyponatremia was a significant independent predictor of costs at 6 mo (41.2% increase in costs; 95% confidence interval, 30.3% to 53.0%) and at 1 yr (45.7% increase; 95% confidence interval, 34.2% to 58.2%). Costs associated with hypernatremia were not significantly different from those incurred by patients with normal serum sodium. In conclusion, hyponatremia is a significant independent predictor of 6-mo and 1-yr direct medical costs.

    View details for DOI 10.1681/ASN.2007070752

    View details for Web of Science ID 000254659100019

    View details for PubMedID 18216314

    View details for PubMedCentralID PMC2390974

  • Impact of heart failure on patients undergoing major noncardiac surgery ANESTHESIOLOGY Hammill, B. G., Curtis, L. H., Bennett-Guerrero, E., O'Connor, C. M., Jollis, J. G., Schulman, K. A., Hernandez, A. F. 2008; 108 (4): 559–67

    Abstract

    Changes in the demographics and epidemiology of patients with cardiovascular comorbidities who undergo major noncardiac surgery require an updated assessment of which patients are at greater risk of mortality or readmission. The authors evaluated short-term outcomes among patients with heart failure, coronary artery disease (CAD), or neither who underwent major noncardiac surgery.Patients were aged 65 and older, had Medicare fee-for-service coverage, and underwent 1 of 13 major noncardiac procedures from 2000 through 2004, excluding patients with end-stage renal disease and patients who did not have at least 1 yr of Medicare fee-for-service eligibility before surgery. Main outcome measures were operative mortality and 30-day all-cause readmission.Of 159,327 procedures, 18% were performed in patients with heart failure and 34% were performed in patients with CAD. Adjusted hazard ratios of mortality and readmission for patients with heart failure, compared with patients with neither heart failure nor CAD, were 1.63 (95% confidence interval, 1.52-1.74) and 1.51 (95% confidence interval, 1.45-1.58), respectively. Adjusted hazard ratios of mortality and readmission for patients with CAD, compared with patients with neither heart failure nor CAD, were 1.08 (95% confidence interval, 1.01-1.16) and 1.16 (95% confidence interval, 1.12-1.20), respectively. These effects were statistically significant. Patients with heart failure were at significantly higher risk for both outcomes compared with patients with CAD.Elderly patients with heart failure who undergo major surgical procedures have substantially higher risks of operative mortality and hospital readmission than other patients, including those with coronary disease, admitted for the same procedures. Improvements in perioperative care are needed for the growing population of patients with heart failure undergoing major noncardiac surgery.

    View details for DOI 10.1097/ALN.0b013e31816725ef

    View details for Web of Science ID 000254467500005

    View details for PubMedID 18362586

  • Outcomes of second revascularization procedures after stent implantation JOURNAL OF MEDICAL SYSTEMS Konstance, R. P., Eisenstein, E. L., Anstrom, K. J., Shaw, L. K., Califf, R. M., Harrington, R. A., Matchar, D. B., Schulman, K. A., Kong, D. F. 2008; 32 (2): 177–86

    Abstract

    Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease. Between January 2000 and July 2005, 4,666 consecutive patients underwent initial coronary stent implantation (DES or BMS). From this population we identified 569 patients undergoing a second target vessel revascularization (DES, BMS, PTCA or CABG). Outcomes were assessed at 6, 12, and 24 months after the second procedure, with follow-up through September 2006. Adjusted cumulative incidence rates were calculated using inverse probability weighted estimators. We found that at 24 months, there were no significant differences in death or myocardial infarction for PTCA, BMS, DES, and CABG (17.7%, 14.9%, 7.5%, and 10.2%, p = 0.26[3dfl]). DES patients had lower rates of death or myocardial infarction or third target vessel procedures than patients receiving PTCA (14.6% vs. 30.0%, p = 0.01) and BMS (14.6% vs. 42.2%, p < 0.01), but rates similar to CABG patients (14.6% vs. 14.6%, p = 0.99). For patients undergoing a second revascularization procedure, PTCA, BMS, DES, and CABG are associated with a similar risk of death or nonfatal myocardial infarction. DES and CABG are associated with lower rates of third revascularization procedures compared to PTCA and BMS. Further studies are needed to determine the optimum application for CABG vs. DES as a second or third revascularization procedure.

    View details for PubMedID 18461821

  • Underuse of left ventricular function assessment in patients with newly diagnosed heart failure Curtis, L. H., Shea, A. M., Hammill, B. G., Schulman, K. A., Douglas, P. S. ELSEVIER SCIENCE INC. 2008: A238–A239
  • Relationships among the Kansas City cardiomyopathy questionnaire and clinical measures in patients with heart failure Flynn, K. E., Lin, L., Ellis, S., Fine, L., Pina, I., Roll, S., Russell, S., Schulman, K., Spertus, J., Whelan, D., Weinfurt, K. ELSEVIER SCIENCE INC. 2008: A269
  • Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin GENETICS IN MEDICINE Flockhart, D. A., O'Kane, D., Williams, M. S., Watson, M. S., Flockhart, D. A., Gage, B., Gandolfi, R., King, R., Lyon, E., Nussbaum, R., O'Kane, D., Schulman, K., Veenstra, D., Williams, M. S., Watson, M. S., ACMG Working Grp Pharmacogenet 2008; 10 (2): 139–50

    Abstract

    American College of Medical Genetics statements and guidelines are designed primarily as an educational resource for medical geneticists and other health care professionals to help them provide quality medical genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These statements and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the health care professional should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the patient's record the rationale for any significant deviation from these standards and guidelines. Warfarin (Coumadin) is a potent drug that when used judiciously and monitored closely, leads to substantial reductions in morbidity and mortality from thromboembolic events. However, even with careful monitoring, initiation of warfarin dosing is associated with highly variable responses between individuals and challenges achieving and maintaining levels within the narrow therapeutic range that can lead to adverse drug events. Variants of two genes, CYP2C9 and VKORC1, account for 30-50% of the variability in dosing of warfarin; thus, many believe that testing of these genes will aid in warfarin dosing recommendations. Evidence about this test is evolving rapidly, as is its translation into clinical practice. In an effort to address this situation, a multidisciplinary expert group was organized in November 2006 to evaluate the role of CYP2C9 and VKORC1 testing in altering warfarin-related therapeutic goals and reduction of adverse drug events. A recently completed Rapid-ACCE (Analytical, Clinical Validity, Clinical Utility, and Ethical, Legal, and Social Implications) Review, commissioned to inform this work group, was the foundation for this analysis. From this effort, specific recommendations for the appropriate use of CYP2C9 and VKORC1 testing were developed and are presented here. The group determined that the analytical validity of these tests has been met, and there is strong evidence to support association between these genetic variants and therapeutic dose of warfarin. However, there is insufficient evidence, at this time, to recommend for or against routine CYP2C9 and VKORC1 testing in warfarin-naive patients. Prospective clinical trials are needed that provide direct evidence of the benefits, disadvantages, and costs associated with this testing in the setting of initial warfarin dosing. Although the routine use of warfarin genotyping is not endorsed by this work group at this time, in certain situations, CYP2C9 and VKORC1 testing may be useful, and warranted, in determining the cause of unusual therapeutic responses to warfarin therapy.

    View details for DOI 10.1097/G1M.0b013e318163c35f

    View details for Web of Science ID 000253277400010

    View details for PubMedID 18281922

  • Incidence and prevalence of heart failure in elderly persons, 1994-2003 ARCHIVES OF INTERNAL MEDICINE Curtis, L. H., Whellan, D. J., Hammill, B. G., Hernandez, A. F., Anstrom, K. J., Shea, A. M., Schulman, K. A. 2008; 168 (4): 418–24

    Abstract

    Recent analyses have presented conflicting evidence regarding the incidence and prevalence of heart failure in the United States. We sought to estimate the annual incidence and prevalence of heart failure and associated survival in elderly persons from January 1, 1994, through December 31, 2003.We conducted a retrospective cohort study of 622,789 Medicare beneficiaries 65 years or older who were diagnosed as having heart failure between 1994 and 2003. The main outcome measures were incidence and prevalence of heart failure and survival following a heart failure diagnosis.The incidence of heart failure declined from 32 per 1000 person-years in 1994 to 29 per 1000 person-years in 2003 (P < .01). Incidence declined most sharply among beneficiaries aged 80 to 84 years (from 57.5 to 48.4 per 1000 person-years, P < .01) and increased slightly among beneficiaries aged 65 to 69 years (from 17.5 to 19.3 per 1000 person-years, P < .01). Although risk-adjusted mortality declined slightly from 1994 to 2003, the prognosis for patients diagnosed as having heart failure remains poor. In 2002, risk-adjusted 1-year mortality was 27.5%, more than 3 times higher than for age- and sex-matched patients.Although the incidence of heart failure has declined somewhat during the past decade, modest survival gains have resulted in an increase in the number of patients living with heart failure. Identifying optimal strategies for the treatment and management of heart failure will become increasingly important as the size of the Medicare population grows.

    View details for DOI 10.1001/archinternmed.2007.80

    View details for Web of Science ID 000253374600013

    View details for PubMedID 18299498

  • Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States BMC NEPHROLOGY Shea, A. M., Curtis, L. H., Szczech, L. A., Schulman, K. A. 2008; 9: 5

    Abstract

    Administrative claims are a rich source of information for epidemiological and health services research; however, the ability to accurately capture specific diseases or complications using claims data has been debated. In this study, the authors examined the validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for the identification of hyponatremia in an outpatient managed care population.We analyzed outpatient laboratory and professional claims for patients aged 18 years and older in the National Managed Care Benchmark Database from Integrated Healthcare Information Services. We obtained all claims for outpatient serum sodium laboratory tests performed in 2004 and 2005, and all outpatient professional claims with a primary or secondary ICD-9-CM diagnosis code of hyponatremia (276.1).A total of 40,668 outpatient serum sodium laboratory results were identified as hyponatremic (serum sodium < 136 mmol/L). The sensitivity of ICD-9-CM codes for hyponatremia in outpatient professional claims within 15 days before or after the laboratory date was 3.5%. Even for severe cases (serum sodium < or = 125 mmol/L), sensitivity was < 30%. Specificity was > 99% for all cutoff points.ICD-9-CM codes in administrative data are insufficient to identify hyponatremia in an outpatient population.

    View details for DOI 10.1186/1471-2369-9-5

    View details for Web of Science ID 000207664700005

    View details for PubMedID 18564417

    View details for PubMedCentralID PMC2447828

  • Pancreatic beta-cell function as a predictor of cardiovascular outcomes and costs: findings from the Cardiovascular Health Study CURRENT MEDICAL RESEARCH AND OPINION Curtis, L. H., Hammill, B. G., Bethel, M., Anstrom, K. J., Liao, L., Gottdiener, J. S., Schulman, K. A. 2008; 24 (1): 41–50

    Abstract

    To explore relationships between beta-cell function and incident cardiovascular events, death, and medical costs among elderly individuals.In a prospective, population-based cohort of 4555 elderly individuals, we examined the effect of beta-cell function on incident cardiovascular events and mortality. We also examined costs for 3715 of these individuals. We used the computer-based homeostasis model assessment (HOMA) to calculate indices of beta-cell function (HOMA-%B) and insulin sensitivity (HOMA-%S) using baseline fasting glucose and insulin levels. All subjects were followed from 1992/1993 for 6 years or until death.Discrete-time survival model of the effects of beta-cell function on incident cardiovascular events and all-cause mortality; and semiparametric estimators for calculations of mean 6-year costs.Controlling for HOMA-%S, a 20% decrease in HOMA-%B was associated with increased odds of incident cardiovascular events (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.05-1.14) and death (OR, 1.10; 95% CI, 1.07-1.14). The relationships persisted after controlling for clinical and sociodemographic confounders. A 20% decrease in HOMA-%B was also associated with increased costs (cost ratio, 1.03; 95% CI, 1.01-1.05). The significant association did not persist after controlling for confounders.The sample comprises relatively healthy elderly individuals and is based on data from 1992 through 1999, which may not reflect current experience. The measure of beta-cell function is an estimate generated from single measures of glucose and insulin.Beta-cell function as measured by HOMA-%B is a significant predictor of incident cardiovascular events and mortality but not of costs, controlling for HOMA-%S and sociodemographic and clinical confounders.

    View details for PubMedID 18021490

  • Using Medicare Administrative Data to Conduct Postmarketing Surveillance of Follow-On Biologics: Issues and Opportunities FOOD AND DRUG LAW JOURNAL Di Martino, L. D., Curtis, L. H., Williams, R. L., Abernethy, D. R., Schulman, K. A. 2008; 63 (4): 891–900

    View details for PubMedID 19601387

  • Economic implications of potential changes to regulatory and reimbursement policies for medical devices Reed, S. D., Shea, A. M., Schulman, K. A. SPRINGER. 2008: 50–56

    Abstract

    To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be "reasonable and necessary" if the patients participate in clinical studies or registries.When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions.The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies.

    View details for DOI 10.1007/s1106-007-0246-9

    View details for Web of Science ID 000252212300011

    View details for PubMedID 18095045

    View details for PubMedCentralID PMC2150632

  • Economic Evaluation of Pharmaceuticals and Clinical Practice DRUG BENEFITS AND RISKS: INTERNATIONAL TEXTBOOK OF CLINICAL PHARMACOLOGY Schulman, K. A., Glick, H. A., Polsky, D., John, K. R., VanBoxtel, C. J., Santoso, B., Edwards, I. R. 2008: 37–55
  • Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions CLINICAL TRIALS Flynn, K. E., Dombeck, C. B., DeWitt, E., Schulman, K. A., Weinfurt, K. P. 2008; 5 (6): 575–86

    Abstract

    Item response theory (IRT) promises more sensitive and efficient measurement of patient-reported outcomes (PROs) than traditional approaches; however, the selection and use of PRO measures from IRT-based item banks differ from current methods of using PRO measures.To anticipate barriers to the adoption of IRT item banks into clinical trials.We conducted semistructured telephone or in-person interviews with 42 clinical researchers who published results from clinical trials in the Journal of the American Medical Association, the New England Journal of Medicine, or other leading clinical journals from July 2005 through May 2006. Interviews included a brief tutorial on IRT item banks.After the tutorial, 39 of 42 participants understood the novel products available from an IRT item bank, namely customized short forms and computerized adaptive testing. Most participants (38/42) thought that item banks could be useful in their clinical trials, but they mentioned several potential barriers to adoption, including economic and logistical constraints, concerns about whether item banks are better than current PRO measures, concerns about how to convince study personnel or statisticians to use item banks, concerns about FDA or sponsor acceptance, and the lack of availability of item banks validated in specific disease populations.Selection bias might have led to more positive responses to the concept of item banks in clinical trials.Clinical investigators are open to a new method of PRO measurement offered in IRT item banks, but bank developers must address investigator and stakeholder concerns before widespread adoption can be expected.

    View details for PubMedID 19029206

  • Updated estimates of survival and cost effectiveness for imatinib versus interferon-alpha plus low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia PHARMACOECONOMICS Reed, S. D., Anstrom, K. J., Li, Y., Schulman, K. A. 2008; 26 (5): 435–46

    Abstract

    For trials in which participants are followed beyond the main study period to assess long-term outcomes, economic evaluations conducted using short-term data should be systematically updated to reflect new information.We used 60-month survival data from the IRIS (International Randomized study of Interferon vs STI571) trial to update previously published cost-effectiveness estimates, based on 19 months of follow-up, of imatinib versus interferon (IFN)-alpha plus low-dose cytarabine in patients with chronic-phase chronic myeloid leukaemia. For patients treated with imatinib, we used the 60-month data to calibrate the survival curves generated from the original cost-effectiveness model. We used historical data to model survival for patients randomized to IFNalpha. We updated costs for medical resources using 2006 Medicare reimbursement rates and applied average wholesale prices (AWPs) and wholesale acquisition costs (WACs) to study medications.Five-year survival for patients randomized to imatinib was better than predicted in the original model (89.4% vs 83.2%). We estimated remaining life expectancy with first-line imatinib to be 19.1 life-years (3.8 life-years over the original model) and 15.2 QALYs (3.1 QALYs over the original estimate). Estimates for IFNalpha remained at 9.1 life-years and 6.3 QALYs. When we applied AWPs to study medications, incremental cost-effectiveness ratios (ICERs) were $US 51,800-57,500 per QALY. When we applied WACs, ICERs were $US 42,000-46,200 per QALY.Although the analysis revealed that the original survival estimates were conservative, the updated cost-effectiveness ratios were consistent with, or slightly higher than, the original estimates, depending on the method for assigning costs to study medications.

    View details for PubMedID 18429659

  • Does the market value racial and ethnic concordance in physician-patient relationships? HEALTH SERVICES RESEARCH Brown, T. T., Scheffler, R. M., Tom, S. E., Schulman, K. A. 2007; 42 (2): 706–26

    Abstract

    To determine if the market-determined earnings per hour of physicians is sensitive to the degree of area-level racial/ethnic concordance (ALREC) in the local physician labor market.1998-1999 and 2000-2001 Community Tracking Study Physician Surveys and Household Surveys, 2000 U.S. Census, and the Area Resource File.Population-averaged regression models with area-level fixed effects were used to estimate the determinants of log earnings per hour for physicians in a two-period panel (N=12,886). ALREC for a given racial/ethnic group is measured as the percentage of physicians who are of a given race/ethnicity less the percentage of the population who are of the corresponding race/ethnicity. Relevant control variables were included.Average earnings per hour for Hispanic and Asian physicians varies with the degree of ALREC that corresponds to a physician's race/ethnicity. Both Hispanic and Asian physicians earn more per hour in areas where corresponding ALREC is negative, other things equal. ALREC varies from negative to positive for all groups. ALREC for Hispanics is negative, on average, due to the small percentage of the physician workforce that is Hispanic. This results in an average 5.6 percent earnings-per-hour premium for Hispanic physicians. However, ALREC for Asians is positive, on average, due to the large percentage of the physician workforce that is Asian. This results in an average 4.0 percent earnings-per-hour discount for Asian physicians. No similar statistically significant results were found for black physicians.The market-determined earnings per hour of Hispanic and Asian physicians are sensitive to the degree of ALREC in the local labor market. Larger sample sizes may be needed to find statistically significant results for black physicians.

    View details for DOI 10.1111/j.1475-6773.2006.00634.x

    View details for Web of Science ID 000244795700007

    View details for PubMedID 17362214

    View details for PubMedCentralID PMC1955351

  • Characteristics of hospitalizations of HIV-infected patients: An analysis of data from the 1994 Healthcare Cost and Utilization Project JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Bentham, W. D., Cai, L. M., Schulman, K. A. 1999; 22 (5): 503–8

    Abstract

    Hospitals are significant resources for care of HIV/AIDS patients. Previous studies that have attempted to identify and track the characteristics of these patients and their hospitalizations have been limited in their ability to produce national estimates of patient use of such resources. This study, using data from the Healthcare Cost and Utilization Project (HCUP-3) attempted to characterize and estimate the cost of hospital usage by HIV/AIDS patients. We estimate that in 1994 approximately 188,506 admissions of HIV/AIDS patients occurred with an average charge of $19,244 U.S. per admission, for an estimated total cost of $3.63 billion. Compared with non-HIV-infected patients, HIV/AIDS patients tended to be male (75.83% versus 41.49%), a member of a minority group (53.51% versus 20.77%), hospitalized in a private, nonprofit, urban teaching hospital with a longer average length of stay (10.27 versus 5.52 days), and to have a higher in-hospital mortality (11.45% versus 2.58%). Approximately half of the hospital charges (47%) for these admissions were absorbed by Medicaid, and 25% by private insurance. The remainder of the charges were borne by the patients themselves. The results presented here for 1994 predate the widespread use of protease inhibitor/ highly active antiretroviral therapy (HAART), thus making this study an important benchmark for the delineation of the effects of HAART and any other future developments in HIV therapy on the characteristics of HIV/AIDS patient resource use on a national level. This study further demonstrates that HCUP is a powerful tool for the estimation and costing of hospital resource use.

    View details for Web of Science ID 000085336600012

    View details for PubMedID 10961613