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Schulman, Kevin Alan

Overview:

Kevin A. Schulman, MD, MBA, is a professor of medicine and the Gregory Mario and Jeremy Mario Professor of Business Administration at Duke University. He is a visiting professor of business administration at Harvard Business School. He holds several leadership appointments at Duke. He is an associate director of the Duke Clinical Research Institute in the School of Medicine, the country's largest academic clinical research organization. In Duke's Fuqua School of Business, he served for more than a decade as the director of the Health Sector Management program, the Master of Management in Clinical Informatics degree program, and the Center for the Study of Health Management. His other university affiliations include the Trent Center for Bioethics, Humanities and History of Medicine; the Duke Translational Medicine Institute; and the Duke Global Health Institute.

Dr. Schulman is a distinguished researcher who has received more than $48 million in research grants. His research interests include health services research and policy, including access to care and the impact of reimbursement and regulatory policies on clinical practice; health economics and economic evaluation in clinical research; and medical decision making, especially in patients with life-threatening conditions. He teaches courses in biotechnology, health policy, and health IT strategy.

Dr. Schulman has published nearly 400 articles and book chapters; his peer-reviewed papers have appeared in the New England Journal of Medicine, JAMA, and Annals of Internal Medicine. He is the senior associate editor of Health Services Research and a member of the editorial/advisory boards of the American Journal of Medicine and the American Heart Journal.

A recipient of numerous awards, Dr. Schulman is a fellow of the American College of Physicians and an elected member of the American Society for Clinical Investigation. He is a voting member of the Medicare Evidence Development and Coverage Advisory Committee. He has served as session chair and panelist at dozens of medical and health care conferences. Dr. Schulman has also served on numerous grant review committees for the National Institutes of Health, the Robert Wood Johnson Foundation, and other bodies. He is a member of the advisory board for the Centre for Healthcare Policy and Management at the China Europe International Business School. In 2010-2011, he was a mentor for the Commonwealth Fund's Harkness Fellowships in Health Care Policy and Practice. He is the founding president of the Business School Alliance for Health Management, a consortium of the leading business schools offering health management programs.

Dr. Schulman received his MD from the New York University School of Medicine and his MBA, with a concentration in health care management, from the Wharton School of the University of Pennsylvania. He completed a residency in internal medicine at the Hospital of the University of Pennsylvania and is board-certified in internal medicine.

Positions:

Gregory Mario and Jeremy Mario Professor of Business Administration

Medicine, General Internal Medicine
School of Medicine

Professor of Medicine

Medicine, General Internal Medicine
School of Medicine

Research Professor of Global Health

Duke Global Health Institute
Institutes and Provost's Academic Units

Associate of the Duke Initiative for Science & Society

Duke Science & Society
Institutes and Provost's Academic Units

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Member in the Duke Clinical Research Institute

Duke Clinical Research Institute
School of Medicine

Director, Center for Clinical and Genetic Economics

Medicine
School of Medicine

Education:

M.B.A. 1988

M.B.A. — University of Pennsylvania

M.D. 1988

M.D. — New York University

News:

Grants:

NINDS Research Education Programs for Residents and Fellows in Neurosurgery

Administered By
Neurosurgery
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
March 01, 2009
End Date
June 30, 2019

Duke KURe Program

Administered By
Obstetrics and Gynecology, Urogynecology
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
August 01, 2013
End Date
July 31, 2018

Duke CTSA (UL1)

Administered By
Duke Clinical & Translational Science Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 26, 2013
End Date
April 30, 2018

FDA Fellow's Course

Administered By
Duke Clinical Research Institute
AwardedBy
Food and Drug Administration
Role
Principal Investigator
Start Date
July 01, 2013
End Date
November 15, 2013

Tools for Economic Analysis of Patient Management Interventions in Heart Failure

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Investigator
Start Date
September 29, 2009
End Date
July 31, 2013

Understanding Patient Expectations of Treatment Outcomes

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
June 08, 2009
End Date
November 30, 2011

HF Action Supplement

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
PI/Director
Start Date
September 30, 2002
End Date
December 31, 2010

DEcIDE Health Outcomes of Carotid Artery Disease

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Co Investigator
Start Date
October 01, 2007
End Date
February 28, 2010

Heart Failure Among the Eldery

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
August 01, 2006
End Date
July 31, 2009

ACTION EQOL STUDY

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 30, 2002
End Date
December 31, 2008

Pilot Project applying the National Clinical Research Associates model within the Duke Translational Medicine Institute

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
July 01, 2007
End Date
June 30, 2008

Preschool Vision Screening in Primary Care Settings

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Mentor
Start Date
July 01, 2003
End Date
June 30, 2008

CSP 442 - #1416

Administered By
Duke Clinical Research Institute
AwardedBy
Department of Veterans Affairs
Role
Principal Investigator
Start Date
April 25, 2000
End Date
March 31, 2005

2003 - 2008 Annual NRSA Trainees Conference

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Principal Investigator
Start Date
September 01, 1999
End Date
March 31, 2004

Coordinating Center for CERTs

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 30, 2002
End Date
September 29, 2003

1999-2003 Annual NRSA Trainees Conference

Administered By
Medicine, General Internal Medicine
AwardedBy
Agency for Health Care Policy and Research
Role
Principal Investigator
Start Date
September 01, 1999
End Date
March 31, 2003
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Publications:

A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department.

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.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.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.A patient-reported approach to assess ED-patient safety yields important, complementary, and potentially actionable safety information.

Authors
Glickman, SW; Mehrotra, A; Shea, CM; Mayer, C; Strickler, J; Pabers, S; Larson, J; Goldstein, B; Mandelkehr, L; Cairns, CB; Pines, JM; Schulman, KA
MLA Citation
Glickman, SW, Mehrotra, A, Shea, CM, Mayer, C, Strickler, J, Pabers, S, Larson, J, Goldstein, B, Mandelkehr, L, Cairns, CB, Pines, JM, and Schulman, KA. "A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department." Journal of patient safety (November 2, 2016).
PMID
27811598
Source
epmc
Published In
Journal of Patient Safety
Publish Date
2016

Extreme Home Makeover - The Role of Intensive Home Health Care.

Authors
Ticona, L; Schulman, KA
MLA Citation
Ticona, L, and Schulman, KA. "Extreme Home Makeover - The Role of Intensive Home Health Care." The New England journal of medicine 375.18 (November 2016): 1707-1709.
PMID
27806216
Source
epmc
Published In
The New England journal of medicine
Volume
375
Issue
18
Publish Date
2016
Start Page
1707
End Page
1709
DOI
10.1056/nejmp1608301

Does the Implantable Cardioverter-Defibrillator Benefit Vary With the Estimated Proportional Risk of Sudden Death in Heart Failure Patients?

Authors
Levy, WC; Li, Y; Reed, SD; Zile, MR; Shadman, R; Dardas, T; Whellan, DJ; Schulman, KA; Ellis, SJ; Neilson, M; O’Connor, CM
MLA Citation
Levy, WC, Li, Y, Reed, SD, Zile, MR, Shadman, R, Dardas, T, Whellan, DJ, Schulman, KA, Ellis, SJ, Neilson, M, and O’Connor, CM. "Does the Implantable Cardioverter-Defibrillator Benefit Vary With the Estimated Proportional Risk of Sudden Death in Heart Failure Patients?." JACC: Clinical Electrophysiology (November 2016).
Source
crossref
Published In
JACC. Clinical electrophysiology
Publish Date
2016
DOI
10.1016/j.jacep.2016.09.006

Reassessing ACOs and Health Care Reform.

Authors
Schulman, KA; Richman, BD
MLA Citation
Schulman, KA, and Richman, BD. "Reassessing ACOs and Health Care Reform." JAMA 316.7 (August 2016): 707-708.
PMID
27533151
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
316
Issue
7
Publish Date
2016
Start Page
707
End Page
708
DOI
10.1001/jama.2016.10874

Patient Preferences for Features of Health Care Delivery Systems: A Discrete Choice Experiment.

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.

Authors
Mühlbacher, AC; Bethge, S; Reed, SD; Schulman, KA
MLA Citation
Mühlbacher, AC, Bethge, S, Reed, SD, and Schulman, KA. "Patient Preferences for Features of Health Care Delivery Systems: A Discrete Choice Experiment." Health services research 51.2 (April 2016): 704-727.
PMID
26255998
Source
epmc
Published In
Health Services Research
Volume
51
Issue
2
Publish Date
2016
Start Page
704
End Page
727
DOI
10.1111/1475-6773.12345

Health Care Tax Inversions--Robbing Both Peter and Paul.

Authors
Warraich, HJ; Schulman, KA
MLA Citation
Warraich, HJ, and Schulman, KA. "Health Care Tax Inversions--Robbing Both Peter and Paul." The New England journal of medicine 374.11 (March 2016): 1005-1007.
PMID
26981932
Source
epmc
Published In
The New England journal of medicine
Volume
374
Issue
11
Publish Date
2016
Start Page
1005
End Page
1007
DOI
10.1056/nejmp1515769

Options to Promote Competitive Generics Markets in the United States.

Authors
Wiske, CP; Ogbechie, OA; Schulman, KA
MLA Citation
Wiske, CP, Ogbechie, OA, and Schulman, KA. "Options to Promote Competitive Generics Markets in the United States." JAMA 314.20 (November 2015): 2129-2130.
PMID
26513309
Source
epmc
Published In
JAMA : the journal of the American Medical Association
Volume
314
Issue
20
Publish Date
2015
Start Page
2129
End Page
2130
DOI
10.1001/jama.2015.13498

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.

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.

Authors
Reed, SD; Neilson, MP; Gardner, M; Li, Y; Briggs, AH; Polsky, DE; Graham, FL; Bowers, MT; Paul, SC; Granger, BB; Schulman, KA; Whellan, DJ; Riegel, B; Levy, WC
MLA Citation
Reed, SD, Neilson, MP, Gardner, M, Li, Y, Briggs, AH, Polsky, DE, Graham, FL, Bowers, MT, Paul, SC, Granger, BB, Schulman, KA, Whellan, DJ, Riegel, B, and Levy, WC. "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 170.5 (November 2015): 951-960.
PMID
26542504
Source
epmc
Published In
American Heart Journal
Volume
170
Issue
5
Publish Date
2015
Start Page
951
End Page
960
DOI
10.1016/j.ahj.2015.08.015

Specialty Pharmaceuticals for Hyperlipidemia--Impact on Insurance Premiums.

Authors
Schulman, KA; Balu, S; Reed, SD
MLA Citation
Schulman, KA, Balu, S, and Reed, SD. "Specialty Pharmaceuticals for Hyperlipidemia--Impact on Insurance Premiums." The New England journal of medicine 373.17 (October 7, 2015): 1591-1593.
PMID
26444460
Source
epmc
Published In
The New England journal of medicine
Volume
373
Issue
17
Publish Date
2015
Start Page
1591
End Page
1593
DOI
10.1056/nejmp1509863

Organizational characteristics and patient experiences with hospital care: a survey study of hospital chief patient experience officers.

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.

Authors
Manary, M; Staelin, R; Kosel, K; Schulman, KA; Glickman, SW
MLA Citation
Manary, M, Staelin, R, Kosel, K, Schulman, KA, and Glickman, SW. "Organizational characteristics and patient experiences with hospital care: a survey study of hospital chief patient experience officers." American journal of medical quality : the official journal of the American College of Medical Quality 30.5 (September 2015): 432-440.
PMID
24951105
Source
epmc
Published In
American Journal of Medical Quality
Volume
30
Issue
5
Publish Date
2015
Start Page
432
End Page
440
DOI
10.1177/1062860614539994

Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure.

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.

Authors
Dardas, T; Li, Y; Reed, SD; O'Connor, CM; Whellan, DJ; Ellis, SJ; Schulman, KA; Kraus, WE; Forman, DE; Levy, WC
MLA Citation
Dardas, T, Li, Y, Reed, SD, O'Connor, CM, Whellan, DJ, Ellis, SJ, Schulman, KA, Kraus, WE, Forman, DE, and Levy, WC. "Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure." The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 34.8 (August 2015): 1017-1023.
PMID
25940075
Source
epmc
Published In
The Journal of Heart and Lung Transplantation
Volume
34
Issue
8
Publish Date
2015
Start Page
1017
End Page
1023
DOI
10.1016/j.healun.2015.03.017

Enhancing the Value of Statewide Hospital Discharge Data: Improving Clinical Content and Race-Ethnicity Data.

Authors
Andrews, RM; Schulman, KA
MLA Citation
Andrews, RM, and Schulman, KA. "Enhancing the Value of Statewide Hospital Discharge Data: Improving Clinical Content and Race-Ethnicity Data." Health services research 50 Suppl 1 (August 2015): 1265-1272.
PMID
26205563
Source
epmc
Published In
Health Services Research
Volume
50 Suppl 1
Publish Date
2015
Start Page
1265
End Page
1272
DOI
10.1111/1475-6773.12342

Hospital overhead costs: The neglected driver of health care spending?

Objective: To examine temporal trends in hospital overhead costs relative to total hospital costs, hospital inpatient beds, and inpatient days in United States hospitals. Methods: Using Medicare data regarding nonfederal acute care hospitals in the United States, we conducted analyses of hospital overhead costs, total hospital costs, inpatient bed capacity, and inpatient days for nonfederal acute care hospitals from 1996 through 2010. Overhead costs were examined as a function of total beds, total inpatient days, and overall costs during this time period. Results: In 1996, baseline hospital overhead costs were $220,497 per inpatient bed and $1,361 per inpatient day in 2010 dollars; mean hospital overhead costs represented 46.1% of total hospital costs. Relative to medical inflation, overhead costs per inpatient bed grew 3.02% per year and overhead costs per inpatient day grew 1.86% per year. Overhead costs as a share of total costs remained unchanged. Conclusions: Overhead costs represent approximately half of total hospital costs. Between 1996 and 2010, mean hospital overhead costs per inpatient bed and per inpatient day increased faster than medical inflation. To adequately constrain rising health care costs, hospitals must address overhead costs as well as direct patient costs.

Authors
Kalman, NS; Hammill, BG; Schulman, KA; Shah, BR
MLA Citation
Kalman, NS, Hammill, BG, Schulman, KA, and Shah, BR. "Hospital overhead costs: The neglected driver of health care spending?." Journal of Health Care Finance 41.4 (January 1, 2015).
Source
scopus
Published In
Journal of health care finance
Volume
41
Issue
4
Publish Date
2015

Market-Based Solutions to Antitrust Threats-- The Rejection of the Partners Settlement

Authors
Richman, B; Herzlinger, R; Schulman, K
MLA Citation
Richman, B, Herzlinger, R, and Schulman, K. "Market-Based Solutions to Antitrust Threats-- The Rejection of the Partners Settlement." New England Journal of Medicine (2015).
PMID
25738542
Source
c-inst-1
Published In
New England Journal of Medicine
Publish Date
2015

Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure

© 2015 International Society for Heart and Lung Transplantation.Background 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. Methods 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. Results 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. Conclusions 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.

Authors
Dardas, T; Li, Y; Reed, SD; O'Connor, CM; Whellan, DJ; Ellis, SJ; Schulman, KA; Kraus, WE; Forman, DE; Levy, WC
MLA Citation
Dardas, T, Li, Y, Reed, SD, O'Connor, CM, Whellan, DJ, Ellis, SJ, Schulman, KA, Kraus, WE, Forman, DE, and Levy, WC. "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 34.8 (2015): 1017-1023.
Source
scival
Published In
The Journal of Heart and Lung Transplantation
Volume
34
Issue
8
Publish Date
2015
Start Page
1017
End Page
1023
DOI
10.1016/j.healun.2015.03.017

Exploring variation in care: alternative conceptual models.

Authors
Dinan, MA; Schulman, KA
MLA Citation
Dinan, MA, and Schulman, KA. "Exploring variation in care: alternative conceptual models." Annals of internal medicine 161.11 (December 2014): 835-836.
PMID
25437412
Source
epmc
Published In
Annals of internal medicine
Volume
161
Issue
11
Publish Date
2014
Start Page
835
End Page
836
DOI
10.7326/m14-2382

Review: in adult outpatients, nurse-managed protocols improve hemoglobin A1c levels and blood pressure.

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Review: in adult outpatients, nurse-managed protocols improve hemoglobin A1c levels and blood pressure." Annals of internal medicine 161.12 (December 2014): JC6-.
PMID
25506878
Source
epmc
Published In
Annals of internal medicine
Volume
161
Issue
12
Publish Date
2014
Start Page
JC6
DOI
10.7326/0003-4819-161-12-201412160-02006

The impact of specialty pharmaceuticals as drivers of health care costs.

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.

Authors
Hirsch, BR; Balu, S; Schulman, KA
MLA Citation
Hirsch, BR, Balu, S, and Schulman, KA. "The impact of specialty pharmaceuticals as drivers of health care costs." Health affairs (Project Hope) 33.10 (October 2014): 1714-1720.
PMID
25288414
Source
epmc
Published In
Health Affairs
Volume
33
Issue
10
Publish Date
2014
Start Page
1714
End Page
1720
DOI
10.1377/hlthaff.2014.0558

Triggering management for quality improvement.

Authors
Scales, CD; Schulman, KA
MLA Citation
Scales, CD, and Schulman, KA. "Triggering management for quality improvement." Health services research 49.5 (October 2014): 1401-1406.
PMID
25255819
Source
epmc
Published In
Health Services Research
Volume
49
Issue
5
Publish Date
2014
Start Page
1401
End Page
1406
DOI
10.1111/1475-6773.12224

Associations between seattle heart failure model scores and medical resource use and costs: findings from HF-ACTION.

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.

Authors
Li, Y; Levy, WC; Neilson, MP; Ellis, SJ; Whellan, DJ; Schulman, KA; O'Connor, CM; Reed, SD
MLA Citation
Li, Y, Levy, WC, Neilson, MP, Ellis, SJ, Whellan, DJ, Schulman, KA, O'Connor, CM, and Reed, SD. "Associations between seattle heart failure model scores and medical resource use and costs: findings from HF-ACTION." Journal of cardiac failure 20.8 (August 2014): 541-547.
PMID
24887579
Source
epmc
Published In
Journal of Cardiac Failure
Volume
20
Issue
8
Publish Date
2014
Start Page
541
End Page
547
DOI
10.1016/j.cardfail.2014.05.009

Shifting toward defined contributions--predicting the effects.

Authors
Schulman, KA; Richman, BD; Herzlinger, RE
MLA Citation
Schulman, KA, Richman, BD, and Herzlinger, RE. "Shifting toward defined contributions--predicting the effects." The New England journal of medicine 370.26 (June 2014): 2462-2465.
PMID
24963565
Source
epmc
Published In
The New England journal of medicine
Volume
370
Issue
26
Publish Date
2014
Start Page
2462
End Page
2465
DOI
10.1056/nejmp1314391

Removing a constraint on hospital utilization: a natural experiment in Maryland.

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.

Authors
Kalman, NS; Hammill, BG; Murray, RB; Schulman, KA
MLA Citation
Kalman, NS, Hammill, BG, Murray, RB, and Schulman, KA. "Removing a constraint on hospital utilization: a natural experiment in Maryland." The American journal of managed care 20.6 (June 2014): e191-e199.
PMID
25180502
Source
epmc
Published In
American Journal of Managed Care
Volume
20
Issue
6
Publish Date
2014
Start Page
e191
End Page
e199

Health City Cayman Islands and the globalization of health services delivery.

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.

Authors
Shah, BR; Narayan, M; Seth, A; Schulman, KA
MLA Citation
Shah, BR, Narayan, M, Seth, A, and Schulman, KA. "Health City Cayman Islands and the globalization of health services delivery." American heart journal 167.5 (May 2014): 770-774.
PMID
24766989
Source
epmc
Published In
American Heart Journal
Volume
167
Issue
5
Publish Date
2014
Start Page
770
End Page
774
DOI
10.1016/j.ahj.2014.02.006

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).

OBJECTIVES: The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL). BACKGROUND: There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial infarction (MI). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Lewis, EF; Li, Y; Pfeffer, MA; Solomon, SD; Weinfurt, KP; Velazquez, EJ; Califf, RM; Rouleau, J-L; Kober, L; White, HD; Schulman, KA; Reed, SD
MLA Citation
Lewis, EF, Li, Y, Pfeffer, MA, Solomon, SD, Weinfurt, KP, Velazquez, EJ, Califf, RM, Rouleau, J-L, Kober, L, White, HD, Schulman, KA, and Reed, SD. "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 2.2 (April 2014): 159-165.
PMID
24720924
Source
epmc
Published In
JACC: Heart Failure
Volume
2
Issue
2
Publish Date
2014
Start Page
159
End Page
165
DOI
10.1016/j.jchf.2013.12.003

Redistribution of health care costs after the adoption of positron emission tomography among medicare beneficiaries with non-small-cell lung cancer, 1998-2005.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "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 : official publication of the International Association for the Study of Lung Cancer 9.4 (April 2014): 512-518.
PMID
24736074
Source
epmc
Published In
Journal of Thoracic Oncology
Volume
9
Issue
4
Publish Date
2014
Start Page
512
End Page
518
DOI
10.1097/jto.0000000000000102

Health City Cayman Islands and the globalization of health services delivery

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. © 2014 Mosby, Inc.

Authors
Shah, BR; Narayan, M; Seth, A; Schulman, KA
MLA Citation
Shah, BR, Narayan, M, Seth, A, and Schulman, KA. "Health City Cayman Islands and the globalization of health services delivery." American Heart Journal 167.5 (January 1, 2014): 770-774.
Source
scopus
Published In
American Heart Journal
Volume
167
Issue
5
Publish Date
2014
Start Page
770
End Page
774
DOI
10.1016/j.ahj.2014.02.006

The Partners HealthCare Settlement and the Future of Health Care Organizations

MLA Citation
"The Partners HealthCare Settlement and the Future of Health Care Organizations." The Economists' Voice 11.1 (January 1, 2014).
Source
crossref
Volume
11
Issue
1
Publish Date
2014
DOI
10.1515/ev-2014-0005

Commentary

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Commentary." Annals of Internal Medicine 161.12 (January 1, 2014): JC6-.
Source
scopus
Published In
Annals of internal medicine
Volume
161
Issue
12
Publish Date
2014
Start Page
JC6

Can team-based care improve patient satisfaction? A systematic review of randomized controlled trials.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Authors
Wen, J; Schulman, KA
MLA Citation
Wen, J, and Schulman, KA. "Can team-based care improve patient satisfaction? A systematic review of randomized controlled trials." PloS one 9.7 (January 2014): e100603-. (Review)
PMID
25014674
Source
epmc
Published In
PloS one
Volume
9
Issue
7
Publish Date
2014
Start Page
e100603
DOI
10.1371/journal.pone.0100603

An evaluation of mobile health application tools.

BACKGROUND: 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. OBJECTIVE: The objective of this study was to describe the characteristics of the most common mobile health care applications available in the Apple iTunes marketplace. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Sama, PR; Eapen, ZJ; Weinfurt, KP; Shah, BR; Schulman, KA
MLA Citation
Sama, PR, Eapen, ZJ, Weinfurt, KP, Shah, BR, and Schulman, KA. "An evaluation of mobile health application tools." JMIR mHealth and uHealth 2.2 (January 2014): e19-.
PMID
25099179
Source
epmc
Published In
JMIR mHealth and uHealth
Volume
2
Issue
2
Publish Date
2014
Start Page
e19
DOI
10.2196/mhealth.3088

Predicting nursing home placement among home- and community-based services program participants.

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.

Authors
Greiner, MA; Qualls, LG; Iwata, I; White, HK; Molony, SL; Sullivan, MT; Burke, B; Schulman, KA; Setoguchi, S
MLA Citation
Greiner, MA, Qualls, LG, Iwata, I, White, HK, Molony, SL, Sullivan, MT, Burke, B, Schulman, KA, and Setoguchi, S. "Predicting nursing home placement among home- and community-based services program participants." The American journal of managed care 20.12 (January 2014): e535-e536.
PMID
25741870
Source
epmc
Published In
American Journal of Managed Care
Volume
20
Issue
12
Publish Date
2014
Start Page
e535
End Page
e536

Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial).

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.

Authors
Piña, IL; Lin, L; Weinfurt, KP; Isitt, JJ; Whellan, DJ; Schulman, KA; Flynn, KE; HF-ACTION Investigators,
MLA Citation
Piña, IL, Lin, L, Weinfurt, KP, Isitt, JJ, Whellan, DJ, Schulman, KA, Flynn, KE, and HF-ACTION Investigators, . "Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)." Am J Cardiol 112.7 (October 1, 2013): 971-976.
PMID
23809621
Source
pubmed
Published In
American Journal of Cardiology
Volume
112
Issue
7
Publish Date
2013
Start Page
971
End Page
976
DOI
10.1016/j.amjcard.2013.05.033

The Mis-Measure of Physician Performance

Authors
Glickman, SW; Schulman, KA
MLA Citation
Glickman, SW, and Schulman, KA. "The Mis-Measure of Physician Performance." AMERICAN JOURNAL OF MANAGED CARE 19.10 (October 2013): 782-785.
PMID
24304157
Source
wos-lite
Published In
American Journal of Managed Care
Volume
19
Issue
10
Publish Date
2013
Start Page
782
End Page
785

Financial incentives in primary care practice: the struggle to achieve population health goals.

Authors
Dolor, RJ; Schulman, KA
MLA Citation
Dolor, RJ, and Schulman, KA. "Financial incentives in primary care practice: the struggle to achieve population health goals." JAMA 310.10 (September 11, 2013): 1031-1032.
PMID
24026597
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
310
Issue
10
Publish Date
2013
Start Page
1031
End Page
1032
DOI
10.1001/jama.2013.277575

Who enrolls in the Medicare Part D prescription drug benefit program? Medication use among patients with heart failure.

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.

Authors
Eapen, ZJ; Hammill, BG; Setoguchi, S; Schulman, KA; Peterson, ED; Hernandez, AF; Curtis, LH
MLA Citation
Eapen, ZJ, Hammill, BG, Setoguchi, S, Schulman, KA, Peterson, ED, Hernandez, AF, and Curtis, LH. "Who enrolls in the Medicare Part D prescription drug benefit program? Medication use among patients with heart failure." Journal of the American Heart Association 2.5 (September 11, 2013): e000242-.
PMID
24025363
Source
epmc
Published In
Journal of the American Heart Association
Volume
2
Issue
5
Publish Date
2013
Start Page
e000242
DOI
10.1161/jaha.113.000242

Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Authors
Reed, SD; Kaul, P; Li, Y; Eapen, ZJ; Davidson-Ray, L; Schulman, KA; Massie, BM; Armstrong, PW; Starling, RC; O'Connor, CM; Hernandez, AF; Califf, RM
MLA Citation
Reed, SD, Kaul, P, Li, Y, Eapen, ZJ, Davidson-Ray, L, Schulman, KA, Massie, BM, Armstrong, PW, Starling, RC, O'Connor, CM, Hernandez, AF, and Califf, RM. "Medical resource use, costs, and quality of life in patients with acute decompensated heart failure: findings from ASCEND-HF." J Card Fail 19.9 (September 2013): 611-620.
PMID
24054337
Source
pubmed
Published In
Journal of Cardiac Failure
Volume
19
Issue
9
Publish Date
2013
Start Page
611
End Page
620
DOI
10.1016/j.cardfail.2013.07.003

Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov.

IMPORTANCE: 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. OBJECTIVE: To perform a comprehensive analysis of the national oncology clinical research portfolio. DESIGN: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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.

Authors
Hirsch, BR; Califf, RM; Cheng, SK; Tasneem, A; Horton, J; Chiswell, K; Schulman, KA; Dilts, DM; Abernethy, AP
MLA Citation
Hirsch, BR, Califf, RM, Cheng, SK, Tasneem, A, Horton, J, Chiswell, K, Schulman, KA, Dilts, DM, and Abernethy, AP. "Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov." JAMA Intern Med 173.11 (June 10, 2013): 972-979.
PMID
23699837
Source
pubmed
Published In
JAMA Internal Medicine
Volume
173
Issue
11
Publish Date
2013
Start Page
972
End Page
979
DOI
10.1001/jamainternmed.2013.627

Variations in use of PET among Medicare beneficiaries with non-small cell lung cancer, 1998-2007.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "Variations in use of PET among Medicare beneficiaries with non-small cell lung cancer, 1998-2007." Radiology 267.3 (June 2013): 807-817.
PMID
23418003
Source
pubmed
Published In
Radiology
Volume
267
Issue
3
Publish Date
2013
Start Page
807
End Page
817
DOI
10.1148/radiol.12120174

Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Li, Y; Neilson, MP; Whellan, DJ; Schulman, KA; Levy, WC; Reed, SD
MLA Citation
Li, Y, Neilson, MP, Whellan, DJ, Schulman, KA, Levy, WC, and Reed, SD. "Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION." J Card Fail 19.5 (May 2013): 311-316.
PMID
23663813
Source
pubmed
Published In
Journal of Cardiac Failure
Volume
19
Issue
5
Publish Date
2013
Start Page
311
End Page
316
DOI
10.1016/j.cardfail.2013.03.008

A Web-based communication aid for patients with cancer: the CONNECT Study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Meropol, NJ; Egleston, BL; Buzaglo, JS; Balshem, A; Benson, AB; Cegala, DJ; Cohen, RB; Collins, M; Diefenbach, MA; Miller, SM; Fleisher, L; Millard, JL; Ross, EA; Schulman, KA; Silver, A; Slater, E; Solarino, N; Sulmasy, DP; Trinastic, J; Weinfurt, KP
MLA Citation
Meropol, NJ, Egleston, BL, Buzaglo, JS, Balshem, A, Benson, AB, Cegala, DJ, Cohen, RB, Collins, M, Diefenbach, MA, Miller, SM, Fleisher, L, Millard, JL, Ross, EA, Schulman, KA, Silver, A, Slater, E, Solarino, N, Sulmasy, DP, Trinastic, J, and Weinfurt, KP. "A Web-based communication aid for patients with cancer: the CONNECT Study." Cancer 119.7 (April 1, 2013): 1437-1445.
PMID
23335150
Source
pubmed
Published In
Cancer
Volume
119
Issue
7
Publish Date
2013
Start Page
1437
End Page
1445
DOI
10.1002/cncr.27874

Costs of newly diagnosed neovascular age-related macular degeneration among medicare beneficiaries, 2004-2008.

PURPOSE: To examine associations between newly diagnosed neovascular age-related macular degeneration and direct medical costs. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Qualls, LG; Hammill, BG; Wang, F; Lad, EM; Schulman, KA; Cousins, SW; Curtis, LH
MLA Citation
Qualls, LG, Hammill, BG, Wang, F, Lad, EM, Schulman, KA, Cousins, SW, and Curtis, LH. "Costs of newly diagnosed neovascular age-related macular degeneration among medicare beneficiaries, 2004-2008." Retina (Philadelphia, Pa.) 33.4 (April 2013): 854-861.
PMID
23296047
Source
epmc
Published In
Retina
Volume
33
Issue
4
Publish Date
2013
Start Page
854
End Page
861
DOI
10.1097/iae.0b013e31826f065e

Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: The findings provide supportive evidence for the economic value of the 21-gene recurrence score assay in node-negative, estrogen receptor-positive breast cancer.

Authors
Reed, SD; Dinan, MA; Schulman, KA; Lyman, GH
MLA Citation
Reed, SD, Dinan, MA, Schulman, KA, and Lyman, GH. "Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer." Genet Med 15.3 (March 2013): 203-211.
PMID
22975761
Source
pubmed
Published In
Genetics in Medicine
Volume
15
Issue
3
Publish Date
2013
Start Page
203
End Page
211
DOI
10.1038/gim.2012.119

Reply to M.S. Hofman et al.

Authors
Dinan, MA; Carpenter, WR; Patz, EF; Abernethy, AP; Biddle, AK; Schulman, KA; Curtis, LH
MLA Citation
Dinan, MA, Carpenter, WR, Patz, EF, Abernethy, AP, Biddle, AK, Schulman, KA, and Curtis, LH. "Reply to M.S. Hofman et al." J Clin Oncol 31.6 (February 20, 2013): 820-. (Letter)
PMID
23544205
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
31
Issue
6
Publish Date
2013
Start Page
820
DOI
10.1200/JCO.2012.46.7373

Comparative effectiveness of nonbiologic versus biologic disease-modifying antirheumatic drugs for rheumatoid arthritis.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Dewitt, EM; Li, Y; Curtis, JR; Glick, HA; Greenberg, JD; Anstrom, KJ; Kremer, JM; Reed, G; Schulman, KA; Reed, SD
MLA Citation
Dewitt, EM, Li, Y, Curtis, JR, Glick, HA, Greenberg, JD, Anstrom, KJ, Kremer, JM, Reed, G, Schulman, KA, and Reed, SD. "Comparative effectiveness of nonbiologic versus biologic disease-modifying antirheumatic drugs for rheumatoid arthritis." J Rheumatol 40.2 (February 2013): 127-136.
PMID
23322461
Source
pubmed
Published In
The Journal of rheumatology
Volume
40
Issue
2
Publish Date
2013
Start Page
127
End Page
136
DOI
10.3899/jrheum.120400

Patient time costs associated with sensor-augmented insulin pump therapy for type 1 diabetes: results from the STAR 3 randomized trial.

BACKGROUND: 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. OBJECTIVE: 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. MEASUREMENTS: Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation. RESULTS: 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). LIMITATIONS: Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities. CONCLUSIONS: 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.

Authors
Kamble, S; Weinfurt, KP; Schulman, KA; Reed, SD
MLA Citation
Kamble, S, Weinfurt, KP, Schulman, KA, and Reed, SD. "Patient time costs associated with sensor-augmented insulin pump therapy for type 1 diabetes: results from the STAR 3 randomized trial." Med Decis Making 33.2 (February 2013): 215-224.
PMID
23128579
Source
pubmed
Published In
Medical Decision Making
Volume
33
Issue
2
Publish Date
2013
Start Page
215
End Page
224
DOI
10.1177/0272989X12464824

Patient-Centered Health Care Delivery Systems: A Framework

Authors
Muehlbacher, AC; Bethge, S; Schulman, KA
MLA Citation
Muehlbacher, AC, Bethge, S, and Schulman, KA. "Patient-Centered Health Care Delivery Systems: A Framework." INTERNATIONAL JOURNAL OF INTEGRATED CARE 13 (2013).
Source
wos-lite
Published In
International Journal of Integrated Care
Volume
13
Publish Date
2013

Costs of newly diagnosed neovascular age-related macular degeneration among medicare beneficiaries, 2004-2008

PURPOSE: To examine associations between newly diagnosed neovascular age-related macular degeneration and direct medical costs.METHODS: 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.RESULTS: 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.CONCLUSION: 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.

Authors
Qualls, LG; Hammill, BG; Wang, F; Lad, EM; Schulman, KA; Cousins, SW; Curtis, LH
MLA Citation
Qualls, LG, Hammill, BG, Wang, F, Lad, EM, Schulman, KA, Cousins, SW, and Curtis, LH. "Costs of newly diagnosed neovascular age-related macular degeneration among medicare beneficiaries, 2004-2008." Retina 33.4 (2013): 854-861.
Source
scival
Published In
Retina
Volume
33
Issue
4
Publish Date
2013
Start Page
854
End Page
861
DOI
10.1097/IAE.0b013e31826f065e

The economics of new drugs: can we afford to make progress in a common disease?

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.

Authors
Hirsch, BR; Schulman, KA
MLA Citation
Hirsch, BR, and Schulman, KA. "The economics of new drugs: can we afford to make progress in a common disease?." Am Soc Clin Oncol Educ Book (2013). (Review)
PMID
23714477
Source
pubmed
Published In
American Society of Clinical Oncology educational book / ASCO. American Society of Clinical Oncology. Meeting
Publish Date
2013
DOI
10.1200/EdBook_AM.2013.33.e126

Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)

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. © 2013 Elsevier Inc. All rights reserved.

Authors
Piña, IL; Lin, L; Weinfurt, KP; Isitt, JJ; Whellan, DJ; Schulman, KA; Flynn, KE
MLA Citation
Piña, IL, Lin, L, Weinfurt, KP, Isitt, JJ, Whellan, DJ, Schulman, KA, and Flynn, KE. "Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)." American Journal of Cardiology 112.7 (2013): 971-976.
Source
scival
Published In
The American Journal of Cardiology
Volume
112
Issue
7
Publish Date
2013
Start Page
971
End Page
976
DOI
10.1016/j.amjcard.2013.05.033

Urinary diversion in patients with spinal cord injury in the United States.

OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Authors
Peterson, AC; Curtis, LH; Shea, AM; Borawski, KM; Schulman, KA; Scales, CD
MLA Citation
Peterson, AC, Curtis, LH, Shea, AM, Borawski, KM, Schulman, KA, and Scales, CD. "Urinary diversion in patients with spinal cord injury in the United States." Urology 80.6 (December 2012): 1247-1251.
PMID
23206770
Source
pubmed
Published In
Urology
Volume
80
Issue
6
Publish Date
2012
Start Page
1247
End Page
1251
DOI
10.1016/j.urology.2012.06.063

A model for the adoption of ICT by health workers in Africa.

PURPOSE: To investigate the potential of information and communication technology (ICT) adoption among maternal and child health workers in rural Nigeria. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Authors
Jimoh, L; Pate, MA; Lin, L; Schulman, KA
MLA Citation
Jimoh, L, Pate, MA, Lin, L, and Schulman, KA. "A model for the adoption of ICT by health workers in Africa." Int J Med Inform 81.11 (November 2012): 773-781.
PMID
22986218
Source
pubmed
Published In
International Journal of Medical Informatics
Volume
81
Issue
11
Publish Date
2012
Start Page
773
End Page
781
DOI
10.1016/j.ijmedinf.2012.08.005

Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.

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.

Authors
Valverde, AM; Reed, SD; Schulman, KA
MLA Citation
Valverde, AM, Reed, SD, and Schulman, KA. "Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases." Health Aff (Millwood) 31.11 (November 2012): 2528-2535. (Review)
PMID
23129684
Source
pubmed
Published In
Health Affairs
Volume
31
Issue
11
Publish Date
2012
Start Page
2528
End Page
2535
DOI
10.1377/hlthaff.2012.0235

In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial).

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.

Authors
Reed, SD; Li, Y; Dunlap, ME; Kraus, WE; Samsa, GP; Schulman, KA; Zile, MR; Whellan, DJ
MLA Citation
Reed, SD, Li, Y, Dunlap, ME, Kraus, WE, Samsa, GP, Schulman, KA, Zile, MR, and Whellan, DJ. "In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial)." Am J Cardiol 110.8 (October 15, 2012): 1150-1155.
PMID
22762718
Source
pubmed
Published In
American Journal of Cardiology
Volume
110
Issue
8
Publish Date
2012
Start Page
1150
End Page
1155
DOI
10.1016/j.amjcard.2012.05.059

Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION.

BACKGROUND: Reports that patients with heart failure and anemia incur greater costs and medical resource use have relied largely on data with limited clinical detail. METHODS: 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. RESULTS: 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. CONCLUSIONS: Patients with lower baseline hemoglobin levels experienced progressively greater resource use and higher costs.

Authors
Reed, SD; Li, Y; Ellis, SJ; Isitt, JJ; Cheng, S; Schulman, KA; Whellan, DJ
MLA Citation
Reed, SD, Li, Y, Ellis, SJ, Isitt, JJ, Cheng, S, Schulman, KA, and Whellan, DJ. "Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION." J Card Fail 18.10 (October 2012): 784-791.
PMID
23040114
Source
pubmed
Published In
Journal of Cardiac Failure
Volume
18
Issue
10
Publish Date
2012
Start Page
784
End Page
791
DOI
10.1016/j.cardfail.2012.08.359

Cost-effectiveness of truncated therapy for hepatitis C based on rapid virologic response.

BACKGROUND: 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. OBJECTIVE: To assess the cost-effectiveness of response-guided therapy versus standard-duration therapy on the basis of best available evidence. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Gellad, ZF; Muir, AJ; McHutchison, JG; Sievert, W; Sharara, AI; Brown, KA; Flisiak, R; Jacobson, IM; Kershenobich, D; Manns, MP; Schulman, KA; Reed, SD
MLA Citation
Gellad, ZF, Muir, AJ, McHutchison, JG, Sievert, W, Sharara, AI, Brown, KA, Flisiak, R, Jacobson, IM, Kershenobich, D, Manns, MP, Schulman, KA, and Reed, SD. "Cost-effectiveness of truncated therapy for hepatitis C based on rapid virologic response." Value Health 15.6 (September 2012): 876-886.
PMID
22999138
Source
pubmed
Published In
Value in Health
Volume
15
Issue
6
Publish Date
2012
Start Page
876
End Page
886
DOI
10.1016/j.jval.2012.06.010

Overbilling and informed financial consent--a contractual solution.

Authors
Richman, BD; Hall, MA; Schulman, KA
MLA Citation
Richman, BD, Hall, MA, and Schulman, KA. "Overbilling and informed financial consent--a contractual solution." N Engl J Med 367.5 (August 2, 2012): 396-397.
PMID
22853013
Source
pubmed
Published In
The New England journal of medicine
Volume
367
Issue
5
Publish Date
2012
Start Page
396
End Page
397
DOI
10.1056/NEJMp1205225

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.

PURPOSE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Dinan, MA; Curtis, LH; Carpenter, WR; Biddle, AK; Abernethy, AP; Patz, EF; Schulman, KA; Weinberger, M
MLA Citation
Dinan, MA, Curtis, LH, Carpenter, WR, Biddle, AK, Abernethy, AP, Patz, EF, Schulman, KA, and Weinberger, M. "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." J Clin Oncol 30.22 (August 1, 2012): 2725-2730.
PMID
22753917
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
30
Issue
22
Publish Date
2012
Start Page
2725
End Page
2730
DOI
10.1200/JCO.2011.40.4392

Seattle Heart Failure Model Scores are Significantly Predictive of Health Utilities and Their Change Over Time

Authors
Li, Y; Neilson, M; Whellan, DJ; Schulman, KA; Levy, WC; Reed, SD
MLA Citation
Li, Y, Neilson, M, Whellan, DJ, Schulman, KA, Levy, WC, and Reed, SD. "Seattle Heart Failure Model Scores are Significantly Predictive of Health Utilities and Their Change Over Time." August 2012.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
18
Issue
8
Publish Date
2012
Start Page
S81
End Page
S81

Cost-effectiveness of sensor-augmented pump therapy in adults with type 1 diabetes in the United States.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Kamble, S; Schulman, KA; Reed, SD
MLA Citation
Kamble, S, Schulman, KA, and Reed, SD. "Cost-effectiveness of sensor-augmented pump therapy in adults with type 1 diabetes in the United States." Value Health 15.5 (July 2012): 632-638.
PMID
22867771
Source
pubmed
Published In
Value in Health
Volume
15
Issue
5
Publish Date
2012
Start Page
632
End Page
638
DOI
10.1016/j.jval.2012.02.011

Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries.

PURPOSE: To examine trends in the treatment of newly diagnosed neovascular age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Curtis, LH; Hammill, BG; Qualls, LG; DiMartino, LD; Wang, F; Schulman, KA; Cousins, SW
MLA Citation
Curtis, LH, Hammill, BG, Qualls, LG, DiMartino, LD, Wang, F, Schulman, KA, and Cousins, SW. "Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries." Am J Ophthalmol 153.6 (June 2012): 1116-24.e1.
PMID
22321802
Source
pubmed
Published In
American Journal of Ophthalmology
Volume
153
Issue
6
Publish Date
2012
Start Page
1116
End Page
24.e1
DOI
10.1016/j.ajo.2011.11.032

Improving the impact of clinical research: A systematic analysis of kidney cancer trials.

Authors
Hirsch, BR; Mitchell, A; Cheng, SK; Tasneem, A; Schulman, KA; Dilts, DM; Abernethy, AP
MLA Citation
Hirsch, BR, Mitchell, A, Cheng, SK, Tasneem, A, Schulman, KA, Dilts, DM, and Abernethy, AP. "Improving the impact of clinical research: A systematic analysis of kidney cancer trials." May 20, 2012.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
30
Issue
15
Publish Date
2012

Drug development risk and the cost of capital.

Authors
Baras, AI; Baras, AS; Schulman, KA
MLA Citation
Baras, AI, Baras, AS, and Schulman, KA. "Drug development risk and the cost of capital. (Published online)" Nat Rev Drug Discov 11.5 (April 13, 2012): 347-348.
PMID
22498751
Source
pubmed
Published In
Nature Reviews Drug Discovery
Volume
11
Issue
5
Publish Date
2012
Start Page
347
End Page
348
DOI
10.1038/nrd3722

Changes in initial treatment for prostate cancer among Medicare beneficiaries, 1999-2007.

PURPOSE: 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. METHODS AND MATERIALS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Dinan, MA; Robinson, TJ; Zagar, TM; Scales, CD; Curtis, LH; Reed, SD; Lee, WR; Schulman, KA
MLA Citation
Dinan, MA, Robinson, TJ, Zagar, TM, Scales, CD, Curtis, LH, Reed, SD, Lee, WR, and Schulman, KA. "Changes in initial treatment for prostate cancer among Medicare beneficiaries, 1999-2007." Int J Radiat Oncol Biol Phys 82.5 (April 1, 2012): e781-e786.
PMID
22331001
Source
pubmed
Published In
International Journal of Radiation: Oncology - Biology - Physics
Volume
82
Issue
5
Publish Date
2012
Start Page
e781
End Page
e786
DOI
10.1016/j.ijrobp.2011.11.024

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.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Dewitt, EM; Grussemeyer, CA; Friedman, JY; Dinan, MA; Lin, L; Schulman, KA; Reed, SD
MLA Citation
Dewitt, EM, Grussemeyer, CA, Friedman, JY, Dinan, MA, Lin, L, Schulman, KA, and Reed, SD. "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 Health 15.2 (March 2012): 277-283.
PMID
22433759
Source
pubmed
Published In
Value in Health
Volume
15
Issue
2
Publish Date
2012
Start Page
277
End Page
283
DOI
10.1016/j.jval.2011.11.027

The potential influence of Internet-based social networking on the conduct of clinical research studies.

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.

Authors
Glickman, SW; Galhenage, S; McNair, L; Barber, Z; Patel, K; Schulman, KA; McHutchison, JG
MLA Citation
Glickman, SW, Galhenage, S, McNair, L, Barber, Z, Patel, K, Schulman, KA, and McHutchison, JG. "The potential influence of Internet-based social networking on the conduct of clinical research studies." J Empir Res Hum Res Ethics 7.1 (February 2012): 71-80.
PMID
22378136
Source
pubmed
Published In
Journal of Empirical Research on Human Research Ethics
Volume
7
Issue
1
Publish Date
2012
Start Page
71
End Page
80
DOI
10.1525/jer.2012.7.1.71

Pharmacoeconomics: Economic Evaluation of Pharmaceuticals

Ongoing concerns about the costs of medical care have led both purchasers and producers of pharmaceuticals to realize that the cost of drugs is not limited to their purchase price. Accompanying costs of preparation, administration, monitoring for and treating side effects, and the economic consequences of successful treatment are all influenced by the clinical and pharmacologic properties of pharmaceutical products. Thus, in addition to differences in efficacy and safety, differences in efficiency (or the effectiveness of the therapy in clinical practice compared with its cost) distinguish drugs from one another. In this chapter, the authors discuss the importance of applying economic concepts to the study of pharmaceuticals, introduce clinical economics and the application of these concepts to pharmaceutical research, review methodologic issues addressed by investigators conducting pharmacoeconomic studies, and offer examples of pharmacoeconomic research. © 2012 John Wiley and Sons, Ltd.

Authors
Schulman, KA; Glick, HA; Polsky, D; Reed, SD
MLA Citation
Schulman, KA, Glick, HA, Polsky, D, and Reed, SD. "Pharmacoeconomics: Economic Evaluation of Pharmaceuticals." (January 3, 2012): 678-708. (Chapter)
Source
scopus
Publish Date
2012
Start Page
678
End Page
708
DOI
10.1002/9781119959946.ch38

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.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Reed, SD; Li, Y; Kamble, S; Polsky, D; Graham, FL; Bowers, MT; Samsa, GP; Paul, S; Schulman, KA; Whellan, DJ; Riegel, BJ
MLA Citation
Reed, SD, Li, Y, Kamble, S, Polsky, D, Graham, FL, Bowers, MT, Samsa, GP, Paul, S, Schulman, KA, Whellan, DJ, and Riegel, BJ. "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." Circ Cardiovasc Qual Outcomes 5.1 (January 2012): 113-119.
PMID
22147884
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
5
Issue
1
Publish Date
2012
Start Page
113
End Page
119
DOI
10.1161/CIRCOUTCOMES.111.962977

Can we begin with the end in mind? End-of-life care preferences before long-term dialysis

Authors
Patel, UD; Schulman, KA
MLA Citation
Patel, UD, and Schulman, KA. "Can we begin with the end in mind? End-of-life care preferences before long-term dialysis." Archives of Internal Medicine 172.8 (2012): 663-664.
PMID
23446995
Source
scival
Published In
Archives of internal medicine
Volume
172
Issue
8
Publish Date
2012
Start Page
663
End Page
664
DOI
10.1001/archinternmed.2012.1151

In reply

Authors
Curtis, LH; Hammill, BG; Schulman, KA; Cousins, SW
MLA Citation
Curtis, LH, Hammill, BG, Schulman, KA, and Cousins, SW. "In reply." Archives of Ophthalmology 130.1 (2012): 125-126.
Source
scival
Published In
Archives of Ophthalmology
Volume
130
Issue
1
Publish Date
2012
Start Page
125
End Page
126
DOI
10.1001/archopht.130.1.125

In reply

Authors
Curtis, LH; Hammill, BG; Schulman, KA; Cousins, SW
MLA Citation
Curtis, LH, Hammill, BG, Schulman, KA, and Cousins, SW. "In reply." Archives of Ophthalmology 130.6 (2012): 807--.
Source
scival
Published In
Archives of Ophthalmology
Volume
130
Issue
6
Publish Date
2012
Start Page
807-
DOI
10.1001/archophthalmol.2012.100

Medical Resource Use, Costs and Quality of Life are Similar Between Patients with Acute Decompensated Heart Failure Treated with Nesiritide Versus Placebo

Authors
Reed, SD; Kaul, P; Hernandez, AF; Li, Y; Eapen, ZJ; Schulman, KA; Whellan, DJ; Westerhout, CM; Massie, B; Howlett, JG; Armstrong, PW; Starling, R; O'Connor, CM; Califf, RM
MLA Citation
Reed, SD, Kaul, P, Hernandez, AF, Li, Y, Eapen, ZJ, Schulman, KA, Whellan, DJ, Westerhout, CM, Massie, B, Howlett, JG, Armstrong, PW, Starling, R, O'Connor, CM, and Califf, RM. "Medical Resource Use, Costs and Quality of Life are Similar Between Patients with Acute Decompensated Heart Failure Treated with Nesiritide Versus Placebo." CIRCULATION 124.21 (November 22, 2011).
Source
wos-lite
Published In
Circulation
Volume
124
Issue
21
Publish Date
2011

End point selection in acute decompensated heart failure clinical trials: economic end points.

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.

Authors
Reed, SD; Eapen, ZJ; Schulman, KA
MLA Citation
Reed, SD, Eapen, ZJ, and Schulman, KA. "End point selection in acute decompensated heart failure clinical trials: economic end points." Heart Fail Clin 7.4 (October 2011): 529-537. (Review)
PMID
21925436
Source
pubmed
Published In
Heart Failure Clinics
Volume
7
Issue
4
Publish Date
2011
Start Page
529
End Page
537
DOI
10.1016/j.hfc.2011.06.014

Delivering affordable cancer care in high-income countries.

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.

Authors
Sullivan, R; Peppercorn, J; Sikora, K; Zalcberg, J; Meropol, NJ; Amir, E; Khayat, D; Boyle, P; Autier, P; Tannock, IF; Fojo, T; Siderov, J; Williamson, S; Camporesi, S; McVie, JG; Purushotham, AD; Naredi, P; Eggermont, A; Brennan, MF; Steinberg, ML; De Ridder, M; McCloskey, SA; Verellen, D; Roberts, T; Storme, G; Hicks, RJ; Ell, PJ; Hirsch, BR; Carbone, DP; Schulman, KA; Catchpole, P; Taylor, D; Geissler, J; Brinker, NG; Meltzer, D; Kerr, D; Aapro, M
MLA Citation
Sullivan, R, Peppercorn, J, Sikora, K, Zalcberg, J, Meropol, NJ, Amir, E, Khayat, D, Boyle, P, Autier, P, Tannock, IF, Fojo, T, Siderov, J, Williamson, S, Camporesi, S, McVie, JG, Purushotham, AD, Naredi, P, Eggermont, A, Brennan, MF, Steinberg, ML, De Ridder, M, McCloskey, SA, Verellen, D, Roberts, T, Storme, G, Hicks, RJ, Ell, PJ, Hirsch, BR, Carbone, DP, Schulman, KA, Catchpole, P, Taylor, D, Geissler, J, Brinker, NG, Meltzer, D, Kerr, D, and Aapro, M. "Delivering affordable cancer care in high-income countries." Lancet Oncol 12.10 (September 2011): 933-980.
PMID
21958503
Source
pubmed
Published In
The Lancet Oncology
Volume
12
Issue
10
Publish Date
2011
Start Page
933
End Page
980
DOI
10.1016/S1470-2045(11)70141-3

Our failure to advance new treatments for glioma to market.

Authors
Sampson, JH; Kaminski, TJ; Schulman, KA
MLA Citation
Sampson, JH, Kaminski, TJ, and Schulman, KA. "Our failure to advance new treatments for glioma to market." J Neurosurg 115.2 (August 2011): 245-247.
PMID
21568655
Source
pubmed
Published In
Journal of neurosurgery
Volume
115
Issue
2
Publish Date
2011
Start Page
245
End Page
247
DOI
10.3171/2010.11.JNS101436

Bladder augmentation versus urinary diversion in patients with spina bifida in the United States.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Wiener, JS; Antonelli, J; Shea, AM; Curtis, LH; Schulman, KA; Krupski, TL; Scales, CD
MLA Citation
Wiener, JS, Antonelli, J, Shea, AM, Curtis, LH, Schulman, KA, Krupski, TL, and Scales, CD. "Bladder augmentation versus urinary diversion in patients with spina bifida in the United States." J Urol 186.1 (July 2011): 161-165.
PMID
21575969
Source
pubmed
Published In
The Journal of Urology
Volume
186
Issue
1
Publish Date
2011
Start Page
161
End Page
165
DOI
10.1016/j.juro.2011.03.023

Training the next generation of physician-executives: an innovative residency pathway in management and leadership.

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.

Authors
Ackerly, DC; Sangvai, DG; Udayakumar, K; Shah, BR; Kalman, NS; Cho, AH; Schulman, KA; Fulkerson, WJ; Dzau, VJ
MLA Citation
Ackerly, DC, Sangvai, DG, Udayakumar, K, Shah, BR, Kalman, NS, Cho, AH, Schulman, KA, Fulkerson, WJ, and Dzau, VJ. "Training the next generation of physician-executives: an innovative residency pathway in management and leadership." Acad Med 86.5 (May 2011): 575-579. (Review)
PMID
21436663
Source
pubmed
Published In
Academic Medicine
Volume
86
Issue
5
Publish Date
2011
Start Page
575
End Page
579
DOI
10.1097/ACM.0b013e318212e51b

Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials.

BACKGROUND: 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. PURPOSE: To investigate current patterns of use of PROs in clinical trials. RESEARCH DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Dinan, MA; Compton, KL; Dhillon, JK; Hammill, BG; Dewitt, EM; Weinfurt, KP; Schulman, KA
MLA Citation
Dinan, MA, Compton, KL, Dhillon, JK, Hammill, BG, Dewitt, EM, Weinfurt, KP, and Schulman, KA. "Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials." Med Care 49.4 (April 2011): 415-419. (Review)
PMID
21368680
Source
pubmed
Published In
Medical Care
Volume
49
Issue
4
Publish Date
2011
Start Page
415
End Page
419
DOI
10.1097/MLR.0b013e3182064aa2

Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

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.

Authors
Glickman, SW; Ndubuizu, A; Weinfurt, KP; Hamilton, CD; Glickman, LT; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Ndubuizu, A, Weinfurt, KP, Hamilton, CD, Glickman, LT, Schulman, KA, and Cairns, CB. "Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research." Acad Med 86.3 (March 2011): 389-393.
PMID
21248607
Source
pubmed
Published In
Academic Medicine
Volume
86
Issue
3
Publish Date
2011
Start Page
389
End Page
393
DOI
10.1097/ACM.0b013e318208289a

Effects of family history and genetic polymorphism on the cost-effectiveness of chemoprevention with finasteride for prostate cancer.

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Reed, SD; Scales, CD; Stewart, SB; Sun, J; Moul, JW; Schulman, KA; Xu, J
MLA Citation
Reed, SD, Scales, CD, Stewart, SB, Sun, J, Moul, JW, Schulman, KA, and Xu, J. "Effects of family history and genetic polymorphism on the cost-effectiveness of chemoprevention with finasteride for prostate cancer." J Urol 185.3 (March 2011): 841-847.
PMID
21239023
Source
pubmed
Published In
The Journal of Urology
Volume
185
Issue
3
Publish Date
2011
Start Page
841
End Page
847
DOI
10.1016/j.juro.2010.10.078

Resource use in the last 6 months of life among medicare beneficiaries with heart failure, 2000-2007.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Unroe, KT; Greiner, MA; Hernandez, AF; Whellan, DJ; Kaul, P; Schulman, KA; Peterson, ED; Curtis, LH
MLA Citation
Unroe, KT, Greiner, MA, Hernandez, AF, Whellan, DJ, Kaul, P, Schulman, KA, Peterson, ED, and Curtis, LH. "Resource use in the last 6 months of life among medicare beneficiaries with heart failure, 2000-2007." Arch Intern Med 171.3 (February 14, 2011): 196-203.
PMID
20937916
Source
pubmed
Published In
Archives of internal medicine
Volume
171
Issue
3
Publish Date
2011
Start Page
196
End Page
203
DOI
10.1001/archinternmed.2010.371

A cautious path forward on accountable care organizations.

Authors
Richman, BD; Schulman, KA
MLA Citation
Richman, BD, and Schulman, KA. "A cautious path forward on accountable care organizations." JAMA 305.6 (February 9, 2011): 602-603.
PMID
21304085
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
305
Issue
6
Publish Date
2011
Start Page
602
End Page
603
DOI
10.1001/jama.2011.111

Assessment of left ventricular function in older Medicare beneficiaries with newly diagnosed heart failure.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Curtis, LH; Greiner, MA; Shea, AM; Whellan, DJ; Hammill, BG; Schulman, KA; Douglas, PS
MLA Citation
Curtis, LH, Greiner, MA, Shea, AM, Whellan, DJ, Hammill, BG, Schulman, KA, and Douglas, PS. "Assessment of left ventricular function in older Medicare beneficiaries with newly diagnosed heart failure." Circ Cardiovasc Qual Outcomes 4.1 (January 1, 2011): 85-91.
PMID
21098783
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
4
Issue
1
Publish Date
2011
Start Page
85
End Page
91
DOI
10.1161/CIRCOUTCOMES.110.958587

Relationship between patient satisfaction with inpatient care and hospital readmission within 30 days.

OBJECTIVES: 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. STUDY DESIGN: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Boulding, W; Glickman, SW; Manary, MP; Schulman, KA; Staelin, R
MLA Citation
Boulding, W, Glickman, SW, Manary, MP, Schulman, KA, and Staelin, R. "Relationship between patient satisfaction with inpatient care and hospital readmission within 30 days." Am J Manag Care 17.1 (January 2011): 41-48.
PMID
21348567
Source
pubmed
Published In
American Journal of Managed Care
Volume
17
Issue
1
Publish Date
2011
Start Page
41
End Page
48

Usability evaluation of a personal health record.

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.

Authors
Segall, N; Saville, JG; L'Engle, P; Carlson, B; Wright, MC; Schulman, K; Tcheng, JE
MLA Citation
Segall, N, Saville, JG, L'Engle, P, Carlson, B, Wright, MC, Schulman, K, and Tcheng, JE. "Usability evaluation of a personal health record." AMIA Annu Symp Proc 2011 (2011): 1233-1242.
PMID
22195184
Source
pubmed
Published In
AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium
Volume
2011
Publish Date
2011
Start Page
1233
End Page
1242

Erratum: Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures

Authors
Dinan, MA; Chou, C-H; Hammill, BG; Graham, FL; Schulman, KA; Telen, MJ; Reed, SD
MLA Citation
Dinan, MA, Chou, C-H, Hammill, BG, Graham, FL, Schulman, KA, Telen, MJ, and Reed, SD. "Erratum: Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures." American Journal of Hematology 86.10 (2011): 906-908.
Source
scival
Published In
American Journal of Hematology
Volume
86
Issue
10
Publish Date
2011
Start Page
906
End Page
908
DOI
10.1002/ajh.22120

Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials

BACKGROUND: 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. PURPOSE: To investigate current patterns of use of PROs in clinical trials. RESEARCH DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Dinan, MA; Compton, KL; Dhillon, JK; Hammill, BG; Witt, EMD; Weinfurt, KP; Schulman, KA
MLA Citation
Dinan, MA, Compton, KL, Dhillon, JK, Hammill, BG, Witt, EMD, Weinfurt, KP, and Schulman, KA. "Use of patient-reported outcomes in randomized, double-blind, placebo-controlled clinical trials." Medical Care (2011).
Source
scival
Published In
Medical Care
Publish Date
2011
DOI
10.1097/MLR.0b013e3182064aa2

A policy approach to the development of molecular diagnostic tests.

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.

Authors
Schulman, KA; Tunis, SR
MLA Citation
Schulman, KA, and Tunis, SR. "A policy approach to the development of molecular diagnostic tests." Nat Biotechnol 28.11 (November 2010): 1157-1159.
PMID
21057480
Source
pubmed
Published In
Nature Biotechnology
Volume
28
Issue
11
Publish Date
2010
Start Page
1157
End Page
1159
DOI
10.1038/nbt1110-1157

Geographic variation and trends in carotid imaging among medicare beneficiaries, 2001 to 2006.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Curtis, LH; Greiner, MA; Patel, MR; Duncan, PW; Schulman, KA; Matchar, DB
MLA Citation
Curtis, LH, Greiner, MA, Patel, MR, Duncan, PW, Schulman, KA, and Matchar, DB. "Geographic variation and trends in carotid imaging among medicare beneficiaries, 2001 to 2006." Circ Cardiovasc Qual Outcomes 3.6 (November 2010): 599-606.
PMID
20940248
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
6
Publish Date
2010
Start Page
599
End Page
606
DOI
10.1161/CIRCOUTCOMES.110.950279

Moving forward with clinical IT on multiple fronts. An interview with Asif Ahmad and Kevin Schulman, M.D., Duke University Health System/Duke University. Interview by Mark Hagland.

Authors
Ahmad, A; Schulman, K
MLA Citation
Ahmad, A, and Schulman, K. "Moving forward with clinical IT on multiple fronts. An interview with Asif Ahmad and Kevin Schulman, M.D., Duke University Health System/Duke University. Interview by Mark Hagland." Healthc Inform 27.10 (October 2010): 45-47. (Interview)
PMID
21049721
Source
pubmed
Published In
Healthcare informatics : the business magazine for information and communication systems
Volume
27
Issue
10
Publish Date
2010
Start Page
45
End Page
47

Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration.

OBJECTIVE: To examine associations between therapies for age-related macular degeneration and risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke. METHODS: 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. RESULTS: 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. CONCLUSION: Bevacizumab and ranibizumab use was not associated with increased risks of mortality, myocardial infarction, bleeding, or stroke compared with photodynamic therapy or pegaptanib use.

Authors
Curtis, LH; Hammill, BG; Schulman, KA; Cousins, SW
MLA Citation
Curtis, LH, Hammill, BG, Schulman, KA, and Cousins, SW. "Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration." Arch Ophthalmol 128.10 (October 2010): 1273-1279.
PMID
20937996
Source
pubmed
Published In
Archives of Ophthalmology
Volume
128
Issue
10
Publish Date
2010
Start Page
1273
End Page
1279
DOI
10.1001/archophthalmol.2010.223

Commentary: Per capita payments in clinical trials: reasonable costs versus bounty hunting.

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.

Authors
Hall, MA; Friedman, JY; King, NMP; Weinfurt, KP; Schulman, KA; Sugarman, J
MLA Citation
Hall, MA, Friedman, JY, King, NMP, Weinfurt, KP, Schulman, KA, and Sugarman, J. "Commentary: Per capita payments in clinical trials: reasonable costs versus bounty hunting." Acad Med 85.10 (October 2010): 1554-1556.
PMID
20881671
Source
pubmed
Published In
Academic Medicine
Volume
85
Issue
10
Publish Date
2010
Start Page
1554
End Page
1556
DOI
10.1097/ACM.0b013e3181ef9cc6

Animal, vegetable, or ... clinical trial?

Authors
Yancy, WS; Maciejewski, ML; Schulman, KA
MLA Citation
Yancy, WS, Maciejewski, ML, and Schulman, KA. "Animal, vegetable, or .. clinical trial?." Ann Intern Med 153.5 (September 7, 2010): 337-339.
PMID
20820043
Source
pubmed
Published In
Annals of internal medicine
Volume
153
Issue
5
Publish Date
2010
Start Page
337
End Page
339
DOI
10.7326/0003-4819-153-5-201009070-00009

Costs of vasospasm in patients with aneurysmal subarachnoid hemorrhage.

OBJECTIVE: To assess the impact of vasospasm on costs, length of stay, and mortality among inpatients with aneurysmal subarachnoid hemorrhage. METHODS: 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. RESULTS: 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. CONCLUSION: Patients with subarachnoid hemorrhage and TCD-defined or symptomatic vasospasm incur higher inpatient costs and longer hospital stays than those without vasospasm.

Authors
Chou, C-H; Reed, SD; Allsbrook, JS; Steele, JL; Schulman, KA; Alexander, MJ
MLA Citation
Chou, C-H, Reed, SD, Allsbrook, JS, Steele, JL, Schulman, KA, and Alexander, MJ. "Costs of vasospasm in patients with aneurysmal subarachnoid hemorrhage." Neurosurgery 67.2 (August 2010): 345-351.
PMID
20644420
Source
pubmed
Published In
Neurosurgery
Volume
67
Issue
2
Publish Date
2010
Start Page
345
End Page
351
DOI
10.1227/01.NEU.0000371980.08391.71

Geographic variation in carotid revascularization among Medicare beneficiaries, 2003-2006.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.

Authors
Patel, MR; Greiner, MA; DiMartino, LD; Schulman, KA; Duncan, PW; Matchar, DB; Curtis, LH
MLA Citation
Patel, MR, Greiner, MA, DiMartino, LD, Schulman, KA, Duncan, PW, Matchar, DB, and Curtis, LH. "Geographic variation in carotid revascularization among Medicare beneficiaries, 2003-2006." Arch Intern Med 170.14 (July 26, 2010): 1218-1225.
PMID
20660840
Source
pubmed
Published In
Archives of internal medicine
Volume
170
Issue
14
Publish Date
2010
Start Page
1218
End Page
1225
DOI
10.1001/archinternmed.2010.194

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.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047437.

Authors
Reed, SD; Whellan, DJ; Li, Y; Friedman, JY; Ellis, SJ; Piña, IL; Settles, SJ; Davidson-Ray, L; Johnson, JL; Cooper, LS; O'Connor, CM; Schulman, KA; HF-ACTION Investigators,
MLA Citation
Reed, SD, Whellan, DJ, Li, Y, Friedman, JY, Ellis, SJ, Piña, IL, Settles, SJ, Davidson-Ray, L, Johnson, JL, Cooper, LS, O'Connor, CM, Schulman, KA, and HF-ACTION Investigators, . "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." Circ Cardiovasc Qual Outcomes 3.4 (July 2010): 374-381.
PMID
20551371
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
4
Publish Date
2010
Start Page
374
End Page
381
DOI
10.1161/CIRCOUTCOMES.109.907287

Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings.

BACKGROUND: Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings. OBJECTIVE: To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings. DESIGN, SETTING, AND PARTICIPANTS: 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. MEASUREMENTS AND MAIN RESULTS: 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). CONCLUSIONS: 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.

Authors
Weinfurt, KP; Hall, MA; Hardy, NC; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, Hardy, NC, Friedman, JY, Schulman, KA, and Sugarman, J. "Oversight of financial conflicts of interest in commercially sponsored research in academic and nonacademic settings." J Gen Intern Med 25.5 (May 2010): 460-464.
PMID
20186498
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
25
Issue
5
Publish Date
2010
Start Page
460
End Page
464
DOI
10.1007/s11606-010-1264-6

Can we close the income and wealth gap between specialists and primary care physicians?

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.

Authors
Vaughn, BT; DeVrieze, SR; Reed, SD; Schulman, KA
MLA Citation
Vaughn, BT, DeVrieze, SR, Reed, SD, and Schulman, KA. "Can we close the income and wealth gap between specialists and primary care physicians?." Health Aff (Millwood) 29.5 (May 2010): 933-940.
PMID
20439883
Source
pubmed
Published In
Health Affairs
Volume
29
Issue
5
Publish Date
2010
Start Page
933
End Page
940
DOI
10.1377/hlthaff.2009.0675

Changes in the use and costs of diagnostic imaging among Medicare beneficiaries with cancer, 1999-2006.

CONTEXT: 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. OBJECTIVE: To examine changes in the use of imaging and how those changes contribute to the overall cost of cancer care. DESIGN, SETTING, AND PATIENTS: 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. MAIN OUTCOME MEASURES: Use and cost of imaging by modality, year, and cancer type. RESULTS: 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. CONCLUSION: 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.

Authors
Dinan, MA; Curtis, LH; Hammill, BG; Patz, EF; Abernethy, AP; Shea, AM; Schulman, KA
MLA Citation
Dinan, MA, Curtis, LH, Hammill, BG, Patz, EF, Abernethy, AP, Shea, AM, and Schulman, KA. "Changes in the use and costs of diagnostic imaging among Medicare beneficiaries with cancer, 1999-2006." JAMA 303.16 (April 28, 2010): 1625-1631.
PMID
20424253
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
303
Issue
16
Publish Date
2010
Start Page
1625
End Page
1631
DOI
10.1001/jama.2010.460

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.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Davis, SN; Horton, ES; Battelino, T; Rubin, RR; Schulman, KA; Tamborlane, WV
MLA Citation
Davis, SN, Horton, ES, Battelino, T, Rubin, RR, Schulman, KA, and Tamborlane, WV. "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 Technol Ther 12.4 (April 2010): 249-255.
Website
http://hdl.handle.net/10161/3233
PMID
20210562
Source
pubmed
Published In
Diabetes Technology & Therapeutics
Volume
12
Issue
4
Publish Date
2010
Start Page
249
End Page
255
DOI
10.1089/dia.2009.0145

Process of care performance measures and long-term outcomes in patients hospitalized with heart failure.

BACKGROUND: 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. OBJECTIVE: To examine the relationship between adherence to hospital-level process measures and long-term patient-level mortality and readmission. RESEARCH DESIGN: Analysis of data from a national clinical registry linked to outcome data from the Centers for Medicare and Medicaid Services (CMS). SUBJECTS: 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. MEASURES: 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. RESULTS: 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). CONCLUSION: 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.

Authors
Patterson, ME; Hernandez, AF; Hammill, BG; Fonarow, GC; Peterson, ED; Schulman, KA; Curtis, LH
MLA Citation
Patterson, ME, Hernandez, AF, Hammill, BG, Fonarow, GC, Peterson, ED, Schulman, KA, and Curtis, LH. "Process of care performance measures and long-term outcomes in patients hospitalized with heart failure." Med Care 48.3 (March 2010): 210-216.
PMID
20125043
Source
pubmed
Published In
Medical Care
Volume
48
Issue
3
Publish Date
2010
Start Page
210
End Page
216
DOI
10.1097/MLR.0b013e3181ca3eb4

Patient satisfaction and its relationship with clinical quality and inpatient mortality in acute myocardial infarction.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Authors
Glickman, SW; Boulding, W; Manary, M; Staelin, R; Roe, MT; Wolosin, RJ; Ohman, EM; Peterson, ED; Schulman, KA
MLA Citation
Glickman, SW, Boulding, W, Manary, M, Staelin, R, Roe, MT, Wolosin, RJ, Ohman, EM, Peterson, ED, and Schulman, KA. "Patient satisfaction and its relationship with clinical quality and inpatient mortality in acute myocardial infarction." Circ Cardiovasc Qual Outcomes 3.2 (March 2010): 188-195.
PMID
20179265
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
2
Publish Date
2010
Start Page
188
End Page
195
DOI
10.1161/CIRCOUTCOMES.109.900597

Relationships between emerging measures of heart failure processes of care and clinical outcomes.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Authors
Hernandez, AF; Hammill, BG; Peterson, ED; Yancy, CW; Schulman, KA; Curtis, LH; Fonarow, GC
MLA Citation
Hernandez, AF, Hammill, BG, Peterson, ED, Yancy, CW, Schulman, KA, Curtis, LH, and Fonarow, GC. "Relationships between emerging measures of heart failure processes of care and clinical outcomes." Am Heart J 159.3 (March 2010): 406-413.
PMID
20211302
Source
pubmed
Published In
American Heart Journal
Volume
159
Issue
3
Publish Date
2010
Start Page
406
End Page
413
DOI
10.1016/j.ahj.2009.12.024

Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Authors
Fortune-Greeley, AK; Hardy, NC; Lin, L; Friedman, JY; Lawlor, JS; Muhlbaier, LH; Hall, MA; Schulman, KA; Sugarman, J; Weinfurt, KP
MLA Citation
Fortune-Greeley, AK, Hardy, NC, Lin, L, Friedman, JY, Lawlor, JS, Muhlbaier, LH, Hall, MA, Schulman, KA, Sugarman, J, and Weinfurt, KP. "Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research." Circ Cardiovasc Qual Outcomes 3.2 (March 2010): 151-158.
PMID
20233979
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
2
Publish Date
2010
Start Page
151
End Page
158
DOI
10.1161/CIRCOUTCOMES.109.849273

Clopidogrel use and clinical events after drug-eluting stent implantation: findings from the HealthCore Integrated Research Database.

BACKGROUND: Relationships between long-term use and level of dual antiplatelet therapy and outcomes after drug-eluting stent implantation are not well established. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Authors
Petersen, JL; Barron, JJ; Hammill, BG; Cziraky, MJ; Anstrom, KJ; Wahl, PM; Eisenstein, EL; Krucoff, MW; Califf, RM; Schulman, KA; Curtis, LH
MLA Citation
Petersen, JL, Barron, JJ, Hammill, BG, Cziraky, MJ, Anstrom, KJ, Wahl, PM, Eisenstein, EL, Krucoff, MW, Califf, RM, Schulman, KA, and Curtis, LH. "Clopidogrel use and clinical events after drug-eluting stent implantation: findings from the HealthCore Integrated Research Database." Am Heart J 159.3 (March 2010): 462-470.e1.
PMID
20211310
Source
pubmed
Published In
American Heart Journal
Volume
159
Issue
3
Publish Date
2010
Start Page
462
End Page
470.e1
DOI
10.1016/j.ahj.2009.11.031

Property, Privacy, and the Pursuit of Integrated Electronic Medical Records1

© Oxford University Press, 2013.Who owns a patient's medical information? The patient, the provider, or the insurer? All of the above? None of the above? In the emerging era of electronic medical records, no legal question is more critical, more contested, or more poorly understood. Ownership was never much in doubt in an age of paper-based records, but now that information can be easily digitized and freed from any particular storage medium, confusion reigns. How this issue is resolved can determine how or whether massive anticipated developments in electronic health records will take shape. The respective property rights of patients, providers, and insurers will strongly influence, if not determine, what form of electronic health-record interchange will predominate. And, whether rights to access and use of medical information can be commercialized may determine whether effective, comprehensive medical information networks can emerge at all in the absence of an overt government mandate. This chapter analyzes property rights in medical information from the perspective of network economics. It proposes that patients be allowed to monetize their access and control rights by assigning them to a trusted and regulated intermediary who may then place those rights in a stream of commerce that determines their value and best use. The funds generated can then be distributed both to patients and providers in order to encourage their creation and use of interconnected electronic records.

Authors
Hall, MA; Schulman, KA
MLA Citation
Hall, MA, and Schulman, KA. "Property, Privacy, and the Pursuit of Integrated Electronic Medical Records1." The Fragmentation of U.S. Health Care: Causes and Solutions. February 24, 2010.
Source
scopus
Publish Date
2010
DOI
10.1093/acprof:oso/9780195390131.003.008

Increased rate of central venous catheterization procedures in community EDs.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Glickman, SW; Krubert, C; Koppenhaver, J; Glickman, LT; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Krubert, C, Koppenhaver, J, Glickman, LT, Schulman, KA, and Cairns, CB. "Increased rate of central venous catheterization procedures in community EDs." The American journal of emergency medicine 28.2 (February 2010): 208-212.
PMID
20159392
Source
epmc
Published In
American Journal of Emergency Medicine
Volume
28
Issue
2
Publish Date
2010
Start Page
208
End Page
212
DOI
10.1016/j.ajem.2008.10.016

Resource use and costs of branch and central retinal vein occlusion in the elderly.

OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSIONS: 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.

Authors
Fekrat, S; Shea, AM; Hammill, BG; Nguyen, H; Kowalski, JW; Schulman, KA; Curtis, LH
MLA Citation
Fekrat, S, Shea, AM, Hammill, BG, Nguyen, H, Kowalski, JW, Schulman, KA, and Curtis, LH. "Resource use and costs of branch and central retinal vein occlusion in the elderly." Curr Med Res Opin 26.1 (January 2010): 223-230.
PMID
19921963
Source
pubmed
Published In
Current Medical Research and Opinion
Volume
26
Issue
1
Publish Date
2010
Start Page
223
End Page
230
DOI
10.1185/03007990903439046

Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly Medicare beneficiaries.

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.

Authors
Hammill, BG; Curtis, LH; Schulman, KA; Whellan, DJ
MLA Citation
Hammill, BG, Curtis, LH, Schulman, KA, and Whellan, DJ. "Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly Medicare beneficiaries." Circulation 121.1 (January 2010): 63-70.
PMID
20026778
Source
epmc
Published In
Circulation
Volume
121
Issue
1
Publish Date
2010
Start Page
63
End Page
70
DOI
10.1161/circulationaha.109.876383

Costs of inpatient care among Medicare beneficiaries with heart failure, 2001 to 2004.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Whellan, DJ; Greiner, MA; Schulman, KA; Curtis, LH
MLA Citation
Whellan, DJ, Greiner, MA, Schulman, KA, and Curtis, LH. "Costs of inpatient care among Medicare beneficiaries with heart failure, 2001 to 2004." Circ Cardiovasc Qual Outcomes 3.1 (January 2010): 33-40.
PMID
20123669
Source
pubmed
Published In
Circulation. Cardiovascular quality and outcomes
Volume
3
Issue
1
Publish Date
2010
Start Page
33
End Page
40
DOI
10.1161/CIRCOUTCOMES.109.854760

Clinical effectiveness of implantable cardioverter-defibrillators among medicare beneficiaries with heart failure.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Authors
Hernandez, AF; Fonarow, GC; Hammill, BG; Al-Khatib, SM; Yancy, CW; O'Connor, CM; Schulman, KA; Peterson, ED; Curtis, LH
MLA Citation
Hernandez, AF, Fonarow, GC, Hammill, BG, Al-Khatib, SM, Yancy, CW, O'Connor, CM, Schulman, KA, Peterson, ED, and Curtis, LH. "Clinical effectiveness of implantable cardioverter-defibrillators among medicare beneficiaries with heart failure." Circ Heart Fail 3.1 (January 2010): 7-13.
PMID
20009044
Source
pubmed
Published In
Circulation. Heart failure
Volume
3
Issue
1
Publish Date
2010
Start Page
7
End Page
13
DOI
10.1161/CIRCHEARTFAILURE.109.884395

Economic content in medical journal advertisements for medical devices and prescription drugs.

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.

Authors
Ackerly, DC; Glickman, SW; Schulman, KA
MLA Citation
Ackerly, DC, Glickman, SW, and Schulman, KA. "Economic content in medical journal advertisements for medical devices and prescription drugs." Pharmacoeconomics 28.5 (2010): 429-438.
PMID
20402543
Source
pubmed
Published In
PharmacoEconomics
Volume
28
Issue
5
Publish Date
2010
Start Page
429
End Page
438
DOI
10.2165/11318780-000000000-00000

Addressing the systems-based practice requirement with health policy content and educational technology.

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.

Authors
Nagler, A; Andolsek, K; Dossary, K; Schlueter, J; Schulman, K
MLA Citation
Nagler, A, Andolsek, K, Dossary, K, Schlueter, J, and Schulman, K. "Addressing the systems-based practice requirement with health policy content and educational technology." Med Teach 32.12 (2010): e559-e565.
PMID
21090944
Source
pubmed
Published In
Medical Teacher (Informa)
Volume
32
Issue
12
Publish Date
2010
Start Page
e559
End Page
e565
DOI
10.3109/0142159X.2010.528809

Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation.

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.

Authors
Patterson, ME; Grant, WC; Glickman, SW; Massie, BM; Ammon, SE; Armstrong, PW; Cleland, JGF; Collins, JF; Teo, KK; Schulman, KA; Reed, SD
MLA Citation
Patterson, ME, Grant, WC, Glickman, SW, Massie, BM, Ammon, SE, Armstrong, PW, Cleland, JGF, Collins, JF, Teo, KK, Schulman, KA, and Reed, SD. "Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation." J Card Fail 15.10 (December 2009): 819-827.
PMID
19944357
Source
pubmed
Published In
Journal of Cardiac Failure
Volume
15
Issue
10
Publish Date
2009
Start Page
819
End Page
827
DOI
10.1016/j.cardfail.2009.07.004

Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures.

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.

Authors
Dinan, MA; Chou, C-H; Hammill, BG; Graham, FL; Schulman, KA; Telen, MJ; Reed, SD
MLA Citation
Dinan, MA, Chou, C-H, Hammill, BG, Graham, FL, Schulman, KA, Telen, MJ, and Reed, SD. "Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures." Am J Hematol 84.11 (November 2009): 703-709.
PMID
19787790
Source
pubmed
Published In
American Journal of Hematology
Volume
84
Issue
11
Publish Date
2009
Start Page
703
End Page
709
DOI
10.1002/ajh.21520

Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Flynn, KE; Lin, L; Ellis, SJ; Russell, SD; Spertus, JA; Whellan, DJ; Piña, IL; Fine, LJ; Schulman, KA; Weinfurt, KP; HF-ACTION Investigators,
MLA Citation
Flynn, KE, Lin, L, Ellis, SJ, Russell, SD, Spertus, JA, Whellan, DJ, Piña, IL, Fine, LJ, Schulman, KA, Weinfurt, KP, and HF-ACTION Investigators, . "Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure." Am Heart J 158.4 Suppl (October 2009): S64-S71.
PMID
19782791
Source
pubmed
Published In
American Heart Journal
Volume
158
Issue
4 Suppl
Publish Date
2009
Start Page
S64
End Page
S71
DOI
10.1016/j.ahj.2009.07.010

Alternative pay-for-performance scoring methods: implications for quality improvement and patient outcomes.

BACKGROUND: 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. OBJECTIVES: 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. RESEARCH DESIGN AND SUBJECTS: 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. MEASURES: Associations between composite scores based on Centers for Medicare and Medicaid Services methodology and alternative adherence scores with inpatient survival after AMI. RESULTS: 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. CONCLUSIONS: 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.

Authors
Glickman, SW; Boulding, W; Roos, JMT; Staelin, R; Peterson, ED; Schulman, KA
MLA Citation
Glickman, SW, Boulding, W, Roos, JMT, Staelin, R, Peterson, ED, and Schulman, KA. "Alternative pay-for-performance scoring methods: implications for quality improvement and patient outcomes." Med Care 47.10 (October 2009): 1062-1068.
PMID
19648833
Source
pubmed
Published In
Medical Care
Volume
47
Issue
10
Publish Date
2009
Start Page
1062
End Page
1068
DOI
10.1097/MLR.0b013e3181a7e54c

Disclosure of financial relationships to participants in clinical research.

Authors
Weinfurt, KP; Hall, MA; King, NMP; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, King, NMP, Friedman, JY, Schulman, KA, and Sugarman, J. "Disclosure of financial relationships to participants in clinical research." N Engl J Med 361.9 (August 27, 2009): 916-921.
PMID
19710491
Source
pubmed
Published In
The New England journal of medicine
Volume
361
Issue
9
Publish Date
2009
Start Page
916
End Page
921
DOI
10.1056/NEJMsb0902598

Personalized medicine and disruptive innovation: implications for technology assessment.

Authors
Schulman, KA; Vidal, AV; Ackerly, DC
MLA Citation
Schulman, KA, Vidal, AV, and Ackerly, DC. "Personalized medicine and disruptive innovation: implications for technology assessment." Genet Med 11.8 (August 2009): 577-581.
PMID
19606052
Source
pubmed
Published In
Genetics in Medicine
Volume
11
Issue
8
Publish Date
2009
Start Page
577
End Page
581
DOI
10.1097/GIM.0b013e3181ae0935

External validity of the cardiovascular health study: a comparison with the Medicare population.

BACKGROUND: 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. OBJECTIVE: To assess the external validity of the CHS. RESEARCH DESIGN: Comparison of the CHS cohort to a national cohort of Medicare beneficiaries and to Medicare beneficiaries residing in the CHS geographic regions. SUBJECTS: CHS participants and a 5% sample of Medicare beneficiaries. MEASURES: Demographic and administrative characteristics, comorbid conditions, resource use, and mortality. RESULTS: 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. CONCLUSION: 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.

Authors
DiMartino, LD; Hammill, BG; Curtis, LH; Gottdiener, JS; Manolio, TA; Powe, NR; Schulman, KA
MLA Citation
DiMartino, LD, Hammill, BG, Curtis, LH, Gottdiener, JS, Manolio, TA, Powe, NR, and Schulman, KA. "External validity of the cardiovascular health study: a comparison with the Medicare population." Med Care 47.8 (August 2009): 916-923.
PMID
19597373
Source
pubmed
Published In
Medical Care
Volume
47
Issue
8
Publish Date
2009
Start Page
916
End Page
923
DOI
10.1097/MLR.0b013e318197b104

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.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
DeWitt, EM; Lin, L; Glick, HA; Anstrom, KJ; Schulman, KA; Reed, SD
MLA Citation
DeWitt, EM, Lin, L, Glick, HA, Anstrom, KJ, Schulman, KA, and Reed, SD. "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." Clin Ther 31.8 (August 2009): 1871-1880.
PMID
19808146
Source
pubmed
Published In
Clinical Therapeutics: the international peer-reviewed journal of drug therapy
Volume
31
Issue
8
Publish Date
2009
Start Page
1871
End Page
1880
DOI
10.1016/j.clinthera.2009.08.020

Cost utility of sequential adjuvant trastuzumab for HER2/Neu-positive breast cancer.

Authors
Reed, SD; Schulman, KA
MLA Citation
Reed, SD, and Schulman, KA. "Cost utility of sequential adjuvant trastuzumab for HER2/Neu-positive breast cancer." Value Health 12.5 (July 2009): 637-640.
PMID
19473336
Source
pubmed
Published In
Value in Health
Volume
12
Issue
5
Publish Date
2009
Start Page
637
End Page
640
DOI
10.1111/j.1524-4733.2009.00564.x

Linking inpatient clinical registry data to Medicare claims data using indirect identifiers.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Authors
Hammill, BG; Hernandez, AF; Peterson, ED; Fonarow, GC; Schulman, KA; Curtis, LH
MLA Citation
Hammill, BG, Hernandez, AF, Peterson, ED, Fonarow, GC, Schulman, KA, and Curtis, LH. "Linking inpatient clinical registry data to Medicare claims data using indirect identifiers." Am Heart J 157.6 (June 2009): 995-1000.
PMID
19464409
Source
pubmed
Published In
American Heart Journal
Volume
157
Issue
6
Publish Date
2009
Start Page
995
End Page
1000
DOI
10.1016/j.ahj.2009.04.002

Cost effectiveness of ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.

Authors
Reed, SD; Li, Y; Anstrom, KJ; Schulman, KA
MLA Citation
Reed, SD, Li, Y, Anstrom, KJ, and Schulman, KA. "Cost effectiveness of ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment." J Clin Oncol 27.13 (May 1, 2009): 2185-2191.
PMID
19332722
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
27
Issue
13
Publish Date
2009
Start Page
2185
End Page
2191
DOI
10.1200/JCO.2008.19.6352

Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial.

CONTEXT: Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent. OBJECTIVE: To test the effects of exercise training on health status among patients with heart failure. DESIGN, SETTING, AND PATIENTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00047437.

Authors
Flynn, KE; Piña, IL; Whellan, DJ; Lin, L; Blumenthal, JA; Ellis, SJ; Fine, LJ; Howlett, JG; Keteyian, SJ; Kitzman, DW; Kraus, WE; Miller, NH; Schulman, KA; Spertus, JA; O'Connor, CM; Weinfurt, KP; HF-ACTION Investigators,
MLA Citation
Flynn, KE, Piña, IL, Whellan, DJ, Lin, L, Blumenthal, JA, Ellis, SJ, Fine, LJ, Howlett, JG, Keteyian, SJ, Kitzman, DW, Kraus, WE, Miller, NH, Schulman, KA, Spertus, JA, O'Connor, CM, Weinfurt, KP, and HF-ACTION Investigators, . "Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial." JAMA 301.14 (April 8, 2009): 1451-1459.
PMID
19351942
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
301
Issue
14
Publish Date
2009
Start Page
1451
End Page
1459
DOI
10.1001/jama.2009.457

Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial.

CONTEXT: 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. OBJECTIVE: To test the efficacy and safety of exercise training among patients with heart failure. DESIGN, SETTING, AND PATIENTS: 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. INTERVENTIONS: Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00047437.

Authors
O'Connor, CM; Whellan, DJ; Lee, KL; Keteyian, SJ; Cooper, LS; Ellis, SJ; Leifer, ES; Kraus, WE; Kitzman, DW; Blumenthal, JA; Rendall, DS; Miller, NH; Fleg, JL; Schulman, KA; McKelvie, RS; Zannad, F; Piña, IL; HF-ACTION Investigators,
MLA Citation
O'Connor, CM, Whellan, DJ, Lee, KL, Keteyian, SJ, Cooper, LS, Ellis, SJ, Leifer, ES, Kraus, WE, Kitzman, DW, Blumenthal, JA, Rendall, DS, Miller, NH, Fleg, JL, Schulman, KA, McKelvie, RS, Zannad, F, Piña, IL, and HF-ACTION Investigators, . "Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial." JAMA 301.14 (April 8, 2009): 1439-1450.
PMID
19351941
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
301
Issue
14
Publish Date
2009
Start Page
1439
End Page
1450
DOI
10.1001/jama.2009.454

Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial.

BACKGROUND: 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. METHODS AND RESULTS: 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

Authors
Massie, BM; Collins, JF; Ammon, SE; Armstrong, PW; Cleland, JGF; Ezekowitz, M; Jafri, SM; Krol, WF; O'Connor, CM; Schulman, KA; Teo, K; Warren, SR; WATCH Trial Investigators,
MLA Citation
Massie, BM, Collins, JF, Ammon, SE, Armstrong, PW, Cleland, JGF, Ezekowitz, M, Jafri, SM, Krol, WF, O'Connor, CM, Schulman, KA, Teo, K, Warren, SR, and WATCH Trial Investigators, . "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 119.12 (March 31, 2009): 1616-1624.
PMID
19289640
Source
pubmed
Published In
Circulation
Volume
119
Issue
12
Publish Date
2009
Start Page
1616
End Page
1624
DOI
10.1161/CIRCULATIONAHA.108.801753

Ownership of medical information.

Authors
Hall, MA; Schulman, KA
MLA Citation
Hall, MA, and Schulman, KA. "Ownership of medical information." JAMA 301.12 (March 25, 2009): 1282-1284.
PMID
19318657
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
301
Issue
12
Publish Date
2009
Start Page
1282
End Page
1284
DOI
10.1001/jama.2009.389

Ethical and scientific implications of the globalization of clinical research.

Authors
Glickman, SW; McHutchison, JG; Peterson, ED; Cairns, CB; Harrington, RA; Califf, RM; Schulman, KA
MLA Citation
Glickman, SW, McHutchison, JG, Peterson, ED, Cairns, CB, Harrington, RA, Califf, RM, and Schulman, KA. "Ethical and scientific implications of the globalization of clinical research." N Engl J Med 360.8 (February 19, 2009): 816-823.
PMID
19228627
Source
pubmed
Published In
The New England journal of medicine
Volume
360
Issue
8
Publish Date
2009
Start Page
816
End Page
823
DOI
10.1056/NEJMsb0803929

Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients.

BACKGROUND AND OBJECTIVES: 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. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 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. RESULTS: 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. CONCLUSIONS: Hemodialysis-dependent patients with fistula or graft access incur high costs and long inpatient stays when hospitalized for S. aureus infection.

Authors
Li, Y; Friedman, JY; O'Neal, BF; Hohenboken, MJ; Griffiths, RI; Stryjewski, ME; Middleton, JP; Schulman, KA; Inrig, JK; Fowler, VG; Reed, SD
MLA Citation
Li, Y, Friedman, JY, O'Neal, BF, Hohenboken, MJ, Griffiths, RI, Stryjewski, ME, Middleton, JP, Schulman, KA, Inrig, JK, Fowler, VG, and Reed, SD. "Outcomes of Staphylococcus aureus infection in hemodialysis-dependent patients." Clin J Am Soc Nephrol 4.2 (February 2009): 428-434.
PMID
19118117
Source
pubmed
Published In
Clinical journal of the American Society of Nephrology : CJASN
Volume
4
Issue
2
Publish Date
2009
Start Page
428
End Page
434
DOI
10.2215/CJN.03760708

Decision making and quality of life in the treatment of cancer: a review.

INTRODUCTION: 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. DISCUSSION: 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.

Authors
Zafar, SY; Alexander, SC; Weinfurt, KP; Schulman, KA; Abernethy, AP
MLA Citation
Zafar, SY, Alexander, SC, Weinfurt, KP, Schulman, KA, and Abernethy, AP. "Decision making and quality of life in the treatment of cancer: a review." Support Care Cancer 17.2 (February 2009): 117-127. (Review)
PMID
18802727
Source
pubmed
Published In
Supportive Care in Cancer
Volume
17
Issue
2
Publish Date
2009
Start Page
117
End Page
127
DOI
10.1007/s00520-008-0505-2

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.

OBJECTIVES: We sought to examine associations between initiation of beta-blocker therapy and outcomes among elderly patients hospitalized for heart failure. BACKGROUND: Beta-blockers are guideline-recommended therapy for heart failure, but their clinical effectiveness is not well understood, especially in elderly patients. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Hernandez, AF; Hammill, BG; O'Connor, CM; Schulman, KA; Curtis, LH; Fonarow, GC
MLA Citation
Hernandez, AF, Hammill, BG, O'Connor, CM, Schulman, KA, Curtis, LH, and Fonarow, GC. "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." J Am Coll Cardiol 53.2 (January 13, 2009): 184-192.
PMID
19130987
Source
pubmed
Published In
Journal of the American College of Cardiology
Volume
53
Issue
2
Publish Date
2009
Start Page
184
End Page
192
DOI
10.1016/j.jacc.2008.09.031

Fueling innovation in medical devices (and beyond): venture capital in health care.

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.

Authors
Ackerly, DC; Valverde, AM; Diener, LW; Dossary, KL; Schulman, KA
MLA Citation
Ackerly, DC, Valverde, AM, Diener, LW, Dossary, KL, and Schulman, KA. "Fueling innovation in medical devices (and beyond): venture capital in health care." Health Aff (Millwood) 28.1 (January 2009): w68-w75.
PMID
19049999
Source
pubmed
Published In
Health Affairs
Volume
28
Issue
1
Publish Date
2009
Start Page
w68
End Page
w75
DOI
10.1377/hlthaff.28.1.w68

Community hospital oversight of clinical investigators' financial relationships.

Authors
Hall, MA; Weinfurt, KP; Lawlor, JS; Friedman, JY; Schulman, KA; Sugarman, J
MLA Citation
Hall, MA, Weinfurt, KP, Lawlor, JS, Friedman, JY, Schulman, KA, and Sugarman, J. "Community hospital oversight of clinical investigators' financial relationships." IRB 31.1 (January 2009): 7-13.
PMID
19241734
Source
pubmed
Published In
IRB
Volume
31
Issue
1
Publish Date
2009
Start Page
7
End Page
13

A health services research agenda for cellular, molecular and genomic technologies in cancer care.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Wideroff, L; Phillips, KA; Randhawa, G; Ambs, A; Armstrong, K; Bennett, CL; Brown, ML; Donaldson, MS; Follen, M; Goldie, SJ; Hiatt, RA; Khoury, MJ; Lewis, G; McLeod, HL; Piper, M; Powell, I; Schrag, D; Schulman, KA; Scott, J
MLA Citation
Wideroff, L, Phillips, KA, Randhawa, G, Ambs, A, Armstrong, K, Bennett, CL, Brown, ML, Donaldson, MS, Follen, M, Goldie, SJ, Hiatt, RA, Khoury, MJ, Lewis, G, McLeod, HL, Piper, M, Powell, I, Schrag, D, Schulman, KA, and Scott, J. "A health services research agenda for cellular, molecular and genomic technologies in cancer care." Public Health Genomics 12.4 (2009): 233-244. (Review)
PMID
19367091
Source
pubmed
Published In
Public health genomics
Volume
12
Issue
4
Publish Date
2009
Start Page
233
End Page
244
DOI
10.1159/000203779

Healthcare expenditure and resource utilization in patients with anaemia and chronic kidney disease: a retrospective claims database analysis.

BACKGROUND/AIMS: We conducted a retrospective claims database analysis to examine the association of anaemia and anaemia management with healthcare expenditure and utilization in patients with chronic kidney disease (CKD) before the onset of dialysis. METHODS: Claims data on patients (aged > or =15 years) with CKD were collected from the Medstat Marketscan Commercial and Medicare Databases between 2000 and 2005. Using these data, patients were evaluated for anaemia of CKD, anaemia treatment status and healthcare costs and use. RESULTS: Of the 37,105 CKD patients, 9,807 (26%) had incident anaemia; 59% of these received at least one type of anaemia treatment, with 48% receiving an erythropoiesis-stimulating agent. The total adjusted per patient per month healthcare expenditure for all CKD patients was USD 2,749. Patients with anaemia had significantly greater overall expenditure, which was 38% higher than those without anaemia. Total expenditure was 17% higher for untreated versus treated anaemic patients, largely due to higher inpatient expenditure in the untreated cohort. CONCLUSION: This analysis suggests that the presence of anaemia is associated with greater medical expenditure in patients with CKD. However, we found that anaemia management may help to lower inpatient costs associated with anaemia in the CKD population.

Authors
Wish, J; Schulman, K; Law, A; Nassar, G
MLA Citation
Wish, J, Schulman, K, Law, A, and Nassar, G. "Healthcare expenditure and resource utilization in patients with anaemia and chronic kidney disease: a retrospective claims database analysis." Kidney Blood Press Res 32.2 (2009): 110-118.
PMID
19372704
Source
pubmed
Published In
Kidney & blood pressure research
Volume
32
Issue
2
Publish Date
2009
Start Page
110
End Page
118
DOI
10.1159/000213166

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

Authors
Massie, BM; Ammon, SE; Collins, JF; Krol, WF; Armstrong, PW; Cleland, JGF; Ezekowitz, M; Jafri, SM; O'Connor, CM; Schulman, KA; Teo, K; Warren, S
MLA Citation
Massie, BM, Ammon, SE, Collins, JF, Krol, WF, Armstrong, PW, Cleland, JGF, Ezekowitz, M, Jafri, SM, O'Connor, CM, Schulman, KA, Teo, K, and Warren, S. "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 120.20 (2009): e165-.
Source
scival
Published In
Circulation
Volume
120
Issue
20
Publish Date
2009
Start Page
e165
DOI
10.1161/CIRCULATIONAHA.109.884650

The authors reply

Authors
Glickman, SW; Cairns, CB; Schulman, KA
MLA Citation
Glickman, SW, Cairns, CB, and Schulman, KA. "The authors reply." New England Journal of Medicine 360.26 (2009): 2793--.
Source
scival
Published In
The New England journal of medicine
Volume
360
Issue
26
Publish Date
2009
Start Page
2793-

Cancer patient preferences for quality and length of life.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Meropol, NJ; Egleston, BL; Buzaglo, JS; Benson, AB; Cegala, DJ; Diefenbach, MA; Fleisher, L; Miller, SM; Sulmasy, DP; Weinfurt, KP; CONNECT Study Research Group,
MLA Citation
Meropol, NJ, Egleston, BL, Buzaglo, JS, Benson, AB, Cegala, DJ, Diefenbach, MA, Fleisher, L, Miller, SM, Sulmasy, DP, Weinfurt, KP, and CONNECT Study Research Group, . "Cancer patient preferences for quality and length of life." Cancer 113.12 (December 15, 2008): 3459-3466.
PMID
18988231
Source
pubmed
Published In
Cancer
Volume
113
Issue
12
Publish Date
2008
Start Page
3459
End Page
3466
DOI
10.1002/cncr.23968

Early and long-term outcomes of heart failure in elderly persons, 2001-2005.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Authors
Curtis, LH; Greiner, MA; Hammill, BG; Kramer, JM; Whellan, DJ; Schulman, KA; Hernandez, AF
MLA Citation
Curtis, LH, Greiner, MA, Hammill, BG, Kramer, JM, Whellan, DJ, Schulman, KA, and Hernandez, AF. "Early and long-term outcomes of heart failure in elderly persons, 2001-2005." Arch Intern Med 168.22 (December 8, 2008): 2481-2488.
PMID
19064833
Source
pubmed
Published In
Archives of internal medicine
Volume
168
Issue
22
Publish Date
2008
Start Page
2481
End Page
2488
DOI
10.1001/archinte.168.22.2481

Resource use and costs associated with diabetic macular edema in elderly persons.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Shea, AM; Curtis, LH; Hammill, BG; Kowalski, JW; Ravelo, A; Lee, PP; Sloan, FA; Schulman, KA
MLA Citation
Shea, AM, Curtis, LH, Hammill, BG, Kowalski, JW, Ravelo, A, Lee, PP, Sloan, FA, and Schulman, KA. "Resource use and costs associated with diabetic macular edema in elderly persons." Arch Ophthalmol 126.12 (December 2008): 1748-1754.
PMID
19064859
Source
pubmed
Published In
Archives of Ophthalmology
Volume
126
Issue
12
Publish Date
2008
Start Page
1748
End Page
1754
DOI
10.1001/archopht.126.12.1748

Long-term outcomes and costs of ventricular assist devices among Medicare beneficiaries.

CONTEXT: 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. OBJECTIVE: To examine the acute and long-term outcomes of Medicare beneficiaries receiving ventricular assist devices alone or after open-heart surgery. DESIGN, SETTING, AND PATIENTS: 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). MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Hernandez, AF; Shea, AM; Milano, CA; Rogers, JG; Hammill, BG; O'Connor, CM; Schulman, KA; Peterson, ED; Curtis, LH
MLA Citation
Hernandez, AF, Shea, AM, Milano, CA, Rogers, JG, Hammill, BG, O'Connor, CM, Schulman, KA, Peterson, ED, and Curtis, LH. "Long-term outcomes and costs of ventricular assist devices among Medicare beneficiaries." JAMA 300.20 (November 26, 2008): 2398-2406.
PMID
19033590
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
300
Issue
20
Publish Date
2008
Start Page
2398
End Page
2406
DOI
10.1001/jama.2008.716

Physician-industry cooperation in the medical device industry.

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.

Authors
Chatterji, AK; Fabrizio, KR; Mitchell, W; Schulman, KA
MLA Citation
Chatterji, AK, Fabrizio, KR, Mitchell, W, and Schulman, KA. "Physician-industry cooperation in the medical device industry." Health Aff (Millwood) 27.6 (November 2008): 1532-1543.
PMID
18997209
Source
pubmed
Published In
Health Affairs
Volume
27
Issue
6
Publish Date
2008
Start Page
1532
End Page
1543
DOI
10.1377/hlthaff.27.6.1532

Considerations of net present value in policy making regarding diagnostic and therapeutic technologies.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Califf, RM; Rasiel, EB; Schulman, KA
MLA Citation
Califf, RM, Rasiel, EB, and Schulman, KA. "Considerations of net present value in policy making regarding diagnostic and therapeutic technologies." Am Heart J 156.5 (November 2008): 879-885.
PMID
19061701
Source
pubmed
Published In
American Heart Journal
Volume
156
Issue
5
Publish Date
2008
Start Page
879
End Page
885
DOI
10.1016/j.ahj.2008.06.038

Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Dev, AT; Kauf, TL; Zekry, A; Patel, K; Heller, K; Schulman, KA; McHutchison, JG
MLA Citation
Dev, AT, Kauf, TL, Zekry, A, Patel, K, Heller, K, Schulman, KA, and McHutchison, JG. "Factors influencing the participation of gastroenterologists and hepatologists in clinical research. (Published online)" BMC Health Serv Res 8 (October 8, 2008): 208-.
PMID
18842135
Source
pubmed
Published In
BMC Health Services Research
Volume
8
Publish Date
2008
Start Page
208
DOI
10.1186/1472-6963-8-208

Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease.

AIM: This study was designed to evaluate the cost-effectiveness of AST-120, an oral adsorbent that attenuates the progression of chronic kidney disease. METHODS: 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. 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. CONCLUSION: 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.

Authors
Takahashi, T; Reed, SD; Schulman, KA
MLA Citation
Takahashi, T, Reed, SD, and Schulman, KA. "Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease." Nephrology (Carlton) 13.5 (October 2008): 419-427.
PMID
18518936
Source
pubmed
Published In
Nephrology
Volume
13
Issue
5
Publish Date
2008
Start Page
419
End Page
427
DOI
10.1111/j.1440-1797.2008.00960.x

Effects of disclosing financial interests on participation in medical research: a randomized vignette trial.

BACKGROUND: Little is known about the effects of investigators' financial disclosures on potential research participants. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Weinfurt, KP; Hall, MA; Friedman, JY; Hardy, C; Fortune-Greeley, AK; Lawlor, JS; Allsbrook, JS; Lin, L; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Hall, MA, Friedman, JY, Hardy, C, Fortune-Greeley, AK, Lawlor, JS, Allsbrook, JS, Lin, L, Schulman, KA, and Sugarman, J. "Effects of disclosing financial interests on participation in medical research: a randomized vignette trial." Am Heart J 156.4 (October 2008): 689-697.
PMID
18946893
Source
pubmed
Published In
American Heart Journal
Volume
156
Issue
4
Publish Date
2008
Start Page
689
End Page
697

Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005.

BACKGROUND: 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. METHODS AND RESULTS: 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). CONCLUSIONS: 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.

Authors
Al-Khatib, SM; Greiner, MA; Peterson, ED; Hernandez, AF; Schulman, KA; Curtis, LH
MLA Citation
Al-Khatib, SM, Greiner, MA, Peterson, ED, Hernandez, AF, Schulman, KA, and Curtis, LH. "Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005." Circ Arrhythm Electrophysiol 1.4 (October 2008): 240-249.
PMID
19169382
Source
pubmed
Published In
Circulation: Arrhythmia and Electrophysiology
Volume
1
Issue
4
Publish Date
2008
Start Page
240
End Page
249
DOI
10.1161/CIRCEP.108.777888

Prostate-specific antigen screening among young men in the United States.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Scales, CD; Antonelli, J; Curtis, LH; Schulman, KA; Moul, JW
MLA Citation
Scales, CD, Antonelli, J, Curtis, LH, Schulman, KA, and Moul, JW. "Prostate-specific antigen screening among young men in the United States." Cancer 113.6 (September 15, 2008): 1315-1323.
PMID
18696715
Source
pubmed
Published In
Cancer
Volume
113
Issue
6
Publish Date
2008
Start Page
1315
End Page
1323
DOI
10.1002/cncr.23667

Lessons from India in organizational innovation: a tale of two heart hospitals.

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.

Authors
Richman, BD; Udayakumar, K; Mitchell, W; Schulman, KA
MLA Citation
Richman, BD, Udayakumar, K, Mitchell, W, and Schulman, KA. "Lessons from India in organizational innovation: a tale of two heart hospitals." Health Aff (Millwood) 27.5 (September 2008): 1260-1270.
PMID
18780909
Source
pubmed
Published In
Health Affairs
Volume
27
Issue
5
Publish Date
2008
Start Page
1260
End Page
1270
DOI
10.1377/hlthaff.27.5.1260

Decisional conflict among patients who accept or decline participation in phase I oncology studies.

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.

Authors
Flynn, KE; Weinfurt, KP; Seils, DM; Lin, L; Burnett, CB; Schulman, KA; Meropol, NJ
MLA Citation
Flynn, KE, Weinfurt, KP, Seils, DM, Lin, L, Burnett, CB, Schulman, KA, and Meropol, NJ. "Decisional conflict among patients who accept or decline participation in phase I oncology studies." J Empir Res Hum Res Ethics 3.3 (September 2008): 69-77.
PMID
19122780
Source
pubmed
Published In
Journal of Empirical Research on Human Research Ethics
Volume
3
Issue
3
Publish Date
2008
Start Page
69
End Page
77
DOI
10.1525/jer.2008.3.3.69

Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.

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.

Authors
Reed, SD; Anstrom, KJ; Seils, DM; Califf, RM; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Seils, DM, Califf, RM, and Schulman, KA. "Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs." Health Aff (Millwood) 27.5 (September 2008): w360-w370.
PMID
18682441
Source
pubmed
Published In
Health Affairs
Volume
27
Issue
5
Publish Date
2008
Start Page
w360
End Page
w370
DOI
10.1377/hlthaff.27.5.w360

Does reimportation reduce price differences for prescription drugs? Lessons from the European Union.

OBJECTIVE: To examine the effect of parallel trade on patterns of price dispersion for prescription drugs in the European Union. DATA SOURCES: Longitudinal data from an IMS Midas database of prices and units sold for drugs in 36 categories in 30 countries from 1993 through 2004. STUDY DESIGN: 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. DATA COLLECTION/EXTRACTION METHODS: 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. PRINCIPAL FINDINGS: 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. CONCLUSIONS: 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.

Authors
Kyle, MK; Allsbrook, JS; Schulman, KA
MLA Citation
Kyle, MK, Allsbrook, JS, and Schulman, KA. "Does reimportation reduce price differences for prescription drugs? Lessons from the European Union." Health Serv Res 43.4 (August 2008): 1308-1324.
PMID
18355258
Source
pubmed
Published In
Health Services Research
Volume
43
Issue
4
Publish Date
2008
Start Page
1308
End Page
1324
DOI
10.1111/j.1475-6773.2008.00838.x

Association between the Medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy.

CONTEXT: 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. OBJECTIVE: To compare patient wait times and travel distances for chemotherapy before and after the enactment of the MMA. DESIGN, SETTING, AND PATIENTS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Shea, AM; Curtis, LH; Hammill, BG; DiMartino, LD; Abernethy, AP; Schulman, KA
MLA Citation
Shea, AM, Curtis, LH, Hammill, BG, DiMartino, LD, Abernethy, AP, and Schulman, KA. "Association between the Medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy." JAMA 300.2 (July 9, 2008): 189-196.
PMID
18612116
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
300
Issue
2
Publish Date
2008
Start Page
189
End Page
196
DOI
10.1001/jama.300.2.189

Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent.

BACKGROUND: 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. METHODS: 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. RESULTS: 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%]). CONCLUSIONS: 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.

Authors
Weinfurt, KP; Seils, DM; Tzeng, JP; Compton, KL; Sulmasy, DP; Astrow, AB; Solarino, NA; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Seils, DM, Tzeng, JP, Compton, KL, Sulmasy, DP, Astrow, AB, Solarino, NA, Schulman, KA, and Meropol, NJ. "Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent." Med Decis Making 28.4 (July 2008): 575-581.
PMID
18378940
Source
pubmed
Published In
Medical Decision Making
Volume
28
Issue
4
Publish Date
2008
Start Page
575
End Page
581
DOI
10.1177/0272989X08315242

Identification of patients with diabetic macular edema from claims data: a validation study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Authors
Bearelly, S; Mruthyunjaya, P; Tzeng, JP; Suñer, IJ; Shea, AM; Lee, JT; Kowalski, JW; Curtis, LH; Schulman, KA; Lee, PP
MLA Citation
Bearelly, S, Mruthyunjaya, P, Tzeng, JP, Suñer, IJ, Shea, AM, Lee, JT, Kowalski, JW, Curtis, LH, Schulman, KA, and Lee, PP. "Identification of patients with diabetic macular edema from claims data: a validation study." Arch Ophthalmol 126.7 (July 2008): 986-989.
PMID
18625948
Source
pubmed
Published In
Archives of Ophthalmology
Volume
126
Issue
7
Publish Date
2008
Start Page
986
End Page
989
DOI
10.1001/archopht.126.7.986

Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSION: ICD-9-CM codes in administrative data are insufficient to identify hyponatremia in an outpatient population.

Authors
Shea, AM; Curtis, LH; Szczech, LA; Schulman, KA
MLA Citation
Shea, AM, Curtis, LH, Szczech, LA, and Schulman, KA. "Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States. (Published online)" BMC Nephrol 9 (June 18, 2008): 5-.
PMID
18564417
Source
pubmed
Published In
BMC Nephrology
Volume
9
Publish Date
2008
Start Page
5
DOI
10.1186/1471-2369-9-5

Using health communication best practices to develop a web-based provider-patient communication aid: the CONNECT study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Designing patient education interventions for translation into practice requires the integration of health communication best practice including user feedback along the developmental process. PRACTICE IMPLICATIONS: This developmental process can be translated to a broad array of community-based patient and provider educational interventions.

Authors
Fleisher, L; Buzaglo, J; Collins, M; Millard, J; Miller, SM; Egleston, BL; Solarino, N; Trinastic, J; Cegala, DJ; Benson, AB; Schulman, KA; Weinfurt, KP; Sulmasy, D; Diefenbach, MA; Meropol, NJ
MLA Citation
Fleisher, L, Buzaglo, J, Collins, M, Millard, J, Miller, SM, Egleston, BL, Solarino, N, Trinastic, J, Cegala, DJ, Benson, AB, Schulman, KA, Weinfurt, KP, Sulmasy, D, Diefenbach, MA, and Meropol, NJ. "Using health communication best practices to develop a web-based provider-patient communication aid: the CONNECT study." Patient Educ Couns 71.3 (June 2008): 378-387.
PMID
18417312
Source
pubmed
Published In
Patient Education and Counseling
Volume
71
Issue
3
Publish Date
2008
Start Page
378
End Page
387
DOI
10.1016/j.pec.2008.02.017

Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research.

STUDY OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Glickman, SW; Anstrom, KJ; Lin, L; Chandra, A; Laskowitz, DT; Woods, CW; Freeman, DH; Kraft, M; Beskow, LM; Weinfurt, KP; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Anstrom, KJ, Lin, L, Chandra, A, Laskowitz, DT, Woods, CW, Freeman, DH, Kraft, M, Beskow, LM, Weinfurt, KP, Schulman, KA, and Cairns, CB. "Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research." Ann Emerg Med 51.6 (June 2008): 775-780.e3.
PMID
18191297
Source
pubmed
Published In
Annals of Emergency Medicine
Volume
51
Issue
6
Publish Date
2008
Start Page
775
End Page
780.e3
DOI
10.1016/j.annemergmed.2007.11.002

Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

BACKGROUND: 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. METHODOLOGY/PRINCIPAL FINDINGS: 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. CONCLUSIONS/SIGNIFICANCE: 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.

Authors
Weinfurt, KP; Seils, DM; Tzeng, JP; Lin, L; Schulman, KA; Califf, RM
MLA Citation
Weinfurt, KP, Seils, DM, Tzeng, JP, Lin, L, Schulman, KA, and Califf, RM. "Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. (Published online)" PLoS One 3.5 (May 7, 2008): e2128-.
Website
http://hdl.handle.net/10161/4492
PMID
18461146
Source
pubmed
Published In
PloS one
Volume
3
Issue
5
Publish Date
2008
Start Page
e2128
DOI
10.1371/journal.pone.0002128

Evidence-based perspectives on pay for performance and quality of patient care and outcomes in emergency medicine.

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.

Authors
Glickman, SW; Schulman, KA; Peterson, ED; Hocker, MB; Cairns, CB
MLA Citation
Glickman, SW, Schulman, KA, Peterson, ED, Hocker, MB, and Cairns, CB. "Evidence-based perspectives on pay for performance and quality of patient care and outcomes in emergency medicine." Ann Emerg Med 51.5 (May 2008): 622-631. (Review)
PMID
18358566
Source
pubmed
Published In
Annals of Emergency Medicine
Volume
51
Issue
5
Publish Date
2008
Start Page
622
End Page
631
DOI
10.1016/j.annemergmed.2008.01.010

Primary PCI in ST-segment elevation myocardial infarction.

Authors
Glickman, SW; Schulman, KA; Cairns, CB
MLA Citation
Glickman, SW, Schulman, KA, and Cairns, CB. "Primary PCI in ST-segment elevation myocardial infarction." N Engl J Med 358.16 (April 17, 2008): 1751-1752. (Letter)
PMID
18426001
Source
pubmed
Published In
The New England journal of medicine
Volume
358
Issue
16
Publish Date
2008
Start Page
1751
End Page
1752

Medical costs of abnormal serum sodium levels.

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.

Authors
Shea, AM; Hammill, BG; Curtis, LH; Szczech, LA; Schulman, KA
MLA Citation
Shea, AM, Hammill, BG, Curtis, LH, Szczech, LA, and Schulman, KA. "Medical costs of abnormal serum sodium levels." J Am Soc Nephrol 19.4 (April 2008): 764-770.
PMID
18216314
Source
pubmed
Published In
Journal of the American Society of Nephrology : JASN
Volume
19
Issue
4
Publish Date
2008
Start Page
764
End Page
770
DOI
10.1681/ASN.2007070752

Postdialysis outcomes associated with consistent anemia treatment in predialysis patients with chronic kidney disease.

AIMS: Anemia and cardiovascular (CV) events are major complications of chronic kidney disease (CKD) during dialysis. We conducted a retrospective observational study in CKD patients with anemia to evaluate the association between predialysis use of erythropoiesis-stimulating agents (ESAs) and postdialysis CV outcomes. METHODS: The study analyzed claims data on incident hemodialysis patients aged > or = 18 years (identified between January 2000 and November 2005). Patients were identified as anemic and ESA-treated prior to dialysis. ESA treatment was categorized into 4 consistency groups (from least to most consistent ESA use). RESULTS: Of 5,848 hemodialysis patients, 52% were identified as anemic prior to onset of dialysis. Predialysis ESA treatment was received by 62% of anemic patients, with only 23% receiving the most consistent treatment. The risk of a CV event was significantly lower for the ESA-treated compared with ESA-untreated patients (relative risk (RR) 0.70, 95% (95% confidence intervals (CI) 0.61 - 0.82)). Compared with ESA-untreated, those who received ESAs had significantly lower risk of acute myocardial infarction (RR 0.65 (95% CI 0.44 - 0.95)) or inpatient mortality (RR 0.52 (95% CI 0.40 - 0.68)). ESA-treated patients in each of the 4 consistency groups had significantly lower risk of CV events compared with ESA-untreated patients, with the greatest benefit seen in patients who received most consistent ESA (RR 0.61 (95% CI 0.48 - 0.76)). CONCLUSIONS: This analysis suggests consistent ESA use to treat anemia of CKD in the predialysis period is associated with improved cardiovascular outcomes in postdialysis patients.

Authors
Wish, JB; Nassar, GM; Schulman, K; del Aguila, M; Provenzano, R
MLA Citation
Wish, JB, Nassar, GM, Schulman, K, del Aguila, M, and Provenzano, R. "Postdialysis outcomes associated with consistent anemia treatment in predialysis patients with chronic kidney disease." Clin Nephrol 69.4 (April 2008): 251-259.
PMID
18397699
Source
pubmed
Published In
Clinical nephrology
Volume
69
Issue
4
Publish Date
2008
Start Page
251
End Page
259

Outcomes of second revascularization procedures after stent implantation.

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.

Authors
Konstance, RP; Eisenstein, EL; Anstrom, KJ; Shaw, LK; Califf, RM; Harrington, RA; Matchar, DB; Schulman, KA; Kong, DF
MLA Citation
Konstance, RP, Eisenstein, EL, Anstrom, KJ, Shaw, LK, Califf, RM, Harrington, RA, Matchar, DB, Schulman, KA, and Kong, DF. "Outcomes of second revascularization procedures after stent implantation." J Med Syst 32.2 (April 2008): 177-186.
PMID
18461821
Source
pubmed
Published In
Journal of Medical Systems
Volume
32
Issue
2
Publish Date
2008
Start Page
177
End Page
186

Impact of heart failure on patients undergoing major noncardiac surgery.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Hammill, BG; Curtis, LH; Bennett-Guerrero, E; O'Connor, CM; Jollis, JG; Schulman, KA; Hernandez, AF
MLA Citation
Hammill, BG, Curtis, LH, Bennett-Guerrero, E, O'Connor, CM, Jollis, JG, Schulman, KA, and Hernandez, AF. "Impact of heart failure on patients undergoing major noncardiac surgery." Anesthesiology 108.4 (April 2008): 559-567.
PMID
18362586
Source
pubmed
Published In
Anesthesiology
Volume
108
Issue
4
Publish Date
2008
Start Page
559
End Page
567
DOI
10.1097/ALN.0b013e31816725ef

Incidence and prevalence of heart failure in elderly persons, 1994-2003.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors
Curtis, LH; Whellan, DJ; Hammill, BG; Hernandez, AF; Anstrom, KJ; Shea, AM; Schulman, KA
MLA Citation
Curtis, LH, Whellan, DJ, Hammill, BG, Hernandez, AF, Anstrom, KJ, Shea, AM, and Schulman, KA. "Incidence and prevalence of heart failure in elderly persons, 1994-2003." Arch Intern Med 168.4 (February 25, 2008): 418-424.
PMID
18299498
Source
pubmed
Published In
Archives of internal medicine
Volume
168
Issue
4
Publish Date
2008
Start Page
418
End Page
424
DOI
10.1001/archinternmed.2007.80

Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin.

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.

Authors
Flockhart, DA; O'Kane, D; Williams, MS; Watson, MS; Flockhart, DA; Gage, B; Gandolfi, R; King, R; Lyon, E; Nussbaum, R; O'Kane, D; Schulman, K; Veenstra, D; Williams, MS; Watson, MS; ACMG Working Group on Pharmacogenetic Testing of CYP2C9, VKORC1 Alleles for Warfarin Use,
MLA Citation
Flockhart, DA, O'Kane, D, Williams, MS, Watson, MS, Flockhart, DA, Gage, B, Gandolfi, R, King, R, Lyon, E, Nussbaum, R, O'Kane, D, Schulman, K, Veenstra, D, Williams, MS, Watson, MS, ACMG Working Group on Pharmacogenetic Testing of CYP2C9, and VKORC1 Alleles for Warfarin Use, . "Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin." Genet Med 10.2 (February 2008): 139-150.
PMID
18281922
Source
pubmed
Published In
Genetics in Medicine
Volume
10
Issue
2
Publish Date
2008
Start Page
139
End Page
150
DOI
10.1097/GIM.0b013e318163c35f

Economic implications of potential changes to regulatory and reimbursement policies for medical devices.

OBJECTIVE: To evaluate the impact of regulatory scenarios on the financial viability of medical device companies. DESIGN: 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. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.

Authors
Reed, SD; Shea, AM; Schulman, KA
MLA Citation
Reed, SD, Shea, AM, and Schulman, KA. "Economic implications of potential changes to regulatory and reimbursement policies for medical devices." J Gen Intern Med 23 Suppl 1 (January 2008): 50-56.
PMID
18095045
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
23 Suppl 1
Publish Date
2008
Start Page
50
End Page
56
DOI
10.1007/s11606-007-0246-9

Pancreatic beta-cell function as a predictor of cardiovascular outcomes and costs: findings from the Cardiovascular Health Study.

OBJECTIVE: To explore relationships between beta-cell function and incident cardiovascular events, death, and medical costs among elderly individuals. RESEARCH DESIGN AND METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. LIMITATIONS: 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. CONCLUSIONS: 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.

Authors
Curtis, LH; Hammill, BG; Bethel, MA; Anstrom, KJ; Liao, L; Gottdiener, JS; Schulman, KA
MLA Citation
Curtis, LH, Hammill, BG, Bethel, MA, Anstrom, KJ, Liao, L, Gottdiener, JS, and Schulman, KA. "Pancreatic beta-cell function as a predictor of cardiovascular outcomes and costs: findings from the Cardiovascular Health Study." Curr Med Res Opin 24.1 (January 2008): 41-50.
PMID
18021490
Source
pubmed
Published In
Current Medical Research and Opinion
Volume
24
Issue
1
Publish Date
2008
Start Page
41
End Page
50
DOI
10.1185/030079908X253573

Updated estimates of survival and cost effectiveness for imatinib versus interferon-alpha plus low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Authors
Reed, SD; Anstrom, KJ; Li, Y; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Li, Y, and Schulman, KA. "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 26.5 (2008): 435-446. (Review)
PMID
18429659
Source
pubmed
Published In
PharmacoEconomics
Volume
26
Issue
5
Publish Date
2008
Start Page
435
End Page
446

Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions.

BACKGROUND: 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. PURPOSE: To anticipate barriers to the adoption of IRT item banks into clinical trials. METHODS: 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. RESULTS: 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. LIMITATIONS: Selection bias might have led to more positive responses to the concept of item banks in clinical trials. CONCLUSIONS: 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.

Authors
Flynn, KE; Dombeck, CB; DeWitt, EM; Schulman, KA; Weinfurt, KP
MLA Citation
Flynn, KE, Dombeck, CB, DeWitt, EM, Schulman, KA, and Weinfurt, KP. "Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions." Clin Trials 5.6 (2008): 575-586.
PMID
19029206
Source
pubmed
Published In
Clinical Trials
Volume
5
Issue
6
Publish Date
2008
Start Page
575
End Page
586
DOI
10.1177/1740774508098414

Patient and Implanting Physician Factors Associated With Mortality and Complications Following Implantable Cardioverter-Defibrillator Implantation, 2002-2005: Al-Khatib - Patient and Physician Factors and ICD Outcomes.

BACKGROUND: Little is known about factors that influence survival and complications following ICD implantation in routine clinical practice. We examined patient and implanting physician factors associated with outcomes of implantable cardioverter-defibrillator (ICD) therapy in Medicare beneficiaries from 2002 through 2005. METHODS AND RESULTS: We limited this analysis to patients aged 65 or older with Medicare fee-for-service coverage who received an ICD between January 2002 and September 2005. The main outcome measures are time to post-procedural 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 three quarters of 2005. The overall complication rate declined from 18.8% in 2002 to 14.2% in 2005 (P

Authors
Al Khatib, SM; Greiner, MA; Peterson, ED; Hernandez, AF; Schulman, KA; Curtis, LH
MLA Citation
Al Khatib, SM, Greiner, MA, Peterson, ED, Hernandez, AF, Schulman, KA, and Curtis, LH. "Patient and Implanting Physician Factors Associated With Mortality and Complications Following Implantable Cardioverter-Defibrillator Implantation, 2002-2005: Al-Khatib - Patient and Physician Factors and ICD Outcomes." Circulation. Arrhythmia and electrophysiology 1.4 (2008): 240-249. (Academic Article)
Source
manual
Published In
Circulation: Arrhythmia and Electrophysiology
Volume
1
Issue
4
Publish Date
2008
Start Page
240
End Page
249

Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities.

Authors
DiMartino, LD; Curtis, LH; Williams, RL; Abernethy, DR; Schulman, KA
MLA Citation
DiMartino, LD, Curtis, LH, Williams, RL, Abernethy, DR, and Schulman, KA. "Using Medicare administrative data to conduct postmarketing surveillance of follow-on biologics: issues and opportunities." Food Drug Law J 63.4 (2008): 891-900.
PMID
19601387
Source
pubmed
Published In
Food and drug law journal
Volume
63
Issue
4
Publish Date
2008
Start Page
891
End Page
900

What are the regulatory and economic challenges posed by drug-eluting stents?

Medical devices are complex therapeutics that pose unique regulatory, ethical, legal, and financial challenges. Drug-eluting stents were heralded initially as a breakthrough in the treatment of coronary artery disease. However, later revelations about the safety and efficacy of drug-eluting stents would highlight challenges in the regulatory approval of medical devices. In this paper, we discuss a few key issues that arose from debates about drug-eluting stents: Are trials for medical devices adequately designed to examine long-term safety? What are the ethics of phase 1 research for medical devices when long-term complications are unknown? What are the intellectual property rights issues for medical technology? How do payment systems create incentives that encourage overuse of medical devices? Copyright © 2008 LLS SAS. All rights reserved.

Authors
Shah, BR; Schulman, KA
MLA Citation
Shah, BR, and Schulman, KA. "What are the regulatory and economic challenges posed by drug-eluting stents?." Dialogues in Cardiovascular Medicine 13.4 (2008): 267-272.
Source
scival
Published In
Dialogues in cardiovascular medicine : DCM
Volume
13
Issue
4
Publish Date
2008
Start Page
267
End Page
272

Economic evaluation of pharmaceuticals and clinical practice

Authors
Schulman, KA; Glick, HA; Polsky, D; John, KR
MLA Citation
Schulman, KA, Glick, HA, Polsky, D, and John, KR. "Economic evaluation of pharmaceuticals and clinical practice." Drug Benefits and Risks: International Textbook of Clinical Pharmacology (2008): 37-53.
Source
scival
Published In
Drug Benefits and Risks: International Textbook of Clinical Pharmacology
Publish Date
2008
Start Page
37
End Page
53

Economic evaluation of pharmaceuticals and clinical practice

Authors
Schulman, KA; Glick, HA; Polsky, D; John, KR
MLA Citation
Schulman, KA, Glick, HA, Polsky, D, and John, KR. "Economic evaluation of pharmaceuticals and clinical practice." Drug Benefits and Risks: International Textbook of Clinical Pharmacology (2008): 37-53.
Source
scival
Published In
Drug Benefits and Risks: International Textbook of Clinical Pharmacology
Publish Date
2008
Start Page
37
End Page
53

Promoting quality: the health-care organization from a management perspective.

BACKGROUND: Although agreement about the need for quality improvement in health care is almost universal, the means of achieving effective improvement in overall care is not well understood. Avedis Donabedian developed the structure-process-outcome framework in which to think about quality-improvement efforts. ISSUE: There is now a robust evidence-base in the quality-improvement literature on process and outcomes, but structure has received considerably less attention. The health-care field would benefit from expanding the current interpretation of structure to include broader perspectives on organizational attributes as primary determinants of process change and quality improvement. SOLUTIONS: We highlight and discuss the following key elements of organizational attributes from a management perspective: (i) executive management, including senior leadership and board responsibilities (ii) culture, (iii) organizational design, (iv) incentive structures and (v) information management and technology. We discuss the relevant contributions from the business and medical literature for each element, and provide this framework as a roadmap for future research in an effort to develop the optimal definition of 'structure' for transforming quality-improvement initiatives.

Authors
Glickman, SW; Baggett, KA; Krubert, CG; Peterson, ED; Schulman, KA
MLA Citation
Glickman, SW, Baggett, KA, Krubert, CG, Peterson, ED, and Schulman, KA. "Promoting quality: the health-care organization from a management perspective." Int J Qual Health Care 19.6 (December 2007): 341-348.
PMID
17947386
Source
pubmed
Published In
International Journal for Quality in Health Care (Elsevier)
Volume
19
Issue
6
Publish Date
2007
Start Page
341
End Page
348
DOI
10.1093/intqhc/mzm047

A framework for quality improvement: an analysis of factors responsible for improvement at hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative.

BACKGROUND: Hospitals are under increasing pressure to improve their quality of care. However, a key question remains: how can hospitals best design and implement successful quality improvement (QI) programs? Hospitals currently employ a variety of QI initiatives but have little empirical evidence on which to base their quality efforts. METHODS: We designed and applied a hospital cross-sectional survey to 212 hospitals participating in CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines), a voluntary QI initiative of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). We factor analysis and an ordinary least squares regression model to determine the key hospital factors most associated with unexpected improvements in institutional QI in the treatment of NSTE ACS. RESULTS: From 2002 to 2004, the following factors had a significant association with unexpected increases in the 2004 QI in NSTE ACS treatment: the use of CRUSADE QI tools, clinical commitment to quality by a cardiology coadvocate, institutional financial commitment to quality, and barriers to QI related to resource availability and cultural resistance to change (all P < .10). Of these factors, optimal use of CRUSADE QI tools was associated with the highest absolute improvement in process adherence score relative to other factors. CONCLUSIONS: We identified several institutional factors associated with improved quality of care in the treatment of high-risk NSTE ACS. We hope that this evidence-based framework will help guide the development and implementation of future QI programs in order to improve the institutional quality of care for NSTE ACS.

Authors
Glickman, SW; Boulding, W; Staelin, R; Mulgund, J; Roe, MT; Lytle, BL; Rumsfeld, JS; Gibler, WB; Ohman, EM; Schulman, KA; Peterson, ED
MLA Citation
Glickman, SW, Boulding, W, Staelin, R, Mulgund, J, Roe, MT, Lytle, BL, Rumsfeld, JS, Gibler, WB, Ohman, EM, Schulman, KA, and Peterson, ED. "A framework for quality improvement: an analysis of factors responsible for improvement at hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative." Am Heart J 154.6 (December 2007): 1206-1220.
PMID
18035096
Source
pubmed
Published In
American Heart Journal
Volume
154
Issue
6
Publish Date
2007
Start Page
1206
End Page
1220
DOI
10.1016/j.ahj.2007.08.001

Characteristics of nontraumatic subarachnoid hemorrhage in the United States in 2003.

OBJECTIVE: Substantial progress has been made in the diagnosis and treatment of subarachnoid hemorrhage (SAH). However, studies of SAH in the United States do not include information more recent than 2001, precluding analysis of shifts in treatment methods. We examined the epidemiology and in-hospital outcomes of nontraumatic SAH in the United States. METHODS: We analyzed nationally representative data from the 2003 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project to determine demographic and hospital characteristics, treatments, and in-hospital outcomes of patients with nontraumatic SAH. RESULTS: In 2003, there were an estimated 31,476 discharges for nontraumatic SAH among patients aged 17 years or older, or 14.5 discharges per 100,000 adults. The in-hospital mortality rate was 25.3%. Microvascular clipping was performed in 7513 discharges, or 23.9% of inpatients with nontraumatic SAH; endovascular coiling was performed in 2849 discharges (9.1%). Adjusted odds of treatment with either procedure were significantly higher in urban teaching hospitals compared with urban nonteaching hospitals (odds ratio, 1.62; 95% confidence interval, 1.00-2.62) or rural hospitals (odds ratio, 3.08; 95% confidence interval, 1.93-4.91). CONCLUSION: The in-hospital mortality rate associated with nontraumatic SAH continues to exceed 25%. Although it is unclear how many patients with nontraumatic SAH were actually diagnosed with a cerebral aneurysm, this study suggests that less than one-third of patients hospitalized for SAH receive surgical or endovascular treatment. Prospective studies are needed to elucidate either what systematic coding error is occurring in the national database or why patients may not receive treatment to secure a ruptured aneurysm.

Authors
Shea, AM; Reed, SD; Curtis, LH; Alexander, MJ; Villani, JJ; Schulman, KA
MLA Citation
Shea, AM, Reed, SD, Curtis, LH, Alexander, MJ, Villani, JJ, and Schulman, KA. "Characteristics of nontraumatic subarachnoid hemorrhage in the United States in 2003." Neurosurgery 61.6 (December 2007): 1131-1137.
PMID
18162891
Source
pubmed
Published In
Neurosurgery
Volume
61
Issue
6
Publish Date
2007
Start Page
1131
End Page
1137
DOI
10.1227/01.neu.0000306090.30517.ae

The Medicare Modernization Act and reimbursement for outpatient chemotherapy: do patients perceive changes in access to care?

BACKGROUND: The primary objectives were to measure and compare time to initiation of chemotherapy for patients undergoing treatment either before or after the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and to measure and compare the location of care for patients undergoing chemotherapy either before or after the enactment of the MMA. METHODS: A Web-based survey was conducted of a convenience sample of patients with cancer. RESULTS: A total of 1421 respondents completed the survey, 684 in the pre-MMA group and 737 in the post-MMA group. Respondents aged >or=65 years in both the pre-MMA and post-MMA groups had a median waiting time to chemotherapy of 3.0 weeks (P = .74). Most respondents aged >or=65 years received chemotherapy in outpatient hospital infusion centers or centers affiliated with private practices (73% in the pre-MMA group vs 62% in the post-MMA group; P = .02). However, in multivariate analysis there was no statistically significant difference in treatment location between the pre-MMA and post-MMA cohorts. CONCLUSIONS: Overall, the findings do not support generalizations from anecdotal reports that patients have been affected by the change in reimbursement to oncologists for chemotherapy as a result of the MMA. The analysis may be confounded by payments to physicians in the concurrent Centers for Medicare and Medicaid Services cancer demonstration project because these payments may have delayed changes in care. Moreover, research is needed to examine the effects of the legislation on vulnerable populations.

Authors
Friedman, JY; Curtis, LH; Hammill, BG; Dhillon, JK; Weaver, CH; Biswas, S; Abernethy, AP; Schulman, KA
MLA Citation
Friedman, JY, Curtis, LH, Hammill, BG, Dhillon, JK, Weaver, CH, Biswas, S, Abernethy, AP, and Schulman, KA. "The Medicare Modernization Act and reimbursement for outpatient chemotherapy: do patients perceive changes in access to care?." Cancer 110.10 (November 15, 2007): 2304-2312.
PMID
17924373
Source
pubmed
Published In
Cancer
Volume
110
Issue
10
Publish Date
2007
Start Page
2304
End Page
2312
DOI
10.1002/cncr.23042

Racial/ethnic variation in perceptions of medical information sources in Durham County, North Carolina.

BACKGROUND: Concerns about health and health care disparities have led some groups to promote better communication of medical information as a potential means of empowering patients to overcome barriers to health care and to practice healthy behaviors. We examined the independent effect of race/ethnicity on perceptions of the usefulness of different sources of health information. METHODS: We analyzed data from a cross-sectional telephone survey of black, Latino, and white adults (n = 515) in Durham County North Carolina, in 2002. Respondents rated the usefulness of medical information sources, nonmedical information sources, and media. We used logistic regression to determine the effect of race/ethnicity on ratings of information sources, adjusting for demographic, socioeconomic, and health status factors. RESULTS: Compared to white respondents, Latinos and black respondents were more likely to perceive as useful the local health department, ministers/churches, community centers, television, and radio. Latinos were less likely than white and black respondents to report the pharmacy as a useful source of medical information. LIMITATIONS: Some findings may be particular to Durham County, especially those based on the Latino subgroup. Also, the response rate (43%) suggests that nonresponse bias may have affected our results. Finally perceived usefulness may affect one's intent to act on information but may not correlate with the benefit gained from a particular source. CONCLUSIONS: There are substantial racial/ethnic differences in perceptions of certain medical information sources. Medical information designed for minority populations may be more effective if disseminated through particular sources.

Authors
Williams, JE; Anstrom, KJ; Friedman, JY; Schulman, KA
MLA Citation
Williams, JE, Anstrom, KJ, Friedman, JY, and Schulman, KA. "Racial/ethnic variation in perceptions of medical information sources in Durham County, North Carolina." N C Med J 68.6 (November 2007): 391-398.
PMID
18236855
Source
pubmed
Published In
North Carolina Medical Journal
Volume
68
Issue
6
Publish Date
2007
Start Page
391
End Page
398

Sex differences in the use of implantable cardioverter-defibrillators for primary and secondary prevention of sudden cardiac death.

CONTEXT: Previous studies of sex differences in the use of implantable cardioverter-defibrillators (ICDs) predate recent expansions in Medicare coverage and did not provide patient follow-up over multiple years. OBJECTIVE: To examine sex differences in ICD use for primary and secondary prevention of sudden cardiac death. DESIGN, SETTING, AND PARTICIPANTS: Analysis of a 5% national sample of research-identifiable files obtained from the US Centers for Medicare & Medicaid Services for the period 1991 through 2005. Patients were those aged 65 years or older with Medicare fee-for-service coverage and diagnosed with acute myocardial infarction and either heart failure or cardiomyopathy but no prior cardiac arrest or ventricular tachycardia (ie, the primary prevention cohort [n = 65,917 men and 70,504 women]), or with cardiac arrest or ventricular tachycardia (ie, the secondary prevention cohort [n = 52,252 men and 47,411 women]), from 1999 through 2005. MAIN OUTCOME MEASURES: Receipt of ICD therapy and all-cause mortality at 1 year. RESULTS: In the 2005 primary prevention cohort, 32.3 per 1000 men and 8.6 per 1000 women received ICD therapy within 1 year of cohort entry. In multivariate analyses, men were more likely than women to receive ICD therapy (hazard ratio [HR], 3.15; 95% confidence interval [CI], 2.86-3.47). Among men and women alive at 180 days after cohort entry, the hazard of mortality in the subsequent year was not significantly lower among those who received ICD therapy (HR, 1.01; 95% CI, 0.82-1.23). In the 2005 secondary prevention cohort, 102.2 per 1000 men and 38.4 per 1000 women received ICD therapy. Controlling for demographic variables and comorbid conditions, men were more likely than women to receive ICD therapy (HR, 2.44; 95% CI, 2.30-2.59). Among men and women alive at 30 days after cohort entry, the hazard of mortality in the subsequent year was significantly lower among those who received ICD therapy (HR, 0.65; 95% CI, 0.60-0.71). CONCLUSION: In the Medicare population, women are significantly less likely than men to receive ICD therapy for primary or secondary prevention of sudden cardiac death.

Authors
Curtis, LH; Al-Khatib, SM; Shea, AM; Hammill, BG; Hernandez, AF; Schulman, KA
MLA Citation
Curtis, LH, Al-Khatib, SM, Shea, AM, Hammill, BG, Hernandez, AF, and Schulman, KA. "Sex differences in the use of implantable cardioverter-defibrillators for primary and secondary prevention of sudden cardiac death." JAMA 298.13 (October 3, 2007): 1517-1524.
PMID
17911496
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
298
Issue
13
Publish Date
2007
Start Page
1517
End Page
1524
DOI
10.1001/jama.298.13.1517

Costs of the metabolic syndrome in elderly individuals: findings from the Cardiovascular Health Study.

OBJECTIVE: The cardiovascular consequences of the metabolic syndrome and its component risk factors have been documented in elderly individuals. Little is known about how the metabolic syndrome and its individual components translate into long-term medical costs. RESEARCH DESIGN AND METHODS: We used log-linear regression models to assess the independent contributions of the metabolic syndrome and its individual components to 10-year medical costs among 3,789 individuals aged > or = 65 years in the Cardiovascular Health Study. RESULTS: As defined by the National Cholesterol Education Program Third Adult Treatment Panel report, the metabolic syndrome was present in 47% of the sample. Total costs to Medicare were 20% higher among participants with the metabolic syndrome ($40,873 vs. $33,010; P < 0.001). Controlling for age, sex, race/ethnicity, and other covariates, we found that abdominal obesity, low HDL cholesterol, and elevated blood pressure were associated with 15% (95% CI 4.3-26.7), 16% (1.7-31.8), and 20% (10.1-31.7) higher costs, respectively. When added to the model, the metabolic syndrome composite variable did not contribute significantly (P = 0.32). CONCLUSIONS: Abdominal obesity, low HDL cholesterol, and hypertension but not the metabolic syndrome per se are important predictors of long-term costs in the Medicare population.

Authors
Curtis, LH; Hammill, BG; Bethel, MA; Anstrom, KJ; Gottdiener, JS; Schulman, KA
MLA Citation
Curtis, LH, Hammill, BG, Bethel, MA, Anstrom, KJ, Gottdiener, JS, and Schulman, KA. "Costs of the metabolic syndrome in elderly individuals: findings from the Cardiovascular Health Study." Diabetes Care 30.10 (October 2007): 2553-2558.
PMID
17623825
Source
pubmed
Published In
Diabetes Care
Volume
30
Issue
10
Publish Date
2007
Start Page
2553
End Page
2558
DOI
10.2337/dc07-0460

Patterns of bisphosphonate use in the United States in the treatment of metastatic bone disease.

PURPOSE: The purpose of this study was to determine the incidence of metastatic bone disease (MBD), the frequency of intravenous (I.V.) bisphosphonate use and its impact on skeletal-related events (SREs), and opioid use. PATIENTS AND METHODS: Patients diagnosed with MBD between 2000 and 2004 were identified using 2 Thomson MarketScan Research Databases. A total of 6783 patients, 1431 with breast cancer, fulfilled the criteria. Pain was assessed as the number of days on opioids, the strength of which was categorized according to the World Health Organization 3-step ladder for pain. RESULTS: Use of I.V. bisphosphonates steadily increased for all cancers from 17% in 2000 to 38% in 2004. For all patients, 61% received mild opioids and 35% received moderate to severe opioids at baseline. Use of I.V. bisphosphonates within the first 90 days after diagnosis of MBD was associated with a 63% decrease in SREs and reduction in use of moderate to severe opioids. Among patients with breast cancer, 10.6% received oral bisphosphonates before diagnosis of MBD, and 33.8% had pain at baseline. There was a 5.4% reduction in the use of moderate to severe opioids. CONCLUSION: Our data support the role of I.V. bisphosphonates in decreasing SRE and improving the quality of life for patients with MBD; the result is less pain and fewer SREs. More than 73% of all patients and 53% of patients with breast cancer never receive I.V. bisphosphonate treatment. Educational measures are warranted to increase the awareness by patients and physicians of the value of I.V. bisphosphonates in MBD.

Authors
Mortimer, JE; Schulman, K; Kohles, JD
MLA Citation
Mortimer, JE, Schulman, K, and Kohles, JD. "Patterns of bisphosphonate use in the United States in the treatment of metastatic bone disease." Clin Breast Cancer 7.9 (August 2007): 682-689.
PMID
17919348
Source
pubmed
Published In
Clinical Breast Cancer
Volume
7
Issue
9
Publish Date
2007
Start Page
682
End Page
689
DOI
10.3816/CBC.2007.n.027

Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer.

GOALS OF WORK: Patients with prostate cancer metastasized to bone frequently experience skeletal morbidities as a result of their disease. We sought to quantify the longitudinal effects on patient-reported outcomes of skeletal-related events (SREs) and to ascertain the declines in health-related quality of life (HRQOL) and pain experienced by patients who experienced SREs. MATERIALS AND METHODS: Data are from a clinical trial for the treatment of SREs associated with advanced prostate cancer metastatic to bone. Outcome measures included the Functional Assessment of Cancer Therapy-General (FACT-G) and the Brief Pain Inventory. Among patients who survived 6 months after randomization, patients with no SREs in the initial 6 months after randomization were matched via propensity scores with those experiencing one or more SREs. Similarly, patients with one SRE were matched with a subset of patients with two or more SREs. MAIN RESULTS: Patients with SREs in the initial period had significantly worse survival and HRQOL than those with no SREs. Significant differences were found between the pain differences, FACT-G total scores, and FACT-G physical, emotional, and functional subscales. Comparisons of patients with single vs multiple SREs showed similar patterns. CONCLUSIONS: The presence of SREs is significantly associated with worse survival and poorer HRQOL in this patient population. Increasing SRE intensity shows a pattern of increasingly decreased survival and poorer HRQOL.

Authors
DePuy, V; Anstrom, KJ; Castel, LD; Schulman, KA; Weinfurt, KP; Saad, F
MLA Citation
DePuy, V, Anstrom, KJ, Castel, LD, Schulman, KA, Weinfurt, KP, and Saad, F. "Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer." Support Care Cancer 15.7 (July 2007): 869-876.
PMID
17262196
Source
pubmed
Published In
Supportive Care in Cancer
Volume
15
Issue
7
Publish Date
2007
Start Page
869
End Page
876
DOI
10.1007/s00520-006-0203-x

Pay for performance, quality of care, and outcomes in acute myocardial infarction.

CONTEXT: Pay for performance has been promoted as a tool for improving quality of care. In 2003, the Centers for Medicare & Medicaid Services (CMS) launched the largest pay-for-performance pilot project to date in the United States, including indicators for acute myocardial infarction. OBJECTIVE: To determine if pay for performance was associated with either improved processes of care and outcomes or unintended consequences for acute myocardial infarction at hospitals participating in the CMS pilot project. DESIGN, SETTING, AND PARTICIPANTS: An observational, patient-level analysis of 105,383 patients with acute non-ST-segment elevation myocardial infarction enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines (CRUSADE) national quality-improvement initiative. Patients were treated between July 1, 2003, and June 30, 2006, at 54 hospitals in the CMS program and 446 control hospitals. MAIN OUTCOME MEASURES: The differences in the use of ACC/AHA class I guideline recommended therapies and in-hospital mortality between pay for performance and control hospitals. RESULTS: Among treatments subject to financial incentives, there was a slightly higher rate of improvement for 2 of 6 targeted therapies at pay-for-performance vs control hospitals (odds ratio [OR] comparing adherence scores from 2003 through 2006 at half-year intervals for aspirin at discharge, 1.31; 95% confidence interval [CI], 1.18-1.46 vs OR, 1.17; 95% CI, 1.12-1.21; P = .04) and for smoking cessation counseling (OR, 1.50; 95% CI, 1.29-1.73 vs OR, 1.28; 95% CI, 1.22-1.35; P = .05). There was no significant difference in a composite measure of the 6 CMS rewarded therapies between the 2 hospital groups (change in odds per half-year period of receiving CMS therapies: OR, 1.23; 95% CI, 1.15-1.30 vs OR, 1.17; 95% CI, 1.14-1.20; P = .16). For composite measures of acute myocardial infarction treatments not subject to incentives, rates of improvement were not significantly different (OR, 1.09; 95% CI, 1.05-1.14 vs OR, 1.08; 95% CI, 1.06-1.09; P = .49). Overall, there was no evidence that improvements in in-hospital mortality were incrementally greater at pay-for-performance sites (change in odds of in-hospital death per half-year period, 0.91; 95% CI, 0.84-0.99 vs 0.97; 95% CI, 0.94-0.99; P = .21). CONCLUSIONS: Among hospitals participating in a voluntary quality-improvement initiative, the pay-for-performance program was not associated with a significant incremental improvement in quality of care or outcomes for acute myocardial infarction. Conversely, we did not find evidence that pay for performance had an adverse association with improvement in processes of care that were not subject to financial incentives. Additional studies of pay for performance are needed to determine its optimal role in quality-improvement initiatives.

Authors
Glickman, SW; Ou, F-S; DeLong, ER; Roe, MT; Lytle, BL; Mulgund, J; Rumsfeld, JS; Gibler, WB; Ohman, EM; Schulman, KA; Peterson, ED
MLA Citation
Glickman, SW, Ou, F-S, DeLong, ER, Roe, MT, Lytle, BL, Mulgund, J, Rumsfeld, JS, Gibler, WB, Ohman, EM, Schulman, KA, and Peterson, ED. "Pay for performance, quality of care, and outcomes in acute myocardial infarction." JAMA 297.21 (June 6, 2007): 2373-2380.
PMID
17551130
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
297
Issue
21
Publish Date
2007
Start Page
2373
End Page
2380
DOI
10.1001/jama.297.21.2373

Does the market value racial and ethnic concordance in physician-patient relationships?

OBJECTIVE: 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. DATA SOURCES: 1998-1999 and 2000-2001 Community Tracking Study Physician Surveys and Household Surveys, 2000 U.S. Census, and the Area Resource File. STUDY DESIGN: 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. PRINCIPAL FINDINGS: 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. CONCLUSIONS: 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.

Authors
Brown, TT; Scheffler, RM; Tom, SE; Schulman, KA
MLA Citation
Brown, TT, Scheffler, RM, Tom, SE, and Schulman, KA. "Does the market value racial and ethnic concordance in physician-patient relationships?." Health Serv Res 42.2 (April 2007): 706-726.
PMID
17362214
Source
pubmed
Published In
Health Services Research
Volume
42
Issue
2
Publish Date
2007
Start Page
706
End Page
726
DOI
10.1111/j.1475-6773.2006.00634.x

Publication or presentation of results from multicenter clinical trials: evidence from an academic medical center.

BACKGROUND: Nonpublication of research results threatens the integrity of clinical research, but the extent of nonpublication and factors associated with publication remain poorly documented. We sought to examine rates of publication or presentation of research findings from multicenter clinical trials and determine what factors are associated with dissemination of results. METHODS: We conducted a follow-up study of 217 prospective, multicenter clinical trials of treatment approved in 1998 by the institutional review board of a large academic medical center, of which 197 had enrolled participants and were not known to be ongoing. Follow-up included searches of the literature and the Internet and telephone and e-mail inquiries to investigators and research sponsors. The main outcome measures were manuscript publication or other presentation of research results. RESULTS: Results of 110 (56%) out of 197 multicenter clinical trials have been published in the peer-reviewed literature. Results of 87 (44%) studies have not been published, and results of 52 (26%) studies have not been disseminated in any form. The rate of dissemination of trial results was highest for studies that were phase 3 (81%), lowest risk (86%), and investigational (76%). The dissemination rate was lowest for studies that were supported by internal funds (50%). However, none of these associations were statistically significant. CONCLUSIONS: Results of almost half of the multicenter clinical trials conducted in part at a large academic medical center have never been published. Mechanisms to ensure public dissemination of clinical trial results are needed.

Authors
Turer, AT; Mahaffey, KW; Compton, KL; Califf, RM; Schulman, KA
MLA Citation
Turer, AT, Mahaffey, KW, Compton, KL, Califf, RM, and Schulman, KA. "Publication or presentation of results from multicenter clinical trials: evidence from an academic medical center." Am Heart J 153.4 (April 2007): 674-680.
PMID
17383311
Source
pubmed
Published In
American Heart Journal
Volume
153
Issue
4
Publish Date
2007
Start Page
674
End Page
680
DOI
10.1016/j.ahj.2007.01.005

Pharmacoeconomics: Economic Evaluation of Pharmaceuticals

Authors
Schulman, KA; Glick, HA; Polsky, D
MLA Citation
Schulman, KA, Glick, HA, and Polsky, D. "Pharmacoeconomics: Economic Evaluation of Pharmaceuticals." (March 14, 2007): 629-652. (Chapter)
Source
scopus
Publish Date
2007
Start Page
629
End Page
652
DOI
10.1002/9780470059876.ch41

Changing gender prevalence of stone disease.

PURPOSE: Recent studies suggest that the incidence of renal stone formation has been increasing and the male predominance of nephrolithiasis is decreasing, which may be due to changes in diet and lifestyle. We examined changes in the prevalence by gender of inpatient hospital discharges for urinary stone disease. MATERIALS AND METHODS: The Nationwide Inpatient Sample was used for analysis. Discharges with an International Classification of Diseases, 9th revision, Clinical Modification principal diagnosis of 592.0 (calculus of kidney) or 592.1 (calculus of ureter) from 1997 to 2002 were included in the investigation. RESULTS: An estimated mean+/-SE 1,013,621+/-19,310 discharges for stone disease occurred from 1997 to 2002. Discharges for renal calculus increased by 18.9% during the study period (p<0.001), while discharges for ureteral calculus remained relatively constant. After adjusting for population changes discharges for renal calculi increased by 14.2% (p=0.002). In females discharges for renal calculi increased by 21.0% and discharges for ureteral calculi increased by 19.2% (each p<0.001). After adjusting for population changes renal calculus and ureteral calculus discharges in females increased by 22.0% (p=0.001) and 14.5% (p=0.005), respectively. CONCLUSIONS: In this nationally representative sample the population adjusted rate of discharges for stone disease in females dramatically increased from 1997 to 2002. This alteration represents a change in the prevalence by gender of treated stone disease from a 1.7:1 to 1.3:1 male-to-female ratio. It may reflect variations in the underlying prevalence by gender of stone disease. We speculate that the increasing incidence of nephrolithiasis might be due to lifestyle associated risk factors, such as obesity.

Authors
Scales, CD; Curtis, LH; Norris, RD; Springhart, WP; Sur, RL; Schulman, KA; Preminger, GM
MLA Citation
Scales, CD, Curtis, LH, Norris, RD, Springhart, WP, Sur, RL, Schulman, KA, and Preminger, GM. "Changing gender prevalence of stone disease." J Urol 177.3 (March 2007): 979-982.
PMID
17296391
Source
pubmed
Published In
The Journal of Urology
Volume
177
Issue
3
Publish Date
2007
Start Page
979
End Page
982
DOI
10.1016/j.juro.2006.10.069

Effect of oseltamivir on the risk of pneumonia and use of health care services in children with clinically diagnosed influenza.

OBJECTIVE: To evaluate the effectiveness of oseltamivir in reducing the rate of complications of influenza in children. RESEARCH DESIGN AND METHODS: Anonymous, patient-level data from Medstat's MarketScan Research Database between 2000 and 2004 were used to identify children with influenza, aged 1-12 years. Patients who received a prescription for oseltamivir within 1 day of influenza diagnosis were compared with those who received no antiviral therapy. MAIN OUTCOME MEASURES: Primary and secondary study outcomes included occurrence of pneumonia within 14 days of onset of influenza, rates of hospitalization for pneumonia, antibiotic use, numbers of healthcare services utilized, and healthcare expenditures. RESULTS: In total, 4447 (17.9%) children received a prescription for oseltamivir within 1 day of when they were first clinically diagnosed with influenza, and 20 407 (82.1%) children received no antiviral treatment. Overall, children who received oseltamivir for the treatment of physician-diagnosed influenza were 51.7% less likely to be clinically diagnosed with pneumonia at a subsequent medical encounter (relative risk 0.483; 95% CI: 0.326, 0.717). This benefit was associated with reductions in antibiotic use, outpatient and emergency room visits, and savings in outpatient medical expenditures. Net expenditures per patient were not significantly different between children receiving oseltamivir and those who received no antiviral treatment (-$16; 95% CI: -13 dollars , +40 dollars) although pharmacy expenditures were higher. Wide regional variations in oseltamivir use were noted. LIMITATIONS: The study was restricted to patients with employer-sponsored health insurance. The lack of a virologic diagnosis of influenza, and an index date based on the first diagnosis of influenza rather than first exposure or symptom onset, may have resulted in a conservative estimate of treatment effect. CONCLUSIONS: Oseltamivir may reduce the risk of influenza-related morbidity in children when prescribed upon presentation of clinically diagnosed influenza. The use of oseltamivir in children may play an important role in managing influenza outbreaks.

Authors
Barr, CE; Schulman, K; Iacuzio, D; Bradley, JS
MLA Citation
Barr, CE, Schulman, K, Iacuzio, D, and Bradley, JS. "Effect of oseltamivir on the risk of pneumonia and use of health care services in children with clinically diagnosed influenza." Curr Med Res Opin 23.3 (March 2007): 523-531.
PMID
17355734
Source
pubmed
Published In
Current Medical Research and Opinion
Volume
23
Issue
3
Publish Date
2007
Start Page
523
End Page
531
DOI
10.1185/030079906X167499

Economic return of clinical trials performed under the pediatric exclusivity program.

CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. OBJECTIVE: To quantify the economic return to industry for completing pediatric exclusivity trials. DESIGN AND SETTING: A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. MAIN OUTCOME MEASURES: Net economic return and net return-to-cost ratio. RESULTS: The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). CONCLUSIONS: The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.

Authors
Li, JS; Eisenstein, EL; Grabowski, HG; Reid, ED; Mangum, B; Schulman, KA; Goldsmith, JV; Murphy, MD; Califf, RM; Benjamin, DK
MLA Citation
Li, JS, Eisenstein, EL, Grabowski, HG, Reid, ED, Mangum, B, Schulman, KA, Goldsmith, JV, Murphy, MD, Califf, RM, and Benjamin, DK. "Economic return of clinical trials performed under the pediatric exclusivity program." JAMA 297.5 (February 7, 2007): 480-488.
Website
http://hdl.handle.net/10161/6722
PMID
17284698
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
297
Issue
5
Publish Date
2007
Start Page
480
End Page
488

Trends in operator and hospital procedure volume and outcomes for percutaneous transluminal coronary angioplasty, 1996 to 2001.

Although the volume/outcome relation for percutaneous transluminal coronary angioplasty (PTCA) is well established, it is unclear how the relation has changed over time. To examine trends in hospital and operator volume and outcomes for PTCA, we conducted a retrospective cohort study of discharge records of patients who underwent PTCA at nonfederal hospitals in Florida and New York from 1996 to 2001. Hospital/operator pairs were divided into 4 classes using American College of Cardiology/American Heart Association volume classifications. Outcome measurements were operator and hospital procedure volume and a combined end point of inpatient mortality and emergency coronary artery bypass graft surgery. Of 452,404 patients, the number of patients who underwent PTCA from 1996 to 2001 increased from 58,180 to 92,277, with a mean annual increase of 9.1%. The risk-adjusted end point of mortality and emergency coronary artery bypass grafting decreased over time, occurring in 2.8% of admissions in 1996 and in 1.6% of admissions in 2001. Class 1 hospital/operator pairs, which were operators performing >or=75 procedures at hospitals performing >400 procedures, had the lowest occurrence of the end point overall and in each year. The risk-adjusted end point difference between classes narrowed over time. In conclusion, outcomes were best for patients receiving care from class 1 hospital/operator pairs, and an increasing proportion of patients received care from class 1 pairs. There were outcome differences within subpopulations of operators in classes 2 and 4, which suggest possibilities for alternative volume classification guidelines.

Authors
Kansagra, SM; Curtis, LH; Anstrom, KJ; Schulman, KA
MLA Citation
Kansagra, SM, Curtis, LH, Anstrom, KJ, and Schulman, KA. "Trends in operator and hospital procedure volume and outcomes for percutaneous transluminal coronary angioplasty, 1996 to 2001." Am J Cardiol 99.3 (February 1, 2007): 339-343.
PMID
17261394
Source
pubmed
Published In
The American Journal of Cardiology
Volume
99
Issue
3
Publish Date
2007
Start Page
339
End Page
343
DOI
10.1016/j.amjcard.2006.08.037

Relationship between body mass index and prostate cancer screening in the United States.

PURPOSE: Obesity is associated with more advanced disease and worse outcomes in men with prostate cancer. To our knowledge the relationship between obesity and prostate cancer screening behavior in men 40 or older is unknown. Thus, we examined associations between body mass index and prostate cancer screening behavior. MATERIALS AND METHODS: We used the 2002 Behavioral Risk Factor Surveillance System to study prostate cancer screening in a representative sample of 57,827 men 40 years or older. Primary outcomes were the proportion of men ever screened and the proportion screened in the last year for prostate cancer. RESULTS: Obese men were more likely than normal weight men to have had a prostate specific antigen test (62.1% vs 56.1%, p <0.001) and to have had a prostate specific antigen test in the last year (44.2% vs 38.2%, p <0.001). After controlling for sociodemographic characteristics obese men remained more likely than normal weight men to have had a prostate specific antigen test (OR 1.46, 95% CI 1.33-1.61) and to have had a prostate specific antigen test in the last year (OR 1.42, 95% CI 1.30-1.55). Respondents reporting an ongoing relationship with a physician (OR 2.88, 95% CI 2.57-3.22) and black nonHispanic men vs white men (OR 1.58, 95% CI 1.38-1.81) were also more likely to have had a prostate specific antigen test in the last year. CONCLUSIONS: Obese men are more likely than normal weight men to be screened for prostate cancer. Associations between advanced stage, worse outcomes and obesity may not be explained by disparities in the screening of obese men for prostate cancer.

Authors
Scales, CD; Curtis, LH; Norris, RD; Schulman, KA; Dahm, P; Moul, JW
MLA Citation
Scales, CD, Curtis, LH, Norris, RD, Schulman, KA, Dahm, P, and Moul, JW. "Relationship between body mass index and prostate cancer screening in the United States." J Urol 177.2 (February 2007): 493-498.
PMID
17222617
Source
pubmed
Published In
The Journal of Urology
Volume
177
Issue
2
Publish Date
2007
Start Page
493
End Page
498
DOI
10.1016/j.juro.2006.09.059

Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study.

BACKGROUND: Although heart failure (HF) afflicts nearly 5 million Americans, the long-term cost of HF care has not been described previously. In a prospective, longitudinal cohort of community-dwelling elderly from 4 regions, we examined the long-term costs and resource use of elderly patients with HF. METHODS: We linked 4860 elderly participants in the National Heart, Lung, and Blood Institute Cardiovascular Health Study to Medicare part A and part B claims from 1992 to 2003. Costs were calculated from Medicare payments and discounted at 3% annually. We applied nonparametric estimators to calculate mean costs and resource use per patient for a 10-year period. To describe the relationship between patient characteristics and long-term costs, we constructed censoring-adjusted regression models. RESULTS: There were 343 participants (84.8% white; 50.1% men; mean age, 78.2 years) with prevalent HF and 4517 participants without HF at study entry. Mean follow-up was 6.7 years (median, 6.4 years). The 10-year survival rates were 33% and 63% for the prevalent HF and nonprevalent HF groups (P < .001), respectively. The mean 10-year medical costs were significantly higher for the prevalent HF cohort (54,704 dollars vs 41 dollars,780, P < .001). The higher costs associated with HF were also reflected in greater resource use with more hospitalizations (P < .05) and more intensive care unit days (P < .05). Participants with HF had more physician visits (P < .05), with most of these encounters involving noncardiology physicians. However, in multivariate models, prevalent HF was not an independent predictor of higher costs. CONCLUSION: Patients with HF consume substantially more health care resources than their elderly peers, and these higher costs persist through 10 years of follow-up. Many of these costs may be related to other comorbid conditions.

Authors
Liao, L; Anstrom, KJ; Gottdiener, JS; Pappas, PA; Whellan, DJ; Kitzman, DW; Aurigemma, GP; Mark, DB; Schulman, KA; Jollis, JG
MLA Citation
Liao, L, Anstrom, KJ, Gottdiener, JS, Pappas, PA, Whellan, DJ, Kitzman, DW, Aurigemma, GP, Mark, DB, Schulman, KA, and Jollis, JG. "Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study." Am Heart J 153.2 (February 2007): 245-252.
PMID
17239685
Source
pubmed
Published In
American Heart Journal
Volume
153
Issue
2
Publish Date
2007
Start Page
245
End Page
252
DOI
10.1016/j.ahj.2006.11.010

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale.

BACKGROUND: Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial. TRIAL DESIGN: The objective of this trial is to determine whether exercise training reduces all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms. After undergoing baseline assessments to determine whether they can safely exercise, patients are randomized to either usual care or exercise training. Patients in the exercise training arm attend 36 supervised facility-based exercise training sessions. Exercise modalities are cycling or walking. After completing 18 sessions, patients initiate home-based exercise and then transition to solely home-based exercise after completing all 36 sessions. Patients return for facility-based training every 3 months to reinforce their exercise training program. Patients are followed for up to 4 years. Physiologic, quality-of-life, and economic end points that characterize the effect of exercise training in this patient population will be measured at baseline and at intervals throughout the trial. Blood samples will be collected to examine biomarkers such as brain natriuretic peptide, tumor necrosis factor, and C-reactive protein. CONCLUSIONS: Because of its relatively low cost, high availability, and ease of use, exercise training is an intervention that could be accessible to most patients with heart failure. The HF-ACTION trial is designed to definitively assess the effect of exercise training on the clinically relevant end points of mortality, hospitalization, and quality of life in patients with heart failure.

Authors
Whellan, DJ; O'Connor, CM; Lee, KL; Keteyian, SJ; Cooper, LS; Ellis, SJ; Leifer, ES; Kraus, WE; Kitzman, DW; Blumenthal, JA; Rendall, DS; Houston-Miller, N; Fleg, JL; Schulman, KA; Piña, IL; HF-ACTION Trial Investigators,
MLA Citation
Whellan, DJ, O'Connor, CM, Lee, KL, Keteyian, SJ, Cooper, LS, Ellis, SJ, Leifer, ES, Kraus, WE, Kitzman, DW, Blumenthal, JA, Rendall, DS, Houston-Miller, N, Fleg, JL, Schulman, KA, Piña, IL, and HF-ACTION Trial Investigators, . "Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale." Am Heart J 153.2 (February 2007): 201-211.
PMID
17239677
Source
pubmed
Published In
American Heart Journal
Volume
153
Issue
2
Publish Date
2007
Start Page
201
End Page
211
DOI
10.1016/j.ahj.2006.11.007

Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives.

Although heart failure disease management (HFDM) programs improve patient outcomes, the implementation of these programs has been limited because of financial barriers. We undertook the present study to understand the economic incentives and disincentives for adoption of disease management strategies from the perspectives of a physician (group), a hospital, an integrated health system, and a third-party payer. Using the combined results of a group of randomized controlled trials and a set of financial assumptions from a single academic medical center, a financial model was developed to compute the expected costs before and after the implementation of a HFDM program by 3 provider types (physicians, hospitals, and health systems), as well as the costs incurred from a payer perspective. The base-case model showed that implementation of HFDM results in a net financial loss to all potential providers of HFDM. Implementation of HFDM as described in our base-case analysis would create a net loss of US dollars 179,549 in the first year for a physician practice, US dollars 464,132 for an integrated health system, and US dollars 652,643 in the first year for a hospital. Third-party payers would be able to save US dollars 713,661 annually for the care of 350 patients with heart failure in a HFDM program. In conclusion, although HFDM programs may provide patients with improved clinical outcomes and decreased hospitalizations that save third-party payers money, limited financial incentives are currently in place for healthcare providers and hospitals to initiate these programs.

Authors
Whellan, DJ; Reed, SD; Liao, L; Gould, SD; O'connor, CM; Schulman, KA
MLA Citation
Whellan, DJ, Reed, SD, Liao, L, Gould, SD, O'connor, CM, and Schulman, KA. "Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives." Am J Cardiol 99.2 (January 15, 2007): 256-260.
PMID
17223429
Source
pubmed
Published In
The American Journal of Cardiology
Volume
99
Issue
2
Publish Date
2007
Start Page
256
End Page
260
DOI
10.1016/j.amjcard.2006.08.019

Cost of cancer care: issues and implications.

Medical technology is increasingly costly in most fields of clinical medicine. Oncology has not been spared from issues related to cost, in part resulting from the tremendous scientific progress that has lead to new tools for diagnosis, treatment, and follow-up of our patients. The increasing cost of health care in general (and cancer care in particular) raises complex questions related to its effects on our economy and the citizens of our society. This article reviews the macroeconomic principles and individual behaviors that govern medical spending, and examines how cost disproportionately affects various populations. Our overall goal is to frame debate about health policy concerns that influence the clinical practice of oncology.

Authors
Meropol, NJ; Schulman, KA
MLA Citation
Meropol, NJ, and Schulman, KA. "Cost of cancer care: issues and implications." J Clin Oncol 25.2 (January 10, 2007): 180-186. (Review)
PMID
17210937
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
25
Issue
2
Publish Date
2007
Start Page
180
End Page
186
DOI
10.1200/JCO.2006.09.6081

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation.

CONTEXT: Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE: To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease. DESIGN, SETTING, AND PATIENTS: An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. MAIN OUTCOME MEASURES: Death, nonfatal MI, and the composite of death or MI at 24-month follow-up. RESULTS: Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, -3.3%; 95% CI, -6.3% to -0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, -4.1%; 95% CI, -7.6% to -0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, -0.7%; 95% CI, -2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, -0.5%; 95% CI, -3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, -3.5%; 95% CI, -5.9% to -1.1%; P = .004) and death or MI (0% vs 4.5%; difference, -4.5%; 95% CI, -7.1% to -1.9%; P<.001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, -1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, -1.6% to 3.6%; P = .44). CONCLUSIONS: The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.

Authors
Eisenstein, EL; Anstrom, KJ; Kong, DF; Shaw, LK; Tuttle, RH; Mark, DB; Kramer, JM; Harrington, RA; Matchar, DB; Kandzari, DE; Peterson, ED; Schulman, KA; Califf, RM
MLA Citation
Eisenstein, EL, Anstrom, KJ, Kong, DF, Shaw, LK, Tuttle, RH, Mark, DB, Kramer, JM, Harrington, RA, Matchar, DB, Kandzari, DE, Peterson, ED, Schulman, KA, and Califf, RM. "Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation." JAMA 297.2 (January 10, 2007): 159-168.
PMID
17148711
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
297
Issue
2
Publish Date
2007
Start Page
159
End Page
168
DOI
10.1001/jama.297.2.joc60179

Developing model language for disclosing financial interests to potential clinical research participants.

Authors
Weinfurt, KP; Allsbrook, JS; Friedman, JY; Dinan, MA; Hall, MA; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Allsbrook, JS, Friedman, JY, Dinan, MA, Hall, MA, Schulman, KA, and Sugarman, J. "Developing model language for disclosing financial interests to potential clinical research participants." IRB 29.1 (January 2007): 1-5.
PMID
17364012
Source
pubmed
Published In
IRB
Volume
29
Issue
1
Publish Date
2007
Start Page
1
End Page
5

Curbing the cardiovascular disease epidemic: aligning industry, government, payers, and academics.

Despite decades of progress in the diagnosis, treatment, and prevention of cardiovascular disease, its prevalence continues to grow in both developed and developing countries. We have constructed a model, the "cycle of quality," which connects the innovation of initial scientific discovery with validated methods of translating research into effective delivery. This model can serve as a basis for evaluating proposed efforts to improve interactions among private and public aspects of health care to accelerate development and appropriate adoption of new treatments, and to achieve greater penetration of effective behavioral therapies and established technologies, resulting in major improvements in cardiovascular health.

Authors
Califf, RM; Harrington, RA; Madre, LK; Peterson, ED; Roth, D; Schulman, KA
MLA Citation
Califf, RM, Harrington, RA, Madre, LK, Peterson, ED, Roth, D, and Schulman, KA. "Curbing the cardiovascular disease epidemic: aligning industry, government, payers, and academics." Health Aff (Millwood) 26.1 (January 2007): 62-74.
PMID
17211015
Source
pubmed
Published In
Health Affairs
Volume
26
Issue
1
Publish Date
2007
Start Page
62
End Page
74
DOI
10.1377/hlthaff.26.1.62

Entry and competition in generic biologics

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologies can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologies are manufactured through fermentation, a process that is more variable and costly. Regulators might require extensive clinical testing of generic biologies to demonstrate equivalence to the branded product. The focus of the debate on generic biologies has been on legal and health concerns, but there are important economic implications. We combine a theoretical model of generic biologies with regression estimates from generic pharmaceuticals to estimate market entry and prices in the generic biologic market. We find that generic biologies will have high fixed costs from clinical testing and from manufacturing, so there will be less entry than would be expected for generic pharmaceuticals. With fewer generic competitors, generic biologies will be relatively close in price to branded biologies. Policy makers should be prudent in estimating financial benefits of generic biologies for consumers and payers. We also examine possible government strategies to promote generic competition. Copyright © 2007 John Wiley & Sons, Ltd.

Authors
Grabowski, HG; Ridley, DB; Schulman, KA
MLA Citation
Grabowski, HG, Ridley, DB, and Schulman, KA. "Entry and competition in generic biologics." Managerial and Decision Economics 28.4-5 (2007): 439-451.
Website
http://hdl.handle.net/10161/6616
Source
scival
Published In
Managerial and Decision Economics
Volume
28
Issue
4-5
Publish Date
2007
Start Page
439
End Page
451
DOI
10.1002/mde.1352

Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants.

BACKGROUND: Disclosing financial interests to potential research participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical research coordinators are typically charged with administering the informed consent process, it is critical to understand their experiences, attitudes and beliefs regarding the disclosure of financial interests in research. PURPOSE: To understand the role of clinical research coordinators in disclosing financial interests in research, and potential barriers to such disclosures. METHODS: We developed a survey designed to measure clinical research coordinators' awareness of financial interests in clinical research, previous experience with disclosing financial interests, comfort with answering questions about financial interests and barriers to disclosing financial interests to potential research participants. Next we conducted cognitive interviews with 10 clinical research coordinators to assess understandability and content validity and to further refine the survey. We then administered the survey to clinical research coordinators attending the 2006 Global Conference of the Association of Clinical Research Professionals. RESULTS: Among 300 clinical research coordinators who completed the survey, there was a general awareness of financial interests in research. Forty-one percent reported disclosing such financial interests to potential research participants, and 28% reported being asked about them. Greater comfort in responding to questions about financial interests was associated with previous experience with disclosure, previous experience answering questions about financial interests, and greater length of time obtaining informed consent. Respondents indicated that there were barriers to disclosure, including lack of information (76%) and that participants would not understand disclosures (26%). LIMITATIONS: Possible sample bias due to using a convenience sample. CONCLUSIONS: Making information about financial interests in research readily available to clinical research coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in research to potential research participants during the informed consent process.

Authors
Friedman, JY; Sugarman, J; Dhillon, JK; Depuy, V; Pierre, CK; Dinan, MA; Allsbrook, JS; Schulman, KA; Weinfurt, KP
MLA Citation
Friedman, JY, Sugarman, J, Dhillon, JK, Depuy, V, Pierre, CK, Dinan, MA, Allsbrook, JS, Schulman, KA, and Weinfurt, KP. "Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants." Clin Trials 4.3 (2007): 272-278.
PMID
17715256
Source
pubmed
Published In
Clinical Trials
Volume
4
Issue
3
Publish Date
2007
Start Page
272
End Page
278
DOI
10.1177/1740774507079239

In reply [3]

Authors
Meropol, NJ; Schulman, KA
MLA Citation
Meropol, NJ, and Schulman, KA. "In reply [3]." Journal of Clinical Oncology 25.22 (2007): 3383--.
Source
scival
Published In
Journal of Clinical Oncology
Volume
25
Issue
22
Publish Date
2007
Start Page
3383-
DOI
10.1200/JCO.2007.12.6771

Is there a price to pay for short-term savings in the clinical development of new pharmaceutical products?

Clinical development of new pharmaceutical compounds has historically been geared toward meeting the information demands of regulatory agencies while minimizing the cost and duration of the drug development process. One strategy for meeting these objectives has been the globalization of the clinical research enterprise. However, the data collected in multinational clinical trials may be suboptimal for entities that make health care reimbursement decisions. As reimbursement authorities begin to demand high-quality data, the design of efficient clinical development programs will become more complex. In this article, we use a model of net present value to explore relationships between the cost and duration of clinical trials and sales for a hypothetical drug in three markets defined by size, price sensitivity, and the relationship between the probability of reimbursement and the quality of the information. We demonstrate how designing clinical trials to meet short-term objectives of minimizing cost and duration can have negative long-term financial consequences in environments where reimbursement decisions are sensitive to the quality of the data produced. To the extent that reimbursement authorities discount evidence collected in multinational clinical trials, those designing clinical trials will need to look beyond globalization as a strategy to minimize trial costs to designs that balance increased trial costs with the ability to provide reimbursement bodies with generalizable data for decision making. All rights reserved. Copyright © 2007 Drug Information Association, Inc.

Authors
Reed, SD; Califf, RM; Schulman, KA
MLA Citation
Reed, SD, Califf, RM, and Schulman, KA. "Is there a price to pay for short-term savings in the clinical development of new pharmaceutical products?." Drug Information Journal 41.4 (2007): 491-499.
Source
scival
Published In
Drug information journal
Volume
41
Issue
4
Publish Date
2007
Start Page
491
End Page
499

Response [2]

Authors
Glickman, SW; Rasiel, EB; Hamilton, CD; Schulman, KA
MLA Citation
Glickman, SW, Rasiel, EB, Hamilton, CD, and Schulman, KA. "Response [2]." Science 315.5815 (2007): 1076-1077.
Source
scival
Published In
Science
Volume
315
Issue
5815
Publish Date
2007
Start Page
1076
End Page
1077

Perspectives on the cost of cancer care

Authors
Meropol, NJ; Schulman, KA
MLA Citation
Meropol, NJ, and Schulman, KA. "Perspectives on the cost of cancer care." Journal of Clinical Oncology 25.2 (2007): 169-170.
Source
scival
Published In
Journal of Clinical Oncology
Volume
25
Issue
2
Publish Date
2007
Start Page
169
End Page
170
DOI
10.1200/JCO.2006.09.9648

Comparison of conflict of interest policies and reported practices in academic medical centers in the United States.

The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.

Authors
Dinan, MA; Weinfurt, KP; Friedman, JY; Allsbrook, JS; Gottlieb, J; Schulman, KA; Hall, MA; Dhillon, JK; Sugarman, J
MLA Citation
Dinan, MA, Weinfurt, KP, Friedman, JY, Allsbrook, JS, Gottlieb, J, Schulman, KA, Hall, MA, Dhillon, JK, and Sugarman, J. "Comparison of conflict of interest policies and reported practices in academic medical centers in the United States." Account Res 13.4 (October 2006): 325-342.
PMID
17849643
Source
pubmed
Published In
Accountability in Research
Volume
13
Issue
4
Publish Date
2006
Start Page
325
End Page
342
DOI
10.1080/08989620601003414

Analytic considerations in economic evaluations of multinational cardiovascular clinical trials.

OBJECTIVES: The growing number of economic evaluations that use data collected in multinational clinical trials raises numerous questions regarding their execution and interpretation. Although recommendations for conducting economic evaluations have been widely disseminated, relatively little guidance has been given for conducting economic evaluations alongside clinical trials, particularly multinational trials. METHODS: Building on a literature review that was conducted in preparation for an expert workshop, we evaluated a subset of methodological issues related to conducting economic evaluations alongside multinational clinical trials. RESULTS: We found wide variation in the types of costs included as part of the analyses and in the methods used to assign costs to hospitalization events. Furthermore, we found that the extrapolation of costs and survival outcomes beyond the trial period is an inconsistent practice and is often not dependent on whether a survival benefit was observed in the trial or on the epidemiology or practice patterns in the country to which the findings are directed. CONCLUSIONS: Although the limited sample size precluded a quantitative analysis of trial characteristics and their associations with the methodologies employed, our findings highlight the need for more guidance to analysts regarding the execution of economic evaluations using data from multinational clinical trials. As the research community grapples with the complexities of methodological and logistical issues involved in multinational economic evaluations, the development of a standardized format to report the basic methodological characteristics of such studies would help to improve transparency and comparability for other analysts and decision-makers.

Authors
Torti, FM; Reed, SD; Schulman, KA
MLA Citation
Torti, FM, Reed, SD, and Schulman, KA. "Analytic considerations in economic evaluations of multinational cardiovascular clinical trials." Value Health 9.5 (September 2006): 281-291. (Review)
PMID
16961546
Source
pubmed
Published In
Value in Health
Volume
9
Issue
5
Publish Date
2006
Start Page
281
End Page
291
DOI
10.1111/j.1524-4733.2006.00117.x

How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation.

Changes in the economics of product development resulting from heightened safety regulations could have a sizable negative impact on drug and biotechnology companies' decisions about investing in innovation. We developed a model to compare the potential economic effects of pre- and postmarketing strategies to identify safety problems with new drugs. Although expanding Phase III clinical testing and postmarketing safety surveillance are not perfect substitutes, our findings suggest that even a large increase in funding for the latter will have a relatively small adverse impact on investment decisions by drug companies and venture capital firms, compared with the former.

Authors
Reed, SD; Califf, RM; Schulman, KA
MLA Citation
Reed, SD, Califf, RM, and Schulman, KA. "How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation." Health Aff (Millwood) 25.5 (September 2006): 1309-1317.
PMID
16966727
Source
pubmed
Published In
Health Affairs
Volume
25
Issue
5
Publish Date
2006
Start Page
1309
End Page
1317
DOI
10.1377/hlthaff.25.5.1309

Geographic variation in the treatment of acute myocardial infarction in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial.

BACKGROUND: The VALIANT trial compared the efficacy and safety of captopril, valsartan, and their combination in patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction (MI). By examining this international trial population of high-risk patients, we sought to determine geographic variations in the use of 3 key treatments for MI. METHODS: We analyzed data from 14,512 high-risk patients with MI in the VALIANT trial from the 20 countries that had enrolled >100 patients. International variation in the proportion of patients receiving (1) reperfusion therapy (thrombolysis or primary percutaneous coronary intervention), (2) beta-blockers, or (3) aspirin at the time of MI was measured by using adjusted W scores. These scores correspond to the number of additional or fewer patients who received each of the therapies compared with the number expected, as estimated from multivariable regression models that account for patients' baseline characteristics. RESULTS: There was marked variation between countries in the use of reperfusion therapy (equivalent to a difference of up to 36/100 potentially eligible patients) and beta-blockers (41/100), whereas there was much less variation in the use of aspirin (13/100). CONCLUSIONS: Marked geographic variation persists in the use of standard evidence-based therapy advocated by international guidelines. Our findings have implications not only for care of patients but also for the conduct of international trials.

Authors
Reed, SD; McMurray, JJV; Velazquez, EJ; Schulman, KA; Califf, RM; Kober, L; Maggioni, AP; Van de Werf, F; White, HD; Diaz, R; Mareev, V; Murin, J; VALIANT Committees and Investigators,
MLA Citation
Reed, SD, McMurray, JJV, Velazquez, EJ, Schulman, KA, Califf, RM, Kober, L, Maggioni, AP, Van de Werf, F, White, HD, Diaz, R, Mareev, V, Murin, J, and VALIANT Committees and Investigators, . "Geographic variation in the treatment of acute myocardial infarction in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial." Am Heart J 152.3 (September 2006): 500-508.
PMID
16923421
Source
pubmed
Published In
American Heart Journal
Volume
152
Issue
3
Publish Date
2006
Start Page
500
End Page
508
DOI
10.1016/j.ahj.2006.02.032

Prostate specific antigen testing in men older than 75 years in the United States.

PURPOSE: Although there is general agreement that men older than 75 years are unlikely to benefit from prostate specific antigen testing, patient reported testing rates in these patients exceed 30%. We examined physician reported PSA testing in elderly men, and physician and practice characteristics associated with testing. MATERIALS AND METHODS: Using the 1999 to 2002 National Ambulatory Medical Care Survey, a nationally representative sample of outpatient visits to nonfederal office based physicians, we measured rates of prostate specific antigen testing by age group in men without prostate cancer who were 40 years or older and who visited outpatient family medicine, internal medicine or urology clinics. RESULTS: An estimated 42.3 million prostate specific antigen tests were performed from 1999 to 2002, of which 5.91 million (14.0%) were performed in men older than 75 years. The population based testing rate was 6.1% in patients 40 to 49-year-old, 26.0% in patients 50 to 75-year-old and 27.8% in patients older than 75 years. Urologists performed 35.4% of prostate specific antigen tests in men older than 75 years. Controlling for sociodemographic variables physicians with a laboratory on site were more likely to perform a prostate specific antigen test (OR 1.35, 95% CI 1.07 to 1.71). In men older than 75 years the odds of prostate specific antigen testing were 1.58 times higher (95% CI 1.01 to 2.50) in practices with a laboratory on site. CONCLUSIONS: Up to a third of men older than 75 years undergo prostate specific antigen testing despite an average life expectancy of less than 10 years. Physician and practice characteristics are associated with prostate specific antigen PSA testing.

Authors
Scales, CD; Curtis, LH; Norris, RD; Schulman, KA; Albala, DM; Moul, JW
MLA Citation
Scales, CD, Curtis, LH, Norris, RD, Schulman, KA, Albala, DM, and Moul, JW. "Prostate specific antigen testing in men older than 75 years in the United States." J Urol 176.2 (August 2006): 511-514.
PMID
16813879
Source
pubmed
Published In
The Journal of Urology
Volume
176
Issue
2
Publish Date
2006
Start Page
511
End Page
514
DOI
10.1016/j.juro.2006.03.060

Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States.

OBJECTIVE: To measure geographic variation in opioid use in a large, commercially insured, outpatient population in the United States. DATA SOURCES: Outpatient prescription drug claims database of a national pharmaceutical benefit manager for 7,873,337 subjects with at least one prescription drug claim in 2000. STUDY DESIGN: We measured the period prevalence of claims for opioid analgesics and controlled-release oxycodone at the state level. We measured geographic variation using the weighted coefficient of variation and systematic component of variation. In county-level multivariable regression, we explored associations between potential explanatory variables and claims for opioid analgesics and controlled-release oxycodone. PRINCIPAL FINDINGS: A total of 567,778 (64.2 per 1,000 total claims) were for oral opioid analgesics. Claim rates by state ranged from <20 to >100 claims per 1,000 total claims. States with long-standing prescription monitoring programs had among the lowest rates. In the county-level data, presence of a statewide prescription monitoring program and proportions of the population aged 15-24 and 65 years and older were independently and negatively associated with claim rates for all opioid analgesics. Surgeons per 1,000, proportion of the population reporting illicit drug use, and proportion who were female were independently and positively associated with claim rates for all opioid analgesics. Only the proportion of the population aged 25-34 and number of surgeons per 1,000 were independently and positively associated with claim rates for oxycodone. CONCLUSIONS: Claim rates for opioid analgesics vary significantly by state. Presence of a statewide prescription monitoring program is associated with lower claim rates at the county level. Future research should use individual-level data to assess whether these findings reflect a reduction in abuse and diversion or suboptimal treatment of pain.

Authors
Curtis, LH; Stoddard, J; Radeva, JI; Hutchison, S; Dans, PE; Wright, A; Woosley, RL; Schulman, KA
MLA Citation
Curtis, LH, Stoddard, J, Radeva, JI, Hutchison, S, Dans, PE, Wright, A, Woosley, RL, and Schulman, KA. "Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States." Health Serv Res 41.3 Pt 1 (June 2006): 837-855.
PMID
16704515
Source
pubmed
Published In
Health Services Research
Volume
41
Issue
3 Pt 1
Publish Date
2006
Start Page
837
End Page
855
DOI
10.1111/j.1475-6773.2006.00511.x

Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer.

BACKGROUND: Zoledronic acid reduces skeletal-related events associated with prostate cancer and has long-term efficacy in pain outcomes. Findings of treatment group differences in pain early in treatment are less reliable. We used a recently recommended analytic approach to examine the effect of zoledronic acid on pain. MATERIALS AND METHODS: In a trial of zoledronic acid (n = 214) versus placebo (n = 208), we used the Brief Pain Inventory to assess pain at baseline, 3 weeks, 6 weeks and every 6 weeks thereafter for a total of 60 weeks. We used a modified longitudinal rank test to determine whether clinically meaningful changes in pain were related to treatment group. RESULTS: Seventy-six of 214 patients (35.5%) receiving zoledronic acid and 62 of 208 patients (29.8%) receiving placebo completed the 60-week visit (P = 0.22). In all 11 pain assessments, patients receiving zoledronic acid reported more favorable, clinically meaningful changes in pain scores. Overall, patients receiving zoledronic acid had a 33% chance of a favorable response, compared with 25% for patients receiving placebo (P = 0.04; 95% CI 0.5% to 15.6%). CONCLUSIONS: Zoledronic acid was more likely than placebo to be associated with clinically meaningful reductions in pain. Thus, zoledronic acid may help to avert the pain experienced by patients with progressing metastatic disease secondary to prostate cancer.

Authors
Weinfurt, KP; Anstrom, KJ; Castel, LD; Schulman, KA; Saad, F
MLA Citation
Weinfurt, KP, Anstrom, KJ, Castel, LD, Schulman, KA, and Saad, F. "Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer." Ann Oncol 17.6 (June 2006): 986-989.
PMID
16533874
Source
pubmed
Published In
Annals of Oncology
Volume
17
Issue
6
Publish Date
2006
Start Page
986
End Page
989
DOI
10.1093/annonc/mdl041

Relationship between clinical outcomes and vascular access type among hemodialysis patients with Staphylococcus aureus bacteremia.

The association between hemodialysis vascular access type, costs, and outcome of Staphylococcus aureus bacteremia (SAB) among patients with ESRD remains incompletely characterized. This study was undertaken to compare resource utilization, costs, and clinical outcomes among SAB-infected patients with ESRD by hemodialysis access type. Adjusted comparisons of costs and outcomes were based on multivariable linear regression and multivariable logistic regression models, respectively. A total of 143 hospitalized hemodialysis-dependent patients had SAB at Duke University Medical Center between July 1996 and August 2001. A total of 111 (77.6%) patients were hospitalized as a result of suspected bacteremia; 32 (22.4%) were hospitalized for other reasons. Of the 111 patients, 59.5% (n = 66) had catheters as their primary access type, 36% (n = 40) had arteriovenous (AV) grafts, and 4.5% (n = 5) had AV fistulas. Patients with fistulas were excluded from analyses because of small numbers. Patients with catheters were more likely to be white, had shorter dialysis vintage, and had higher Acute Physiology and Chronic Health Evaluation II scores compared with patients with grafts. Unadjusted 12-wk mortality did not significantly differ between patients with catheters compared with patients with grafts (22.7 versus 10.0%; P = 0.098); neither did 12-wk costs differ by access type ($22,944 +/- 18,278 versus $23,969 +/- 13,731, catheter versus graft; P > 0.05). In adjusted analyses, there was no difference in 12-wk mortality (odds ratio 1.63; 95% confidence interval 0.29 to 9.02; catheter versus graft) or 12-wk costs (means ratio 0.84; 95% confidence interval 0.60 to 1.17; catheter versus graft) among SAB-infected patients with ESRD on the basis of hemodialysis access type. Twelve-week mortality and costs that are associated with an episode of SAB are high in hemodialysis patients, regardless of vascular access type. Efforts should focus on the prevention of SAB in this high-risk group.

Authors
Inrig, JK; Reed, SD; Szczech, LA; Engemann, JJ; Friedman, JY; Corey, GR; Schulman, KA; Reller, LB; Fowler, VG
MLA Citation
Inrig, JK, Reed, SD, Szczech, LA, Engemann, JJ, Friedman, JY, Corey, GR, Schulman, KA, Reller, LB, and Fowler, VG. "Relationship between clinical outcomes and vascular access type among hemodialysis patients with Staphylococcus aureus bacteremia." Clin J Am Soc Nephrol 1.3 (May 2006): 518-524.
PMID
17699254
Source
pubmed
Published In
Clinical journal of the American Society of Nephrology : CJASN
Volume
1
Issue
3
Publish Date
2006
Start Page
518
End Page
524
DOI
10.2215/CJN.01301005

Medicine. A portfolio model of drug development for tuberculosis.

Authors
Glickman, SW; Rasiel, EB; Hamilton, CD; Kubataev, A; Schulman, KA
MLA Citation
Glickman, SW, Rasiel, EB, Hamilton, CD, Kubataev, A, and Schulman, KA. "Medicine. A portfolio model of drug development for tuberculosis." Science 311.5765 (March 3, 2006): 1246-1247.
PMID
16513969
Source
pubmed
Published In
Science
Volume
311
Issue
5765
Publish Date
2006
Start Page
1246
End Page
1247
DOI
10.1126/science.1119299

Spending on postapproval drug safety.

Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was 56 million dollars (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that total spending on postapproval safety by the top twenty drug manufacturers was 800 million dollars in 2003. We also examined, using regression analysis, the relationship between the number of safety personnel and the number of initial adverse-event reports. This study offers information for the debate on proposed changes to safety surveillance.

Authors
Ridley, DB; Kramer, JM; Tilson, HH; Grabowski, HG; Schulman, KA
MLA Citation
Ridley, DB, Kramer, JM, Tilson, HH, Grabowski, HG, and Schulman, KA. "Spending on postapproval drug safety." Health Aff (Millwood) 25.2 (March 2006): 429-436.
Website
http://hdl.handle.net/10161/6397
PMID
16522583
Source
pubmed
Published In
Health Affairs
Volume
25
Issue
2
Publish Date
2006
Start Page
429
End Page
436
DOI
10.1377/hlthaff.25.2.429

Geographic variations in the use of medical and surgical therapies for benign prostatic hyperplasia.

PURPOSE: Patients with BPH have several treatment options. Little is known about geographic variations in surgical rates for BPH and the market relationships to medical therapy, health resources and sociodemographic factors. MATERIALS AND METHODS: We conducted a cross-sectional study using administrative data from 5 states in 2000. Rates of surgical and medical therapy were calculated per 100,000 men 55 years old or older. Main outcome measures were county level weighted coefficient of variation and systematic component of variation in therapy rates, as well as surgery rates as a function of medication dispensing rates, health care resources and sociodemographic characteristics. RESULTS: North Carolina had the lowest surgery rates (26.3 minimally invasive procedures and 332.1 invasive surgeries per 100,000) and finasteride dispensing rates (503.5 per 100,000). Overall rates of medical therapy were 5 times higher than surgery rates. Geographic variations in surgical and medical therapy rates were significant for each state, and North Carolina had the greatest variation. An increase of 11.6 per 100,000 (95% CI, 6.5-55.8) in annual county level finasteride dispensing would be associated with a decrease in the surgery rate of 1 per 100,000, controlling for other variables. CONCLUSIONS: There is significant systematic variation in rates of surgical and medical therapy for BPH at county and state levels. The relationship between finasteride and surgery in randomized clinical trials is generalizable to the marketplace. Finasteride rates are inversely related to surgery rates, and tamsulosin rates are positively associated with surgery rates. Surgery rates are not significantly associated with urologists per capita.

Authors
Sung, JC; Curtis, LH; Schulman, KA; Albala, DM
MLA Citation
Sung, JC, Curtis, LH, Schulman, KA, and Albala, DM. "Geographic variations in the use of medical and surgical therapies for benign prostatic hyperplasia." J Urol 175.3 Pt 1 (March 2006): 1023-1027.
PMID
16469610
Source
pubmed
Published In
The Journal of Urology
Volume
175
Issue
3 Pt 1
Publish Date
2006
Start Page
1023
End Page
1027
DOI
10.1016/S0022-5347(05)00409-X

Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants.

PURPOSE: To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure. METHOD: The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure. RESULTS: Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant. CONCLUSIONS: Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

Authors
Weinfurt, KP; Dinan, MA; Allsbrook, JS; Friedman, JY; Hall, MA; Schulman, KA; Sugarman, J
MLA Citation
Weinfurt, KP, Dinan, MA, Allsbrook, JS, Friedman, JY, Hall, MA, Schulman, KA, and Sugarman, J. "Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants." Acad Med 81.2 (February 2006): 113-118.
PMID
16436571
Source
pubmed
Published In
Academic Medicine
Volume
81
Issue
2
Publish Date
2006
Start Page
113
End Page
118

Medicare and cost-effectiveness analysis.

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Medicare and cost-effectiveness analysis." N Engl J Med 354.2 (January 12, 2006): 207-209. (Letter)
PMID
16407521
Source
pubmed
Published In
The New England journal of medicine
Volume
354
Issue
2
Publish Date
2006
Start Page
207
End Page
209
DOI
10.1056/NEJMc052992

Costs for heart failure with normal vs reduced ejection fraction.

BACKGROUND: Among the elderly population, heart failure (HF) with normal ejection fraction (EF) is more common than classic HF with low EF. However, there are few data regarding the costs of HF with normal EF. In a prospective, population-based cohort of elderly participants, we compared the costs and resource use of patients with HF and normal and reduced EF. METHODS: A total of 4549 participants (84.5% white; 40.6% male) in the National Heart, Lung, and Blood Institute Cardiovascular Health Study were linked to Medicare claims from 1992 through 1998. By protocol echo examinations or clinical EF assessments, 881 participants with HF were characterized as having abnormal or normal EF. We applied semiparametric estimators to calculate mean costs per subject for a 5-year period. RESULTS: There were 495 HF participants with normal EF (186 prevalent at study entry and 309 incident during the study period) and 386 participants with abnormal EF (166 prevalent and 220 incident). Participants with abnormal EF had more cardiology encounters and cardiac procedures. However, compared with abnormal EF participants, the 5-year costs for normal EF participants were similar in both the prevalent ($33,023 with abnormal EF and $32,580 with normal EF; P=.93) and incident ($49,128 with abnormal EF and $45,604 with normal EF; P=.55) groups. In models accounting for comorbid conditions, the costs with normal and abnormal EF remained similar. CONCLUSIONS: Over a 5-year period, patients with HF and normal EF consume as many health care resources as those with reduced EF. These data highlight the substantial financial burden of HF with normal EF among the elderly population.

Authors
Liao, L; Jollis, JG; Anstrom, KJ; Whellan, DJ; Kitzman, DW; Aurigemma, GP; Mark, DB; Schulman, KA; Gottdiener, JS
MLA Citation
Liao, L, Jollis, JG, Anstrom, KJ, Whellan, DJ, Kitzman, DW, Aurigemma, GP, Mark, DB, Schulman, KA, and Gottdiener, JS. "Costs for heart failure with normal vs reduced ejection fraction." Arch Intern Med 166.1 (January 9, 2006): 112-118.
PMID
16401819
Source
pubmed
Published In
Archives of internal medicine
Volume
166
Issue
1
Publish Date
2006
Start Page
112
End Page
118
DOI
10.1001/archinte.166.1.112

The cost of acute myocardial infarction in the new millennium: evidence from a multinational registry.

BACKGROUND: Although geographic variation in the treatment of acute myocardial infarction (AMI) has been recognized, the impact of evidence-based international treatment guidelines on such variation is unclear. We sought to characterize resource use and cost of initial hospitalization for AMI in 9 countries and compare the contribution of length of stay (LOS) and procedure use to cost. METHODS: We applied country-specific cost estimates to data from the international AMI registry associated with the VALIANT trial. The registry includes demographic, medical history, treatment, and discharge information for 5573 patients with AMI admitted to 84 sites in 9 countries from November 1999 to June 2001. Hospitalization cost was estimated by imputed discharge diagnosis-related group code and adjusted for the LOS and procedures. Generalized linear regression was used to adjust cost by country; the contribution of LOS and procedures to cost was assessed by ordinary least squares regression. RESULTS: Unadjusted mean cost for initial AMI hospitalization was 9993 dollars (95% CI 9702 dollars-10,228 dollars). After adjustment for baseline patient-level variation, the lowest average cost was 1605 dollars (Argentina) and the highest was 9196 dollars (United States). Length of stay explained more of the variation in cost (50.7%) than did procedure intensity (31.9%). CONCLUSIONS: International differences in the cost of AMI persist, reflecting variations in procedure use and especially LOS. Relative differences in resource costs and incentives inherent in the provision and financing of health care likely contribute to treatment and cost variation and limit the widespread adoption of international practice guidelines.

Authors
Kauf, TL; Velazquez, EJ; Crosslin, DR; Weaver, WD; Diaz, R; Granger, CB; McMurray, JJV; Rouleau, J-L; Aylward, PE; White, HD; Califf, RM; Schulman, KA
MLA Citation
Kauf, TL, Velazquez, EJ, Crosslin, DR, Weaver, WD, Diaz, R, Granger, CB, McMurray, JJV, Rouleau, J-L, Aylward, PE, White, HD, Califf, RM, and Schulman, KA. "The cost of acute myocardial infarction in the new millennium: evidence from a multinational registry." Am Heart J 151.1 (January 2006): 206-212.
PMID
16368320
Source
pubmed
Published In
American Heart Journal
Volume
151
Issue
1
Publish Date
2006
Start Page
206
End Page
212
DOI
10.1016/j.ahj.2005.02.028

Racial differences in health concern.

An understanding of racial differences in risk-related affect may help explain racial differences in health behaviors and outcomes and provide additional opportunities for intervention. In phone interviews with a random community sample of 197 whites, 155 blacks and 163 Latinos, we assessed concern that respondents' health would be hurt by their diet, an inability to exercise, an inability to follow a doctor's recommendations and disease. A multivariate analysis of variance with follow-up profile analysis revealed that whites were less concerned than blacks and Latinos about an inability to follow their doctors' recommendations (ps < 0.01). There were no racial differences in the other health concern variables. Interventions to inform blacks and Latinos about their health risks must strike a balance between creating enough health concern to encourage health behavior but not so much that it interferes with health-promoting behaviors.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Bright, CM; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Bright, CM, Schulman, KA, and Bosworth, HB. "Racial differences in health concern." J Natl Med Assoc 98.1 (January 2006): 36-42.
PMID
16532976
Source
pubmed
Published In
Journal of the National Medical Association
Volume
98
Issue
1
Publish Date
2006
Start Page
36
End Page
42

A portfolio model of drug development for tuberculosis

Because of inadequate funding and the lack of promising drugs, no new antituberculosis drugs are likely to become available before 2010.

Authors
Glickman, SW; Rasiel, EB; Hamilton, CD; Kubataev, A; Schulman, KA
MLA Citation
Glickman, SW, Rasiel, EB, Hamilton, CD, Kubataev, A, and Schulman, KA. "A portfolio model of drug development for tuberculosis." Science 311.5765 (2006): 1246-1247.
Source
scival
Published In
Science
Volume
311
Issue
5765
Publish Date
2006
Start Page
1246
End Page
1247
DOI
10.1126/science.1119299

Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial.

INTRODUCTION: A 16-week, open-label, multicentre, randomised trial of weekly epoetin alfa 40 000 units versus biweekly darbepoetin alfa 200microg among 358 patients with solid-tumour cancers and chemotherapy-induced anaemia demonstrated superior haematological outcomes with epoetin alfa. We sought to compare resource use, costs and clinical outcomes between treatment groups and report the results using a cost-consequences framework. METHODS: Pre-specified methods were used to assign costs (US dollars, year 2004-5 values) to medical resources and patient time using a societal perspective. Costs for inpatient care, outpatient care and physician services were based on US Medicare reimbursement rates. Indirect costs assigned to patient time spent receiving study medication were based on the mean hourly wage in the US. In the base-case analysis, the average wholesale price was used to assign costs to medications. Clinical outcomes included all haemoglobin levels and transfusions recorded throughout the trial. Sensitivity analyses were performed to evaluate the impact of different costing methods, cost sources, perspectives and methods to assign haemoglobin values following a blood transfusion. RESULTS: Over a mean follow-up duration of 11.8 weeks, the average cost of study medications and their administration was the single largest component of total costs and was similar between groups (epoetin alfa 5979 US dollars and darbepoetin alfa 5935 US dollars, difference 44 US dollars; 95% CI -590, 692). There were no significant differences in the proportions of patients hospitalised (epoetin alfa 24.6%, darbepoetin alfa 22.0%; p = 0.57). Patients randomised to epoetin alfa experienced more inpatient days, on average, than patients randomised to darbepoetin alfa (2.6 vs 1.6, 95% CI for the difference, 0.07, 2.27). However, with regard to transfusions, patients in the epoetin alfa arm required fewer units of blood than patients in the darbepoetin alfa arm (0.46 vs 0.88, 95% CI for the difference -0.77, -0.08). Mean total costs, comprising costs for study medications and their administration, inpatient care, transfusions, unplanned radiation therapy, haematology and laboratory services, chemotherapy and non-chemotherapy drugs and indirect costs were 14,976 US dollars in the epoetin alfa arm compared with 14,101 US dollars in the darbepoetin alfa arm, a difference of 875 US dollars (95% CI for difference -849, 2607), of which 98% of the difference was attributable to higher inpatient costs in the epoetin alfa arm (2374 US dollars vs 1520 US dollars; 95% CI for difference -33, 1955). Assessments of multiple clinical measures demonstrated improved outcomes with epoetin alfa relative to darbepoetin alfa. CONCLUSION: Most clinical outcome measures suggested greater improvement with epoetin alfa relative to darbepoetin alfa, but most costs for both agents appeared similar. Decision makers must evaluate the differences in costs and efficacy measures that are most relevant from their perspectives.

Authors
Reed, SD; Radeva, JI; Daniel, DB; Mody, SH; Forlenza, JB; McKenzie, RS; Schulman, KA
MLA Citation
Reed, SD, Radeva, JI, Daniel, DB, Mody, SH, Forlenza, JB, McKenzie, RS, and Schulman, KA. "Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial." Pharmacoeconomics 24.5 (2006): 479-494.
PMID
16706573
Source
pubmed
Published In
PharmacoEconomics
Volume
24
Issue
5
Publish Date
2006
Start Page
479
End Page
494

Overregulation of health care: Musings on disruptive innovation theory

Authors
Curtis, LH; Schulman, KA
MLA Citation
Curtis, LH, and Schulman, KA. "Overregulation of health care: Musings on disruptive innovation theory." Law and Contemporary Problems 69.4 (2006): 195-206.
Source
scival
Published In
Law and contemporary problems
Volume
69
Issue
4
Publish Date
2006
Start Page
195
End Page
206

Erratum: Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States (Health Services Research (2006))

Authors
Curtis, LH; Stoddard, J; Radeva, JI; Hutchison, S; Dans, PE; Wright, A; Woosley, RL; Schulman, KA
MLA Citation
Curtis, LH, Stoddard, J, Radeva, JI, Hutchison, S, Dans, PE, Wright, A, Woosley, RL, and Schulman, KA. "Erratum: Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States (Health Services Research (2006))." Health Services Research 41.3 I (2006): 856-859.
Source
scival
Published In
Health Services Research
Volume
41
Issue
3 I
Publish Date
2006
Start Page
856
End Page
859
DOI
10.1111/j.1475-6773.2006.00573.x

Trends in health care resource use for hepatitis C virus infection in the United States.

Chronic hepatitis C virus (HCV) infection affects approximately 3 million people in the United States and places tremendous demands on the health care system. As many observers have predicted, the disease burden continues to grow as the infected population ages. In this study, we analyzed inpatient data from the Healthcare Cost and Utilization Project, outpatient data from the National Ambulatory Medical Care Survey, and drug data from the Verispan Source Prescription Audit. We examined recent growth in the use of health care resources among HCV patients by age group and found average annual increases of 25% to 30% for hospitalizations, charges, hospital days, and physician visits. Corresponding time-trend coefficients were positive (P < .001). From 1994 to 2001, the HCV burden increased among patients aged 40 to 60 years, reflecting the natural history of disease progression. In sensitivity analysis, HCV outcome growth rates remained significant, unless more than 3 out of 4 cases were initially underreported. Also, patients co-infected with HIV and HCV in 2001 constituted 7.5 times as many hospitalizations and incurred 2.9 times the charges in 1994, relative to all HIV hospitalizations and charges. Our findings highlight the urgency concerning HCV outcomes. In conclusion, as patients continue to age and disease burden progresses, suboptimal decisions regarding HCV treatments will bring increasing opportunity costs for the health care system and society.

Authors
Grant, WC; Jhaveri, RR; McHutchison, JG; Schulman, KA; Kauf, TL
MLA Citation
Grant, WC, Jhaveri, RR, McHutchison, JG, Schulman, KA, and Kauf, TL. "Trends in health care resource use for hepatitis C virus infection in the United States." Hepatology 42.6 (December 2005): 1406-1413.
PMID
16317670
Source
pubmed
Published In
Hepatology
Volume
42
Issue
6
Publish Date
2005
Start Page
1406
End Page
1413
DOI
10.1002/hep.20941

Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes.

PURPOSE: Although Staphylococcus aureus is a leading cause of nosocomial infection, little is known about the impact of S. aureus bacteremia on patients with prosthetic devices. This investigation sought to define the clinical outcome, health care resource use, and infection-associated costs of S. aureus bacteremia in patients with prostheses. SUBJECTS AND METHODS: All hospitalized patients with a prosthetic device and S. aureus bacteremia during the 96-month study period were identified prospectively. Clinical data were collected at the time of hospitalization. Data regarding infection-related resource utilization and infection-related costs within 12 weeks of the initial bacteremia were also recorded. RESULTS: 298 patients with > or =1 prosthesis and S. aureus bacteremia were identified (cardiovascular device--122 patients, orthopedic device--73 patients, long-term catheter--71 patients, and other devices-32 patients). Overall, 58% of patients underwent surgery as a consequence of the infection. Infection-related complications occurred in 41% and the overall 12-week mortality was 27%. The mean infection-related cost was 67439 dollars for patients with hospital-acquired S. aureus bacteremia and 37868 dollars for community-acquired S. aureus bacteremia (cost difference 29571 dollars; 95% confidence interval, 14370 dollars-49826 dollars). Rates of device infection, complications, 12-week mortality, and mean cost varied by prosthesis type. CONCLUSION: S. aureus bacteremia in patients with prosthetic devices is associated with frequent complications, substantial cost, and significant health care resource utilization.

Authors
Chu, VH; Crosslin, DR; Friedman, JY; Reed, SD; Cabell, CH; Griffiths, RI; Masselink, LE; Kaye, KS; Corey, GR; Reller, LB; Stryjewski, ME; Schulman, KA; Fowler, VG
MLA Citation
Chu, VH, Crosslin, DR, Friedman, JY, Reed, SD, Cabell, CH, Griffiths, RI, Masselink, LE, Kaye, KS, Corey, GR, Reller, LB, Stryjewski, ME, Schulman, KA, and Fowler, VG. "Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes." Am J Med 118.12 (December 2005): 1416-.
PMID
16378797
Source
pubmed
Published In
American Journal of Medicine
Volume
118
Issue
12
Publish Date
2005
Start Page
1416
DOI
10.1016/j.amjmed.2005.06.011

Implications of pharmacogenomics for drug development and clinical practice.

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

Authors
Ginsburg, GS; Konstance, RP; Allsbrook, JS; Schulman, KA
MLA Citation
Ginsburg, GS, Konstance, RP, Allsbrook, JS, and Schulman, KA. "Implications of pharmacogenomics for drug development and clinical practice." Arch Intern Med 165.20 (November 14, 2005): 2331-2336. (Review)
PMID
16287761
Source
pubmed
Published In
Archives of internal medicine
Volume
165
Issue
20
Publish Date
2005
Start Page
2331
End Page
2336
DOI
10.1001/archinte.165.20.2331

Can prospect theory explain risk-seeking behavior by terminally ill patients?

Patients with life-threatening conditions sometimes appear to make risky treatment decisions as their condition declines, contradicting the risk-averse behavior predicted by expected utility theory. Prospect theory accommodates such decisions by describing how individuals evaluate outcomes relative to a reference point and how they exhibit risk-seeking behavior over losses relative to that point. The authors show that a patient's reference point for his or her health is a key factor in determining which treatment option the patient selects, and they examine under what circumstances the more risky option is selected. The authors argue that patients' reference points may take time to adjust following a change in diagnosis, with implications for predicting under what circumstances a patient may select experimental or conventional therapies or select no treatment.

Authors
Rasiel, EB; Weinfurt, KP; Schulman, KA
MLA Citation
Rasiel, EB, Weinfurt, KP, and Schulman, KA. "Can prospect theory explain risk-seeking behavior by terminally ill patients?." Med Decis Making 25.6 (November 2005): 609-613.
Website
http://hdl.handle.net/10161/2641
PMID
16282211
Source
pubmed
Published In
Medical Decision Making
Volume
25
Issue
6
Publish Date
2005
Start Page
609
End Page
613
DOI
10.1177/0272989X05282642

Burden of illness in Parkinson's disease.

This study quantifies direct medical care costs for individual patients with Parkinson's disease (PD) and projects total national costs of PD. Anonymous, patient-level data on health care utilization and cost were obtained from Medstat's MarketScan Research Databases. Patients were selected for study if they had either two instances of a diagnosis of PD or one diagnosis and two or more prescriptions for PD-related medication. A control group of persons without PD was selected for comparison. Total annual health care utilization and costs were calculated for both PD patients and controls. A total of 20,016 patients with PD were identified and followed up for an average of 853 days. The mean age of the patients was 73.6 years, and 51.2% were women. Total annual direct costs were 23,101 US Dollars (SD 27,529) per patient with PD versus 11,247 US Dollars (SD 16,486) for controls. The regression-adjusted incremental direct cost of PD versus control was 10,349 US Dollars (95% confidence interval, 9,053, 11,645). Adding 25,326 US Dollars in indirect costs, and multiplying by 645,000 cases of PD in the United States, the total cost to the nation is projected to be 23 billion US Dollars annually. This estimate is higher than most previous studies, with important implications for health care delivery systems worldwide.

Authors
Huse, DM; Schulman, K; Orsini, L; Castelli-Haley, J; Kennedy, S; Lenhart, G
MLA Citation
Huse, DM, Schulman, K, Orsini, L, Castelli-Haley, J, Kennedy, S, and Lenhart, G. "Burden of illness in Parkinson's disease." Mov Disord 20.11 (November 2005): 1449-1454.
PMID
16007641
Source
pubmed
Published In
Movement Disorders
Volume
20
Issue
11
Publish Date
2005
Start Page
1449
End Page
1454
DOI
10.1002/mds.20609

Evidence-based therapies and mortality in patients hospitalized in December with acute myocardial infarction.

BACKGROUND: Previous studies suggest that patients hospitalized with acute myocardial infarction (MI) in December have poor outcomes, and some studies have hypothesized that the cause may be the infrequent use of evidence-based therapies during the December holiday season. OBJECTIVE: To compare the care and outcomes of patients with acute MI hospitalized in December and patients hospitalized during other months. DESIGN: Retrospective analysis of data from the Cooperative Cardiovascular Project. SETTING: Nonfederal, acute care hospitals in the United States. PATIENTS: 127 959 Medicare beneficiaries hospitalized between January 1994 and February 1996 with confirmed acute MI. MEASUREMENTS: Use of aspirin, beta-blockers, and reperfusion therapy (thrombolytic therapy or percutaneous coronary intervention), and 30-day mortality. RESULTS: When the authors controlled for patient, hospital, and physician characteristics, the use of evidence-based therapies was not significantly lower but 30-day mortality was higher (21.7% vs. 20.1%; adjusted odds ratio, 1.07 [95% CI, 1.02 to 1.12]) among patients hospitalized in December. LIMITATIONS: This was a nonrandomized, observational study. Unmeasured characteristics may have contributed to outcome differences. CONCLUSIONS: Thirty-day mortality rates were higher for Medicare patients hospitalized with acute MI in December than in other months, although the use of evidence-based therapies was not significantly lower.

Authors
Meine, TJ; Patel, MR; DePuy, V; Curtis, LH; Rao, SV; Gersh, BJ; Schulman, KA; Jollis, JG
MLA Citation
Meine, TJ, Patel, MR, DePuy, V, Curtis, LH, Rao, SV, Gersh, BJ, Schulman, KA, and Jollis, JG. "Evidence-based therapies and mortality in patients hospitalized in December with acute myocardial infarction." Ann Intern Med 143.7 (October 4, 2005): 481-485.
PMID
16204160
Source
pubmed
Published In
Annals of internal medicine
Volume
143
Issue
7
Publish Date
2005
Start Page
481
End Page
485

Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia.

OBJECTIVE: To examine associations between early hemoglobin response and alternative measures of efficacy following treatment with an erythropoietic agent for chemotherapy-related anemia. RESEARCH DESIGN AND METHODS: Preliminary data from an ongoing randomized, multicenter, 16-week, open-label clinical trial of epoetin alfa versus darbepoetin alfa were used to dichotomize patients based on attainment of early hemoglobin response (> or = 1 g/dL increase in hemoglobin level within 4 weeks of treatment initiation). Measures of efficacy were compared between patients with early hemoglobin response and those without. Sensitivity analyses were then performed to evaluate the impact of various methods for handling censored data and hemoglobin values following blood transfusion. MAIN OUTCOME MEASURES: Efficacy measures included: the proportion of patients with a > or = 1 g/dL increase in hemoglobin by 4 weeks or a > or = 2 g/dL increase by 8 weeks; mean hemoglobin levels at 4, 8, 12, and 16 weeks; area under the curve for change in hemoglobin level; proportion of patients who required a blood transfusion after 4 weeks; proportion of follow-up days on which patients had hemoglobin levels within the therapeutic range of 11 g/dL to 13 g/dL; and proportion of patients who never had a hemoglobin level within this range. RESULTS: A total of 274 patients were included (66.1% female, mean age 62.4), of whom 48.9% had an early hemoglobin response and 51.1% did not. Mean duration of follow-up was 10.1 +/- 5.05 weeks. All metrics indicated superior longer-term response among patients with early hemoglobin response compared to patients without early response. The findings were robust across sensitivity analyses. Although the analysis establishes a significant relationship between early hemoglobin response and alternative efficacy metrics, causality cannot be inferred. CONCLUSIONS: Early hemoglobin response is significantly associated with various metrics of clinical response to erythropoietic agents and is an appropriate measure for evaluating treatment effects.

Authors
Reed, SD; Radeva, JI; Daniel, DB; Fastenau, JM; Williams, D; Schulman, KA
MLA Citation
Reed, SD, Radeva, JI, Daniel, DB, Fastenau, JM, Williams, D, and Schulman, KA. "Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia." Curr Med Res Opin 21.10 (October 2005): 1527-1533.
PMID
16238892
Source
pubmed
Published In
Current Medical Research and Opinion
Volume
21
Issue
10
Publish Date
2005
Start Page
1527
End Page
1533
DOI
10.1185/030079905X65394

Impact of disease severity and gastrointestinal side effects on the health state preferences of patients with osteoarthritis.

OBJECTIVE: To describe the health state preferences of patients with osteoarthritis (OA) according to the level of pain and disability and the extent of gastrointestinal side effects from nonsteroidal antiinflammatory drugs (NSAIDs). METHODS: Using combinations of 5 OA health states (4 specifying medication use) and 6 gastrointestinal side effect profiles, we developed 25 scenarios. In an Internet survey, adults with OA evaluated 5 randomly chosen health state-side effect scenarios (in addition to scenarios for congestive heart failure and wearing dentures, as benchmarks). They rated the scenarios on a 0-100 scale, in which 100 corresponds to best imaginable health. Unadjusted mean ratings were calculated using a difference-in-difference approach. A generalized linear model was used to estimate the effects of disease severity and side effect severity on the ratings, after controlling for patient characteristics. RESULTS: A total of 4,386 respondents whose mean age was 55.3 years, of whom 3,107 (70.8%) were women and 4,007 (91.4%) were white, completed the survey. Mean adjusted ratings for health state-side effect scenarios ranged from 94.9 for the mildest scenario to 25.3 for the most severe scenario. Severity of NSAID side effects had a greater negative influence on the ratings in milder OA states than in more severe OA states. Ratings were lower among men (P < 0.001) and among respondents with OA pain in the previous 24 hours (P < 0.001). Disease severity had a greater effect on ratings than did side effect severity. CONCLUSION: Patients consider pain and functional limitations associated with OA to be important determinants of well-being. Future research should attempt to determine whether patients prefer reductions in their OA-related pain and disability over improvements in treatment side effect profiles.

Authors
Chang, J; Kauf, TL; Mahajan, S; Jordan, JM; Kraus, VB; Vail, TP; Reed, SD; Omar, MA; Kahler, KH; Schulman, KA
MLA Citation
Chang, J, Kauf, TL, Mahajan, S, Jordan, JM, Kraus, VB, Vail, TP, Reed, SD, Omar, MA, Kahler, KH, and Schulman, KA. "Impact of disease severity and gastrointestinal side effects on the health state preferences of patients with osteoarthritis." Arthritis Rheum 52.8 (August 2005): 2366-2375.
PMID
16052538
Source
pubmed
Published In
Arthritis and Rheumatism
Volume
52
Issue
8
Publish Date
2005
Start Page
2366
End Page
2375
DOI
10.1002/art.21227

Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT).

BACKGROUND: In a multinational clinical trial, valsartan was statistically not inferior to captopril in reducing mortality and cardiovascular morbidity after myocardial infarction (MI) in patients with signs of heart failure and/or left ventricular dysfunction. We conducted a prospective economic evaluation to compare within-trial resource use, costs, and quality of life in patients receiving valsartan, captopril, or both after MI. METHODS: We assigned country-specific unit costs to resource use data for 14703 patients and measured health-related quality of life in a subset of 4524 patients. We used the nonparametric bootstrap method to compare rates of resource use and costs, and a piecewise linear mixed-effects regression analysis to compare longitudinal measures of quality of life. RESULTS: There were no significant differences in rates of resource use between the valsartan and captopril groups. During an average follow-up of 2 years, total costs for patients receiving valsartan were significantly higher than for patients receiving captopril (USD 14103 vs USD 13038; 95% CI USD 369-USD 1875). The cost differential was caused primarily by the cost of the study medications (USD 1056 for valsartan vs USD 165 for captopril; 95% CI USD 867 to USD 912). Quality of life did not differ significantly between groups. CONCLUSIONS: For most patients at high risk after MI, the availability of generic captopril confers a cost advantage over valsartan because of lower medication costs. The difference will be smaller or nonexistent in settings where brand-name ACE inhibitors are prescribed.

Authors
Reed, SD; Radeva, JI; Weinfurt, KP; McMurray, JJV; Pfeffer, MA; Velazquez, EJ; Allsbrook, JS; Masselink, LE; Sellers, MA; Califf, RM; Schulman, KA; VALIANT Investigators,
MLA Citation
Reed, SD, Radeva, JI, Weinfurt, KP, McMurray, JJV, Pfeffer, MA, Velazquez, EJ, Allsbrook, JS, Masselink, LE, Sellers, MA, Califf, RM, Schulman, KA, and VALIANT Investigators, . "Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT)." Am Heart J 150.2 (August 2005): 323-329.
PMID
16086938
Source
pubmed
Published In
American Heart Journal
Volume
150
Issue
2
Publish Date
2005
Start Page
323
End Page
329
DOI
10.1016/j.ahj.2004.08.037

Perceived discrimination and reported delay of pharmacy prescriptions and medical tests.

BACKGROUND: Access to health care varies according to a person's race and ethnicity. Delaying treatment is one measure of access with important health consequences. OBJECTIVE: Determine whether perceptions of unfair treatment because of race or ethnicity are associated with reported treatment delays, controlling for economic constraints, self-reported health, depression, and demographics. DESIGN: Cross-sectional, observational study. PARTICIPANTS: A randomly selected community sample of 181 blacks, 148 Latinos, and 193 whites in Durham County, NC. MEASUREMENTS: A phone survey conducted in 2002 to assess discrimination, trust in medical care, quality of care, and access to care. Treatment delays were measured by whether or not a person reported delaying or forgoing filling a prescription and delaying or forgoing having a medical test/treatment in the past 12 months. Perceived discrimination was measured as unfair treatment in health care and as racism in local health care institutions. RESULTS: The odds of delaying filling prescriptions were significantly higher (odds ratio (OR)=2.02) for persons who perceived unfair treatment, whereas the odds of delaying tests or treatments were significantly higher (OR=2.42) for persons who thought racism was a problem in health care locally. People with self-reported depression and people who reported not working had greater odds of delaying both types of care. CONCLUSIONS: A prospective cohort study with both personal and macro measures of discrimination, as well as more refined measures of treatment delays, would help us better understand the relationship between perceived discrimination and treatment delays.

Authors
Van Houtven, CH; Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Van Houtven, CH, Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "Perceived discrimination and reported delay of pharmacy prescriptions and medical tests." J Gen Intern Med 20.7 (July 2005): 578-583.
PMID
16050850
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
20
Issue
7
Publish Date
2005
Start Page
578
End Page
583
DOI
10.1111/j.1525-1497.2005.0123.x

Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples.

BACKGROUND: We sought to compare findings of a national survey of perceptions of racial/ethnic discrimination in healthcare to those of a community survey, with emphasis on the perceptions of Latinos. METHODS: Responses from a national survey were compared to a telephone survey of residents of Durham County, North Carolina. RESULTS: Black respondents in the Durham sample were more likely than those in the national sample to feel that a healthcare provider had treated them with disrespect because of health insurance status (28% vs 14%; P < 0.001). Approximately one third of Durham Latinos and 14% of Latinos in the national sample felt they had been treated with disrespect because of their English-language ability (P < 0.01). Compared to a national sample of white participants, white respondents in Durham were more likely to believe that black persons are worse off in terms of receiving routine medical care (40% vs 27%; P < 0.01) and having health insurance (58% vs 43%; P < 0.01). As compared to their national counterparts, there was a similar trend for how white respondents in Durham perceived how Latinos fared (P < 0.001 for all comparisons). CONCLUSIONS: Overall the perception of bias in healthcare was greater among Durham residents, especially among newly immigrated Latinos, than among their national counterparts.

Authors
Friedman, JY; Anstrom, KJ; Weinfurt, KP; McIntosh, M; Bosworth, HB; Oddone, EZ; Bright, CM; Schulman, KA
MLA Citation
Friedman, JY, Anstrom, KJ, Weinfurt, KP, McIntosh, M, Bosworth, HB, Oddone, EZ, Bright, CM, and Schulman, KA. "Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples." N C Med J 66.4 (July 2005): 267-275.
PMID
16206530
Source
pubmed
Published In
North Carolina Medical Journal
Volume
66
Issue
4
Publish Date
2005
Start Page
267
End Page
275

Variations in coronary procedure utilization depending on body mass index.

BACKGROUND: Increased body mass index (BMI) (calculated as weight in kilograms divided by the square of height in meters) is a risk factor for coronary heart disease and is associated with lower preventive services utilization. The relationship between BMI and utilization of diagnostic or therapeutic procedures for coronary heart disease has not been examined. METHODS: We evaluated 109 664 Medicare patients who were hospitalized for acute myocardial infarction in a nongovernmental acute care hospital between 1994 and 1996, were 65 years or older, and weighed 159 kg or less. We used logistic regression to examine the relationship of BMI with utilization of cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass grafting while adjusting for patient and hospital characteristics. RESULTS: Participants had a mean age of 75.8 years; 53% were men and 90% were white. Individuals with a BMI of 25.0 to 35.0 had the highest rates of coronary procedure utilization. Compared with patients with a BMI of 25.0 to 29.9, those with a BMI of 35.0 to 39.9 had a reduced adjusted odds ratio (OR) of receiving coronary artery bypass grafting (OR, 0.88; 95% confidence interval [CI], 0.79-0.98), whereas patients with a BMI of 40.0 or greater had the lowest odds of receiving cardiac catheterization (OR, 0.82; 95% CI, 0.73-0.92), percutaneous coronary intervention (OR, 0.89; 95% CI, 0.77-1.03), and coronary artery bypass grafting (OR, 0.68; 95% CI, 0.57-0.82). Patients who did not receive coronary revascularization had higher mortality rates than those who did. CONCLUSIONS: For patients hospitalized with acute myocardial infarction, those with a very high BMI were less likely to receive invasive coronary procedures. Future research should investigate reasons for these variations in coronary procedure utilization.

Authors
Yancy, WS; Olsen, MK; Curtis, LH; Schulman, KA; Cuffe, MS; Oddone, EZ
MLA Citation
Yancy, WS, Olsen, MK, Curtis, LH, Schulman, KA, Cuffe, MS, and Oddone, EZ. "Variations in coronary procedure utilization depending on body mass index." Arch Intern Med 165.12 (June 27, 2005): 1381-1387.
PMID
15983287
Source
pubmed
Published In
Archives of internal medicine
Volume
165
Issue
12
Publish Date
2005
Start Page
1381
End Page
1387
DOI
10.1001/archinte.165.12.1381

Atypical antipsychotic drugs and diabetes mellitus in a large outpatient population: a retrospective cohort study.

PURPOSE: Previous research has suggested an association between use of atypical antipsychotics and onset of diabetes mellitus. We sought to compare the incidence of new onset diabetes among patients receiving atypical antipsychotics, traditional antipsychotics or antidepressants. METHODS: Retrospective cohort study of outpatients with claims for atypical antipsychotics (n = 10 265) compared to controls with claims for traditional antipsychotics (n = 4607), antidepressants (n = 60 856) or antibiotics (n = 59 878) in the administrative claims database of a large pharmaceutical benefit manager between June 2000 and May 2002. Main outcome measures were adjusted and unadjusted incidence rates of diabetes (new cases per 1000 per year) in a 12-month period, as measured using new prescriptions for antidiabetic drugs after a 6-month lead-in period. RESULTS: Annual unadjusted incidence rates of diabetes (new cases per 1000 per year) were 7.5 for atypical antipsychotics, 11.3 for traditional antipsychotics, 7.8 for antidepressants and 5.1 for antibiotics. In multivariable analyses, age, male sex and Chronic Disease Score were associated with greater odds of diabetes onset. There were no statistically significant differences in outcome between the atypical antipsychotic, traditional antipsychotic and antidepressant groups. Multivariable comparisons among specific agents showed increased odds of diabetes for clozapine, olanzapine, ziprasidone and thioridazine (relative to risperidone), but these comparisons did not reach statistical significance. CONCLUSIONS: In a large prescription claims database, outpatients taking atypical antipsychotics did not have higher rates of diabetes onset, compared to subjects taking traditional antipsychotics or antidepressants.

Authors
Østbye, T; Curtis, LH; Masselink, LE; Hutchison, S; Wright, A; Dans, PE; Schulman, KA; Krishnan, RR
MLA Citation
Østbye, T, Curtis, LH, Masselink, LE, Hutchison, S, Wright, A, Dans, PE, Schulman, KA, and Krishnan, RR. "Atypical antipsychotic drugs and diabetes mellitus in a large outpatient population: a retrospective cohort study." Pharmacoepidemiol Drug Saf 14.6 (June 2005): 407-415.
PMID
15372671
Source
pubmed
Published In
Pharmacoepidemiology and Drug Safety
Volume
14
Issue
6
Publish Date
2005
Start Page
407
End Page
415
DOI
10.1002/pds.1016

Clinical outcomes and costs due to Staphylococcus aureus bacteremia among patients receiving long-term hemodialysis.

OBJECTIVE: To examine the clinical outcomes and costs associated with Staphylococcus aureus bacteremia among hemodialysis-dependent patients. DESIGN: Prospectively identified cohort study. SETTING: A tertiary-care university medical center in North Carolina. PATIENTS: Two hundred ten hemodialysis-dependent adults with end-stage renal disease hospitalized with S. aureus bacteremia. RESULTS: The majority of the patients (117; 55.7%) underwent dialysis via tunneled catheters, and 29.5% (62) underwent dialysis via synthetic arteriovenous fistulas. Vascular access was the suspected source of bacteremia in 185 patients (88.1%). Complications occurred in 31.0% (65), and the overall 12-week mortality rate was 19.0% (40). The mean cost of treating S. aureus bacteremia, including readmissions and outpatient costs, was $24,034 per episode. The mean initial hospitalization cost was significantly greater for patients with complicated versus uncomplicated S. aureus bacteremia ($32,462 vs $17,011; P = .002). CONCLUSION: Interventions to decrease the rate of S. aureus bacteremia are needed in this high-risk, hemodialysis-dependent population.

Authors
Engemann, JJ; Friedman, JY; Reed, SD; Griffiths, RI; Szczech, LA; Kaye, KS; Stryjewski, ME; Reller, LB; Schulman, KA; Corey, GR; Fowler, VG
MLA Citation
Engemann, JJ, Friedman, JY, Reed, SD, Griffiths, RI, Szczech, LA, Kaye, KS, Stryjewski, ME, Reller, LB, Schulman, KA, Corey, GR, and Fowler, VG. "Clinical outcomes and costs due to Staphylococcus aureus bacteremia among patients receiving long-term hemodialysis." Infect Control Hosp Epidemiol 26.6 (June 2005): 534-539.
PMID
16018428
Source
pubmed
Published In
Infection Control and Hospital Epidemiology
Volume
26
Issue
6
Publish Date
2005
Start Page
534
End Page
539
DOI
10.1086/502580

Prevalence of atypical antipsychotic drug use among commercially insured youths in the United States.

BACKGROUND: Use of atypical antipsychotic medications in pediatric populations is increasing. Although previous studies have presented data by age or sex, none has documented sex-specific prevalence by age group. OBJECTIVE: To estimate the 1-year prevalence of atypical antipsychotic use by age and sex among commercially insured youths in the United States. DESIGN: Period prevalence study, January through December 2001. SETTING: Administrative claims database of a large pharmaceutical benefit manager for 6 213 824 outpatients. MAIN OUTCOME MEASURES: Period prevalence of outpatient prescription claims for atypical antipsychotic drugs among commercially insured, continuously enrolled youths. RESULTS: The prevalence of atypical antipsychotic use was 267.1 per 100 000 subjects aged 19 years and younger (16 599/6 213 824) and was more than twice as high for male patients as for female patients, although male and female patients were nearly equally represented in the overall population. Prevalence peaked at 594.3 per 100 000 subjects among male patients aged 10 to 14 years and 291.0 per 100 000 subjects among female patients aged 15 to 19 years. Nearly one fourth (3830/16 599) of patients with a claim for an atypical antipsychotic were aged 9 years and younger, and nearly 80% of these (3021/3830) were boys. CONCLUSIONS: Although evidence regarding the safety and efficacy of atypical antipsychotics in young children is limited, nearly one fourth of patients with claims for these drugs were aged 9 years or younger, and a large majority of these were boys. Understanding the long-term effects on the developing brain of early and prolonged exposure to atypical antipsychotics is crucial given their use in pediatric populations.

Authors
Curtis, LH; Masselink, LE; Østbye, T; Hutchison, S; Dans, PE; Wright, A; Krishnan, RR; Schulman, KA
MLA Citation
Curtis, LH, Masselink, LE, Østbye, T, Hutchison, S, Dans, PE, Wright, A, Krishnan, RR, and Schulman, KA. "Prevalence of atypical antipsychotic drug use among commercially insured youths in the United States." Arch Pediatr Adolesc Med 159.4 (April 2005): 362-366.
PMID
15809391
Source
pubmed
Published In
Archives of Pediatrics and Adolescent Medicine
Volume
159
Issue
4
Publish Date
2005
Start Page
362
End Page
366
DOI
10.1001/archpedi.159.4.362

The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer.

BACKGROUND: We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. PATIENTS AND METHODS: Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. RESULTS: There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. CONCLUSIONS: SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.

Authors
Weinfurt, KP; Li, Y; Castel, LD; Saad, F; Timbie, JW; Glendenning, GA; Schulman, KA
MLA Citation
Weinfurt, KP, Li, Y, Castel, LD, Saad, F, Timbie, JW, Glendenning, GA, and Schulman, KA. "The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer." Ann Oncol 16.4 (April 2005): 579-584.
PMID
15734776
Source
pubmed
Published In
Annals of Oncology
Volume
16
Issue
4
Publish Date
2005
Start Page
579
End Page
584
DOI
10.1093/annonc/mdi122

Metaanalysis and review of heart failure disease management randomized controlled clinical trials.

BACKGROUND: The medical community has turned to disease management (DM) to bridge the gap between proven therapies and clinical practice for patients with heart failure (HF). The aim of this study was to assess the effectiveness of DM programs in reducing hospitalization and mortality in patients with HF on the basis of the results of existing trials. METHODS: We compared the published results from 19 randomized controlled clinical trials evaluating HF DM programs. A random effects model was used to combine the hazards ratio for all-cause hospitalization across the studies evaluating specific types of HF DM programs. RESULTS: We identified 19 relevant studies, with 5752 enrolled patients, which assessed the benefits of HF DM programs. The overall effect was a significant decrease in all-cause hospitalization for patients with HF. There was significant heterogeneity in the results (P < .0001). CONCLUSIONS: The results of this analysis indicate that HF DM is an intervention that could significantly decrease hospitalization for patients with HF. However, due to differences in the types of strategies and the variety of health care settings in which they were evaluated, further studies of HF DM programs with multiple participating centers are required.

Authors
Whellan, DJ; Hasselblad, V; Peterson, E; O'Connor, CM; Schulman, KA
MLA Citation
Whellan, DJ, Hasselblad, V, Peterson, E, O'Connor, CM, and Schulman, KA. "Metaanalysis and review of heart failure disease management randomized controlled clinical trials." Am Heart J 149.4 (April 2005): 722-729. (Review)
PMID
15990759
Source
pubmed
Published In
American Heart Journal
Volume
149
Issue
4
Publish Date
2005
Start Page
722
End Page
729
DOI
10.1016/j.ahj.2004.09.023

Reducing the costs of phase III cardiovascular clinical trials.

BACKGROUND: The pharmaceutical industry spends approximately 26.4 billion dollars annually for research and development (4.1 billion dollars in cardiovascular products). We compared pharmaceutical companies' planned resource use and costs in Phase III cardiovascular trials and identified cost-saving strategies. METHODS AND RESULTS: We developed 2 case scenarios (a 17,000-patient, open-label acute coronary syndromes [ACS] trial and a 14,500-patient, double-blind congestive heart failure [CHF]) trial and surveyed 6 pharmaceutical experts about expected resources (e.g., number of sites, case report form [CRF] pages, and monitoring visits) needed for the trials. Using a validated model, we estimated costs under each expert's assumptions. ACS trial costs averaged 83 million dollars (median, 67 million dollars; range, 57 dollars to 158 million dollars) and 142 million dollars (median, 135 million dollars; range, 102 dollars to 207 million dollars) for the CHF trial. Site-related expenses (site management and payments) were >65% of total costs for both trials. In sensitivity analyses, total costs were reduced >40% by simultaneously reducing CRF pages, monitoring visits, and site-payment amounts but maintaining the numbers of patients and sites. CONCLUSIONS: With a set number of sites and patients, the most efficient way to reduce trial costs and still meet the trial's scientific objectives is to reduce management complexity. Modest changes in management parameters release significant monies to answer more research questions.

Authors
Eisenstein, EL; Lemons, PW; Tardiff, BE; Schulman, KA; Jolly, MK; Califf, RM
MLA Citation
Eisenstein, EL, Lemons, PW, Tardiff, BE, Schulman, KA, Jolly, MK, and Califf, RM. "Reducing the costs of phase III cardiovascular clinical trials." Am Heart J 149.3 (March 2005): 482-488.
PMID
15864237
Source
pubmed
Published In
American Heart Journal
Volume
149
Issue
3
Publish Date
2005
Start Page
482
End Page
488
DOI
10.1016/j.ahj.2004.04.049

Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.

Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, North Carolina, we sought to identify areas of agreement about how the primary findings of economic evaluations in multinational clinical trials should be generated and presented. In this paper, we propose a framework for classifying multinational economic evaluations according to (a) the sources of an analyst's estimates of resource use and clinical effectiveness and (b) the analyst's method of estimating costs. We review existing studies in the cardiology literature in the context of the proposed framework. We then describe important methodological and practical considerations in conducting multinational economic evaluations and summarize the advantages and disadvantages of each approach. Finally, we describe opportunities for future research. Delineation of the various approaches to multinational economic evaluation may assist researchers, peer reviewers, journal editors, and decision makers in evaluating the strengths and limitations of particular studies.

Authors
Reed, SD; Anstrom, KJ; Bakhai, A; Briggs, AH; Califf, RM; Cohen, DJ; Drummond, MF; Glick, HA; Gnanasakthy, A; Hlatky, MA; O'Brien, BJ; Torti, FM; Tsiatis, AA; Willan, AR; Mark, DB; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Bakhai, A, Briggs, AH, Califf, RM, Cohen, DJ, Drummond, MF, Glick, HA, Gnanasakthy, A, Hlatky, MA, O'Brien, BJ, Torti, FM, Tsiatis, AA, Willan, AR, Mark, DB, and Schulman, KA. "Conducting economic evaluations alongside multinational clinical trials: toward a research consensus." Am Heart J 149.3 (March 2005): 434-443.
PMID
15864231
Source
pubmed
Published In
American Heart Journal
Volume
149
Issue
3
Publish Date
2005
Start Page
434
End Page
443
DOI
10.1016/j.ahj.2004.11.001

Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation.

BACKGROUND: Everolimus decreases acute rejection and cardiac allograft vasculopathy after heart transplantation. We compared within-trial costs and resource use over 1 yr of follow-up in de novo heart transplant patients randomized to everolimus 1.5 mg/d (n = 209), everolimus 3.0 mg/d (n = 211), or azathioprine (n = 214). PATIENTS AND METHODS: Resource use data were collected prospectively for 634 patients from 14 countries. We used the nonparametric bootstrap method to test for differences in mean costs and to estimate confidence intervals for cost-effectiveness ratios. RESULTS: Everolimus patients had lower incidence of efficacy failure compared with azathioprine patients (41.6%, everolimus 1.5 mg; 32.2%, everolimus 3.0 mg; 52.8%, azathioprine). Compared with patients receiving azathioprine, everolimus patients spent more days in the hospital [36.3 d for everolimus 1.5 mg/d (p = 0.21); 38.4 d for everolimus 3.0 mg/d (p = 0.01); 32.2 d for azathioprine]. Mean total costs, excluding the study medications, were not significantly different among treatment groups ($72 065 for everolimus 1.5 mg; $72 631 for everolimus 3.0 mg; $70 815 for azathioprine). CONCLUSIONS: Over 1 yr of follow-up after heart transplantation, everolimus did not significantly increase treatment costs, excluding the costs of the study medications, while reducing efficacy failure. Longer follow-up and the cost of everolimus are required to fully evaluate the cost-effectiveness of everolimus vs. azathioprine in post-transplant maintenance.

Authors
Radeva, JI; Reed, SD; Kaló, Z; Kauf, TL; Cantu, E; Cretin, N; Schulman, KA
MLA Citation
Radeva, JI, Reed, SD, Kaló, Z, Kauf, TL, Cantu, E, Cretin, N, and Schulman, KA. "Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation." Clin Transplant 19.1 (February 2005): 122-129.
PMID
15659145
Source
pubmed
Published In
Clinical Transplantation
Volume
19
Issue
1
Publish Date
2005
Start Page
122
End Page
129
DOI
10.1111/j.1399-0012.2004.00312.x

Economic evaluation of zoledronic acid versus pamidronate for the prevention of skeletal-related events in metastatic breast cancer and multiple myeloma.

Skeletal complications of cancer decrease health-related quality of life. Bisphosphonates can prevent skeletal-related events. We collected resource use data prospectively for 930 patients alongside a multinational trial of zoledronic acid versus pamidronate for patients with metastatic multiple myeloma or breast cancer and > or =1 bone lesion. Country-specific unit costs were assigned to counts of resource use from randomization through last trial visit. Total costs were calculated by summing costs for medical resources, plus costs of institutional care and study medications and administration. Resource use was similar for both groups. Approximately half of the patients were hospitalized at least once during the mean follow-up of 10 months (52.8% for zoledronic acid versus 52.6% for pamidronate; P = 0.9504). The average number of hospital days was 8.9 for zoledronic acid versus 9.2 for pamidronate (P = 0.728). The mean total cost was 16,434 dollars for zoledronic acid and 15,735 dollars for pamidronate, an incremental cost of 699 dollars (95% confidence interval [CI], -1047 to 2163). Mean total costs for patients with multiple myeloma were 1982 dollars (95% CI, -1491 to 5335) higher for zoledronic acid (17,958 dollars) than for pamidronate (15,976 dollars). However, among patients with breast cancer, total costs in both groups were approximately equal (15,703 dollars for zoledronic acid versus 15,680 dollars for pamidronate; 95% CI for the difference: -1875 to 2012). There were no significant cost differences between patients receiving zoledronic acid and those receiving pamidronate.

Authors
Reed, SD; Radeva, JI; Glendenning, GA; Coleman, RE; Schulman, KA
MLA Citation
Reed, SD, Radeva, JI, Glendenning, GA, Coleman, RE, and Schulman, KA. "Economic evaluation of zoledronic acid versus pamidronate for the prevention of skeletal-related events in metastatic breast cancer and multiple myeloma." Am J Clin Oncol 28.1 (February 2005): 8-16.
PMID
15685028
Source
pubmed
Published In
American Journal of Clinical Oncology: Cancer Clinical Trials
Volume
28
Issue
1
Publish Date
2005
Start Page
8
End Page
16

Costs and outcomes among hemodialysis-dependent patients with methicillin-resistant or methicillin-susceptible Staphylococcus aureus bacteremia.

OBJECTIVE: Comorbid conditions have complicated previous analyses of the consequences of methicillin resistance for costs and outcomes of Staphylococcus aureus bacteremia. We compared costs and outcomes of methicillin resistance in patients with S. aureus bacteremia and a single chronic condition. DESIGN, SETTING, AND PATIENTS: We conducted a prospective cohort study of hemodialysis-dependent patients with end-stage renal disease and S. aureus bacteremia hospitalized between July 1996 and August 2001. We used propensity scores to reduce bias when comparing patients with methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) S. aureus bacteremia. Outcome measures were resource use, direct medical costs, and clinical outcomes at 12 weeks after initial hospitalization. RESULTS: Fifty-four patients (37.8%) had MRSA and 89 patients (62.2%) had MSSA. Compared with patients with MSSA bacteremia, patients with MRSA bacteremia were more likely to have acquired the infection while hospitalized for another condition (27.8% vs 12.4%; P = .02). To attribute all inpatient costs to S. aureus bacteremia, we limited the analysis to 105 patients admitted for suspected S. aureus bacteremia from a community setting. Adjusted costs were higher for MRSA bacteremia for the initial hospitalization (21,251 dollars vs 13,978 dollars; P = .012) and after 12 weeks (25,518 dollars vs 17,354 dollars; P = .015). At 12 weeks, patients with MRSA bacteremia were more likely to die (adjusted odds ratio, 5.4; 95% confidence interval, 1.5 to 18.7) than were patients with MSSA bacteremia. CONCLUSIONS: Community-dwelling, hemodialysis-dependent patients hospitalized with MRSA bacteremia face a higher mortality risk, longer hospital stays, and higher inpatient costs than do patients with MSSA bacteremia.

Authors
Reed, SD; Friedman, JY; Engemann, JJ; Griffiths, RI; Anstrom, KJ; Kaye, KS; Stryjewski, ME; Szczech, LA; Reller, LB; Corey, GR; Schulman, KA; Fowler, VG
MLA Citation
Reed, SD, Friedman, JY, Engemann, JJ, Griffiths, RI, Anstrom, KJ, Kaye, KS, Stryjewski, ME, Szczech, LA, Reller, LB, Corey, GR, Schulman, KA, and Fowler, VG. "Costs and outcomes among hemodialysis-dependent patients with methicillin-resistant or methicillin-susceptible Staphylococcus aureus bacteremia." Infect Control Hosp Epidemiol 26.2 (February 2005): 175-183.
PMID
15756889
Source
pubmed
Published In
Infection Control and Hospital Epidemiology
Volume
26
Issue
2
Publish Date
2005
Start Page
175
End Page
183
DOI
10.1086/502523

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials.

BACKGROUND: There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials. METHODS: Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified. RESULTS: The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies. CONCLUSIONS: Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

Authors
Weinfurt, KP; Depuy, V; Castel, LD; Sulmasy, DP; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Depuy, V, Castel, LD, Sulmasy, DP, Schulman, KA, and Meropol, NJ. "Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials." Cancer 103.1 (January 1, 2005): 140-147.
PMID
15534885
Source
pubmed
Published In
Cancer
Volume
103
Issue
1
Publish Date
2005
Start Page
140
End Page
147
DOI
10.1002/cncr.20730

Effect of adverse storage conditions on performance of glucometer test strips.

OBJECTIVE: A study was conducted to assess the impact of adverse storage environments, i.e., not manufacturer recommended, on the performance of reagent test strips used with a point of care testing (POCT) glucometer to measure whole blood glucose levels. DESIGN/SETTING: Glucose reagent test strips were placed in open, i.e., uncapped, and closed, i.e., capped vials. These vials were those used by the manufacturer to package and store the reagent test strips. One of each type of vial was placed in the manufacturer-recommended storage environment at room temperature and the adverse environments (incubator, direct light to mimic sunlight exposure, humidity, and refrigerated). The Accu-Chek Easy glucometer and reagent test strips as well as Accu-Chek Easy high and low glucose control solutions, manufactured by Roche, were used for this study. MAIN OUTCOME MEASURES: On day-3, day-7, and then once every 7 days, one strip from each vial in each environment was tested with the same glucometer using both a high and a low glucose control. The strip was considered failed for a type of vial and storage environment when either control was out of the reference range on a regular testing day and still out of range when tested the subsequent day. Testing continued up to 50 days. RESULTS: For the tested environments it was found that, overall, test strip stability lasted longer for closed vials than open vials. For open vials in adverse storage conditions, the refrigerator environment offered the longest stability at 35 to 50 days and direct light and humidity offered the shortest periods of stability at 3 to 14 days. CONCLUSIONS: The results of this study support the manufacturer's recommendations to store POCT glucose test strips in their original vial, capped, and at room temperature, though refrigeration may offer an alternative storage environment with acceptable stability. As compliance with testing, quality control, and storage instructions is often an issue with POCT, the manufacturers of these systems for blood glucose measurement should design storage systems that allow the patient to store the glucose meter and the reagent strips in the same location. Manufacturers may also need to consider designing storage systems that are more portable, knowing that patients must take the glucose meters and test strips with them when they travel. Roche's Accu-Chek Compact system is an example of such a design. The glucose test strips are incorporated into a drum that is stored in the Accu-Chek meter itself. When a patient performs a fingerstick blood glucose measurement, the drum advances to move a test strip outside the meter. When the test is complete, the test strip is ejected for disposal. Future studies to clarify the effect of adverse storage conditions, particularly refrigeration, on the integrity of POCT test systems and reagent strips is warranted with currently marketed brands.

Authors
Bamberg, R; Schulman, K; MacKenzie, M; Moore, J; Olchesky, S
MLA Citation
Bamberg, R, Schulman, K, MacKenzie, M, Moore, J, and Olchesky, S. "Effect of adverse storage conditions on performance of glucometer test strips." Clin Lab Sci 18.4 (2005): 203-209.
PMID
16315736
Source
pubmed
Published In
Clinical Laboratory Science
Volume
18
Issue
4
Publish Date
2005
Start Page
203
End Page
209

For the patient. Who trusts healthcare institutions? Results from a community-based sample.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "For the patient. Who trusts healthcare institutions? Results from a community-based sample." Ethn Dis 15.1 (2005): 150-.
PMID
15720061
Source
pubmed
Published In
Ethnicity & disease
Volume
15
Issue
1
Publish Date
2005
Start Page
150

Who trusts healthcare institutions? Results from a community-based sample.

OBJECTIVE: The goal of this research was to examine racial differences in trust in various healthcare institutions. METHOD: In telephone interviews, 195 Whites, 183 Blacks, and 171 Latinos from Durham, NC indicated how often they trust various institutions (community doctors, local hospitals, county health department, insurance companies, and state and federal government) to do what is best for patients. RESULTS: In bivariate analyses, trust in various healthcare institutions was associated with race; Whites and Latinos trusted physicians more often than Blacks, and Latinos trusted the health department, insurance companies, and both government entities more often than Whites and Blacks (Ps < .01). In adjusted analyses controlling for marital status, financial status, and education, race was still associated with trust. Whites trusted physicians more often than Blacks, and Latinos trusted insurance companies, the state government, and the federal government more often than Whites and Blacks (Ps < .01). CONCLUSIONS: Racial differences in trust of healthcare institutions vary by institution type. Future studies of trust and interventions designed to improve trust must account for race and target institution differences.

Authors
Voils, CI; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Voils, CI, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "Who trusts healthcare institutions? Results from a community-based sample." Ethn Dis 15.1 (2005): 97-103.
PMID
15720055
Source
pubmed
Published In
Ethnicity & disease
Volume
15
Issue
1
Publish Date
2005
Start Page
97
End Page
103

Cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia.

BACKGROUND: Despite a lack of long-term data, imatinib has become standard therapy for patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML) who are not candidates for allogeneic stem cell transplantation. In the current study, the authors estimated the incremental cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine (IFN+LDAC) as first-line therapy for these patients. METHODS: Data from the International Randomized Interferon versus STI571 Study and the literature were used to estimate lifetime costs, survival, and quality-adjusted survival. Survival estimates were based on published survival curves for patients who achieved and those who did not achieve a complete cytogenetic response after treatment with interferon-alpha. RESULTS: The mean estimated survival with first-line imatinib therapy was 15.30 years, compared with 9.07 years with IFN+LDAC. Undiscounted lifetime costs were approximately $424,600 with imatinib and $182,800 with IFN+LDAC. Using a 3% discount rate, the incremental survival gain with imatinib was 3.93 life-years and 3.89 quality-adjusted life-years (QALYs). Incremental discounted lifetime costs were found to be $168,100 higher with imatinib, resulting in incremental cost-effectiveness ratios of $43,100 per life-year saved (95% confidence interval [95% CI], $37,600-51,100) and $43,300 per QALY (95% CI, $38,300-49,100). CONCLUSIONS: The results of the current study demonstrate that compared with IFN+LDAC, imatinib is a cost-effective first-line therapy in patients with newly diagnosed chronic-phase CML.

Authors
Reed, SD; Anstrom, KJ; Ludmer, JA; Glendenning, GA; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Ludmer, JA, Glendenning, GA, and Schulman, KA. "Cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia." Cancer 101.11 (December 1, 2004): 2574-2583.
PMID
15493042
Source
pubmed
Published In
Cancer
Volume
101
Issue
11
Publish Date
2004
Start Page
2574
End Page
2583
DOI
10.1002/cncr.20694

Long-term survival estimates for imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia.

BACKGROUND: The authors estimated survival among patients with chronic myeloid leukemia for a cost-effectiveness analysis of imatinib versus interferon-alpha plus low-dose cytarabine (IFN+LDAC). METHODS: Two-year survival and cytogenetic response were determined using data from 553 patients who received first-line imatinib in the International Randomized Interferon versus ST571 Study (IRIS). Long-term survival was modeled on complete cytogenetic response (CCyR) after 2 years. Long-term survival for patients with a CCyR was modeled using data from a cohort study of 317 patients with CCyRs. Long-term survival for patients without a CCyR was modeled using data from a trial of 275 patients who were treated with IFN+LDAC. Computation of lifetime survival estimates for imatinib assumed a proportional hazards relation between survival for an age-matched and gender-matched cohort and survival for patients with and without a CCyR. RESULTS: For IRIS patients receiving imatinib, the estimated survival was 95.8% and the CCyR rate was 73.8%. The average residual life expectancy was estimated to be 16.71 years for CCyR patients and 5.78 years for non-CCyR patients. The estimated life expectancy after treatment with imatinib was 15.30 years, compared with 9.07 years for patients who were treated with IFN+LDAC in previous studies. CONCLUSIONS: Assuming the relation between CCyR and survival with interferon-alpha holds for imatinib, higher CCyR rates with imatinib therapy will result in an estimated 6.23 life-years gained compared with treatment with IFN+LDAC.

Authors
Anstrom, KJ; Reed, SD; Allen, AS; Glendenning, GA; Schulman, KA
MLA Citation
Anstrom, KJ, Reed, SD, Allen, AS, Glendenning, GA, and Schulman, KA. "Long-term survival estimates for imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia." Cancer 101.11 (December 1, 2004): 2584-2592.
PMID
15493041
Source
pubmed
Published In
Cancer
Volume
101
Issue
11
Publish Date
2004
Start Page
2584
End Page
2592
DOI
10.1002/cncr.20674

Commentary: The unknown benefit of complementary and alternative medicine.

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Commentary: The unknown benefit of complementary and alternative medicine." J Altern Complement Med 10.6 (December 2004): 911-.
PMID
15673982
Source
pubmed
Published In
Journal of Alternative and Complementary Medicine
Volume
10
Issue
6
Publish Date
2004
Start Page
911
DOI
10.1089/acm.2004.10.911

Perceptions of racial and ethnic differences in access to healthcare.

Authors
Seils, DM; Schulman, KA
MLA Citation
Seils, DM, and Schulman, KA. "Perceptions of racial and ethnic differences in access to healthcare." N C Med J 65.6 (November 2004): 350-352.
PMID
15714723
Source
pubmed
Published In
North Carolina Medical Journal
Volume
65
Issue
6
Publish Date
2004
Start Page
350
End Page
352

An exploration of relative health stock in advanced cancer patients.

OBJECTIVE: The authors sought to empirically test whether relative health stock, a measure of patients' sense of loss in their health due to illness, influences the treatment decisions of patients facing life-threatening conditions. Specifically, they estimated the effect of relative health stock on advanced cancer patients' decisions to participate in phase I clinical trials. METHOD: A multicenter study was conducted to survey 328 advanced cancer patients who were offered the opportunity to participate in phase I trials. The authors asked patients to estimate the probabilities of therapeutic benefits and toxicity, their relative health stock, risk preference, and the importance of quality of life. RESULTS: Controlling for health-related quality of life, an increase in relative health stock by 10 percentage points reduced the odds of choosing to participate in a phase I trial by 16% (odds ratio = 0.84, 95% confidence interval = 0.72, 0.97). CONCLUSION: Relative health stock affects advanced cancer patients' treatment decisions.

Authors
Gaskin, DJ; Weinfurt, KP; Castel, LD; DePuy, V; Li, Y; Balshem, A; Benson, A; Burnett, CB; Corbett, S; Marshall, J; Slater, E; Sulmasy, DP; Van Echo, D; Meropol, NJ; Schulman, KA
MLA Citation
Gaskin, DJ, Weinfurt, KP, Castel, LD, DePuy, V, Li, Y, Balshem, A, Benson, A, Burnett, CB, Corbett, S, Marshall, J, Slater, E, Sulmasy, DP, Van Echo, D, Meropol, NJ, and Schulman, KA. "An exploration of relative health stock in advanced cancer patients." Med Decis Making 24.6 (November 2004): 614-624.
PMID
15534342
Source
pubmed
Published In
Medical Decision Making
Volume
24
Issue
6
Publish Date
2004
Start Page
614
End Page
624
DOI
10.1177/0272989X04271041

Parents' reported preference scores for childhood atopic dermatitis disease states.

BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis. METHODS: Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state. RESULTS: A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis.

Authors
Friedman, JY; Reed, SD; Weinfurt, KP; Kahler, KH; Walter, EB; Schulman, KA
MLA Citation
Friedman, JY, Reed, SD, Weinfurt, KP, Kahler, KH, Walter, EB, and Schulman, KA. "Parents' reported preference scores for childhood atopic dermatitis disease states. (Published online)" BMC Pediatr 4.1 (October 18, 2004): 21-.
PMID
15491500
Source
pubmed
Published In
BMC Pediatrics
Volume
4
Issue
1
Publish Date
2004
Start Page
21
DOI
10.1186/1471-2431-4-21

Regionalization of percutaneous transluminal coronary angioplasty and implications for patient travel distance.

CONTEXT: Minimum procedure volume thresholds have been proposed to improve outcomes among patients undergoing percutaneous transluminal coronary angioplasty (PTCA). How regionalization policies would affect patient travel distances is not known. OBJECTIVE: To examine the effect of regionalization of PTCA on patient travel distances. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of discharge records, which were examined to determine hospital and operator procedure volumes, of 97,401 patients undergoing PTCA in New York, New Jersey, and Florida in 2001. Travel distances were measured at baseline and under 2 regionalization scenarios in which hospital-operator pairs not meeting minimum volume standards stopped providing services. MAIN OUTCOME MEASURES: Observed and expected patient travel distances, and risk-adjusted mortality. RESULTS: With a minimum volume standard of 175 per operator and 400 per hospital (class 1), 25% of patients had a shorter travel distance, 10% had a longer travel distance, and 65% experienced no change. Most patients with longer travel distances under this standard would travel no more than 25 miles farther, and most patients with shorter travel distances would save no more than 10 miles. With a minimum volume standard of 75 per operator and 400 per hospital (class 2), 11% of patients had a shorter travel distance, 2% had a longer travel distance, and 87% experienced no change. Under both standards, less than 1% of patients would travel more than 50 miles farther than their observed travel distance. Risk-adjusted mortality was higher for lower-volume hospital-operator pairs (1.2% for class 3 vs 0.9% for class 2 and 0.8% for class 1; P<.001 for both comparisons). CONCLUSION: Regionalization of PTCA would not increase travel distance for most patients; however, potential costs of regionalization not related to travel must be examined before such policies can be recommended.

Authors
Kansagra, SM; Curtis, LH; Schulman, KA
MLA Citation
Kansagra, SM, Curtis, LH, and Schulman, KA. "Regionalization of percutaneous transluminal coronary angioplasty and implications for patient travel distance." JAMA 292.14 (October 13, 2004): 1717-1723.
PMID
15479937
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
292
Issue
14
Publish Date
2004
Start Page
1717
End Page
1723
DOI
10.1001/jama.292.14.1717

Inappropriate prescribing for elderly Americans in a large outpatient population.

BACKGROUND: We sought to determine the extent of potentially inappropriate outpatient prescribing for elderly patients, as defined by the Beers revised list of drugs to be avoided in elderly populations. METHODS: We conducted a retrospective cohort study using the outpatient prescription claims database of a large, national pharmaceutical benefit manager. The cohort included 765,423 subjects 65 years or older, who were covered by a pharmaceutical benefit manager and filed 1 or more prescription drug claims during 1999. Main outcome measures were the proportion of subjects who filled a prescription for 1 or more drugs of concern and the proportion of subjects who filled prescriptions for 2 or more of the drugs. RESULTS: A total of 162,370 subjects (21%) filled a prescription for 1 or more drugs of concern. Amitriptyline and doxepin accounted for 23% of all claims for Beers list drugs, and 51% of those claims were for drugs with the potential for severe adverse effects. More than 15% of subjects filled prescriptions for 2 drugs of concern, and 4% filled prescriptions for 3 or more of the drugs within the same year. The most commonly prescribed classes were psychotropic drugs and neuromuscular agents. CONCLUSIONS: The common use of potentially inappropriate drugs should serve as a reminder to monitor their use closely. Pharmaceutical claims databases can be important tools for accomplishing this task, though clinical and laboratory data are needed to improve the sensitivity and specificity of patient-specific alerts.

Authors
Curtis, LH; Østbye, T; Sendersky, V; Hutchison, S; Dans, PE; Wright, A; Woosley, RL; Schulman, KA
MLA Citation
Curtis, LH, Østbye, T, Sendersky, V, Hutchison, S, Dans, PE, Wright, A, Woosley, RL, and Schulman, KA. "Inappropriate prescribing for elderly Americans in a large outpatient population." Arch Intern Med 164.15 (August 9, 2004): 1621-1625.
PMID
15302631
Source
pubmed
Published In
Archives of internal medicine
Volume
164
Issue
15
Publish Date
2004
Start Page
1621
End Page
1625
DOI
10.1001/archinte.164.15.1621

State-mandated continuing medical education and the use of proven therapies in patients with an acute myocardial infarction.

OBJECTIVES: The purpose of this study was to determine whether state-mandated continuing medical education (CME) requirements affect the use of evidence-based therapies and outcomes in patients with acute myocardial infarction (AMI). BACKGROUND: The Institute of Medicine recommends that educational programs demonstrate their effect through process and outcome measures. METHODS: We analyzed 134,609 patients according to whether or not CME was mandated in the state of physician practice. A hierarchical multivariable model was developed that controlled for state, hospital, physician, and patient level characteristics to determine the association between state CME requirements and the use of evidence-based therapies. Primary outcome measures were admission aspirin use and reperfusion therapy, and discharge aspirin and beta-blocker prescription. Thirty-day and one-year mortality were secondary outcome measures. RESULTS: States with and without CME requirements had similar rates of aspirin use at admission and discharge (79.9% vs. 79.4% and 72.5% vs. 72.5%, respectively) and beta-blocker prescription at discharge (53.6% vs. 55.3%). The rate of reperfusion therapy at admission was significantly higher in states requiring CME (53.1%) compared with states without CME (47.9%) (p < 0.0001). After adjustment, patients admitted in CME-requiring states were significantly more likely to receive reperfusion therapy, mainly owing to "patented" thrombolytic therapy (odds ratio 1.15; p = 0.016). There was no association between CME requirements and one-year mortality. CONCLUSIONS: State-mandated CME had little association with AMI care or outcome, other than an increased use of patented thrombolytic therapy. Further research is needed to maximize the measurable effect of CME on the use of proven therapies irrespective of whether patented or generic medications are involved.

Authors
Patel, MR; Meine, TJ; Radeva, J; Curtis, L; Rao, SV; Schulman, KA; Jollis, JG
MLA Citation
Patel, MR, Meine, TJ, Radeva, J, Curtis, L, Rao, SV, Schulman, KA, and Jollis, JG. "State-mandated continuing medical education and the use of proven therapies in patients with an acute myocardial infarction." J Am Coll Cardiol 44.1 (July 7, 2004): 192-198.
PMID
15234433
Source
pubmed
Published In
JACC - Journal of the American College of Cardiology
Volume
44
Issue
1
Publish Date
2004
Start Page
192
End Page
198
DOI
10.1016/j.jacc.2004.03.070

Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT).

BACKGROUND: The Valsartan Heart Failure Trial (Val-HeFT) compared valsartan versus placebo in 5010 patients taking prescribed background therapy for New York Heart Association class II to IV heart failure. Valsartan reduced the risk of heart failure hospitalization and improved clinical signs and symptoms of heart failure. We sought to compare resource use, costs, and health outcomes among patients taking prescribed therapy for heart failure and randomly assigned to receive valsartan or placebo. METHODS: Measures of resource use were based on data collected during the trial. Unit cost estimates were collected from individual countries and converted to 1999 US dollars. Total costs were estimated for hospitalizations, inpatient and outpatient physician services, ambulance transportation, deaths outside the hospital, and outpatient cardiovascular medications. RESULTS: Mean follow-up was 23 months. Mean costs for heart failure hospitalizations were 423 dollars lower among patients receiving valsartan (95% CI, -706 to -146). Mean total costs were 9008 dollars for patients receiving valsartan and 8464 dollars for patients receiving placebo, a net incremental cost of 545 dollars (95% CI, -149 to 1148), including the cost of valsartan. There was an overall reduction in total costs of 929 dollars (95% CI, -3243 to 1533) among patients not receiving an ACE inhibitor at baseline but a slight increase in costs of 334 dollars (95% CI, -497 to 1199) among those receiving an ACE inhibitor without a beta-blocker and a 1246 dollars increase (95% CI, 54 to 2230) in patients receiving both an ACE inhibitor and a beta-blocker at baseline. CONCLUSIONS: Valsartan provided clinical benefits at a mean incremental cost of 285 dollars per year during the trial. In patients not taking ACE inhibitors, valsartan was economically attractive, increasing survival while reducing or marginally increasing overall costs.

Authors
Reed, SD; Friedman, JY; Velazquez, EJ; Gnanasakthy, A; Califf, RM; Schulman, KA
MLA Citation
Reed, SD, Friedman, JY, Velazquez, EJ, Gnanasakthy, A, Califf, RM, and Schulman, KA. "Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)." Am Heart J 148.1 (July 2004): 122-128.
PMID
15215801
Source
pubmed
Published In
American Heart Journal
Volume
148
Issue
1
Publish Date
2004
Start Page
122
End Page
128
DOI
10.1016/j.ahj.2003.12.040

Differential pricing of pharmaceuticals in the internet age.

The Internet provides healthcare consumers with more information about available prices and provides pharmaceutical manufacturers with more information about consumers' willingness to pay. The former effect tends to undermine price differences while the latter tends to support them. We believe that the former effect will dominate and that the Internet will undermine differential pricing of pharmaceuticals. This should be a concern for manufacturers and policy makers, because differential pricing of pharmaceuticals can increase access for the poor and increase incentives for innovation. We suggest strategic responses for manufacturers and policy makers.

Authors
Ridley, DB; Schulman, KA
MLA Citation
Ridley, DB, and Schulman, KA. "Differential pricing of pharmaceuticals in the internet age." J Ambul Care Manage 27.3 (July 2004): 210-214.
PMID
15287210
Source
pubmed
Published In
Journal of Ambulatory Care Management
Volume
27
Issue
3
Publish Date
2004
Start Page
210
End Page
214

Socioeconomic status and outcome following acute myocardial infarction in elderly patients.

BACKGROUND: Although the Medicare entitlement provides universal hospital care coverage for elderly Americans, disparities in care processes after acute myocardial infarction still exist. Whether these disparities account for increased mortality among elderly poor patients is not known. METHODS: To determine the association between socioeconomic status and acute myocardial infarction treatment, procedure use, and 30-day and 1-year mortality, we analyzed data from 132 130 elderly Medicare beneficiaries hospitalized for acute myocardial infarction between January 1994 and February 1996. Patients were categorized into 10 groups of increasing income using the median income of the ZIP code of residence. RESULTS: The highest-income beneficiaries received higher rates of evidence-based medical therapy and had lower adjusted 30-day and 1-year mortality rates compared with the middle-income beneficiaries (30-day relative risk, 0.89 [95% confidence interval, 0.85-0.94]; and 1-year relative risk, 0.92 [95% confidence interval, 0.88-0.97]). Conversely, the lowest-income beneficiaries received lower rates of evidence-based medical treatment and had higher adjusted 30-day and 1-year mortality rates relative to the middle-income beneficiaries (30-day relative risk, 1.09 [95% confidence interval, 1.04-1.13]; and 1-year relative risk, 1.05 [95% confidence interval, 1.00-1.10]). Coronary revascularization rates were similar among income groups. CONCLUSIONS: Despite the Medicare entitlement, there remain significant socioeconomic disparities in medical treatment and mortality among elderly patients following acute myocardial infarction. Income was independently associated with short- and long-term mortality. More research is required to determine the mechanisms contributing to adverse outcomes among poor elderly patients and to determine whether expansion of Medicare coverage will alleviate these disparities.

Authors
Rao, SV; Schulman, KA; Curtis, LH; Gersh, BJ; Jollis, JG
MLA Citation
Rao, SV, Schulman, KA, Curtis, LH, Gersh, BJ, and Jollis, JG. "Socioeconomic status and outcome following acute myocardial infarction in elderly patients." Arch Intern Med 164.10 (May 24, 2004): 1128-1133.
PMID
15159271
Source
pubmed
Published In
Archives of internal medicine
Volume
164
Issue
10
Publish Date
2004
Start Page
1128
End Page
1133
DOI
10.1001/archinte.164.10.1128

The insurance effect on prescription drug expenditures among the elderly: findings from the 1997 Medical Expenditure Panel Survey.

BACKGROUND: Despite continuing debate over a prescription drug benefit for the Medicare program, there has been relatively little research estimating the potential cost of providing such a benefit. OBJECTIVE: The objective of this study was to estimate the effect of prescription drug insurance on outpatient prescription drug expenditures among the elderly. RESEARCH DESIGN: We studied respondents aged > or =65 years to the 1997 Medical Expenditure Panel Survey, a representative survey of the U.S. noninstitutionalized population. Survey-weighted linear regression models were used to estimate the probability of any expenditures and total expenditures while controlling for sociodemographic characteristics, chronic conditions, and health status. MEASURES: We used prescription drug insurance status and outpatient prescription drug expenditures. RESULTS: An estimated 34 million elderly people filled 630 million prescriptions in 1997. Thirty-seven percent did not have prescription drug insurance. Total prescription drug expenditures exceeded $23 billion. Persons without prescription drug insurance spent slightly less than $7 billion; those with insurance spent more than $16 billion. After controlling for health status, comorbidity, and demographic characteristics, prescription drug insurance increased expenditures by $183 per person. The marginal increase in total expenditures of extending the average observed benefit to those currently uninsured is $2.3 billion (95% confidence interval, $1.2-3.5 billion). CONCLUSIONS: Proposals for a Medicare drug benefit provide high copayments to protect against insurance effects and to address uncertainty in cost estimates of the proposed benefit. By quantifying the insurance effect on expenditures among the elderly, the data reported here could reduce uncertainty in the budget estimation process.

Authors
Curtis, LH; Law, AW; Anstrom, KJ; Schulman, KA
MLA Citation
Curtis, LH, Law, AW, Anstrom, KJ, and Schulman, KA. "The insurance effect on prescription drug expenditures among the elderly: findings from the 1997 Medical Expenditure Panel Survey." Med Care 42.5 (May 2004): 439-446.
PMID
15083104
Source
pubmed
Published In
Medical Care
Volume
42
Issue
5
Publish Date
2004
Start Page
439
End Page
446

Cost-effectiveness of zoledronic acid for the prevention of skeletal complications in patients with prostate cancer.

PURPOSE: We estimated the cost-effectiveness of zoledronic acid vs placebo for decreasing skeletal complications in men with prostate cancer. MATERIALS AND METHODS: We performed a cost-effectiveness analysis alongside a multinational clinical trial of zoledronic acid. Cost estimation was based on prospectively collected resource use data for 85.3% of enrolled patients. Cost-effectiveness ratios were based on within-trial data on clinical outcomes, quality of life and study medication cost. RESULTS: Patients receiving zoledronic acid experienced fewer hospital days during a mean followup of 9 months (average 5.6 vs 8.0 days; p = 0.1910). Mean direct costs excluding study medication were US dollars 5365 for patients receiving zoledronic acid and US dollars 5689 for patients receiving placebo, a difference of US dollars 324 (95% CI US dollars 1781 to US dollars 1146). The global average cost of zoledronic acid plus its administration during the trial was US dollars 5677 (US dollars 450 per dose). The nominal cost per skeletal complication avoided was US dollars 112300 (95% CI US dollars 6900 to US dollars 48700) and the cost per additional patient free of skeletal complications was US dollars 51400 (95% CI US dollars 26900 to US dollars 243700). Nominal within-trial cost per quality adjusted life-year was US dollars 159200, which varied widely in sensitivity analyses. CONCLUSIONS: The nominal base case estimate of the cost per quality adjusted life-year for zoledronic acid in the prevention of skeletal complications of prostate cancer is consistent with that of bisphosphonates in breast cancer. However, the cost-effectiveness ratios for bisphosphonates are higher than commonly cited thresholds for conferring cost-effectiveness.

Authors
Reed, SD; Radeva, JI; Glendenning, GA; Saad, F; Schulman, KA
MLA Citation
Reed, SD, Radeva, JI, Glendenning, GA, Saad, F, and Schulman, KA. "Cost-effectiveness of zoledronic acid for the prevention of skeletal complications in patients with prostate cancer." J Urol 171.4 (April 2004): 1537-1542.
PMID
15017215
Source
pubmed
Published In
The Journal of Urology
Volume
171
Issue
4
Publish Date
2004
Start Page
1537
End Page
1542
DOI
10.1097/01.ju.0000116777.94426.60

Differences in care-seeking behavior for acute chest pain in the United States and Japan.

BACKGROUND: Delay from onset of acute myocardial infarction symptoms to the delivery of medical care is a major determinant of prognosis. Although studies have explored patient factors for delay in seeking care, there are limited data on international differences in care-seeking behavior. METHODS: We surveyed 1032 people in the United States and 1422 people in Japan in January 1997 on decision-making responses to a chest pain scenario representing acute MI. Participants were asked about how they would seek initial care and how promptly they would seek care. RESULTS: The mean age was 43.6 years in the United States and 48.3 years in Japan. For the hypothetical scenario, US respondents were more likely to seek care at an emergency department (22.9% vs 16.2% in Japan) or through emergency medical services/911 (55.9% vs 32.9% in Japan, P =.001). American subjects were also more likely to seek care immediately (83.1% vs 56.4% in Japan, P =.001). CONCLUSION: Respondents in the United States and Japan differed substantially in their responses to a hypothetical chest pain scenario. Whether these differences result from cultural or health care system factors and whether these apparent attitudes produce gaps in real responses to acute coronary syndromes must be explored in further studies.

Authors
Liao, L; Whellan, DJ; Tabuchi, K; Schulman, KA
MLA Citation
Liao, L, Whellan, DJ, Tabuchi, K, and Schulman, KA. "Differences in care-seeking behavior for acute chest pain in the United States and Japan." Am Heart J 147.4 (April 2004): 630-635.
PMID
15077077
Source
pubmed
Published In
American Heart Journal
Volume
147
Issue
4
Publish Date
2004
Start Page
630
End Page
635
DOI
10.1016/j.ahj.2003.10.006

A multinational review of recent trends and reports in dementia caregiver burden.

This systematic review of the literature focuses on the influence of ethnic, cultural, and geographic factors on the caregivers of patients with dementia. In particular, we explore the impact of cultural expectations on five important questions: 1) Do the characteristics of dementia affect caregiver burden? 2) Do characteristics of the caregiver independently predict burden? 3) Does the caregiver affect patient outcomes? 4) Does support or intervention for caregiver result in reduced caregiver burden or improved patient outcomes? 5) Finally, do patient interventions result in reduced caregiver burden or improved patient outcomes? Our findings suggest that noncognitive, behavioral disturbances of patients with dementia result in increased caregiver burden and that female caregivers bear a particularly heavy burden across cultures, particularly in Asian societies. Caregiver burden influences time to medical presentation of patients with dementia, patient condition at presentation, and patient institutionalization. Moreover, interventions designed to reduce caregiver burden have been largely, although not universally, unsuccessful. Pharmacological treatments for symptoms of dementia were found to be beneficial in reducing caregiver burden. The consistency of findings across studies, geographic regions, cultural differences, and heathcare delivery systems is striking. Yet, there are critical differences in cultural expectations and social resources. Future interventions to reduce caregiver burden must consider these differences, identify patients and caregivers at greatest risk, and develop targeted programs that combine aspects of a number of interventional strategies.

Authors
Torti, FM; Gwyther, LP; Reed, SD; Friedman, JY; Schulman, KA
MLA Citation
Torti, FM, Gwyther, LP, Reed, SD, Friedman, JY, and Schulman, KA. "A multinational review of recent trends and reports in dementia caregiver burden." Alzheimer Dis Assoc Disord 18.2 (April 2004): 99-109. (Review)
PMID
15249854
Source
pubmed
Published In
Alzheimer Disease and Associated Disorders
Volume
18
Issue
2
Publish Date
2004
Start Page
99
End Page
109

The Warfarin and Antiplatelet Therapy in Heart Failure trial (WATCH): rationale, design, and baseline patient characteristics.

BACKGROUND: The role of anticoagulation in patients with chronic heart failure has long been an area of interest and controversy. Traditionally the goal of anticoagulation has been to prevent embolic events, but recent trials also demonstrated that oral anticoagulation also prevents vascular events in patients with prior myocardial infarction, who constitute the majority of heart failure patients. Although antiplatelet agents also reduce postinfarction vascular events, few data are available in heart failure patients, and some evidence suggests that aspirin may also have the potential to worsen heart failure morbidity and mortality, possibly by interfering with the effects of angiotensin-converting enzyme inhibitors. Methods and results The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial was undertaken to determine the optimal antithrombotic agent for heart failure patients. WATCH was a prospective-randomized trial in which symptomatic heart failure patients in sinus rhythm with ejection fractions < or =35% taking angiotensin-converting enzyme inhibitors (unless not tolerated) and diuretics were randomized to open-label warfarin (target International Normalized Ratio 2.5-3.0) or double-blind antiplatelet therapy with aspirin 162 mg or clopidogrel 75 mg. Two primary comparisons were specified: anticoagulation with warfarin versus antiplatelet therapy with aspirin and antiplatelet therapy with clopidogrel versus antiplatelet therapy with aspirin. The primary outcome is the composite of death from all causes, nonfatal myocardial infarction, and nonfatal stroke analyzed as time to first event using the intent-to-treat approach. The secondary endpoint was the broader composite of death from all causes, nonfatal myocardial infarction, non-fatal stroke, and hospitalizations for worsening heart failure, unstable angina pectoris, and systemic or pulmonary artery embolic events. Additional prespecified analyses include heart failure events, coronary events, and resource utilization. CONCLUSIONS: Although the trial was designed to enter 4500 patients, it was terminated 18 months prematurely in June 2003 by the VA Cooperative Study Program because of poor enrollment with a resulting reduction of its power to achieve its original objective. This manuscript describes the study rationale, protocol design, and the baseline characteristics of the 1587 patients who were entered into the study. The WATCH trial will help define the optimal approach to antithrombotic therapy in the contemporary management of patients with chronic heart failure resulting from left ventricular systolic dysfunction.

Authors
Massie, BM; Krol, WF; Ammon, SE; Armstrong, PW; Cleland, JG; Collins, JF; Ezekowitz, M; Jafri, SM; O'Connor, CM; Packer, M; Schulman, KA; Teo, K; Warren, S
MLA Citation
Massie, BM, Krol, WF, Ammon, SE, Armstrong, PW, Cleland, JG, Collins, JF, Ezekowitz, M, Jafri, SM, O'Connor, CM, Packer, M, Schulman, KA, Teo, K, and Warren, S. "The Warfarin and Antiplatelet Therapy in Heart Failure trial (WATCH): rationale, design, and baseline patient characteristics." J Card Fail 10.2 (April 2004): 101-112.
PMID
15101020
Source
pubmed
Published In
Journal of Cardiac Failure
Volume
10
Issue
2
Publish Date
2004
Start Page
101
End Page
112

Impact of managed care on the treatment, costs, and outcomes of fee-for-service Medicare patients with acute myocardial infarction.

OBJECTIVE: To examine the effects of market-level managed care activity on the treatment, cost, and outcomes of care for Medicare fee-for-service acute myocardial infarction (AMI) patients. DATA SOURCES/STUDY SETTING: Patients from the Cooperative Cardiovascular Project (CCP), a sample of Medicare beneficiaries discharged from nonfederal acute-care hospitals with a primary discharge diagnosis of AMI from January 1994 to February 1996. STUDY DESIGN: We estimated models of patient treatment, costs, and outcomes using ordinary least squares and logistic regression. The independent variables of primary interest were market-area managed care penetration and competition. The models included controls for patient, hospital, and other market area characteristics. DATA COLLECTION/EXTRACTION METHODS: We merged the CCP data with Medicare claims and other data sources. The study sample included CCP patients aged 65 and older who were admitted during 1994 and 1995 with a confirmed AMI to a nonrural hospital. PRINCIPAL FINDINGS: Rates of revascularization and cardiac catheterization for Medicare fee-for-service patients with AMI are lower in high-HMO penetration markets than in low-penetration ones. Patients admitted in high-HMO-competition markets, in contrast, are more likely to receive cardiac catheterization for treatment of their AMI and had higher treatment costs than those admitted in low-competition markets. CONCLUSIONS: The level of managed care activity in the health care market affects the process of care for Medicare fee-for-service AMI patients. Spillovers from managed care activity to patients with other types of insurance are more likely when managed care organizations have greater market power.

Authors
Bundorf, MK; Schulman, KA; Stafford, JA; Gaskin, D; Jollis, JG; Escarce, JJ
MLA Citation
Bundorf, MK, Schulman, KA, Stafford, JA, Gaskin, D, Jollis, JG, and Escarce, JJ. "Impact of managed care on the treatment, costs, and outcomes of fee-for-service Medicare patients with acute myocardial infarction." Health Serv Res 39.1 (February 2004): 131-152.
PMID
14965081
Source
pubmed
Published In
Health Services Research
Volume
39
Issue
1
Publish Date
2004
Start Page
131
End Page
152

The effect of dementia on outcomes and process of care for Medicare beneficiaries admitted with acute myocardial infarction.

OBJECTIVES: To determine differences in mortality after admission for acute myocardial infarction (AMI) and in use of noninvasive and invasive treatments for AMI between patients with and without dementia. DESIGN: Retrospective chart review. SETTING: Cooperative Cardiovascular Project. PATIENTS: Medicare patients admitted for AMI (N=129,092) in 1994 and 1995. MEASUREMENTS: Dementia noted on medical chart as history of dementia, Alzheimer's disease, chronic confusion, or senility. Outcome measures included mortality at 30 days and 1-year postadmission; use of aspirin, beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, thrombolytic therapy, cardiac catheterization, coronary angioplasty, and cardiac bypass surgery compared by dementia status. RESULTS: Dementia was associated with higher mortality at 30 days (relative risk (RR)=1.16, 95% confidence interval (CI)=1.09-1.22) and at 1-year postadmission (RR=1.18, 95% CI=1.13-1.23). There were few to no differences in the use of aspirin and beta-blockers between patients with and without a history of dementia. Patients with a history of dementia were less likely to receive ACE inhibitors during the stay (RR=0.89, 95% CI=0.86-0.93) or at discharge (RR=0.90, 95% CI=0.86-0.95), thrombolytic therapy (RR=0.82, 95% CI=0.74-0.90), catheterization (RR=0.51, 95% CI=0.47-0.55), coronary angioplasty (RR=0.58, 95% CI=0.51-0.66), and cardiac bypass surgery (RR=0.41, 95% CI=0.33-0.50) than patients without a history of dementia. CONCLUSION: The results imply that the presence of dementia had a major effect on mortality and care patterns for this condition.

Authors
Sloan, FA; Trogdon, JG; Curtis, LH; Schulman, KA
MLA Citation
Sloan, FA, Trogdon, JG, Curtis, LH, and Schulman, KA. "The effect of dementia on outcomes and process of care for Medicare beneficiaries admitted with acute myocardial infarction." J Am Geriatr Soc 52.2 (February 2004): 173-181.
PMID
14728624
Source
pubmed
Published In
Journal of American Geriatrics Society
Volume
52
Issue
2
Publish Date
2004
Start Page
173
End Page
181

Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions.

BACKGROUND: Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes. OBJECTIVES: The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL. RESEARCH DESIGN: We conducted a prospective quality-of-life study within a randomized, controlled trial. SUBJECTS: We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs). MAIN OUTCOME MEASURES: HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories. RESULTS: For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains. CONCLUSIONS: Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

Authors
Weinfurt, KP; Castel, LD; Li, Y; Timbie, JW; Glendenning, GA; Schulman, KA
MLA Citation
Weinfurt, KP, Castel, LD, Li, Y, Timbie, JW, Glendenning, GA, and Schulman, KA. "Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions." Med Care 42.2 (February 2004): 164-175.
PMID
14734954
Source
pubmed
Published In
Medical Care
Volume
42
Issue
2
Publish Date
2004
Start Page
164
End Page
175
DOI
10.1097/01.mlr.0000108746.69256.45

Exploring options for improving healthcare.

New medical technologies generally must receive clearance or approval for marketing by the US Food and Drug Administration and be covered by an insurer, such as the Centers for Medicare and Medicaid Services, before becoming available for widespread clinical use. These 2 approval processes are discrete and usually occur sequentially rather than collaboratively and simultaneously. To explore potential mechanisms for increasing regulatory collaboration between these 2 key health care agencies, the Duke Clinical Research Institute and Health Strategies Consultancy convened an informal meeting of agency, academic, and industry leaders on December 8 and 9, 2002, titled "Registration/Approval and Coverage/Payment: Exploring Options for Improving Healthcare." This article arises from the discussion at this conference; it does not represent the official views of any person or institution involved. Although the group did not attempt to reach a consensus, it examined several important issues surrounding this regulatory debate. Herein are proposed options for enhancing regulatory efficiency through greater coordination between the FDA and CMS, and discussion of these proposals from the perspectives of members of both agencies, members of stakeholder organizations, and academic observers.

Authors
Wang, SS; Mendelson, DN; Schulman, KA; Mark, DB
MLA Citation
Wang, SS, Mendelson, DN, Schulman, KA, and Mark, DB. "Exploring options for improving healthcare." Am Heart J 147.1 (January 2004): 23-30. (Review)
PMID
14691414
Source
pubmed
Published In
American Heart Journal
Volume
147
Issue
1
Publish Date
2004
Start Page
23
End Page
30

Technologies for receiving test results in primary care practices and the impact of managed care

• Objective: To assess the availability and use of technologies that facilitate the receipt of diagnostic test results in primary care offices, physicians' perceptions of delays in receiving results, and the effect of managed care market penetration on these factors. • Design: Cross-sectional survey study. • Setting and participants: 2000 primary care physicians in 4 metropolitan areas with high managed care penetration and 4 areas with low penetration. • Measurements: A mailed survey measured the presence of technology in physician offices; methods for receiving results of laboratory tests, radiology studies, mammography, and Papanicolaou (Pap) tests; length of time to receive test results; how often physicians failed to receive results in a timely fashion; how often physicians had to repeat tests because of such failures; and how often these failures caused clinically significant delays in treatment. • Results: 41% of physicians received laboratory results electronically, and 16% received mammography and Pap test results electronically. Approximately two thirds of physicians reported that they did not receive laboratory test results and radiology studies in a timely fashion at least a little of the time. Nearly half did not receive mammography and Pap test results in a timely fashion at least a little of the time. Physicians perceived a clinically significant delay in treatment because of delays in reporting of laboratory (37%), radiology (35%), and mammography and Pap test (13%) results. Managed care penetration was not associated with receiving timely laboratory and radiology results or experiencing treatment delays. • Conclusion: Receipt of study results is problematic, regardless of the level of managed care penetration. Efforts should be directed at developing integrated systems that improve the tracking and receipt of study results at the practice level.

Authors
Harpole, LH; Oddone, EZ; Stechuchak, KM; Schulman, KA
MLA Citation
Harpole, LH, Oddone, EZ, Stechuchak, KM, and Schulman, KA. "Technologies for receiving test results in primary care practices and the impact of managed care." Journal of Clinical Outcomes Management 11.4 (2004): 216-222.
Source
scival
Published In
Journal of Clinical Outcomes Management
Volume
11
Issue
4
Publish Date
2004
Start Page
216
End Page
222

The relationship between perceived barriers to healthcare and self-rated health

The main purpose of the current investigation is to examine the extent to which health care barriers are uniquely associated with individual differences in self-rated health. Self-rated health can be easily assessed and is predictive of mortality, health care use and other health outcomes. In this sample of 586 community residents, the six healthcare barriers examined uniquely accounted for 12% of the variance in self-rated health and demographic variables uniquely accounted for an additional 11% of the variance in self-rated health. In conclusion, healthcare barriers were just as important as age, race, gender, and education when accounting for explained variance in self-rated health. Future studies should consider intervening on health care barriers to improve self appraisals of health and subsequently improve health outcomes.

Authors
Hong, TB; Oddone, EZ; Weinfurt, KP; Friedman, JY; Schulman, KA; Bosworth, HB
MLA Citation
Hong, TB, Oddone, EZ, Weinfurt, KP, Friedman, JY, Schulman, KA, and Bosworth, HB. "The relationship between perceived barriers to healthcare and self-rated health." Psychology, Health and Medicine 9.4 (2004): 476-482.
Source
scival
Published In
Psychology, Health and Medicine
Volume
9
Issue
4
Publish Date
2004
Start Page
476
End Page
482
DOI
10.1080/13548500412331298966

Commentary: Garson's "Physicians, Coverage, Quality, and Cost: The Intertwined Caduceus"

It is not sufficient to recommend that we adopt information systems, promote cost-effective care, improve processes of care through education, and implement evidence-based practice. Specific strategies must be tested, reformulated, and tested again so that policymakers will have a useful set of strategies available to them. © 2004 by the American College of Cardiology Foundation.

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Commentary: Garson's "Physicians, Coverage, Quality, and Cost: The Intertwined Caduceus"." Journal of the American College of Cardiology 43.1 (2004): 6-7.
Source
scival
Published In
Journal of the American College of Cardiology
Volume
43
Issue
1
Publish Date
2004
Start Page
6
End Page
7
DOI
10.1016/j.jacc.2003.07.038

Does the ownership of the admitting hospital make a difference? Outcomes and process of care of Medicare beneficiaries admitted with acute myocardial infarction.

BACKGROUND: Concerns have been expressed about quality of for-profit hospitals and their use of expensive technologies. OBJECTIVE: To determine differences in mortality after admission for acute myocardial infarction (AMI) and in the use of low- and high-tech services for AMI among for-profit, public, and private nonprofit hospitals. STUDY DESIGN, SETTING, AND PATIENTS: Cooperative Cardiovascular Project data for 129,092 Medicare patients admitted for AMI from 1994 to 1995. MAIN OUTCOME MEASURES: Mortality at 30 days and 1 year postadmission; use of aspirin, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers at discharge, thrombolytic therapy, catheterization, percutaneous transluminal coronary angioplasty (PTCA), and coronary artery bypass graft (CABG) compared by ownership. RESULTS: Mortality rates at 30 days and at 1 year at for-profit hospitals were no different from those at public and private nonprofit hospitals. Without patient illness variables, nonprofit hospitals had lower mortality rates at 30 days (relative risk [RR], 0.95; 95% confidence interval [CI], 0.91-0.99) and at 1 year (RR, 0.96; 95% CI, 0.93-0.99) than did for-profit hospitals, but there was no difference in mortality between public and for-profit hospitals. Beneficiaries at nonprofit hospitals were more likely to receive aspirin (RR, 1.04; 95% CI, 1.03-1.05) and ACE inhibitors (RR, 1.05; 95% CI, 1.02-1.08) than at for-profit hospitals, but had lower rates of PTCA (RR, 0.91; 95% CI, 0.86-0.96) and CABG (RR, 0.93; 95% CI, 0.86-1.00). CONCLUSIONS: Although outcomes did not vary by ownership, for-profit hospitals were more likely to use expensive, high-tech procedures. This pattern appears to be the result of for-profit hospitals' propensity to locate in areas with demand for high-tech care for AMI.

Authors
Sloan, FA; Trogdon, JG; Curtis, LH; Schulman, KA
MLA Citation
Sloan, FA, Trogdon, JG, Curtis, LH, and Schulman, KA. "Does the ownership of the admitting hospital make a difference? Outcomes and process of care of Medicare beneficiaries admitted with acute myocardial infarction." Med Care 41.10 (October 2003): 1193-1205.
PMID
14515115
Source
pubmed
Published In
Medical Care
Volume
41
Issue
10
Publish Date
2003
Start Page
1193
End Page
1205
DOI
10.1097/01.MLR.0000088569.50763.15

Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication.

PURPOSE: To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials. METHODS: Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations. RESULTS: Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001). CONCLUSION: Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

Authors
Meropol, NJ; Weinfurt, KP; Burnett, CB; Balshem, A; Benson, AB; Castel, L; Corbett, S; Diefenbach, M; Gaskin, D; Li, Y; Manne, S; Marshall, J; Rowland, JH; Slater, E; Sulmasy, DP; Van Echo, D; Washington, S; Schulman, KA
MLA Citation
Meropol, NJ, Weinfurt, KP, Burnett, CB, Balshem, A, Benson, AB, Castel, L, Corbett, S, Diefenbach, M, Gaskin, D, Li, Y, Manne, S, Marshall, J, Rowland, JH, Slater, E, Sulmasy, DP, Van Echo, D, Washington, S, and Schulman, KA. "Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication." J Clin Oncol 21.13 (July 1, 2003): 2589-2596.
PMID
12829680
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
21
Issue
13
Publish Date
2003
Start Page
2589
End Page
2596
DOI
10.1200/JCO.2003.10.072

The correlation between patient characteristics and expectations of benefit from Phase I clinical trials.

BACKGROUND: Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials. METHODS: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data. RESULTS: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy. CONCLUSIONS: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

Authors
Weinfurt, KP; Castel, LD; Li, Y; Sulmasy, DP; Balshem, AM; Benson, AB; Burnett, CB; Gaskin, DJ; Marshall, JL; Slater, EF; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Castel, LD, Li, Y, Sulmasy, DP, Balshem, AM, Benson, AB, Burnett, CB, Gaskin, DJ, Marshall, JL, Slater, EF, Schulman, KA, and Meropol, NJ. "The correlation between patient characteristics and expectations of benefit from Phase I clinical trials." Cancer 98.1 (July 1, 2003): 166-175.
PMID
12833469
Source
pubmed
Published In
Cancer
Volume
98
Issue
1
Publish Date
2003
Start Page
166
End Page
175
DOI
10.1002/cncr.11483

Economic evaluation of breast cancer treatment: considering the value of patient choice.

PURPOSE: To use 5 years of primary data to compare the incremental cost-effectiveness of breast conservation and radiation versus mastectomy with the restriction of choice to a single therapy versus providing a choice of either therapy. PATIENTS AND METHODS: We evaluated a random retrospective cohort of 2,517 Medicare beneficiaries treated for newly diagnosed stage I or II breast cancer from 1992 through 1994. The outcome measures were quality-adjusted life-years (QALYs) and 5-year medical costs. Risk and propensity score adjustments were used in the analysis. RESULTS: A breast conservation and radiation regimen has significantly higher costs than mastectomy in the first year after surgery; the adjusted 5-year costs are $14,054 (95% confidence interval, $9,791 to $18,312) greater than those of mastectomy. The adjusted incremental cost-effectiveness ratio comparing breast conservation and radiation to mastectomy was $219,594 per QALY for the comparison of the two strategies. If the possibility of patient choice from maintaining the availability of multiple treatments versus restricting choice to mastectomy alone provides a quality-of-life gain of 0.031 QALYs, then the cost-effectiveness ratio of this choice option is $80,440 per QALY. CONCLUSION: The current system of providing a choice between mastectomy and breast conservation surgery is economically attractive when the economic analysis includes the benefit of patient choice of treatment.

Authors
Polsky, D; Mandelblatt, JS; Weeks, JC; Venditti, L; Hwang, Y-T; Glick, HA; Hadley, J; Schulman, KA
MLA Citation
Polsky, D, Mandelblatt, JS, Weeks, JC, Venditti, L, Hwang, Y-T, Glick, HA, Hadley, J, and Schulman, KA. "Economic evaluation of breast cancer treatment: considering the value of patient choice." J Clin Oncol 21.6 (March 15, 2003): 1139-1146.
PMID
12637482
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
21
Issue
6
Publish Date
2003
Start Page
1139
End Page
1146
DOI
10.1200/JCO.2003.03.126

Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients.

Many drugs prolong the QT interval and increase the risk of torsade de pointes. Concurrent use of two or more of these drugs can further increase the risk, but the prevalence of concurrent prescription of QT-prolonging drugs is not known. Using the administrative claims database of a national pharmaceutical benefit manager, we conducted a retrospective cohort study in 4,825,345 subjects aged 18 years or older. After identifying 50 drugs with QT-prolonging potential, and an additional 26 drugs that inhibit the metabolic clearance of QT-prolonging drugs, we measured the frequency of overlapping prescriptions for two or more of these drugs in the outpatient setting in 1999. Nearly 1.1 million subjects (22.8%) filled 4.4 million prescriptions for QT-prolonging drugs. Of these, 103,119 subjects (9.4%) filled overlapping prescriptions for two or more of the drugs or for a QT-prolonging drug and another drug that inhibits its clearance; 7249 subjects (0.7%) filled overlapping prescriptions for three or more of these drugs. Twenty-two percent of subjects who filled overlapping prescriptions were aged 65 or older; 74% were women. Antidepressants were involved in nearly 50% of the cases. Concurrent prescription of QT-prolonging drugs is common in the outpatient setting, and antidepressants are involved in half of these cases. Large pharmaceutical claims databases are useful for detecting potentially harmful prescribing behaviors, but better clinical evidence on medication safety is needed before such a system can be implemented fully.

Authors
Curtis, LH; Østbye, T; Sendersky, V; Hutchison, S; Allen LaPointe, NM; Al-Khatib, SM; Usdin Yasuda, S; Dans, PE; Wright, A; Califf, RM; Woosley, RL; Schulman, KA
MLA Citation
Curtis, LH, Østbye, T, Sendersky, V, Hutchison, S, Allen LaPointe, NM, Al-Khatib, SM, Usdin Yasuda, S, Dans, PE, Wright, A, Califf, RM, Woosley, RL, and Schulman, KA. "Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients." Am J Med 114.2 (February 1, 2003): 135-141.
PMID
12586234
Source
pubmed
Published In
The American Journal of Medicine
Volume
114
Issue
2
Publish Date
2003
Start Page
135
End Page
141

Outcomes research in oncology: improving patients' experiences with cancer treatment.

Outcomes research in oncology is a relatively young field, but its potential for expanding our understanding of patients' experiences with cancer gives it increasing relevance to clinical oncology research. We provide a brief overview of the growing prevalence of oncology outcomes research, and we discuss some of the key areas of inquiry currently engaging outcomes researchers. In doing so, we introduce the articles in this supplemental section, which address some of the unique concerns of outcomes researchers and outline the most important challenges confronting this research community.

Authors
Schulman, KA; Seils, DM
MLA Citation
Schulman, KA, and Seils, DM. "Outcomes research in oncology: improving patients' experiences with cancer treatment." Clin Ther 25.2 (February 2003): 665-670. (Review)
PMID
12749520
Source
pubmed
Published In
Clinical Therapeutics
Volume
25
Issue
2
Publish Date
2003
Start Page
665
End Page
670

Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer.

We performed an economic analysis of data from 180 women in a clinical trial of conventional-dose chemotherapy vs high-dose chemotherapy plus stem-cell transplantation for metastatic breast cancer responding to first-line chemotherapy. Data on resource use, including hospitalizations, medical procedures, medications, and diagnostic tests, were abstracted from subjects' clinical trial records. Resources were valued using the Medicare Fee Schedule for inpatient costs at one academic medical center and average wholesale prices for medications. Monthly costs were calculated and stratified by treatment group and clinical phase. Mean follow-up was 690 days in the transplantation group and 758 days in the conventional-dose chemotherapy group. Subjects in the transplantation group were hospitalized for more days (28.6 vs 17.8, P=0.0041) and incurred higher costs (US dollars 84055 vs US dollars 28169) than subjects receiving conventional-dose chemotherapy, with a mean difference of US dollars 55886 (95% CI, US dollars 47298-US dollars 63666). Sensitivity analyses resulted in cost differences between the treatment groups from US dollars 36528 to US dollars 75531. High-dose chemotherapy plus stem-cell transplantation resulted in substantial additional morbidity and costs at no improvement in survival. Neither the survival results nor the economic findings support the use of this procedure outside of the clinical trial setting.

Authors
Schulman, KA; Stadtmauer, EA; Reed, SD; Glick, HA; Goldstein, LJ; Pines, JM; Jackman, JA; Suzuki, S; Styler, MJ; Crilley, PA; Klumpp, TR; Mangan, KF; Glick, JH
MLA Citation
Schulman, KA, Stadtmauer, EA, Reed, SD, Glick, HA, Goldstein, LJ, Pines, JM, Jackman, JA, Suzuki, S, Styler, MJ, Crilley, PA, Klumpp, TR, Mangan, KF, and Glick, JH. "Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer." Bone Marrow Transplant 31.3 (February 2003): 205-210.
PMID
12621482
Source
pubmed
Published In
Bone Marrow Transplantation
Volume
31
Issue
3
Publish Date
2003
Start Page
205
End Page
210
DOI
10.1038/sj.bmt.1703795

Direct costs of allergic rhinitis in the United States: estimates from the 1996 Medical Expenditure Panel Survey.

BACKGROUND: Previous estimates of the cost of allergic rhinitis predate the substantial increase in the use of second-generation antihistamines and intranasal corticosteroids. OBJECTIVE: We sought to update estimates of the direct costs of allergic rhinitis in the United States and to estimate prescription medication expenditures by type of insurance coverage. METHODS: Data from the 1996 Medical Expenditure Panel Survey were used in a cross-sectional analysis of resource use and costs. RESULTS: Approximately 7.7% of the population are estimated to have had allergic rhinitis in 1996. The total direct medical cost of allergic rhinitis was estimated at $3.4 billion, with the majority attributable to prescription medications (46.6%) and outpatient visits (51.9%). Fifty-one percent of the prescription medication expenditures were for second-generation antihistamines, 25% for intranasal corticosteroids, and 5% for first-generation antihistamines. Fifty-eight percent of patients with allergic rhinitis received 1 or more prescription drugs for its treatment during the study year. Among these patients, mean prescription expenditures were $131 (95% CI, $119-$143), of which $50 (95% CI, $43-$56) were paid out of pocket. The mean prescription medication expenditure was $103 (95% CI, $70-$136) for persons with Medicaid, $155 (95% CI, $140-$169) for private insurance, $213 (95% CI, $0-$521) for other insurance, and $69 (95% CI, $57-$80) for no prescription drug insurance. CONCLUSION: The direct costs of allergic rhinitis have increased substantially since the introduction of second-generation antihistamines and intranasal corticosteroids, especially costs attributable to prescription medications. Individuals with no insurance coverage have higher total out-of-pocket prescription expenditures than those with coverage.

Authors
Law, AW; Reed, SD; Sundy, JS; Schulman, KA
MLA Citation
Law, AW, Reed, SD, Sundy, JS, and Schulman, KA. "Direct costs of allergic rhinitis in the United States: estimates from the 1996 Medical Expenditure Panel Survey." J Allergy Clin Immunol 111.2 (February 2003): 296-300.
PMID
12589348
Source
pubmed
Published In
Journal of Allergy and Clinical Immunology
Volume
111
Issue
2
Publish Date
2003
Start Page
296
End Page
300

Toward estimating the impact of changes in immigrants' insurance eligibility on hospital expenditures for uncompensated care.

BACKGROUND: The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave states the option to withdraw Medicaid coverage of nonemergency care from most legal immigrants. Our goal was to assess the effect of PRWORA on hospital uncompensated care in the United States. METHODS: We collected the following state-level data for the period from 1994 through 1999: foreign-born, noncitizen population and health uninsurance rates (US Census Current Population Survey); percentage of teaching hospitals (American Hospital Association Annual Survey of Hospitals); and each state's decision whether to implement the PRWORA Medicaid bar for legal permanent residents or to continue offering nonemergency Medicaid coverage using state-only funds (Urban Institute). We modeled uncompensated care expenditures by state (also from the Annual Survey of Hospitals) in both univariate and multivariable regression analyses. RESULTS: When measured at the state level, there was no significant relationship between uncompensated care expenditures and states' percentage of noncitizen immigrants. Uninsurance rates were the only significant factor in predicting uncompensated hospital care expenditures by state. CONCLUSIONS: Reducing the number of uninsured patients would most surely reduce hospital expenditures for uncompensated care. However, data limitations hampered our efforts to obtain a monetary estimate of hospitals' financial losses due specifically to the immigrant eligibility changes in PRWORA. Quantifying the impact of these provisions on hospitals will require better data sources.

Authors
Castel, LD; Timbie, JW; Sendersky, V; Curtis, LH; Feather, KA; Schulman, KA
MLA Citation
Castel, LD, Timbie, JW, Sendersky, V, Curtis, LH, Feather, KA, and Schulman, KA. "Toward estimating the impact of changes in immigrants' insurance eligibility on hospital expenditures for uncompensated care." BMC Health Serv Res 3.1 (January 10, 2003): 1-.
PMID
12523939
Source
pubmed
Published In
BMC Health Services Research
Volume
3
Issue
1
Publish Date
2003
Start Page
1

Understanding attitudes toward clinical research.

General attitudes toward clinical research can have substantial effects on the research process. Recent studies, including the study by Apolone and Mosconi in this issue, suggest that certain attitudes toward research and evaluations of the risks and benefits of therapies may differ according to various cultural, rhetorical, and health contexts. Researchers must work to further understand societal attitudes toward research and to improve the attractiveness of clinical research for the general population.

Authors
Schulman, KA
MLA Citation
Schulman, KA. "Understanding attitudes toward clinical research." J Ambul Care Manage 26.1 (January 2003): 88-90.
PMID
12545518
Source
pubmed
Published In
Journal of Ambulatory Care Management
Volume
26
Issue
1
Publish Date
2003
Start Page
88
End Page
90

The cost of inefficiency in US hospitals, 1985-1997.

We conducted a descriptive analysis of data from the Hospital Cost Report Information System from 1985 through 1997 on nonfederal, short-stay hospitals in the United States with 12-month reporting periods and valid data for the primary outcomes. The main outcome measures were change in number of beds, inpatient days, overhead cost per bed, and overhead cost per inpatient day. Actual outcomes were compared to predicted outcomes from: (1) a scenario holding the ratio of overhead cost per volume constant throughout the study period; and (2) a scenario holding overhead expenditures for 1985 constant as volume changed. The sample contained a mean of 3,605 hospitals per year. Volume declined annually by 2.2 beds (95 percent confidence interval [CI], 2.1 to 2.2; P

Authors
Shah, BR; Reed, SD; Francis, J; Ridley, DB; Schulman, KA
MLA Citation
Shah, BR, Reed, SD, Francis, J, Ridley, DB, and Schulman, KA. "The cost of inefficiency in US hospitals, 1985-1997." Journal of health care finance 30.1 (2003): 1-9. (Academic Article)
PMID
12967239
Source
manual
Published In
Journal of health care finance
Volume
30
Issue
1
Publish Date
2003
Start Page
1
End Page
9

Comparison of hospital costing methods in an economic evaluation of a multinational clinical trial.

OBJECTIVES: To develop and evaluate strategies for estimating hospitalization costs in multinational clinical trials. METHODS: Hospital cost estimates for eleven diagnoses were collected from twelve countries participating in a trial of therapies for congestive heart failure. Estimates were combined with U.S.-based diagnosis-related group weights to compute country-specific unit cost estimates for all reasons for hospitalization. Variations of hospital costing methods were developed. The unit cost method assigns a country-specific unit cost estimate to each hospitalization. The other methods adjust for length of stay using a daily cost (DC) estimate for each diagnosis, based on either the mean length of stay (DC-mean method) or the median length of stay (DC-median method) for each diagnosis in each country. Additional modifications were explored through adjustment of the distribution of daily costs incurred during a hospital stay. RESULTS: The mean cost for all hospitalizations was dollars 10,242 (SD, 10,042) using the unit cost method, dollars 10,242 (SD, 12,760) using the standard DC-mean method, and dollars 13,967 (SD, 18,762) using the standard DC-median method. In comparisons of costs for all 5,486 hospitalizations incurred by a subset of 2,352 patients in the trial, the unit cost method provided 92% power to detect a dollars 1,000 cost difference. The standard DC-mean method provided 76% power, and the standard DC-median method provided 44% power. CONCLUSIONS: Hospital costing methods that adjust for differences in length of stay require a significantly larger sample to attain comparable statistical power as methods that assign unadjusted unit cost estimates to hospitalization events.

Authors
Reed, SD; Friedman, JY; Gnanasakthy, A; Schulman, KA
MLA Citation
Reed, SD, Friedman, JY, Gnanasakthy, A, and Schulman, KA. "Comparison of hospital costing methods in an economic evaluation of a multinational clinical trial." Int J Technol Assess Health Care 19.2 (2003): 396-406.
PMID
12862196
Source
pubmed
Published In
International Journal of Technology Assessment in Health Care
Volume
19
Issue
2
Publish Date
2003
Start Page
396
End Page
406

Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception.

The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.

Authors
Weinfurt, KP; Sulmasy, DP; Schulman, KA; Meropol, NJ
MLA Citation
Weinfurt, KP, Sulmasy, DP, Schulman, KA, and Meropol, NJ. "Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception." Theor Med Bioeth 24.4 (2003): 329-344.
PMID
14620488
Source
pubmed
Published In
Theoretical Medicine and Bioethics
Volume
24
Issue
4
Publish Date
2003
Start Page
329
End Page
344

Clinical-trial agreements between medical schools and industry [7] (multiple letters)

Authors
Novak, JW; Barnes, M; Gallin, KE; Meyer, RE; Korn, D; Schulman, KA; Seils, DM; Califf, RM
MLA Citation
Novak, JW, Barnes, M, Gallin, KE, Meyer, RE, Korn, D, Schulman, KA, Seils, DM, and Califf, RM. "Clinical-trial agreements between medical schools and industry [7] (multiple letters)." New England Journal of Medicine 348.5 (2003): 476-478.
PMID
12556555
Source
scival
Published In
New England Journal of Medicine
Volume
348
Issue
5
Publish Date
2003
Start Page
476
End Page
478
DOI
10.1056/NEJM200301303480523

Patient choice of breast cancer treatment: impact on health state preferences.

BACKGROUND: Multiple treatment options exist for many medical conditions. The extent to which physicians should involve the patient in the choice the treatment to be delivered is not well understood. OBJECTIVE: To test the impact of breast cancer treatment choice on patients' health state preferences. DESIGN AND SETTING: A cohort from 29 hospitals (primarily referral centers) in Massachusetts, Texas, Washington DC, and New York. Subjects were surveyed at 5 months, 1 year, and 2 years following surgery and asked whether they had a choice in the type of treatment received. SUBJECTS: Women age 67 or older treated in 1996 to 1997 for localized breast cancer (n = 683). MEASURES: Patient preferences for current health state, assessed with patient valuations using the visual analogue scale (VAS) from the EuroQol instrument and with general public valuations using the Health Utilities Index (HUI), and 1-year medical costs. RESULTS: For the adjusted analysis at 5 months, the adjusted mean VAS score was 78.7 for women who reported a choice and 75.3 for women who reported no choice, a difference of 3.4 (P = 0.03). The difference in the HUI score was 3.6 (P= 0.10) and the difference in the 1-year medical costs was -4363 dollars (P = 0.01). There were no statistically significant differences at the 1-year and 2-year interviews. CONCLUSIONS: A woman's perception of choice of surgical treatment for breast cancer is associated with a short-term benefit on her preference of health state, suggesting choice helps with recovery, but does not provide long-term benefits.

Authors
Polsky, D; Keating, NL; Weeks, JC; Schulman, KA
MLA Citation
Polsky, D, Keating, NL, Weeks, JC, and Schulman, KA. "Patient choice of breast cancer treatment: impact on health state preferences." Med Care 40.11 (November 2002): 1068-1079.
PMID
12409852
Source
pubmed
Published In
Medical Care
Volume
40
Issue
11
Publish Date
2002
Start Page
1068
End Page
1079
DOI
10.1097/01.MLR.0000032188.93444.20

Treatment patterns and costs associated with sessile colorectal polyps.

OBJECTIVES: Because of the paucity of existing literature on treatment and costs associated with sessile lesions, the objectives of this study were to perform a retrospective analysis on patients with sessile polyps to identify patient and polyp characteristics, to determine treatment patterns, and to estimate the cost of treating these patients. METHODS: We conducted a retrospective, observational cohort study of 280 patients who presented to a large teaching hospital between 1997 and 2000 with at least one sessile or broad-based pedunculated colorectal polyp of any size or histology, not including adenocarcinoma greater than stage T1. RESULTS: Mean polyp size was 1.3 cm, and two thirds of polyps were removed in a single procedure. The number of repeat procedures increased with polyp size (Kendall T-b = 0.47; 95% CI = 0.39-0.55). Patients with polyps > or = 2 cm were 5.88 times more likely than patients with smaller polyps to undergo a surgical procedure. Surgical procedures required 88.01 min longer than nonsurgical procedures (95% CI = 74.43-102.42). Mean total cost of treatment was $2,038 (range $153 to $14,838). Open resection ($6,165) was the most costly surgical procedure, and piecemeal polypectomy ($892) was the most costly nonsurgical therapeutic procedure. CONCLUSIONS: One third of polyps required more than one procedure. Surgical procedures accounted for the majority of resource use in this sample. Finally, patients with polyps > or = 2 cm incurred almost half the total costs while accounting for only 22% of the sample. The greatest economic gains could be made by improving efficiency of polyp removal for these patients.

Authors
Onken, JE; Friedman, JY; Subramanian, S; Weinfurt, KP; Reed, SD; Malenbaum, JH; Schmidt, T; Schulman, KA
MLA Citation
Onken, JE, Friedman, JY, Subramanian, S, Weinfurt, KP, Reed, SD, Malenbaum, JH, Schmidt, T, and Schulman, KA. "Treatment patterns and costs associated with sessile colorectal polyps." Am J Gastroenterol 97.11 (November 2002): 2896-2901.
PMID
12425565
Source
pubmed
Published In
The American Journal of Gastroenterology (Elsevier)
Volume
97
Issue
11
Publish Date
2002
Start Page
2896
End Page
2901
DOI
10.1111/j.1572-0241.2002.07058.x

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

BACKGROUND: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. METHODS: From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. RESULTS: Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. CONCLUSIONS: Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.

Authors
Schulman, KA; Seils, DM; Timbie, JW; Sugarman, J; Dame, LA; Weinfurt, KP; Mark, DB; Califf, RM
MLA Citation
Schulman, KA, Seils, DM, Timbie, JW, Sugarman, J, Dame, LA, Weinfurt, KP, Mark, DB, and Califf, RM. "A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors." N Engl J Med 347.17 (October 24, 2002): 1335-1341.
PMID
12397192
Source
pubmed
Published In
The New England journal of medicine
Volume
347
Issue
17
Publish Date
2002
Start Page
1335
End Page
1341
DOI
10.1056/NEJMsa020349

The determinants of HMOs' contracting with hospitals for bypass surgery.

OBJECTIVE: Selective contracting with health care providers is one of the mechanisms HMOs (Health Maintenance Organizations) use to lower health care costs for their enrollees. However, are HMOs compromising quality to lower costs? To address this and other questions we identify factors that influence HMOs' selective contracting for coronary artery bypass surgery (CABG). STUDY DESIGN: Using a logistic regression analysis, we estimated the effects of hospitals' quality, costliness, and geographic convenience on HMOs' decision to contract with a hospital for CABG services. We also estimated the impact of HMO characteristics and market characteristics on HMOs' contracting decision. DATA SOURCES: A 1997 survey of a nationally representative sample of 50 HMOs that could have potentially contracted with 447 hospitals. PRINCIPAL FINDINGS: About 44 percent of the HMO-hospital pairs had a contract. We found that the probability of an HMO contracting with a hospital increased as hospital quality increased and decreased as distance increased. Hospital costliness had a negative but borderline significant (0.10 < p < 0.05) effect on the probability of a contract across all types of HMOs. However, this effect was much larger for IPA (Independent Practice Association)-model HMOs than for either group/staff or network HMOs. An increase in HMO competition increased the probability of a contract while an increase in hospital competition decreased the probability of a contract. HMO penetration did not affect the probability of contracting. HMO characteristics also had significant effects on contracting decisions. CONCLUSIONS: The results suggest that HMOs value quality, geographic convenience, and costliness, and that the importance of quality and costliness vary with HMO. Greater HMO competition encourages broader hospital networks whereas greater hospital competition leads to more restrictive networks.

Authors
Gaskin, DJ; Escarce, JJ; Schulman, K; Hadley, J
MLA Citation
Gaskin, DJ, Escarce, JJ, Schulman, K, and Hadley, J. "The determinants of HMOs' contracting with hospitals for bypass surgery." Health Serv Res 37.4 (August 2002): 963-984.
PMID
12236393
Source
pubmed
Published In
Health Services Research
Volume
37
Issue
4
Publish Date
2002
Start Page
963
End Page
984

Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis.

When patients cannot provide responses to health-related quality-of-life (HRQOL) measures in clinical trials, family or friends may be asked to respond. We present a simple, comprehensive method for assessing agreement between patients with head injury and their proxy responders. In contrast to more traditional approaches, this method defines agreement separately for each patient-proxy pair, and compares HRQOL profiles along three dimensions-level, or the average of the ratings; scatter, or the variability in the ratings; and shape, or the ranks of the ratings. We demonstrate this method in the context of a clinical trial of a treatment for traumatic head injury and compare the results to those obtained using traditional analyses. Options for incorporating proxy responses into clinical trial analyses are discussed.

Authors
Weinfurt, KP; Trucco, SM; Willke, RJ; Schulman, KA
MLA Citation
Weinfurt, KP, Trucco, SM, Willke, RJ, and Schulman, KA. "Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis." J Clin Epidemiol 55.6 (June 2002): 608-618.
PMID
12063103
Source
pubmed
Published In
Journal of Clinical Epidemiology
Volume
55
Issue
6
Publish Date
2002
Start Page
608
End Page
618

Economic evaluation of filgrastim, sargramostim, and sequential sargramostim and filgrastim after myelosuppressive chemotherapy.

Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, sargramostim, and sequential sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential sargramostim and filgrastim are less costly than sargramostim alone after MC, as well as therapeutically more beneficial.

Authors
Weaver, CH; Buckner, CD; Curtis, LH; Bajwa, K; Weinfurt, KP; Wilson-Relyea, BJ; Schulman, KA
MLA Citation
Weaver, CH, Buckner, CD, Curtis, LH, Bajwa, K, Weinfurt, KP, Wilson-Relyea, BJ, and Schulman, KA. "Economic evaluation of filgrastim, sargramostim, and sequential sargramostim and filgrastim after myelosuppressive chemotherapy." Bone Marrow Transplant 29.2 (January 2002): 159-164.
PMID
11850711
Source
pubmed
Published In
Bone Marrow Transplantation
Volume
29
Issue
2
Publish Date
2002
Start Page
159
End Page
164
DOI
10.1038/sj.bmt.1703341

A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease.

Our goal was to calculate resource use associated with administration of zoledronic acid, compared with pamidronate, as palliative care for patients with metastatic bone lesions. We conducted a time-and-motion study of therapy administration at each of three outpatient chemotherapy infusion sites participating in clinical trials of zoledronic acid and pamidronate. We developed a data-collection instrument to record all staff effort and patient resource use in drug administration. The main outcome measures were (a) direct costs of therapy administration per patient and (b) opportunity benefits expressed as the availability of resources gained per year. The average visit time for patients receiving the study dose of zoledronic acid, 4 mg, was 1 h, 6 min, compared to 2 h, 52 min for patients receiving a 90-mg dose of pamidronate. Infusion time accounted for much of the difference. In the base-case analysis, total direct costs per patient were $728 for zoledronic acid and $776 for pamidronate. The opportunity benefit for infusion of zoledronic acid vs pamidronate in the base case was 1.8 chairs per day, or 426 chairs per 240-workday year. Results were sensitive to changes in infusion facility size, days of operation, and average number of patients treated. Shorter infusion time associated with the administration of zoledronic acid, compared with pamidronate, yields substantial time savings for patients, as well as opportunity benefits for outpatient oncology facilities.

Authors
DesHarnais Castel, L; Bajwa, K; Markle, JP; Timbie, JW; Zacker, C; Schulman, KA
MLA Citation
DesHarnais Castel, L, Bajwa, K, Markle, JP, Timbie, JW, Zacker, C, and Schulman, KA. "A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease." Support Care Cancer 9.7 (October 2001): 545-551.
PMID
11680835
Source
pubmed
Published In
Supportive Care in Cancer
Volume
9
Issue
7
Publish Date
2001
Start Page
545
End Page
551

The role of reperfusion therapy in paced patients with acute myocardial infarction.

BACKGROUND/OBJECTIVE: Our purpose was to evaluate the effectiveness of reperfusion therapy among elderly paced patients with acute myocardial infarction (MI). Current guidelines make no recommendation for the use of reperfusion therapy among patients who have a paced rhythm during MI. METHODS: We evaluated 1954 Medicare beneficiaries 65 years and older treated for acute MI between 1994 and 1996 who had a paced rhythm for use of reperfusion therapy. Use of reperfusion therapy was evaluated for associations with outcomes by logistic regression and Cox proportional hazards models incorporating propensity score analysis. RESULTS: Reperfusion therapy was used in 171 (8.8%) patients; 70 were treated with primary PTCA and 101 with thrombolytic therapy. Patients who received reperfusion therapy had 30-day mortality rates similar to those who did not receive reperfusion (26.3% vs 25.7%, P =.87). Multivariate adjustment for mortality risk factors and treatment propensity indicated no survival benefit associated with reperfusion therapy at 30 days (relative risk [RR] 1.07, 95% confidence interval [CI] 0.77-1.43) or long-term follow-up (hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks varied by type of reperfusion therapy. Patients treated with primary percutaneous transluminal coronary angioplasty were at comparable risk of mortality at 30 days (RR 0.73, 95% CI 0.40-1.23) but at lower risk at long-term follow-up (HR 0.60, 95% CI 0.40-0.88). Mortality risks were unchanged among patients treated with thrombolytics at 30 days (RR 1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08, 95% CI 0.82-1.43). CONCLUSION: We find suggestive evidence that primary percutaneous transluminal coronary angioplasty provides a long-term survival benefit in the treatment of elderly patients with acute MI who have a paced rhythm.

Authors
Rathore, SS; Gersh, BJ; Weinfurt, KP; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Gersh, BJ, Weinfurt, KP, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "The role of reperfusion therapy in paced patients with acute myocardial infarction." Am Heart J 142.3 (September 2001): 516-519.
PMID
11526367
Source
pubmed
Published In
American Heart Journal
Volume
142
Issue
3
Publish Date
2001
Start Page
516
End Page
519
DOI
10.1067/mhj.2001.117602

A claims data approach to defining an episode of care.

OBJECTIVE: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine. DATA SOURCES: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992. STUDY DESIGN: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques. DATA COLLECTION METHODS: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization. PRINCIPAL FINDINGS: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks. CONCLUSIONS: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

Authors
Schulman, KA; Yabroff, KR; Kong, J; Gold, KF; Rubenstein, LE; Epstein, AJ; Glick, H
MLA Citation
Schulman, KA, Yabroff, KR, Kong, J, Gold, KF, Rubenstein, LE, Epstein, AJ, and Glick, H. "A claims data approach to defining an episode of care." Pharmacoepidemiol Drug Saf 10.5 (August 2001): 417-427.
PMID
11802588
Source
pubmed
Published In
Pharmacoepidemiology and Drug Safety
Volume
10
Issue
5
Publish Date
2001
Start Page
417
End Page
427
DOI
10.1002/pds.673

Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, sargramostim, or sequential sargramostim and filgrastim.

Myelosuppressive chemotherapy is frequently used for mobilization of autologous CD34(+) progenitor cells into the peripheral blood for subsequent collection and support of high-dose chemotherapy. The administration of myelosuppressive chemotherapy is typically followed by a myeloid growth factor and is associated with variable CD34 cell yields and morbidity. The two most commonly used myeloid growth factors for facilitation of CD34 cell harvests are granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF). We performed a randomized phase III clinical trial comparing G-CSF, GM-CSF, and sequential administration of GM-CSF and G-CSF following administration of myelosuppressive chemotherapy. We evaluated CD34 yields, morbidity, and cost-effectiveness of the three cytokine schedules. One hundred and fifty-six patients with multiple myeloma, breast cancer, or lymphoma received cyclophosphamide with either paclitaxel or etoposide and were randomized to receive G-CSF 6 microg/kg/day s.c., GM-CSF 250 microg/m(2)/day s.c., or GM-CSF for 6 days followed by G-CSF until completion of the stem cell harvest. Compared with patients who received GM-CSF, patients who received G-CSF had faster recovery of absolute neutrophil count to 0.5 x 10(9) per liter (median of 11 vs14 days, P = 0.0001) with fewer patients requiring red blood cell transfusions (P= 0.008); fewer patients with fever (18% vs 52%, P = 0.001); fewer hospital admissions (20% vs 42%, P = 0.13); and less intravenous antibiotic therapy (24% vs 59%, P = 0.001). Patients who received G-CSF also yielded more CD34 cells (median 7.1 vs 2.0 x 10(6) kg per apheresis, P = 0.0001) and a higher percentage achieved 2.5 x 10(6) CD34 cells per kilogram (94% vs 78%, P = 0.21) and 5 x 10(6) CD34 cells per kilogram (88% vs 53%, P = 0.01) or more CD34 cells per kilogram with fewer aphereses (median 2 vs 3, P = 0.002) and fewer days of growth factor treatment (median 12 vs 14, P = 0.0001). There were no significant differences in outcomes between groups receiving G-CSF alone and the sequential regimen. After high-dose chemotherapy, patients who had peripheral blood stem cells mobilized with G-CSF or the sequential regimen received higher numbers of CD34 cells and had faster platelet recovery with fewer patients requiring platelet transfusions than patients receiving peripheral blood stem cells mobilized by GM-CSF. In summary, G-CSF alone is superior to GM-CSF alone for the mobilization of CD34(+) cells and reduction of toxicities following myelosuppressive chemotherapy. An economic analysis evaluating the cost-effectiveness of these three effective schedules is ongoing at the time of this writing.

Authors
Weaver, CH; Schulman, KA; Buckner, CD
MLA Citation
Weaver, CH, Schulman, KA, and Buckner, CD. "Mobilization of peripheral blood stem cells following myelosuppressive chemotherapy: a randomized comparison of filgrastim, sargramostim, or sequential sargramostim and filgrastim." Bone Marrow Transplant 27 Suppl 2 (May 2001): S23-S29.
PMID
11436117
Source
pubmed
Published In
Bone Marrow Transplantation
Volume
27 Suppl 2
Publish Date
2001
Start Page
S23
End Page
S29
DOI
10.1038/sj.bmt.1702865

An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation.

BACKGROUND: Immunosuppressive therapy with cyclosporin A has substantially improved clinical outcomes for renal transplantation. Whether basiliximab (a chimeric monoclonal antibody) demonstrates economic and quality-of-life advantages over other induction therapies has not yet been shown. METHODS: A multi-centre open-label clinical trial was conducted among renal transplant recipients in the US, in which patients were randomized into two induction therapy regimens: basiliximab and antithymocyte globulin (ATG) as part of a quadruple immunosuppressive regimen. Medical resources used and a EuroQol visual analogue scale (VAS) rating of quality of life were collected prospectively for the 135 dosed subjects for a period of 1 year post-treatment. We analysed the differences between treatment groups in 1-year costs and 1-year quality-adjusted survival. We also conducted a post hoc analysis of outcomes among the subgroup of patients identified as high risk. RESULTS: A significant difference was observed in first-year post-treatment costs (basiliximab, $45857; ATG, $54729; difference, $8872 (95% CI, $1169 to $16573). The savings from basiliximab can be attributed to the less expensive induction therapy (basiliximab, $2378; ATG, $8670; difference, $6292 (95% CI, $5165 to $7419)) and other savings during the initial hospitalization totalling $2609. One-year quality-adjusted survival was the same in both groups (basiliximab, 81.5; ATG, 81.1; difference, 0.45 (95% CI, -5.9 to 6.8)). The results of the post hoc analysis of the 48 high-risk patients were comparable to the analysis of all patients. CONCLUSIONS: These results demonstrate lower first-year post-treatment costs in renal-transplant recipients receiving basiliximab compared to ATG with no differences in quality-adjusted survival. The results also suggest similar differences among high-risk subjects.

Authors
Polsky, D; Weinfurt, KP; Kaplan, B; Kim, J; Fastenau, J; Schulman, KA
MLA Citation
Polsky, D, Weinfurt, KP, Kaplan, B, Kim, J, Fastenau, J, and Schulman, KA. "An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation." Nephrol Dial Transplant 16.5 (May 2001): 1028-1033.
PMID
11328911
Source
pubmed
Published In
Nephrology Dialysis Transplantation
Volume
16
Issue
5
Publish Date
2001
Start Page
1028
End Page
1033

Treatment of patients with myocardial infarction who present with a paced rhythm.

BACKGROUND: A paced rhythm can mask the electrocardiographic features of an acute myocardial infarction, complicating timely recognition and treatment. OBJECTIVE: To evaluate characteristics, treatment, and outcomes among patients presenting with paced rhythms during myocardial infarction. DESIGN: Retrospective cohort study. SETTING: U.S. acute care hospitals. PATIENTS: 102 249 Medicare beneficiaries at least 65 years of age who were treated for acute myocardial infarction between 1994 and 1996. MEASUREMENTS: Provision of three treatments for acute myocardial infarction (emergent reperfusion, aspirin, and beta-blockers), death at 30 days, and long-term follow-up. RESULTS: 1954 patients (1.9%) presented with paced rhythms during myocardial infarction. These patients were older; were predominantly male; and had higher rates of congestive heart failure, diabetes, and previous infarction. They were significantly less likely to receive emergent reperfusion (relative risk [RR], 0.27 [95% CI, 0.22 to 0.33]), aspirin (RR at admission, 0.91 [CI, 0.88 to 0.94]; RR at discharge, 0.87 [CI, 0.83 to 0.92]), and beta-blockers at admission (RR, 0.89 [CI, 0.82 to 0.96]). In addition, there was a trend toward decreased use of beta-blockers at discharge (RR, 0.91 [CI, 0.76 to 1.06]). Crude mortality rates were higher among patients with paced rhythms than among those without at 30 days (25.8% vs. 21.3%; P = 0.001) and at 1 year (47.1% vs. 36.1%; P = 0.001). Among patients with paced rhythms, risk for death at 30 days decreased after adjustment for illness severity and decreased use of therapy (RR, 1.03 [CI, 0.93 to 1.14]). Patients with paced rhythms remained at additional risk for long-term mortality (hazard ratio, 1.12 [CI, 1.06 to 1.18]). CONCLUSIONS: Patients with paced rhythms were less likely than those without to receive treatment for acute myocardial infarction and had poorer short- and long-term outcomes. However, this mortality risk diminished after adjustment for treatment. This suggests that improved recognition and treatment of myocardial infarction may improve outcomes, particularly in the short term.

Authors
Rathore, SS; Weinfurt, KP; Gersh, BJ; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Weinfurt, KP, Gersh, BJ, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "Treatment of patients with myocardial infarction who present with a paced rhythm." Ann Intern Med 134.8 (April 17, 2001): 644-651.
PMID
11304104
Source
pubmed
Published In
Annals of internal medicine
Volume
134
Issue
8
Publish Date
2001
Start Page
644
End Page
651

Effect of diabetes mellitus and insulin use on survival after acute myocardial infarction in the elderly (the Cooperative Cardiovascular Project).

Using data from a retrospective cohort study of Medicare beneficiaries hospitalized with an acute myocardial infarction (AMI), we evaluated the role of diabetes mellitus on 30-day and 1-year mortality. We classified subjects as nondiabetics, diabetics controlled with diet alone, diabetics receiving an oral hypoglycemic agent, and diabetics on insulin at time of admission. We compared baseline admission characteristics of subgroups using chi-square and Wilcoxon rank-sum tests and evaluated the effect of each diabetic state using sequential logistic models. We identified 80,832 nondiabetic patients, 9,862 diet-controlled diabetic patients, 14,664 diabetics receiving an oral hypoglycemic agent, and 12,241 diabetic patients on insulin therapy. Although mean age was similar among the groups, prevalence of hypertension, prior AMI, prior congestive heart failure, and prior revascularization were higher among diabetic patients, particularly those taking insulin. Diabetic patients, particularly those taking insulin, were less likely to receive aspirin and beta blockers and to undergo coronary revascularization. Diabetic patients had higher 30-day and 1-year mortality than nondiabetic patients. After adjustment for demographics, clinical and hospital characteristics, and treatment strategies, insulin-treated diabetics had the highest risk of mortality, followed by diabetics receiving oral hypoglycemic agents, followed by diet-controlled diabetics. Thus, diabetes is highly prevalent among elderly patients with an AMI. Mortality rates for these patients, particularly insulin-using diabetics, are higher than among their nondiabetic counterparts. Preventive and therapeutic strategies must be developed to ensure improved short- and long-term outcomes for elderly patients with diabetes and AMI.

Authors
Berger, AK; Breall, JA; Gersh, BJ; Johnson, AE; Oetgen, WJ; Marciniak, TA; Schulman, KA
MLA Citation
Berger, AK, Breall, JA, Gersh, BJ, Johnson, AE, Oetgen, WJ, Marciniak, TA, and Schulman, KA. "Effect of diabetes mellitus and insulin use on survival after acute myocardial infarction in the elderly (the Cooperative Cardiovascular Project)." Am J Cardiol 87.3 (February 1, 2001): 272-277.
PMID
11165959
Source
pubmed
Published In
The American Journal of Cardiology
Volume
87
Issue
3
Publish Date
2001
Start Page
272
End Page
277

A comparison of scoring weights for the EuroQol derived from patients and the general public.

OBJECTIVE: General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public. METHODS: The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public. RESULTS: The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%. CONCLUSIONS: The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of variation in health valuations. Scoring weights based on patient responses are significantly higher than those derived from the general public. Further research is required to understand the source of these differences.

Authors
Polsky, D; Willke, RJ; Scott, K; Schulman, KA; Glick, HA
MLA Citation
Polsky, D, Willke, RJ, Scott, K, Schulman, KA, and Glick, HA. "A comparison of scoring weights for the EuroQol derived from patients and the general public." Health Econ 10.1 (January 2001): 27-37.
PMID
11180567
Source
pubmed
Published In
Health Economics
Volume
10
Issue
1
Publish Date
2001
Start Page
27
End Page
37

Acute myocardial infarction complicated by heart block in the elderly: prevalence and outcomes.

BACKGROUND: Although second- and third-degree heart block (HB) are common conduction disorders associated with acute myocardial infarction (MI), patient characteristics and HBs association with outcomes, particularly among the elderly, remain poorly defined. METHODS: We evaluated 106,780 Medicare beneficiaries aged 65 years and older treated for acute MI between January 1994 and February 1996 for development of HB. HB and non-HB patients were compared by univariate analysis, and the influence of HB on outcomes was evaluated by unadjusted and multiple logistic regression. RESULTS: HB was documented in 5048 (4.7%) patients; 1646 presented with HB and 3402 developed HB during hospitalization. HB was more common among patients with inferior infarctions than anterior infarctions (7.3% vs 3.0%, P =.001), particularly the cohort of patients with inferior MI treated with reperfusion therapy (8.3%). HB patients had higher rates of in-hospital mortality (29.6% vs. 17.5% vs. non-HB patients, P =.001). After adjustment for demographic and clinical factors, HB remained an independent predictor of in-hospital mortality (relative risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48), but HB had no prognostic significance at 1 year among hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality risks varied on the basis of MI location. Both anterior MI (RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI 1.39-1.66) patients with HB had increased risks of in-hospital mortality. There was a trend toward increased mortality among patients with anterior MI (RR 1.15, 95% CI 0.99-1.32) at 1 year, whereas those with inferior MI were at lower risk (RR 0.83, 95% CI 0.75-0.98). CONCLUSIONS: HB is a common complication of acute MI in elderly patients, particularly among patients with inferior MIs who received reperfusion therapy. HB is independently associated with short-term but not long-term mortality.

Authors
Rathore, SS; Gersh, BJ; Berger, PB; Weinfurt, KP; Oetgen, WJ; Schulman, KA; Solomon, AJ
MLA Citation
Rathore, SS, Gersh, BJ, Berger, PB, Weinfurt, KP, Oetgen, WJ, Schulman, KA, and Solomon, AJ. "Acute myocardial infarction complicated by heart block in the elderly: prevalence and outcomes." Am Heart J 141.1 (January 2001): 47-54.
PMID
11136486
Source
pubmed
Published In
American Heart Journal
Volume
141
Issue
1
Publish Date
2001
Start Page
47
End Page
54
DOI
10.1067/mhj.2001.111259

Sex differences in the referral process for invasive cardiac procedures.

Nearly twice as many women in the United States die of heart disease and stroke every year as die from all types of cancer. Several studies have shown that women are less likely than men to be referred for invasive cardiac procedures. Despite extensive literature documenting sex differences in invasive cardiac procedure use, few studies have investigated the ways in which sex may affect the patient and physician decision-making process in referrals for cardiac care. This paper presents a framework outlining 8 stages of the referral process and discusses the role sex plays in each one. This framework was adapted from one describing the influence of race on the referral process for invasive cardiac procedures. A representative sample of the literature is reviewed to describe the influence of sex at each stage.

Authors
Seils, DM; Friedman, JY; Schulman, KA
MLA Citation
Seils, DM, Friedman, JY, and Schulman, KA. "Sex differences in the referral process for invasive cardiac procedures." J Am Med Womens Assoc (1972) 56.4 (2001): 151-160.
PMID
11759782
Source
pubmed
Published In
Journal- American Medical Womens Association
Volume
56
Issue
4
Publish Date
2001
Start Page
151
End Page
160

Zoledronic acid versus pamidronate as palliative therapy in cancer patients: A Canadian time and motion analysis

Pamidronate was an important advance in the palliative treatment of patients with cancer. However, pamidronate must be infused over at least 2 hours in most patients. Zoledronic acid represents the next-generation bisphosphonate with a potential for improved efficacy in the palliative care setting. One important advantage of zoledronic acid is that it can be administered over a 15-minute infusion. To measure the overall efficiency of zoledronic acid as compared with pamidronate in the outpatient setting, a USA microcosting model was adapted to Canadian inputs. Time and motion data were collected from six patients being treated with zoledronic acid or pamidronate in three USA outpatient cancer clinics. Resource use and time impact on outpatient clinical staff were reanalyzed using Canadian cost estimates. This included the evaluation of fixed, variable, and labour costs obtained from Canadian sources. The manufacturer provided drug costs. The base case analysis assumed a 5300-ft2 outpatient chemotherapy clinic with eight infusion chairs designated for bisphosphonate administration in the province of Ontario. Mean treatment times in the original USA data collected were 2 hours, 52 minutes for pamidronate, and 1 hour, 6 minutes for zoledronic acid (a difference of 1 hour, 46 minutes). In the Canadian version of the microcosting model, the overall treatment cost was Can$673 for pamidronate and Can$682 for zoledronic acid (2001 Canadian dollars). Findings suggest that the shorter zoledronic acid infusion time would allow an additional 27 bisphosphonate patients to be treated per day. Alternatively, approximately one additional hour of chair time could be made available with each zoledonic acid infusion. Sensitivity analyses revealed that (a) the base case results were consistent when geographic region was varied, and (b) the shorter the infusion time for zoledronic acid relative to pamidronate, the lesser the cost difference and more patients could be treated daily. In conclusion, zoledronic acid may enhance the overall efficiency of outpatient chemotherapy clinics by reducing patient waiting time for bisphosphonate administration. These benefits would be obtained at an incremental cost of Can$9 per infusion.

Authors
Dranitsaris, G; Castel, LD; Baladi, JF; Schulman, KA
MLA Citation
Dranitsaris, G, Castel, LD, Baladi, JF, and Schulman, KA. "Zoledronic acid versus pamidronate as palliative therapy in cancer patients: A Canadian time and motion analysis." Journal of Oncology Pharmacy Practice 7.1 (2001): 27-33.
Source
scival
Published In
Journal of Oncology Pharmacy Practice
Volume
7
Issue
1
Publish Date
2001
Start Page
27
End Page
33
DOI
10.1191/1078155201jp077oa

Theory versus practice: A review of 'willingness-to-pay' in health and health care

This paper is based upon an extensive review of 71 willingness-to-pay (WTP) surveys of health and health care published in English during the period 1985-1998. The aim of the paper is to outline the arguments advanced for the superiority of WTP over quality-adjusted-life-years (QALYs) as a measure of benefit of health care programmes, and to review how empirical WTP studies adhere to their implications. An important argument is that WTP enables a more comprehensive valuation of benefits than QALYs. Our main focus is therefore to provide a careful review of the scenario descriptions used in the surveys, according to which types of benefits are being valued, and how comprehensively the descriptions are presented. Furthermore, the 'cost-benefit argument', that WTP can assist in improving social efficiency, is discussed before we inquire into the extent to which the studies actually compare WTP with social costs. Copyright © 2001 John Wiley & Sons, Ltd.

Authors
Polsky, D; Willke, RJ; Scott, K; Schulman, KA; Glick, HA
MLA Citation
Polsky, D, Willke, RJ, Scott, K, Schulman, KA, and Glick, HA. "Theory versus practice: A review of 'willingness-to-pay' in health and health care." Health Economics 10.1 (2001): 39-52.
PMID
11180568
Source
scival
Published In
Health Economics
Volume
10
Issue
1
Publish Date
2001
Start Page
39
End Page
52
DOI
10.1002/1099-1050(200101)10:1<39::AID-HEC563>3.0.CO;2-E

A framework for research and evaluation into the effects of managed care on the pharmaceutical marketplace: Excerpts from the final report

Authors
Allen, JR; Anthony, CJ; Bosco, LA; Burke, LB; Byrns, PJ; Casnoff, CA; Clark, D; Fishburn, B; Fulda, TR; Gagnon, J-P; Golodner, LF; Gondek, K; Grabowski, H; Grezlak, CR; Gross, DJ; Katz, E; Lawrence, E; Lipton, HL; Maine, LL; Matsumoto, J; McKercher, PL; Miller, M; Morris, L; Novitch, M; Palumbo, FB; Penna, PM; Persinger, GS; Pollard, M; Rucker, TD; Schur, C; Schweitzer, SO; Schulke, DG; Schulman, KA; Seidman, RC; Shulman, SA; Sleath, BL; Whitehouse, J; Wilford, BB; Williams, K; Woosley, RL
MLA Citation
Allen, JR, Anthony, CJ, Bosco, LA, Burke, LB, Byrns, PJ, Casnoff, CA, Clark, D, Fishburn, B, Fulda, TR, Gagnon, J-P, Golodner, LF, Gondek, K, Grabowski, H, Grezlak, CR, Gross, DJ, Katz, E, Lawrence, E, Lipton, HL, Maine, LL, Matsumoto, J, McKercher, PL, Miller, M, Morris, L, Novitch, M, Palumbo, FB, Penna, PM, Persinger, GS, Pollard, M, Rucker, TD, Schur, C, Schweitzer, SO, Schulke, DG, Schulman, KA, Seidman, RC, Shulman, SA, Sleath, BL, Whitehouse, J, Wilford, BB, Williams, K, and Woosley, RL. "A framework for research and evaluation into the effects of managed care on the pharmaceutical marketplace: Excerpts from the final report." Journal of Research in Pharmaceutical Economics 10.4 (2001): 235-263.
Source
scival
Published In
Journal of Research in Pharmaceutical Economics
Volume
10
Issue
4
Publish Date
2001
Start Page
235
End Page
263

Time to presentation with acute myocardial infarction in the elderly: associations with race, sex, and socioeconomic characteristics.

BACKGROUND: Although prompt treatment is a cornerstone of the management of acute myocardial infarction (AMI), prior studies have shown that one fourth of AMI patients arrive at the hospital >6 hours after symptom onset. It would be valuable to identify individuals at highest risk for late arrival, but predisposing factors have yet to be fully characterized. METHODS AND RESULTS: Data from the Cooperative Cardiovascular Project, involving Medicare beneficiaries aged >65 years hospitalized between January 1994 and February 1996 with confirmed AMI, were used to identify patients who presented "late" (>/=6 hours after symptom onset). Patient characteristics were tested for associations with late presentation by use of backward stepwise logistic regression. Among 102 339 subjects, 29.4% arrived late. Significant predictors of late arrival (odds ratio, 95% CI) included diabetes (1.11, 1.07 to 1.14) and a history of angina (1.32, 1.28 to 1.35), whereas prior MI (0.82, 0.79 to 0.85), prior angioplasty (0.80, 0.75 to 0.85), prior bypass surgery (0.93, 0.89 to 0.98), and cardiac arrest (0.52, 0.46 to 0. 58) predicted early presentation. Additionally, initial evaluation at an outpatient clinic (2.63, 2.51 to 2.75) and daytime presentation (1.67, 1.59 to 1.72) predicted late arrival. Finally, female sex, black race, and poverty, which were evaluated with an 8-level race-sex-socioeconomic status interaction term, were also risk factors for delay. CONCLUSIONS: Delayed hospital presentation is a common problem among Medicare beneficiaries with AMI. Factors associated with delay include not only clinical and logistical issues but also race, sex, and socioeconomic characteristics. Education efforts designed to hasten AMI treatment should be directed at individuals with risk factors for late arrival.

Authors
Sheifer, SE; Rathore, SS; Gersh, BJ; Weinfurt, KP; Oetgen, WJ; Breall, JA; Schulman, KA
MLA Citation
Sheifer, SE, Rathore, SS, Gersh, BJ, Weinfurt, KP, Oetgen, WJ, Breall, JA, and Schulman, KA. "Time to presentation with acute myocardial infarction in the elderly: associations with race, sex, and socioeconomic characteristics." Circulation 102.14 (October 3, 2000): 1651-1656.
PMID
11015343
Source
pubmed
Published In
Circulation
Volume
102
Issue
14
Publish Date
2000
Start Page
1651
End Page
1656

The Development of Standard Economic Datasets for Use in the Economic Evaluation of Medicines

Authors
Backhouse, ME; Gnanasakthy, A; Schulman, KA; Akehurst, R; Glick, H
MLA Citation
Backhouse, ME, Gnanasakthy, A, Schulman, KA, Akehurst, R, and Glick, H. "The Development of Standard Economic Datasets for Use in the Economic Evaluation of Medicines." Therapeutic Innovation & Regulatory Science 34.4 (October 1, 2000): 1273-1291.
Source
crossref
Published In
Therapeutic Innovation and Regulatory Science
Volume
34
Issue
4
Publish Date
2000
Start Page
1273
End Page
1291
DOI
10.1177/009286150003400435

The Role of the Food and Drug Administration in Pharmacoeconomic Evaluation during the Drug Development Process

Authors
Kim, J; Morris, CB; Schulman, KA
MLA Citation
Kim, J, Morris, CB, and Schulman, KA. "The Role of the Food and Drug Administration in Pharmacoeconomic Evaluation during the Drug Development Process." Therapeutic Innovation & Regulatory Science 34.4 (October 1, 2000): 1207-1213.
Source
crossref
Published In
Therapeutic Innovation and Regulatory Science
Volume
34
Issue
4
Publish Date
2000
Start Page
1207
End Page
1213
DOI
10.1177/009286150003400428

Mobilization, collection, and processing of autologous peripheral blood stem cells: development of a clinical process with associated costs.

We surveyed five academic medical centers to develop a clinical process for patients undergoing cytokine mobilization and leukapheresis prior to autologous peripheral blood stem cell transplantation. Costs were obtained from three centers and applied to each component of the pathway. Costs were divided into three categories: (1) pre-apheresis evaluation; (2) process of apheresis; (3) post-apheresis and peripheral blood stem cells processing. All centers participated in the development of the leukapheresis pathway. Because charges vary greatly among institutions, costs were determined from three of the institutions and a mean was calculated for each of the components of the process. Pre-apheresis costs consisted of central line placement, blood work, and the price of cytokine (rhG-CSF). Costs associated with apheresis included professional fees (for physicians and nurses), leukapheresis with stem cell cryopreservation, storage, sterility testing, analysis of circulating CD34+ cell counts, and 1 day of cytokine therapy. The post-apheresis process included thawing with sterility testing along with CD34+ cell number analysis and the performance of clonogenic assays. Total costs were as follows: (1) pre-apheresis, $2711; (2) apheresis, $2990; and, (3) post-apheresis/stem cell processing, $754. This survey from five academic medical centers provides the average costs associated with three main components of the apheresis procedure. Because many patients require multiple aphereses, interventions to achieve target CD34+ cell collections in as few collections as possible would result in significant cost reduction.

Authors
Meehan, KR; Areman, EM; Ericson, SG; Matias, C; Seifeldin, R; Schulman, K
MLA Citation
Meehan, KR, Areman, EM, Ericson, SG, Matias, C, Seifeldin, R, and Schulman, K. "Mobilization, collection, and processing of autologous peripheral blood stem cells: development of a clinical process with associated costs." J Hematother Stem Cell Res 9.5 (October 2000): 767-771.
PMID
11091501
Source
pubmed
Published In
Journal of hematotherapy & stem cell research
Volume
9
Issue
5
Publish Date
2000
Start Page
767
End Page
771
DOI
10.1089/15258160050196812

Race, sex, poverty, and the medical treatment of acute myocardial infarction in the elderly.

BACKGROUND: Race, sex, and poverty are associated with the use of diagnostic cardiac catheterization and coronary revascularization during treatment of acute myocardial infarction (AMI). However, the association of sociodemographic characteristics with the use of less costly, more readily available medical therapies remains poorly characterized. METHODS AND RESULTS: We evaluated 169 079 Medicare beneficiaries >/=65 years of age treated for AMI between January 1994 and February 1996 to determine the association of patient race, sex, and poverty with the use of medical therapy. Multivariable regression models were constructed to evaluate the unadjusted and adjusted influence of sociodemographic characteristics on the use of 2 admission (aspirin, reperfusion) and 2 discharge therapies (aspirin, beta-blockers) indicated during the treatment of AMI. Therapy use varied by patient race, sex, and poverty status. Black patients were less likely to undergo reperfusion (RR 0.84, 95% CI 0. 78, 0.91) or receive aspirin on admission (RR 0.97, 95% CI 0.96, 0. 99) and beta-blockers (RR 0.94, 95% CI 0.88, 1.00) at discharge. Female patients were less likely to receive aspirin on admission (RR 0.98, 95% CI 0.97, 0.99) and discharge (RR 0.98, 95% CI 0.96, 0.99). Poor patients were less likely to receive aspirin (RR 0.97, 95% CI 0. 96, 0.98) or reperfusion (RR 0.97, 95% CI 0.93, 1.00) on admission and aspirin (RR 0.98, 95% CI 0.96, 1.00), or beta-blockers (RR 0.95, 95% CI 0.91, 0.99) on discharge. CONCLUSIONS: Medical therapies are currently underused in the treatment of black, female, and poor patients with AMI.

Authors
Rathore, SS; Berger, AK; Weinfurt, KP; Feinleib, M; Oetgen, WJ; Gersh, BJ; Schulman, KA
MLA Citation
Rathore, SS, Berger, AK, Weinfurt, KP, Feinleib, M, Oetgen, WJ, Gersh, BJ, and Schulman, KA. "Race, sex, poverty, and the medical treatment of acute myocardial infarction in the elderly." Circulation 102.6 (August 8, 2000): 642-648.
PMID
10931804
Source
pubmed
Published In
Circulation
Volume
102
Issue
6
Publish Date
2000
Start Page
642
End Page
648

Patterns of breast carcinoma treatment in older women: patient preference and clinical and physical influences.

BACKGROUND: Older women have high rates of breast carcinoma, and there are substantial variations in the patterns of care for this population group. METHODS: The authors studied 718 breast carcinoma patients age 67 years and older who were diagnosed with localized disease between 1995 and 1997 from 29 hospitals in 5 regions. Data were collected from patients, charts, and surgeons. Logistic regression analysis was used to evaluate determinants of treatment. RESULTS: Women who were concerned about body image were 1.8 times more likely (95% confidence interval [95% CI], 1.1-2.8) to receive breast conservation surgery and radiotherapy than women without this preference, controlling for other factors. In contrast, women who preferred receiving no therapy beyond surgery were 3.9 times more likely (95% CI, 2.9-6.1) to undergo mastectomy than other women, after considering other factors. Radiotherapy was omitted after breast conservation 3.4 times more often (95% CI, 2.0-5.6) among women age 80 years and older than among women ages 67-79 years, controlling for covariates. Black women tended to have radiotherapy omitted after breast conservation surgery 2.0 times more often (95% CI, 0.9-4.4) than white women (P = 0.09). Women age 80 years and older also were 70% less likely (odds ratio = 0.3; 95% CI, 0.1-0.8) to receive chemotherapy than women ages 67-79 years, controlling for health, functional status, and other covariates. CONCLUSIONS: After considering other factors, patient preferences and age were found to be associated with breast carcinoma treatment patterns in older women. Further research and training are needed to provide care for the growing population of older women that is both clinically appropriate and consonant with a woman's preferences.

Authors
Mandelblatt, JS; Hadley, J; Kerner, JF; Schulman, KA; Gold, K; Dunmore-Griffith, J; Edge, S; Guadagnoli, E; Lynch, JJ; Meropol, NJ; Weeks, JC; Winn, R
MLA Citation
Mandelblatt, JS, Hadley, J, Kerner, JF, Schulman, KA, Gold, K, Dunmore-Griffith, J, Edge, S, Guadagnoli, E, Lynch, JJ, Meropol, NJ, Weeks, JC, and Winn, R. "Patterns of breast carcinoma treatment in older women: patient preference and clinical and physical influences." Cancer 89.3 (August 1, 2000): 561-573.
PMID
10931455
Source
pubmed
Published In
Cancer
Volume
89
Issue
3
Publish Date
2000
Start Page
561
End Page
573

Mandated coverage for cancer-screening services: whose guidelines do states follow?

OBJECTIVES: To determine the prevalence and nature of state coverage mandates for cancer screening. METHODS: We contacted insurance departments in 50 states, Washington, DC, and Puerto Rico for copies of state codes that mandate coverage of screening for breast, cervical, prostate, and colorectal cancer by private insurers. We further compared mandates, when identified, with American Cancer Society (ACS) and U.S. Preventive Services Task Force (USPSTF) guidelines for likely sources of screening recommendations. RESULTS: Forty-three states and the District of Columbia currently mandate coverage of cancer screening. Breast cancer-screening coverage was most frequently mandated (n =44), followed by cervical (n =22), prostate (n =18), and colorectal cancer screening (n =1). Twenty-three states used ACS guidelines only, 18 states used ACS and non-ACS/non-USPSTF guidelines, and 3 states used only non-ACS/non-USPSTF guidelines in development of coverage mandates. No state screening coverage mandate reflected USPSTF-screening guidelines. Of 85 mandates in place, 57 have been passed since 1990. CONCLUSIONS: Although state mandates for insurer coverage of cancer screening are common and increasing, we found noticeable inter- and intra-state variation in coverage, selection, and use of screening guidelines.

Authors
Rathore, SS; McGreevey, JD; Schulman, KA; Atkins, D
MLA Citation
Rathore, SS, McGreevey, JD, Schulman, KA, and Atkins, D. "Mandated coverage for cancer-screening services: whose guidelines do states follow?." Am J Prev Med 19.2 (August 2000): 71-78.
PMID
10913895
Source
pubmed
Published In
American Journal of Preventive Medicine
Volume
19
Issue
2
Publish Date
2000
Start Page
71
End Page
78

Platelet transfusions: utilization and associated costs in a tertiary care hospital.

We implemented a prospective study to evaluate platelet transfusion utilization, resource use, and costs in a tertiary care hospital over a 6-month period. All hospitalized patients receiving platelet transfusions between July and December 1996 were followed prospectively to determine platelet use and costs. Clinical and financial data were collected, evaluated, and compared to identify trends in resource utilization based on admitting service and platelet-refractory status. One thousand nine hundred forty-four platelet units were transfused to 245 hospitalized patients (50.6% male, mean age 49 years) during the study period. The majority of platelet units transfused were single donor (N = 1,460, 75%) and administered to bone marrow patients and patients with a hematological malignancy/disorder. Median hospitalization costs per admission were $27,750, ranging from a high of $58,729 for admission to the Bone Marrow Transplant service to $13,856 per admission to the Internal Medicine/Other service. Patients were refractory to platelet transfusions during 21.6% of hospitalizations. Hospital stays were longer (35.0 days vs. 14.4 days, P < 0.001) and inpatient hospital costs ($103,956 vs. $37,817, P < 0.001) were more than two and a half times higher for patients refractory to platelet transfusions. Platelet utilization, resource use, and costs vary by admitting service. Refractoriness to platelet transfusion was associated with significantly greater costs and lengths of stay. Monitoring platelet transfusion practices, particularly for patients refractory to platelet transfusions, may be beneficial for limiting costs and improving efficacy.

Authors
Meehan, KR; Matias, CO; Rathore, SS; Sandler, SG; Kallich, J; LaBrecque, J; Erder, H; Schulman, KA
MLA Citation
Meehan, KR, Matias, CO, Rathore, SS, Sandler, SG, Kallich, J, LaBrecque, J, Erder, H, and Schulman, KA. "Platelet transfusions: utilization and associated costs in a tertiary care hospital." Am J Hematol 64.4 (August 2000): 251-256.
PMID
10911376
Source
pubmed
Published In
American Journal of Hematology
Volume
64
Issue
4
Publish Date
2000
Start Page
251
End Page
256

The association between institutional primary angioplasty procedure volume and outcome in elderly Americans.

BACKGROUND: The association between greater procedure volume and improved patient outcome in cardiac procedures has been established in percutaneous transluminal coronary angioplasty (PTCA), coronary stent placement and coronary bypass surgery. The association between primary angioplasty volume and outcome has not been evaluated. METHODS: We evaluated the association between the volume of primary angioplasty procedures with short- and long-term outcome in 6,124 patients with documented acute myocardial infarction. Patients without shock on presentation treated with primary coronary angioplasty within 12 hours of hospital admission were selected from consecutive infarct patients included in the Cooperative Cardiovascular Project database. Patients were divided into quartiles based on the volume of primary PTCA procedures performed at their admitting hospital. RESULTS: The majority of United States (US) hospitals performed less than three primary PTCA procedures per month. Patients admitted to hospitals in the lowest volume quartile of primary PTCA had 31% higher 30-day mortality than those admitted to the highest volume quartile. After adjustment for baseline differences in patient characteristics, there was an association between admission to higher volume primary PTCA hospitals and lower 30-day mortality (odds ratio per volume quartile = 0.91; 95% confidence interval = 0.83-0.99). CONCLUSION: Eighty-two percent of US hospitals perform less than three primary PTCA procedures per month. In elderly Americans treated with primary PTCA, we observed an association between admission to higher volume hospitals and lower short- and long-term mortality. This association was independent of total PTCA volumes.

Authors
Every, NR; Maynard, C; Schulman, K; Ritchie, JL
MLA Citation
Every, NR, Maynard, C, Schulman, K, and Ritchie, JL. "The association between institutional primary angioplasty procedure volume and outcome in elderly Americans." J Invasive Cardiol 12.6 (June 2000): 303-308.
PMID
10859715
Source
pubmed
Published In
Journal of Invasive Cardiology
Volume
12
Issue
6
Publish Date
2000
Start Page
303
End Page
308

Race and sex differences in the management of coronary artery disease.

Although numerous studies have documented race and sex differences in the treatment of coronary artery disease, the available analyses have not been comprehensively evaluated. In this review, we summarize prior estimates of race and sex disparities in the utilization of standard tests and therapies, and we evaluate studies of factors that may contribute to gaps in care. The studies presented consistently demonstrate that blacks and women with coronary artery disease, compared with whites and men, are substantially less likely to receive standard interventions. Studies also indicate that racial differences relate in part to socioeconomic factors, process-of-care variables, and patient preferences, whereas sex differences relate in part to clinical factors. In both cases, however, our understanding is limited by deficiencies in currently available datasets. Moreover, factors that have been shown to contribute to race and sex disparities in medical care fail to explain them fully. In both cases, physician decision-making appears to contribute as well, suggesting that subconscious biases may contribute to treatment disparities. We conclude by proposing initiatives to remedy race and sex disparities in medical care. Efforts should focus on increasing physician awareness of this problem. Studies should gather data that are currently unavailable for analysis, including detailed clinical variables and patient-level socioeconomic information. Finally, novel quality assurance programs, designed to evaluate and improve the care of blacks and women with coronary artery disease, should be promptly undertaken.

Authors
Sheifer, SE; Escarce, JJ; Schulman, KA
MLA Citation
Sheifer, SE, Escarce, JJ, and Schulman, KA. "Race and sex differences in the management of coronary artery disease." Am Heart J 139.5 (May 2000): 848-857. (Review)
PMID
10783219
Source
pubmed
Published In
American Heart Journal
Volume
139
Issue
5
Publish Date
2000
Start Page
848
End Page
857

The effects of patient sex and race on medical students' ratings of quality of life.

PURPOSE: Although previous studies have examined race and sex differences in health care, few studies have investigated the possible role of physician bias. We evaluated the influence of race and sex on medical students' perceptions of patients' symptoms to determine if there are differences in these perceptions early in medical training. SUBJECTS AND METHODS: One-hundred sixty-four medical students were randomly assigned to view a video of a black female or white male actor portraying patients with identical symptoms of angina. We evaluated students' perceptions of the actors' health state (based on their assessment of quality of life) using a visual analog scale and a standard rating technique, as well as the type of chest pain diagnosis. RESULTS: Students assigned a lower value (indicating a less desirable health state) to the black woman than to the white man with identical symptoms [visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P <0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001). Nonminority students reported higher mean values for the white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14 for the black female patient), whereas minority students' assessments did not differ by patient. Male students assigned a slightly lower value to the black female patient (standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male patient). Students were less likely to characterize the black female patient's symptoms as angina (46% vs 74% for the white male patient, P = 0.001). CONCLUSIONS: The way that medical students perceive patient symptoms appears to be affected by nonmedical factors.

Authors
Rathore, SS; Lenert, LA; Weinfurt, KP; Tinoco, A; Taleghani, CK; Harless, W; Schulman, KA
MLA Citation
Rathore, SS, Lenert, LA, Weinfurt, KP, Tinoco, A, Taleghani, CK, Harless, W, and Schulman, KA. "The effects of patient sex and race on medical students' ratings of quality of life." Am J Med 108.7 (May 2000): 561-566.
PMID
10806285
Source
pubmed
Published In
The American Journal of Medicine
Volume
108
Issue
7
Publish Date
2000
Start Page
561
End Page
566

Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients.

BACKGROUND: Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30). METHODS: Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients. RESULTS: Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA. CONCLUSIONS: Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.

Authors
Weinfurt, KP; Willke, RJ; Glick, HA; Freimuth, WW; Schulman, KA
MLA Citation
Weinfurt, KP, Willke, RJ, Glick, HA, Freimuth, WW, and Schulman, KA. "Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients." Med Care 38.4 (April 2000): 404-410.
PMID
10752972
Source
pubmed
Published In
Medical Care
Volume
38
Issue
4
Publish Date
2000
Start Page
404
End Page
410

Acute myocardial infarction complicated by atrial fibrillation in the elderly: prevalence and outcomes.

BACKGROUND: Although atrial fibrillation (AF) is a common complication of acute myocardial infarction (MI), patient characteristics and association with outcomes remain poorly defined in the elderly. METHODS AND RESULTS: We evaluated 106 780 Medicare beneficiaries > or =65 years of age from the Cooperative Cardiovascular Project treated for acute MI between January 1994 and February 1996 to determine the prevalence and prognostic significance of AF complicating acute MI in elderly patients. Patients were categorized on the basis of the presence of AF, and those with AF were further subdivided by time of AF (present on arrival versus developing during hospitalization). AF and non-AF patients were compared by univariate analysis, and logistic regression modeling was used to identify clinical predictors of AF. The influence of AF on outcomes was evaluated by unadjusted Kaplan-Meier survival curves and logistic regression models. AF was documented in 23 565 patients (22. 1%): 11 510 presented with AF and 12,055 developed AF during hospitalization. AF patients were older, had more advanced heart failure, and were more likely to have had a prior MI and undergone coronary revascularization. AF patients had poorer outcomes, including higher in-hospital (25.3% versus 16.0%), 30-day (29.3% versus 19.1%), and 1-year (48.3% versus 32.7%) mortality. AF remained an independent predictor of in-hospital (odds ratio [OR], 1. 21), 30-day (OR, 1.20), and 1-year (OR, 1.34) mortality after multivariate adjustment. Patients developing AF during hospitalization had a worse prognosis than patients who presented with AF. CONCLUSIONS: AF is a common complication of acute MI in elderly patients and independently influences mortality, particularly when it develops during hospitalization.

Authors
Rathore, SS; Berger, AK; Weinfurt, KP; Schulman, KA; Oetgen, WJ; Gersh, BJ; Solomon, AJ
MLA Citation
Rathore, SS, Berger, AK, Weinfurt, KP, Schulman, KA, Oetgen, WJ, Gersh, BJ, and Solomon, AJ. "Acute myocardial infarction complicated by atrial fibrillation in the elderly: prevalence and outcomes." Circulation 101.9 (March 7, 2000): 969-974.
PMID
10704162
Source
pubmed
Published In
Circulation
Volume
101
Issue
9
Publish Date
2000
Start Page
969
End Page
974

Randomized trial of filgrastim, sargramostim, or sequential sargramostim and filgrastim after myelosuppressive chemotherapy for the harvesting of peripheral-blood stem cells.

PURPOSE: The purpose of this study was to compare the effects of filgrastim, sargramostim, or sequential sargramostim and filgrastim on CD34(+) cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC). PATIENTS AND METHODS: One hundred fifty-six patients were randomized to receive filgrastim (n = 51), sargramostim (n = 52), or sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81). RESULTS: Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 x 10(9)/L or greater (a median of 11 v 14 days; P =. 0001), with fewer patients requiring RBC transfusions (P =.008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P =.013), and less intravenous antibiotic therapy (24% v 69%; P =.001). Patients who received filgrastim yielded more CD34(+) cells (median, 7.1 v 2.0 x 10(6)/kg/apheresis; P =.0001), and a higher fraction achieved 2.5 x 10(6) (94% v 78%; P =.021) and 5 x 10(6) (88% v 53%; P =.001) or more CD34(+) cells/kg with fewer aphereses (median, 2 v 3; P =.002) and fewer days of growth-factor treatment (median, 12 v 14; P =.0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD34(+) cells and had faster platelet recovery (P =.015), with fewer patients (P =.014) receiving fewer platelet transfusions (P =.001) than patients receiving sargramostim-mobilized PBSCs. CONCLUSION: It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD34(+) cells and reduction of toxicities after MC.

Authors
Weaver, CH; Schulman, KA; Wilson-Relyea, B; Birch, R; West, W; Buckner, CD
MLA Citation
Weaver, CH, Schulman, KA, Wilson-Relyea, B, Birch, R, West, W, and Buckner, CD. "Randomized trial of filgrastim, sargramostim, or sequential sargramostim and filgrastim after myelosuppressive chemotherapy for the harvesting of peripheral-blood stem cells." J Clin Oncol 18.1 (January 2000): 43-53.
PMID
10623692
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
18
Issue
1
Publish Date
2000
Start Page
43
End Page
53
DOI
10.1200/JCO.2000.18.1.43

Impact of quality of life on patient expectations regarding phase I clinical trials.

PURPOSE: Quality of life (QOL) is increasingly recognized as a critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options. METHODS: Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations. RESULTS: Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P <.01; mean expected toxicity, 29.8% v 16.0%, P <.01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P <.01) and less potential for toxicity (29.8% v 45.6%, P =.01) for experimental therapy, compared with standard therapy. Short Form-36 general health perception correlated with patient perception of potential benefit from experimental therapy (r =.48, P =.01). CONCLUSION: Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity. Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials.

Authors
Cheng, JD; Hitt, J; Koczwara, B; Schulman, KA; Burnett, CB; Gaskin, DJ; Rowland, JH; Meropol, NJ
MLA Citation
Cheng, JD, Hitt, J, Koczwara, B, Schulman, KA, Burnett, CB, Gaskin, DJ, Rowland, JH, and Meropol, NJ. "Impact of quality of life on patient expectations regarding phase I clinical trials." J Clin Oncol 18.2 (January 2000): 421-428.
PMID
10637258
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
18
Issue
2
Publish Date
2000
Start Page
421
End Page
428
DOI
10.1200/JCO.2000.18.2.421

Medical errors: how the US Government is addressing the problem.

November's Institute of Medicine (IOM) report on medical errors has sparked debate among US health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nationwide mandatory reporting with public release of performance data to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. Any successful safety program will require a national effort to make significant investments in information technology infrastructure, and to provide an environment and education that enables providers to contribute to an active quality-improvement process.

Authors
Schulman, KA; Kim, JJ
MLA Citation
Schulman, KA, and Kim, JJ. "Medical errors: how the US Government is addressing the problem." Curr Control Trials Cardiovasc Med 1.1 (2000): 35-37.
PMID
11714405
Source
pubmed
Published In
Current controlled trials in cardiovascular medicine
Volume
1
Issue
1
Publish Date
2000
Start Page
35
End Page
37
DOI
10.1186/cvm-1-1-035

The effect of race on the referral process for invasive cardiac procedures.

Coronary artery disease is the leading cause of death in the United States. Blacks are more likely than whites to experience premature disease, and they have poorer prognosis after acute myocardial infarction. Multiple studies have demonstrated that blacks are less likely to be referred for certain invasive cardiac procedures. Few studies have examined the effect of race on physician and patient decision making in referrals for cardiac procedures. The authors present a framework for the complex series of steps involved in obtaining invasive cardiac care. Patient race can affect each of these steps, and differences in physician and patient race may be a particular impediment to effective communication about symptoms and preferences and to the establishment of a therapeutic partnership. The potential role of communication in race-discordant physician-patient relationships suggests a need for more research in physician decision making and for efforts to promote cultural competency as a core component of medical education.

Authors
Einbinder, LC; Schulman, KA
MLA Citation
Einbinder, LC, and Schulman, KA. "The effect of race on the referral process for invasive cardiac procedures." Med Care Res Rev 57 Suppl 1 (2000): 162-180.
PMID
11092162
Source
pubmed
Published In
Medical Care Research and Review
Volume
57 Suppl 1
Publish Date
2000
Start Page
162
End Page
180
DOI
10.1177/1077558700057001S08

The factuality of health records [10] (multiple letters)

Authors
Fusaro, RM; Sulmasy, DP; Freeman, VG; Schulman, KA
MLA Citation
Fusaro, RM, Sulmasy, DP, Freeman, VG, and Schulman, KA. "The factuality of health records [10] (multiple letters)." Archives of Internal Medicine 160.14 (2000): 2224-2225.
PMID
10904477
Source
scival
Published In
Archives of Internal Medicine
Volume
160
Issue
14
Publish Date
2000
Start Page
2224
End Page
2225

Primary angioplasty vs thrombolysis in elderly patients [1] (multiple letters)

Authors
Thiemann, D; Berger, AK; Schulman, KA; Gersh, BJ; Every, NR
MLA Citation
Thiemann, D, Berger, AK, Schulman, KA, Gersh, BJ, and Every, NR. "Primary angioplasty vs thrombolysis in elderly patients [1] (multiple letters)." Journal of the American Medical Association 283.5 (2000): 601-602.
PMID
10665691
Source
scival
Published In
JAMA : the journal of the American Medical Association
Volume
283
Issue
5
Publish Date
2000
Start Page
601
End Page
602

The development of standard economic datasets for use in the economic evaluation of medicines

Regulatory imperatives and competitive forces have led pharmaceutical companies to focus on extending the scope of their randomized controlled trials (RCTs) to collect data to address economic as well as safety and efficacy questions. To guide researchers, a significant literature exists on various methodological aspects of conducting economic evaluations within an RCT framework. Little has been published, however, about data handling issues surrounding the management of the economic data collection effort. Thus, the objective of this paper is to present an overview of a project conducted in order to tackle various aspects of the economic data management process with a view to improving the efficiency of study conduct. The project outputs include case report forms (CRF), guidelines for CRF completion, and templates for producing statistical analysis plans and study protocols. Directions for further research are highlighted.

Authors
Backhouse, ME; Gnanasakthy, A; Schulman, KA; Akehurst, R; Glick, H
MLA Citation
Backhouse, ME, Gnanasakthy, A, Schulman, KA, Akehurst, R, and Glick, H. "The development of standard economic datasets for use in the economic evaluation of medicines." Drug Information Journal 34.4 (2000): 1273-1291.
Source
scival
Published In
Drug Information Journal
Volume
34
Issue
4
Publish Date
2000
Start Page
1273
End Page
1291

The role of the food and drug administration in pharmacoeconomic evaluation during the drug development process

Economic analysis is increasingly being integrated into Phase III clinical trials. In 1995, the Clinical Economics Research Unit of Georgetown University Medical Center implemented a survey to assess the use of pharmacoeconomic data in the clinical development process. This survey gathered information regarding the companies' use of economic analyses in the drug approval process and the analyses commented upon by the Food and Drug Administration (FDA) in its review (17). The results from the 1995 survey found that companies reported that pharmacoeconomic data were increasingly being submitted to the FDA in product approval packages, and that the FDA increasingly commented on these data. Given the growth of interest in economic evaluation since 1995, the survey was re-implemented in 1998 to examine the current state of the art in economic evaluation. The results indicate continuing and expanding interest in submitting pharmacoeconomic data to the FDA during the drug development process and reports of recent approval of economic claims in product labeling.

Authors
Kim, J; Morris, CB; Schulman, KA
MLA Citation
Kim, J, Morris, CB, and Schulman, KA. "The role of the food and drug administration in pharmacoeconomic evaluation during the drug development process." Drug Information Journal 34.4 (2000): 1207-1213.
Source
scival
Published In
Drug Information Journal
Volume
34
Issue
4
Publish Date
2000
Start Page
1207
End Page
1213

Characteristics of hospitalizations of HIV-infected patients: an analysis of data from the 1994 healthcare cost and utilization project.

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.

Authors
Bentham, WD; Cai, L; Schulman, KA
MLA Citation
Bentham, WD, Cai, L, and Schulman, KA. "Characteristics of hospitalizations of HIV-infected patients: an analysis of data from the 1994 healthcare cost and utilization project." J Acquir Immune Defic Syndr 22.5 (December 15, 1999): 503-508.
PMID
10961613
Source
pubmed
Published In
Journal of Acquired Immune Deficiency Syndromes
Volume
22
Issue
5
Publish Date
1999
Start Page
503
End Page
508

Lying for patients: physician deception of third-party payers.

BACKGROUND: Some physicians may resort to deception to secure third-party payer approval for patient procedures. Related physician attitudes, including willingness to use deception, are not well understood. OBJECTIVE: To determine physician willingness to deceive a third-party payer and physician attitudes toward deception of third-party payers. METHODS: A cross-sectional mailed survey was used to evaluate physician willingness to use deception in 6 vignettes of varying clinical severity: coronary bypass surgery, arterial revascularization, intravenous pain medication and nutrition, screening mammography, emergent psychiatric referral, and cosmetic rhinoplasty. We evaluated 169 board-certified internists randomly selected from 4 high- and 4 low-managed care penetration metropolitan markets nationwide for willingness to use deception in each vignette. RESULTS: Physicians were willing to use deception in the coronary bypass surgery (57.7%), arterial revascularization (56.2%), intravenous pain medication and nutrition (47.5%), screening mammography (34.8%), and emergent psychiatric referral (32.1%) vignettes. There was little willingness to use deception for cosmetic rhinoplasty (2.5%). Rates were highest for physicians practicing in predominantly managed care markets, for clinically severe vignettes, and for physicians spending less time in clinical practice. Physician ratings of the justifiability of deception varied by perspective and vignette. CONCLUSIONS: Many physicians sanction the use of deception to secure third-party payers' approval of medically indicated care. Such deception may reflect a tension between the traditional ethic of patient advocacy and the new ethic of cost control that restricts patient and physician choice in the use of limited resources.

Authors
Freeman, VG; Rathore, SS; Weinfurt, KP; Schulman, KA; Sulmasy, DP
MLA Citation
Freeman, VG, Rathore, SS, Weinfurt, KP, Schulman, KA, and Sulmasy, DP. "Lying for patients: physician deception of third-party payers." Arch Intern Med 159.19 (October 25, 1999): 2263-2270.
PMID
10547165
Source
pubmed
Published In
Archives of internal medicine
Volume
159
Issue
19
Publish Date
1999
Start Page
2263
End Page
2270

Study of Hypertensive Prescribing Practices (SHyPP): A National Survey of Primary Care Physicians.

BACKGROUND: Approximately 50 million people in the U.S. have hypertension. The Joint National Committee (JNC V) guidelines provide treatment recommendations for hypertension. These guidelines promote initiating therapy with diuretics and à -blockers because these agents have been shown to reduce hypertension related morbidity and mortality. OBJECTIVES: To survey primary care physicians' antihypertensive prescribing practices, their perceptions about antihypertensive medication cost and safety, and their perceptions of the effects of managed care. DESIGN: A direct mail survey was distributed to a national random sample of 500 office based, primary care internists, family practitioners, and general practitioners. RESULTS: 72% of the physicians who responded reported being aware of the JNC V guidelines. Younger physicians claimed to be more aware of and more likely to follow JNC V guidelines than older physicians. Only 25% of physicians reported initiating treatment at systolic blood pressures greater than 140 mm Hg as recommended by the JNC V guidelines. Most physicians reported initiating treatment at higher pressures. Diuretics were selected for initial antihypertensive treatment by 36% of physicians, ACE inhibitors by 35%, à -blockers by 16%, and calcium channel blockers (CCBs) by 7%. Up to 27% of physicians admitted not knowing the cost of specific medications. Approximately half of the physicians reported that they and their patients were more concerned about medication cost and safety today than 18 months ago. A greater number of younger physicians reported that managed care formularies infringed upon their prescribing practices. CONCLUSIONS: Antihypertensive prescribing patterns are inconsistent with JNC V guidelines. Actual practice may deviate even more from these guidelines than reported in this survey. Also, physicians perceive that managed care is increasingly affecting their prescribing practices. (c)1999 by Le Jacq Communications, Inc.

Authors
Schulman, KA; Mehta, SS; Gersh, BJ; Schneider, EC; Wilcox, CS
MLA Citation
Schulman, KA, Mehta, SS, Gersh, BJ, Schneider, EC, and Wilcox, CS. "Study of Hypertensive Prescribing Practices (SHyPP): A National Survey of Primary Care Physicians." J Clin Hypertens (Greenwich) 1.2 (October 1999): 106-114.
PMID
11416601
Source
pubmed
Published In
Journal of Clinical Hypertension
Volume
1
Issue
2
Publish Date
1999
Start Page
106
End Page
114

ACI-TIPI clinical trial. Acute cardiac ischemia time-insensitive predictive instrument.

Authors
Weinfurt, KP; Rathore, SS; Schulman, KA
MLA Citation
Weinfurt, KP, Rathore, SS, and Schulman, KA. "ACI-TIPI clinical trial. Acute cardiac ischemia time-insensitive predictive instrument." Ann Intern Med 131.6 (September 21, 1999): 476-477. (Letter)
PMID
10498573
Source
pubmed
Published In
Annals of internal medicine
Volume
131
Issue
6
Publish Date
1999
Start Page
476
End Page
477

Racial differences in the use of invasive cardiac procedures: A continuous quality improvement approach.

Authors
Sheifer, SE; Schulman, KA
MLA Citation
Sheifer, SE, and Schulman, KA. "Racial differences in the use of invasive cardiac procedures: A continuous quality improvement approach." Am Heart J 138.3 Pt 1 (September 1999): 396-399.
PMID
10467186
Source
pubmed
Published In
American Heart Journal
Volume
138
Issue
3 Pt 1
Publish Date
1999
Start Page
396
End Page
399

Item responsiveness of a rhinitis and asthma symptom score during a pollen season.

Twenty-one asthma patients with allergic rhinitis completed a series of self-administered questionnaires (21-item symptom score for rhinosinusitis and asthma, bother scale, McMaster Asthma Quality of Life Questionnaire [MAQOL] and Euroqol) at 2-week intervals from August to November 1994. Relative responsiveness of the instruments was assessed in reference to the maximum and minimum average scores for MAQOL, with area under the curve (AUC) and correlation coefficients between the different instruments. Symptom score, MAQOL, and bother scale provided similar results for both extreme values and AUC, whereas Euroqol utilities were less responsive. These results suggest that the symptom scores and bother scales are responsive and valid, and might prove valuable in everyday practice, clinical trials, and quality assurance programs.

Authors
Wasserfallen, JB; Gold, K; Schulman, KA; Baraniuk, JN
MLA Citation
Wasserfallen, JB, Gold, K, Schulman, KA, and Baraniuk, JN. "Item responsiveness of a rhinitis and asthma symptom score during a pollen season." J Asthma 36.5 (August 1999): 459-465.
PMID
10461935
Source
pubmed
Published In
Journal of Asthma (Informa)
Volume
36
Issue
5
Publish Date
1999
Start Page
459
End Page
465

Primary coronary angioplasty vs thrombolysis for the management of acute myocardial infarction in elderly patients.

CONTEXT: Despite evidence from randomized trials that, compared with early thrombolysis, primary percutaneous transluminal coronary angioplasty (PTCA) after acute myocardial infarction (AMI) reduces mortality in middle-aged adults, whether elderly patients with AMI are more likely to benefit from PTCA or early thrombolysis is not known. OBJECTIVE: To determine survival after primary PTCA vs thrombolysis in elderly patients. DESIGN: The Cooperative Cardiovascular Project, a retrospective cohort study using data from medical charts and administrative files. SETTING: Acute care hospitals in the United States. PATIENTS: A total of 20683 Medicare beneficiaries, who arrived within 12 hours of the onset of symptoms, were admitted between January 1994 and February 1996 with a principal discharge diagnosis of AMI, and were eligible for reperfusion therapy. MAIN OUTCOME MEASURES: Thirty-day and 1-year survival. RESULTS: A total of 80356 eligible patients had an AMI at hospital arrival and met the inclusion criteria, of whom 23.2% received thrombolysis and 2.5% underwent primary PTCA within 6 hours of hospital arrival. Patients undergoing primary PTCA had lower 30-day (8.7% vs 11.9%, P=.001) and 1-year mortality (14.4% vs 17.6%, P=.001). After adjusting for baseline cardiac risk factors and admission and hospital characteristics, primary PTCA was associated with improved 30-day (hazard ratio [HR] of death, 0.74; 95% confidence interval [CI], 0.63-0.88) and 1-year (HR, 0.88; 95% CI, 0.73-0.94) survival. The benefits of primary coronary angioplasty persisted when stratified by hospitals' AMI volume and the presence of on-site angiography. In patients classified as ideal for reperfusion therapy, the mortality benefit of primary PTCA was not significant at 1-year follow-up (HR, 0.92; 95% CI, 0.78-1.08). CONCLUSION: In elderly patients who present with AMI, primary PTCA is associated with modestly lower short- and long-term mortality rates. In the subgroup of patients who were classified as ideal for reperfusion therapy, the observed benefit of primary PTCA was no longer significant.

Authors
Berger, AK; Schulman, KA; Gersh, BJ; Pirzada, S; Breall, JA; Johnson, AE; Every, NR
MLA Citation
Berger, AK, Schulman, KA, Gersh, BJ, Pirzada, S, Breall, JA, Johnson, AE, and Every, NR. "Primary coronary angioplasty vs thrombolysis for the management of acute myocardial infarction in elderly patients." JAMA 282.4 (July 28, 1999): 341-348.
PMID
10432031
Source
pubmed
Published In
JAMA : the journal of the American Medical Association
Volume
282
Issue
4
Publish Date
1999
Start Page
341
End Page
348

Determining an episode of care using claims data. Diabetic foot ulcer.

OBJECTIVE: Amid changes in the organization and financing of health care, health care decision makers are increasingly interested in episodes of care. We sought to determine an episode of care for diabetic foot ulcer using an administrative claims database. RESEARCH DESIGN AND METHODS: We used 1993-1995 claims data to assess resource utilization for privately insured patients with diabetic foot ulcers. Over a 26-week period, we determined the episode length by comparing differences in average daily charges and proportion of patients with charges before and after foot ulcer diagnosis. All 13 weeks before diagnosis were used to calculate baseline values. Significance was determined by CIs, which were calculated by a nonparametric bootstrap technique. Costs associated with the episode were also calculated. A sensitivity analysis using weeks with highest and lowest values as baseline was also conducted. RESULTS: Based on average daily charges, the episode of care for diabetic foot ulcer was 5 weeks. Using proportion of patients with charges, the episode was longer than 13 weeks. The cost for an episode of care ranged from $900 to $2,600. In the sensitivity analyses, episodes of care ranged from 1 to 13 weeks. CONCLUSIONS: Episodes of care can be defined by the period beginning with increased resource consumption and ending when resource consumption returns to baseline levels. With the growth of managed care and disease management programs, episode-of-care analysis may have an increasingly important role in health care provision and delivery.

Authors
Mehta, SS; Suzuki, S; Glick, HA; Schulman, KA
MLA Citation
Mehta, SS, Suzuki, S, Glick, HA, and Schulman, KA. "Determining an episode of care using claims data. Diabetic foot ulcer." Diabetes Care 22.7 (July 1999): 1110-1115.
PMID
10388976
Source
pubmed
Published In
Diabetes Care
Volume
22
Issue
7
Publish Date
1999
Start Page
1110
End Page
1115

A comparison of preference assessment instruments used in a clinical trial: responses to the visual analog scale from the EuroQol EQ-5D and the Health Utilities Index.

OBJECTIVES: To compare preference assessments that were made by using the EuroQol EQ-5D and the Health Utilities Index Mark II. SUBJECTS: 561 patients in a randomized trial of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. MEASURES: Three preference assessments (a value score for the EuroQol instrument and value and utility scores for the Health Utilities Index) made three months after randomization. The averages for each of the three scores, stratified by clinical outcomes and attributes of the Health Utilities Index health status classification system, were compared. To evaluate potential sources of difference between the instruments, the authors estimated two alternative Health Utilities Index scoring rules that were based on patient responses to the EuroQol instrument. RESULTS: Patients' ratings of their current health made by using the 100-point visual analog scale from the EuroQol instrument were more similar to the utility scores for the Health Utilities Index than they were to the value scores for the Health Utilities Index. The biggest differences between the visual analog scores for the EuroQol instrument and the utility scores for the Health Utilities index were seen at higher levels of functioning. CONCLUSION: For states representing higher levels of functioning, differences were seen between patients' self-ratings obtained by using the EuroQol instrument and the patients' utility scores on the Health Utilities Index; for states representing lower levels of functioning, substantial agreement was observed between these two scores. Differences observed at the higher levels of functioning suggest that further research is needed to determine whether the Health Utility Index's assignment of a score of 1.0 to the reference state representing being healthy is appropriate.

Authors
Glick, HA; Polsky, D; Willke, RJ; Schulman, KA
MLA Citation
Glick, HA, Polsky, D, Willke, RJ, and Schulman, KA. "A comparison of preference assessment instruments used in a clinical trial: responses to the visual analog scale from the EuroQol EQ-5D and the Health Utilities Index." Med Decis Making 19.3 (July 1999): 265-275.
PMID
10424833
Source
pubmed
Published In
Medical Decision Making
Volume
19
Issue
3
Publish Date
1999
Start Page
265
End Page
275
DOI
10.1177/0272989X9901900305

Regulating manufacturer-affiliated communication in the information age.

Authors
Schulman, KA; Abernethy, DR; Rathore, SS; Woosley, RL
MLA Citation
Schulman, KA, Abernethy, DR, Rathore, SS, and Woosley, RL. "Regulating manufacturer-affiliated communication in the information age." Clin Pharmacol Ther 65.6 (June 1999): 593-597.
PMID
10391664
Source
pubmed
Published In
Clinical Pharmacology & Therapeutics (Nature)
Volume
65
Issue
6
Publish Date
1999
Start Page
593
End Page
597
DOI
10.1016/S0009-9236(99)90080-2

A claims data approach to defining an episode of care.

OBJECTIVE: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine. DATA SOURCES: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992. STUDY DESIGN: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques. DATA COLLECTION METHODS: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization. PRINCIPAL FINDINGS: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks. CONCLUSIONS: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

Authors
Schulman, KA; Yabroff, KR; Kong, J; Gold, KF; Rubenstein, LE; Epstein, AJ; Glick, H
MLA Citation
Schulman, KA, Yabroff, KR, Kong, J, Gold, KF, Rubenstein, LE, Epstein, AJ, and Glick, H. "A claims data approach to defining an episode of care." Health Serv Res 34.2 (June 1999): 603-621.
PMID
10357292
Source
pubmed
Published In
Health Services Research
Volume
34
Issue
2
Publish Date
1999
Start Page
603
End Page
621

Economics and cost-effectiveness in evaluating the value of cardiovascular therapies. ACE inhibitors in the management of congestive heart failure: comparative economic data.

Authors
Boyko, WL; Glick, HA; Schulman, KA
MLA Citation
Boyko, WL, Glick, HA, and Schulman, KA. "Economics and cost-effectiveness in evaluating the value of cardiovascular therapies. ACE inhibitors in the management of congestive heart failure: comparative economic data." Am Heart J 137.5 (May 1999): S115-S119.
PMID
10220611
Source
pubmed
Published In
American Heart Journal
Volume
137
Issue
5
Publish Date
1999
Start Page
S115
End Page
S119

Treatment of hypertension in patients with comorbidities: results from the study of hypertensive prescribing practices (SHyPP).

Approximately 50 million people have hypertension. Many agents with differing efficacy, side effects, dosing schedules, and costs are available to treat hypertension. Joint National Committee (JNC) guidelines attempt to simplify this decision by recommending specific agents based on special considerations such as comorbidities. The objective of this study was to survey primary care physicians' antihypertensive prescribing practices and their treatment recommendations for patients with comorbidities. A direct mail survey was sent to a national random sample of 500 office-based primary care internists, family practitioners, and general practitioners. There were no significant differences between initial treatment recommendations at the time of the survey and those recommended before the survey. However, there were several therapeutic classes whose reported utilization for specific comorbidities significantly changed over 18 months. Angiotensin converting enzyme (ACE) inhibitors reportedly increased in patients with congestive heart failure and diabetes. In addition, the reported use of selective beta-blockers increased for patients with a history of myocardial infarction. Physicians did not follow JNC recommendations when initiating treatment in black patients, older patients, or those with mild renal failure. Younger physicians were more likely than older physicians to select agents consistent with guideline recommendations. Physicians did not adhere to JNC guidelines when initiating treatment in patients with comorbidities; however, more physicians are prescribing recommended agents today as compared to 18 months ago. Younger physicians were more likely to prescribe agents consistent with the guidelines. More direct efforts are needed to ensure awareness and compliance with these guidelines.

Authors
Mehta, SS; Wilcox, CS; Schulman, KA
MLA Citation
Mehta, SS, Wilcox, CS, and Schulman, KA. "Treatment of hypertension in patients with comorbidities: results from the study of hypertensive prescribing practices (SHyPP)." Am J Hypertens 12.4 Pt 1 (April 1999): 333-340.
PMID
10232492
Source
pubmed
Published In
American Journal of Hypertension
Volume
12
Issue
4 Pt 1
Publish Date
1999
Start Page
333
End Page
340

Effect of CD34(+) cell dose on resource utilization in patients after high-dose chemotherapy with peripheral-blood stem-cell support.

PURPOSE: The mean time to neutrophil and platelet recovery for patients receiving high-dose chemotherapy (HDC) supported with peripheral-blood stem cells (PBSCs) is related to the dose of CD34(+) cells infused. The effect of cell dose on resource utilization after transplantation has not been previously reported. MATERIALS AND METHODS: We assessed CD34(+) cell dose and resource utilization for 1,317 patients undergoing transplantation with PBSCs from April 1991 to June 1997. PBSCs were collected after mobilization with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). Daily measurement of the CD34(+) content of the PBSC collection was performed by a central laboratory using a single CD34(+) analysis technique. Resource utilization included engraftment parameters, length of stay, and transfusion requirements for 100 days posttransplantation. Analysis included descriptive statistics and multiple regression. RESULTS: Mean patient age was 47 years, and 86% of patients were female. Median cell dose was 3.6 x 10(6)/kg and 13.2 x 10(6)/kg for patients receiving less than 5.0 x 10(6) CD34(+) cells/kg and 5.0 x 10(6) or more CD34(+) cells/kg, respectively. Patients receiving less than 5. 0 x 10(6) CD34(+) cells/kg were more likely to have metastatic breast cancer or non-Hodgkin's lymphoma and required more platelet and RBC transfusions, 3.3 more hospital days, and increased antibiotic and antifungal use. In univariate analysis, the cost of care was $41,516 (+/-$20,876 SD) and $32,382 (+/-$16,353 SD) for patients with less than 5.0 x 10(6) CD34(+) cells/kg and 5.0 x 10(6) or more CD34(+) cells/kg, respectively. In multivariate analysis, patients with less than 5.0 x 10(6) CD34(+) cells/kg had an increase in costs of $5,062 (+/- $1,262 SE). CONCLUSION: Infusion of more than 5.0 x 10(6) CD34(+) cells/kg was associated with a reduction in resource utilization. Achieving a target of 5.0 x 10(6) CD34(+) cells/kg should have important clinical and economic benefits for patients.

Authors
Schulman, KA; Birch, R; Zhen, B; Pania, N; Weaver, CH
MLA Citation
Schulman, KA, Birch, R, Zhen, B, Pania, N, and Weaver, CH. "Effect of CD34(+) cell dose on resource utilization in patients after high-dose chemotherapy with peripheral-blood stem-cell support." J Clin Oncol 17.4 (April 1999): 1227-.
PMID
10561183
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
17
Issue
4
Publish Date
1999
Start Page
1227
DOI
10.1200/JCO.1999.17.4.1227

The timing of do-not-resuscitate orders and hospital costs.

The relation between the timing of do-not-resuscitate (DNR) orders and the cost of medical care is not well understood. This prospective observational study compares hospital costs and length of stay of 265 terminally ill patients with admission DNR orders, delayed DNR orders (occurring after 24 hours), or no DNR orders (full code). Patients whose orders remained full code throughout a hospital stay had similar lengths of stay, total hospital costs, and daily costs as patients with admission DNR orders. Patients with delayed DNR orders, by contrast, had a greater mortality, longer length of stay, and higher total costs than full code or admission DNR patients, but similar daily costs. The causes of delay in DNR orders and the associated higher costs are a matter for future research.

Authors
De Jonge, KE; Sulmasy, DP; Gold, KG; Epstein, A; Harper, MG; Eisenberg, JM; Schulman, KA
MLA Citation
De Jonge, KE, Sulmasy, DP, Gold, KG, Epstein, A, Harper, MG, Eisenberg, JM, and Schulman, KA. "The timing of do-not-resuscitate orders and hospital costs." J Gen Intern Med 14.3 (March 1999): 190-192.
PMID
10203626
Source
pubmed
Published In
Journal of General Internal Medicine
Volume
14
Issue
3
Publish Date
1999
Start Page
190
End Page
192

Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials.

As the population ages and more expensive high-technology services become available, health care costs continue to spiral upward. Because the financial resources for health care are limited, economic analysis can help to evaluate expenditures and set priorities. Economic analysis of medical technology or medical care evaluates a medical service by comparing its dollar cost with its dollar benefit (cost-benefit), by measuring its dollar cost in relation to its outcomes (cost-effectiveness) as well as in relation to its utility or quality-adjusted outcomes (cost-utility), or simply by tabulating the costs involved (cost-identification). Direct costs are generated as services are provided. In addition, patients' productivity is affected, and these costs can be considered, especially in determining the benefit of a service that decreases morbidity or mortality. Intangible costs are those of pain, suffering, and grief. The point of view, or perspective, of the study determines the costs and benefits that will be measured in the analysis. Sensitivity analysis, which can evaluate the stability of the conclusions to the data used, is an important assessment within economic analysis. Economic analysis of new pharmaceutical therapies is increasingly being incorporated into clinical trials. Although there are some limitations of pharmacoeconomic information in clinical studies of drug safety and efficacy, these trials are often the only opportunity for economic data collection before adoption and reimbursement decisions are made. Validation after the drug has been introduced should complement economic information developed from clinical trials.

Authors
Schulman, KA; Ohishi, A; Park, J; Glick, HA; Eisenberg, JM
MLA Citation
Schulman, KA, Ohishi, A, Park, J, Glick, HA, and Eisenberg, JM. "Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials." Keio J Med 48.1 (March 1999): 1-11. (Review)
PMID
10206013
Source
pubmed
Published In
The Keio journal of medicine
Volume
48
Issue
1
Publish Date
1999
Start Page
1
End Page
11

The effect of race and sex on physicians' recommendations for cardiac catheterization.

BACKGROUND: Epidemiologic studies have reported differences in the use of cardiovascular procedures according to the race and sex of the patient. Whether the differences stem from differences in the recommendations of physicians remains uncertain. METHODS: We developed a computerized survey instrument to assess physicians' recommendations for managing chest pain. Actors portrayed patients with particular characteristics in scripted interviews about their symptoms. A total of 720 physicians at two national meetings of organizations of primary care physicians participated in the survey. Each physician viewed a recorded interview and was given other data about a hypothetical patient. He or she then made recommendations about that patient's care. We used multivariate logistic-regression analysis to assess the effects of the race and sex of the patients on treatment recommendations, while controlling for the physicians' assessment of the probability of coronary artery disease as well as for the age of the patient, the level of coronary risk, the type of chest pain, and the results of an exercise stress test. RESULTS: The physicians' mean (+/-SD) estimates of the probability of coronary artery disease were lower for women (probability, 64.1+/-19.3 percent, vs. 69.2+/-18.2 percent for men; P<0.001), younger patients (63.8+/-19.5 percent for patients who were 55 years old, vs. 69.5+/-17.9 percent for patients who were 70 years old; P<0.001), and patients with nonanginal pain (58.3+/-19.0 percent, vs. 64.4+/-18.3 percent for patients with possible angina and 77.1+/-14.0 percent for those with definite angina; P=0.001). Logistic-regression analysis indicated that women (odds ratio, 0.60; 95 percent confidence interval, 0.4 to 0.9; P=0.02) and blacks (odds ratio, 0.60; 95 percent confidence interval, 0.4 to 0.9; P=0.02) were less likely to be referred for cardiac catheterization than men and whites, respectively. Analysis of race-sex interactions showed that black women were significantly less likely to be referred for catheterization than white men (odds ratio, 0.4; 95 percent confidence interval, 0.2 to 0.7; P=0.004). CONCLUSIONS: Our findings suggest that the race and sex of a patient independently influence how physicians manage chest pain.

Authors
Schulman, KA; Berlin, JA; Harless, W; Kerner, JF; Sistrunk, S; Gersh, BJ; Dubé, R; Taleghani, CK; Burke, JE; Williams, S; Eisenberg, JM; Escarce, JJ
MLA Citation
Schulman, KA, Berlin, JA, Harless, W, Kerner, JF, Sistrunk, S, Gersh, BJ, Dubé, R, Taleghani, CK, Burke, JE, Williams, S, Eisenberg, JM, and Escarce, JJ. "The effect of race and sex on physicians' recommendations for cardiac catheterization." N Engl J Med 340.8 (February 25, 1999): 618-626.
PMID
10029647
Source
pubmed
Published In
The New England journal of medicine
Volume
340
Issue
8
Publish Date
1999
Start Page
618
End Page
626
DOI
10.1056/NEJM199902253400806

Towards a composite scoring solution for the Neurobehavioral Functioning Inventory.

Little research has been conducted towards the development and evaluation of a measure of quality of life specific to head/brain injury populations. Accordingly, we examined responses to the Neurobehavioral Functioning Inventory in the context of a clinical trial for head injury patients (n = 655) conducted in 14 countries. To reduce the 66 item scale into a smaller number of composite scales, principal components analysis was conducted. Scales were constructed assessing four categories of symptoms: cognitive deficits, depression, aggression and somatization. The internal reliabilities (alpha coefficient) of the four scales were generally acceptable (range = 0.79-0.92). Scores on all four scales correlated significantly with patient-rated overall quality of life and all but the aggression scale correlated significantly with overall clinical severity. The need for more formal evaluation of this and other disease-specific measures is discussed.

Authors
Weinfurt, KP; Willke, R; Glick, HA; Schulman, KA
MLA Citation
Weinfurt, KP, Willke, R, Glick, HA, and Schulman, KA. "Towards a composite scoring solution for the Neurobehavioral Functioning Inventory." Qual Life Res 8.1-2 (1999): 17-24.
PMID
10457735
Source
pubmed
Published In
Quality of Life Research
Volume
8
Issue
1-2
Publish Date
1999
Start Page
17
End Page
24

ACI-TIPI clinical trial [3] (multiple letters)

Authors
Weinfurt, KP; Rathore, SS; Schulman, KA; Selker, HP; Griffith, JL; Beshansky, JR
MLA Citation
Weinfurt, KP, Rathore, SS, Schulman, KA, Selker, HP, Griffith, JL, and Beshansky, JR. "ACI-TIPI clinical trial [3] (multiple letters)." Annals of Internal Medicine 131.6 (1999): 476-477.
Source
scival
Published In
Annals of internal medicine
Volume
131
Issue
6
Publish Date
1999
Start Page
476
End Page
477

Race, sex, and physicians' referrals for cardiac catheterization [1] (multiple letters)

Authors
Helft, G; Worthley, SG; Chokron, S; Davidoff, F; Schulman, KA; Berlin, JA; Escarce, JJ; Curfman, GD; Kassirer, JP
MLA Citation
Helft, G, Worthley, SG, Chokron, S, Davidoff, F, Schulman, KA, Berlin, JA, Escarce, JJ, Curfman, GD, and Kassirer, JP. "Race, sex, and physicians' referrals for cardiac catheterization [1] (multiple letters)." New England Journal of Medicine 341.4 (1999): 285-287.
PMID
10419386
Source
scival
Published In
The New England journal of medicine
Volume
341
Issue
4
Publish Date
1999
Start Page
285
End Page
287
DOI
10.1056/NEJM199907223410412

Treatment of hypertension in patients with comorbidities: Results from the study of hypertensive prescribing practices (SHyPP)

Approximately 50 million people have hypertension. Many agents with differing efficacy, side effects, dosing schedules, and costs are available to treat hypertension. Joint National Committee (JNC) guidelines attempt to simplify this decision by recommending specific agents based on special considerations such as comorbidities. The objective of this study was to survey primary care physicians' antihypertensive prescribing practices and their treatment recommendations for patients with comorbidities. A direct mail survey was sent to a national random sample of 500 office-based primary care internists, family practitioners, and general practitioners. There were no significant differences between initial treatment recommendations at the time of the survey and those recommended before the survey. However, there were several therapeutic classes whose reported utilization for specific comorbidities significantly changed over 18 months. Angiotensin converting enzyme (ACE) inhibitors reportedly increased in patients with congestive heart failure and diabetes. In addition, the reported use of selective β- blockers increased for patients with a history of myocardial infarction. Physicians did not follow JNC recommendations when initiating treatment in black patients, older patients, or those with mild renal failure. Younger physicians were more likely than older physicians to select agents consistent with guideline recommendations. Physicians did not adhere to JNC guidelines when initiating treatment in patients with comorbidities; however, more physicians are prescribing recommended agents today as compared to 18 months ago. Younger physicians were more likely to prescribe agents consistent with the guidelines. More direct efforts are needed to ensure awareness and compliance with these guidelines.

Authors
Mehta, SS; Wilcox, CS; Schulman, KA
MLA Citation
Mehta, SS, Wilcox, CS, and Schulman, KA. "Treatment of hypertension in patients with comorbidities: Results from the study of hypertensive prescribing practices (SHyPP)." American Journal of Hypertension 12.4 I (1999): 333-340.
Source
scival
Published In
American Journal of Hypertension
Volume
12
Issue
4 I
Publish Date
1999
Start Page
333
End Page
340
DOI
10.1016/S0895-7061(98)00270-2

ACE inhibitors in the management of congestive heart failure: Comparative economic data

Authors
Jr, WLB; Glick, HA; Schulman, KA
MLA Citation
Jr, WLB, Glick, HA, and Schulman, KA. "ACE inhibitors in the management of congestive heart failure: Comparative economic data." American Heart Journal 137.5 (1999): S115-S119.
Source
scival
Published In
American Heart Journal
Volume
137
Issue
5
Publish Date
1999
Start Page
S115
End Page
S119
DOI
10.1016/S0002-8703(99)70443-6

Traditional health outcomes in the evaluation of diagnostic tests

Authors
Bossuyt, PMM; Lijmer, JG; Beam, CA; Campbell, G; Burken, MI; Greenfield, S; Gatsonis, C; Bree, RL; Mushlin, AI; Dorfman, GS; Hillman, B; Schulman, K; Jarvik, JG
MLA Citation
Bossuyt, PMM, Lijmer, JG, Beam, CA, Campbell, G, Burken, MI, Greenfield, S, Gatsonis, C, Bree, RL, Mushlin, AI, Dorfman, GS, Hillman, B, Schulman, K, and Jarvik, JG. "Traditional health outcomes in the evaluation of diagnostic tests." Academic Radiology 6.SUPPL. 1 (1999): S77-S88.
PMID
9891171
Source
scival
Published In
Academic Radiology
Volume
6
Issue
SUPPL. 1
Publish Date
1999
Start Page
S77
End Page
S88
DOI
10.1016/S1076-6332(99)80092-0

Utilization of diagnostic tests: Assessing appropriateness

Authors
Dorfman, GS; Normand, S-LT; Flamm, CR; Greenfield, S; Hillman, B; Gatsonis, C; Bree, RL; Langlotz, CP; Mushlin, AI; Schulman, K
MLA Citation
Dorfman, GS, Normand, S-LT, Flamm, CR, Greenfield, S, Hillman, B, Gatsonis, C, Bree, RL, Langlotz, CP, Mushlin, AI, and Schulman, K. "Utilization of diagnostic tests: Assessing appropriateness." Academic Radiology 6.SUPPL. 1 (1999): S40-S57.
PMID
9891166
Source
scival
Published In
Academic Radiology
Volume
6
Issue
SUPPL. 1
Publish Date
1999
Start Page
S40
End Page
S57
DOI
10.1016/S1076-6332(99)80084-1

Racial differences in the use of invasive cardiac procedures: A continuous quality improvement approach

Authors
Sheifer, SE; Schulman, KA
MLA Citation
Sheifer, SE, and Schulman, KA. "Racial differences in the use of invasive cardiac procedures: A continuous quality improvement approach." American Heart Journal 138.3 I (1999): 396-399.
Source
scival
Published In
American Heart Journal
Volume
138
Issue
3 I
Publish Date
1999
Start Page
396
End Page
399
DOI
10.1016/S0002-8703(99)70138-9

Resource costing for multinational neurologic clinical trials: methods and results.

We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

Authors
Schulman, K; Burke, J; Drummond, M; Davies, L; Carlsson, P; Gruger, J; Harris, A; Lucioni, C; Gisbert, R; Llana, T; Tom, E; Bloom, B; Willke, R; Glick, H
MLA Citation
Schulman, K, Burke, J, Drummond, M, Davies, L, Carlsson, P, Gruger, J, Harris, A, Lucioni, C, Gisbert, R, Llana, T, Tom, E, Bloom, B, Willke, R, and Glick, H. "Resource costing for multinational neurologic clinical trials: methods and results." Health Econ 7.7 (November 1998): 629-638.
PMID
9845256
Source
pubmed
Published In
Health Economics
Volume
7
Issue
7
Publish Date
1998
Start Page
629
End Page
638

Prescription medication use in older Americans: a national report card on prescribing.

BACKGROUND AND OBJECTIVES: Due to their high prevalence of disease, older Americans receive more prescription medication than any other age group. We evaluated prescription medication use in patients age 50 or older; categorized and reported medication use by age group, drug class, and therapeutic class; and examined differences in prescribing patterns for older patients. METHODS: All prescription medications reported in the 1995 National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory care visits in the United States for patients age 50 and older (n = 16,289), were evaluated in a cross-sectional analysis. We evaluated the number of prescription medications reported for each patient visit and ranked use of drug and therapeutic classes. RESULTS: Most patients seeing physicians (61%) had a prescription for at least one medication, ranging from a mean of 1.27 medications in patients ages 50-64 to 1.58 in patients over 85. Calcium channel blockers and angiotensin-converting enzyme inhibitors were prescribed more than beta blockers in all patients. Data also indicated a significant decrease in estrogen/progestin and antidepressant medication use in older patients. CONCLUSIONS: Our findings indicate prescribing patterns inconsistent with national guidelines and decreased medication use, suggesting underprescription. Active intervention may be needed to improve the pharmacological treatment of older patients.

Authors
Rathore, SS; Mehta, SS; Boyko, WL; Schulman, KA
MLA Citation
Rathore, SS, Mehta, SS, Boyko, WL, and Schulman, KA. "Prescription medication use in older Americans: a national report card on prescribing." Fam Med 30.10 (November 1998): 733-739.
PMID
9827345
Source
pubmed
Published In
Family medicine
Volume
30
Issue
10
Publish Date
1998
Start Page
733
End Page
739

Estimating country-specific cost-effectiveness from multinational clinical trials.

Because costs and outcomes of medical treatments may vary from country to country in important ways, decision makers are increasingly interested in having data based on their own country's health care situations. This paper proposes methods for estimating country-specific cost-effectiveness ratios from data available from multinational clinical trials. It examines how clinical and economic outcomes interact when estimating treatment effects on cost and proposes empirical methods for capturing these interactions and incorporating them when making country-specific estimates. We use data from a multinational phase III trial of tirilazad mesylate for the treatment of subarachnoid haemorrhage to illustrate these methods. Our findings suggest that it is possible for meaningful country-by-country differences to be found in such trial data. These differences can be useful in informing reimbursement, utilization, and other decisions taken at the country level.

Authors
Willke, RJ; Glick, HA; Polsky, D; Schulman, K
MLA Citation
Willke, RJ, Glick, HA, Polsky, D, and Schulman, K. "Estimating country-specific cost-effectiveness from multinational clinical trials." Health Econ 7.6 (September 1998): 481-493.
PMID
9809707
Source
pubmed
Published In
Health Economics
Volume
7
Issue
6
Publish Date
1998
Start Page
481
End Page
493

Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.

In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

Authors
Neymark, N; Kiebert, W; Torfs, K; Davies, L; Fayers, P; Hillner, B; Gelber, R; Guyatt, G; Kind, P; Machin, D; Nord, E; Osoba, D; Revicki, D; Schulman, K; Simpson, K
MLA Citation
Neymark, N, Kiebert, W, Torfs, K, Davies, L, Fayers, P, Hillner, B, Gelber, R, Guyatt, G, Kind, P, Machin, D, Nord, E, Osoba, D, Revicki, D, Schulman, K, and Simpson, K. "Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop." Eur J Cancer 34.9 (August 1998): 1317-1333.
PMID
9849412
Source
pubmed
Published In
European Journal of Cancer
Volume
34
Issue
9
Publish Date
1998
Start Page
1317
End Page
1333

Outcomes and costs within a disease management program for advanced congestive heart failure.

Authors
Schulman, KA; Mark, DB; Califf, RM
MLA Citation
Schulman, KA, Mark, DB, and Califf, RM. "Outcomes and costs within a disease management program for advanced congestive heart failure." Am Heart J 135.6 Pt 2 Su (June 1998): S285-S292. (Review)
PMID
9630091
Source
pubmed
Published In
American Heart Journal
Volume
135
Issue
6 Pt 2 Su
Publish Date
1998
Start Page
S285
End Page
S292

Physician resource use and willingness to participate in assisted suicide.

OBJECTIVE: To explore the relationship between general internists' tendency to conserve medical resources and their willingness to participate in physician-assisted suicide (PAS). DESIGN AND PARTICIPANTS: Survey of a random sample of general internists in 6 urban areas of the United States. MEASUREMENTS: We assessed the physicians' use of medical resources by constructing a scale based on 6 hypothetical clinical scenarios in which respondents were given a choice between resource-intensive and resource-conserving options. We then presented a scenario of a competent terminally ill patient with breast cancer making stable and persistent requests for PAS. RESULTS: Sixty-seven (33%) of the 206 respondents indicated that they would participate in the suicide of the depicted patient. In a multivariate model, physicians who were more conservative with resources were 6.4 times more likely than their resource-intensive counterparts to prescribe the requested drugs (P = .02); minority physicians were less willing than whites to participate in PAS (odds ratio, 0.34; P = .03). Physicians' number of years in practice, location, sex, reported percentage of fee-for-service patients, and self-reported strength and direction of financial incentives in the respondents' practices were not associated with willingness to prescribe drugs for PAS. CONCLUSIONS: Most general internists, especially minority physicians, are personally reluctant to participate in PAS. While the characteristics of their practices do not affect PAS, physicians who tend to practice resource-conserving medicine are significantly more likely than their resource-intensive counterparts to provide a lethal prescription at the request of a terminally ill patient.

Authors
Sulmasy, DP; Linas, BP; Gold, KF; Schulman, KA
MLA Citation
Sulmasy, DP, Linas, BP, Gold, KF, and Schulman, KA. "Physician resource use and willingness to participate in assisted suicide." Arch Intern Med 158.9 (May 11, 1998): 974-978.
PMID
9588430
Source
pubmed
Published In
Archives of internal medicine
Volume
158
Issue
9
Publish Date
1998
Start Page
974
End Page
978

Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage: Economic evaluation of a phase III clinical trial in Europe and Australia

This study used data from a multinational phase III randomized, double- blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox®) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.

Authors
Glick, H; Willke, R; Polsky, D; Liana, T; Alves, WM; Kassell, N; Schulman, K
MLA Citation
Glick, H, Willke, R, Polsky, D, Liana, T, Alves, WM, Kassell, N, and Schulman, K. "Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage: Economic evaluation of a phase III clinical trial in Europe and Australia." International Journal of Technology Assessment in Health Care 14.1 (March 18, 1998): 145-160. (Review)
Source
scopus
Published In
International Journal of Technology Assessment in Health Care
Volume
14
Issue
1
Publish Date
1998
Start Page
145
End Page
160

Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin's and non-Hodgkin's lymphoma. IL-3 BMT Study Team.

Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79892 (95% CI $69343 to $90544) for patients receiving GM-CSF alone and $89651 (95% CI $79769 to $102114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective.

Authors
Schulman, KA; Dorsainvil, D; Yabroff, KR; DiCesare, J; Felser, J; Eisenberg, JM; Glick, HA
MLA Citation
Schulman, KA, Dorsainvil, D, Yabroff, KR, DiCesare, J, Felser, J, Eisenberg, JM, and Glick, HA. "Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin's and non-Hodgkin's lymphoma. IL-3 BMT Study Team." Bone Marrow Transplant 21.6 (March 1998): 607-614.
PMID
9543065
Source
pubmed
Published In
Bone Marrow Transplantation
Volume
21
Issue
6
Publish Date
1998
Start Page
607
End Page
614
DOI
10.1038/sj.bmt.1701142

Comparison of the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage between Canada and the United States.

OBJECTIVE: Using data from a randomized trial of tirilazad mesylate, we assessed the differences between Canada and the United States in the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage during the first 90 days after admission to the hospital. METHODS: Of the 877 patients for whom economic data were available, 194 were enrolled in Canada and 683 were enrolled in the United States. The differences between the countries in patient characteristics, use of medical resources, and outcomes were analyzed by comparing means and the 95% confidence intervals (CIs) around the differences in means. These differences also were predicted with use of multivariable regression analysis. RESULTS: The average hospital stay was 4.2 days longer (95% CI, 1.3 to 7.1 days) in Canada, but most of the extra stay was among patients admitted to the study in poor neurological condition. In general, however, hospital stays in Canada were substantially less intensive. Patients treated in Canada spent 3.7 fewer days (95% CI, 1.2 to 6.1 days) in nursing homes and rehabilitation centers than did patients in the United States. No statistically significant differences were seen for Glasgow Outcome Scale score, death, and occurrence of vasospasm. CONCLUSIONS: For patients admitted to the study in good neurological condition, the apparent difference in length of stay between Canada and the United States was caused by a shift in the sites of formal care rather than to the length of this care. For those admitted in poor neurological condition, both the length and sites of care differed between the two countries. No significant difference in outcomes appeared to justify these differences in the use of medical resources.

Authors
Glick, HA; Polsky, D; Willke, RJ; Alves, WM; Kassell, N; Schulman, K
MLA Citation
Glick, HA, Polsky, D, Willke, RJ, Alves, WM, Kassell, N, and Schulman, K. "Comparison of the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage between Canada and the United States." Stroke 29.2 (February 1998): 351-358.
PMID
9472873
Source
pubmed
Published In
Stroke
Volume
29
Issue
2
Publish Date
1998
Start Page
351
End Page
358

Treatment choices by seriously ill patients: the Health Stock Risk Adjustment model.

Anecdotal evidence suggests that patients who have life-threatening conditions often choose to undergo high-cost, high-risk treatments for them. This kind of risk-seeking behavior seems irrational because most patients are risk-averse. The Health Stock Risk Adjustment (HSRA) model seeks to explain this phenomenon. The model is based on the concept of relative health stock--the ratio of patients' expected quality-adjusted life years (QALYs) after a diagnosis to their expected QALYs before the diagnosis. The model predicts risk-averse patients will behave in a risk-seeking manner as their relative health stocks deteriorate. The HSRA model can help physicians better understand why some seriously ill patients seek high-risk treatments while others elect to forgo treatment. State legislatures and insurers are attempting to appropriately design insurance benefits for patients with life-threatening conditions. The HSRA model can help predict which patients will most likely take advantage of these benefits.

Authors
Gaskin, DJ; Kong, J; Meropol, NJ; Yabroff, KR; Weaver, C; Schulman, KA
MLA Citation
Gaskin, DJ, Kong, J, Meropol, NJ, Yabroff, KR, Weaver, C, and Schulman, KA. "Treatment choices by seriously ill patients: the Health Stock Risk Adjustment model." Med Decis Making 18.1 (January 1998): 84-94.
PMID
9456213
Source
pubmed
Published In
Medical Decision Making
Volume
18
Issue
1
Publish Date
1998
Start Page
84
End Page
94
DOI
10.1177/0272989X9801800116

Evaluating cancer costs in NCI trials.

Economic evaluation is playing an increasingly important role in the assessment of clinical treatment strategies for cancer patients. Physicians and patients can use the comprehensive data on the cost and effectiveness of cancer therapies emerging from economic studies to help make treatment decisions. The data from economic analyses will afford clinical investigators an increasingly important tool to help determine the optimal treatment strategies for cancer patients and to help inform health policy decision-makers about the importance of specific cancer therapeutic strategies. In this chapter, we have outlined a set of procedures that can be used to assess the costs of care within NCI clinical trials. We review the economic framework for assessment of clinical trials, then review a proposed strategy for economic assessment. The design was successfully implemented, and the results have been recently published.

Authors
Schulman, KA; Boyko, WL
MLA Citation
Schulman, KA, and Boyko, WL. "Evaluating cancer costs in NCI trials." Cancer Treat Res 97 (1998): 37-52. (Review)
PMID
9711408
Source
pubmed
Published In
Cancer Treatment and Research
Volume
97
Publish Date
1998
Start Page
37
End Page
52

Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. Economic evaluation of a phase III clinical trial in Europe and Australia.

This study used data from a multinational phase III randomized, double-blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.

Authors
Glick, H; Willke, R; Polsky, D; Llana, T; Alves, WM; Kassell, N; Schulman, K
MLA Citation
Glick, H, Willke, R, Polsky, D, Llana, T, Alves, WM, Kassell, N, and Schulman, K. "Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage. Economic evaluation of a phase III clinical trial in Europe and Australia." Int J Technol Assess Health Care 14.1 (1998): 145-160.
PMID
9509802
Source
pubmed
Published In
International Journal of Technology Assessment in Health Care
Volume
14
Issue
1
Publish Date
1998
Start Page
145
End Page
160

The Mather et al Article Reviewed

Authors
Schulman, K
MLA Citation
Schulman, K. "The Mather et al Article Reviewed." ONCOLOGY 12.2 (1998): 219-223.
Source
scival
Published In
ONCOLOGY
Volume
12
Issue
2
Publish Date
1998
Start Page
219
End Page
223

Outcomes and costs within a disease management program for advanced congestive heart failure

Disease management programs offer the potential to improve the care of patients with advanced congestive heart failure, to provide accountability on the part of managed care programs to payers and employers for the care of these patients, and to improve the efficiency of MCOs. Implementation of a disease management program entails two steps: (1) evaluation and proof of the disease management concept and (2) ongoing monitoring for the continuous quality improvement process outlined in this article. Once the concept of disease management for patients with congestive heart failure has been proven to be an effective and efficient concept, it can then be implemented on a wider basis across MCOs.

Authors
Schulman, KA; Mark, DB; Califf, RM
MLA Citation
Schulman, KA, Mark, DB, and Califf, RM. "Outcomes and costs within a disease management program for advanced congestive heart failure." American Heart Journal 135.6 II SUPPL. (1998): S285-S292.
Source
scival
Published In
American Heart Journal
Volume
135
Issue
6 II SUPPL.
Publish Date
1998
Start Page
S285
End Page
S292

Physician-assisted suicide [1] (multiple letters)

Authors
Malter, A; Sulmasy, DP; Schulman, KA
MLA Citation
Malter, A, Sulmasy, DP, and Schulman, KA. "Physician-assisted suicide [1] (multiple letters)." Archives of Internal Medicine 158.22 (1998): 2513--.
PMID
9855391
Source
scival
Published In
Archives of internal medicine
Volume
158
Issue
22
Publish Date
1998
Start Page
2513-

Beyond survival: Economic analyses of chemotherapy in advanced, inoperable NSCLC

Research shows that chemotherapy for inoperable non-small-cell lung cancer (NSCLC) improves survival. The economic implications of this treatment choice may be substantial. This paper reviews studies examining the cost- effectiveness of chemotherapy in this setting. MEDLINE, PDQ, Cancerlit, EMBASE, and the Nursing and Allied Health databases were searched using the terms cost, cost-effectiveness, chemotherapy, and non-small-cell lung cancer. The search identified 17 studies. Most of these studies utilized data from various sources to model the impact and cost of chemotherapy. The remaining studies were concurrent or retrospective analyses of individual clinical trials. Findings suggest that chemotherapy for stages IIIb and IV non-small- cell lung cancer can be cost-effective and, in some cases, may actually be less expensive than supportive care alone. Economic analyses also indicate that allocating resources for chemotherapy in this setting can be justified relative to many treatment expenditures for other types of cancer and other diseases. Application of these findings may be hindered by the wide variety of techniques used and by several methodologic issues, including the failure to address patients' treatment preferences. Yet, economic analyses of inoperable non-small-cell lung cancer can provide important information to complement survival and quality-of-life data in resource allocation decisions.

Authors
Mather, D; Sullivan, SD; Parasuraman, TV; Smith, TJ; Mitchell, RB; Schulman, K
MLA Citation
Mather, D, Sullivan, SD, Parasuraman, TV, Smith, TJ, Mitchell, RB, and Schulman, K. "Beyond survival: Economic analyses of chemotherapy in advanced, inoperable NSCLC." ONCOLOGY 12.2 (1998): 199-223.
PMID
9507521
Source
scival
Published In
Oncology
Volume
12
Issue
2
Publish Date
1998
Start Page
199
End Page
223

Hemodialysis patient management by telemedicine: design and implementation.

The authors describe the design and implementation of a personal computer based telemedicine system for managing patients by telemedicine. With three identical systems connected by high speed T1 lines, the physician (or allied healthcare giver) can interact, by videoconferencing, and by using multimedia files, with patients at two remote hemodialysis sites. The physician is able to visualize specifically the patient's fistula/graft, and auscultate fistula, heart and lung sounds, and incorporate still pictures or audio sounds in the patient's multimedia database folder, which also contains an electronic and paperless medical record. In addition there is the capability of downloading into this database all the machine parameters during dialysis.

Authors
Winchester, JF; Tohme, WG; Schulman, KA; Collmann, J; Johnson, A; Meissner, MC; Rathore, S; Khanafer, N; Eisenberg, JM; Mun, SK
MLA Citation
Winchester, JF, Tohme, WG, Schulman, KA, Collmann, J, Johnson, A, Meissner, MC, Rathore, S, Khanafer, N, Eisenberg, JM, and Mun, SK. "Hemodialysis patient management by telemedicine: design and implementation." ASAIO J 43.5 (September 1997): M763-M766.
PMID
9360149
Source
pubmed
Published In
ASAIO Journal
Volume
43
Issue
5
Publish Date
1997
Start Page
M763
End Page
M766

Resource utilization control processes as indicators of quality in managed care organizations: a proposal.

Central to the development of a competitive market for managed care products is the ability to measure the quality of care provided by individual managed care organizations (MCOs). Several types of quality measures could be considered for this purpose: patient and provider satisfaction, a listing of specific services provided to patients, or clinical outcomes of such services. Although assessing quality with measures of the process of care is commonplace, we propose developing measures of the production processes that control utilization of health care resources within an organization. Evaluation of these production or resource utilization control processes, although not a substitute for health outcomes assessment, may improve our knowledge of the delivery of services within managed care organizations. We present a paradigm for evaluation of health care resource utilization control processes within managed care organizations based on our description of internal and external controls for health care resource management. This paradigm can serve as a framework for further research into the quality of care provided by these organizations and the processes of health care resource management in MCOs.

Authors
Roulidis, ZC; DeChant, HK; Schulman, KA
MLA Citation
Roulidis, ZC, DeChant, HK, and Schulman, KA. "Resource utilization control processes as indicators of quality in managed care organizations: a proposal." Am J Med 103.2 (August 1997): 146-151.
PMID
9274898
Source
pubmed
Published In
The American Journal of Medicine
Volume
103
Issue
2
Publish Date
1997
Start Page
146
End Page
151

Access to bone marrow transplantation for leukemia and lymphoma: the role of sociodemographic factors.

PURPOSE: Use of bone marrow transplantation (BMT), a complex, costly treatment for many forms of cancers, has increased significantly in recent years. The increasingly competitive health care marketplace raises concerns about patient access to costly medical procedures such as BMT. We attempted to evaluate patient access to BMT for the treatment of leukemias and lymphomas. METHODS: We analyzed inpatient hospital discharge data from four states (California, Maryland, Massachusetts, and New York) for 2 years (1988 and 1991) to examine whether the use of BMT for patients with either leukemia or lymphoma varies by sociodemographic characteristics and insurance coverage. We developed a sorting algorithm to collapse the discharge data into patient level records. We used logistic regression to analyze the odds of receiving a BMT stratified by disease type (leukemia or lymphoma). RESULTS: After controlling for other factors, black patients with leukemia are 51% to 53% as likely as whites, while black patients with lymphoma are 34% to 45% as likely as white patients to undergo a BMT (P < .05). Medicaid, self-pay patients, and Health Maintenance Organization (HMO) enrollees with either leukemia or lymphoma are significantly less likely to undergo a BMT compared with patients with private insurance. Younger patients are significantly more predisposed to undergo a BMT than older patients. The odds of receiving a BMT have increased over time, but the rates of increase vary by state. Consistent with clinical expectations, the relative odds of BMT vary significantly by type of leukemia or lymphoma. CONCLUSION: Substantial variation exists in access to BMT for patients with either leukemia or lymphoma. Black patients, those enrolled in HMOs, those covered by Medicaid, and self-pay patients were less likely to receive a BMT when admitted for either leukemia or lymphoma. These findings raise concerns about access to cancer treatments for patients in the current health care system.

Authors
Mitchell, JM; Meehan, KR; Kong, J; Schulman, KA
MLA Citation
Mitchell, JM, Meehan, KR, Kong, J, and Schulman, KA. "Access to bone marrow transplantation for leukemia and lymphoma: the role of sociodemographic factors." J Clin Oncol 15.7 (July 1997): 2644-2651.
PMID
9215836
Source
pubmed
Published In
Journal of Clinical Oncology
Volume
15
Issue
7
Publish Date
1997
Start Page
2644
End Page
2651
DOI
10.1200/JCO.1997.15.7.2644

Development and validation of a rhinoconjunctivitis and asthma symptom score for use as an outcome measure in clinical trials.

BACKGROUND: The measurement of health outcomes has become a priority for assessing and containing health care costs. OBJECTIVE: To develop and fully validate a simple symptom scale assessing both asthma and rhinoconjunctivitis, two interdependent conditions. METHODS: A self-administered questionnaire of 31 items was tested in 102 patients with asthma and rhinoconjunctivitis between September 1992 and December 1994. The items were rated on a six-point Likert scale ranging from none to extremely severe and included commonly recorded symptoms of inflammation such as irritation, congestion, and discharge in the skin, eyes, nose, sinus, pharynx, and chest. RESULTS: Validation included (1) responsiveness: scores for 18 patients evaluated during an emergency room visit were statistically significantly different from those recorded after recovery and in a control group of 24 patients with asthma; (2) reliability: external consistency was 0.8 at 1 week, and internal consistency was 0.8 for individual organs and 0.7 for individual symptoms; (3) validity: a five-point scale better captured the distribution of values; irrelevant and redundant items were eliminated. The optimal questionnaire included 21 items. CONCLUSIONS: The symptom score was applicable, responsive, reliable, and valid. Used with existing validated tools such as treatment needs and quality of life assessment, it may provide a comprehensive picture of allergic airway disease for quality assurance or research purposes.

Authors
Wasserfallen, JB; Gold, K; Schulman, KA; Baraniuk, JN
MLA Citation
Wasserfallen, JB, Gold, K, Schulman, KA, and Baraniuk, JN. "Development and validation of a rhinoconjunctivitis and asthma symptom score for use as an outcome measure in clinical trials." J Allergy Clin Immunol 100.1 (July 1997): 16-22.
PMID
9257782
Source
pubmed
Published In
Journal of Allergy and Clinical Immunology
Volume
100
Issue
1
Publish Date
1997
Start Page
16
End Page
22

A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST).

This trial evaluated the effects of epoprostenol on patients with severe left ventricular failure. Patients with class IIIB/IV congestive heart failure and decreased left ventricular ejection fraction were eligible for enrollment if angiography documented severely compromised hemodynamics while the patient was receiving a regimen of digoxin, diuretics, and an angiotensin-converting enzyme inhibitor. We randomly assigned 471 patients to epoprostenol infusion or standard care. The primary end point was survival; secondary end points were clinical events, congestive heart failure symptoms, distance walked in 6 minutes, and quality-of-life measures. The median dose of epoprostenol was 4.0 ng/kg/min, resulting in a significant increase in cardiac index (1.81 to 2.61 L/min/m2), a decrease in pulmonary capillary wedge pressure (24.5 to 20.0 mm Hg), and a decrease in systemic vascular resistance (20.76 to 12.33 units). The trial was terminated early because of a strong trend toward decreased survival in the patients treated with epoprostenol. Chronic intravenous epoprostenol therapy is not associated with improvement in distance walked, quality of life, or morbid events and is associated with an increased risk of death.

Authors
Califf, RM; Adams, KF; McKenna, WJ; Gheorghiade, M; Uretsky, BF; McNulty, SE; Darius, H; Schulman, K; Zannad, F; Handberg-Thurmond, E; Harrell, FE; Wheeler, W; Soler-Soler, J; Swedberg, K
MLA Citation
Califf, RM, Adams, KF, McKenna, WJ, Gheorghiade, M, Uretsky, BF, McNulty, SE, Darius, H, Schulman, K, Zannad, F, Handberg-Thurmond, E, Harrell, FE, Wheeler, W, Soler-Soler, J, and Swedberg, K. "A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST)." Am Heart J 134.1 (July 1997): 44-54.
PMID
9266782
Source
pubmed
Published In
American Heart Journal
Volume
134
Issue
1
Publish Date
1997
Start Page
44
End Page
54

Confidence intervals for cost-effectiveness ratios: a comparison of four methods.

We evaluated four methods for computing confidence intervals for cost-effectiveness ratios developed from randomized controlled trials: the box method, the Taylor series method, the nonparametric bootstrap method and the Fieller theorem method. We performed a Monte Carlo experiment to compare these methods. We investigated the relative performance of each method and assessed whether or not it was affected by differing distributions of costs (normal and log normal) and effects (10% absolute difference in mortality resulting from mortality rates of 25% versus 15% in the two groups as well as from mortality rates of 55% versus 45%) or by differing levels of correlation between the costs and effects (correlations of -0.50, -0.25, 0.0, 0.25 and 0.50). The principal criterion used to evaluate the performance of the methods was the probability of miscoverage. Symmetrical miscoverage of the intervals was used as a secondary criterion for evaluating the four methods. Overall probabilities of miscoverage for the nonparametric bootstrap method and the Fieller theorem method were more accurate than those for the other the methods. The Taylor series method had confidence intervals that asymmetrically underestimated the upper limit of the interval. Confidence intervals for cost-effectiveness ratios resulting from the nonparametric bootstrap method and the Fieller theorem method were more dependably accurate than those estimated using the Taylor series or box methods. Routine reporting of these intervals will allow individuals using cost-effectiveness ratios to make clinical and policy judgments to better identify when an intervention is a good value for its cost.

Authors
Polsky, D; Glick, HA; Willke, R; Schulman, K
MLA Citation
Polsky, D, Glick, HA, Willke, R, and Schulman, K. "Confidence intervals for cost-effectiveness ratios: a comparison of four methods." Health Econ 6.3 (May 1997): 243-252.
PMID
9226142
Source
pubmed
Published In
Health Economics
Volume
6
Issue
3
Publish Date
1997
Start Page
243
End Page
252

Quality assessment in contracting for tertiary care services by HMOs: a case study of three markets.

BACKGROUND: Few studies have examined the provision of tertiary care services by managed care organizations (MCOs). Moreover, little is known about the role of quality assessment and quality assurance mechanisms in the contracting process. Site visits were conducted in 1995 in three geographic areas to describe and evaluate the contracting processes for tertiary care services, especially neonatal intensive care and coronary artery bypass graft surgery, of health maintenance organizations (HMOs). METHODS: Three market areas in the United States, each with differing levels of "maturity", as primarily defined in terms of managed care penetration, were selected for study. Interviews were conducted with HMO and hospital managers about the processes for identifying potential tertiary care hospitals and mechanisms for quality assessment and quality improvement (QI) that are considered in the contracting process. FINDINGS: The most sophisticated contracting arrangements were found in the most mature market-where HMOs select hospitals for tertiary care services based on both the price and quality of services, with quality assessed through both objective and subjective data. Yet in all three markets, quality assessment was the least well-developed component of tertiary care contracting. Even in the mature market, we found inconsistent use of even validated quality or outcomes measures in hospital contracting. CONCLUSION: The potential of MCOs to increase quality depends on their ability to identify high-quality hospitals and their willingness to direct enrollees to those hospitals. Yet inconsistent evidence was found that mechanisms for evaluating and rewarding quality are being fully adopted in the three markets studied.

Authors
Schulman, KA; Rubenstein, LE; Seils, DM; Harris, M; Hadley, J; Escarce, JJ
MLA Citation
Schulman, KA, Rubenstein, LE, Seils, DM, Harris, M, Hadley, J, and Escarce, JJ. "Quality assessment in contracting for tertiary care services by HMOs: a case study of three markets." Jt Comm J Qual Improv 23.2 (February 1997): 117-127.
PMID
9061441
Source
pubmed
Published In
The Joint Commission journal on quality improvement
Volume
23
Issue
2
Publish Date
1997
Start Page
117
End Page
127

Mathematical models in decision analysis.

Decision analysis offers powerful techniques to understand and evaluate uncertain clinical situations better. Decision analytic models are appearing with increasing frequency in health policy planning, clinical information and decision-support computer systems, evaluations of clinical pathways, development of clinical practice or utilization review guidelines, and epidemiologic research. This article describes the structure, application, and limitations of the more popular decision analytic methods, including decision trees, Markov models, Monte Carlo simulation, survival and hazard functions, fuzzy logic, and sensitivity analysis. Understanding the nature of these methods will help readers to assess better the appropriateness of their use in published reports.