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Reed, Shelby Derene

Overview:

Shelby D. Reed, PhD, is a professor in medicine at the Duke University School of Medicine. She works primarily at the Duke Clinical Research Institute. Dr. Reed holds a PhD in pharmaceutical health services research from the University of Maryland School of Pharmacy and completed a 2-year postdoctoral fellowship in the Pharmaceutical Outcomes Research and Policy Program and the Center for AIDS Research at the University of Washington. Dr. Reed has nearly 20 years of experience in economic evaluation, health services research and health policy. Dr. Reed has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of medical diagnostics and interventions in numerous therapeutic areas. She was a member of the ISPOR Task Forces that published recommendations for Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials in 2005 and 2015. She has led a wide range of economic and epidemiological studies using secondary data from health care claims, clinical trials, surveys and disease registries. In her evaluations of health policy issues, she has developed computer models to analyze the potential economic impact of trends in clinical trial design, changes in reimbursement policies, financial incentives and the regulatory process in the development of orphan drugs, and the societal value of alternative approaches to identifying drug safety problems. 

Positions:

Professor in Medicine

Medicine, General Internal Medicine
School of Medicine

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

Education:

Ph.D. 1998

Ph.D. — University of Maryland, College Park

Grants:

Urinary Stone Disease Research Network: Scientific Data Research Center

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
September 01, 2016
End Date
August 31, 2021

Improving Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients

Administered By
Psychiatry & Behavioral Sciences, Behavioral Medicine
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
July 01, 2016
End Date
June 30, 2021

Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART

Administered By
Psychiatry & Behavioral Sciences, Behavioral Medicine
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
June 01, 2016
End Date
May 31, 2021

Patient-centered home-based hematopoietic stem cell transplantation

Administered By
Medicine, Cellular Therapy
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
May 01, 2016
End Date
April 30, 2021

National Utilization Patterns of Oncotype DX in Early Stage Breast Cancer

Administered By
Duke Clinical Research Institute
AwardedBy
Agency for Healthcare Research and Quality
Role
Mentor
Start Date
August 01, 2015
End Date
July 31, 2018

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

Incentivizing behavior change skills to promote weight loss

Administered By
School of Nursing
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
August 01, 2015
End Date
April 30, 2018

Multi-factorial Intervention to Slow Progression of Diabetic Kidney Disease

Administered By
Medicine, General Internal Medicine
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
May 15, 2013
End Date
April 30, 2018

Cardiovascular Risk Profile of LAL Deficiency Patients

Administered By
Duke Clinical Research Institute
AwardedBy
Alexion Pharmaceuticals, Inc.
Role
Principal Investigator
Start Date
December 01, 2016
End Date
November 30, 2017

Stated-Preferences in Knee Arthroplasty

Administered By
Duke Clinical Research Institute
AwardedBy
Zimmer, Inc.
Role
Co Investigator
Start Date
July 27, 2016
End Date
October 31, 2017

Optimizing treatment for E. faecalis infective endocarditis: ampicillin plus ceftriaxone versus ampicillin plus gentamicin

Administered By
Duke Clinical Research Institute
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
August 01, 2016
End Date
July 31, 2017

Integrated Population Program for Diabetic Kidney Disease

Administered By
Medicine, General Internal Medicine
AwardedBy
National Institutes of Health
Role
Economist
Start Date
August 01, 2014
End Date
July 31, 2017

Thyrogen Utilization Patterns in the Treatment of Thyroid Cancer

Administered By
Duke Clinical Research Institute
AwardedBy
Genzyme Corporation
Role
Co Investigator
Start Date
June 30, 2015
End Date
June 30, 2017

REHAB HF

Administered By
Duke Clinical Research Institute
AwardedBy
Wake Forest University Health Sciences
Role
Principal Investigator
Start Date
June 01, 2014
End Date
March 31, 2017

Tissue and Data Acquisition Activity for the Study of Gynecologic Disease

Administered By
Obstetrics and Gynecology, Gynecologic Oncology
AwardedBy
Henry M. Jackson Foundation
Role
Collaborator
Start Date
August 19, 2016
End Date
February 28, 2017

Janssen TIDM Diabetes Study

Administered By
Duke Clinical Research Institute
AwardedBy
Janssen Research & Development, LLC
Role
Principal Investigator
Start Date
November 17, 2015
End Date
December 31, 2016

Patient Valued Comparative Effectiveness of Corticosteroids Versus Anti-TF Alpha Therapy

Administered By
Duke Clinical Research Institute
AwardedBy
University of Pennsylvania
Role
Principal Investigator
Start Date
February 01, 2014
End Date
December 31, 2016

Preference Studies in Alzheimer's Disease

Administered By
Duke Clinical Research Institute
AwardedBy
Janssen Research & Development, LLC
Role
Principal Investigator
Start Date
June 04, 2015
End Date
June 30, 2016

Pharmacogenetic Testing: Challenges of Clinical Integration

Administered By
Institutes and Centers
AwardedBy
National Institutes of Health
Role
Co Investigator
Start Date
July 01, 2007
End Date
August 31, 2015

Cardiac Imaging

Administered By
Duke Clinical Research Institute
AwardedBy
BC Cancer Research Centre
Role
Co Investigator
Start Date
July 01, 2014
End Date
January 31, 2015

Hospice to Palliative Care: Maximizing Patient Preference and Cost Savings

Administered By
Center for Health Policy & Inequalities Research
AwardedBy
Agency for Healthcare Research and Quality
Role
Investigator
Start Date
September 30, 2009
End Date
July 31, 2014

Tools for Economic Analysis of Patient Management Interventions in Heart Failure

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

HF Action Supplement

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

Take Control of Your Blood Pressure (TCYB) Study

Administered By
Medicine, General Internal Medicine
AwardedBy
National Institutes of Health
Role
Economist
Start Date
June 01, 2003
End Date
January 31, 2010

ACTION EQOL STUDY

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

Management of Allergic Rhinitis in the Working-Aged Population

Administered By
Institutes and Centers
AwardedBy
Agency for Healthcare Research and Quality
Role
Investigator
Start Date
September 04, 2001
End Date
March 03, 2003
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Publications:

Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale.

BACKGROUND: Acute decompensated heart failure (ADHF) is a leading cause of hospitalization in older persons in the United States. Reduced physical function and frailty are major determinants of adverse outcomes in older patients with hospitalized ADHF. However, these are not addressed by current heart failure (HF) management strategies and there has been little study of exercise training in older, frail HF patients with recent ADHF. HYPOTHESIS: Targeting physical frailty with a multi-domain structured physical rehabilitation intervention will improve physical function and reduce adverse outcomes among older patients experiencing a HF hospitalization. STUDY DESIGN: REHAB-HF is a multi-center clinical trial in which 360 patients ≥60 years hospitalized with ADHF will be randomized either to a novel 12-week multi-domain physical rehabilitation intervention or to attention control. The goal of the intervention is to improve balance, mobility, strength and endurance utilizing reproducible, targeted exercises administered by a multi-disciplinary team with specific milestones for progression. The primary study aim is to assess the efficacy of the REHAB-HF intervention on physical function measured by total Short Physical Performance Battery score. The secondary outcome is 6-month all-cause rehospitalization. Additional outcome measures include quality of life and costs. CONCLUSIONS: REHAB-HF is the first randomized trial of a physical function intervention in older patients with hospitalized ADHF designed to determine if addressing deficits in balance, mobility, strength and endurance improves physical function and reduces rehospitalizations. It will address key evidence gaps concerning the role of physical rehabilitation in the care of older patients, those with ADHF, frailty, and multiple comorbidities.

Authors
Reeves, GR; Whellan, DJ; Duncan, P; O'Connor, CM; Pastva, AM; Eggebeen, JD; Hewston, LA; Morgan, TM; Reed, SD; Rejeski, WJ; Mentz, RJ; Rosenberg, PB; Kitzman, DW; REHAB-HF Trial Investigators,
MLA Citation
Reeves, GR, Whellan, DJ, Duncan, P, O'Connor, CM, Pastva, AM, Eggebeen, JD, Hewston, LA, Morgan, TM, Reed, SD, Rejeski, WJ, Mentz, RJ, Rosenberg, PB, Kitzman, DW, and REHAB-HF Trial Investigators, . "Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale." Am Heart J 185 (March 2017): 130-139.
PMID
28267466
Source
pubmed
Published In
American Heart Journal
Volume
185
Publish Date
2017
Start Page
130
End Page
139
DOI
10.1016/j.ahj.2016.12.012

Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes?

To determine the number of total thyroidectomies per surgeon per year associated with the lowest risk of complications.The surgeon volume-outcome association has been established for thyroidectomy; however, a threshold number of cases defining a "high-volume" surgeon remains unclear.Adults undergoing total thyroidectomy were identified from the Health Care Utilization Project-National Inpatient Sample (1998-2009). Multivariate logistic regression with restricted cubic splines was utilized to examine the association between the number of annual total thyroidectomies per surgeon and risk of complications.Among 16,954 patients undergoing total thyroidectomy, 47% had thyroid cancer and 53% benign disease. Median annual surgeon volume was 7 cases; 51% of surgeons performed 1 case/y. Overall, 6% of the patients experienced complications. After adjustment, the likelihood of experiencing a complication decreased with increasing surgeon volume up to 26 cases/y (P < 0.01). Among all patients, 81% had surgery by low-volume surgeons (≤25 cases/y). With adjustment, patients undergoing surgery by low-volume surgeons were more likely to experience complications (odds ratio 1.51, P = 0.002) and longer hospital stays (+12%, P = 0.006). Patients had an 87% increase in the odds of having a complication if the surgeon performed 1 case/y, 68% for 2 to 5 cases/y, 42% for 6 to 10 cases/y, 22% for 11 to 15 cases/y, 10% for 16 to 20 cases/y, and 3% for 21 to 25 cases/y.This is the first study to identify a surgeon volume threshold (>25 total thyroidectomies/y) that is associated with improved patient outcomes. Identifying a threshold number of cases defining a high-volume thyroid surgeon is important, as it has implications for quality improvement, criteria for referral and reimbursement, and surgical education.

Authors
Adam, MA; Thomas, S; Youngwirth, L; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Thomas, S, Youngwirth, L, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes?." Annals of surgery 265.2 (February 2017): 402-407.
PMID
28059969
Source
epmc
Published In
Annals of Surgery
Volume
265
Issue
2
Publish Date
2017
Start Page
402
End Page
407
DOI
10.1097/sla.0000000000001688

Cost Comparison of Genetic Testing Strategies in Women With Epithelial Ovarian Cancer.

The advent of multigene panels has increased genetic testing options for women with epithelial ovarian cancer (EOC). We designed a decision model to compare costs and probabilities of identifying a deleterious mutation or variant of uncertain significance (VUS) using different genetic testing strategies.A decision model was developed to compare costs and outcomes of two testing strategies for women with EOC: multigene testing (MGT) versus single-gene testing for BRCA1/2. Outcomes were mean cost and number of deleterious mutations and VUSs identified. Model inputs were obtained from published genetic testing data in EOC. One-way sensitivity analyses and Monte Carlo probabilistic sensitivity analyses were performed.No family history model: MGT cost $1,160 more on average than BRCA1/2 testing and identified an additional 3.8 deleterious mutations for every 100 women tested. For each additional deleterious mutation identified, MGT cost $30,812 and identified 5.4 additional VUSs. Family history model: MGT cost $654 more on average and identified an additional 7.0 deleterious mutations for every 100 women tested. For each additional deleterious mutation identified, MGT cost $9,909 and identified 2.6 additional VUSs.MGT was associated with a higher additional cost per deleterious mutation identified and a higher ratio of VUS burden to actionable information in women with no family history as compared with women with a family history. Family history should be considered when determining an initial genetic testing platform in women with EOC.

Authors
Foote, JR; Lopez-Acevedo, M; Buchanan, AH; Secord, AA; Lee, PS; Fountain, C; Myers, ER; Cohn, DE; Reed, SD; Havrilesky, LJ
MLA Citation
Foote, JR, Lopez-Acevedo, M, Buchanan, AH, Secord, AA, Lee, PS, Fountain, C, Myers, ER, Cohn, DE, Reed, SD, and Havrilesky, LJ. "Cost Comparison of Genetic Testing Strategies in Women With Epithelial Ovarian Cancer." Journal of oncology practice (January 3, 2017): JOP2016011866-.
PMID
28045615
Source
epmc
Published In
Journal of Oncology Practice
Publish Date
2017
Start Page
JOP2016011866

Increased Costs with Multidrug Resistant Gram Negative Bloodstream Infections Are Primarily Due to Patients with Hospital-Acquired Infections.

The clinical and economic impact of bloodstream infections (BSI) due to multidrug resistant (MDR) Gram negative bacteria is incompletely understood. From 2009-2015, all adult inpatients with Gram negative BSI at our institution were prospectively enrolled. MDR status was defined as resistance to ≥3 antibiotic classes. Clinical outcomes and inpatient costs associated with the MDR phenotype were identified. Among 891 unique patients with Gram negative BSI, 292 (33%) were infected with MDR bacteria. In an adjusted analysis, only history of Gram negative infection was associated with MDR BSI versus non-MDR BSI (odds ratio 1.60; 95% confidence interval [CI] 1.19-2.16; P=0.002). Patients with MDR BSI had increased BSI recurrence (1.7% [5/292] vs 0.2% [1/599]; P=0.02) and longer hospital length of stay (median 10.0 vs.8.0 days; P=0.0005). Unadjusted in-hospital mortality did not significantly differ between MDR (26.4% [77/292]) and non-MDR (21.7% [130/599]) groups (P=0.12). Unadjusted mean costs were 1.62 times higher in MDR versus non-MDR BSI ($59,266 vs. $36,452; P=0.003). This finding persisted after adjustment for patient factors and appropriate empiric antibiotic therapy (means ratio 1.18; 95% CI 1.03-1.36; P=0.01). Adjusted analysis of patient sub-populations revealed that increased cost of MDR BSI occurred primarily among patients with hospital-acquired infections (MDR means ratio 1.41, 95% CI 1.10-1.82, P=0.008). MDR Gram negative BSI are associated with recurrent BSI, longer hospital length of stay, and increased mean inpatient costs. MDR BSI in patients with hospital-acquired infections primarily account for the increased cost.

Authors
Thaden, JT; Li, Y; Ruffin, F; Maskarinec, SA; Hill-Rorie, JM; Wanda, LC; Reed, SD; Fowler, VG
MLA Citation
Thaden, JT, Li, Y, Ruffin, F, Maskarinec, SA, Hill-Rorie, JM, Wanda, LC, Reed, SD, and Fowler, VG. "Increased Costs with Multidrug Resistant Gram Negative Bloodstream Infections Are Primarily Due to Patients with Hospital-Acquired Infections." Antimicrobial agents and chemotherapy (December 19, 2016).
Website
http://hdl.handle.net/10161/13738
PMID
27993852
Source
epmc
Published In
Antimicrobial agents and chemotherapy
Publish Date
2016

Developing the Value Proposition for Personalized Medicine

© 2017 Elsevier Inc. All rights reserved.Standard methodological approaches have successfully been applied to evaluate the cost-effectiveness of numerous personalized medicine tests, particularly for companion diagnostics developed in the context of a clinical trial. However, disagreement has emerged about the extent to which existing methods can characterize the value of personalized medicine. This chapter provides an overview of cost-effectiveness analysis and the factors determining the value of personalized medicine. The authors identify limitations of the traditional cost-effectiveness analysis framework and methodological issues that will arise with increasing use of multiple "omics" profiles to guide individualized selection of treatments.

Authors
Reed, SD; Faulkner, E; Veenstra, DL
MLA Citation
Reed, SD, Faulkner, E, and Veenstra, DL. "Developing the Value Proposition for Personalized Medicine." Genomic and Precision Medicine: Foundations, Translation, and Implementation: Third Edition. December 15, 2016. 327-342.
Source
scopus
Publish Date
2016
Start Page
327
End Page
342
DOI
10.1016/B978-0-12-800681-8.00022-0

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

International Experiences in Quantitative Benefit-Risk Analysis to Support Regulatory Decisions.

Authors
Reed, SD; Lavezzari, G
MLA Citation
Reed, SD, and Lavezzari, G. "International Experiences in Quantitative Benefit-Risk Analysis to Support Regulatory Decisions." Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 19.6 (September 2016): 727-729.
PMID
27712697
Source
epmc
Published In
Value in Health
Volume
19
Issue
6
Publish Date
2016
Start Page
727
End Page
729
DOI
10.1016/j.jval.2016.06.004

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

Heart Rhythm Monitoring Strategies for Cryptogenic Stroke: 2015 Diagnostics and Monitoring Stroke Focus Group Report.

Authors
Albers, GW; Bernstein, RA; Brachmann, J; Camm, J; Easton, JD; Fromm, P; Goto, S; Granger, CB; Hohnloser, SH; Hylek, E; Jaffer, AK; Krieger, DW; Passman, R; Pines, JM; Reed, SD; Rothwell, PM; Kowey, PR
MLA Citation
Albers, GW, Bernstein, RA, Brachmann, J, Camm, J, Easton, JD, Fromm, P, Goto, S, Granger, CB, Hohnloser, SH, Hylek, E, Jaffer, AK, Krieger, DW, Passman, R, Pines, JM, Reed, SD, Rothwell, PM, and Kowey, PR. "Heart Rhythm Monitoring Strategies for Cryptogenic Stroke: 2015 Diagnostics and Monitoring Stroke Focus Group Report." Journal of the American Heart Association 5.3 (March 15, 2016): e002944-. (Review)
PMID
27068633
Source
epmc
Published In
Journal of the American Heart Association
Volume
5
Issue
3
Publish Date
2016
Start Page
e002944
DOI
10.1161/jaha.115.002944

Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes?

: Supplemental Digital Content is available in the text OBJECTIVE:: To determine the number of total thyroidectomies per surgeon per year associated with the lowest risk of complications.The surgeon volume-outcome association has been established for thyroidectomy; however, a threshold number of cases defining a "high-volume" surgeon remains unclear.Adults undergoing total thyroidectomy were identified from the Health Care Utilization Project-National Inpatient Sample (1998-2009). Multivariate logistic regression with restricted cubic splines was utilized to examine the association between the number of annual total thyroidectomies per surgeon and risk of complications.Among 16,954 patients undergoing total thyroidectomy, 47% had thyroid cancer and 53% benign disease. Median annual surgeon volume was 7 cases; 51% of surgeons performed 1 case/y. Overall, 6% of the patients experienced complications. After adjustment, the likelihood of experiencing a complication decreased with increasing surgeon volume up to 26 cases/y (P < 0.01). Among all patients, 81% had surgery by low-volume surgeons (≤25 cases/y). With adjustment, patients undergoing surgery by low-volume surgeons were more likely to experience complications (odds ratio 1.51, P = 0.002) and longer hospital stays (+12%, P = 0.006). Patients had an 87% increase in the odds of having a complication if the surgeon performed 1 case/y, 68% for 2 to 5 cases/y, 42% for 6 to 10 cases/y, 22% for 11 to 15 cases/y, 10% for 16 to 20 cases/y, and 3% for 21 to 25 cases/y.This is the first study to identify a surgeon volume threshold (>25 total thyroidectomies/y) that is associated with improved patient outcomes. Identifying a threshold number of cases defining a high-volume thyroid surgeon is important, as it has implications for quality improvement, criteria for referral and reimbursement, and surgical education.

Authors
Adam, MA; Thomas, S; Youngwirth, L; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Thomas, S, Youngwirth, L, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes?." Annals of surgery (March 8, 2016).
PMID
26967630
Source
epmc
Published In
Annals of Surgery
Publish Date
2016

Chemotherapy costs associated with receipt of the adoption of oncotype DX in early-stage breast cancer within the SEER-Medicare population

Authors
Dinan, MA; Mi, X; Reed, SD; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Lyman, GH, and Curtis, LH. "Chemotherapy costs associated with receipt of the adoption of oncotype DX in early-stage breast cancer within the SEER-Medicare population." March 1, 2016.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
34
Issue
7
Publish Date
2016

The clinical course of health status and association with outcomes in patients hospitalized for heart failure: insights from ASCEND-HF.

A longitudinal and comprehensive analysis of health-related quality of life (HRQOL) was performed during hospitalization for heart failure (HF) or soon after discharge.A post-hoc analysis was performed of the ASCEND-HF trial. The EuroQOL five dimensions questionnaire (EQ-5D) was administered to study participants at baseline, 24 h, discharge/day 10, and day 30. EQ-5D includes functional dimensions mapped to corresponding utility scores (i.e. 0 = death and 1 = perfect health), and a visual analogue scale (VAS) ranging from 0 (i.e. 'worst imaginable health state') to 100 (i.e. 'best imaginable health state'). The association between baseline and discharge EQ-5D measurements and subsequent clinical outcomes including death and rehospitalization were assessed using multivariable logistic regression and Cox proportional hazards regression. A total of 6943 patients (97%) had complete EQ-5D data at baseline. Mapped utility and VAS scores (mean ± SD) increased over time, respectively, from 0.56 ± 0.23 and 45 ± 22 at baseline to 0.67 ± 0.26 and 58 ± 22 at 24 h and to 0.79 ± 0.20 and 68 ± 22 at discharge, and remained stable at day 30. Lower mapped utility scores at baseline [odds ratio (OR) per 0.1 decrease in utility score 1.03, 95% confidence interval (CI) 1.00-1.06] and discharge (OR 1.10, 95% CI 1.05-1.15) and VAS scores at baseline (OR per 10 point decrease 1.05, 95% CI 1.01-1.09) were significantly associated with increased risk of 30-day all-cause death or HF rehospitalization.Patients hospitalized for HF had severely impaired health status at baseline and, although this improved substantially during admission, health status remained abnormal at discharge.

Authors
Ambrosy, AP; Hernandez, AF; Armstrong, PW; Butler, J; Dunning, A; Ezekowitz, JA; Felker, GM; Greene, SJ; Kaul, P; McMurray, JJ; Metra, M; O'Connor, CM; Reed, SD; Schulte, PJ; Starling, RC; Tang, WHW; Voors, AA; Mentz, RJ
MLA Citation
Ambrosy, AP, Hernandez, AF, Armstrong, PW, Butler, J, Dunning, A, Ezekowitz, JA, Felker, GM, Greene, SJ, Kaul, P, McMurray, JJ, Metra, M, O'Connor, CM, Reed, SD, Schulte, PJ, Starling, RC, Tang, WHW, Voors, AA, and Mentz, RJ. "The clinical course of health status and association with outcomes in patients hospitalized for heart failure: insights from ASCEND-HF." European journal of heart failure 18.3 (March 2016): 306-313.
PMID
26467269
Source
epmc
Published In
European Journal of Heart Failure (Elsevier)
Volume
18
Issue
3
Publish Date
2016
Start Page
306
End Page
313
DOI
10.1002/ejhf.420

Potential Cost-effectiveness of Early Identification of Hospital-acquired Infection in Critically Ill Patients.

Limitations in methods for the rapid diagnosis of hospital-acquired infections often delay initiation of effective antimicrobial therapy. New diagnostic approaches offer potential clinical and cost-related improvements in the management of these infections.We developed a decision modeling framework to assess the potential cost-effectiveness of a rapid biomarker assay to identify hospital-acquired infection in high-risk patients earlier than standard diagnostic testing.The framework includes parameters representing rates of infection, rates of delayed appropriate therapy, and impact of delayed therapy on mortality, along with assumptions about diagnostic test characteristics and their impact on delayed therapy and length of stay. Parameter estimates were based on contemporary, published studies and supplemented with data from a four-site, observational, clinical study. Extensive sensitivity analyses were performed. The base-case analysis assumed 17.6% of ventilated patients and 11.2% of nonventilated patients develop hospital-acquired infection and that 28.7% of patients with hospital-acquired infection experience delays in appropriate antibiotic therapy with standard care. We assumed this percentage decreased by 50% (to 14.4%) among patients with true-positive results and increased by 50% (to 43.1%) among patients with false-negative results using a hypothetical biomarker assay. Cost of testing was set at $110/d.In the base-case analysis, among ventilated patients, daily diagnostic testing starting on admission reduced inpatient mortality from 12.3 to 11.9% and increased mean costs by $1,640 per patient, resulting in an incremental cost-effectiveness ratio of $21,389 per life-year saved. Among nonventilated patients, inpatient mortality decreased from 7.3 to 7.1% and costs increased by $1,381 with diagnostic testing. The resulting incremental cost-effectiveness ratio was $42,325 per life-year saved. Threshold analyses revealed the probabilities of developing hospital-acquired infection in ventilated and nonventilated patients could be as low as 8.4 and 9.8%, respectively, to maintain incremental cost-effectiveness ratios less than $50,000 per life-year saved.Development and use of serial diagnostic testing that reduces the proportion of patients with delays in appropriate antibiotic therapy for hospital-acquired infections could reduce inpatient mortality. The model presented here offers a cost-effectiveness framework for future test development.

Authors
Tsalik, EL; Li, Y; Hudson, LL; Chu, VH; Himmel, T; Limkakeng, AT; Katz, JN; Glickman, SW; McClain, MT; Welty-Wolf, KE; Fowler, VG; Ginsburg, GS; Woods, CW; Reed, SD
MLA Citation
Tsalik, EL, Li, Y, Hudson, LL, Chu, VH, Himmel, T, Limkakeng, AT, Katz, JN, Glickman, SW, McClain, MT, Welty-Wolf, KE, Fowler, VG, Ginsburg, GS, Woods, CW, and Reed, SD. "Potential Cost-effectiveness of Early Identification of Hospital-acquired Infection in Critically Ill Patients." Annals of the American Thoracic Society 13.3 (March 2016): 401-413.
Website
http://hdl.handle.net/10161/12538
PMID
26700878
Source
epmc
Published In
Annals of the American Thoracic Society
Volume
13
Issue
3
Publish Date
2016
Start Page
401
End Page
413
DOI
10.1513/annalsats.201504-205oc

Relation of Elevated Heart Rate in Patients With Heart Failure With Reduced Ejection Fraction to One-Year Outcomes and Costs.

There are limited data describing outcomes associated with an elevated heart rate in patients with heart failure with reduced ejection fraction (HFrEF) in routine clinical practice. We identified patients with HFrEF at Duke University Hospital undergoing echocardiograms and heart rate assessments without paced rhythms or atrial fibrillation. Outcomes (all-cause mortality or hospitalization and medical costs per day alive) were assessed using electronic medical records, hospital cost accounting data, and national death records. Patients were stratified by heart rate (<70 and ≥70 beats/min) and compared using generalized linear models specified with gamma error distributions and log links for costs and proportional hazard models for mortality/hospitalization. Of 722 eligible patients, 582 patients (81%) were treated with β blockers. The median heart rate was 81 beats/min (25th and 75th percentiles 69 to 96) and 527 patients (73%) had a heart rate ≥70 beats/min. After multivariate adjustment, a heart rate ≥70 beats/min was associated with increased 1-year all-cause mortality or hospitalization, hazard ratio 1.37 (95% CI 1.07 to 1.75) and increased medical costs per day alive, cost ratio 2.03 (95% CI 1.53 to 2.69). In conclusion, at a large tertiary care center, despite broad use of β blockers, a heart rate ≥70 beats/min was observed in 73% of patients with HFrEF and associated with worse 1-year outcomes and increased direct medical costs per day alive.

Authors
DeVore, AD; Schulte, PJ; Mentz, RJ; Hardy, NC; Kelly, JP; Velazquez, EJ; Maya, JF; Kielhorn, A; Patel, HK; Reed, SD; Hernandez, AF
MLA Citation
DeVore, AD, Schulte, PJ, Mentz, RJ, Hardy, NC, Kelly, JP, Velazquez, EJ, Maya, JF, Kielhorn, A, Patel, HK, Reed, SD, and Hernandez, AF. "Relation of Elevated Heart Rate in Patients With Heart Failure With Reduced Ejection Fraction to One-Year Outcomes and Costs." The American journal of cardiology 117.6 (March 2016): 946-951.
PMID
26805662
Source
epmc
Published In
The American Journal of Cardiology
Volume
117
Issue
6
Publish Date
2016
Start Page
946
End Page
951
DOI
10.1016/j.amjcard.2015.12.031

Resource Use in the Last Year of Life Among Patients Who Died With Versus of Prostate Cancer.

We conducted a retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data of men with prostate cancer. Among 34,727 patients, those who died of their prostate cancer had more hospice and outpatient use, less inpatient and intensive care unit use, and lower overall costs. Efforts to shift care toward the outpatient setting might provide more efficient and judicious care for patients during the end of life.Prostate cancer poses a significant financial burden in the United States. However, most men with prostate cancer will die from noncancer causes. Concerns about increased resource utilization at the end of life have not been appropriately examined in this context.We conducted a retrospective analysis of Surveillance, Epidemiology, and End Results-Medicare data of men who were diagnosed with and died of, as opposed to with, prostate cancer between 2000 and 2007. Within these 2 populations, we compared changes in the use of medical interventions, hospice, and overall health care costs to Medicare in the last year of life.Among 34,727 patients, those who died of prostate cancer had lower costs ($43,572 vs. $45,830; P < .001), largely because of lower mean inpatient costs ($20,769 vs. $29,851) and fewer hospitalizations (1.8 vs. 2.1), inpatient days (12.2 vs. 15.7), intensive care unit (ICU) days (1.4 vs. 3.4), and skilled nursing facility days (11.7 vs. 14.7; P < .001 for all). Outpatient and hospice costs were significantly greater among patients who died of prostate cancer, as was use of chemotherapy and androgen deprivation therapy. Patients who died of prostate cancer had approximately 12% lower costs than patients who died from other causes in adjusted analyses (fold-change, 0.88; 95% confidence interval [CI], 0.85-0.92). The single strongest predictor of increased costs at the end of life was receipt of multiple invasive procedures (fold increase in costs, 2.39; 95% CI, 2.22-2.58).Patients who died of prostate cancer rather than from other causes had more hospice and outpatient use, less inpatient and ICU use, and lower overall costs. Efforts to shift care toward outpatient settings might provide more efficient and judicious care for patients during the end of life.

Authors
Dinan, MA; Li, Y; Zhang, Y; Stewart, SB; Curtis, LH; George, DJ; Reed, SD
MLA Citation
Dinan, MA, Li, Y, Zhang, Y, Stewart, SB, Curtis, LH, George, DJ, and Reed, SD. "Resource Use in the Last Year of Life Among Patients Who Died With Versus of Prostate Cancer." Clinical genitourinary cancer 14.1 (February 2016): 28-37.e2.
PMID
26382223
Source
epmc
Published In
Clinical genitourinary cancer
Volume
14
Issue
1
Publish Date
2016
Start Page
28
End Page
37.e2
DOI
10.1016/j.clgc.2015.07.006

Out-of-Pocket Spending for Ambulatory Physical Therapy Services From 2008 to 2012: National Panel Survey.

Out-of-pocket (OOP) expenditures are incurred as insurers and employers shift some of the burden of health care costs onto consumers. As cost-sharing increases, OOP expenditures could be a barrier to physical therapy care.The purposes of this study were: (1) to identify factors associated with any OOP physical therapy spending and (2) to identify factors associated with higher spending among individuals incurring OOP costs.The study was a retrospective analysis using the 4 most recently available panels of data from the Medical Expenditure Panel Survey (MEPS) encompassing 2008-2012.A data file containing episodes of physical therapy care for 2,189 people was created. Logistic regression was used to identify factors related to having an OOP expenditure. A multivariable generalized linear model was used to identify factors related to mean OOP expenditures.On average, an episode of care encompassed 9.9 visits, with mean total expenditures of $1,708 (median: $792). Fifty-four percent of episodes of care had an OOP expenditure. For individuals with OOP expenditures, the mean OOP expenditure for an episode of care was $351 (median: $144). Being female or non-Hispanic and having a higher income were associated with higher odds of incurring an OOP expenditure, whereas being in worse general health, >65 years of age, or nonwhite and having public funding were associated with lower odds of incurring an OOP expenditure. Amounts of OOP spending were higher in urban areas and in all census geographic regions relative to the Northeast region.Estimates are based on household-reported survey data, limited to ambulatory care, and do not include institutionalized individuals.At 54%, the proportion of individuals with OOP expenditures for physical therapy is lower than for general medical care. Several predictors were found of having OOP expenditures and of the magnitude of those expenditures.

Authors
Chevan, J; Riddle, DL; Reed, SD
MLA Citation
Chevan, J, Riddle, DL, and Reed, SD. "Out-of-Pocket Spending for Ambulatory Physical Therapy Services From 2008 to 2012: National Panel Survey." Physical therapy 95.12 (December 2015): 1680-1691.
PMID
26112257
Source
epmc
Published In
Physical Therapy
Volume
95
Issue
12
Publish Date
2015
Start Page
1680
End Page
1691
DOI
10.2522/ptj.20150018

A Bedside Risk Calculator to Preoperatively Distinguish Follicular Thyroid Carcinoma from Follicular Variant of Papillary Thyroid Carcinoma.

Follicular thyroid carcinoma (FTC) and follicular variant of papillary thyroid carcinoma (FV-PTC) are difficult entities to distinguish based on cytology prior to pathologic evaluation of surgical specimens but may have different treatment algorithms. The current study describes trends in rates of FTC versus FV-PTC in the U.S. and develops a risk assessment tool to aid clinicians in predicting final diagnosis and shaping treatment plans.Relative rates of FTC and FV-PTC in the surveillance, epidemiology, and end results (SEER) database were evaluated for temporal trends from 1988 to 2011. Using multivariable logistic regression, a simplified scoring system was developed to estimate the risk of FTC versus FV-PTC using patient and tumor characteristics. The National Cancer Data Base was used for model validation.Of 115,091 thyroid cancer cases in the SEER database from 1988 to 2011, 23,980 involved FTC (n = 5056; 21 %) or FV-PTC (n = 18,924; 79 %). In 1988, half of follicular cases were FV-PTC; however, FV-PTC accounted for over 85 % of these lesions by 2010. Increasing age >45 years, male gender, black race, increasing tumor size, and distant metastases were strongly associated with increased risk of FTC, while lymph node disease and extrathyroidal extension were associated with FV-PTC. A bedside risk assessment nomogram using these preoperative variables classified patient risk of FTC from 2 to 70 %. FV-PTC has become the dominant malignancy with follicular cytology, accounting for >85 % of these cases. A simple bedside risk assessment tool can risk stratify patients with follicular lesions and inform patient and clinician discussions and decision making.

Authors
Englum, BR; Pura, J; Reed, SD; Roman, SA; Sosa, JA; Scheri, RP
MLA Citation
Englum, BR, Pura, J, Reed, SD, Roman, SA, Sosa, JA, and Scheri, RP. "A Bedside Risk Calculator to Preoperatively Distinguish Follicular Thyroid Carcinoma from Follicular Variant of Papillary Thyroid Carcinoma." World journal of surgery 39.12 (December 2015): 2928-2934.
PMID
26324158
Source
epmc
Published In
World Journal of Surgery
Volume
39
Issue
12
Publish Date
2015
Start Page
2928
End Page
2934
DOI
10.1007/s00268-015-3192-4

Staphylococcus aureus infections following knee and hip prosthesis insertion procedures

Authors
Arduino, JM; Kaye, KS; Reed, SD; Peter, SA; Sexton, DJ; Chen, LF; Hardy, NC; Tong, SYC; Smugar, SS; Fowler, VG; Anderson, DJ
MLA Citation
Arduino, JM, Kaye, KS, Reed, SD, Peter, SA, Sexton, DJ, Chen, LF, Hardy, NC, Tong, SYC, Smugar, SS, Fowler, VG, and Anderson, DJ. "Staphylococcus aureus infections following knee and hip prosthesis insertion procedures." Antimicrobial Resistance and Infection Control 4.1 (December 2015).
Source
crossref
Published In
Antimicrobial Resistance and Infection Control
Volume
4
Issue
1
Publish Date
2015
DOI
10.1186/s13756-015-0057-4

Longitudinal Trends in Costs of Palliative Radiation for Metastatic Prostate Cancer

Authors
Robinson, TJ; Dinan, MA; Li, Y; Lee, WR; Reed, SD
MLA Citation
Robinson, TJ, Dinan, MA, Li, Y, Lee, WR, and Reed, SD. "Longitudinal Trends in Costs of Palliative Radiation for Metastatic Prostate Cancer." JOURNAL OF PALLIATIVE MEDICINE 18.11 (November 1, 2015): 933-939.
Source
wos-lite
Published In
Journal of Palliative Medicine
Volume
18
Issue
11
Publish Date
2015
Start Page
933
End Page
939
DOI
10.1089/jpm.2015.0171

Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009.

Guidelines recommend consideration of chemotherapy for most patients with early-stage, estrogen receptor-positive, invasive breast cancer in the absence of additional prognostic information. The 21-gene recurrence score (RS) assay has been shown in limited academic settings to reduce physician recommendations for adjuvant chemotherapy. Associations between the adoption of the assay and receipt of chemotherapy in the general population have not been examined.To examine whether adoption of the RS assay in a nationally representative sample of patients with early-stage breast cancer was associated with use of chemotherapy.Retrospective cohort study of Medicare beneficiaries who received a diagnosis of incident breast cancer between 2005 and 2009 using Surveillance, Epidemiology, and End Results data set with linked Medicare claims.Receipt of chemotherapy within 12 months after diagnosis.A total of 44,044 patients had low-risk (24.0%), intermediate-risk (51.3%), or high-risk disease (24.6%, lymph node positive) as defined by National Comprehensive Cancer Network (NCCN) guidelines and met the study criteria. We observed no overall association between receipt of the RS assay and chemotherapy (odds ratio [OR], 1.03 [99% CI, 0.88-1.19]). In multivariable analysis, there was a significant interaction between NCCN risk and use of the RS assay, with assay use associated with lower chemotherapy use in high-risk patients (OR, 0.36 [99% CI, 0.26-0.50]) and greater chemotherapy use in low-risk patients (OR, 3.71 [99% CI, 2.30-5.98]), compared with no receipt of the assay (P=.006 for the overall interaction). Results were similar in prespecified subgroup analyses of patients 70 years and younger, with the exception of a shift toward lower chemotherapy use during 2008 (OR, 0.90 [99% CI, 0.77-.1.05]; P=.09) and 2009 (OR, 0.81 [99% CI, 0.66-0.99]; P=.007). In unadjusted analyses, overall chemotherapy use decreased over time in patients 70 years or younger with high-risk disease and those receiving the assay.The impact of the adoption of the RS assay on receipt of chemotherapy was strongly population dependent and was associated with relatively lower chemotherapy use in groups with high-risk disease and relatively higher chemotherapy use in patients with low-risk disease. Overall use of chemotherapy decreased during the study period in patients who were most likely to receive chemotherapy.

Authors
Dinan, MA; Mi, X; Reed, SD; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Lyman, GH, and Curtis, LH. "Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009." JAMA oncology 1.8 (November 2015): 1098-1109.
PMID
26313372
Source
epmc
Published In
JAMA oncology
Volume
1
Issue
8
Publish Date
2015
Start Page
1098
End Page
1109
DOI
10.1001/jamaoncol.2015.2722

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

Minimally Invasive Distal Pancreatectomy for Cancer: Short-Term Oncologic Outcomes in 1,733 Patients.

Data from high-volume institutions suggest that minimally invasive distal pancreatectomy (MIDP) provides favorable perioperative outcomes and adequate oncologic resection for pancreatic cancer; however, these outcomes may not be generalizable. This study examines patterns of use and short-term outcomes from MIDP (laparoscopic or robotic) versus open distal pancreatectomy (ODP) for pancreatic adenocarcinoma in the United States.Adult patients undergoing distal pancreatectomy were identified from the National Cancer Database, 2010-2011. Multivariable modeling was applied to compare short-term outcomes from MIDP versus ODP for pancreatic adenocarcinoma.1733 patients met inclusion criteria: 535 (31 %) had MIDP and 1198 (69 %) ODP. Use of MIDP increased 43 % between 2010 and 2011; the conversion rate from MIDP to ODP was 23 %. MIDP cases were performed at 215 hospitals, with 85 % of hospitals performing <10 cases overall. After adjustment, pancreatic adenocarcinoma patients undergoing MIDP versus ODP had a similar likelihood of complete resection (OR 1.48, p = 0.10), number of lymph nodes removed (RR 1.01, p = 0.91), and 30-day readmission rate (OR 1.02, p = 0.96); however, length of stay was shorter (RR 0.84, p < 0.01).Use of MIDP for cancer is increasing, with most centers performing a low volume of these procedures. Use of MIDP for body and tail pancreatic adenocarcinoma appears to have short-term outcomes that are similar to those of open procedures with the benefit of a shorter hospital stay. Larger studies with longer follow-up are needed.

Authors
Adam, MA; Choudhury, K; Goffredo, P; Reed, SD; Blazer, D; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Choudhury, K, Goffredo, P, Reed, SD, Blazer, D, Roman, SA, and Sosa, JA. "Minimally Invasive Distal Pancreatectomy for Cancer: Short-Term Oncologic Outcomes in 1,733 Patients." World journal of surgery 39.10 (October 2015): 2564-2572.
PMID
26154576
Source
epmc
Published In
World Journal of Surgery
Volume
39
Issue
10
Publish Date
2015
Start Page
2564
End Page
2572
DOI
10.1007/s00268-015-3138-x

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

Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients.

To describe national practice patterns regarding utilization of minimally invasive pancreaticoduodenectomy (MIPD) and compare short-term outcomes with those following open pancreaticoduodenectomy for cancer.There is increasing interest in use of MIPD; however, published data are limited to single institutional experiences.Adult patients undergoing pancreaticoduodenectomy were identified from the National Cancer Database, 2010-2011. Descriptive statistics and multivariable modeling were employed to characterize use of MIPD (laparoscopic or robotic) and compare short-term outcomes to those following open pancreaticoduodenectomy.A total of 7061 patients underwent pancreaticoduodenectomy: 983 had MIPD and 6078 had open procedures. The use of MIPD increased by 45% (179 cases) from 2010 to 2011. The majority of hospitals (92%) performing MIPD were low volume (≤ 10 cases/2 years). Factors independently associated with undergoing MIPD included fewer comorbidities, treatment at an academic institution, and a neuroendocrine tumor diagnosis (all P < 0.01). The unadjusted 30-day mortality rate was 5.1% for MIPD versus 3.1% after open surgery. For patients with adenocarcinoma, there were no differences between MIPD and open pancreaticoduodenectomy after multivariable adjustment in number of lymph nodes removed, rate of positive surgical margins, length of stay, or readmissions. However, 30-day mortality was higher for patients undergoing MIPD versus open surgery (odds ratio = 1.87, confidence interval: 1.25-2.80, P = 0.002).While there is increasing interest in employing MIPD for adenocarcinoma, its use is associated with increased 30-day mortality. The majority of hospitals performing MIPD were low volume. These results may suggest that MIPD is a complex procedure for which comprehensive protocols outlining criteria for implementation might be warranted to optimize patient safety.

Authors
Adam, MA; Choudhury, K; Dinan, MA; Reed, SD; Scheri, RP; Blazer, DG; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Choudhury, K, Dinan, MA, Reed, SD, Scheri, RP, Blazer, DG, Roman, SA, and Sosa, JA. "Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients." Annals of surgery 262.2 (August 2015): 372-377.
PMID
26158612
Source
epmc
Published In
Annals of Surgery
Volume
262
Issue
2
Publish Date
2015
Start Page
372
End Page
377
DOI
10.1097/sla.0000000000001055

Elevated Heart Rate in Patients with Heart Failure with Reduced Ejection Fraction: Associations with One-Year Survival and Costs

Authors
DeVore, AD; Schulte, PJ; Mentz, RJ; Hardy, NC; Kelly, JP; Velazquez, EJ; Maya, JF; Kielhorn, A; Patel, H; Reed, SD; Hernandez, AF
MLA Citation
DeVore, AD, Schulte, PJ, Mentz, RJ, Hardy, NC, Kelly, JP, Velazquez, EJ, Maya, JF, Kielhorn, A, Patel, H, Reed, SD, and Hernandez, AF. "Elevated Heart Rate in Patients with Heart Failure with Reduced Ejection Fraction: Associations with One-Year Survival and Costs." August 2015.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
21
Issue
8
Publish Date
2015
Start Page
S121
End Page
S122

Presence and Number of Lymph Node Metastases Are Associated With Compromised Survival for Patients Younger Than Age 45 Years With Papillary Thyroid Cancer.

PURPOSE: Cervical lymph node metastases are recognized as a prognostic indicator only in patients age 45 years or older with papillary thyroid cancer (PTC); patients younger than age 45 years are perceived to have low-risk disease. The current American Joint Committee on Cancer staging for PTC in patients younger than age 45 years does not include cervical lymph node metastases. Our objective was to test the hypothesis that the presence and number of cervical lymph node metastases have an adverse impact on overall survival (OS) in patients younger than age 45 years with PTC. PATIENTS AND METHODS: Adult patients younger than age 45 years undergoing surgery for stage I PTC (no distant metastases) were identified from the National Cancer Data Base (NCDB; 1998-2006) and from SEER 1988-2006 data. Multivariable models were used to examine the association of OS with the presence of lymph node metastases and number of metastatic nodes. RESULTS: In all, 47,902 patients in NCDB (11,740 with and 36,162 without nodal metastases) and 21,855 in the SEER database (5,188 with and 16,667 without nodal metastases) were included. After adjustment, OS was compromised for patients with nodal metastases compared with patients who did not have them (NCDB: hazard ratio (HR), 1.32; 95% CI, 1.04 to 1.67; P = .021; SEER: HR, 1.29; 95% CI, 1.08 to 1.56; P = .006). After adjustment, increasing number of metastatic lymph nodes was associated with decreasing OS up to six metastatic nodes (HR, 1.12; 95% CI, 1.01 to 1.25; P = .03), after which more positive nodes conferred no additional mortality risk (HR, 0.99; 95% CI, 0.99 to 1.05; P = .75). CONCLUSION: Our results suggest that cervical lymph node metastases are associated with compromised survival in young patients, warranting consideration of revised American Joint Committee on Cancer staging. A change point of six or fewer metastatic lymph nodes seems to carry prognostic significance, thus advocating for rigorous preoperative screening for nodal metastases.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Reed, SD; Scheri, RP; Hyslop, T; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Reed, SD, Scheri, RP, Hyslop, T, Roman, SA, and Sosa, JA. "Presence and Number of Lymph Node Metastases Are Associated With Compromised Survival for Patients Younger Than Age 45 Years With Papillary Thyroid Cancer." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 33.21 (July 2015): 2370-2375.
PMID
26077238
Source
epmc
Published In
Journal of Clinical Oncology
Volume
33
Issue
21
Publish Date
2015
Start Page
2370
End Page
2375
DOI
10.1200/jco.2014.59.8391

Nationwide utilization of cardiac imaging in patients undergoing cardiotoxic chemotherapy

Authors
Dinan, MA; Li, Y; Reed, SD; Cheung, WY
MLA Citation
Dinan, MA, Li, Y, Reed, SD, and Cheung, WY. "Nationwide utilization of cardiac imaging in patients undergoing cardiotoxic chemotherapy." May 20, 2015.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
33
Issue
15
Publish Date
2015

Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009.

In 2006, the Centers for Medicare & Medicaid Services approved coverage for the use of the 21-gene recurrence score (RS) assay in women with early-stage, estrogen receptor-positive, node-negative breast cancers to help guide recommendations for adjuvant chemotherapy. Use of the assay in community settings has not been previously examined in a nationally representative sample of patients.To examine trends in the use of the RS assay in routine clinical practice in a nationally representative sample of women with breast cancer.Retrospective observational study of Medicare beneficiaries diagnosed with incident breast cancer between 2005 and 2009, as recorded in a Surveillance, Epidemiology, and End Results data set with linked Medicare claims through 2010.Demographic and clinical variables associated with the use of the assay.A total of 70,802 patients met the study criteria. Use of the RS assay increased from 1.1% in 2005 to 10.1% in 2009 (P < .001). The majority of tests (60.9%) occurred in patients with National Comprehensive Cancer Network-defined intermediate-risk disease (ie, estrogen receptor-positive, node-negative tumors >1 cm). Most patients with other than intermediate-risk disease had borderline indications for testing, including T1b (47.5%) or N1 (26.8%) disease. Testing was associated with younger age, fewer comorbid conditions, higher-grade disease, and being married. Among patients younger than 70 years with intermediate-risk disease, testing rates increased from 7.7% in 2005 to 38.8% in 2009 (P < .001). In multivariable analysis, testing was modestly higher in Northeast than in Western registries (odds ratio, 1.83; 95% CI, 1.49-2.26) but was otherwise not associated with region, local census tract demographic characteristics, black race, location in an urban area, or tumor histologic characteristics.The RS assay was adopted quickly in clinical practice after the Medicare coverage decision in 2006, and use appears to be consistent with guidelines and equitable across geographic and racial groups. Factors influencing adoption of the assay and its impact on adjuvant chemotherapy use in clinical practice remain important areas of study.

Authors
Dinan, MA; Mi, X; Reed, SD; Hirsch, BR; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Hirsch, BR, Lyman, GH, and Curtis, LH. "Initial Trends in the Use of the 21-Gene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009." JAMA oncology 1.2 (May 2015): 158-166.
PMID
26181015
Source
epmc
Published In
JAMA oncology
Volume
1
Issue
2
Publish Date
2015
Start Page
158
End Page
166
DOI
10.1001/jamaoncol.2015.43

Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.

Authors
Ramsey, SD; Willke, RJ; Glick, H; Reed, SD; Augustovski, F; Jonsson, B; Briggs, A; Sullivan, SD
MLA Citation
Ramsey, SD, Willke, RJ, Glick, H, Reed, SD, Augustovski, F, Jonsson, B, Briggs, A, and Sullivan, SD. "Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report." Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 18.2 (March 2015): 161-172.
PMID
25773551
Source
epmc
Published In
Value in Health
Volume
18
Issue
2
Publish Date
2015
Start Page
161
End Page
172
DOI
10.1016/j.jval.2015.02.001

Cost-Effectiveness Analysis Alongside Clinical Trials II-An ISPOR Good Research Practices Task Force Report

Authors
Ramsey, SD; Willke, RJ; Glick, H; Reed, SD; Augustovski, F; Jonsson, B; Briggs, A; Sullivan, SA
MLA Citation
Ramsey, SD, Willke, RJ, Glick, H, Reed, SD, Augustovski, F, Jonsson, B, Briggs, A, and Sullivan, SA. "Cost-Effectiveness Analysis Alongside Clinical Trials II-An ISPOR Good Research Practices Task Force Report." VALUE IN HEALTH 18.2 (March 2015): 161-172.
Source
wos-lite
Published In
Value in Health
Volume
18
Issue
2
Publish Date
2015
Start Page
161
End Page
172
DOI
10.1016/j.jval.2015.07.001

Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years.

Papillary thyroid cancer (PTC) patients <45 years old are considered to have an excellent prognosis; however, current guidelines recommend total thyroidectomy for PTC tumors >1.0 cm, regardless of age.Our objective was to examine the impact of extent of surgery on overall survival (OS) in patients <45 years old with stage I PTC of 1.1 to 4.0 cm.Adult patients <45 years of age undergoing surgery for stage I PTC were identified from the National Cancer Data Base (NCDB, 1998-2006) and the Surveillance, Epidemiology, and End RESULTS dataset (SEER, 1988-2006).Multivariable modeling was used to compare OS for patients undergoing total thyroidectomy vs lobectomy.In total, 29 522 patients in NCDB (3151 lobectomy, 26 371 total thyroidectomy) and 13 510 in SEER (1379 lobectomy, 12 131 total thyroidectomy) were included. Compared with patients undergoing lobectomy, patients having total thyroidectomy more often had extrathyroidal and lymph node disease. At 14 years, unadjusted OS was equivalent between total thyroidectomy and lobectomy in both databases. After adjustment, OS was similar for total thyroidectomy compared with lobectomy across all patients with tumors of 1.1 to 4.0 cm (NCDB: hazard ratio = 1.45 [confidence interval = 0.88-2.51], P = 0.19; SEER: 0.95 (0.70-1.29), P = 0.75) and when stratified by tumor size: 1.1 to 2.0 cm (NCDB: 1.12 [0.50-2.51], P = 0.78; SEER: 0.95 [0.56-1.62], P = 0.86) and 2.1 to 4.0 cm (NCDB: 1.93 [0.88-4.23], P = 0.10; SEER: 0.94 [0.60-1.49], P = 0.80).After adjusting for patient and clinical characteristics, total thyroidectomy compared with thyroid lobectomy was not associated with improved survival for patients <45 years of age with stage I PTC of 1.1 to 4.0 cm. Additional clinical and pathologic factors should be considered when choosing extent of resection.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years." The Journal of clinical endocrinology and metabolism 100.1 (January 2015): 115-121.
PMID
25337927
Source
epmc
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
100
Issue
1
Publish Date
2015
Start Page
115
End Page
121
DOI
10.1210/jc.2014-3039

Implementing Lung Cancer Screening Using Low-Dose Computed Tomography: Recommendations From an Expert Panel.

In December 2013, the US Preventive Services Task Force issued a final B-level recommendation indicating that individuals between the ages of 55 and 80 years who have a 30-pack-year smoking history and have smoked within the past 15 years should receive annual low-dose computed tomography (CT) lung cancer screening. We convened a multidisciplinary panel of experts to create practical guidance for efficiently implementing effective CT lung cancer screening programs.The lung cancer screening panel included 12 members, representing a broad range of stakeholders. The panel discussed clinical and system issues related to the implementation of CT lung cancer screening and developed recommendations for implementing CT lung cancer screening programs.The panel identified five main goals that must be achieved to maximize the efficiency and effectiveness of implementing CT lung cancer screening: one, accurately identify individuals eligible for screening; two, provide access to screening at qualified facilities for eligible individuals; three, ensure appropriate follow-up for positive and negative screening results; four, promote continuous quality improvement of screening programs and downstream care; and five, provide smoking cessation support for all current smokers. The panel proposed a series of stakeholder-specific recommendations for achieving these goals.Implementation of effective and efficient population-based CT lung cancer screening will require involvement and coordination of stakeholders across the health care system to address the data and infrastructural needs that were identified.

Authors
Ramsey, SD; Malin, JL; Goulart, B; Ambrose, LF; Kanne, JP; McKee, AB; Reed, SD; Schwartz, JS; Sullivan, SD
MLA Citation
Ramsey, SD, Malin, JL, Goulart, B, Ambrose, LF, Kanne, JP, McKee, AB, Reed, SD, Schwartz, JS, and Sullivan, SD. "Implementing Lung Cancer Screening Using Low-Dose Computed Tomography: Recommendations From an Expert Panel." Journal of oncology practice 11.1 (January 2015): e44-e49.
PMID
25491043
Source
epmc
Published In
Journal of Oncology Practice
Volume
11
Issue
1
Publish Date
2015
Start Page
e44
End Page
e49
DOI
10.1200/jop.2014.001528

Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years

© 2015 by the Endocrine Society.Context: Papillary thyroid cancer (PTC) patients <45 years old are considered to have an excellent prognosis; however, current guidelines recommend total thyroidectomy for PTC tumors 1.0 cm, regardless of age. Objective: Our objective was to examine the impact of extent of surgery on overall survival (OS) in patients <45 years old with stage I PTC of 1.1 to 4.0 cm. Design, Setting, and Patients: Adult patients <45 years of age undergoing surgery for stage I PTC were identified from the National Cancer Data Base (NCDB, 1998-2006) and the Surveillance, Epidemiology, and End Results dataset (SEER, 1988-2006). Main Outcome Measure: Multivariable modeling was used to compare OS for patients undergoing total thyroidectomy vs lobectomy. Results: In total, 29 522 patients in NCDB (3151 lobectomy, 26 371 total thyroidectomy) and 13 510 in SEER (1379 lobectomy, 12 131 total thyroidectomy) were included. Compared with patients undergoing lobectomy, patients having total thyroidectomy more often had extrathyroidal and lymph node disease. At 14 years, unadjusted OS was equivalent between total thyroidectomy and lobectomy in both databases. After adjustment, OS was similar for total thyroidectomy compared with lobectomy across all patients with tumors of 1.1 to 4.0 cm (NCDB: hazard ratio = 1.45 [confidence interval = 0.88-2.51], P = 0.19; SEER: 0.95 (0.70 -1.29), P = 0.75) and when stratified by tumor size: 1.1 to 2.0 cm (NCDB: 1.12 [0.50 -2.51], P=0.78; SEER: 0.95 [0.56 -1.62], P=0.86) and 2.1 to 4.0 cm (NCDB: 1.93 [0.88-4.23], P = 0.10; SEER: 0.94 [0.60 -1.49], P = 0.80). Conclusions: After adjusting for patient and clinical characteristics, total thyroidectomy compared with thyroid lobectomy was not associated with improved survival for patients <45 years of age with stage I PTC of 1.1 to 4.0 cm. Additional clinical and pathologic factors should be considered when choosing extent of resection.

Authors
Adam, MA; Pura, J; Goffredo, P; Dinan, MA; Hyslop, T; Reed, SD; Scheri, RP; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Goffredo, P, Dinan, MA, Hyslop, T, Reed, SD, Scheri, RP, Roman, SA, and Sosa, JA. "Impact of extent of surgery on survival for papillary thyroid cancer patients younger than 45 years." Journal of Clinical Endocrinology and Metabolism 100.1 (2015): 115-121.
Source
scival
Published In
Journal of Clinical Endocrinology and Metabolism
Volume
100
Issue
1
Publish Date
2015
Start Page
115
End Page
121
DOI
10.1210/jc.20143039

Patient preferences in advanced or recurrent ovarian cancer.

The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen.Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer.In total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P < .0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P = .01), 3.4 (P < .001), and 7.5 (P < .001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate.PFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity.

Authors
Havrilesky, LJ; Alvarez Secord, A; Ehrisman, JA; Berchuck, A; Valea, FA; Lee, PS; Gaillard, SL; Samsa, GP; Cella, D; Weinfurt, KP; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Alvarez Secord, A, Ehrisman, JA, Berchuck, A, Valea, FA, Lee, PS, Gaillard, SL, Samsa, GP, Cella, D, Weinfurt, KP, Abernethy, AP, and Reed, SD. "Patient preferences in advanced or recurrent ovarian cancer." Cancer 120.23 (December 2014): 3651-3659.
PMID
25091693
Source
epmc
Published In
Cancer
Volume
120
Issue
23
Publish Date
2014
Start Page
3651
End Page
3659
DOI
10.1002/cncr.28940

Robotic thyroidectomy for cancer in the US: patterns of use and short-term outcomes.

We describe nationally representative patterns of utilization and short-term outcomes from robotic versus open thyroidectomy for thyroid cancer.Descriptive statistics and multivariable analysis were used to analyze patterns of use of robotic thyroidectomy from the National Cancer Database (2010-2011). Short-term outcomes were compared between patients undergoing robotic versus open thyroidectomy, while adjusting for confounders.A total of 68,393 patients with thyroid cancer underwent thyroidectomy; 225 had robotic surgery and 57,729 underwent open surgery. Robotic thyroid surgery use increased by 30 % from 2010 to 2011 (p = 0.08). Robotic cases were reported from 93 centers, with 89 centers performing <10 robotic cases. Compared with the open group, the robotic group was younger (51 vs. 47 years; p < 0.01) and included more Asian patients (4 vs. 8 %; p = 0.006) and privately-insured patients (68 vs. 77 %; p = 0.01). Tumor size was similar between patients undergoing robotic versus open surgery. Total thyroidectomy was performed less frequently in the robotic group (67 vs. 84 % open; p < 0.0001). Patients were relatively more likely to undergo robotic surgery if they were female (odds ratio [OR] 1.6; p = 0.04), younger (OR 0.8/10 years; p < 0.0001), or underwent lobectomy (OR 2.4; p < 0.0001). In adjusted multivariable analysis, there were no differences in the number of lymph nodes removed or length of stay between groups; however, there was a non-significant increase in the incidence of positive margins with robotic thyroidectomy.Use of robotic thyroidectomy for thyroid cancer is limited to a few institutions, with short-term outcomes that are comparable to open surgery. Multi-institutional studies should be undertaken to compare thyroidectomy-specific complications and long-term outcomes.

Authors
Adam, MA; Speicher, P; Pura, J; Dinan, MA; Reed, SD; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Speicher, P, Pura, J, Dinan, MA, Reed, SD, Roman, SA, and Sosa, JA. "Robotic thyroidectomy for cancer in the US: patterns of use and short-term outcomes." Annals of surgical oncology 21.12 (November 2014): 3859-3864.
PMID
24934584
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
12
Publish Date
2014
Start Page
3859
End Page
3864
DOI
10.1245/s10434-014-3838-8

Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States.

Nonfunctional pancreatic neuroendocrine tumors (PNETs) ≤2 cm have uncertain malignant potential, and optimal treatment remains unclear. Objectives of this study were to better understand their malignant potential, determine whether extent of surgery or lymph node dissection is associated with overall survival (OS), and identify other factors associated with OS.Patients with nonfunctional PNETs ≤2 cm were identified from the National Cancer Data Base (1998 to 2011). Descriptive statistics were used for patient characteristics and surgical resection patterns. Five-year OS was estimated using Kaplan-Meier analyses across extent of surgery and compared using the log-rank test. Cox proportional regression modeling was used to test the association between survival and extent of surgery.A total of 1854 patients with nonfunctional PNETs ≤2 cm were included. From 1998 to 2011, these tumors increased three-fold as a proportion of all PNETs. Among tumors ≤0.5 cm, 33 % presented with regional lymph node metastases and 11 % with distant metastases. Five-year OS for patients not undergoing surgery was 27.6 % vs. 83.0 % for partial pancreatectomy, 72.3 % for pancreaticoduodenectomy, and 86.0 % for total pancreatectomy (p < 0.01). Multivariate analysis demonstrated no difference in OS based on type of surgery or the addition of regional lymphadenectomy (p = 0.16). Younger age and later year of diagnosis were independently associated with improved survival.Small nonfunctional PNETs represent an increasing proportion of all PNETs and have a significant risk of malignancy. Survival is improving over time despite older age at diagnosis. Type of surgical resection and the addition of lymph node resection were not associated with OS.

Authors
Gratian, L; Pura, J; Dinan, M; Roman, S; Reed, S; Sosa, JA
MLA Citation
Gratian, L, Pura, J, Dinan, M, Roman, S, Reed, S, and Sosa, JA. "Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States." Annals of surgical oncology 21.11 (October 2014): 3515-3521.
PMID
24841347
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3515
End Page
3521
DOI
10.1245/s10434-014-3769-4

Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States.

Adrenocortical carcinoma (ACC) is a rare, aggressive disease with no apparent change in treatment or survival in the United States over the past two decades. Our objective was to determine whether treatment patterns or clinical outcomes vary by hospital case volume.Patients with ACC were identified from the National Cancer Database (1998-2011). High-volume centers (HVCs) were defined by a case load of ≥4 cases of primary adrenal malignancy annually, which corresponded to the 90th percentile. All other facilities were considered low-volume centers (LVCs).A total of 2,765 ACC patients were treated across 1,046 facilities. Compared to patients treated at LVCs, patients treated at HVCs were younger (50 vs. 54 years), with larger tumors (11.2 vs. 10.5 cm), and underwent higher rates of surgery (78.8 vs. 73.4 %), radical resection (17.3 vs. 13.9 %), regional lymph node evaluation (23.2 vs. 18.8 %), and chemotherapy including mitotane (43.8 vs. 31.0 %, all p < 0.05).There were no significant differences in median length of stay (5 vs. 5 days), 30-day readmission rates (4.0 % for HVCs vs. 3.9 % for LVCs), or 30-day postoperative mortality rates (1.9 % for HVCs vs. 3.7 % for LVCs). Median overall survival was 2.0 years for HVCs and 1.9 years for LVCs, p = 0.53. After adjusting for patient and tumor characteristics, overall survival did not differ significantly between patients treated at HVCs versus LVCs [HR = 0.89 (95 % confidence interval 0.70, 1.12)].Treatment at HVCs was associated with more aggressive surgical resection and chemotherapy use. Prognosis remained poor despite more aggressive treatment.

Authors
Gratian, L; Pura, J; Dinan, M; Reed, S; Scheri, R; Roman, S; Sosa, JA
MLA Citation
Gratian, L, Pura, J, Dinan, M, Reed, S, Scheri, R, Roman, S, and Sosa, JA. "Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States." Annals of surgical oncology 21.11 (October 2014): 3509-3514.
PMID
25069860
Source
epmc
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3509
End Page
3514
DOI
10.1245/s10434-014-3931-z

Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients.

To examine the association between the extent of surgery and overall survival in a large contemporary cohort of patients with papillary thyroid cancer (PTC).Guidelines recommend total thyroidectomy for PTC tumors >1 cm, based on older data demonstrating an overall survival advantage for total thyroidectomy over lobectomy.Adult patients with PTC tumors 1.0-4.0 cm undergoing thyroidectomy in the National Cancer Database, 1998-2006, were included. Cox proportional hazards models were applied to measure the association between the extent of surgery and overall survival while adjusting for patient demographic and clinical factors, including comorbidities, extrathyroidal extension, multifocality, nodal and distant metastases, and radioactive iodine treatment.Among 61,775 PTC patients, 54,926 underwent total thyroidectomy and 6849 lobectomy. Compared with lobectomy, patients undergoing total thyroidectomy had more nodal (7% vs 27%), extrathyroidal (5% vs 16%), and multifocal disease (29% vs 44%) (all Ps < 0.001). Median follow-up was 82 months (range, 60-179 months). After multivariable adjustment, overall survival was similar in patients undergoing total thyroidectomy versus lobectomy for tumors 1.0-4.0 cm [hazard ratio (HR) = 0.96; 95% confidence interval (CI), 0.84-1.09); P = 0.54] and when stratified by tumor size: 1.0-2.0 cm [HR = 1.05; 95% CI, 0.88-1.26; P = 0.61] and 2.1-4.0 cm [HR = 0.89; 95% CI, 0.73-1.07; P = 0.21]. Older age, male sex, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (P < 0.0001).Current guidelines suggest total thyroidectomy for PTC tumors >1 cm. However, we did not observe a survival advantage associated with total thyroidectomy compared with lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.

Authors
Adam, MA; Pura, J; Gu, L; Dinan, MA; Tyler, DS; Reed, SD; Scheri, R; Roman, SA; Sosa, JA
MLA Citation
Adam, MA, Pura, J, Gu, L, Dinan, MA, Tyler, DS, Reed, SD, Scheri, R, Roman, SA, and Sosa, JA. "Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients." Annals of surgery 260.4 (October 2014): 601-605.
PMID
25203876
Source
epmc
Published In
Annals of Surgery
Volume
260
Issue
4
Publish Date
2014
Start Page
601
End Page
605
DOI
10.1097/sla.0000000000000925

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial.

A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients' doctors' offices (N=129 patients); the control group received usual care (N=127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain.

Authors
Broderick, JE; Keefe, FJ; Bruckenthal, P; Junghaenel, DU; Schneider, S; Schwartz, JE; Kaell, AT; Caldwell, DS; McKee, D; Reed, S; Gould, E
MLA Citation
Broderick, JE, Keefe, FJ, Bruckenthal, P, Junghaenel, DU, Schneider, S, Schwartz, JE, Kaell, AT, Caldwell, DS, McKee, D, Reed, S, and Gould, E. "Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial." Pain 155.9 (September 2014): 1743-1754.
PMID
24865795
Source
epmc
Published In
PAIN
Volume
155
Issue
9
Publish Date
2014
Start Page
1743
End Page
1754
DOI
10.1016/j.pain.2014.05.024

Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting.

To describe the rationale and design of a pilot program to implement and evaluate pharmacogenetic (PGx) testing in a primary care setting.Several factors have impeded the uptake of PGx testing, including lack of provider knowledge and challenges with operationalizing PGx testing in a clinical practice setting.We plan to compare two strategies for the implementation of PGx testing: a pharmacist-initiated testing arm compared with a physician-initiated PGx testing arm. Providers in both groups will be required to attend an introduction to PGx seminar. Anticipated results: We anticipate that providers in the pharmacist-initiated group will be more likely to order PGx testing than providers in the physician-initiated group.Overall, we aim to generate data that will inform an effective delivery model for PGx testing and to facilitate a seamless integration of PGx testing in primary care practices.

Authors
Haga, SB; LaPointe, NMA; Cho, A; Reed, SD; Mills, R; Moaddeb, J; Ginsburg, GS
MLA Citation
Haga, SB, LaPointe, NMA, Cho, A, Reed, SD, Mills, R, Moaddeb, J, and Ginsburg, GS. "Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting." Pharmacogenomics 15.13 (September 2014): 1677-1686.
PMID
25410893
Source
epmc
Published In
Pharmacogenomics
Volume
15
Issue
13
Publish Date
2014
Start Page
1677
End Page
1686
DOI
10.2217/pgs.14.109

Can delaying the onset of type 2 diabetes be cost-effective?

Authors
Gray, AM; Leal, J; Rivero-Arias, O; Reed, SD; Li, Y; Schulman, KA; Califf, RM; Holman, RR
MLA Citation
Gray, AM, Leal, J, Rivero-Arias, O, Reed, SD, Li, Y, Schulman, KA, Califf, RM, and Holman, RR. "Can delaying the onset of type 2 diabetes be cost-effective?." DIABETOLOGIA 57 (September 2014): S120-S121.
Source
wos-lite
Published In
Diabetologia
Volume
57
Publish Date
2014
Start Page
S120
End Page
S121

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

Statistical considerations in economic evaluations: a guide for cardiologists.

The author reviews statistical methods commonly applied in economic evaluations that rely on individual patient-level data. The paper includes a review of foundational concepts, unique characteristics of health economic data, and methods developed to address them. The paper then highlights issues that should be considered in the interpretation of findings from economic evaluations.

Authors
Reed, SD
MLA Citation
Reed, SD. "Statistical considerations in economic evaluations: a guide for cardiologists." European heart journal 35.25 (July 2014): 1652-1656.
PMID
24801070
Source
epmc
Published In
European Heart Journal (Elsevier)
Volume
35
Issue
25
Publish Date
2014
Start Page
1652
End Page
1656
DOI
10.1093/eurheartj/ehu174

A framework to evaluate the cost-effectiveness of the NADiA ProsVue slope to guide adjuvant radiotherapy among men with high-risk characteristics following prostatectomy for prostate cancer.

OBJECTIVES: The NADiA ProsVue is a prognostic system that measures prostate-specific antigen slope to identify men at lower risk of clinical recurrence of prostate cancer after radical prostatectomy. We developed a decision-modeling framework to evaluate its cost-effectiveness to guide the use of adjuvant radiotherapy (ART). METHODS: We populated the model using patient-level data and external sources. Patients were classified as intermediate risk or high risk on the basis of Cancer of the Prostate Risk Assessment-Postsurgical (CAPRA-S) nomogram and then stratified by the ProsVue slope (≤2 pg/mL/mo; >2 pg/mL/mo) and receipt of ART. In sensitivity analyses, we varied the effect of the ProsVue slope on the use of ART and other model parameters. RESULTS: The cost-effectiveness of the ProsVue-guided strategy varied widely because of small differences in quality-adjusted life-years (QALYs) at 10 years. In the intermediate-risk group, when the use of ART decreased from 20% (standard care) to 7.5% among patients with a ProsVue slope value of 2 pg/mL/mo or less, the incremental cost-effectiveness ratio was $25,160/QALY. In the high-risk group, the use of ART would have to decrease from 40% (standard care) to 11.5% among those with a ProsVue slope value of 2 pg/mL/mo or less to obtain a ratio of $50,000/QALY. The cost-effectiveness ratios were sensitive to varying benefits of salvage therapy, quality of life, and costs of ART and ProsVue testing. CONCLUSIONS: The effect of the ProsVue system on costs will be dependent on the extent to which ART decreases among men identified as having a low risk of recurrence. Its effect on QALYs will remain conditional on uncertain clinical and quality-of-life benefits associated with ART.

Authors
Reed, SD; Stewart, SB; Scales, CD; Moul, JW
MLA Citation
Reed, SD, Stewart, SB, Scales, CD, and Moul, JW. "A framework to evaluate the cost-effectiveness of the NADiA ProsVue slope to guide adjuvant radiotherapy among men with high-risk characteristics following prostatectomy for prostate cancer." Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 17.5 (July 2014): 545-554.
PMID
25128047
Source
epmc
Published In
Value in Health
Volume
17
Issue
5
Publish Date
2014
Start Page
545
End Page
554
DOI
10.1016/j.jval.2014.04.010

Relative influence of factors determining a woman's preference for treatment options in ovarian cancer.

Authors
Havrilesky, LJ; Secord, AA; Ehrisman, JA; Berchuck, A; Valea, FA; Lee, PS; Gaillard, S; Celia, D; Weinfurt, K; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Secord, AA, Ehrisman, JA, Berchuck, A, Valea, FA, Lee, PS, Gaillard, S, Celia, D, Weinfurt, K, Abernethy, AP, and Reed, SD. "Relative influence of factors determining a woman's preference for treatment options in ovarian cancer." May 20, 2014.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
32
Issue
15
Publish Date
2014

Initial utilization of Oncotype DX in the Medicare population between 2005 and 2007

Authors
Dinan, MA; Mi, X; Reed, SD; Hirsch, BR; Lyman, GH; Curtis, LH
MLA Citation
Dinan, MA, Mi, X, Reed, SD, Hirsch, BR, Lyman, GH, and Curtis, LH. "Initial utilization of Oncotype DX in the Medicare population between 2005 and 2007." May 20, 2014.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
32
Issue
15
Publish Date
2014

RELATIVE INFLUENCE OF FACTORS DETERMINING A WOMAN'S PREFERENCE FOR TREATMENT OPTIONS IN OVARIAN CANCER: A DISCRETE CHOICE EXPERIMENT

Authors
Havrilesky, LJ; Secord, AA; Ehrisman, J; Berchuck, A; Valea, FA; Lee, PS; Cella, D; Weinfurt, K; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Secord, AA, Ehrisman, J, Berchuck, A, Valea, FA, Lee, PS, Cella, D, Weinfurt, K, Abernethy, AP, and Reed, SD. "RELATIVE INFLUENCE OF FACTORS DETERMINING A WOMAN'S PREFERENCE FOR TREATMENT OPTIONS IN OVARIAN CANCER: A DISCRETE CHOICE EXPERIMENT." VALUE IN HEALTH 17.3 (May 2014): A93-A93.
Source
wos-lite
Published In
Value in Health
Volume
17
Issue
3
Publish Date
2014
Start Page
A93
End Page
A93

USE OF PSA SLOPE TO GUIDE ADJUVANT RADIOTHERAPY IN POST-PROSTATECTOMY PROSTATE CANCER HAS POTENTIAL TO BE COST EFFECTIVE

Authors
Reed, SD; Stewart, BS; Scales, CD; Moul, JW
MLA Citation
Reed, SD, Stewart, BS, Scales, CD, and Moul, JW. "USE OF PSA SLOPE TO GUIDE ADJUVANT RADIOTHERAPY IN POST-PROSTATECTOMY PROSTATE CANCER HAS POTENTIAL TO BE COST EFFECTIVE." May 2014.
Source
wos-lite
Published In
Value in Health
Volume
17
Issue
3
Publish Date
2014
Start Page
A86
End Page
A86

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

Will the future of health care lead to the end of the robotic golden years?

Authors
Biehn Stewart, S; Reed, SD; Moul, JW
MLA Citation
Biehn Stewart, S, Reed, SD, and Moul, JW. "Will the future of health care lead to the end of the robotic golden years?." European Urology 65.2 (February 1, 2014): 325-327.
Source
scopus
Published In
European Urology
Volume
65
Issue
2
Publish Date
2014
Start Page
325
End Page
327
DOI
10.1016/j.eururo.2012.10.019

Will the future of health care lead to the end of the robotic golden years?

Authors
Biehn Stewart, S; Reed, SD; Moul, JW
MLA Citation
Biehn Stewart, S, Reed, SD, and Moul, JW. "Will the future of health care lead to the end of the robotic golden years?." Eur Urol 65.2 (February 2014): 325-327.
PMID
23116656
Source
pubmed
Published In
European Urology
Volume
65
Issue
2
Publish Date
2014
Start Page
325
End Page
327
DOI
10.1016/j.eururo.2012.10.019

A framework to evaluate the cost-effectiveness of the NADiA prosvue slope to guide adjuvant radiotherapy among men with high-risk characteristics following prostatectomy for prostate cancer

Objectives The NADiA ProsVue is a prognostic system that measures prostate-specific antigen slope to identify men at lower risk of clinical recurrence of prostate cancer after radical prostatectomy. We developed a decision-modeling framework to evaluate its cost-effectiveness to guide the use of adjuvant radiotherapy (ART). Methods We populated the model using patient-level data and external sources. Patients were classified as intermediate risk or high risk on the basis of Cancer of the Prostate Risk Assessment-Postsurgical (CAPRA-S) nomogram and then stratified by the ProsVue slope (≤2 pg/mL/mo; >2 pg/mL/mo) and receipt of ART. In sensitivity analyses, we varied the effect of the ProsVue slope on the use of ART and other model parameters. Results The cost-effectiveness of the ProsVue-guided strategy varied widely because of small differences in quality-adjusted life-years (QALYs) at 10 years. In the intermediate-risk group, when the use of ART decreased from 20% (standard care) to 7.5% among patients with a ProsVue slope value of 2 pg/mL/mo or less, the incremental cost-effectiveness ratio was $25,160/QALY. In the high-risk group, the use of ART would have to decrease from 40% (standard care) to 11.5% among those with a ProsVue slope value of 2 pg/mL/mo or less to obtain a ratio of $50,000/QALY. The cost-effectiveness ratios were sensitive to varying benefits of salvage therapy, quality of life, and costs of ART and ProsVue testing. Conclusions The effect of the ProsVue system on costs will be dependent on the extent to which ART decreases among men identified as having a low risk of recurrence. Its effect on QALYs will remain conditional on uncertain clinical and quality-of-life benefits associated with ART. ;copy;2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Authors
Reed, SD; Stewart, SB; Scales, CD; Moul, JW
MLA Citation
Reed, SD, Stewart, SB, Scales, CD, and Moul, JW. "A framework to evaluate the cost-effectiveness of the NADiA prosvue slope to guide adjuvant radiotherapy among men with high-risk characteristics following prostatectomy for prostate cancer." Value in Health 17.5 (January 1, 2014): 545-554.
Source
scopus
Published In
Value in Health
Volume
17
Issue
5
Publish Date
2014
Start Page
545
End Page
554
DOI
10.1016/j.jval.2014.04.010

Robotic Thyroidectomy for Cancer in the US: Patterns of Use and Short-Term Outcomes

© 2014, Society of Surgical Oncology.Background: We describe nationally representative patterns of utilization and short-term outcomes from robotic versus open thyroidectomy for thyroid cancer.Methods: Descriptive statistics and multivariable analysis were used to analyze patterns of use of robotic thyroidectomy from the National Cancer Database (2010–2011). Short-term outcomes were compared between patients undergoing robotic versus open thyroidectomy, while adjusting for confounders.Results: A total of 68,393 patients with thyroid cancer underwent thyroidectomy; 225 had robotic surgery and 57,729 underwent open surgery. Robotic thyroid surgery use increased by 30 % from 2010 to 2011 (p = 0.08). Robotic cases were reported from 93 centers, with 89 centers performing <10 robotic cases. Compared with the open group, the robotic group was younger (51 vs. 47 years; p < 0.01) and included more Asian patients (4 vs. 8 %; p = 0.006) and privately-insured patients (68 vs. 77 %; p = 0.01). Tumor size was similar between patients undergoing robotic versus open surgery. Total thyroidectomy was performed less frequently in the robotic group (67 vs. 84 % open; p < 0.0001). Patients were relatively more likely to undergo robotic surgery if they were female (odds ratio [OR] 1.6; p = 0.04), younger (OR 0.8/10 years; p < 0.0001), or underwent lobectomy (OR 2.4; p < 0.0001). In adjusted multivariable analysis, there were no differences in the number of lymph nodes removed or length of stay between groups; however, there was a non-significant increase in the incidence of positive margins with robotic thyroidectomy.Conclusions: Use of robotic thyroidectomy for thyroid cancer is limited to a few institutions, with short-term outcomes that are comparable to open surgery. Multi-institutional studies should be undertaken to compare thyroidectomy-specific complications and long-term outcomes.

Authors
Abdelgadir Adam, M; Speicher, P; Pura, J; Dinan, MA; Reed, SD; Roman, SA; Sosa, JA
MLA Citation
Abdelgadir Adam, M, Speicher, P, Pura, J, Dinan, MA, Reed, SD, Roman, SA, and Sosa, JA. "Robotic Thyroidectomy for Cancer in the US: Patterns of Use and Short-Term Outcomes." Annals of Surgical Oncology 21.12 (January 1, 2014): 3859-3864.
Source
scopus
Published In
Annals of Surgical Oncology
Volume
21
Issue
12
Publish Date
2014
Start Page
3859
End Page
3864
DOI
10.1245/s10434-014-3838-8

Patient preferences in advanced or recurrent ovarian cancer

© 2014 American Cancer Society.BACKGROUND: The objective of this study was to elucidate relative preferences of women with ovarian cancer for symptoms, treatment-related side effects, and progression-free survival (PFS) relevant to choosing a treatment regimen.METHODS: Women with advanced or recurrent ovarian cancer participated in a survey that included 3 methods to measure patient preferences (ratings, rankings, and a discrete-choice experiment) for 7 attributes: mode of administration, visit frequency, peripheral neuropathy, nausea and vomiting, fatigue, abdominal discomfort, and PFS. Participants were asked to choose between 2 unlabeled treatment scenarios that were characterized using the 7 attributes. Each participant completed 12 choice questions in which attribute levels were assigned according to an experimental design and a fixed-choice question representing 2 chemotherapy regimens for ovarian cancer.RESULTS: In total, 95 women completed the survey. Participants' ratings and rankings revealed greater concern and importance for PFS than for any other attribute (P<.0001 for all). The discrete-choice experiment revealed that the relative odds that a participant would choose a scenario with 18 months, 21 months, and 24 months of PFS versus 15 months of PFS were 1.5 (P5.01), 3.4 (P<.001), and 7.5 (P<.001), respectively. However, participants' choices indicated that they were willing to accept a shorter PFS to avoid severe side effects: 6.7 months to reduce nausea and vomiting from severe to mild, 5.0 months to reduce neuropathy from severe to mild, and 3.7 months to reduce abdominal symptoms from severe to moderate.CONCLUSIONS: PFS is the predominant driver of patient preferences for chemotherapy regimens. However, women in the current study were willing to trade significant PFS time for reductions in treatment-related toxicity.

Authors
Havrilesky, LJ; Secord, AA; Ehrisman, JA; Berchuck, A; Valea, FA; Lee, PS; Gaillard, SL; Samsa, GP; Cella, D; Weinfurt, KP; Abernethy, AP; Reed, SD
MLA Citation
Havrilesky, LJ, Secord, AA, Ehrisman, JA, Berchuck, A, Valea, FA, Lee, PS, Gaillard, SL, Samsa, GP, Cella, D, Weinfurt, KP, Abernethy, AP, and Reed, SD. "Patient preferences in advanced or recurrent ovarian cancer." Cancer 120.23 (January 1, 2014): 3651-3659.
Source
scopus
Published In
Cancer
Volume
120
Issue
23
Publish Date
2014
Start Page
3651
End Page
3659
DOI
10.1002/cncr.28940

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial

A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients' doctors' offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain.

Authors
Broderick, JE; Keefe, FJ; Bruckenthal, P; Junghaenel, DU; Schneider, S; Schwartz, JE; Kaell, AT; Caldwell, DS; McKee, D; Reed, S; Gould, E
MLA Citation
Broderick, JE, Keefe, FJ, Bruckenthal, P, Junghaenel, DU, Schneider, S, Schwartz, JE, Kaell, AT, Caldwell, DS, McKee, D, Reed, S, and Gould, E. "Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized, controlled trial." Pain 155.9 (January 1, 2014): 1743-1754.
Source
scopus
Published In
PAIN
Volume
155
Issue
9
Publish Date
2014
Start Page
1743
End Page
1754
DOI
10.1016/j.pain.2014.05.024

Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States

BACKGROUND: Nonfunctional pancreatic neuroendocrine tumors (PNETs) ≤2 cm have uncertain malignant potential, and optimal treatment remains unclear. Objectives of this study were to better understand their malignant potential, determine whether extent of surgery or lymph node dissection is associated with overall survival (OS), and identify other factors associated with OS.METHODS: Patients with nonfunctional PNETs ≤2 cm were identified from the National Cancer Data Base (1998 to 2011). Descriptive statistics were used for patient characteristics and surgical resection patterns. Five-year OS was estimated using Kaplan-Meier analyses across extent of surgery and compared using the log-rank test. Cox proportional regression modeling was used to test the association between survival and extent of surgery.RESULTS: A total of 1854 patients with nonfunctional PNETs ≤2 cm were included. From 1998 to 2011, these tumors increased three-fold as a proportion of all PNETs. Among tumors ≤0.5 cm, 33 % presented with regional lymph node metastases and 11 % with distant metastases. Five-year OS for patients not undergoing surgery was 27.6 % vs. 83.0 % for partial pancreatectomy, 72.3 % for pancreaticoduodenectomy, and 86.0 % for total pancreatectomy (p < 0.01). Multivariate analysis demonstrated no difference in OS based on type of surgery or the addition of regional lymphadenectomy (p = 0.16). Younger age and later year of diagnosis were independently associated with improved survival.CONCLUSIONS: Small nonfunctional PNETs represent an increasing proportion of all PNETs and have a significant risk of malignancy. Survival is improving over time despite older age at diagnosis. Type of surgical resection and the addition of lymph node resection were not associated with OS.

Authors
Gratian, L; Pura, J; Dinan, M; Roman, S; Reed, S; Sosa, JAN
MLA Citation
Gratian, L, Pura, J, Dinan, M, Roman, S, Reed, S, and Sosa, JAN. "Impact of extent of surgery on survival in patients with small nonfunctional pancreatic neuroendocrine tumors in the United States." Annals of surgical oncology 21.11 (2014): 3515-3521.
Source
scival
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3515
End Page
3521
DOI
10.1245/s10434-014-3769-4

Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States

BACKGROUND: Adrenocortical carcinoma (ACC) is a rare, aggressive disease with no apparent change in treatment or survival in the United States over the past two decades. Our objective was to determine whether treatment patterns or clinical outcomes vary by hospital case volume.METHODS: Patients with ACC were identified from the National Cancer Database (1998-2011). High-volume centers (HVCs) were defined by a case load of ≥4 cases of primary adrenal malignancy annually, which corresponded to the 90th percentile. All other facilities were considered low-volume centers (LVCs).RESULTS: A total of 2,765 ACC patients were treated across 1,046 facilities. Compared to patients treated at LVCs, patients treated at HVCs were younger (50 vs. 54 years), with larger tumors (11.2 vs. 10.5 cm), and underwent higher rates of surgery (78.8 vs. 73.4 %), radical resection (17.3 vs. 13.9 %), regional lymph node evaluation (23.2 vs. 18.8 %), and chemotherapy including mitotane (43.8 vs. 31.0 %, all p < 0.05).There were no significant differences in median length of stay (5 vs. 5 days), 30-day readmission rates (4.0 % for HVCs vs. 3.9 % for LVCs), or 30-day postoperative mortality rates (1.9 % for HVCs vs. 3.7 % for LVCs). Median overall survival was 2.0 years for HVCs and 1.9 years for LVCs, p = 0.53. After adjusting for patient and tumor characteristics, overall survival did not differ significantly between patients treated at HVCs versus LVCs [HR = 0.89 (95 % confidence interval 0.70, 1.12)].CONCLUSIONS: Treatment at HVCs was associated with more aggressive surgical resection and chemotherapy use. Prognosis remained poor despite more aggressive treatment.

Authors
Gratian, L; Pura, J; Dinan, M; Reed, S; Scheri, R; Roman, S; Sosa, JAN
MLA Citation
Gratian, L, Pura, J, Dinan, M, Reed, S, Scheri, R, Roman, S, and Sosa, JAN. "Treatment patterns and outcomes for patients with adrenocortical carcinoma associated with hospital case volume in the United States." Annals of surgical oncology 21.11 (2014): 3509-3514.
Source
scival
Published In
Annals of Surgical Oncology
Volume
21
Issue
11
Publish Date
2014
Start Page
3509
End Page
3514
DOI
10.1245/s10434-014-3931-z

Differences in Treatment, Outcomes, and Quality of Life Among Patients With Heart Failure in Canada and the United States

Objectives: The aim of this study was to compare clinical outcomes, resource utilization, and health-related quality of life between Canadian and U.S. patients enrolled in ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). A further aim was to supplement the within-trial analysis with a contemporaneous population-based comparison of all patients hospitalized with primary diagnoses of heart failure (HF) in the 2 countries. Background: Little is known about intercountry differences in outcomes of patients with HF in Canada and the United States. Methods: Trial patients consisted of 465 Canadian and 2,684 U.S. patients enrolled in ASCEND-HF. Population-level cohorts consisted of 1.9 million U.S. and 81,016 Canadians hospitalized for HF in 2007 and2008. Results: Canadian patients in ASCEND-HF were older, were more likely to be white, and had lower body weights and blood pressures than U.S. patients. Canadians also had lower baseline-adjusted odds of 30-day mortality (odds ratio: 0.46; 95% confidence interval: 0.23 to 0.92) and better health-related quality of life than U.S. patients. In both countries, trial patients differed significantly from population-level cohorts. In contrast to ASCEND-HF, unadjusted in-hospital mortality at the population level was significantly lower in the United States (3.4%) compared with Canada (11.1%) (p< 0.01). Conclusions: Intercountry differences in outcomes of patients hospitalized with HF differed significantly between trial and population cohorts. Further study on how cardiac care is delivered in the 2 countries and how it influences the results of clinical trials and population-level outcomes, especially in the long term, is warranted. (A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure; NCT00475852). © 2013 American College of Cardiology Foundation.

Authors
Kaul, P; Reed, SD; Hernandez, AF; Howlett, JG; Ezekowitz, JA; Li, Y; Zheng, Y; Rouleau, JL; Starling, RC; O'Connor, CM; Califf, RM; Armstrong, PW
MLA Citation
Kaul, P, Reed, SD, Hernandez, AF, Howlett, JG, Ezekowitz, JA, Li, Y, Zheng, Y, Rouleau, JL, Starling, RC, O'Connor, CM, Califf, RM, and Armstrong, PW. "Differences in Treatment, Outcomes, and Quality of Life Among Patients With Heart Failure in Canada and the United States." JACC: Heart Failure 1.6 (December 1, 2013): 523-530.
PMID
24622005
Source
scopus
Published In
JACC: Heart Failure
Volume
1
Issue
6
Publish Date
2013
Start Page
523
End Page
530
DOI
10.1016/j.jchf.2013.07.004

Longitudinal Trends in Costs for Palliative Radiation for Metastatic Prostate Cancer

Authors
Robinson, TJ; Dinan, MA; Li, Y; Lee, WR; Reed, SD
MLA Citation
Robinson, TJ, Dinan, MA, Li, Y, Lee, WR, and Reed, SD. "Longitudinal Trends in Costs for Palliative Radiation for Metastatic Prostate Cancer." October 1, 2013.
PMID
26241733
Source
wos-lite
Published In
International Journal of Radiation Oncology, Biology, Physics
Volume
87
Issue
2
Publish Date
2013
Start Page
S490
End Page
S490

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

Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF.

BACKGROUND: Hospital readmission is an important clinical outcome of patients with heart failure. Its relation to length of stay for the initial hospitalization is not clear. METHODS AND RESULTS: We used hierarchical modeling of data from a clinical trial to examine variations in length of stay across countries and across hospitals in the United States and its association with readmission within 30 days of randomization. Main outcomes included associations between country-level length of stay and readmission rates, after adjustment for patient-level case mix; and associations between length of stay and readmission rates across sites in the United States. Across 27 countries with 389 sites and 6848 patients, mean length of stay ranged from 4.9 to 14.6 days (6.1 days in the United States). Rates of all-cause readmission ranged from 2.5% to 25.0% (17.8% in the United States). There was an inverse correlation between country-level mean length of stay and readmission (r=-0.52; P<0.01). After multivariable adjustment, each additional inpatient day across countries was associated with significantly lower risk of all-cause readmission (odds ratio, 0.86; 95% confidence interval, 0.75-0.98; P=0.02) and heart failure readmission (odds ratio, 0.79; 95% confidence interval, 0.69-0.99; P=0.03). Similar trends were observed across US study sites concerning readmission for any cause (odds ratio, 0.92; 95% confidence interval, 0.85-1.00; P=0.06) and readmission for heart failure (odds ratio, 0.90; 95% confidence interval, 0.80-1.01; P=0.07). Across countries and across US sites, longer median length of stay was independently associated with lower risk of readmission. CONCLUSIONS: Countries with longer length of stay for heart failure hospitalizations had significantly lower rates of readmission within 30 days of randomization. These findings may have implications for developing strategies to prevent readmission, defining quality measures, and designing clinical trials in acute heart failure. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.

Authors
Eapen, ZJ; Reed, SD; Li, Y; Kociol, RD; Armstrong, PW; Starling, RC; McMurray, JJ; Massie, BM; Swedberg, K; Ezekowitz, JA; Fonarow, GC; Teerlink, JR; Metra, M; Whellan, DJ; O'Connor, CM; Califf, RM; Hernandez, AF
MLA Citation
Eapen, ZJ, Reed, SD, Li, Y, Kociol, RD, Armstrong, PW, Starling, RC, McMurray, JJ, Massie, BM, Swedberg, K, Ezekowitz, JA, Fonarow, GC, Teerlink, JR, Metra, M, Whellan, DJ, O'Connor, CM, Califf, RM, and Hernandez, AF. "Do countries or hospitals with longer hospital stays for acute heart failure have lower readmission rates?: Findings from ASCEND-HF." Circ Heart Fail 6.4 (July 2013): 727-732.
PMID
23770519
Source
pubmed
Published In
Circulation. Heart failure
Volume
6
Issue
4
Publish Date
2013
Start Page
727
End Page
732
DOI
10.1161/CIRCHEARTFAILURE.112.000265

Resource use and costs in the last year of life among Medicare beneficiaries who died from prostate cancer versus with the disease between 2000 and 2007.

Authors
Reed, SD; Dinan, MA; Li, Y; Zhang, Y; Curtis, LH; George, DJ; Stewart, SB
MLA Citation
Reed, SD, Dinan, MA, Li, Y, Zhang, Y, Curtis, LH, George, DJ, and Stewart, SB. "Resource use and costs in the last year of life among Medicare beneficiaries who died from prostate cancer versus with the disease between 2000 and 2007." May 20, 2013.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
31
Issue
15
Publish Date
2013

Longitudinal trends in costs for palliative radiation for metastatic prostate cancer

Authors
Robinson, TJ; Dinan, MA; Li, Y; Lee, R; Reed, SD
MLA Citation
Robinson, TJ, Dinan, MA, Li, Y, Lee, R, and Reed, SD. "Longitudinal trends in costs for palliative radiation for metastatic prostate cancer." May 20, 2013.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
31
Issue
15
Publish Date
2013

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials

Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

Authors
Keefe, RSE; Kraemer, HC; Epstein, RS; Frank, E; Haynes, G; Laughren, TP; McNulty, J; Reed, SD; Sanchez, J; Leon, AC
MLA Citation
Keefe, RSE, Kraemer, HC, Epstein, RS, Frank, E, Haynes, G, Laughren, TP, McNulty, J, Reed, SD, Sanchez, J, and Leon, AC. "Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials." Innovations in Clinical Neuroscience 10.5-6 (May 1, 2013).
Source
scopus
Published In
Innovations in Clinical Neuroscience
Volume
10
Issue
5-6
Publish Date
2013

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

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

OBJECTIVE: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. DESIGN: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. SETTING: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. PARTICIPANTS: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. RESULTS: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. CONCLUSION: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

Authors
Keefe, RSE; Kraemer, HC; Epstein, RS; Frank, E; Haynes, G; Laughren, TP; McNulty, J; Reed, SD; Sanchez, J; Leon, AC
MLA Citation
Keefe, RSE, Kraemer, HC, Epstein, RS, Frank, E, Haynes, G, Laughren, TP, McNulty, J, Reed, SD, Sanchez, J, and Leon, AC. "Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials." Innov Clin Neurosci 10.5-6 Suppl A (May 2013): 4S-19S.
PMID
23882433
Source
pubmed
Published In
Innovations in Clinical Neuroscience
Volume
10
Issue
5-6 Suppl A
Publish Date
2013
Start Page
4S
End Page
19S

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

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

How country-specific should a country-specific cost-effectiveness analysis be?

Authors
Reed, SD
MLA Citation
Reed, SD. "How country-specific should a country-specific cost-effectiveness analysis be?." Eur Heart J 34.3 (January 2013): 166-167.
PMID
22809680
Source
pubmed
Published In
European Heart Journal (Elsevier)
Volume
34
Issue
3
Publish Date
2013
Start Page
166
End Page
167
DOI
10.1093/eurheartj/ehs204

Update on the role of epothilones in metastatic breast cancer

The role of epothilones in the treatment of locally advanced and metastatic breast cancer remains unclear. While the pivotal studies for ixabepilone were published between 2005 and 2010, and the agent received approval in 2007 from the U.S. Food and Drug Administration, its uptake in routine treatment of breast cancer that is resistant to anthracyclines and taxanes remains inconsistent. The other agents in the class, patupilone and sagopilone, are being studied in a number of cancer types. In this review, the recently published literature on epothilones in various populations and at various dosages is reviewed including the associated adverse event profile and recent biomarker and genomic studies. While the literature has become increasing robust, the precise clinical role for the epothilones in the management of patients with breast cancer remains to be fully defined. © 2012 Springer Science+Business Media New York.

Authors
Hirsch, BR; Reed, SD; Lyman, GH
MLA Citation
Hirsch, BR, Reed, SD, and Lyman, GH. "Update on the role of epothilones in metastatic breast cancer." Current Breast Cancer Reports 5.1 (2013): 51-56.
Source
scival
Published In
Current Breast Cancer Reports
Volume
5
Issue
1
Publish Date
2013
Start Page
51
End Page
56
DOI
10.1007/s12609-012-0095-3

Oncology comparative effectiveness research:Amultistakeholder perspective on principles for conduct and reporting

Comparative effectiveness research (CER) can assist patients, clinicians, purchasers, and policy makers in making more informed decisions that will improve cancer care and outcomes. Despite its promise, the factors that distinguish CER from other types of evidence remain mysterious to many oncologists. One concern is whether CER studies will improve decision making in oncology or only add to the massive amount of research information that decision makers must sift through as part of their professional responsibilities. In this report, we highlight several issues that distinguish CER from the most common way evidence is generated for cancer therapy- phase I-III clinical trials. To identify the issues that are most relevant to busy decision makers,weassembled a panel of active professionals with a wide range of roles in cancer care delivery. This panel identified five themes that they considered most important for CER in oncology, as well as fundamental threats to the validity of individual CER studies-threats they termed the "kiss of death" for their applicability to practice. In discussing these concepts,wealsotoucheduponthe notion of whether cancer is special among health issues with regard to how evidence is generated and used. © AlphaMed Press 2013.

Authors
Ramsey, SD; Sullivan, SD; Reed, SD; Shih, Y-CT; Schaecher, K; Dhanda, R; Patt, D; Pendergrass, K; Walker, M; Malin, J; Schwartzberg, L; Neumann, K; Yu, E; Ravelo, A; Small, A
MLA Citation
Ramsey, SD, Sullivan, SD, Reed, SD, Shih, Y-CT, Schaecher, K, Dhanda, R, Patt, D, Pendergrass, K, Walker, M, Malin, J, Schwartzberg, L, Neumann, K, Yu, E, Ravelo, A, and Small, A. "Oncology comparative effectiveness research:Amultistakeholder perspective on principles for conduct and reporting." Oncologist 18.6 (2013): 760-767.
PMID
23650020
Source
scival
Published In
The oncologist
Volume
18
Issue
6
Publish Date
2013
Start Page
760
End Page
767
DOI
10.1634/theoncologist.2012-0386

Cost effectiveness of gene expression profiling for early stage breast cancer: a decision-analytic model.

Authors
Reed, SD; Lyman, GH
MLA Citation
Reed, SD, and Lyman, GH. "Cost effectiveness of gene expression profiling for early stage breast cancer: a decision-analytic model." Cancer 118.24 (December 15, 2012): 6298-6299. (Letter)
PMID
22674145
Source
pubmed
Published In
Cancer
Volume
118
Issue
24
Publish Date
2012
Start Page
6298
End Page
6299
DOI
10.1002/cncr.27665

Does variation in either age at start of therapy or duration of therapy make chemoprevention with finasteride cost-effective?

BACKGROUND: Incremental cost-effectiveness ratios (ICERs) of finasteride for prostate cancer prevention are consistent with estimates beyond $100 000 per quality-adjusted life-year (QALY). The majority of these analyses are based on chemoprevention starting in men aged 50-55 years. We sought to evaluate the impact of varying both age at commencement of therapy and length of therapy on the cost-effectiveness of finasteride. METHODS: A probabilistic Markov model was designed to estimate lifetime prostate health-related costs and quality-adjusted survival for men receiving or not receiving chemoprevention with finasteride. ICERs across scenarios varying age at start of therapy and duration of chemoprevention were compared. RESULTS: The ICER for men starting chemoprevention at age 50 and continuing to age 75 was $88 800 per QALY when assuming finasteride causes a constant risk reduction across all tumor grades (base case 1) and $142 300 per QALY when assuming a differential treatment effect according to Gleason score (base case 2). When starting age is increased, the ICERs trend downward and nadir at 65 years to $64 700 per QALY (base case 1) and $118 600 per QALY (base case 2). Altering duration of therapy had minimal impact. Patient-level experiences with finasteride and BPH significantly influenced the cost-effectiveness of chemoprevention. CONCLUSIONS: Initiating chemoprevention at ages when prostate cancer incidence is higher improves its cost-effectiveness profile. Only when assuming a constant risk reduction for all tumor grades, did finasteride fall below $100 000 per QALY, but this finding was not upheld when accounting for side effects associated with the drug.

Authors
Stewart, SB; Scales, CD; Moul, JW; Reed, SD
MLA Citation
Stewart, SB, Scales, CD, Moul, JW, and Reed, SD. "Does variation in either age at start of therapy or duration of therapy make chemoprevention with finasteride cost-effective?." Prostate Cancer Prostatic Dis 15.4 (December 2012): 380-385.
PMID
22777393
Source
pubmed
Published In
Prostate Cancer and Prostatic Diseases
Volume
15
Issue
4
Publish Date
2012
Start Page
380
End Page
385
DOI
10.1038/pcan.2012.26

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

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

Cost-effectiveness of the 21-gene recurrence score assay in the setting of multifactorial decision making for chemotherapy in early-stage 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 setting of multifactorial decision making for chemotherapy in early-stage breast cancer." May 20, 2012.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
30
Issue
15
Publish Date
2012

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

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

A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: The KASTPain protocol

Abstract. Background: Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA) despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing. Methods/design. The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Discussion. The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Trial Registration. NCT01620983. © 2012 Riddle et al.; licensee BioMed Central Ltd.

Authors
Riddle, DL; Keefe, FJ; Ang, D; Khaled, J; Dumenci, L; Jensen, MP; Bair, MJ; Reed, SD; Kroenke, K
MLA Citation
Riddle, DL, Keefe, FJ, Ang, D, Khaled, J, Dumenci, L, Jensen, MP, Bair, MJ, Reed, SD, and Kroenke, K. "A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: The KASTPain protocol." BMC Musculoskeletal Disorders 13 (2012).
PMID
22906061
Source
scival
Published In
BMC Musculoskeletal Disorders
Volume
13
Publish Date
2012
DOI
10.1186/1471-2474-13-149

Economic evaluation of direct-acting antiviral therapy in chronic hepatitis C.

In 2011, the protease inhibitors boceprevir and telaprevir were approved in the United States and European Union for the treatment of hepatitis C infection. While remarkably effective, the newly approved therapies are also accompanied by additional side effects and considerable costs. Understanding the balance between costs and effectiveness is critical to making decisions about the optimal use of these new agents, especially for health care systems constrained by rising costs. Our goal for this review is to facilitate an understanding of the importance of cost-effectiveness analyses in guiding policy decisions about the use of newly approved drugs as well as future therapies for hepatitis C.

Authors
Gellad, ZF; Reed, SD; Muir, AJ
MLA Citation
Gellad, ZF, Reed, SD, and Muir, AJ. "Economic evaluation of direct-acting antiviral therapy in chronic hepatitis C." Antivir Ther 17.6 Pt B (2012): 1189-1199. (Review)
PMID
23186646
Source
pubmed
Published In
Antiviral therapy
Volume
17
Issue
6 Pt B
Publish Date
2012
Start Page
1189
End Page
1199
DOI
10.3851/IMP2430

Update on the Role of Epothilones in Metastatic Breast Cancer

The role of epothilones in the treatment of locally advanced and metastatic breast cancer remains unclear. While the pivotal studies for ixabepilone were published between 2005 and 2010, and the agent received approval in 2007 from the U.S. Food and Drug Administration, its uptake in routine treatment of breast cancer that is resistant to anthracyclines and taxanes remains inconsistent. The other agents in the class, patupilone and sagopilone, are being studied in a number of cancer types. In this review, the recently published literature on epothilones in various populations and at various dosages is reviewed including the associated adverse event profile and recent biomarker and genomic studies. While the literature has become increasing robust, the precise clinical role for the epothilones in the management of patients with breast cancer remains to be fully defined. © 2012 Springer Science+Business Media New York.

Authors
Hirsch, BR; Reed, SD; Lyman, GH
MLA Citation
Hirsch, BR, Reed, SD, and Lyman, GH. "Update on the Role of Epothilones in Metastatic Breast Cancer." Current Breast Cancer Reports (2012): 1-6.
Source
scival
Published In
Current Breast Cancer Reports
Publish Date
2012
Start Page
1
End Page
6
DOI
10.1007/s12609-012-0095-3

When evaluating parameter uncertainty is not enough: the case of dasatinib and nilotinib for imatinib-resistant chronic myeloid leukemia.

Authors
Reed, SD
MLA Citation
Reed, SD. "When evaluating parameter uncertainty is not enough: the case of dasatinib and nilotinib for imatinib-resistant chronic myeloid leukemia." Value Health 14.8 (December 2011): 1055-1056.
PMID
22152174
Source
pubmed
Published In
Value in Health
Volume
14
Issue
8
Publish Date
2011
Start Page
1055
End Page
1056
DOI
10.1016/j.jval.2011.10.001

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

THE COST-EFFECTIVENESS OF A TELAPREVIR-INCLUSIVE REGIMEN AS INITIAL THERAPY FOR GENOTYPE 1 HEPATITIS C INFECTION IN INDIVIDUALS WITH THE CC IL-28B POLYMORPHISM

Authors
Gellad, ZF; Naggie, S; Reed, SD; Clark, PJ; Thompson, AJ; Schulman, KA; Muir, AJ
MLA Citation
Gellad, ZF, Naggie, S, Reed, SD, Clark, PJ, Thompson, AJ, Schulman, KA, and Muir, AJ. "THE COST-EFFECTIVENESS OF A TELAPREVIR-INCLUSIVE REGIMEN AS INITIAL THERAPY FOR GENOTYPE 1 HEPATITIS C INFECTION IN INDIVIDUALS WITH THE CC IL-28B POLYMORPHISM." October 2011.
Source
wos-lite
Published In
Hepatology
Volume
54
Publish Date
2011
Start Page
417A
End Page
418A

Resource Use and Medical Costs by Cause of Death in HF-ACTION

Authors
Li, Y; Whellan, DJ; Dunlap, ME; Kraus, WE; Samsa, G; Schulman, KA; Zile, M; Reed, SD
MLA Citation
Li, Y, Whellan, DJ, Dunlap, ME, Kraus, WE, Samsa, G, Schulman, KA, Zile, M, and Reed, SD. "Resource Use and Medical Costs by Cause of Death in HF-ACTION." JOURNAL OF CARDIAC FAILURE 17.8 (August 2011): S78-S78.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
17
Issue
8
Publish Date
2011
Start Page
S78
End Page
S78

Seattle Heart Failure Model Scores Significantly Predict Medical Resource Use and Costs in HF-ACTION

Authors
Reed, SD; Li, Y; Ellis, SJ; Whellan, DJ; Schulman, KA; O'Connor, CM; Levy, WC
MLA Citation
Reed, SD, Li, Y, Ellis, SJ, Whellan, DJ, Schulman, KA, O'Connor, CM, and Levy, WC. "Seattle Heart Failure Model Scores Significantly Predict Medical Resource Use and Costs in HF-ACTION." JOURNAL OF CARDIAC FAILURE 17.8 (August 2011): S80-S80.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
17
Issue
8
Publish Date
2011
Start Page
S80
End Page
S80

Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries.

Authors
Dinan, MA; Robinson, TJ; Zagar, TM; Scales, CD; Curtis, LH; Reed, SD; Schulman, KA; Lee, WR
MLA Citation
Dinan, MA, Robinson, TJ, Zagar, TM, Scales, CD, Curtis, LH, Reed, SD, Schulman, KA, and Lee, WR. "Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries." May 20, 2011.
Source
wos-lite
Published In
Journal of Clinical Oncology
Volume
29
Issue
15
Publish Date
2011

Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries.

6115 Background: The traditional treament approaches for localized prostate cancer have included androgen suppression, watchful waiting, open radical prostatectomy, external beam radiation therapy and interstitial brachytherapy. In the last decade a number of novel treatment options have been developed including minimally invasive radical prostatectomy (MIRP) and intensity-modulated radiation therapy (IMRT).In this study, we examined changes in the treatment of Medicare beneficiaries diagnosed with incident prostate cancer between 1999 and 2007. The primary outcome was utiliziation of radiation, surgery, or androgen suppression therapy in the first 12 months following newly diagnosed prostate cancer by year of incidence.The study sample included 20 399 cases of incident prostate cancer identified between 1999 and 2007. Overall rates of surgery and radiotherapy within the first 12 months of diagnosis remained unchanged across the study period, however the proportion of beneficiaries receiving androgen suppression monotherapy decreased by half, with watchful waiting increasing from 16% to 23% of all beneficiaries. From 2002 to 2007, IMRT replaced 3-D conformal treatment as the most common method of prostate radiotherapy, and was used in two-thirds of all Medicare prostate cancer patients receiving any radiotherapy by 2007. During this same period, minimally invasive radical prostatectomy began to replace open surgical approaches, and was used in half of all radical prostatectomies by 2007.By 2007 IMRT had replaced 3D conformal radiotherapy (3D-CRT) as the predominant method of radiotherapy used in the Medicare prostate cancer population. With Medicare reimbursement for IMRT averaging $48,000 per beneficiary vs $22,000 for 3D-CRT, this trend has significant budgetary implications. The aging of the US population over the next decade will cause the number of men with newly diagnosed prostate cancer to climb. When combined with growth in the use of newer high-cost technologies, Medicare spending for prostate cancer will further accelerate.

Authors
Dinan, MA; Robinson, TJ; Zagar, TM; Scales, CD; Curtis, LH; Reed, SD; Schulman, KA; Lee, WR
MLA Citation
Dinan, MA, Robinson, TJ, Zagar, TM, Scales, CD, Curtis, LH, Reed, SD, Schulman, KA, and Lee, WR. "Financial implications of changes in the initial treatment of prostate cancer among Medicare beneficiaries." Journal of clinical oncology : official journal of the American Society of Clinical Oncology 29.15_suppl (May 2011): 6115-.
PMID
28022527
Source
epmc
Published In
Journal of Clinical Oncology
Volume
29
Issue
15_suppl
Publish Date
2011
Start Page
6115

Do heart failure disease management programs make financial sense under a bundled payment system?

BACKGROUND: Policy makers have proposed bundling payments for all heart failure (HF) care within 30 days of an HF hospitalization in an effort to reduce costs. Disease management (DM) programs can reduce costly HF readmissions but have not been economically attractive for caregivers under existing fee-for-service payment. Whether a bundled payment approach can address the negative financial impact of DM programs is unknown. METHODS: Our study determined the cost-neutral point for the typical DM program and examined whether published HF DM programs can be cost saving under bundled payment programs. We used a decision analytic model using data from retrospective cohort studies, meta-analyses, 5 randomized trials evaluating DM programs, and inpatient claims for all Medicare beneficiaries discharged with an HF diagnosis from 2001 to 2004. We determined the costs of DM programs and inpatient care over 30 and 180 days. RESULTS: With a baseline readmission rate of 22.9%, the average cost for readmissions over 30 days was $2,272 per patient. Under base-case assumptions, a DM program that reduced readmissions by 21% would need to cost $477 per patient to be cost neutral. Among evaluated published DM programs, 2 of the 5 would increase provider costs (+$15 to $283 per patient), whereas 3 programs would be cost saving (-$241 to $347 per patient). If bundled payments were broadened to include care over 180 days, then program saving estimates would increase, ranging from $419 to $1,706 per patient. CONCLUSIONS: Proposed bundled payments for HF admissions provide hospitals with a potential financial incentive to implement DM programs that efficiently reduce readmissions.

Authors
Eapen, ZJ; Reed, SD; Curtis, LH; Hernandez, AF; Peterson, ED
MLA Citation
Eapen, ZJ, Reed, SD, Curtis, LH, Hernandez, AF, and Peterson, ED. "Do heart failure disease management programs make financial sense under a bundled payment system?." Am Heart J 161.5 (May 2011): 916-922.
PMID
21570523
Source
pubmed
Published In
American Heart Journal
Volume
161
Issue
5
Publish Date
2011
Start Page
916
End Page
922
DOI
10.1016/j.ahj.2011.02.016

THE COST-EFFECTIVENESS OF INITIATING SENSOR-AUGMENTED PUMP THERAPY VERSUS MULTIPLE DAILY INJECTIONS OF INSULIN IN ADULTS WITH TYPE 1 DIABETES: EVALUATING A TECHNOLOGY IN EVOLUTION

Authors
Kamble, S; Perry, BM; Shafiroff, J; Schulman, KA; Reed, SD
MLA Citation
Kamble, S, Perry, BM, Shafiroff, J, Schulman, KA, and Reed, SD. "THE COST-EFFECTIVENESS OF INITIATING SENSOR-AUGMENTED PUMP THERAPY VERSUS MULTIPLE DAILY INJECTIONS OF INSULIN IN ADULTS WITH TYPE 1 DIABETES: EVALUATING A TECHNOLOGY IN EVOLUTION." VALUE IN HEALTH 14.3 (May 2011): A82-A82.
Source
wos-lite
Published In
Value in Health
Volume
14
Issue
3
Publish Date
2011
Start Page
A82
End Page
A82

PATIENT TIME AND INDIRECT COSTS ASSOCIATED WITH SENSOR-AUGMENTED INSULIN PUMP THERAPY IN TYPE 1 DIABETES

Authors
Kamble, S; Weinfurt, KP; Perry, BM; Schulman, KA; Reed, SD
MLA Citation
Kamble, S, Weinfurt, KP, Perry, BM, Schulman, KA, and Reed, SD. "PATIENT TIME AND INDIRECT COSTS ASSOCIATED WITH SENSOR-AUGMENTED INSULIN PUMP THERAPY IN TYPE 1 DIABETES." VALUE IN HEALTH 14.3 (May 2011): A84-A84.
Source
wos-lite
Published In
Value in Health
Volume
14
Issue
3
Publish Date
2011
Start Page
A84
End Page
A84

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

Comparative effectiveness research in lung diseases and sleep disorders: Recommendations from the National Heart, Lung, and Blood Institute Workshop

The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, andeconomic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.

Authors
Lieu, TA; Au, D; Krishnan, JA; Moss, M; Selker, H; Harabin, A; Taggart, V; Connors, A; Apter, A; Blaisdell, C; Boat, TF; Clark, N; Drotar, D; Lewin, D; Marshall, BC; Punturieri, A; Redline, S; Reed, SD; Schatz, M; Smith, R; Soumerai, SB; Thompson, BT
MLA Citation
Lieu, TA, Au, D, Krishnan, JA, Moss, M, Selker, H, Harabin, A, Taggart, V, Connors, A, Apter, A, Blaisdell, C, Boat, TF, Clark, N, Drotar, D, Lewin, D, Marshall, BC, Punturieri, A, Redline, S, Reed, SD, Schatz, M, Smith, R, Soumerai, SB, and Thompson, BT. "Comparative effectiveness research in lung diseases and sleep disorders: Recommendations from the National Heart, Lung, and Blood Institute Workshop." American Journal of Respiratory and Critical Care Medicine 184.7 (2011): 848-856.
PMID
21965016
Source
scival
Published In
American journal of respiratory and critical care medicine
Volume
184
Issue
7
Publish Date
2011
Start Page
848
End Page
856
DOI
10.1164/rccm.201104-0634WS

Erratum: Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement

Authors
Kamble, S; Telen, MJ; Dinan, MA; Grussemeyer, CA; Reed, SD
MLA Citation
Kamble, S, Telen, MJ, Dinan, MA, Grussemeyer, CA, and Reed, SD. "Erratum: Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement." American Journal of Hematology 86.10 (2011): 903--.
Source
scival
Published In
American Journal of Hematology
Volume
86
Issue
10
Publish Date
2011
Start Page
903-
DOI
10.1002/ajh.22121

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

What do international pharmacoeconomic guidelines say about economic data transferability?

OBJECTIVES: The objectives of this article were to assess the positions of the various national pharmacoeconomic guidelines on the transferability (or lack of transferability) of clinical and economic data and to review the methods suggested in the guidelines for addressing issues of transferability. METHODS: A review of existing national pharmacoeconomic guidelines was conducted to assess recommendations on the transferability of clinical and economic data, whether there are important differences between countries, and whether common methodologies have been suggested to address key transferability issues. Pharmacoeconomic guidelines were initially identified through the ISPOR Web site. In addition, those national guidelines not included in the ISPOR Web site, but known to us, were also considered. RESULTS: Across 27 sets of guidelines, baseline risk and unit costs were uniformly considered to be of low transferability, while treatment effect was classified as highly transferable. Results were more variable for resource use and utilities, which were considered to have low transferability in 63% and 45% of cases, respectively. There were some differences between older and more recent guidelines in the treatment of transferability issues. CONCLUSIONS: A growing number of jurisdictions are using guidelines for the economic evaluation of pharmaceuticals. The recommendations in existing guidelines regarding the transferability of clinical and economic data are quite diverse. There is a case for standardization in dealing with transferability issues. One important step would be to update guidelines more frequently.

Authors
Barbieri, M; Drummond, M; Rutten, F; Cook, J; Glick, HA; Lis, J; Reed, SD; Sculpher, M; Severens, JL; ISPOR Good Research Practices Economic Data Transferability Task Force,
MLA Citation
Barbieri, M, Drummond, M, Rutten, F, Cook, J, Glick, HA, Lis, J, Reed, SD, Sculpher, M, Severens, JL, and ISPOR Good Research Practices Economic Data Transferability Task Force, . "What do international pharmacoeconomic guidelines say about economic data transferability?." Value Health 13.8 (December 2010): 1028-1037.
PMID
20667054
Source
pubmed
Published In
Value in Health
Volume
13
Issue
8
Publish Date
2010
Start Page
1028
End Page
1037
DOI
10.1111/j.1524-4733.2010.00771.x

Do Heart Failure Disease Management Programs Make Financial Sense Under a Bundled Payment System?

Authors
Eapen, ZJ; Reed, SD; Curtis, LH; Hernandez, AF; Peterson, ED
MLA Citation
Eapen, ZJ, Reed, SD, Curtis, LH, Hernandez, AF, and Peterson, ED. "Do Heart Failure Disease Management Programs Make Financial Sense Under a Bundled Payment System?." CIRCULATION 122.21 (November 23, 2010).
Source
wos-lite
Published In
Circulation
Volume
122
Issue
21
Publish Date
2010

Resource Use and Expenditures Among Adult Sickle Cell Patients with and without Depression.

Authors
Kamble, S; Reed, SD; Flahiff, C; Adam, S; DeCastro, LM
MLA Citation
Kamble, S, Reed, SD, Flahiff, C, Adam, S, and DeCastro, LM. "Resource Use and Expenditures Among Adult Sickle Cell Patients with and without Depression." November 19, 2010.
Source
wos-lite
Published In
Blood
Volume
116
Issue
21
Publish Date
2010
Start Page
653
End Page
653

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

Variation in the type and frequency of postoperative invasive Staphylococcus aureus infections according to type of surgical procedure.

OBJECTIVE: To determine the epidemiological characteristics of postoperative invasive Staphylococcus aureus infection following 4 types of major surgical procedures.design. Retrospective cohort study. SETTING: Eleven hospitals (9 community hospitals and 2 tertiary care hospitals) in North Carolina and Virginia. PATIENTS: Adults undergoing orthopedic, neurosurgical, cardiothoracic, and plastic surgical procedures. METHODS: We used previously validated, prospectively collected surgical surveillance data for surgical site infection and microbiological data for bloodstream infection. The study period was 2003 through 2006. We defined invasive S. aureus infection as either nonsuperficial incisional surgical site infection or bloodstream infection. Nonparametric bootstrapping was used to generate 95% confidence intervals (CIs). P values were generated using the Pearson chi2 test, Student t test, or Wilcoxon rank-sum test, as appropriate. RESULTS: In total, 81,267 patients underwent 96,455 procedures during the study period. The overall incidence of invasive S. aureus infection was 0.47 infections per 100 procedures (95% CI, 0.43-0.52); 227 (51%) of 446 infections were due to methicillin-resistant S.aureus. Invasive S. aureus infection was more common after cardiothoracic procedures (incidence, 0.79 infections per 100 procedures [95%CI, 0.62-0.97]) than after orthopedic procedures (0.37 infections per 100 procedures [95% CI, 0.32-0.42]), neurosurgical procedures (0.62 infections per 100 procedures [95% CI, 0.53-0.72]), or plastic surgical procedures (0.32 infections per 100 procedures [95% CI, 0.17-0.47]) (P < .001). Similarly, S. aureus bloodstream infection was most common after cardiothoracic procedures (incidence, 0.57 infections per 100 procedures [95% CI, 0.43-0.72]; P < .001, compared with other procedure types), comprising almost three-quarters of the invasive S. aureus infections after these procedures. The highest rate of surgical site infection was observed after neurosurgical procedures (incidence, 0.50 infections per 100 procedures [95% CI, 0.42-0.59]; P < .001, compared with other procedure types), comprising 80% of invasive S.aureus infections after these procedures. CONCLUSION: The frequency and type of postoperative invasive S. aureus infection varied significantly across procedure types. The highest risk procedures, such as cardiothoracic procedures, should be targeted for ongoing preventative interventions.

Authors
Anderson, DJ; Arduino, JM; Reed, SD; Sexton, DJ; Kaye, KS; Grussemeyer, CA; Peter, SA; Hardy, C; Choi, YI; Friedman, JY; Fowler, VG
MLA Citation
Anderson, DJ, Arduino, JM, Reed, SD, Sexton, DJ, Kaye, KS, Grussemeyer, CA, Peter, SA, Hardy, C, Choi, YI, Friedman, JY, and Fowler, VG. "Variation in the type and frequency of postoperative invasive Staphylococcus aureus infections according to type of surgical procedure." Infect Control Hosp Epidemiol 31.7 (July 2010): 701-709.
Website
http://hdl.handle.net/10161/4152
PMID
20518637
Source
pubmed
Published In
Infection Control and Hospital Epidemiology
Volume
31
Issue
7
Publish Date
2010
Start Page
701
End Page
709
DOI
10.1086/653205

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

PSY55 IS HOSPITAL EXPERIENCE ASSOCIATED WITH BETTER IN-HOSPITAL OUTCOMES AMONG SICKLE CELL PATIENTS WITH ACUTE CHEST SYNDROME: RESULTS FROM A NATIONAL DATABASE

Authors
Kamble, S; Reed, SD
MLA Citation
Kamble, S, and Reed, SD. "PSY55 IS HOSPITAL EXPERIENCE ASSOCIATED WITH BETTER IN-HOSPITAL OUTCOMES AMONG SICKLE CELL PATIENTS WITH ACUTE CHEST SYNDROME: RESULTS FROM A NATIONAL DATABASE." Value in Health 13.3 (May 2010): A216-A216.
Source
crossref
Published In
Value in Health
Volume
13
Issue
3
Publish Date
2010
Start Page
A216
End Page
A216
DOI
10.1016/S1098-3015(10)73056-4

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

DISCRIMINATORY POWER OF THE KCCQ IN ESTIMATING HEALTH UTILITIES IN HEART FAILURE PATIENTS

Authors
Li, Y; Whellan, DJ; Samsa, GP; Schulman, K; Reed, SD
MLA Citation
Li, Y, Whellan, DJ, Samsa, GP, Schulman, K, and Reed, SD. "DISCRIMINATORY POWER OF THE KCCQ IN ESTIMATING HEALTH UTILITIES IN HEART FAILURE PATIENTS." VALUE IN HEALTH 13.3 (May 2010): A170-A170.
Source
wos-lite
Published In
Value in Health
Volume
13
Issue
3
Publish Date
2010
Start Page
A170
End Page
A170
DOI
10.1016/S1098-3015(10)72828-X

Comparison of costs, length of stay, and mortality associated with Candida glabrata and Candida albicans bloodstream infections.

We compared costs, length of stay, and mortality between adults with Candida albicans and Candida glabrata bloodstream infections. Early evidence of C glabrata, as defined by a positive culture within 2 days of admission, was associated with higher costs ($56,026 vs $32,810; P = .04) and longer hospital stays (19.7 vs 14.5 days; P = .05) compared with early evidence of C albicans. Mortality was similar between the groups.

Authors
Moran, C; Grussemeyer, CA; Spalding, JR; Benjamin, DK; Reed, SD
MLA Citation
Moran, C, Grussemeyer, CA, Spalding, JR, Benjamin, DK, and Reed, SD. "Comparison of costs, length of stay, and mortality associated with Candida glabrata and Candida albicans bloodstream infections." Am J Infect Control 38.1 (February 2010): 78-80.
PMID
19836856
Source
pubmed
Published In
American Journal of Infection Control
Volume
38
Issue
1
Publish Date
2010
Start Page
78
End Page
80
DOI
10.1016/j.ajic.2009.06.014

Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension.

BACKGROUND: The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention. METHODS: We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in the study interventions. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs. RESULTS: During 24 months, patients incurred a mean of $6,965 (s.d., $22,054) in inpatient costs and $8,676 (s.d., $9,368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (s.d., $2) for home blood pressure monitoring, $345 (s.d., $64) for the behavioral intervention ($31 per telephone encounter), and $416 (s.d., $93) for the combined intervention. Patient time costs were estimated at $585 (s.d., $487) for home monitoring, $55 (s.d., $16) for the behavioral intervention, and $741 (s.d., $529) for the combined intervention. CONCLUSIONS: Our analysis demonstrated that the interventions are cost-additive to the health-care system in the short term and that patients' time costs are nontrivial.

Authors
Reed, SD; Li, Y; Oddone, EZ; Neary, AM; Orr, MM; Grubber, JM; Graham, FL; Olsen, MK; Svetkey, LP; Dolor, RJ; Powers, BJ; Adams, MB; Bosworth, HB
MLA Citation
Reed, SD, Li, Y, Oddone, EZ, Neary, AM, Orr, MM, Grubber, JM, Graham, FL, Olsen, MK, Svetkey, LP, Dolor, RJ, Powers, BJ, Adams, MB, and Bosworth, HB. "Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension." Am J Hypertens 23.2 (February 2010): 142-148.
PMID
19927132
Source
pubmed
Published In
American Journal of Hypertension
Volume
23
Issue
2
Publish Date
2010
Start Page
142
End Page
148
DOI
10.1038/ajh.2009.215

Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement.

Authors
Kamble, S; Telen, MJ; Dinan, MA; Grussemeyer, CA; Reed, SD
MLA Citation
Kamble, S, Telen, MJ, Dinan, MA, Grussemeyer, CA, and Reed, SD. "Costs and length of stay for patients with and without sickle cell disease after hysterectomy, appendectomy, or knee replacement." Am J Hematol 85.1 (January 2010): 79-81. (Letter)
PMID
20029954
Source
pubmed
Published In
American Journal of Hematology
Volume
85
Issue
1
Publish Date
2010
Start Page
79
End Page
81
DOI
10.1002/ajh.21576

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

In-Hospital Outcomes Among Sickle Cell Patients with Acute Chest Syndrome: Results From a National Database.

Authors
Kamble, S; Reed, SD; Grussemeyer, C; Telen, MJ
MLA Citation
Kamble, S, Reed, SD, Grussemeyer, C, and Telen, MJ. "In-Hospital Outcomes Among Sickle Cell Patients with Acute Chest Syndrome: Results From a National Database." November 20, 2009.
Source
wos-lite
Published In
Blood
Volume
114
Issue
22
Publish Date
2009
Start Page
557
End Page
557

Two self-management interventions to improve hypertension control: a randomized trial.

BACKGROUND: Fewer than 40% of persons with hypertension in the United States have adequate blood pressure (BP) control. OBJECTIVE: To compare 2 self-management interventions for improving BP control among hypertensive patients. DESIGN: A 2 x 2 randomized trial, stratified by enrollment site and patient health literacy status, with 2-year follow-up. (ClinicalTrials.gov registration number: NCT00123058). SETTING: 2 university-affiliated primary care clinics. PATIENTS: 636 hypertensive patients. INTERVENTION: A centralized, blinded, and stratified randomization algorithm was used to randomly assign eligible patients to receive usual care, a behavioral intervention (bimonthly tailored, nurse-administered telephone intervention targeting hypertension-related behaviors), home BP monitoring 3 times weekly, or the behavioral intervention plus home BP monitoring. MEASUREMENTS: The primary outcome was BP control at 6-month intervals over 24 months. RESULTS: 475 patients (75%) completed the 24-month BP follow-up. At 24 months, improvements in the proportion of patients with BP control relative to the usual care group were 4.3% (95% CI, -4.5% to 12.9%) in the behavioral intervention group, 7.6% (CI, -1.9% to 17.0%) in the home BP monitoring group, and 11.0% (CI, 1.9%, 19.8%) in the combined intervention group. Relative to usual care, the 24-month difference in systolic BP was 0.6 mm Hg (CI, -2.2 to 3.4 mm Hg) for the behavioral intervention group, -0.6 mm Hg (CI, -3.6 to 2.3 mm Hg) for the BP monitoring group, and -3.9 mm Hg (CI, -6.9 to -0.9 mm Hg) for the combined intervention group; patterns were similar for diastolic BP. LIMITATION: Changes in medication use and diet were monitored only in intervention participants; 24-month outcome data were missing for 25% of participants, BP control was adequate at baseline in 73% of participants, and the study setting was an academic health center. CONCLUSION: Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care. .

Authors
Bosworth, HB; Olsen, MK; Grubber, JM; Neary, AM; Orr, MM; Powers, BJ; Adams, MB; Svetkey, LP; Reed, SD; Li, Y; Dolor, RJ; Oddone, EZ
MLA Citation
Bosworth, HB, Olsen, MK, Grubber, JM, Neary, AM, Orr, MM, Powers, BJ, Adams, MB, Svetkey, LP, Reed, SD, Li, Y, Dolor, RJ, and Oddone, EZ. "Two self-management interventions to improve hypertension control: a randomized trial." Ann Intern Med 151.10 (November 17, 2009): 687-695.
PMID
19920269
Source
pubmed
Published In
Annals of internal medicine
Volume
151
Issue
10
Publish Date
2009
Start Page
687
End Page
695
DOI
10.7326/0003-4819-151-10-200911170-00148

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

COST OF EXERCISE TRAINING AND ITS IMPACT ON MEDICAL RESOURCE USE AND COSTS: RESULTS OF HF-ACTION TRIAL

Authors
Reed, SD; Whellan, DJ; Li, Y; Friedman, JY; Pina, IL; Settles, SJ; Davidson-Ray, L; Johnson, J; Cooper, LS; O'Connor, CM; Schulman, KA
MLA Citation
Reed, SD, Whellan, DJ, Li, Y, Friedman, JY, Pina, IL, Settles, SJ, Davidson-Ray, L, Johnson, J, Cooper, LS, O'Connor, CM, and Schulman, KA. "COST OF EXERCISE TRAINING AND ITS IMPACT ON MEDICAL RESOURCE USE AND COSTS: RESULTS OF HF-ACTION TRIAL." VALUE IN HEALTH 12.7 (October 2009): A323-A323.
Source
wos-lite
Published In
Value in Health
Volume
12
Issue
7
Publish Date
2009
Start Page
A323
End Page
A323
DOI
10.1016/S1098-3015(10)74588-5

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 of Exercise Training and Its Impact on Medical Resource Use and Costs: Results of HF-ACTION

Authors
Reed, SD; Whellan, DJ; Li, Y; Friedman, JY; Pina, IL; Settles, SJ; Davidson-Ray, L; Johnson, J; Cooper, LS; O'Connor, CM; Schulman, KA
MLA Citation
Reed, SD, Whellan, DJ, Li, Y, Friedman, JY, Pina, IL, Settles, SJ, Davidson-Ray, L, Johnson, J, Cooper, LS, O'Connor, CM, and Schulman, KA. "Cost of Exercise Training and Its Impact on Medical Resource Use and Costs: Results of HF-ACTION." JOURNAL OF CARDIAC FAILURE 15.6 (August 2009): S93-S93.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
15
Issue
6
Publish Date
2009
Start Page
S93
End Page
S93

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

Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report.

ABSTRACT A growing number of jurisdictions now request economic data in support of their decision-making procedures for the pricing and/or reimbursement of health technologies. Because more jurisdictions request economic data, the burden on study sponsors and researchers increases. There are many reasons why the cost-effectiveness of health technologies might vary from place to place. Therefore, this report of an ISPOR Good Practices Task Force reviews what national guidelines for economic evaluation say about transferability, discusses which elements of data could potentially vary from place to place, and recommends good research practices for dealing with aspects of transferability, including strategies based on the analysis of individual patient data and based on decision-analytic modeling.

Authors
Drummond, M; Barbieri, M; Cook, J; Glick, HA; Lis, J; Malik, F; Reed, SD; Rutten, F; Sculpher, M; Severens, J
MLA Citation
Drummond, M, Barbieri, M, Cook, J, Glick, HA, Lis, J, Malik, F, Reed, SD, Rutten, F, Sculpher, M, and Severens, J. "Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report." Value Health 12.4 (June 2009): 409-418.
PMID
19900249
Source
pubmed
Published In
Value in Health
Volume
12
Issue
4
Publish Date
2009
Start Page
409
End Page
418
DOI
10.1111/j.1524-4733.2008.00489.x

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

CO4 COMPARISON OF INPATIENT COST ESTIMATION METHODS: USING DATA FROM A CYSTIC FIBROSIS TRIAL

Authors
Dinan, M; Morgan Dewitt, E; Grussemeyer, C; Reed, SD
MLA Citation
Dinan, M, Morgan Dewitt, E, Grussemeyer, C, and Reed, SD. "CO4 COMPARISON OF INPATIENT COST ESTIMATION METHODS: USING DATA FROM A CYSTIC FIBROSIS TRIAL." Value in Health 12.3 (May 2009): A7-A7.
Source
crossref
Published In
Value in Health
Volume
12
Issue
3
Publish Date
2009
Start Page
A7
End Page
A7
DOI
10.1016/S1098-3015(10)73094-1

Candida albicans and non-albicans bloodstream infections in adult and pediatric patients: comparison of mortality and costs.

We compared length of stay, inpatient costs, and mortality associated with Candida albicans and non-albicans bloodstream infections in adults and children. Compared with adults, children with Candida bloodstream infections had longer lengths of stay (36.7 vs. 20.7 days; P < 0.001) and higher inpatient costs ($133,871 vs. $56,725; P < 0.001) but lower mortality (28.3% vs. 43.5%; P < 0.001).

Authors
Moran, C; Grussemeyer, CA; Spalding, JR; Benjamin, DK; Reed, SD
MLA Citation
Moran, C, Grussemeyer, CA, Spalding, JR, Benjamin, DK, and Reed, SD. "Candida albicans and non-albicans bloodstream infections in adult and pediatric patients: comparison of mortality and costs." Pediatr Infect Dis J 28.5 (May 2009): 433-435.
PMID
19319021
Source
pubmed
Published In
Pediatric Infectious Disease Journal
Volume
28
Issue
5
Publish Date
2009
Start Page
433
End Page
435
DOI
10.1097/INF.0b013e3181920ffd

TRIAL-BASED ECONOMIC EVALUATION ALONGSIDE THE TCYB (TAKE CONTROL OF YOUR BLOOD PRESSURE) TRIAL

Authors
Reed, SD; Li, Y; Oddone, EZ; Neary, AM; Orr, MM; Grubber, JM; Graham, FL; Olsen, MK; Svetkey, LP; Dolor, RJ; Powers, BJ; Adams, MB; Bosworth, HB
MLA Citation
Reed, SD, Li, Y, Oddone, EZ, Neary, AM, Orr, MM, Grubber, JM, Graham, FL, Olsen, MK, Svetkey, LP, Dolor, RJ, Powers, BJ, Adams, MB, and Bosworth, HB. "TRIAL-BASED ECONOMIC EVALUATION ALONGSIDE THE TCYB (TAKE CONTROL OF YOUR BLOOD PRESSURE) TRIAL." VALUE IN HEALTH 12.3 (May 2009): A152-A152.
Source
wos-lite
Published In
Value in Health
Volume
12
Issue
3
Publish Date
2009
Start Page
A152
End Page
A152
DOI
10.1016/S1098-3015(10)73820-1

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

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

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

Clinical outcomes and costs among patients with Staphylococcus aureus bacteremia and orthopedic device infections.

We evaluated costs and outcomes of patients with S. aureus bacteremia and orthopedic device infections (ODI). Patients with ODI had higher relapse of S. aureus infection, compared to bacteremic patients without ODI. Costs and outcomes were similar among ODI patients undergoing device removal and those treated with debridement and retention.

Authors
Lalani, T; Chu, VH; Grussemeyer, CA; Reed, SD; Bolognesi, MP; Friedman, JY; Griffiths, RI; Crosslin, DR; Kanafani, ZA; Kaye, KS; Ralph Corey, G; Fowler, VG
MLA Citation
Lalani, T, Chu, VH, Grussemeyer, CA, Reed, SD, Bolognesi, MP, Friedman, JY, Griffiths, RI, Crosslin, DR, Kanafani, ZA, Kaye, KS, Ralph Corey, G, and Fowler, VG. "Clinical outcomes and costs among patients with Staphylococcus aureus bacteremia and orthopedic device infections." Scandinavian journal of infectious diseases (July 2008): 1-5. (Academic Article)
Source
manual
Published In
Scandinavian Journal of Infectious Diseases (Informa)
Publish Date
2008
Start Page
1
End Page
5

A financial analysis of operative facial fracture management.

BACKGROUND: The financial impact of operative facial fracture management has not been systematically investigated. This study aims to provide a descriptive financial analysis of patients undergoing operative facial fracture management at a single academic medical center and the financial impact on the health system. METHODS: The records of 202 patients who underwent operative facial fracture management over a 3-year period (2003 to 2005) were analyzed. All physician (professional) and hospital charges related to fracture management were included. Professional charges were subdivided by specialty and by payer type; hospital charges included operating room, recovery room, intensive care unit, hospital bed, supply charges, pharmaceuticals, laboratory charges, and radiographs. For comparison, similar data were obtained for the general plastic surgery population and for orthopedic surgery patients. RESULTS: The sum of all professional charges billed was $2,478,234 (average, $12,268 per patient). Collections for these professional services totaled $675,434, yielding an overall reimbursement rate of 27 percent. Reimbursement rates ranged from 38 percent for critical care physicians to 24 percent for surgery and neuroradiology. The highest collection rates occurred in children covered by the State Children's Health Insurance Program and in prison inmates (53 percent and 99 percent, respectively). The lowest collection rates were obtained from uninsured patients (10 percent total billing over collections). Total hospital charges were $18,120,027 (average, $89,703 per patient); the total collections were $2,770,115 (15 percent reimbursement rate). CONCLUSIONS: This study provides a descriptive financial analysis of operative facial fracture management. The unfavorable financial circumstances associated with facial trauma care may present a challenge to academic medical centers and plastic surgeons.

Authors
Erdmann, D; Price, K; Reed, S; Follmar, KE; Levin, LS; Marcus, JR
MLA Citation
Erdmann, D, Price, K, Reed, S, Follmar, KE, Levin, LS, and Marcus, JR. "A financial analysis of operative facial fracture management." Plast Reconstr Surg 121.4 (April 2008): 1323-1327.
PMID
18349651
Source
pubmed
Published In
Plastic and Reconstructive Surgery
Volume
121
Issue
4
Publish Date
2008
Start Page
1323
End Page
1327
DOI
10.1097/01.prs.0000304603.19047.0b

Economic evaluation of propofol and lorazepam for critically ill patients undergoing mechanical ventilation.

OBJECTIVE: The economic implications of sedative choice in the management of patients receiving mechanical ventilation are unclear because of differences in costs and clinical outcomes associated with specific sedatives. Therefore, we aimed to determine the cost-effectiveness of the most commonly used sedatives prescribed for mechanically ventilated critically ill patients. DESIGN, SETTING, AND PATIENTS: Adopting the perspective of a hospital, we developed a probabilistic decision model to determine whether continuous propofol or intermittent lorazepam was associated with greater value when combined with daily awakenings. We also evaluated the comparative value of continuous midazolam in secondary analyses. We assumed that patients were managed in a medical intensive care unit and expected to require ventilation for > or = 48 hrs. Model inputs were derived from primary analysis of randomized controlled trial data, medical literature, Medicare reimbursement rates, pharmacy databases, and institutional data. MAIN RESULTS: We measured cost-effectiveness as costs per mechanical ventilator-free day within the first 28 days after intubation. Our base-case probabilistic analysis demonstrated that propofol dominated lorazepam in 91% of simulations and, on average, was both $6,378 less costly per patient and associated with more than three additional mechanical ventilator-free days. The model did not reveal clinically meaningful differences between propofol and midazolam on costs or measures of effectiveness. CONCLUSION: Propofol has superior value compared with lorazepam when used for sedation among the critically ill who require mechanical ventilation when used in the setting of daily sedative interruption.

Authors
Cox, CE; Reed, SD; Govert, JA; Rodgers, JE; Campbell-Bright, S; Kress, JP; Carson, SS
MLA Citation
Cox, CE, Reed, SD, Govert, JA, Rodgers, JE, Campbell-Bright, S, Kress, JP, and Carson, SS. "Economic evaluation of propofol and lorazepam for critically ill patients undergoing mechanical ventilation." Crit Care Med 36.3 (March 2008): 706-714. (Review)
PMID
18176312
Source
pubmed
Published In
Critical Care Medicine
Volume
36
Issue
3
Publish Date
2008
Start Page
706
End Page
714
DOI
10.1097/CCM.0B013E3181544248

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

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

Clinical outcomes and costs among patients with Staphylococcus aureus bacteremia and orthopedic device infections.

We evaluated costs and outcomes of patients with S. aureus bacteremia and orthopedic device infections (ODI). Patients with ODI had higher relapse of S. aureus infection, compared to bacteremic patients without ODI. Costs and outcomes were similar among ODI patients undergoing device removal and those treated with debridement and retention.

Authors
Lalani, T; Chu, VH; Grussemeyer, CA; Reed, SD; Bolognesi, MP; Friedman, JY; Griffiths, RI; Crosslin, DR; Kanafani, ZA; Kaye, KS; Ralph Corey, G; Fowler, VG
MLA Citation
Lalani, T, Chu, VH, Grussemeyer, CA, Reed, SD, Bolognesi, MP, Friedman, JY, Griffiths, RI, Crosslin, DR, Kanafani, ZA, Kaye, KS, Ralph Corey, G, and Fowler, VG. "Clinical outcomes and costs among patients with Staphylococcus aureus bacteremia and orthopedic device infections." Scand J Infect Dis 40.11-12 (2008): 973-977.
PMID
18615359
Source
pubmed
Published In
Scandinavian Journal of Infectious Diseases (Informa)
Volume
40
Issue
11-12
Publish Date
2008
Start Page
973
End Page
977
DOI
10.1080/00365540802245146

C. albicans and C. glabrata bloodstream infections in adults: Outcomes and associated costs

Authors
Grussemeyer, CA; Friedman, JY; Spalding, JR; Benjamin, DK; Moran, C; Reed, SD
MLA Citation
Grussemeyer, CA, Friedman, JY, Spalding, JR, Benjamin, DK, Moran, C, and Reed, SD. "C. albicans and C. glabrata bloodstream infections in adults: Outcomes and associated costs." VALUE IN HEALTH 11.3 (2008): A24-A24.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A24
End Page
A24
DOI
10.1016/S1098-3015(10)70088-7

Inpatient costs and clinical outcomes of S. aureus bloodstream and non-bloodstream infection in patients with end-stage renal disease: Findings from a multi-center trial

Authors
Li, Y; Friedman, JY; O'Neal, BF; Hohenboken, MJ; Griffiths, RI; Stryjewski, ME; Schulman, KA; Inrig, JK; Fowler, VG; Reed, SD
MLA Citation
Li, Y, Friedman, JY, O'Neal, BF, Hohenboken, MJ, Griffiths, RI, Stryjewski, ME, Schulman, KA, Inrig, JK, Fowler, VG, and Reed, SD. "Inpatient costs and clinical outcomes of S. aureus bloodstream and non-bloodstream infection in patients with end-stage renal disease: Findings from a multi-center trial." VALUE IN HEALTH 11.3 (2008): A304-A304.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A304
End Page
A304
DOI
10.1016/S1098-3015(10)70959-1

Is there a learning curve associated with exercise training in patients with heart failure?

Authors
Li, Y; Friedman, JY; Compton, KL; Tzeng, JP; Schulman, KA; Reed, SD
MLA Citation
Li, Y, Friedman, JY, Compton, KL, Tzeng, JP, Schulman, KA, and Reed, SD. "Is there a learning curve associated with exercise training in patients with heart failure?." VALUE IN HEALTH 11.3 (2008): A215-A216.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A215
End Page
A216
DOI
10.1016/S1098-3015(10)70683-5

Change in health-related quality of life following non-fatal cardiovascular events in post-myocardial infarction patients

Authors
Lewis, EF; Li, Y; Pfeffer, MA; Solomon, SD; Weinfurt, KP; Velazquez, EJ; Califf, R; White, HD; Rouleau, JL; Schulman, KA; Reed, SD
MLA Citation
Lewis, EF, Li, Y, Pfeffer, MA, Solomon, SD, Weinfurt, KP, Velazquez, EJ, Califf, R, White, HD, Rouleau, JL, Schulman, KA, and Reed, SD. "Change in health-related quality of life following non-fatal cardiovascular events in post-myocardial infarction patients." VALUE IN HEALTH 11.3 (2008): A205-A206.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A205
End Page
A206
DOI
10.1016/S1098-3015(10)70652-5

Higher inpatient costs among patients with subarachnoid hemorrhage complicated by vasospasm

Authors
Chou, CH; Reed, SD; Allsbrook, JS; Steele, JL; Schulman, KA; Alexander, MJ
MLA Citation
Chou, CH, Reed, SD, Allsbrook, JS, Steele, JL, Schulman, KA, and Alexander, MJ. "Higher inpatient costs among patients with subarachnoid hemorrhage complicated by vasospasm." VALUE IN HEALTH 11.3 (2008): A142-A142.
Source
wos-lite
Published In
Value in Health
Volume
11
Issue
3
Publish Date
2008
Start Page
A142
End Page
A142
DOI
10.1016/S1098-3015(10)70451-4

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

Impact of non-fatal cardiovascular events on change in health-related quality of life in patients who survive myocardial infarction

Authors
Lewis, E; Li, Y; Reed, SD; Weinfurt, KP; Solomon, SD; Pfeffer, MA
MLA Citation
Lewis, E, Li, Y, Reed, SD, Weinfurt, KP, Solomon, SD, and Pfeffer, MA. "Impact of non-fatal cardiovascular events on change in health-related quality of life in patients who survive myocardial infarction." October 16, 2007.
Source
wos-lite
Published In
Circulation
Volume
116
Issue
16
Publish Date
2007
Start Page
859
End Page
859

Demographics and treatment modality: Predictors of vasospasm in 201 consecutive patients with aneurysmal subarachnoid hemorrhage

Authors
Reed, SD; Allsbrook, JS; Steele, J; Schulman, KA; Alexander, MJ
MLA Citation
Reed, SD, Allsbrook, JS, Steele, J, Schulman, KA, and Alexander, MJ. "Demographics and treatment modality: Predictors of vasospasm in 201 consecutive patients with aneurysmal subarachnoid hemorrhage." February 2007.
Source
wos-lite
Published In
Stroke
Volume
38
Issue
2
Publish Date
2007
Start Page
592
End Page
592

Gender differences in morbidity associated with aneurysmal subarachnoid hemorrhage

Authors
Reed, SD; Allsbrook, JS; Steele, J; Schulman, KA; Alexander, MJ
MLA Citation
Reed, SD, Allsbrook, JS, Steele, J, Schulman, KA, and Alexander, MJ. "Gender differences in morbidity associated with aneurysmal subarachnoid hemorrhage." February 2007.
Source
wos-lite
Published In
Stroke
Volume
38
Issue
2
Publish Date
2007
Start Page
594
End Page
594

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

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

60-month data from iris used to update estimates of survival and cost-effectiveness of first-line imatinib in patients with chronic phase chronic myeloid leukemia

Authors
Reed, SD; Anstrom, KJ; Li, Y; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Li, Y, and Schulman, KA. "60-month data from iris used to update estimates of survival and cost-effectiveness of first-line imatinib in patients with chronic phase chronic myeloid leukemia." VALUE IN HEALTH 10.3 (2007): A12-A12.
Source
wos-lite
Published In
Value in Health
Volume
10
Issue
3
Publish Date
2007
Start Page
A12
End Page
A12
DOI
10.1016/S1098-3015(10)68568-3

Patterns of antibiotic use for patients with mild cystic fibrosis

Authors
Friedman, JY; Hardy, C; Morgan Dewitt, E; Schulman, KA; Reed, SD
MLA Citation
Friedman, JY, Hardy, C, Morgan Dewitt, E, Schulman, KA, and Reed, SD. "Patterns of antibiotic use for patients with mild cystic fibrosis." PEDIATRIC PULMONOLOGY (2007): 371-371.
Source
wos-lite
Published In
Pediatric Pulmonology
Publish Date
2007
Start Page
371
End Page
371

A comparison of inpatient outcomes between sickle cell disease and non-sickle cell disease patients undergoing high-volume surgical procedures

Authors
Chou, CH; Reed, SD; Telen, MJ; Schulman, KA
MLA Citation
Chou, CH, Reed, SD, Telen, MJ, and Schulman, KA. "A comparison of inpatient outcomes between sickle cell disease and non-sickle cell disease patients undergoing high-volume surgical procedures." VALUE IN HEALTH 10.3 (2007): A152-A153.
Source
wos-lite
Published In
Value in Health
Volume
10
Issue
3
Publish Date
2007
Start Page
A152
End Page
A153
DOI
10.1016/S1098-3015(10)69001-8

Updated cost-effectiveness analysis of first-line imatinib compared to interferon-alpha in patients with newly diagnosed chronic myeloid leukemia in the chronic phase using 60-month data from IRIS.

Authors
Reed, SD; Anstrom, KJ; Li, Y; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Li, Y, and Schulman, KA. "Updated cost-effectiveness analysis of first-line imatinib compared to interferon-alpha in patients with newly diagnosed chronic myeloid leukemia in the chronic phase using 60-month data from IRIS." November 16, 2006.
Source
wos-lite
Published In
Blood
Volume
108
Issue
11
Publish Date
2006
Start Page
945A
End Page
945A

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

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

Cost savings with implementation of PNA FISH testing for identification of Candida albicans in blood cultures.

Antifungal expenditures are substantial for many hospitals. Using caspofungin for the treatment of candidemia accounts for a sizable proportion of the costs. A cost minimization study that used a decision analytic model was done to compare in-hospital diagnosis and treatment costs using the Candida albicans peptide nucleic acid fluorescence in situ hybridization (PNA FISH) test versus the C. albicans screen test for differentiating C. albicans from non-albicans Candida species bloodstream infections. Assuming physician notification of yeast identity concurrent with blood culture positivity, potential savings resulting from use of the C. albicans PNA FISH test compared with the C. albicans screen test averaged $1837 per patient treated, although laboratory costs for doing the C. albicans PNA FISH test ($82.72) exceeded those for the C. albicans screen test ($2.83). Savings were realized through a decrease in antifungal drug costs, particularly caspofungin. Incorporating the C. albicans PNA FISH test as part of the initial identification algorithm for yeasts recovered from blood can result in substantial savings for hospitals.

Authors
Alexander, BD; Ashley, ED; Reller, LB; Reed, SD
MLA Citation
Alexander, BD, Ashley, ED, Reller, LB, and Reed, SD. "Cost savings with implementation of PNA FISH testing for identification of Candida albicans in blood cultures." Diagn Microbiol Infect Dis 54.4 (April 2006): 277-282.
PMID
16466898
Source
pubmed
Published In
Diagnostic Microbiology and Infectious Disease
Volume
54
Issue
4
Publish Date
2006
Start Page
277
End Page
282
DOI
10.1016/j.diagmicrobio.2005.10.011

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

The effect of valsartan, captopril, or both on atherosclerotic events after acute myocardial infarction: An analysis of the valsartan in acute myocardial infarction trial (VALIANT)

OBJECTIVES: We attempted to compare the effect of an angiotensin-converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) on atherosclerotic events. BACKGROUND: Angiotensin-converting enzyme inhibitors and ARBs interrupt the renin-angiotensin system by distinct mechanisms. It is not clear whether ARBs reduce atherosclerotic events such as myocardial infarction (MI) like ACE inhibitors. This evidence gap may reflect the nature of the studies conducted, to date. Placebo-controlled studies enrolled cohorts at low risk of atherosclerotic events (e.g., patients with chronic heart failure, most treated with an ACE inhibitor). One of the main active controlled trials was confounded by a blood pressure difference between treatments. METHODS: We compared the effects of captopril, valsartan, and their combination on atherosclerotic events in 14,703 patients randomized in the Valsartan in Acute Myocardial Infarction Trial (VALIANT). RESULTS: The number of individuals adjudicated as having a fatal or non-fatal MI in the captopril group was 559 (total investigator reported events 798), 587 (796) in the valsartan group, and 554 (756) in the combination group; valsartan versus captopril, p = 0.651 (0.965); combination versus captopril, p = 0.187 (0.350). Overall, all atherosclerotic events examined occurred at a similar frequency in the captopril and valsartan groups. CONCLUSIONS: Angiotensin receptor blockers appear to be as effective as ACE inhibitors in reducing atherosclerotic events, even when used in addition to other secondary preventive treatments. These data, although not conclusive, also support the hypothesis that adding an ARB to an ACE inhibitor may have a small additional anti-infarction effect, a possibility that needs to be prospectively tested. © 2006 by the American College of Cardiology Foundation.

Authors
McMurray, J; Solomon, S; Pieper, K; Reed, S; Rouleau, J; Velazquez, E; White, H; Howlett, J; Swedberg, K; Maggioni, A; Køber, L; Werf, FVD; Califf, R; Pfeffer, M
MLA Citation
McMurray, J, Solomon, S, Pieper, K, Reed, S, Rouleau, J, Velazquez, E, White, H, Howlett, J, Swedberg, K, Maggioni, A, Køber, L, Werf, FVD, Califf, R, and Pfeffer, M. "The effect of valsartan, captopril, or both on atherosclerotic events after acute myocardial infarction: An analysis of the valsartan in acute myocardial infarction trial (VALIANT)." Journal of the American College of Cardiology 47.4 (2006): 726-733.
PMID
16487836
Source
scival
Published In
JACC - Journal of the American College of Cardiology
Volume
47
Issue
4
Publish Date
2006
Start Page
726
End Page
733
DOI
10.1016/j.jacc.2005.09.055

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

PCV23 ECONOMIC EVALUATION OFVALSARTAN IN PATIENTS WITH CHRONIC HEART FAILURE IN THE HUNGARIAN HEALTH CARE SETTING

Authors
Kosa, J; Reed, SD; Radeva, J
MLA Citation
Kosa, J, Reed, SD, and Radeva, J. "PCV23 ECONOMIC EVALUATION OFVALSARTAN IN PATIENTS WITH CHRONIC HEART FAILURE IN THE HUNGARIAN HEALTH CARE SETTING." Value in Health 8.6 (November 2005): A95-A95.
Source
crossref
Published In
Value in Health
Volume
8
Issue
6
Publish Date
2005
Start Page
A95
End Page
A95
DOI
10.1016/S1098-3015(10)67435-9

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

The effect of valsartan, captopril, or both on atherosclerotic events after myocardial infarction: An analysis of the VALIANT trial

Authors
McMurray, JJV; Solomon, SD; Reed, SD; Velazquez, EJ; White, H; Howlett, JG; Maggioni, AP; Kober, L
MLA Citation
McMurray, JJV, Solomon, SD, Reed, SD, Velazquez, EJ, White, H, Howlett, JG, Maggioni, AP, and Kober, L. "The effect of valsartan, captopril, or both on atherosclerotic events after myocardial infarction: An analysis of the VALIANT trial." August 2005.
Source
wos-lite
Published In
Journal of Cardiac Failure
Volume
11
Issue
6
Publish Date
2005
Start Page
S156
End Page
S156

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

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

Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force report

Objectives: A growing number of prospective clinical trials include economic end points. Recognizing the variation in methodology and reporting of these studies, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) chartered the Task Force on Good Research Practices: Randomized Clinical Trials-Cost-Effectiveness Analysis. Its goal was to develop a guidance document for designing, conducting, and reporting cost-effectiveness analyses conducted as a part of clinical trials. Methods: Task force cochairs were selected by the ISPOR Board of Directors. Cochairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and a draft report developed by the panel were presented at the 2004 International and European ISPOR meetings, respectively. The manuscript was then submitted to a reference group for review and comment. Results: The report addresses issues related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members agreed that trials should be designed to evaluate effectiveness (rather than efficacy), should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted with an intention-to-treat approach. Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses. Conclusions: Trial-based cost-effectiveness studies have appeal because of their high internal validity and timeliness. Improving the quality and uniformity of these studies will increase their value to decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions. © ISPOR.

Authors
Ramsey, S; Willke, R; Briggs, A; Brown, R; Buxton, M; Chawla, A; Cook, J; Glick, H; Liljas, B; Petitti, D; Reed, S
MLA Citation
Ramsey, S, Willke, R, Briggs, A, Brown, R, Buxton, M, Chawla, A, Cook, J, Glick, H, Liljas, B, Petitti, D, and Reed, S. "Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force report." Value in Health 8.5 (2005): 521-533.
PMID
16176491
Source
scival
Published In
Value in Health
Volume
8
Issue
5
Publish Date
2005
Start Page
521
End Page
533
DOI
10.1111/j.1524-4733.2005.00045.x

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

Pharmacy-based assessment of adherence to HAART predicts virologic and immunologic treatment response and clinical progression to AIDS and death.

Although adherence to HAART at a level above 95% has been associated with optimal viral suppression, the impact of different levels of adherence on long-term clinical outcomes has not been determined. We used an objective pharmacy-based measure to examine the association between three levels of adherence to HAART and disease progression among a population-based cohort of HIV-infected patients attending an urban HIV specialty clinic. Higher levels of adherence to HAART were significantly associated with longer time to virologic failure (P < 0.001), greater increase in CD4 cell count (P = 0.04), and lower risk of progression to clinical AIDS or death (P < 0.007). After controlling for other factors, patients with low adherence had over five times the risk of disease progression than patients with moderate adherence (P = 0.007) or patients with high adherence (P = 0.001). There was no significant difference in the risk of progression between patients with moderate and high levels of adherence (P > 0.2). Patients who progressed to AIDS or death had significantly higher viral loads (P = 0.01) and lower CD4 cell counts (P = 0.03) than patients who experienced virologic failure, but did not progress.

Authors
Kitahata, MM; Reed, SD; Dillingham, PW; Van Rompaey, SE; Young, AA; Harrington, RD; Holmes, KK
MLA Citation
Kitahata, MM, Reed, SD, Dillingham, PW, Van Rompaey, SE, Young, AA, Harrington, RD, and Holmes, KK. "Pharmacy-based assessment of adherence to HAART predicts virologic and immunologic treatment response and clinical progression to AIDS and death." Int J STD AIDS 15.12 (December 2004): 803-810.
PMID
15601486
Source
pubmed
Published In
International Journal of STD & AIDS
Volume
15
Issue
12
Publish Date
2004
Start Page
803
End Page
810
DOI
10.1258/0956462042563666

The association of an early hemoglobin response with alternative metrics to evaluate treatment efficacy of erythropoietic agents.

Authors
Reed, SD; Radeva, JI; Daniel, D; Fastenau, JM; Williams, D; Schulman, KA
MLA Citation
Reed, SD, Radeva, JI, Daniel, D, Fastenau, JM, Williams, D, and Schulman, KA. "The association of an early hemoglobin response with alternative metrics to evaluate treatment efficacy of erythropoietic agents." November 16, 2004.
Source
wos-lite
Published In
Blood
Volume
104
Issue
11
Publish Date
2004
Start Page
71A
End Page
71A

CN3 COST-EFFECTIVENESS OF IMATINIB VERSUS INTERFERON (IFN-a) PLUS LOW-DOSE CYTARABINE (ARA-C) FOR NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) IN THE THE NETHERLANDS

Authors
Groot, MT; Anstrom, KD; Reed, SD; Uyl-de Groot, CA
MLA Citation
Groot, MT, Anstrom, KD, Reed, SD, and Uyl-de Groot, CA. "CN3 COST-EFFECTIVENESS OF IMATINIB VERSUS INTERFERON (IFN-a) PLUS LOW-DOSE CYTARABINE (ARA-C) FOR NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) IN THE THE NETHERLANDS." Value in Health 7.6 (November 2004): 644-644.
Source
crossref
Published In
Value in Health
Volume
7
Issue
6
Publish Date
2004
Start Page
644
End Page
644
DOI
10.1016/S1098-3015(10)65656-2

The clinical and economic impact of Staphylococcus aureus bacteremia in patients with cardiovascular devices

Authors
Chu, VH; Cabell, H; Friedman, JY; Reed, SD; Griffiths, RI; Kaye, KS; Crosslin, DR; Masselink, LE; Stryjewski, ME; Engemann, JJ; Reller, LB; Schulman, KA; Corey, GR; Fowler, VG
MLA Citation
Chu, VH, Cabell, H, Friedman, JY, Reed, SD, Griffiths, RI, Kaye, KS, Crosslin, DR, Masselink, LE, Stryjewski, ME, Engemann, JJ, Reller, LB, Schulman, KA, Corey, GR, and Fowler, VG. "The clinical and economic impact of Staphylococcus aureus bacteremia in patients with cardiovascular devices." October 26, 2004.
Source
wos-lite
Published In
Circulation
Volume
110
Issue
17
Publish Date
2004
Start Page
566
End Page
566

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

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

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

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 economic burden of allergic rhinitis: a critical evaluation of the literature.

Although a large number of economic analyses of allergic rhinitis have been published, there are relatively few empirically based studies, particularly outside the US. The majority of these analyses can be classified as burden-of-illness studies. Most estimates of the annual cost of allergic rhinitis range from dollars US 2-5 billion (2003 values). The wide range of estimates can be attributed to differences in identifying patients with allergic rhinitis, differences in cost assignment, limitations associated with available data and difficulties in assigning indirect costs (associated with reduced productivity) of allergic rhinitis. Approximately one-third of burden-of-illness studies include direct and indirect costs of allergic rhinitis, about one-third focus on direct costs only, and the remaining one-third focus exclusively on indirect costs due to reduced productivity. Indirect costs attributable to allergic rhinitis were higher in studies only estimating indirect costs (dollars US 5.5-9.7 billion) than in those estimating both direct and indirect costs (dollars US 1.7-4.3 billion). Although there are many economic evaluations of allergic rhinitis treatments in the published medical literature, very few represent formal cost-effectiveness evaluations that compare the incremental costs and benefits of alternative treatment strategies. Those that are incremental cost-effectiveness analyses have several limitations, including small samples, short study periods and the lack of a standardized measure of effectiveness. To date, the medical literature is lacking a comprehensive economic evaluation of general treatment strategies for allergic rhinitis. In undertaking such an analysis, serious consideration must be given to the study population of interest, the choice of appropriate comparators, the perspective from which the analysis is conducted, the target audience, the changing healthcare marketplace and the selection of a measure of effectiveness that incorporates both positive and negative aspects of treatments for allergic rhinitis. Future work would benefit from the development of a consensus on a summary measure of effectiveness that could be used in cost-effectiveness analyses of therapies for allergic rhinitis as well as additional empirical work to measure the association between severity of disease and its impact on worker productivity.

Authors
Reed, SD; Lee, TA; McCrory, DC
MLA Citation
Reed, SD, Lee, TA, and McCrory, DC. "The economic burden of allergic rhinitis: a critical evaluation of the literature." Pharmacoeconomics 22.6 (2004): 345-361. (Review)
PMID
15099121
Source
pubmed
Published In
PharmacoEconomics
Volume
22
Issue
6
Publish Date
2004
Start Page
345
End Page
361

A cost-effectiveness evaluation of imatinib versus interferon-alpha plus low-dose Ara-C for first-line treatment of patients with newly diagnosed chronic myeloid leukemia in the chronic phase.

Authors
Reed, SD; Anstrom, KJ; Foster, JA; Glendening, AG; Schulman, KA
MLA Citation
Reed, SD, Anstrom, KJ, Foster, JA, Glendening, AG, and Schulman, KA. "A cost-effectiveness evaluation of imatinib versus interferon-alpha plus low-dose Ara-C for first-line treatment of patients with newly diagnosed chronic myeloid leukemia in the chronic phase." November 16, 2003.
Source
wos-lite
Published In
Blood
Volume
102
Issue
11
Publish Date
2003
Start Page
252A
End Page
252A

Impact of osteoarthritis severity and NSAID-related gastrointestinal side effects on patients' ratings of health states.

Authors
Chang, J; Kauf, TL; Reed, SD; Friedman, JY; Omar, M; Kahler, KH; Schulman, KA
MLA Citation
Chang, J, Kauf, TL, Reed, SD, Friedman, JY, Omar, M, Kahler, KH, and Schulman, KA. "Impact of osteoarthritis severity and NSAID-related gastrointestinal side effects on patients' ratings of health states." September 2003.
Source
wos-lite
Published In
Arthritis and Rheumatism
Volume
48
Issue
9
Publish Date
2003
Start Page
S293
End Page
S293

Productivity loss as an indicator of unmet needs for osteoarthritis patients.

Authors
Chang, J; Kauf, TL; Reed, SD; Friedman, JY; Omar, M; Kahler, KH; Schulman, KA
MLA Citation
Chang, J, Kauf, TL, Reed, SD, Friedman, JY, Omar, M, Kahler, KH, and Schulman, KA. "Productivity loss as an indicator of unmet needs for osteoarthritis patients." September 2003.
Source
wos-lite
Published In
Arthritis and Rheumatism
Volume
48
Issue
9
Publish Date
2003
Start Page
S292
End Page
S293

A Bayesian approach to aid in formulary decision making: incorporating institution-specific cost-effectiveness data with clinical trial results.

Pharmacy and therapeutics committees commonly cite a lack of generalizability as a reason for not incorporating cost-effectiveness information into decision making. To address this concern, many committees undertake site-specific economic evaluations, which are often limited by small sample sizes and nonrandomized designs. We show how 2 complementary approaches were used to minimize these limitations in an economic evaluation of abciximab at 1 institution. Using a propensity score methodology, we selected patients who did not receive abciximab for the comparison cohort. Then, we adopted a Bayesian, hierarchical, random-effects model to integrate site-specific and clinical trial data. We applied the posterior distributions of effectiveness with local cost data in a traditional decision-analytic model. In 74% of the simulations, abciximab was cost-effective at 1 institution at the $50,000 per life year saved threshold, assuming a 50:50 split of patients undergoing coronary stenting and angioplasty. Among patients undergoing coronary stenting, the cost-effectiveness ratio of the addition of abciximab was at or below the $50,000 per life year saved threshold in 66.0% of the simulations.

Authors
Reed, SD; Dillingham, PW; Briggs, AH; Veenstra, DL; Sullivan, SD
MLA Citation
Reed, SD, Dillingham, PW, Briggs, AH, Veenstra, DL, and Sullivan, SD. "A Bayesian approach to aid in formulary decision making: incorporating institution-specific cost-effectiveness data with clinical trial results." Med Decis Making 23.3 (May 2003): 252-264.
PMID
12809323
Source
pubmed
Published In
Medical Decision Making
Volume
23
Issue
3
Publish Date
2003
Start Page
252
End Page
264
DOI
10.1177/0272989X03023003007

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

Management of allergic rhinitis in the working-age population.

Authors
McCrory, DC; Williams, JW; Dolor, RJ; Gray, RN; Kolimaga, JT; Reed, S; Sundy, J; Witsell, DL
MLA Citation
McCrory, DC, Williams, JW, Dolor, RJ, Gray, RN, Kolimaga, JT, Reed, S, Sundy, J, and Witsell, DL. "Management of allergic rhinitis in the working-age population." Evid Rep Technol Assess (Summ) 67 (January 2003): 1-4.
PMID
12674744
Source
pubmed
Published In
Evidence report/technology assessment (Summary)
Issue
67
Publish Date
2003
Start Page
1
End Page
4

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

Within-trial resource utilization and costs of patients randomized to treatment with imatinib (STI571) versus interferon-alpha (IFN-alpha) combined with cytarabine (Ara-C) in newly diagnosed patients with chronic myeloid leukemia in chronic phase.

Authors
Reed, SD; Radeva, JI; Glendenning, A; Schulman, KA; Grp, IRISS
MLA Citation
Reed, SD, Radeva, JI, Glendenning, A, Schulman, KA, and Grp, IRISS. "Within-trial resource utilization and costs of patients randomized to treatment with imatinib (STI571) versus interferon-alpha (IFN-alpha) combined with cytarabine (Ara-C) in newly diagnosed patients with chronic myeloid leukemia in chronic phase." November 16, 2002.
Source
wos-lite
Published In
Blood
Volume
100
Issue
11
Publish Date
2002
Start Page
187A
End Page
187A

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

Valsartan is cost-effective in heart failure patients not receiving ACE inhibitors

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. "Valsartan is cost-effective in heart failure patients not receiving ACE inhibitors." October 15, 2002.
Source
wos-lite
Published In
Circulation
Volume
106
Issue
16
Publish Date
2002
Start Page
E77
End Page
E77

Economic issues and antibiotic resistance in the community.

BACKGROUND: Inappropriate antibiotic use is generally considered to be the primary cause of antibiotic resistance in the community. Multiple economic factors, at the level of physicians, patients, healthcare organizations, and pharmaceutical companies, foster poor antibiotic use. OBJECTIVE: To describe the influence of economic factors on the use and development of antibiotics and to evaluate the extent to which the cost of resistance is important in the economic evaluation of antibiotic products. DATA SOURCES: Literature identified through MEDLINE (1966-May 2001), bibliographies from relevant articles, government reports, and proceedings from conferences about antibiotic resistance. DATA SYNTHESIS: Economic factors at all levels of the healthcare system contribute to the inappropriate use of antibiotics in the community setting. Relatively little economic research has been published on antibiotic resistance, and very few cost-effectiveness analyses of antibiotic treatment alternatives have explicitly included the cost of resistance. CONCLUSIONS: A better understanding of economic factors that influence the prescribing, marketing, and development of antibiotics could lead to more successful efforts at curtailing the growth of antibiotic resistance in the community setting.

Authors
Reed, SD; Laxminarayan, R; Black, DJ; Sullivan, SD
MLA Citation
Reed, SD, Laxminarayan, R, Black, DJ, and Sullivan, SD. "Economic issues and antibiotic resistance in the community." Ann Pharmacother 36.1 (January 2002): 148-154. (Review)
PMID
11816243
Source
pubmed
Published In
The Annals of pharmacotherapy
Volume
36
Issue
1
Publish Date
2002
Start Page
148
End Page
154
DOI
10.1345/aph.1A121

Cost-effectiveness of valsartan in patients not receiving angiotensin-converting enzyme inhibitors at baseline

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. "Cost-effectiveness of valsartan in patients not receiving angiotensin-converting enzyme inhibitors at baseline." 2002.
Source
wos-lite
Published In
European Heart Journal (Elsevier)
Volume
23
Publish Date
2002
Start Page
137
End Page
137

Treatment with tissue plasminogen activator and inpatient mortality rates for patients with ischemic stroke treated in community hospitals.

BACKGROUND AND PURPOSE: Most analyses of intravenous tissue plasminogen activator (IV tPA) use for acute stroke in routine practice have been limited by sample size and generally restricted to patients treated in large academic medical facilities. In the present study, we sought to estimate among community hospitals the use of IV tPA and to identify factors associated with the use of IV tPA and inpatient mortality. METHODS: We evaluated a retrospective cohort of 23 058 patients with ischemic stroke from 137 community hospitals. RESULTS: Three hundred sixty-two (1.6%) patients were treated with IV tPA, and 9.9% of those patients died during the hospitalization period. In 35.0% of the hospitals, no patients were treated with IV tPA, whereas 14.6% of hospitals treated approximately 3.0% with IV tPA. After control for multiple factors, younger patients, more severely ill patients (OR 2.02, 95% CI 1.36 to 3.01), and patients treated in rural hospitals (OR 1.80, 95% CI 0.99 to 3.26) were more likely to receive IV tPA, whereas black patients were less likely (OR 0.54, 95% CI 0.31 to 0.95). There also was a trend showing that women were less likely to receive IV tPA (OR 0.84, 95% CI 0.69 to 1.03). Factors associated with an increased odds of inpatient mortality included receipt of IV tPA among men (OR 2.81, 95% CI 1.72 to 4.58) and increased age. Black patients were 27% less likely to die during hospitalization (95% CI 0.60 to 0.90). CONCLUSIONS: In this large, retrospective evaluation of community hospital practice, the use IV tPA and inpatient mortality rates among IV tPA-treated patients were consistent with those of other studies. The likelihood of receiving IV tPA varies by race, age, disease severity, and possibly gender. These factors may influence mortality rates.

Authors
Reed, SD; Cramer, SC; Blough, DK; Meyer, K; Jarvik, JG
MLA Citation
Reed, SD, Cramer, SC, Blough, DK, Meyer, K, and Jarvik, JG. "Treatment with tissue plasminogen activator and inpatient mortality rates for patients with ischemic stroke treated in community hospitals." Stroke 32.8 (August 2001): 1832-1840.
PMID
11486113
Source
pubmed
Published In
Stroke
Volume
32
Issue
8
Publish Date
2001
Start Page
1832
End Page
1840

Inpatient costs, length of stay, and mortality for cerebrovascular events in community hospitals.

BACKGROUND: Accurate estimates of inpatient cost, length of stay (LOS), and mortality are necessary for the development of economic models to estimate the cost-effectiveness of stroke-related treatments. Estimates based on data from academic institutions may not be generalizable to community hospitals. In this study, the authors estimated inpatient costs, LOS, and in-hospital mortality for patients with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), ischemic cerebral infarction (ICI), and TIA who were treated in community hospitals. METHODS: The authors selected patients using International Classification of Diseases-9-Clinical Modification primary diagnosis codes from the HBSI EXPLORE database. They analyzed patient-level data and inpatient costs, derived from detailed utilization data, for all patients admitted to 137 community hospitals in 1998. Multivariate statistical techniques were used to examine patient-, hospital-, and outcome-related factors associated with inpatient costs. RESULTS: Patients with SAH incurred the highest average cost ($23,777, n = 1,124), followed by patients with ICH ($10,241, n = 3,139), ICI ($5,837, n = 18,740), and TIA ($3,350, n = 7,861). Patient subgroups ranked in the same order for average LOS at 11.5 days for SAH, 7.5 days for ICH, 5.9 days for ICI, and 3.4 days for TIA. Almost one third of patients with SAH (29.0%) and ICH (33.1%) died during hospitalization, whereas 7.0% with ICI and 0.2% with TIA died. For each event, as patient age increased, average costs consistently decreased. Also, average costs were higher among patients treated in community teaching hospitals compared to community nonteaching hospitals for each cerebrovascular event (10 to 29%). CONCLUSIONS: Inpatient costs, LOS, and mortality for patients with cerebrovascular disease are dependent on patient and hospital characteristics.

Authors
Reed, SD; Blough, DK; Meyer, K; Jarvik, JG
MLA Citation
Reed, SD, Blough, DK, Meyer, K, and Jarvik, JG. "Inpatient costs, length of stay, and mortality for cerebrovascular events in community hospitals." Neurology 57.2 (July 24, 2001): 305-314.
PMID
11468317
Source
pubmed
Published In
Neurology
Volume
57
Issue
2
Publish Date
2001
Start Page
305
End Page
314

Cost effectiveness of abciximab during routine medical practice

Objective: To estimate the cost per ischaemic event (death, nonfatal myocardial infarction, subsequent revascularisation procedure) avoided at 6 months in high risk patients undergoing coronary revascularisation treated with abciximab during routine medical care. Design: Retrospective, matched cohort design. Setting: University teaching hospital. Patients: 62 abciximab-treated patients and 62 patients not treated with abciximab with high risk coronary lesions were matched according to gender, hyperlipidaemia, diabetes mellitus and stenting. Main Outcome Measures: Using a third-party payer's perspective, an incremental cost-effectiveness ratio (ICER) was computed as the cost per ischaemic event avoided over 6 months. Fieller's theorem was used to estimate confidence sets and confidence ellipses were generated to visually represent the variability in the data. Results: At 6 months, abciximab-treated patients experienced an approximately 40% lower rate of ischaemic events (16.1 vs 27.4%; p = 0.128). The point estimate of the ICER was $US21 789 per ischaemic event avoided. Fieller's theorem resulted in a 95 % confidence set consisting of 2 half-lines (-infinity to -$US115 461) and ($US391 to +infinity), reflecting the finding that the ICER denominator was not significantly different from zero at the p = 0.05 level. Conclusions: In high risk patients treated during routine care, the effectiveness of abciximab was consistent with efficacy rates from clinical trials. However, abciximab-treated patients remained approximately $US2400 more costly at 6 months.

Authors
Reed, SO; Mullins, CD; Magder, LS
MLA Citation
Reed, SO, Mullins, CD, and Magder, LS. "Cost effectiveness of abciximab during routine medical practice." PharmacoEconomics 18.3 (2000): 265-274.
PMID
11147393
Source
scival
Published In
PharmacoEconomics
Volume
18
Issue
3
Publish Date
2000
Start Page
265
End Page
274

Difficulties in applying clinical trial information to the practice setting: case of a high-cost drug.

Authors
Reed, SD; Mullins, CD; Roffman, DS; Mays, DA
MLA Citation
Reed, SD, Mullins, CD, Roffman, DS, and Mays, DA. "Difficulties in applying clinical trial information to the practice setting: case of a high-cost drug." Am J Health Syst Pharm 55.22 (November 15, 1998): 2409-2414.
PMID
9825038
Source
pubmed
Published In
American Journal of Health-System Pharmacy
Volume
55
Issue
22
Publish Date
1998
Start Page
2409
End Page
2414

Cerebral lateralization and heartbeat discrimination.

Authors
Hantas, MN; Katkin, ES; Reed, SD
MLA Citation
Hantas, MN, Katkin, ES, and Reed, SD. "Cerebral lateralization and heartbeat discrimination." Psychophysiology 21.3 (May 1984): 274-278.
PMID
6739668
Source
pubmed
Published In
Psychophysiology
Volume
21
Issue
3
Publish Date
1984
Start Page
274
End Page
278
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Research Areas:

  • Academic Medical Centers
  • Alzheimer Disease
  • Ambulatory Care
  • Anemia, Sickle Cell
  • Angiotensin-Converting Enzyme Inhibitors
  • Anti-Bacterial Agents
  • Anticoagulants
  • Antifungal Agents
  • Antineoplastic Agents
  • Arthritis, Rheumatoid
  • Arthroplasty, Replacement, Knee
  • Bacterial Infections
  • Behavior Therapy
  • Biotechnology
  • Blood Pressure
  • Blood Pressure Monitoring, Ambulatory
  • Blood Transfusion
  • Brain
  • Brain Ischemia
  • Breast Neoplasms
  • Candida glabrata
  • Cardiac Surgical Procedures
  • Cardiovascular Diseases
  • Cardiovascular Surgical Procedures
  • Cerebrovascular Disorders
  • Chemoprevention
  • Chemotherapy, Adjuvant
  • Chronic Disease
  • Clinical Trial
  • Clinical Trials as Topic
  • Cohort Studies
  • Commerce
  • Comorbidity
  • Comparative Effectiveness Research
  • Continental Population Groups
  • Cost Savings
  • Cost of Illness
  • Cost-Benefit Analysis
  • Costs
  • Costs and Cost Analysis
  • Data Collection
  • Data Interpretation, Statistical
  • Decision Making
  • Decision Support Techniques
  • Decision Trees
  • Dermatitis, Atopic
  • Device Approval
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • Diffusion of Innovation
  • Disease Management
  • Disease Progression
  • Disease-Free Survival
  • Drug Approval
  • Drug Costs
  • Drug Industry
  • Drug Prescriptions
  • Drug Therapy, Combination
  • Economics, Hospital
  • Economics, Pharmaceutical
  • Efficiency, Organizational
  • Evidence-Based Medicine
  • Exercise Therapy
  • Financial Management
  • Financing, Organized
  • Follow-Up Studies
  • Forecasting
  • Fractures, Bone
  • Gene Expression Profiling
  • Government Regulation
  • Health Care Costs
  • Health Care Rationing
  • Health Expenditures
  • Health Resources
  • Health Services
  • Health Services Research
  • Health Status
  • Heart Failure
  • Hospital Costs
  • Hospital Mortality
  • Hospitalization
  • Hypertension
  • Inpatients
  • Insulin Infusion Systems
  • Kidney Failure, Chronic
  • Length of Stay
  • Linear Models
  • Lymph Node Excision
  • Medical Laboratory Science
  • Medicine
  • Methicillin-Resistant Staphylococcus aureus
  • Models, Economic
  • Models, Statistical
  • Multivariate Analysis
  • Myocardial Infarction
  • Myocardial Ischemia
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Neoplasms
  • Orthopedic Procedures
  • Osteoarthritis
  • Outcome Assessment (Health Care)
  • Outcome and Process Assessment (Health Care)
  • Ovarian Neoplasms
  • Pancreatectomy
  • Pancreatic Neoplasms
  • Patient Care Management
  • Patient Discharge
  • Patient Readmission
  • Patient-Centered Care
  • Perception
  • Peripheral Nervous System Diseases
  • Pharmacy
  • Physician's Practice Patterns
  • Policy Making
  • Polymorphism, Genetic
  • Predictive Value of Tests
  • Program Evaluation
  • Proportional Hazards Models
  • Prostatic Neoplasms
  • Quality of Life
  • Questionnaires
  • Radiotherapy, Adjuvant
  • Randomized Controlled Trials as Topic
  • Recurrence
  • Registries
  • Renal Dialysis
  • Research Design
  • Resource Allocation
  • Respiratory Function Tests
  • Risk Assessment
  • Risk Factors
  • Social Values
  • Socioeconomic Factors
  • Staphylococcal Infections
  • Staphylococcus aureus
  • Stem Cell Transplantation
  • Stents
  • Stroke
  • Subarachnoid Hemorrhage
  • Surgical Procedures, Operative
  • Surgical Wound Infection
  • Terminal Care
  • Thyroid Neoplasms
  • Thyroidectomy
  • Treatment Outcome
  • Ventricular Dysfunction, Left