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Understanding Health Outcomes And Pharmacoeconomics [Pehme köide]

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  • Formaat: Paperback / softback, 218 pages, kaal: 284 g
  • Ilmumisaeg: 06-Oct-2011
  • Kirjastus: Jones and Bartlett Publishers, Inc
  • ISBN-10: 076377099X
  • ISBN-13: 9780763770990
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Understanding Health Outcomes And PharmacoeconomicsSuurem pilt
  • Formaat: Paperback / softback, 218 pages, kaal: 284 g
  • Ilmumisaeg: 06-Oct-2011
  • Kirjastus: Jones and Bartlett Publishers, Inc
  • ISBN-10: 076377099X
  • ISBN-13: 9780763770990
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9780763770990.html
Märksõnad:
Understanding Health Outcomes and Pharmacoeconomics presents an overview of the tools used to assess patient-related health status including associated health outcomes and the analyses that are used to determine cost-effectiveness in evaluating pharmacotherapeutic interventions to improve health. Including data and examples from several different countries, this comprehensive text will help students understand the basis for decisions made at the local and governmental level that impact the use of pharmaceuticals and provide a strong foundation for understanding the principles used in cost-effective decision making. With commentaries, cases studies, and highlighting international differences, this text concludes with a discussion of the need for a universal system for documenting medication use.

Understanding Health Outcomes and Pharmacoeconomics provides definitions of comparative effectiveness research (CER) and comparisons of pharmacoeconomic models (including cost-effectivess, cost-benefit, and cost utility analyses). This inclusive text provides describes how CER is linked to various pharmacoeconomic models by providing examples from clinical trials with comparative pharmacotherapy and cost parameters.

From the Introduction: The need for interprofessional education was made apparent in the 2003 Health Professions Education: A Bridge to Quality report. All healthcare professionals must be educated to deliver patient-centered care as members of an interprofessional team, emphasizing evidence-based practice, quality improvement approaches, and informatics. An enhanced understanding of pharmacoeconomic principles is a step in the right direction for healthcare practitioners as we do our best to ensure optimal medication therapy outcomes for patients and society at-large. George E. MacKinnon III, PhD, RPh, FASHP
Foreword xiii
Contributors xv
Reviewers xix
About the Author xxi
SECTION I Introduction to Measuring Health Status
1(82)
Chapter 1 Introduction
3(6)
George E. MacKinnon III
Chapter 2 Drug Development and Approval
Patricia M. Finnegan
George E. MacKinnon III
Introduction
9(1)
Drug Development and Regulation at the Turn of the 20th Century
9(1)
Evolution of Drug Development and Approval
10(1)
Drug Development and Approval Present and Future
10(1)
Regulation
Department of Health and Human Services
10(1)
Evolution of Drug Regulation: Focus on Safety
11(1)
Evaluating Safety and Efficacy
12(1)
Sex, Age, and Racial Differences in Clinical Trials
12(1)
Focus on Cost Control and Faster Access to New Therapies
13(2)
The Bayh-Dole Act
13(1)
The Orphan Drug Act
13(1)
Drug Price Competition and Patent Term Restoration Act
13(1)
Prescription Drug User Fee Act
14(1)
International Conference on Harmonization
14(1)
Drug Discovery, Development, and Approval
15(6)
Overview
15(1)
Drug Discovery
16(1)
Preclinical Development
16(1)
Investigational New Drug Application
17(1)
Clinical Studies
17(1)
Application for Approval of a New Drug
18(1)
FDA Review and Approval
18(1)
Postapproval Activities
18(1)
Generic Drugs
19(1)
Biosimilars
19(1)
Over-the-Counter Drugs
20(1)
Drug Development and Approval in the Future
21(2)
Summary
23(1)
References
23(1)
Additional Resources
23(2)
Chapter 3 Measuring Health Status and Health-Related Quality-of-Life Assessment
25(14)
Nalin Payakachat
Matthew M. Murawski
Introduction
25(1)
Measurement of Health
26(4)
HRQL Instrument Development
30(2)
Psychometric Properties
32(3)
Reliability
32(2)
Validity
34(1)
Summary
35(1)
References
36(2)
Additional Resources
38(1)
Chapter 4 Health Surveys (Disease-Specific and Generic Questionnaires) and Utility Assessment
39(18)
Patricia van Hanswijck de Jonge
Donald E. Stull
Measurement of Health and Health-Related Quality-of-Life
39(4)
Measuring Health Status
40(1)
Measuring Health States and Health State Preferences
41(2)
Measurement of Health States and Health State Preferences for Use in Cost Utility Analyses
43(10)
Health States, Health State Preferences, and Health Utility
43(1)
What Are Health Utilities and How Are They Elicited?
44(5)
Which Method of Utility Elicitation Is the Right Method?
49(2)
Converting Condition-Specific, Non---Preference-Based Measures into Preference-Based Outcomes for CUA
51(2)
Summary
53(1)
References
54(3)
Chapter 5 Overview of Statistical Analysis in Biomedical Research
57(26)
Chenghui Li
Introduction
57(1)
Study Design and Bias
58(3)
Study Design
58(1)
Validity and Bias
59(2)
Probability and Uncertainty
61(6)
Probabilities and Distribution
61(5)
Uncertainty
66(1)
Estimating Risk
67(8)
Relative Risk and Odds Ratio
67(3)
Logistic Regression and Adjusted OR
70(1)
Survival Analysis
71(4)
Estimating Mean Cost
75(4)
Estimating Mean Cost and Statistical Tests: Mean Cost or Median Cost?
75(1)
Transformation and Smearing
76(1)
Generalized Linear Model
76(1)
Two-Part Model
77(1)
Censored Cost Data
78(1)
Uncertainty
79(1)
Summary
79(1)
References
79(4)
SECTION II Evaluating Levels of Evidence
83(68)
Chapter 6 Randomized Controlled Trials
85(22)
Nathaniel M. Rickles
Matthew Wolfe
Introduction
85(2)
Development of an RCT
87(7)
Selection of Study Participants
87(2)
Determination of Sample Size
89(2)
Recruitment of Study Participants
91(1)
Assignment of Study Participants
91(3)
Consent and Ethical Considerations
94(4)
RCT Implementation
98(2)
RCT Analysis and Evaluation
100(3)
Clinical and Statistical Significance
103(1)
Summary
103(3)
References
106(1)
Chapter 7 Systematic Reviews and Meta-Analyses
107(16)
Gerald E. Schumacher
Introduction
107(1)
Comparing Narrative Review, Systematic Review, and Meta-Analysis
108(2)
Examples of Systematic Reviews and Meta-Analyses in Drug Treatment
110(1)
Example A
110(1)
Example B
110(1)
Example C
111(1)
Example D
111(1)
Example E
111(1)
Steps in Conducting and Interpreting Systematic Reviews and Meta-Analyses
111(7)
Step 1 State Objectives of the Review and Outline Eligibility Criteria for Studies to Be Included
112(1)
Step 2 Search the Literature for Studies That Appear to Meet the Eligibility Criteria
112(1)
Step 3 Tabulate the Characteristics of Each Trial Indentified and Assess Its Methodologic Quality
113(1)
Step 4 Apply Eligibility Criteria and Justify Any Exclusions
113(1)
Step 5 For Quantitative Reviews, Assemble and Aggregate the Most Comprehensive Data Set Feasible
113(1)
Step 6 Analyze the Results of the Eligible Studies Using Statistical Synthesis of Data (the MA Step)
113(5)
Step 7 Prepare a Structured Report of the Review, Stating Objectives, Methods, Critical Analysis of Data, Limitations of the Review and Analysis, and Recommendations for Use of the Review
118(1)
Summary
118(3)
References
121(2)
Chapter 8 Medical and Prescription Claims Databases
123(16)
Donald G. Klepser
Introduction
123(1)
What Exactly Is a Claims Database?
124(4)
Enrollment File
126(1)
Medical Claims Databases
126(1)
Prescription Claims
127(1)
What Are the Advantages and Disadvantages of Using Claims Databases?
128(2)
Advantages
128(1)
Disadvantages
129(1)
Types of Studies Conducted with Medical and Prescription Claims Databases
130(2)
Utilization Studies
130(1)
Adverse Event Studies
130(1)
Comparative Effectiveness
130(1)
Health Policy Research
131(1)
How Does One Get Access to Medical and Prescription Claims Databases?
131(1)
Developing a Study That Uses a Claims Database
132(4)
Study Design
133(2)
Analysis of Claims Data
135(1)
Mini-Case
136(1)
Summary
137(1)
References
137(2)
Chapter 9 Uses of Real-World Data in Evidence Development
139(12)
Carl V. Asche
Introduction
139(1)
Study Types
139(1)
Prospective Explanatory Studies: Process and Characteristics
140(1)
Gold Standard for Health Care: RCTs
140(1)
Which Study Type Should Be Used and When?
141(1)
Types of Real-World Studies
141(3)
Supplements to RCTs
141(1)
Observational Studies
141(1)
Patient Registries
142(1)
Patient-Reported Outcomes
142(1)
Data Sources: Retrospective Data Analysis
143(1)
Electronic Health Records
144(1)
Good Process in Real-World Data
144(1)
Data Sources: The ISPOR Digest of International Databases
145(1)
Real-World Case Studies
146(3)
Case Study 1
146(1)
Case Study 2
147(1)
Case Study 3
148(1)
Conclusions from Real-World Case Studies
149(1)
Summary
149(1)
References
149(2)
SECTION III Pharmacoeconomics
151(56)
Chapter 10 Decision Analysis
153(10)
George E. MacKinnon III
Decision Analysis Techniques
154(7)
Decision Tables
154(1)
Decision Trees
155(6)
References
161(2)
Chapter 11 Introduction to Economic Analysis, Cost Determinants, and Modeling
163(8)
Jaewhan Kim
Junhua Yu
Introduction
163(1)
Types of Economic Analysis
164(1)
Elements of Economic Analysis
165(2)
Perspective
165(1)
Cost Determinants
166(1)
Measuring Outcomes
166(1)
Discounting Cost and Outcomes
167(1)
Sensitivity Analysis for Uncertainty and Variability
167(1)
Modeling in Economic Evaluations
167(2)
Limitations of Economic Analysis
169(1)
Additional Resources
169(2)
Chapter 12 Cost-of-Illness Analysis and Budget Impact Models
171(8)
Steven E. Marx
Introduction
171(2)
Cost of Illness
173(1)
Budget Impact Models
174(3)
Summary
177(1)
References
178(1)
Chapter 13 Cost-Effectiveness Analysis, Cost-Utility Analysis, and Cost-Benefit Analysis
179(16)
Junhua Yu
Jaewhan Kim
Cost-Effectiveness Analysis
179(8)
Methods
180(7)
Summary
187(1)
Cost-Utility Analysis
187(2)
Methods
189(1)
Summary
189(1)
Cost-Benefit Analysis
189(3)
Method
191(1)
Summary
191(1)
References
192(3)
Chapter 14 Comparative Effectiveness
195(12)
Patrick D. Meek
Amy C. Renaud-Mutart
Leon E. Cosler
Introduction
195(1)
Background on CER
196(1)
Forms of CER
197(3)
CER and Analytic Techniques Involving Costs
200(3)
Situations in Which Comparative Effectiveness Analysis with an Economic Analysis Would Be the Best Choice
203(1)
Impact of CER in the United States
203(2)
Use of CER Studies in International Single-Payer and Social Insurance Health Care Models
203(1)
Existing Capacity for CER in the United States
204(1)
Proposal to Establish a Quasi-Governmental National Comparative Effectiveness Center in the United States
204(1)
CER and Clinical Pharmacy Practice
205(1)
References
206(1)
Index 207
Dr. George E. MacKinnon III, is presently the Vice President of Academic Affairs of the American Association of Colleges of Pharmacy in Alexandria, VA. Prior to joining AACP he was Director of Global Health Economics & Outcomes Research at the headquarters of Abbott Laboratories. Dr. MacKinnon taught one of the first required courses in health economics and outcomes assessment in an academic pharmacy program in the 1990s. He also assisted in the development of numerous pharmacist-medical practice initiatives as well as several post-graduate residency training programs in various practice settings over the years. He served as the Founding Editor of InetCE SM, an Internet-based continuing education publication from 1996-2006, has authored over 60 publications and has written three book chapters in texts related to medication use.