Sunday, May 18, 2003

8:00am – 12:00pm

Introduction to Decision Analysis

Faculty: Mark Roberts MD, MPP, FACP, Professor, University of Pittsburgh, Pittsburgh, PA, USA.

Course description: Decision analysis is a tool that uses an explicit, quantitative structure to describe and analyze complex health care decisions. This course will provide an introduction to the principles and practice of decision analysis. Upon completion of the course, participants will be able to evaluate the appropriateness of decision analysis in different settings, construct simple decision trees, understand the basic mechanics of tree evaluation and sensitivity analysis, and acquire skill in the interpretation of a published decision analysis. Extension of basic techniques, such as cost-effectiveness analysis and the assessment of patient preferences will be briefly discussed. Pen and paper exercises will be used to illustrate these principles. This course is suitable for thoses with little experience with decision analysis

Value / Valuation in Measuring Outcomes (Preference-based Techniques)

Faculty: Paul Krabbe PhD, Senior Researcher, University Medical Centre Nijmegen, Nijmegen, The Netherlands.

Course Description: This course offers a unique combination of theory and practice that examines the explicit valuations systems of generic instruments (including HUI, EQ-5D and SF-6D) as well as those implicit in widely used condition-specific instruments (including FACT-L, QLQC-30 and HADS). Examples from the published literature will be discussed using a critical review framework designed to test the status of such value systems. Practical experience of the principal preference-based techniques used in valuing health outcomes, such as visual analogue scale, standard gamble, and time trade-off will be offered as an integral part of the course. Each participant must bring a laptop computer. The course is designed for those with at least an intermediate level experience of quality of life issues and practice.

Elements of Pharmaceutical Pricing

Faculty: Jack Mycka, President & GM, Acumen Strategic Consulting Group LLC, Glen Ridge, NJ, USA.

Course Description: The elements of pharmaceutical pricing decisions and the role of pharmacoeconomics in shaping those decisions will be discussed. This course is designed for those with some experience in either pharmacoeconomics or pharma- ceutical pricing.

Introduction to Quality of Life and Patient Reported Outcomes

Faculty: Steven Erickson PharmD, University of Michigan, College of Pharmacy, Ann Arbor, MI, USA.

Course Description: Conceptual, methodological, and practical methods for measuring patient reported outcomes will be presented. An emphasis will be placed on health-related quality of life; with additional discussion provided on symptom and treatment satisfaction assessment strategies. A strategy to aid in selecting appropriate instruments will be presented. Reliability, validity, responsiveness, methods of administration and scoring, and issues of analysis and interpretation will be discussed using practical examples and exercises. This course is designed for those with either little or intermediate experience in health-related quality-of-life assessment.

Introduction to Statistics

Faculty: Thomas R. Einarson PhD, Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Course Description: This course is designed to present an overview of the foundations upon which major statistical tests are based and tests which may be used to address Pharmacoeconomic problems. The major emphasis will be on application and interpretation of statistical results, not statistical theory. Surveyed will be the most commonly utilized statistical tests (t-test, ANOVA, Correlation, regression, chi square) and the types of variables associated with each test. This course will assist ISPOR attendees who are interested in increasing their understanding of the general principles associated with elementary statistics and how to apply these tests to problems presented in their work environment. This course is designed for those with little or no statistical training.

Introduction to Bayesian Approaches to Health Economics and Outcomes Research

Faculty: Bryan Luce PhD, MBA, Senior Research Leader & CEO,
MEDTAP International, Bethesda, MD, USA; Anthony O’Hagan BBc, PhD, Professor of Statistics, University of Sheffield, Sheffield, UK; Dennis Fryback PhD, Professor of Preventive Medicine & Industrial Engineering, University of Wisconsin, Madison, WI, USA

Course Description: This course is designed to provide an overview of the Bayesian approach and its applications to health economics and outcomes research. The course will cover basic elements of Bayesian statistics, contrasting briefly with classical (frequentist) statistics and introduce available statistical packages. The second half of the session will focus on the Bayesian “informative prior” and several example vignettes of how a Bayesian analysis can be used within outcomes modeling problems. Participants will learn how a Bayesian approach is different and why it is useful for their work and what tools are available to them. This course is designed for those with a limited understanding of Bayesian statistical concepts.

1:00pm – 5:00pm

Introduction to Outcomes Research

Faculty: Jeff Trotter MM, President, Ovation Research Group, Highland Park, IL, USA.

Course Description: This course will take participants from the problem stage to the design stage for outcomes research problems commonly encountered in healthcare settings. The importance of selecting the right outcome, population, setting, and time frame will be shown. Case studies and group work will allow participants to leave knowing how to convert a problem into a "do-able" research study. This course is for those with little or no experience in outcomes or clinical research.

Cost Estimation and Assessing Financial (Budget) Impact of New HealthCare Technologies

Faculty: Josephine Mauskopf PhD, Division Director, Global Health Economics, RTI Health Solutions, RTI International, RTP, NC, USA.; Daniel Mullins, PhD,
Associate Professor, University of Maryland School of Pharmacy, Baltimore MD, USA.

Course Description: This course will describe techniques in pharmacoeconomics that focus on cost. This will include methods to determine the cost-of-illness of a health condition using a “top-down” or “bottom-up” approach. Participants will also learn how to estimate the impact of new healthcare technologies on disease-specific costs from different decision-maker perspectives. Actuarial methods using straight-line projections and nonlinear trends will be described. Both static and dynamic methods for estimating the budget impact of adding a new drug to a health plan formulary will also be presented. This course is designed for those with some experience with pharmacoeconomic analysis.

Advanced Pharmacoeconomic Modeling

Faculty: Marc F. Botteman M.Sc., M.A., Executive Director, International Health Economics, HERQuLES: Health Economic Research & Quality of Life Evaluation Services, Abt Associates Clinical Trials, Bethesda, MD, USA.

Course Description: Participants will learn how to use and implement intermediate-to-advanced decision analysis techniques (i.e., Markov models and first- and second-order Monte Carlo simulations) for cost-effectiveness analyses. After a brief review of these methods and their appropriate use, the course will focus on the steps involved in developing Markov models and conducting Monte Carlo simulations. To illustrate how these methods are applied, a few simple examples will be demonstrated in Microsoft Excel or decision analysis software, as appropriate. Issues related to the selection of model input parameters and their distributions for use in probabilistic sensitivity analyses will be reviewed. Participants will learn how to analyze, interpret, and present results (e.g. using acceptability curves or analyses of the cost-effectiveness plane). Publications from healthcare journals presenting additional examples and theoretical considerations will be provided as a course supplement. This intermediate course requires basic understanding of decision analysis. Also, because computers are not available for participants' use, please note that the course will be characterized more as seminar-style, rather than as a hands-on modeling workshop.

Advanced Quality of Life and Patient Reported Outcomes

Faculty: Linda Abetz MA, Research Director, Mapi Values, Bollington, UK;
Bruce Crawford, Senior Project Director, Mapi Values, Boston, MA, USA

Course Description: This course will provide an in-depth discussion of operating characteristics, validity testing, analysis and interpretation with examples of each. This course is designed for those with experience in health-related quality-of-life assessment.

Introduction to Pharmacoepidemiology

Faculty: Fadia T. Shaya PhD, MPH, Assistant Research Professor,
Outcomes Research/Epidemiology, Assistant Director, Center on Drugs and Public Policy, University of Maryland, School of Pharmacy, Baltimore, MD, USA.

Course Description: Pharmacoepidemiology is the application of epidemiological knowledge and methods to study the effects (both positive and negative) of drugs in human populations. Its purpose is to describe and predict drug treatment in a defined time, space, and population. This course will provide an overview of the contribution of epidemiology to the study of drug uses and effects. Risk assessment methodologies, and pharmacoepidemiologic study design strategies (observational, analytic, and interventional studies) including their strengths and weaknesses will be presented. A special consideration will be given to the contribution of pharmacoepidemiology to outcomes research, and its relevance to decision-making. This course is for those with no or little experience with pharmacoepidemiology.

Meta-Analysis and Systematic Literature Review – Introduction

Faculty: Joseph C. Cappelleri PhD, MPH, Pfizer Inc., Groton, CT, USA

Course Description: Meta-analysis may be defined as the statistical analysis of data from multiple studies for the purpose of synthesizing and summarizing results, as well as for quantitatively evaluating sources of heterogeneity and bias. A systematic literature review often includes meta-analysis and involves an explicit, detailed description of how a review was conducted. This course highlights and expounds upon four key areas: 1) impetus for meta-analysis and systematic reviews, 2) basic steps to perform a quantitative systematic review, 3) statistical methods of combining data, and 4) appraisal and use of meta-analytic reports. The material is motivated via applications in pharmacoeconomics, outcomes research, and clinical studies from the published literature and hypothetical examples. Interactive exercises are part of the course. This course is designed for those with little experience with meta-analysis.

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