ISPOR Short Course Educational Objectives: ISPOR Short Courses are provided to enhance the development of individuals involved in pharmacoeconomics and outcomes research or who use this research in health care decision-making. Faculty, who have published in the specific discipline, present each course. Each participant receives a course syllabus/workbook and a Certificate of Completion. The participant will be able to: learn new methodologies and outcomes research techniques; improve skills in the specific course subject selected; and be able to apply learned skills to their specific work environment.

Morning sessions (8 -12 am)

Pharmacoeconomics - Applications
Faculty: Brenda Motheral RPh, MBA, PhD, Professor, University of Arizona, College of Pharmacy, Tucson, AZ, USA. Dr. Motheral is author of numerous articles in the areas of outcomes research, claims database methodology, and managed care. Her research projects include evaluation of drug benefit plan design, pharmacoeconomic evaluation of infectious disease, and prescription utilization.
Course Description: Major components of outcomes and pharmacoeconomic research: cost-effectiveness, cost benefit, cost-utility, and cost-minimization analysis, quality-of-life measures, discounting, decision-analytic modeling, utilities, and the merits of prospective and retrospective studies will be presented.

Decision Analysis - Introduction
Faculty: Mark S. Roberts, MD, MPP, FACP, Associate Professor of Medicine; Associate Professor of Health Services Administration, University of Pittsburgh Schools of Medicine and Public Health, Pittsburgh, PA, USA. Dr. Roberts is a general internist with substantial formal and practical training in quantitative methods, decision sciences, cost-effectiveness analysis. He has authored numerous articles on decision analysis and the application of decision analysis to problems in medical care. His primary research interest is the application of quantitative methods to the examination of health care interventions, and he has special interests in the use of mathematical modeling and simulation of disease processes.
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.

Meta-analysis and Other Statistical Methods - Introduction
Faculty: Thomas R. Einarson PhD, Associate Professor, Faculty of Pharmacy and Faculty of Medicine at the University of Toronto, Toronto, Ontario, Canada. Dr. Einarson lectures in drug use studies as well as quantitative methods of analysis and has published over 30 meta-analyses and methodological papers as well as 16 pharmaceonomic analyses containing or based on meta-analyses. He has lectured worldwide on meta-analysis and quantitative methods of analysis.
Course Description: Meta-analysis and other analytical methods for assessing the quality of evidence for health care interventions will be discussed. Steps involved in conducting a meta-analysis including inter-rater agreement and the advantages and limitations of meta-analysis will be presented. The participant will perform a literature search, extract pertinent data, and develop a plan for analysis. Using a prepared checklist, a published meta-analysis will be critiqued.

Quality-of-Life, Health Status, and Outcomes Assessment
Faculty: Pennifer Erickson PhD, Co-founder O.L.G.A (On-Line Guide to Quality-of-Life Assessment), State College, PA, USA. Dr. Erickson has numerous publications on quality-of-life including her book, Health Status and Health Policy: Quality of Life in Health care Evaluation and Resource Allocation. She has more than 20 years experience in the field of health-related quality of life and health outcomes research and has developed a database on QoL instruments.
Course Description: Conceptual, methodological, and practical methods for measuring quality of life, health status and other types of health outcomes will be presented. Theoretical frameworks, reliability, validity, responsiveness, methods of administration, respondent and administrative burdens, and issues of analysis and interpretation will be discussed using examples drawn from specific quality-of-life instruments and their applications. A model of selecting appropriate instruments from the many existing generic and disease-specific instruments will be presented.

Afternoon Sessions (1 - 5 pm)

Decision Analysis - Applications
Faculty: Donald B. Chalfin, MD, MS, FCCP, FCCM, Director of Surgical Critical Care at the Beth Israel Medical Center in New York City, NY, USA. Dr. Chalfin is an internist and critical care medicine physician and is appointed as an Associate Professor of Medicine at the Albert Einstein College of Medicine where he teaches evidence-based medicine and decision analysis. Dr. Chalfin researches, lectures, and publishes frequently on cost-effectiveness analysis, medical economics, clinical decision analysis, and neural network modeling and computer applications in critical care medicine. He also serves as a consultant to the pharmaceutical industry specializing in decision analysis and economic modeling.
Course Description: This course will present how decision analysis has been used in health and medical care issues, with an emphasis upon development of models that can be applied to policy development and cost-effectiveness analysis in addition to depiction of difficult clinical problems. The course will present a review of standard decision analysis applications along with more complex models and techniques, including Monte Carlo simulations and Markov processes.

Meta-Analysis and Other Statistical Tools - Applications
Faculty: I. Elaine Allen PhD, Statistician and Vice President of Scientific Affairs, MetaWorks, Inc, Boston, MA, USA. Dr. Allen has extensive scientific experience in statistical analysis and applied meta-analysis. Her experience includes interactions with all agencies of the FDA on the design and analysis of clinical trials through multiple NDAs, PLAs, device filings and panel meetings. She has published widely in medical and statistical journals on meta-analysis and on statistical issues in clinical and biological research and statistical computing.
Course Description: Evidence-based medical information and methodology, the rationale for meta-analysis, flowcharts, measures of effect sizes, and the types of meta-analysis (qualitative synthesis, mapping, vote-count techniques, Bayesian hierarchical models, survival analysis, receiver operator characteristic curves and meta-regression models) will be discussed.

Retrospective Database Analyses
Faculty: Renée J. G. Arnold, PharmD, President and Harry Harjono, MS, Mphil, Program Manager, Pharmacon International Inc, New York City, NY, USA. Dr. Arnold is Clinical Associate Professor of Pharmacy at Long Island University and The Rutgers' College of Pharmacy. She is author of numerous articles in the areas of pharmacology, pharmacoeconomics and cost containment strategies. Mr. Harjono has hands-on experience on the analysis of large datasets and internet-based patient outcomes assessment software.
Course Description: Retrospective data analysis, such as data from medical claims or the U.S. government will be discussed. The advantages and disadvantages of using these datasets to perform economic analyses, in and of themselves and relative to prospective studies, will be discussed. Issues of data quality, bias, data sources, manual validation of electronic data, transparency of methodology and privacy will be outlined. Several examples of retrospective database analyses will be given. Participants will be given problems faced by managers/directors evaluating results of database analyses, e.g., what to do when you are faced with spurious results following a query; how do you determine disease severity when it is not a specific element in the database.

How to Develop Pharmacoeconomic Guidelines for Use in Health Care Decision Making
Faculty: Sean D. Sullivan PhD, Associate Professor, University of Washington, Seattle, WA, USA, and Paul C. Langley PhD Professor, University of Colorado, Denver, CO, USA.
Course Description: This short course will address a key issue in the development of pharmacoeconomics - is pharmacoeconomic research meeting the needs of drug purchasers and other key decision makes? The course will demonstrate that the traditional pharmacoeconomics of cost-outcomes analyses, which emphasize claims for cost-effectiveness based on clinical trials and synthetic decision models, are not only overly simplistic in their approach but are of very limited application in meeting the needs of drug purchasers. Unfortunately, in continuing to emphasize these techniques in workshops and seminars, we run the risk of putting the future of pharmacoeconomics in jeopardy. It is important that drug purchasers articulate their information needs. One way that this can be done is through the development of formulary submission guidelines. These set analytical and evidentiary standards which drug manufacturers and others are required to meet in making a case for their product. The course will focus on two practical issues: first, what should be the evidentiary standards in formulary submissions - the systems impact approach to pharmacoeconomic evaluations and, second, how should a health care system or medical group implement guidelines? Two sets of guidelines are considered: the Regence Washington Health guidelines (1997) and the Blue Cross and Blue Shield of Colorado and Nevada guidelines (1998).