Pre-Meeting Short Courses

Short Course Development & Quality Assurance Task Force Co-Chairs

Kati Copley-Merriman MS, MBA,
Director of Outcomes Research, Pfizer Pharmaceuticals, Ann Arbor, Michigan, USA

Lorne Basskin PharmD,
Assistant Professor, Butler University, Indianapolis, Indiana, USA

Committee Members

Andrea Biddle PhD
Assistant Professor University of North Carolina, Chapel Hill, NC USA

David Lilienfeld MD, MS, MPH
Associate Director of Pharmacoepidemiology, Bristol Myers-Squibb, Princeton, NJ USA

Michael Minshall MPH,
Health Outcomes Research Scientist, Eli Lilly & Company, Indianapolis, IN, USA

Amy Phillips PharmD,
Outcomes Research Fellow, Thomas Jefferson University, Philadelphia, PA, USA

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 healthcare decision-making. Faculties, who have published in the specific discipline, present these courses. Each participant receives a course syllabus/workbook and an ISPOR Certificate of Completion. The participants learn new methodologies and outcomes research techniques; improve skills in the specific course subject selected; and are able to apply learned skills to their specific work environment.

MORNING SESSIONS
Sunday, May 20, 2001 (8-12 am)
Decision Analysis - Introduction
Faculty: Mark Roberts MD, MPP, FACP, Assistant Professor of Medicine, University of Pittsburgh, PA, USA
Course Description: Decision analysis is a tool that provides an explicit structure for solving complicated healthcare problems. This course will describe the basic structure and analysis of decision trees, the calculation of expected utilities, sensitivity analysis, the assessment of patient values, and inclusion of quality-of-life parameters. Simple examples will be used to illustrate these concepts, and more complex examples from the literature will be presented.
This course is designed for those with little or no experience in decision analysis.
Quality-of-life Assessment - First Principles
Faculty: Pennifer Erickson PhD, Co-Founder, OLGA, State College, PA, USA
Course Description: Conceptual, methodological, and practical methods for measuring quality-of-life will be presented. Reliability, validity, responsiveness, methods of administration and scoring, and issues of analysis and interpretation will be discussed using examples taken from specific health-related quality-of-life instruments and their applications. An algorithm for selecting appropriate instruments from the many existing generic and specific measures will be presented.
This course is designed for those with little or intermediate experience in health-related quality-of-life assessment.
Basic Statistics and Their Application to Pharmacoeconomic Data
Faculty: James E. De Muth PhD, Professor, Extension Services in Pharmacy, University of Wisconsin, Madison, WI, USA
Course Description: This course is designed to present an overview of the foundations upon which major statistical tests are based and the application of these tests to 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. The course will assist participants 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 suggested as a prerequisite to Statistical Considerations in Pharmacoeconomic Evaluations - Advanced (pm course) for those who lack a background in basic inferential statistics or need a brief review.
Analytic and Statistical Issues in Retrospective Databases Analyses
Faculty: William Crown PhD, MA, Vice President, Outcomes Research, MEDSTAT Group, Cambridge, MA, USA
Course Description: This course will cover: characteristics of retrospective databases that create challenges for research studies; the dangers of omitted variable bias—particularly, selection bias; statistical tests for omitted variables and alternative approaches to controlling for selection bias; alternative methods for dealing with influential observations—especially in cost studies; pros and cons of using logs, dropping outliers, capping outliers at maximum levels; new approaches for dealing with outliers including bootstrapping and nonlinear exponential regression; censoring in administrative databases; issues of non-continuous enrollment, left and right censoring; statistical methods for dealing with censored data; guidelines for model specification; and interpretation and limitations of dummy variables. Participants will also learn to determine when you need separate equations; when you need to worry about simultaneous equations; and how to conduct specification tests for a variety of different problems. The course will focus on concepts and examples, not formal derivations.
This course is designed for those with prior experience in analyzing claims databases.
Identification and Selection of Clinical Study Designs
Faculty: Karen F. Gold PhD, Director, Biostatistics & Outcomes Research, Abt Associates Clinical Trials, Bethesda, MD, USA
Course Description: The design of prospective observational and survey, longitudinal, quasi-experimental and randomized clinical studies as well as retrospective clinical studies will be presented. Commonly used designs will be presented and discussed with respect to validity, reliability, generalizability, potential bias and study reproducibility. Focus will be on providing participants with the tools necessary to take a given study, analyze it and determine its weak and strong points and, devise a stronger alternative study using a different design but answering the same research questions as the original design.
This course is designed for those with some experience with clinical studies.
Elements in Pharmaceutical Pricing and Pharmacoeconomics
Faculty: Mick Kolassa PhD, Associate Professor, School of Pharmacy, University of Mississippi, University, MS, 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 pharmaceutical pricing.
AFTERNOON SESSIONS
Sunday, May 20, 2001 (8-12 am)
Decision Analysis - Advanced
Faculty: Donald Chalfin MD, MS, Director, SICU and SICC, Beth Israel Medical Center, Albert Einstein College of Medicine, New York, NY, USA
Course Description: Complex models and techniques, including Monte Carlo simulations, Markov models, Bayesian analysis, and DEALE (declining exponential approximation of life expectancy) will be discussed. How these techniques are used in health care decision-making will be emphasized.
This course is a continuation of Decision Analysis - Introduction (am course).
Quality-of-life Instrument Design & Testing Advanced Psychometric Models
Faculty: Jane Scott Lennox PhD, President, Piedmont Research, Chapel Hill, NC, USA
Course Description: This section will discuss the role of advanced psychometric analysis in the construction and evaluation of quality-of-life instruments. The course will use the latent variable model as an organizing theme around the following conventional approaches to scale evaluation: 1) internal consistency, 2) exploratory factor analysis, 3) confirmatory factor analysis, 4) structural equation models with latent variables and 5) item response modeling. These techniques will be initially presented in the context of Spearman's classical psychometric theory and expanded into a discussion of how each has evolved to contribute unique understanding of measure quality.
This course is for those with experience with quality-of-life instruments and psychometric models.
Statistical Considerations in Pharmacoeconomic Evaluations - Advanced
Faculty: Joseph Heyse PhD, Executive Director, Biostatistics & Research Data Systems Vaccines, Merck Research Laboratories, Blue Bell, PA, USA and John Cook PhD, Director, Biostatistics & Research Data Systems Vaccines, Merck Research Laboratories, Blue Bell, PA, USA
Course Description: This course will provide an overview of the terminology, family of technologies, and key methodological features of pharmacoeconomic evaluations. The primary focus will be on the statistical considerations of planning & analyzing studies and interpreting the results, including comparisons of types of analyses used and discussing important study design features for both clinical-economic trials and modeling studies based on available epidemiological and clinical data. Methods of statistical analysis for cost data and for estimating cost-effectiveness ratios will be thoroughly reviewed, making extensive use of real-life examples and published studies.
This course is designed for those with experience in conducting pharmacoeconomic studies.
Meta-Analysis and Systemic Literature Review - Introduction
Faculty: Joseph C. Cappelleri PhD, MPH, Associate Director, Pfizer Inc., Groton, CT, USA and Joseph Lau MD, New England Medical Center and Tufts University Medical School, MA, 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 short 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.
Measuring Productivity
Faculty: Paul Greenberg PhD, Principal & Director, Health Economics Practice, Analysis Group, Cambridge, MA, USA
Course Description: Intervention, observational and retrospective productivity studies will be discussed. Measurement issues including linking available data, role of assumptions and models, using job classification information, self-report vs. objective measurement will be examined. The issues and needs of the corporate benefit managers, FDA and other users of productivity measurements will be explored including examples of studies.
This course is designed for those with little experience with productivity studies.
Understanding the U.K.'s National Institute for Clinical Excellence (NICE) Protocols
Faculty: Judith Bentkover PhD, President & CEO, Innovative Health Solutions, Brookline, MA, USA and Peter Neumann ScD, Assistant Professor, Harvard School of Public Health, Boston, MA, USA
Course Description: This course is designed to provide participants with an understanding of the role of NICE, the basics of the NICE appraisal process, and the implications of NICE—and other similar organizations nationwide—for the pharmaceutical, biotechnology and medical device industries. By preparing and presenting case studies of fictitious drug products for a simulated submission to NICE, participants will have hands-on experience with the submission process. As part of the short course exercise, participants will also have an opportunity to review one of the fictitious drug products from the perspective of a NICE "regulator", thus providing an opportunity for participants to experience the "other side" of the process.
This course is designed for those with some experience with drug approval processes.

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