May 16-19, 2004, Crystal Gateway Marriott, Arlington, VA
PRE-MEETING SHORT COURSES
Saturday, May 15:
Full Day Courses (8:00am-5:00pm)
Pharmacoeconomics
Pharmacoeconomics for Decision-makers - (full-day course)
Faculty:
Lorne Basskin PharmD, President, Trinka
Publications, Cooper City, FL, USA
Course description: This course is
designed to teach clinicians and new researchers how to incorporate
pharmacoeconomics into study design and data analysis. Participants will
learn how to collect and calculate the costs of different alternatives,
determine the economic impact of clinical outcomes, and how to identify,
track and assign costs to different types of health care resources used.
The development of economic protocols and data collection sheets will be
discussed. Different pharmacoeconomic models and techniques will be
demonstrated and practiced in lectures and case studies. These include
cost-minimization, cost-of-illness, cost-effectiveness, cost-benefit,
and cost-utility analysis. Decision analysis, sensitivity analysis, and
discounting, will all be demonstrated and practiced. Participants will
also learn to compare and evaluate interventions such as drugs, devices
and clinical services. This course is suitable for those with little
or no experience with pharmacoeconomics.
Modeling
Advanced Modeling
and Decision Analysis (Full Day Course)
Faculty:Marc Botteman MA,
Executive Director, Abt Associates Inc., HERQuLES, Bethesda, MD, USA;
Ben van Hout PhD, Scientific Director, PharMerit, Capelle a/d IJssel,
The Netherlands; Bart Heeg MSc, PharMerit, Capelle a/d IJssel,
The Netherlands
Course Description: Models are
mathematical frameworks in which knowledge from a variety of sources can
be brought together in a structured framework.
Modeling provides an analytic tool that enables researchers to estimate
the costs and outcomes of different treatment options, as well as the
uncertainties surrounding those outcomes. In the first part of this full
day course, participants will learn when and how to use, implement,
simulate, and evaluate Markov models, discrete event models, and other
modeling techniques used to conduct burden-of-illness and
cost-effectiveness analyses. This will be accomplished by first
providing a review of these methods and their appropriate use, in light
of the ISPOR Principles of Good Practice for Decision Analytic Modeling
in Health Care Evaluations. Then, using a series of related examples,
the course will carefully review the practical steps involved in
developing and using these kinds of models.
These examples will be presented using predominantly Microsoft Excel,
supplemented with add on simulation software, as opposed to dedicated,
stand-alone decision analysis software, as the goal of the course is to
provide an in depth understanding of the simple yet powerful
mathematical underpinnings of each of these methods using a relatively
transparent tool rather than to teach a new programming language. The
second section of this course will cover in details the practical steps
involved in the selection and modeling of data inputs and practical
aspects related to the determination of when, why and how to handle
stochastic (i.e., first order Monte Carlo Simulations) and probabilistic
uncertainty (i.e., second order Monte Carlo Simulations). The ISPOR
Principles of Good Practice will again be reviewed and discussed in this
context. These will include in particular data identification, data
modeling, and data incorporation considerations.
Issues related to the selection of model input parameters and their
distributions for use in probabilistic sensitivity analyses will be
considered. Participants will learn the steps required conducting,
analyzing, interpreting, and presenting results from probabilistic
sensitivity analyses (e.g. using analyses of the cost-effectiveness
plane, the "ellipses", and acceptability curves). An introduction to the
expected value of perfect information [EVPI] will be provided in the
context of the use of probabilistic sensitivity analyses.
The above concepts will be illustrated with a series of related examples
using Microsoft Excel. 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. The course will be conducted more as a seminar,
rather than as a hands-on modeling workshop. However, we encourage
participants to bring their own laptop computers (with a CD ROM drive
and Microsoft Excel) to facilitate the use of the examples and add-on
software demo that will be provided. Additionally, we encourage early
course registration to allow for early distribution of the examples and
add-on software. This intermediate course requires basic
understanding of decision analysis.
May 15: Morning Courses (8:00am-12:00pm)
Quality of Life / Patient-reported Outcomes
Introduction to Quality of Life / Patient-reported
Outcomes
Faculty:Linda Abetz MA,
Research Director, Mapi Values, Bollington, UK; Bruce Crawford MA, MPH, Senior Project Director/Manager US
Operations, Mapi Values, Boston, MA, USA,
Course description: Basic concepts
of health-related quality of life, patient satisfaction, work
performance in clinical trial and health services research will be
presented. Participants will be asked to identify PRO domains and
sub-domains from an anonymous patient interview. The advantages and
disadvantages of different types of questionnaires will be provided,
with examples provided for each type (an exhaustive list of
questionnaires will NOT be provided). Finally, the practical methods and
issues to consider when choosing or developing an instrument for a
clinical study will be discussed, including cross-cultural issues.
Participants will be asked to choose a questionnaire for a hypothetical
study and develop a questionnaire based on a patient interview. This
course is suitable for those with little or no experience with quality
of life or patient-reported outcomes measurement.
Economic Analysis
Cost Estimation:
Finding and Extracting Cost Data
Faculty:Judith A. O’Brien RN,
BSPA, Vice President, Director of Cost Development Research, Caro
Research Institute, Concord, MA, USA
Course
Description: This course will focus on practical aspects of
cost development for pharmacoeconomic studies. The objective is to help
the participant bridge the gap between understanding pharmacoeconomic
theory and the practice of developing cost estimates. Factors to
consider when costing pharmacoeconomic analyses, such as perspective,
data sources, data classification systems, developing resource use
profiles, obtaining unit costs, and making cost adjustments will be
presented. Examples of issues encountered when identifying and
extracting cost data will be discussed. This course is designed for
those with some experience with pharmacoeconomic analysis.
Clinical Assessment
Introduction to Pharmacoepidemiology
Faculty:Adrian Levy PhD,
Assistant Professor, University of British Columbia, Vancouver, BC,
Canada
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.
May 15: Afternoon Courses (1:00-5:00PM)
Quality of Life / Patient-reported Outcomes
Quality of Life /
Patient-reported Outcomes in Clinical Trials
Faculty: Bruce Crawford MA, MPH,
Senior Project Director/Manager US Operations, Mapi Values, Boston, MA,
USA, Linda Abetz MA, Research Director, Mapi Values, Bollington,
UK
Course description: Practical
methods for assessing health-related quality of life and patient
reported outcomes (PRO) in clinical trials and health services research
will be presented. Reliability, validity, responsiveness, item
reduction, missing data, data imputation, and issues of analysis and
interpretation will be discussed. New methods for development,
validation and testing cross-cultural equivalence will be presented (eg,
Rasch and structural equation modeling, simultaneous development).
This course is designed for those with either little or intermediate
experience in health-related quality-of-life assessment.
Economic Analysis
Financial Impact /
Cost of Illness
Faculty:Josephine Mauskopf PhD,
Division Director, Global Health Economics, RTI Health Solutions, RTI
International, RTP, NC, USA; C. Daniel Mullins PhD, Professor,
University of Maryland, School of Pharmacy, Baltimore, MD, USA
Course Description: This will
describe 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. Cost Estimation: Finding and Extracting
Cost Data is suggested as a prerequisite.
Clinical Assessment
Randomized Clinical Trial
And Observational/Naturalistic Study Design
Faculty: Adrian Levy PhD,
Assistant Professor, University of British Columbia, Vancouver, BC,
Canada
Course description: This course will
describe the design of randomized clinical trial and as well as
observational (naturalistic) clinical studies. Study design issues as
well as a comparison of designs will be discussed. Research problems
commonly encountered in healthcare settings as well as other issues,
such as outcomes, population, setting, time frame, will be discussed.
Examples using case studies will be presented. This course is for
those with little or no experience in outcomes or clinical research.
