11th Annual Conference of the
International Society for Quality of Life Research
October 16 - 19, 2004 ~ Hong Kong
The Hong Kong Academy of Medicine
Hong Kong Special Administrative Region
People's Republic of China
Co-organized by the Hospital Authority of Hong Kong
http://www.ha.org.hk

Harmonizing International Health-Related Quality of Life (HRQOL) Research

Workshop Titles and Descriptions

All workshops are being held on Saturday, October 16 and
will be 3 hours in duration.

Saturday, October 16
Morning Workshops: 9:30 am - 12:30 pm

Workshop #1
QUALITY OF LIFE ASSESSMENT: INTRODUCTION AND OVERVIEW
Sharon Wood Dauphinee, PhD, PT, McGill University, Montreal, PQ, Canada

In this introductory workshop the following topics will be presented: conceptualization of the quality of life (QOL) and health related quality of life (HRQL) constructs; why, when, how, and by whom should these constructs be assessed, classification of HRQL measures, modes of administering the measures, criteria for selecting HRQL measures for clinical practice and research, the relationship between study design and HRQL information, and issues related to analysis, interpretation and culture in HRQL studies.
A generic measure and a disease-specific measure will be completed by attendees using a simulated case history.
Level-Introductory

Workshop #2
ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN PHARMACEUTICAL DRUG DEVELOPMENT PROGRAM – AN INTRODUCTION
Wayne Weng, PhD, Novo Nordisk Pharmaceuticals, Inc., New Jersey, USA, Benny Zee, PhD, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

This workshop will provide an introduction to the assessment of HRQOL in a pharmaceutical drug development program. It will cover a broad range of practical issues about HRQOL evaluation in a pharmaceutical drug development process.

This workshop will discuss whether HRQOL is an important component to be included in the pharmaceutical drug development program. If it is important, at what stage should we start preparation of the HRQOL evaluation? This workshop will provide an overview of HRQOL evaluation in a clinical study, including the choice of a HRQOL instrument, the objective of HRQOL evaluation, the key components that should be included in a study protocol, and logistic issues on the actual HRQOL assessment. In addition, we will point out practical strategies for the implementation of HRQOL evaluations in a clinical trial to increase compliance and the chances of drawing useful conclusion.
Sample size and power considerations as well as statistical methods for analyzing HRQOL data will be reviewed, and illustrated with clinical examples.
By the completion of the workshop, the participants should be familiar with HRQOL assessment in a pharmaceutical drug development program and feel comfortable in applying them to their own situations.
Level – Introductory

Workshop #3
INTERPRETATION AND USES OF HEALTH-RELATED QUALITY OF LIFE (HRQOL) SCORES IN CLINICAL PRACTICE
David Osoba, MD, West Vancouver, BC, Canada, Madeleine King, PhD, Centre for Health Economics, Research & Evaluation, University of Technology, Sydney, NSW, Australia

This workshop will provide an introduction to the interpretation and use of health-related quality of life (HRQOL) measures and results in clinical research and practice. Co-presented by a clinician and a statistician, it will cover a broad range of issues in a very practical way with an emphasis on clinical contexts, issues and relevance.
The clinician's concern is with finding clinical meaning in HRQOL score differences both between and within groups as well as for individuals over time. Such meaning is of importance to patients and health care professionals for making medical decisions about therapy and medical management. Yet, interpreting the clinical significance of effects observed on HRQOL scales is problematic because their units of measurement are unfamiliar to clinical researchers, practicing clinicians and other health care professionals involved in the direct care of patients.
The statistician's concern is with drawing valid inferences from group-based results, which requires understanding and differentiating statistical significance and clinical importance. Related issues of effect size, sample size, power and probabilistic error rates (types I and II) will be presented in this workshop.
Clinicians are faced with translating group-based data into potential benefit for the individual. This workshop will review, critique and compare some of the methods that are helpful to the clinician. It will draw heavily on experience from clinical trials in a variety of clinical settings, ranging from primary prevention, secondary prevention, curative treatment, and palliative therapy through to palliative care.
At the completion of the workshop, the participant should be familiar enough with these approaches to feel comfortable with interpreting the data presented in HRQOL literature and applying it to clinical situations.
Level-Introductory

Workshop #4
CROSS-CULTURAL TRANSLATION AND ADAPTATION OF HRQOL MEASURES
Cindy L. Lam, FRCGP, Family Medicine Unit, The University of Hong Kong, Hong Kong SAR, China, Bing-Li Ting, Project Manager, Health Research Asia, Singapore, Singapore, Mona L. Martin, RN, MPA, Director, Health Research Associates, Inc., Seattle, WA

The workshop will provide an overview of concepts such as linguistic equivalence, validity, and the purpose of standardized methods for developing and testing cross-cultural versions of HRQOL measures. We will review the commonly used methods and discuss the usual empirical testing of a translation. Examples will be provided from actual projects that the workshop speakers have carried out previously. The participants will be invited to take part in exercises during the workshop to give them opportunity to apply the concepts and experience issues that arise from various steps in the cross-cultural process. Special emphasis will be given to additional problems arise in the adaptation of English measures into Asian languages. We hope to make this an interactive workshop with at least 50% of the time devoted to exercises, questions and answers. At the completion of the workshop, the participant should be familiar enough with the concepts and methods to appropriately carry out the standardized steps of the translation or adaptation of a simple HRQOL measure.
Level-Introductory

Workshop #5
UTILITY APPROACH TO THE ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE
David Feeny, PhD, Institute of Health Economics, Edmonton, AB, Canada, George W. Torrance, PhD,
Vice President, Scientific Affairs, Innovus Research Inc., Burlington, ON, Canada

The Workshop will be an Introductory level presentation on the utility approach to assessing health-related quality of life. Topics will include the conceptual foundations, practical methods for the direct elicitation of preference scores (visual analogue scale [Feeling Thermometer], time tradeoff, and standard gamble), multi-attribute approaches (EuroQol EQ-5D, Health Utilities Index [HUI], Short-Form 6D, and Quality of Well-Being Scale [QWB]), a review of evidence on reliability, validity, responsiveness, and the interpretation of utility scores, and examples of applications. The Workshop will include hands on experience in the direct assessment of utility scores and in completing questionnaires from several systems and the analysis and interpretation of the results. Applications will be drawn from diverse settings including osteoarthritis of the knee, multiple sclerosis, total hip arthroplasty, acute lymphoblastic leukemia, rehabilitation, and population health. Guidance on criteria for selecting a utility measure for a study will also be provided. The session will include interactive demonstrations and discussion and didactic presentations.
Level-Introductory

Workshop #6
APPLICATION OF DISCRETE CHOICE EXPERIMENTS TO MEASUREMENT AND VALUATION OF HEALTH OUTCOMES
Jane P. Hall, PhD, Centre for Health Economics Research and Evaluation, Jordan J. Louviere, CHERE and Marketing, Rosalie C. Viney, CHERE, University of Technology, Sydney, Broadway, NSW, Australia

Discrete choice experiment methods can be applied to the design of quality of life measurement tools and the analysis of quality of life data, and represent a potential alternative to the conventional methods of standard gamble and time trade-off to elicitation of utility weights for use in economic evaluation. However, the application of the methods in this area is complex. There is increasing interest in health services research in the use of discrete choice experiments to understand consumers choices about health and health care, and to infer valuations of different health outcomes. Typically in discrete choice experiments, each respondent is presented with a series of hypothetical choice sets and asked to choose the preferred alternative. Alternatives are described in terms of a set of underlying attributes. As the number of choice sets formed by the combination of attributes at different levels is potentially very large, experimental design methods are used to develop a manageable number of choice sets, and statistical models are used to determine the contribution of each attribute to preferences. In health economics, the main area of application in health so far, applications have tended to rely on small fractional factorial designs, with questionable statistical properties. This workshop will provide an introduction to the principles of experimental design, and apply these principles in the area of measurement and valuation of health outcomes.
Level – Introductory

Workshop #7
THE INTERNATIONAL CLASSIFICATION OF FUNCTION DISABILITY AND HEALTH (ICF) AND ITS APPLICATION IN CLINICAL PRACTICE AND RESEARCH
Gerold Stucki, MS, Physical Rehabilitation and Medicine Clinic/Outpatient Clinic, Clinic of the University of Munich, Munich, Germany, Alarcos Cieza, MD, University of Munich, Munich, Germany, Leonard Li and Nancy Mayo, PhD, McGill University, Royal Victoria Hospital, Montreal, ON, Canada

With the approval of the new International Classification of Functioning, Disability and Health (ICF) by the World Health Assembly in May 2001, all WHO member states are now being requested to implement the ICF in the health sector. Besides health, the WHO promotes the use of the ICF in education, insurance, labor, health and disability policy, and health statistics. The aim of this workshop is to introduce the contents and structure of the ICF, as well as the bio-psycho-social model, which is the basis of the classification. The ICF Core Sets – tools to implement the ICF in clinical practice and research – will be presented in detail. The development process of the ICF Core Sets will be presented on the basis of an exercise in which the participants will have the opportunity to actively implement the ICF. Since Health Related Quality of Life (HRQoL)- and ICF-based approaches will often be used concurrently in clinical practice, research, and health reporting, it is essential for clinicians and researchers to understand the relationship between HRQOL instruments and the ICF. The process of linking HRQoL instruments to the ICF, which makes possible the content comparisons among instruments, will be introduced in detail. The usefulness of such a linkage process in identifying the best measures to most efficiently cover the required categories of functioning in studies will also be discussed. At the completion of the workshop, all participating clinicians or researchers should be familiar with the different components and structure of the ICF, the process of implementing the ICF in clinical practice and research, and the relationship between HRQoL measures and the ICF.
Level-Introductory

Saturday, October 16
Afternoon Workshops: 1:30 - 4:30 pm

Workshop #8
DESIGN AND ANALYSIS OF STUDIES OF HEALTH-RELATED QUALITY OF LIFE
Diane L. Fairclough, DrPH, Preventive Medicine and Biometry, University of Colorado Health Sciences Center, Denver, CO

Assessment of health-related quality of life (HRQOL) is being incorporated into clinical trials with increasing frequency. This workshop is intended to answer the following questions: What are the similarities and differences between HRQOL and other traditional clinical trial endpoints? What are the specific issues in the design, conduct, analysis and reporting of studies with HRQOL assessment? Specifically, we will address the need for clear definition of goals and objectives, methods for multidimensional data, and strategies for avoiding/handling dropout. The course will include illustrations of specific concepts using data from two trials: one with a life-threatening disease and the second with a chronic condition. Students will be expected to participate by suggesting solutions to hypothetical situations designed to illustrate the concepts. Handouts will include a copy of the presentation and a reference list for additional study. After completing this workshop, participants will be able to: 1. Participate in the development of studies incorporating HRQOL assessments. 2. Develop well-defined goals and objectives for studies incorporating HRQOL. 3. Discuss the advantages and disadvantages of a number of strategies for handling multiple endpoints and missing data. The participants are expected to be familiar with basic issues of the design and analysis of clinical trials such as hypothesis testing, Type I and II error, and introductory statistical methods including t-tests and regression models. Participants are not expected to have advanced training in statistics.
Level-Introductory

Workshop #9
CROSS-CULTURAL EXPERIENCE OF SYMPTOM MEASURMENT: METHOD AND UTILIZATION IN CANCER PATIENTS
Charles S. Cleeland, PhD, Symptom Research, University of Texas MD Anderson Cancer Center, Houston, TX, Andrei A. Novik, MD, PhD,FRCP (Glasg), Hematology Oncology, Pirogov National Medical Surgical Center, Moscow, Russia, Xin S. Wang, MD, Symptom Research, UT MD Anderson Cancer Center, Houston, TX, Tatyana I. Ionova, PhD, Quality of Life, Multinational Center of Quality of Life Research, St. Petersburg, Russia

Cancer patients exhibit pronounced symptom burden and impairment of HRQL caused by disease and by treatment-related symptoms. Better symptom control can produce significant improvement in HRQoL. Effective control is possible if symptoms are assessed with instruments that can adequately evaluate their prevalence and severity. Implementation of symptom assessment in routine cancer practice is a first step toward improving quality of care for advanced cancer patients. Many trials and clinical studies are now done in multiple countries, making it critical to develop symptom measures in multiple languages, and to evaluate their equivalence. These measures can also improve the implementation of symptom control guidelines in many countries. 1)Discuss current progress in symptom research; 2)Review principles that guided the development of the Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI) and M. D. Anderson Symptom Inventory (MDASI); 3)Present results of HRQL and symptom assessment in the United States, Russia, China, Japan; and 4)Discuss cross-cultural issues in symptom assessment. Outline of this workshop: 1)Symptom assessment: background, methods and tools-BPI, BFI, MDASI. 2)Psychometric properties: cross-cultural data 3)Quality-of-life impairment in advanced cancer. 4) Quality of life in advanced cancer as compared to population norms. 5)Comparative analysis of symptom prevalence and severity in hematologic malignancies and solid tumors. 6)Application to clinical practice.
Level-Introductory

Workshop #10
OBATINING HEALTH STATE UTILITY VALUES IN PRACTICE
John E. Brazier, PhD, Sheffield Health Economics Group, The University of Sheffield, Sheffield, Yorkshire, UK

This workshop is concerned with the use of measures of health related quality of life (HRQoL) in economic evaluation, including their use in deriving the health state utility values as required to calculate Quality Adjusted Quality Life Years (QALYs). The workshop is designed to provide a practical introduction to the problems and issues around the topic. It assumes a basic knowledge HRQoL measurement and preference-elicitation techniques (such as standard gamble and time trade-off). Students unfamiliar with the latter are recommended attending the ISOQOL workshop introducing Health State Preference/Utility Assessment. There will be four brief presentations: 1. The limitations of using HRQoL measure in economic evaluation 2. Methods for adapting non-preference-based measures for use in economic evaluation, including arbitrary weighting, mapping QoL measures onto preference based measures and estimating preference-based measures of health from QoL measures (with the SF-6D as a case study) 3. A review of existing preference-based measures (e.g. HUI-III, EQ-5D and SF-6D) Organization of workshop: 50% will be composed of these four brief presentations on each of these topics, 35% on a small group exercise addressing the appropriateness of different methods for obtaining health state utility values in different contexts and 15% Q&A (though questions are welcomed throughout).
Level-Introductory

Workshop #11
EVALUATING CHANGE IN HEALTH-RELATED QUALITY OF LIFE MEASURES
Kathleen W. Wyrwich, PhD, Research Methodology and Health Services Research, Saint Louis University, St. Louis, Missouri

Although numerous measures have been developed for the evaluation of health related quality of life (HRQoL), strategies for identifying meaningful intra-individual and group change in these measures have not kept pace with instrument development. As a result, clinical trial researchers, quality assurance assessment teams, practicing clinicians, and patients are without established standards to evaluate change in HRQoL measures. This course will review, critique and compare the methods that have been applied to establish intra-individual and group HRQoL change standards, which include anchor- and distribution-based techniques. Practical approaches to improving and advancing HRQoL change evaluations that enhance the interpretation of intra-individual and group change, as well as a review of controversies that have developed will be provided. In addition, the course will explore future qualitative and quantitative challenges in this area of HRQoL research. The workshop outline includes: 1. Who are the stakeholders in HRQoL change evaluations?; 2. Review and critique of evaluation methods to date (Anchor-based and Distribution-based); 3. Relationships between evaluation methods; 4. Controversies associated with these methods; 5. Practical approaches; 6. Challenges ahead; and 7. Additional questions and discussion. The workshop will be divided between 70% lecture, 15% class exercises, and 15% discussion and answer periods. Participants are strongly encourages to bring a hand calculator.
Level-Advanced

Workshop #12
METHODS FOR CROSS-CULTURAL DEVELOPMENT, TRANSLATION/ ADAPTATION, AND EVALUATION OF HEALTH OUTCOMES MEASURES
Sonya Eremenco, MA, FACIT Multilingual Translations Project, Benjamin Arnold, BA, CORE, Evanston Northwestern Healthcare, Evanston, IL

Cross-cultural translation of existing instruments has become an essential component of research methodology in preparation for multinational clinical trials. However, to improve cross-cultural equivalence, it is important to consider the process by which an instrument was initially developed prior to any translation work. This workshop will cover: 1) criteria for instrument selection; 2) the basics of instrument development including a comparison of sequential, parallel, and simultaneous approaches; 3) instrument translation and adaptation methodologies; 4) types of cross-cultural equivalence to assess; 5) use of qualitative evaluation methods such as cognitive interviewing techniques to assess linguistic validity; and 6) an overview of quantitative methods used to evaluate translations and cross-cultural equivalence. In addition, we will present the decentered model to refine the original instrument to improve measurement equivalence. Decentering, a method in which the source document is refined based on information gained from the translation/adaptation process, can be an important mechanism for ensuring that the source document in particular is modified to reflect what its translations have incorporated. We will also present strategies to employ when modification of the original instrument is not feasible. A decentered model is recommended to achieve equivalence between language versions of a questionnaire and further refine its original version. This important component of the methodology can ultimately offer better measurement opportunities for future outcomes measures including health status assessments, quality of life instruments, and utilities.
Level-Introductory

Workshop #13
COMPUTERIZED DYNAMIC ASSESSMENT OF HEALTH-RELATED OF QUALITY OF LIFE
John E. Ware, Jr., PhD, CEO & Chief Science Officer, QualityMetric, Inc., Lincoln, RI, Jakob B. Bjorner, MD, PhD, Deputy Chief Science Officer, QualityMetric, Inc., Lincoln, RI, and Mark Kosinski, MA, Senior Scientist. QualityMetric Inc., Lincoln, RI

This workshop begins with an overview of trends in the standardization of health metrics and how different methods are more or less useful in meeting the distinct requirements of population surveys, clinical trials and individual patient assessments. Applications of item response theory (IRT) focusing on the measurement of generic and disease-specific health-related quality of life outcomes are used to illustrate the overall analytic approach recommended by the faculty and how IRT differs from the “classical” psychometric approach. Methods and results from specific analyses and software packages used at each step in applying IRT are presented to illustrate item trace line exploration (Testgraf software), the factor analysis of categorical data to test for multidimensionality (Mplus software), Rasch item response model estimation (OPLM software), and IRT modeling (Parscale software). The logic of computerized adaptive testing (CAT) applied to dynamic health assessment (DYNHA software) is also be illustrated. The use of IRT in the cross-calibration of widely-used measures, enabling comparisons of results, is also explained. The goals are to explain the advantages of administering items using CAT. Both “real data simulations” and evaluations of actual CAT administrations will be demonstrated. Other advanced topics covered include: (a) how item and test “information functions” at specific scale levels are used by CAT for individual patients throughout the score range; (b) how IRT and CAT can be used to develop better “static” measures; (c) strategies for using IRT models for missing date estimation; and, (d) demonstrations of practical implications of CAT for purposes of reducing respondent burden and achieving the score precision necessary for monitoring individual patient health outcomes.
Level-Advanced

Workshop #14
THE RASCH MODEL OF ITEM RESPONSE THEORY: ADVANCED COURSE
David Andrich, PhD. Professor, School of Education, Murdoch University, Murdoch, Western Australia, Alan Tennant, PhD, Professor, Department of Rehabilitation Studies, University of Leeds, Leeds, UK

Modern item response theory, and in particular Rasch models, have had an accelerated application in studies of health status and quality of life. One of the main themes in these studies is assessing the validity of the construct while at the same time making comparisons across countries. In making comparisons valid, it is necessary to establish some kind of invariance across countries of the operation of items that make up the scales. The Rasch models have particular advantages in establishing such invariance as it is an integral property of the models, and the question becomes an empirical one as to whether or not data fit the chosen Rasch model with respect to this criterion of invariance. In this advanced workshop on Rasch models, the theme is the study of differential item functioning (DIF) and the understanding of DIF from the perspective of the Item Characteristic Curve (ICC). The idea of qualitative targetting in selecting items that are relevent for some countries and not others will be studied as a parallel to quantitative targetting where items with a high or low location on a trait are given only to persons who also have a correspondingly high and low locations on a trait. The detection of DIF across countries and across the trait is carried out in a unified way and in a single analysis. Interactive up-to-date software (RUMM2020) will be used in the workshop, and participants are encouraged to bring their own data sets that can be used in illustrative analyses in the workshop.
Level-Advanced