ISOQOL Morning Workshops
October 11, 20062. Methods for Cross-Cultural Development, Translation/ Adaptation, and Evaluation of Health Outcomes Measures
Sonya L. Eremenco, CORE (Center on Outcomes, Research and Education), Evanston Northwestern Healthcare, Evanston, IL, Ramona Lucas, Institut Catalā de l´Envelliment, Barcelona, Spain
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 incorporate an awareness of cross-cultural issues prior to beginning translation work. This workshop will cover: 1) cross-cultural instrument development including a comparison of sequential, parallel, and simultaneous approaches; 2) instrument translation and adaptation methodologies; 3) assessment of cross-cultural equivalence during the translation process; 4) use of qualitative evaluation methods such as cognitive interviewing techniques to assess linguistic validity and evaluate translations and cross-cultural equivalence. In addition, we will present the decentered model to modify 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 instruments including health status assessments, quality of life instruments, and other patient reported outcomes. Workshop structure includes Q&A and interactive exercises on translation methodology and cognitive interviewing.
Level: Basic
3. Interpreting Utility (Preference-Based) Measures of Health-Related Quality of Life
David H. Feeny, Institute of Health Economics, Institute of Health Economics, Edmonton, AB, Canada, George W. Torrance, Innovus Research Inc., Innovus Research Inc., Toronto, ON, Canada
The Workshop will be at an Advanced level, focusing on the interpretation of utility scores from direct and multi-attribute (indirect) approaches to measurement. The direct approaches will include the visual analogue scale,time tradeoff, and standard gamble. Major multi-attribute utility measures will include EQ-5D, Health Utilities Index (HUI), and Short-Form 6D. In addition, recent work on disease-specific utility instruments will be presented. The Workshop will include hands on experience in the direct assessment of utility scores, completing questionnaires from several systems, and analyzing and interpreting the results. The interpretation of scores will be considered in the context of comparing groups at a point in time as well as comparing within-person change over time. Applications will be drawn from diverse settings including osteoarthritis of the knee, multiple sclerosis, total hip arthroplasty, and acute lymphoblastic leukemia. Evidence on clinically important differences will be discussed. Attendees should, at a minimum, have a basic knowledge of the conceptual foundations and practical approaches of the utility approach to assessing health-related quality of life. Outline I. Introduction and Brief Review II. Demonstration of Administration of Selected Measures III Making Inferences about Clinically Important Differences/Changes in Utility Scores from Multi-Attribute Scoring Functions IV Comparing Utility Scores Among Groups at a Point in Time V Assessing Changes in Utility Scores over Time VI Disease-Specific Utility Measures VII Present and Discuss Results from Demonstration of Administration of Selected Measures VIII Summary and Synthesis of Evidence on Interpretation and Clinically Important Differences/Changes
Level: Advanced
4. Applications of Item Response Theory Modeling for Improving Health Outcomes Measurement
Bryce B. Reeve, Outcomes Research Branch, National Cancer Institute, Bethesda, MD, Chih-Hung Chang, Feinberg School of Medicine, Northwestern University, Chicago, IL
There is a great need in health outcomes research to develop instruments that accurately measure a person's health status with minimal response burden. This need for psychometrically sound and clinically meaningful measures calls for better analytical tools beyond the methods available from traditional measurement theory. Applications of item response theory (IRT) modeling have increased considerably because of its utility for instrument development and evaluation, assessment of measurement equivalence, instrument linking, and computerized adaptive testing. IRT models the relationship, in probabilistic terms, between a person's response to a survey question and their standing on a health construct such as fatigue or depression. This information allows instrument developers to develop reliable and efficient quality of life measures tailored for an individual or group. This introductory workshop will discuss the basics of IRT models and applications of these models to improve health outcomes measurement. Illustrations will be used throughout the presentation that focuses on measuring key health-related quality of life domains in different disease populations.
Level: Basic
5. Pediatric HRQL Assessment in Research and Clinical Practice
Monika Bullinger, PhD., Corinna Petersen, PhD, Institute for Medical Psychology, Hamburg University Medical School, Hamburg, Germany
Health-related quality of life of children is increasingly addressed in pediatric research and practice. QOL research in children is important especially for chronically ill children who are confronted with disease and treatment as patients - as are their families. It is important to know how children feel in order to monitor and optimize treatment. However, the question of at which age children are able to report on their feelings has still is intensively discussed, as is the role of self report compared to proxy report and the choice of measures.
As concerns quality of life assessment in children, three dimensions of quality of life measurement can be distinguished. The first concerns the specificity of assessment intended. Disease specific assessments aim at substantial and comprehensive analyses of the health-related quality of life of children suffering from specific chronic conditions. In contrast, generic assessment focuses on relevant aspects of children's perceived health independent of the actual medical condition of the child. A second dimension concerns the type of assessment intended, i.e. the use of questionnaires or interviews, of observational methods or computer assisted programs. The questionnaire method is usually favored for the economy of its use, as well as the psychometric quality criteria, which include reliability, validity and sensitivity. Finally, and most critically, is the dimension of who assesses the quality of life of children. In general, expert ratings, that is external observation of children's quality of life, have been favored; however, the essence of quality of life assessment is the self rating method.
This workshop reviews the state of the art of quality of life assessment in children/adolescents as it relates to the underlying concepts, the instruments available, and application in research and practice. An overview over generic as well as a deeper insight into the construction and performance of disease-specific measures will be given. Experiences - also from large multinational research networks- in assessing health related quality of life in conditions such as asthma, diabetes, epilepsy, rheumatoid arthritis, cystic fibrosis, atopic dermatitis, hemophilia , cerebral palsy and brain injury will be shared.
The presentation will include a demonstration of instruments, a discussion over instrument development the practical use of such instruments, and a thorough evaluation of the evidence of their use in clinical studies and patient care. Special attention will be given to cross-cultural testing and performance of these measures (eg. from the DISABKIDS project). The goal is to familiarize attendees with the current state of the art in pediatric QoL assessment, also as a help in choosing appropriate measures in research and clinical contexts. The level of the course is basic.
Level: Basic
6. Introduction to the analysis of longitudinal studies of HRQOL studies
Diane Fairclough DrPH
This course will provide an introduction to the analysis of longitudinal studies in which missing data can be considered ignorable or missing at random (MAR). We will describe strategies for distinguishing between repeated measures models and growth curve models. Examples will be given for building and testing hypotheses for both simple and complex models including strategies for inclusion of time-varying covariates and interaction. We will discuss useful covariance structures and their interpretation. Finally we will discuss the concepts of moderation and mediation, and how to construct the appropriate models and tests. Handouts will include all slides and SAS code for examples. The workshop will include discussion (20% of time) and hands-on experience with selected techniques (20% of time).
After completing this workshop, participants will be able to:
- Choose between a repeated measures and growth curve model for the analysis of longitudinal data
- Build models and construct hypothesis tests for both simple an complex models
- Distinguish the concepts of moderation and mediations, set up the appropriate models for these concepts.
Level: Basic
7. Specifying Patient-Reported Outcome Measures for Complex Interventions: A Framework to Ensure the Right Outcomes are Assessed at the Right Time
Richard H. Osborne, Centre for Rheumatic Diseases, Medicine (RMH/WH), University of Melbourne, Melbourne, Victoria, Australia
The choice of the right measures to capture intended and unintended effects of interventions can be difficult for researchers and evaluators alike. With the plethora of measures available and the wide range of possible intended impacts of interventions, including immediate and long term effects, a framework to support measure specification is warranted. This workshop will use chronic disease self-management and education programs as a working example of a complex intervention. These are typically group-based, run for 2.5 hours over 6 weeks and are thought to have a very wide range of immediate impacts (eg, education/knowledge), intermediate impacts (eg, empowerment, life quality) and longer term impacts (eg, use of health services, reduction of symptoms/mortality). Evaluation of these interventions is complex. Some of the issues that can confound measurement in this setting include; " Poor specification of the objective of the initiative leading to poor specification of outcome measures. " Through involvement in a program, participants can develop a better understanding of their health and relevant self-management outcomes and the meaning of questionnaire items. " Social comparison, which may attenuate participants perceptions of disease severity. " Response shift, identified in a substantial number of individuals. " Halo effects, where participants develop a bond with the course leader/peers. " Varying levels of self-management proficiency amongst participants - some may already be knowledgeable and empowered, whereas others may have a greater capacity to benefit and receive large gains through participation. The communication of outcomes using averages or proportion of responders is therefore an important issue. The workshop will include insights derived from the HEI-Q (Health Education Impact Questionnaire with 42 items and 8 independent scales) which has been applied to 75+ organisations and 2000+ individuals. The HEI-Q was designed in partnership with consumers, leaders, physicians, funders and policymakers (Federal, State and Veteran agencies). It has been designed to overcome some of the measurement difficulties above. Participants are strongly encouraged to bring their own project to the workshop for the framework to be actively applied.
Level: Basic
8. The Language of Quality of Life Assessment: The Stroke and Alzheimer's Patient
Ivan Barofsky, The Quality of Life Institute, East Sandwich, MA
1). Participants will practice disaggregating items (both English and non-English items) from standard quality of life assessments into literal and figurative components (including various figurative forms; analogies, similes, and metaphors). 2). Become knowledgeable concerning the research literature dealing with changes in literal and figurative expression for persons with stroke or Alzheimers disease. Participate in a discussion about whether responses by stroke and Alzheimers patients have the same meaning as responses by normal controls. 3) Design quality of life studies so that they take advantage of changes in neurocognitive processes (e.g., dynamics of literal or figurative language expression, dual processing) following a stroke or Alzheimers disease to determine if responses by these patients have the same meaning as responses by normal controls. 4). Apply the literal/figurative distinction to translated items.
Level: Basic