Monika Bullinger, PhD and Ulrike Ravens-Sieberer, PhD

While quality of life research in adults has progressed substantially over the past 15 years, health-related quality of life of children has only recently been addressed. QOL research in children is important because children can be confronted with disease and treatment as patients. It is important to know how children feel and how treatment can be optimised. Also, children can suffer substantial strain from diseases in other family members. Lastly, epidemiological research has so far neglected living conditions that might be detrimental to the health-related quality of life of children; exceptions are a few studies published in the area of public health and clinical psychology.

Reflections on how to assess quality of life of children also bear on the focus of such assessment. Basically, there are three dimensions to quality of life assessment in children. 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 or of observational methods. The questionnaire method is usually favoured 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 favoured; however, the essence of quality of life assessment is the self rating method. The question of whether and at which age children are able to report on their feelings has been intensively discussed, and principally deemed realisable under the condition that an instrument corresponding to the child's abilities can be chosen.

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. Presentation will include a comprehensive literature review, demonstration of instruments as well as their computer assisted versions, and a thorough evaluation of the evidence of their use in clinical studies and patient care. Generic as well as disease-specific measures (e.g. asthma, diabetes, epilepsy, rheumatoid arthritis) will be focussed on. The material presented will profit from results of recent discussions within an international expert group, collaborating in two large EC funded projects on "Quality of Life of Children with Disabilities (DISABKIDS)" and "Assessing Health Related Quality of Life in Representative Samples of European Children (KIDSCREEN)."

Diane Fairclough, DrPH

This course will examine methods of imputation for missing QOL data in longitudinal studies. Simple imputation methods will be briefly discussed but the focus will be on multiple imputation methods such as Approximate Bayesian Bootstrap (ABB), explicit models, `closest predictor' and delta-adjustment. We will discuss the strengths and weaknesses of these methods in longitudinal studies with non-ignorable (NMAR) missing data. The workshop will include some hands-on experience with these techniques (participants are encouraged to bring a hand calculator). Participants should have some experience with the analysis of multivariate or longitudinal data.

Francis Guilleme, MD, PhD

Workshop Outline
1. Presentation of the topic
2. Identification of native English and Non English speaking participants
3. Separation in sub-groups (as many as needed with maximum 10 people per group mixing English and Non English members at least 2 sub-groups)

Training phase 1:
Each group gets a set of source items (sampled from a variety of HRQL questionnaires: 2 sets are prepared in advance)
Non English group members translate in their own language: firstly without communication with English members, secondly with communication

Training phase 2:
1. Plenary presentation of the problems encountered will be helpful to highlight difficulties at the translation step
2. Specific problems to back-translation step will be pointed out
3. Guidelines will be presented and discussed with participants

Dennis Revicki, PhD, Mary Kay Margolis, MHA, MPH and Les Lenart, MD

This workshop provides an introduction to the theory and the direct and indirect methods of health state preference and utility assessment. It includes a basic overview of the rating scale, standard gamble, time trade-off, and multi-attribute techniques. The presentation includes a discussion of important issues associated with developing health state preference/utility measures and selecting a scaling method. We will introduce and summarize critical issues associated with preference/utility measurement including population effects, contextual effects, cognitive processing, and beliefs and attitudes. Examples will be provided of several techniques for measuring preferences/utilities. A computerized standard gamble exercise will be completed and compared to alternative methods of measuring preferences/utilities.

After completing this workshop, participants will be able to:
1. Understand the basic principles of preference/utility measurement
2. Identify frequently used methods for measuring preferences/utilities
3. Understand the strengths and limitations of preference/utility measures in evaluating health outcomes

Marianne Sullivan, PhD and Lars-Olaf Persson, PhD

Interpreting HRQL results from clinical studies is oftentimes perplexing and complex. Patient groups with severe and/or chronic conditions often do not report worse health status than healthy respondents and clinically effective treatments/ interventions frequently do not improve HRQL, particularly mental and psychological health status. Such seemingly counterintuitive results lead clinicians to either question the reliability of patient reports, the validity and/or responsiveness of the HRQL instruments used, or the value of the interventions performed. Or are there other ways to explain the results?

• Can we believe the patients?
  
• To what extent are patient reports related to behavioural and/ or clinical data?
  
• Can we integrate patient-based information in medical decision-making?
  

We will provide illustrative research examples and interpret the results from a psychological point of view. In particular, we will discuss the role of personality traits, coping and illusionary thinking in HRQL ratings. We will also challenge the traditional view that treatments improving lab tests and other surrogate measures must also benefit the patient's HRQL. A recent evidence-based review will be presented where HRQL was for the first time used as one of four primary outcome measures.

Objectives

• Introduction to psychological interpretation models that may help in understanding HRQL results;
• Concrete examples from studies illustrating the phenomena discussed;
• Arguments for integrating patient-based information in medical decision-making.

Hanne Thorsen, PhD

In recent years there have been major advances in methods for gathering questionnaire content designed to assess some form of subjective health status, for example, the use of face-to-face interviews with representatives of patient groups and focus groups. However, there has been a decline in the amount of attention paid to the more detailed aspects of questionnaire design such as the instructions to respondents, the format, layout and wording of items and interpretation of items by different groups. Also the choice of user friendly response options seems to be a topic which is seldom discussed. All of these can have profound effects on responses and missing data. It is suggested that too much emphasis has been placed upon quantitative methods for the establishment of validity and not enough on qualitative work with individuals.

The emphasis of the workshop will be on ensuring "respondent friendliness'" of questionnaires, an issue that is often neglected. The participants will be asked to complete several pre-existing questionnaires.

Based on this exercise the following topics will be raised and discussed after short introductions by the lecturer and some other members of the EQUAL group.

• General introduction to technical aspects of questionnaire developments:
• Generation of items from different sources;
• Interpretation of questionnaire items;
• The influence of the title of a questionnaire on respondents willingness to complete;
• Questionnaire layout & appearance; effects on responding;
• Layout of response option(s) and ease of completion;
• Advantages and disadvantages of different kinds of response options.

John Ware, Jr., PhD, Jakob Bjorner, MD, PhD and Mark Kosinski MS

This workshop covers advances in methods for monitoring health outcomes based on item response theory, the logic of computerized dynamic methods of data collection and processing, and the connectivity made possible by the Internet. The advantages of scoring health status on a standard metric, regardless of assessment method, will be demonstrated across different applications, including: (a) population health monitoring; (b) clinical trials and outcomes research; and (c) screening and monitoring individual patients in everyday clinical practice.