Table 1 Overview of the Quality of Life Special Study module sessions and associated learning outcomes

1. What is QoL and why might we wish to assess it?

• Provide definitions of the terms quality of life and health-related quality of life.

• Identify situations when the assessment of QoL may be appropriate and provide the rationale for such an assessment.

2. How can we measure QoL?

• Identify the key features of generic and disease specific instruments and the advantages/disadvantages of such measures.

3. Methodological considerations for the assessment of QoL in a clinical trial.

• Discuss how to choose an appropriate instrument(s) to assess the QoL of patients with a particular disease.

• Describe methodological issues that should be considered when assessing QoL in a clinical trial.

4. Assessing the reporting of QoL in clinical trials

• Be able to evaluate the reporting of QoL in clinical trials.

5. Use and assessment of QoL in routine clinical practice

• Explain the potential advantages and disadvantages of routine QoL assessment.

6. How is QoL used in licensing/policy making?

• Identify key issues that need to be addressed for QoL to be considered as a credible criterion in the drug regulatory process.

• Understand the different methods that are used for eliciting patient preferences.

• Define and perform simple calculations of quality adjusted life years and understand their use in cost-utility analysis.