Table 1.

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

Session	Key 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.