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1 Introduction Questionnaires for assessing QoL usually contain multiple questions, although a few may attempt to rely upon a single global question such as ‘Overall, what has your quality of life been like over the last week? (very good, better than average, about average, worse than average, very bad)’. Some QoL questionnaires are designed such that all items are combined together, for example items might be averaged to produce an overall score for QoL. Most instruments, however, recognise that QoL has many dimensions and will attempt to group the items into separate scales corresponding to the different dimensions.

The QLQ-H&N35, described by Bjordal et al. (1999), is one of several modules that address additional issues (Appendix E7). This supplements the core QLQ-C30 with an additional 35 items for patients with head and neck cancer. Functional Assessment of Cancer Therapy – General (FACT-G) The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of QoL questionnaires targeting chronic illnesses. The core questionnaire, or FACT-G, was developed by Cella et al. (1993) and is a widely used cancer-specific instrument (Appendix E8).

Clearly, there are situations where such information is not relevant. For example, when evaluating a potentially curative treatment that is not very likely to have adverse side effects, or if the treatments and side effects are similar in the various study arms, it might be unnecessary to make such assessment. However, many trial groups now insist that the investigators should at least consider the QoL implications and should positively justify not including the assessment of QoL. When is QoL assessment a relevant endpoint?

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