Choosing the questionnaire

Given the decision to include QL in the trial and to collect information from patients at certain timepoints, the question arises of the best way to collect this information.

The usual answer is to use one of the standard questionnaires that have been rigorously developed and validated over the last few years.

The development of a questionnaire is complicated and time consuming. Most of the standard questionnaires cover the domains and items that will be of interest in a clinical trial and therefore in the vast majority of cases there would be no justification for embarking on the development of a new questionnaire. However, some patients may have atypical symptoms, and some new treatments may result in uncommon side effects. If it is felt important to collect such information on the QL form, then it is always more advisable to add extra questions to a standard form than to start afresh.

It is important to remember that questionnaires developed in one context may not be effective in another. The questionnaires referred to in this chapter were all developed for use in clinical trials, they were therefore not designed for the assessment of individual patients in a clinical situation, or for other objectives such as resource allocation.

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