The assessment of QL can potentially play a key role in choosing between treatments, but to do so requires that much work has gone into the design and conduct of the QL assessment of the trial. The first key to a successful QL component is the pre-defining of a QL hypothesis which will help identify the questionnaire to use, the timepoints to administer it, and the analyses to be conducted (details on the analysis, interpretation and presentation of QL data are included in Chapter 9). The second important factor is to ensure that guidelines and infrastructure are in place to ensure good compliance. Patients need to know about the impact treatments will have on their QL, and it is important that we can supply them with reliable information.

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