Sample sizes for randomized trials measuring quality of life in cancer patients.

This paper describes the methods appropriate for calculating sample sizes for clinical trials assessing quality of life (QOL). An example from a randomized trial of patients with small cell lung cancer completing the Hospital Anxiety and Depression Scale (HADS) is used for illustration. Sample size estimates calculated assuming that the data are either of the Normal form or binary are compared to estimates derived using an ordered categorical approach. In our example, since the data are very skewed, the Normal and binary approaches are shown to be unsatisfactory: binary methods may lead to substantial over estimates of sample size and Normal methods take no account of the asymmetric nature of the distribution. When summarizing normative data for QOL scores the frequency distributions should always be given so that one can assess if non-parametric methods should be used for sample size calculations and analysis. Further work is needed to discover what changes in QOL scores represent clinical importance for health technology interventions.