ABSTRACT
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The objective of this chapter is to inform those engaged in clinical trials research about the special statistical issues involved in analyzing longitudinal quality of life (QOL) outcome data. Because these data are collected in trials for patients with a life-threatening disease, it is common to see a drop-off in submission rates for patient-reported questionnaire data, often due to death and deteriorating health. Data sets with such missing data must be analyzed appropriately in order not to arrive at misguided conclusions regarding change in QOL over the treatment course. Methods will be suggested for complete or near-complete datasets as well as for those where missing data are a concern.
