Do quality of life assessments make a difference in the evaluation of cancer treatments?

The question posed by this set of quality of life papers is whether or not quality of life assessments in cancer clinical trials help evaluate the effects of cancer treatment on patient functioning. In this discussion, missing data problems, particularly those commonly found in advanced stage disease trials, are highlighted. Researchers are encouraged to investigate the extent of bias associated with missing data and to select analysis approaches accordingly. In the worst case, it may not be possible to analyze data longitudinally; descriptive or graphical portrayals of the data may be more appropriate. The importance of instrument reliability (minimizing measurement error) is emphasized for clinical trials research, particularly with respect to enhancing a trial's ability to detect quality of life differences by treatment arm. One strategy for addressing missing data is evaluated with respect to its impact on the measurement properties of the quality of life questionnaire. Clinical trials groups have been successful in obtaining quality of life data in multi-site settings and patients, by and large, appreciate the effort to include a systematic and standardized report of the effects of treatment on their functioning.