Quality of life assessment in chemotherapy trials for non-small cell lung cancer: are theory and practice significantly different?

Abstract

The problems inherent in quality of life (QL) research reviewed in this report support the view that theory and practice are significantly different. Quality of life data could be collected in many non-small cell lung cancer patients, yet this happens only for a few. Well-defined and constructed QL instruments are available to measure QL, yet clinicians seem reluctant to turn the emphasis away from traditional end points of response and survival. Quality of life study design guidelines exist, yet instrument selection, timing of assessments, and sample size calculations become more difficult in clinical practice. When assessing palliation, symptoms can be quantified by QL measures and analyzed statistically, but there is no agreement regarding the definition of palliation and the clinical correlates for changes in QL scores are unknown. Quality of life data collection assumes that patients attend per protocol and that personnel are available to implement QL assessments; however, compliance is problematic in palliative patients because centers are often lacking resources to collect good quality and quantity data. Although QL data can be summarized numerically to show treatment differences, these differences may not be clear-cut and numerical scores may be of little value to clinicians in discussing treatment with patients. Despite these practical difficulties, considerable experience and expertise now exist to direct QL trials successfully and to better address the challenges that are emerging. There are huge numbers of patients with non-small cell lung cancer, and there has to be a real commitment from clinicians to ensure that the opportunity is taken to logically implement QL research and thereby improve patient care.