Quality of life research in cancer clinical trials: a need for common rules and language.

Abstract

While increasing attention is being paid to the feasibility of incorporating quality of life investigations into cancer clinical trials, and QOL data have played a prominent role in some recent trials, such studies remain the exception rather than the rule. This paper addresses a number of measurement, research design, and implementation issues surrounding clinical-trial-based quality of life studies. These include: the appropriate source of quality of life data; global versus multidimensional approaches to conceptualizing quality of life; the feasibility and desirability of a quality of life measurement "gold standard;" generic versus disease-specific measures; the role of psychometrics in selecting quality of life measures; the frequency and timing of data collection; and patient accrual and differential loss to follow-up. Where appropriate, areas of real or potential consensus on the methods of conducting quality of life investigations are highlighted.