Health-related quality of life measurement in heart failure: challenges for the new millennium.

Health-related quality of life (HRQL), representing a patient-driven end point, has been increasingly emphasized in randomized clinical trials of new heart failure therapies. Measurement of HRQL depends on the use of validated instruments, with attention paid to the timing of administration and analysis of data in the context of conventional morbidity and mortality end points. In a review of HRQL measurement in heart failure drug trials published from 1966 to 1999, we found that important data, such as the number of participating subjects, are often lacking. HRQL is analyzed as a stand-alone end point without consideration of the underlying clinical trajectory of the disease. Improvements in trials methodology are warranted if quality-of-life data are to be meaningful in the determination of drug efficacy in heart failure.