Quality of life as outcome measures in randomized clinical trials. An overview of three general medical journals.

A survey of 75 randomized trials published in 1986 in the Annals of Internal Medicine, American Journal of Medicine, and New England Journal of Medicine was carried out by two observers using predetermined criteria about the importance of health status as an outcome measurement and the quality-of-health status measurement that was used. The kappa statistic was used to measure agreement among the two observers. Although a number of investigators used well-established quality-of-life measurements, in only 10 of 55 trials in which health status was judged crucial or important were measures with established validity and responsiveness used. Despite the fact that reliable measurement of quality of life is now feasible, it is underutilized in randomized clinical trials.