Quality of life as a therapeutic end-point. An analysis of therapeutic trials in hypertension.

The term 'quality of life' is finding increasing use in the popular press and the medical community. In both areas, its use often lacks precision: a comprehensive and universal definition probably does not exist. Indeed, the precise elements contributing probably vary from person to person and from time to time. There is broad agreement that 5 major areas always need assessment, including physical and emotional state, performance of social roles, intellectual function and general feelings of well-being or life satisfaction. A wide range of instruments has been employed in a large number of studies on the effects of antihypertensive agents on quality of life in the patient with hypertension. Hypertension represents a special problem in which the patient is thought to be free of related symptoms, and treatment designed to improve natural history brings with it the burden of adverse reactions. Although some insights have been gained on the relative influence of various therapeutic regimens on the quality of life of treated patients, in many of the studies too little consideration has been given to the use of instruments that have been validated in the patient population to be studied, to the power of the study and its design, to the contribution of confounding variables such as age and gender, and to evidence that short term trials (measured in weeks) can miss important changes that occur over months in a process where treatment is life-long. For these reasons, we believe, the literature on the subject is burdened by many reports that describe no difference among treatment regimens where important differences might exist. On the positive side, important advances have been made in our understanding of the elements that contribute to quality of life and in approaches to its assessment.