Interpreting quality-of-life clinical trial data for use in the clinical practice of antihypertensive therapy.

The use of quality-of-life indices in therapeutic trials is gaining recognition as important outcome variables for evaluating the total impact of antihypertensive therapy. While the statistical significance of treatment differentials in quality-of-life indices has been well documented, their clinical relevance still remains unclear. The interpretation of clinical trial quality-of-life treatment differentials depends on a clear understanding of the normal variability in the index due to changes in day-to-day living and the relationship between the size of the differential and shifts in population responses. Using the results from a large-scale randomized clinical trial on quality of life and antihypertensive therapy, a rationale for the interpretation of clinical trial results for use by the practicing clinician is presented.