This study was undertaken to construct a health-related quality-of-life (QO
L) questionnaire for hypertensive patients from preexisting instruments and
to validate its use in full form and in a shortened version. Two hundred s
eventy hypertensive patients who were stable while taking antihypertensive
medication (control group), changing medication because of side effects, or
newly treated for hypertension were enrolled in a prospective, observation
al, longitudinal study. At baseline and at months 1, 2, and 3, patients com
pleted a questionnaire covering 7 domains of QOL. The criteria for evaluati
ng the scales were internal consistency, test-retest reliability, construct
validity, and responsiveness to change. Data were analyzed for the full qu
estionnaire and the shortened version. Internal consistency and test-retest
correlation values were 0.69 to 0.95 for scales in the full questionnaire
and 0.57 to 0.92 in the shortened version. Construct validity was supported
by statistically significant, positive correlations with a global QOL item
for all but 1 scale in both versions. Responsiveness to change was support
ed by increases in scores between baseline and month 3 for all scales in pa
tients changing their medication because of side effects; scores remained u
nchanged (on all but 1 scale) in the stable (control) group. By uniformly a
pplying standard validation criteria to a set of preexisting instruments, w
e created a new QOL questionnaire. Results were similar in both the full fo
rm and shortened version.