Assessment of the Vital Signs Quality of Life Questionnaire in three studies on hypertension.

The Vital Signs Quality of Life Questionnaire is a patient survey developed to assess the effects of treatment on 25 variables associated with a sense of well-being and perceptions of general health, mental functioning and social performance. Data collected from this questionnaire in three studies on hypertension were analysed and are presented here. In study 1, low-dose verapamil significantly reduced office and ambulatory diastolic (DBP) and systolic (SBP) blood pressure (P < 0.01) in patients with mild hypertension. In study 2, verapamil and nifedipine significantly and similarly reduced office DBP and SBP in patients with mild to moderate hypertension. In study 3, significantly greater reductions in ambulatory DBP and SBP were observed with verapamil compared with placebo (P < 0.01) in elderly patients with mild to moderate hypertension. Reported adverse experiences were not different from those known to be associated with the study drugs. There was significant improvement in the intensity of quality of life (QOL) variables (P = 0.03) and in the total (sum of frequency and intensity) QOL score (P = 0.02) following treatment in study 1. In study 2, there were no significant changes in QOL scores following treatment with either verapamil or nifedipine. In study 3, QOL scores remained statistically unchanged for both treatment groups; however, there was a trend toward improvement with verapamil and worsening with pacebo. Taken together, the data show no negative effects of verapamil on QOL, even though verapamil demonstrated significant anti-hypertensive effectiveness. The questionnaire displayed a high level reliability, as measured by Cronbach's alpha (0.91 for both frequency and intensity).