Why the study?
Does methyldopa or isradipine improve self-structured quality of life compared to placebo in men with mild hypertension?
Does methyldopa or isradipine improve self-structured quality of life compared to placebo in men with mild hypertension?
A combined quantitative and qualitative approach to measuring quality of life reveals that patients define QOL differently than physicians, with isradipine showing benefits in self-defined domains.
Patient-defined QOL domains may capture isradipine benefits missed by standard scales; challenges reliance on prestructured measures in hypertension trials.
This study included the introduction of a new, qualitative, self-structured measure of quality of life (QOL) after meta-analysis had shown that prestructured quantitative measures yielded insignificant results. This study compared the pre- and post-treatment evaluations of 268 men with mild hypertension, aged 40 to 65 years, who were randomly allocated to three treatment groups (methyldopa, isradipine, and placebo) with that of 155 normotensive subjects. It was found that the study participants defined QOL qualitatively differently from the way it was defined by physicians. Normotensive subjects showed a better QOL status in most prestructured measures whereas the patients taking isradipine showed better results on evaluation of the current level of their self-defined domains. The combined quantitative and qualitative approach to measuring QOL may help to clarify this important aspect of medical research, both conceptually and methodologically.
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Baron et al. (1993) studied this question.
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