Example from the literature

Testa et al. (1993) describe an RCT evaluating hypertensive therapy in men. Two angiotensin-converting-enzyme inhibitors, captopril and enalapril, were compared. In total, 379 active men with mild to moderate hypertension, aged 55 to 79, were randomised between the treatment arms. QoL was one of the main outcome measures. Several QoL scales were used, including an Overall QoL scale based on a mean score from 11 subscales.

In order to interpret the magnitude of the differences in QoL that were observed, stressful life events that produced an equivalent change in QoL scores were considered, and the responses to the Overall QoL scale were re-calibrated accordingly (see Chapter 16). Overall QoL scores shifted positively for captopril by 0.11 units, and negatively for enalapril by 0.11. Negative shifts of 0.11 corresponded to those encountered when there was "major change in work responsibility", "in-law troubles" or "mortgage foreclosure". On the basis of these investigations, a clinically important change was deemed to be one between 0.1 and 0.2.

It was concluded that, although the therapies were indistinguishable in terms of clinical assessments of efficacy and safety, they produced substantial and different changes in QoL.

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