When considering the use of quality of life as a primary end-point in phase III to IV comparative trials, the trial designer generally faces some unresolved questions. These include: How does one explain that some dimensions [quality-of-life (QOL) instruments usually have more than 1 dimension]...

Background: Intermittent claudication (IC) occurs in patients with peripheral occlusive arterial disease and results in leg pain after walking a certain distance - the claudication distance. Until recently, no specific questionnaire has been available to measure quality of life in patients with...