Determination and importance of clinical and patient-based measures in outcome assessment of peripheral arterial occlusive disease

Therapeutic effectiveness is the overall effect of an intervention on clinical and quality-of-life measures. Traditionally, in peripheral arterial disease, this has been evaluated in terms of clinical outcomes only. The lack of correlation between quality-of-life and clinical measures means that these cannot adequately describe overall patient benefit or adverse effects from an intervention. Therefore, patient-based measures such as changes in disease-specific questionnaire scores must be included in the evaluation of therapeutic effectiveness.