Vascular Quality of Life Questionnaire-6 Before and After Supervised Exercise Therapy in Patients with Intermittent...

Area of Science:

• Vascular Medicine
• Health Outcomes Research
• Patient-Reported Outcomes

Background:

• Peripheral arterial disease, specifically intermittent claudication (IC), significantly impacts patients' health-related quality of life (HRQoL).
• The Vascular Quality of Life Questionnaire-6 (VascuQoL-6) is a disease-specific tool for assessing HRQoL in IC patients.
• Establishing minimally important difference (MID) and substantial clinical benefit (SCB) for the VascuQoL-6 is crucial for interpreting clinical trial results.

Purpose of the Study:

• To determine the MID and SCB of the VascuQoL-6 in Dutch patients with IC undergoing supervised exercise therapy (SET).
• To provide benchmarks for assessing meaningful HRQoL improvements in IC patients post-SET.

Main Methods:

• 124 IC patients completed the VascuQoL-6 before and after a three-month SET program.
• An anchor question assessed patient-perceived health status changes.
• MID and SCB were calculated using both anchor-based and distribution-based methods.

Main Results:

• VascuQoL-6 scores improved significantly after SET (16.3 to 18.7, p < .001).
• MID values for improvement ranged from +2.0 to +3.8, and for deterioration from +0.2 to -2.2.
• Substantial clinical benefit (SCB) ranged from +3.7 to +5.0, with 32%-41% of patients achieving clinically meaningful HRQoL improvement.

Conclusions:

• Around one in three IC patients report a clinically meaningful HRQoL improvement after three months of SET.
• The calculated MID and SCB values offer guidance for interpreting VascuQoL-6 score changes in clinical practice.
• Utilizing MID and SCB cutoff points can enhance the interpretation of trial outcomes and establish benchmarks for SET effectiveness.