Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency, although existing generic quality of life instruments (NHP, SF-36 or SIP) cannot completely identify their specific complaints. The Chronic Venous Insufficiency Questionnaire (CIVIQ) has been developed by iterative process. First, a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency, other than physical symptoms of discomfort. A second study involving 2,001 subjects was used to reduce the number of items. Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale. The importance items found in patients with venous insufficiency were subjected to factorial analyses (PCA, PAF). The final version is a 20-item self-administered questionnaire which explores four dimensions: psychological, physical and social functioning and pain. Internal consistency of the questionnaire was validated for each dimension (Cronbach's alpha > 0.820 for three out of four factors). Reproducibility was confirmed in a 60 patient test-retest study. Pearson's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940. Finally, the questionnaire was tested in a randomized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument, together with the patient's own quality of life. This study demonstrated that convergence was valid: Pearson's correlation coefficients between clinical score differences and quality of life score differences were small (from 0.199-0.564) but were statistically different from 0 (p < 0.001). Standardized response mean (SRM) and effect size (ES) were calculated to assess sensitivity to change. SRM and ES both demonstrated considerable responsiveness to change (> 0.80). Reliability, face, content, construct validity and responsiveness were also determined for this specific quality of life questionnaire relating to venous insufficiency. Results suggest that this questionnaire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency.