Development and validation of a disease-specific questionnaire on the quality of life of patients with chronic venous insufficiency

Abstract

Background: Recording of Quality of Life (QoL) is taking on increasing importance in medicine. Although QoL cannot be measured directly, numerous methods studies have demonstrated that important areas of QoL can be addressed by validated questionnaires. The present study was designed to examine a new disease-specific, German-language questionnaire, the Freiburger Questionnaire of QoL in venous diseases (FLQA), with respect to reliability, validity and patient acceptance-among patients with chronic venous insufficiency (CVI).

Patients and methods: The FLQA consists of 83 items and differentiates between limitations in QoL in 7 scales: physical complaints, everyday life, social life, emotional status, therapy, satisfaction, occupation. Data were collected from 246 patients with CVI stage I (n = 107), II (n = 75) and III (venous ulcer, n = 64) in the Widmer classification.

Results: In the psychometric test, the majority of scales showed little or no top or bottom effect. The internal consistency of the scales was generally high (Cronbach's Alpha in all scales more than alpha = .70 and in 4 scales above alpha = .90). The convergent validity with the Nottingham Health Profile and the ALLTAG was high in several scales. The FLQA showed good discriminant validity and significantly differentiated between the clinical CVI stages in several areas of QoL. The change sensitivity during the course of therapy was also good. In a feasibility test, the acceptance values among patients were high with respect to ease of understanding and description of the QoL areas relevant to them. The mean time to fill out the questionnaire was 21 +/- 6 minutes.

Conclusion: Overall, the FLQA appears suitable to reliably record characteristics of QoL in patients with CVI in both course and cross-sectional studies.