Background: Chronic venous disorders (CVD) have an impact on quality of life (QoL), both physically and psychologically. As of now, several vein specific QoL scales exist, but no patient-reported outcome (PRO) is available which takes into account altogether symptoms, impairment of activities, appearance of the legs and concerns regarding health risk. Since clinical severity and disability are mostly evaluated in severe patients, where the main outcome - namely skin changes - is obvious but rare, the authors considered that a reproducible and clinically relevant survey that could account for specific patients' complaints was needed, particularly for CEAP C0s-C3 patients.
Objectives: The objective of this study was to build a specific autoquestionnaire and to establish its statistical validity and clinical relevance.
Methods: A review of existing questionnaires and an analysis of relevant literature were carried out by a committee of experts. The committee then developed a questionnaire of 46 items, with special attention to relevance for venous disorders and patients' main complaints. After construction, the French version was field-tested and results statistically analyzed. In the specific QoL & Outcome Response - Venous (SQOR-V), each item is given a value by the patient and items are grouped in five dimensions. Each dimension is weighed to a maximum value of 20, yielding an overall maximum score of 100.
Results: Two hundred and two questionnaires were analyzed for the initial evaluation and 152 at a second (test-retest). Determination of the Cronbach's alpha coefficient (0.96) and structural analysis demonstrated an excellent internal and structural coherence. Test-retest comparisons confirmed good reproducibility. Comparison with SF-12 and CED-D questionnaires and with CEAP classification groups verified both structural and clinical validity.
Conclusions: This study demonstrates QoL impairment in patients suffering from chronic venous disorders (CVD). It also verifies the statistical validity of the SQOR-V questionnaire. More studies are needed to demonstrate the improvement in specificity and accuracy this questionnaire provides compared to existing vein-specific QoL scales, and to determine its ability to assess efficacy of any kind of treatment at any stage of the disease. Provided adequate acknowledgment of its authors, the use of SQOR-V is free. An English version is available, currently pending validation.