Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs.

OBJECTIVE We conducted a systematic review of the literature about quality-of-life (QOL) scales in chronic venous disorders (CVDs) comprising leg ulcers to identify the respective advantages and deficits of existing tools. METHODS A research protocol was built following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the PICO (population, intervention, comparator, and outcome) criteria. The following databases were screened: MEDLINE, SCOPUS, EMBASE, CINHAL, and Cochrane. Psychometric and linguistic validation studies in English were included, as were clinical trials that have used QOL scales in CVDs. The data search was up to date as of October 31, 2013. RESULTS Inclusion criteria were met in 103 of the 511 recorded references, in which 10 scales were identified: two for the full spectrum of CVDs, three for patients with CVDs without leg ulceration, four for leg ulcers, and one exclusively for patients with varicose veins. Among them, the ChronIc Venous Insufficiency Questionnaire (CIVIQ), Aberdeen Varicose Vein Questionnaire (AVVQ), and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) scales were the most highly used according to the literature, and CIVIQ and VEINES-QOL were the most extensively validated scales and had the longest iterative validation process. A total of 31 psychometric and linguistic validations of the 10 QOL scales and 66 clinical trials that have used these scales were identified. The validation studies were based on acceptability, content validity, construct validity, reliability, and responsiveness. The clinical trials were composed of 25 randomized controlled trials and 41 observational studies. Only the randomized controlled trials are considered in the present article. CONCLUSIONS This systematic review confirmed that CVDs have an important effect on QOL. The majority of the studies addressed the application rather than the validation of the 10 identified scales. Two scales, CIVIQ and VEINES-QOL, emerged as being thoroughly validated instruments, although factorial stability was not demonstrated for the VEINES-QOL. Our findings confirm a paucity of validation studies.