Psychometric properties of the short version of the Freiburg Life Quality Assessment for chronic venous disease (FLQA-VS-10).

Abstract Background Chronic venous disease is a frequent vascular condition. International societies recommend the assessment of health-related quality of life (HRQoL) instruments in patients with vascular diseases. For this purpose, the 10-item questionnaire FLQA-VS-10 had previously been developed. The aim of this study was to validate this instrument in a prospective study. Methods We recruited 100 patients with recurrent varicosis or (in)complete venous insufficiency undergoing interventional vein treatment (high ligation of the great or the small saphenous vein, or endovenous ablation therapy) who answered the questionnaire along with instruments assessing convergent validation criteria at four timepoints: pre- (T1) and post-surgical (T2) and twice three years later with one week in-between (T3 and T4). Results Patients had a mean age of 56.0 years (SD 13.7), 66.0% were women. Patients presented with recurrent varicosis of the sapheno-femoral junction (28.0%), recurrent varicosis of the sapheno-popliteal junction (1.0%), (in)complete insufficiency of the great saphenous vein (69.0%), or complete insufficiency of the small saphenous vein (2.0%). The items showed few missing values. The FLQA-VS-10 global score showed no ceiling effect (patients reporting highest possible impairments in HRQoL) but a floor effect (patients reporting lowest possible impairments in HRQoL), which was highest at the post-surgical assessments. The internal consistency of the global score was high at all timepoints. Convergent validity and responsiveness analysis revealed that, the FLQA-VS-10 correlated in the expected direction with convergent instruments, including the FLQA-V (venous-disease specific HRQoL) and the EQ-5D-5L (generic HRQoL). Data from T3 and T4 revealed a high test-retest reliability (intraclass correlation = 0.92). Overall, patients stated that the FLQA-VS-10 was comprehensible, comprehensive, and easy-to-answer. Conclusion Our data suggest that the FLQA-VS-10 is a reliable, valid, responsive, and feasible HRQoL questionnaire for patients with chronic venous diseases. This questionnaire can serve as short and easy-to-use instrument to assess patient-reported outcomes in the treatment of these patients.