Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome

Objective: We directly compared the Villalta scale and the Venous Clinical Severity Score (VCSS) to determine which of the two measures would be better at capturing clinically important cases of post-thrombotic syndrome (PTS) and PTS severity compared with patient-reported quality of life (QOL) scores. Methods: We performed a secondary analysis of the ATTRACT (acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial study population. We calculated the correlations of the Villalta scores and VCSSs with QOL scores (short-form 36-item health survey [SF-36] physical component summary [PCS] and mental component summary [MCS]; and VEINES [venous insufficiency epidemiological and economic study]-QOL/symptom [VEINES-QOL/Sym] questionnaire) at each study visit (6, 12, 18, and 24 months of follow-up). The correlation of the random intercept (mean scores) and random slope (rate of change of the scores) among the Villalta scores, VCSS, and VEINES-QOL/Sym scores was assessed using a multivariate longitudinal model. Results: The median correlation between Villalta scores and VCSSs was 0.72. The median correlation between the Villalta scores and VEINES-QOL and VEINES-Sym scores at all follow-up visits was −0.68 and −0.71, respectively. The median correlation between the Villalta scores and SF-36 PCS and MCS scores was −0.51 and −0.31, respectively. For the VCSSs, the median correlation with the VEINES-QOL and VEINES-Sym scores at all follow-up visits was −0.39 and −0.41, respectively. The median correlation between the VCSSs and SF-36 PCS and MCS scores was −0.32 and −0.13, respectively. The correlations between the random effects in the multivariate longitudinal models showed a similar pattern. The effect of covariate adjustment by age, sex, and body mass index was minor. Conclusions: The Villalta scores and VCSSs correlated strongly. The Villalta scale showed a substantially greater correlation with venous disease-specific and general QOL scores compared with the correlation with the VCSS. Our findings suggest that when a single scale is used to assess for clinically meaningful PTS, the Villalta scale will better capture the effects of PTS on patient-reported QOL.