RESUMEN
OBJECTIVE: The objective of this study was to evaluate the relationship between patient-reported symptoms, functional limitations, and psychological impact of varicose veins (VVs) vs pathophysiologic mechanism, incorporating demographic and behavioral factors. METHODS: We conducted a pooled analysis from two clinical studies (Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction Incompetence [VANISH-1] and Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence [VANISH-2]) in patients with VVs (superficial venous reflux only). Health outcomes were classified on the basis of the Wilson-Cleary conceptual framework continuum linking clinical and anatomic factors (Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] clinical class and great saphenous vein [GSV] diameter, respectively) to patient-reported outcomes: Varicose Vein Symptoms Questionnaire (VVSymQ) score; modified Venous Insufficiency Epidemiologic and Economic Study on Quality of Life/Symptoms (m-VEINES-QOL/Sym) limitations in daily activities (functional limitations hereafter) score; and m-VEINES-QOL/Sym psychological impact score. Association of clinical and anatomic categories with each of the patient-reported outcomes was assessed using analysis of variance for statistical significance and standardized mean differences for clinical meaningfulness. Hierarchical regression modeling was applied to evaluate the direct association of the VVSymQ symptom score with the m-VEINES-QOL/Sym functional limitations score and the indirect association with the m-VEINES-QOL/Sym psychological impact score, adjusting for clinical, behavioral, and demographic factors. RESULTS: Among 516 patients, approximately three-fourths were women (mean age, 49 years), approximately 70% were overweight or obese, 42% were C2 and 32% were C3, and 88% reported never or only intermittently wearing compression stockings. VVSymQ (symptom) scores did not vary by GSV diameter but were significantly worse for those with severe disease stage, especially C5 or C6. Among m-VEINES-QOL/Sym work-related function items, 47% of patients reported difficulty at work and 31% reported cutting down at work. On nonwork function items, standing for prolonged periods was most affected; 53% were limited a little and 22% were limited a lot. Concern about appearance and choice of clothing predominated among psychological impact items, with 74% and 65%, respectively, affected all or most of the time. The m-VEINES-QOL/Sym functional limitation and psychological impact scores varied by neither GSV diameter nor CEAP C class, but they varied directly with VVSymQ (symptom) score quartiles. Multivariable regression analysis revealed that VVSymQ symptom scores continued to be associated with m-VEINES-QOL/Sym psychological impact scores, even after adjustment for m-VEINES-QOL/Sym functional limitation scores. CONCLUSIONS: Substantial patient-reported functional limitation and psychological impact of VVs were observed. Limitations on work, standing for prolonged periods, concern about appearance, and clothing choice were most affected. Patient-reported VVSymQ (symptom) score, an objective patient-reported measure of symptom severity in VVs, was the key predictor of patient-reported m-VEINES-QOL/Sym functional limitations. Symptoms and functional limitations led to greater psychological impact. Physicians should routinely ascertain symptoms and functional limitations to enhance quality of care and to document medical necessity.