OBJECTIVE: To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency (SVI) have greater benefits from treatment than those with only symptomatic varicose veins. BACKGROUND: A commonly held view is that SVI is only a minor ailment, yet randomized clinical trials (RCTs) show that treatment improves quality of life (QoL) and is cost-effective. In an effort to curb the treatment costs of this common disorder, rationing is applied in many health care systems, often limiting the reimbursement of treatment to those with soft tissue changes. METHODS: This cohort study draws its data from an interventional RCT. After informed consent, consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation. This analysis differentially studies the outcomes of patients with simple varicose veins (C2: n = 191) and soft tissue complications (C3-4: n = 76). Effectiveness outcomes measured up to 1 year included the following: Qol [short form 36 (SF36), EuroQol, and the Aberdeen Varicose Veins Questionnaire], clinical recurrence, and the need for secondary procedures. Multivariable regression analysis was used to control for potential confounding factors. RESULTS: Both groups saw significant improvements in QoL. All improvements were equal between groups apart from the SF36 domain of Bodily Pain, where C2 saw an improvement of 12.8 [95% confidence interval (CI): 4.8-20.8] points over C3-4 participants (P = 0.002), who also suffered more recurrence [odds ratio (OR) = 2.7, 95% CI: 1.2-6.1, P = 0.022] and required more secondary procedures (OR = 4.4, 95% CI: 1.2-16.3, P = 0.028). CONCLUSIONS: This study suggests that rationing by clinical severity contradicts the evidence. Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence. TRIAL REGISTRATION: NCT00759434 Clinicaltrials.gov.
RCT Entities:
OBJECTIVE: To test the hypothesis that patients with soft tissue changes related to superficial venous insufficiency (SVI) have greater benefits from treatment than those with only symptomatic varicose veins. BACKGROUND: A commonly held view is that SVI is only a minor ailment, yet randomized clinical trials (RCTs) show that treatment improves quality of life (QoL) and is cost-effective. In an effort to curb the treatment costs of this common disorder, rationing is applied in many health care systems, often limiting the reimbursement of treatment to those with soft tissue changes. METHODS: This cohort study draws its data from an interventional RCT. After informed consent, consecutive patients with symptomatic unilateral SVI were randomized to receive surgical ligation and stripping or endovenous laser ablation. This analysis differentially studies the outcomes of patients with simple varicose veins (C2: n = 191) and soft tissue complications (C3-4: n = 76). Effectiveness outcomes measured up to 1 year included the following: Qol [short form 36 (SF36), EuroQol, and the Aberdeen Varicose Veins Questionnaire], clinical recurrence, and the need for secondary procedures. Multivariable regression analysis was used to control for potential confounding factors. RESULTS: Both groups saw significant improvements in QoL. All improvements were equal between groups apart from the SF36 domain of Bodily Pain, where C2 saw an improvement of 12.8 [95% confidence interval (CI): 4.8-20.8] points over C3-4 participants (P = 0.002), who also suffered more recurrence [odds ratio (OR) = 2.7, 95% CI: 1.2-6.1, P = 0.022] and required more secondary procedures (OR = 4.4, 95% CI: 1.2-16.3, P = 0.028). CONCLUSIONS: This study suggests that rationing by clinical severity contradicts the evidence. Delaying treatment until the development of skin damage leads to a degree of irreversible morbidity and greater recurrence. TRIAL REGISTRATION: NCT00759434 Clinicaltrials.gov.
Authors: F Pannier; T Noppeney; J Alm; F X Breu; G Bruning; I Flessenkämper; H Gerlach; K Hartmann; B Kahle; H Kluess; E Mendoza; D Mühlberger; A Mumme; H Nüllen; K Rass; S Reich-Schupke; D Stenger; M Stücker; C G Schmedt; T Schwarz; J Tesmann; J Teßarek; S Werth; E Valesky Journal: Hautarzt Date: 2022-04-19 Impact factor: 1.198
Authors: D Carradice; J Forsyth; A Mohammed; C Leung; L Hitchman; A E Harwood; T Wallace; G E Smith; B Campbell; I Chetter Journal: BJS Open Date: 2018-08-29