Objective: This prospective multicenter investigation was conducted to define the repeatability of duplex-based identification of venous reflux and the relative effect of key parameters on the reproducibility of the test. Methods: Repeatability was studied by having the same technologist perform duplicate tests, at the same time of the day, using the same reflux-provoking maneuver and with the patient in the same position. Reproducibility was examined by having two different technologists perform the test at the same time of the day, using the same reflux-provoking maneuver and with the patient in the same position. Facilitated reproducibility was studied by having two different technologists examine the same patients immediately after an educational intervention. Limits of agreement between two duplex scans were studied by changing three elements of the test: time of the day (morning vs afternoon), patient's position (standing vs supine), and reflux initiation (manual vs automatic compressiondecompression) . Results: The study enrolled 17 healthy volunteers and 57 patients with primary chronic venous disease. Repeatability of reflux time measurements in deep veins did not significantly differ with the time of day, the patient's position, or the reflux-provoking maneuver. Reflux measurements in the superficial veins were more repeatable (P <.05) when performed in the morning with the patient standing. The agreement between the clinical interpretations significantly depended on a selected cut point (Spearman's ρ, -0.4; P <.01). Interpretations agreed in 93.4% of the replicated measurements when a 0.5-second cut point was selected. The training intervention improved the frequency of agreement to 94.4% (κ = 0.9). Alternations of the time of the duplex scan, the patient's position, and the reflux-provoking maneuver significantly decreased reliability. Conclusions: This study provides evidence to develop a new standard for duplex ultrasound detection of venous reflux. Reports should include information on the time of the test, the patient's position, and the provoking maneuver used. Adopting a uniform cut point of 0.5 second for pathologic reflux can significantly improve the reliability of reflux detection. Implementation of a standard protocol should elevate the minimal standard for agreement between repeated tests from the current 70% to at least 80% and with more rigid standardization, to 90%.
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine