Service de Dermatologie, Hôpital Nord, Université Picardie Jules Verne, Amiens, France.
Service de Dermatologie, Hôpital Nord, Université Picardie Jules Verne, Amiens, France.
J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):837-843. doi: 10.1016/j.jvsv.2017.05.019.
An accurate and reliable method for measuring venous leg ulcer (VLU) area is important in assessing treatment effects. The new three-dimensional (3D) LifeViz digital imaging system (QuantifiCare S.A., Valbonne, France) combines a compact, easy to use stereovision camera and image management software to provide 3D medical images. The aim of this prospective study was to investigate whether the 3D LifeViz digital imaging system could be considered a suitable alternative to manual transparent wound tracing for the measurement of VLU area and 4-week healing rates.
A prospective cohort study was conducted in two tertiary centers between November 2013 and January 2014. The intrarater variability of the digital imaging system was assessed by comparison of the target wound (TW) areas obtained at the inclusion visit (W0) and 2 days after W0 for each local rater. The inter-rater variability of the two methods at W0 and the study end visit was assessed using the TW area measurements obtained by local and central raters.
A total of 36 consecutive outpatients, each presenting with at least one VLU and representing a total of 44 TWs, were recruited. At inclusion, comparable results were observed with both methods in terms of mean VLU area, showing a good correlation of the digital imaging method with the transparent tracing method (concordance correlation coefficient [CCC], 0.989; 95% confidence interval [C], 0.983-0.992). Furthermore, this system detected the same changes in the 4-week healing rate as the transparent tracing method, showing that both methods were equivalent in measuring changes in VLU areas over time (CCC, 0.996; 95% CI, 0.994-0.997). Strong intrarater and inter-rater concordances demonstrated good reproducibility of the digital imaging system for VLU area measurements (CCC, 0.994 [95% CI, 0.992-0.995] for intrarater variability; and CCC ≥0.99 for each center for inter-rater variability). Moreover, regardless of the operator measuring the VLUs, the reliability of image capture and image quality remained excellent.
The 3D LifeViz digital imaging system is a noncontact stereophotographic method that provides measurements of VLU area or changes in VLU areas that are as accurate and reliable as those obtained using the planimetry method and in conditions as close as possible to those of a clinical trial.
准确、可靠的静脉性下肢溃疡（VLU）面积测量方法对于评估治疗效果非常重要。新型三维（3D）LifeViz 数字成像系统（法国 Valbonne 的 QuantifiCare S.A.）结合了紧凑、易于使用的立体视觉相机和图像管理软件，提供 3D 医学图像。本前瞻性研究旨在探讨 3D LifeViz 数字成像系统是否可替代手动透明伤口描记法用于测量 VLU 面积和 4 周愈合率。
2013 年 11 月至 2014 年 1 月期间，在两家三级中心进行了前瞻性队列研究。通过比较每位本地评估员在纳入时（W0）和 W0 后 2 天获得的目标伤口（TW）面积，评估数字成像系统的内部评估者变异性。使用本地和中央评估员获得的 TW 面积测量值，评估两种方法在 W0 和研究结束时的外部评估者变异性。
共纳入 36 例连续门诊患者，每位患者至少有一处 VLU，共 44 处 TW。在纳入时，两种方法测量的平均 VLU 面积相似，数字成像法与透明描记法具有良好的相关性（一致性相关系数[CCC]，0.989；95%置信区间[CI]，0.983-0.992）。此外，该系统检测到 4 周愈合率的相同变化，与透明描记法一样，两种方法在测量 VLU 面积随时间的变化方面等效（CCC，0.996；95%CI，0.994-0.997）。强烈的内部和外部评估者一致性表明，数字成像系统用于 VLU 面积测量具有良好的可重复性（CCC，0.994[95%CI，0.992-0.995]为内部评估者变异性；每个中心的 CCC≥0.99 为外部评估者变异性）。此外，无论测量 VLU 的操作员是谁，图像采集和图像质量的可靠性仍然非常出色。
3D LifeViz 数字成像系统是一种非接触式立体摄影方法，可提供 VLU 面积或 VLU 面积变化的测量值，其准确性和可靠性与使用平面测量法获得的测量值相同，且条件尽可能接近临床试验。
