Soeder Jana, Stöfken Luisa, Mendoza Erika, Steinhilber Benjamin, Volk Carmen
Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen, Tübingen, Germany.
Venenpraxis, Wunstorf, Germany.
Biomed Phys Eng Express. 2025 Sep 3;11(5). doi: 10.1088/2057-1976/adfde8.
. Determine the reproducibility of the Clinical (C) aspect of the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification and the duplex ultrasound examination (DUS) for describing an individual's lower extremity chronic venous disorder status.. 33 study participants were examined via CEAP classification and DUS on seven vein segments on two days by two measurement teams (two investigators each). Recommendations for standardization were considered (morning, standing position, manual reflux-provocation manoeuver). One investigator of one measurement team performed the CEAP classification under consistent conditions on both days (test-retest reliability). Additionally, the CEAP classification was performed by two investigators, each from a different measurement team, of the same participant, on the same day (inter-rater reliability). For DUS, test-retest reliability involved one rater evaluating ultrasound images of the same participant taken by the same team across both days. Inter-rater reliability was assessed by having two raters evaluate the same image, while inter-observer reliability was determined by having one rater evaluate the images performed by both teams on the same days. Bland-Altman plots (including systematic bias), weighted kappa, intraclass correlation coefficient, standard error of measurement, and smallest real difference were computed.. Regarding CEAP, classifications agreed with 76% (test-retest, k= 0.71) and 63% (inter-rater, k= 0.63). Difficulties occurred when differentiating between the lowest three C-classes. No systematic errors were found for DUS in all vein segments. Inter-rater reliability in DUS was very high (sem-range = [0.05-0.13]; ICC-range = [0.45-1.00]), compared to test-retest (sem-range = [0.07-0.93]; ICC-range = [-0.21 to -0.94]) and inter-observer reliability (sem-range = [0.12-0.61]; ICC-range = [-0.01 to -0.95]). When evaluating whether a reflux was classified pathological, the absolute agreement was very high with ≥94% across all vein segments.. Study results indicated that when considering recommendations for standardization, a high reproducibility of DUS and CEAP classification can be achieved. In future epidemiological field studies, using several raters evaluating the same ultrasound images and finding consensus in case of disagreement seems reasonable.
确定临床 - 病因 - 解剖 - 病理生理学（CEAP）分类中临床（C）方面以及双功超声检查（DUS）在描述个体下肢慢性静脉疾病状态方面的可重复性。33名研究参与者由两个测量团队（每个团队两名研究人员）在两天内对七个静脉节段进行CEAP分类和DUS检查。考虑了标准化建议（早晨、站立位、手动反流激发操作）。一个测量团队的一名研究人员在两天内在一致条件下进行CEAP分类（重测信度）。此外，同一天由来自不同测量团队的两名研究人员对同一参与者进行CEAP分类（评分者间信度）。对于DUS，重测信度涉及一名评分者评估同一团队在两天内为同一参与者拍摄的超声图像。评分者间信度通过让两名评分者评估同一图像来评估，而观察者间信度通过让一名评分者评估两个团队在同一天进行的图像来确定。计算了布兰德 - 奥特曼图（包括系统偏差）、加权kappa值、组内相关系数、测量标准误差和最小实际差异。关于CEAP，分类的一致性在重测时为76%（k = 0.71），在评分者间为63%（k = 0.63）。区分最低的三个C级时存在困难。在所有静脉节段中未发现DUS存在系统误差。与重测（测量标准误差范围 = [0.07 - 0.93]；组内相关系数范围 = [-0.21至 -0.94]）和观察者间信度（测量标准误差范围 = [0.12 - 0.61]；组内相关系数范围 = [-0.01至 -0.95]）相比，DUS的评分者间信度非常高（测量标准误差范围 = [0.05 - 0.13]；组内相关系数范围 = [0.45 - 1.00]）。在评估反流是否被分类为病理性时，所有静脉节段的绝对一致性非常高，≥94%。研究结果表明，考虑标准化建议时，DUS和CEAP分类可实现较高的可重复性。在未来的流行病学现场研究中，让多名评分者评估同一超声图像并在存在分歧时达成共识似乎是合理的。
