Perrin M, Allaert F A
Vascular Department, Clinique du Grand Large, 26 Chemin de Decines, Chassieu, France.
Eur J Vasc Endovasc Surg. 2006 Sep;32(3):326-32. doi: 10.1016/j.ejvs.2006.02.018. Epub 2006 May 24.
To evaluate intra- and inter-observer reproducibility of the classification for recurrent varicose veins after surgery (REVAS).
Intra- and inter-observer reproducibility of each component of the REVAS classification were evaluated by a Kappa test.
A multi-centre study conducted in 8 countries enrolled 199 REVAS patients. Patients were examined twice by the same observer, and once by another physician. Investigations included physical examination and duplex scanning. A form based on the CEAP and the REVAS classification was filled in after each examination.
The analysis revealed that of the 8 items in the REVAS, intra-observer reproducibility was excellent for three items and good for five, and that inter-observer reproducibility was good for 6 items and moderate for two. Making a slight change in the proposed answers to one question, which is somewhat ambiguous, would increase inter-observer reproducibility. Analysis of the cause of intermediate reproducibility underlines the necessity of validating a duplex scanning protocol and a standardised duplex scanning report.
The good or excellent intra-observer reproducibility of the REVAS provides the main required criteria for use in clinical trials or cohort studies where patients are usually followed up by the same investigator to determine their spontaneous or treatment-related outcome.
评估手术后复发性静脉曲张(REVAS)分类的观察者内和观察者间的可重复性。
通过Kappa检验评估REVAS分类各组成部分的观察者内和观察者间的可重复性。
一项在8个国家开展的多中心研究纳入了199例REVAS患者。患者由同一名观察者检查两次,另一名医生检查一次。检查包括体格检查和双功超声扫描。每次检查后填写一份基于CEAP和REVAS分类的表格。
分析显示,在REVAS的8项内容中,观察者内可重复性在3项中为优秀,5项中为良好;观察者间可重复性在6项中为良好,2项中为中等。对一个有点含糊的问题的建议答案稍作修改,将提高观察者间的可重复性。对中等可重复性原因的分析强调了验证双功超声扫描方案和标准化双功超声扫描报告的必要性。
REVAS良好或优秀的观察者内可重复性为临床试验或队列研究提供了主要所需标准,在这些研究中,患者通常由同一名研究者随访,以确定其自发或与治疗相关的结果。