Data from: A reliability study of colour-Doppler sonography for the diagnosis of chronic cerebrospinal venous insufficiency shows low inter-rater agreement

Objective: Chronic cerebrospinal venous insufficiency (CCSVI) has been extremely variable associated with multiple sclerosis in color-Doppler sonographic studies. We aimed to evaluate inter-rater agreement in color doppler sonograpy venous examination. Design: Inter-rater agreement study. Setting: First-referral multiple sclerosis centre. Participants: thirty-eight multiple sclerosis patients, and 55 age-matched (± 5 years) controls. Intervention: sonography was carried out in accordance with Zamboni's five criteria by 8 sonographers with different expertise, blinded to the status of cases and controls. Each subject was evaluated by two operators. Primary and secondary outcome measures: inter-rater agreement was measured through the Kappa statistics and the Intraclass Correlation Coefficient. Results: The agreement was no higher than chance for criterion 2-reflux in the deep cerebral veins (Kappa=-0.02) and 4-flow not Doppler-detectable in one or both the internal jugular (IJVs) or vertebral veins (VVs) (-0.09). It was substantially low for criterion 1-reflux in the IJVs and/or VVs (0.29), criterion 3-IJV stenosis or malformations (0.23), and criterion 5-absence of IJV diameter increase when passing from sitting to supine position (0.22). The Kappa value for CCSVI as a whole was 0.20 (95% confidence limits=-0.01 - 0.42). Intraclass Correlation Coefficients for the measure of cross-sectional area ranged from 0.05 to 0.25. Inter-rater agreement was low for CCSVI experts (kappa= 0.24; -0.11 to 0.59), and non-experts (0.20; -0.33 to 0.73); neurologists (0.21; -0.06 to 0.47) and non neurologists (0.18; -0.20 to 0.56); cases (0.19; -0.14 to 0.52) and controls (0.21; -0.08 to 0.49). Zamboni-trained neurosonographers ascertained CCSVI more frequently than non-trained. Conclusions: Agreement was unsatisfactory for the diagnosis of CCSVI as a whole, for each of its five criteria, and according to different subgroups. Standardization of the method is urgently needed prior to its further application in studies of patients with multiple sclerosis or other neurological diseases.研究背景：在彩色多普勒超声相关研究中，慢性脑脊液静脉功能不全（chronic cerebrospinal venous insufficiency, CCSVI）与多发性硬化的关联呈现极强的变异性。本研究旨在评估彩色多普勒静脉超声检查中的评级者间一致性。 研究设计：评级者间一致性研究。 研究地点：首批转诊多发性硬化诊疗中心。 研究对象：38名多发性硬化患者，以及55名年龄匹配（±5岁）的对照个体。 检查方案：由8名不同专业水平的超声医师按照赞邦尼（Zamboni）提出的五项标准进行超声检查，所有医师对研究对象的病例/对照状态设盲。每名受试者均由两名操作者分别完成评估。 主要及次要结局指标：通过Kappa统计量与组内相关系数（Intraclass Correlation Coefficient, ICC）评估评级者间一致性。 研究结果：针对第二项标准——大脑深静脉反流（Kappa=-0.02），以及第四项标准——单侧或双侧颈内静脉（internal jugular veins, IJVs）或椎动脉（vertebral veins, VVs）未检测到多普勒血流（Kappa=-0.09），其评级一致性甚至低于随机水平。对于第一项标准（颈内静脉和/或椎动脉反流，Kappa=0.29）、第三项标准（颈内静脉狭窄或畸形，Kappa=0.23）以及第五项标准（从坐位转为仰卧位时颈内静脉直径无增加，Kappa=0.22），评级一致性仅处于较低水平。整体CCSVI诊断的Kappa值为0.20（95%置信区间：-0.01~0.42）。横截面面积测量的组内相关系数范围为0.05~0.25。不同亚组的评级者间一致性均较低：CCSVI专业医师组（Kappa=0.24；95%置信区间：-0.11~0.59）、非专业医师组（Kappa=0.20；95%置信区间：-0.33~0.73）、神经科医师组（Kappa=0.21；95%置信区间：-0.06~0.47）、非神经科医师组（Kappa=0.18；95%置信区间：-0.20~0.56）、病例组（Kappa=0.19；95%置信区间：-0.14~0.52）以及对照组（Kappa=0.21；95%置信区间：-0.08~0.49）。接受过赞邦尼方法培训的神经超声医师相较于未受训者，更易确诊CCSVI。 研究结论：无论针对CCSVI的整体诊断，还是其五项分项标准，亦或是不同亚组人群，评级一致性均未达到满意水平。在将该方法进一步应用于多发性硬化或其他神经系统疾病患者的研究之前，亟需对其检查流程进行标准化。