Winkfield Betsy, Aubé Christophe, Burtin Pascal, Calès Paul
Department of Hepatogastroenterology, University Hospital and University, Angers, France.
Eur J Gastroenterol Hepatol. 2003 Sep;15(9):959-66. doi: 10.1097/00042737-200309000-00004.
A determination of the inter-observer variability is an important step before determining diagnostic accuracy and requires a specific methodology and statistical tests. The aim of this study was to report the results, characteristics and methodological quality of agreement studies performed in hepatology.
A search of published studies yielded 42 that could be used in this evaluation: three were clinical studies, 11 were in the field of endoscopy, 12 in histopathology and 16 in radiology. The studies were described with a grid of 28 items and evaluated with a quality score (QUAS; maximum, 35) including 22 items.
The following agreement level was noted: intra-observer > inter-observer > inter-centre. The following signs had good agreement. Endoscopy: size and red signs of oesophageal varices; histopathology: cirrhosis, fibrosis and steatosis; Doppler: mean portal vein and superior mesenteric artery velocities, hepatic artery area and perfusion indexes. Frequent methodological weaknesses were noted. The real agreement (such as the kappa index excluding chance), and the prevalence of signs and biases were rarely assessed. Standardized observations (67% of the studies), blind assessment (48%), simultaneous observations (7%), and the recording technique were not frequently used. The mean QUAS was 13 +/- 6 with 17 +/- 4 in histopathology versus 11 +/- 6 in radiology (P < 0.05). Using multiple regression, four variables independently predicted the QUAS with R2 = 0.77: adapted tests, multiple observations, intra-class correlation coefficient and agreement proportion.
Methodology was often insufficient. Agreement is often measured under biased conditions. Some areas were not or were rarely studied, e.g., biology and ultrasound. The agreement and QUAS were often poor, suggesting the need for studies with improved observation and methodological quality of agreement.
在确定诊断准确性之前，确定观察者间的变异性是重要的一步，这需要特定的方法和统计检验。本研究的目的是报告肝脏病学领域一致性研究的结果、特征和方法学质量。
对已发表研究进行检索，得到42项可用于本评价的研究：3项为临床研究，11项在内镜检查领域，12项在组织病理学领域，16项在放射学领域。这些研究通过一个包含28项内容的表格进行描述，并采用包含22项内容的质量评分（QUAS；最高35分）进行评价。
观察到以下一致性水平：观察者内＞观察者间＞中心间。以下体征具有良好的一致性。内镜检查：食管静脉曲张的大小和红色征；组织病理学：肝硬化、纤维化和脂肪变性；多普勒检查：门静脉平均流速、肠系膜上动脉平均流速、肝动脉面积和灌注指数。注意到常见的方法学缺陷。很少评估实际一致性（如排除机遇的kappa指数）以及体征和偏倚的发生率。标准化观察（67%的研究）、盲法评估（48%）、同步观察（7%）和记录技术使用不频繁。QUAS的平均值为13±6，组织病理学为17±4，放射学为11±6（P＜0.05）。使用多元回归分析，4个变量独立预测QUAS，R2 = 0.77：适应性检验、多次观察、组内相关系数和一致性比例。
方法学往往不足。一致性通常在有偏倚的条件下进行测量。一些领域未被研究或很少被研究，如生物学和超声检查。一致性和QUAS往往较差，提示需要开展观察和方法学质量更高的一致性研究。
