Development and validation of the Nancy histological index for UC

Development and validation of the Nancy histological index for UC
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DOI:
10.1136/gutjnl-2015-310187
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发表时间:
2017-01-01
期刊:
GUT
影响因子:
24.5
通讯作者:
Peyrin-Biroulet, Laurent
Peyrin-Biroulet, Laurent
中科院分区:
医学1区
文献类型:
--
作者:
Marchal-Bressenot, Aude;Salleron, Julia;Peyrin-Biroulet, Laurent

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目的建立一种有效的评价UC组织学疾病活动性的指标,并建立其反应性。结果是全球视觉评价(GVE)。八个组织学特征进行了测试。Nancy指数是通过多元线性回归和自助过程开发的,以创建最匹配GVE的指数。通过调整后的R平方(调整后的R-2)评估拟合优度。第二步是验证该指数:由来自不同中心的三位病理学家对100份活检进行南希指数评分。评价了每位阅片人的阅片人间可靠性。结果经Bootstrap验证后向选择,3/8的项目被选中:溃疡(校正R-2=0.55)、急性炎症浸润(校正R-2=0.88)和慢性炎症浸润(校正R-2=0.79)。Nancy指数定义为5级分类,范围从0级(无显著组织学疾病活动性)至4级(严重活动性疾病)。阅片者内部可靠性的组内相关系数(ICC)为0.88(95%CI 0.82至0.92),该指数具有良好的阅片者间可靠性(ICC=0.86(0.81至0.99))。Nancy指数与Geboes评分或GVE之间的相关性非常好。该指数具有良好的反应性与Geboes评分的变化和Nancy指数的变化之间的高度相关性(0.910(0.813至0.955))。结论三个描述性组织学指数已被验证用于临床实践和临床试验。
Objective We developed a validated index for assessing histological disease activity in UC and established its responsiveness.Methods Two hundred biopsies were scored. The outcome was the Global Visual Evaluation (GVE). Eight histological features were tested. The Nancy index was developed by multiple linear regression and bootstrap process to create an index that best matched the GVE. Goodness of fit was assessed by the adjusted R squared (adjusted R-2). The second step was the validation of the index: 100 biopsies were scored for the Nancy index by three pathologists from different centres. Inter-reader reliability was evaluated for each reader. The relationship between the change of the Nancy index and the Geboes index was assessed to assess the responsiveness.Results After backward selection with bootstrap validation, 3/8 items were selected: ulceration (adjusted R-2=0.55), acute inflammatory infiltrate (adjusted R-2=0.88) and chronic inflammatory infiltrate (adjusted R-2=0.79). The Nancy index is defined by a 5-level classification ranging from grade 0 (absence of significant histological disease activity) to grade 4 (severely active disease). The intraclass correlation coefficient (ICC) for the intrareader reliability was 0.88 (95% CI 0.82 to 0.92) and the index had good interreader reliability (ICC=0.86 (0.81 to 0.99)). The correlation between the Nancy index and the Geboes score or the GVE was very good. The index had a good responsiveness with a high correlation between changes in the Geboes score and changes in the Nancy index (0.910 (0.813 to 0.955)).Conclusions A three descriptor histological index has been validated for use in clinical practice and clinical trials.