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炎症性肠病(IBD)疾病活动评分的临床活动指数准确性如何?

How accurate are clinical activity indices for scoring of disease activity in inflammatory bowel disease (IBD)?

作者信息

Jørgensen Lone G M, Fredholm Lisbeth, Hyltoft Petersen Per, Hey Henrik, Munkholm Pia, Brandslund Ivan

机构信息

The Laboratory Centre, Vejle County Hospital, Denmark.

出版信息

Clin Chem Lab Med. 2005;43(4):403-11. doi: 10.1515/CCLM.2005.073.

Abstract

Clinical activity indices are essential instruments in monitoring inflammatory bowel diseases such as Crohn's disease (CD) and ulcerative colitis (UC). To subclassify components of disease indices in CD and UC, investigate technical noise in estimation of the indices, establish a signal-to-noise ratio (SNR), evaluate correlation between indices and calculate the reference change value (RCV) for selected biochemical variables in individual cases, 50 patients with CD and 49 patients with UC were included in the study. Qualitative index variables were assessed for scoring errors. The standard deviation (SD) was estimated according to a rectangular model, while SD in biochemical variable scoring was estimated according to a Gaussian model; a combined SD was also calculated. These values were investigated for their individual contribution to variation. The 95% CI of an index value was based on +/- 1.96 x SD(combined) and a change in separate biochemical variables was calculated as RCV 1.96 x radical2 x SD(combined). Correlation between different disease activity indices was assessed for unexplained variation. The Crohn's disease activity index (CDAI) had the highest variation compared to the van Hees (Hees) and the Harvey-Bradshaw index (HBI) in CD, but it also had the best SNR, whereas HBI had the lowest. In UC the clinical activity index (CAI) showed the highest variance, but the best SNR compared to Seo's activity index (AI). The 95% CI of the CDAI discriminatory activity sum of 150 in individual cases was 105-195, whereas the 95% interval for a change was +/-62.4. Self-reported wellness contributed 40% to total variance in the CDAI. Factors of clinical importance increased errors in estimates and variance of the indices. Poor correlation was obtained between activity indices, with up to 70% unexplained variance. The SD(combined) for estimated errors was as high as 23 points, with the best SNR being approximately 20. Index factors increase the sensitivity of SNRs to errors and lower the disease specificity. Sensitivity optimisation may be achieved by standardisation of the variables and their use.

摘要

临床活动指数是监测克罗恩病(CD)和溃疡性结肠炎(UC)等炎症性肠病的重要工具。为了对CD和UC疾病指数的组成部分进行亚分类,研究指数估计中的技术噪声,建立信噪比(SNR),评估指数之间的相关性并计算个体病例中选定生化变量的参考变化值(RCV),本研究纳入了50例CD患者和49例UC患者。对定性指数变量的评分误差进行了评估。标准差(SD)根据矩形模型进行估计,而生化变量评分的SD根据高斯模型进行估计;还计算了综合SD。研究了这些值对变异的个体贡献。指数值的95%置信区间基于±1.96×SD(综合),单独生化变量的变化计算为RCV 1.96×根号2×SD(综合)。评估了不同疾病活动指数之间的相关性以确定无法解释的变异。与CD中的范赫斯(Hees)指数和哈维-布拉德肖指数(HBI)相比,克罗恩病活动指数(CDAI)的变异最高,但它也具有最佳的SNR,而HBI的SNR最低。在UC中,临床活动指数(CAI)的方差最高,但与徐氏活动指数(AI)相比具有最佳的SNR。个体病例中CDAI鉴别活动总和为150时的95%置信区间为105 - 195,而变化的95%区间为±62.4。自我报告的健康状况对CDAI总方差的贡献为40%。具有临床重要性的因素增加了估计误差和指数的方差。活动指数之间相关性较差,高达70%的变异无法解释。估计误差的SD(综合)高达23分,最佳SNR约为20。指数因素增加了SNR对误差的敏感性并降低了疾病特异性。通过变量的标准化及其使用可以实现敏感性优化。

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