BACKGROUND & AIMS Mucosal healing (MH) has become a goal of therapy for Crohn's disease (CD), but frequent endoscopies are not feasible. We aimed to develop and validate a non-invasive index to assess mucosal inflammation in children with CD. METHODS We collected data from the multi-center prospective ImageKids study, in which children with CD underwent ileocolonoscopy with magnetic resonance enterography. We investigated the association of pediatric CD activity index (PCDAI) items and laboratory test results with the simple endoscopic score for CD (SESCD). We used these data in a blended mathematical judgmental clinimetric approach to develop a weighted categorized index to identify children with CD who have MH, which we called the MINI index. We validated the index using data from 3 independent patient cohorts. The derivation and validation cohorts included 154 and 168 children, respectively (age 14.1 ± 2.5 years and 14.2 ± 3.9 years), of whom 16% and 36% had MH (defined as SESCD<3). RESULTS In multivariable models, the stooling item of the PCDAI, erythrocyte sedimentation rate, and level of fecal calprotectin were associated with SESCD (all P < .05). We added data on level of C-reactive protein to develop the MINI index. MINI scores below 8 identified children with MH with 88% sensitivity and 85% specificity in the derivation cohort and with 84% sensitivity and 87% specificity in the validation cohorts. Ninety percent of the patients in the validation cohort with scores of 8 or more had active mucosal inflammation, yet 78% of patients with scores below 8 had MH. Scores below 6 increase the positive predictive value to 86%. CONCLUSIONS We developed an index to non-invasively assess mucosal inflammation in children with CD. This index, identifies children with MH with high sensitivity and specificity. The added benefit of MINI over measurement of fecal calprotectin was small but significant, especially for patients with concentrations of fecal calprotectin from 100 to 599 μg/g. ClinicalTrials.gov no: NCT01881490.

中文翻译：

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小儿克罗恩病粘膜炎症无创性指标的开发和验证。

背景与目的黏膜愈合（MH）已成为克罗恩病（CD）的治疗目标，但频繁的内镜检查是不可行的。我们旨在开发和验证一种非侵入性指标，以评估CD儿童的粘膜炎症。方法我们收集了来自多中心前瞻性ImageKids研究的数据，在该研究中，患有CD的儿童接受了磁共振肠造影的回肠结肠镜检查。我们调查了儿科CD活动指数（PCDAI）项目和实验室测试结果与CD的简单内镜评分（SESCD）的关联。我们将这些数据用于混合数学判断斜度法，以建立加权分类指数，以识别患有MH的CD儿童，我们将其称为MINI指数。我们使用来自3个独立患者队列的数据验证了该指数。推导和验证队列分别包括154和168名儿童（年龄14.1±2.5岁和14.2±3.9岁），其中16％和36％患有MH（定义为SESCD <3）。结果在多变量模型中，PCDAI的粪便含量，红细胞沉降率和粪便钙卫蛋白水平与SESCD相关（所有P <.05）。我们添加了C反应蛋白水平的数据以开发MINI指数。MINI分数低于8的儿童可识别出MH的儿童，其衍生队列的敏感性为88％，特异性为85％，而验证队列的敏感性为84％，敏感性为87％。在验证队列中得分为8或更高的患者中有90％患有活动性粘膜炎症，而得分在8以下的患者中有78％的患者患有MH。低于6的分数将阳性预测值提高到86％。结论我们建立了一个指数，用于非侵入性评估CD儿童的粘膜炎症。该指数以高敏感性和特异性鉴定出患有MH的儿童。与粪便钙卫蛋白的测量相比，MINI的额外好处很小，但意义重大，特别是对于粪便钙卫蛋白浓度为100至599μg/ g的患者。ClinicalTrials.gov编号：NCT01881490。