Le Huy Duc, Pflaum Theresa, Labrenz Johannes, Sari Soner, Bretschneider Fabienne, Tran Florian, Lassen Arne, Nikolaus Susanna, Szymczak Silke, Kormilez Diana, Rosenstiel Philip, Schreiber Stefan, Aden Konrad, Röcken Christoph
Institute of Clinical Molecular Biology, Christian-Albrechts-University and University Hospital Schleswig-Holstein, Kiel, Germany.
Department of Pathology, Christian-Albrechts-University and University Hospital Schleswig-Holstein, Kiel, Germany.
J Crohns Colitis. 2023 Apr 3;17(3):389-395. doi: 10.1093/ecco-jcc/jjac146.
Histological disease severity assessment in ulcerative colitis [UC] has become a mainstay in the definition of clinical endpoints ['histological remission'] in clinical trials of UC. Several scores have been established in the microscopic assessment of disease activity, but the Nancy index [NI] stands out as being the histological index with the fewest scoring items. To what extent histological assessment using the NI is affected by interobserver reliability in a real-word setting is poorly understood. We therefore performed a single-centre retrospective analysis of NI assessment in patients with UC.
We retrospectively evaluated the NI in two independent cohorts [total: 1085 biopsies, 547 UC patients] of clinically diagnosed UC patients, who underwent colonoscopy between 2007 and 2020. Cohort #1 consisted of 637 biopsies from 312 patients, while Cohort #2 consisted of 448 biopsies from 235 patients. Two blinded pathologists with different levels of expertise scored all biopsies from each cohort. A consensus conference was held for cases with discrepant scoring results. Finally, an overall consensus scoring was obtained from both cohorts.
The interobserver agreement of the NI was substantial after the assessment of 1085 biopsy samples (κ = 0.796 [95% confidence interval, CI: 0.771-0.820]). An improvement of the interobserver agreement was found with increasing numbers of samples evaluated by both observers (Cohort #1: κ = 0.772 [95% CI: 0.739-0.805]; Cohort #2: κ = 0.829 [95% CI: 0.793-0.864]). Interobserver discordance was highest in NI grade 1 [observer 1: n = 128; observer 2: n = 236]. Interobserver discordance was lowest in NI grades 0 [observer 1: n = 504; observer 2: n = 479] and 3 [observer 1: n = 71; observer 2: n = 66].
The NI is an easy-to-use index with high interobserver reliability for assessment of the histological disease activity of UC patients in a real-world setting. While NI grades 0 and 3 had a high level of agreement between observers, NI grade 1 had a poorer level of agreement. This highlights the clinical need to specify histological characteristics leading to NI grade 1.
在溃疡性结肠炎（UC）的临床试验中，组织学疾病严重程度评估已成为定义临床终点（“组织学缓解”）的主要依据。在疾病活动度的微观评估中已经建立了多个评分系统，但南希指数（NI）作为评分项目最少的组织学指数脱颖而出。在实际临床环境中，使用NI进行组织学评估受观察者间可靠性的影响程度尚不清楚。因此，我们对UC患者的NI评估进行了单中心回顾性分析。
我们回顾性评估了2007年至2020年间接受结肠镜检查的临床诊断为UC患者的两个独立队列（共1085份活检样本，547例UC患者）中的NI。队列1包括312例患者的637份活检样本，而队列2包括235例患者的448份活检样本。两位专业水平不同的盲法病理学家对每个队列的所有活检样本进行评分。对评分结果存在差异的病例召开了共识会议。最后，从两个队列中获得了总体共识评分。
在评估了1085份活检样本后，NI的观察者间一致性较高（κ = 0.796 [95%置信区间，CI：0.771 - 0.820]）。随着两位观察者评估样本数量的增加，观察者间一致性有所提高（队列1：κ = 0.772 [95% CI：0.739 - 0.805]；队列2：κ = 0.829 [95% CI：0.793 - 0.864]）。观察者间不一致性在NI 1级中最高（观察者1：n = 128；观察者2：n = 236）。观察者间不一致性在NI 0级（观察者1：n = 504；观察者2：n = 479）和3级（观察者1：n = 71；观察者2：n = 66）中最低。
NI是一种易于使用的指数，在实际临床环境中评估UC患者的组织学疾病活动度时具有较高的观察者间可靠性。虽然NI 0级和3级在观察者之间的一致性较高，但NI 1级的一致性较差。这突出了临床上明确导致NI 1级的组织学特征的必要性。
