Artificial Intelligence Analysis of Endoscopy Outperforms Conventional Endoscopic Scoring for Agreement With Symptoms and Quality of Life in a Phase 3 Ulcerative Colitis Trial.

We compared the artificial intelligence (AI) endoscopic cumulative disease score (CDS) with the Mayo endoscopic score (MES) for agreement with symptoms and health related quality of life (HR-QoL) in UC.

我们比较了人工智能（AI）内镜累积疾病评分（CDS）与Mayo内镜评分（MES）在与症状和健康相关生活质量（HR-QoL）的一致性方面。

Methods

Endoscopic video was obtained from TrueNorth, a 52-week phase 3 trial comparing ozanimod (OZA) with placebo (PBO) for UC.

从TrueNorth获取内镜视频，这是一项为期52周的3期临床试验，比较了奥扎莫德（OZA）与安慰剂（PBO）治疗溃疡性结肠炎（UC）的效果。

End of maintenance CDS was compared with endoscopically inactive (MES 0, 1) vs active (MES 2, 3) groups by partial Mayo remission (PMS, ≤2) and treatment using the Mann-Whitney U test.

通过部分Mayo缓解（PMS, ≤2）和治疗，使用Mann-Whitney U检验比较了维持治疗结束时的临床疾病活动度评分（CDS）与内镜下无活动（MES 0, 1）组和活动（MES 2, 3）组。

CDS and MES were compared with EuroQol 5 Dimension HR-QoL measures using the Kruskal-Wallis test.

使用Kruskal-Wallis检验比较了CDS和MES与EuroQol 5维健康相关生活质量(HR-QoL)测量结果。

Low CDS cutoff for PMS remission used the Youden index, with agreement to PMS assessed using Cohen's κ.

使用Youden指数确定了CDS对PMS缓解的低临界值，并使用Cohen的κ评估了与PMS的一致性。

Results

In 387 subjects, among endoscopically active subjects (MES 2, 3), the CDS was lower in those achieving PMS symptomatic remission (83.8 vs 186.9, P < 0.0001).

在387名受试者中，内镜下活动性受试者（MES 2、3）中，达到PMS症状缓解者的临床疾病活动度评分较低（83.8 vs 186.9，P < 0.0001）。

EuroQol 5 Dimension had better agreement with CDS than MES (κ = 0.53 vs 0.44) and detected QoL differences within MES 2, 3 subjects for patient-reported health dimensions.

EuroQol 5维度与临床疾病活动度评分的一致性优于内镜下疾病活动度评分（κ = 0.53 vs 0.44），并且在内镜下疾病活动度评分2、3的受试者中检测到患者报告的健康维度的生活质量差异。

Compared with low endoscopic maximum intensity (MES 0, 1), low-cumulative disease burden (CDS <40, area under the curve 0.85) had better agreement with PMS remission (κ = 0.57 vs 0.72).

与低内镜最大强度（MES 0, 1）相比，低累积疾病负担（CDS <40，曲线下面积0.85）与PMS缓解有更好的一致性（κ = 0.57 vs 0.72）。

When defining adequate endoscopic criteria as PMS remission plus either low MES or low CDS, the difference between OZA vs PBO remission increased from 22.6% to 28.6%.

当将充分的内镜标准定义为PMS缓解加上低MES或低CDS时，OZA与PBO缓解之间的差异从22.6%增加到28.6%。

Discussion

AI-enabled endoscopic scoring has better agreement with symptomatic remission and HR-QoLs compared with MES and could quantitatively redefine adequate mucosal healing.

AI辅助的内镜评分与症状缓解和健康相关生活质量(HR-QoL)有更好的一致性，与MES相比，可以定量重新定义适当的粘膜愈合。