对复杂性肛周瘘克罗恩病患者的 MAGNIFI-CD 指数进行外部验证。

IF 4.7 2区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING European Radiology Pub Date : 2025-03-01 Epub Date: 2024-08-30 DOI:10.1007/s00330-024-11029-3
Kim J Beek, Lieven G M Mulders, Kyra L van Rijn, Karin Horsthuis, Jeroen A W Tielbeek, Christianne J Buskens, Geert R D'Haens, Krisztina B Gecse, Jaap Stoker
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引用次数: 0

摘要

背景:对肛周瘘性克罗恩病(pfCD)进行客观治疗监测的需求与日俱增。因此,我们设计了用于克罗恩病瘘管成像的磁共振新指数(MAGNIFI-CD),并在 ADMIRE-CD 试验队列中进行了内部验证。本研究旨在对 MAGNIFI-CD 指数进行外部验证,以监测 pfCD 患者对药物和手术治疗方案的反应:方法:2007 年 1 月至 2021 年 5 月期间,对接受手术和/或药物治疗的连续复杂 pfCD 患者建立了一个回顾性纵向队列,并进行了基线和随访 MRI。MAGNIFI-CD 指数由两名独立的腹部放射科医生进行评分,他们对时间点和临床结果进行了盲测。对临床重要改善的反应性、可靠性和测试准确性进行了评估。根据瘘管引流评估和医生的总体评估,选择了反应和缓解的临界值:共纳入 65 名患者(51% 为女性,中位年龄为 32 岁)。结果显示,MAGNIFI-CD 具有临床相关的反应性,临床缓解者和反应者明显减少,MAGNIFI-CD 的中位数从 18.0 [7.5-20.0] 降至 9.0 [0.8-16.0] (p 结论:MAGNIFI-CD 的临床相关反应性明显降低:MAGNIFI-CD指数是一种反应灵敏、可靠的核磁共振成像评分工具,可用于监测肛周瘘性克罗恩病的治疗情况:MAGNIFI-CD指数是一种结构合理、反应灵敏的评分工具,用于评估瘘管的严重程度和活动性,可定量检测肛瘘性克罗恩病患者治疗反应的变化,从而促进临床试验终点的确定:要点:肛周瘘管化克罗恩病(pfCD)的客观治疗监测需要定义明确的反应和缓解临界值。我们定义了随访 6 个月时缓解和反应的临界值。观察者之间的一致性良好。MAGNIFI-CD指数在治疗监测方面反应灵敏、结果可靠,适合用于临床试验。
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External validation of the MAGNIFI-CD index in patients with complex perianal fistulising Crohn's disease.

Background: There is an increasing need for objective treatment monitoring in perianal fistulising Crohn's disease (pfCD). Therefore, the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) index has been designed and internally validated on the ADMIRE-CD trial cohort. The aim of this study was to externally validate the MAGNIFI-CD index to monitor response to medical and surgical treatment regimens in pfCD.

Methods: A retrospective longitudinal cohort was established of consecutive patients with complex pfCD treated with surgical and/or medical therapy and a baseline and follow-up MRI between January 2007 and May 2021. The MAGNIFI-CD index was scored by two independent, abdominal radiologists blinded for time points and clinical outcomes. Responsiveness, reliability, and test accuracy regarding clinically important improvement were assessed. Cut-offs for response and remission were selected classified on fistula drainage assessment and physician global assessment.

Results: A total of 65 patients (51% female, median age 32 years) were included. A clinically relevant responsiveness of the MAGNIFI-CD was shown, with a significant decrease in clinical remitters and responders with a median MAGNIFI-CD of 18.0 [7.5-20.0] to 9.0 [0.8-16.0] (p < 0.001) and non-significant change in non-responders with a median MAGNIFI-CD of 20.0 [12.0-23.0] to 18.0 [13.0-21.0] (p = 0.22). There was an 'almost perfect' interobserver agreement (ICC = 0.87; 95% CI 0.80-0.92) for the MAGNIFI-CD index. An optimal cut-off value was defined as a decrease of 2 points for clinical response, and a MAGNIFI-CD ≤ 6 for remission at follow-up MRI.

Conclusion: The MAGNIFI-CD index is a responsive and reliable MRI scoring instrument for treatment monitoring in perianal fistulising Crohn's disease.

Clinical relevance statement: The MAGNIFI-CD index is a well-structured, responsive scoring instrument to assess fistula severity and activity that allows quantitative detection of changes in therapy response in patients with perianal fistulising Crohn's disease, thereby facilitating endpoints in clinical trials.

Key points: Well-defined cut-offs for response and remission are needed for objective treatment monitoring of perianal fistulising Crohn's disease (pfCD). Cut-off values for remission and for response at 6 months follow-up were defined. Interobserver agreement was good. The MAGNIFI-CD index is responsive and reliable for treatment monitoring and is suitable for use in clinical trials.

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来源期刊
European Radiology
European Radiology 医学-核医学
CiteScore
11.60
自引率
8.50%
发文量
874
审稿时长
2-4 weeks
期刊介绍: European Radiology (ER) continuously updates scientific knowledge in radiology by publication of strong original articles and state-of-the-art reviews written by leading radiologists. A well balanced combination of review articles, original papers, short communications from European radiological congresses and information on society matters makes ER an indispensable source for current information in this field. This is the Journal of the European Society of Radiology, and the official journal of a number of societies. From 2004-2008 supplements to European Radiology were published under its companion, European Radiology Supplements, ISSN 1613-3749.
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