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Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn's Disease.
Gastroenterology ( IF 25.7 ) Pub Date : 2019-07-20 , DOI: 10.1053/j.gastro.2019.07.027
Pieter Hindryckx 1 , Vipul Jairath 2 , Guangyong Zou 3 , Brian G Feagan 2 , William J Sandborn 4 , Jaap Stoker 5 , Reena Khanna 6 , Larry Stitt 3 , Tanja van Viegen 7 , Lisa M Shackelton 7 , Stuart A Taylor 8 , Cynthia Santillan 9 , Banafsche Mearadji 5 , Geert D'Haens 10 , Marie-Paule Richard 11 , Julian Panes 12 , Jordi Rimola 13
Affiliation  

BACKGROUND & AIMS There is no validated magnetic resonance imaging (MRI) index for assessment of perianal fistulas in patients with Crohn's disease (CD). We developed and internally validated a new instrument. METHODS We used paired baseline and week-24 MRI scans from 160 participants in a randomized placebo-controlled trial of stem cell therapy for patients with perianal fistulizing CD. Four radiologists scored disease activity using index items identified during previous studies and exploratory items. Reliability was assessed using intraclass correlation coefficients. We developed an index using backward elimination linear regression analysis, in which potential independent variables were items having intraclass correlation coefficients of at least 0.4 and the dependent variable was perianal fistulizing disease activity, measured on a 100-mm visual analogue scale. The final model was internally validated using the .632 bootstrap method to correct model optimism and quantify calibration accuracy. We evaluated responsiveness of the index by assessing longitudinal validity and estimating standardized effect sizes. RESULTS We developed the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) using 6 items. The optimism-corrected R2 of the model was 0.71, which was comparable to R2 for the original sample (0.74). The calibration slope for the model was 0.98. Compared with the original and modified versions of the Van Assche Index, the MAGNIFI-CD had improved operating characteristics. Estimates of intraclass correlation coefficients for MAGNIFI-CD, the modified Van Assche Index, and Van Assche Index were 0.85 (95% confidence interval [CI], 0.77-0.90), 0.81 (95% CI, 0.74-0.86), and 0.81 (95% CI, 0.71-0.86) for intra-rater reliability, and 0.74 (95% CI, 0.63-0.80), 0.67 (95% CI, 0.55-0.75) and 0.68 (95% CI, 0.56-0.77) for inter-rater reliability. Corresponding standardized effect size estimates were 1.02 (95% CI, 0.65-1.39), 0.84 (95% CI, 0.48-1.21), and 0.68 (95% CI, 0.33-1.03). CONCLUSIONS We developed an index called the MAGNIFI-CD, which is based on 6 items. It assesses MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to previous indices. This index may be used as an outcome measure in clinical trials comparing treatment effects in patients with perianal fistulizing CD. Although the performance of the MAGNIFI-CD indicates its stability and reasonable external validity, external validation is needed.

中文翻译:

磁共振指数在克罗恩病患者中评估瘘管的开发和验证。

背景与目的目前尚无用于评估克罗恩病(CD)患者肛周瘘管的经过验证的磁共振成像(MRI)指数。我们开发并在内部验证了一种新仪器。方法我们在160名参与者的成年安慰剂对照随机对照试验中,对肛周瘘管CD患者进行了基线和第24周MRI扫描配对。四位放射科医生使用先前研究中确定的指标项目和探索性项目对疾病活动进行了评分。使用组内相关系数评估可靠性。我们使用反向消除线性回归分析开发了一个指数,其中潜在的独立变量是类别内相关系数至少为0.4的项,而因变量是肛周瘘管疾病的活动,以100毫米视觉模拟标尺测量。使用.632引导程序方法对内部模型进行内部验证,以校正模型的乐观度并量化校准精度。我们通过评估纵向有效性和评估标准化效应量来评估该指标的响应度。结果我们使用6个项目开发了用于CD瘘管成像的磁共振新指标(MAGNIFI-CD)。乐观校正后的模型的R2为0.71,与原始样品的R2(0.74)不相上下。该模型的校准斜率为0.98。与Van Assche索引的原始版本和修改版本相比,MAGNIFI-CD具有改进的操作特性。MAGNIFI-CD,改良的Van Assche指数和Van Assche指数的类内相关系数估计为0.85(95%置信区间[CI],0.77-0.90),评估者内部可靠性分别为0.81(95%CI,0.74-0.86)和0.81(95%CI,0.71-0.86),以及0.74(95%CI,0.63-0.80),0.67(95%CI,0.55-0.75)和0.68(95%CI,0.56-0.77)以确保评估者之间的可靠性。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。评估者内部可靠性为81(95%CI,0.71-0.86),对于评估者内部可靠性为0.74(95%CI,0.63-0.80),0.67(95%CI,0.55-0.75)和0.68(95%CI,0.56-0.77)评估者之间的可靠性。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。评估者内部可靠性为81(95%CI,0.71-0.86),对于评估者内部可靠性为0.74(95%CI,0.63-0.80),0.67(95%CI,0.55-0.75)和0.68(95%CI,0.56-0.77)评估者间的可靠性。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。63-0.80),0.67(95%CI,0.55-0.75)和0.68(95%CI,0.56-0.77)以确保评估者之间的可靠性。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。63-0.80),0.67(95%CI,0.55-0.75)和0.68(95%CI,0.56-0.77)以确保评估者之间的可靠性。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。相应的标准化效应量估计值为1.02(95%CI,0.65-1.39),0.84(95%CI,0.48-1.21)和0.68(95%CI,0.33-1.03)。结论我们开发了一个名为MAGNIFI-CD的索引,该索引基于6个项目。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。它评估MRI数据并确定肛周瘘管CD活动性(与以前的指标相比有改善)。该指数可用作临床试验中比较肛周瘘管CD患者治疗效果的结果指标。尽管MAGNIFI-CD的性能表明其稳定性和合理的外部有效性,但仍需要外部验证。
更新日期:2019-11-18
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