替代内镜阅读范式确定性结肠炎的得分可靠性和效果大小
Walter Reinisch1, Vivek Pradhan2, Saira Ahmad3
1Department of Internal Medicine III, Division Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.
在性结肠炎试验中,内镜梅奥分数的中央读数显示读数之间的可靠性较低. 基于共识的阅读模式显著提高了可靠性,对于准确评估治疗效果至关重要.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 医学成像分析 医学成像分析
背景情况:
- 监管机构主张在性结肠炎 (UC) 临床试验中对内镜进行中央阅读.
- 地方/站点阅读器与中央阅读器的作用仍然不确定.
- 内镜梅奥分数 (eMS) 是UC试验中关键的结果指标.
研究的目的:
- 评估本地和中央确定的eMS的可靠性.
- 评估不同阅读模式对eMS可靠性的影响.
- 为了确定阅读范式对研究效果大小的影响.
主要方法:
- 从图兰多研究 (NCT01620255) 中对eMS数据的回顾性分析.
- 检查七个阅读范式,包括局部阅读器 (LR) 和中央阅读器 (CR1,CR2),包括共识阅读 (ConCR).
- 使用类内相关系数 (ICC) 评估评价者之间的可靠性,以及对内镜改善的影响.
主要成果:
- 两个训练有素的中央阅读器之间的eMS分数超过40%是不一致的.
- 中央阅读器表现出显著的变化 (CR1与CR2ICC:0.475).
- 中央和局部读数之间的一致性是可变的 (LR与CR1 ICC:0.682;LR与CR2 ICC:0.526).
- 包含LR和CR之间共识的阅读范式提高了ICC估计的>0.8.8.
- 在第12周,基于共识的方法产生了超过0.9的ICC估计值,这对于检测治疗差异来说是最有利的.
结论:
- 两个训练有素的eMS中央阅读器之间的ICC是意想不到的低.
- 目前UC试验中的中央阅读过程存在明显的弱点.
- 基于共识的阅读模式提高了可靠性,并且在检测治疗效果方面更优越.
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