疾病活动指数在儿科炎性肠病中的操作性质:系统性审查
Ruben J Colman1, Virginia Solitano2,3,4, John K MacDonald4
1Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Stanford University School of Medicine, USA.
Inflammatory bowel diseases
|March 28, 2024
概括
准确的疾病活动指数对于儿科炎性肠病 (pIBD) 药物试验至关重要. 这次审查发现索引属性的显著差异,突出了在pIBD研究中需要改进工具的需要.
科学领域:
- 儿科胃肠病学 儿科胃肠病学
- 临床试验方法论 临床试验方法论
- 炎症性肠道疾病研究研究
背景情况:
- 准确的疾病活动指数对于儿科炎性肠病 (pIBD) 药物开发和治疗至关重要.
- 这项研究旨在确定和评估pIBD随机对照试验 (RCT) 中使用的指数.
研究的目的:
- 确定在pIBD RCT中使用的所有评分指数.
- 批判性地评估这些指标的运行特性,包括有效性,可靠性,响应性和可行性.
主要方法:
- 在 MEDLINE,EMBASE 和 CENTRAL 数据库中进行全面的文献搜索,截至 2022 年 12 月 6 日.
- 包括评估临床,内镜,成像或患者报告的结果测量 (PROM) 在pIBD (克罗恩氏病和性结肠炎) 的研究.
- 对符合条件的指数的有效性,可靠性,响应性和可行性的系统总结.
主要成果:
- 确定了70个RCT,其中41项研究报告了14个指数的属性 (克罗恩病9项,性结肠炎5项).
- 儿科克罗恩病活动指数 (PCDAI) 显示出可变的有效性和可靠性,整体可行性较低.
- 与PCDAI相比,粘膜炎非侵入性指数显示出优越的操作特性;其他指数,如克罗恩病简化内镜粘膜评估和儿科性结肠炎活动指数显示出有希望的结果,但需要进一步评估.
结论:
- 对pIBD临床试验终点的操作性质有很大差异.
- 显然需要进一步验证和开发用于pIBD研究的新指数.
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