专家共识 开发新生儿脑病研究的住院常见数据元素的专家共识方法
Eric S Peeples1,2,3, Ulrike Mietzsch4,5, Eleanor J Molloy6,7
1Department of Pediatrics, University of Nebraska Medical Center, Omaha.
Neurology
|February 9, 2026
概括
研究人员开发了共同数据元素 (CDE),以在全球注册表中标准化新生儿脑病 (NE) 和缺氧缺血脑病 (HIE) 数据收集. 该倡议旨在提高NE和HIE成果研究的质量和可比性.
科学领域:
- 新生儿医学 新生儿医学
- 临床研究方法论临床研究方法论
- 数据科学是数据科学.
背景情况:
- 新生儿脑病变 (NE),包括缺氧缺血脑病变 (HIE),导致全球显著的发病率和死亡率.
- 现有的NE/HIE数据注册表缺乏标准化数据收集,只有0.3%的变量在国际注册表中一致报告.
- 这种不一致性阻碍了对比分析和质量改进工作.
研究的目的:
- 为新生儿脑病变 (NE) 和缺氧缺血脑病变 (HIE) 登记处开发一套标准化常见住院患者数据元素 (CDE).
- 为了实现未来的协调,并提高国际NE/HIE研究小组收集的数据的质量.
主要方法:
- 采用了经过修改的Delphi方法,涉及14名国际NE专家.
- 专家们将1281个先前识别的变量分为"核心"",补充"或"不需要收集".
- 通过共识会议和来自全球注册表领导人和会议与会者的反,清单草案得到了完善.
主要成果:
- 最终建立了164个核心和225个补充CDE的最终组.
- 这些元素分为11个不同的领域,涵盖人口统计,怀孕,分娩,治疗干预和结果.
- 这些领域包括人口统计,怀孕/劳动/分娩,分娩室,运输,酸,治疗性低温,神经监测/发作,神经成像,实验室值,医院过程和出院.
结论:
- 开发的CDE代表了标准化NE/HIE研究和报告的关键一步.
- 标准化将促进该领域更有效,更强大的临床研究.
- 未来的研究应该专注于定义HIE和开发CDE,以获得长期的,以家庭为中心的后续数据.
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