康巴特项目:研究协议,用于开发儿童脑瘤患者手术后发病率的核心结局集
Sandhya Trichinopoly Krishna1,2,3, Nicola Harman4, Conor Mallucci5
1Department of Neurosurgery, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. sandhya.krishna1@nhs.net.
Trials
|August 12, 2025
概括
这项研究旨在制定儿童脑瘤手术的核心结果集,以标准化术后不良事件的报告. 这将改善数据的一致性,并使研究和临床实践之间的比较更好.
科学领域:
- 神经瘤学神经瘤学
- 儿科手术 儿科手术
- 临床结果研究研究
背景情况:
- 中枢神经系统瘤是儿童中最常见的固体瘤,也是癌症死亡的主要原因.
- 高发病率与儿科大脑瘤及其治疗有关.
- 目前的术后发病率报告是不一致的,原因是各种结果措施和缺乏共同的语言.
研究的目的:
- 为儿童脑瘤手术开发一个核心结果集 (COS).
- 建立一套标准化的术后结果报告的最低标准.
- 提高儿科神经瘤学病发率数据的一致性和可比性.
主要方法:
- 根据COS-STAD和COS-STAP的建议制定协议.
- 系统的文献审查,以确定报告的不良结果及其测量.
- 与患者和护理人员进行定性访谈,以确定患者重要的结果.
- 与国家和国际利益相关者 (临床医生,研究人员,患者,护理人员) 进行两轮eDelphi调查,以就核心结果达成共识.
- 国际共识会议讨论和最终确定核心成果.
主要成果:
- 该COMBAT (儿童脑瘤的核心术后发病率组) 项目将确定一组核心的不良结果.
- 通过严格的德尔菲过程,将在最关键的术后危害方面达成共识.
- 开发的COS将为结果测量提供标准化的框架.
结论:
- 迫切需要一种标准化的方法来报告儿科脑瘤手术中的术后发病率.
- 在COMBAT项目将建立一个共同的语言来测量和报告手术发病率.
- 这将提高研究和临床实践的质量,促进跨研究和服务的比较.
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