神经外科手术的核心结果:为肘部神经病变开发了一个核心结果集
Thomas J Wilson1, Gavin A Davis2, Nora F Dengler3
11Department of Neurosurgery, Stanford University, Stanford, California.
Journal of neurosurgery
|October 25, 2023
概括
一个新的核心结果集 (COS-UNE) 的神经病在肘部 (UNE) 已开发,以标准化报告. 这种以共识为导向的方法旨在提高研究的一致性,并促进对这种常见疾病的治疗比较.
科学领域:
- 神经外科 神经外科
- 神经学 神经学
- 临床试验设计 临床试验设计
背景情况:
- 肘部神经病变 (UNE) 影响1%-6%的人口,但缺乏标准化的治疗共识.
- 现有文献中不一致的结果报告阻碍了比较研究和元分析.
- 需要一个核心结果集 (COS) 来解决这些报告不一致性对UNE研究.
研究的目的:
- 为肘部神经病变 (COS-UNE) 制定一个核心结局.
- 为UNE研究建立标准化的成果指标和定义.
- 提高对UNE的临床研究的质量和可比性.
主要方法:
- 根据COS-STAD的建议,采用了5个阶段的修改后的Delphi方法.
- 该联盟的开发涉及来自11个国家的21名神经外科医生.
- 进行了文献审查,德尔菲调查以获得结果和定义共识,并举行了最终的共识会议.
主要成果:
- 最终的COS-UNE包括22个数据点,涉及人口统计,诊断,患者报告的结果,运动/感官功能和并发症.
- 建立了标准化的仪器,测试方法和定义.
- 协商一致的随访时间为手术前和手术后的3,6个月和12个月,至少为6个月.
结论:
- 开发的COS-UNE为未来对UNE的神经外科研究提供了最低的数据集.
- 标准化报告将提高一致性,并促进UNE研究中的元分析.
- 作者主张将COS-UNE纳入常规临床实践和研究设计.
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