临床研究中脑膜瘤的核心结果集 (COSMIC):研究研究的国际患者和医疗保健专业的共识
Christopher P Millward1,2, Terri S Armstrong3, Sabrina Bell4,5
1Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Neuro-oncology practice
|August 15, 2025
概括
为了在临床试验中标准化结果测量,开发了内膜瘤的两个核心结果集 (COS). 这些集合确保对有效性和观察性研究的关键数据的一致报告.
科学领域:
- 神经瘤学神经瘤学
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 核心结果集 (COS) 为特定健康状况的临床试验标准化结果测量.
- 内膜瘤研究需要标准化的结果报告,以提高研究的可比性.
- 开发了两种不同的COS:COSMIC:对有效性试验的干预和COSMIC:对偶然/未经治疗的脑膜瘤的观察.
研究的目的:
- 为内膜瘤开发两个核心结果集 (COS).
- 确保在未来的临床研究中一致测量和报告关键结果.
- 促进对治疗有效性和脑膜瘤的观察性研究进行标准化数据收集.
主要方法:
- 成立一个国际研究咨询小组,以多元化利益相关方的代表.
- 利用eDelphi调查收集国际参与者对结果重要性的评级.
- 进行在线共识会议,批准最终的核心成果集.
主要成果:
- 在COSMIC:干预调查中,从199名参与者的投入后,包括15个结果.
- 在COSMIC:观察调查中,在129名参与者的投入后,包括16个结果.
- 两组人都有八个核心结果,包括瘤生长,功能,生活质量和生存指标. 角色和社会功能是观察集的特点.
结论:
- 开发的COS将确保在未来的脑膜瘤临床研究中对利益相关者决定的结果进行一致的测量和报告.
- 跨研究的标准化结果报告将提高研究结果的可比性和可靠性.
- 这些COS的摄入对于促进对内膜瘤的理解和管理至关重要.
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