登革热临床试验的核心结果测量组:国际德尔菲共识研究 (DEN-CORE)
Sophie Yacoub1, Anastasia Demidova2, Xin Hui S Chan3
1Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.
The Lancet. Infectious diseases
|October 10, 2025
概括
通过国际共识,为登革热临床试验制定了一个新的核心结果测量套件 (COMS). 这一标准化套件提高了登革热研究的结果可比性和证据综合.
科学领域:
- 热带医学 热带医学
- 传染性疾病 传染性疾病
- 临床试验方法论 临床试验方法论
背景情况:
- 登革热是一种由蚊子传播的快速传播的病毒性疾病,全球发病率不断增加.
- 登革热临床试验结果测量仪器的异质性阻碍了可比性和证据综合.
- 需要一种标准化的方法来协调登革热研究中的结果选择和测量.
研究的目的:
- 根据国际共识,为登革热临床试验制定一个全球相关的核心结果测量套件 (COMS).
- 建立一个标准化的框架,用于登革热研究中的结果选择和测量.
- 改善登革热临床试验中的可比性和证据综合.
主要方法:
- 这项研究遵循了有效性试验中核心结果措施 (COMET) 和核心结果制定标准发展 (COS-STAD) 的指导方针.
- 两阶段的国际共识过程包括系统的文献审查,定性访谈,专家审查,修改的Delphi调查和共识研讨会.
- 来自重症监护专家的投入为重症监护病房 (ICU) 和高依赖病房设置提供了建议.
主要成果:
- 对于住院和早期登革热,最终确定了一套核心结果 (COS),分别包括7个和11个结果.
- 为利用现有的ICU特定的COS用于重症监护试验提出了建议.
- 为九个临床医生报告的结果制定了统一的定义.
结论:
- DEN-CORE COMS提供了一个基于共识的框架,用于协调登革热试验中的结果选择和测量.
- 这种标准化将提高登革热临床试验结果的可比性.
- COMS将支持改善登革热管理的政策和临床决策.
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