对湿疹的协调结果措施 (HOME) 实施路线图
Yael A Leshem1,2, Eric L Simpson3, Christian Apfelbacher4,5
1Division of Dermatology, Rabin Medical Center, Petach-Tikva, Israel.
The British journal of dermatology
|August 7, 2023
概括
在临床试验中实施核心结果集 (COS) 是一个挑战. "HOME路线图"为制定改善COS采用和研究中一致报告的策略提供了实用指南.
科学领域:
- 临床试验方法论 临床试验方法论
- 健康研究成果研究结果
- 皮肤病学研究 皮肤病学研究
背景情况:
- 核心结果集 (COS) 标准化临床试验的最低结果,以减少异质性和选择性报告.
- 将COS应用于临床试验具有重大挑战,特别是在皮肤病学方面缺乏具体指导.
研究的目的:
- 为实施核心成果集 (COS) 制定一个结构化,实用的路线图.
主要方法:
- 埃克齐马 (HOME) 协调结果测量委员会的专家意见.
- 关于COS实施和有效性试验 (COMET) 资源中的核心成果措施的文献综述.
- 综合包括障碍物,促进者和实施科学原则在内的主题.
主要成果:
- HOME实施路线图包括三个阶段:定义范围和目标,在COS开发期间准备实施,并代地纳入研究.
- 实施项目的关键主题包括利益相关者的参与,普遍适用性和减少行政负担.
- 实施策略应由正式的框架提供信息,并进行反复评估和调整.
结论:
- 持续使用和报告COS对于提高研究质量和临床实践适用性至关重要.
- "HOME实施路线图"提供了一个务实的框架,指导制定有效的COS实施策略.
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