如何使用疹核心结果集的协调结果措施用于亚托皮炎试验:用户指南
Kim S Thomas1, Laura Howells1, Yael A Leshem2,3
1Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
The British journal of dermatology
|December 20, 2023
概括
对湿疹的协调结果措施 (HOME) 核心结果集 (COS) 为亚托皮炎 (AD) 试验提供了指导. 这确保了统一的数据收集和报告,改善了湿疹研究和患者护理.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 结果测量 结果测量
背景情况:
- 对湿疹的协调结果措施 (HOME) 倡议为亚托皮炎 (AD) 临床试验建立了一个核心结果集 (COS).
- 需要指导,以增加家庭成本的采用和有效使用.
研究的目的:
- 提供关于在AD临床试验中实施HOME COS的实用建议.
- 解决有关HOME COS的常见问题,包括获得工具和培训要求.
- 为样本大小计算提供数据,并促进标准化报告.
主要方法:
- 为使用HOME COS的调查人员制定实用指南.
- 关于 HOME COS 的常见问题答案汇编.
- 在湿疹试验中包含样本大小计算的示例数据.
主要成果:
- 为计划AD临床试验的研究人员提供了实际指导.
- 澄清了获取结果测量工具和必要培训的信息.
- 提供示例数据,以帮助在湿疹研究的样本大小计算.
结论:
- 广泛采用HOME COS将导致更全面的试验结果.
- 对结果数据的标准化报告将促进元分析.
- 改进的临床试验数据最终将提高患者对疹患者的护理.
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