关于手湿疹试验的核心领域的共识:迹象,症状,控制和生活质量
Henriette Rönsch1, Karl Philipp Drewitz2, Amber Reck Atwater3,4
1Department of Dermatology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
概括
这项研究确定了手湿疹 (HE) 试验的核心结果领域,重点关注迹象,症状,生活质量和疾病控制. 这些标准化措施将提高手湿疹研究的可比性.
科学领域:
- 皮肤病学 皮肤病学
- 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:
- 手湿疹 (HE) 是一种普遍且复杂的皮肤病.
- 缺乏统一的核心结果阻碍了跨 HE 临床试验的比较.
研究的目的:
- 为了在未来手湿疹治疗试验中测量结果,就必要的领域和子领域达成共识.
主要方法:
- 两轮国际在线Delphi调查 (eDelphi) 涉及高等教育专家,包括医生,患者和研究人员.
- 达成共识的标准:包含≥80%的协议,排除≤50%;在混合会议上讨论有争议的项目.
主要成果:
- 在核心领域达成共识:"HE的迹象" (5个子域),"HE的症状" (2个子域),"HE相关的生活质量" (4个子域) 和"HE控制时间" (4个子域).
- "脱皮/化"和"情绪影响/心理健康"是有争议的子领域.
- "皮肤屏障功能"和"患者报告的治疗经验"的领域被排除在核心集之外.
结论:
- 未来的HE试验应该标准化HE标志,症状,生活质量和疾病控制的测量,以获得可比和有意义的结果.
- 手湿疹核心成果集 (HECOS) 倡议现在将专注于确定适当的测量仪器.
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