在临床研究中测量粘膜皮虫结局:一个范围审查
Billal Tedbirt1, Eva W H Korte2, Marjolein A J Hiel2
1Department of Dermatology, Centre de Reference des Maladies Bulleuses Autoimmunes, Rouen University Hospital and INSERM U1234, Normandie University, CHU Rouen, 1 Rue de Germont, 76031, Rouen Cedex, France. billal.tedbirt@chu-rouen.fr.
Clinical drug investigation
|September 23, 2025
概括
这次范围审查确定了粘膜皮虫病 (MMP) 研究的285个结局. 标准化结果测量和纳入患者观点对于未来的MMP研究至关重要.
科学领域:
- 自身免疫性公牛性疾病
- 皮肤病学 皮肤病学
- 临床结果研究研究的临床结果.
背景情况:
- 粘膜皮炎 (MMP) 是一种罕见的自身免疫性疾病,影响粘膜.
- 目前的MMP治疗缺乏强有力的证据,并且可以耐受不良,特别是在老年患者中.
研究的目的:
- 综合地绘制和列出过去二十年来MMP的所有报告结果和结果测量工具 (OMI).
- 在科学文献中提供MMP结果测量的概述.
主要方法:
- 在主要的科学数据库和临床试验注册表中进行了广泛的范围审查.
- 包括的研究跨越2002年1月至2023年12月,重点是临床试验,前性队列研究和系统审查.
主要成果:
- 包括39项研究,产生了285个不同的结果,分为29个领域.
- 共同的结果领域包括临床反应,安全和资源使用. 研究人员报告的结果占主导地位 (85%),患者报告的结果有限 (8%).
- 使用了各种各样的OMI,由于MMP的异质呈现,发现了显著的多样性.
结论:
- 标准化,基于共识的结果定义和高质量的工具对于提高MMP研究有效性至关重要.
- 纳入患者的观点和批判性地评估OMI测量属性是未来研究的关键建议.
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