相关实验视频
一个核心领域为pyoderma gangrenosum试验结果的核心领域:来自UPGRADE倡议的国际eDelphi和共识研究
Michael E Jacobson1, Jonathan W Rick2, Louise A A Gerbens3
1Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
The British journal of dermatology
|November 12, 2023
概括
这项研究建立了一个核心领域,用于pyoderma gangrenosum临床试验. 关键结果包括疼痛,生活质量和临床症状,以标准化对这种罕见皮肤疾病的研究.
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
- 结果测量 结果测量
背景情况:
- 皮肤病 (PG) 是一种罕见的性皮肤病,缺乏标准化的结果测量方法.
- 标准化对于评估新疗法至关重要,因为越来越多的研究管道.
- 核心结果集 (COS) 确保在临床试验中进行一致的测量.
研究的目的:
- 建立关于临床试验的必要领域的共识. 在 pyoderma gangrenosum.
- 为了开发"了解白皮病:疾病影响的审查和分析" (UPGRADE) 核心领域集.
- 提高PG研究中的数据质量和可解释性.
主要方法:
- 系统的文献审查和合作讨论确定了115个项目.
- 参与患者和专家的国际eDelphi实验优先考虑的领域.
- 协商一致会议根据参与者投票改进了核心领域集.
主要成果:
- 从最初的项目中提取了15个潜在的域名.
- "疼痛"",生活质量"和"临床症状"作为核心领域达成共识.
- "疾病过程/疾病进展"需要进一步细化以供未来考虑.
结论:
- 针对PG临床试验的UPGRADE核心领域已通过国际共识建立.
- 未来的努力将集中在为这些领域开发和选择结果测量工具上.
- 这种标准化将促进对新型PG疗法的一致评估.
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