皮肤质瘤治疗有效性的最低数据集 (MIDSTEP):e-Delphi研究的国际协议,以代表UPGRADE倡议开发临床医生驱动的治疗有效性注册表
Olivia M Haddadin1, Michael E Jacobson2, Diana M Chen3
1School of Medicine, Oregon Health and Science University, Portland, OR, USA.
Archives of dermatological research
|September 27, 2023
概括
开发Pyoderma gangrenosum治疗有效性的最低数据集 (MIDSTEP) 旨在通过为Pyoderma Gangrenosum治疗有效性 (PyGaTE) 注册表创建标准化数据集来改善患者的治疗结果. 这将加强对这种罕见的炎症状况的临床决策和试验设计.
科学领域:
- 皮肤病学 皮肤病学
- 临床流行病学 临床流行病学
- 健康 结果 研究 研究 结果
背景情况:
- 炎症性皮肤炎 (PG) 是一种罕见的,研究不足的炎症性疾病,由于治疗和证据有限,它对患者造成了重大负担和不良结果.
- 对PG治疗的现有临床证据质量不佳,阻碍了患者护理和治疗策略的改进.
- 高质量的数据对于推进PG研究,改善临床决策和为未来临床试验的设计提供信息至关重要.
研究的目的:
- 概述制定治疗甘性皮肤炎治疗有效性的最低数据集 (MIDSTEP) 的协议.
- 建立一个核心数据集,用于PyGaTE国际注册.
- 为改善临床决策,为试验设计提供信息,并促进PG的国际研究,生成真实世界的数据.
主要方法:
- 一个多阶段项目,包括对域名项目生成的文献审查.
- 一个e-Delphi练习,涉及各种利益相关者 (专家,患者,倡导者) 来完成核心数据集.
- 基于COMET指南和既定注册表实践的系统方法.
主要成果:
- 该协议详细介绍了一种分阶段的方法,用于开发一套标准化数据集,以确定PG治疗的有效性.
- 该MIDSTEP项目将以PyGaTE国际登记处为高潮,用于收集真实世界的数据.
- 关于标准化结果的共识和集中数据库将使PG治疗的系统比较和分析成为可能.
结论:
- MIDSTE和PyGaTE注册表旨在生成和传播关键的现实数据,以改善PG患者的治疗结果.
- 标准化数据收集将促进现有治疗方法的基于证据的比较.
- 这一举措有可能开发一种黄金标准的治疗方法来治疗白皮病.
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