SPIRIT 2025声明:随机试验协议的更新指南
An-Wen Chan1, Isabelle Boutron2,3, Sally Hopewell4
1Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
JAMA
|April 28, 2025
概括
更新的SPIRIT 2025声明为完整的随机试验方案提供了基于证据的指导. 这确保了对所有利益相关者的透明度,并提高了临床试验设计和报告的质量.
科学领域:
- 临床试验方法
- 研究报告标准
背景情况:
- 随机试验协议对于研究规划,进行和报告至关重要.
- 现有的协议通常缺乏关键设计和行为元素的完整性.
- 为了提高协议的完整性,SPIRIT (标准协议项目:干预试验建议) 声明于2013年制定.
研究的目的:
- 系统地更新随机试验协议中最低项目的SPIRIT建议.
- 通过结合最新的证据和最佳实践,确保指南保持相关性.
主要方法:
- 进行了范围审查和证据数据库,以确定SPIRIT 2013检查清单的潜在变化.
- 包括SPIRIT/CONSORT扩展和其他报告准则的建议.
- 在3轮的德尔菲调查中,317名参与者和30名专家的共识会议进行了修订.
主要成果:
- 更新的SPIRIT 2025声明包括34个试验协议的最低项目.
- 主要变化包括一个新的开放科学部分,加强对危害和干预描述的关注,以及患者/公众参与项目.
- 一个扩展的检查清单和解释/编制文档已被开发用于实施.
结论:
- 更新的SPIRIT 2025声明旨在提高随机试验协议的透明度和完整性.
- 广泛遵守可以使研究人员,参与者,资助者,道德委员会,期刊和政策制定者受益.
- 这一修订确保了指导与不断变化的研究标准和实践保持一致.
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