精神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.
PLoS medicine
|April 28, 2025
概括
更新的SPIRIT 2025指南增强了随机试验协议,包括关于开放科学和患者参与的新项目,为所有利益相关者提高了透明度.
科学领域:
- 临床试验 临床试验
- 研究方法研究方法研究方法学
- 科学报告科学报告
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.
- 现有的协议在关键设计和行为元素中往往缺乏完整性.
- 2013年建立了SPIRIT (标准协议项目:干预试验建议) 声明,以提高协议的完整性.
研究的目的:
- 系统地更新 SPIRIT 关于随机试验协议中最低项目的建议.
- 确保SPIRIT指南与不断变化的证据和最佳实践保持一致.
主要方法:
- 使用范围审查和项目特定数据库来确定SPIRIT检查清单的潜在变化.
- 纳入了SPIRIT/CONSORT扩展和其他报告准则的建议.
- 进行了三轮的Delphi调查,共有317名参与者,并与30名专家举行了共识会议.
主要成果:
- "SPIRIT 2025"声明包括34个基于证据的临床试验协议的最低项目.
- 关键的更新包括一个新的开放科学部分,加强对危害和比较器的关注,以及患者参与.
- 一个新的项目涉及患者和公众参与试验设计,进行和报告.
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.
- 广泛采用可以使研究人员,参与者,资助者和监管机构受益.
- 增强的协议促进了更好的研究规划,进行,报告和外部审查.
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