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. anwen.chan@utoronto.ca.
Nature medicine
|April 28, 2025
概括
这项研究更新了标准协议项目:对干预试验的建议 (SPIRIT) 2025声明,以提高随机试验协议的完整性. 修订后的指导方针提高了透明度和报告,以改善临床研究.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究诚信和报告标准研究诚信和报告标准
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,但往往缺乏完整性.
- 2013年的SPIRIT (标准协议项目:干预试验建议) 声明提供了改善协议完整性的指导.
- 定期更新是必要的,以确保SPIRIT指南与不断变化的证据和最佳实践保持相关性.
研究的目的:
- 系统地更新 SPIRIT 对随机试验协议所需的最低项目的建议.
- 提高临床试验协议的透明度,完整性和质量.
- 确保SPIRIT指南保持时效,适用于现代研究需求.
主要方法:
- 使用范围审查和项目特定数据库来确定SPIRIT 2013检查清单的潜在变化.
- 通过SPIRIT/CONSORT扩展和其他报告准则 (例如TIDieR) 的首席作者来丰富建议.
- 在3轮的Delphi调查中,共有317名参与者,随后是30名专家的共识会议,最终完成了修改.
主要成果:
- 更新的SPIRIT 2025声明包括34个最低项目,时间表图,扩展的检查清单和解释/编制文件.
- 关键的变化包括一个新的开放科学部分,加强对评估危害和描述干预措施/比较器的重视,以及患者/公众参与项目.
- 更新包括添加两个新项目,修订五个,并删除/合并前一个版本的五个项目.
结论:
- 更新的SPIRIT 2025声明提供了基于证据的建议,以提高随机试验协议的完整性和透明度.
- 预计SPIRIT 2025的广泛采用将使研究人员,参与者,资助者,监管机构和其他利益相关者受益.
- 修订后的指导方针旨在提高干预试验报告的整体质量和可靠性.
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