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, ON, M5S 1B2, Canada anwen.chan@utoronto.ca.
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. 合规提高了所有利益相关者的透明度和完整性.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究诚信和报告工作
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.
- 该SPIRIT (标准协议项目:干预试验建议) 声明是在2013年开发的,以提高协议的完整性.
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.
- 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:
- 使用范围审查和证据数据库来确定SPIRIT检查清单的潜在变化.
- 综合了SPIRIT/CONSORT扩展和其他报告准则的建议.
- 参与317名参与者的三轮Delphi调查和30名专家的共识会议完善了拟议的修改.
主要成果:
- 更新的SPIRIT 2025声明包括34个基于证据的临床试验协议的最低项目.
- 关键的变化包括一个新的开放科学部分,加强对危害和比较者的关注,以及一个关于患者和公众参与的新项目.
- 更新还包括修订的检查列表,时间表图,扩展的检查列表和解释/编制文件.
结论:
- 广泛采用SPIRIT 2025声明可以显著提高随机试验协议的透明度和完整性.
- 增强的协议有利于调查人员,参与者,资助者,道德委员会,期刊和政策制定者.
- 更新后的建议旨在加强临床试验证据的可靠性和有用性.
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