一个国际的Delphi共识报告的设置在迷幻的临床试验
Chloé Pronovost-Morgan1,2,3, Kyle T Greenway4,5,6, Leor Roseman7,8
1Faculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada. chloe.pronovost-morgan@mail.mcgill.ca.
Nature medicine
|June 3, 2025
概括
新的指导方针标准化了迷幻药物临床试验的报告. 心理测试临床试验 (ReSPCT) 准则的报告确保了关键背景的一致记录,提高了研究的严谨性.
科学领域:
- 心理药理学 心理药理学
- 临床研究方法论 临床研究方法论
背景情况:
- 迷幻药物与使用者的精神状态 ("设置") 和环境 ("设置") 显著相互作用.
- 现有的迷幻药研究往往缺乏方法论的严格性来报告这些关键的非药理学因素.
- 需要标准化的报告来提高迷幻药物临床试验的质量和可重复性.
研究的目的:
- 为了产生基于共识的指导方针,报告心理临床研究中的设置变量.
- 建立一个标准化的框架,用于记录心理研究中的环境和上下文因素.
- 在研究中解决当前对"设置和设置"的概念化中的模两可.
主要方法:
- 德尔菲共识研究涉及四轮在线调查,涉及89名国际专家 (研究人员,临床医生,过去的试验参与者).
- 专家们确定,评价,辩论并改进了潜在重要的迷幻设置变量.
- 对于≥70%的专家来说,共识被定义为"重要"或"非常重要".
主要成果:
- 30个非药理学变量达到了共识,并形成了心理临床试验 (ReSPCT) 中设置报告指南.
- ReSPCT指南分为物理环境,剂量治疗程序,治疗框架/协议和主观经验.
- 该研究发现,目前在迷幻研究中对"设置和设置"的理解存在显著的模两可.
结论:
- ReSPCT指导方针为在迷幻药临床研究中设计和记录非药理学变量的新标准.
- 遵守这些准则将提高迷幻研究的方法严谨性和一致性.
- 这些指导方针旨在提高幻觉药物临床试验结果的整体质量和解释性.
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