社区咨询和公开披露用于输管镇静剂选择的随机试验
Ariel A Lewis1, Tiffany L Israel2, Kevin P Seitz3
1Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN.
medRxiv : the preprint server for health sciences
|November 19, 2025
概括
社区参与紧急研究试验,使用知情同意例外 (EFIC) 达到了超过120万人. 虽然比以前的研究成本更低,但这些公众商努力仍然是重大投资.
科学领域:
- 临床试验 临床试验
- 紧急医疗 紧急医疗
- 公共卫生 公共卫生
背景情况:
- 对于紧急治疗的随机试验可以在潜在的同意不可行时使用知情同意的例外 (EFIC).
- 在注册开始之前,EFIC试验需要社区咨询和公开披露.
- 输管选择镇静剂的随机试验 (RSI) 是一项大型的EFIC试验,在14个美国地点进行.
研究的目的:
- 报告在RSI试验中用于社区咨询和公开披露的具体方法.
- 详细说明参与社区进行EFIC试验的方法和结果.
主要方法:
- 社区咨询和公开披露在5个区域注册站点组中的每一个地方执行.
- 一个中央协调中心提供了标准化模板和一个参与协调员来支持特定地点的计划.
- 方法包括面对面的调查,市政厅,社交媒体活动,专门的试验网站,传单和传统媒体宣传.
主要成果:
- 社区咨询和公开披露活动于2021年2月至2024年6月进行.
- 调查了789多名患者/家庭,并邀请了200多个当地团体参加参与活动.
- 通过社交媒体,网站,传单和媒体功能,公开披露的努力达到了超过120万个人.
结论:
- 在RSI试验中,试验前的社区参与涉及1000多名患者,家庭和社区成员.
- 公开披露举措成功覆盖了120多万个人.
- 虽然成本和持续时间低于EFIC之前的试验,但财务和时间投资仍然很大.
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