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探索受控人类感染模型 (CHIM) 试验中的参与者经验:一项修改后的基础理论研究
Anna G Mack1, Donna M Halperin1,2, Bailey M Selig1
1Canadian Center for Vaccinology, Dalhousie University, IWK Health, Nova Scotia Health, Halifax, Nova Scotia, Canada.
PloS one
|August 6, 2025
概括
建立信任对于受控人类感染模型 (CHIM) 试验的参与者来说至关重要. 这种伙伴关系通过开放的沟通和支持来促进,增强了参与者的体验,并为未来的试验质量改进提供了信息.
科学领域:
- 临床研究 临床研究
- 疫苗学 疫苗学 疫苗学
- 参与者经验 参与者经验
背景情况:
- 控制型人类感染模型 (CHIM) 试验通过感染健康志愿者来加速疫苗开发.
- CHIM试验涉及风险,包括身体,心理和社会伤害,以及长期住院等不舒服的程序.
- 关于CHIM试验中的参与者经验和决策的理解有限.
研究的目的:
- 探索参与者在 Bordetella pertussis 控制的人类感染模型试验中的经验.
- 在CHIM试验中开发参与者旅程的理论模型.
主要方法:
- 在Bordetella pertussis CHIM试验中进行了一项修改的基于理论的研究.
- 26名参与者在一年的参与过程中接受了半结构化采访.
- 在数据收集和分析中使用了恒定的比较方法,直到理论和.
主要成果:
- 核心类别"信任的伙伴关系"出现了,描述了不断发展的参与者-研究人员关系.
- 信任在决策过程中至关重要,建立在透明的沟通和考虑参与者价值观的基础上.
- 持续的参与,情感支持,有效的沟通和对贡献的认可在整个试验阶段都保持了信任.
结论:
- 信任的研究人员与参与者的伙伴关系对于受控人类感染模型试验的经验至关重要.
- 从这项研究中得出的质量改进建议应指导未来的CHIM试验规划和协调.
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