在临床研究中纳入患者报告结果的伦理考虑:PRO伦理准则
Samantha Cruz Rivera1,2,3, Olalekan Lee Aiyegbusi1,2,4, Jonathan Ives5
1Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
JAMA
|May 17, 2022
概括
临床研究中患者报告结果的新伦理准则旨在确保高质量的数据. 这些指导方针解决了关键的伦理问题,以保护参与者和研究人员,加强在医疗保健决策和政策中使用PRO.
科学领域:
- 医疗服务研究
- 临床研究伦理
- 患者报告的结果
背景情况:
- 患者报告的结果对于医疗保健决策,政策和个性化护理至关重要.
- 越来越多的PRO需要在临床研究中解决相关的伦理问题.
- 现有的道德框架可能无法完全应对PRO实施的独特挑战.
研究的目的:
- 专门为在临床研究中使用PRO制定基于共识的国际伦理准则.
- 提供一个标准化的框架来解决整个PRO生命周期的伦理问题.
- 加强PRO在医疗保健和研究中的负责任和有效整合.
主要方法:
- 对PRO在临床研究中的伦理影响进行了系统审查.
- 采用了96名参与者的国际德尔菲进程和25名参与者的共识会议.
- 准则的制定遵循了EQUATOR网络的框架,并纳入了SPIRIT-PRO扩展的建议.
主要成果:
- 通过共识制定了一套全面的PRO特定的道德准则.
- 其中重点领域包括研究理由,数据监测,参与者负担和传播.
- 这些指导方针涵盖了诸如PRO评估时间表,缺少的数据以及患者合作伙伴的参与等问题.
结论:
- 开发的PRO伦理准则为PRO临床研究中的伦理问题提供了建议.
- 遵守这些准则可以确保高质量的PRO数据收集.
- 解决这些道德问题可以最大限度地降低参与者的风险和伤害,保护整体福利.
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