为使用成年代理报告制定基于共识的考虑:一个ISOQOL工作组倡议的ISOQOL工作组倡议
Brittany Lapin1,2, Matthew L Cohen3, Nadia Corsini4
1Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Avenue, JJN3, Cleveland, OH, 44195, USA. LapinB@ccf.org.
Journal of patient-reported outcomes
|June 2, 2023
概括
成年人群中的代理报告缺乏明确的指导方针. 这项研究制定了一个检查清单,以帮助研究人员和临床医生在研究和临床护理中有效地使用代理,解决数据收集和报告不一致的问题.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床流行病学临床流行病学
- 患者报告的结果
背景情况:
- 代理报告在研究和临床护理中使用,当患者无法自我报告结果时.
- 在成年人群中代理报告的现有方法指南很少.
- 关于代理选择,数据收集,分析和报告存在缺乏清晰度.
研究的目的:
- 审查有关代理报告的现有文档和临床结果评估措施.
- 在成年人群中制定基于共识的考虑,以使用代理报告.
主要方法:
- 组建了一个具有代理使用专业知识的国际专家小组.
- 对监管,专业和个人措施来源进行了有针对性的审查.
- 使用标准化收集表格提取与代理相关的信息.
主要成果:
- 在39个来源中,代理的定义和特征是不一致的.
- 监管文件定义了代理,但不鼓励使用它们,承认了例外情况.
- 许多来源缺乏关于代理选择,使用上下文,可报告域名和数据报告的指导.
结论:
- 在捕获,解释和报告来自成年人群中的代理数据方面存在显著的缺乏清晰度.
- 为帮助研究人员和临床医生制定了考虑因素的清单.
- 需要进一步的指导和未来的研究来改善代理报告实践.
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