随机临床试验的完整性和患者,护理人员和公众的参与:一个覆盖范围的综合性审查
Balázs Juhász1,2, Klejda Harasani3, Sandra Martín-Peláez1,4,5
1Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.
Accountability in research
|August 14, 2025
概括
患者,护理人员和公众参与 (PCPI) 提高了随机临床试验 (RCT) 的完整性. 早期的公民参与对于道德认可和负责任的研究设计,进行和报告至关重要,提高了可信度.
科学领域:
- 临床研究 临床研究
- 医疗保健服务研究 医疗服务研究
- 研究诚信研究诚信
背景情况:
- 患者,护理人员和公众参与 (PCPI) 在研究中越来越多地得到认可.
- 通过PCPI,可以大大提高研究研究的完整性.
- 本综述侧重于PCPI在随机临床试验中的作用.
研究的目的:
- 收集关于PCPI对RCT完整性的贡献的证据.
- 了解PCPI如何影响临床研究中的伦理标准和可信度.
- 发现关于PCPI在出版后问题中的作用的研究缺口.
主要方法:
- 进行了一次覆盖范围的总体审查.
- 2024年7月17日,在三个数据库中进行了搜索.
- 包括针对PCPI和临床研究完整性的系统审查,并使用修改后的AMSTAR-2仪器进行质量评估.
主要成果:
- 确定了27项系统性审查,主要研究的重叠程度较低.
- 包含的评论的质量各不相同,其中21条被评为非常低.
- 调查结果强调了早期公民参与的重要性,PCPI在伦理审批中的作用,以及需要进行研究诚信培训.
结论:
- 证据支持需要一个共识方法来定义PCPI在RCT中的作用.
- 发展这种共识将提高临床研究的可信度和可信度.
- 需要进一步研究PCPI在RCT发布后方面的作用.
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