在非药物,非手术试验中建立国际共识 报告干预指南 准确性:ReFiND协议
Luis Fernando Sousa Filho1, Melanie K Farlie1, Terry Haines1
1School of Primary and Allied Health Care, Monash University, Melbourne, Australia.
Contemporary clinical trials
|May 16, 2024
概括
本研究概述了关于非药物,非手术干预 (ReFiND) 报告准则的发展. ReFiND旨在提高非药物干预的临床试验的透明度和可重复性.
科学领域:
- 临床试验方法论 临床试验方法论
- 干预准确性报告的干预准确性报告
- 卫生研究透明度 卫生研究透明度
背景情况:
- 在试验中对干预准确性的报告不足,妨碍了透明度和可重复性.
- 大多数非药物,非手术干预的试验缺乏全面的准确性报告.
- 报告准确度不佳会掩盖经过测试的干预组件和实施细节.
研究的目的:
- 描述一个新的报告准则的开发过程,以保证干预准确性.
- 建立一种标准化的方法,用于报告非药物,非手术干预试验中的真实性.
- 提高涉及非药物干预的研究的透明度和可重复性.
主要方法:
- 通过六个阶段的过程,制定非药物,非手术干预 (ReFiND) 报告准则的准确性.
- 组建一个指导方针开发小组.
- 进行现有忠诚指导文件的范围审查.
- 使用Delphi研究来达成对报告项目的共识.
- 召开共识会议,最终确定指南内容.
- 开发传播和实施战略.
主要成果:
- 详细介绍了ReFiND指南开发协议的细节.
- 为制定指南,概述了一个涉及专家共识的全面过程.
- 该协议包括范围审查,德尔菲研究,共识会议和传播计划的阶段.
结论:
- 该ReFiND指南将提供共识开发的一系列项目,以改善试验中的忠实性报告.
- 该指南预计将大大提高非药物,非手术干预研究的透明度和可重复性.
- 改进的报告将有助于了解哪些干预组件得到了有效的测试和实施.
相关概念视频
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