在分散的随机对照试验中评估报告的完整性和特征:一个范围审查协议
Juntao Wang1, Shuhui Li1, Chen Zhao2
1School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
本研究使用新的检查清单来评估分散的随机对照试验 (RCT) 中报告的完整性. 结果将为这些不断变化的试验设计提供改进的CONSORT报告准则.
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗信息学 医疗信息学
- 基于证据的医学基于证据的医学.
背景情况:
- 由于远程技术的进步,分散的临床试验 (DCT) 正在迅速增加.
- 现有的CONSORT 2025指南面临着解决DCT特定报告需求的挑战.
- 本研究解决了在分散的随机对照试验中加强报告标准的需要.
研究的目的:
- 评估分散的随机对照试验的报告特征和完整性.
- 为了确定DCT当前的报告缺口.
- 为DCT制定CONSORT扩展指南提供信息.
主要方法:
- 在2023年出版的六个数据库中对DCT进行系统搜索.
- 使用定制的26项"CONSORT-DRCT"检查清单评估报告的完整性,重点关注分散的元素和干预细节.
- 由两名研究人员进行的独立审查,计算了评审者间的协议,随后进行了描述性和子组分析.
主要成果:
- (结果将在研究完成后填写)
结论:
- 该协议为审查DCT报告质量提供了一个框架.
- 预计这些发现将为完善 CONSORT 对分散的随机对照试验的指导方针提供见解.
- 改进的报告标准将提高DCT的透明度和可靠性.
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