在针随机对照试验中报告和影响患者报告结果的因素:一个横截面研究协议
Yuting Duan1,2, Pinge Zhao3, Shujuan Liu4
1Sleep Research Institute of Chinese Medicine, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China.
BMJ open
|February 7, 2024
概括
本研究评估了针随机对照试验 (RCT) 中患者报告的结果 (PROs),评估其报告质量和与研究设计元素 (如盲目) 的关系. 这些发现旨在改善针研究中的PRO报告标准.
科学领域:
- 整合和补充医学是整合和补充医学.
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 患者报告的结果 (PROs) 对于从患者的角度评估干预至关重要.
- 在针随机对照试验 (RCT) 中,PRO越来越多地被使用.
- 在针RCT中PRO的报告质量仍然未被检查.
研究的目的:
- 在针RCT中描述PROs.
- 使用CONSORT PRO扩展程序评估PRO的报告质量.
- 在针RCT中探索研究隐藏,盲目和PRO报告之间的关联.
主要方法:
- 在七个数据库 (2012年1月至2022年10月) 中,系统地搜索使用PROs.进行针RCT的文献.
- 提取基本特征,隐藏和盲目的数据.
- 评估PRO报告质量和协会的后勤分析.
主要成果:
- 总结了包括针RCT中的PROs的基本特征.
- 根据CONSORT PRO扩展标准对PRO报告质量的评估.
- 发现了隐藏,蒙蔽和PRO报告之间的关联.
结论:
- 突出了针RCT中PRO报告质量的变化.
- 提供了对影响PRO报告的因素的见解.
- 为提高针研究中的PRO报告标准提出建议.
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