康索尔2025声明:关于随机试验报告的更新指南.
Sally Hopewell1, An-Wen Chan2, Gary S Collins3
1Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford OX3 7LD, UK.
概括
更新的CONSORT 2025声明改进了随机试验报告,包括新项目和开放科学部分. 这为研究人员和读者确保了更清晰,更透明的试验出版物.
科学领域:
- 医学研究方法学 医学研究方法学
- 临床试验报告标准 临床试验报告标准
背景情况:
- 随机试验对于医疗保健证据至关重要,但报告质量往往低于最佳.
- 联合报告试验标准 (CONSORT) 声明旨在提高试验报告的质量.
- 之前的CONSORT版本于1996年,2001年和2010年出版.
研究的目的:
- 为了提交更新的CONSORT 2025声明.
- 将最近的方法进步和用户反纳入报告准则中.
- 提高随机试验报告的清晰度和透明度.
主要方法:
- 使用范围审查和项目特定数据库来识别潜在的检查列表变更.
- 纳入了CONSORT扩展,其他指南 (TIDieR) 和专家沟通的建议.
- 进行了三轮国际Delphi调查,共有317名参与者和30名专家的专家共识会议.
主要成果:
- 对CONSORT检查清单进行了实质性修订,包括增加7个新项目,修改3个,删除1个,并整合扩展中的项目.
- 现在CONSORT 2025检查清单包括30个必需项和参与者流程图.
- 增加了一个关于开放科学的新部分,并制定了一个扩展的检查清单,其中包含实施细节.
结论:
- 作者,编辑和审稿人应采用CONSORT 2025来编写和评估随机试验手稿.
- 更新的指导方针促进了对试验结果的更清晰,更透明的报告.
- 康索尔2025有助于更好地理解和利用随机试验的证据.
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