康索特声明:修订了改善平行组随机试验报告质量的建议
D Moher1, K F Schulz, D G Altman
1University of Ottawa, Thomas C Chalmers Centre for Systematic Reviews, Ottawa, Ontario, Canada.
Lancet (London, England)
|April 27, 2001
概括
改善随机对照试验 (RCT) 报告对于理解研究有效性至关重要. 修订后的CONSORT声明提供了一个检查清单和流程图,以提高RCT结果的透明度和解释.
科学领域:
- 临床试验 临床试验
- 医学研究方法学 医学研究方法学
- 基于证据的医学基于证据的医学.
背景情况:
- 准确解释随机对照试验 (RCT) 需要了解其设计,进行,分析和结果.
- 尽管有教育努力,但RCT的报告质量仍然不够优.
- 最初的CONSORT (报告试验综合标准) 声明是为了改善RCT报告而开发的.
研究的目的:
- 提出修订后的CONSORT声明,包括新的证据,并解决对原始声明的批评.
- 提高RCT报告的透明度和清晰度.
- 为了使读者能够更好地评估试验结果的有效性和相关性.
主要方法:
- 开发一个修订后的CONSORT检查清单,包含22个项目.
- 包括对判断治疗效果偏差和发现可靠性至关重要的项目.
- 修订CONSORT流程图,以说明参与者通过四个试验阶段 (注册,分配,跟进,分析) 的进展.
主要成果:
- 修订后的检查清单包括透明RCT报告的基本项目.
- 更新的流程图明确显示了初级数据分析中的参与者数量.
- 修订后的CONSORT声明旨在提高对RCT行为和结果评估的理解.
结论:
- 修订后的CONSORT声明为改善RCT报告提供了一个全面的框架.
- 通过CONSORT检查清单和流程图提高透明度,有助于对试验结果进行批判性评估.
- 遵守CONSORT指南对于确保临床试验证据的可靠性和可解释性至关重要.
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