随机对照试验报告中的流程图的值
1Medical Research Council Health Services Research Collaboration, Department of Social Medicine, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, England. m.egger@bristol.ac.uk
JAMA
|April 20, 2001
概括
随机对照试验 (RCT) 的流程图与更好的报告质量有关. 研究人员提出了改进的流程图结构,以提高试验报告的清晰度和完整性.
科学领域:
- 临床试验方法论 临床试验方法论
- 科学报告标准 科学报告标准
背景情况:
- 综合试验报告标准 (CONSORT) 建议为临床试验提供流程图.
- 这些图形对试验报告质量的影响仍然不清楚.
研究的目的:
- 评估随机对照试验 (RCT) 中流程图所提供的信息.
- 评估RCT报告的整体完整性,重点关注参与者流动.
- 检查五个主要的通用和内科医学期刊的报告实践.
主要方法:
- 分析了1998年发表的270份随机对照试验 (RCT) 报告.
- 这些期刊包括:内科医学年鉴,BMJ,JAMA,柳叶刀和新英格兰医学杂志.
- 收集关于流程图的存在,其内容,以及关于参与者流程的整体报告完整性的数据.
主要成果:
- 51.5%的RCT报告包括了流动图,日志变化很大 (21.0%93.8%).
- 流程图往往缺乏关键信息,例如分配给干预 (52.5%) 或纳入分析 (23.0%) 的参与者数量.
- 流程图的发布与参与者流程的更完整报告有关.
结论:
- 流程图与随机对照试验 (RCT) 中报告质量的提高有关.
- 当前流程图结构是不理想的.
- 建议修订流程图,以涵盖平行组试验阶段的基本计数.
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