发布的早期阶段剂量检测临床试验报告中CONSORT流图的报告质量:需要改进
Emily Alger1, Yuqi Zhang1, Christina Yap1
1The Institute of Cancer Research, 15 Cotswold Road, Sutton SM2 5NG, United Kingdom.
Contemporary clinical trials
|July 1, 2023
概括
大多数早期阶段剂量检测 (EPDF) 试验缺乏完整的流程图. 建议改进图表,以提高试验结果的透明度和可解释性,以便更好地报告临床试验.
科学领域:
- 临床试验方法论 临床试验方法论
- 药学研究 药学研究
- 生物统计学 生物统计学
背景情况:
- 评估早期阶段剂量检测 (EPDF) 试验流程图中的信息完整性.
- 评估遵守CONSORT建议和报告剂量 (降级) 特征的情况.
- 在EPDF试验中发现当前流程图报告实践中的缺陷.
研究的目的:
- 根据CONSORT标准,评估EPDF发布的试验流程图中信息的完整性.
- 提出增强的流程图模板,以有效地说明剂量 (降级) 过程.
- 收集专家对试验流程图中剂量信息的实用性和首选呈现方式的反.
主要方法:
- 2011-2020年间发表的259项EPDF试验的系统审查,在PubMed.
- 根据15个CONSORT标准对流程图进行评分,并对剂量 (降级) 报告进行额外评估.
- 开发新的流程图模板,并向方法学家和临床试验人员提供反.
主要成果:
- 只有38%的审查试验包括了流程图,在报告失去了后续和不遵守干预的原因时,有显著的遗漏.
- 很少有试验 (39%) 详细说明了连续的剂量决定阶段.
- 高比例的专家 (87%) 认为将 (降级) 步骤纳入是有益的,他们更喜欢 (90%) 在图中显示更大的剂量.
结论:
- 发表的EPDF试验经常缺乏全面的流程图,阻碍了透明度和可解释性.
- 提议的增强流程图旨在改善参与者流程和剂量调整的可视化.
- 实施标准化,信息化的流程图对于提高早期临床试验报告质量至关重要.
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