开发适应性临床试验偏差项目清单的方法审查:协议和理由
Phillip Staibano1,2, Tyler McKechnie2,3, Alex Thabane2
1Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
PloS one
|December 12, 2024
概括
本研究旨在开发适应性临床试验 (ACT) 的偏差风险工具. 通过审查现有文献,我们将确定关键的方法学概念,以提高ACT的质量和标准化.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 基于证据的医学基于证据的医学.
背景情况:
- 随机临床试验 (RCT) 是标准的,但面临着早期终止和延迟报告等局限性.
- 适应性临床试验 (ACT) 通过预先计划的修改提供了简化设计和更快的报告.
- 需要一种特定的偏见风险工具来评估ACT的独特特征并确保其质量.
研究的目的:
- 制定一个全面的偏差风险列表,以及适应性临床试验 (ACT) 特定的概念.
- 为验证的偏见风险工具奠定基础,以提高ACT的质量和标准化.
- 为未来的Delphi研究提供信息,并最终开发一个强大的ACT偏见风险评估工具.
主要方法:
- 在主要引用数据库 (例如,MEDLINE,EMBASE,CENTRAL) 和灰色文献中进行系统的数据库搜索.
- 包括方法注册表,以识别现有的偏差风险,为ACT提供工具.
- 重复选和审查过程,高级作者作为仲裁员,随后是偏见项目和质量概念的提取和合成.
主要成果:
- 识别和综合现有的偏差项目和与ACT相关的概念的方法风险.
- 将提取的项目分为偏差和其他方法质量方面 (例如报告) 的分类.
- 为未来的ACT特定工具创建偏差风险项目候选清单.
结论:
- 这种方法审查是创建针对ACT量身定制的偏见风险工具的基本步骤.
- 这些发现将指导后续的Delphi研究,并验证一个新的偏见风险评估工具.
- 开发的工具旨在提高适应性临床试验的方法严谨性和标准化.
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