在系统性审查和元分析中,对随机对照试验的偏差评估的个人参与者数据信息风险
James X Sotiropoulos1, Kylie E Hunter2, Jannik Aagerup3
1Faculty of Medicine and Health, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia; Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.
本研究提供了使用个人参与者数据 (IPD) 评估随机对照试验 (RCT) 偏差风险 (ROB) 的指导. IPD增强了ROB评估,提高了证据综合的可靠性,以便做出更好的临床决策.
科学领域:
- 证据综合 证据综合
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
背景情况:
- 评估偏差风险 (ROB) 对于解释证据综合发现至关重要.
- 传统的ROB评估依赖于公布的数据,这些数据可能不完整或不清楚.
- 个人参与者数据 (IPD) 为更深入的ROB评估提供了潜力,但缺乏指导.
研究的目的:
- 开发使用IPD为随机对照试验 (RCT) 的ROB评估提供信息的初步指导.
- 通过案例研究和专家咨询,试点和完善这些指导.
主要方法:
- 文献审查,专家咨询和初步指导项目开发.
- 在两次IPD元分析 (MA) 中试点使用ROB-1,然后对ROB-2进行调整.
- 评估研讨会以完善和比较IPD信息评估与仅发表数据评估.
主要成果:
- 在ROB领域确定了12个项目,其中IPD可以增强评估.
- IPD促进了对选择和消耗偏差的额外检查.
- 基于IPD的评估导致33项研究中的25项ROB判断发生变化,经常解决"不清楚"的领域.
结论:
- 基于IPD的ROB评估的初步指导可以提高准确性.
- 在IPD-MAs中应用可以减少ROB,创建更可靠的证据基础.
- 这种方法支持更明智的政策和临床实践决策.
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