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随机对照试验中的选择偏差风险被评为低偏差使用偏差风险,版本2 (RoB2) 工具

Steffen Mickenautsch^1,2, Veerasamy Yengopal¹

¹Faculty of Dentistry, University of the Western Cape, Cape Town, ZAF.

|August 1, 2024

概括

许多被评为偏差风险低的随机对照试验仍然含有显著的选择偏差. 这挑战了当前偏见评估工具和已发表的试验结果的可靠性.

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:

柯克伦的偏差风险2 (RoB2) 工具被广泛用于评估随机对照试验 (RCT).
对"低偏差"评级的准确性存在担忧,这可能会影响综合证据的可靠性.

研究的目的:

评估由RoB 2工具评价为"偏差低"的RCT中选择偏差的实际风险.
评估RoB 2评级的有效性及其对临床证据评估的影响.

主要方法:

对识别RCT的系统审查的系统文献搜索.
在1070个具有"低偏差"和"高偏差"RoB 2评级的RCT中进行选择偏差的统计测试.
误差评估的错误遗漏率 (FOR) 和负概率比率 (-LR) 的计算.

主要成果:

7.61%的"低偏差" (RoB 2) RCT 呈现出高选择偏差风险 (FOR 7.61%).
在RoB 2域1 (随机化) 中被评为"偏差低"的RCT显示,选择偏差风险高的可能性增加了6% (-LR:1.06).

结论:

科克兰的RoB 2工具可能会高估RCT的质量",低偏差"评级并不总是保证不受选择偏差的影响.
调查结果质疑对来自"低偏差"评级的RCT的证据的信任,并强调仅依赖预先规定的评估标准的局限性.

关键词:

偏见测试偏见测试偏见测试临床试验临床试验临床试验临床试验临床试验 i2i2 在线观看偏差风险 2 工具工具选择偏差是一种选择偏差.系统性审查系统性审查

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