论文标题
确定性偏差的估计及其对临床试验的影响以及事件时间结果的影响
Estimation of ascertainment bias and its effect on power in clinical trials with time-to-event outcomes
论文作者
论文摘要
尽管临床试验的黄金标准是盲目所有各方（参与者，研究人员和评估者）来治疗分配，但这并不总是可能性。当上述某些人知道治疗分配时，这使研究开放给了后随机后偏见的引入。在减少伤害并增强对长者（Stride）试验的信心的策略中，我们被介绍给我们的临床医生进行治疗的临床医生，以及参与研究的个人，将确定性偏见引入一些构成主要结果的事件中。在本手稿中，我们提出了估计确定性偏差的方法，以期为事件发生时间结果，并讨论其对试验的总体力量的影响与更改结果定义的整体功能，以更严格的无偏见的定义，从而限制了对测量值的关注，从而不太受到潜在差异评估的影响。我们发现，在大多数情况下，最好将定义修改为更严格的定义，就像大步前进一样，即使可以观察到更少的事件。
While the gold standard for clinical trials is to blind all parties -- participants, researchers, and evaluators -- to treatment assignment, this is not always a possibility. When some or all of the above individuals know the treatment assignment, this leaves the study open to the introduction of post-randomization biases. In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) trial, we were presented with the potential for the unblinded clinicians administering the treatment, as well as the individuals enrolled in the study, to introduce ascertainment bias into some but not all events comprising the primary outcome. In this manuscript, we present ways to estimate the ascertainment bias for a time-to-event outcome, and discuss its impact on the overall power of a trial versus changing of the outcome definition to a more stringent unbiased definition that restricts attention to measurements less subject to potentially differential assessment. We found that for the majority of situations, it is better to revise the definition to a more stringent definition, as was done in STRIDE, even though fewer events may be observed.
