论文标题

使用第二代p值对通过监视频率控制的I型错误进行顺序监视

Sequential monitoring using the Second Generation P-Value with Type I error controlled by monitoring frequency

论文作者

Chipman, Jonathan J., Greevy Jr., Robert A., Mayberry, Lindsay, Blume, Jeffrey D.

论文摘要

许多自适应监测方案将所需的证据调整为对控制I型错误的假设。这转变为从确定科学相关性和毫不妥协的证据程度上转移。我们建议在重复间隔内顺序监测第二代P值(SGPV),直到建立科学相关性的证据(SEQSGPV)。 SEQSGPV涵盖了现有的策略来监测实际等效区域(绳索)或等价区域(ROE)假设。因此,我们的重点是正式化顺序SGPV监视;建立一组新型的科学假设,称为Prism,它是围绕原假设的绳索的roe。并使用监视频率和新颖的确认步骤来控制I型错误。在直接和延迟的结果下,我们在监视棱镜,绳索和无效的ROE假设时评估有限和限制SEQSGPV操作特性。在广泛的模拟中,SEQSGPV PRISM监测减少了等待时间,以进行完全顺序监测,平均样本量以及无效下的无假设结论的逆转。借助现实世界数据,我们设计了SEQSGPV监控的随机试验。 SEQSGPV是方法不合时宜的,易于实现。调整监视频率/肯定并监视单方面的棱镜协同控制I型错误。棱镜监视和调整监视频率以控制I型错误可能具有SEQSGPV以外的应用程序。

Many adaptive monitoring schemes adjust the required evidence toward a hypothesis to control Type I error. This shifts focus away from determining scientific relevance with an uncompromised degree of evidence. We propose sequentially monitoring the Second Generation P-Value (SGPV) on repeated intervals until establishing evidence for scientific relevance (SeqSGPV). SeqSGPV encompasses existing strategies to monitor Region of Practical Equivalence (ROPE) or Region of Equivalence (ROE) hypotheses. Hence, our focus is to formalize sequential SGPV monitoring; establish a novel set of scientific hypotheses, called PRISM, which is a ROE with a ROPE surrounding the null hypothesis; and use monitoring frequency and a novel affirmation step to control Type I error. Under immediate and delayed outcomes, we assess finite and limiting SeqSGPV operating characteristics when monitoring PRISM, ROPE, and null-bound ROE hypotheses. In extensive simulations, SeqSGPV PRISM monitoring reduced wait time for fully sequential monitoring, average sample size, and reversals of null hypothesis conclusions under the null. With real-world data, we design a SeqSGPV-monitored randomized trial. SeqSGPV is method-agnostic and easy to implement. Adjusting monitoring frequency/affirmation and monitoring a one-sided PRISM synergistically control Type I error. PRISM monitoring and adjusting monitoring frequency to control Type I error may have application beyond SeqSGPV.

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