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.
翻译:许多适应性监测计划调整了必要的证据,以假想控制I类误差。这将重点从确定科学相关性转向确定科学相关性和证据的不折不扣程度。我们提议对第二代P-Value(SGPV)进行连续连续监测,直至确立科学相关性的证据(SeqSGPV )。SeqSGPV包含监测实际等效区域或等效区域假设的现有战略。因此,我们的重点是正式确定SGPV的顺序监测;建立一套新型科学假设,称为PRISM,这是一个围绕无效假设的ROE;使用监测频率和新的确认步骤来控制I类误差。在立即和延迟的结果下,我们评估SeqSGPV运行特性的有限和限制。在广泛的模拟中,SeqSGPV PRIS监测将缩短等待完全连续监测的时间,平均样本规模,并在无效的状态下建立一套虚构结论。我们设计SqeqSG-Riream Riamrodrodroad性监测SM-SMRyrial-SMAral-SMRyal-SIMRyal-SMRyal-SMRisal-SMRisal-SIM。我们设计和SIMRyal-SM-SM-SM-SIMRyal-SM-SM-SM-Syal-SM-SM-SM-S-S-SM-SM-SM-SM-SM-S-S-SM-SIM-SM-SM-S-SD-S-SD-Syal-Syal-SD-S-S-S-S-S-S-SD-S-S-S-S-S-S-S-S-SD-S-S-S-S-S-S-S-S-S-S-S-S-SD-SD-SD-SD-SD-SD-SD-SD-SD-SD-SD-S-SD-S-S-S-S-S-S-S-S-S-S-S-S-R-S-S-S-S-S-S-S-R-S-S-SD-