Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, 412 E. Spokane Falls Blvd., Spokane, WA, 99202, United States.
Accid Anal Prev. 2019 May;126:184-190. doi: 10.1016/j.aap.2018.01.020. Epub 2018 Feb 7.
In December 2014, the Federal Aviation Administration (FAA) completed a major revision of the rules and regulations governing flight and duty time in commercial aviation (Federal Aviation Regulation (FAR) Part 117). Scientists were included in the revision process and provided insights into sleep, sleep loss, the circadian rhythm, and their effects on performance that were incorporated into the new rule. If a planned flight was non-compliant with the regulation, for example if it exceeded flight and duty time limits, it could only be flown under an FAA-approved Fatigue Risk Management System (FRMS) as meeting an Alternative Method of Compliance (AMOC). One method that a flight could qualify as an AMOC is if it could be demonstrated empirically that it was as safe as or safer than a similar flight, designated the Safety Standard Operation (SSO), that was compliant with the regulation. In the present paper, we demonstrate the FRMS process using a comparison between a non-compliant AMOC flight from the US west coast to Australia and a compliant SSO flight from the US west coast to Taiwan. The AMOC was non-compliant because it exceeded the flight time limits in the prescriptive rule. Once a data collection exemption was granted by the FAA, both the outbound and inbound AMOC and SSO routes were studied on four Safety Performance Indicators (SPIs). The SPIs studied were inflight sleep, cognitive performance, self-reported fatigue, and self-reported sleepiness. These measures were made at top of descent (TOD), a critical phase of flight. The study was designed as a paired comparison. Forty volunteer pilots studied flew both the AMOC and the SSO flights for a total of 80 studied flights. Using statistical non-inferiority applied to the AMOC and SSO SPIs, we demonstrated, as required by the new rule, that the US-Australia AMOC flight was "as safe as, or safer than" the US-Taiwan SSO flight. In the context of FRMS, statistical non-inferiority is a concept and technique of great utility, straightforward in application, producing clear visual representations of the findings, and providing a direct answer to the question posed by the regulation - is the AMOC flight "as safe as, or safer than" the SSO.
2014 年 12 月，联邦航空管理局（FAA）完成了对商业航空飞行和执勤时间规则和条例的重大修订（联邦航空条例（FAR）第 117 部分）。科学家们参与了修订过程，并提供了有关睡眠、睡眠剥夺、昼夜节律及其对性能的影响的见解，这些见解被纳入了新规则。例如，如果计划飞行不符合规定，例如超过飞行和执勤时间限制，则只能在 FAA 批准的疲劳风险管理系统（FRMS）下飞行，作为符合替代合规方法（AMOC）的规定。飞行可以符合 AMOC 的一种方法是，如果可以从经验上证明它与符合规定的类似飞行（指定为安全标准操作（SSO））一样安全或更安全。在本文中，我们使用从美国西海岸到澳大利亚的不合规 AMOC 飞行与从美国西海岸到台湾的合规 SSO 飞行之间的比较来展示 FRMS 过程。AMOC 不合规是因为它超过了规定规则中的飞行时间限制。一旦 FAA 授予数据收集豁免，就对 AMOC 和 SSO 往返航线的四个安全绩效指标（SPI）进行了研究。研究的 SPI 是飞行中睡眠、认知表现、自我报告的疲劳和自我报告的困倦。这些措施是在下降顶点（TOD）进行的，这是飞行的关键阶段。该研究设计为配对比较。40 名志愿飞行员总共飞行了 80 次 AMOC 和 SSO 飞行。使用应用于 AMOC 和 SSO SPI 的统计非劣效性，我们证明了，按照新规则的要求，美国-澳大利亚 AMOC 航班“与、或优于”美国-台湾 SSO 航班。在 FRMS 的背景下，统计非劣效性是一个非常有用的概念和技术，应用简单，对结果进行了清晰的可视化表示，并直接回答了法规提出的问题 - AMOC 航班“与、或优于”SSO。
