Department of Anesthesiology.
Department of Kinesiology, Arnold School of Public Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA.
J Neurosurg Anesthesiol. 2019 Jan;31(1):115-118. doi: 10.1097/ANA.0000000000000550.
An important element of designing research studies is the selection of appropriate outcome measures to ensure that the question posed is properly answered given the evidence. The selection of outcome measures is especially important when tackling complex, interdisciplinary problems, where appropriate outcome measures may not be as simple as a blood test or a laboratory value. One such area of study is the research into neurodevelopmental outcomes after early exposure to anesthetic agents. Concern has arisen recently that certain anesthetic agents may be toxic to the developing brain; a public-private partnership, SmartTots, was formed in conjunction with the Food and Drug Administration and various stakeholders to develop safe anesthetic regimens for neonates and infants who require surgery. However, as research has progressed, questions have arisen regarding the best outcome measures to use in order to detect a true effect, as well as the optimal window in which to measure. These issues were discussed in a round table meeting during the SmartTots meeting in September 2017, and a summary of the discussion is presented here.
设计研究的一个重要环节是选择合适的结果测量指标，以确保在所提出的问题下，基于现有证据能够得到正确的答案。在处理复杂的跨学科问题时，选择结果测量指标尤为重要，因为在这种情况下，合适的结果测量指标可能不像血液测试或实验室值那么简单。早期接触麻醉剂对神经发育结果的研究就是这样一个领域。最近人们开始担心某些麻醉剂可能对发育中的大脑有毒性；因此，一个公私合作伙伴关系——SmartTots 与食品和药物管理局以及各种利益相关者一起成立，旨在为需要手术的新生儿和婴儿制定安全的麻醉方案。然而，随着研究的进展，人们开始提出关于使用哪些最佳结果测量指标来检测真实效果的问题，以及测量的最佳窗口。这些问题在 2017 年 9 月的 SmartTots 会议上的一次圆桌会议上进行了讨论，这里呈现了讨论的总结。
