结果(博弈论)
代理(哲学)
边距(机器学习)
食品药品监督管理局
论证(复杂分析)
临床试验
还原论
风险分析(工程)
心理学
重症监护医学
医学
认识论
医学物理学
管理科学
运营管理
精算学
计算机科学
经济
数理经济学
哲学
机器学习
内科学
病理
作者
Solangel Rodriguez-Materon,Gregory P. Guyton
标识
DOI:10.1016/j.fcl.2023.12.001
摘要
Noninferiority studies in surgery are, by their very nature, reductionist. They use multiple variables to generate a yes or no answer about the new device being tested. A binary outcome is appropriate for a regulatory agency such as the Food and Drug Administration, but the clinical situation is more nuanced. It is critical to understand the underlying philosophies and choices that go into trial design when a surgeon is recommending a new device. In the case of Cartiva, any of 3 reasonable alternative means of defining surgical success would have altered the final outcome of the MOTION trial. Additionally, using a more rigorous noninferiority margin rather than adding an additional cushion based upon the argument that motion alone had extra inherent value would have also led to failure of the trial to demonstrate noninferiority.
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