Harvin John A, Zarzaur Ben L, Nirula Raminder, King Benjamin T, Malhotra Ajai K
Surgery, University of Texas McGovern Medical School, Houston, Texas, USA.
Surgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Trauma Surg Acute Care Open. 2020 Feb 4;5(1):e000420. doi: 10.1136/tsaco-2019-000420. eCollection 2020.
High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods.
需要高质量的临床试验来改善受伤患者的护理。创伤领域的传统随机临床试验由于诸多问题，在产生新知识方面面临挑战，这些问题包括进行个体随机化存在后勤困难、治疗效果的审前估计不明确导致研究往往缺乏足够的效力，以及鉴于患者和创伤中心的异质性，难以评估干预措施的可推广性。在本综述中，我们讨论了能够解决其中一些困难的替代临床试验设计。这些设计包括实用试验、整群随机化、整群随机阶梯楔形设计、析因试验和适应性设计。此外，我们还讨论了与传统的频率主义方法相比，贝叶斯推理方法如何能为创伤和急性 care 外科医生提供更多知识。 （注：原文中“acute care”直译为“急性护理”，这里结合医学语境，推测可能是“急性创伤护理”，但因不确定，保留英文未翻译完整）
