Jansen Jan O, Pallmann Philip, MacLennan Graeme, Campbell Marion K
From the Departments of Surgery and Intensive Care Medicine (J.O.J.), Aberdeen Royal Infirmary, Aberdeen & Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom; Department of Mathematics and Statistics (P.P.), Lancaster University, Lancaster, United Kingdom; and Health Services Research Unit (G.M.L., M.K.C.), University of Aberdeen, Aberdeen, United Kingdom.
J Trauma Acute Care Surg. 2017 Oct;83(4):736-741. doi: 10.1097/TA.0000000000001638.
Conducting clinical trials in trauma care is challenging. As new treatments become available, we are faced with the dilemma of how to confirm their effectiveness and strengthen the evidence base. Randomized controlled trials are the criterion standard, but target groups in trauma care are often small and specialized, making the classic approach to trial design difficult. Bayesian designs represent an innovative means of increasing trial efficiency and conducting trials with more realistic sample sizes. This article examines the design of such trials, using the UK-REBOA Trial as an example.
在创伤护理领域开展临床试验具有挑战性。随着新治疗方法的出现，我们面临着如何确认其有效性并加强证据基础的困境。随机对照试验是标准规范，但创伤护理的目标群体往往规模小且具有特殊性，这使得经典的试验设计方法难以实施。贝叶斯设计是提高试验效率以及采用更符合实际样本量进行试验的一种创新手段。本文以英国主动脉内球囊反搏试验为例，探讨此类试验的设计。
