Rudicel S, Esdaile J
J Bone Joint Surg Am. 1985 Oct;67(8):1284-93.
The classic randomized clinical trial is difficult to apply to the evaluation of surgical procedures. After reviewing the structure and rationale of cohort studies and randomized clinical trials, four types of bias in randomized clinical trials that present difficulties in clinical studies are identified. Other problems that may limit the willingness of orthopaedic surgeons to conduct randomized clinical trials relate to the surgical procedure itself, the outcome of the trial of interest, surgical philosophy, and the ethical implications for a surgeon of a randomized clinical trial. A recently proposed variation of the classic randomized clinical-trial model, the randomized-surgeon design, appears to solve some of these problems.
经典的随机临床试验很难应用于外科手术的评估。在回顾了队列研究和随机临床试验的结构及基本原理后，确定了随机临床试验中在临床研究中存在困难的四种偏倚类型。其他可能限制骨科医生进行随机临床试验意愿的问题与手术本身、感兴趣的试验结果、手术理念以及随机临床试验对医生的伦理影响有关。最近提出的经典随机临床试验模型的一种变体，即随机外科医生设计，似乎解决了其中一些问题。
