Solomkin J S, Dellinger E P, Christou N V, Mason A D
Arch Surg. 1987 Feb;122(2):158-64. doi: 10.1001/archsurg.1987.01400140040004.
Several recent publications have identified important methodologic problems in the design and conduct of antimicrobial trials in surgery. Developed by consensus of the members of the Scientific Studies Committee of the Surgical Infection Society, this report provides broad guidelines for the construction of antimicrobial trials. The central issues identified include pretrial definition of study purpose, entry criteria, assignment device, and statistical analysis. These issues are fundamental in designing studies with an acceptable likelihood of finding differences among those antimicrobial regimens at least risk to the study subjects. The importance of stratifying patients on the basis of background condition, disease, and severity of illness is stressed. The inclusion in a study of variables that enhance the statistical power and, therefore, the believability of this study is stressed as an important means of clarifying substantial differences between therapies.
最近的几篇出版物指出了外科抗菌试验设计与实施过程中的一些重要方法学问题。本报告由外科感染协会科学研究委员会成员共同商议制定，为抗菌试验的构建提供了广泛的指导方针。确定的核心问题包括研究目的的预试验定义、纳入标准、分组方法和统计分析。这些问题对于设计研究至关重要，因为只有这样才有可能在那些对研究对象风险最小的抗菌治疗方案之间找到差异。强调了根据患者背景状况、疾病和病情严重程度进行分层的重要性。还强调将能够提高统计效能从而增强研究可信度的变量纳入研究，这是明确不同治疗方法之间显著差异的重要手段。
