Thoma Achilleas, Farrokhyar Forough, Waltho Daniel, Braga Luis H, Sprague Sheila, Goldsmith Charlie H
Hamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).
Can J Surg. 2017 Dec;60(6):426-432. doi: 10.1503/cjs.000317.
A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.
一项精心设计的随机对照试验（RCT）是确定一种新型手术干预措施与现行措施是否存在差异的最优研究设计。传统上，当我们想要证明一种新的手术干预措施优于标准措施时，我们会分析随机对照试验的数据，以查看“无差异”的零假设是否可以被拒绝（即两种手术干预措施具有相同的效果）。非劣效性随机对照试验设计旨在确定一种新的干预措施在可接受的风险或益处范围内是否不比现行（标准）措施差，这个范围被称为“非劣效性界值”。在过去十年中，我们观察到非劣效性随机对照试验的发表数量有所增加。本文探讨了这种研究设计类型，并讨论了可用于评估此类研究的工具。
