Department of Bioethics, 10 Center Drive, Clinical Center NIH, Bethesda, MD 20892, USA.
BMC Med Res Methodol. 2011 Mar 31;11:34. doi: 10.1186/1471-2288-11-34.
There is an ongoing controversy over the relative merits of randomized controlled trials (RCTs) and non-randomized observational studies in assessing efficacy and guiding policy. In this paper we examine male circumcision to prevent HIV infection as a case study that can illuminate the appropriate role of different types of evidence for public health interventions.
Based on an analysis of two Cochrane reviews, one published in 2003 before the results of three RCTs, and one in 2009, we argue that if we rely solely on evidence from RCTs and exclude evidence from well-designed non-randomized studies, we limit our ability to provide sound public health recommendations. Furthermore, the bias in favor of RCT evidence has delayed research on policy relevant issues.
This case study of circumcision and HIV prevention demonstrates that if we rely solely on evidence from RCTs and exclude evidence from well-designed non-randomized studies, we limit our ability to provide sound public health recommendations.
在评估疗效和指导政策方面，随机对照试验（RCT）和非随机观察性研究的相对优势一直存在争议。本文以男性包皮环切术预防 HIV 感染为例，探讨了不同类型证据在公共卫生干预中的适当作用。
基于对两项 Cochrane 综述的分析，一项发表于 2003 年，即三项 RCT 结果公布之前，另一项发表于 2009 年。我们认为，如果仅依赖 RCT 证据，排除精心设计的非随机研究证据，我们将限制提供合理公共卫生建议的能力。此外，对 RCT 证据的偏好偏见延迟了对相关政策问题的研究。
本案例研究表明，如果我们仅依赖 RCT 证据，排除精心设计的非随机研究证据，我们将限制提供合理公共卫生建议的能力。
