非劣效性和等效性随机试验报告:CONSORT 2010 声明的扩展。
Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.
机构信息
Statistika Consultoria, São Paulo, Brazil.
出版信息
JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
The CONSORT (Consolidated Standards of Reporting Trials) Statement, which includes a checklist and a flow diagram, is a guideline developed to help authors improve the reporting of the findings from randomized controlled trials. It was updated most recently in 2010. Its primary focus is on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another. The CONSORT Statement has been extended to other trial designs such as cluster randomization, and recommendations for noninferiority and equivalence trials were made in 2006. In this article, we present an updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials, based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and provide illustrative examples and explanations for those items that differ from the main 2010 CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the reliability of their results and conclusions.
CONSORT(临床试验报告统一标准)声明,包括核对表和流程图,是为了帮助作者提高随机对照试验结果报告质量而制定的指南。最近一次更新是在 2010 年。它主要侧重于评估一种治疗方法与另一种治疗方法的优越性的个体随机试验,有 2 个平行组。CONSORT 声明已经扩展到其他试验设计,如集群随机化,并且在 2006 年对非劣效性和等效性试验提出了建议。在本文中,我们根据 2010 年 CONSORT 声明和 2008 年 CONSORT 声明(用于报告摘要),为报告非劣效性和等效性试验,提出了 CONSORT 核对表的更新扩展,并为与主要 2010 CONSORT 核对表不同的项目提供了说明和解释示例。目的是提高非劣效性和等效性试验的报告质量,使读者能够评估其结果和结论的可靠性。