Department of Preventive and Restorative Dentistry, College of Dental Medicine, University of Sharjah, Sharjah, UAE.
Division of Restorative Dentistry, Dublin Dental University Hospital, Trinity College Dublin, Dublin, Ireland.
Int Endod J. 2021 Mar;54(3):354-365. doi: 10.1111/iej.13434. Epub 2020 Nov 18.
Randomized clinical trials are positioned at the highest level of primary clinical evidence, as they are designed to be unbiased with a reduced risk of systematic error. The Consolidated Standards of Reporting Trials (CONSORT) statement was first developed in 1996 to improve the reporting quality of randomized clinical trials with updates being published subsequently. Recently, the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for the field of Endodontics to address the suboptimal quality of randomized clinical trials submitted to Endodontic journals, which result in many being rejected. A principal flaw in submissions is the fact that many authors are unclear on the keys terms that should be used when developing manuscripts for publication. Clearly, authors should be aware of the most common terms used when conducting and reporting randomized clinical trials. Hence, the aim of the current paper is to present a comprehensive glossary of the terminology used in randomized clinical trials in order to assist authors when designing, executing and writing-up randomized clinical trials.
随机临床试验处于主要临床证据的最高水平,因为它们旨在设计为无偏倚,系统性误差的风险降低。《临床试验报告的统一标准》(CONSORT)声明最初于 1996 年制定,以提高随机临床试验的报告质量,随后进行了更新。最近,专门为牙髓学领域制定了《牙髓学随机临床试验的首选报告项目》(PRIRATE)2020 指南,以解决提交给牙髓学期刊的随机临床试验质量不佳的问题,这导致许多临床试验被拒绝。提交的主要缺陷是,许多作者不清楚在为发表而撰写手稿时应使用哪些关键词。显然,作者应该了解在进行和报告随机临床试验时最常用的术语。因此,本文的目的是提供一个随机临床试验中使用的术语的综合词汇表,以帮助作者在设计、执行和撰写随机临床试验时使用。