Nagendrababu V, Kishen A, Murray P E, Nekoofar M H, de Figueiredo J A P, Priya E, Jayaraman J, Pulikkotil S J, Jakovljevic A, Dummer P M H
Department of Preventive and Restorative Dentistry, College of Dental Medicine, University of Sharjah, Sharjah, UAE.
Faculty of Dentistry, University of Toronto, Toronto, ON, Canada.
Int Endod J. 2021 Jun;54(6):858-886. doi: 10.1111/iej.13481. Epub 2021 Mar 7.
Laws and ethics require that before conducting human clinical trials, a new material, device or drug may have to undergo testing in animals in order to minimize health risks to humans, unless suitable supporting grandfather data already exist. The Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) 2021 guidelines were developed exclusively for the specialty of Endodontology by integrating and adapting the ARRIVE (Animals in Research: Reporting In Vivo Experiments) guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles using a validated consensus-based methodology. Implementation of the PRIASE 2021 guidelines will reduce potential sources of bias and thus improve the quality, accuracy, reproducibility, completeness and transparency of reports describing animal studies in Endodontology. The PRIASE 2021 guidelines consist of a checklist with 11 domains and 43 individual items and a flowchart. The aim of the current document is to provide an explanation for each item in the PRIASE 2021 checklist and flowchart and is supplemented with examples from the literature in order for readers to understand their significance and to provide usage guidance. A link to the PRIASE 2021 explanation and elaboration document and PRIASE 2021 checklist and flowchart is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org/priase/).
法律和伦理要求,在进行人体临床试验之前,一种新的材料、器械或药物可能必须先在动物身上进行测试,以将对人类的健康风险降至最低,除非已经存在合适的支持性既往数据。2021年牙髓病学动物研究报告规范(PRIASE)指南是专门为牙髓病学专业制定的,通过使用经过验证的基于共识的方法,整合并改编了动物研究:体内实验报告(ARRIVE)指南以及出版物中的临床和实验室图像(CLIP)原则。实施2021年PRIASE指南将减少潜在的偏倚来源,从而提高描述牙髓病学动物研究报告的质量、准确性、可重复性、完整性和透明度。2021年PRIASE指南由一个包含11个领域和43个单独条目的清单以及一个流程图组成。本文档的目的是对2021年PRIASE清单和流程图中的每个条目进行解释,并辅以文献中的示例,以便读者理解其重要性并提供使用指导。2021年PRIASE解释与阐述文档以及2021年PRIASE清单和流程图的链接可在牙髓病学研究设计报告规范(PRIDE)网站(http://pride-endodonticguidelines.org/priase/)上获取。