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《口腔健康研究中观察性研究和临床试验报告的OHStat指南:解释与阐述》

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration.

作者信息

Best A M, Lang T A, Greenberg B L, Gunsolley J C, Ioannidou E

机构信息

School of Dentistry and Department of Biostatistics, School of Medicine, Virginia Commonwealth University, Richmond, VA, USA.

University of Chicago Medical Writing Program, Chicago, IL, USA.

出版信息

JDR Clin Trans Res. 2024 Jul 12:23800844241247029. doi: 10.1177/23800844241247029.

Abstract

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in , the , and the . Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

摘要

充分且透明的报告对于严格评估研究至关重要。然而,有证据表明,口腔健康研究的设计、实施、分析、解释和报告仍有很大的改进空间。因此,口腔健康研究设计与分析特别工作组(由来自学术界和行业的统计学家和试验专家组成)召集了一组作者,制定方法学和统计报告指南,确定记录和评估口腔健康观察性研究和临床试验所需的最低信息:OHstat指南。草案已分发给85种口腔健康期刊的编辑、特别工作组成员和赞助商,并在2020年12月由49名研究人员参加的研讨会上进行了讨论。最终版本随后于2021年9月得到特别工作组的批准,于2022年提交期刊评审,并于2023年进行了修订。该清单由48条指南组成:5条关于介绍性信息,17条关于方法,13条关于统计分析,6条关于结果,7条关于解释;7条是临床试验特有的。这些指南中的每一条都确定了相关信息,解释了其重要性,并经常描述最佳实践。该清单已在多个期刊上发表。这篇文章同时发表在《 》、《 》和《 》上。提交给这些及其他口腔健康期刊发表的稿件应附上完整的清单,以帮助作者、期刊编辑和审稿人核实稿件是否提供了充分记录和评估该研究所需的信息。

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