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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:稿件清单》

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

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, Virgina.

University of Chicago Medical Writing Program, Chicago, Illinois.

出版信息

J Endod. 2024 Nov;50(11):1655-1661. doi: 10.1016/j.joen.2024.05.007. Epub 2024 Jul 14.

Abstract

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample 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-identified the minimum information needed to report 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 guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

摘要

充分且透明的报告对于批判性评估已发表的研究至关重要。然而,大量证据表明,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(来自学术界和行业的统计学家和试验专家)确定了报告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。草案分发给了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。随后,特别工作组的写作小组对指南进行了修订。这些指南大量借鉴了《报告试验的统一标准》(CONSORT)、《加强流行病学观察性研究报告》(STROBE)和CONSORT危害指南,并纳入了报告统计数据的SAMPL指南、记录图像的CLIP原则以及表明证据质量的GRADE。该指南还建议使用置信区间以临床有意义的单位报告估计值,而不是依赖P值。此外,OHStat引入了7条与文本本身相关的新指南,例如检查摘要与文本之间的一致性、构建讨论内容以及列出结论以使结论更具体。OHStat并未取代其他报告指南;它将与牙科研究最相关的指南整合到了一份文件中。使用OHStat指南的手稿将提供更多特定于口腔健康研究的信息。

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