The OHStat guidelines for reporting observational studies and clinical trials in oral health research: manuscript checklist.

A M Best, T A Lang, B L Greenberg, J C Gunsolley, E Ioannidou
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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 writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology, 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 seven 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.

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OHStat口腔健康研究观察性研究和临床试验报告指南:手稿核对表。
充分和透明的报告对于批判性地评估已发表的研究是必要的,但大量证据表明,口腔健康研究的设计、实施、分析、解释和报告都可以大大改进。因此,由来自学术界和工业界的统计学家和试验专家组成的口腔健康研究设计与分析工作组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限度信息:OHStat 指南。草案已分发给 85 份口腔健康期刊的编辑以及特别工作组成员和赞助商,并在 2020 年 12 月的研讨会上进行了讨论,49 名研究人员参加了此次研讨会。随后,工作组写作小组对指南进行了修订。该指南在很大程度上借鉴了《试验报告综合标准》(CONSORT)、《加强流行病学观察性研究的报告》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 原则以及表示证据质量的 GRADE。该指南还建议使用置信区间以有临床意义的单位报告估计值,而不是依赖 P 值。此外,OHStat还引入了七条与文本本身有关的新指南,如检查摘要与文本之间的一致性、安排讨论的结构、列出结论使其更具体等。OHStat并不取代其他报告指南,而是将与口腔医学研究最相关的指南整合到一份文件中。使用OHStat指南的手稿将提供更多与口腔健康研究相关的信息。
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