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OHStat 指导原则:口腔健康研究中报告观察性研究和临床试验的规范:手稿清单。

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

出版信息

Angle Orthod. 2024 Sep 1;94(5):479-487. doi: 10.2319/OHStat_Guidelines.1.

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.

摘要

充分和透明的报告对于批判性评价已发表的研究是必要的,但有充分的证据表明,口腔健康研究的设计、实施、分析、解释和报告可以大大改进。因此,口腔健康研究设计和分析工作组、学术界和工业界的统计学家和试验人员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 85 种口腔健康期刊的编辑以及工作组的成员和赞助商,并在 2020 年 12 月的一次研讨会上进行了讨论,该研讨会有 49 名研究人员参加。随后,工作组的写作小组对指南进行了修订。该指南主要借鉴了临床试验报告的统一标准(CONSORT)、加强观察性研究报告的流行病学和 CONSORT 危害指南,并纳入了报告统计学的 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报告以临床有意义的单位表示的估计值,而不是依赖 P 值。此外,OHStat 还引入了七个新的指南,这些指南涉及文本本身,例如检查摘要和文本之间的一致性、构建讨论和列出结论以使它们更加具体。OHStat 不会取代其他报告指南;它将最相关的牙科研究指南纳入一个单一的文件中。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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