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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:手稿清单。

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

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

J Dent Res. 2024 Oct;103(11):1076-1082. doi: 10.1177/00220345241247028. Epub 2024 Jul 12.

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 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

充分和透明的报告对于批判性评价已发表的研究是必要的。然而,大量证据表明,口腔健康研究的设计、实施、分析、解释和报告可以大大改进。因此,口腔健康研究设计和分析工作组——来自学术界和工业界的统计学家和临床试验人员——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,有 49 名研究人员参加。该指南随后由工作组的写作小组进行了修订。该指南大量借鉴了临床试验报告的统一标准(CONSORT)、流行病学观察性研究报告的强化标准(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 原则以及表示证据质量的 GRADE。该指南还建议使用置信区间报告具有临床意义的单位的估计值,而不是依赖 P 值。此外,OHStat 引入了 7 条新的指南,涉及文本本身,例如检查摘要和文本之间的一致性、构建讨论以及列出结论以使它们更具体。OHStat 不会替代其他报告指南;它将与牙科研究最相关的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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