Professor Emeritus, School of Dentistry and Department of Biostatistics, School of Medicine, Virginia, Commonwealth University, Richmond, VA.
Adjunct Faculty, University of Chicago Medical Writing Program, Chicago, IL.
J Oral Maxillofac Surg. 2024 Nov;82(11):1494-1501. doi: 10.1016/j.joms.2024.06.175. Epub 2024 Jul 12.
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 Oral Health Statistical (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, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and Consolidated Standards for Reporting Trials harms guidelines and incorporate the Statistical Analysis and Methods in Published Literature guidelines for reporting statistics, the Clinical and Laboratory Images in Publications principles for documenting images, and the Grading of Recommendations Assessment, Development and Evaluation 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 researches into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.
充分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（由学术界和工业界的统计学家和试验人员组成）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：口腔健康统计学（OHStat）指南。草案分发给 85 种口腔健康期刊的编辑、工作组成员和赞助商，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。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的统一报告标准、流行病学观察性研究的加强报告标准（STROBE）以及临床试验危害报告指南，并纳入了报告统计学的发表文献统计分析和方法指南、发表文献中临床和实验室图像记录原则以及评估、发展和评估推荐等级（GRADE）以指示证据质量。该指南还建议使用置信区间报告有临床意义的单位中的估计值，而不是依赖 P 值。此外，OHStat 还引入了 7 条新指南，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。使用 OHStat 指南的手稿将提供更具体的口腔健康研究信息。
