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

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 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.