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口腔健康研究中观察性研究和临床试验报告的口腔健康统计指南:解释和说明。

The Oral Health Statistics Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration.

机构信息

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.

出版信息

J Oral Maxillofac Surg. 2024 Nov;82(11):1475-1493. doi: 10.1016/j.joms.2024.06.174. Epub 2024 Jul 12.

Abstract

Adequate and transparent reporting is necessary for critically appraising research. Yet, 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-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the Oral Health Statistics (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 final version was subsequently approved by the task force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in Journal of Dental Research Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

摘要

充分透明的报告对于研究评价至关重要。然而,有证据表明,口腔健康研究的设计、实施、分析、解释和报告可以大大改进。为此,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——召集了一组作者,制定了方法学和统计报告指南,确定了记录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(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。最终版本随后于 2021 年 9 月由工作组批准,于 2022 年提交期刊评审,并于 2023 年进行修订。清单包括 48 条指南:5 条用于介绍性信息,17 条用于方法,13 条用于统计分析,6 条用于结果,7 条用于解释;7 条专门针对临床试验。这些指南中的每一条都确定了相关信息,解释了其重要性,并经常描述最佳实践。清单已在多个期刊上发表。该文章同时发表在《牙科学研究杂志临床与转化研究》、《美国牙科学会杂志》和《口腔颌面外科学杂志》上。提交给这些和其他口腔健康期刊发表的完整检查表应伴随稿件,以帮助作者、期刊编辑和审稿人验证稿件提供了充分记录和评估研究所需的信息。

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