University of Bern, Medical Faculty, School of Dental Medicine, Department of Orthodontics and Dentofacial Orthopedics, Bern, Switzerland.
Division of Plastic Surgery, University of British Columbia, Victoria, BC, Canada.
Br J Dermatol. 2019 Mar;180(3):534-552. doi: 10.1111/bjd.17239. Epub 2019 Jan 4.
Evidence shows that the quality of reporting of randomised controlled trials (RCTs) is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings and researchers from extracting information for systematic reviews and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of RCTs. Within person trials are used for conditions that can affect two or more body sites, and are a useful and efficient tool because the comparisons between interventions are within people. Such trials are most commonly conducted in ophthalmology, dentistry, and dermatology. The reporting of within person trials has, however, been variable and incomplete, hindering their use in clinical decision making and by future researchers. This document presents the CONSORT extension to within person trials. It aims to facilitate the reporting of these trials. It extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT within person checklist items are provided.
证据表明，随机对照试验（RCT）的报告质量并不理想。报告不透明妨碍了读者判断试验结果的可靠性和有效性，也妨碍了研究人员从系统评价和结果中提取信息，导致研究浪费。《临床试验报告的统一标准》（CONSORT）声明旨在改进 RCT 的报告。个体内试验用于可以影响两个或多个身体部位的情况，是一种有用且高效的工具，因为干预措施之间的比较是在个体内进行的。此类试验最常用于眼科、牙科和皮肤科。然而，个体内试验的报告一直存在差异且不完整，这阻碍了它们在临床决策和未来研究中的应用。本文介绍了 CONSORT 扩展到个体内试验。它旨在促进这些试验的报告。它扩展了 CONSORT 2010 清单中的 16 项，并引入了修改后的流程图和基线表以提高透明度。提供了良好报告的示例和 CONSORT 个体内清单项目的循证理由。
