CONSORT 2010 statement: extension checklist for reporting within person randomised trials.
CONSORT 2010 statement: extension checklist for reporting within person randomised trials.
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DOI：
10.1136/bmj.j2835
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发表时间：
2017-06-30
期刊：
影响因子：
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通讯作者：
Altman DG
中科院分区：
文献类型：
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作者：
Pandis N;Chung B;Scherer RW;Elbourne D;Altman DG
有证据表明，随机对照试验（RCTs）的报告质量并非最佳。缺乏透明的报告阻碍了读者判断试验结果的可靠性和有效性，也阻碍了研究人员为系统评价提取信息，从而导致研究浪费。制定试验报告综合标准（CONSORT）声明是为了改进随机对照试验的报告。人体内试验用于可能影响两个或多个身体部位的情况，是一种有用和有效的工具，因为干预措施之间的比较是在人体内进行的。此类试验最常在眼科、牙科和皮肤病学中进行。然而，人体试验的报告是可变的和不完整的，阻碍了它们在临床决策和未来研究人员中的应用。本文档介绍了CONSORT扩展到人体内试验。它的目的是促进这些试验的报告。它扩展了CONSORT 2010清单中的16个项目，并引入了修改后的流程图和基线表，以提高透明度。在人员清单项目中提供了良好的报告和基于证据的CONSORT理由的例子。
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.