Better reporting of harms in randomized trials: An extension of the CONSORT statement
Better reporting of harms in randomized trials: An extension of the CONSORT statement
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DOI：
10.7326/0003-4819-141-10-200411160-00009
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发表时间：
2004-11-16
影响因子：
39.2
通讯作者：
Moher, D
中科院分区：
文献类型：
--
作者：
Ioannidis, JPA;Evans, SJW;Moher, D
针对大量证据和随机对照试验（rct）低质量报告的后果，许多医学期刊和编辑团体现在已经认可了CONSORT（试验报告综合标准）声明，这是一份22项清单和流程图。由于CONSORT的主要目的是提高疗效报告的质量，因此只有1个清单项目专门涉及安全性报告。大量证据表明，从随机对照试验中报告与危害有关的数据也需要改进。2003年5月，包括期刊编辑和科学家在内的CONSORT小组成员在加拿大魁北克省蒙特贝罗开会讨论这个问题。结果是以下文件：标准的CONSORT清单，其中包含关于报告危害相关问题的10项新建议，附带的解释和强调正确报告的具体方面的示例。我们希望这份文件，连同其他与const相关的材料（www.consort-statement.org），将帮助作者改进他们对随机对照试验中危害相关数据的报告。更好的报道将有助于读者批判性地评价和解释试验结果。期刊可以通过修改《作者指南》来支持这一目标，这样他们就可以让作者参考本文档。
In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety.Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting.We hope that this document, in conjunction with other CONSORT-related materials (www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.