Ioannidis John P A, Evans Stephen J W, Gøtzsche Peter C, O'Neill Robert T, Altman Douglas G, Schulz Kenneth, Moher David
University of Ioannina School of Medicine and Biomedical Research Institute, Foundation for Research and Technology-Hellas, Ioannina, Greece.
Ann Intern Med. 2004 Nov 16;141(10):781-8. doi: 10.7326/0003-4819-141-10-200411160-00009.
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 (http://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.
鉴于随机对照试验（RCT）报告质量欠佳的证据确凿且后果严重，许多医学期刊和编辑团体现已认可《CONSORT声明》（统一研究报告标准），该声明包含一份22项的清单及流程图。由于CONSORT主要旨在提高疗效报告的质量，仅有一项清单条目专门涉及安全性报告。大量证据表明，RCT中与危害相关的数据报告也有待改进。CONSORT小组的成员，包括期刊编辑和科学家，于2003年5月在加拿大魁北克省蒙特贝洛开会讨论这一问题。结果形成了以下文件：标准的CONSORT清单，附带10条关于报告与危害相关问题的新建议、解释及示例，以突出正确报告的具体方面。我们希望这份文件，连同其他与CONSORT相关的材料（http://www.consort-statement.org），将有助于作者改进他们对RCT中与危害相关数据的报告。更好的报告将有助于读者严格评估和解读试验结果。期刊可通过修订作者须知来支持这一目标，引导作者参考这份文件。
