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有充分的证据表明目前随机对照试验(RCT)的报告质量不尽如人意。最近的方法学调查表明,不恰当的报告及试验设计将使治疗措施的效果产生偏倚。这种系统偏差正严重损害RCT本可摒弃系统偏差的特征。RCT中的系统偏差反映出了科学性差,而科学性差会严重影响正确的伦理标准。科学家和编辑们共同制定了CONSORT(试验报告统一标准,ConsolidatedStandardsofReportingTrials,)声明以提高RCT报告质量。CONSORT声明由清单和流程图组成,作者可用来报告RCT。许多优秀期刊和重要国际性编辑组织已经采用CONSORT声明。CONSORT声明为作者提高临床试验报告质量提供指南,使得评价和解释RCT结果更方便。此文旨在增强大家对CONSORT声明的理解、应用和传播,并对每个清单项目的意义和原理进行了说明。很多项目都列出优秀报告的示例,并尽可能参考相关的经验性研究,还列出几个流程图的示例。CONSORT声明的说明和详述文件在以下网址可找到:http://www.consort-statement.org,这是提高随机对照试验报告质量的有益资源。
There is ample evidence that the quality of the current randomized controlled trial (RCT) report is not satisfactory. Recent methodological surveys have shown that inappropriate reporting and experimental design will bias the effectiveness of treatment measures. This systematic bias is seriously undermining the characteristics of the RCT that can abandon the system bias. Systematic deviations in RCT reflect poor science, and poor science can seriously affect the correct ethical standards. Scientists and editors jointly developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of RCT reports. The CONSORT statement consists of a list and a flow chart that authors can use to report RCTs. Many excellent journals and important international editing organizations have adopted the CONSORT statement. The CONSORT statement provides guidelines for authors to improve the quality of clinical trial reports, making it easier to evaluate and interpret RCT results. This article aims to enhance the understanding, application, and dissemination of the CONSORT statement, and explains the significance and principles of each list item. Many projects list examples of excellent reports and reference relevant empirical studies as much as possible. Several examples of flow charts are also listed. The description and detailed documentation for the CONSORT statement can be found at http://www.consort-statement.org, a helpful resource for improving the quality of randomized controlled trial reporting.