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要正确理解随机对照试验(randomizedcontrolledtrial,RCT)的结果,读者必须了解其设计方案、实施过程、分析方法和结果解释。为达此目的,要求作者必须完整清晰地将这些内容表述出来。虽然经过数十年的教育,RCT的报告方法仍然需要改进。一些研究人员和编辑为此编写了CONSORT(ConsolidatedStandardsofReportingTrials,临床试验报告的统一标准)声明第1版,采用清单和流程图的方式帮助作者提高报告质量。本文根据读者对第一版的反馈对CONSORT声明进行了修改,并补充了新的证据。清单条目分为题目、、引言、方法、结果和评论共6个部分。修订版清单包括了22项条目,均为经验证据证明如不报告就会导致疗效估计偏倚的信息或作以判断结果可靠性和相关性的基本信息,配以流程图来描述受试者参与RCT的过程。修订版流程图描述了试验的4个步骤(包括登记、干预的分配、随访和分析),并明确注明了原始数据分析中各干预组人数。读者可通过人数判断作者是否进行了意向性分析(ITT)。总之,CONSORT声明旨在改进RCT的报告质量,方便读者了解研究实施情况并判断其结果的真实性。
To properly understand the results of randomized controlled trials (RCTs), readers must understand the design, implementation, analytical methods, and interpretation of results. To this end, require the author must be complete and clear expression of these elements out. Although after decades of education, the RCT reporting method still needs improvement. Some researchers and editors developed the first edition of CONSORT (Consolidated Standards of Reporting Trips), a statement that helps authors improve reporting by using lists and flowcharts. This article revises the CONSORT statement based on the reader’s feedback on the first edition and adds new evidence. Inventory items are divided into topics, introduction, methods, results and comments a total of six parts. The revised list includes 22 items, all of which are empirical evidence that information is not biased in the event of failure to report or that provides baseline information for assessing the reliability and relevance of results, together with a flow chart describing the participants’ participation in the RCT the process of. The revised flow chart describes the four steps of the trial, including registration, allocation of interventions, follow-up and analysis, and clearly identifies the number of interventions in the original data analysis. Readers can judge whether the author conducted an intention analysis (ITT) by the number of people. In summary, the CONSORT statement aims to improve the quality of RCT reporting and to make it easier for readers to understand the research implementation and to judge the authenticity of the results.