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要想理解随机对照试验(RCT)的结果,读者必须了解其设计、实施、分析和解释。这种目标只能通过作者的完全透明而实现。尽管做了几十年的教育努力,RCTs的报告方法仍然需要改进。调查人员和编辑们为了帮助作者提高报告的质量,通过使用核对表和流程图的形式开发了原CONSORT(报告试验的强化标准)。这里介绍的修改过的CONSORT声明,融合了新的证据,听取了对早期声明的批评意见。核对表的项目涵盖了文题、摘要、引言、方法、结果和讨论部分的内容。修订的核对表包括精选的22个项目,经验证据表明不报告这些信息会对疗效产生错误估计,或者需要这些信息以判断发现的可靠性和相关性。我们有意安插了流程图,以便描述受试者参与RCT的经过。修订的流程图描述了试验的4个阶段(登记、干预分配、随访和分析)的信息。流程图清楚地显示了每个干预组的受试者数量,包含在资料的初步分析中。包含这些数字便于读者判断作者是否采用了意向性治疗分析法(intentiontotreat)。总之,CONSORT声明旨在提高报告RCT的质量,便于读者了解试验的实施,以及评价其结果的有效性。
To understand the results of a randomized controlled trial (RCT), the reader must understand its design, implementation, analysis, and interpretation. This goal can only be achieved by the author’s complete transparency. Despite decades of educational efforts, the reporting methods of RCTs still need improvement. In order to help authors improve the quality of their reports, investigators and editors developed the original CONSORT (reinforcing standard for reporting trials) by using checklists and flowcharts. The revised CONSORT statement introduced here incorporates new evidence and listens to criticism of early declarations. Checklist items cover topics, abstracts, introductions, methods, results and discussion sections. The revised checklist includes a selection of 22 items. Empirical evidence suggests that not reporting such information will produce an erroneous estimate of efficacy, or that such information will be required to determine the reliability and relevance of the findings. We intentionally inserted a flow chart to describe the subject’s participation in the RCT. The revised flow chart describes the four phases of the trial (registration, intervention allocation, follow-up, and analysis). The flow chart clearly shows the number of subjects in each intervention group and is included in the preliminary analysis of the data. Including these numbers makes it easy for readers to determine whether the author has adopted an intention to treat. In summary, the CONSORT statement aims to improve the quality of the report RCT, facilitate the reader to understand the implementation of the trial, and evaluate the effectiveness of the results.