The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
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DOI：
10.1016/s0140-6736(00)04337-3
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发表时间：
2001-04-14
期刊：
影响因子：
168.9
通讯作者：
Altman, DG
中科院分区：
文献类型：
--
作者：
Moher, D;Schulz, KF;Altman, DG
为了理解随机对照试验（RCT）的结果，读者必须了解其设计、实施、分析和解释。只有通过作者的完全透明才能实现这一目标。尽管几十年的教育努力，RCT的报告需要改进。研究人员和编辑开发了最初的CONSORT（报告试验的统一标准）声明，以帮助作者通过使用检查表和现在的图表来改进报告。这里提出的修订后的CONSORT声明纳入了新的证据，并解决了对原始声明的一些批评。检查表项目与标题、摘要、引言、方法、结果和讨论的内容有关。修订后的清单包括22个项目，因为经验证据表明，不报告这些信息与治疗效果的偏倚估计有关，或者因为这些信息对于判断结果的可靠性或相关性至关重要。我们打算用流程图来描述参与者通过RCT的过程。修订后的流程图描述了试验四个阶段的信息（入组、干预分配、随访和分析）。该图明确显示了每个干预组的参与者数量，包括在主要数据分析中。包含这些数字可以让读者判断作者是否做了意向治疗分析。总之，CONSORT声明旨在改善RCT的报告，使读者能够理解试验的实施并评估其结果的有效性。
To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and now diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, followup, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.