CONSORT Statement 2001 PDFs:
The CONSORT Statement
The CONSORT Statement is intended to improve the reporting of a randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. It emphasizes that this can only be achieved through complete transparency from authors.
Investigators and editors developed and revised the CONSORT (CONsolidated Standards of Reporting Trials) Statement to help authors improve reporting of two-parallel design RCTs by using a checklist and flow diagram. Extensions of the CONSORT Statement have been developed for other types of study designs, interventions and data.
The Checklist
The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results and Discussion. You can browse these items using the menu on the left.
The checklist includes the 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings.
- A template of the CONSORT checklist is available to download (MS Word; also available as a PDF).
The Flow Diagram
The flow diagram is intended to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow-up, 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.
- A template of the CONSORT flow diagram is available to download (MS Word; also available as a PDF).
Explanation and Elaboration Document
It is strongly recommended that the CONSORT Statement be used in conjunction with the CONSORT Explanation and Elaboration Document. This document is intended to enhance the use, understanding and dissemination of the CONSORT Statement. Through examples and explanations, the meaning and rationale for each checklist item are presented. You can find these under each checklist item using the menu on the left.
- Download a PDF of the full-text of the CONSORT Statement 2001 Explanatory and Elaboration document.
Citing the CONSORT Statement from the website (for authors)
If you are using the CONSORT Statement from this website, we recommend using
journal article citations rather than citing the CONSORT Statement
website. Click here for more information.
Translations
The CONSORT Statement is available in 10 different languages other than English.
Page last edited: 07 May 2009
