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CONSORT Statement 2010:

CONSORT 2010 Explanation and Elaboration Document:

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. The most up-to-date revision of the CONSORT Statement is CONSORT 2010, which can be freely viewed and downloaded from this website. All previous versions of the CONSORT Statement are out-dated.

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, Discussion, and Other information. Details of these items, as found in the CONSORT 2010 Explanation and Elaboration document, can be browsed using the menu on the left.

The checklist includes the 25 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.

  • Templates of the CONSORT 2010 checklist are available to download in MS Word and in 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 (enrollment, 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.

  • Templates of the CONSORT 2010 flow diagram are available to download in MS Word and in 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 full-text copy of the explanation and elaboration document from the box at the top right corner of this page.

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

We would welcome the opportunity to make CONSORT available in different languages. Please see our translation policy for more information.

Page last edited: 20 January 2012