Abstract |
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors.
CONSORT 2010 was developed through collaboration and consensus between clinical trial methodologists, guideline developers, knowledge translation specialists, and journal editors (see CONSORT group ). CONSORT 2010 is the current version of the guideline and supersedes the 2001 and 1996 versions . It contains a 25-item checklist and flow diagram, freely available for viewing and downloading through this website.
Extensions of the CONSORT Statement have been developed for different types of trial designs, different interventions, and different types of data.
The most important documents for understanding the CONSORT 2010 statement are the following:
The CONSORT 2010 Statement: This is a declaration of the standard, and how it was developed. This declaration or "statement" has been published in many prominent journals, including the British Medical Journal, the Lancet and PLoS Medicine. You can download the CONSORT 2010 Statement documents here.
The CONSORT 2010 Explanation and Elaboration (E&E) Document: This 32-page document provides an explanation of each of the CONSORT Checklist items, and how to apply them in your reporting. You can download the CONSORT 2010 E&E Document here.
The CONSORT 2010 Checklist: This is a checklist of each of the 25 items that must be reported in a Randomized Clinical Trial Report in order for it to be compliant with the standard. You can see an example of how the CONSORT checklist can be applied to a well-reported study by navigating to the Sample Study in the menu above. You can download the CONSORT 2010 Checklist here.
The CONSORT 2010 Flow Diagram: This is a simple flow diagram showing how your study population was recruited and handled during the course of your study. You must complete a flow diagram in order to be compliant with the CONSORT 2010 standard. You can download the CONSORT 2010 Flow Diagram template here.
http://www.consort-statement.org/consort-2010 |