Development of CONSORT 2010
Since the revision in 2001, the evidence base to inform CONSORT had grown considerably; empirical data have highlighted new concerns regarding the reporting of randomized controlled trials, such as selective outcome reporting.(55) (56) (57)
Therefore, a CONSORT Group meeting was convened. Thirty-one members of the CONSORT 2010 group met in Montebello, Canada in January 2007 to update the 2001 CONSORT Statement. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. Some participants were given primary responsibility for aggregating and synthesizing the relevant evidence on a particular checklist item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORT versions, only those items deemed absolutely fundamental to reporting an RCT were kept. Moreover, an item may be fundamental to a trial but not included, such as approval by an institutional ethical review board, because funding bodies strictly enforce ethical review and medical journals usually address reporting ethical review in their instructions for authors. Other items may seem desirable, such as on-site monitoring, but a lack of empirical evidence or any consensus on their value cautions against inclusion at this point. The statement thus addresses the minimum criteria.
After the meeting, the CONSORT Executive convened teleconferences and in-person meetings to revise the checklist. After seven major iterations, a revised checklist was distributed to the larger group for feedback. With that feedback, the Executive met twice in person to consider all the comments and to produce a penultimate version. That served as the basis for writing the first draft of this paper, which was then distributed to the group for feedback. After consideration of their comments, the Executive finalized the statement.
The CONSORT Executive then drafted an updated explanation and elaboration (E&E) manuscript, with assistance from other members of the larger group. The substance of the 2007 CONSORT meeting provided the material for the update. The updated E&E was distributed to the entire group for additions, deletions, and changes. That final iterative process converged to the CONSORT 2010 E&E.
A summary of the specific changes to the CONSORT checklist is found in the CONSORT Statement.
Page last edited: 24 March 2010
