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Research Methods & Reporting

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

BMJ 2010; 340 doi: (Published 24 March 2010) Cite this as: BMJ 2010;340:c332

Items 23 & 24: prospective trial registration and submission of trial protocol to enhanced transparency of reporting

The latest iteration of the CONSORT statement is a significant improvement
on the previous version,
and reflects the organic evolution of this guideline over the past decade. The
2010 version is clearer,
but will demand greater rigour in completing the checklist. Precision is
increased with some checklist
items having been broken into sub-items and authors required to provide
page numbers for each
sub-item on the checklist. IÕm particularly gladdened by the addition of item
1B requiring a structured
summary in line with the CONSORT abstracts recommendation. The author is
required to explicitly
describe the allocation concealment mechanisms and blinding. Where
previously word count was an
issue, full online publication of RCTs without word limits should allow a full
and clear account of the
actual steps taken to ensure allocation concealment, etc. Readability of
reports of RCTs should be
enhanced with the requirement to provide a table of baseline characteristics
of each group.

However the most important additions to the new 2010 CONSORT statement
are the requirement for
prospective trial registration and the making available to the editorial panel
of the trial protocol.
Authors will need to adhere closely to their protocol and will enable
comparison of the conduct and
reporting of the trial with the protocol after publication. Items 23 and 24 can
only improve the quality
of not only trial conduct but also trial reporting. Enhanced transparency of
reporting will improve the
quality of the trials themselves and in turn the veracity of the results upon
which clinicians base the
care of their patients. The CONSORT group is to be applauded.

Competing interests:
None declared

Competing interests: No competing interests

28 March 2010
Grant M Dex
Clinical Lecturer in Primary Care
Division of Primary Care, University of Nottingham, NG7 2RD