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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

New guidelines for trial reporting – CONSORT 2010

Progress in healthcare depends on the application of innovation from
many types of biomedical research. While appropriate design, conduct and
analysis are key characteristics of quality, a critical aspect of
translating findings to healthcare is clear and transparent reporting.

The first CONSORT statement was published in 1996 [1] and revised in
2001. [2-4] The aim then, and now, was to improve how randomised
controlled trials (RCTs) are reported so that they can be accurately
assessed by readers, editors and reviewers. Some success has been
achieved and the reporting of some RCTs is excellent. [5, 6] Despite
CONSORT statement has been around for 14 years, complete and clear
information on all aspects of all RCTs is still missing from many reported
studies. [7]

How does the 2010 statement [8] differ from the 2001 version? [2-4]
There are general and specific improvements. Wording was simplified and
clarified, and consistency in language improved. Some items have been
split into sub-items to avoid confusion. Specific changes include
requiring a description of how blinding is done, but eliminating the need
to explain how its success was determined, since research has raised
questions about the validity of such estimates. Numbers for “intention-to
-treat” analysis are no longer required because the authors consider this
term widely misused. Instead, they ask for the number of participants in
each analysis and whether the analysis was by original assigned group.
These are just some examples of changes in the CONSORT 2010 checklist [8]
which was described as a “service history” for RCTs. [9]

In the CONSORT 2010 statement, [8] the text on how the success of
blinding was evaluated has been removed. This seems to be opposite to the
views advocated by other investigators. [10, 11] This issue has been
discussed briefly in the separate explanatory paper. [12] Researchers,
however, may want to read a more fuller explanation of the rationale for
removal of the sub-item on testing for blinding in the commentary by
Schulz et al. [13]

The revised statement [8] alone will not improve reporting of RCTs.
To be effective, the CONSORT statement must be used in practice, which
will require commitments from authors, editors and peer reviewers.

With more complete reporting, the whole process of evaluating the
quality of research should be easier. In my work as a systematic
reviewer, it is such a joy to come across a clearly reported trial when
abstracting data.

1 Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al.
Improving the quality of reporting of randomized controlled trials. The
CONSORT statement. JAMA 1996;276:637-9.

2 Moher D, Schulz KF, Altman DG. The CONSORT statement: revised
recommendations for improving the quality of reports of parallel-group
randomised trials. Lancet 2001;357:1191-4.

3 Moher D, Schulz KF, Altman DG; CONSORT Group. The CONSORT
statement: revised recommendations for improving the quality of reports of
parallel-group randomized trials. Ann Intern Med 2001;134:657-62.

4 Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT statement:
revised recommendations for improving the quality of reports of parallel-
group randomized trials. JAMA 2001;285:1987-91.

5 Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al.
Does the CONSORT checklist improve the quality of reports of randomised
controlled trials? A systematic review. Med J Aust 2006;185:263-7.

6 Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG. The quality of
reports of randomised trials in 2000 and 2006: comparative study of
articles indexed in PubMed. BMJ 2010;340:c723.

7 Chan AW, Altman DG. Epidemiology and reporting of randomised
trials published in PubMed journals. Lancet 2005;365:1159-62.

8 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated
guidelines for reporting parallel group randomised trials. BMJ

9 Williams HC. Cars, CONSORT 2010, and Clinical Practice. Trials

10 Fergusson D, Glass KC, Waring D, Shapiro S. Turning a blind eye:
the success of blinding reported in a random sample of randomised, placebo
controlled trials. BMJ 2004;328:432.

11 Kolahi J, Bang H, Park J. Towards a proposal for assessment of
blinding success in clinical trials: up-to-date review. Community Dent
Oral Epidemiol 2009;37:477-84.

12 Moher D, Hopewell S, Schulz KF, Montori V, Gøtzche PC, Devereaux
PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines
for reporting parallel group randomised trials. BMJ 2010;340:c869.

13 Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT 2010 changes
and testing blindness in RCTs. Lancet 2010;375:1144-6.

Competing interests:
None declared

Competing interests: No competing interests

12 April 2010
C. Albert Yeung
Consultant in Dental Public Health
NHS Lanarkshire, 14 Beckford Street, Hamilton ML3 0TA