The Consolidated Standards for Reporting of Trials (CONSORT) statement
was developed to help improve the quality of reports of randomized controlled
trials (RCTs). To date, a paucity of data exists regarding whether it has
achieved this goal.
To determine whether use of the CONSORT statement is associated with
improvement in the quality of reports of RCTs.
Design and Setting
Comparative before-and-after evaluation in which reports of RCTs published
in 1994 (pre-CONSORT) were compared with RCT reports from the same journals
published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that
adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).
Main Outcome Measures
Number of CONSORT items included in a report, frequency of unclear reporting
of allocation concealment, and overall trial quality score based on the Jadad
scale, a 5-point quality assessment instrument.
Compared with 1994, the number of CONSORT checklist items in reports
of RCTs increased in all 4 journals in 1998, and this increase was statistically
significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7;
95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting
of allocation concealment decreased for each of the 4 journals, and this change
was statistically significant for adopters (pre-CONSORT, 61%; mean change, −22%;
95% CI, −38% to −6%). Similarly, 3 of the 4 journals showed an
improvement in the quality score for reports of RCTs, and this increase was
statistically significant for adopter journals overall (pre-CONSORT, 2.7;
mean change, 0.4; 95% CI, 0.1-0.8).
Use of the CONSORT statement is associated with improvements in the
quality of reports of RCTs.