Use of the CONSORT Statement and Quality of Reports of Randomized Trials

TLDR

The CONSORT statement was created to improve the reporting quality of randomized controlled trials. The authors performed a comparative before‑and‑after study of 211 RCT reports from four high‑impact journals, comparing 1994 pre‑CONSORT papers with 1998 post‑CONSORT papers and assessing CONSORT item completion, allocation concealment clarity, and Jadad quality scores. Use of CONSORT was associated with a significant increase in reported checklist items, a reduction in unclear allocation concealment, and a modest but significant rise in overall Jadad quality scores across the adopter journals.

Abstract

ContextThe 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.ObjectiveTo determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.Design and SettingComparative 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 MeasuresNumber 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.ResultsCompared 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).ConclusionUse of the CONSORT statement is associated with improvements in the quality of reports of RCTs.