An assessment of the compliance of randomized controlled trials published in two high impact journals with the CONSORT statement.

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement has been developed to improve the quality of reporting of clinical trials. There is possibly suboptimal adherence to the CONSORT statement in published trials. We evaluated the compliance of randomized controlled trials ( RCTs) published in the Journal of the American Medical Association (JAMA) and British Medical Journal (BMJ) in 2013 to the CONSORT statement 2010. A PubMed search for RCTs published in JAMA and BMJ for 2013 was done. Scores were assigned to each subitem of CONSORT by one of four authors and disputes were resolved by mutual consensus. The total score for each RCT was calculated and converted to a percentage total score (PTS). Scores were expressed as median (range). The median scores between journals and types of RCTs were compared using the Mann-Whitney U test. There were 97 RCTs (69 in JAMA and 28 in the BMJ) comprising parallel (75), cluster (14) and non-inferiority (8) design studies. The overall median (range) of PTS of all RCTs was 82% (59.4%-97.1 %). JAMA had an overall median (range) PTS of 81.6% (59.4%-97.1 %) and the BMJ 84% (65.2%-92.2%). The difference was not statistically significant (p=0.25). Between trial designs, the highest PTS was seen with parallel (which included parallel, crossover and factorial designs) with a median (range) of 85.1% (68.4%-90.2%) followed by cluster randomized trials 82.8% (65.2%-92.2%) and non-inferiority trials 78.6% (72.7%-85.7%). There was no significant difference between the three trial designs (p=0.48). A wide range in PTS (59.4%-97.1 %) even in high impact journals indicates poor compliance of reported trials with CONSORT.