An assessment of the reporting quality of randomised controlled trials relating to anti-arrhythmic agents (2002-2011)

Despite being the gold-standard for investigations, randomised controlled trials can deliver biased results if methodology is flawed. The CONSORT statements are intended to guide the reporting of trials. We assessed the reporting quality of anti-arrhythmic drug trials over the last decade.

Medline and Embase databases were searched for anti-arrhythmic drug trials between 2002 and 2011. Results were searched by two authors and relevant papers selected. Papers were scored according to the 2001 and 2010 CONSORT statements by two reviewers and compared against surrogate markers of paper quality.

694 papers were retrieved. 59 papers met the inclusion criteria. The mean CONSORT 2010 score was 15.4 out of 25 (SD 3.05). The least reported items related to abstract content (0%), randomization (6.8%), and protocol referencing (8.5%). There was a significant correlation between the CONSORT 2010 score and the annual and 5-year impact factors of the publishing journal (R=0.44 and R=0.45 respectively; p<0.001 for both). No significant correlation was found between the year of publication or number of authors, and 2010 CONSORT score.

Although several papers gained high scores, no paper successfully met all criteria laid out in either the CONSORT 2001 or 2010 statements. Correlation between CONSORT 2010 score and impact factor lends support to this as a marker for paper quality. The lack of reporting clarity found, indicates that application of the CONSORT guidelines remains incomplete within the cardiology literature. Further work is needed collectively by trial groups, funding agencies, authors, and journals to improve reporting.