Publication:

Assessing the reporting quality of randomized-controlled clinical trials involving novel oral anticoagulants in patients with atrial fibrillation based on the CONSORT statement

Background Inadequate reporting of the published randomized controlled trials (RCTs) may restrict the generalizability of treatment effectiveness and tolerability of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). The main objective of this study was to assess the reporting quality of RCTs for efficacy and safety of NOACs vs. warfarin in patients with AF based on the consolidated standards of reporting trials (CONSORT) statement.

Methods Pubmed was searched for relevant english-language RCTs. Eligible articles included pivotal RCTs and articles reporting results from sub-populations or post-hoc secondary analysis of the pivotal trials (non-pivotal trials). Eligible articles were assessed according to 37-item/sub-item checklist of CONSORT statement 2010. The assessment was overall and according to trial’s type, NOAC treatment and impact factor (IF) of journals.

Results Search identified 92 articles eligible for evaluation. Half of CONSORT items were reported by more than 90% of the articles and 25% of items were reported in all articles. The majority of pivotal studies (94%) answered >75% of CONSORT items, while only half of non-pivotal studies had similar compliance (p 0.05), while IF had a significant effect in quality (p<0.01).

Conclusions RCTs for efficacy and safety of NOACs vs. warfarin in AF patients found to be well reported. Though, the quality of reporting is affected by type of trial and journals’ IF.