Analysis of the quality of evidenceon the effectiveness of direct oral anticoagulants
Bias; Clinical Trial; Anticoagulants; Medicine Package Inserts;
Thrombosis.
Introduction: Direct oral anticoagulants (DOACs) have been presented as a new
anticoagulant front in the prevention of thromboembolism. Imprecisions in design,
conduct, and analysis may bias the effect of the intervention to be underestimated
or overestimated. Objective: To analyze the quality of scientific evidence on the
efficacy of DOACs available in package leaflets. Method: To achieve the
objective, the study was divided into two stages: (i) identification and analysis of
the availability of bibliographic references contained in the package leaflets of
DOACs consulted through the electronic bularium of the Agência Nacional de
Vigilância Sanitária (ANVISA); and (ii) analysis of the quality of the studies
contained in the package leaflets using. In this step the Cochrane Risk of Bias
tool was used. This tool has seven domains, and each domain was classified as
high, uncertain, or low risk of bias according to the authors' assessment. The
analysis was performed by two independent authors. In case of disagreement, a
third reviewer was consulted. After evaluation, graphs of the analyses were
generated using Revman 5.4 software. Results: Twenty-five studies were
evaluated. The results showed that the clinical trials used as references in the
professional package leaflets of DOACs have great methodological uncertainties.
Conclusion: Therefore, the present study evidenced that the quality of clinical
trials used as references for DOACs' package inserts showed many uncertain
domains in their clinical trials and should be analyzed with caution. It is suggested
the need for strict protocols that establish the description of the methods in a clear
and cohesive way.