Analysis of the quality of scientific evidence on efficacy and safety in the package leaflets of direct oral anticoagulants marketed in Brazil
DOI:
https://doi.org/10.11606/issn.2176-7262.rmrp.2023.196548Keywords:
Bias, Clinical trial, Anticoagulants, Medicine Package Inserts, ThrombosisAbstract
Objective: Identify and analyze the quality of scientific evidence on the efficacy and safety of direct oral anticoagulants (DOAC) available in clinical trials referenced in the package leaflets of drugs marketed in Brazil. Method: This is a descriptive documentary study divided into two stages: (i) identification and analysis of the availability of the bibliographic references contained in the package leaflets of DOACs and (ii) analysis of the quality of the studies
contained in the package leaflets through the Cochrane Risk of Bias RevMan tool version 5.4. Seven domains of importance for clinical teaching were analyzed, and each domain was classified as high, uncertain or low risk of bias, according to the assessment of the collaborators. Results: Ten package leaflets intended for health professionals were analyzed. Of these, 25 clinical trials were evaluated. The analysis of the quality of the scientific evidence referenced in the package leaflets for health professionals showed that the cited studies presented methodological consistency. However, in most studies, the domains were classified as uncertain bias, i.e., it was not possible to identify how
these points were addressed in the studies. Conclusion: Therefore, the present study evidenced that the quality of clinical trials referenced in the package leaflets of DOACs presented methodological uncertainties in their trials. It is suggested the need for regulations that establish updates of the information content present in the professional
package inserts and establish a description of the methods in a clear and cohesive way.
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Copyright (c) 2023 Denner Henrique Isaias Souza, Nivea Aparecida de Almeida, Mara Luiza de Paiva Domingues, André de Oliveira Baldoni, Nayara Ragi Baldoni Couto , Danyelle Romana Alves Rios
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