Banca de DEFESA: MARA LUIZA DE PAIVA DOMINGUES

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : MARA LUIZA DE PAIVA DOMINGUES
DATE: 04/05/2022
TIME: 14:00
LOCAL: Google meeting: meet.google.com/eaz-fgjn-ezr
TITLE:

Assessment of the risk of bias of clinical trials referenced in the Technical Notes for Ordering Direct Oral Anticoagulants

KEY WORDS:

Technical Notes; Judicialization; Anticoagulants; Clinical Trial; Bias

PAGES: 46
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUMMARY:

Introduction: Started in the 1990s, the judicialization of health care in Brazil contemplates direct oral anticoagulants (DOAC). The increase in demand resulted in the creation of the “eNatJus” system, which stores Technical Notes (NTs) that assist in the decisions of health processes. Thus, studies to evaluate the quality of clinical trials used in the elaboration of NTs are necessary and allow greater security in decisions. Objective: To evaluate the clinical trials that make up the NTs referring to the DOAC by classifying the risk of bias. Methods: The NTs related to apixaban, dabigatran, edoxaban and rivaroxaban DOAC requests were selected on the e-NatJus website and, after excluding duplicate bibliographic references, an analysis of the clinical trials used for their writing was performed. The risk of bias of clinical trials (low, high or uncertain bias) was assessed using the Cochrane Risk of Bias tool and the results of the analyzes were added in Review Manager 5.4 (Revman 5.4) for graphing. Results: 181 NTs were selected, 236 articles were analyzed and after applying the inclusion criteria, 28 clinical trials were analyzed in full. None of the clinical trials were free from bias. The majority of clinical trials, 71% (20/28) showed low risk of bias with respect to attrition bias and reporting bias. On the other hand, 61% (17/28) of the trials did not control for selection, performance and detection bias, since they present uncertainties and high risk of bias. In addition, it was observed that 21% (6/28) of clinical trials had risk of bias for conflict of interest. Conclusion: The biases present in the clinical trials cited as a bibliographic reference of the NT referring to the DOAC request are significant and compromise their quality.

BANKING MEMBERS:
Presidente - 1039964 - ANDRE DE OLIVEIRA BALDONI
Externa à Instituição - LEILISMARA SOUSA NOGUEIRA - UNIFAL-MG
Externa à Instituição - KÉRILIN STANCINE SANTOS ROCHA - UFES
Externa à Instituição - CARINA CARVALHO SILVESTRE - UFJF