Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia.

OBJECTIVE: To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. METHODS: Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. RESULTS: Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. CONCLUSION: The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.

Frequency of A1C tests undertaken by patients assisted by pharmaceutical care services in Brazil.

BACKGROUND AND AIMS: The test of glycated hemoglobin is used to assess the glycemic control of patients with diabetes mellitus, however is essential that the monitoring is carried out with adequate frequency. In this context, the objective of study is evaluate the frequency of A1C tests undertaken by patients assisted by pharmaceutical care services. METHODS: Descriptive study that included patients with DM treated at pharmaceutical care services in Brazil. This service is provided by pharmacists, for optimizing of patient's drug therapy to achieve outcomes that improve a patient's quality of life. Frequency of A1C tests was collected, with a minimum interval of three and a maximum of six months being considered adequate. Tests performed with a minimum interval of less than three or greater than six months frequency were considered inadequate. The comparison of the mean time between the A1C tests between the groups was investigated by the Student's t-test. The significance level adopted was p < 0.05. The study was conducted using data recorded from March 2018 to December 2019. RESULTS: The study included 66 patients and 67% of these underwent A1C test with inadequate frequency. The mean time between A1C tests was significantly higher (p < 0.0001) in group with inadequate frequency. CONCLUSION: Only one third of DM patients treated by pharmaceutical care services are monitored with adequate A1C frequency. It is necessary to identify the causes of this underutilization and to develop tools to optimize the monitoring.

Quality of clinical studies present in the package inserts of coagulation factors used in the treatment of hemophilia

ABSTRACT Objective To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. Methods Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. Results Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. Conclusion The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.