Mestrado em Assistência e Avaliação em Saúde (FF)

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Navegando Mestrado em Assistência e Avaliação em Saúde (FF) por Por Orientador "Itria, Alexander"

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    Avaliação da eficácia do nusinersena (Spinraza®) no tratamento de atrofia muscular espinhal: uma revisão sistemática
    (Universidade Federal de Goiás, 2019-11-01) Borges, Stéfani Sousa; Itria, Alexander; http://lattes.cnpq.br/7278290457268315; Itria, Alexander; Reis, Angela Adamski da Silva; D’Alessandro, Walmirton Bezerra; Suzuki, Karina; Tobias, Gabriela Camargo
    Spinal muscular atrophy (SMA) is an autosomal recessive neurodegenerative disease characterized by mutations or deletions of the survival motor neuron 1 (SMN1) gene, which leads to degeneration of motor neurons of the spinal cord. Nusinersen, commercially known as Spinraza®, has been approved and incorporated into the Brazilian health system as the first pharmacological treatment for SMA, however, a number of ethical issues have been raised, indicating the need for further studies to confirm the drug’s efficacy. In view of this, the objectives of this study were to assess the efficacy of nusinersen (Spinraza®) in SMA’s treatment through a systematic review of randomized controlled trials (RCTs) and cohort studies, and to evaluate the methodological quality of the included studies. The identification and selection of the studies were conducted by two reviewers, blinded and independent in following databases: Cochrane Library, Embase, Lilacs (via Virtual Health Library) and Medline (via Pubmed). An additional search in references of the included articles and in the international database Clinical Trials was conducted to capture as many publications as possible. As inclusion criteria, were selected the full published full articles of human studies whose objective(s) was to evaluate the efficacy of nusinersena in SMA’s treatment. For quality assessment and bias identification, included RCTs were assessed according to the CONSORT (Consolidated Standards of Reporting Trials) Recommendation and cohort studies in accordance with STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) Recommendation. The search in the databases returned 427 publications, of which 112 were removed by duplication and 309 excluded because they did not meet any of the inclusion criteria, totalizing six publications included in this review, of which two RCTs and four cohort studies. The total population of the analyzed articles yielded 461 both sexes individuals and diagnosed SMA Types I, II or III. The most used motor function improvement rating scales among the studies were HINE-2 and CHOP INTEND. The efficacy of nusinersen (Spinraza®) was compared between studies taking into account the research design, population included, and outcomes identified based on the progress of motor scale scores. The validity of the outcomes was discussed according to the quality of each publication and the risks of biases identified under the CONSORT and STROBE Recommendations. Financial support from the drug-producing industry was identified as the main bias in some of the studies. Scientific evidence has shown a significant improvement in motor function in patients treated with nusinersena, although the combination of the outcomes discussed in this review are not considered sufficient to confirm an increase in patient survival. It was identified that an improvement in the patterns of conduct and reporting of studies included in the review are important attitudes to be adopted.
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    Custos decorrentes de eventos adversos a medicamento em pacientes hospitalizados
    (Universidade Federal de Goiás, 2018-04-05) Nascimento, Lais Cardoso do; Itria, Alexander; http://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4777764P2; Itria, Alexander; Lemos, Lucimeire Fermino; Cardoso, Larissa Barbosa
    Theoretical Background: The adverse drug event (ADE) may occur due to adverse reaction and medication error. Damage caused by adverse events (AD) can lead to increased hospitalization time, rehospitalization, greater morbidity, the need for diagnostic and therapeutic interventions, irreversible consequences such as death and great economic impact. Objective: This study aims to analyze the costs of adverse drug events in hospitalized patients. Methods: This is a retrospective study carried out in a public hospital in the state of Goiás, Brazil, with patients admitted to the adult hospitalization clinics in the year 2016 and who suffered ADE. The colection of data occurred between May and October 2017. The data were collected through a nursing record and patient records. Additional hospitalization time, hours worked by the health professional, therapeutic and diagnostic procedures, and resources used by these users related to ADE were analyzed. In case of death, the average annual salary was calculated by the years of lost work lives for the society. The costs of the materials were obtained through a bidding system and the cost accounting unit of the hospital itself, the Federal Government Price Panel, and procedures through the SIGTAP Table. The data was typed in the Excel worksheet and analyzed by simple statistics. The present study was submitted and approved in the ethics committee with protocol in GEP / HC / UFG nº 030/2017 and was followed what is recommended by Resolution 466/2012. Results: We identified 164 cases of medication errors and adverse reactions in the nursing records. However, only the cases of patients in which the medical record was reported and that additional intervention were included in the study, which totaled 80 cases, 25 of which could have been avoided. The total costs due to EAM identified in the study were R $ 96,877.90. There were direct costs totaling R $ 26,463.90, of which R $ 20,430.36 was obtained from the hospital's perspective and R $ 6,033.54 from the SUS perspective. And of this amount R $ 14,380.13 was due to non-preventable EAM and R $ 12,083.77 due to preventable EAM. In the perspective of society, there were indirect costs of R $ 70,414.00, due to the death due to medication failure. Conclusion: It is concluded that the financial impact requires attention of managers, in the sense that avoiding such costs, it opens up possibilities for new investments.