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- ItemA Systematic Review and a Meta-Analysis of the Yellow Fever Vaccine in the Elderly Population(Vaccines, 2022)We conducted a systematic review and a meta-analysis to assess the risk of serious adverse events in the elderly after yellow fever vaccination compared to the non-elderly population. We searched multiple databases and grey literature, and we selected research without language and publication date restrictions. Studies were analyzed in a descriptive way and meta-analyzed and expressed in terms of prevalence ratio and risk ratio with a 95% confidence interval, depending on the degree of heterogeneity found. A total of 18 studies were included and 11 were meta-analyzed. The results obtained through the meta-analysis showed a risk of serious adverse events after yellow fever vaccination three times higher for the elderly when compared to the non-elderly popula- tion and five times higher for persons > 70 years. In relation to adverse event types, viscerotropic disease associated with the yellow fever vaccine had a risk that was six times higher when com- pared to the population < 60 years. The evidence found supports that the vaccine indication in individuals > 60 years of age should be based on a careful analysis of individual benefit-risk assess- ments. The results found suggest a higher risk of events for individuals > 70 years, especially for viscerotropic and neurotropic disease associated with YFV contraindicating the use of the YFV in this age group.
- ItemYellow fever vaccine safety in immunocompromised individuals: a systematic review and meta-analysis(Journal of Travel Medicine, 2023)Background: Yellow fever (YF) is an arbovirus with variable severity, including severe forms with high mor- tality. The vaccination is the most effective measure to protect against the disease. Non-serious and serious adverse events have been described in immunocompromised individuals, but previous studies have failed to demonstrate this association. This systematic review assessed the risk of adverse events after YF vaccination in immunocompromised individuals compared with its use in non-immunocompromised individuals. Methods: A search was conducted in the MEDLINE, LILACS, EMBASE, SCOPUS, DARE, Toxiline, Web of Science and grey literature databases for publications until February 2021. Randomized and quasi-randomized clinical trials and observational studies that included immunocompromised participants (individuals with HIV infection, organ transplants, with cancer, who used immunosuppressive drugs for rheumatologic diseases and those on immunosuppressive therapy for other diseases) were selected. The methodological quality of observational or non-randomized studies was assessed by the ROBINS-I tool. Two meta-analyses were performed, proportion and risk factor analyses, to identify the summary measure of relative risk (RR) in the studies that had variables suitable for combination. Results: Twenty-five studies were included, most with risk of bias classified as critical. Thirteen studies had enough data to carry out the proposed meta-analyses. Seven studies without a comparator group had their results aggregated in the proportion meta-analysis, identifying an 8.5% [95% confidence interval (CI) 0.07–21.8] risk of immunocompromised individuals presenting adverse events after vaccination. Six cohort studies were combined, with an RR of 1.00 (95% CI 0.78–1.29). Subgroup analysis was performed according to the aetiology of immunosuppression and was also unable to identify an increased risk of adverse events following vaccination. Conclusions: It is not possible to affirm that immunocompromised individuals, regardless of aetiology, have a higher risk of adverse events after receiving the YF vaccine.
- ItemCritérios de definição de preços de medicamentos no Brasil e em países selecionados: uma revisão comparada(Jornal Brasileiro de Economia da Saúde, 2021)Objetivos: Comparar os critérios de formação de preços de medicamentos no Brasil e em países selecionados, analisar o mecanismo de formação de preços de medicamentos no Brasil e analisar o mecanismo de formação de preços de medicamentos em países selecionados. Métodos: Foi realizada uma revisão narrativa da literatura por meio do levantamento de informações em bases de dados, em sites das agências nacionais e organismos internacionais e em literatura “cinzenta”, a respeito dos sistemas de saúde e mecanismos de formação de preços de medicamentos no Brasil e nos países selecionados (Austrália, Canadá, Espanha, Estados Unidos, França, Grécia, Itália, Nova Zelândia e Portugal). Resultados: A maioria dos países pesquisados utiliza o referenciamento ex- terno e interno de preços, realiza ajustes e correções de preços ao longo do tempo e faz estudos de avaliação econômica. O valor da terapia ou seu benefício para o paciente ou sistema de saúde é um fator importante tanto na determinação do preço como da incorporação no sistema de saúde. Conclusão: Este trabalho permitiu identificar as semelhanças entre as práticas recomendadas e implementadas internacionalmente e as realizadas no Brasil, bem como os problemas relacionados à definição de preços das novas terapias, além das lacunas no modelo regulatório atual.
- ItemDupilumabe para asma grave não controlada(Instituto Nacional de Cardiologia, 2023)
- ItemStated Preferences in Non-Small-Cell Lung Cancer: A Discrete Choice Experiment.(Patient Prefer Adherence, 2021)Introduction The different alternatives for non-small-cell lung cancer (NSCLC) treatment can increase survival but cause important adverse events. Therefore, patients’ preference can play a critical role in decision-making. Among stated preference methods, discrete choice experiment (DCE) is the most applied in health care to elicit preferences. This research aims to elicit patients’ preference evaluating the trade-off between the risks (adverse events) and benefits (survival) of systemic treatments, from the perspective of Brazilian patients with locally advanced, metastatic or recurrent NSCLC. Methods A DCE was performed following the steps of attributes selection; construction of tasks and respondents’ preference elicitation. Patients chose between 2 hypothetical treatments described by the attributes tiredness, hair loss, skin rash, hospitalization, administration mode and survival. A paper-and-pencil survey method was used to elicit the answers from the participants. The statistical data analysis used a mixed logit model to predict the relative importance of the attributes. Results Most of the 65 patients interviewed were men (53.8%), mean age of 65 (95% confidence interval [CI]: 63–67) years and lung cancer stage IV (67.7%). Except for hospitalization and administration mode, the attributes coefficients were statistically significant (p < 0.005) for patients’ preferences. Patients would require a minimum survival gain of 11.72 (CI: 10.28–4.22) months and 19.72 (CI: 17.31‐7.09) months to accept a treatment that causes severe tiredness and severe skin rash, respectively. The market share of the treatments was calculated according to the DCE aggregate-level estimation, considering the impact of each treatment’s side effects. Paclitaxel plus carboplatin had an estimated market share of 31%, followed by gefitinib (27%), erlotinib (24%) and docetaxel (18%). Conclusion In general, less than a year of survival gain would not suffice for the appearance of severe skin rash or tiredness.