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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.
- 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.
- ItemArcabouço legal da incorporação e acesso a dispositivos médicos no Brasil: estrutura, tipos de avaliação e oportunidades para avanços(Jornal Brasileiro de Economia da Saúde, 2020)Objective: Present in a structured way the Brazilian legal framework related to the classification, nomenclatures and stages of adoption of medical devices into SUS and into Supplementary Health. Methods: Review and critical analysis of official publications and legal frameworks applicable to the regulation, adoption and access of medical devices in Brazil. Results: Based on the findings, it was possible to define the classifications and nomenclatures used by government agencies and mapping the flow of technological adoption, comprising four stages: a first national macroprocess of market incorporation from obtaining the health register at Anvisa, when the device becomes available for sale in the country; two other national macroprocesses for the definition of reimbursement and financing policies for the SUS and for the Supplementary Health that occur from submissions to Conitec and ANS; and, one process of local adoption with the acquisition by health facilities and services, representing the effective access to the population. Conclusion: The wide heterogeneity of medical devices makes the promotion of access to these technologies more challenging, requiring by Health Technology Assessment specialists a broader understanding of flows, classifications, strategies of assessment and possibilities for financing and reimbursement that have significant differences from those applicable to medicines. This work allowed to identify the main stages of adoption, suggesting the correction of detected weaknesses, as well as advances in order to promote medical devices access to the population with greater speed and efficiency