Outbreak of extensively drug-resistant Serratia marcescens in an intensive care unit.

We present the investigation and control of an extensively drug-resistant Serratia marcescens outbreak in a 30-bed intensive care unit (ICU). Within 6 weeks, 4 critically ill trauma patients were infected by the same strain. Intensive containment measures limited the spread of this strain while sustaining the capacity of the trauma ICU.

Immunogenicity and safety of inactivated quadrivalent influenza vaccine compared with the trivalent vaccine for influenza infection: an overview of systematic reviews.

BACKGROUND: Influenza infection is a highly preventable transmissible viral disease associated with mild upper respiratory symptoms and more severe conditions such as lethal pneumonia. Studies have shown that a broader spectrum influenza vaccine could reduce influenza's burden of disease in low- and middle-income countries. A considerable number of systematic reviews reported that quadrivalent influenza vaccines are considered more effective compared to trivalent vaccines, hence, there is a need for an overview in order to synthesize the current evidence pertaining to the comparison between quadrivalent and trivalent inactivated influenza vaccines. OBJECTIVE: The aim was to summarize the evidence from systematic reviews that investigated the immunogenicity and safety of the Influenza's inactivated quadrivalent vaccine (QIV) compared to the trivalent vaccine (TIV), in the general population. METHODS: We searched articles up to December 2022 at: Web of Science, EMBASE, MEDLINE, Cochrane Library, and SCOPUS. The search strategy was conducted following the PICO model. We included systematic reviews comparing the primary outcomes of immunogenicity (seroprotection rate and seroconversion rate) and adverse events using risk ratios. The AMSTAR 2 and ROBIS were used for quality assessments, and GRADE was used for evidence certainty assessments. FINDINGS: We included five systematic reviews, totalling 47,740 participants. The Quadrivalent Inactivated Influenza Vaccine (QIV) exhibited enhanced immunogenicity in the context of B-lineage mismatch when compared to the Trivalent Inactivated Influenza Vaccine (TIV). While the safety profile of QIV was found to be comparable to that of TIV, the QIV showed a higher incidence of solicited local pain among children and adolescents, as well as an increased frequency of local adverse events within the adult population. CONCLUSION: Our findings suggest that the QIV provides a superior immunogenicity response compared to the TIV in all age groups evaluated, especially when a lineage mismatch occurred. The safety of QIV was considered similar to the TIV, with no serious or systemic solicited or unsolicited adverse events; tough pain at the injection site was greater for QIV. We recommend caution owing to the high risk of bias in the selection process and no protocol registration.

A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults.

BACKGROUND: To enhance the production and availability of influenza vaccines in different regions of the world is paramount to mitigate the global burden of this disease. Instituto Butantan developed and manufactured an embryonated egg-based inactivated split-virion trivalent seasonal influenza vaccine as part of a technology transfer partnership with Sanofi Pasteur. METHODS: This is a phase IV, randomized, double-blind, active-controlled, multicenter clinical trial including adults 18-60 and > 60 years recruited during the 2019 southern hemisphere influenza season. Subjects were randomized 1:1 to receive either the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine (SP-TIV) or Instituto Butantan Trivalent Seasonal Influenza Vaccine (IB-TIV). Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination. RESULTS: 624 participants were randomized and vaccinated. In both intention-to-treat and per-protocol analysis, non-inferiority of the SP-TIV versus IB-TIV was demonstrated for the three influenza strains. In the per-protocol analysis, the SP-GMT/IB-GMT ratios for H1N1, H3N2, and B were 0.9 (95%CI, 0.7-1.1), 1.2 (95%CI, 1.0-1.4), and 1.1 (95%CI, 0.9-1.3), respectively. Across vaccination groups, the most common adverse reactions (AR) were limited to the injection-site, including pain and tenderness. The majority of the ARs were graded 1 and/or 2 and lasted less than one day. No serious adverse reaction was observed. CONCLUSION: This study demonstrated the non-inferiority of the immunogenicity of a single-dose of Instituto Butantan versus a single dose of the Sanofi Pasteur Seasonal Trivalent Influenza Vaccine in adults. Both vaccines were well tolerated and presented similar safety profiles.

Dose-sparing effect of two adjuvant formulations with a pandemic influenza A/H7N9 vaccine: A randomized, double-blind, placebo-controlled, phase 1 clinical trial.

The emergence of potentially pandemic viruses has resulted in preparedness efforts to develop candidate vaccines and adjuvant formulations. We evaluated the dose-sparing effect and safety of two distinct squalene-based oil-in-water adjuvant emulsion formulations (IB160 and SE) with influenza A/H7N9 antigen. This phase I, randomized, double-blind, placebo-controlled, dose-finding trial (NCT03330899), enrolled 432 healthy volunteers aged 18 to 59. Participants were randomly allocated to 8 groups: 1A) IB160 + 15µg H7N9, 1B) IB160 + 7.5µg H7N9, 1C) IB160 + 3.75µg H7N9, 2A) SE + 15µg H7N9, 2B) SE + 7.5µg H7N9, 2C) SE + 3.75µg H7N9, 3) unadjuvanted vaccine 15µg H7N9 and 4) placebo. Immunogenicity was evaluated through haemagglutination inhibition (HI) and microneutralization (MN) tests. Safety was evaluated by monitoring local and systemic, solicited and unsolicited adverse events (AE) and reactions (AR) 7 and 28 days after each study injection, respectively, whereas serious adverse events (SAE) were monitored up to 194 days post-second dose. A greater increase in antibody geometric mean titers (GMT) was observed in groups receiving adjuvanted vaccines. Vaccinees receiving IB160-adjuvanted formulations showed the greatest response in group 1B, which induced an HI GMT increase of 4.7 times, HI titers ≥40 in 45.2% of participants (MN titers ≥40 in 80.8%). Vaccinees receiving SE-adjuvanted vaccines showed the greatest response in group 2A, with an HI GMT increase of 2.5 times, HI titers ≥40 in 22.9% of participants (MN titers ≥40 in 65.7%). Frequencies of AE and AR were similar among groups. Pain at the administration site and headache were the most frequent local and systemic solicited ARs. The vaccine candidates were safe and the adjuvanted formulations have a potential dose-sparing effect on immunogenicity against influenza A/H7N9. The magnitude of this effect could be further explored.

Outbreak caused by the SARS-CoV-2 Omicron variant in the psychiatric ward of a general hospital in Brazil.

BACKGROUND: An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant was detected in the psychiatric ward of a general hospital in Brasília, Brazil. METHODS: We report the investigation, clinical outcomes, viral sequencing, and control measures applied to outbreak containment. RESULTS: The overall attack rate was 95% (23/24) in a period of 13 days. Among the cases, 78% (18/23) were vaccinated and 17% (4/23) required intensive care. The Omicron variant was isolated from the 19 sequenced samples. CONCLUSIONS: The findings highlight the potential harm that highly transmissible variants may generate among hospitalized populations, particularly those with comorbidities.

Outbreak caused by the SARS-CoV-2 Omicron variant in the psychiatric ward of a general hospital in Brazil

ABSTRACT Background: An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant was detected in the psychiatric ward of a general hospital in Brasília, Brazil. Methods: We report the investigation, clinical outcomes, viral sequencing, and control measures applied to outbreak containment. Results: The overall attack rate was 95% (23/24) in a period of 13 days. Among the cases, 78% (18/23) were vaccinated and 17% (4/23) required intensive care. The Omicron variant was isolated from the 19 sequenced samples. Conclusions: The findings highlight the potential harm that highly transmissible variants may generate among hospitalized populations, particularly those with comorbidities.

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups.

INTRODUCTION: Active pharmacovigilance studies are pivotal to better characterize vaccine safety. METHODS: These are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS). RESULTS: A total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination. CONCLUSION: The results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

COVID-19 in long-term care facilities in Brazil: serological survey in a post-outbreak setting.

This cross-sectional seroepidemiological survey presents the seroprevalence of SARS-CoV-2 in a population living in 15 Long-Term Care Facilities (LTCFs), after two intra-institutional outbreaks of COVID-19 in the city of Botucatu, Sao Paulo State, Brazil. Residents were invited to participate in the serological survey performed in June and July 2020. Sociodemographic and clinical characterization of the participants as well as the LTCF profile were recorded. Blood samples were collected, processed and serum samples were tested using the rapid One Step COVID-19 immunochromatography test to detect IgM and IgG anti-SARS-CoV-2. Among 209 residents, the median of age was 81 years old, 135 (64.6%) were female and 171 (81.8%) self-referred as being white. An overall seroprevalence of 11.5% (95% CI: 7.5% - 16.6%) was found. The highest seroprevalences of 100% and 76.9% were observed in LTCFs that had experienced COVID-19 outbreaks. Most residents with positive immunochromatography tests (70.8%) referred previous contact with a confirmed COVID-19 case. Although there was a relatively low seroprevalence of COVID-19 in the total number of elderly people, this population is highly vulnerable and LTCFs are environments at higher risk for COVID-19 dissemination. A well-established test for COVID-19 policies, the adequate characterization of the level of interaction between residents and the healthcare provider team and the level of complexity of care are crucial to monitor and control the transmission of SARS-CoV-2 in these institutions.

Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review. / Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida.

This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

Health technology assessment as a tool to support decision-making in public and universal oral health care / Avaliação de tecnologias em saúde como ferramenta para a tomada de decisão em saúde pública e serviços universais de saúde bucal

Objective: To discuss the importance of health technology assessment (HTA) to allow oral health policies to be planned to meet the needs of prevention, promotion and recovery of patients' health. Methods: It is an opinion article. Oral diseases can be a considerable economic burden for the individual and for society, leading to a global impact of US$ 544.41 billion in 2015. Results: Brazil has made great progress in terms of oral health care after the publication of the National Policy of Oral Health (PNSB). However, the current challenge is still great, especially with regard to the management of health technologies within the PNSB. Conclusion: The accomplishment of HTA to support decision-making on allocation of the financial resources used may prevent the Smiling Brazil program from becoming vulnerable to the waste of the scarce resources allocated to this are, which would result in low effectiveness, inefficiency and inequity of the health system.

Objetivo: Discutir a importância dos estudos de avaliação econômica em saúde para permitir que as políticas de saúde bucal possam ser planejadas para atender às necessidades de prevenção, promoção e recuperação da saúde dos pacientes. Métodos: Este artigo se trata de um ensaio. As doenças bucais podem ser um fardo econômico considerável para o indivíduo e para a sociedade. Estima-se que, globalmente, esse impacto tenha sido de 544,41 bilhões de dólares em 2015. Resultados: O Brasil avançou muito em termos de cuidados em saúde bucal após a publicação da Política Nacional de Saúde Bucal. Entretanto, o desafio atual ainda é grande, especialmente no que diz respeito à gestão de tecnologias em saúde na Política Nacional de Saúde Bucal (PNSB). Conclusão: A realização de avaliações econômicas, para subsidiar a tomada de decisão na alocação dos recursos financeiros utilizados, pode impedir que o programa Brasil Sorridente se torne vulnerável ao desperdício dos escassos recursos que são alocados na área, o que resultaria em baixa efetividade, ineficiência e iniquidade do sistema de saúde.

Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.

BACKGROUND: The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV. METHODS: We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials.gov, NCT01696422. FINDINGS: Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4. INTERPRETATION: Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing. FUNDING: Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, Fundação de Amparo à Pesquisa do Estado de São Paulo, and Fundação Butantan.

Resorbable Versus Titanium Fixation of Le Fort I Osteotomy.

Resorbable and titanium systems have been used in maxillary fixation. The aim of this review was to evaluate stability and morbidity of Le Fort I osteotomy by comparing both systems. It was performed in 11 databases, and reported according to preferred reporting items for systematic reviews and meta-analysis. Randomized and nonrandomized clinical trials, and retrospective comparative studies with patients who underwent nonsegmented Le Fort I osteotomy were included. Eleven articles were selected, with a total of 262 patients treated with resorbable and 252 with titanium fixation. The meta-analysis showed that when measured at point A, horizontal stability was 0.06 mm (95% confidence interval [CI] -0.19, 0.30), vertical stability for impaction was -0.43 mm (95% CI -0.94, 0.07), and for inferior repositioning was -1.29 mm (95% CI -2.62, 0.04). Morbidity was similar in the groups. Regarding infection, resorbable presented an absolute risk (AR) = 0.032, and titanium an AR = 0.025 (P = 1.0). For soft tissue reaction, an AR = 0.120 was shown for resorbable, and an AR = 0.132 for titanium (P = 0.85). Removal of fixation showed an AR = 0.024 for resorbable, and an AR = 0.025 for titanium (P = 1.0). Based on these results, resorbable and metal fixation systems seem to be equivalent with respect to stability and morbidity. This review was limited by the quality of the studies. Future studies should address these quality limitations to improve comparison between these 2 fixation approaches.

Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida / Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review

Resumo O objetivo deste trabalho foi avaliar efeitos de tratamentos medicamentosos para infecções por coronavírus. Revisão sistemática rápida com buscas nas bases MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov e International Clinical Trials Registry Platform. Foram incluídos 36 estudos avaliando alternativas medicamentosas contra SARS, SARS-CoV-2 e MERS. A maioria dos estudos incluídos foi conduzida na China com delineamento observacional para tratamento da COVID-19. Os tratamentos mais estudados foram antimaláricos e antivirais. Nos antimaláricos, a metanálise de dois estudos com 180 participantes não identificou benefício da hidroxicloroquina em relação à negativação da carga viral via reação em cadeia de polimerase em tempo real e o uso de antivirais comparado ao cuidado padrão foi similar em relação aos desfechos. As evidências científicas disponíveis são preliminares e de baixa qualidade metodológica, o que sugere cautela na interpretação dos dados. Pesquisas que avaliem a eficácia comparativa em ensaios clínicos randomizados, controlados, com tempo de acompanhamento adequado e com os métodos devidamente divulgados e sujeitos à revisão científica por pares são necessárias. Recomenda-se atualização periódica da presente revisão.

Abstract This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

Pharmacovigilance capacity strengthening for WHO prequalification: The case of the trivalent influenza vaccine manufactured by Instituto Butantan.

Instituto Butantan is a biomedical research center and vaccine manufacturer affiliated with the São Paulo State Secretary of Health in Brazil. In 2013, Instituto Butantan successfully licensed its trivalent influenza vaccine, in order to support the Brazilian National Immunization Program's influenza vaccination strategy, which was introduced in 1999. In order to respond to the increasing influenza vaccine demand worldwide, Instituto Butantan is undergoing prequalification of its trivalent influenza vaccine by the World Health Organization (WHO). A key requirement of the prequalification review was the submission of a pharmacovigilance plan, including an active surveillance evaluation, for the trivalent influenza vaccine, and proof of a functional pharmacovigilance system at Instituto Butantan. The aim of this paper is to describe the capacity strengthening process of the pharmacovigilance system at Instituto Butantan for the WHO prequalification of the trivalent influenza vaccine. This process was supported by PATH and the U.S. Federal Government Biomedical Advanced Research and Development Authority (BARDA). The key strategic axes for this capacity strengthening process included the improvement of organizational structure, human resources training, internal processes and procedures, appropriate documentation, and acquisition of an E2B compliant pharmacovigilance database. The project led to the establishment of a functional pharmacovigilance system compliant with international regulatory requirements.

Cost-effectiveness of implant-supported dental prosthesis compared to conventional dental prosthesis.

OBJECTIVE: To conduct a cost-effectiveness analysis of alternatives for rehabilitation treatment of mandibular edentulism in the context of the Brazilian Unified Health System (implant-supported total dental prosthesis versus conventional total dental prosthesis). METHODS: A Markov model was developed to capture long-term clinical and economic outcomes. The model's population was comprised of a hypothetical cohort of 1,000,000 patients, aged 55 years, with total mandibular edentulism and without medical contraindications for performing surgical procedures. The adopted analysis perspective was that of the Brazilian Unified Health System. Based on the proposed model, we calculated cost - in BRL, and effectiveness - measured by quality-adjusted prosthesis year (QAPY). The time horizon of the analysis was 20 years. RESULTS: Considering a 5% discount in costs and effects, the incremental cost-effectiveness ratio of implant-supported total dental prostheses compared to conventional total dental prosthesis (BRL 464.22/QAPY) was lower than the willingness to pay threshold adopted in the model (BRL 3,050.00/QAPY). CONCLUSIONS: The results of this economic analysis showed that the rehabilitation of mandibular edentulous patients by implant-supported total prosthesis is very cost-effective when compared to conventional complete prosthesis, considering the cost-effectiveness limits employed.

Cost-effectiveness of implant-supported dental prosthesis compared to conventional dental prosthesis / Custo-efetividade da prótese implanto-suportada comparada à prótese total convencional

ABSTRACT OBJECTIVE To conduct a cost-effectiveness analysis of alternatives for rehabilitation treatment of mandibular edentulism in the context of the Brazilian Unified Health System (implant-supported total dental prosthesis versus conventional total dental prosthesis). METHODS A Markov model was developed to capture long-term clinical and economic outcomes. The model's population was comprised of a hypothetical cohort of 1,000,000 patients, aged 55 years, with total mandibular edentulism and without medical contraindications for performing surgical procedures. The adopted analysis perspective was that of the Brazilian Unified Health System. Based on the proposed model, we calculated cost - in BRL, and effectiveness - measured by quality-adjusted prosthesis year (QAPY). The time horizon of the analysis was 20 years. RESULTS Considering a 5% discount in costs and effects, the incremental cost-effectiveness ratio of implant-supported total dental prostheses compared to conventional total dental prosthesis (BRL 464.22/QAPY) was lower than the willingness to pay threshold adopted in the model (BRL 3,050.00/QAPY). CONCLUSIONS The results of this economic analysis showed that the rehabilitation of mandibular edentulous patients by implant-supported total prosthesis is very cost-effective when compared to conventional complete prosthesis, considering the cost-effectiveness limits employed.

RESUMO OBJETIVO Conduzir uma análise de custo-efetividade das alternativas para tratamento reabilitador do edentulismo mandibular no contexto do Sistema Único de Saúde (prótese total implanto-suportada e prótese total convencional). MÉTODOS Foi desenvolvido um modelo de Markov para captar os resultados clínicos e econômicos de longo prazo. A população do modelo consistiu em uma coorte hipotética de 1.000.000 pacientes, com 55 anos, desdentados totais mandibulares e sem contraindicações médicas para a realização de procedimentos cirúrgicos. A perspectiva de análise adotada foi a do Sistema Único de Saúde. Com base no modelo proposto, calculamos o custo (em reais) e a efetividade, medida pelo ano de prótese ajustado à qualidade (QAPY). O horizonte temporal da análise foi de 20 anos. RESULTADOS Considerando o desconto de 5% nos custos e efeitos, a razão de custo-efetividade incremental da prótese total implanto-suportada em relação à prótese total convencional (R$ 464,22/QAPY) foi menor que o limiar de disposição a pagar adotado no modelo (R$ 3.050,00/QAPY). CONCLUSÕES Os resultados desta análise econômica mostraram que a reabilitação de edêntulos mandibulares por meio da prótese total implanto-suportada é muito custo-efetiva em comparação à prótese total convencional, de acordo com os limites de custo-efetividade empregados.

Avaliação de tecnologias de saúde e políticas informadas por evidências / Health technology assessment and evidence-informed policies

O Instituto de Saúde é uma instituição de ensino e pesquisa da Secretaria de Estado da Saúde de São Paulo, criada em 1969, que tem como missão "produzir conhecimento científico e tecnológico no campo da Saúde Coletiva e promover sua apropriação para o desenvolvimento de políticas públicas, visando à melhoria da qualidade de vida da população, prestando assessoria e colaborando na formação de recursos humanos, em consonância com os princípios do SUS: universalidade, integralidade, equidade e participação social". Em 2009, passamos por uma reorganização na estrutura funcional, quando foi criado o Centro de Tecnologias de Saúde para o SUS-SP, em resposta a novas necessidades da gestão da saúde no estado de São Paulo. As atribuições desse Centro consistem na realização da avaliação de tecnologias de saúde em uso e a serem incorporadas pelo Sistema Único de Saúde, na proposição de parcerias e cooperação técnica para o desenvolvimento da avaliação de tecnologias de saúde, com as diferentes instâncias dos sistemas pertinentes, na difusão do conhecimento produzido, promovendo o fomento e a indução da avaliação de tecnologias de saúde para o SUS/SP, de acordo com a agenda de prioridades definidas pela SES-SP. Para realizar essas atribuições tivemos que buscar meios para rapidamente capacitar pesquisadores em Avaliação de Tecnologias de Saúde (ATS) e em Políticas Informadas por Evidências (PIE). Isso foi possível graças aos cursos presenciais e à distância, patrocinados pelo Ministério da Saúde e seus parceiros. A possibilidade de participarmos como membros da Rede Brasileira de Avaliação de Tecnologias em Saúde (REBRATS) desde 2012, e da Rede para Políticas Informadas por Evidências (EVIPNet Brasil) desde 2014, ampliou sobremaneira nosso aprendizado e capacidade de lidar com esses dois temas.