Does patient and public involvement impact public health decision-making? A 10 year retrospective analysis of public consultation in Brazil.

BACKGROUND:  The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec's recommendations following these PC. METHODS:  This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec's recommendations following PC. RESULTS:  A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33-13.35, p = 0.02). CONCLUSIONS: Increased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.

Rethinking approaches of science, technology, and innovation in healthcare during the COVID-19 pandemic: the challenge of translating knowledge infrastructures to public needs.

The coronavirus disease 2019 (COVID-19) outbreak made it clear that despite the potential of science, technology, and innovation (ST&I) to positively impact healthcare systems worldwide, as shown by the rapid development of SARS-CoV-2 test diagnostics and new mRNA vaccines, healthcare stakeholders have faced significant challenges in responding to the crisis through well-integrated ST&I-oriented health initiatives and policies. Therefore, the pandemic has mobilized experts, industry, and governments to evaluate alternative trajectories to promote a more efficient dialogue between ST&I and public health. This article presents a critical thinking about the contemporary asymmetries in the technical and political infrastructures available for particular approaches in ST&I in health, such as precision medicine, and for public health systems worldwide, uncovering a persistent gap in the translation of knowledge and technologies to adequately coordinated responses to the pandemic. We stimulate the understanding of this process as a matter of translation between platforms of knowledge and policy rationales shaped by different institutionalized frames of organizational practices and agendas. We draw attention to the need to strengthen governance tools for the promotion of ST&I as a strategic component of the post-pandemic agenda in public health, to prepare societies to respond efficiently to future emergencies.

Challenges of interpreting epidemiologic surveillance pertussis data with changing diagnostic and immunization practices: the case of the state of São Paulo, Brazil.

BACKGROUND: A significant increase in pertussis incidence occurred in Brazil, from 2011 to 2014, despite high coverage of childhood immunization with whole-cell-pertussis (wP) containing vaccines. This study presents pertussis surveillance data from São Paulo state and discusses the challenges to interpret them considering pertussis cyclic epidemic behavior, the introduction of new diagnostic techniques and new vaccination strategies, and enhanced disease awareness during epidemics. METHODS: Observational study including pertussis cases reported to the Surveillance System in São Paulo state, from January 2001 to December 2015. Pertussis cases data were retrieved from the National Notifiable Diseases Information System (SINAN) website and from São Paulo state Epidemiological Surveillance Center (CVE/SP) database. Vaccination coverage and homogeneity data were collected from the Unified Health System Department of Informatics (DATASUS). We presented cases distribution by year, age group and diagnostic criteria and calculated pertussis incidence rates. The proportions of cases among different age groups were compared using chi-square test for trend. RESULTS: Infants less than 1 year of age were the most affected during the whole period, but the proportions of cases in this age group had a significant decreasing trend, with significant increase in the proportions of cases reported among older age groups (1-4, 5-10 and ≥20 years). Cases among infants aged less than 6 months represented ≥90% of all cases in children less than 1 year of age in all but 2 years (2012 and 2015). A non-significant decrease in the proportion of cases among infants aged < 2 months was observed in parallel to a significant increase in the proportion of cases in infants aged 6-11 months. CONCLUSIONS: A pertussis outbreak has occurred in a state with universal use of wP vaccine. The disease cyclic behavior has probably had a major role in the increased incidence rates registered in São Paulo state, from 2011 to 2014, as well as in the decreased incidence in 2015. Maternal vaccination cannot explain the drop in the number of cases among all age groups, in 2015, as herd protection is not expected, but may have had an impact on the number of cases in infants aged < 2 months.

Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations.

BACKGROUND: The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures. METHODS: This is a descriptive study based on CONITEC official reports from July 2012 through December 2016. Data were collected with a specific extraction form and analysed using descriptive statistics. RESULTS: We evaluated 199 CONITEC recommendation reports. The annual number of reports increased during the study period. The absolute annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed for 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The type of technology most frequently evaluated was 'drugs' (68.3%), followed by 'procedures' (20.1%). Overall, 117 (58.8%) reports were internal demands, 75 (37.7%) were external demands and 7 (3.5%) were mixed demands. There were differences between internal and external demands in terms of the evidence used in the reports and the decision regarding the recommendation to incorporate the technologies. Among the internal demands, the recommendation to incorporate the new technology was made for 70.9% of the reports, only 9.6% of which included full HTAs. Among the external demands, the incorporation of the new technology was recommended for 17.3% of the reports, 76.9% of which included full HTAs. Of the 101 reports in which incorporation of the new technology was recommended, 88 (87.1%) did not include a full health economic evaluation and ICER calculation. There are compliance difficulties with the recommendations in the CONITEC internal regulations regarding the type and quality of evidence considered in the analysis of recommendation reports. CONCLUSIONS: The characteristics of the evidence used in recommendation reports and those considered to be mandatory were very different, indicating problems in decision-making processes. There is a need to study, with a broader perspective, the factors that influence the type of evidence used in decision-making processes in order to contribute to the development of better practices and policies.

Assessing the risks for stillbirth in São Paulo, Brazil: protocol for a multidisciplinary case-control study - FetRisks.

Stillbirth is a fundamental component of childhood mortality, but its causes are still insufficiently understood. This study aims to explore stillbirth risk factors by using a multidisciplinary approach to stimulate public policies and protocols to prevent stillbirth, improve maternal care and support bereaved families. METHODS AND ANALYSIS: In this case-control study with stillbirths and live births in 14 public hospitals in São Paulo, mothers are interviewed at hospitals after delivery, and hospital records and prenatal care registries are reviewed. Maternal and umbilical cord blood samples and placentas are collected to analyse angiogenesis and infection biomarkers, and the placenta's anatomopathological exam. Air pollutant exposure is estimated through the participant's residence and work addresses. Traditional and non-invasive autopsies by image-guided histopathology are conducted in a subset of stillbirths. Subsample mothers of cases are interviewed at home 2 months after delivery on how they were dealing with grief. Information contained in the official prenatal care registries of cases and controls is being compiled. Hospital managers are interviewed about the care offered to stillbirth mothers. Data analysis will identify the main risk factors for stillbirth, investigate their interrelations, and evaluate health services care and support for bereaved families. We hope this project will contribute to the understanding of stillbirth's risk factors and related health services in Brazil, providing new knowledge about this central public health problem, contributing to the improvement of public policies and prenatal and puerperal care, helping to prevent stillbirths and improve the healthcare and support for bereaved families. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee of the Municipal Health Secretary (process no 16509319.0.3012.5551) and of the Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (process no 16509319.0.0000.0068). Results will be communicated to the study participants, policy-makers and the scientific community.

[Performance of the mobile emergency care service from the perspective of managers and professionals: case study in a region of the state of São Paulo, Brazil]. / Desempenho do serviço de atendimento móvel de urgência na perspectiva de gestores e profissionais: estudo de caso em região do estado de São Paulo, Brasil.

This article aims to analyze the perspective of managers and professionals about the performance of the Mobile Emergency Care Service (SAMU) in the Grande ABC region. This is a qualitative case study based on the formulation of a theoretical-logical model of intervention and semi-structured interviews. The Theoretical-Logical Model translated the dimensions of SAMU analysis: regulation, care and management. The regulation process was understood as a strategic space where the judgment of the patient's need and the ambulance dispatch time have the potential to influence the outcomes of the cases transported. In health care, the main themes that emerged were investment in the qualification of the team and in telemedicine with the perspective of improving the quality of care and making the diagnosis more accurate. In management, challenges such as integrating SAMU with tertiary centers, improving the information system, and monitoring and evaluation were highlighted aiming to qualify the regulatory processes by aligning them with the objectives proposed in the health policy. The set of data analyzed reinforces the capacity of the SAMU in emergency care in the region; however, the intervention needs to overcome important challenges in order to improve the prognosis of the cases transported.

Este artigo tem como objetivo analisar a perspectiva de gestores e profissionais sobre o desempenho do SAMU na região do Grande ABC. Trata-se de estudo de caso, de abordagem qualitativa, baseado na formulação de modelo teórico-lógico da intervenção e entrevistas semiestruturadas. O Modelo teórico-lógico traduziu as dimensões de análise do SAMU: regulação, assistência e gestão. O processo de regulação foi entendido como espaço estratégico onde o julgamento da necessidade do paciente e o tempo de despacho da ambulância tem potencial de influenciar nos desfechos dos casos transportados. Na assistência os principais temas que emergiram foram investimento na qualificação da equipe e em telemedicina com a perspectiva de melhorar a qualidade do cuidado e tornar o diagnóstico mais preciso. No âmbito da gestão desafios como integração do SAMU com centros terciários, aperfeiçoamento do sistema de informação e monitoramento e avaliação foram destacados visando qualificar os processos regulatórios alinhando-os aos objetivos propostos na política de saúde. O conjunto de dados analisados reforça a capacidade do SAMU na atenção de urgência na região, no entanto a intervenção precisa superar importantes desafios em busca de melhor prognóstico entre os casos transportados.

Evaluation of mobile emergency service with the use of mixed method.

This is an evaluative study, with sequential explanatory mixed methods, aimed at evaluating the performance of the Brazilian Mobile Emergency Medical Service (SAMU) in the Grande ABC region, located in the state of São Paulo, Brazil. In the quantitative approach, an analysis of interrupted time series was performed to evaluate the immediate and gradual effects of the SAMU on hospital mortality due to acute myocardial infarction. The qualitative approach was conducted via semi-structured interviews and a thematic analysis was applied for the interpretation of the results, exploring the attitudes and values of the interviewees regarding the performance of SAMU in the Grande ABC region. Interrupted time series analysis showed a -0.04% reduction in the underlying mortality rate since SAMU implementation (95%CI: -0.0816; -0.0162; p-value = 0.0040) and a reduction in the mortality level, -2.89 (95%CI: -4.3293; -1.4623; p-value = 0.0001), both with statistical significance. To improve the robustness of the results, a control region was used, showing a statistically significant difference in the post-intervention result of -0.0639 (95%CI: -0.1060; -0.0219; p-value = 0.0001). The interviews revealed that the SAMU has the potential to intervene in the prognosis of transported cases, however, challenges related to the availability of beds, expansion of telemedicine, and continuous training of professionals for qualified emergency care in the event of a heart attack must be overcome. The results indicate that the studied intervention is part of a set of factors that, together, generate more conditions to achieve a better result.

Cost-effectiveness analysis of a universal infant immunization program with meningococcal C conjugate vaccine in Brazil.

OBJECTIVE: To analyze the cost-effectiveness of a meningococcal C vaccination program in Brazil. METHODS: A hypothetical cohort of 3,194,038 children born in Brazil in 2006 was followed for 10 years. A decision tree model was developed using the TreeAge Pro 2007 software program to compare universal infant vaccination with the current program. Epidemiological and cost estimates were based on data retrieved from National Health Information Systems and the literature. The analysis was conducted from the public health care system and societal perspectives. Costs are expressed in 2006 Brazilian reals (R$). RESULTS: At 94% coverage, the program would avoid 1,218 cases, 210 deaths, and 14,473 life-years lost, a reduction of, respectively, 45%, 44%, and 44%, for the 10-year period. Vaccination costs of R$320.9 million would not be offset by R$4 to R$7.9 million decreases in disease treatment costs. A national vaccination program would cost R$21,620 per life-year saved from the perspective of the health-care system and R$21,896 per life-year saved from society's perspective. Results were most sensitive to case fatality rate, disease incidence, and vaccine cost. CONCLUSIONS: A universal childhood vaccination program against meningococcal C proved to be a cost-effective strategy, supporting the recent decision of the Brazilian government. These results could contribute to defining the most favorable price of the vaccine and to monitoring its impact on the population.

COVID-19 and the medicines regulation challenges in times of pandemic. / COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia.

The SARS-CoV-2 pandemic has brought challenges related to prevention, protection and care. Coping strategies, such as social distancing, individual protection for the population and workers, increase in the number of intensive care beds, provision of human resources and equipment are necessary actions. However, there are yet no specific effective and safe medicines that justify their use. The challenge imposed on the regulatory framework for medicines is aimed at providing timely access to medicines capable of modifying the course of the disease and leading to better treatment outcomes, with health safety. Regulatory agencies must protect the health by assessing the actual benefits and harms of the medicines under these specific conditions. The article discusses the main regulatory challenges and response of regulatory agencies to the demands imposed by the COVID-19 pandemic, especially, drug development strategies and regulatory strategies related to off-label use. Emergency drug use authorization and alternatives for extended/compassionate use are addressed, as well as clinical trials, safety assessment and monitoring of adverse events.

A pandemia de SARS-CoV-2 trouxe desafios relacionados à prevenção, proteção e cuidado. Estratégias de enfrentamento, como distanciamento social, medidas de proteção individual da população e trabalhadores, ampliação dos leitos de terapia intensiva, disponibilização de recursos humanos e equipamentos são ações necessárias. Não há, ainda, medicamentos específicos com eficácia e segurança que justifiquem sua utilização. O desafio imposto ao marco regulatório de medicamentos volta-se para o acesso tempestivo a medicamentos capazes de modificar o curso da doença e conduzir a melhores desfechos no tratamento, com segurança sanitária. Cabe às agências reguladoras a proteção da saúde com a atribuição de avaliar os reais benefícios e malefícios dos medicamentos nestas condições especificas. O artigo apresenta as ações das agências reguladoras e discute os desafios na implementação da política regulatória de medicamentos frente às exigências impostas pela pandemia de COVID-19. São abordadas, especialmente, estratégias de desenvolvimento de fármacos e estratégias regulatórias sobre a indicação de uso off label, do uso emergencial de medicamentos e das alternativas de uso extendido/compassivo, bem como da realização de ensaios clínicos e da avaliação da segurança e monitoramento de eventos adversos.

[National Pharmacovigilance Systems in Brazil and Portugal: similarities, differences, and challenges]. / Sistema Nacional de Farmacovigilância no Brasil e em Portugal: semelhanças, diferenças e desafios.

National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety, and improved quality of care. Fast-track drug registration, which has become increasingly frequent, hinders assessment of the efficacy and safety of new drugs, adding difficulties to current regulation and health protection. The article applies indicators proposed by the World Health Organization to analyze the National PVS of Portugal and Brazil. Brazil's PVS was established later than that of Portugal, generates fewer safety signals, has a lower notification rate for suspected adverse drug events (ADEs), and displays difficulty in producing and disseminating information to health professionals and the population. Portugal has the advantage of being a member state of the European Medicines Agency. The article also suggests that the differences are related to the political and social context that hinders the implementation of public policies and compromises the effectiveness of the Brazilian PVS. Challenges for PVS include awareness-raising of health professionals, the adoption of methods to complement voluntary notification, pharmacovigilance of biological and genetic drugs, and assessment of the system's impact. An additional challenge for the Brazilian PVS is to improve the notifications' uptake and quality, including from industry, generate safety signals in the national context, and communicate risk in timely fashion to health professionals and the population.

Patient and public involvement in health technology decision-making processes in Brazil.

OBJECTIVE: The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS: This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS: The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS: There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.

Income and out-of-pocket health expenditure in living arrangements of families with older adults in Brazil.

The main objective of this study was to characterize household sociodemographic and economic patterns of different living arrangements of families with older adults in Brazil and their relationship with income and out-of-pocket health expenditure. Data were extracted from the 2008-2009 Brazilian Household Budget Survey (POF, in Portuguese) database of the Brazilian Institute of Geography and Statistics. Families with older adults represented 28% of all families, being smaller and having higher average income when compared to families without older adults. Older adults were head of the household in 85% of the families, with income based mainly on social protection policies. The families with older adult or couple as head of the household had significantly higher average monthly income. The proportion of out-of-pocket health expenditure per income quintile per capita was higher for families with one older adult or couple as head of the household, when compared to families without older adult as head of the household and even more in families without older adults at all. These findings allow the identification of potential positive impacts on the quality of life of families with older adults in Brazil. The higher household income of families with older adults is a consequence of the expansion of inclusive social protection policies for this population in the 2000s in Brazil, especially for families with lower average income levels, representing 4/5 of this population. The economic and political crisis in the 2010s have probably reduced these families' relative advantage, and this study will compare with results of the next survey.

Cost-effectiveness analysis of universal adult immunization with tetanus-diphtheria-acellular pertussis vaccine (Tdap) versus current practice in Brazil.

BACKGROUND: A pertussis outbreak occurred in Brazil from 2011 to 2014, despite high coverage of whole-cell pertussis containing vaccines in early childhood. Infants were the most affected. This study aimed to evaluate the cost-effectiveness of introducing universal adult vaccination with Tdap into the National Immunization Program in Brazil. METHODS: Economic evaluation using a dynamic model to compare two strategies: (1) universal vaccination with single dose of Tdap at 20 years of age and (2) current practice (only pregnant women pertussis vaccination). The health system perspective was adopted. Temporal horizon was 10 years. Discount rate of 5% was applied to costs and benefits. Vaccine effectiveness (VE) was obtained from a population-based observational study. Epidemiological, resource utilization and cost estimates were obtained from the Brazilian Health Information Systems. The primary outcome was cost per life year saved (LYS), based on life expectancy at birth in Brazil in 2015. Univariate and multivariate sensitivity analysis were performed. RESULTS: Adult vaccination with VE of 82.6% and coverage of 40%, at price of US$7.01 per dose, and assuming herd protection would avoid 167 infant deaths by pertussis, saving 12,325 years of life and costing a total of US$105495891.61, from the health system perspective. The universal immunization would result in ICER of US$8459.13. The results were highly sensitive to disease incidence. CONCLUSIONS: The results suggest that universal adult vaccination with Tdap would not be a cost-effective intervention for preventing pertussis cases and deaths in infants in Brazil.

Traffic-related air pollution and perinatal mortality: a case-control study.

BACKGROUND: Ambient levels of air pollution may affect the health of children, as indicated by studies of infant and perinatal mortality. Scientific evidence has also correlated low birth weight and preterm birth, which are important determinants of perinatal death, with air pollution. However, most of these studies used ambient concentrations measured at monitoring sites, which may not consider differential exposure to pollutants found at elevated concentrations near heavy-traffic roadways. OBJECTIVES: Our goal was to examine the association between traffic-related pollution and perinatal mortality. METHODS: We used the information collected for a case-control study conducted in 14 districts in the City of São Paulo, Brazil, regarding risk factors for perinatal deaths. We geocoded the residential addresses of cases (fetal and early neonatal deaths) and controls (children who survived the 28th day of life) and calculated a distance-weighted traffic density (DWTD) measure considering all roads contained in a buffer surrounding these homes. RESULTS: Logistic regression revealed a gradient of increasing risk of early neonatal death with higher exposure to traffic-related air pollution. Mothers exposed to the highest quartile of the DWTD compared with those less exposed exhibited approximately 50% increased risk (adjusted odds ratio = 1.47; 95% confidence interval, 0.67-3.19). Associations for fetal mortality were less consistent. CONCLUSIONS: These results suggest that motor vehicle exhaust exposures may be a risk factor for perinatal mortality.

Economic evaluation of adolescents and adults' pertussis vaccination: A systematic review of current strategies.

The reemergence of pertussis in the last two decades led to the introduction of adolescents and adults immunization strategies of tetanus-diphtheria-acellular pertussis vaccines (Tdap) in several countries. The health authorities must consider economic aspects when deciding to recommend and fund new programs. Here we present a systematic review of worldwide full economic evaluations of pertussis vaccination targeting adolescents or adults published from 2000. Studies were identified by searching MEDLINE, Excerpta Medica, CRD, and Lilacs databases. Twenty-seven economic evaluations of different strategies with Tdap were identified. Booster vaccination for adolescents and adults were the most frequent, followed by cocooning and pregnant women vaccination. Strategies performance varied considerably among different studies. Assumptions regarding underreporting correction, herd protection and vaccine coverage were crucial to cost-effectiveness results. Understanding the model and the parameters used is essential to understand the results, and identify the major issues important to public health decisions.

Systematic review of health economic evaluation studies of dengue vaccines.

OBJECTIVES: To review the literature on economic evaluation of dengue vaccination to produce evidence to support a local cost-effectiveness study and to subsidize the decision to introduce a dengue vaccine in the Brazilian National Immunization Program. METHODS: We systematically searched multiple databases (MEDLINE (via PubMed), EMBASE, SCOPUS, NHS Economic Evaluation Database (NHS EED), HTA Database (via Centre for Reviews and Dissemination - CRD) and LILACS), selecting full HEEs of dengue vaccine. Two independent reviewers screened articles for relevance and extracted the data. The methodology for the quality reporting was assessed using CHEERS checklist. We performed a qualitative narrative synthesis. RESULTS: Thirteen studies conducted in Asian and Latin America countries were reviewed. All studies were favorable to the incorporation of the vaccine. However, the assumptions and values assumed for vaccine efficacy, safety and duration of protection, as well as the choice of the study population and the type of model used in the analyses, associated to an insufficient reporting of the methodological steps, affect the validity of the studies' results. The quality reporting appraisal showed that the majority (8/13) of the studies reported less than 55% of the CHEERS checklists' items. CONCLUSIONS: This systematic review shows that the economic evaluation of dengue vaccination did not adhere to key recommended general methods for economic evaluation. The presented cost-effectiveness results should not be transferred to other countries. It is recommended to conduct studies with local epidemiological and cost data, as well as assumptions about vaccination that reflect the results observed in clinical trials.

Post-graduation in Collective Health and the National Public Health System. / Pós-Graduação senso estrito em Saúde Coletiva e o Sistema Único de Saúde.

This article deals with a public policy in education, Post Graduation in Collective Health, to identify forms of dialogue of this policy, with the public health policy, the SUS, starting in 1990. The main product of PGSC policy is the training of masters and doctors, essential for teaching and research in the field. Bibliographic review and analysis of CAPES documents and databases based the analysis. Education policy was consistent over time and core to social development, alongside health policy, without presenting formal points of intercession, and its impacts occur mainly through the formation of good and committed professionals, teachers and researchers. In PGSC, professional masters programs are more relevant, for a more direct link of postgraduate programs with the SUS, and the initiatives of the Ministry of Health to finance priorities in research for the Health System. Even ininitiatives that explicitly seek to approximate the knowledge produced by PG with praxis in the SUS, the mechanisms involved in translating or impacting scientific knowledge into concrete practice are complex and must be context specific andthematic.

Este artigo trata de política pública em educação, a Pós-Graduação em Saúde Coletiva, para identificar formas de diálogo dessa política, a partir de 1990, com a política pública em saúde, o SUS. Toma-se como produto principal da política de PGSC a formação de mestres e doutores, essenciais para a docência e a pesquisa na área. Foi realizada revisão bibliográfica e análise de documentos e bases de dados da CAPES. Concluiu-se que a política de educação foi consistente ao longo do tempo e nuclear para o desenvolvimento social, ao lado da política de saúde, sem apresentar pontos formais de intercessão, e seus impactos ocorrerão, principalmente, por meio de formação de bons e comprometidos profissionais, docentes e pesquisadores. Na PGSC mostram-se relevantes os mestrados profissionais, para vinculação mais direta das pós-graduações com o SUS, e os editais propostos pelo Ministério da Saúde para o financiamento de temas prioritários para o Sistema de Saúde. Os autores consideram que, mesmo nas iniciativas explícitas de aproximação do conhecimento produzido pela PG com a práxis no SUS, os mecanismos envolvidos na translação, tradução ou impacto do conhecimento científico para a prática concreta são complexos e devem ser analisados por meio de recortes por temas e contextos específicos.

Systematic Review of Health Economic Evaluation Studies Developed in Brazil from 1980 to 2013.

BACKGROUND: Brazil has sought to use economic evaluation to support healthcare decision-making processes. While a number of health economic evaluations (HEEs) have been conducted, no study has systematically reviewed the quality of Brazilian HEE. The objective of this systematic review was to provide an overview regarding the state of HEE research and to evaluate the number, characteristics, and quality of reporting of published HEE studies conducted in a Brazilian setting. METHODS: We systematically searched electronic databases (MEDLINE, EMBASE, Latin American, and Caribbean Literature on Health Sciences Database, Scientific Electronic Library Online, NHS Economic Evaluation Database, health technology assessment Database, Bireme, and Biblioteca Virtual em Saúde Economia da Saúde); citation indexes (SCOPUS, Web of Science), and Sistema de Informação da Rede Brasileira de Avaliação de Tecnologia em Saúde. Partial and full HEEs published between 1980 and 2013 that referred to a Brazilian setting were considered for inclusion. RESULTS: In total, 535 studies were included in the review, 36.8% of these were considered to be full HEE. The category of healthcare technologies more frequently assessed were procedures (34.8%) and drugs (28.8%) which main objective was treatment (72.1%). Forty-four percent of the studies reported their funding source and 36% reported a conflict of interest. Overall, the full HEE quality of reporting was satisfactory. But some items were generally poorly reported and significant improvement is required: (1) methods used to estimate healthcare resource use quantities and unit costs, (2) methods used to estimate utility values, (3) sources of funding, and (4) conflicts of interest. CONCLUSION: A steady number of HEE have been published in Brazil since 1980. To improve their contribution to inform national healthcare policy efforts need to be made to enhance the quality of reporting of HEEs and promote improvements in the way HEEs are designed, implemented (i.e., using sound methods for HEEs) and reported.

Systematic review of economic evaluations of the 23-valent pneumococcal polysaccharide vaccine (PPV23) in individuals 60 years of age or older.

OBJECTIVES: To systematically review the economic evaluations of 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults aged ≥60 years to inform the development of local studies through the discussion of parameters and assumptions that influence the results of the analyses. METHODS: We searched the MEDLINE, Excerpta Medica, Cochrane Library, Latin-American and Caribbean Health Sciences Literature (LILACS), Brazilian Regional Library of Medicine, National Health Service Economic Evaluation, and Centre for Reviews and Dissemination-as well as the Scopus citation index and the Web of Science for full economic evaluations of PPV23 published up to March 2016. Two independent reviewers screened the articles for relevance and extracted the data. Main study characteristics and methods (clinical and epidemiological data, cost and incremental cost-effectiveness ratios (ICERs) were extracted and compared. Costs were updated to 2016 international dollars. RESULTS: Twenty-seven studies published from 1980 to 2016 were reviewed. Most studies were conducted in Europe and the USA; three studies were conducted in Latin America (Brazil, 2; Colombia, 1). In addition to the scenario comparing the vaccination with the PPV23 to non-vaccination, three studies also compared PPV23 to pneumococcal conjugate 13-valent vaccine (PCV13). All studies used static models. Most used a lifetime (44.4%) or 5-6 year's time horizon (33.3%). Only three studies considered herd protection from children immunization with PCV13 in the model. Most studies considered PPV23 cost-effective (less than US$50,000 per LYG or QALY) and sometimes cost-saving (results ranging from cost-saving to US$84,636/QALY). The estimates of disease burden, the efficacy/effectiveness of PPV23, and the effects of herd protection from childhood immunization had most influence on the results. CONCLUSIONS: Well-designed cost-effectiveness studies of PPV23 that represent the current epidemiological scenario and reduce uncertainty related to efficacy/effectiveness are extremely relevant to informing the decision-making process.

Cost effectiveness of the cancer prevention program for carriers of the BRCA1/2 mutation.

OBJECTIVE: To analyze the cost effectiveness of the diagnostic program for the germline mutation in BRCA1/2 genes and of preventative strategies for the relatives of patients diagnosed with ovarian cancer associated with this mutation. METHODS: The study analyzed the cost effectiveness by developing an analysis of the Markov decision process from the perspective of the National Health System. The strategies compared reflect upon the adoption of genetic testing and preventative strategies for relatives or the usual care currently proposed. The incremental cost-effectiveness ratio was expressed in terms of cost per case avoided. The sensitivity analysis was performed in a univariate and deterministic manner. RESULTS: The study showed increments for effectiveness and for costs when performing genetic testing and adopting prophylactic measures for family members. The incremental cost-effectiveness ratio was estimated at R$908.58 per case of cancer avoided, a figure considered lower than the study's cost-effectiveness threshold (R$7,543.50). CONCLUSIONS: The program analyzed should be considered a cost-effective strategy for the national situation. Studies in various other countries have reached similar conclusions. One possible ramification of this research might the need to perform a budgetary-impact analysis of making the program one of the country's health policies.