Implante transcateter de valva aórtica para o tratamento da estenose aórtica grave: uma revisão sistemática de estudos de avaliação econômica completa / Transcatheter aortic valve implantation for the treatment of severe aortic stenosis: a systematic review of complete economic evaluation studies

Objetivo: Comparar o implante transcateter de valva aórtica (TAVI) ao tratamento conservador em pacientes inoperáveis ou à cirurgia de troca valvar (SAVR) em pacientes com risco cirúrgico alto ou intermediário conforme a Society of Thoracic Surgeons (STS), por meio de uma revisão sistemática de avaliações econômicas completas. Avaliar a variabilidade de modelos econômicos, parâmetros, pressupostos e sua influência nos resultados finais. Métodos: Foi realizada uma busca da literatura nas bases Medline, EMBASE, Cochrane Library, Web of Science, SciELO e International HTA Base e busca manual. Foram incluídas análises econômicas completas baseadas em modelos econômicos publicadas entre 2011 e 2022, em português, inglês e espanhol. A qualidade dos estudos foi avaliada usando o instrumento QHES (Quality of Health Economic Studies). Resultados: Foram incluídos 36 estudos, majoritariamente análises de custo-utilidade (64%), da Europa (41%), utilizando dados de eficácia dos estudos PARTNER. O modelo de Markov (61%) foi predominante. O custo da prótese do TAVI foi um parâmetro de impacto na análise de sensibilidade nos três grupos. Os estudos alcançaram uma boa qualidade no instrumento QHES. Conclusão: O TAVI tendeu a ser custo-efetivo em relação aos comparadores. Os modelos não foram homogêneos nos parâmetros, horizontes temporais e taxa de desconto, podendo impactar a custo-efetividade do TAVI e dificultar a comparação dos resultados entre diferentes países e perspectivas.

ABSTRACT Objective: To compare transcatheter aortic valve implantation (TAVI) to conservative treatment in inoperable patients or to valve replacement surgery (SAVR) in patients at high or intermediate surgical risk according to the Society of Thoracic Surgeons (STS), through a systematic review of comprehensive economic evaluations. Evaluate the variability of economic models, parameters, assumptions and their influence on final results. Methods: A literature search was performed in Medline, EMBASE, Cochrane Library, Web of Science, SciELO and International HTA Base and manual search. Complete economic analyzes based on economic models published between 2011 and 2022 in Portuguese, English and Spanish were included. The quality of the studies was evaluated using the QHES (Quality of Health Economic Studies) instrument. Results: Thirty-six studies were included, mostly cost-utility analyses (64%), from Europe (41%), and using efficacy data from the PARTNER studies. The Markov model (61%) was predominant. The cost of the TAVI prosthesis was the most important parameter in the sensitivity analysis in the three groups. The studies achieved a good quality in QHES instrument. Conclusion: TAVI tended to be cost-effective relative to comparators. The models were not homogeneous in parameters, time horizons and discount rate, which may have an impact on the cost-effectiveness of TAVI, making it difficult to compare the results between different countries and perspectives.

Health, economic and social burden of tobacco in Latin America and the expected gains of fully implementing taxes, plain packaging, advertising bans and smoke-free environments control measures: a modelling study.

OBJECTIVE: To investigate the tobacco-attributable burden on disease, medical costs, productivity losses and informal caregiving; and to estimate the health and economic gains that can be achieved if the main tobacco control measures (raising taxes on tobacco, plain packaging, advertising bans and smoke-free environments) are fully implemented in eight countries that encompass 80% of the Latin American population. DESIGN: Markov probabilistic microsimulation economic model of the natural history, costs and quality of life associated with the main tobacco-related diseases. Model inputs and data on labour productivity, informal caregivers' burden and interventions' effectiveness were obtained through literature review, surveys, civil registrations, vital statistics and hospital databases. Epidemiological and economic data from January to October 2020 were used to populate the model. FINDINGS: In these eight countries, smoking is responsible each year for 351 000 deaths, 2.25 million disease events, 12.2 million healthy years of life lost, US$22.8 billion in direct medical costs, US$16.2 billion in lost productivity and US$10.8 billion in caregiver costs. These economic losses represent 1.4% of countries' aggregated gross domestic products. The full implementation and enforcement of the four strategies: taxes, plain packaging, advertising bans and smoke-free environments would avert 271 000, 78 000, 71 000 and 39 000 deaths, respectively, in the next 10 years, and result in US$63.8, US$12.3, US$11.4 and US$5.7 billions in economic gains, respectively, on top of the benefits being achieved today by the current level of implementation of these measures. CONCLUSIONS: Smoking represents a substantial burden in Latin America. The full implementation of tobacco control measures could successfully avert deaths and disability, reduce healthcare spending and caregiver and productivity losses, likely resulting in large net economic benefits.

Análise de custo de um centro de reprodução humana assistida no Sistema Único de Saúde / Cost analysis of an assisted human reproduction center in the Unified Health System (SUS)

Resumo O objetivo do estudo foi estimar o custo da implantação de um centro de reprodução humana em um hospital público de referência nacional localizado no Rio de Janeiro. A população elegível foi a de homens e mulheres que possuem diagnóstico das causas mais frequentes de infertilidade. Os itens de custos incluídos foram consultas, exames, equipamentos, recursos humanos e insumos. Os custos foram identificados e quantificados a partir de consulta a clínicas de reprodução assistida, especialistas e literatura. Foram valorados através de bases públicas. A análise dos dados foi realizada através de um modelo de decisão analítico. A perspectiva do estudo foi do SUS provedor. O custo por procedimento na alta complexidade foi de R$ 18.829 para a fertilização in vitro com injeção intracitoplasmática de espermatozoide e de R$ 5.649 para a inseminação artificial. O investimento inicial necessário para funcionamento do centro de alta complexidade para a realização de 480 ciclos foi de R$ 15.903.361 no primeiro ano, o qual incluiu a estruturação do ambiente físico. A estimativa do investimento necessário para a incorporação e manutenção dos serviços no SUS é indispensável para a gestão financeira.

Abstract This study aimed to estimate the cost of implementing a center for assisted human reproduction in a public reference hospital in Rio de Janeiro. The cost analysis was carried out from the perspective of the SUS provider of assistance. The eligible population was men and women diagnosed with the most frequent causes of infertility. The cost items included in primary care and medium complexity were consultations and examinations and in high complexity were equipment, human resources and supplies. Costs were identified and quantified through consultation with assisted reproduction clinics, specialists and literature. They have been valued through public databases. Data analysis was performed using an analytical decision model that included costs of assisted reproduction and effectiveness procedures. The cost per procedure in high complexity was R$ 18,829 for in vitro fertilization with intracytoplasmic sperm injection and R$ 5,649 for artificial insemination. The initial investment required to operate the high complexity center for 480 cycles was R$ 15,903,361 in the first year, which included structuring the physical environment. Estimating the investment required for the incorporation and maintenance of services in SUS is essential for the management of available financial resources.

The economic burden of congenital Zika Syndrome in Brazil: an overview at 5 years and 10 years.

BACKGROUND: The aim of this paper is to estimate the economic burden of children with congenital Zika Syndrome (CZS) in Brazil over 5-10 years. METHODS: We conducted a modelling study based on data collected in a case-control study in Brazil, including children with CZS (cases) and typically developing children (controls), born in 2015 and 2016. In total, 484 participants were recruited in two sites, Recife and Rio de Janeiro. Social and economic information was collected in a survey from the carers of cases and controls, and detailed healthcare utilisation was recorded for each child in the Rio de Janeiro cohort prospectively in a database. We used this information to estimate the cost per child with severe, moderate and no CZS and incremental cost per child with severe and moderate versus no CZS from a disaggregated societal perspective. These estimates were incorporated into an economic burden model to estimate the incremental burden of the CZS epidemic in Brazil over 5 years and 10 years. FINDINGS: The societal cost per child with severe CZS was US$50 523 to 10 years of age (born in 2015 and 2016), substantially higher than the costs for moderate CZS (US$29 283) and without CZS (US$12 331). The incremental economic burden of severe versus no CZS in Brazil over 10 years was US$69.4 million from the household and US$129.0 million from the government perspective. For moderate CZS, these figures amounted to US$204.1 million and US$86.6 million. Over 10 years, 97% of the total societal economic cost of severe CZS is borne by the government, but only 46% for moderate CZS. INTERPRETATION: The economic burden of CZS is high at the household, provider and government levels. The compensatory government payments helped to alleviate some of the additional costs incurred by families with a child qualifying for the disability benefits, and could be scaled to include the children with moderate CZS.

Portable wide-field digital imaging for screening of neonatal visual impairment causes in Rio de Janeiro, Brazil: a budget impact analysis.

OBJECTIVE: To estimate the budget impact of portable wide-field digital imaging incorporation on screening neonatal causes of childhood blindness and visual impairment in Rio de Janeiro, Brazil. DESIGN: Budget impact analysis. SETTING: Rio de Janeiro, Brazil. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the direct cost of indirect binocular ophthalmoscopy, red reflex test and portable wide-field digital image screening comprising all babies born in Rio de Janeiro's government maternity wards. The secondary outcome was the budget impact of implementing portable wide-field digital image screening in Rio de Janeiro, Brazil. RESULTS: Considering 100% coverage of maternity wards, the total budget impact between 2020 and 2024 would be US$3 820 706.04, ranging from US$3 139 844.34 to US$6 099 510.35. The additional cost would be US$3 124 457.28, ranging from US$2 714 492.26 to US$4 880 608.63. CONCLUSION: The cost of universal digital imaging screening corresponds to less than 1% of the government health budget of the city of Rio de Janeiro. The information provided in this study may help government decision-makers evaluate the feasibility of implementing this new strategy in the municipal setting. Further health economic evaluations should be performed to verify the affordability of the implementation of this screening strategy in the Brazilian scenario, taking into account scarce human resources.

Guidelines for Utility Measurement for Economic Analysis: The Brazilian Policy.

INTRODUCTION: Health-related quality of life is expressed in utilities, also referred to as utility estimates or parameters. Considerations about the source and type of utility values are especially important in a modeling context, where the lack of transparency, including the lack of a hierarchy for utility data sources, is a major issue to any estimation and can potentially compromise model reliability. OBJECTIVES: This document aims to present the first version of the Brazilian guidelines for utility measurement to support economic analysis. METHODS: A virtual workshop and a modified Delphi panel with 10 health technology specialists followed a rapid evaluation of 110 technical documents and indexed publications. The recommendations are based on the proposition that has received the most votes, although contentious issues are addressed in the suggestion or discussion. The rationale for the final decision is included in the text. RESULTS: The consensus includes 50 recommendations with the following topics: Transparency and Reliability, Model Design, Conditions Under Which Generic Questionnaires Are Not Sensible or Valid, Utility Evidence Hierarchy, Utility Data Searching, Modeling Utility Values, Extrapolating Quality Adjusted Life-Years for Models With Lifetime Horizons, Caregiver Utility, Utility Data Synthesis, Quality/Certainty of the Evidence, and Utility Estimates in End-of-Life Conditions. CONCLUSIONS: The goal of this project is to create unified national standards for using utility metrics in economic analysis in Brazil. This set of recommendations is not obligatory, but it is meant to serve as a guide and lead to the development of better and more transparent economic models in the country.

[Catastrophic expenditure on congenital Zika syndrome: results of a cross-sectional study of caregivers of children in Rio de Janeiro, Brazil]. / Gasto catastrófico na síndrome congênita do vírus Zika: resultados de um estudo transversal com cuidadores de crianças no Rio de Janeiro, Brasil.

In 2015, there was an increase in cases of congenital malformations in newborns in Brazil, associated with maternal Zika virus infection, having serious social and economic repercussions for the families. The study aimed to estimate the prevalence of catastrophic expenditure by families of children with severe or mild/moderate congenital Zika syndrome (CZS) in comparison to families of children without a diagnosis of CZS in the state of Rio de Janeiro. Catastrophic expenditure occurs when spending exceeds a given proportion of the family income due to a disease. Family caregivers of children with severe CZS were younger and had less schooling and lower income. Prevalence of catastrophic expenditure was higher in families of children with CZS. Among caregivers of children with severe CZS, the prevalence of catastrophic expenditure was higher in those with severe or very severe depression, anxiety, and stress. Low social support among caregivers was also a determinant factor for increased prevalence of catastrophic expenditure. The burden on caregivers of children with severe CZS exacerbates a situation of vulnerability that requires the expansion of mechanisms for financial and social protection, through linkage of various policies capable of effectively reaching this group.

Em 2015, houve um aumento de casos de más-formações congênitas entre recém-nascidos no Brasil associado ao vírus Zika, com repercussões sociais e econômicas para as famílias. O objetivo deste estudo foi estimar a prevalência de gasto catastrófico para famílias de crianças com síndrome congênita do vírus Zika (SCZ) grave, leve/moderada em comparação com famílias de crianças sem diagnóstico de SCZ, no Estado do Rio de Janeiro. O termo gasto catastrófico ocorre quando o gasto excede determinada proporção da renda da família devido à doença. Os cuidadores de crianças com SCZ grave eram mais jovens, com menor escolaridade e renda. A prevalência de gasto catastrófico foi maior em famílias de crianças com SCZ. Dentre os cuidadores de crianças com SCZ grave, identificou-se que a prevalência de gasto catastrófico foi mais elevada entre aqueles que apresentaram graus de depressão, ansiedade e estresse graves ou muito graves. O baixo apoio social entre os cuidadores também foi determinante para o aumento da prevalência do gasto. A carga que incide sobre os cuidadores de crianças com SCZ grave potencializa uma situação de vulnerabilidade que demanda a amplificação do acesso aos mecanismos de proteção financeira e social, através da articulação de diferentes políticas que sejam capazes de alcançar efetivamente esse grupo.

En 2015, hubo un aumento de casos de malformaciones congénitas entre recién nacidos en Brasil, asociado al virus zika con repercusiones sociales y económicas para las familias. El objetivo de este estudio fue estimar la prevalencia de gasto catastrófico para las familias de niños con síndrome congénito del virus Zika (SCZ) grave, leve/moderado, en comparación con familias de niños sin diagnóstico de SCZ, en el estado de Río de Janeiro. El término gasto catastrófico se usa cuando el gasto excede una determinada proporción de la renta de la familia, debido a la enfermedad. Los cuidadores de niños con SCZ grave eran más jóvenes, con menor escolaridad y renta. La prevalencia de gasto catastrófico fue mayor en familias de niños con SCZ. Entre los cuidadores de niños con SCZ grave se identificó que la prevalencia de gasto catastrófico fue más elevada entre aquellos que presentaron grados de depresión, ansiedad y estrés grave o muy grave. El bajo apoyo social entre los cuidadores también fue determinante para el aumento de la prevalencia del gasto. La carga que incide sobre los cuidadores de niños con SCZ grave potencia una situación de vulnerabilidad que demanda la ampliación del acceso a los mecanismos de protección financiera y social, a través de la coordinación de diferentes políticas que sean capaces de alcanzar efectivamente a ese grupo.

Cost-Utility Analysis of Wide-Field Imaging as an Auxiliary Technology for Retinopathy of Prematurity Care in Brazil.

Purpose: To evaluate the cost-utility of wide-field imaging (WFI) as a complementary technology for retinopathy of prematurity (ROP) screening from the Brazilian Unified Health System's perspective. Introduction: ROP is one of the leading causes of avoidable childhood blindness worldwide, especially in middle-income countries. The current ROP screening involves indirect binocular ophthalmoscopy (IBO) by ROP expert ophthalmologists. However, there is still insufficient ROP screening coverage. An alternative screening strategy is the combination of WFI with IBO. Methods: A cost-utility analysis was performed using a deterministic decision-tree simulation model to estimate incremental cost-utility for ROP care. Two screening strategies were compared: (1) IBO and (2) combination of WFI of all eligible preterm infants and IBO for type 2 ROP or worse and for non-readable images. Eligible population included preterm infants <32 weeks of gestational age or birth weight equal to or <1,500 g. The temporal horizon was lifetime. Visual outcome data was converted to utility, and the health benefits were estimated on quality-adjusted life-years (QALY). Incremental cost per QALY gained was calculated from the health system perspective. Costs were estimated considering equipment, maintenance, consumables, and staff. A micro-costing approach was used for WFI. Two technician nurses were trained for imaging execution and had their time evaluated. Two ROP expert ophthalmologists had their time evaluated for imaging reading. One-way sensitivity analysis and probabilistic sensitivity analysis were performed. Results: Combined screening strategy resulted in a cost-effective program considering 90% ROP screening coverage. Costs per examination: (1) screening with IBO: US dollar (US $) 34.36; (2) screening with combination: US $58.20; (3) laser treatment: US $642.09; (4) long-term follow-up: ranged from US $69.33 to 286.91, based on the infant's visual function. Incremental cost per QALY gained was US $1,746.99/QALY per infant screened with the combination strategy. One-way sensitivity analysis resulted in cost-effectiveness for all parameters. Probabilistic sensitivity analyses yielded a 100% probability of combination being cost-effective in a willingness-to-pay threshold of US $1,800/QALY. Conclusion: The combined strategy for ROP screening was cost-effective. It enhances access for appropriate ROP care in middle-income countries and dminishes opportunity costs for ophthalmologists.

Critérios de definição de preços de medicamentos no Brasil e em países selecionados: uma revisão comparada / Criteria for setting drug prices in Brazil and selected countries: a comparative review

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 externo 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

Objectives: To compare the criteria for setting prices of medicines in Brazil and in selected countries, to analyze the mechanism for setting prices of medicines in Brazil and to analyze the mechanism for setting prices of medicines in selected countries. Methods: A narrative review of the literature was carried out by collecting information in databases, on websites of national agencies and international organizations and in "gray" literature, regarding health systems and price formation mechanisms of medicines in Brazil and selected countries (Australia, Canada, Spain, United States, France, Greece, Italy, New Zealand and Portugal). Results: Most of the countries surveyed use external and internal price referencing, make price adjustments and corrections over time and carry out economic evaluation studies. The value of therapy or its benefit to the patient or health care system is an important factor in both pricing and incorporation into the health care system. Conclusion: This work allowed identify the similarities between the practices recommended and implemented internationally and those carried out in Brazil, as well as the problems related to the pricing of new therapies, in addition to the gaps in the current regulatory model

Gasto catastrófico na síndrome congênita do vírus Zika: resultados de um estudo transversal com cuidadores de crianças no Rio de Janeiro, Brasil / Catastrophic expenditure on congenital Zika syndrome: results of a cross-sectional study of caregivers of children in Rio de Janeiro, Brazil / Gasto catastrófico en el síndrome congénito del virus Zika: resultados de un estudio transversal con cuidadores de niños en Río de Janeiro, Brasil

Em 2015, houve um aumento de casos de más-formações congênitas entre recém-nascidos no Brasil associado ao vírus Zika, com repercussões sociais e econômicas para as famílias. O objetivo deste estudo foi estimar a prevalência de gasto catastrófico para famílias de crianças com síndrome congênita do vírus Zika (SCZ) grave, leve/moderada em comparação com famílias de crianças sem diagnóstico de SCZ, no Estado do Rio de Janeiro. O termo gasto catastrófico ocorre quando o gasto excede determinada proporção da renda da família devido à doença. Os cuidadores de crianças com SCZ grave eram mais jovens, com menor escolaridade e renda. A prevalência de gasto catastrófico foi maior em famílias de crianças com SCZ. Dentre os cuidadores de crianças com SCZ grave, identificou-se que a prevalência de gasto catastrófico foi mais elevada entre aqueles que apresentaram graus de depressão, ansiedade e estresse graves ou muito graves. O baixo apoio social entre os cuidadores também foi determinante para o aumento da prevalência do gasto. A carga que incide sobre os cuidadores de crianças com SCZ grave potencializa uma situação de vulnerabilidade que demanda a amplificação do acesso aos mecanismos de proteção financeira e social, através da articulação de diferentes políticas que sejam capazes de alcançar efetivamente esse grupo.

In 2015, there was an increase in cases of congenital malformations in newborns in Brazil, associated with maternal Zika virus infection, having serious social and economic repercussions for the families. The study aimed to estimate the prevalence of catastrophic expenditure by families of children with severe or mild/moderate congenital Zika syndrome (CZS) in comparison to families of children without a diagnosis of CZS in the state of Rio de Janeiro. Catastrophic expenditure occurs when spending exceeds a given proportion of the family income due to a disease. Family caregivers of children with severe CZS were younger and had less schooling and lower income. Prevalence of catastrophic expenditure was higher in families of children with CZS. Among caregivers of children with severe CZS, the prevalence of catastrophic expenditure was higher in those with severe or very severe depression, anxiety, and stress. Low social support among caregivers was also a determinant factor for increased prevalence of catastrophic expenditure. The burden on caregivers of children with severe CZS exacerbates a situation of vulnerability that requires the expansion of mechanisms for financial and social protection, through linkage of various policies capable of effectively reaching this group.

En 2015, hubo un aumento de casos de malformaciones congénitas entre recién nacidos en Brasil, asociado al virus zika con repercusiones sociales y económicas para las familias. El objetivo de este estudio fue estimar la prevalencia de gasto catastrófico para las familias de niños con síndrome congénito del virus Zika (SCZ) grave, leve/moderado, en comparación con familias de niños sin diagnóstico de SCZ, en el estado de Río de Janeiro. El término gasto catastrófico se usa cuando el gasto excede una determinada proporción de la renta de la familia, debido a la enfermedad. Los cuidadores de niños con SCZ grave eran más jóvenes, con menor escolaridad y renta. La prevalencia de gasto catastrófico fue mayor en familias de niños con SCZ. Entre los cuidadores de niños con SCZ grave se identificó que la prevalencia de gasto catastrófico fue más elevada entre aquellos que presentaron grados de depresión, ansiedad y estrés grave o muy grave. El bajo apoyo social entre los cuidadores también fue determinante para el aumento de la prevalencia del gasto. La carga que incide sobre los cuidadores de niños con SCZ grave potencia una situación de vulnerabilidad que demanda la ampliación del acceso a los mecanismos de protección financiera y social, a través de la coordinación de diferentes políticas que sean capaces de alcanzar efectivamente a ese grupo.

Cost-effectiveness of newer technologies for the diagnosis of Mycobacterium tuberculosis infection in Brazilian people living with HIV.

Tuberculosis is the leading cause of death among people living with HIV (PLH). Preventive tuberculosis therapy reduces mortality in PLH, especially in those with a positive tuberculin skin test (TST). New, more specific technologies for detecting latent tuberculosis infection (LTBI) are now commercially available. We sought to analyse the cost-effectiveness of four different strategies for the diagnosis of LTBI in PLH in Brazil, from the Brazilian public health care system perspective. We developed a Markov state-transition model comparing four strategies for the diagnosis of LTBI over 20 years. The strategies consisted of TST with the currently used protein purified derivative (PPD RT 23), two novel skin tests using recombinant allergens (Diaskintest [Generium Pharmaceutical, Moscow, Russia] and EC [Zhifei Longcom Biologic Pharmacy Co., Anhui, China]), and the QuantiFERON-TB-Gold-Plus (Qiagen, Hilden, Germany). The main outcome was cost (in 2020 US dollars) per quality-adjusted life years (QALY). For the base case scenario, the Diaskintest was dominant over all other examined strategies. The cost saving estimate per QALY was US $1375. In sensitivity analyses, the Diaskintest and other newer tests remained cost-saving compared to TST. For PLH, TST could be replaced by more specific tests in Brazil, considering the current national recommendations.

The health and economic burden of smoking in 12 Latin American countries and the potential effect of increasing tobacco taxes: an economic modelling study.

BACKGROUND: Worldwide, smoking tobacco causes 7 million deaths annually, and this toll is expected to increase, especially in low-income and middle-income countries. In Latin America, smoking is a leading risk factor for death and disability, contributes to poverty, and imposes an economic burden on health systems. Despite being one of the most effective measures to reduce smoking, tobacco taxation is underused and cigarettes are more affordable in Latin America than in other regions. Our aim was to estimate the tobacco-attributable burden on mortality, disease incidence, quality of life lost, and medical costs in 12 Latin American countries, and the expected health and economic effects of increasing tobacco taxes. METHODS: In this modelling study, we developed a Markov probabilistic microsimulation economic model of the natural history, medical costs, and quality-of-life losses associated with the most common tobacco-related diseases in 12 countries in Latin America. Data inputs were obtained through a literature review, vital statistics, and hospital databases from each country: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Honduras, Mexico, Paraguay, Peru, and Uruguay. The main outcomes of the model are life-years, quality-adjusted life-years, disease events, hospitalisations, disease incidence, disease cost, and healthy years of life lost. We estimated direct medical costs for each tobacco-related disease included in the model using a common costing methodology for each country. The disease burden was estimated as the difference in disease events, deaths, and associated costs between the results predicted by the model for current smoking prevalence and a hypothetical cohort of people in each country who had never smoked. The model estimates the health and financial effects of a price increase of cigarettes through taxes, in terms of disease and health-care costs averted, and increased tax revenues. FINDINGS: In the 12 Latin American countries analysed, we estimated that smoking is responsible for approximately 345 000 (12%) of the total 2 860 921 adult deaths, 2·21 million disease events, 8·77 million healthy years of life lost, and $26·9 billion in direct medical costs annually. Health-care costs attributable to smoking were estimated to represent 6·9% of the health budgets of these countries, equivalent to 0·6% of their gross domestic product. Tax revenues from cigarette sales cover 36·0% of the estimated health expenditures caused by smoking. We estimated that a 50% increase in cigarette price through taxation would avert more than 300 000 deaths, 1·3 million disease events, gain 9 million healthy life-years, and save $26·7 billion in health-care costs in the next 10 years, with a total economic benefit of $43·7 billion. INTERPRETATION: Smoking represents a substantial health and economic burden in these 12 countries of Latin America. Tobacco tax increases could successfully avert deaths and disability, reduce health-care spending, and increase tax revenues, resulting in large net economic benefits. FUNDING: International Development Research Centre (IDRC), Canada.

Validation and calibration of the patient-reported outcomes measurement information system: Pediatric PROMIS® Emotional Distress domain item banks, Portuguese version (Brazil/Portugal).

OBJECTIVE: This paper goal was to validate the Portuguese version (Brazil/Portugal) of the Anger, Anxiety, and Depressive Symptoms item banks of the Pediatric PROMIS® Emotional Distress domain (version 1.0) for the Brazilian and Portuguese pediatric population. METHOD: The total of 1216 participants answered a self-applied version of the Portuguese Anger, Anxiety, and Depressive Symptoms item banks. Reliability was assessed through internal consistency, test-retest reliability, and total information curve (TIC). Confirmatory Factor Analysis (CFA) with a bifactor model was used to confirm construct validity and IRT assumptions. Item calibration was performed according to Graded Response Model (GRM). Differential Item Functioning (DIF) was analyzed according the participants' age, gender, health condition (healthy versus chronic disease), and language. RESULTS: Internal consistency reliability (Cronbach's alpha coefficient = 0.84) and test-retest reliability (intraclass correlation = 0.93) were accurate. Unidimensionality, Local Independency, and construct validity were verified by CFA (CFI = 0.93; TLI = 0.93; RMSEA = 0.05; χ2 = 3052.4 with DIF = 557 and P value = 0.595). GRM was adjusted, and Emotional Distress had a satisfactory coverage. DIF was not significant. CONCLUSION: The results obtained indicate the adequacy of the psychometric properties of the Portuguese version (Brazil/Portugal) of the Anger, Anxiety, and Depressive Symptoms item banks of the Pediatric PROMIS® Emotional Distress domain.

Análise de custo da assistência de crianças e adolescentes com condições crônicas complexas / Analysis of the cost of care for children and adolescents with medical complex chronic conditions

Resumo O objetivo deste artigo foi identificar a utilização de tecnologias e estimar o custo direto da atenção hospitalar de crianças e adolescentes com condições crônicas complexas em um hospital público federal especializado na assistência de alta complexidade a pacientes pediátricos. O trabalho foi realizado concomitantemente com um estudo de coorte durante o período de um ano e incluiu 146 pacientes com condições complexas crônicas e 37 pacientes não-crônicos. A análise identificou que a maioria dos pacientes com condições complexas crônicas internou em média duas vezes em um ano e que tinham doenças com o envolvimento de pelo menos dois sistemas orgânicos. O uso de drenos e cateteres e a gastrostomia foram as tecnologias de maior utilização. Na comparação com os pacientes não-crônicos, o custo direto mediano dos pacientes com condições complexas crônicas foi superior quando se comparou a utilização de tecnologias. O estudo indica um elevado custo da atenção hospitalar para esses pacientes. Documentar a utilização de tecnologias e o custo da atenção hospitalar permite subsidiar os gestores e contribuir para a tomada de decisões de planejamento, gestão e financiamento das políticas de saúde na área pediátrica.

Abstract This paper aimed to identify the use of technology and to analyze the cost of hospital care for children and adolescents with medical complex chronic conditions at a public federal hospital specialized in high-complexity pediatric care, and was performed concomitantly with a prospective cohort study conducted over a one-year period. It included 146 patients with complex medical chronic conditions and 37 non-chronic patients. The analysis showed that most patients had, on average, two hospitalizations a year and were diagnosed with diseases related to at least two organic systems. Catheters, drains and gastrostomy were the most common technologies used. Median direct costs of patients with medically complex chronic conditions were higher than those of non-chronic patients when comparing the use of technology. The study shows high hospitalization cost to these patients. Technology use and hospitalization care costs documentation yields more data to support decision-makers in the planning, managing, and financing of pediatric health policies.

Rare diseases and the associative dialogue: resignifications for moral experiences. / Adoecimentos raros e o diálogo associativo: ressignificações para experiências morais.

This paper aims to discuss the experience of relatives of children and adolescents with rare diseases as a moral experience. Moral experience is characterized by suffering that is socially interpreted as a catastrophic event, mobilizing resources for signification and meaning that allow the reconstruction of identity, the appreciation of itineraries from a rare diagnosis, as well as the search for peers. Thus, the construction of relationships of recognition, alterity, and belonging is fundamental. From a symbolic interactionist perspective, the results show two significant cores: (1) shock as a surprise in the face of an unexpected diagnosis, leading to the search for peers and promotion of social recognition; (2) the cost involved with the course of a rare disease that implies a care work and the acquisition of associative capital as a possibility of strengthening and building the social capital of health care.

Neste artigo, buscamos discutir a experiência de familiares de crianças e adolescentes com doenças raras como uma experiência moral. A experiência moral se caracteriza pelo sofrimento que é lido, coletivamente, como acontecimento catastrófico, mobilizando recursos para significação e sentido que possibilitem reconstruções identitárias, valoração de novas trajetórias a partir de um diagnóstico raro, assim como a busca de pares. Nesse sentido, é fundamental a construção de relações de reconhecimento, alteridade e pertencimento. A partir de uma perspectiva interacionista simbólica, os resultados mostram dois núcleos: (1) o susto como surpresa diante do diagnóstico inesperado, levando a busca de pares e promoção do reconhecimento social; (2) o custo envolvido com a trajetória de uma doença rara que implica um trabalho de care e a aquisição de capital associativo como possibilidade de fortalecimento e construção de capital social de cuidado à saúde.

Analysis of the cost of care for children and adolescents with medical complex chronic conditions. / Análise de custo da assistência de crianças e adolescentes com condições crônicas complexas.

This paper aimed to identify the use of technology and to analyze the cost of hospital care for children and adolescents with medical complex chronic conditions at a public federal hospital specialized in high-complexity pediatric care, and was performed concomitantly with a prospective cohort study conducted over a one-year period. It included 146 patients with complex medical chronic conditions and 37 non-chronic patients. The analysis showed that most patients had, on average, two hospitalizations a year and were diagnosed with diseases related to at least two organic systems. Catheters, drains and gastrostomy were the most common technologies used. Median direct costs of patients with medically complex chronic conditions were higher than those of non-chronic patients when comparing the use of technology. The study shows high hospitalization cost to these patients. Technology use and hospitalization care costs documentation yields more data to support decision-makers in the planning, managing, and financing of pediatric health policies.

O objetivo deste artigo foi identificar a utilização de tecnologias e estimar o custo direto da atenção hospitalar de crianças e adolescentes com condições crônicas complexas em um hospital público federal especializado na assistência de alta complexidade a pacientes pediátricos. O trabalho foi realizado concomitantemente com um estudo de coorte durante o período de um ano e incluiu 146 pacientes com condições complexas crônicas e 37 pacientes não-crônicos. A análise identificou que a maioria dos pacientes com condições complexas crônicas internou em média duas vezes em um ano e que tinham doenças com o envolvimento de pelo menos dois sistemas orgânicos. O uso de drenos e cateteres e a gastrostomia foram as tecnologias de maior utilização. Na comparação com os pacientes não-crônicos, o custo direto mediano dos pacientes com condições complexas crônicas foi superior quando se comparou a utilização de tecnologias. O estudo indica um elevado custo da atenção hospitalar para esses pacientes. Documentar a utilização de tecnologias e o custo da atenção hospitalar permite subsidiar os gestores e contribuir para a tomada de decisões de planejamento, gestão e financiamento das políticas de saúde na área pediátrica.

Adoecimentos raros e o diálogo associativo: ressignificações para experiências morais / Rare diseases and the associative dialogue: resignifications for moral experiences

Resumo Neste artigo, buscamos discutir a experiência de familiares de crianças e adolescentes com doenças raras como uma experiência moral. A experiência moral se caracteriza pelo sofrimento que é lido, coletivamente, como acontecimento catastrófico, mobilizando recursos para significação e sentido que possibilitem reconstruções identitárias, valoração de novas trajetórias a partir de um diagnóstico raro, assim como a busca de pares. Nesse sentido, é fundamental a construção de relações de reconhecimento, alteridade e pertencimento. A partir de uma perspectiva interacionista simbólica, os resultados mostram dois núcleos: (1) o susto como surpresa diante do diagnóstico inesperado, levando a busca de pares e promoção do reconhecimento social; (2) o custo envolvido com a trajetória de uma doença rara que implica um trabalho de care e a aquisição de capital associativo como possibilidade de fortalecimento e construção de capital social de cuidado à saúde.

Abstract This paper aims to discuss the experience of relatives of children and adolescents with rare diseases as a moral experience. Moral experience is characterized by suffering that is socially interpreted as a catastrophic event, mobilizing resources for signification and meaning that allow the reconstruction of identity, the appreciation of itineraries from a rare diagnosis, as well as the search for peers. Thus, the construction of relationships of recognition, alterity, and belonging is fundamental. From a symbolic interactionist perspective, the results show two significant cores: (1) shock as a surprise in the face of an unexpected diagnosis, leading to the search for peers and promotion of social recognition; (2) the cost involved with the course of a rare disease that implies a care work and the acquisition of associative capital as a possibility of strengthening and building the social capital of health care.

Burden of smoking in Brazil and potential benefit of increasing taxes on cigarettes for the economy and for reducing morbidity and mortality. / Carga do tabagismo no Brasil e benefício potencial do aumento de impostos sobre os cigarros para a economia e para a redução de mortes e adoecimento.

The prevalence of smoking in Brazil has decreased considerably in recent decades, but the country still has a high burden of disease associated with this risk factor. The study aimed to estimate the burden of mortality, morbidity, and costs for society associated with smoking in 2015 and the potential impact on health outcomes and the economy based on price increases for cigarettes through taxes. Two models were developed: the first is a mathematical model based on a probabilistic microsimulation of thousands of individuals using hypothetical cohorts that considered the natural history, costs, and quality of life of these individuals. The second is a tax model applied to estimate the economic benefit and health outcomes in different price increase scenarios in 10 years. Smoking was responsible for 156,337 deaths, 4.2 million years of potential life lost, 229,071 acute myocardial infarctions, 59,509 strokes, and 77,500 cancer diagnoses. The total cost was BRL 56.9 billion (USD 14.7 billion), with 70% corresponding to the direct cost associated with healthcare and the rest to indirect cost due to lost productivity from premature death and disability. A 50% increase in cigarette prices would avoid 136,482 deaths, 507,451 cases of cardiovascular diseases, 64,382 cases of cancer, and 100,365 cases of stroke. The estimated economic benefit would be BRL 97.9 billion (USD 25.5 billion). In conclusion, the burden of disease and economic losses associated with smoking is high in Brazil, and tax increases are capable of averting deaths, illness, and costs to society.

A prevalência do tabagismo no Brasil reduziu sobremaneira nas últimas décadas, mas o país ainda tem uma elevada carga de doença associada a este fator de risco. O objetivo deste trabalho foi estimar a carga de mortalidade, morbidade e custos para a sociedade associada ao tabagismo em 2015 e o potencial impacto gerado em desfechos de saúde e para a economia a partir do aumento de preços dos cigarros por meio de impostos. Foram desenvolvidos dois modelos: o primeiro é um modelo matemático baseado em uma microssimulação probabilística de milhares de indivíduos usando-se coortes hipotéticas que considerou a história natural, custos e a qualidade de vida destes indivíduos. O segundo é um modelo de impostos aplicado para estimar o benefício econômico e em desfechos de saúde de diferentes cenários de aumento de preços em 10 anos. O tabagismo foi responsável por 156.337 mortes, 4,2 milhões de anos de vida perdidos, 229.071 infartos agudos do miocárdio, 59.509 acidentes vasculares cerebrais e 77.500 diagnósticos de câncer. O custo total foi de R$ 56,9 bilhões, dos quais 70% corresponderam ao custo direto associado à assistência à saúde e o restante ao custo indireto devido à perda de produtividade por morte prematura e incapacidade. Um aumento de 50% do preço do cigarro evitaria 136.482 mortes, 507.451 casos de doenças cardiovasculares, 64.382 de casos de câncer e 100.365 acidentes vasculares cerebrais. O benefício econômico estimado seria de R$ 97,9 bilhões. Concluiu-se que a carga da doença e econômica associada ao tabagismo é elevada no Brasil e o aumento de impostos é capaz de evitar mortes, adoecimento e custos para a sociedade.

La prevalencia del tabaquismo en Brasil se redujo sobremanera en las últimas décadas, pero el país todavía cuenta con una elevada carga de enfermedad asociada a este factor de riesgo. El objetivo de este trabajo fue estimar la carga de mortalidad, morbilidad y costes para la sociedad, asociada al tabaquismo en 2015, y el impacto potencial generado en los desenlaces de salud y para la economía a partir del aumento de precios del tabaco a través de impuestos. Se desarrollaron dos modelos: el primero es un modelo matemático, basado en una microsimulación probabilística de millares de individuos, a través de cohortes hipotéticas, que consideró la historia natural, costes y calidad de vida de esos individuos. El segundo se trata de un modelo de impuestos aplicado para estimar el beneficio económico y en desenlaces de salud de diferentes escenarios con el aumento de precios durante 10 años. El tabaquismo fue responsable de 156.337 muertes, 4,2 millones de años de vida perdidos, 229.071 infartos agudos de miocardio, 59.509 accidentes vasculares cerebrales y 77.500 diagnósticos de cáncer. El coste total fue de BRL 56,9 billones (USD 14,7 billones), de los cuales un 70% correspondieron al coste directo asociado a la asistencia a la salud y lo restante al coste indirecto, debido a la pérdida de productividad por muerte prematura e incapacidad. Un aumento de un 50% del precio del tabaco evitaría 136.482 muertes, 507.451 casos de enfermedades cardiovasculares, 64.382 de casos de cáncer y 100.365 accidentes vasculares cerebrales. El beneficio económico estimado sería de BRL 97,9 billones (USD 25,5 billones). Se concluyó que la carga de la enfermedad y económica asociada al tabaquismo es elevada en Brasil y el aumento de impuestos es capaz de evitar muertes, enfermedad y costes para la sociedad.