Cost-Effectiveness Analysis of Varenicline Versus Currently Funded Smoking Cessation Strategies in Brazil.

OBJECTIVES: To assess the cost-effectiveness of varenicline in comparison to currently funded smoking cessation strategies in Brazil. METHODS: We modeled the lifetime direct costs and health-related quality of life of a hypothetical cohort of smokers with a single attempt to quit smoking using one of the following: (1) cognitive behavioral therapy (CBT) without any pharmacological intervention, (2) varenicline, (3) bupropion, (4) nicotine replacement therapy (NRT) with transdermal patch, (5) bupropion in combination with NRT transdermal patch, and (6) combined NRT (oral plus transdermal). All drug alternatives were considered with concomitant CBT. The analysis relied on a Markov model based on the Benefits of Smoking Cessation and Outcomes study and used different age and sex categories in the consideration of relative risks and incidence rates of the diseases included in the model. The analysis was conducted from the healthcare system perspective, and a 3% discounting rate for costs and outcomes was applied. Model parameter values were sourced from published literature. Probabilistic and deterministic sensitivity analyses assessed robustness. RESULTS: Among the smoking cessation alternatives available in Brazil, varenicline and combined NRT were estimated to have higher effectiveness; varenicline, however, was dominated due to its higher average cost. In the base-case analysis, combined NRT had an incremental gain of 0.25 quality-adjusted life-years (QALYs) in comparison to the second-best option (bupropion in combination with NRT transdermal patch) and an incremental cost-effectiveness ratio of R$2173.47/QALY ($595.45/QALY). CONCLUSIONS: Combination of oral and transdermal NRT (coupled with CBT) was the most effective smoking cessation option and was 100% cost-effective within a conservative willingness-to-pay threshold.

[Risk of initiation to smoking with the use of electronic cigarettes: systematic review and meta-analysis]. / Risco de iniciação ao tabagismo com o uso de cigarros eletrônicos: revisão sistemática e meta-análise.

This article aims to evaluate the association between the use of electronic cigarettes and initiation to smoking, through a systematic review with meta-analysis of longitudinal studies. A bibliographic search was performed on the MEDLINE, Embase, LILACS and PsycInfo databases. Reference selection, data extraction and risk of bias assessment of the studies were independently carried out in pairs, and the disagreements were discussed with a third researcher to reach a consensus. Meta-analysis was performed using the Mantel-Haenszel random effects model. Among the 25 studies included, 22 evaluated the outcome of conventional cigarette experimentation and nine assessed the outcome of current smoking (in the last 30 days). The meta-analysis showed that the use of electronic cigarettes increased the risk of conventional cigarette experimentation by almost three and a half times (RR=3.42; 95%CI 2.81-4.15), and by more than four times the risk of current smoking (RR=4.32; 95%CI 3.13-5.94). The risk of smoking initiation is significantly higher among electronic cigarette users. The marketing authorization of such devices may represent a threat to public health policies in Brazil.

O objetivo deste artigo é avaliar a associação entre uso de cigarros eletrônicos e iniciação ao tabagismo, por meio de uma revisão sistemática com meta-análise de estudos longitudinais. Busca bibliográfica foi realizada nas bases MEDLINE, Embase, LILACS e PsycInfo. As etapas de seleção de referências, extração dos dados e avaliação do risco de viés dos estudos foi realizada em dupla, de forma independente e as divergências discutidas com um terceiro pesquisador para obtenção de consenso. Meta-análise foi realizada por meio do modelo Mantel-Haenszel de efeitos aleatórios. Dentre os 25 estudos incluídos, 22 avaliaram o desfecho de experimentação de cigarro convencional e nove avaliaram o desfecho de tabagismo atual (nos últimos 30 dias). A meta-análise demonstrou que o uso de cigarro eletrônico aumentou em quase três vezes e meia o risco de experimentação de cigarro convencional (RR=3,42; IC95% 2,81-4,15) e em mais de quatro vezes o risco de tabagismo atual (RR=4,32; IC95% 3,13-5,94). O risco de iniciação ao tabagismo é significativamente maior entre usuários de cigarro eletrônico. A liberação da comercialização desses dispositivos pode representar uma ameaça para as políticas de saúde pública no Brasil.

Risco de iniciação ao tabagismo com o uso de cigarros eletrônicos: revisão sistemática e meta-análise / Risk of initiation to smoking with the use of electronic cigarettes: systematic review and meta-analysis

Resumo O objetivo deste artigo é avaliar a associação entre uso de cigarros eletrônicos e iniciação ao tabagismo, por meio de uma revisão sistemática com meta-análise de estudos longitudinais. Busca bibliográfica foi realizada nas bases MEDLINE, Embase, LILACS e PsycInfo. As etapas de seleção de referências, extração dos dados e avaliação do risco de viés dos estudos foi realizada em dupla, de forma independente e as divergências discutidas com um terceiro pesquisador para obtenção de consenso. Meta-análise foi realizada por meio do modelo Mantel-Haenszel de efeitos aleatórios. Dentre os 25 estudos incluídos, 22 avaliaram o desfecho de experimentação de cigarro convencional e nove avaliaram o desfecho de tabagismo atual (nos últimos 30 dias). A meta-análise demonstrou que o uso de cigarro eletrônico aumentou em quase três vezes e meia o risco de experimentação de cigarro convencional (RR=3,42; IC95% 2,81-4,15) e em mais de quatro vezes o risco de tabagismo atual (RR=4,32; IC95% 3,13-5,94). O risco de iniciação ao tabagismo é significativamente maior entre usuários de cigarro eletrônico. A liberação da comercialização desses dispositivos pode representar uma ameaça para as políticas de saúde pública no Brasil.

Abstract This article aims to evaluate the association between the use of electronic cigarettes and initiation to smoking, through a systematic review with meta-analysis of longitudinal studies. A bibliographic search was performed on the MEDLINE, Embase, LILACS and PsycInfo databases. Reference selection, data extraction and risk of bias assessment of the studies were independently carried out in pairs, and the disagreements were discussed with a third researcher to reach a consensus. Meta-analysis was performed using the Mantel-Haenszel random effects model. Among the 25 studies included, 22 evaluated the outcome of conventional cigarette experimentation and nine assessed the outcome of current smoking (in the last 30 days). The meta-analysis showed that the use of electronic cigarettes increased the risk of conventional cigarette experimentation by almost three and a half times (RR=3.42; 95%CI 2.81-4.15), and by more than four times the risk of current smoking (RR=4.32; 95%CI 3.13-5.94). The risk of smoking initiation is significantly higher among electronic cigarette users. The marketing authorization of such devices may represent a threat to public health policies in Brazil.

Clinical practice guidelines in Brazil - developing a national programme.

In Brazil, governmental and non-governmental organisations develop practice guidelines (PGs) in order to optimise patient care. Although important improvements have been made over the past years, many of these documents still lack transparency and methodological rigour. In order to conduct a critical analysis and define future steps in PG development in Brazil, we carried out a structured assessment of strengths, weaknesses, opportunities and threats (SWOT analysis) for the development of a national guideline programme. Participants consisted of academia, methodologists, medical societies and healthcare system representatives. In summary, the PG development process has improved in Brazil and current investments in methodological research and capacity-building are ongoing. Despite the centralised processes for public PGs, standardised procedures for their development are not well established and human resources are insufficient in number and capacity to develop the amount of trustworthy documents needed. Brazil's capacity could be strengthened and initial efforts have been made such as the adoption of standards proposed by world-renowned institutions in PG development and enhancement of the involvement of key stakeholders. Further steps involve the alignment between health technology assessment and PG processes for synergy and the development of a national network to promote the interaction between groups involved in the development of PGs. The lessons learned from this paper could be used to foster debate on guideline development, especially for countries facing similar threats on this topic.

Breast Cancer Quality of Life and Health-state Utility at a Brazilian Reference Public Cancer Center.

Objectives: To evaluate health-related-quality-of-life and derive health-state-utility (HSU) from breast cancer patients, before and after routine therapy at a Brazilian reference public cancer center.Methods: In a prospective cohort study, a consecutive sample of outpatients newly diagnosed with breast cancer was submitted to two interviews (baseline, 6-month) to complete EQ-5D-3L/VAS and EORTC-QLQ-C30/BR23 questionnaires. Demographic and clinical information was reviewed from medical records.Results: For 196 patients, EQ-5D domains of pain/discomfort and anxiety/depression were mainly affected, but partially improved overtime, while mobility/usual activities/self-care worsened after therapy. EORTC-QLQ-C30/BR23 scales mostly affected were emotional functioning, insomnia, pain, sexual enjoyment and future self-health perspective at baseline, while financial difficulties, insomnia, fatigue and therapy side-effects at follow-up. Overtime mean scores were 71.4 (95%CI68.5-74.4) and 76.1 (95%CI73.3-78.8) for EQ-5D-VAS, and 0.712 (95%CI0.686-0.737) and 0.732 (95%CI0.707-0.757) for HSU. HSU was 0.689 (95%CI0.648-0.730) in stages III-IV, and 0.692 (95%CI0.652-0.731) under two/three chemotherapy regimens.Conclusion: In a context of impairments in emotional functioning, sexual enjoyment, symptoms burden, and poor future self-health perspective, breast cancer produced a mean HSU of 0.712. After routine care, there was a small improvement in quality of life, with lower HSU particularly in advanced disease and multiple chemotherapy regimens.

[Economic assessment of dexrazoxane in prophylaxis of cardiotoxicity in children undergoing chemotherapy with anthracyclines]. / Avaliação econômica do uso de dexrazoxano na profilaxia de cardiotoxicidade em crianças em tratamento quimioterápico com antraciclinas.

Cancer in individuals 0 to 19 years of age is considered rare when compared to incidence in older age brackets, and is estimated at 2% to 3% of all malignant tumors recorded in Brazil. The use of anthracyclines is frequently associated with cardiotoxicity, and these drugs are part of approximately 60% of treatment protocols in pediatric oncology. Among the existing strategies for the prevention of cardiotoxicity, dexrazoxane obtained favorable results based on intermediate outcomes (biochemical markers and echocardiographic parameters). This study was based on a cost-effectiveness assessment comparing the use of dexrazoxane in different populations, besides an assessment of the budget impact from the technology's potential incorporation. The patient's lifetime was used as the timeline, and the analysis was performed from the perspective of the Brazilian Unified National Health System (SUS). A budget impact analysis was also performed for each technology. After a literature search, a Markov model was developed, capable of comparing the use of dexrazoxane in six profiles of patients at risk of developing cardiotoxicity. Use of the drug in children under 5 years of age proved to be the most cost-effective alternative (incremental cost effectiveness ratio - ICER of BRL 6,156.96), followed by use in all patients (ICER of BRL 58,968.70). If the price decreased to less than BRL 250.00 per vial, the alternative of using the drug in all children would become the most cost-effective. The budget impact at 5 years was BRL 30,622,404.81 for use only in children under 5 years of age. Using the technology in all the children could produce an incremental impact of BRL 94,352,898.77.

O câncer em indivíduos de 0 a 19 anos é considerado raro, quando comparado à incidência em faixas etárias maiores, sendo estimado entre 2% e 3% de todos os tumores malignos registrados no Brasil. O uso de antraciclinas está frequentemente associado ao aparecimento de cardiotoxicidade e faz parte de aproximadamente 60% dos protocolos terapêuticos em oncologia pediátrica. Dentre as estratégias existentes para a prevenção de cardiotoxicidade, o dexrazoxano obteve resultados favoráveis pautados em desfechos intermediários (marcadores bioquímicos e medidas ecocardiográficas). Foi desenvolvida, neste trabalho, uma avaliação de custo-efetividade que compare o uso do dexrazoxano em diferentes populações, além de uma avaliação do impacto orçamentário causado pela possível incorporação da tecnologia. Foi utilizado o horizonte temporal de toda a vida do paciente e a perspectiva de análise do Sistema Único de Saúde. Uma análise de impacto orçamentário para cada tecnologia também foi construída. Após uma busca na literatura, foi desenvolvido um modelo de Markov capaz de comparar o uso do dexrazoxano em seis perfis de pacientes com risco de desenvolver cardiotoxicidade. Usar o medicamento nas crianças menores de cinco anos de idade se mostrou a alternativa mais custo-efetiva (razão de custo-efetividade incremental - RCEI de R$ 6.156,96), seguida de usar em todos os pacientes (RCEI de R$ 58.968,70). Caso o preço diminua a um valor menor que R$ 250,00 por frasco, a alternativa de usar em todas as crianças se torna a mais custo-efetiva. O impacto orçamentário ao final de cinco anos foi de R$ 30.622.404,81 para uso apenas nas crianças menores de cinco anos. Usar a tecnologia em todas as crianças produziria um impacto incremental de R$ 94.352.898,77.

El cáncer en individuos de 0 a 19 años está considerado raro, cuando se compara la incidencia en franjas etarias mayores, estimándose entre 2% y 3% de todos los tumores malignos registrados en Brasil. El uso antraciclinas está frecuentemente asociado a la aparición de cardiotoxicidad y forma parte de aproximadamente un 60% de los protocolos terapéuticos en oncología pediátrica. Entre las estrategias existentes para la prevención de cardiotoxicidad, el dexrazoxano obtuvo resultados favorables pautados en desenlaces intermedios (marcadores bioquímicos y medidas ecocardiográficas). Se desarrolló en este trabajo, una evaluación de costo efectividad que compare el uso del dexrazoxano en diferentes poblaciones, además de una evaluación del impacto presupuestario causado por la posible incorporación de la tecnología. Se utilizó el horizonte temporal de toda la vida del paciente y la perspectiva de análisis del SUS. También se realizó un análisis del impacto presupuestario para cada tecnología. Tras una búsqueda en la literatura, se desarrolló un modelo de Markov capaz de comparar el uso del dexrazoxano en 6 perfiles de pacientes con riesgo de desarrollar cardiotoxicidad. Usar el medicamento en los niños menores de 5 años de edad se mostró la alternativa más costo-efectiva (relación costo-efectividad incremental - RCEI de BRL 6.156,96), seguido de usarlo en todos los pacientes (RCEI de BRL 58.968,7). En caso de que el precio disminuya a un valor inferior a BRL 250,00 por frasco, la alternativa de usarlo en todos los niños se convierte en la más costo-efectiva. El impacto presupuestario tras 5 años fue de BRL 30.622.404,81 para su uso exclusivo en niños menores de 5 años. Usar esta tecnología en todos los niños, tendría un impacto presupuestario incrementándolo hasta los BRL 94.352.898,77.

Patient Preferences for Breast Cancer Treatment Interventions: A Systematic Review of Discrete Choice Experiments.

INTRODUCTION: Understanding how patients value different characteristics of an intervention and make trade-offs in a therapy choice context with potential benefit and possible harm may result in decisions for which a better reflected value is delivered. This systematic review summarizes patient preferences for breast cancer treatments elicited by discrete choice experiments (DCE). METHODOLOGY: The electronic databases MEDLINE (PubMed), Scopus, PsycINFO, CINAHL, LILACS, and Web of Science were last searched on May 9, 2019 without restrictions regarding language and time of publication. Original studies reporting patient preferences related to breast cancer treatment (surgery, radiotherapy, endocrine therapy, chemotherapy or palliative care) elicited by DCE were eligible. A narrative synthesis of the relative importance and trade-offs of the treatment attributes of each study was reported. RESULTS: Five studies conducted in Japan, Thailand, USA and the Netherlands with 146-298 participants evaluated preferences regarding chemotherapy regimens for advanced/metastatic disease, and breast reconstruction after mastectomy. The attributes with major relative effects on preferences were greater survival, better aesthetic result of the surgery, and lower side effects and complication rates. Patients would trade a better aesthetic result to minimize complication rates, and, in advanced disease, the willingness to pay was greater for gains in survival and to avoid some severe adverse events. CONCLUSION: Despite the relative lack of evidence in this specific context, our review shows that breast cancer patients naturally value greater benefit and, in scenarios of advanced and metastatic disease, are willing to face risks of some side effects for gains in survival.

Target therapy versus dacarbazine in first-line treatment of advanced non-surgical and metastatic melanoma: budget impact analysis from the perspective of the Brazilian National Health System, 2018-2020. / Terapia-alvo versus dacarbazina no tratamento de primeira linha do melanoma avançado não cirúrgico e metastático: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde, 2018-2020.

OBJECTIVE: to estimate the incremental budget impact of target therapy for first-line treatment of advanced non-surgical and metastatic melanoma compared to dacarbazine treatment. METHODS: budget impact analysis, from the Brazilian National Health System (SUS) perspective; based on demographic data and incidence estimates, the population over a three-year time horizon (2018-2020) was delimited and the direct medical costs were estimated; the reference scenario was treatment with dacarbazine, and the alternative scenarios were target therapy with vemurafenib, dabrafenib, vemurafenib + cobimetinib and dabrafenib + trametinib; uncertainty assessment was conducted through scenario analysis. RESULTS: the incremental budget impact ranged from R$ 451,867,881.00 to R$ 768,860,968.00, representing 0.70 to 1.53% of total SUS annual outpatient drugs expenditure; in best and worst scenario, results ranged from R$ 289,160,835.00 to R$ 1,107,081,926.00. CONCLUSION: the use of target therapy compared to dacarbazine implies an excessive impact on the budget, this bring unfovorable to its possible incorporation.

Cost-Effectiveness of Proton Versus Photon Therapy in Pediatric Medulloblastoma Treatment: A Patient Volume-Based Analysis.

BACKGROUND: Proton radiation therapy offers advantages over photon therapy, assisting with severe side effect avoidance. Pediatric patients with medulloblastoma have demonstrated benefit from this technology in recently published cohort studies. OBJECTIVES: To compare the costs and benefits between proton and photon therapy in treating pediatric medulloblastoma. METHODS: The model was built with a lifetime horizon from the Brazilian health system perspective using a 3% discount rate. A microsimulation model was developed after a literature search, comparing scenarios of equipment life span and number of patients treated per year (50, 100, and 150 patients with 10, 25, and 20 years of equipment life span). The baseline parameters were 50 patients treated annually and 20 years of equipment life span. RESULTS: The quality-adjusted life-year gain was 2.71, and the average incremental cost-effectiveness ratio was $34 590.54 per quality-adjusted life-year. For the willingness-to-pay threshold of 1 gross domestic product per capita, it was observed that the incorporation of the technology would be cost-effective if more than 150 patients were treated per year. The weight of the equipment life span and other variables was limited when it varied in the sensitivity analysis, without significant changes to the model results. CONCLUSIONS: Proton therapy is not cost-effective for pediatric medulloblastoma treatment from the Brazilian health system perspective. The investment is not worth when considering the number of potential patients and the country dimensions.

Custo-utilidade de terapias-alvo comparadas à dacarbazina para o tratamento de primeira linha do melanoma avançado não-cirúrgico e metastático no Sistema Único de Saúde do Brazil.

OBJECTIVE: To estimate the incremental cost-utility ratio (ICUR) of isolated and combined targeted therapy regimens compared to dacarbazine for first-line treatment of advanced and metastatic melanoma with BRAF V600 mutation. METHODS: A Markov model with three health states (no progression, progression and death), monthly duration cycle and 10-year time horizon was constructed to compare targeted therapy regimens (vemurafenib, dabrafenib, vemurafenib/cobimetinib and dabrafenib/trametinib) with dacarbazine chemotherapy under the Brazilian public health perspective. One-way and probabilistic sensitivity analyses were performed. RESULTS: Mean cost was R$5662.50 ($1490.13) for dacarbazine, R$175 937.18 (46 299.26) for vemurafenib, R$167 461.70 ($44 068.87) for dabrafenib, R$425 901 ($112 079.21) for vemurafenib/cobimetinib and R$411 799.81 ($108 368.37) for dabrafenib/trametinib, whereas QALY was 0.91 for dacarbazine, 1.08 for vemurafenib, 1.12 for dabrafenib, 1.64 for vemurafenib/cobimetinib and 1.56 for dabrafenib/trametinib. The ICUR was estimated from R$572 165.76 ($150 569.94) to R$1 012 524.56 ($266 453.83) per patient, and the most impactful parameters were risk of progression and death, and treatment cost. CONCLUSION: The incorporation of targeted therapies in the Brazilian public health system would produce an additional expenditure of at least 19 times the national GDP per capita to increase in one year the quality-adjusted survival of each patient with advanced/metastatic BRAF-mutant melanoma.

Avaliação econômica do uso de dexrazoxano na profilaxia de cardiotoxicidade em crianças em tratamento quimioterápico com antraciclinas / Economic assessment of dexrazoxane in prophylaxis of cardiotoxicity in children undergoing chemotherapy with anthracyclines / Evaluación económica del uso del dexrazoxano en la profilaxia de cardiotoxicidad en niños en tratamiento quimioterápico con antraciclinas

Resumo: O câncer em indivíduos de 0 a 19 anos é considerado raro, quando comparado à incidência em faixas etárias maiores, sendo estimado entre 2% e 3% de todos os tumores malignos registrados no Brasil. O uso de antraciclinas está frequentemente associado ao aparecimento de cardiotoxicidade e faz parte de aproximadamente 60% dos protocolos terapêuticos em oncologia pediátrica. Dentre as estratégias existentes para a prevenção de cardiotoxicidade, o dexrazoxano obteve resultados favoráveis pautados em desfechos intermediários (marcadores bioquímicos e medidas ecocardiográficas). Foi desenvolvida, neste trabalho, uma avaliação de custo-efetividade que compare o uso do dexrazoxano em diferentes populações, além de uma avaliação do impacto orçamentário causado pela possível incorporação da tecnologia. Foi utilizado o horizonte temporal de toda a vida do paciente e a perspectiva de análise do Sistema Único de Saúde. Uma análise de impacto orçamentário para cada tecnologia também foi construída. Após uma busca na literatura, foi desenvolvido um modelo de Markov capaz de comparar o uso do dexrazoxano em seis perfis de pacientes com risco de desenvolver cardiotoxicidade. Usar o medicamento nas crianças menores de cinco anos de idade se mostrou a alternativa mais custo-efetiva (razão de custo-efetividade incremental - RCEI de R$ 6.156,96), seguida de usar em todos os pacientes (RCEI de R$ 58.968,70). Caso o preço diminua a um valor menor que R$ 250,00 por frasco, a alternativa de usar em todas as crianças se torna a mais custo-efetiva. O impacto orçamentário ao final de cinco anos foi de R$ 30.622.404,81 para uso apenas nas crianças menores de cinco anos. Usar a tecnologia em todas as crianças produziria um impacto incremental de R$ 94.352.898,77.

Abstract: Cancer in individuals 0 to 19 years of age is considered rare when compared to incidence in older age brackets, and is estimated at 2% to 3% of all malignant tumors recorded in Brazil. The use of anthracyclines is frequently associated with cardiotoxicity, and these drugs are part of approximately 60% of treatment protocols in pediatric oncology. Among the existing strategies for the prevention of cardiotoxicity, dexrazoxane obtained favorable results based on intermediate outcomes (biochemical markers and echocardiographic parameters). This study was based on a cost-effectiveness assessment comparing the use of dexrazoxane in different populations, besides an assessment of the budget impact from the technology's potential incorporation. The patient's lifetime was used as the timeline, and the analysis was performed from the perspective of the Brazilian Unified National Health System (SUS). A budget impact analysis was also performed for each technology. After a literature search, a Markov model was developed, capable of comparing the use of dexrazoxane in six profiles of patients at risk of developing cardiotoxicity. Use of the drug in children under 5 years of age proved to be the most cost-effective alternative (incremental cost effectiveness ratio - ICER of BRL 6,156.96), followed by use in all patients (ICER of BRL 58,968.70). If the price decreased to less than BRL 250.00 per vial, the alternative of using the drug in all children would become the most cost-effective. The budget impact at 5 years was BRL 30,622,404.81 for use only in children under 5 years of age. Using the technology in all the children could produce an incremental impact of BRL 94,352,898.77.

Resumen: El cáncer en individuos de 0 a 19 años está considerado raro, cuando se compara la incidencia en franjas etarias mayores, estimándose entre 2% y 3% de todos los tumores malignos registrados en Brasil. El uso antraciclinas está frecuentemente asociado a la aparición de cardiotoxicidad y forma parte de aproximadamente un 60% de los protocolos terapéuticos en oncología pediátrica. Entre las estrategias existentes para la prevención de cardiotoxicidad, el dexrazoxano obtuvo resultados favorables pautados en desenlaces intermedios (marcadores bioquímicos y medidas ecocardiográficas). Se desarrolló en este trabajo, una evaluación de costo efectividad que compare el uso del dexrazoxano en diferentes poblaciones, además de una evaluación del impacto presupuestario causado por la posible incorporación de la tecnología. Se utilizó el horizonte temporal de toda la vida del paciente y la perspectiva de análisis del SUS. También se realizó un análisis del impacto presupuestario para cada tecnología. Tras una búsqueda en la literatura, se desarrolló un modelo de Markov capaz de comparar el uso del dexrazoxano en 6 perfiles de pacientes con riesgo de desarrollar cardiotoxicidad. Usar el medicamento en los niños menores de 5 años de edad se mostró la alternativa más costo-efectiva (relación costo-efectividad incremental - RCEI de BRL 6.156,96), seguido de usarlo en todos los pacientes (RCEI de BRL 58.968,7). En caso de que el precio disminuya a un valor inferior a BRL 250,00 por frasco, la alternativa de usarlo en todos los niños se convierte en la más costo-efectiva. El impacto presupuestario tras 5 años fue de BRL 30.622.404,81 para su uso exclusivo en niños menores de 5 años. Usar esta tecnología en todos los niños, tendría un impacto presupuestario incrementándolo hasta los BRL 94.352.898,77.

Terapia-alvo versus dacarbazina no tratamento de primeira linha do melanoma avançado não cirúrgico e metastático: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde, 2018-2020 / Terapia dirigida versus dacarbazina en el tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico: análisis de impacto presupuestario en la perspectiva del Sistema Nacional de Salud de Brasil, 2018-2020 / Target therapy versus dacarbazine in first-line treatment of advanced non-surgical and metastatic melanoma: budget impact analysis from the perspective of the Brazilian National Health System, 2018-2020

Objetivo: estimar o impacto orçamentário incremental da terapia-alvo para tratamento de primeira linha do melanoma avançado não cirúrgico e metastático, em comparação à dacarbazina. Métodos: análise de impacto orçamentário na perspectiva do Sistema Único de Saúde (SUS) do Brasil; a partir de dados demográficos e estimativas da incidência, foi delimitada a população no horizonte temporal de três anos (2018-2020) e estimados os custos diretos médicos; foi considerado cenário de referência o tratamento com dacarbazina, e como cenários alternativos a terapia-alvo com vemurafenibe, dabrafenibe, vemurafenibe + cobimetinibe e dabrafenibe + trametinibe; a avaliação das incertezas foi conduzida mediante análise por cenários. Resultados: o impacto orçamentário incremental variou de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% dos gastos anuais totais com medicamentos ambulatoriais no SUS; no melhor e no pior cenário, os resultados variaram de R$ 289.160.835,00 a R$ 1.107.081.926,00. Conclusão: a terapia-alvo, comparada à dacarbazina, implica impacto excessivo no orçamento, desfavorecendo eventual incorporação.

Objetivo: estimar el impacto presupuestario incremental de la terapia dirigida para tratamiento de primera línea del melanoma avanzado no quirúrgico y metastásico comparado con la dacarbazina. Métodos: análisis de impacto presupuestario, en la perspectiva del Sistema Único de Salud (SUS) de Brasil; a partir de datos demográficos y estimaciones de incidencia se delimitó la población en un horizonte temporal de tres años (2018-2020) y se estimaron los costos directos médicos. El escenario de referencia fue el tratamiento con dacarbazina y los escenarios alternativos la terapia dirigida con vemurafenib, dabrafenib, vemurafenib + cobimetinib y dabrafenib + trametinib; la evaluación de incertidumbre se llevó a cabo mediante análisis por escenarios. Resultados: el impacto presupuestario incremental varió de R$ 451.867.881,00 a R$ 768.860.968,00, representando 0,70 a 1,53% de gastos anuales totales con medicamentos de ambulatorios en el SUS; en el mejor y el peor escenario los resultados variaron de R$ 289.160.835,00 a R$ 1.107.081.926,00. Conclusión: el uso de terapia dirigida comparado a la dacarbazina implica en impacto excesivo en el presupuesto, desfavoreciendo una eventual incorporación.

Objective: to estimate the incremental budget impact of target therapy for first-line treatment of advanced non-surgical and metastatic melanoma compared to dacarbazine treatment. Methods: budget impact analysis, from the Brazilian National Health System (SUS) perspective; based on demographic data and incidence estimates, the population over a three-year time horizon (2018-2020) was delimited and the direct medical costs were estimated; the reference scenario was treatment with dacarbazine, and the alternative scenarios were target therapy with vemurafenib, dabrafenib, vemurafenib + cobimetinib and dabrafenib + trametinib; uncertainty assessment was conducted through scenario analysis. Results: the incremental budget impact ranged from R$ 451,867,881.00 to R$ 768,860,968.00, representing 0.70 to 1.53% of total SUS annual outpatient drugs expenditure; in best and worst scenario, results ranged from R$ 289,160,835.00 to R$ 1,107,081,926.00. Conclusion: the use of target therapy compared to dacarbazine implies an excessive impact on the budget, this bring unfovorable to its possible incorporation.

Sports Practices and Cardiovascular Risk in Teenagers / Práticas Esportivas e Risco Cardiovascular em Adolescentes

Abstract Background: Cardiovascular diseases are the leading cause of deaths in the world, and many events could be prevented by healthy life habits. Objectives: To compare the occurrence of cardiovascular risk factors in adolescents enrolled at public schools in the city of Rio de Janeiro, including a renowned school for sport practices. Methods: Cross-sectional study, convenience sampling of 422 students enrolled at the Experimental Olympic Gymnasium (EOG) and at Figueiredo Pimentel School (FP). Using descriptive analyses, continuous variables were expressed as mean and standard deviation or median and interquartile ranges, and the Student's t-test or the chi-square test, respectively, was used for comparisons. The sports were classified according to the metabolic equivalent of task (MET) (below or above 5). Results: We included 274 students enrolled at the EOG and 148 at FP. Mean age was similar between schools -12.5 ± 1.6 years at FP and 12.6 ± 0.9 at the EOG; 65.5% of the students at FP and 43.8% of the students at the EOG were female (p < 0.01). Significant differences in the prevalence of hypertension (20% vs. 6.3%, p < 0.01) and borderline cholesterol levels (27.7% vs. 17.3%, p = 0.01) were found between FP and EOG students, respectively. Conclusion: High prevalence of hypertension, overweight/obesity and altered blood lipid profile was found in this group of adolescents. Regular sports training program combined with little influence of their eating habits outside school may contribute to a better metabolic profile and reduction in cardiovascular risk factors in students. Public health measures are also need.

Resumo Fundamento: As doenças cardiovasculares são a maior causa de mortes no mundo e muitos eventos poderiam ser evitados por meio de hábitos saudáveis de vida. Objetivos: Comparar a ocorrência de fatores de risco cardiovascular em adolescentes de escolas públicas do município do Rio de Janeiro, sendo uma delas, modelo em práticas esportivas. Métodos: Estudo transversal; amostra de conveniência de 422 escolares do Ginásio Experimental Olímpico (GEO) e da Escola Municipal Figueiredo Pimentel (FP). Foi realizada análise descritiva dos dados utilizando média e desvio-padrão (DP) ou mediana e intervalo interquartil para variáveis contínuas (testes t de Student e qui-quadrado para comparação, respectivamente). As modalidades esportivas foram classificadas de acordo com o equivalente metabólico (MET), se abaixo ou acima de 5. Resultados: duzentos e setenta e quatro alunos eram do GEO e 148 da FP. A média de idade era semelhante - 12,5 ± 1,6 na EMFP e 12,6 ± 0,9 no GEO; 65,5% dos alunos eram do sexo feminino na FP e 43,8% no GEO (p < 0,01). Da amostra geral, 40% apresentaram sobrepeso ou obesidade. Observaram-se diferenças entre a prevalência de hipertensão (20% vs. 6,3%; p < 0,01 nos alunos da FP e do GEO, respectivamente) e de níveis de colesterol total considerados limítrofes (27,7% vs. 17,3%; p = 0,01 na FP e no GEO, respectivamente). Conclusão: Hipertensão, sobrepeso/obesidade e lipidograma capilar alterado foram muito prevalentes nos adolescentes. Um programa de treinamento esportivo regular com menos interferência alimentar extraescola parece contribuir para um melhor perfil metabólico e menor risco cardiovascular entre estudantes. Ainda, medidas efetivas de saúde pública são necessárias.

Sports Practices and Cardiovascular Risk in Teenagers.

BACKGROUND: Cardiovascular diseases are the leading cause of deaths in the world, and many events could be prevented by healthy life habits. OBJECTIVES: To compare the occurrence of cardiovascular risk factors in adolescents enrolled at public schools in the city of Rio de Janeiro, including a renowned school for sport practices. METHODS: Cross-sectional study, convenience sampling of 422 students enrolled at the Experimental Olympic Gymnasium (EOG) and at Figueiredo Pimentel School (FP). Using descriptive analyses, continuous variables were expressed as mean and standard deviation or median and interquartile ranges, and the Student's t-test or the chi-square test, respectively, was used for comparisons. The sports were classified according to the metabolic equivalent of task (MET) (below or above 5). RESULTS: We included 274 students enrolled at the EOG and 148 at FP. Mean age was similar between schools -12.5 ± 1.6 years at FP and 12.6 ± 0.9 at the EOG; 65.5% of the students at FP and 43.8% of the students at the EOG were female (p < 0.01). Significant differences in the prevalence of hypertension (20% vs. 6.3%, p < 0.01) and borderline cholesterol levels (27.7% vs. 17.3%, p = 0.01) were found between FP and EOG students, respectively. CONCLUSION: High prevalence of hypertension, overweight/obesity and altered blood lipid profile was found in this group of adolescents. Regular sports training program combined with little influence of their eating habits outside school may contribute to a better metabolic profile and reduction in cardiovascular risk factors in students. Public health measures are also need.

Cardiovascular effects of SPARK conducted electrical weapon in healthy subjects.

BACKGROUND: The increasing use of conducted electronic weapons (CEW) cause concern regarding its secure application, specially regarding the implications in the cardiovascular system. METHODS: The objective was to determine Spark CEW safety through cardiovascular parameters analysis of healthy volunteers subjected to its use. RESULTS: Volunteers over 18years without cardiovascular disease or recent use of illegal drugs were submitted, before and after being affected with Spark CEW, to clinical evaluation; blood collection for serum laboratory tests; transthoracic electrocardiography at rest, transthoracic echodopplercardiogram and 24hour Holter. RESULTS: All 71 patients reported being incapable of any voluntary reaction during the shock of the application time. No arrhythmia or myocardial necrosis was related to the use of non-lethal weapon SPARK. Reported adverse events were self-limited, and mostly mild. CONCLUSIONS: SPARK brand CEW is effective in incapacitating individuals by the shock of the application time, without causing.

Comparison of thromboprophylaxis patterns in arthroplasty in public and private hospitals / Comparação entre padrões de tromboprofilaxia na artroplastia em hospitais público e privado

Objective To compare therapy for prophylaxis of venous thromboembolism and costs related to hospitalization of patients undergoing total knee and hip replacement within the context of the Brazilian health system.Methods A retrospective study of patients undergoing arthroplasty in 2010 in a public hospital and two private hospitals in the state of São Paulo, conducted by means of medical record review. Costs were estimated based on the use of health care resources during hospitalization. A descriptive analysis was performed using frequency and mean (standard deviation) according to the type of care delivered (by public or private organization).Results A total of 215 patients were evaluated, and 56.3% were submitted to knee surgery and 43.7%, to hip replacement. Approximately 88% and 98% of patients from public and private health services, respectively, received some form of venous thromboembolism prophylaxis, and enoxaparin was the drug most widely used in both systems. The total cost of prophylaxis was R$ 1,873.01 (R$ 26.38 per patient) in the public service and R$ 21,559.73 (R$ 163.33 per patient) in the private service. For the individuals who presented with thromboembolism, the average cost of hospitalization was R$ 6,210.80 and R$ 43,792.59 per patient in public and private health services, respectively.Conclusion Thromboembolism prophylaxis in patients undergoing arthroplasty is most commonly used in the private health services than public organizations, despite its high costs in both services. The cost per patient with thrombosis during hospitalization was higher than the total cost of prophylaxis, suggesting that prevention is associated to better cost-benefit ratio.

Objetivo Comparar a terapia para profilaxia de tromboembolismo venoso e os custos de pacientes submetidos à artroplastia total de joelho e de quadril dentro do sistema de saúde brasileiro.Métodos Estudo retrospectivo com pacientes submetidos à artroplastia no ano de 2010, em um hospital público e dois hospitais privados no Estado de São Paulo, por meio da revisão de prontuários. Os custos foram estimados com base na utilização de recursos em saúde durante a hospitalização. Análise descritiva de frequência e média (desvio padrão), de acordo com o tipo de atendimento em saúde (público ou privado).Resultados Um total de 215 pacientes foram avaliados, sendo 56,3% submetidos à cirurgia de joelho e 43,7% à cirurgia de quadril. Cerca de 88% e 98% dos pacientes provenientes do serviço público e privado de saúde, respectivamente, receberam algum tipo de profilaxia para tromboembolismo, sendo a enoxaparina o medicamento mais utilizado em ambos sistemas. O custo total da profilaxia foi de R$ 1.873,01 (R$ 26,38 por paciente) no serviço público e R$ 21.559,73 (R$ 163,33 por paciente) no serviço privado. Para os indivíduos com tromboembolismo, o custo médio da internação foi de R$ 6.210,80 e R$ 43.792,59 por paciente atendido nos serviços de saúde público e privado, respectivamente.Conclusão A profilaxia em pacientes submetidos à artroplastia é mais utilizada em pacientes do serviço de saúde privado do que público, apesar dos altos custos em ambos os serviços. Os pacientes com tromboembolismo tiveram um custo maior do que aqueles apenas com profilaxia, mostrando que a prevenção está associada a um maior custo-benefício.

Comparison of thromboprophylaxis patterns in arthroplasty in public and private hospitals.

OBJECTIVE: To compare therapy for prophylaxis of venous thromboembolism and costs related to hospitalization of patients undergoing total knee and hip replacement within the context of the Brazilian health system. METHODS: A retrospective study of patients undergoing arthroplasty in 2010 in a public hospital and two private hospitals in the state of São Paulo, conducted by means of medical record review. Costs were estimated based on the use of health care resources during hospitalization. A descriptive analysis was performed using frequency and mean (standard deviation) according to the type of care delivered (by public or private organization). RESULTS: A total of 215 patients were evaluated, and 56.3% were submitted to knee surgery and 43.7%, to hip replacement. Approximately 88% and 98% of patients from public and private health services, respectively, received some form of venous thromboembolism prophylaxis, and enoxaparin was the drug most widely used in both systems. The total cost of prophylaxis was R$ 1,873.01 (R$ 26.38 per patient) in the public service and R$ 21,559.73 (R$ 163.33 per patient) in the private service. For the individuals who presented with thromboembolism, the average cost of hospitalization was R$ 6,210.80 and R$ 43,792.59 per patient in public and private health services, respectively. CONCLUSION: Thromboembolism prophylaxis in patients undergoing arthroplasty is most commonly used in the private health services than public organizations, despite its high costs in both services. The cost per patient with thrombosis during hospitalization was higher than the total cost of prophylaxis, suggesting that prevention is associated to better cost-benefit ratio.

Time from symptom onset to the initiation of treatment of pulmonary tuberculosis in a city with a high incidence of the disease.

OBJECTIVE: To estimate the time elapsed between the onset of symptoms and the initiation of treatment of pulmonary tuberculosis among treatment-naïve patients with positive results in sputum smear microscopy, and to evaluate the variables associated with delays in diagnosis and in treatment initiation. METHODS: This was a descriptive exploratory study involving 199 treatment-naïve tuberculosis patients > 12 years of age with AFB-positive sputum smear microscopy results between 2006 and 2008. At their first (treatment initiation) visit to a primary health care clinic in the city of Nova Iguaçu, Brazil, the patients were interviewed and their ancillary test results were reviewed. RESULTS: The medians (and respective interquartile ranges) of the time from symptom onset to the initiation of treatment of pulmonary tuberculosis, from symptom onset to seeking medical attention, from entry into care to diagnosis, and from entry into care to treatment initiation, in weeks, were 11 (6-24), 8 (4-20), 2 (1-8), and 1 (1-1), respectively. The variables gender, age, level of education, previous use of antibiotics, HIV status, site of first medical visit, and radiological extent of tuberculosis showed no associations with the time from entry into care to diagnosis and to treatment initiation. The main reason for the delay in seeking medical attention reported by the patients was their inability to recognize their symptoms as indicators of a disease. CONCLUSIONS: Among the patients studied, there was an unacceptably long delay between the onset of symptoms and the initiation of tuberculosis treatment.

Tempo entre o início dos sintomas e o tratamento de tuberculose pulmonar em um município com elevada incidência da doença / Time from symptom onset to the initiation of treatment of pulmonary tuberculosis in a city with a high incidence of the disease

OBJETIVO: Estimar o tempo entre o início dos sintomas e o início do tratamento de pacientes com tuberculose pulmonar virgens de tratamento e com resultado positivo na baciloscopia direta do escarro, assim como avaliar as variáveis associadas à demora no diagnóstico e no início do tratamento. MÉTODOS: Estudo descritivo exploratório em pacientes virgens de tratamento para tuberculose, com idade > 12 anos e resultado positivo para BAAR no escarro. Entre 2006 e 2008, os 199 pacientes incluídos no estudo foram entrevistados, e seus exames complementares foram revisados no momento da consulta para o início de tratamento para tuberculose em uma unidade básica de saúde no município de Nova Iguaçu (RJ). RESULTADOS: As medianas (e seus respectivos intervalos interquartílicos) para o tempo entre o início dos sintomas e o início do tratamento, o tempo até a procura por atendimento médico, o tempo até o diagnóstico e o tempo até o início do tratamento, em semanas, foram, respectivamente, 11 (6-24), 8 (4-20), 2 (1-8) e 1 (1-1).As variáveis gênero, idade, escolaridade, uso prévio de antibióticos, status HIV, local da primeira consulta médica e extensão radiológica da doença não se associaram ao tempo até o diagnóstico ou ao tempo até o início do tratamento. A principal razão para a demora dos pacientes em procurar o serviço de saúde foi sua dificuldade em reconhecer seus sintomas como indicativos de doença. CONCLUSÕES: Os tempos até o diagnóstico e até o início do tratamento para tuberculose foram inaceitavelmente longos na amostra estudada.

OBJECTIVE: To estimate the time elapsed between the onset of symptoms and the initiation of treatment of pulmonary tuberculosis among treatment-naïve patients with positive results in sputum smear microscopy, and to evaluate the variables associated with delays in diagnosis and in treatment initiation. METHODS: This was a descriptive exploratory study involving 199 treatment-naïve tuberculosis patients > 12 years of age with AFB-positive sputum smear microscopy results between 2006 and 2008. At their first (treatment initiation) visit to a primary health care clinic in the city of Nova Iguaçu, Brazil, the patients were interviewed and their ancillary test results were reviewed. RESULTS: The medians (and respective interquartile ranges) of the time from symptom onset to the initiation of treatment of pulmonary tuberculosis, from symptom onset to seeking medical attention, from entry into care to diagnosis, and from entry into care to treatment initiation, in weeks, were 11 (6-24), 8 (4-20), 2 (1-8), and 1 (1-1), respectively. The variables gender, age, level of education, previous use of antibiotics, HIV status, site of first medical visit, and radiological extent of tuberculosis showed no associations with the time from entry into care to diagnosis and to treatment initiation. The main reason for the delay in seeking medical attention reported by the patients was their inability to recognize their symptoms as indicators of a disease. CONCLUSIONS: Among the patients studied, there was an unacceptably long delay between the onset of symptoms and the initiation of tuberculosis treatment.

III Brazilian Thoracic Association Guidelines on tuberculosis.

New scientific articles about tuberculosis (TB) are published daily worldwide. However, it is difficult for health care workers, overloaded with work, to stay abreast of the latest research findings and to discern which information can and should be used in their daily practice on assisting TB patients. The purpose of the III Brazilian Thoracic Association (BTA) Guidelines on TB is to critically review the most recent national and international scientific information on TB, presenting an updated text with the most current and useful tools against TB to health care workers in our country. The III BTA Guidelines on TB have been developed by the BTA Committee on TB and the TB Work Group, based on the text of the II BTA Guidelines on TB (2004). We reviewed the following databases: LILACS (SciELO) and PubMed (Medline). The level of evidence of the cited articles was determined, and 24 recommendations on TB have been evaluated, discussed by all of the members of the BTA Committee on TB and of the TB Work Group, and highlighted. The first version of the present Guidelines was posted on the BTA website and was available for public consultation for three weeks. Comments and critiques were evaluated. The level of scientific evidence of each reference was evaluated before its acceptance for use in the final text.