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INTRODUCTION: Incidence and mortality for bladder cancer has changed very little over the past 20 years. Approximately 40% of patients with high-risk nonmuscle invasive bladder cancer eventually recur/progress. It is important to understand the economic impact of disease recurrence/progression in bladder cancer. Our aim was to estimate and understand the direct costs associated with the treatment of bladder cancer from the payer's perspective in the USA, in the year of 2021, including costs for both newly diagnosed bladder cancer (stages 0a-IV) and recurrent patients. METHODS: An economic model was constructed to calculate the number of patients receiving each treatment modality at every stage of disease and their respective costs. Epidemiological data were based on the CancerMPact Patient Metrics (PM) database and treatment modality data retrieved from CMP Treatment Architecture (TA), 2021 version. Resource utilization and costs were obtained from medical literature and public data sources. Only direct costs were considered. RESULTS: There were an estimated 83,532 newly diagnosed patients with bladder cancer of all stages in 2021 with a projected total cost of treatment of ~$2.6 billion. Average cost per newly diagnosed patient varied from $19,521 (stage 0a) to $169,533 (metastatic disease). Cost profile differed substantially among the stages of disease. For the 75,760 patients that were expected to have a recurrence in 2021, an additional cost of ~$3.9 billion was estimated at an average cost per patient of $52,179. The expected total cost to treat newly diagnosed and newly recurrent patients is reported in this model, with the total cost in 2021 estimated to exceed $6.5 billion. CONCLUSIONS: Treatment and resource costs increase for bladder cancer as the disease recurs/progresses. More effective treatments that can delay recurrence/progression may reduce the economic burden associated with bladder cancer.
The costs of treating bladder cancer in the USA are high, expected to have exceeded $6.5 billion in the year 2021. The average cost for newly diagnosed patients ranges from $19,521 for the earliest stage of disease to $169,533 for metastatic disease. Average costs per patient increase upon disease recurrence and more effective initial treatments to delay disease recurrence or progression may reduce the costs associated with bladder cancer.
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Aim: To report the treatment patterns of advanced/metastatic non-small-cell lung cancer (NSCLC) in China from a physician survey (CancerMPact®). Materials & methods: A total of 206 Chinese physicians from 27 cities in urban mainland China reported on their treatment of NSCLC in September 2021. Results: Platinum doublets received 70.5% utilization for squamous NSCLC with PD-L1 expression <1% in first-line, whereas nonsquamous NSCLC was treated with platinum doublets (35.2%) or bevacizumab with platinum doublets (35.3%). Checkpoint inhibitors were utilized in >50% of all PD-L1-positive NSCLC cases. Driver-mutated NSCLC was most frequently treated with targeted therapy or platinum-based combinations. Conclusion: NSCLC treatment in China varies by histology, PD-L1 status and driver mutations, illustrating the complexity of decision-making for Chinese physicians as treatment markets expand.
The most common type of lung cancer is called non-small-cell lung cancer (NSCLC). When lung cancer spreads beyond the lung, it is called advanced. Doctors in China who treat advanced NSCLC were identified. They were surveyed in September 2021 and asked about how they treat their patients. The survey included 206 doctors from 27 cities in China. There are many drugs available for NSCLC. This means that it can be hard for doctors to decide how to treat their patients. The doctors in China often reported using multiple drugs together, instead of using only one drug. One type of drug that can be used to treat NSCLC is called a checkpoint inhibitor (CPI). The doctors reported that they often used CPIs to treat their patients. They also reported that they were more likely to use CPIs made in China rather than CPIs that were made outside of China. Before receiving treatment, most patients were tested for biomarkers. Biomarkers can tell doctors important information about cancers. Doctors can use biomarkers to help decide which treatments to offer their patients. In China, the doctors often did use certain drugs based on patient biomarkers. This choice often depended on the specific biomarker that the patient had. There are many different factors for doctors to consider when treating NSCLC. More and more drugs are becoming available to use in China. While this is good news for patients with cancer, treatment decisions are becoming more complex for doctors.
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Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Padrões de Prática Médica , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/genética , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/terapia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/terapia , China/epidemiologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Masculino , Feminino , Inquéritos e Questionários , Inibidores de Checkpoint Imunológico/uso terapêutico , Pessoa de Meia-Idade , Mutação , Antígeno B7-H1/antagonistas & inibidores , Bevacizumab/uso terapêuticoRESUMO
Aim: To assess physician-reported treatment of metastatic bladder cancer in Japan. Methods: 76 physicians completed the CancerMPact® survey in July 2020, considering patients treated within 6 months. Results: Physicians treated a mean of 38.1 patients per month. Of cisplatin-eligible and -ineligible patients, 97.6 and 89.3%, respectively, received first-line platinum-based therapy, most commonly cisplatin plus gemcitabine (72.9%) and carboplatin plus gemcitabine (59.7%). 1.6 and 5.6% received first-line immune checkpoint inhibitors, respectively. 48.4 and 45.0%, respectively, progressed and received second-line therapy, most commonly with pembrolizumab (61.7%). Conclusion: In 2020, most patients with metastatic bladder cancer in Japan received first-line platinum-based chemotherapy; however, >50% received no subsequent treatment, highlighting the need for new treatment regimens to improve outcomes and maximize first-line treatment benefits.
In 2020, researchers surveyed 76 Japanese doctors who specialized in bladder and urinary system disorders about how they treated people with bladder cancer. Cisplatin, a type of chemotherapy drug, was the most common first treatment. For people who were unable to receive cisplatin, doctors often prescribed a similar chemotherapy drug called carboplatin. Just under half of the people received a second treatment for their cancer. New treatments are now available for bladder cancer, including the immunotherapy drug avelumab, which is given to people whose cancer stops growing or shrinks with their first chemotherapy treatment. More research is needed to better understand how bladder cancer is treated in Japan, including how new treatments are used.
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Carcinoma de Células de Transição , Neoplasias da Bexiga Urinária , Humanos , Cisplatino , Gencitabina , Japão/epidemiologia , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/epidemiologia , Carboplatina/uso terapêutico , Desoxicitidina , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma de Células de Transição/patologiaRESUMO
Objetivo: Analisar a influência da pandemia da COVID-19 na execução dos exames de rastreamento e diagnóstico dos cânceres de próstata, mama e colo uterino na população brasileira. Métodos: Estudo analítico transversal e quantitativo com levantamento do número desses exames realizados pelo SUS (Sistema Único de Saúde). Os dados foram extraídos do Datasus nos períodos de pré-pandemia (março/2019 a fevereiro/2020) e pandemia (março/2020 a fevereiro/2021). Foram extraídos os números de exames realizados mês a mês e comparados os períodos pré-pandemia com o de pandemia. Foi realizada uma análise estatística descritiva, e as médias mensais de exames realizados nos dois períodos foram comparadas usando o teste t de Student. Resultados: Na comparação entre os períodos pré-pandemia e de pandemia, houve diminuição de média de 45,2% no número de exames citopatológicos, (194.978 exames por mês a menos; p < 0,00001), de 44,4% nos exames de mamografia (142.015 mamografias a menos por mês; p < 0,00001) e de 24,4% nos exames de antígeno prostático específico (PSA) (148.815 exames a menos por mês; p = 0,0012). Conclusão: A influência da pandemia gerou uma diminuição considerável no número de exames de rastreamento, mamografia, dosagem de PSA e citopatológico, o que deverá se traduzir em aumento nos casos de doença avançada, com graves consequências negativas para os pacientes e para o sistema de saúde.
Objective: To analyze the impact of COVID-19 pandemic on the number of screening and diagnostic cancer tests performed for prostate, breast and cervical cancer in the Brazilian population. Methods: This was a transversal analytical and quantitative study on the number of screening and diagnostic cancer tests performed in the public Brazilian health care system SUS (Sistema Único de Saúde). Data were collected from the Datasus (online SUS database) during pre-pandemic (March/2019 to February/2020) and pandemic periods (March/2020 to February/2021). We obtained the number of tests performed monthly for each of the tests and compared the two periods. Descriptive statistics were employed and the monthly average number of tests performed in each period were compared using the T Student test. Results: Comparing the pre-pandemic levels with pandemic levels, we found that there was a 45.2% decrease in the number of Papanicolaou (PAP smear) tests (194,978 less exams per month, p < 0,00001), 44.4% decrease in mammograms (142,015 less tests per month, p < 0,00001), and a reduction of 24.4% in the number of prostate specific antigen (PSA) tests per month (minus 148,815 exams performed, p < 0.0012). Conclusion: There was a statistically significant reduction in the number of screening/diagnostic mammograms, PAP smears and PSA performed during the pandemic period, compared to the period before COVID-19. This reduction may result in an increase in the number of cases diagnosed at an advanced stage, with grave consequences for the patients and for the sustainability of the healthcare system.
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Neoplasias da Próstata , Neoplasias da Mama , Neoplasias do Colo do Útero , COVID-19RESUMO
Objetivo: Realizar avaliação econômica de lipegfilgrastim, fator de crescimento de longa duração (G-CSF), com os demais medicamentos da classe terapêutica disponíveis para a diminuição da duração da neutropenia grave (NG) e da incidência de neutropenia febril (NF), em pacientes adultos tratados com quimioterapia citotóxica para neoplasias malignas. Métodos: Revisão sistemática da literatura de evidências científicas sobre a eficácia e a segurança de lipegfilgrastim e análise de custo-minimização em comparação com pegfilgrastim ou filgrastim sob a perspectiva do Sistema Suplementar no Brasil. A análise incluiu tempo de tratamento de estudos clínicos, custo de infusão/ honorários médicos e custo com aquisição de medicamentos, distribuídos em três perspectivas: cenário 1 (conservador), cenário 2 (moderado) e cenário 3 (mundo real). Resultados: Seis estudos foram incluídos na análise, sendo três estudos randomizados e três revisões sistemáticas. O lipegfilgrastim resultou numa duração média de NG significativamente menor ao placebo e não inferior ao pegfilgrastim. Um estudo que comparou indiretamente lipegfilgrastim com filgrastim não encontrou diferenças estatisticamente significativas em redução de duração de NG e incidência de NF. O lipegfilgrastim apresentou redução de custos diretos de -R$ 3.673,50/paciente comparado com pegfilgrastim em todos os cenários avaliados e, na comparação com filgrastim, observou-se redução de -R$ 57.403,40; -R$ 19.183,67 e de -R$ 42,50/paciente nos cenários 1, 2 e 3, respectivamente. Conclusões: Lipegfilgrastim apresentou perfil de custo-minimização favorável em comparação com pegfilgrastim ou filgrastim, e surge como uma importante alternativa para o tratamento da redução da duração da neutropenia e da incidência da neutropenia febril durante a realização de tratamento quimioterápico, que pode representar economia de recursos para o Sistema de Saúde Suplementar.
jective: To develop an economic evaluation of lipegfilgrastin, long acting G-CSF, compared to other available G-CSF to reduce the duration of severe neutropenia (SN) and the incidence of febrile neutropenia (FN) in adult patients treated with cytotoxic chemotherapy for cancer in the Brazilian private Health System. Methods: Systematic literature review of scientific evidence evaluating the efficacy and safety of lipegfilgrastin and cost-minimization analysis comparing to pegfilgrastin or filgrastin in the Brazilian private Health System. The analysis includes time of treatment with filgrastin from clinical trials (scenario 1) or real world data (scenario 2 and 3) and considers direct medical costs. Results: Six studies were included in the analysis: three randomized controlled trials and three systematic reviews. Lipegfilgrastin resulted in a statistically significant reduction of median SN duration compared to placebo and non-inferior compared to pegfilgrastin. A study that performed an indirect comparison of lipegfilgrastin and filgrastin did not find any difference statistically significant reduction of SN duration and FN incidence. Lipefilgrastin resulted in a cost-difference of -R$ 3.673,50/patient compared to pegfilgrastin in all scenarios and -R$ 57.403,40; -R$ 19.183,67 and -R$ 42,50/patient compared to filgrastin in scenario 1, 2 and 3 respectively. Conclusions: Lipegfilgrastim showed a favorable cost-minimization profile compared to pegfilgrastin or filgrastin and is an important alternative treatment in reducing the duration of neutropenia and the incidence of febrile neutropenia during the course of chemotherapy, and may result in resource savings for the Brazilian Private Health System.
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Humanos , Fator Estimulador de Colônias de Granulócitos , Tratamento Farmacológico , Neutropenia FebrilRESUMO
Objectives At present there are several drugs for the treatment of advanced renal cell carcinoma (ARCC). The main objective of this work was to perform a systematic review (SR) and meta-analysis (MA) of clinical randomized studies that compared target cell therapies (TCT). Materials and Methods SR identified clinical randomized trials that compared TCT versus interferon-alpha in the treatment of patients with ARCC. In order to analyze efficiency, it was evaluated free-survival progression (FSP), total survival (TS) and response rate (RR). Results In relation to first line treatment, seven studies of TCT were identified using sunitinib, sorafenib, bevacizumab and temsirolimus; and two studies with sorafenib and everolimus for second line treatment. Relative risk (RRi) of MA for FSP of first line therapies was: 0.83, CI = 0.78-0.87, I2 = 94% and p < 0.00001. Best results of RR of specific FSP among studies were: 0.38, sunitinib, CI = 0.25-0.58, bevacizumab, 0.62, CI = 0.47-0.83; and temsirolimus, 0.78, CI = 0.70-0.87. MA didn't show any benefit regarding TS of first line treatment of all analyzed drugs. As for RR significant results were: sunitinib, 3.83 CI = 2.86-5.12; bevacizumab, 2.52 CI = 1.78-3.57 and bevacizumab, 1.97 CI = 1.43-2.71. Conclusions: For first line treatment, sunitinib was the most effective TCT in relation to FPS; there was no alteration of TS and RR was small but significant for sunitinib and bevacizumab. Available studies could not conclude any results for second line treatments. .
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Feminino , Humanos , Masculino , Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Neoplasias Renais/tratamento farmacológico , Terapia de Alvo Molecular/métodos , Carcinoma de Células Renais/mortalidade , Carcinoma de Células Renais/secundário , Progressão da Doença , Neoplasias Renais/mortalidade , Metástase Neoplásica , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida , Resultado do TratamentoRESUMO
Context Unspecified Ulcerative Rectocolitis is a chronic disease that affects between 0.5 and 24.5/105 inhabitants in the world. National and international clinical guidelines recommend the use of aminosalicylates (including mesalazine) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis, and recommend the maintenance of these agents after remission is achieved. However, multiple daily doses required for the maintenance of disease remission compromise compliance with treatment, which is very low (between 45% and 65%). Use of mesalazina in granules (2 g sachet) once daily - Pentasa® sachets 2 g - can enhance treatment adherence, reflecting in an improvement in patients' outcomes. Objective To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day. From an economic standpoint, to analyze the impact of the adoption of this dosage in Brazil's public health system, considering patients' adherence to treatment. Methods A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis, published by the Ministry of Health in the lobby SAS/MS n° 861 of November 4 th, 2002 and on the algorithms published by the Associação Brasileira de Colite Ulcerativa e Doença de Crohn, aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets. Results The use of mesalazine increases the chances of remission induction and maintenance when compared to placebo, and higher doses are associated with greater chance of success without increasing the risk of adverse events. Conclusion The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens, ...
Contexto A retocolite ulcerativa inespecífica é uma doença crônica que atinge entre 0,5 e 24,5/105 habitantes no mundo. Diretrizes clínicas nacionais e internacionais recomendam o emprego de aminosalicilatos (entre eles, a mesalazina) como terapia de primeira linha na indução da remissão da retocolite ulcerativa inespecífica, com manutenção destes agentes após a remissão. Mas as múltiplas doses diárias necessárias comprometem a adesão ao tratamento, que é muito baixa (entre 45% e 65%). A utilização de mesalazina em grânulos (sachê 2 g) dose única diária - Pentasa® sachê 2 g - pode aumentar a aderência ao tratamento, refletindo numa melhora nos desfechos dos pacientes. Objetivo Avaliar as evidências sobre o uso de mesalazina para a manutenção da remissão em pacientes com retocolite ulcerativa inespecífica e sua eficácia quando tomada uma vez versus mais de uma vez ao dia. Do ponto de vista econômico, avaliar o impacto que a adoção desta posologia teria para o sistema público de saúde do país, comparada ao tratamento padrão atual, considerando a adesão dos pacientes. Métodos Foi elaborada uma árvore de decisão construída a partir do Protocolo Clínico e Diretrizes Terapêuticas de Colite Ulcerativa, publicado pelo Ministério da Saúde na portaria SAS/MS n° 861, de 04 de novembro de 2002, e de algoritmos publicados pela Associação Brasileira de Colite Ulcerativa e Doença de Crohn, objetivando-se obter o custo-efetividade da mesalazina dose única diária em grânulos comparado com mesalazina duas vezes ao dia em comprimidos. Resultados O emprego de mesalazina aumenta as chances de indução da remissão e sua manutenção, quando comparado a ...
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Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anti-Inflamatórios não Esteroides/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Árvores de Decisões , Mesalamina/administração & dosagem , Anti-Inflamatórios não Esteroides/economia , Análise Custo-Benefício , Mesalamina/economia , Cooperação do Paciente , Projetos Piloto , Estudos Prospectivos , Resultado do TratamentoRESUMO
Evidence-based techniques have been increasingly used in the creation of clinical guidelines and the development of recommendations for medical practice. The use of levels of evidence allows the reader to identify the quality of scientific information that supports the recommendations made by experts. The objective of this review was to address current concepts related to the clinical impact, diagnosis, and treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. For the preparation of this review, the authors defined a group of questions that would be answered in accordance with the principles of PICO–an acronym based on questions regarding the Patients of interest, Intervention being studied, Comparison of the intervention, and Outcome of interest. For each question, a structured review of the literature was performed using the Medline database in order to identify the studies with the methodological design most appropriate to answering the question. The questions were designed so that each of the authors could write a response. A first draft was prepared and discussed by the group. Recommendations were then made on the basis of the level of scientific evidence, in accordance with the classification system devised by the Oxford Centre for Evidence-Based Medicine, as well as the level of agreement among the members of the group. .
As técnicas de medicina baseada em evidências são cada vez mais utilizadas para a construção de diretrizes clínicas e recomendações para a prática médica. O uso de níveis de evidências permite que o leitor identifique a qualidade da informação científica que sustenta as recomendações feitas pelos especialistas. Esta revisão teve por objetivo abordar conceitos atuais sobre o impacto clínico, diagnóstico e tratamento das infecções por Pseudomonas aeruginosa em pacientes com fibrose cística. Para a elaboração desta revisão, o grupo de autores definiu as perguntas que seriam respondidas, seguindo os preceitos de PICO, acrônimo baseado em perguntas referentes aos Pacientes de interesse, Intervenção a ser estudada, Comparação da intervenção e Outcome (desfecho) de interesse. Para cada pergunta, uma revisão estruturada da literatura foi realizada nas bases de dados do Medline, buscando identificar os estudos com desenho metodológico mais adequado para responder à questão. As perguntas foram designadas para que cada um dos autores redigisse uma resposta, e um primeiro rascunho foi elaborado e discutido pelo grupo em uma reunião presencial. Após essa discussão, recomendações foram emitidas com base na força das evidências e na concordância entre os membros do grupo segundo o sistema de classificação do Oxford Centre for Evidence Based Medicine. .
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Humanos , Fibrose Cística/microbiologia , Pseudomonas aeruginosa , Infecções por Pseudomonas/diagnóstico , Infecções por Pseudomonas/tratamento farmacológico , Medicina Baseada em Evidências , PrognósticoRESUMO
A correção cirúrgica de algumas cardiopatias congênitas complexas envolve a reconstrução da via de saída do ventrículo direito com a interposição de homoenxertos, biopróteses, enxertos de jugular bovina ou outros condutos valvulados entre o ventrículo direito e o tronco da artéria pulmonar. Apesar de essas cirurgias poderem ser realizadas com baixa mortalidade, a vida útil das válvulas ou dos condutos implantados é normalmente pequena (< 10 anos), seja por degeneração e/ou calcificação. Graus variáveis de estenose pulmonar na maioria das vezes associada a insuficiência pulmonar são consequências da degeneração dos condutos. Em 2000, Bonhoeffer et al. foram os primeiros a relatar o implante transcateter de bioprótese valvular pulmonar (ITVP) com um dispositivo que posteriormente foi denominado de válvula Melody® (Medtronic, Minneapolis, Estados Unidos). A técnica foi inicialmente desenvolvida para limitar a necessidade de múltiplos procedimentos cirúrgicos, substituindo, em última análise, uma nova troca cirúrgica valvular. Estudos subsequentes na Europa e Estados Unidos atestaram para a segurança e eficácia dessa técnica em um número maior de pacientes. Como a Agência Nacional de Vigilância Sanitária (Anvisa) concedeu a aprovação para o uso clínico da válvula biológica pulmonar transcateter Melody® em fevereiro de 2013, consideramos necessária e oportuna a avaliação judiciosa da utilização dessa nova tecnologia antes que ela fosse aplicada em larga escala em nosso país. O objetivo deste estudo foi realizar uma revisão sistemática da literatura sobre o ITVP em pacientes com disfunções de homoenxertos, condutos valvulados e biopróteses implantados cirurgicamente na via de saída do ventrículo direito.
Surgical repair of some complex congenital heart diseases involves reconstruction of the right ventricular outflow tract using homografts, bioprostheses, bovine jugular grafts or other valved conduits between the right ventricle and the main pulmonary artery. Although these surgical procedures may be performed with low mortality rates, the life span of these implanted valves or conduits is usually short (< 10 years) due to either degeneration and/or calcification. Variable degrees of pulmonary stenosis, often associated with pulmonary insufficiency, are consequences of conduit degeneration. In 2000, Bonhoeffer et al. were the first to report the transcatheter pulmonary valve implantation (TPVI) of a bioprosthetic pulmonary valve later named Melody® valve (Medtronic, Minneapolis, USA). The technique was initially developed to limit the need for multiple surgical procedures, and, ultimately, to work as a surrogate of a new surgical valve replacement. Subsequent clinical studies in Europe and the United States confirmed the safety and efficacy of this technique in a larger number of patients. Since the National Sanitary Surveillance Agency (Agência Nacional de Vigilância Sanitária - Anvisa) granted approval for clinical use of the Melody® transcatheter pulmonary biological valve in February 2103, we deemed that a judicious assessment of this new technology was timely and necessary before the widespread use in our country. The objective of this study was to perform a systematic literature review on the use of TPVI in patients with dysfunctional homografts, valved conduits and bioprostheses implanted surgically in the right ventricular outflow tract.
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Humanos , Cateterismo Cardíaco/métodos , Próteses e Implantes , Próteses Valvulares Cardíacas , Valva Pulmonar/cirurgia , Cardiopatias Congênitas/cirurgia , Literatura de Revisão como AssuntoRESUMO
INTRODUÇÃO: O implante por cateter de bioprótese valvular aórtica (TAVI, do inglês transcatheter aortic valve implantation) constitui nova modalidade de tratamento destinada, sobretudo, aos pacientes com elevado risco cirúrgico. Para esses pacientes, o TAVI resultou em aumento da sobrevivência e melhora da qualidade de vida, comparativamente ao tratamento padrão (medicamentoso, com ou sem valvuloplastia aórtica percutânea). Nosso objetivo foi realizar análise de custo-efetividade da implementação do TAVI no Sistema de Saúde Suplementar brasileiro. MÉTODOS: Foram desenvolvidos um modelo preditivo, para avaliar custo-efetividade real do procedimento em longo prazo, e uma regressão de Weibull com tempo horizonte de 5 e 10 anos, para estimar dados de sobrevida por mais de 24 meses. Adicionalmente, foi desenvolvido modelo de Markov sequencial e determinístico. Resultados foram expressos como razão de custo-efetividade incremental (RCEI) por anos de vida ganhos e anos de vida livres de progressão. RESULTADOS: Para o cenário padrão, no qual o custo da TAVI foi estipulado em R$ 65 mil, o valor da RCEI (custo/ano de vida salvo) em 5 anos foi de R$ 72.520,65. Alterando-se o tempo horizonte para 10 anos, esse valor diminuiu para R$ 41.653,01. CONCLUSÕES: O modelo apontou que o TAVI apresenta efetividade superior e maior custo incremental. Além disso, a incorporação do TAVI no Rol de Procedimentos e Eventos em Saúde da Agência Nacional de Saúde Suplementar acarretaria impacto orçamentário incremental nos próximos 5 anos, variando de R$ 70 milhões a R$ 121 milhões, compatível com o de outras tecnologias já incorporadas no âmbito da Saúde Suplementar.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a new modality of treatment especially dedicated to patients with high surgical risk. In these patients, TAVI increased survival and improved quality of life when compared to standard treatment (drug therapy with or without percutaneous aortic balloon valvuloplasty). Our objective was to perform a cost-efficacy analysis of the implementation of TAVI in the Brazilian Supplemental Health System. METHODS: We developed a predictive model to assess the cost-effectiveness of the procedure in the long-term, and a Weibull regression analysis with a time horizon of 5 and 10 years, to estimate survival data for over 24 months. In addition, a deterministic sequential Markov model was developed. Results were expressed as incremental cost-effectiveness ratio (ICER) per years of life saved and progression-free years of life. RESULTS: In a standard scenario, where the cost of TAVI was estimated as R$ 65 millions, the ICER value (cost/year of life saved) in 5 years was R$ 72,520.65. When the time horizon was adjusted for 10 years, this amount decreased to R$ 41,653.01. CONCLUSIONS: The model indicated that TAVI has superior effectiveness and higher incremental cost. Furthermore, the incorporation of TAVI in the List of Health Procedures and Events of the Brazilian Supplemental Health System would have an incremental budgetary impact over the next 5 years, ranging from R$ 70 millions to R$ 121 millions, consistent with other technologies which have already been incorporated by the system.
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Bioprótese , Catéteres , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Implante de Prótese de Valva Cardíaca/instrumentação , Análise Custo-Benefício/economia , Fatores de Risco , Saúde Suplementar/economiaRESUMO
INTRODUCTION: Myelodysplastic syndrome is an incurable and rare hematological disease that affects the production of blood cells. One aim of treatment is to maintain the blood-cell count to near-normal levels. This is mainly achieved with hematopoietic- growth factors and transfusions. Our objective was to determine the cost of supportive treatment/care for patients with low and intermediate I risk myelodysplastic syndrome in respect to private healthcare plans in Brazil. METHOD: We adapted the National Comprehensive Cancer Network treatment guidelines for intermediate risk myelodysplastic syndrome patients to the Brazilian reality, adopting a decision tree to explore treatment combinations. Then, we calculated the costs for each branch of the tree, according to national prices. We also estimated total costs for a cohort of 100 patients, distributed across treatment combinations according to the expected epidemiology. We assumed a horizon of one year of treatment. RESULTS: The mean cost of treatment for low and intermediate I risk myelodysplastic syndrome is US$ 42,758/patient/year. This cost can vary from US$ 24,282 to US$ 121,952, according to patient characteristics and the treatment used. Overall, patients that require immunotherapy with antithymocyte globulins are associated with the highest cost. Those that achieve disease stability solely with the use of erythropoietin were associated with the lowest cost. CONCLUSION: In Brazil, treatment of low and intermediate I risk myelodysplastic syndrome is associated with a mean cost of the order of US$ 42,700/patient/year. New types of therapy have the potential to change this scenario if they can diminish the requirements for supportive care.
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Humanos , Efeitos Psicossociais da Doença , Neoplasias Hematológicas , NeoplasiasRESUMO
PURPOSE: In Brazil, National data regarding the epidemiology of renal cell carcinoma (RCC) are scarce. The aim of this study was to describe the demographic, clinical, and pathologic characteristics of RCC diagnosed and treated by members of the SBU - Brazilian Society of Urology. MATERIALS AND METHODS: For this cross-sectional study, data were collected through an on line questionnaire available to the members of the Brazilian Society of Urology (SBU). Between May 2007 and May 2008, voluntary participant urologists collected data on demographic, clinical and pathological characteristics from patients diagnosed with RCC in their practice. RESULTS: Fifty SBU affiliated institutions contributed with patient information to the study. Of the 508 patients, 58.9 percent were male, 78.9 percent were white, and the mean age was 59.8 years. Smoking history, high blood pressure and a body mass index above 30 kg/m2 were present in 14.8 percent, 46.1 percent and 17.9 percent of the patients, respectively. Abdominal ultrasound and computed tomography were the main diagnostic methods. The majority of the cases were localized tumors and metastasis were presented in 9.5 percent of the patients; 98.4 percent underwent nephrectomy. Clear cell carcinoma was the most common histological type. In comparison with private institutions, stage IV disease was less frequent among patients treated at public health services (P = 0.033). CONCLUSIONS: RCC in Brazil is more common in white men in their sixth decade of life. Ultrasound is the main diagnostic tool for the diagnosis of clear cell carcinoma and we found that localized disease was predominant. A national registry of RCC is feasible and may provide valuable information.
Assuntos
Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Carcinoma de Células Renais/epidemiologia , Neoplasias Renais/epidemiologia , Distribuição por Idade , Brasil/epidemiologia , Estudos Transversais , Demografia , Fatores de Risco , Distribuição por SexoRESUMO
Introdução: Massas adrenais clinicamente silenciosas, diagnosticadas sem intenção, incidentalmente, durante exame de imagem realizado para outras condições clínicas ("incidentaloma") têm sido cada vez mais encontradas devido ao constante progresso dos métodos de imagem e de sua indicação relativamente elástica. São inúmeras as causas, diagnósticos e tratamentos dessas massas, levando o médico a definir se a massa é hormonalmente ativa e se há risco de a lesão ser maligna. Entretanto os métodos para esclarecimento dessas questões ainda não estão bem definidos. Objetivo: Avaliar as melhores formas de diagnóstico, tratamento e seguimento da lesão incidental de adrenal. Método: Foi realizada uma revisão sistemática da literatura até outubro de 2004, analisando seu grau de evidência. Resultados: Foram encontrados dois trabalhos de revisão sistemática que selecionaram e estudaram artigos até setembro de 2003 e, então, adicionados ao estudo mais 28 artigos provenientes de revisão bibliográfica sistemática até outubro de 2004. Conclusões: Em geral os "incidentalomas" são não funcionantes, mas a avaliação endócrina demonstrou que não é raro o achado de hiperfunção hormonal subclínica, reforçando a necessidade de dosagem de certas substâncias, como metanefrinas, realização do teste de supressão de dexametasona em baixas dosagens e mensuração da relação da aldosterona plasmática/atividade plasmática da renina. "Incidentalomas" não funcionantes menores de 4cm devem ser observados entre 4 e 6cm devem ser analisados por suas características de imagem maiores de 6 cm devem ser operados. "Incidentalomas" funcionantes devem ser submetidos à adrenalectomia. Massas adrenais não operadas devem ser acompanhadas por dois anos, por meio de exames de imagem e de função.
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Humanos , Masculino , Feminino , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Adulto , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Glândulas Suprarrenais , Adrenalectomia/métodos , Diagnóstico por Imagem , Glândulas Endócrinas/anormalidades , Procedimentos Cirúrgicos EndócrinosRESUMO
O texto traz uma reflexão sobre os principais momentos da execução experimental, e aborda seqüencialmente: a) o que é a pesquisa?, b) por que fazer pesquisa?, c) como a pesquisa pode ser útil posteriormente?, d) quais são as etapas da pesquisa?, e) quem serão os autores da pesquisa? Finaliza citando a importância da análise de resultados e sua inserção no contexto da coletividade
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Pesquisa , Ética em Pesquisa , Projetos de PesquisaRESUMO
An unbiased systematic review (SR) should analyse as many articles as possible in order to provide the best evidence available. However, many SR use only databases with high English-language content as sources for articles. Literatura Latino Americana e do Caribe em Ciências da Saúde (LILACS) indexes 670 journals from the Latin American and Caribbean health literature but is seldom used in these SR. Our objective is to evaluate if LILACS should be used as a routine source of articles for SR. First we identified SR published in 1997 in five medical journals with a high impact factor. Then we searched LILACS for articles that could match the inclusion criteria of these SR. We also checked if the authors had already identified these articles located in LILACS. In all, 64 SR were identified. Two had already searched LILACS and were excluded. In 39 of 62 (63%) SR a LILACS search identified articles that matched the inclusion criteria. In 5 (8%) our search was inconclusive and in 18 (29%) no articles were found in LILACS. Therefore, in 71% (44/72) of cases, a LILACS search could have been useful to the authors. This proportion remains the same if we consider only the 37 SR that performed a meta-analysis. In only one case had the article identified in LILACS already been located elsewhere by the authors' strategy. LILACS is an under-explored and unique source of articles whose use can improve the quality of systematic reviews. This database should be used as a routine source to identify studies for systematic reviews.
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Humanos , Literatura de Revisão como Assunto , Metanálise como Assunto , Projetos de Pesquisa Epidemiológica , Bases de Dados Bibliográficas , Sistemas On-Line , Região do Caribe , Base de DadosRESUMO
OBJECTIVE: LILACS is a triple language database edited by BIREME and PAHO in Sao Paulo, Brazil, with interfaces in Spanish, Portuguese and English. This database indexes more than 670 medical journals in Latin America and Caribbean. Only 40 of these are indexed also in MEDLINE. So, LILACS is a unique source of scientific information [www.epm.br/cochrane/lilacs.htm]. If we believe that a comprehensive, unbiased search is one of the key differences between a systematic review and a traditional review, (like stated by the Cochrane Reviewers' Handbook), and if the LILACS database came to proof to be an useful source of studies that fit the inclusion criteria of systematic reviews, this database must be included among those searched in Cochrane systematic reviews. METHODS: We searched the Cochrane Database of Systematic Reviews using the term "Neoplasms" in order to identify complete reviews. For each review, we sought if the authors had already searched LILACS. If not, we performed a LILACS search in order to try to find articles that could fit the inclusion criteria of the review. For randomized studies (RCT), we used the optimal search strategy for RCT for use in LILACS described by Castro et al (1999). For others methodological designs, we used free search. RESULTS: We retrieved 45 completed systematic reviews. None described a search in LILACS. In our search, we found articles that may fit the inclusion criteria for 23 (51%) of these reviews. In four reviews (9%) we found articles that could fit the inclusion criteria, but we were not able to make a clear assertive. In the others 18 reviews (40%) we found no articles that could fit the inclusion criteria. So, in 60% (27/45) of this sample of Cochrane reviews a search in LILACS could be useful. If Cochrane reviews are really intending to include as many articles as possible, a LILACS search must be mandatory. Editors of review groups and peer-reviewers must take attention to the inclusion of this database among those searched. The access to and the search in LILACS is easy and improving : LILACS is a internet free access database at www.bireme.br. There is an optimal search strategy for clinical trials already described (Castro et al 1999), and the Brazilian Cochrane Center is conducting a process of re-tagging] RCT in the appropriate publication type. CONCLUSION: Cochrane systematic reviews must use LILACS like routine searched database
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Viés de Seleção , LILACS , Revisões Sistemáticas como AssuntoRESUMO
Objective: To define and disseminate the optimal search strategy for clinical trials in the Latin American and Caribbean Health Science Literature (LILACS). This strategy was elaborated based on the optimal search strategy for MEDLINE recommended by Cochrane Collaboration for the identification of clinical trials in electronic databases. Design: Technical information. Setting: Clinical Trials and Meta-Analysis Unit, Federal University of Spo Paulo, in conjunction with the Brazilian Cochrane Center, Säo Paulo, Brazil. (http://www.epm.br/cochrane). Data: LILACS/CD-ROM (Latin American and Caribbean Health Science information Database), 27th edition, January 1997, edited by BIREME (Latin American and Caribbean Health Science Information Center). LILACS indexes 670 journals in the region, with abstracts in English, Portuguese or Spanish; only 41 overlap in the MEDLINE-EMBASE. Of the 168.902 citations since 1982, 104,016 are in human trials, and 38,261 citations are potentiality clinical trials. Search strategy was elaborated combining headings with text word in three languages, adapting the interface of the LILACS. We will be working by locating clinical trials in LILACS for Cochrane Controlled Trials Database. This effort is being coordinated by the Brazilian Cochrane Center.