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Arq. bras. cardiol ; 113(1): 62-68, July 2019. graf
Artigo em Inglês | LILACS-Express | ID: biblio-1011226


Abstract Background: Data from the international literature have shown changes in the profile of cardiologists and in their medical practices. However, there is no data on this in Brazilian cardiologists. Objective: To evaluate professional and personal characteristics of a sample of Brazilian cardiologists. Methods: This was a cross-sectional study; a questionnaire was sent by e-mail to cardiologists, active members of the Brazilian Society of Cardiology in 2017. The results were analyzed, and the level of significance set at p < 0.05. Results: The questionnaire was sent to 13,462 cardiologists, with 2,101 (15.6%) respondents, mostly men (71.8% versus 28.2%). Age distribution and marital status were significantly different between the sexes (p < 0.001). The number of cardiologists without children was higher among women (40.5% versus 16.1%; p < 0.001). The most common place of work was the public hospital (46.5%), followed by private hospital (28.5%) and private office (21.1%). The office was the main place of work for 23.9% of men and 14% of women (p < 0.001), with predominance of individuals older than 50 years (31.7% versus 10.1%, respectively; p < 0.001). Most cardiologists (64.2%) worked more than 40 hours a week (69% of them men and 51.9% of the women; p < 0.001). Eighty-eight percent of the sample earned more than BRL 11,000 (US$ 3,473.43), and 66.5% of the men earned more than BRL 20,000 (US$ 6,315.32) per month, versus 31.2% of the women (p < 0.001). A high level of work-related stress was reported by 11.3% of respondents. Conclusion: Most cardiologists were men, who showed higher workload and higher income; 11.3% of the cardiologists perceived stress as a great deal.

Resumo Fundamento: Dados internacionais mostram mudanças no perfil e nas características da atuação dos cardiologistas. No entanto, não há na literatura dados acerca da realidade brasileira. Objetivo: Avaliar as características profissionais e pessoais de amostra de cardiologistas brasileiros. Método: Estudo transversal realizado por meio de questionário enviado via e-mail para os cardiologistas adimplentes da Sociedade Brasileira de Cardiologia em 2017. Os resultados foram analisados considerando nível de significância de p < 0,05. Resultados: Foram enviados 13.462 questionários, havendo 2.101 (15,6%) respostas, com predominância de homens (71,8% versus 28,2%). A distribuição etária e o estado civil foram significativamente diferentes entre os gêneros (p < 0,001). O número de cardiologistas sem filhos foi maior entre as mulheres (40,5% versus 16,1%; p < 0,001). O local de trabalho mais frequente foi hospital público (46,5%), seguido por hospital privado (28,5%) e consultório privado (21,1%). O consultório é a principal atividade de 23,9% dos homens e 14% das mulheres (p < 0,001), predominantemente entre aqueles com mais de 50 anos (31,7% versus 10,1%, respectivamente; p < 0,001). A maioria (64,2%) trabalha mais de 40 horas semanais (69% dos homens e 51,9% das mulheres; p < 0,001). A renda mensal de 88% é superior a R$ 11.000 (US$ 3,473.43), e 66,5% dos homens recebem mais que R$ 20.000,00 (US$ 6,315.32) mensais, contra 31,2% das mulheres (p < 0,001). Nível elevado de estresse foi relatado por 11,3%. Conclusões: Os homens são maioria entre os cardiologistas, têm maior carga de trabalho e renda superior à das mulheres. A taxa de estresse em grande proporção foi de 11,3%.

Arq Bras Cardiol ; 113(1): 62-68, 2019 Jun 27.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31271595


BACKGROUND: Data from the international literature have shown changes in the profile of cardiologists and in their medical practices. However, there is no data on this in Brazilian cardiologists. OBJECTIVE: To evaluate professional and personal characteristics of a sample of Brazilian cardiologists. METHODS: This was a cross-sectional study; a questionnaire was sent by e-mail to cardiologists, active members of the Brazilian Society of Cardiology in 2017. The results were analyzed, and the level of significance set at p < 0.05. RESULTS: The questionnaire was sent to 13,462 cardiologists, with 2,101 (15.6%) respondents, mostly men (71.8% versus 28.2%). Age distribution and marital status were significantly different between the sexes (p < 0.001). The number of cardiologists without children was higher among women (40.5% versus 16.1%; p < 0.001). The most common place of work was the public hospital (46.5%), followed by private hospital (28.5%) and private office (21.1%). The office was the main place of work for 23.9% of men and 14% of women (p < 0.001), with predominance of individuals older than 50 years (31.7% versus 10.1%, respectively; p < 0.001). Most cardiologists (64.2%) worked more than 40 hours a week (69% of them men and 51.9% of the women; p < 0.001). Eighty-eight percent of the sample earned more than BRL 11,000 (US$ 3,473.43), and 66.5% of the men earned more than BRL 20,000 (US$ 6,315.32) per month, versus 31.2% of the women (p < 0.001). A high level of work-related stress was reported by 11.3% of respondents. CONCLUSION: Most cardiologists were men, who showed higher workload and higher income; 11.3% of the cardiologists perceived stress as a great deal.

Eur J Health Econ ; 2019 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-31286291


Micro-costing studies still deserving for methods orientation that contribute to achieve a patient-specific resource use level of analysis. Time-driven activity-based costing (TDABC) is often employed by health organizations in micro-costing studies with that objective. However, the literature shows many deviations in the implementation of TDABC, which might compromise the accuracy of the results obtained. One reason for that can be attributed to the non-existence of a step-by-step orientation to conduct cost analytics with the TDABC specific for micro-costing studies in healthcare. This article aimed at exploring the literature and practical cases to propose an eight-step framework to apply TDABC in micro-costing studies for health care organizations. The 8-step TDABC framework is presented and detailed exploring online spreadsheets already coded to demonstrate data structure and math formula building. A list of analyses that can be performed is suggested, including an explanation about the information that each analysis can provide to increase the organization capability to orient decision making. The case study developed show that actual micro-costing of health care processes can be achieved with the 8-step TDABC framework and its use in future researches can contribute to increase the number of studies that achieve high-quality level in cost information, and consequently, in health resource evaluation.

BMC Public Health ; 19(1): 657, 2019 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-31142294


BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals. METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention. DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices. TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.

Promoção da Saúde/métodos , Hipertensão/prevenção & controle , Estilo de Vida , Idoso , Protocolos Clínicos , Humanos , Pessoa de Meia-Idade
Int J Technol Assess Health Care ; 35(3): 195-203, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31023393


BACKGROUND: Healthcare organizations have invested efforts on hospital-based health technology assessment (HB-HTA) and enterprise risk management (ERM) processes for novel systems to obtain more accurate data on which to base strategic decisions. This study proposes to analyze how HB-HTA and ERM processes can share personal resources and skills to achieve principles with value-oriented results. METHODS: Literature on ERM and HB-HTA and data from interviews with healthcare managers compose the research data sources, which were submitted to a qualitative data analysis. It was oriented to identify the association between ERM and HB-HTA application in hospitals and the common principles between both processes, in addition to proposing the capability to share personal resources between both teams in a matrix. RESULTS: The common principles and personal background suggested for HB-HTA and ERM teams allowed the build of a matrix identifying how both teams can work in an integrated manner being more effective and value-oriented. The shared resource matrix reports how each professional (with a specific background) may interact with each activity associated to HB-HTA or ERM implementation guidelines. CONCLUSIONS: The identification of common principles and capabilities between ERM and HB-HTA suggested advances with the literature from both research areas. The opportunity to share personal resources also contributes to the implementation of those processes in hospitals with less financial resources, approaching its own management to be more efficient with the care chain.

Artigo em Português | LILACS-Express | ID: biblio-1005738


Objetivo: No cenário da avaliação de tecnologias em saúde (ATS), as estimativas de custos são um fator crítico no desenvolvimento das avaliações econômicas completas, especialmente pelo uso de diferentes metodologias de custeio. A fim de contribuir com a acurácia dos dados de custos usados nessas análises, este artigo sugere recomendações para apuração de custos em saúde no Brasil. Métodos: Reuniram-se pesquisadores de ATS de diferentes expertises e centros de pesquisa do Brasil, e ao longo de dois anos foram conduzidas revisões da literatura nacional e internacional e discussões sobre as formas de abordar a temática. Três simpósios foram realizados reunindo os pesquisadores com o propósito de alcançar o consenso entre os autores sobre as melhores recomendações para a realização de estudos de Microcusteio. Resultados: Consolidou-se em forma de uma recomendação este artigo que representa uma versão compacta da diretriz completa a ser publicada pela Rede Brasileira de Avaliação de Tecnologias em Saúde. A metodologia de Microcusteio é considerada como padrão-ouro para a identificação dos custos em saúde. Os métodos de definição do estudo, coleta e análise de dados apresentados são descritos de modo a permitir uma valoração dos custos validada e homogênea, principalmente para o uso dessa informação em avaliações econômicas de saúde. Conclusão: Essa recomendação tem o propósito de aumentar a acurácia das estimativas dos custos de saúde no nosso meio e homogeneizar a comunicação entre estudos conduzidos por diferentes grupos de pesquisa. Por fim, é esperado que a utilização dessas recomendações contribua para que as decisões baseadas em dados econômicos sejam mais acuradas e equânimes quando da incorporação de tecnologias no país.

Objective: In the context of health technology assessment (HTA), cost estimates are a critical factor in the development of economic evaluations, especially through the use of different costing methodologies. In order to contribute to the accuracy of the cost data used in these analyzes, this article suggests recommendations to develop health cost analysis in Brazil. Methods: HTA researchers with heterogeneous background and from different Brazilian research centers were engaged on the development of this health cost analysis recommendation over two years. Reviews of national and international literature and discussions on how to approach the theme were conducted. Three symposia were held bringing together the researchers with the purpose of reaching consensus among the authors on the best recommendations for micro-accounting studies. Results: This article was consolidated as a recommendation, which represents a compact version of the complete guideline that will be published by the Brazilian Health Technology Assessment Network (REBRATS). The Microcosting methodology is considered as a gold standard for the analysis of health costs. Methods to define the study, to perform data collection and analysis are described in order to allow a validated and homogeneous cost evaluation, mainly for the use of this information in economic health assessments. Conclusion: This recommendation is intended to increase the health cost estimated accuracy in our country and to homogenize the communication between studies conducted by different research groups. Finally, it is expected that the use of these recommendations will contribute to make decisions based on economic data more accurate and equitable when incorporating health technologies in the country.

J. bras. econ. saúde (Impr.) ; 10(3): 232-238, dez. 2018.
Artigo em Português | LILACS, ECOS | ID: biblio-980926


Objetivo: Desenvolver um modelo para o gerenciamento de projetos em centros de pesquisa clínica (CPCs) no cenário público-privado e privado. Métodos: Estudo transversal prospectivo com aplicação de um questionário específico em CPCs no Brasil. Esse instrumento avaliou a aplicação prática das 10 áreas de conhecimento do Project Management Body of Knowledge (PMBOK®) (gerenciamento da integração, do escopo, do tempo, de custos, de qualidade, de recursos humanos, de comunicações, de riscos, de aquisições e partes interessadas) com relação à prática diária da pesquisa clínica nos CPC do país. Resultados: Dos 195 centros de pesquisa elegíveis, 55 responderam ao questionário completo. O profissional com o cargo de gerente de projetos é inexistente em 37 centros (67,3%) ativos e não há Escritório de Gerenciamento de Projetos (EGP) em 41 centros (74,5%). O controle de despesas e receitas é realizado por 50 centros (90,9%), entretanto 28 (50,9%) realizam avaliação da rentabilidade. Quanto ao gerenciamento da qualidade, 28 (50,9%) não têm parâmetros de qualidade implantados e 11 (40,7%) não realizam auditoria interna. Falhas de comunicação estão presentes em 48 centros (87,2%). A partir da avaliação da aplicação prática das 10 áreas de conhecimento do Guia PMBOK®, foi desenvolvido um modelo de gerenciamento de projetos com aplicabilidade aos centros. Conclusões: É possível que os centros tenham melhor definição do escopo de cada projeto, custos e prazos possuam baixa margem de variabilidade, se estabeleça boa comunicação entre as partes envolvidas e que o impacto econômico do gerenciamento possa ser reconhecido.

Objective: To develop a model for the management of research projects, in public-private and private scenarios. Methods: Prospective cross-sectional study with the application of a specific questionnaire for research centers in the country. This instrument evaluated the practical application of the 10 areas of Project Management Body of Knowledge (PMBOK®) (management of integration, scope, time, costs, quality, human resources, communications, risks, acquisitions and stakeholders) of in relation to the daily practice of clinical research in the country's research centers. Results: Of the 195 eligible research centers, 55 centers answered the complete questionnaire. The professional with the position of project manager does not exist in 37 active centers (67.3%), there is no project management office (PMO) in 41 centers (74.5%). The control of expenses and revenues is carried out by 50 centers (90.9%), however, 28 (50.9%) carry out an evaluation of the profitability. Regarding quality management, 28 (50.9%) did not have quality parameters implanted and 11 (40.7%) did not perform internal audit. Communication failures are present in 48 (87.2%) centers. Based on the evaluation of the practical application of the 10 knowledge areas of the PMBOK® Guide, the project management model was developed with applicability to clinical research centers. Conclusions: It is possible that the centers have a better definition of the scope of each project, the costs and deadlines have a low margin of variability, a good communication between the parties is established and the economic impact of the management can be recognized.

Humanos , Gestão em Saúde , Academias e Institutos , Gestão do Conhecimento para a Pesquisa em Saúde
Artigo em Inglês | MEDLINE | ID: mdl-30576452


Objective: The fractional flow reserve (FFR) versus angiography for multivessel evaluation (FAME) study has demonstrated that FFR substantially reduces major adverse cardiac events and resource utilization in coronary artery disease (CAD) patients. We aimed to assess the cost utility of FFR in percutaneous coronary interventions (PCI) from the perspective of the Brazilian Public Health System (SUS). Design: Patient-level cost-utility analysis along the FAME study. Participants: Multivessel coronary artery disease patients. Intervention: PCI, either guided by FFR or by angiography alone. Setting: The procedure costs were based on the mean amount of unitary resource utilization multiplied by the costs from SUS reimbursement list. The utilities were derived using Brazilian weights for time trade-off European Quality of Life-5 Dimensions. The World Health Organization recommendation based on gross domestic product per capita (international dollars [I$] 35 876/quality-adjusted life year [QALY]) was used as willingness-to-pay threshold. Main Outcome Measure: We determined the incremental cost-utility ratio (ICUR) in I$ per QALY gained during the 1-year time horizon. Results: One-year costs were I$ 8931 for the angiography-guided PCI and I$ 8968 for the FFR-guided PCI, resulting in an incremental cost of I$ 37. Effectiveness during 1 year was 0.798 QALYs for angiography-guided PCI and 0.811 for FFR-guided PCI, resulting in an incremental effectiveness of 0.013 QALYs. The base-case ICUR of FFR versus angiography-guided PCI was 2780 I$/QALY. Cost-saving results are achieved with a FFR price reduction of at least 2.2%. Conclusions: Developing countries should give attention to strategies proven to be cost-effective in other health systems. In our analysis, FFR-guided PCI is very cost-effective in the Brazilian SUS and with a minimal price reduction of the device, FFR could be cost saving.

Arq Bras Cardiol ; 111(3): 436-539, 2018 Sep.
Artigo em Português | MEDLINE | ID: mdl-30379264
PLoS Negl Trop Dis ; 12(8): e0006742, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30125291


BACKGROUND: Chagas disease is a neglected chronic condition caused by Trypanosoma cruzi, with high prevalence and burden in Latin America. Ventricular arrhythmias are common in patients with Chagas cardiomyopathy, and amiodarone has been widely used for this purpose. The aim of our study was to assess the effect of amiodarone in patients with Chagas cardiomyopathy. METHODOLOGY: We searched MEDLINE, Embase and LILACS up to January 2018. Data from randomized and observational studies evaluating amiodarone use in Chagas cardiomyopathy were included. Two reviewers selected the studies, extracted data and assessed risk of bias. Overall quality of evidence was accessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). PRINCIPAL FINDINGS: We included 9 studies (3 before-after studies, 5 case series and 1 randomized controlled trial). Two studies with a total of 38 patients had the full dataset, allowing individual patient data (IPD) analysis. In 24-hour Holter, amiodarone reduced the number of ventricular tachycardia episodes in 99.9% (95%CI 99.8%-100%), ventricular premature beats in 93.1% (95%CI 82%-97.4%) and the incidence of ventricular couplets in 79% (RR 0.21, 95%CI 0.11-0.39). Studies not included in the IPD analysis showed a reduction of ventricular premature beats (5 studies), ventricular tachycardia (6 studies) and ventricular couplets (1 study). We pooled the incidence of adverse side effects with random effects meta-analysis; amiodarone was associated with corneal microdeposits (61.1%, 95%CI 19.0-91.3, 5 studies), gastrointestinal events (16.1%, 95%CI 6.61-34.2, 3 studies), sinus bradycardia (12.7%, 95%CI 3.71-35.5, 6 studies), dermatological events (10.6%, 95%CI 4.77-21.9, 3 studies) and drug discontinuation (7.68%, 95%CI 4.17-13.7, 5 studies). Quality of evidence ranged from moderate to very low. CONCLUSIONS: Amiodarone is effective in reducing ventricular arrhythmias, but there is no evidence for hard endpoints (sudden death, hospitalization). Although our findings support the use of amiodarone, it is important to balance the potential benefits and harms at the individual level for decision-making.

Value Health Reg Issues ; 17: 142-147, 2018 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-30149318


BACKGROUND: A review of the literature on economic analyses in cancer (prevention, diagnosis, and treatment) using activity-based costing (ABC) or time-driven activity-based costing (TDABC) for measuring costs and to examine how these approaches have been applied to assess and manage cancer costs. METHODS: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We conducted a search for studies that used ABC or TDABC to calculate the cost of cancer in prevention, diagnosis, and treatment. Only English- and Portuguese-language articles were retrieved from Medline, Lilacs, ScieLO, and Embase (January 1990 to August 2016). RESULTS: In total, 421 studies were evaluated. However, only 27 papers were included. The first publications were from the early 2000s, but most of the studies were published in 2016 (n = 10). Most of the studies were carried out in the United States (n = 6) and Belgium (n = 6). Cancer treatment was the major focus of all studies (n = 20), followed by screening programs evaluations (n = 4) and diagnosis (n = 3). Among treatment modalities, economic analysis of radiotherapy was the most common topic of study. Retrospective clinical data represented 57.6% of the studies. More than 50% of the studies presented unspecified economic analysis. The hospital perspective was the most prevalent perspective among the studies (46.1%). CONCLUSIONS: ABC and TDABC economic analyses are a promising area of studies in oncology costs.

J. bras. econ. saúde (Impr.) ; 10(2): 126-133, Agosto/2018.
Artigo em Português | LILACS, ECOS | ID: biblio-914924


Objetivo: Avaliar a custo-utilidade e o impacto orçamentário (IO) da abiraterona para o tratamento de câncer de próstata resistente à castração, em pacientes previamente tratados com docetaxel. Métodos: Foi construído um modelo de Markov com ciclos mensais sob a perspectiva do Sistema Único de Saúde (SUS), em um horizonte temporal de cinco anos e taxa de desconto de 5%. A estimativa de efetividade foi oriunda do principal ensaio clínico dessa condição de saúde. Para dados de utilidade, aplicaram-se estimativas internacionais, enquanto para custos se utilizaram tabelas de remuneração do SUS. Para o IO, a população-alvo foi estimada com base em dados do Departamento de Informática do SUS (DATASUS). Resultados: A abiraterona ocasionou ganho de 1,045 ano de vida ajustado para qualidade (QALY) e 1,609 ano de vida ganho (AVG), enquanto para o placebo esses valores foram de 0,763 e 1,299, respectivamente. O custo total na estratégia abiraterona foi de R$ 83.295 e para o placebo, de R$ 2.895. A relação de custo-efetividade incremental (RCEI) foi de R$ 284.416 por QALY ganho. Em nenhuma das análises de sensibilidade os valores ficaram abaixo de R$ 100.000 por QALY. Mesmo quando variados simultaneamente seis parâmetros, todos no seu limite mais favorável à abiraterona, os resultados seguiram elevados, com RCEI de R$ 98.330 por QALY. O IO foi de R$ 270 milhões em cinco anos no cenário mais conservador (tempo médio de tratamento de 7,4 meses e 10% de novos casos/ano). Conclusão: A abiraterona se mostrou pouco custo-efetiva nesta situação clínica, com RCEI superior a nove vezes o PIB per capita por QALY, sendo os resultados robustos em análise de sensibilidade.

Objective: To evaluate the cost-utility and the budget impact (BI) of abiraterone in patients with castration-resistant prostate cancer previously treated with docetaxel. Methods: A Markov model was constructed, with monthly cycles, under the perspective of the Brazilian Public Healthcare System (SUS), in a 5-year time horizon, and with a 5% discount rate. The effectiveness estimate was obtained from the pivotal clinical trial for abiraterone in this health condition. For utility data, international estimates were applied; while for costs, SUS reimbursement information were used. In the BI analysis, the target population was estimated with claims data from DATASUS. Results: Abiraterone resulted in a gain of 1.045 quality-adjusted life years (QALY) and 1.609 life years gained (LYG), while for placebo these values were 0.763 and 1.299, respectively. The total cost for the abiraterone strategy was BRL 83,295, and for placebo, BRL 2,895. The incremental cost-effectiveness ratio (ICER) was BRL 284,416 per QALY gained. None of the estimates from the sensitivity analysis was below BRL 100,000 per QALY. Even when six parameters were variated simultaneously in the range more favorable to abiraterone, the results were still elevated, with an ICER of BRL 98,330 per QALY. The BI was BRL 270 million in 5 years in the most conservative scenario (average time of the treatment of 7.4 months and 10% of the new cases/year). Conclusion: Abiraterone shows unfavorable cost-effective results for this clinical condition in Brazil, with an ICER above 9 times the per capita per QALY. Results were robust in sensitivity analysis.

Humanos , Cadeias de Markov , Análise Custo-Benefício , Neoplasias de Próstata Resistentes à Castração , Acetato de Abiraterona
Value Health Reg Issues ; 17: 88-93, 2018 May 10.
Artigo em Inglês | MEDLINE | ID: mdl-29754016


OBJECTIVES: To assess the measurement equivalence of the original paper version of an adapted tablet version of the EuroQol five-dimensional questionnaire (EQ-5D). METHODS: A randomly selected sample of 509 individuals aged 18 to 64 years from the general population responded to the EQ-5D at two time points separated by a minimum interval of 24 hours and were allocated to one of the following groups: test-retest group (tablet-tablet) or crossover group (paper-tablet and tablet-paper). Agreement between methods was determined using the intraclass correlation coefficient (ICC) and the κ coefficient. RESULTS: In the crossover group, the following ICC values were obtained: 0.76 (confidence interval [CI] 0.58-0.89) for EQ-5D scores and 0.77 (CI 0.68-0.84) for visual analogue scale in subjects responding first to the tablet version; 0.83 (CI 0.75-0.89) for EQ-5D scores and 0.75 (CI 0.67-0.85) for visual analogue scale in subjects responding first to the paper version. In the test-retest group, the ICC was 0.85 (CI 0.73-0.91) for EQ-5D scores and 0.79 (CI 0.66-0.87) for visual analogue scale. The κ values were higher than 0.69 in this group. The internal consistencies of the paper and tablet methods were similar. CONCLUSIONS: The paper and tablet versions of the EQ-5D are equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar among individuals.

Am Heart J ; 198: 129-134, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29653634


BACKGROUND: Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. OBJECTIVES: The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. DESIGN: The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. SUMMARY: The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

JAMA ; 319(13): 1331-1340, 2018 04 03.
Artigo em Inglês | MEDLINE | ID: mdl-29525821


Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: Identifier: NCT01448642.

Síndrome Coronariana Aguda/tratamento farmacológico , Atorvastatina/administração & dosagem , Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/terapia , Idoso , Atorvastatina/efeitos adversos , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Método Duplo-Cego , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia
Arq Bras Cardiol ; 109(3 Supl 1): 1-104, 2017 Jan-Feb.
Artigo em Inglês, Português | MEDLINE | ID: mdl-29044300
Int. j. cardiovasc. sci. (Impr.) ; 30(5): f:408-l:415, set.-out. 2017. tab, graf
Artigo em Português | LILACS | ID: biblio-859024


Fundamento: A cirurgia de revascularização miocárdica (CRM) e a intervenção coronária percutânea (ICP) são estratégias amplamente utilizadas no manejo da doença arterial coronariana (DAC) estável. Objetivo: Avaliar o prognóstico de pacientes com DAC estável inicialmente tratada com terapia médica (TM), em comparação com os pacientes submetidos a procedimentos de revascularização. Métodos: Estudo prospectivo de coorte com 560 pacientes ambulatoriais de um hospital terciário com seguimento médio de 5 anos. Os pacientes foram classificados nos grupos TM (n = 288), ICP (n = 159) e CRM (n = 113) de acordo com sua estratégia inicial de tratamento. Os desfechos primários foram mortalidade global e eventos combinados de morte, síndrome coronária aguda e AVC. Resultados: Durante o seguimento, as taxas de mortalidade foram de 11,1% em TM, 11,9% em ICP e 15,9% em pacientes submetidos à CRM, sem diferença estatística (Hazard Ratio [HR] para ICP, 1,05; Intervalo de Confiança de 95% [IC95%], 0,59 a 1,84; e HR para CRM, 1,20; IC95%, 0,68 a 2,15). Os desfechos combinados ocorreram com maior frequência entre os pacientes inicialmente submetidos à ICP em relação à TM (HR 1,50, IC 95% 1,05 a 2,14) e não diferiram entre TM e CRM (HR 1,24, IC95% 0,84 a 1,83). Entre os pacientes com diabetes (n = 198), a ICP foi a única estratégia terapêutica preditiva de desfechos combinados (HR 2,14; IC 95%: 1,25 a 3,63). Conclusão: Neste estudo observacional de doença arterial coronariana estável, não houve diferença na mortalidade global entre as estratégias iniciais de terapia médico ou de cirurgia de revascularização. Os pacientes inicialmente tratados com ICP tiveram maior chance de desenvolver eventos cardiovasculares maiores combinados

Background: Coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention (PCI) are widely-used strategies in the management of stable coronary artery disease (CAD). Objective: To evaluate the prognosis of patients with stable CAD initially treated by medical therapy (MT), compared to the patients who were submitted to revascularization procedures. Methods: We conducted a prospective cohort study of 560 patients from an outpatient clinic in a tertiary hospital, with a mean follow-up of 5 years. Patients were classified into MT (n = 288), PCI (n = 159) and CABG (n=113) groups according to their initial treatment strategy. Primary endpoints were overall mortality and combined events of death, acute coronary syndrome, and stroke. Results: During follow-up, death rates were 11.1% in MT, 11.9% in PCI and 15.9% in CABG patients, with no statistical difference (hazard ratio [HR] for PCI, 1.05; 95% confidence interval [95%CI], 0.59 to 1.84; and HR for CABG, 1.20; 95% CI: 0.68 to 2.15). Combined outcomes occurred more often among patients initially submitted to PCI compared to MT (HR 1.50, 95% CI 1.05 to 2.14), and did not differ between MT and CABG patients (HR 1.24, 95% CI 0.84 to 1.83). Among patients with diabetes (n=198), PCI was the only therapeutic strategy predictive of combined outcomes (HR 2.14; 95% CI 1.25 to 3.63). Conclusion: In this observational study of stable coronary artery disease, there was no difference in overall mortality between initial medical therapy or revascularization surgery strategies. Patients initially treated with PCI had greater chance to develop combined major cardiovascular events

Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos de Coortes , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Tratamento Farmacológico , Conduta do Tratamento Medicamentoso , Revascularização Miocárdica/métodos , Fatores Etários , Hospitais Públicos , Análise Multivariada , Prognóstico , Fatores de Risco , Fatores Sexuais , Taxa de Sobrevida , Centros de Atenção Terciária , Resultado do Tratamento
Arq. bras. cardiol ; 109(3,supl.1): 1-104, Sept. 2017. tab, graf
Artigo em Inglês | LILACS-Express | ID: biblio-887936