Produção Docente
URI Permanente para esta coleção
Navegar
Navegando Produção Docente por Título
Agora exibindo 1 - 20 de 134
Resultados por página
Opções de Ordenação
- ItemThe 21st Century Cures Act: can the regulatory framework survive the “cures”?(Cadernos de Saúde Pública, 2015) Osorio-de-Castro, Claudia Garcia Serpa; Caetano, Rosângela; Pepe, Vera Lúcia EdaisIn 1963, Edward Lorenz proposed a theory, which has now entered into lore, that the ripples in the air produced by the fluttering of a butterfly’s wings may cause a hurricane on the other side of the planet. In July 2015, the House of Representatives of the United States Congress approved an act that considerably alters the USA’s regulatory framework. The act, known as the 21st Century Cures Act (“ an act to accelerate the discovery, development, and delivery of 21st Century cures, and for other purposes ” 1) is now to be examined by the Senate. Both the Democratic and Republican parties worked jointly to pass this legislation.
- ItemA novel risk score for predicting new-onset atrial fibrillation in subjects with chronic chagas heart disease(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa-Filho, José; Kantharia, Bharat K.Introduction: Atrial fibrillation affects about 20% of subjects with chronic Chagas disease (CCD) and heralds poor prognosis. This study prospectively investigated echocardiographic and electrocardiographic parameters aiming at creating a risk score for new-onset AF (NOAF) in CCD and to compare its performance to Rassi score. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Patients were assessed by 12-lead ECG, 24h ambulatory ECG and 1D/2D echocardiogram. NOAF lasting >24h was tracked at three to six-month intervals. Results: During a follow-up of (mean±SEM) 91.2 ± 3.2 months, 18 developed NOAF (incidence: 30.2 ± 2.6 /year), and 20 died (rate: 26.4 ± 1.4 /year). Relative risk of NOAF for cardiac death was 3.6 (p=0.001). In multivariate Cox proportional hazard model, PVC>3,000/24h (p=0.02), LAD>3.3cm (p=0.001), and PAP>30mmHg (p=0.004) were independent predictors for NOAF (Table inset). A prognostic score for NOAF was developed by calculating weighted points proportional to beta coefficient in Cox model (table inset). ROC analysis of novel score showed optimal cut-off value at 2 (Figure A). KM curves of novel score for NOAF is presented in Figure B (proportional hazard test: rho=0.1; p=0.6). In 1,000 bootstraps, ROC c-statistic of novel score was significantly superior to Rassi score (Figure C). Conclusions: In CCD, high grade PVC, LAD>3.3cm and PAP>30mmHg are independent predictors for NOAF. Novel risk score improves NOAF predictive accuracy in this population.
- ItemA risk score based on spectral turbulence analysis of the signal averaged ECG for predicting cardiac death in subjects with chronic chagas heart disease(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa, Eduardo C.; Barbosa-Filho, José; Kantharia, Bharat K.Introduction: Cardiac involvement is the main cause of death in chronic Chagas disease (CCD). This study prospectively investigated signal-averaged ECG (SAECG), 24h-ambulatory ECG and echocardiogram parameters in CCD aiming at developing a predictive score for death. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Deaths were ascertained by review of medical records. SAECG was acquired on admission. Spectral turbulence analysis (STA) was carried out on XYZ leads after short-time Fourier transform mapping of ventricular activation, and applying intersegment spectral correlation technique. Results: During a follow-up of (mean±SEM) 95.3 ± 3.1 months, 20 patients died (rate: 26.4 ± 1.4/year). In multivariate Cox proportional hazard model, NSVT/24h (p=0.006), LVEF<50% (p<0.001), and positive STA (p=0.001) were independent predictors of death (Table inset). A prognostic score was developed by calculating weighted points proportional to beta coefficient in Cox model (Table inset). ROC analysis showed optimal cut-off value at 5 (Figure A). KM curves of novel score for deaths are presented in Figure B (proportional hazard test: rho=-0.5; p=0.06). In 1,000 bootstraps, ROC c-statistic of novel score was superior to Rassi score (Figure C). Conclusions: In CCD, NSVT, LVEF<50% and high SAECG spectral turbulence are independent predictors of death. A novel risk score improves predictive accuracy in this population.
- ItemA simple protocol for tuberculin skin test reading certification(Cadernos de Saúde Pública, 2021) Gloria, Lara de Lima; Bastos, Mayara Lisboa; Santos Jr, Bráulio dos; Trajman, AneteAlthough tuberculosis preventive therapy is one of the cornerstones for eliminating the disease, many barriers exist in the cascade of care for latent tuberculosis infection, including the need to certify healthcare professionals for reading tuberculin skin tests (TST). This paper proposes and evaluates a simple protocol for TST reading training. Primary care workers from different backgrounds received a 2-hour theoretical course, followed by a practical course on bleb reading. Blebs were obtained by injecting saline into sausages and then in volunteers. A certified trainer then evaluated the effectiveness of this protocol by analyzing the trainees' ability to read TST induration in clinical routine, blinded to each other's readings. Interobserver agreement was analyzed using the Bland-Altman test. The trainees' reading accuracy was calculated using two cut-off points - 5 and 10mm - and the effect of the number of readings was analyzed using a linear mixed model. Eleven healthcare workers read 53 saline blebs and 88 TST indurations, with high agreement for TST reading (0.07mm average bias). Sensitivity was 100% (94.6; 100.0) at 5mm cut-off and 87.3% (75.5; 94.7) at 10mm cut-off. The regression model found no effect of the number of readings [coefficient: -0.007 (-0.055; 0.040)]. A simple training protocol for reading TST with saline blebs simulations in sausages and volunteers was sufficient to achieve accurate TST induration readings, with no effect observed for the number of readings. Training with saline blebs injected into voluntary individuals is safer and easier than the traditional method.
- ItemAbdominal aortic aneurysmatic Ssc shrinking is the new paradigm after endovascular treatment(Clinics in Surgery, 2021-07) Espinosa, Gaudencio; Saad, Pedro; di Luccio, Giovanni; Vaz, Pedro Duarte; Baptista, Luiz; Magliano, CarlosObjectives: Aneurysmal Sac (SAC) absorption after endovascular treatment (EVAR) of Abdominal Aortic Aneurysms (AAA) is related to a better prognosis but its long-term mandatory and predictive factors remain unclear. Our study aims to assess the impact of its total resorption on patient survival, as well as the factors that favor resorption. Methods: We followed a187 patients who underwent EVAR with a fully thrombosed SAC for 22 years in the postoperative control of Angio-CT. We established the significance of the factors for SAC resorption by logistic regression models, evaluating comorbidities, diameter, sex and age of the patient. We also compared the impact of absorption sac absorption with survival. Results: Diameter and age were significant for the resorption of the SAC together or even independently (p-value <0.001), the diameter (OR-0.29) showed a greater influence than age (OR= -0.063). The comorbidities studied and the sex of the patients was not statistically significant. Patients who had significant absorption (≥ 10 mm) had a survival rate of 12.72 ± 0.96 years, those with moderate absorption (5 mm to 9 mm) had of 8.34 ± 1.62 years and those without significant resorption or growth had 3.27 ± 0.48 years (p-value <0.001). Among patients with absorption of ≥ 5 mm in the first year, we found greater chances of total absorption (OR=4.72 p-value <0.001). Conclusion: Total sac resorption proved to be an important prognostic factor for patient survival after EVAR. The age of the patient and mainly the initial diameter of the sac were the factors significantly associated with the resorption of the sac.
- ItemAccuracy of ltrassonography in the diagnosis of hepatic steatosis and abdominal fat in adolescents: a systematic rewiew(PARIPEX - Indian Journal of Research, 2018) Takey, Márcia; d'Abreu, Henrique César Chaves; Beker, Roseanne Szumsztajn B; Santos, Bráulio; Santos, Marisa da Silva; Kuschnir, Maria Cristina CaetanoINTRODUCTION: With the growing number of overweight adolescents, there was an increase in the prevalence of non-alcoholic fatty liver disease. MATERIAL AND METHOD: We performed a systematic review of the literature to identify and synthesize the available evidence on the ultrasonography accuracy in the diagnosis of hepatic steatosis and measurement of abdominal fat compared to computed tomography or magnetic resonance imaging in obese adolescents. Seven databases (MEDLINE, Cochrane Database of Systematic Reviews, SCOPUS, WEB of SCIENCE, EMBASE, LILACS and ADOLEC) were reviewed. RESULTS: three studies were included in a qualitative synthesis. CONCLUSIONS: Ultrasonography does not have the accuracy needed to classify the degree of steatosis. Magnetic resonance imaging would be considered a more useful and objective method than ultrasonography to discriminate differences in liver fat content and for monitoring of young patients with hepatic steatosis
- ItemAcetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT)(Circulation, 2011) ACT Investigators; Tura, Bernardo R; Santos Junior, Bráulio dos; Cramer, HelenaBackground: It remains uncertain whether acetylcysteine prevents contrast-induced acute kidney injury. Methods and results: We randomly assigned 2308 patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced acute kidney injury (age >70 years, renal failure, diabetes mellitus, heart failure, or hypotension) to acetylcysteine 1200 mg or placebo. The study drugs were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 12.7% in the acetylcysteine group and 12.7% in the control group (relative risk, 1.00; 95% confidence interval, 0.81 to 1.25; P=0.97). A combined end point of mortality or need for dialysis at 30 days was also similar in both groups (2.2% and 2.3%, respectively; hazard ratio, 0.97; 95% confidence interval, 0.56 to 1.69; P=0.92). Consistent effects were observed in all subgroups analyzed, including those with renal impairment. Conclusions: In this large randomized trial, we found that acetylcysteine does not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in at-risk patients undergoing coronary and peripheral vascular angiography. Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
- ItemAcurácia do relacionamento probabilístico na avaliação da alta complexidade em cardiologia(Revista de Saúde Pública, 2011) Migowski, Arn; Chaves, Rogério Brant Martins; Coeli, Cláudia Medina; Ribeiro, Antonio Luiz Pinho; Tura, Bernardo Rangel; Kuschnir, Maria Cristina Caetano; Azevedo, Vitor Manuel Pereira; Floriano, Daniel Brasil; Magalhães, Carlos Alberto Moreira; Pinheiro, Márcia Cristina Chagas Macedo; Xavier, Regina Maria de AquinoOBJETIVO: Avaliar a viabilidade de estratégia de relacionamento probabilístico de bases de dados na identificação de óbitos de pacientes submetidos a procedimentos de alta complexidade em cardiologia. MÉTODOS: O custo de processamento foi estimado com base em 1.672 registros de pacientes submetidos à cirurgia de revascularização do miocárdio, relacionados com todos os registros de óbito no Brasil em 2005. A acurácia do relacionamento baseou-se em linkage probabilístico entre 99 registros de autorização de internação hospitalar de pacientes submetidos a cirurgias cardíacas em instituto de referência em cardiologia, com status vital conhecido, e todos os registros de óbito do estado do Rio de Janeiro em 2005. O linkage foi realizado em quatro etapas: padronização das bases, blocagem, pareamento e classificação dos pares. Utilizou-se a blocagem em cinco passos, com chaves de blocagem com combinação de variáveis como soundex do primeiro e último nome, sexo e ano de nascimento. As variáveis utilizadas no pareamento foram "nome completo", com a utilização da distância de Levenshtein, e "data de nascimento". RESULTADOS: O segundo e o quinto passos de blocagem tiveram os maiores números de pares formados e os maiores tempos de processamento para o pareamento. O quarto passo demandou menor custo de processamento. No estudo de acurácia, após os cinco passos de blocagem, a sensibilidade do linkage foi de 90,6% e a especificidade foi de 100%. CONCLUSÕES: A estratégia de relacionamento probabilístico utilizada apresenta boa acurácia e poderá ser utilizada em estudos sobre a efetividade dos procedimentos de alta complexidade e alto custo em cardiologia.
- ItemAdverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials(The Lancet: Infectious Diseases, 2020) Campbell, Jonathon R; Trajman, Anete; Cook, Victoria J; Johnston, James C; Adjobimey, Menonli; Ruslami, Rovina; Eisenbeis, Lisa; Fregonese, Federica; Valiquette, Chantal; Beneditti, Andrea; Menzies, DickBackground An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. Methods We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1–2 rash and all events of grade 3–5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent,three-member adjudication panel (trial registration: NCT00170209; NCT00931736). Findings Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1–2 rash or any grade 3–5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference –1·2%, 95% CI –1·9 to –0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18–34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1–3·0) for individuals aged 35–64 years and 3·0 (1·2–6·8) for individuals aged 65–90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1–3·6) and concomitant medication use (2·8, 1·5–5·2), but not age, with an adjusted OR of 1·1 (0·6–2·1) for individuals aged 35–64 years and 1·7 (0·5–4·7) for individuals aged 65–90 years. One treatment-related death occurred in the isoniazid group. Interpretation In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety.
- ItemAdverse events related to intravenous antibiotic therapy: a prospective observational study in the treatment of infective endocarditis(BMJ Open, 2012) Paula, Débora Holanda Gonçalves de; Tura, Bernardo Rangel; Lamas, Cristiane da CruzObjective: The goal of this prospective observational study was to identify adverse events (AEs) related to the use of intravenous access sites used for infective endocarditis (IE) treatment in a tertiary care hospital. Design: This is an observational, analytical and prospective study on AEs resulting from the use of intravenous access sites in patients under antimicrobial treatment for IE. Patients enrolled in the International Collaboration on Endocarditis (ICE) study had their peripheral, short-term central catheters (CVC) and peripherally inserted central catheters (PICC) monitored for AEs. Setting: Tertiary care hospital for cardiac surgery in Rio de Janeiro, Brazil. Patients: Patients over 14 years of age, hospitalised in 2009 and 2010 with possible or definite criteria for IE by the modified Duke criteria were included. Main outcome measures: AEs related to intravenous catheters: erythema and infiltration, fever, obstruction, externalisation and blood stream infection. Results: Thirty-seven episodes of IE in 35 patients were studied. Mean patient age was 44.32±15.2 years; 22 (63%) were men. The number of vascular catheters studied were 253, 148 of which were peripheral, 85 CVC (21 of which for haemodialysis) and 20 PICC. The most frequent AEs were 'erythema' and 'infiltration' for peripheral catheters, 'fever' for CVCs and 'obstruction' and 'externalisation' for PICCs. The number of catheter-days was 360 for peripheral catheters, 1.156 for CVC and 420 for PICC. Kaplan-Meier curves for CVC and PICC showed statistical difference for obstruction (p<0.001) in PICCs. More bacteraemia occurred in CVC compared with PICC. Conclusions: The choice of intravenous access sites is critical in the treatment of IE. Close observation for AEs and stricter implementation of infection control measures and better manipulation of catheters are suggested.
- ItemAnálise de custo-efetividade da Sinvastatina versus Atorvastatina na prevenção secundária de eventos cardiovasculares no Sistema Único de Saúde brasileiro(Value in Health, 2011) Araujo, Denizar Vianna; Souza, Camila Pepe Ribeiro de; Bahia, Luciana Ribeiro; Rey, Helena Cramer Veiga; Santos Junior, Braulio; Tura, Bernardo Rangel; Berwanger, Otavio; Buehler, Anna Maria; Silva, Marcus TolentinoObjective The objective of this study is to perform an economic evaluation analyzing the treatment with atorvastatin and simvastatin in comparison to placebo treatment, within the Brazilian Public Healthcare System (SUS) scenario, for patients with high risk of cardiovascular disease; analyzing if the additional cost related to statin treatment is justified by the clinical benefits expected, in terms of cardiovascular event and mortality reduction. Methods Cardiovascular event risk and mortality risk were used as outcomes. Statin efficacy at LDL-c and cardiovascular events levels lowering data was obtained from a systematic review of literature. A decision analytic model was developed to perform a cost-effectiveness analysis comparing atorvastatin 10mg/day and simvastatin 40mg/day to placebo treatment in patients with dyslipidemia in Brazil. The target population of this study was a hypothetic cohort of men and women with a mean age of 50 years old and high risk of cardiovascular disease. The model includes only direct costs obtained from Ambulatory and Hospital Information System and Price Database of Brazilian Ministry of Health. The comparative cost-effectiveness analysis itself was done through Excel spreadsheets covering a 5 -years time horizon. Results The result shows that atorvastatin 10mg/day in comparison to placebo has higher cost with higher effectiveness in the time horizon of 5 years (Incremental Cost Effectiveness Ratio of R$ 433.065,05 per life year gained). In this scenario atorvastatin is not cost effective in comparison to placebo. The simvastatin 40mg/day appears to be a strategy with lower cost and higher effectiveness in comparison to placebo, in the time horizon analyzed (5 years). In the multivariate probabilistic sensitivity analysis, simvastatin showed 53% of the results in the quadrant with greater effectiveness and lower cost. Conclusions This study is an important tool for public decision makers. The study can be used in the decision process of increasing cardiovascular disease treatment access with budgetary sustainability for Ministry of Health. In comparison to placebo, the results show that sinvastatin is a cost saving strategy while atorvastatin is not cost effective.
- ItemAnálise de custo-efetividade do reúso de cateteres de cinecoronariografia sob a perspectiva de uma instituição pública no Município do Rio de Janeiro, Brasil(Cadernos de Saúde Pública, 2013) Veras, Bruna Medeiros Gonçalves de; Senna, Kátia Marie Simões e; Correia, Marcelo Goulart; Santos, Marisa da SilvaO objetivo foi comparar a relação de custo-efetividade entre o uso de cateteres cardíacos novos com cateteres reprocessados sob a perspectiva de uma instituição pública federal. Foi elaborado um modelo analítico de decisão elaborado para estimar a razão de custo-efetividade entre duas estratégias de utilização de materiais para cateterismo cardíaco utilizando, como desfecho clínico, a ocorrência de reação pirogênica. Os custos foram estimados por coleta direta nos setores envolvidos e valorados em Real (R$) para o ano de 2012. A árvore de decisão foi construída com as probabilidades de pirogenia descritas em estudo clínico. O custo para o reúso foi de R$ 109,84, e, para cateteres novos, de R$ 283,43. A estratégia de reúso demonstrou ser custo-efetiva, e a razão de custo-efetividade incremental indicou que, para evitar um caso de pirogenia, serão gastos R$ 13.561,75. O estudo aponta o reúso de cateteres como uma estratégia de menor custo comparada ao uso exclusivo de cateteres novos e pode contribuir para a tomada de decisão dos gestores.
- ItemAnálise do impacto orçamentário da viscossuplementação no tratamento não cirúrgico da osteoartrite de joelho(Cadernos de Saúde Pública, 2019) Silva, Grasiela Martins da; Senna, Katia Marie Simões e; Sousa, Eduardo Branco de; Tura, Bernardo RangelA osteoartrite de joelho afeta cerca de 3,8% da população mundial e se manifesta por dor, edema, rigidez e redução da função articular, impactando na qualidade de vida do paciente. O tratamento consiste na modalidade farmacológica, não farmacológica e cirúrgica. A viscossuplementação (ácido hialurônico intra-articular) se propõe a oferecer alívio dos sintomas e a possibilidade de adiamento da cirurgia. Este estudo estimou o impacto orçamentário entre a associação desse medicamento e o tratamento não cirúrgico (tratamento padrão), sob a perspectiva do Sistema Único de Saúde. Com base no pressuposto de que 5% dos portadores da doença seguem para tratamento e nos custos diretos das modalidades: farmacológica e não farmacológica foram calculados os cenários de referência e alternativos que compararam as diferentes opções de tratamento para um horizonte temporal de três anos. A análise principal estimou um impacto orçamentário incremental de aproximadamente R$ 126 milhões (1 ampola anual) e R$ 252 milhões (2 ampolas anuais). Já a diacereína, um condroprotetor oral, avaliada como uma opção alternativa, mostrou um impacto de R$ 334 milhões no orçamento em relação ao tratamento padrão, o que proporciona um aumento de 24% no custo em relação ao uso de 2 ampolas anuais de ácido hialurônico, tornando-a economicamente menos vantajosa. A viscossuplementação pode proporcionar maior qualidade de vida ao paciente, redução de custos para o sistema e otimização do fluxo de atendimento nas unidades de saúde. As estimativas apresentadas neste estudo podem auxiliar o gestor quanto à melhor utilização dos recursos financeiros e consequente tomada de decisão quanto à incorporação da tecnologia.
- ItemAnálise em longo prazo na síndrome coronariana aguda: existem diferenças na morbimortalidade?(Arquivos Brasileiros de Cardiologia, 2010) Aguiar, Adolfo Alexandre Farah de; Mourilhe-Rocha, Ricardo; Esporcatte, Roberto; Amorim, Liana Correa; Tura, Bernardo Rangel; Albuquerque, Denilson Campos deFUNDAMENTO: A insuficiência cardíaca (IC) tem grande importância como preditor de morbimortalidade em pacientes com síndrome coronariana aguda (SCA). OBJETIVO: Avaliar os preditores de morbimortalidade na SCA em longo prazo. MÉTODOS: Foi um estudo de coorte de 403 pacientes consecutivos com queixas de dor torácica. Descreveram-se dados demográficos, clínicos, laboratoriais e terapêuticos, sendo avaliados durante a internação e até oito anos após alta, em relação à presença ou ausência de eventos cardiovasculares e óbitos. RESULTADOS: Foram 403 pacientes com queixas de dor torácica, em que 65,8% apresentavam diagnóstico de SCA sem supra de ST, 27,8% SCA com supra de ST e 6,5% sem SCA. Destes, foram avaliados os 377 pacientes com SCA, em que 37,9% eram do sexo feminino, e a média de idade foi de 62,2 ± 11,6 anos. A presença de IC antes ou durante a hospitalização influenciou a mortalidade. Dos fatores prognósticos, a creatinina inicial merece destaque, sendo o ponto de corte de 1,4 mg/dl (acurácia = 62,1%; HR = 3,27; p < 0,001). Notamos pior prognóstico para cada acréscimo de dez anos de idade (HR = 1,37; p < 0,001) e para cada incremento de 10 bpm na frequência cardíaca (HR = 1,22 p < 0,001). Quanto às terapias utilizadas antes e após 2002, houve aumento de uso de betabloqueadores, inibidores da enzima conversora da angiotensina (IECAs), estatinas e antiplaquetários, tendo impacto na mortalidade. CONCLUSÃO: Presença de IC admissional, creatinina, idade e FC foram preditores independentes de mortalidade. Observou-se que pacientes com IC atendidos antes de 2002 apresentaram pior sobrevida em relação aos atendidos após 2002 e que a mudança na terapia foi a responsável por isso.
- ItemApplication of the MCDA method for assessing new technologies for familial hypercholesterolaemia treatment(Jornal Brasileiro de Economia da Saúde, 2021) Santos. Marisa da Silva; Morais, Quenia Cristina Dias; Cramer, Helena; Assad, Marcelo; Tura, Bernardo; Santos Jr, Braulio; Nascimento, Aline doObjective: Familial hypercholesterolaemia is a hereditary disease characterized by very high levels of low-density lipoprotein cholesterol and an elevated risk of early-onset cardiovascular disorders. New drugs provide alternatives for the treatment of patients with homozygous familial hypercholesterolaemia. The study aims to explore a practical application of multiple-criteria decision analysis on prioritization of new and emerging technologies for familial hypercholesterolaemia. Methods: The decision model was constructed using the MACBETH method. There were three stages: structuring the problem, measuring the performance of alternatives, and building the model. The weights for alternatives and levels were obtained by indirect comparisons, which evaluated the attractiveness of the performance levels of the criteria using the swing weights technique. Results: The drugs lomitapide, ezetimibe, evolocumab, and mipomersen were selected as alternatives for decision-making. “Cardiovascular Death”, “Stroke” and “Acute Myocardial Infarction” had the three most significant weights. The criteria with the lowest weights were “Comfort” and “LDL-C Reduction”. The top-ranked technology was evolocumab, with an overall score of 59.87, followed by ezetimibe, with a score of 37.21. Conclusion: How to apply the result of a higher score in the actual decisionmaking process still requires further studies. The case in question showed that evolocumab has more performance benefits than other drugs but with a cost approximately 50 times higher.
- ItemAquisição de medicamentos para a Doença de Alzheimer no Brasil: uma análise no sistema federal de compras, 2008 a 2013(Ciência e Saúde coletiva, 2015) Costa, Roberta Dorneles Ferreira da; Osorio-de-Castro, Claudia Garcia Serpa; Silva, Rondineli Mendes da; Maia, Aurélio de Araújo; Ramos, Mariana de Carvalho Barbosa; Caetano, RosângelaO processo de transição demográfica brasileiro tem levado a substancial envelhecimento populacional e a aumento na prevalência de síndromes demenciais, entre as quais se destaca a Doença de Alzheimer (DA). Desde 2002, o tratamento farmacológico da doença possui Protocolo Clínico e Diretrizes Terapêuticas (PCDT) específico e os medicamentos recomendados são de financiamento pelo Ministério da Saúde. O estudo investigou a aquisição dos medicamentos utilizados no tratamento da DA a partir do Sistema Integrado de Administração de Serviços Gerais, traçando um perfil evolutivo das quantidades adquiridas, gastos e preços praticados no período de 2008 a 2013. Foram analisados os dados relativos a todas as apresentações adquiridas, inclusive as ausentes do PCDT. Os preços unitários foram deflacionados para dezembro/2013, pelo IPCA. Foram compradas mais de 47 milhões de unidades e gastos R$ 90,1 milhões com medicamentos para DA. Destaca-se nos gastos a participação da rivastigmina em suas diversas apresentações. Medicamentos não indicados pelo PCDT representaram 3% dos gastos, com percentuais de compra associados ao atendimento de ações judiciais pouco expressivos. No período, ocorreu redução dos preços médios ponderados corrigidos de todos os medicamentos, mesmo dos não presentes no PCDT.
- ItemThe Assessment for Disinvestment of Intramuscular Interferon Beta for Relapsing-Remitting Multiple Sclerosis in Brazil(PharmacoEconomics, 2018-02) Lemos, Livia Lovato Pires de; Guerra Junior, Augusto Afonso; Santos, Marisa; Magliano, Carlos; Diniz, Isabela; Souza, Kathiaja; Pereira, Ramon Gonçalves; Alvares, Juliana; Godman, Brian; Bennie, Marion; Zimmermann, Ivan Ricardo; Santos, Vânia Cristina Canuto dos; Petramale, Clarice Alegre; Acurcio, Francisco de AssisIn Brazil, inclusion and exclusion of health technologies within the Unified Health System (SUS) is the responsibility of the National Committee for Health Technology Incorporation (CONITEC). A recent Cochrane systematic review demonstrated that intramuscular interferon beta 1a (IFN-b-1a-IM) was inferior to the other beta interferons (IFN-bs) for multiple sclerosis (MS). As a result, CONITEC commissioned an analysis to review possible disinvestment within SUS. The objective of this paper is to describe the disinvestment process for IFN-b-1a-IM in Brazil. The first assessment comprised a literature review and mixed treatment comparison meta-analysis. The outcome of interest was the proportion of relapse-free patients in 2 years. This analysis confirmed the inferiority of IFN-b-1a-IM. Following this, CONITEC recommended disinvestment, with the decision sent for public consultation. More than 3000 contributions were made on CONITEC’s webpage, most of them against the preliminary decision. As a result, CONITEC commissioned a study to assess the effectiveness of IFN-b-1a-IM among Brazilian patients in routine clinical care. The second assessment involved an 11-year follow-up of a non-concurrent cohort of 12,154 MS patients developed by deterministic-probabilistic linkage of SUS administrative databases. The realworld assessment further demonstrated that IFN-b-1a-IM users had a statistically higher risk of treatment failure, defined as treatment switching or relapse treatment or death, with the assessment showing that IFN-b-1a-IM was inferior to the other IFN-bs and to glatiramer acetate in both direct and indirect analysis. In the drug ranking with 40,000 simulations, IFN-b-1a-IM was the worst option, with a success rate of only 152/40,000. Following this, CONITEC decided to exclude the intramuscular presentation of IFN-b from the current MS treatment guidelines, giving patients who are currently on this treatment the option of continuing until treatment failure. In conclusion, we believe this is the first example of this new disinvestment process in action, providing an exemplar for other treatments in Brazil as well as other countries.
- ItemAssociation between Carotid Intima-media Thickness and Early-onset Coronary Artery Disease: Does the site of Sonographic Evaluation Matter?(Heart, Lung and Circulation, 2015) Oliveira, Glaucia M.M.; Lorenzo, Andrea De; Souza, Elaine Guimarães de; Santos, BraulioBackground: Intima-media thickness (IMT) is frequently used for risk stratification (RS) due to the association with coronary artery disease (CAD). Nonetheless, the best carotid site to scan is uncertain, especially in the young. The aim of this study was to evaluate the diagnostic performance of IMT measurements performed at different carotid sites. Methods: Eighty-nine subjects 45 years were studied (55 with known CAD and 34 controls). IMT measurements were performed at the common carotid (CC), bulb and internal branch (IB) of both carotid arteries, (2112 measures). The diagnostic performance of IMT measurements performed at different sites, regarding the presence of CAD, was evaluated with ROC curves. Results: Carotid plaques were found in 20.0% of the patients and 6.0% of the controls. The diagnostic performance of carotid IMT measures obtained at the CC, bulb or IB was not significantly different, with the CC and IB being slightly better (AUC ROC =0.82 and 0.80 respectively). Conclusions: IMT measures obtained at different carotid sites are associated with CAD in young ( 45 years) individuals. The diagnostic performance of IMT measured at the CC and IB is the more accurate measure, and this may be the most adequate for the measurement of IMT in this population.
- ItemAutorização para uso off-label pode ser benéfica para o Sistema Único de Saúde?(Cadernos de Saúde Pública, 2023) Santos, Marisa da Silva; Costa, Marcia Gisele Santos da; Tura, Bernardo Rangel; Torres, Priscila; Martins, Sandro José; Toscas, Fotini SantosCom relação ao artigo publicado na seção Perspectivas de CSP 1, gostaríamos de apresentar uma visão diferente de um grupo de pesquisadores envolvidos de modo direto no processo de incorporação da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (Conitec) desde a criação da Comissão de Incorporação de Tecnologias do Ministério da Saúde (Citec).
- ItemAvaliação de custo-efetividade do cateterismo em veia jugular interna guiado por ultrassom no Sistema Único de Saúde brasileiro(Jornal Brasileiro de Economia da Saúde, 2019) Boller, Carlos Eduardo Pessanha; Senna, Kátia Marie Simões; Teixeira, Roberta da Silva; Goulart, Marcelo Correa; Tura, Bernardo Rangel; Santos, Marisa da SilvaObjective: To determine the economic feasibility of the central catheterization technique in the internal jugular vein guided by the ultrasound compared to the standard technique, under the perspective of the Brazilian Unified Health System. Methods: Cost-effectiveness analysis using decision tree model under a population of adult patients in a tertiary unit scenario. The direct costs of the materials and procedures were estimated using banks of national procurement records. The outcomes were the occurrence or not of severe accidental arterial puncture (the main complication associated with the puncture site). Analyzes of deterministic and probabilistic sensitivity were also conducted, as well as acceptability curve. Results: The intervention cost the model in R$ 53.81. The calculated incremental cost-effectiveness ratio was R$ 17,936.66 due to a serious complication avoided and the acceptability curve showed that the technique is cost-effective under an intention to pay R$ 18,125.00. In the probabilistic sensitivity analysis, 63.6% of the simulations were cost-effective. Conclusion: The intervention is cost-effective, contributing to the reduction of severe complications and the result can provide security for decision making regarding the standardization of the use of ultrasonography as a guideline of the procedure.