Abstract INTRODUCTION: The use of insecticide-impregnated dog collars is a potentially useful tool for the control of visceral leishmaniasis. The objective of the present study was to perform a cost-effectiveness analysis of a program based on insecticide-impregnated collars compared to traditional visceral leishmaniasis control strategies used in Brazil. METHODS: A cost-effectiveness analysis was performed from the perspective of the Unified Health System, using data from the Visceral Leishmaniasis Control Program implemented in the municipality of Montes Claros, Minas Gerais. The direct costs of the three control strategies, which were 1) canine infection screening + sacrifice, 2) residual chemical control of the vector, and 3) insecticide-impregnated dog collars (Scalibor®), were evaluated over the two-year study period. RESULTS: The total cost of the program in the area subjected to the traditional control strategies (strategies 1 and 2; control area) was R$ 1,551,699.80, and in the area subjected to all three control strategies (intervention area), it was R$ 1,898,190.16. The collar program was considered highly cost-effective at preventing canine visceral leishmaniasis (incremental cost-effectiveness ratio of approximately R$ 578 per avoided dog sacrifice). CONCLUSIONS: These results provide support for the decision by the Brazilian Ministry of Health in 2019 to provide insecticide-impregnated collars for the control of canine visceral leishmaniasis in a pilot project.

Abstract INTRODUCTION: Visceral leishmaniasis (VL) is fatal if not diagnosed and treated. This study aimed to estimate the cost-effectiveness of diagnostic-therapeutic alternatives for VL in Brazil. METHODS: A decision model estimated the life expectancy and costs of six diagnostic-therapeutic strategies. RESULTS: IT LEISH + liposomal amphotericin B emerged the best option, presenting lower costs and higher effectiveness. DAT-LPC + liposomal amphotericin B showed an incremental cost-effectiveness ratio of US$ 326.31 per life year. CONCLUSIONS: These findings indicate the feasibility of incorporating DAT and designating liposomal amphotericin B as the first-line drug for VL in Brazil.

Abstract Background: The SAMe-TT2R2 score was introduced to identify atrial fibrillation patients with a high risk of not achieving a good time in therapeutic range (TTR) during vitamin K antagonists (VKA) therapy. Objective: The aim of this study was to evaluate this score in venous thromboembolism (VTE) patients. Patients and methods: A retrospective cohort study of patients receiving care at the outpatient anticoagulation clinic of a tertiary care teaching hospital. Patients were classified as having low (score 0-1) or high risk (score ≥ 2) of not achieving a good TTR. The area under the ROC curve was calculated to assess the ability of the score to predict a TTR ≥ 65%. Adverse event-free survival curves according to the SAMe-TT2R2 score were calculated by the Kaplan-Meier method and compared by the log-rank test. A p-value < 0.05 was considered statistically significant. Results: We investigated 111 patients during a median follow-up of 2.3 (0.7-6.4) years. Mean age was 54.1 ± 15.7 years and 71 (64.0%) were women. Low- and high-risk groups had similar mean TTR (51.9 vs. 49.6%; p = 0.593). The two groups did not differ significantly in the percentage of patients achieving a TTR ≥ 65% (35.6 vs. 25.8%; p = 0.370). The c-statistic was 0.595 (p = 0.113) for TTR ≥ 65%. Adverse event-free survival during anticoagulation was also similar in both groups (p = 0.136). Conclusions: The SAMe-TT2R2 score does not seem to be a useful tool in oral anticoagulation decision-making for patients with VTE and should not be used in this setting.

RESUMO Introdução A medicina é uma atividade laborativa conhecida por elevados padrões de exigência. O período de formação do profissional médico inclui a residência médica, etapa em que fatores estressores podem ser magnificados. Assim, essa população poderia estar mais suscetível a síndrome de exaustão emocional, despersonalização e reduzida realização profissional, conhecida como burnout. Objetivo Determinar a prevalência de burnout e de cada uma de suas dimensões na população de médicos residentes do Hospital de Clínicas de Porto Alegre (HCPA) e investigar características sócio-ocupacionais associadas. Métodos Estudo transversal com médicos residentes do Hospital de Clínicas de Porto Alegre (HCPA), realizado no período de dezembro de 2015 a janeiro de 2016, mediante aplicação de um instrumento informatizado que contém dois questionários: um com variáveis sociodemográficas e o questionário Maslach Burnout Inventory (MBI). Análise estatística foi realizada pelo software SPSS versão 18, sendo utilizado o teste exato de Fisher e o teste do Qui-Quadrado de Pearson para as correlações. Resultados Dos 506 médicos residentes do HCPA, 151 participaram voluntariamente do estudo. Burnout esteve presente em 123 participantes (81,5%). “Exaustão emocional” foi a mais frequente dimensão (53%), seguida por “despersonalização” (47,7%) e “falta de realização profissional” (45%). Gênero masculino e residentes do segundo ano apresentaram maior possibilidade estatística de desenvolver burnout, sendo que os últimos também apresentaram menor realização profissional e maior despersonalização. Residentes do quarto ano estiveram menos associados à despersonalização e ao burnout de maneira global. Residentes de especialidades cirúrgicas estiveram menos associados à exaustão emocional. Cursar Psiquiatria mostrou-se um fator protetor para despersonalização, enquanto Radiologia apresentou ser um risco para essa dimensão. Conclusão A alta prevalência de burnout entre médicos residentes, especialmente entre aqueles que cursam o segundo ano, suscita preocupação, uma vez que pode levar ao risco de desenvolver depressão, ao abandono profissional e à diminuição na qualidade assistencial prestada aos pacientes. Assim, medidas preventivas contra seu desenvolvimento, associadas ao diagnóstico precoce e manejo clínico adequado, são fundamentais para a redução de sua prevalência.

ABSTRACT Introduction Medicine is a labor activity known for high standards of demand. The medical professional’s training period includes medical residency, a step in which stressors factors can be magnified. Thus, this population could be more susceptible to the syndrome of emotional exhaustion, depersonalization and reduced professional accomplishment, known by burnout. Objective To determine the prevalence of burnout and of each of its dimensions in the population of medical residents of the Hospital de Clínicas de Porto Alegre (HCPA) and to investigate associated socio-occupational characteristics. Methods A cross-sectional study was carried out with medical residents of the Hospital de Clínicas de Porto Alegre (HCPA) conducted from December 2015 to January 2016, using a computerized instrument containing two questionnaires: one with sociodemographic variables and the Maslach Burnout Inventory (MBI).Statistical analysis was performed by SPSS Software version 18, using Fisher’s exact test and Pearson’s chi-square test. for correlations. Results Of the 506 HCPA medical residents’, 151 participated voluntarily in the study. Burnout was present in 123 participants (81.5%). “Emotional exhaustion” was the most frequent dimension (53%), followed by “depersonalization” (47.7%) and “lack of professional achievement” (45%). Male gender and residents of the second year had a higher statistical possibility of developing Burnout, and the latter, also presented lower professional achievement and greater depersonalization. Fourth-year residents were less associated with depersonalization and burnout overall. Residents of surgical specialties were less associated with emotional exhaustion. Studying psychiatry was shown to be a protective factor for depersonalization, while radiology presented a risk to this dimension. Conclusion The high prevalence of burnout among medical residents especially among those attending the second year, raises concern, since it can lead to the risk of developing depression, to professional abandonment, to a decrease in the quality of care provided to patients. Thus, preventive measures against its development associated to the early diagnosis and adequate clinical management are fundamental for the reduction of its prevalence.

Resumo Fundamento: O escore HAS-BLED foi desenvolvido para avaliar o risco em um ano de sangramento maior em pacientes com fibrilação atrial (FA) anticoagulados com antagonistas da vitamina K (AVK). Objetivo: O objetivo deste estudo foi avaliar a capacidade do escore HAS-BLED e de seus componentes em predizer sangramento maior em pacientes atendidos em um ambulatório de anticoagulação de um hospital terciário. Métodos: Foi realizado um estudo coorte retrospectivo com pacientes com FA tratados com AVK. Análise de regressão logística foi realizada para avaliar a capacidade de cada componente do escore em predizer sangramento maior. O nível de significância adotado em todos os testes foi de 5%. Resultados: Foram estudados 263 pacientes com média de idade de 71,1 ± 10,5 anos ao longo de um período de tratamento de 237,6 pacientes-ano. A mediana do escore HAS-BLED foi de 2 (1-3). A incidência de sangramento maior foi de 5,7%, sendo mais elevada nos pacientes de alto risco que nos pacientes de baixo risco (9,6 vs. 3,1%; p = 0,052). A área sob a curva ROC foi de 0,70 (p = 0,01). Um ponto de corte ≥ 3 mostrou sensibilidade de 66,7%, especificidade de 62,1%, valor preditivo positivo de 9,6% e valor preditivo negativo de 96,9%. Sobrevida livre de sangramento maior foi menor no grupo de alto risco (p = 0,017). Na análise multivariada, o único preditor independente de sangramento maior entre os componentes do escore foi o uso concomitante de antiplaquetários (OR 5,13, IC95%: 1,55-17,0; p = 0,007). Conclusão: O escore HAS-BLED foi capaz de prever sangramento maior na população de pacientes com FA estudada. Entre os componentes do escore, atenção especial deve ser dada para o uso concomitante de antiplaquetários, que mostrou associação independente. Em pacientes com FA em uso de AVK como terapia anticoagulante, o uso de antiplaquetários deve ser realizado somente naqueles pacientes com avaliação risco-benefício favorável.

Abstract Background: HAS-BLED score was developed to assess 1-year major bleeding risk in patients anticoagulated with vitamin K antagonists (VKA) due to atrial fibrillation (AF). Objective: Of this study was to assess the ability of HAS-BLED score and its components to predict major bleeding in patients treated in an anticoagulation outpatient clinic of a tertiary hospital. Methods: A retrospective cohort study on AF patients treated with VKA was conducted. Logistic regression analysis was performed to evaluate the ability of individual score components to predict major bleeding. The significance level adopted in all tests was 5%. Results: We studied 263 patients with a mean age of 71.1 ± 10.5 years over a period of 237.6 patients-year. Median HAS-BLED score was 2 (1-3). The overall incidence of major bleeding was 5.7%, and it was higher among high-risk HAS-BLED score patients than in low risk patients (9.6 vs. 3.1%; p = 0.052). Area under the ROC curve was 0.70 (p = 0.01). Cut-off point ≥ 3 showed sensibility of 66.7%, specificity of 62.1%, positive predictive value of 9.6% and negative predictive value of 96.9%. Major bleeding-free survival was lower in high-risk group (p = 0.017). In multivariate analysis, concurrent antiplatelet use was the only independent predictor of major bleeding among score components (OR 5.13, 95%CI: 1.55-17.0; p = 0.007). Conclusion: HAS-BLED score was able to predict major bleeding in this cohort of AF patients. Among score components, special attention should be given for concomitant antiplatelet use, which was independently associated to this outcome. Antiplatelets in AF patients under VKA anticoagulation should be used in selected patients with favorable risk-benefit assessment.

Abstract INTRODUCTION: The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. METHODS: The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. RESULTS: The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. CONCLUSIONS: This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained.

Resumo: O estudo teve como objetivo estimar os custos financeiros da incorporação e/ou substituição dos testes diagnósticos para a leishmaniose visceral (LV) humana no Brasil. A análise foi realizada na perspectiva do Sistema Único de Saúde (SUS) ao longo de três anos. Foram avaliados seis testes diagnósticos: reação de imunofluorescência indireta (RIFI), teste rápido IT LEISH, exame parasitológico de aspirado de medula óssea, teste de aglutinação direta DAT-LPC padronizado pelo Laboratório de Pesquisas Clínicas do Instituto René Rachou, Fundação Oswaldo Cruz, teste rápido Kalazar Detect e reação em cadeia da polimerase (PCR). Os parâmetros utilizados foram o número de casos suspeitos de LV notificados ao Ministério da Saúde em 2014 e o custo direto dos testes diagnósticos. Os custos do diagnóstico de casos suspeitos de LV ao longo de três anos usando o RIFI e DAT-LPC foram estimados em USD 280.979,91 e USD 121.371,48, respectivamente. De acordo com a análise, comparado ao uso do RIFI, a incorporação do DAT-LPC pelo SUS resultaria numa economia de USD 159.608,43. Com relação ao impacto dos testes rápidos, o uso do IT LEISH resultou em economia de USD 21.708,72 ao longo de três anos. Comparado ao exame parasitológico, o diagnóstico com PCR resultou em economia de USD 3.125.068,92 ao longo de três anos. Neste estudo, a substituição do RIFI pelo DAT-LPC mostrou ser financeiramente vantajosa. Além disso, a substituição do teste rápido Kalazar Detect com o IT LEISH em 2015 foi economicamente apropriada, e a substituição do exame parasitológico pela PCR está economicamente indicada.

Abstract: The aim of the present study was to estimate the financial costs of the incorporation and/or replacement of diagnostic tests for human visceral leishmaniasis (VL) in Brazil. The analysis was conducted from the perspective of the Brazilian Unified National Health System (SUS) over a period of three years. Six diagnostic tests were evaluated: the indirect immunofluorescence antibody test (IFAT), the IT LEISH rapid test, the parasitological examination of bone marrow aspirate, the direct agglutination test (DAT-LPC) standardized in the Clinical Research Laboratory, René Rachou Institute of the Oswaldo Cruz Foundation, the Kalazar Detect rapid test, and polymerase chain reaction (PCR). The assumptions used were the number of suspected cases of VL reported to the Brazilian Ministry of Health in 2014 and the direct cost of diagnostic tests. The costs to diagnose suspected cases of VL over three years using the IFAT and the DAT-LPC were estimated at USD 280,979.91 and USD 121,371.48, respectively. The analysis indicated that compared with the use of the IFAT, the incorporation of the DAT-LPC into the SUS would result in savings of USD 159,608.43. With regard to the budgetary impact of rapid tests, the use of IT LEISH resulted in savings of USD 21.708,72 over three years. Compared with a parasitological examination, diagnosis using PCR resulted in savings of USD 3,125,068.92 over three years. In this study, the replacement of the IFAT with the DAT-LPC proved financially advantageous. In addition, the replacement of the Kalazar Detect rapid test with the IT LEISH in 2015 was economically valuable, and the replacement of parasitological examination with PCR was indicated.

Resumen: El objetivo del estudio fue estimar los costes financieros de la incorporación y/o sustitución de las pruebas diagnósticas para la leishmaniasis visceral (LV) humana en Brasil. El análisis se realizó desde la perspectiva del Sistema Único de Salud (SUS) a lo largo de tres años. Se evaluaron seis pruebas diagnósticas: reacción de inmunofluorescencia indirecta (RIFI), test rápido IT LEISH, examen parasitológico de aspirado de medula ósea, test de aglutinación directa DAT-LPC, estandarizado por el Laboratorio de Investigación Clínica del Centro de Investigación René Rachou, Fundación Oswaldo Cruz, test rápido Kalazar Detect y la reacción en cadena de la polimerasa (PCR). Los parámetros utilizados fueron el número de casos sospechosos de LV notificados al Ministerio de Salud en 2014 y el coste directo de los test diagnósticos. Los costes del diagnóstico de casos sospechosos de LV a lo largo de tres años, usando el RIFI y DAT-LPC, se estimaron en USD 280.979,91 y USD 121.371,48, respectivamente. De acuerdo con el análisis, comparado con el uso del RIFI, la incorporación del DAT-LPC por el SUS resultaría en un ahorro de USD 159.608,43. En relación con el impacto de los test rápidos, el uso del IT LEISH aportaba un ahorro de USD 21.708,72 a lo largo de tres años. Comparado con el examen parasitológico, el diagnóstico con PCR suponía un ahorro de USD 3.125.068,92 a lo largo de tres años. De acuerdo con el estudio, la sustitución del RIFI con el DAT-LPC mostró ser financieramente ventajosa. Asimismo, la sustitución del test rápido Kalazar Detect con el IT LEISH en 2015 representó un ahorro económico, y los resultados favorecieron la sustitución del examen parasitológico con PCR.

Resumo: O estudo teve como objetivo estimar os custos financeiros da incorporação e/ou substituição dos testes diagnósticos para a leishmaniose visceral (LV) humana no Brasil. A análise foi realizada na perspectiva do Sistema Único de Saúde (SUS) ao longo de três anos. Foram avaliados seis testes diagnósticos: reação de imunofluorescência indireta (RIFI), teste rápido IT LEISH, exame parasitológico de aspirado de medula óssea, teste de aglutinação direta DAT-LPC padronizado pelo Laboratório de Pesquisas Clínicas do Instituto René Rachou, Fundação Oswaldo Cruz, teste rápido Kalazar Detect e reação em cadeia da polimerase (PCR). Os parâmetros utilizados foram o número de casos suspeitos de LV notificados ao Ministério da Saúde em 2014 e o custo direto dos testes diagnósticos. Os custos do diagnóstico de casos suspeitos de LV ao longo de três anos usando o RIFI e DAT-LPC foram estimados em USD 280.979,91 e USD 121.371,48, respectivamente. De acordo com a análise, comparado ao uso do RIFI, a incorporação do DAT-LPC pelo SUS resultaria numa economia de USD 159.608,43. Com relação ao impacto dos testes rápidos, o uso do IT LEISH resultou em economia de USD 21.708,72 ao longo de três anos. Comparado ao exame parasitológico, o diagnóstico com PCR resultou em economia de USD 3.125.068,92 ao longo de três anos. Neste estudo, a substituição do RIFI pelo DAT-LPC mostrou ser financeiramente vantajosa. Além disso, a substituição do teste rápido Kalazar Detect com o IT LEISH em 2015 foi economicamente apropriada, e a substituição do exame parasitológico pela PCR está economicamente indicada.

Abstract: The aim of the present study was to estimate the financial costs of the incorporation and/or replacement of diagnostic tests for human visceral leishmaniasis (VL) in Brazil. The analysis was conducted from the perspective of the Brazilian Unified National Health System (SUS) over a period of three years. Six diagnostic tests were evaluated: the indirect immunofluorescence antibody test (IFAT), the IT LEISH rapid test, the parasitological examination of bone marrow aspirate, the direct agglutination test (DAT-LPC) standardized in the Clinical Research Laboratory, René Rachou Institute of the Oswaldo Cruz Foundation, the Kalazar Detect rapid test, and polymerase chain reaction (PCR). The assumptions used were the number of suspected cases of VL reported to the Brazilian Ministry of Health in 2014 and the direct cost of diagnostic tests. The costs to diagnose suspected cases of VL over three years using the IFAT and the DAT-LPC were estimated at USD 280,979.91 and USD 121,371.48, respectively. The analysis indicated that compared with the use of the IFAT, the incorporation of the DAT-LPC into the SUS would result in savings of USD 159,608.43. With regard to the budgetary impact of rapid tests, the use of IT LEISH resulted in savings of USD 21.708,72 over three years. Compared with a parasitological examination, diagnosis using PCR resulted in savings of USD 3,125,068.92 over three years. In this study, the replacement of the IFAT with the DAT-LPC proved financially advantageous. In addition, the replacement of the Kalazar Detect rapid test with the IT LEISH in 2015 was economically valuable, and the replacement of parasitological examination with PCR was indicated.

Resumen: El objetivo del estudio fue estimar los costes financieros de la incorporación y/o sustitución de las pruebas diagnósticas para la leishmaniasis visceral (LV) humana en Brasil. El análisis se realizó desde la perspectiva del Sistema Único de Salud (SUS) a lo largo de tres años. Se evaluaron seis pruebas diagnósticas: reacción de inmunofluorescencia indirecta (RIFI), test rápido IT LEISH, examen parasitológico de aspirado de medula ósea, test de aglutinación directa DAT-LPC, estandarizado por el Laboratorio de Investigación Clínica del Centro de Investigación René Rachou, Fundación Oswaldo Cruz, test rápido Kalazar Detect y la reacción en cadena de la polimerasa (PCR). Los parámetros utilizados fueron el número de casos sospechosos de LV notificados al Ministerio de Salud en 2014 y el coste directo de los test diagnósticos. Los costes del diagnóstico de casos sospechosos de LV a lo largo de tres años, usando el RIFI y DAT-LPC, se estimaron en USD 280.979,91 y USD 121.371,48, respectivamente. De acuerdo con el análisis, comparado con el uso del RIFI, la incorporación del DAT-LPC por el SUS resultaría en un ahorro de USD 159.608,43. En relación con el impacto de los test rápidos, el uso del IT LEISH aportaba un ahorro de USD 21.708,72 a lo largo de tres años. Comparado con el examen parasitológico, el diagnóstico con PCR suponía un ahorro de USD 3.125.068,92 a lo largo de tres años. De acuerdo con el estudio, la sustitución del RIFI con el DAT-LPC mostró ser financieramente ventajosa. Asimismo, la sustitución del test rápido Kalazar Detect con el IT LEISH en 2015 representó un ahorro económico, y los resultados favorecieron la sustitución del examen parasitológico con PCR.