Accuracy of rapid point-of-care serological tests for leprosy diagnosis: a systematic review and meta-analysis

BACKGROUND Leprosy is a chronic infectious disease, still endemic in many countries that may lead to neurological, ophthalmic, and motor sequelae if not treated early. Access to timely diagnosis and multidrug therapy (MDT) remains a crucial element in the World Health Organization's strategy to eliminate the disease as a public health problem. OBJECTIVES This systematic review aims to evaluate the accuracy of rapid point-of-care (POC) tests for diagnosis of leprosy. METHODS Searches were carried out in electronic databases (PubMed, EMBASE, CRD, Cochrane Library and LILACS) in April 2021 for patients with suspicion or confirmatory diagnostic of leprosy, classified in multibacillary (MB) or paucibacillary (PB) cases, performing rapid POC serological tests compared to clinical evaluation, smear microscopy and immunohistochemistry analysis. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2). A meta-analysis was undertaken to generate pooled estimates of diagnostic parameters, presenting sensitivity, specificity and diagnostic odds ratio (DOR) values. The review protocol was registered at PROSPERO, CRD # 42014009658. FINDINGS From 893 potentially relevant references, 12 articles were included reporting 16 diagnostic tests accuracy studies with 5395 individuals enrolled. Meta-analysis of NDO-LID and PGL-I tests data in MB patients showed sensitivity and specificity [95% confidence interval (CI)] of 0.83 (0.71-0.91), 0.91 (0.72-0.97); and 0.92 (0.86-0.96), 0.93 (0.78-0.98); respectively, with high heterogeneity among the studies. MAIN CONCLUSIONS Our results can inform policymakers regarding the possibility of implementing accurate, rapid POC tests for leprosy in public health services, especially within primary health care.

Snakebites caused by the genera Bothrops and Lachesis in the Brazilian Amazon: a study of factors associated with severe cases and death

ABSTRACT Background: Snakebites are a major problem in developing countries owing to their high morbidity rates, severity, and sequelae. In Brazil, most cases of envenomation are caused by Bothrops and Lachesis snakes. The present study aimed to evaluate variables associated with death, systemic complications, and amputations in victims of envenomation due to Bothrops or Lachesis snake. Methods: An analytical epidemiological study was performed with data from the Notifiable Diseases Information System (Sistema de Informação de Agravos de Notificação [SINAN]) relating to the Brazilian Amazon for the period 2010-2015. A hierarchical Poisson regression analysis was performed with three aspects, namely, individual characteristics, sociodemographic characteristics, and clinical conditions. Results: The following associations were observed: i) advanced age (>65 years), sepsis, renal failure, and hemorrhagic manifestations were related to two outcomes - death due to snakebite and death from all causes; ii) more advanced age (≥46 years), time to health care longer than 6 hours, renal and hemorrhagic manifestations, and region of occurrence being rural areas were associated with systemic complications; and iii) children (up to 12 years old) were associated with amputations. Conclusions: Knowledge of the characteristics associated with severe outcomes in snakebites may help identify patients who will require more intensive care or longer follow-up and may provide the physician with counseling rationale for their possible prognosis.

Tuberculose e diabetes: associação com características sociodemográficas e de diagnóstico e tratamento. Brasil, 2007-2011 / Tuberculosis and diabetes: association with sociodemographic characteristics and diagnosis and treatment of tuberculosis. Brazil, 2007-2011

RESUMO: Introdução: A comorbidade tuberculose e diabetes ainda continua um desafio para a saúde pública mundial. Objetivo: Analisar o perfil sociodemográfico e as características do diagnóstico e tratamento dos casos de tuberculose com e sem diabetes no Brasil. Métodos: Estudo transversal, com dados do Sistema de Informação de Agravos de Notificação e do Sistema de Gestão Clínica de Hipertensão Arterial e Diabetes Mellitus da Atenção Básica, no período de 2007 a 2011. Modelo de regressão de Poisson com variância robusta foi utilizado para estimar a razão de prevalência (RP) e seus respectivos intervalos de confiança. Resultados: A comorbidade estudada foi encontrada em 7,2% dos casos. Modelo hierárquico mostrou maior RP entre indivíduos do sexo feminino (RP = 1,31; intervalo de confiança de 95% - IC95% 1,27 - 1,35); maior associação nas faixas etárias 40-59 anos e ≥ 60 anos (RP = 11,70; IC95% 10,21 - 13,39 e RP = 17,49; IC95% 15,26-20,05) e com resultado positivo da baciloscopia - primeira amostra (RP = 1,40; IC95% 1,35 - 1,47). Reingresso após abandono e abandono foram inversamente associados na comorbidade (RP = 0,66; IC95% 0,57 - 0,76 e RP = 0,79; IC95% 0,72 - 0,87). Conclusão: Os achados, como a relação inversa do abandono ao tratamento da tuberculose no grupo das pessoas com comorbidade, reforçam a importância de ações integradas nos serviços para mudar o cenário dessa desafiadora comorbidade.

ABSTRACT: Introduction: Tuberculosis and diabetes comorbidity remains a challenge for global public health. Objective: To analyze the sociodemographic profile and the diagnostic and treatment characteristics of tuberculosis cases with and without diabetes in Brazil. Methods: This is a cross-sectional study with data from the Notifiable Diseases Information System and the Hypertension and Diabetes Mellitus Primary Care Clinical Management System, from 2007 to 2011. We adopted a Poisson regression model with robust variance to estimate the prevalence ratios (PR) and their respective confidence intervals. Results: We found the studied comorbidity in 7.2% of cases. The hierarchical model showed a higher PR among women (PR=1.31; 95% confidence interval - 95%CI 1.27-1.35); a greater association in the age groups 40-59 years and ≥ 60 years (PR=11.70; 95%CI 10.21-13.39, and PR=17.49; 95%CI 15.26-20.05), and in those with positive sputum smear microscopy results - 1st sample (PR=1.40; 95%CI 1.35-1.47). Return after treatment discontinuation and treatment discontinuation were inversely associated with comorbidity (PR=0.66; 95%CI 0.57-0.76 and PR=0.79; 95%CI 0.72-0.87). Conclusion: The findings, such as the inverse relationship with tuberculosis treatment discontinuation in the group of people with comorbidity, reinforce the importance of integrated actions in health services to change the scenario of this challenging comorbidity.

The cost of a disease targeted for elimination in Brazil: the case of schistosomiasis mansoni

BACKGROUND Schistosomiasis mansoni is a poverty-related parasitic infection that has a variety of clinical manifestations. We consider the disability and deaths caused by schistosomiasis unacceptable for a tool-ready disease. Its condition in Brazil warrants an analysis that will enable better understanding of the local health losses and contribute to the complex decision-making process. OBJECTIVE This study estimates the cost of schistosomiasis in Brazil in 2015. METHODS We conducted a cost of illness study of schistosomiasis mansoni in Brazil in 2015 based on a prevalence approach and from a societal perspective. The study included 26,499 schistosomiasis carriers, 397 hepatosplenic cases, 48 cases with the neurological form, 284 hospitalisations, and 11,368.26 years of life lost (YLL) of which 5,187 years are attributable to economically active age groups. RESULTS The total cost of schistosomiasis mansoni in Brazil was estimated to be US$ 41,7million in 2015 with 94.61% of this being indirect costs. CONCLUSIONS The economic burden of schistosomiasis mansoni in Brazil is high and results in the loss of productivity. Its persistence in Brazil is a challenge to public health and requires inter-sectorial interventions in areas such as indoor water supply, basic sanitation, and education.

Epidemiological features, echocardiographic findings, and parasite load in patients with Chagas disease

Abstract INTRODUCTION Chagas disease is a major public health problem that is endemic in Brazil and Latin America. This study aimed to determine the socioeconomic, demographic, and clinical characteristics of 171 patients (mean age, 45 years; female, 65%) with Chagas disease at Hospital Universitário de Brasília, Federal District, Brazil. METHODS We implemented this cross-sectional study using a clinical epidemiological questionnaire, electrocardiography, echocardiography, and quantitative detection of Trypanosoma cruzi DNA in blood using qRT-PCR. RESULTS Among the patients, 26.3% had a full elementary education, and 13.2% were illiterate. Most (63.6%) were economically classified as class C, and 51.5% were born in Bahia state. A total of 62.0% participants reported previous contact with the triatomine bug. The clinical forms of the disease were indeterminate (69.51%), cardiac (15.24%), digestive (10.37%), and mixed (4.88%). The most common electrocardiographic abnormality was complete right bundle branch block in association with a divisional anterosuperior block. Only 14.6% of the patients complied with benznidazole medication for at least 60 days, and 164 of them were assessed by echocardiography. The parasite load was positive in 56% of the patients. CONCLUSIONS: Chagas disease affected mostly women, with the indeterminate chronic form of the disease.

Home care in the Federal District: factors associated with the first occurrence of acute lower respiratory infection and death

Abstract INTRODUCTION: We aimed to evaluate the frequency and associated factors of acute respiratory infection and death among home care patients in Sobradinho/DF, Brazil. METHODS: Data were obtained from patients' medical records. Bivariate and multivariate analyses were performed. Odds ratio and 95% confidence interval were estimated. RESULTS: Factors associated with respiratory infection were ages <40 and >80 years and accommodation. Female sex was a protective factor. Age >30 years and dependency for daily activities were associated with death. CONCLUSIONS: These factors can improve clinical results in this specific home care and open new opportunities and questions for future research.

Systematic Review of Health Economic Evaluations of Diagnostic Tests in Brazil: How accurate are the results?

The aim of this study is to identify and characterize the health economic evaluations (HEEs) of diagnostic tests conducted in Brazil, in terms of their adherence to international guidelines for reporting economic studies and specific questions in test accuracy reports. We systematically searched multiple databases, selecting partial and full HEEs of diagnostic tests, published between 1980 and 2013. Two independent reviewers screened articles for relevance and extracted the data. We performed a qualitative narrative synthesis. Forty-three articles were reviewed. The most frequently studied diagnostic tests were laboratory tests (37.2%) and imaging tests (32.6%). Most were non-invasive tests (51.2%) and were performed in the adult population (48.8%). The intended purposes of the technologies evaluated were mostly diagnostic (69.8%), but diagnosis and treatment and screening, diagnosis, and treatment accounted for 25.6% and 4.7%, respectively. Of the reviewed studies, 12.5% described the methods used to estimate the quantities of resources, 33.3% reported the discount rate applied, and 29.2% listed the type of sensitivity analysis performed. Among the 12 cost-effectiveness analyses, only two studies (17%) referred to the application of formal methods to check the quality of the accuracy studies that provided support for the economic model. The existing Brazilian literature on the HEEs of diagnostic tests exhibited reasonably good performance. However, the following points still require improvement: 1) the methods used to estimate resource quantities and unit costs, 2) the discount rate, 3) descriptions of sensitivity analysis methods, 4) reporting of conflicts of interest, 5) evaluations of the quality of the accuracy studies considered in the cost-effectiveness models, and 6) the incorporation of accuracy measures into sensitivity analyses.

Tuberculose e diabetes: relacionamento probabilístico de bases de dados para o estudo da associação entre ambas doenças / Tuberculosis y diabetes: la relación probabilística de bases de datos para estudiar la asociación entre la enfermedades / Tuberculosis and diabetes: probabilistic linkage of databases to study the association between both diseases

OBJETIVO: descrever o perfil dos casos de comorbidade tuberculose-diabetes no Brasil. MÉTODOS: estudo descritivo com dados do Sistema de Informação de Agravos de Notificação - tuberculose (Sinan-tuberculose) e do Sistema de Gestão Clínica de Hipertensão Arterial e Diabetes Mellitus da Atenção Básica (Hiperdia), de 2007 a 2011; o relacionamento probabilístico foi realizado com auxílio do software Reclink. RESULTADOS: foram encontrados 24.443 casos de comorbidade, incluindo 3.181 não registrados no Sinan-tuberculose; do total de casos recuperados, predominaram indivíduos do sexo masculino (57,2%), faixa etária de 40 a 59 anos (52,3%), raça/cor da pele preta/parda (68,4%), cinco a oito anos de estudo (78,4%), uso não regular de álcool (86,5%) e sorologia negativa para o vírus da imunodeficiência humana - HIV (91,8%). CONCLUSÃO: os casos captados tiveram perfil semelhante àqueles registrados no Sinan-tuberculose e o relacionamento dos dados de diferentes sistemas de informações possibilitou a detecção de casos não captados pela vigilância.

OBJETIVO: describir el perfil de comorbilidad de casos entre tuberculosis y diabetes en Brasil. MÉTODOS: estudio descriptivo con datos del sistema de información de casos de notificación obligatoria - tuberculosis (Sinan-tuberculosis) y el Sistema de Gestión Clínica de Hipertensión y Diabetes Mellitus de Atención Primaria (Hiperdia), 2007-2011; la relación probabilística se realizó con el software Reclink. RESULTADOS: encontramos 24.443 casos de comorbilidad, incluyendo 3.181 casos no registrado en Sinan-tuberculosis; del número total de casos recuperados predominaron varones (57,2%), edades entre 40-59 años (52,3%), negro/mulato (68,4%), cinco a ocho años de estudio (78,4%), no uso alcohol (86,5%) y serología negativa para el virus de inmunodeficiencia humana HIV (91,8%). CONCLUSIÓN: los casos captados tuvieron un perfil similar a los del Sinan-tuberculosis y el relacionamiento de datos entre diferentes sistemas de información ayudó a la detección de casos no captador por la vigilancia.

OBJECTIVE: to describe the profile of cases of tuberculosis and diabetes comorbidity in Brazil. METHODS: this is a descriptive study with data from the Brazilian Information System for Notifiable Diseases - tuberculosis (Sinan-TB) and from the System of Registration and Monitoring of Hypertension and Diabetes Mellitus (Hiperdia), from 2007 to 2011; probabilistic linkage was carried out with Reclink software. RESULTS: 24,443 cases of comorbidity were found, including 3,181 cases not registered on Sinan-TB; of the total number of recovered cases, mostly were males (57.2%), aged 40-59 years (52.3%), black/brown-skinned (68.4%), with five to eight years of schooling (78.4%), with no regular use of alcohol (86.5%) and negative serology for the HIV virus (91.8%). CONCLUSION: the cases found had similar profile to those registered on Sinan-TB and the probabilistic linkage of data from different information systems enabled the detection of cases not captured by surveillance.

Glucose-6-phosphate dehydrogenase deficiency and the use of primaquine: top-down and bottom-up estimation of professional costs / Deficiência de glicose-6-fosfato desidrogenase e uso de primaquina: estimativa de custos de profissionais por macrocusteio e microcusteio

ABSTRACT The aim of this study has been to study whether the top-down method, based on the average value identified in the Brazilian Hospitalization System (SIH/SUS), is a good estimator of the cost of health professionals per patient, using the bottom-up method for comparison. The study has been developed from the context of hospital care offered to the patient carrier of glucose-6-phosphate dehydrogenase (G6PD) deficiency with severe adverse effect because of the use of primaquine, in the Brazilian Amazon. The top-down method based on the spending with SIH/SUS professional services, as a proxy for this cost, corresponded to R$60.71, and the bottom-up, based on the salaries of the physician (R$30.43), nurse (R$16.33), and nursing technician (R$5.93), estimated a total cost of R$52.68. The difference was only R$8.03, which shows that the amounts paid by the Hospital Inpatient Authorization (AIH) are estimates close to those obtained by the bottom-up technique for the professionals directly involved in the care.

RESUMO A pesquisa teve por objetivo estudar se o macrocusteio, baseado no valor médio identificado no Sistema de Internação Hospitalar (SIH/SUS), constitui um bom estimador do custo de profissionais de saúde por paciente, tendo como comparação o método de microcusteio. O estudo foi desenvolvido no contexto da assistência hospitalar oferecida ao portador da deficiência de glicose-6-fosfato desidrogenase (dG6PD) do sexo masculino com evento adverso grave devido ao uso da primaquina, na Amazônia Brasileira. O macrocusteio baseado no gasto em serviços profissionais do SIH/SUS, como proxy desse custo, correspondeu a R$60,71, e o microcusteio, baseado nos salários do médico (R$30,43), do enfermeiro (R$16,33) e do técnico de enfermagem (R$5,93), estimou um custo total de R$52,68. A diferença foi de apenas R$8,03, mostrando que os valores pagos pela Autorização de Internação Hospitalar (AIH) são estimadores próximos daqueles obtidos por técnica de microcusteio para os profissionais envolvidos diretamente no cuidado.

Validation of the rapid test carestart(tm) G6PD among malaria vivax-infected subjects in the Brazilian Amazon

Abstract: INTRODUCTION: In the Brazilian Amazon, malaria infections are primarily caused by Plasmodium vivax. The only drug that kills the hypnozoite form of P. vivax is primaquine, thereby preventing relapse. However, treating glucose-6-phosphate dehydrogenase (G6PD)-deficient individuals with primaquine can lead to severe hemolysis. G6PD deficiency (G6PDd) affects approximately 400 million people worldwide, most of whom live in malaria-endemic areas. Therefore, clinicians need tools that can easily and reliably identify individuals with G6PDd. This study estimated the accuracy of the Carestart(tm) G6PD rapid test (Access Bio) in the diagnosis of G6PDd in male participants with and without P. vivax acute malaria. METHODS: Male participants were recruited in Manaus. Malaria diagnosis was determined by thick blood smear. G6PD quantitative analysis was performed spectro photometrically at a wave length of 340nm. The Carestart(tm) G6PD test was performed using venous blood. Genotyping was performed for individuals whose samples had an enzyme activity less than 70% of the normal value. RESULTS: Six hundred and seventy-four male participants were included in this study, of whom 320 had a diagnosis of P. vivax malaria. In individuals with enzyme activity lower than 30% (n=13), the sensitivity, specificity, positive predictive value, and negative predictive value of the Carestart(tm) G6PD test were as follows: 61.5% (95%CI: 35.5%-82.3%), 98.3% (95%CI: 97.0%-99.1%), 42.1% (95%CI: 23.1%-63.7%), and 99.2% (95%CI: 98.2%-82.3%), 98.3% (95%CI: 97.0%-99.1%), 42.1% (95%CI: 23.1%-63.7%), and 99.2% (95%CI: 98.2%-99.7%), respectively. Increases in sensitivity were observed when increasing the cut-off value. CONCLUSIONS: Despite low sensitivity, Carestart(tm) G6PD remains a good alternative for rapid diagnosis of G6PDd in malaria-endemic regions.

Record of hospitalizations for ambulatory care sensitive conditions: validation of the hospital information system / Registro das internacoes por condicoes sensiveis a atencao primaria: validacao do sistema de informacao hospitalar / Registro de internaciones por condiciones sensibles a la atencion primaria: validacion del sistema de informacion hospitalaria

OBJECTIVE: to estimate the sensitivity, specificity and positive and negative predictive values of the Unified Health System's Hospital Information System for the appropriate recording of hospitalizations for ambulatory care-sensitive conditions. METHOD: the hospital information system records for conditions which are sensitive to ambulatory care, and for those which are not, were considered for analysis, taking the medical records as the gold standard. Through simple random sampling, a sample of 816 medical records was defined and selected by means of a list of random numbers using the Statistical Package for Social Sciences. RESULT: the sensitivity was 81.89%, specificity was 95.19%, the positive predictive value was 77.61% and the negative predictive value was 96.27%. In the study setting, the Hospital Information System (SIH) was more specific than sensitive, with nearly 20% of care sensitive conditions not detected. CONCLUSION: there are no validation studies in Brazil of the Hospital Information System records for the hospitalizations which are sensitive to primary health care. These results are relevant when one considers that this system is one of the bases for assessment of the effectiveness of primary health care. .

OBJETIVO: estimar a sensibilidade, a especificidade e os valores preditivos positivo e negativo do Sistema de Informação Hospitalar do Sistema Único de Saúde, para o registro adequado de internações por condições sensíveis à atenção primária. MÉTODO: foram considerados para análise os diagnósticos por condições sensíveis e condições não sensíveis à atenção primária, tendo o prontuário como padrão-ouro. Por meio de amostragem aleatória simples, foi definida amostra de 816 prontuários, selecionados por lista de números randômicos, utilizando-se o Statistical Package for Social Sciences. RESULTADO: a sensibilidade foi de 81,89%, a especificidade de 95,19%, o valor preditivo positivo de 77,61% e o valor preditivo negativo de 96,27%. No cenário do estudo, o Sistema de Informações Hospitalares foi mais específico do que sensível, com quase 20% de internações sensíveis não detectadas. CONCLUSÃO: não existem estudos no Brasil para validação do Sistema de Informação Hospitalar usando as internações sensíveis à atenção primária. Estes resultados são relevantes quando se considera que esse sistema é uma das bases de avaliação da efetividade da atenção primária à saúde. .

OBJETIVO: estimar la sensibilidad, la especificidad y los valores predictivos positivo y negativo del Sistema de Información Hospitalaria del Sistema Único de Salud para el registro adecuado de Internaciones por Condiciones Sensibles a la Atención Primaria. MÉTODO: fueron considerados para el análisis los diagnósticos por condiciones sensibles y condiciones no sensibles a la atención primaria, teniendo la ficha médica como estándar oro. Por medio de muestreo aleatorio simple fue definida una muestra de 816 fichas, seleccionadas con una lista de números aleatorios utilizando el programa Statistical Package for Social Sciences. RESULTADO: la sensibilidad fue de 81,89%, la especificidad de 95,19, el valor predictivo positivo de 77,61% y el valor predictivo negativo de 96,27%. En el escenario del estudio, el Sistema de Informaciones Hospitalarios fue más específico que sensible, con casi 20% de Internaciones Sensibles no detectadas. CONCLUSIÓN: no existen estudios en Brasil para validación del Sistema de Información Hospitalario usando las internaciones sensibles a la atención primaria. Estos resultados son relevantes cuando se considera que ese sistema es una de las bases de evaluación de la efectividad de la atención primaria a la salud. .

Internações por Condições Sensíveis a Atenção Primaria em uma metrópole brasileira / Hospitalizaciones por condiciones sensibles a la atencion primaria en una metropoli brasilena / Fospitalisations for ambulatory care sensitive conditions in a brazilian metropolis

Este estudo tem como objetivo descrever o perfil das Internações por Condições Sensíveis à Atenção Primária (ICSAP) no município de Curitiba no período de 2005 a 2007. Foi realizado um estudo ecológico, com dados obtidos no Sistema de Informações Hospitalares. Para análise, foi utilizada a estatística descritiva. Observou-se que em Curitiba as ICSAP seguem tendência de estabilização, sendo as causas mais frequentes a angina e a insuficiência cardíaca, maior frequência para o sexo feminino e a faixa etária ≥ 65 anos. Os resultados observados assemelham-se aos de outros estudos e foram, quase na totalidade, altamente significativos do ponto de vista estatístico. Entretanto, devem ser vistos com cuidado, pois se se trata de um indicador que apresenta algumas limitações, dentre as quais a própria confiabilidade do diagnóstico e o uso de dados secundários.

Este estudio tuvo como objetivo describir el perfil de las hospitalizaciones por condiciones sensibles a la Atención Primaria (ICSAP) en el municipio de Curitiba, durante en el período de 2005 a 2007. Fue realizado un estudio ecológico, con datos extraídos del Sistema de Informaciones Hospitalarias. Para el análisis fue utilizado la estadística descriptiva. Se observó que en Curitiba las ICSAP siguen la tendencia de estabilización, siendo las causas más frecuentes la angina de pecho y la insuficiencia cardíaca, con mayor frecuencia para el sexo femenino y el grupo etáreo ≥65 años. Los resultados observados son similares a otros estudios y fueron, casi en su totalidad, altamente significativos desde el punto de vista estadístico. Sin embargo, deben ser analizados cuidadosamente pues se trata de un indicador con algunas limitaciones, entre las que podemos destacar la propia confiabilidad del diagnóstico y el uso de datos secundarios.

This study describes the profile of Hospitalisations for Ambulatory Care Sensitive Conditions (ACSCs) in Curitiba from 2005 to 2007. An ecological study was conducted using the data obtained from the Brazilian Hospital Information System (Sistema de Informações Hospitalares). Descriptive statistics was used for analysis. It was observed that there was a trend toward stabilisation in ACSCs in Curitiba, the most frequent causes being angina and heart failure, with an increased frequency in females and individuals aged ≥65 years. The results were similar to those observed in other studies, and almost in their entirety, were highly significant from a statistical point of view. However, the studies should be viewed with caution because it is an indicator presenting some limitations, including the reliability of diagnosis and the use of secondary data.

QUADAS e STARD: avaliação da qualidade de estudos de acurácia de testes diagnósticos / QUADAS y STARD: evaluación de la calidad de estudios de precisión de pruebas diagnósticas / QUADAS and STARD: evaluating the quality of diagnostic accuracy studies

OBJETIVO: Comparar duas abordagens baseadas em critérios do Quality Assessment of Diagnostic Accuracy Studies (QUADAS) e do Standards for Reporting Studies of Diagnostic Accuracy (STARD) na avaliação de qualidade de estudos de validação do teste rápido OptiMal®, para diagnóstico de malária. MÉTODOS: Foi realizada busca de artigos de validação do teste rápido na base bibliográfica Medline acessada pelo PubMed, no ano de 2007. Treze artigos foram recuperados na busca. Foram combinados 12 critérios do QUADAS e três do STARD para comparação com os critérios do QUADAS isoladamente. Foi considerado que artigos de regular a boa qualidade atenderiam pelo menos 50 por cento dos critérios do QUADAS. RESULTADOS: Dos 13 artigos recuperados, 12 cumpriram pelo menos 50 por cento dos critérios do QUADAS, e apenas dois atenderam à combinação dos critérios. Considerando-se a combinação dos dois critérios (> 6 QUADAS e > 3STARD), dois estudos (15,4 por cento) apresentaram boa qualidade metodológica. A seleção de artigos usando a combinação proposta variou de dois a oito artigos, dependendo do número de itens considerados como ponto de corte. CONCLUSÕES: A combinação do QUADAS com o STARD tem o potencial de conferir maior rigor nas avaliações da qualidade de artigos publicados sobre validação de testes diagnósticos em malária, por incorporar a checagem de informações relevantes não alcançáveis pelo uso do QUADAS isoladamente.

OBJETIVO: Comparar dos abordajes basados en criterios del Quality Assessment of Diagnostic Accuracy Studies (QUADAS) y del Standards for Reporting Studies of Diagnostic Accuracy (STARD) en la evaluación de calidad de estudios de validación de la prueba rápida OptiMal®, para diagnóstico de malaria.MÉTODOS: Se realizó búsqueda de artículos de validación de la prueba rápida en la base bibliográfica Medline accedida por el PubMed, en el año de 2007. Trece artículos fueron recuperados en la búsqueda. Se combinaron 12 criterios del QUADAS y tres del STARD para comparación con los criterios del QUADAS aisladamente. Se consideró que artículos de regular a buena calidad atenderían al menos 50% de los criterios del QUADAS.RESULTADOS: De los 13 artículos recuperados, 12 cumplieron con al menos 50% de los criterios del QUADAS, y sólo dos atendieron la combinación de los criterios. Considerándose la combinación de los dos criterios (> 6 QUADAS e > 3STARD), dos estudios (15,4%) presentaron buena calidad metodológica. La decisión cuanto a la selección de artículos utilizando la combinación utilizada varió de dos a ocho artículos, dependiendo del ponto de corte considerado. CONCLUSIONES: La combinación del QUADAS con el STARD tiene el potencial de conferir mayor rigor en las evaluaciones de la calidad de artículos publicados sobre validación de pruebas diagnósticas en malaria, por incorporar el chequeo de informaciones relevantes no alcanzables por el uso del QUADAS aisladamente.

Análise de custo-efetividade de teste rápido para o diagnóstico de casos novos de malária em doze municípios endêmicos do Estado do Pará / Cost-effectiveness analysis of rapid test for the diagnosis of new malaria cases in twelve endemic municipalities of the State of Pará, Brazil

Introdução: A malária humana apresenta sintomas inespecíficos e exige diagnóstico laboratorial e identificação da espécie para o seu manejo. O diagnóstico baseia-se na microscopia, exame barato, que exige profissionais experientes. Nos últimos anos surgiram testes imunocromatográficos de execução rápida e custo mais elevado em comparação à microscopia. Estudos de validação demonstraram sensibilidade e especificidade comparáveis à microscopia, podendo ser alternativa confiável em áreas sem laboratório. Objetivo: Realizar análise de custo-efetividade do uso do OptiMAL® - teste rápido (TR) registrado no Brasil e validado em áreas endêmicas - comparado à microscopia. Métodos: A perspectiva da análise foi a do sistema público de saúde brasileiro SUS, o horizonte analítico de seis meses e o ano de 2006, a referência temporal. Doze municípios do Estado do Pará constituíram a área de estudo. Foi construído modelo de decisão considerando dois desfechos: casos diagnosticados adequadamente e casos conduzidos adequadamente em três cenários: o cenário 1 corresponde a 100% dos exames realizados, o cenário 2 considera somente os exames feitos nas áreas com laboratório e o cenário 3 corresponde a 30% dos exames, realizados em áreas isoladas. Os parâmetros epidemiológicos principais foram prevalência da malária entre indivíduos sintomáticos e acurácia - sensibilidade e especificidade - dos métodos diagnósticos, cujas estimativas foram obtidas a partir do Sistema de Informação de Vigilância Epidemiológica da Malária e literatura científica. Foram estimados custos diretos médicos e não-médicos, considerando diretrizes nacionais e dados municipais. Fontes de dados de custos incluíram o Sistema de Informação de Insumos Estratégicos, a Tabela de Procedimentos do SUS e o Sistema de Informação Hospitalar do SUS. Foram estimadas as razões média e adicional de custo-efetividade (RCEA) e realizada análise de sensibilidade. O software utilizado foi o TreeAge Pro 2005. Resultados: O TR foi dominado pela microscopia nos cenários 1 e 2. Em áreas isoladas a estratégia microscopia apresentou RCEA de R$1.193,00 por caso diagnosticado adequadamente e de R$1.016,67 por caso conduzido adequadamente quando comparada com o OptiMAL®. O TR tornou-se mais custo-efetivo nos dois desfechos dos três cenários com a redução da acurácia da gota espessa, na análise de sensibilidade. Conclusões: o TR foi menos custo-efetivo em todos os cenários, quando a acurácia da microscopia manteve-se elevada.

Introduction: Diagnosis of malaria is based on blood microscopy, a lowcost procedure that requires experienced technicians. Rapid immunochromatography tests (RDT) were developed with the advantage of being easy-to-use tools but with higher costs. RDT validation showed similar accuracy compared to microscopy suggesting that the RDT could be a reliable alternative in areas without lab facilities. Objective: To perform costeffectiveness analysis for the use of OptiMAL® in comparison with the thick blood smear microscopy. Methods: The study was conducted from the perspective of the Brazilian Public Health System, the analytic horizon was of six months, and the time frame was 2006. The analysis was performed through a decision tree with two outcomes: properly diagnosed cases and properly conducted cases. There were defined three scenarios in 12 municipalities of the State of Pará: the scenario 1 considered the whole malaria tests performed in 2006; the scenario 2 considered the malaria tests performed in the endemic areas with access to lab facilities; and the scenario 3 considered the 30% malaria tests performed in areas without lab facilities. The main epidemiological measures were the prevalence of malaria and the accuracy of the diagnostic methods. Epidemiological estimates were obtained from the Brazilian Malaria Surveillance Information System and the scientific literature. Direct medical and non-medical costs were estimated taking into consideration the national guidelines and the data obtained from the municipalities. Cost data sources were the Information System for Strategic Resources from the Health Surveillance Secretariat, the Reimbursement Values Table and the Hospital Information System of the Brazilian Public Health System. The average and the incremental costeffectiveness ratio (ICER) were estimated and it was conducted a sensitivity analysis. Data were analyzed with the TreeAge Pro 2005 software. Results: RDT strategy was dominated by the microscopy strategy in the scenarios 1 and 2. The ICER for the microscopy strategy in the scenario 3 was R$1,193.00 per properly diagnosed case and it was R$1,016.67 per properly conducted case compared with the OptiMAL® strategy. The sensitivity analysis showed that the RDT was cost-effective for both outcomes in all the scenarios when the thick blood smear accuracy was reduced. Conclusions: The RDT is the least cost effective strategy, providing that microscopy accuracy is high.