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.

Burden of Disease of Guillain-Barré Syndrome in Brazil before and during the Zika virus epidemic 2014-2016.

OBJECTIVE: To estimate the burden of disease of Guillain-Barré syndrome (GBS) in Brazil in 2014, 1 year before the Zika virus epidemic, and in 2015 and 2016 during the epidemic. METHODS: The burden of disease of GBS was estimated using the summary measure of population health: Disability Adjusted Life Years (DALY), that combines both mortality (Years of Life Lost YLLs) and morbidity (Years Lived with Disability) components. The study population was composed of GBS hospitalised cases and deaths from the information systems of the Brazilian Unified Health System. RESULTS: The GBS incidence rate in 2014, 2015 and 2016 was 0.74, 0.96, 1.02/100 000 respectively, and the mortality rate in the same period was 0.08, 0.009 and 0.11/100 000 habitants. The DALYs calculated using the point estimate of GBS disability weight and its values of the confidence interval (0.198 and 0.414) were 5725.90 (5711.79-5742.89) in 2014, 6054.61 (6035.57-6077.54) in 2015 and 7588.49 (7570.20-7610.51) in 2016. The DALYs were high among the male population and in age groups between 20 and 50 years. CONCLUSIONS: The increase in DALYs in the years 2015 and 2016 compared to 2014 probably resulted from the introduction of ZIKV in Brazil, reinforcing the importance of investments in the prevention of ZIKV infection and in the care of GBS patients.

OBJECTIF: Estimer la charge de morbidité du syndrome de Guillain-Barré (SGB) au Brésil en 2014, un an avant l'épidémie du virus Zika (ZIKV) et en 2015 et 2016 pendant l'épidémie. MÉTHODES: La charge de la maladie du SGB a été estimée à l'aide de la mesure récapitulative de la santé de la population: années de vie ajustées en fonction de l'incapacité (AVCI), qui combine à la fois les composantes de la mortalité (années de vie perdues AVP) et de la morbidité (années vécues avec une incapacité). La population de l'étude était composée de cas hospitalisés du SGB et de décès provenant des systèmes d'information du système de santé unifié brésilien. RÉSULTATS: Le taux d'incidence du SGB en 2014, 2015 et 2016 était de 0,74 ; 0,96 et 1,02/100.000 respectivement et le taux de mortalité au cours de la même période était de 0,08 ; 0,009 et 0,11/100.000 habitants. Les AVCI calculées à l'aide des points d'estimation du poids de l'incapacité du SGB et de ses valeurs de l'intervalle de confiance (0,198 et 0,414) étaient de 5.725,90 (5.711,79-5.742,89) en 2014 ; 6.054,61 (6.035,57-6.077,54) en 2015 et 7.588,49 (7.570,20 - 7.610,51) en 2016. Les AVCI étaient élevés parmi la population masculine et dans les groupes d'âge entre 20 et 50 ans. CONCLUSIONS: L'augmentation des AVCI en 2015 et 2016 par rapport à 2014 résulte probablement de l'introduction du ZIKV au Brésil, renforçant l'importance des investissements dans la prévention de l'infection par le ZIKV et dans la prise en charge des patients atteints de SGB.

Systematic review of factors associated with the development of Guillain-Barré syndrome 2007-2017: what has changed?

OBJECTIVE: The objective of this study was to describe the factors associated with the development of Guillain-Barré syndrome, both infectious and non-infectious, during and after the A(H1N1) influenza pandemic in 2009 and the recent Zika virus epidemic in the Americas. METHOD: Systematic review of literature on factors associated with the development of the Guillain-Barré syndrome published between 2007 and 2017 listed in EBSCO, MEDLINE and LILACS databases. The quality of the studies was evaluated using the Newcastle Ottawa Scale. RESULTS: Thirty-four articles met inclusion criteria and were selected for analysis. Their quality was considered good in relation to most of the items evaluated. Many aetiological agents had the results of association with Guillain-Barré syndrome, among them Campylobacter jejuni, influenza vaccine - both pandemic and seasonal vaccines, respiratory infection, gastrointestinal infection among others. The aetiological agents found are, in most part, the same reported prior to the study period. The association with surgeries, chikungunya virus (CHIKV), Zika virus and quadrivalent human papillomavirus vaccine stand out as new aetiological agents in the list of the various possible agents that trigger Guillain-Barré syndrome reported in the study period. There were no Brazilian studies identified during this period. CONCLUSIONS: The results of the review reaffirmed C. jejuni as the major trigger of GBS, whereas the association of influenza vaccines and GBS is less clear; Zika virus infection in association with GBS was found in only one study.

Treatment for human visceral leishmaniasis: a cost-effectiveness analysis for Brazil.

OBJECTIVE: To estimate the cost-effectiveness of strategies for the treatment of VL in Brazil. METHODS: Cost-effectiveness study comparing three therapeutic options: meglumine antimoniate (MA), liposomal amphotericin B (LAMB) and a combination of LAMB plus MA (LAMB plus MA), from public health system and societal perspectives. An analytical decision-making model was used to compare strategies for the following outcomes: early therapeutic failure avoided at 30 days, days of hospitalisation avoided and VL cure at 180 days. The efficacy and safety parameters of the drugs came from a randomised, open-label trial and the cost data came from a cost-of-illness study, both carried out in Brazil. RESULTS: For all outcomes analysed, the LAMB strategy was more effective. The MA strategy was inferior to the LAMB plus MA strategy for the outcomes early therapeutic failure avoided and cure. When only LAMB and MA were compared from a societal perspective, a cost of US$ 278.56 was estimated for each additional early therapeutic failure avoided, a cost of US$ 26.88 for each additional day of hospitalisation avoided and a cost of US$ 89.88 for each additional case of cured VL, for the LAMB strategy vs. MA. CONCLUSION: In Brazil, the LAMB strategy proved to be cost-effective for treating VL, considering a GDP per capita as the willingness-to-pay threshold, for all of the outcomes analysed in comparison to MA.

OBJECTIF: Estimer la rentabilité des stratégies de traitement de la leishmaniose viscérale (LV) au Brésil. MÉTHODES: Etude coût-efficacité comparant trois options thérapeutiques: l'antimoniate de méglumine (AM), amphotéricine B liposomale (LAMB) et une combinaison de LAMB et MA (LAMB plus AM), du point de vue du système de santé publique et sociétal. Un modèle décisionnel analytique a été utilisé pour comparer les stratégies pour les résultats suivants: échec thérapeutique précoce évité à 30 jours, jours d'hospitalisation évités et guérison de la LV à 180 jours. Les paramètres d'efficacité et de sécurité des médicaments provenaient d'un essai randomisé ouvert et les données relatives aux coûts, d'une étude sur le coût de la maladie, toutes deux menées au Brésil. RÉSULTATS: Pour tous les résultats analysés, la stratégie LAMB était plus efficace. La stratégie AM était inférieure à la stratégie LAMB plus AM pour les résultats: échec thérapeutique précoce évité et guérison. Lorsque seules les stratégies LAMB et AM ont été comparées d'un point de vue sociétal, un coût de 278,56 USD a été estimé pour chaque échec thérapeutique précoce additionnel évité, un coût de 26,88 USD pour chaque jour d'hospitalisation additionnel évité et un coût de 89,88 USD pour chaque cas additionnel de LV guéri, pour la stratégie LAMB par rapport à AM. CONCLUSION: Au Brésil, la stratégie LAMB s'est avérée rentable pour traiter la LV, considérant un PIB par habitant comme seuil de volonté de payer, pour tous les résultats analysés par rapport à l'AM.

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.

Cost of visceral leishmaniasis care in Brazil.

OBJECTIVE: To estimate the Brazilian direct and indirect costs of human visceral leishmaniasis (VL) in 2014. METHODS: Cost-of-illness study on the Brazilian public health system and societal perspective. VL cases registered in the Notifiable Diseases Information System in the year of 2014 were considered. Direct medical costs regarding diagnostic, treatment and care provided to patients with VL were estimated through the top-down approach. The indirect costs related to productivity loss due to premature mortality and morbidity were estimated by means of the human-capital method. RESULTS: In 2014, 9895 suspected cases of VL were reported in the Notifiable Diseases Information System, and 3453 were later confirmed. There were 234 patients with Leishmania-HIV coinfection underwent a secondary prophylaxis. The total cost of VL in Brazil was US$ 14 190 701.50 (US$ 14 189 150.10 to 14 199 940.53) that varied according to the sensitivity analysis. The total of direct medical costs corresponded to US$ 1 873 681.96 (US$1 872 130.55 to 1 882 920.99), and the majority of costs was associated with hospitalisation (40%), followed by treatment (22%), and secondary prophylaxis (18%). Productivity loss corresponded to US$ 11 421 683.37 for premature mortality and US$ 895 336.18 for work absence due to hospitalisation by the illness. CONCLUSIONS: VL represents an expensive health problem for the Brazilian public health system and society, mainly because of its productivity loss due to premature mortality. Interventions to reduce VL lethality could have a great impact on decreasing the cost of illness.

Rapid diagnostic test for G6PD deficiency in Plasmodium vivax-infected men: a budget impact analysis based in Brazilian Amazon.

OBJECTIVE: The aim of this study was to estimate the incremental budget impact (IBI) of a rapid diagnostic test to detect G6PDd in male patients infected with Plasmodium vivax in the Brazilian Amazon, as compared with the routine protocol recommended in Brazil which does not include G6PDd testing. METHODS: The budget impact analysis was performed from the perspective of the Brazilian health system, in the Brazilian Amazon for the years 2013, 2014 and 2015. The analysis used a decision model to compare two scenarios: the first consisting of the routine recommended in Brazil which does not include prior diagnosis of dG6PD, and the second based on the use of RDT CareStart™ G6PD (CS-G6PD) in all male subjects diagnosed with vivax malaria. The expected implementation of the diagnostic test was 30% in the first year, 70% the second year and 100% in the third year. RESULTS: The analysis identified negative IBIs which were progressively smaller in the 3 years evaluated. The sensitivity analysis showed that the uncertainties associated with the analytical model did not significantly affect the results. CONCLUSION: A strategy based on the use of CS-G6PD would result in better use of public resources in the Brazilian Amazon.

Serological diagnosis of canine visceral leishmaniasis in Brazil: systematic review and meta-analysis.

OBJECTIVE: To evaluate the quality and accuracy of serological diagnosis of canine visceral leishmaniasis in the Americas. METHODS: A systematic review found original studies in the databases MEDLINE, EMBASE and LILACS up to November 2012 and in complementary sources up to February 2013. Studies were evaluated in accordance with QUADAS 2 and STARD parameters and recommended in accordance with GRADE parameters. Meta-analysis was carried out with Meta-DiSc software, using the random-effect model. RESULTS: Two hundred and eighty-four studies were identified, of which 25 met the inclusion criteria, comprising the final synthesis. All but one was conducted in Brazil, and only two were judged to be of good quality. 15 studies involving immuno-enzymatic tests with crude antigens (cELISA), 11 studies on indirect immunofluorescence tests (IFAT) and three on the immunochromatographic dual-path platform (DPP) test were meta-analysed. The combined results for sensitivity and specificity were cELISA: 0.89 (CI 95% 0.87-0.91) and 0.87 (CI 95% 0.86-0.88); IFAT: 0.88 (CI 95% 0.85-0.91) and 0.63 (CI 95% 0.61-0.65); and DPP: 0.83 (CI 95% 0.78-0.88) and 0.73 (CI 95% 0.70-0.75). CONCLUSION: Enzyme-linked immunosorbent assay with crude antigens and DPP tests have moderate accuracy for the diagnosis of canine visceral leishmaniasis, and the quality of the design, implementation and analysis of validation studies on diagnostic tests for this disease urgently require improvement. The recommendation for use of the evaluated tests is based on evidence that is scarce and restricted to Brazil.

G6PD deficiency in male individuals infected by Plasmodium vivax malaria in the Brazilian Amazon: a cost study.

BACKGROUND: Deficiency of the enzyme G6PD (G6PDd) is caused by mutations in the gene G6PD, which plays an important role in protecting the red blood cell against oxidizing agents; it is linked to chromosome X, and it may affects both sexes. The clinically relevant manifestations, such as acute haemolytic anaemia, mainly occur in men, however. The 8-aminoquinoline primaquine, which is the medication used in the radical treatment of malaria caused by Plasmodium vivax, represents the main factor that triggers complications associated with G6PDd. The current study aims to estimate the costs of G6PDd among male individuals infected by P. vivax in the Brazilian Amazon. METHODS: This is an economic analysis developed within the Brazilian National Health System perspective for the years of 2009, 2010 and 2011. Direct medical and non-medical costs were estimated for G6PDd in the Brazilian Amazon, considering among those suffering from the deficiency the costs of diagnosing infection by P. vivax, its treatment and severe adverse events that require hospitalization and were connected to the use of primaquine. RESULTS: The estimates of the average costs of diagnosing vivax malaria, of its treatment and of severe adverse events after using primaquine among the carriers of G6PDd, over the three evaluated years, corresponded to US$ 739,410.42; US$ 2,120.04 and US$ 4,858,108.87, respectively. The results indicate that the average total cost in the study period corresponded to US$ 5,599,639.33, varying in accordance with the sensitivity analysis between US$ 4,439,512.14 and US$ 6,702,619.24. CONCLUSION: The results indicate that the use of primaquine among men with G6PDd who are infected by P. vivax represents a heavy burden on the public health service of Brazil.

Clinical complications of G6PD deficiency in Latin American and Caribbean populations: systematic review and implications for malaria elimination programmes.

BACKGROUND: Although G6PDd individuals are generally asymptomatic throughout their life, the clinical burden of this genetic condition includes a range of haematological conditions, including acute haemolytic anaemia (AHA), neonatal jaundice (NNJ) and chronic non-sphaerocytic anaemia (CNSA). In Latin America (LA), the huge knowledge gap regarding G6PDd is related to the scarce understanding of the burden of clinical manifestation underlying G6PDd carriage. The aim of this work was to study the clinical significance of G6PDd in LA and the Caribbean region through a systematic review. METHODS: A systematic search of the published literature was undertaken in August 2013. Bibliographies of manuscripts were also searched and additional references were identified. Only original research was included. All study designs were included, as long as any clinical information was present. Studies were eligible for inclusion if they reported clinical information from populations living in LA or Caribbean countries or about migrants from these countries living in countries outside this continent. RESULTS: The Medline search generated 487 papers, and the LILACS search identified 140 papers. After applying the inclusion criteria, 100 original papers with any clinical information on G6PDd in LA were retrieved. Additionally, 16 articles were included after reading the references from these papers. These 116 articles reported data from 18 LA and Caribbean countries. The major clinical manifestations reported from LA countries were those related to AHA, namely drug-induced haemolysis. Most of the published works regarding drug-induced haemolysis in LA referred to haemolytic crises in P. vivax malaria patients during the course of the treatment with primaquine (PQ). Favism, infection-induced haemolysis, NNJ and CNSA appear to play only a minor public health role in this continent. CONCLUSION: Haemolysis in patients using PQ seems to be the major clinical manifestation of G6PDd in LA and contributes to the morbidity of P. vivax infection in this continent, although the low number of reported cases, which could be linked to under-reporting of complications. These results support the need for better strategies to diagnose and manage G6PDd in malaria field conditions. Additionally, Malaria Control Programmes in LA should not overlook this condition in their national guidelines.

Patient profile and treatment satisfaction of Brazilian leprosy patients in a clinical trial of uniform six-month multidrug therapy (U-MDT/CT-BR).

OBJECTIVE: To describe the profile of patients who participated in the Randomised Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR) and determine the level of satisfaction with a uniform therapy regimen, especially among paucibacillary patients. DESIGN: This is a descriptive cross-sectional epidemiologic study nested in the wider U-MDT/CT-BR. The study was conducted using a convenience sample composed of patients from the Dona Libânia Dermatology Centre in Fortaleza, Ceará and from the Alfredo da Matta Foundation in Manaus, Amazonas in Brazil. The absolute and relative frequencies of categorical variables and the median age were calculated. Hypothesis testing was done using the Chi-squared and Mann-Whitney tests with a 0.05 level of significance. RESULTS: Of the 859 patients included in the clinical trial, 342 were interviewed. The majority of patients were male (58.2%) and multibacillary (78.3%) with a median age of 42 (7-65) years. Most of the interviewees had not completed primary education (48.0%), earned an income below three times the minimum wage (53.8%), were non-smokers (85.1%), did not regularly consume alcohol (88.3%), had not experienced any leprosy-related discrimination (69.2%) and showed a basic knowledge of the disease. With regards to paucibacillary patients, 87.8% and 90.9% of the PB U-MDT and PB R-MDT groups, respectively, indicated that they had not thought of defaulting treatment at any time. On a satisfaction scale of 1-5 (with five as the highest score), 92.7% of PB U-MDT and 100.0% of PB R-MDT patients gave a mark between three and five. CONCLUSIONS: The data suggest that the introduction of clofazimine into the therapeutic regimen did not diminish the level of treatment satisfaction among PB patients.

Costs of hospital admissions due to COVID-19 in the federal capital of Brazil: a study based on hospital admission authorizations.

This is a cost analysis study based on hospital admissions, conducted from the perspective of the Brazilian Unified Health System (SUS), carried out in a cohort of patients hospitalized at the University Hospital of Brasília (UHB) due to Severe Acute Respiratory Infections (SARI) caused by COVID-19, from April 1, 2020, to March 31, 2022. An approach based on macro-costing was used, considering the costs per patient identified in the Hospital Admission Authorizations (HAA). Were identified 1,015 HAA from 622 patients. The total cost of hospitalizations was R$ 2,875,867.18 for 2020 and 2021. Of this total, 86.41 % referred to hospital services and 13.59 % to professional services. The highest median cost per patient identified was for May 2020 (R$ 19,677.81 IQR [3,334.81-33,041.43]), while the lowest was in January 2021 (R$ 1,698.50 IQR [1,602.70-2,224.11]). The high cost of treating patients with COVID-19 resulted in a high economic burden of SARI due to COVID-19 for UHB and, consequently, for SUS.

[Hospitalisations for ambulatory care sensitive conditions in a Brazilian metropolis]. / Internações por Condições Sensíveis à Atenção Primária em uma metrópole brasileira.

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.

Frequency and clinical characteristics of hypophysitis and hypopituitarism in patients undergoing immunotherapy - A systematic review.

Objective: To describe the frequency of hypophysitis and hypopituitarism in cancer patients who are undergoing antineoplastic treatment with immunotherapy, as well as to describe the clinical, epidemiological, and demographic characteristics of these patients. Methods: A systematic search of the literature in PubMed, Embase, Web of Science, ClinicalTrials.gov and Cochrane Controlled Register of Trials took place on May 8 and 9, 2020. Randomized and nonrandomized clinical trials, cohort studies, case-control studies, case series and case reports were included. Results: A total of 239 articles were obtained, in which 963 cases of hypophysitis and 128 cases of hypopituitarism were found in a treated population of 30,014 individuals (3.20% and 0.42% of the evaluated population, respectively). In the cohort studies, the incidence of hypophysitis and hypopituitarism ranged from 0% to 27.59% and from 0% to 17.86%, respectively. In the non-randomized clinical trials, the incidence of hypophysitis and hypopituitarism ranged from 0% to 25% and from 0% to 14.67%, and in randomized clinical trials from 0% to 16.2% and from 0% to 33.33%. The most common hormonal changes were in the corticotrophic, thyrotrophic and gonadotrophic axes. The main magnetic resonance imaging (MRI) findings were enlargement of the pituitary gland and enhanced contrast uptake. The main symptoms presented by patients with hypophysitis were fatigue and headache. Conclusion: The present review reported a frequency of hypophysitis and hypopituitarism of 3.20% and 0.42%, respectively, in the evaluated population. The clinical-epidemiological characteristics of patients affected by hypophysitis were also described. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42020175864.

Incidence of Guillain-Barré syndrome in the world between 1985 and 2020: A systematic review.

Introduction: Guillain-Barré syndrome (GBS) is an acute inflammatory demyelinating polyradiculoneuropathy that affects the peripheral nervous system. The study aimed to describe the incidence of GBS in the world up to the year 2020. Methods: A systematic review was conducted. Searches were done in four databases, PUBMED, EMBASE, EBSCO and Biblioteca virtual em Saude (BVS), and in grey literature and manual search in the reference lists of eligible studies. Results: A total of 72 studies were included. The incidence of GBS among the cohort studies varied from 0.30 to 6.08 cases per 100.000 habitants and 0.42 to 6.58 cases per 100.000 person-years. Among the self-controlled studies, the risk incidence ranged from 0.072 to 1 case per 100.000 habitants and 1.73 to 4.30 cases per 100.000 person-years. Conclusions: The reported incidence of GBS in the world among the studies included in the review is slightly higher than that reported in previous studies. The highest incidence rates were associated with public health events of international concern.

Cost-effectiveness of diagnostic for malaria in Extra-Amazon Region, Brazil.

BACKGROUND: Rapid diagnostic tests (RDT) for malaria have been demonstrated to be effective and they should replace microscopy in certain areas. METHOD: The cost-effectiveness of five RDT and thick smear microscopy was estimated and compared. Data were collected on Brazilian Extra-Amazon Region. Data sources included the National Malaria Control Programme of the Ministry of Health, the National Healthcare System reimbursement table, laboratory suppliers and scientific literature. The perspective was that of the Brazilian public health system, the analytical horizon was from the start of fever until the diagnostic results provided to patient and the temporal reference was that of year 2010. Two costing methods were produced, based on exclusive-use microscopy or shared-use microscopy. The results were expressed in costs per adequately diagnosed cases in 2010 U.S. dollars. One-way sensitivity analysis was performed considering key model parameters. RESULTS: In the cost-effectiveness analysis with exclusive-use microscopy, the RDT CareStart™ was the most cost-effective diagnostic strategy. Microscopy was the most expensive and most effective, with an additional case adequately diagnosed by microscopy costing US$ 35,550.00 in relation to CareStart™. In opposite, in the cost-effectiveness analysis with shared-use microscopy, the thick smear was extremely cost-effective. Introducing into the analytic model with shared-use microscopy a probability for individual access to the diagnosis, assuming a probability of 100% of access for a public health system user to any RDT and, hypothetically, of 85% of access to microscopy, this test saw its effectiveness reduced and was dominated by the RDT CareStart™. CONCLUSION: The analysis of cost-effectiveness of malaria diagnosis technologies in the Brazilian Extra-Amazon Region depends on the exclusive or shared use of the microscopy. Following the assumptions of this study, shared-use microscopy would be the most cost-effective strategy of the six technologies evaluated. However, if used exclusively for diagnosing malaria, microscopy would be the worst use of resources. Microscopy would not be the most cost-effective strategy, even when structure is shared with other programmes, when the probability of a patient having access to it was reduced. Under these circumstances, the RDT CareStart™ would be the most cost-effective strategy.

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

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.

Cost effectiveness of OptiMal® rapid diagnostic test for malaria in remote areas of the Amazon Region, Brazil.

BACKGROUND: In areas with limited structure in place for microscopy diagnosis, rapid diagnostic tests (RDT) have been demonstrated to be effective. METHOD: The cost-effectiveness of the Optimal® and thick smear microscopy was estimated and compared. Data were collected on remote areas of 12 municipalities in the Brazilian Amazon. Data sources included the National Malaria Control Programme of the Ministry of Health, the National Healthcare System reimbursement table, hospitalization records, primary data collected from the municipalities, and scientific literature. The perspective was that of the Brazilian public health system, the analytical horizon was from the start of fever until the diagnostic results provided to patient and the temporal reference was that of year 2006. The results were expressed in costs per adequately diagnosed cases in 2006 U.S. dollars. Sensitivity analysis was performed considering key model parameters. RESULTS: In the case base scenario, considering 92% and 95% sensitivity for thick smear microscopy to Plasmodium falciparum and Plasmodium vivax, respectively, and 100% specificity for both species, thick smear microscopy is more costly and more effective, with an incremental cost estimated at US$549.9 per adequately diagnosed case. In sensitivity analysis, when sensitivity and specificity of microscopy for P. vivax were 0.90 and 0.98, respectively, and when its sensitivity for P. falciparum was 0.83, the RDT was more cost-effective than microscopy. CONCLUSION: Microscopy is more cost-effective than OptiMal® in these remote areas if high accuracy of microscopy is maintained in the field. Decision regarding use of rapid tests for diagnosis of malaria in these areas depends on current microscopy accuracy in the field.

Treatment With Liposomal Amphotericin B for All Confirmed Cases of Human Visceral Leishmaniasis in Brazil: A Budget Impact Analysis.

OBJECTIVES: To estimate the budget impact of the expansion of liposomal amphotericin B use for all confirmed cases of visceral leishmaniasis (VL) in Brazil. Currently, the first-line medicine for VL treatment is meglumine antimoniate. Liposomal amphotericin B is indicated only for patients with a greater risk of severity by the disease. METHODS: The analysis was performed from the perspective of the Brazilian public healthcare system over 3 years, considering the following 2 scenarios: the reference scenario with the current recommendations for VL treatment and the alternative scenario based on the use of liposomal amphotericin B for all patients. A diffusion rate of 60% was used in the first year, 80% in the second year, and 100% in the third year. The epidemiological parameters used in the analysis came from the Notifiable Diseases Information System and from a clinical trial that evaluated the efficacy and safety of medicines for the treatment of VL in the country. The costs were related to the treatment of VL and to hospital and outpatient care. RESULTS: In the reference scenario, the total cost for treatment of the 3453 VL confirmed cases in 2014 was $1 447 611.75. The incremental budget impact with the use of liposomal amphotericin B for all the VL confirmed cases was $299 646.43 in the third year. CONCLUSIONS: The analysis presented will support the decision process for the use and expansion of liposomal amphotericin B for all VL confirmed cases in Brazil.

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

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.

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.