Mestrado Profissional em Avaliação de Tecnologias em Saúde

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    Accuracy of Zika virus disease case definition during simultaneous Dengue and Chikungunya epidemics
    (PLOS One, 2017) Braga, José Ueleres; Bressan, Clarisse; Dalvi, Ana Paula Razal; Calvet, Guilherme Amaral; Daumas, Regina Paiva; Rodrigues, Nadia; Wakimoto, Mayumi; Nogueira, Rita Maria Ribeiro; Nielsen-Saines, Karin; Brito, Carlos; Filippis, Ana Maria Bispo de; Brasil, Patrícia
    Background Zika is a new disease in the American continent and its surveillance is of utmost importance, especially because of its ability to cause neurological manifestations as Guillain-Barre ́ syn- drome and serious congenital malformations through vertical transmission. The detection of suspected cases by the surveillance system depends on the case definition adopted. As the laboratory diagnosis of Zika infection still relies on the use of expensive and complex molec- ular techniques with low sensitivity due to a narrow window of detection, most suspected cases are not confirmed by laboratory tests, mainly reserved for pregnant women and new- borns. In this context, an accurate definition of a suspected Zika case is crucial in order for the surveillance system to gauge the magnitude of an epidemic. Methodology We evaluated the accuracy of various Zika case definitions in a scenario where Dengue and Chikungunya viruses co-circulate. Signs and symptoms that best discriminated PCR con- firmed Zika from other laboratory confirmed febrile or exanthematic diseases were identified to propose and test predictive models for Zika infection based on these clinical features. Results and discussion Our derived score prediction model had the best performance because it demonstrated the highest sensitivity and specificity, 866% and 783%, respectively. This Zika case definition also had the highest values for auROC (0903) and R2 (0417), and the lowest Brier score 0096. Conclusions In areas where multiple arboviruses circulate, the presence of rash with pruritus or conjuncti- val hyperemia, without any other general clinical manifestations such as fever, petechia or anorexia is the best Zika case definition.
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    Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT)
    (Circulation, 2011) ACT Investigators; Tura, Bernardo R; Santos Junior, Bráulio dos; Cramer, Helena
    Background: It remains uncertain whether acetylcysteine prevents contrast-induced acute kidney injury. Methods and results: We randomly assigned 2308 patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced acute kidney injury (age >70 years, renal failure, diabetes mellitus, heart failure, or hypotension) to acetylcysteine 1200 mg or placebo. The study drugs were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 12.7% in the acetylcysteine group and 12.7% in the control group (relative risk, 1.00; 95% confidence interval, 0.81 to 1.25; P=0.97). A combined end point of mortality or need for dialysis at 30 days was also similar in both groups (2.2% and 2.3%, respectively; hazard ratio, 0.97; 95% confidence interval, 0.56 to 1.69; P=0.92). Consistent effects were observed in all subgroups analyzed, including those with renal impairment. Conclusions: In this large randomized trial, we found that acetylcysteine does not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in at-risk patients undergoing coronary and peripheral vascular angiography. Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
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    Assessment of quality of life using the EQ- 5D-3L instrument for hospitalized patients with femoral fracture in Brazil
    (Health and Quality of Life Outcomes, 2018) Souza, Ivanise Arouche Gomes de; Pereira, Claudia Cristina de Aguiar; Monteiro, Andrea Liborio
    Background: Quality of life has become a key outcome in assessing the effectiveness of treatments and interventions in health. Methods: Accordingly, this research study aimed to measure quality of life using the EQ-5D-3L instrument for patients from the Jamil Haddad National Institute of Traumatology and Orthopedics (Instituto Nacional de Traumatologia e Ortopedia Jamil Haddad – INTO) with femoral fractures, hospitalized between 11/2015 and 10/2016. Results: A total of 165 orthopedic trauma patients with femoral fractures, aged 18 years or older, who were hospitalized and operated upon in the INTO were assessed. The assessment instruments were applied at admission and in the first and second follow-up visits to the outpatient clinic. Most study subjects were women and older than 60 years. Proximal femoral fracture was the most commonly found fracture. The Visual Analog Scale (VAS) assessments over the study period showed an increasing gain in self-assessed quality of life. Similarly, the EQ-5D-3L showed significant improvements in quality of life assessed in the five dimensions of the instrument:mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Conclusion: This type of assessment may help in decision-making and cost-utility assessments related to orthopedic trauma.
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    Assessment of the IgA Immunoassay Diagnostic Potential of the Mycobacterium tuberculosis MT10.3-MPT64 Fusion Protein in Tuberculous Pleural Fluid
    (CLINICAL AND VACCINE IMMUNOLOGY, 2010) Araujo, Leonardo Silva; Moraes, Renata Maciel; Trajman, Anete; Saad, Maria Helena Féres
    Pleural tuberculosis (PL-TB) remains difficult to diagnose. An enzyme-linked immunosorbent assay (ELISA) was developed based on a construction containing the fusion of the Rv3019c (MT10.3) and Rv1980c (MPT64) gene sequences, and its performance was evaluated in an area where TB is endemic. A total of 92 pleural fluid (PF) samples at serial dilutions of 1:50 to 1:800 were included in the ELISA IgA MT10.3-MPT64 evaluation: 70 from TB patients and 22 from patients with other pleurisies. Confirmation of the expression and subsequent purification of the protein was made by SDS-PAGE and Western blot assays, resulting in a 36-kDa protein. ELISA IgA MT10.3-MPT64 showed sensitivities of 61.4%, 58.6%, 62.9%, 67.1%, and 70% at each PF dilution, respectively. The cumulative results of all dilutions increased sensitivity to 81.4% without jeopardizing spec- ificity. Similar results were also obtained at the combined dilutions of 1:50, 1:200, and 1:800 or 1:50 plus 1:800 dilutions (80%). The overall sensitivity of the reference test, i.e., histopathological examination, was 74%. But, via the ELISA IgA MT10.3-MPT64 test, sensitivity was high for specimens with a negative culture (23/27; 85.2%) or nonspecific histopathology (17/18; 94.4%). Our findings demonstrated the promising use of this test as an adjunct in PL-TB diagnoses, particularly in cases with lower bacterial loads and false-negative results in the reference tests, since the new test includes such important features as quick and easy application, high sensitivity and, perhaps most importantly, affordability, which is so crucial for its widespread use in developing countries.
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    Budget Impact of Cryoablation Versus Radiofrequency Ablation of Atrial Fibrillation in the Brazilian Public Healthcare System
    (Value in Health Regional Issues, 2019) Paço, Patricia; Tura, Bernardo; Santos, Marisa; Amparo, Pedro; De Lorenzo, Andrea
    Background: Cryoablation is a new technology for ablation of atrial fibrillation (AF), effective and safe when compared with standard radiofrequency (RF) ablation. Nevertheless, the economic impact of its incorporation is unknown, especially considering the public health system of a developing country. This study analyzed the budget impact of cryoablation incorporation for treatment of paroxysmal AF in the Brazilian public health system. Methods: The budget impact was calculated as the cost difference between the current scenario (RF ablation guided by electroanatomic mapping) and the new scenario (cryoablation). The cost of each intervention was obtained by multiplying the price of a single procedure by the number of candidates for it. Other technologies (RF ablation guided by intracardiac echocardiography or with a nonirrigated catheter) were considered in a sensitivity analysis. Results: The budget impact showed savings of $43 097 096.84 with cryoablation. In the sensitivity analysis, cryoablation resulted in cost savings compared with RF ablation guided by intracardiac echocardiography, whereas in comparison to RF ablation with the nonirrigated catheter, cryoablation was more expensive. A market share assessment, performed using an incorporation rate of 3% per year, indicated savings of approximately $800 000 per 5 years. Conclusions: Cryoablation of AF resulted in cost savings compared with the current scenario (RF ablation guided by electroanatomic mapping). When alternative technologies were considered, cryoablation was more expensive than RF ablation with a nonirrigated catheter, but it also resulted in savings compared with RF ablation guided by intracardiac echocardiography. Overall, cryoablation of AF may reduce expenditures in the Brazilian public health system.
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    Clinical Features and Treatment Outcomes of Patients with Drug-Resistant and Drug- Sensitive Tuberculosis: A Historical Cohort Study in Porto Alegre, Brazil
    (PLOS ONE, 2016) Micheletti, Vania Celina Dezoti; Kritski, Afrânio Lineu; Braga, José Ueleres
    Purpose To evaluate the clinical features and treatment outcomes of patients with pulmonary tuber- culosis, stratified by level of drug resistance. Methods This was a historical cohort study based on data from the II National Anti-Tuberculosis Drug Resistance Survey (2006–2007) collected at eight participating health care facilities in Porto Alegre, southern Brazil. The cohort was followed for 3 years after the start of treatment. Results Of 299 cases of smear-positive pulmonary tuberculosis included in the study, 216 (72.2%) were diagnosed at five public primary health care units and 83 (27.8%) at three public hospi- tals. Among these cases, the prevalence of drug-resistant tuberculosis was 14.4%, and that of multidrug-resistant tuberculosis was 4.7%. Overall, 32.0% of drug-resistant and 2.0% of multidrug-resistant cases occurred in previously treated patients. The most common comor- bidity in the sample was HIV infection (26.2%). There was no association between drug- resistant or multidrug-resistant tuberculosis and sociodemographic variables. Cure was achieved in 66.7% of patients, and the default rate was 21.2%. The 2-month sputum conver- sion rate was 34.2%, and the relapse rate was 16.9%. Patients with drug-resistant tubercu- losis had lower rates of cure (45.2%) and 2-month sputum conversion (25%), as well as a higher relapse rate (30.7%). Conclusion These results highlight the urgent need for a more effective TB control program in this geo- graphical setting, with a major emphasis on treatment of drug-resistant and multidrug-resis- tant tuberculosis.
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    Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients receiving concurrent chemoradiation
    (Oral Oncology, 2016) Antunes, Heilton S; Schluckebier, Luciene Fontes; Herchenhorn, Daniel; Small, Isabele A.; Araújo, Carlos M.M.; Viégas, Celia Maria Pais; Rampini, Mariana P.; Ferreira, Elza M.S.; Dias, Fernando L.; Teich, Vanessa; Teich, Nelson; Ferreira, Carlos G.
    Background: Oral mucositis is a major event increasing treatment costs of head and neck squamous cell carcinoma (HNSCC) patients treated with chemoradiation (CRT). This study was designed to estimate the cost-effectiveness of low-level laser therapy (LLLT) to prevent oral mucositis in HNSCC patients receiving CRT. Methods: From June 2007 to December 2010, 94 patients with HNSCC of nasopharynx, oropharynx, and hypopharynx entered a prospective, randomized, double blind, placebo-controlled, phase III trial. CRT consisted of conventional radiotherapy (RT: 70.2 Gy, 1.8 Gy/d, 5 times/wk) + concurrent cisplatin (100 mg/m2 ) every 3 weeks. An InGaAlP (660 nm–100 mW–4 J/cm2 ) laser diode was used for LLLT. Results: From the perspective of Brazil’s public health care system (SUS), total costs were higher in Placebo Group (PG) than Laser Group (LG) for opioid use (LG = US$ 9.08, PG = US$ 44.28), gastrostomy feeding (LG = US$ 50.50, PG = US$ 129.86), and hospitalization (PG = US$ 77.03). In LG, the cost was higher for laser therapy only (US$ 1880.57). The total incremental cost associated with the use of LLLT was US$ 1689.00 per patient. The incremental cost-effectiveness ratio (ICER) was US$ 4961.37 per grade 3–4 OM case prevented compared to no treatment. Conclusions: Our results indicate that morbidity was lower in the Laser Group and that LLLT was more cost-effective than placebo up to a threshold of at least US$ 5000 per mucositis case prevented. Clinical trial information: NCT01439724.
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    Digital rectal examination and its associated factors in the early detection of prostate cancer: a cross-sectional population-based study
    (BMC Public Health, 2019) Soares, Samara Carollyne Mafra; Cancela, Marianna de Camargo; Migowski, Arn; Souza, Dyego Leandro Bezerra de
    Background: Digital rectal examination (DRE) is one of the most common strategies for prostate cancer early detection. However, the use for screening purposes has a controversial benefit and potential harms can occur due to false-positive results, overdiagnosis and overtreatment. The objective of this study is to calculate the prevalence and identify factors associated with the receipt of DRE in Brazilian men. Methods: We selected men older than 40 from a nationwide population-based survey (13,625 individuals) excluding those with prostate cancer diagnosis. Information was extracted from the most recent database of the Brazilian National Health Survey (PNS 2013). Statistical analysis was carried out to calculate incidence rate ratios, with 95% confidence intervals and p values, through multivariate analysis with Poisson regression and robust variance. Results: Men having private health insurance (63.3%; CI = 60.5–66.0) presented higher prevalence of DRE than those in the public health system (41.6%; CI = 39.8–43.4). The results show a positive association between DRE and men having private health insurance, aged 60–69, living with a spouse, never smokers, and living in urban areas. Among public health services users, this positive association was observed among men aged 70–79, living with a spouse, having bad/very bad health self-perception, abstainers, ex-smokers, with undergraduate studies, presenting four or more comorbidities, and residing in urban areas. Conclusions: Prostate cancer screening with DRE is quite frequent in Brazil, specially among men with private health plans and better access to health services, healthier lifestyle and at more advanced ages, characteristics which increase the risk of overdiagnosis and overtreatment.
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    Does my patient have chronic Chagas disease? Development and temporal validation of a diagnostic risk score
    (Revista da Sociedade Brasileira de Medicina Tropical, 2016) Brasil, Pedro Emmanuel Alvarenga Americano do; Xavier, Sergio Salles; Holanda, Marcelo Teixeira; Hasslocher-Moreno, Alejandro Marcel; Braga, José Ueleres
    INTRODUCTION: With the globalization of Chagas disease, unexperienced health care providers may have difficulties in identifying which patients should be examined for this condition. This study aimed to develop and validate a diagnostic clinical prediction model for chronic Chagas disease. METHODS: This diagnostic cohort study included consecutive volunteers suspected to have chronic Chagas disease. The clinical information was blindly compared to serological tests results, and a logistic regression model was fit and validated. RESULTS: The development cohort included 602 patients, and the validation cohort included 138 patients. The Chagas disease prevalence was 19.9%. Sex, age, referral from blood bank, history of living in a rural area, recognizing the kissing bug, systemic hypertension, number of siblings with Chagas disease, number of relatives with a history of stroke, ECG with low voltage, anterosuperior divisional block, pathologic Q wave, right bundle branch block, and any kind of extrasystole were included in the final model. Calibration and discrimination in the development and validation cohorts (ROC AUC 0.904 and 0.912, respectively) were good. Sensitivity and specificity analyses showed that specificity reaches at least 95% above the predicted 43% risk, while sensitivity is at least 95% below the predicted 7% risk. Net benefit decision curves favor the model across all thresholds. CONCLUSIONS: A nomogram and an online calculator (available at http://shiny.ipec.fiocruz.br:3838/pedrobrasil/chronic_chagas_disease_prediction/) were developed to aid in individual risk estimation.
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    Effect of Using Triclosan-Impregnated Polyglactin Suture to Prevent Infection of Saphenectomy Wounds in CABG: A Prospective, Double-Blind, Randomized Clinical Trial
    (Brazilian journal of Cardiovascular Surgery, 2019) Santos Filho, Paulo Samuel; Santos, Marisa; Colafranceschi, Alexandre Siciliano; Pragana, Andrea Nunes de Souza; Correia, Marcelo Goulart; Simões, Heloisa Helena; Rocha, Fernando Alves; Soggia, Maria Eduarda de Vasconcelos; Santos, Ana Paula Malta Samuel; Coutinho, Annie de Azeredo; Figueira, Matheus Swarovsky; Tura, Bernardo Rangel
    Objective: To evaluate the efficacy of triclosan-coated suture for the reduction of infection in saphenectomy wounds of patients undergoing coronary artery bypass graft (CABG) surgery.Methods: A total of 508 patients who underwent saphenectomy in CABG surgery were included in a prospective, randomized, double-blind trial from February/2011 to June/2014. Patients were randomized into the triclosan-coated suture group (n= 251) and the conventional non-antibiotic suture group (n=257). Demographic (gender and age), clinical (body mass index, diabetes, and use of analgesics), and intraoperative (cardiopulmonary bypass and cross-clamp times) variables and those related to the saphenectomy wound (pain, dehiscence, erythema, infection, necrosis, and hyperthermia) were measured and analyzed.Results: Of the 508 patients who underwent saphenectomy, 69.9% were males and 40.2% were diabetic. Thirty-three (6.5%) patients presented infection: 13 (5.3%) with triclosan and 20 (7.9%) with conventional suture (P=0.281). Among diabetic patients (n=204), triclosan suture was used in 45.1% with four cases of infection; conventional suture was used in 54.9% of them, with 11 cases of infection. Most patients (94.3%) underwent on-pump CABG. Wound pain was observed in 9.9% of patients with triclosan-coated suture and in 17.9% with conventional suture (P=0.011). Wound hyperthermia was found in 1.6% of patients with triclosan-coated suture and in 5.4% of those with conventional suture (P=0.028).Conclusion: Triclosan-coated suture shows lower infection rate in saphenectomy of patients undergoing CABG, although the differences were not statistically significant. Pain and wound hyperthermia were less frequent in patients with triclosan-coated sutures compared with conventional sutures.
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    Effectiveness of RHZE-FDC (fixed-dose combination)compared to RH-FDC + Z for tuberculosistreatment in Brazil: a cohort study
    (BMC Infectious Diseases, 2015) Braga, José Ueleres; Trajman, Anete
    Background:In 2009, Brazil was the sole high-burden country to use three drugs [rifampin (R), isoniazid (H) andpyrazinamide (Z)] as the standard treatment for sensitive tuberculosis, with RH in fixed-dose combination (FDC).In December 2009, the country has adopted the FDC four-drug regimen including ethambutol (E). The rationalewas the expectation to reduce default and resistance rates, by increasing adherence to treatment and avoidingmonotherapy. However, there is no consensus on the superior effectiveness of the RHZE-FDC regimen overRH-FDC + Z. In particular, few studies evaluated its influence on default and smear negativation rates.Methods:We conducted a historic cohort study to assess the effectiveness of RHZE-FDC for the treatment oftuberculosis in Brazil, measured by the rates of treatment default and smear negativation in the second month oftreatment, using secondary data from the national information system known as SINAN-TB.Results:The RHZE-FDC had a protective effect against treatment default compared to RH-FDC + Z, reducing itby 14%. However, it was not possible to show an effect of the RHZE-FDC on the rate of second month smearnegativation. In addition to the regimen, other well-studied individual characteristics, such as older age (over 38 years)and higher education occupation were also protective against default. Conversely, alcoholism increased the probabilityof defaulting. These programmatic findings suggests the benefits of RHZE-FDC over RH-FDC + Z.Conclusion:Our analysis of a cohort database in a high burden country shows that compared to RH-FDC + Z,RHZE-FDC reduces the default rates, independently of other influencing individual or health service factors.Keywords:Effectiveness, Fixed-dose combination, Treatment, Tuberculosis
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    Effectiveness of RHZE-FDC (fixed-dose combination)compared to RH-FDC + Z for tuberculosistreatment in Brazil: a cohort study
    (BMC Infectious Diseases, 2015) Braga, José Ueleres; Trajman, Anete
    Background:In 2009, Brazil was the sole high-burden country to use three drugs [rifampin (R), isoniazid (H) andpyrazinamide (Z)] as the standard treatment for sensitive tuberculosis, with RH in fixed-dose combination (FDC).In December 2009, the country has adopted the FDC four-drug regimen including ethambutol (E). The rationalewas the expectation to reduce default and resistance rates, by increasing adherence to treatment and avoidingmonotherapy. However, there is no consensus on the superior effectiveness of the RHZE-FDC regimen overRH-FDC + Z. In particular, few studies evaluated its influence on default and smear negativation rates.Methods:We conducted a historic cohort study to assess the effectiveness of RHZE-FDC for the treatment oftuberculosis in Brazil, measured by the rates of treatment default and smear negativation in the second month oftreatment, using secondary data from the national information system known as SINAN-TB.Results:The RHZE-FDC had a protective effect against treatment default compared to RH-FDC + Z, reducing itby 14%. However, it was not possible to show an effect of the RHZE-FDC on the rate of second month smearnegativation. In addition to the regimen, other well-studied individual characteristics, such as older age (over 38 years)and higher education occupation were also protective against default. Conversely, alcoholism increased the probabilityof defaulting. These programmatic findings suggests the benefits of RHZE-FDC over RH-FDC + Z.Conclusion:Our analysis of a cohort database in a high burden country shows that compared to RH-FDC + Z,RHZE-FDC reduces the default rates, independently of other influencing individual or health service factors.
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    Effects of an exercise program on blood pressure in patients with treated hypertension and chronic Chagas' heart disease
    (Revista da Sociedade Brasileira de Medicina Tropical, 2012) Oliveira, Claudia Rosa de; Sousa, Andréa Silvestre de; Santos, Bráulio; Fialho, Paloma Hargreaves; Santos. Carla Cristiane Soares dos; Oliveira, Juliana Rega de; Souza, Marcus Vinícius
    Introduction: Previous studies describe an imbalance of the autonomic nervous system in Chagas' disease causing increased sympathetic activity, which could influence the genesis of hypertension. However, patients undergoing regular physical exercise could counteract this condition, considering that exercise causes physiological responses through autonomic and hemodynamic changes that positively affect the cardiovascular system. This study aimed to evaluate the effects of an exercise program on blood pressure in hypertensive patients with chronic Chagas' heart disease. Methods: We recruited 17 patients to a 24-week regular exercise program and used ambulatory blood pressure monitoring before and after training. We determined the differences in the systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) from the beginning to the end of the study. Results: The blood pressures were evaluated in general and during periods of wakefulness and sleep, respectively: SBP (p = 0.34; 0.23; 0.85), DBP (p = 0.46; 0.44; 0.94) and MBP (p = 0.41; 0.30; 0.97). Conclusions: There was no statistically significant change in blood pressure after the 24-week exercise program; however, we concluded that physical training is safe for patients with chronic Chagas' disease, with no incidence of increase in blood pressure.
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    Effects of an exercise program on the functional capacity of patients with chronic Chagas' heart disease, evaluated by cardiopulmonary testing
    (Revista da Sociedade Brasileira de Medicina Tropical, 2012) Fialho, Paloma Hargreaves; Tura, Bernardo Rangel; Sousa, Andréa Silvestre de; Oliveira, Claudia Rosa de; Soares, Carla Cristiane Santos; Oliveira, Juliana Rega de; Souza, Marcus Vinícius; Coelho, Marina Pereira; Souza, Fernando César de Castro e; Cunha, Ademir Batista da; Kopiler, Daniel Arkader
    Introduction: Despite all efforts to restrict its transmission, Chagas' disease remains a severe public health problem in Latin America, affecting 8-12 million individuals. Chronic Chagas' heart disease, the chief factor in the high mortality rate associated with the illness, affects more than half a million Brazilians. Its evolution may result in severe heart failure associated with loss of functional capacity and quality of life, with important social and medical/labor consequences. Many studies have shown the beneficial effect of regular exercise on cardiac patients, but few of them have focused on chronic Chagas' heart disease. Methods: This study evaluated the effects of an exercise program on the functional capacity of patients with chronic Chagas' disease who were treated in outpatient clinics at the Evandro Chagas Institute of Clinical Research and the National Institute of Cardiology, Rio de Janeiro, Brazil. The exercises were performed 3 times a week for 1 h (30 min of aerobic activity and 30 min of resistance exercises and extension) over 6 months in 2010. Functional capacity was evaluated by comparing the direct measurement of the O₂ uptake volume (VO₂) obtained by a cardiopulmonary exercise test before and after the program (p < 0.05). Results: Eighteen patients (13 females) were followed, with minimum and maximum ages of 30 and 72 years, respectively. We observed an average increase of VO(2peak) > 10% (p = 0.01949). Conclusions: The results suggest a statistically significant improvement in functional capacity with regular exercise of the right intensity.
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    Four Months of Rifampin or Nine Months of Isoniazid for Latent Tuberculosis in Adults
    (The New England Journal of Medicine, 2018) Menzies, D.; Adjobimey, M.; Ruslami, R.; Trajman, A.; Sow, O.; Kim, H.; Baah, J. Obeng; Marks, G.B.; Long, R.; Hoeppner, V.; Elwood, K.; Al‐Jahdali, H.; Gninafon, M.; Apriani, L.; Koesoemadinata, R.C.; Kritski, A.; Rolla, V.; Bah, B.; Camara, A.; Boakye, I.; Cook, V.J.; Goldberg, H.; Valiquette, C.; K. Hornby; Dion, M.-J.; Li, P.-Z.; Hill, P.C.; Schwartzman, K.; Benedetti, A.
    BACKGROUND: A 9-month regimen of isoniazid can prevent active tuberculosis in persons with latent tuberculosis infection. However, the regimen has been associated with poor adherence rates and with toxic effects. METHODS: In an open-label trial conducted in nine countries, we randomly assigned adults with latent tuberculosis infection to receive treatment with a 4-month regimen of rifampin or a 9-month regimen of isoniazid for the prevention of confirmed active tuberculosis within 28 months after randomization. Noninferiority and potential superiority were assessed. Secondary outcomes included clinically diagnosed active tuberculosis, adverse events of grades 3 to 5, and completion of the treatment regimen. Outcomes were adju- dicated by independent review panels. RESULTS: Among the 3443 patients in the rifampin group, confirmed active tuberculosis developed in 4 and clinically diagnosed active tuberculosis developed in 4 during 7732 person-years of follow-up, as compared with 4 and 5 patients, respectively, among 3416 patients in the isoniazid group during 7652 person-years of follow-up. The rate differences (rifampin minus isoniazid) were less than 0.01 cases per 100 person-years (95% confidence inter- val [CI], −0.14 to 0.16) for confirmed active tuberculosis and less than 0.01 cases per 100 person-years (95% CI, −0.23 to 0.22) for confirmed or clinically diagnosed tuberculosis. The upper boundaries of the 95% confidence interval for the rate differences of the confirmed cases and for the confirmed or clinically diagnosed cases of tuberculosis were less than the prespecified noninferiority margin of 0.75 percentage points in cu- mulative incidence; the rifampin regimen was not superior to the isoniazid regimen. The difference in the treatment-completion rates was 15.1 percentage points (95% CI, 12.7 to 17.4). The rate differences for adverse events of grade 3 to 5 occurring within 146 days (120% of the 4-month planned duration of the rifampin regimen) were −1.1 percentage points (95% CI, −1.9 to −0.4) for all events and −1.2 percentage points (95% CI, −1.7 to −0.7) for hepatotoxic events. CONCLUSIONS: The 4-month regimen of rifampin was not inferior to the 9-month regimen of isoniazid for the prevention of active tuberculosis and was associated with a higher rate of treat- ment completion and better safety. (Funded by the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council; ClinicalTrials.gov number, NCT00931736.).
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    Harms and benefits of mammographic screening for breast cancer in Brazil
    (PLOS ONE, 2024) Migowski, Arn; Nadanovsky, Paulo; Vianna, Cid Manso de Mello
    Introduction In the absence of evidence on the effect of mammographic screening on overall mortality, comparing the number of deaths avoided with the number of deaths caused by screening would be ideal, but the only existing models of this type adopt a very narrow definition of harms. The objective of the present study was to estimate the number of deaths prevented and induced by various mammography screening protocols in Brazil. Methods A simulation study of cohorts of Brazilian women screened, considering various age groups and screening interval protocols, was performed based on life tables. The number of deaths avoided and caused by screening was estimated, as was the absolute risk reduction, the number needed to invite for screening—NNS, the net benefit of screening, and the ratio of “lives saved” to “lives lost”. Nine possible combinations of balances between benefits and harms were performed for each protocol, in addition to other sensitivity analyses. Results and conclusions The most efficient protocol was biennial screening from 60 to 69 years of age, with almost three times more deaths avoided than biennial screening from 50 to 59 years of age, with a similar number of deaths avoided by biennial screening from 50 to 69 years of age and with the greatest net benefit. Compared with the best scenario of annual screening from 40 to 49 years of age, the NNS of the protocol with biennial screening from 60 to 69 years of age was three-fold lower. Even in its best scenario, the addition of annual screening from 40 to 49 years of age to biennial screening from 50 to 69 years of age results in a decreased net ben- efit. However, even in the 50–69 year age group, the estimated reduction in breast cancer mortality for Brazil was half that estimated for the United Kingdom.
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    Health-related quality of life in elderly: a review of the EQ-5D use.
    (Jornal Brasileiro de Economia da Saúde, 2016) Veras, Bruna Medeiros Gonçalves de; Magliano, Carlos Alberto da Silva; Santos, Marisa da Silva; Duarte, Elizabeth da Rosa; Blatt, Carine Raquel; Stein, Airton Tetelbom
    Objective: To systematically identify and review studies that used EQ-5D to assess health-related quality of life (QoL) in elderly. Methods: Relevant literature was searched in MEDLINE and Lilacs databases and the EuroQol Plenary Meetings Proceedings (June/2003 to June/2013). The inclusion criteria were subjects aged 60 years or more and the use of the EQ-5D questionnaire. Two independent reviewers screened title, abstract, full text and performed data extraction. The country where the study had been conducted, demographic characteristics of the population, objectives, common criteria used by the studies to the exclusion of patients/participants and presentation of the data were the variables analyzed. Results: A total of 90 studies were included with 34,449 subjects, the mean age was 75.6 ± 4.3 years. The majority of the studies were from Europe (66.7%). Studies in Africa and South America were not identified. The main diseases investigated were orthopedic (20.0%) and cardiovascular diseases (15.5%). The study’s results were most frequently based on personal interviews (41.1%) involving directly the elderly (92.2%). The most common exclusion criteria were health conditions that could result in bias or confounding on the study protocol (61.1%) and low cognitive level (50.0%). The EQ-5D results were presented in different ways: means (82.2%) or medians (5.6%) associated with measures of dispersion as standard deviation (61.1%) and confidence interval (22.2%), or according to the answers in the descriptive system (22.2%). Conclusions: The lack of standardization in the exhibition of the results limits a direct comparison among different interventions.
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    Impact of Early Valve Surgery on Outcome of Staphylococcus aureus Prosthetic Valve Infective Endocarditis: Analysis in the International Collaboration of Endocarditis–Prospective Cohort Study
    (Infectious Diseases Society of America, 2015) Chirouze, Catherine; Alla, François; Fowler, Vance G.; Sexton, Daniel J.; Corey, G. Ralph; Chu, Vivian H.; Wang, Andrew; Erpelding, Marie-Line; Durante-Mangoni, Emanuele; Fernández-Hidalgo, Nuria; Giannitsioti, Efthymia; Hannan, Margaret M.; Lejko-Zupanc, Tatjana; Miró, José M.; Muñoz, Patricia; Murdoch, David R.; Tattevin, Pierre; Tribouilloy, Christophe; Hoen, Bruno; Ferraiuoli, Giovanna; Golebiovski, Wilma; Lamas, Cristiane; Santos, Marisa; Weksler, Clara
    Background: The impact of early valve surgery (EVS) on the outcome of Staphylococcus aureus (SA) prosthetic valve infective endocarditis (PVIE) is unresolved. The objective of this study was to evaluate the association between EVS, performed within the first 60 days of hospitalization, and outcome of SA PVIE within the International Collaboration on Endocarditis-Prospective Cohort Study. Methods: Participants were enrolled between June 2000 and December 2006. Cox proportional hazards modeling that included surgery as a time-dependent covariate and propensity adjustment for likelihood to receive cardiac surgery was used to evaluate the impact of EVS and 1-year all-cause mortality on patients with definite left-sided S. aureus PVIE and no history of injection drug use. Results: EVS was performed in 74 of the 168 (44.3%) patients. One-year mortality was significantly higher among patients with S. aureus PVIE than in patients with non-S. aureus PVIE (48.2% vs 32.9%; P = .003). Staphylococcus aureus PVIE patients who underwent EVS had a significantly lower 1-year mortality rate (33.8% vs 59.1%; P = .001). In multivariate, propensity-adjusted models, EVS was not associated with 1-year mortality (risk ratio, 0.67 [95% confidence interval, .39-1.15]; P = .15). Conclusions: In this prospective, multinational cohort of patients with S. aureus PVIE, EVS was not associated with reduced 1-year mortality. The decision to pursue EVS should be individualized for each patient, based upon infection-specific characteristics rather than solely upon the microbiology of the infection causing PVIE. Keywords: 1-year mortality; endocarditis; prosthetic valve; surgery.
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    Macrophage migration inhibitory factor is associated with positive cultures in patients with sepsis after cardiac surgery
    (Shock, 2005) Mendonça-Filho, Hugo Tannus Furtado de; Gomes, Gleice Silva; Nogueira, Pedro Miguel Mattos; Fernandes, Marco Aurelio de Oliveira; Tura, Bernardo Rangel; Santos, Marisa; Castro-Faria-Neto, Hugo Caire
    This prospective consecutive observational study describes the blood levels of macrophage migration inhibitory factor (MIF), other cytokines, and markers of acute-phase response in 49 consecutive patients who developed the clinical syndrome of sepsis after cardiac surgery. Before starting antimicrobial treatment, all patients underwent microbiologic screening, and blood samples were collected. These samples subsequently were assayed for MIF, macrophage chemoattractant protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6 and -10, procalcitonin (PCT), and C-reactive protein (CRP). Patients with positive cultures (n = 25) had a higher mortality (P = 0.046) and higher levels of MIF (P < 0.001) than those with negative cultures (n = 24). We could not detect significant difference between the groups concerning the levels of CRP, PCT, IL6, IL10, MCP-1, or TNF-alpha. MIF levels showed an area under receiver operator curve of 0.823 for the prediction of culture-proven bacterial infection, with the best cut-off value at 988.5 pg/mL. In conclusion, circulating levels of MIF could be indicated as a valuable marker of microbiologically documented sepsis in patients after cardiac surgery, which suggests that MIF may be prospectively explored as a useful diagnostic tool in this setting.
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    Mortality and morbidity of patients on the waiting list for coronary artery bypass graft surgery
    (Interactive Cardiovascular and Thoracic Surgery, 2018) Fonseca, Viviane Belidio Pinheiro da; Lorenzo, Andrea De; Tura, Bernardo Rangel; Pittella, Felipe José Monassa; Rocha, Antônio Sérgio Cordeiro da
    Objectives: The public health care system in Brazil has extensive waiting lists of patients requiring complex operations such as coronary artery bypass grafting (CABG). The purpose of this study was to identify the mortality and morbidity rates of the patients awaiting CABG and identify predictors of adverse events and their association with perioperative outcomes. Methods: We conducted a retrospective analysis of outpatient medical records of patients referred for this elective procedure in Rio de Janeiro, Brazil. Excluded from the study were records of patients with any of the following: an indication for urgent surgery, unstable angina or concomitant surgical valvular disease or subsequent transfer to clinical or percutaneous therapy. Results: A total of 274 patients were identified and met the inclusion criteria, with a median waiting time for an operation of 142.7 days. While waiting for CABG surgery, 31 (11.3%) patients died of any cause and 42 (15.3%) patients had a serious cardiac event (death, myocardial infarction or unstable angina). Of the 22 (8%) incidents of acute myocardial infarction, 8 (2.9%) were non-fatal and 14 (5.1%) were fatal. There was a greater risk of death awaiting CABG surgery in patients with a left ventricular ejection fraction below 45% (hazard ratio = 2.33, 95% confidence interval 1.02-5.32; P = 0.039). The operative mortality rate was 5.8%. Although there was no evidence of worse perioperative outcomes in patients with prolonged waiting times for an operation, there was an association between waiting more than 16 weeks for an operation and death while on the list. Conclusions: Extensive waiting periods for CABG contribute to higher mortality and morbidity rates, especially in patients with left ventricular dysfunction.