Body mass index and sex differences for mortality in hospitalized COVID-19 patients: a path analysis using a brazilian national database.

Previous studies have shown that associations between obesity and other comorbidities favor worse outcomes in COVID-19. However, it is not clear how these factors interrelate and whether effects on men and women differ. We conducted an observational, cross-sectional study using a national COVID-19 inpatient database. We studied differences in direct and indirect effects of obesity and comorbidities according to sex and body mass index (BMI) categories in hospitalized COVID-19 patients in Brazil using path analysis models and logistic regression. For men, path analysis showed a direct association between BMI and death and a negative correlation of death and chronic cardiovascular disease (CCD). For women, the association of BMI and death was indirect, mediated by admission to the ICU and comorbidities and association with CCD was non-significant. In the logistic regression analyses, there was a positive association between death and BMI, age, diabetes mellitus, kidney and lung diseases and ICU admission. We highlight the need to consider the distinct impact of obesity and sex on COVID-19, of monitoring of BMI and of the design for specific male-targeted approaches to manage obesity.

Pitfalls in acute febrile illness diagnosis: Interobserver agreement of signs and symptoms during a dengue outbreak.

AIMS AND OBJECTIVES: To compare and evaluate interobserver (nurses and physicians) agreement for dengue clinical signs and symptoms, including the World Health Organization diagnostic algorithm. BACKGROUND: Agreement of clinical history defines the capacity of the examiner to measure a given clinical parameter in a reproducible and consistent manner, which is prerequisite for diagnosis validity. Nurses play a major role in the triage and care of dengue patients in many countries. STUDY DESIGN: This is a sub-study on interobserver agreement performed as part of a cross-sectional diagnostic accuracy study for acute febrile illness (AFI) using the checklist STARD. METHODS: A previously validated semi-structured sign and symptom standardised questionnaire for AFI was independently administered to 374 patients by physician and nurse pairs. The interobserver agreement was estimated using kappa statistics. RESULTS: For a set of 27 signs and symptoms, we found six interobserver discrepancies (examiner detected red eyes, lethargy, exanthema, dyspnoea, bleeding and myalgia) as identified by regular and moderate kappa indexes. Four signs (patient observed red eyes, cough, diarrhoea and vomiting) and one symptom (earache) had near-perfect agreement. Most signs and symptoms showed substantial agreement. The WHO (Dengue guidelines for diagnosis, treatment, prevention and control: new edition, World Health Organization, 2009) clinical criteria for dengue comprise a group of symptoms known as "pains and aches." Interobserver agreement for abdominal pain, retro-orbital pain and arthralgia exceed that found for headache and myalgia. CONCLUSIONS: During a dengue outbreak, the interobserver agreement for most of the signs and symptoms used to assess AFI was substantial. RELEVANCE TO CLINICAL PRACTICE: This result suggests good potential applicability of the tool by health professionals following training. A well-trained health professional is qualified to apply the standardised questionnaire to evaluate suspected dengue cases during outbreaks.

Increased sensitivity of NS1 ELISA by heat dissociation in acute dengue 4 cases.

BACKGROUND: Dengue is an acute febrile illness considered the major arboviral disease in terms of morbidity, mortality, economic impact and dissemination worldwide. Brazil accounts for the highest notification rate, with circulation of all four dengue serotypes. The NS1 antigen is a dengue highly conserved specific soluble glycoprotein essential for viral replication and viability that can be detected 0 to 18 days from the onset of fever (peak first 3 days). It induces a strong humoral response and is known as a complement-fixing antigen. Lower NS1 test sensitivity occurs in secondary dengue infections probably due to immune complex formation impairing antigen detection by ELISA. METHODS: We compared the sensitivity of NS1 ELISA in heat dissociated and non-dissociated samples from 156 RT-PCR confirmed acute dengue-4 cases from 362 prospectively enrolled patients. RESULTS: Secondary infections accounted for 83.3% of cases. NS1 ELISA was positive in 42.5% and indeterminate in 10.2% of dengue-4 cases. After heat dissociation, 7 negative and 16 indeterminate samples turned positive, increasing the overall test sensitivity to 57.7%. CONCLUSIONS: Although it is time consuming and requires the use of specific laboratory equipment, NS1 ELISA combined with heat dissociation could be a slightly better alternative for triage in suspected dengue cases.

Precisão e confiabilidade de um teste imuno-cromatográfico rápido NS1 para diagnóstico DENV-1 no ponto de atendimento e no laboratório.

BACKGROUND: Rapid immunochromatographic tests (ICT) for dengue non-structural protein 1 (NS1) have shown good performance for diagnosing acute-phase dengue in serum in laboratory settings, but rarely have been assessed in whole blood and at point of care (POC). This study compare the accuracy and inter- and intra-observer reliability of the NS1 Bioeasy™ ICT in whole blood at POC versus serum in the laboratory, during a DENV-1 epidemic. METHODS: Cross-sectional study involving 144 adults spontaneously demanding care in an emergency department within 4 days of onset of acute febrile illness. Accuracy of NS1 Bioeasy™ ICT was compared in whole blood and serum, both at 15 and 30 min, blinded to the reference RT-PCR or NS1 ELISA. Non-dengue patients were also tested for Zika virus with RT-PCR. Reliability of whole blood and serum readings by the same or different observers was measured by simple kappa (95% CI). RESULTS: At 15 min, sensitivity (Sn) of NS1 Bioeasy™ ICT in whole blood/POC was 76.7% (95% CI: 68.0-84.1) and specificity (Sp) was 87.0% (95% CI: 66.4-97.2). Sn in serum/laboratory was 82% (95% CI: 74.1-88.6) and Sp 100% (95% CI: 85.8-100). Positive likelihood ratio was 5.9 (95% CI: 2.0-17.0) for whole blood/POC and 19.8 (95% CI: 2.9-135.1) for serum/laboratory. Reliability of matched readings of whole blood/POC and serum/laboratory by the same observer (k = 0.83, 95% CI: 0.74-0.93) or different observers (k = 0.81, 95% CI: 0.72-0.92) was almost perfect, with higher discordant levels in the absence of dengue. Results did not differ statistically at 5%. CONCLUSIONS: NS1 Bioeasy™ ICT in DENV-1 epidemics is a potentially confirmatory test. Invalid results at 15 min should be reread at 30 min. To optimize impact of implementing ICT in the management of false-negatives it should be incorporated into an algorithm according to setting and available specimen. TRIAL REGISTRATION: UTN U1111-1145-9451 .

Correction to: Accuracy and reliability of an NS1 rapid immunochromatographic test for DENV-1 diagnosis at point of care and in the laboratory.

An error occurred during the publication of the original article [1].

Accuracy of clinical criteria and an immunochromatographic strip test for dengue diagnosis in a DENV-4 epidemic.

BACKGROUND: Early diagnosis of dengue infection is important for decision-making and timely implementation of therapeutic measures. Although rapid NS1 assays have been used for dengue diagnosis since 2008, their performance in DENV-4 cases has not yet been fully assessed. METHODS: We evaluated the accuracy of NS1 Bioeasy™ immunochromatographic strip test and of three clinical criteria for dengue diagnosis. Patients presenting at an emergency care center within 72 h of an acute febrile illness during the 2013 DENV-4 epidemic in Rio de Janeiro were consecutively enrolled for clinical and laboratory evaluation. We classified patients as suspected dengue or not according to three clinical criteria: WHO 2009, WHO 1997, and INI-FIOCRUZ. Dengue diagnosis was defined by RNA detection using RT-PCR and the negative cases were negative for all dengue serotypes and also Platelia™ NS1 ELISA. We obtained accuracy indices for NS1 Bioeasy™ alone and in combination with the clinical criteria. RESULTS: RT-PCR for DENV-4 was positive in 148 out of 325 patients. Positive likelihood ratio, sensitivity, and specificity of NS1 Bioeasy™ with WHO 2009, WHO 1997, and INI-FIOCRUZ criteria were 22.6 (95% CI 7.2-70.6), 40.6% (95% CI 32.3-49.3), and 98.2% (95% CI 94.9-99.6); 18.3 (95% CI 6.8-49.2), 44.2 (95% CI 35.8-52.9), 97.6 (95% CI 94.0-99.3); 26.2 (95% CI 6.5-106.5), 29.7 (95% CI 22.4-37.8), 98.9 (95% CI 96.0-99.9), respectively. WHO 1997 clinical criteria presented high sensitivity to rule out disease, but extremely low specificity. INI-FIOCRUZ had moderate sensitivity and specificity, and could target a group to a more specific test. CONCLUSIONS: Although the large rates of false negative results using NS1 Bioeasy™ rapid test advise against its use for triaging (rule out) purposes in DENV-4 epidemics, it could be used as a confirmatory tool in a bedside algorithm.

Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Influenza and its complications are common at all ages, especially in children. Vaccines and anti-influenza drugs aim to prevent it. Preventative approaches with favorable risk profiles should be considered for flu, particularly since the evidence of the efficacy of anti-viral drugs is debated. METHODS: This pragmatic clinical trial was conducted in the Brazilian Public Health System in Petrópolis (BPHSP) with children aged from 1 to 5 years old. The medications used were mainly selected based on in vitro experiments (InfluBio), and in successful qualitative clinical experiences (Homeopathic Complex). Following informed parental consent, subjects were randomly distributed, in a blind manner, to three experimental groups: Homeopathic Complex, Placebo, and InfluBio. BPHSP health agents collected flu and acute respiratory infection symptomatic episodes monthly following the established protocol. The number of these episodes was registered in one year (2009-2010). RESULTS: Out of the 600 children recruited, 445 (74.17%) completed the study (149: Homeopathic complex; 151: Placebo; 145: InfluBio). The number of flu and acute respiratory infection symptomatic episodes detected in this clinical trial was low; however, it was different between homeopathic groups and placebo (p < 0.001). In the first year post-intervention, 46/151 (30.5%) of children in the placebo group developed 3 or more flu and acute respiratory infection episodes, while there was no episode in the group of 149 children who used Homeopathic Complex, and only 1 episode in the group of 145 (1%) children who received InfluBio. CONCLUSION: These results suggested that the use of homeopathic medicines minimized the number of flu and acute respiratory infection symptomatic episodes in children, signalizing that the homeopathic prophylactic potential should be investigated in further studies.

Clinical profile of dengue in the elderly using surveillance data from two epidemics.

BACKGROUND: Population aging and mobility have increased the exposure of elderly individuals to dengue. This study evaluated the clinical features of dengue in the elderly during the epidemic (2008 and 2012) and interepidemic (2009 and 2010) periods. METHODS: This cross-sectional study was based on dengue surveillance data from Rio de Janeiro, Brazil: 2008 (n=31,210), 2009‒2010 (n=2,884), and 2012 (n=30,773). The analysis was stratified by age group (<60 and ≥60 years). RESULTS: Case-fatality rates were higher in the elderly. In 2008, elderly individuals were found to be more prone to hematuria and thrombocytopenia. CONCLUSIONS: These results can improve the understanding of dengue in elderly individuals who live in or travel to tropical regions.

Histopathology of cutaneous sporotrichosis in Rio de Janeiro: a series of 119 consecutive cases.

BACKGROUND: Sporotrichosis is the most common subcutaneous mycosis in Rio de Janeiro. Histopathological examination reveals diffuse granulomatous and suppurative dermatitis, and the fungus is rarely identifiable in tissue. We describe the histopathological features of cutaneous sporotrichosis, and investigate the association between them and the lack of visualization of the fungus. METHODS: A total of 119 samples of confirmed sporotrichosis cases were studied. The characteristics of the inflammatory infiltrate, the presence of epidermal changes, necrosis and fibrosis, and the parasite burden were analyzed. The association between histopathological changes and the lack of visualization of the fungus was evaluated using prevalence ratios. RESULTS: Granulomas were observed in all samples, suppurative granulomas in 100 (84%) and diffuse dermatitis in 114 (95.8%). Liquefaction and caseous necrosis were present in 78 (65.5%) and 52 (43.7%) samples, respectively. The fungus was not seen in 77 (64.7%) samples. Epithelioid, tuberculoid or foreign-body-type granulomas, caseous, fibrinoid or absent necrosis, predominance of lymphocytes among nonphagocytic cells and fibrosis were associated with the lack of visualization of the fungus. CONCLUSION: The histopathological characteristics of sporotrichosis were variable when the causative fungus was not seen. In a proper context, the diagnosis of sporotrichosis remains a potential consideration even in the absence of demonstrable yeast.

Dimensional structure of the demand control support questionnaire: a Brazilian context.

UNLABELLED: According to Karasek, job strain results from an interaction between high demands and low decision latitude. PURPOSE: To reassess the dimensional structure and evaluate the internal consistency of demand control support questionnaire (DCSQ), a shortened version of job content questionnaire that was not sufficiently evaluated in validation studies. METHODS: The study investigated 825 workers who completed the DCSQ in Rio de Janeiro, Brazil; to 399 workers, the questionnaire was self-administered at a hospital (2004-2005), and 426 workers were interviewed at nine restaurants (2006-2007). Confirmatory factor analysis using structural equation models was used to test theoretical structure of dimensionality. Internal consistency was evaluated by composite reliability and convergent validity by average variance extracted. RESULTS: Confirmatory factor analysis supported the instrument in three dimensions: demands, skill discretion and decision authority. The best fit model was achieved by removing social support at work and the item repetitive work (skill discretion). A cross-loading from learning new things on demands and an error measurement correlation between work fast and work intense were confirmed. Composite reliability was acceptable for all dimensions, except for demands (0.58), which also showed inadequate average variance extracted (0.32). This final model was confirmed in separate analyses according to work setting, but the loadings of demands were lower for restaurant workers. CONCLUSION: Our results indicated that skill discretion and decision authority formed two distinct dimensions. Additionally, the item repetitive work should be removed, as well as one of the items work fast or work intense (demands). Future research is still required to confirm these findings.

Immunoenzymatic assay for the diagnosis of American tegumentary leishmaniasis using soluble and membrane-enriched fractions from infectious Leishmania (Viannia) braziliensis.

The diagnosis of American tegumentary leishmaniasis (ATL) is based on the visualization or isolation of the parasite, which is a time-consuming and poorly sensitive method. In this study, we evaluated the accuracy and reliability of ELISA for the diagnosis of ATL using soluble (SF) and membrane-enriched (MF) antigen fractions obtained from an infectious strain of Leishmania (Viannia) braziliensis. A total of 152 serum samples investigated at a referral center in Rio de Janeiro, Brazil, between 2005 and 2007 were studied. Each sample was tested twice with each fraction for the calculation of reliability (intraclass coefficient (ICC)). Cut-off values of 0.22 (SF) and 0.33 (MF) were defined. The use of the fractions resulted in good discrimination between patients, with a large area under the curve (P<0.0001), but no difference was observed between the two fractions (P=0.45). Sensitivity was 89.5% for each fraction, specificity was 89.5% for SF and 93.4% for MF, and the positive likelihood ratio was 8.5 for SF and 13.6 for MF. The ICCs were excellent (SF: 0.96 and MF: 0.90). The antigens tested provided precision and accuracy for the diagnosis of ATL, with SF being recommended due to its lower cost and greater practicality.

Rapid immunochromatographic tests for the diagnosis of dengue: a systematic review and meta-analysis.

Dengue is an important arthropod-borne viral disease in terms of morbidity, mortality, economic impact and challenges in vector control. Benchmarks are expensive, time consuming and require trained personnel. Preventing dengue complications with rapid diagnosis has been based on the testing of easy-to-perform optimized immunochromatographic methods (ICT). This is a systematic meta-analysis review of the diagnostic accuracy of IgA, NS1, IgM and/or IgG ICT studies in suspected cases of acute or convalescent dengue, using a combination of RT-PCR, ELISA NS1, IgM IgG or viral isolation as a reference standard. This protocol was registered in PROSPERO (CRD42014009885). Two pairs of reviewers searched the PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS and EMBASE databases, selected, extracted, and quality-assessed by QUADAS 2. Of 3,783 studies, we selected 57, of which 40 in meta-analyses according to the analyte tested, with high heterogeneity (I2 > 90%), as expected for diagnostic tests. We detected higher pooled sensitivity in acute phase IgA (92.8%) with excellent (90%) specificity. ICT meta-analysis with NS1/IgM/IgG showed 91% sensitivity and 96% specificity. Poorer screening performance was for IgM/IgG ICT (sensitivity = 56%). Thus, the studies with NS1/IgM/IgG ICT showed the best combined performance in the acute phase of the disease.

Diagnostic parameters and reliability of four rapid immunochromatographic tests for dengue 4.

BACKGROUND: Although performance of rapid immunochromatographic tests (RITs) for dengue virus (DENV) serotypes 1, 2 and 3 is relatively settled, evidence on accuracy of RITs for DENV-4 are based on studies with small sample sizes and with discrepant results. OBJECTIVES: To assess accuracy and inter-observer agreement of RITs targeting dengue nonstructural protein-1 (NS1) antigen - Dengue NS1-Bioeasy™, Dengue NS1 Ag Strip-Bio-Rad™, IVB Dengue Ag NS1-Orangelife™ and Dengue NS1-K130-Bioclin™ in DENV-4 samples. METHODS: Study sample (n = 324) included adults presenting at an emergency unit in Rio de Janeiro, Brazil, with fever of ≤72 h and two or more dengue symptoms. A serum sample from each patient was tested by each RIT. A positive reverse-transcription polymerase chain reaction was considered as the reference standard for dengue diagnosis. The diagnostic parameters analyzed for each RIT were sensitivity, specificity, positive and negative predictive values, and likelihood ratios. Each RIT was read by homogeneous (two junior nurses) or heterogeneous (one junior nurse and one senior biologist) pairs. Agreement was estimated by simple kappa with 95% confidence interval, positive (Ppos) and negative (Pneg) proportion concordance and prevalence and bias adjusted kappa, rated from poor (k < 0.0) to almost perfect (0.8 < k < 1.0), and perfect (k = 1). RESULTS: NS1 RITs for DENV-4 diagnosis showed high specificity (95.9%-99.4%), but low sensitivity (14.7%-45.4%). Bioeasy™ had the best performance, with a positive likelihood ratio of 26.0 (95% CI: 8.4;81.0). Inter-observer agreement was almost perfect for all evaluated RITs. Mismatches in confirmed dengue were more common for the Bioclin™ (Ppos 88.3-90.0 %) and Orangelife™ (Ppos 91.7-94.1 %) tests. CONCLUSIONS: For DENV-4, the tested RITs had high specificity, but lower sensitivity compared to published results for other serotypes. They should not be used for screening purposes. Different brands may have very different performances. This should be considered upon deciding of using RITs in DENV-4 outbreaks.

24-hour Holter findings in infants with in-utero exposure to the Zika virus: a series of cases.

Severe neurological problems and other special manifestations such as high prevalence of structural cardiac changes has been described in infants vertically exposed to the Zika virus (ZIKV) and has been called congenital Zika virus syndrome (CZS). Previous studies have shown that the 24-hour Holter heart rate variability (HRV) analysis allows the prediction of worse outcomes in infants with neurological impairment and higher risk of sudden infant death syndrome (SIDS), hypertension, diabetes mellitus and other cardiovascular diseases. This study describes the 24-hour Holter findings of infants with confirmed vertical exposure to the ZIKV by positive polymerase chain reaction (PCR) assays in the mother's blood during pregnancy and/or in the urine or cerebrospinal fluid of the newborn. Data analysis was descriptive and included two subgroups according to the presence of fetal distress, positive PCR to ZIKV in the newborn, CZS and severe microcephaly. Heart rate, pauses, arrhythmias, ST segment and QT interval analyses and HRV evaluation through R-R, SDNN, pNN50 and rMMSD were described. The Mann-Whitney test was performed to assess differences between the two subgroups. The sample consisted of 15 infants with a mean age of 16 months, nine of whom were male. No arrhythmias or QT interval changes were observed. The comparison of HRV through the Mann-Whitney test showed a significant difference between patients with and without CZS, with and without severe microcephaly, with lower HRV in the groups with severe microcephaly and CZS. The study suggests that there is an increased risk of SIDS and cardiovascular diseases in this group of patients.

Comparative study of amplification systems in immunoenzyme assays for the diagnosis of American tegumentary leishmaniasis.

We compared the accuracy and reliability of three amplification systems for enzyme immunoassays in the detection of specific IgG antibodies for the diagnosis of cutaneous leishmaniasis caused by Leishmania (Viannia) braziliensis in patients from an endemic area in Rio de Janeiro, Brazil. Partially soluble antigens obtained from the promastigote forms of L. (V.) braziliensis were used. For development of the reaction, two chromogens, 1,2-orthophenylenediamine (OPD) and 3,3',5,5'-tetramethylbenzidine (TMB), and a fluorogen, 4-methylumbelliferylphosphate (MUP), were tested. The performance of each system was compared using the following parameters: accuracy, intraclass correlation coefficient (ICC), and area under the receiver operating characteristic (ROC) curve. Sensitivity was the same (97.4%) for all systems. The reliability was excellent (ICC = 98.6, 98.7, and 99.1%) and specificity was 93.7, 95.8, and 97.4% for OPD, MUP, and TMB, respectively, showing no statistical significance. Despite the absence of differences in the performance of the three systems, the use of TMB is suggested because of its operational advantages, such as low cost compared with fluorogens, easy manipulation, greater stability, and lower toxicity.

Effectiveness and safety of isoniazid chemoprophylaxis for HIV-1 infected patients from Rio de Janeiro.

The clinical and epidemiological characteristics, adverse events, treatment adherence and effectiveness of isoniazid chemoprophylaxis were analyzed in a cohort of 138 tuberculosis/HIV-coinfected patients. An open, non-randomized, pragmatic prophylactic trial was conducted on adult patients with a normal chest X-ray and positive tuberculin skin test (>or= 5 mm) who received isoniazid chemoprophylaxis (300 mg/day) for six months. The mean of follow up was 2.8 years (SD 1.3). Adherence to chemoprophylaxis was 87.7% (121/138). Only one patient presented tuberculosis after the end of chemoprophylaxis, corresponding to 0.3 cases per 100 persons per year. The relative risk of some adverse effects was 4.6 times higher (95% CI: 1.9-11.5) in patients with positive anti-HCV serology (4/9, 44.4%) compared to those with negative serology (12/129, 9.6%) (p = 0.002). This study provides evidence regarding the effectiveness and safety of a short and self-administered isoniazid regimen. We recommend the implementation of this routine by health service practitioners.

Quality assessment of clinical guidelines for the treatment of obesity in adults: application of the AGREE II instrument.

There are various guidelines for the treatment of obesity, and thus the quality of these clinical guidelines has become a matter of concern. The objective was to describe and assess the quality of clinical guidelines for treatment of obesity in adults. We collected several studies, dated from 1998 to 2016, produced by different countries. The literature search included the National Guideline Clearinghouse (NGC), Guidelines International Network (GIN), PubMed (MEDLINE), Scopus, Web of Science, webpages of health institutions from different countries, and search sites, with the criterion: "clinical guidelines for treatment of obesity in adults and published until the 2016". The guidelines were assessed with the Appraisal of Guidelines for Research & Evaluation (AGREE II), according to the domains of the instrument. The search identified 21 guidelines: nine from Europe, six from North America, three from Latin America, and one each from Asia and Oceania and a transnational association. The Australian guideline had the best assessment. Of the six guidelines with the highest scores, five had been elaborated by the government sector responsible for the country's health. The domains "scope and purpose" and "clarity of presentation" had the highest score. Except for the Canadian guideline, the three guidelines drafted before the elaboration of AGREE II had the worst quality. In the domain "stakeholder involvement", only four guidelines (Australia, Scotland, France, and England) mentioned patient participation. Guideline development and quality enhancement are ongoing processes requiring systematic appraisal of the guideline production process and existing guidelines.

Clinical profile of dengue in the elderly using surveillance data from two epidemics

ABSTRACT Background: Population aging and mobility have increased the exposure of elderly individuals to dengue. This study evaluated the clinical features of dengue in the elderly during the epidemic (2008 and 2012) and interepidemic (2009 and 2010) periods. Methods: This cross-sectional study was based on dengue surveillance data from Rio de Janeiro, Brazil: 2008 (n=31,210), 2009‒2010 (n=2,884), and 2012 (n=30,773). The analysis was stratified by age group (<60 and ≥60 years). Results: Case-fatality rates were higher in the elderly. In 2008, elderly individuals were found to be more prone to hematuria and thrombocytopenia. Conclusions: These results can improve the understanding of dengue in elderly individuals who live in or travel to tropical regions.

Características de adultos com obesidade grave em tratamento ambulatorial no Rio de Janeiro e fatores associados à perda de peso / Characteristics of adults with severe obesity in clinical treatment in Rio de Janeiro and factors associated with weight loss / Características de adultos con obesidad severa en tratamiento clínico en Rio de Janeiro y factores asociados a la pérdida de peso

Resumo Introdução O tratamento da obesidade grave é pouco estudado no Sistema Único de Saúde (SUS). Objetivo: Descrever clientela, atendimento e fatores associados à perda de peso em Centros de Referência em Obesidade (CRO), na cidade do Rio de Janeiro. Método Coorte retrospectiva baseada em registros de prontuários de 317 indivíduos com obesidade grave atendidos em três CRO-RJ entre 2011 e 2016. Foram descritas frequências e estimados riscos relativos com IC 95% para perda de ≥ 5% do peso inicial aos 6 e 12 meses de tratamento. Resultados Predominaram mulheres (76,3%), negros (69,5%), com média de 44,6 anos (DP 11,9), tratamento prévio para obesidade (62,1%), história familiar de obesidade (42,6%) e 2 ou mais comorbidades (52%). A mediana do IMC inicial foi de 51,5 kg/m2, e a do tempo de tratamento, 10 meses. Somente 14,8% perderam ≥ 5% do peso inicial após 12 meses de tratamento, sendo o risco relativo de perda de peso 78% maior entre indivíduos brancos. Predominaram tratamento dietético e mudanças de hábitos de vida, com baixo uso de medicamentos antiobesidade (14%) e cirurgia bariátrica (3%, sendo 1% no SUS). Conclusão Os resultados do tratamento sugerem necessidade de readequar práticas terapêuticas às indicadas para indivíduos com superobesidade, inclusive maior acesso à cirurgia bariátrica.

Abstract Background There are few studies on severe obesity in the Brazilian Unified Health System (SUS). Objective To describe patients, treatment approaches and factors associated with weight loss at the Obesity Reference Centers (CRO), in the city of Rio de Janeiro. Method Retrospective cohort study based on medical records of 317 patients with severe obesity admitted to three CRO-RJ, between 2011 and 2016. Frequencies were described and relative risks with 95% CI of ≥ 5% loss of body weight at 6 and 12 months of treatment were estimated. Results Patients were mainly black (69.5%), women (76.3%), mean age 44.6 years (SD 11.9), reporting ≥ 2 comorbidities (52%), previous treatment (62.1%) and family history of obesity (42.6%). The initial mean BMI was 51.5 kg/m2; average treatment time was 10 months. 14.8% lost ≥ 5% of the initial weight after 12 months of treatment and the relative risk of weight loss was 78% higher among white patients. Approaches based on diet and changes in lifestyle predominated. 14% used anti-obesity drugs and 3% underwent bariatric surgery (1% in the SUS). Conclusion Treatment results suggest the need to adjust management to follow treatment guidelines for superobesity, including bariatric surgery.

Resumen Introducción El tratamiento de la obesidad severa está poco estudiado en el SUS. Objetivo Describir la clientela, el manejo y los factores asociados con la pérdida de peso en los Centros de Referencia para la Obesidad (CRO), en la ciudad de Río de Janeiro. Método Cohorte retrospectiva basada en registros médicos de 317 individuos con obesidad severa tratados en tres CRO-RJ entre 2011 y 2016. Se describieron las frecuencias y estimaron riesgos relativos con un IC del 95% para la pérdida de ≥ 5% del peso inicial a los 6 y 12 meses de tratamiento. Resultados Predominaron las mujeres (76.3%), negros (69.5%), con una media de 44.6 años (DE 11.9), tratamiento previo (62.1%), antecedentes familiares de obesidad (42.6%) y dos o más comorbilidades (52.0%). La mediana del IMC inicial fue de 51.5 kg/m2 y el tiempo de tratamiento fue de 10 meses. Solo el 14.8% perdió ≥ 5% de su peso inicial después de 12 meses de tratamiento, con un riesgo de pérdida de peso 78% mayor entre los individuos blancos. Predominaron el tratamiento dietético y los cambios en los hábitos de estilo de vida, con un bajo uso de medicamentos contra la obesidad (14%) y cirugía bariátrica (3%, 1% en SUS). Conclusión Los resultados del tratamiento sugieren la necesidad de reajustar las prácticas terapéuticas a las indicadas en la superobesidad, incluido un mayor acceso a la cirugía bariátrica.

Low versus high dose of antimony for American cutaneous leishmaniasis: A randomized controlled blind non-inferiority trial in Rio de Janeiro, Brazil.

BACKGROUND: Although high dose of antimony is the mainstay for treatment of American cutaneous leishmaniasis (ACL), ongoing major concerns remain over its toxicity. Whether or not low dose antimony regimens provide non-inferior effectiveness and lower toxicity has long been a question of dispute. METHODS: A single-blind, non-inferiority, randomized controlled trial was conducted comparing high dose with low dose of antimony in subjects with ACL treated at a referral center in Rio de Janeiro, an endemic area of Leishmania (Viannia) braziliensis transmission. The primary outcome was clinical cure at 360 days of follow-up in the modified-intention-to-treat (mITT) and per-protocol (PP) populations. Non-inferiority margin was 15%. Secondary objectives included occurrence of epithelialization, adverse events and drug discontinuations. This study was registered in ClinicalTrials.gov: NCT01301924. RESULTS: Overall, 72 patients were randomly assigned to one of the two treatment arms during October 2008 to July 2014. In mITT, clinical cure was observed in 77.8% of subjects in the low dose antimony group and 94.4% in the high dose antimony group after one series of treatment (risk difference 16.7%; 90% CI, 3.7-29.7). The results were confirmed in PP analysis, with 77.8% of subjects with clinical cure in the low dose antimony group and 97.1% in the high dose antimony group (risk difference 19.4%; 90% CI, 7.1-31.7). The upper limit of the confidence interval exceeded the 15% threshold and was also above zero supporting the hypothesis that low dose is inferior to high dose of antimony after one series of treatment. Nevertheless, more major adverse events, a greater number of adverse events and major adverse events per subject, and more drug discontinuations were observed in the high dose antimony group (all p<0.05). Interestingly, of all the subjects who were originally allocated to the low dose antimony group and were followed up after clinical failure, 85.7% achieved cure after a further treatment with local therapy or low dose of antimony. CONCLUSIONS: Compared with high dose, low dose of antimony was inferior at the pre-specified margin after one series of treatment of ACL, but was associated with a significantly lower toxicity. While high dose of antimony should remain the standard treatment for ACL, low dose antimony treatment might be preferred when toxicity is a primary concern.