Seguimiento Funcional hasta Seis Meses después de Sobrevivir a Cuidados Intensivos: Lecciones aprendidas de un Estudio Chileno Multicéntrico / Functional follow-up six months after surviving intensive care: lessons learned from a Chilean multicenter study

Introducción. Las tasas de retención en los estudios de seguimiento oscilan entre el 32 y 100%, demostrando el desafío que implica realizar estudios longitudinales de sobrevivientes de la unidad de cuidados intensivos (UCI). Objetivo. Identificar las estrategias implementadas y lecciones aprendidas en un estudio prospectivo multicéntrico de seguimiento de sobrevivientes de la UCI durante la pandemia. Métodos. Estudio post-hoc de las lecciones aprendidas mediante encuestas y entrevistas dirigidas a explorar la experiencia de los investigadores y coordinadores del estudio IMPACCT COVID-19, realizado en siete centros chilenos entre octubre 2020 y abril 2021 evaluando el síndrome post-cuidados intensivos de sobrevivientes hasta seis meses después. Resultados. Identificamos ocho lecciones: 1) selección de instrumentos de medición, 2) identificación de centros participantes, 3) aprobación del estudio, 4) financiamiento, 5) capacitación de evaluadores, 6) coordinación/aseguramiento de calidad, 7) reclutamiento y 8) seguimiento de pacientes. Incluso durante el primer año de pandemia, reclutamos 252 pacientes a una tasa de 1,4 pacientes/día con una retención del 48% a los 6 meses de seguimiento. El uso de redes académicas existentes y las estrategias de comunicación entre investigadores, coordinadores y evaluadores fueron aspectos positivos; mientras que la fidelización con evaluadores al egreso de la UCI y con pacientes durante el seguimiento son aspectos que deberían considerarse en futuros estudios. Conclusiones. Se evaluaron más de 250 pacientes en seis meses durante la pandemia, con tasas de retención post UCI acorde a la literatura. Futuros estudios debiesen optimizar los procesos de medición y de seguimiento para minimizar la pérdida de pacientes.

Background. Retention rates of follow-up studies range from 32 to 100%, demonstrating the challenge to conduct longitudinal studies of intensive care unit (ICU) survivors. Objective. To identify the strategies implemented and lessons learned in a multicenter prospective follow-up study of ICU survivors during pandemic times. Methods. Post-hoc study of lessons learned through surveys and interviews aimed at exploring the experience of the researchers and coordinators of the IMPACCT COVID-19 study. The original study was performed in seven Chilean sites between October 2020 and April 2021 evaluating the post-intensive care syndrome of survivors up to six-month follow-up. Results. We identified eight lessons: 1) selection of measurement instruments, 2) identification of participating sites, 3) Study approval, 4) funding, 5) evaluators training, 6) coordination/quality assurance, 7) recruitment, and 8) patient follow-up. Even during the first year of the pandemic, we recruited 252 patients at a rate of 1.4 patients/day with a retention rate of 48% at 6 months of follow-up. The use of existing academic networks and communication strategies between researchers, coordinators and evaluators were positive aspects; while evaluators fidelity at ICU discharge and patient engagement during follow-up are aspects should be considered. Conclusions. More than 250 patients were evaluated in six months during the pandemic, with post-ICU retention rates consistent with the literature. Future studies should optimize measurement and monitoring processes to minimize patient atrition.

Death of hospitalized neonates of different gestational age in Shaanxi Province: a multi-center survey / 中华围产医学杂志

Objective:To investigate the current status of hospitalized neonatal death of different gestational ages in Shaanxi Province.Methods:All neonatal deaths in six hospitals in Shaanxi Province from 2016 to 2020 were retrospectively analyzed, and the differences in perinatal complications, the causes of death, and the age at death were compared using Chi-square (or Fisher's exact ) test. Results:(1) Totally, 220 488 neonates were delivered in the obstetric department of the six hospitals during the study period; 71 782 out of them were admitted to the neonatal department. While 424 neonatal death was reported, giving the total hospitalized neonates mortality rate of 5.5‰ (394/71 782), which included 152 deaths of transferred patients ( n=9 103, 16.7‰), 226 premature (53.3%), 196 term (46.2%), and two post-term infants (0.5%). (2) Among mothers of dead neonates, 73.6% were found to have at least one perinatal complication. The most common one was fetal distress (146 cases, 34.4%), followed by gestational diabetes mellitus (113 cases, 26.7%), amniotic fluid abnormalities ( n=73, 17.2%), maternal infectious diseases ( n=71, 16.8%), and hypertensive disorders in pregnancy (HDP) ( n=52, 12.3%). The lower the gestational age, the higher the proportion of multiple pregnancies and assisted reproduction technology applied (Fisher exact test, P<0.05). On the contrary, the higher the gestational age, the higher the cesarean section rate ( χ 2=26.69, P<0.001). HDP was more likely to occur in the gestational age of 28-31 +6 and 32-34 +6 weeks ( χ 2=37.16, P<0.001), and amniotic fluid abnormalities were more likely to occur in those over 37 weeks ( χ 2=27.47, P<0.001). (3) The five leading causes of neonatal death were neonatal respiratory distress syndrome (NRDS, n=100, 23.6%), neonatal asphyxia ( n=88, 20.8%), maternal infectious diseases ( n=80, 18.9%), and birth defects ( n=54, 12.7%), and pulmonary hemorrhage ( n=22, 5.2%). The first three causes of death in term and post-term infants were neonatal asphyxia ( n=65, 32.8%), birth defects ( n=42, 21.2%), and infectious diseases ( n=26, 13.1%). NRDS ( n=83, 36.7%), infectious diseases ( n=54, 23.9%), and neonatal asphyxia ( n=23, 10.2%) were the three leading causes of death of premature babies. (4) Out of the 326 (76.9%) neonatal deaths within seven days after birth, 162 (38.2%) died within 24 h after birth and 164 cases (38.7%) between one to seven days after birth. Conclusions:Most neonatal deaths occurred among preterm ones and within seven days after birth, whose mothers suffered perinatal complications. The causes of neonatal death vary among different gestational age groups.

Avaliação do Seguimento de 1 Ano dos Pacientes Incluídos no Registro da Prática Clínica em Pacientes de Alto Risco Cardiovascular (REACT) / Evaluation of 1-Year Follow-up of Patients Included in the Registry of Clinical Practice in Patients at High Cardiovascular Risk (REACT)

Resumo Fundamento Na prática clínica, há evidências de falhas na prescrição de terapias baseadas em evidências para pacientes de alto risco cardiovascular. Entretanto, no Brasil, ainda são insuficientes os dados sobre a evolução ao longo de 1 ano desses pacientes. Objetivos Descrição no acompanhamento de 12 meses da utilização de terapias baseadas em evidência e da ocorrência de desfechos cardiovasculares maiores e seus principais preditores em um registro brasileiro multicêntrico de pacientes de alto risco cardiovascular. Métodos Estudo observacional prospectivo que documentou a prática clínica ambulatorial de indivíduos acima de 45 anos e de alto risco cardiovascular tanto em prevenção primária como secundária. Os pacientes foram seguidos por 1 ano e avaliou-se a prescrição de terapias baseadas em evidência e a ocorrência de eventos cardiovasculares maiores (infarto agudo do miocárdio [IAM], acidente vascular cerebral [AVC], parada cardíaca e mortalidade por causa cardiovascular). Valores de p < 0,05 foram considerados estatisticamente significantes. Resultados De julho de 2010 até agosto de 2014, 5.076 indivíduos foram incluídos em 48 centros, sendo 91% dos 4.975 pacientes elegíveis acompanhados em centros de cardiologia e 68,6% em prevenção secundária. Em 1 ano, o uso concomitante de antiplaquetários, estatinas e inibidores da enzima conversora de angiotensina (IECA) reduziu de 28,3% para 24,2% (valor de p < 0,001). A taxa de eventos cardiovasculares maiores foi de 5,46%, e os preditores identificados foram: idade, pacientes em prevenção secundária e nefropatia diabética. Conclusões Neste grande registro nacional de pacientes de alto risco cardiovascular, foram identificados preditores de risco semelhantes aos registros internacionais, porém a adesão da prescrição médica a terapias baseadas em evidência esteve abaixo dos dados da literatura internacional e apresentou piora significativa em 1 ano. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background In clinical practice, there is evidence of failure to prescribe evidence-based therapies for patients at high cardiovascular risk. However, in Brazil, data on 1-year outcomes of these patients remain insufficient. Objectives To describe the use of evidence-based therapies and the occurrence of major cardiovascular outcomes and their major predictors in a 12-month follow-up of a Brazilian multicenter registry of patients at high cardiovascular risk. Methods This prospective observational study documented the outpatient clinical practice of managing patients over 45 years of age and of high cardiovascular risk in both primary and secondary prevention. Patients were followed-up for 1 year, and the prescription of evidence-based therapies and the occurrence of major cardiovascular events (myocardial infarction, stroke, cardiac arrest, and cardiovascular death) were assessed. P-values < 0.05 were considered statistically significant. Results From July 2010 to August 2014, a total of 5076 individuals were enrolled in 48 centers, 91% of the 4975 eligible patients were followed-up in cardiology centers, and 68.6% were in secondary prevention. At 1 year, the concomitant use of antiplatelet agents, statins, and angiotensin-converting enzyme inhibitors reduced from 28.3% to 24.2% (p < 0.001). Major cardiovascular event rate was 5.46%, and the identified predictors were age, patients in secondary prevention, and diabetic nephropathy. Conclusions In this large national registry of patients at high cardiovascular risk, risk predictors similar to those of international registries were identified, but medical prescription adherence to evidence-based therapies was inferior and significantly worsened at 1 year. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Avaliação do Seguimento de um Ano dos Pacientes Incluídos no Registro Brasileiro de Síndromes Coronárias Agudas (ACCEPT) / One year follow-up Assessment of Patients Included in the Brazilian Registry of Acute Coronary Syndromes (ACCEPT)

Resumo Fundamento Existe carência de informações prospectivas sobre a evolução em um ano após uma síndrome coronária aguda (SCA) em uma grande amostra de pacientes brasileiros. Objetivos Avaliar a prescrição de terapias baseadas em evidência, a ocorrência de desfechos graves e os preditores para estes desfechos em um registro brasileiro multicêntrico de pacientes com SCA. Métodos O ACCEPT é um estudo observacional prospectivo que incluiu pacientes internados com diagnóstico de SCA em 47 hospitais brasileiros. Os pacientes foram seguidos por 1 ano e coletou-se dados sobre prescrição médica e ocorrência de eventos cardiovasculares maiores (mortalidade cardiovascular, reinfarto e acidente vascular encefálico - AVE). Valores de p < 0,05 foram considerados estatisticamente significantes. Resultados Um total de 5.047 pacientes foram incluídos neste registro, de agosto de 2010 até abril de 2014. Foi confirmado o diagnóstico de SCA em 4.782 pacientes (94,7%) e, dentre os 3 diagnósticos possíveis, o mais comum foi SCA com elevação do segmento ST (35,8%). A taxa de eventos cardiovasculares maiores foi de 13,6 % em 1 ano. A prescrição completa de terapias baseadas em evidência na admissão hospitalar foi de 62,1%. Idade, atendimento público, infarto agudo do miocárdio, AVE, insuficiência renal, diabetes e qualidade da terapia estiveram associados de forma independente à ocorrência de eventos cardiovasculares maiores. Conclusões No seguimento de 1 ano do registro ACCEPT, mais de 10% dos pacientes apresentaram eventos cardiovasculares maiores e esta taxa variou de acordo com a qualidade da terapia. Há necessidade da elaboração de estratégias para melhorar o uso de terapias baseadas em evidência no sentido de minimizar os eventos cardiovasculares na população brasileira. (Arq Bras Cardiol. 2020; 114(6):995-1003)

Abstract Background There is lack of prospective data on evolution within one year of acute coronary syndromes (ACS) in a representative population of Brazilian patients. Objectives To assess the prescription of evidence-based therapies, the incidence of severe outcomes and the predictors for these outcomes in a multicenter Brazilian registry of ACS patients. Methods The ACCEPT is a prospective observational study, which included patients hospitalized with a diagnostic of ACS in 47 Brazilian hospitals. The patients were followed for a 1 year and data were collected on the medical prescription and the occurrence of major cardiovascular events (cardiovascular mortality, reinfarction and cerebrovascular accident - CVA). Values of p < 0.05 were considered statistically significant. Results A total of 5,047 patients were included in this registry from August 2010 to April 2014. The diagnosis of ACS was confirmed in 4,782 patients (94.7%) and, among those, the most frequent diagnosis was ACS with ST segment elevation (35.8%). The rate of major cardiovascular events was 13.6 % within 1 year. Adherence to prescription of evidence-based therapy at admission was of 62.1%. Age, public service, acute myocardial infarction, CVA, renal failure, diabetes and quality of therapy were associated independently with the occurrence of major cardiovascular events. Conclusions During the one-year follow-up of the ACCEPT registry, more than 10% of the patients had major cardiovascular events and this rate ranged according with the quality of therapy. Strategies must be elaborated to improve the use of evidence-based therapies to minimize the cardiovascular events among the Brazilian population. (Arq Bras Cardiol. 2020; 114(6):995-1003)

Prevalence of gallstones among university teachers and related risk factors: A multicenter study / 临床肝胆病杂志

ObjectiveTo investigate the prevalence rate of gallstones among university teachers in Tianjin, China, and related risk factors. MethodsPhysical examination data were collected from the teachers from five universities who participated in physical examination in Physical Examination Center, Tianjin Medical University Cancer Institute and Hospital, in 2015, and abdominal ultrasound was used for the diagnosis of gallstones. The chi-square test was used for comparison of categorical data between groups. Univariate and multivariate logistic regression analyses were used to identify the risk factors for gallstones in the teachers from different universities, and a meta-analysis was used for the pooled analysis of prevalence rate and risk factors. ResultsA total of 8006 university teachers were enrolled, among whom 440 were diagnosed with gallstones, and the pooled prevalence rate of gallstones was 5.5%. The meta-analysis showed that hypertension (odds ratio ［OR］=1.67, 95% confidence interval ［CI］: 1.32-2.12, P＜0.001), fatty liver (OR=1.39, 95%CI: 1.12-1.72, P＜0.001), kidney stones (OR=1.90, 95%CI: 1.15-3.14, P=0.01), and high levels of hexokinase (OR=1.42, 95%CI: 1.03-1.94, P=0.03), alanine aminotransferase (OR=1.32, 95%CI: 1.01-1.73, P=0.04), and globulin (OR=1.74, 95%CI: 1.08-2.79, P=0.02) were risk factors for gallstones. ConclusionThere is a relatively low prevalence rate of gallstones among university teachers in Tianjin, and hypertension, fatty liver, kidney stones, and high levels of hexokinase, alanine aminotransferase, and globulin may be the risk factors for gallstones.

Extended Use of Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Retrospective Multicenter Study / 결핵

BACKGROUND: Beyond its current function as a rescue therapy in acute respiratory distress syndrome (ARDS), extracorporeal membrane oxygenation (ECMO) may be applied in ARDS patients with less severe hypoxemia to facilitate lung protective ventilation. The purpose of this study was to evaluate the efficacy of extended ECMO use in ARDS patients. METHODS: This study reviewed 223 adult patients who had been admitted to the intensive care units of 11 hospitals in Korea and subsequently treated using ECMO. Among them, the 62 who required ECMO for ARDS were analyzed. The patients were divided into two groups according to pre-ECMO arterial blood gas: an extended group (n=14) and a conventional group (n=48). RESULTS: Baseline characteristics were not different between the groups. The median arterial carbon dioxide tension/fraction of inspired oxygen (FiO2) ratio was higher (97 vs. 61, p<0.001) while the median FiO2 was lower (0.8 vs. 1.0, p<0.001) in the extended compared to the conventional group. The 60-day mortality was 21% in the extended group and 54% in the conventional group (p=0.03). Multivariate analysis indicated that the extended use of ECMO was independently associated with reduced 60-day mortality (odds ratio, 0.10; 95% confidence interval, 0.02–0.64; p=0.02). Lower median peak inspiratory pressure and median dynamic driving pressure were observed in the extended group 24 hours after ECMO support. CONCLUSION: Extended indications of ECMO implementation coupled with protective ventilator settings may improve the clinical outcome of patients with ARDS.

A multi-center clinical retrospective study on the therapeutic effect of endoscopic myringoplasty / 中华耳鼻咽喉头颈外科杂志

Objective@#To analyze the therapeutic effect of endoscopic myringoplasty.@*Methods@#A retrospective analysis of 523 patients with chronic otitis media who underwent endoscopic myringoplasty between June 2016 and June 2017 in eight tertiary hospitals in China. Among all the patients, 256 were male and 267 were female, aged from 18 to 68 years old. The grafts used to repair the tympanic membrane were all tragus cartilage-perichondrium complex. All patients were followed up at 1 month, 3 months, 6 months, 9 months, and 12 months after surgery, at least 3 months. The closure rate of tympanic membrane perforation by different factors, the hearing results, and the incidence of postoperative complications were analyzed. SPSS 21.0 software was used to analyze the data.@*Results@#Three months after operation, the closure rates of anterior, inferior, posterior and subtotal perforation were 92.4% (109/118), 94.9% (93/98), 95.6% (129/135), and 89.0% (153/172) respectively, the difference was not statistically significant (χ2=5.779, P=0.123). The closure rates of small, medium and large perforations were 100.0% (82/82), 93.7% (178/190) and 89.2% (224/251) respectively. The difference was statistically significant (χ2=10.927, P=0.004). The closure rates of dry ear and wet ear tympanic membrane perforation were 93.1% (392/421), 90.2% (92/102), the difference was not statistically significant (χ2=1.011, P=0.915). The preoperative pure tone audiometry(PTA) was (38.4±5.3) dBHL, while, the 3-month postoperative PTA was (25.1±5.7) dBHL. The difference was statistically significant (t=39.079, P<0.001). The preoperative air bone gap (ABG) was (22.4±4.3) dB, while 3 months postoperative ABG was (9.1±3.8) dB. The difference was statistically significant (t=53.004, P<0.001). Of all 523 patients, 14 (2.7%) had middle ear infection, 8 (1.5%) had dislocated tympanic membrane, 12 (2.3%) had parageusia, 35 (6.7%) had tinnitus, 28 (5.4%) had hearing loss, 26 (5.0%) had vertigo,33 (6.3%) had reperforation, 2 (0.4%) had secondary cholesteatoma, and none had facioplegia.@*Conclusions@#Endoscopic myringoplasty is a safe and effective surgical method with good postoperative outcome.

Factores perinatales asociados a la mortalidad neonatal en recién nacidos de muy bajo peso: estudio multicéntrico / Perinatal factors associated with neonatal mortality in very low birth weight infants: A multicenter study

Introducción. Objetivos. Evaluar los factores de riesgo asociados a la mortalidad neonatal en recién nacidos de muy bajo peso (RNMBP, ≤ 1500 g) y el impacto de la administración antenatal de corticoides. Población y métodos. Análisis retrospectivo de una cohorte de RNMBP de 26 centros perinatales terciarios y universitarios de la Red Neonatal Sudamericana (NEOCOSUR), que incluye Argentina, Brasil, Chile, Paraguay, Perú y Uruguay, entre 2000 y 2011, y que cuenta con 11455 registros. Las características maternas, neonatales y la morbilidad se compararon entre los RNMBP que murieron y los sobrevivientes hasta el alta. Las variables asociadas con la muerte neonatal se determinaron mediante regresión logística. Se estimó el efecto del corticoide prenatal sobre la morbimortalidad neonatal utilizando el método de pareamiento. Resultados. La tasa de mortalidad neonatal fue de 22,3% con una elevada variabilidad entre los centros. Los factores independientemente asociados a menor mortalidad de los RNMBP fueron la administración de corticoides prenatal (OR 0,49; IC 95%: 0,43-0,54), mejor puntaje Z del peso de nacimiento (OR 0,63; 0,61-0,65), hipertensión arterial (OR 0,67; 0,58-0,77) y cesárea (OR 0,75; 0,65-0,85). Mediante pareamiento, el riesgo de muerte se redujo en 38% asociado a los corticoides prenatales. Conclusiones. Se identificaron importantes factores perinatales asociados con la mortalidad neonatal en RNMBP y se demostró el impacto de la administración de corticoides prenatales en la Red NEOCOSUR.

Introduction. Objectives. To assess risk factors associated withneonatal mortality in very low birth weight (VLBW) infants (< 1500 g) and the impact of the administration of antenatal corticosteroids. Population and methods. Retrospective analysis of a VLBW infant cohort from 26 tertiary care and teaching sites member of the South American Neonatal Network (NEOCOSUR), which includes Argentina, Brazil, Chile, Paraguay, Peru, and Uruguay, conducted between 2000 and 2011 on 11 455 records. Maternal and neonatal characteristics and morbidity were compared between deceased VLBW infants and those who survived to discharge. Outcome measures associated with neonatal mortality were established by logistic regression. The effect of antenatal corticosteroids on neonatal morbidity and mortality was estimated using the matching method. Results. The neonatal mortality rate was 22.3%, and variability among sites was elevated. Factors that were independently associated with a lower mortality of VLBW infants included the administration of antenatal corticosteroids (OR: 0.49, 95% CI: 0.43-0.54), a better birth weight Z-score (OR: 0.63, 0.61-0.65), arterial hypertension (OR: 0.67, 0.58-0.77), and C-section (OR: 0.75, 0.65-0.85). The matching method allowed reducing the risk of death by 38% in association with antenatal corticosteroids. Conclusions. Major perinatal factors were identified in association with neonatal mortality in VLBW infants, and the impact of antenatal corticosteroid use in the NEOCOSUR Network was demonstrated.

I RBH - First Brazilian Hypertension Registry / I RBH – Primeiro Registro Brasileiro de Hipertensão Arterial

Abstract Background: A registry assessing the care of hypertensive patients in daily clinical practice in public and private centers in various Brazilian regions has not been conducted to date. Such analysis is important to elucidate the effectiveness of this care. Objective: To document the current clinical practice for the treatment of hypertension with identification of the profile of requested tests, type of administered treatment, level of blood pressure (BP) control, and adherence to treatment. Methods: National, observational, prospective, and multicenter study that will include patients older than 18 years with hypertension for at least 4 weeks, following up in public and private centers and after signing a consent form. The study will exclude patients undergoing dialysis, hospitalized in the previous 30 days, with class III or IV heart failure, pregnant or nursing, with severe liver disease, stroke or acute myocardial infarction in the past 30 days, or with diseases with a survival prognosis < 1 year. Evaluations will be performed at baseline and after 1 year of follow-up. The parameters that will be evaluated include anthropometric data, lifestyle habits, BP levels, lipid profile, metabolic syndrome, and adherence to treatment. The primary outcomes will be hospitalization due to hypertensive crisis, cardiocirculatory events, and cardiovascular death, while secondary outcomes will be hospitalization for heart failure and requirement of dialysis. A subgroup analysis of 15% of the sample will include noninvasive central pressure evaluation at baseline and study end. The estimated sample size is 3,000 individuals for a prevalence of 5%, sample error of 2%, and 95% confidence interval. Results: The results will be presented after the final evaluation, which will occur at the end of a 1-year follow-up. Conclusion: The analysis of this registry will improve the knowledge and optimize the treatment of hypertension in Brazil, as a way of modifying the prognosis of cardiovascular disease in the country.

Resumo Fundamento: Ainda não foi realizado um registro brasileiro para avaliar, na prática clínica diária, o atendimento a pacientes hipertensos tanto em serviços públicos quanto privados distribuídos pelas diversas regiões do país. Este conhecimento é importante como forma de verificar a efetividade deste atendimento. Objetivo: Documentar a prática clínica vigente para o tratamento da hipertensão arterial, através do conhecimento do perfil dos exames realizados, do tipo de tratamento recebido, do nível de controle da pressão arterial (PA) e da adesão ao tratamento. Métodos: Estudo nacional, observacional, prospectivo e multicêntrico que incluirá pacientes > 18 anos, hipertensos há ≥ 4 semanas, em acompanhamento em serviços públicos e privados e com assinatura do consentimento. Serão excluídos pacientes em diálise, internados nos últimos 30 dias, com insuficiência cardíaca classe III ou IV, gravidez ou amamentação, hepatopatia grave, acidente vascular cerebral ou infarto agudo nos 30 dias anteriores e doenças com prognóstico de sobrevida < 1 ano. As avaliações serão realizadas ao início e final do estudo, após acompanhamento por 1 ano. Parâmetros a serem avaliados incluirão dados antropométricos, hábitos de vida, PA, perfil lipídico, síndrome metabólica e adesão ao tratamento. Os desfechos primários serão internação por crise hipertensiva, evento cardiocirculatório e óbito cardiovascular, e os desfechos secundários serão internação por insuficiência cardíaca e necessidade de diálise. Uma análise de subgrupo avaliará a pressão central de forma não invasiva em 15% da amostra no início e final do estudo. A amostra estimada é de 3.000 indivíduos para prevalência de 5%, erro amostral de 2% e intervalo de confiança de 95%. Resultados: Os resultados serão apresentados após a avaliação final que ocorrerá quando encerrado 1 ano de seguimento. Conclusão: A análise deste registro trará melhor conhecimento sobre o tratamento da hipertensão no Brasil e possibilitará a otimização do mesmo, como forma de interferir no prognóstico da doença cardiovascular em nosso meio.

Reproducibility of Left Ventricular Mass by Echocardiogram in the ELSA-Brasil / Reprodutibilidade de Medidas Ecocardiográficas da Massa Ventricular Esquerda no ELSA-Brasil

Background: Echocardiography, though non-invasive and having relatively low-cost, presents issues of variability which can limit its use in epidemiological studies. Objective: To evaluate left ventricular mass reproducibility when assessed at acquisition (online) compared to when assessed at a reading center after electronic transmission (offline) and also when assessed by different readers at the reading center. Methods: Echocardiographers from the 6 ELSA-Brasil study investigation centers measured the left ventricular mass online during the acquisition from 124 studies before transmitting to the reading center, where studies were read according to the study protocol. Half of these studies were blindly read by a second reader in the reading center. Results: From the 124 echocardiograms, 5 (4%) were considered not measurable. Among the remaining 119, 72 (61%) were women, mean age was 50.2 ± 7.0 years and 2 had structural myocardial abnormalities. Images were considered to be optimal/ good by the reading center for 110 (92.4%) cases. No significant difference existed between online and offline measurements (1,29 g, CI 95% −3.60-6.19), and the intraclass correlation coefficient between them was 0.79 (CI 95% 0.71-0.85). For images read by two readers, the intraclass correlation coefficient was 0.86 (CI 95% 0.78-0.91). Conclusion: There were no significant drifts between online and offline left ventricular mass measurements, and reproducibility was similar to that described in previous studies. Central quantitative assessment of echocardiographic studies in reading centers, as performed in the ELSA-Brasil study, is feasible and useful in clinical and epidemiological studies performed in our setting. .

Fundamento: A ecocardiografia, apesar de não invasiva e de relativo baixo custo, tem na variabilidade de medidas repetidas um dos principais limitantes a sua utilização em estudos epidemiológicos. Objetivo: Avaliar a reprodutibilidade da massa ventricular esquerda obtida em centros de investigação (on-line) com aquela obtida em centro de leitura (off-line) e entre medidas realizadas por diferentes avaliadores no centro de leitura. Métodos: Ecocardiografistas dos seis centros de investigação do ELSA-Brasil mediram on-line a massa ventricular esquerda e outras medidas ecocardiográficas de 124 exames antes de enviá-los ao centro de leitura, onde foram lidos off-line de acordo com o protocolo do estudo. Metade desses exames foi medida de forma cega por um segundo leitor. Resultados: Dos 124 exames, cinco (4%) foram considerados não mensuráveis. Dos 119 restantes, 72 (61%) eram de mulheres, com idade média de 50,2 ± 7,0 anos, sendo apenas dois exames com alteração estrutural cardíaca. Em 110 (92,4%) dos exames, as imagens foram consideradas ótimas/boas pelo centro de leitura. Não foram observadas diferenças significativas entre as médias da massa ventricular esquerda obtidas on-line e off-line (1,29 g, IC 95% −3,60-6,19), sendo o coeficiente de correlação intraclasse de 0,79 (IC 95% 0,72-0,85). Para as medidas realizadas no centro de leitura, % 0,78-0,91). Conclusão: Não houve diferenças sistemáticas relevantes na medida da massa ventricular esquerda on-line versus off-line e a reprodutibilidade das medidas foi similar à de estudos anteriores. A realização das medidas em centros de leitura, como utilizado no ELSA-Brasil, é factível e útil em estudos clínico-epidemiológicos realizados em nosso meio. .

Successful patterns of maintenance therapy in human common cancer / 国际肿瘤学杂志

Maintenance therapy is an important strategy for cancer treatment,which mainly include continuation maintenance therapy and switch maintenance therapy,with a classical model of metronomic chemo-therapy.Maintenance therapy can be an effective treatment option for patients with non-small cell lung cancer, breast cancer,colorectal cancer and ovarian cancer.

Avaliação da percepção do ambiente de ensino e sua relação com a qualidade de vida em estudantes de medicina / Assessment of learning environment perception and its relationship to quality of life in medical students

INTRODUÇÃO: O ambiente de ensino da faculdade de medicina influencia a aprendizagem e o bem-estar dos estudantes. O objetivo do nosso estudo foi avaliar a percepção do ambiente de ensino e sua associação com a qualidade de vida de estudantes de 22 escolas médicas brasileiras. MÉTODOS: Este é um estudo multicêntrico, com coleta de dados em uma plataforma eletrônica (plataforma VERAS), no qual foram utilizados os questionários: DREEM (Dundee Ready Education Environment Measure) para avaliação da percepção do ambiente de ensino e VERAS-Q, WHOQOL-BREF e a autoavaliação para a avaliação da percepção da qualidade de vida. Foram comparadas as diferenças de percepção do ambiente de ensino e qualidade de vida entre os sexos e os diferentes anos do curso. RESULTADOS: De 1.650 estudantes randomizados, 1.350 (81,8%) completaram todos os questionários da plataforma VERAS. A média do escore total do DREEM (119,4 ± 27,1) revelou que a percepção do ambiente de ensino é mais positiva que negativa. Houve uma pequena diferença significativa entre a média dos escores dos estudantes do sexo masculino (121,0 ± 27,2) e feminino (118,0 ± 27,0) (p=0,048). Estudantes do sexo feminino apresentaram médias dos escores significativamente menores nos domínios Acadêmico e Social do DREEM (p < 0,001). As médias dos escores dos estudantes do último ano do curso foram significativamente menores em relação aos estudantes do ciclo básico no escore total e em todos os domínios do DREEM (p < 0,05), exceto no Acadêmico. Os itens que tiveram média abaixo de 2,0 (n=11), sinalizando áreas problemáticas do curso, estiveram presentes em todos os domínios do DREEM. Estudantes do sexo feminino apresentaram menores médias dos escores de qualidade de vida no escore total e nos domínios Físico, Psicológico e Uso do Tempo do VERAS-Q (p < 0,001). Estudantes dos últimos anos do curso tiveram escores menores no escore total e no domínio Ambiente de Ensino do VERAS-Q (p < 0,05). Entre os respondentes, 40%...

INTRODUCTION: The educational environment of medical school influences students' learning and well-being. The aim of this study was to assess perceptions of the educational environment among students from 22 Brazilian medical schools and to determine the association between these perceptions and quality of life measures. METHODS: This is a multi-centre study with a random sample of medical students from different years in medical school. We used educational environment (Dundee Ready Education Environment Measure - DREEM questionnaire) and quality of life (VERAS-Q, WHOQOL-BREF questionnaires and self-assessment) perception measures in an electronic survey. Differences in educational environment perceptions and quality of life were evaluated across genders and years in medical school. RESULTS: From 1,650 invited students, 1,350 (81.8%) completed all questionnaires. Total DREEM scores (119.4 ± 27.1) revealed that the perceptions of the educational environment were positive. There was a small significant difference between male (121.0 ± 27.2) and female (118.0 ± 27.0) students (p=0.048). Female students had significantly lower mean scores on the Academic and Social DREEM domains (p < 0,001). The mean scores of students in final years were significantly lower than of those in the basic cycle in the total DREEM score and in all domains of DREEM (p < 0.05), except in the Academic domain. Items that had a mean score below 2.0 (n = 11), indicating problem areas of the program, were present in all domains of the DREEM. Female students had lower scores on physical, psychological and time management domains and the total score of the VERAS-Q compared to male students (p < 0.001). Students in the final years of medical school had lower total scores and in the learning environment domain of the VERAS-Q (p < 0.05). Among the respondents, 40% declared that their quality of life in medical school is good, but 59% affirmed that they cannot manage their...

Perguntas minimas para rastrear dependencia em atividades da vida diaria em idosos / Preguntas necesarias para rastrear dependencia en actividades de la vida diaria en ancianos / Screening for dependence in activities of daily living in the elderly: minimum set of questions

OBJETIVO: Analisar questões não redundantes sobre independência nas atividades da vida diária de idosos que representem o espectro de dependência em idosos. MÉTODOS: Projeto multicêntrico com amostra populacional probabilística de 5.371 idosos residentes em São Paulo, SP, Rio de Janeiro, RJ, Bambuí, MG, e Fortaleza, CE, em 2008. Foi realizado inquérito domiciliar e aplicado questionário com 20 atividades da vida diária dos idosos para autoavaliação da dificuldade/necessidade de ajuda para realizá-las. As respostas foram analisadas segundo: a prevalência de alguma dificuldade ou necessidade de ajuda para cada atividade da vida diária; a frequência de não resposta; e o agrupamento das atividades numa análise fatorial. RESULTADOS: As atividades pessoais (e.g., vestir-se) tiveram prevalência de dificuldade ou necessidade de ajuda referida baixa quando comparadas às atividades instrumentais (e.g., fazer compras), além de terem taxas de respostas inválidas mais baixas. Foram identificados três fatores de agrupamento das atividades da vida diária: mobilidade (andar 100 m); necessidades pessoais (tomar banho); e o que outra pessoa pode fazer pelo idoso (lavar roupa). As atividades da vida diária com maiores autovalores em cada grupo foram analisadas à luz da prevalência de necessidade de ajuda referida e da proporção de respostas válidas. Três atividades foram selecionadas como representativas do espectro de dependência e bem compreendidas pelos idosos: levantar da cama, banhar-se e andar 100 m. CONCLUSÕES: Com três atividades da vida diária podemos ter um instrumento de rastreio simples e confiável capaz de identificar idosos com necessidade de ajuda no dia a dia. A estimativa de demanda por cuidados na vida diária é um indicador ...

OBJETIVO: Analizar aspectos no redundantes sobre independencia en las actividades de la vida diaria de ancianos que representen el espectro de dependencia en ancianos. MÉTODOS: Proyecto multicéntrico con muestra poblacional probabilística de 5.371 ancianos residentes en Sao Paulo, SP, Rio de Janeiro, RJ, Bambuí, MG y Fortaleza, CE, (Brasil), en 2008. Se realizó pesquisa domiciliar y se aplicó cuestionario con 20 actividades de la vida diaria de los ancianos para auto-evaluación de la dificultad/necesidad de ayuda para realizarlas. Las respuestas fueron analizadas de acuerdo a: la prevalencia de alguna dificultad o necesidad de ayuda en cada actividad de la vida diaria; la frecuencia de respuesta no válidas; y el agrupamiento de las actividades en un análisis factorial. RESULTADOS: Las actividades personales (ej: vestirse) tuvieron prevalencia de dificultad o necesidad de ayuda referida baja al compararse con las actividades instrumentales (ej: hacer compras), además de tener tasas de respuestas: inválidas más bajas. Se identificaron tres factores de agrupamiento de las actividades de la vida diaria: movilidad (andar 100m); necesidades personales (bañarse) y lo que otra persona puede hacer por el anciano (lavar ropa). Las actividades de la vida diaria con mayores auto-valores en cada grupo fueron analizadas a la luz de la prevalencia de necesidad de ayuda referida y de la proporción de respuestas válidas. Tres actividades fueron seleccionadas como representativas del espectro de dependencia y bien comprendidas por los ancianos: levantar de la cama, bañarse y andar 100 m. CONCLUSIONES: Con tres actividades de la vida diaria podemos tener un instrumento de rastreo simple y confiable capaz de identificar ancianos con necesidad de ayuda en el día a día. La estimativa de demanda por cuidados en la vida diaria es un indicador importante para ...

OBJECTIVE: To analyze non-redundant questions on independence in activities of daily living in the elderly, representing the spectrum of dependency. METHODS: Multicenter project with a probabilistic population sample of 5,371 elderly residents in Sao Paulo, SP, Rio de Janeiro, RJ, Fortaleza, CE and Bambui, MG in 2008. A household survey was carried out and a questionnaire with 20 activities of daily living applied for the elderly to self-assess the difficulty/need for help in performing them. The responses were analyzed according to: the prevalence of some kind of difficulty/need for help for each activities of daily living, the frequency of non-response, and the grouping of activities in factor analysis. RESULTS: The personal activities (e.g., dressing) have, on average, a low prevalence of difficulty or need for help, compared to instrumental activities (e.g., shopping), and have lower rates of non- response. In factor analysis it was possible to identify three factors grouping the activities of daily living: one relative to mobility (e.g., walking 100 m), another for personal needs (e.g., bathing) and one relative to what someone else can do for the elderly (e.g., washing clothes). The activities of daily living with the highest eigenvalues in each group were also analyzed in the light of the prevalence of reported need for help and the proportion of non response. Three activities of daily living were selected as representing the spectrum of dependency and being well understood by the elderly - getting out of bed, bathing and walking 100 m. CONCLUSIONS: With only three activities of daily living we can have a simple and reliable screening instrument capable of identifying elderly in need of help in daily life. Estimating demand for care on a daily basis is an important indicator for planning and administration of health services within the paradigm of chronic diseases and population aging. .

Questionario do ELSA-Brasil: desafios na elaboracao de instrumento multidimensional / Questionnaire development in ELSA-Brasil: challenges of a multidimensional instrument

O artigo apresenta o processo de elaboração do questionário utilizado no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). Iniciamos pelo relato sobre a "Seleção de Temas" abordados no questionário, cujo conteúdo teria que abranger o conhecimento disponível acerca da complexa rede de causalidade dos desfechos de interesse, assim como possibilitar a comparabilidade com estudos semelhantes. Contextualizamos a "tradução e a adaptação de instrumentos de medida", necessárias no caso de escalas de avaliação de vizinhanças, do instrumento para diagnóstico de transtornos depressivos e de ansiedade, e do questionário de frequência alimentar. A seguir, comentamos os critérios que nortearam a "ordem dos blocos temáticos" e finalmente a importância prática dos "pré-testes e estudos-piloto". As relações entre o conjunto de informações reunidas no ELSA poderão constituir contribuição original sobre os fatores que causam ou agravam os desfechos de interesse no contexto brasileiro, assim como sobre seus fatores de proteção.

This article describes the development of the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) questionnaire. We first address the selection of topics whose contents have to cover the knowledge available on the complex causal network of outcomes and allow comparability with similar studies. Then we deal with the "translation and adaptation of measurement instruments" including neighborhood environment rating scales, depression and anxiety disorder rating scale and a food frequency questionnaire and discuss criteria that guided "theme block sequencing". And finally we focus on the practical importance of "pretesting and pilot studies". The ELSA may provide an original contribution regarding factors that cause or aggravate the outcomes of interest in the Brazilian population, as well as protective factors.

Delineamento e implementacao do biobanco do ELSA-Brasil: estudo prospectivo na populacao brasileira / Design and implementation of the ELSA-Brasil biobank: a prospective study in a Brazilian population

O Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) é uma coorte prospectiva multicêntrica de funcionários públicos delineada para avaliar os determinantes das doenças crônicas, principalmente a doença cardiovascular e o diabetes tipo 2. Neste artigo são descritos os principais pontos do delineamento e implementação do projeto do biobanco do ELSA-Brasil. São detalhados aspectos econômicos, políticos, logísticos e tecnológicos do estudo. O artigo também discute o protocolo final de estocagem de material biológico e as instalações implementadas para atingir esse objetivo. O processo de delineamento e implementação do biobanco do ELSA-Brasil durou três anos. Tanto os biobancos centrais quanto os locais foram constituídos de acordo com as melhores práticas de estocagem de material biológico, usando soluções tecnológicas diferentes para as diferentes necessidades previstas no estudo.

The Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) is a multicenter prospective cohort of civil servants designed to assess the determinants of chronic diseases, especially cardiovascular diseases and type 2 diabetes. The present article describes the main design and implementation points of the ELSA-Brasil biobank project. Economic, political, logistical and technological aspects of this study are characterized. Additionally, it discusses the final biorepository protocol and the facilities implemented to achieve this objective. The design and implementation process of the ELSA-Brasil biobank took three years to be performed. Both the central and local biobanks were built according to the best biorepository techniques, using different technological solutions for the distinct needs expected in this study.

Adaptacao transcultural e confiabilidade de medidas de caracteristicas autorreferidas de vizinhanca no ELSA-Brasil / Cross-cultural adaptation and reliability of measurements on self-reported neighborhood characteristics in ELSA-Brasil

OBJETIVO: Descrever o processo de adaptação de escalas de medida de características de vizinhança para o português brasileiro. MÉTODOS: As dimensões abordadas foram coesão social, ambiente propício para atividade física, disponibilidade de alimentos saudáveis, segurança em relação a crimes, violência percebida e vitimização. No processo de adaptação foram avaliados aspectos de equivalência entre as escalas originais e respectivas versões para o português. A confiabilidade teste-reteste foi avaliada em submostra de 261 participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) que responderam ao mesmo questionário em dois momentos distintos em um intervalo de tempo de sete a 14 dias entre as duas aplicações. RESULTADOS: Os aspectos de equivalência avaliados mostraram-se adequados. O coeficiente de correlação intraclasse variou entre 0,83 (IC95% 0,78;0,87) para Coesão Social e 0,90 (IC95% 0,87;0,92) para Ambiente para Atividade Física. As escalas apresentaram consistência interna (alfa de Cronbach) que variaram entre 0,60 e 0,84. CONCLUSÕES: As medidas autorreferidas de características de vizinhança tiveram reprodutibilidade muito boa e boa consistência interna. Os resultados sugerem que essas escalas podem ser utilizadas em estudos com população brasileira que apresente características similares àquelas do ELSA-Brasil. .

OBJECTIVE: To describe the process involved in adapting scales for measuring neighborhood characteristics to Brazilian Portuguese. METHODS: The dimensions addressed were social cohesion, environment suitable for physical activity, availability of healthy foods, safety, perceived violence and victimization. The adaptation process involved assessment of equivalence between the original scales and the Portuguese versions. The test-retest reliability was assessed in a subsample of 261 participants from the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil), who answered the same questionnaire on two different occasions, separated by an interval of 7 to 14 days. RESULTS: The aspects of equivalence assessed were shown to be adequate. The intraclass correlation coefficient ranged from 0.83 (95%CI 0.78;0.87) for Social Cohesion to 0.90 (95%CI 0.87;0.92) for Walking Environment. The scales showed internal consistency (Cronbach's alpha) ranging from 0.60 to 0.84. CONCLUSIONS: The measurements on self-reported neighborhood characteristics had very good reproducibility and good internal consistency (Cronbach's alpha). The results suggest that these scales can be used in studies involving Brazilian populations with characteristics similar to those of ELSA-Brasil. .

Comite de publicacoes em estudo multicentrico e sistema informatizado de apoio - publiELSA / Publications committee of a multicenter study and computerized support system - publiELSA

O comitê de publicações de um estudo multicêntrico visa organizar as propostas de artigos, garantindo: amplo acesso aos dados, qualidade e precedência. Foi desenvolvido um sistema online de informação e gerenciamento de propostas de estudos - o publiELSA - , composto por três módulos: (i) submissão e aprovação da proposta; (ii) acompanhamento da proposta aprovada; e (iii) relatórios consolidados. O primeiro permite a qualquer interessado buscar e conhecer artigos já publicados e em andamento, e submeter novas propostas. O processo de aprovação e transferência dos dados para o pesquisador responsável é organizado nessa etapa. O segundo módulo visa ao monitoramento das propostas aprovadas até sua publicação final e o terceiro permite buscas e visualização de propostas e artigos. O sistema tem aspectos inovadores, sobretudo o incentivo à cooperação entre os diversos pesquisadores, por meio da circulação de informes sobre cada proposta submetida. Estimula-se assim a interação dos diferentes olhares e experiências envolvidos nesta pesquisa.

The publications committee of a multicenter study has the aim of organizing the proposals for articles, so as to ensure wide-ranging access to the data, quality and precedence. An online information and management system for study proposals (publiELSA) was developed, composed of three modules: (i) submission and approval of proposals; (ii) follow-up of approved proposals; and (iii) consolidated reports. The first module allows any interested party to search for and become acquainted with articles that have already been published or are in progress and submit new proposals. The approval process and data transfer to the researcher responsible is organized at this stage. In the second module, the aim is to monitor proposals approved until they are finally published. The third module enables searching for and viewing proposals and articles. The system has innovative characteristics, especially with regard to encouraging cooperation between different researchers, through circulation of information on each proposal submitted. In this manner, interaction between different viewpoints and experiences involved in the research is stimulated.

Reprodutibilidade da pressao arterial medida no ELSA-Brasil com a monitorizacao pressorica de 24h / Reproducibilidad de la presion arterial medida en el ELSA con el monitoreo de las medidas presoricas de 24h / Reproducibility of arterial pressure measured in the ELSA-Brasil with 24-hour pressure monitoring

OBJETIVO: Determinar a reprodutibilidade da pressão arterial casual de participantes do Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil) e confirmar o diagnóstico pressórico pela monitorização. MÉTODOS: A pressão arterial casual foi medida em aparelho oscilométrico. Uma subamostra dos participantes do estado do Espírito Santo (N = 255) foi reavaliada com igual metodologia de uma a dez semanas após; além disso, foi realizada monitorização. O diagnóstico de hipertensão seguiu os pontos de corte de 140/90 mmHg ou 130/80 mmHg para a pressão casual e na monitorização, respectivamente. A hipertensão do jaleco branco foi definida pela presença hipertensão na medida casual e normotensão na monitorização e o inverso para a hipertensão mascarada. RESULTADOS: Os dados referem-se a 230 participantes que nas duas ocasiões estavam sem medicação (N1 = 153) ou sob a mesma medicação anti-hipertensiva (N2 = 77). No N1, a normotensão casual foi confirmada em 120 dos 134 pela monitorização. No N2, a monitorização confirmou o controle pressórico em 43 dos 54 participantes com pressão controlada pela medida casual. A concordância geral de diagnósticos entre a pressão casual e monitorada foi de 78% (kappa = 0,44). No grupo N1, seis indivíduos (4%) apresentaram hipertensão do jaleco branco e 23 (25%), mascarada. CONCLUSÕES: A concordância de diagnósticos entre a pressão arterial casual e a monitorada foi moderada. A padronização rigorosa da medida casual adotada no ELSA-Brasil foi capaz de reduzir a hipertensão do jaleco branco. A alta frequência de hipertensão mascarada sugere que a medida pressórica da monitorização ...

OBJECTIVE: To determine the reproducibility of casual arterial pressure measurement and to confirm pressure diagnosis by monitoring of participants in the ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health). METHODS: Casual blood pressure was measured with an oscilometric device. A sub-sample of participants (N = 255) from Espírito Santo state (Southeastern Brazil) was reevaluated using the same methodology following one to ten weeks and, in addition, underwent arterial blood pressure monitoring. Diagnosis of hypertension used cut off points of 140/90 mmHg for casual pressure and 130/80 mmHg for arterial blood pressure monitoring. White coat hypertension was defined as the presence of hypertension in casual blood pressure and normal arterial blood pressure monitoring, and converse findings characterized masked hypertension. RESULTS: Data are from 230 participants that on the two occasions were free from antihypertensive medication (N1 = 153) or under the same antihypertensive regimen (N2 = 77). Normotension was confirmed by arterial blood pressure monitoring in120 out of 134 participants of the N1 group. In N2, blood pressure control was confirmed by arterial blood pressure monitoring in 43 of 54 participants with controlled hypertension per casual blood pressure. Overall diagnostic concordance between casual blood pressure and arterial blood pressure monitoring was 78% (kappa = 0.44). In the N1 group, six subjects (4%) presented white coat hypertension, and 23 subjects (25%) presented with masked hypertension. CONCLUSIONS: Diagnostic concordance between casual blood pressure and arterial blood pressure monitoring was moderate. The rigorous standardization of casual blood pressure measurement adopted in the ELSA-Brasil study was able to reduce white coat hypertension. The high frequency of masked hypertension ...

Desafios a implantacao do centro de leitura de eletrocardiografia no ELSA-Brasil / Desafios en la implantacion del centro de lectura de electrocardiografia en el ELSA-Brasil / Challenges to implementation of the ECG reading center in ELSA-Brasil

O eletrocardiograma é um método estabelecido de avaliação cardiovascular de baixo custo utilizado há décadas em estudos epidemiológicos de grande porte. Apesar disso, sua utilização em estudos desse tipo se constitui em desafio, especialmente quando se pretende implantar Centro de Leitura próprio. Este artigo descreve o processo, dificuldades e desafios de implantação do Centro de Leitura em eletrocardiograma no Estudo Longitudinal de Saúde do Adulto (ELSA-Brasil). Dentre os aspectos discutidos, ressaltam-se: os critérios para escolha dos eletrocardiógrafos e da central de armazenamento e manejo dos aparelhos; o pessoal necessário; os procedimentos de aquisição e de transmissão dos eletrocardiogramas para o Centro de Leitura; os sistemas de codificação dos traçados, com ênfase para o código de Minnesota; os aspectos éticos e práticos relacionados à entrega dos laudos aos participantes do estudo; e os aspectos relacionados ao controle de qualidade.

Electrocardiography is an established low-cost method of cardiovascular assessment, utilized for decades large epidemiological studies. Nonetheless, its use in large epidemiological studies presents challenges, especially when seeking to develop a reading center. This article describes the process, difficulties and challenges of implementing an electrocardiogram reading center in Brazilian Longitudinal Study for Adult Health (ELSA-Brasil). Among the issues discussed, we have emphasized: the criteria for selection of the electrocardiography machine and the central for storage and management of the machines; the required personnel; the procedures for acquisition and transmission of electrocardiographs to the Reading Center; coding systems, with emphasis on the Minnesota code; ethical and practical issues regarding the delivery of reports to study participants; and aspects related to quality control.

Aspectos eticos em estudos longitudinais: o caso do ELSA-Brasil / Ethical issues in longitudinal studies: the case of ELSA-Brasil

Historicamente a discussão acerca da eticidade dos atos em pesquisas com seres humanos privilegiou os estudos experimentais, pelo maior potencial de danos aos sujeitos envolvidos. Todavia, os estudos observacionais também envolvem riscos e suscitam questões relevantes. Neste artigo pretende-se apresentar e discutir aspectos éticos do desenvolvimento do ELSA-Brasil, um estudo longitudinal e multicêntrico, com financiamento público, no qual os sujeitos da pesquisa e pesquisadores pertencem às mesmas instituições. São descritos os procedimentos adotados para atender às exigências e compromissos éticos e a casuística que orientou as ações segundo seus princípios norteadores (beneficência, autonomia e justiça social). São apresentados alguns problemas morais que exigiram ponderação sobre riscos e benefícios na confluência com os objetivos do estudo e comentam-se peculiaridades de um estudo longitudinal e seus potenciais benefícios.

The debate about ethics in research with human beings has historically emphasized experimental studies because of their greater potential to harm the subjects involved. However, observational studies also include risks and relevant questions to be discussed. This article aims to present and discuss the ethical aspects involved in the implementation of ELSA-Brasil, a longitudinal multicenter study, with public funding, in which the research subjects and investigators are employees of the same institutions. The procedures adopted to meet the ethical requirements and commitments are described, as well as the casuistics that guided the actions according to their guiding principles (beneficence, autonomy and social justice). We present some moral problems that required consideration of risks and benefits at the confluence with the study's objectives, and we conclude with comments on the peculiarities and the potential benefits of a longitudinal study.