ABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology. Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.
Subject(s)
Clinical Trials as Topic/organization & administration , Datasets as Topic/standards , Editorial Policies , Information Dissemination , Periodicals as Topic/standards , Clinical Trials as Topic/standards , Humans , International Cooperation , Societies, MedicalABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship- emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
ABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.
Subject(s)
Biomedical Research , Editorial Policies , Information Dissemination , Publishing , Humans , Periodicals as TopicABSTRACT
Abstract: The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Resumen: El Comite internacional de editores de revistas medicas (CIERM) propone recomendaciones para mejorar los standares editoriales y la calidad científica de las revistas biomédicas. Estas recomendaciones abarcan desde requerimeintos ténicos uniformados a temas editoriales mas complejos y evasivos, como los aspectos bioéticos relacionados con el proceso científico. Recientemente se han propuesto algunas iniciativas editoriales, como el registro de los ensayos clinicos, la declaración de los conflictos de interés y los nuevos criterios para autoría (que destacan la responsabilidad de los autores sobre el estudio). El año pasado se presentó una nueva iniciativa editorial para resaltar la importancia de compartir los datos generados en los estudios clinicos. En este artículo se discute esta nueva iniciativa editorial, con la idea de difundir su conocimiento entre los lectores, investigadores, autores y editores de la red de editores de revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.
Subject(s)
Periodicals as Topic , Publishing , Cardiology , Information Dissemination , Editorial Policies , International CooperationABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Subject(s)
Cardiology , Editorial Policies , Information Dissemination , Periodicals as Topic , Publishing , International CooperationABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability - have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Subject(s)
Clinical Trials as Topic , Editorial Policies , Information Dissemination , Journalism, Medical/standards , Authorship , Bioethics , Cardiology , Disclosure , Societies, MedicalABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Subject(s)
Editorial Policies , Information Dissemination , Guidelines as TopicABSTRACT
Abstract The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.
Resumo O Comitê Internacional de Editores de Revistas Médicas (ICMJE) fornece recomendações para aprimorar o padrão editorial e a qualidade científica das revistas biomédicas. Tais recomendações variam desde requisitos técnicos de uniformização até assuntos editoriais mais complexos e elusivos, como os aspectos éticos do processo científico. Recentemente, foram propostos registro de ensaios clínicos, divulgação de conflitos de interesse e novos critérios de autoria, enfatizando a importância da responsabilidade e da responsabilização. No último ano, lançou-se uma nova iniciativa editorial para fomentar o compartilhamento dos dados de ensaios clínicos. Esta revisão discute essa nova iniciativa visando a aumentar a conscientização de leitores, investigadores, autores e editores filiados à Rede de Editores da Sociedade Europeia de Cardiologia.
Subject(s)
Humans , Periodicals as Topic/standards , Clinical Trials as Topic/organization & administration , Information Dissemination , Editorial Policies , Datasets as Topic/standards , Societies, Medical , Clinical Trials as Topic/standards , International CooperationABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
ABSTRACT
Objective: Cardiopulmonary exercise testing is a tool that helps clinicians to establish diagnosis and calculate risk stratification in adults. However, the utility of this test among children with congenital heart disease has not been fully explored. The goal of this study was to describe reference values for cardiopulmonary performance of healthy children. Methods: This study included 103 apparently healthy children (aged from 4 to 18 years; 61 boys), who underwent cardiopulmonary test using a treadmill protocol. All tests took place at 2240m above sea level (Mexico City). Results: Exercise time was 11 ± 4 min. There were no complications. Peak oxygen uptake correlated closely with height in both genders (girls r = 0.84; boys r = 0.84, p < 0.001). A multivariable linear regression model showed that body surface area, exercise time, gender and heart rate reserve were significant predictors of peak oxygen uptake (R² =0.815, p<0.001). Peak oxygen uptake was strongly associated with age even among children younger than thirteen years (r = 0.74, p <0.001). Conclusion: This study provides physiological values for the major cardiopulmonary variables obtained from exercise testing using a treadmill among healthy children. Cardiopulmonary exercise test can be safely and effectively performed in young children even as young as 4 years old. Variables including age, gender and height are strongly associated with exercise time, peak heart rate and peak oxygen uptake. Regression equations for predicting peak heart rate and peak oxygen uptake are presented as reference values that allow researchers to compare children with heart disease versus those who are healthy.
Objetivo: La prueba de esfuerzo cardiopulmonar es una herramienta que ayuda a los médicos a establecer el diagnóstico y estratificar el riesgo en adultos. Sin embargo, su utilidad en los niños no se ha explorado a fondo. El objetivo fue describir los valores de esta prueba en niños sanos en altitud moderadamente alta. Métodos: Se realizaron pruebas de esfuerzo cardiopulmonar a 103 niños sanos (4 a 18 años, 61 varones) mediante tapiz rodante y a 2240m sobre el nivel del mar (Ciudad de México). Resultados: El tiempo de ejercicio fue de 11 ± 4 min, sin complicaciones. El consumo de oxígeno pico se correlacionó estrechamente con la talla en ambos géneros (niñas r = 0.84; niños r = 0.84, p < 0.001). El modelo multivariado que incluyó superficie corporal, tiempo de ejercicio, género y la frecuencia cardíaca de reserva fue un fuerte predictor del consumo de oxígeno pico (R²=0.815, p<0.001). Conclusión: Las pruebas de esfuerzo cardiopulmonar mediante tapiz rodante se pueden realizar con seguridad y eficacia en niños, incluso de 4 años de edad. Variables como la edad, el género y la talla están fuertemente asociados con el tiempo de ejercicio, la frecuencia cardiaca máxima y el de oxígeno pico. Las ecuaciones de regresión obtenidas para calcular la frecuencia cardíaca máxima y el consumo de oxígeno pico pueden ayudar, tanto a clínicos como a investigadores, a comparar el comportamiento de niños con cardiopatías frente a los que no las tienen.
Subject(s)
Adolescent , Child , Child, Preschool , Female , Humans , Male , Altitude , Exercise Test , Reference ValuesABSTRACT
OBJECTIVE: Cardiopulmonary exercise testing is a tool that helps clinicians to establish diagnosis and calculate risk stratification in adults. However, the utility of this test among children with congenital heart disease has not been fully explored. The goal of this study was to describe reference values for cardiopulmonary performance of healthy children. METHODS: This study included 103 apparently healthy children (aged from 4 to 18 years; 61 boys), who underwent cardiopulmonary test using a treadmill protocol. All tests took place at 2240m above sea level (Mexico City). RESULTS: Exercise time was 11±4min. There were no complications. Peak oxygen uptake correlated closely with height in both genders (girls r=0.84; boys r=0.84, p<0.001). A multivariable linear regression model showed that body surface area, exercise time, gender and heart rate reserve were significant predictors of peak oxygen uptake (R(2)=0.815, p<0.001). Peak oxygen uptake was strongly associated with age even among children younger than thirteen years (r=0.74, p<0.001). CONCLUSION: This study provides physiological values for the major cardiopulmonary variables obtained from exercise testing using a treadmill among healthy children. Cardiopulmonary exercise test can be safely and effectively performed in young children even as young as 4 years old. Variables including age, gender and height are strongly associated with exercise time, peak heart rate and peak oxygen uptake. Regression equations for predicting peak heart rate and peak oxygen uptake are presented as reference values that allow researchers to compare children with heart disease versus those who are healthy.
Subject(s)
Altitude , Exercise Test , Adolescent , Child , Child, Preschool , Female , Humans , Male , Reference ValuesABSTRACT
The modified Fontan procedure represents the final stage of reconstructive surgery for most patients with functionally univentricular hearts. Although outcomes following Fontan procedures performed at sea level are widely reported, less has been documented and reported concerning outcomes in regions at high altitude. To clarify the main features involved, we present our institutional experience with Fontan operations performed in Mexico city (2,240 m above the sea level), with an emphasis on historical evolution of treatment. A retrospective and observational study was undertaken, which included 98 patients over a period of 18 years, and clinical outcomes in terms of morbidity and mortality were analyzed. A change in operative technique from intra-cardiac nonfenestrated Fontan procedure to extra-cardiac fenestrated technique occurred in 2001. Early mortality rates before and after this change in surgical approach were 26% and 4.7%, respectively. The most common morbidity was the occurrence of pleural effusions (98% of patients), which also appears to be a risk factor for operative mortality. Much remains unknown about the pathophysiology of the Fontan circulation at high altitude, and we need to develop morphological study protocols that include pulmonary biopsy to increase our knowledge and inform our therapeutic actions.
ABSTRACT
Introducción y objetivos. Describir nuestra experiencia en la corrección quirúrgica del origen anómalo de la arteria coronaria izquierda del tronco de la arteria pulmonar (ALCAPA), con énfasis en la técnica del reimplante coronario y sus resultados. Métodos. Se realizó un estudio descriptivo, longitudinal y retrospectivo de los pacientes con ALCAPA operados con técnica de reimplante coronario en un periodo de 19 años. Se exponen tres técnicas del reimplante coronario, dependiendo de la situación de la coronaria izquierda anómala, y la evolución postoperatoria en términos de morbimortalidad. Resultados. Se analizó a 15 pacientes (el 86% mujeres) con una media de edad de 6,2 años (2 meses-24 años). El 80% se hospitalizó por insuficiencia cardiaca. El 67% tenía disfunción ventricular izquierda y el 27%, insuficiencia mitral importante o grave. Se practicó cirugía valvular mitral concomitante en 4 pacientes. Las principales complicaciones postoperatorias inmediatas fueron bajo gasto cardiaco (38%), derrame pleural (17%) e isquemia transitoria (13%). No hubo mortalidad operatoria ni a medio plazo. Conclusiones. El reimplante coronario es la opción quirúrgica de elección para el manejo de los pacientes con ALCAPA por su excelente supervivencia posquirúrgica y su baja morbilidad operatoria (AU)
Introduction and objectives. We report our experience in the surgical correction of anomalous origin of left coronary artery from pulmonary artery (ALCAPA), with an emphasis on the coronary reimplantation technique and its outcome. Methods. We designed a retrospective, longitudinal, descriptive study that included patients with ALCAPA who underwent surgery involving coronary reimplantation over a 19-year period. We describe perioperative details such as variations in the surgical technique and the postoperative outcome in terms of morbidity and mortality. Results. We studied 15 patients (86% females) with a mean age of 6.2 years (range, 2 months to 24 years). Heart failure was the principal cause for hospitalization in 80% of our patients. Left ventricular dysfunction was present in 67%, and 27% had significant or severe mitral valve regurgitation. We describe 3 surgical techniques for coronary reimplantation, the choice of which depends on the site of origin of the anomalous left coronary artery. Four patients underwent an additional mitral valve procedure. The most common immediate postoperative complications were low cardiac output (38%), pleural effusion (17%), and transient ischemia (13%). There was no operative or medium-term mortality. Conclusions. Coronary reimplantation is the technique of choice for surgical correction of ALCAPA due to the excellent postoperative survival and low operative morbidity (AU)
Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Young Adult , Adult , Pulmonary Artery/surgery , Heart Defects, Congenital/diagnosis , Heart Defects, Congenital/surgery , Heart Failure/surgery , Postoperative Complications/therapy , Sternotomy/methods , Catheterization/methods , Mitral Valve Insufficiency/complications , Mitral Valve Insufficiency/surgery , Heart Defects, Congenital/physiopathology , Heart Defects, Congenital , Retrospective Studies , Indicators of Morbidity and Mortality , Anastomosis, Surgical/methods , 28599 , Radiography, Thoracic/methods , Mitral Valve InsufficiencyABSTRACT
INTRODUCTION AND OBJECTIVES: We report our experience in the surgical correction of anomalous origin of left coronary artery from pulmonary artery (ALCAPA), with an emphasis on the coronary reimplantation technique and its outcome. METHODS: We designed a retrospective, longitudinal, descriptive study that included patients with ALCAPA who underwent surgery involving coronary reimplantation over a 19-year period. We describe perioperative details such as variations in the surgical technique and the postoperative outcome in terms of morbidity and mortality. RESULTS: We studied 15 patients (86% females) with a mean age of 6.2 years (range, 2 months to 24 years). Heart failure was the principal cause for hospitalization in 80% of our patients. Left ventricular dysfunction was present in 67%, and 27% had significant or severe mitral valve regurgitation. We describe 3 surgical techniques for coronary reimplantation, the choice of which depends on the site of origin of the anomalous left coronary artery. Four patients underwent an additional mitral valve procedure. The most common immediate postoperative complications were low cardiac output (38%), pleural effusion (17%), and transient ischemia (13%). There was no operative or medium-term mortality. CONCLUSIONS: Coronary reimplantation is the technique of choice for surgical correction of ALCAPA due to the excellent postoperative survival and low operative morbidity.
Subject(s)
Abnormalities, Multiple/surgery , Coronary Vessel Anomalies/surgery , Pulmonary Artery/abnormalities , Pulmonary Artery/surgery , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Longitudinal Studies , Male , Postoperative Complications/epidemiology , Retrospective Studies , Time Factors , Treatment Outcome , Vascular Surgical Procedures/methods , Young AdultSubject(s)
Cardiology/history , Heart Defects, Congenital , Brazil , History, 20th Century , History, 21st Century , MexicoABSTRACT
The epidemic of childhood obesity, the risk of developing left ventricular hypertrophy, and evidence of the early development of atherosclerosis in children would make the detection of and intervention in childhood hypertension important to reduce long-term health risks; however, supporting data are lacking. Secondary hypertension is more common in preadolescent children, with most cases caused by renal disease. Primary or essential hypertension is more common in adolescents and has multiple risk factors, including obesity and a family history of hypertension. Evaluation involves a through history and physical examination, laboratory tests, and specialized studies. Management is multifaceted. Nonpharmacologic treatments include weight reduction, exercise, and dietary modifications. Although the evidence of first line therapy for hypertension is still controversial, the recommendations for pharmacologic treatment are based on symptomatic hypertension, evidence of end-organ damage, stage 2 of hypertension, or stage 1 of hypertension unresponsive to lifestyle modifications, and hypertension with diabetes mellitus.
Subject(s)
Hypertension , Adolescent , Child , Humans , Hypertension/diagnosis , Hypertension/epidemiology , Hypertension/therapyABSTRACT
The epidemic of childhood obesity, the risk of developing left ventricular hypertrophy, and evidence of the early development of atherosclerosis in children would make the detection of and intervention in childhood hypertension important to reduce long-term health risks; however, supporting data are lacking. Secondary hypertension is more common in preadolescent children, with most cases caused by renal disease. Primary or essential hypertension is more common in adolescents and has multiple risk factors, including obesity and a family history of hypertension. Evaluation involves a through history and physical examination, laboratory tests, and specialized studies. Management is multifaceted. Nonpharmacologic treatments include weight reduction, exercise, and dietary modifications. Although the evidence of first line therapy for hypertension is still controversial, the recommendations for pharmacologic treatment are based on symptomatic hypertension, evidence of end-organ damage, stage 2 of hypertension, or stage 1 of hypertension unresponsive to lifestyle modifications, and hypertension with diabetes mellitus.
Subject(s)
Adolescent , Child , Humans , Hypertension , Hypertension , Hypertension , HypertensionABSTRACT
OBJECTIVES: To compare the short- and mid-term outcomes of surgical (SUR) vs. transcatheter closure of secundum atrial septal defect (ASD) using Amplatzer septal occluder (ASO) in adults with a very similar spectrum of the disease; and to identify predictors for the primary end point. DESIGN: Single-center, concurrent comparative study. Surgically treated patients were randomly matched (2:1) by age, sex, date of procedure, ASD size, and hemodynamic profile. SETTING: Tertiary referral center. PATIENTS: One hundred sixty-two concurrent patients with ASD submitted to ASO (n = 54) or SUR closure (n = 108) according with their preferences. MAIN OUTCOME MEASURES: Primary end point was a composite index of major events including failure of the procedure, important bleeding, critical arrhythmias, serious infections, embolism, or any major cardiovascular intervention-related complication. Predictors of these major events were investigated. RESULTS: Atrial septal defects were successfully closed in all patients, and there was no mortality. The primary event rate was 13.2% in ASO vs. 25.0% in SUR (P = .001). Multivariate analysis showed that higher rate of events was significantly associated with age >40 years; systemic/pulmonary output ratio <2.1; and systolic pulmonary arterial pressure >50 mm Hg; while in the ASO group the event rate was only associated with the ASD size (>15 cm(2)/m(2); relative risk = 1.75, 95% confidence interval 1.01-8.8). There were no differences in the event-free survival curves in adults with ages <40 years. CONCLUSIONS: The efficacy for closure ASD was similar in both groups. The higher morbidity observed in SUR group was observed only in the patients submitted to the procedure with age >40 years. The length of hospital stay was shorter in the ASO group. Surgical closure is a safe and effective treatment, especially in young adults. There is certainly nothing wrong with continuing to do surgery in countries where the resources are limited.
