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Resumen El uso de dispositivos cardiacos implantables ha aumentado en los últimos años, lo que ha generado un aumento en el número de procedimientos de extracción de electrodos a medida que se intervienen pacientes con un mayor número de comorbilidades. En la actualidad, la técnica percutánea de extracción es de elección en la mayoría de los pacientes debido a los excelentes resultados alcanzados y a una morbi-mortalidad asociada inferior a la de la extracción quirúrgica. No obstante, algunos pacientes pueden presentar retos que aumentan el grado de dificultad técnica del procedimiento, entre los que se encuentran variantes anatómicas, calcificaciones extensas o la necesidad de extraer electrodos de fijación pasiva. Se expone el caso de la extracción de un electrodo disfuncionante en una paciente portadora de marcapasos por bloqueo auriculoventricular completo, con estimulación diafragmática por electrodo ventricular de fijación pasiva implantado a través de una vena cava superior izquierda persistente en una vena posterolateral del seno coronario.
Abstract The use of cardiac electronic devices has increased over the last decades, which has generated an increase in the number of electrode extraction procedures, as a greater number of patients with multiple comorbidities undergo cardiac electronic device implantation. Currently, the percutaneous technique is preferable in most patients, given its excellent clinical results and lower morbidity and mortality compared to surgical extraction. Nonetheless, some clinical scenarios increase procedural difficulty, including anatomical variants, or the need to extract passive fixation leads. We present a case of a patient with pacemaker due to complete atrioventricular block, with diaphragmatic stimulation caused by a passive fixation ventricular electrode that was implanted in a posterolateral vein of the coronary sinus through a persistent left superior vena cava, who underwent successful transvenous lead extraction.
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BACKGROUND: Intracardiac echocardiography (ICE) is increasingly used during left atrial appendage occlusion (LAAO) as an alternative to transesophageal echocardiography (TEE). The objective of this study is to evaluate the impact of ICE versus TEE guidance during LAAO on procedural characteristics and acute outcomes, as well the presence of peri-device leaks and residual septal defects during follow-up. METHODS: All studies comparing ICE-guided versus TEE-guided LAAO were identified. The primary outcomes were procedural efficacy and occurrence of procedure-related complications. Secondary outcomes included lab efficiency (defined as a reduction in in-room time), procedural time, fluoroscopy time, and presence of peri-device leaks and residual interatrial septal defects (IASD) during follow-up. RESULTS: Twelve studies (n = 5637) were included. There were no differences in procedural success (98.3% vs. 97.8%; OR 0.73, 95% CI 0.42-1.27, p = .27; I2 = 0%) or adverse events (4.5% vs. 4.4%; OR 0.81 95% CI 0.56-1.16, p = .25; I2 = 0%) between the ICE-guided and TEE-guided groups. ICE guidance reduced in in-room time (mean-weighted 28.6-min reduction in in-room time) without differences in procedural time or fluoroscopy time. There were no differences in peri-device leak (OR 0.93, 95% CI 0.68-1.27, p = 0.64); however, an increased prevalence of residual IASD was observed with ICE-guided versus TEE-guided LAAO (46.3% vs. 34.2%; OR 2.23, 95% CI 1.05-4.75, p = 0.04). CONCLUSION: ICE guidance is associated with similar procedural efficacy and safety, but could result in improved lab efficiency (as established by a significant reduction in in-room time). No differences in the rate of periprocedural leaks were found. A higher prevalence of residual interatrial septal defects was observed with ICE guidance.
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Apêndice Atrial , Fibrilação Atrial , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Fibrilação Atrial/complicações , Ecocardiografia Transesofagiana , Resultado do TratamentoRESUMO
Resumen Introducida inicialmente en la década de los cincuenta para la evaluación de las presiones de la aurícula izquierda y posteriormente para la realización de valvuloplastia mitral, la punción transeptal es, con frecuencia, la vía de acceso para efectuar procedimientos que involucren las cavidades izquierdas. En la actualidad, se usa comúnmente en los laboratorios de electrofisiología, tanto para la ablación de arritmias en cavidades izquierdas como para los procedimientos de cierre percutáneo de orejuela. No obstante, con la llegada de diversas técnicas para el manejo percutáneo de la válvula mitral, se espera un aumento progresivo de su uso por parte de cardiólogos intervencionistas. En este artículo, se revisa la técnica para hacer una punción transeptal segura y se dan recomendaciones y estrategias para el manejo de la punción transeptal difícil.
Abstract Initially described in 1959 as a technique to measure left atrial pressures, and later used during balloon mitral valvuloplasty, transeptal puncture (TSP) is frequently the access route for procedures involving the left heart chambers. Currently, it is mostly used in electrophysiology laboratories for arrhythmia ablation and during left atrial appendage occlusion procedures. However, with the ongoing development of percutaneous mitral valve interventions, it is expected that a greater number of interventional cardiologists will be using this technique in the near future. In this article, we review the technique to perform TSP safely, and we provide recommendations and different strategies to deal with difficult TSPs.
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Resumen El cierre percutáneo de orejuela se ha posicionado como una estrategia eficaz en la prevención de embolia en pacientes con fibrilación auricular. La mayoría de los procedimientos en el mundo se realizan mediante ecocardiografía transesofágica, que implica, en la mayoría de los casos, el uso de sedación profunda guiada por anestesiología o incluso anestesia general, lo que conlleva tiempos de sala y de procedimiento prolongados, potenciales retardos en la programación del procedimiento (por baja disponibilidad de servicios de anestesiología y de ecocardiografía) y exposición a los riesgos propios de la sedación profunda y la anestesia general. Adicionalmente, el mayor número de personas requeridos en sala para el cierre percutáneo de orejuela guiado por ecacardiografía transesofágica aumenta la cantidad de personas expuestas a radiación ionizante, particularmente el ecocardiografista, que se ubica próximo al angiógrafo y con frecuencia debe introducir sus manos en el campo de fluoroscopia. En los últimos años, la ecocardiografía intracardíaca ha cobrado importancia para guiar los procedimientos de cierre percutáneo de orejuela debido a su amplia disponibilidad en los laboratorios de electrofisiología, y a la posibilidad de realizar procedimientos con menor tiempo de uso de sala y de recuperación, ya que evita el uso de anestesia general y a que facilita los procedimientos con alta el mismo día, lo que se podría asociar a una disminución global de los costos de procedimientos. En este artículo se discute la evidencia actual que avala el uso de ecocardiografía intracardiaca en el cierre percutáneo de orejuela.
Abstract Left atrial appendage occlusion has proven to be an effective strategy in reducing the risk of stroke and systemic embolism in patients with atrial fibrillation. Worldwide, most left atrial appendage occlusions are performed using transesophageal echocardiography, which requires the use of monitored anesthesia care or general anesthesia, resulting in prolonged in-room and procedural times, delays in procedural scheduling (due to a low availability of anesthetic and echocardiography services) and the risks associated with anesthesia per se. Moreover, the additional personnel required to perform left atrial appendage occlusion guided by transesophageal echocardiography increases the number of people exposed to ionizing radiation, which is particularly high for the transesophageal echocardiography operator, who stands beside the fluoroscopy tube and frequently introduces his/her hands in the fluoroscopy field. Intracardiac echocardiography has gained acceptance to guide left atrial appendage occlusion in recent years, given its high availability in electrophysiology labs, as well as its potential to reduce in-room and procedural times, reduce the need for extensive recovery times, avoid the use of general anesthesia and facilitating same-day discharge, all of which could result in a reduction of total procedure-related costs. In this article, we discuss the evidence supporting the use of intracardiac echocardiography guidance during left atrial appendage occlusion.
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Strong evidence exists based on metanalysis of the relationship between toxoplasmosis and many psychiatric diseases: schizophrenia, bipolar disorder, and suicidal behavior. Herein, we estimate the number of cases based on the attributable fraction due to toxoplasmosis on these diseases. The population attributable fraction of mental disease associated with toxoplasmosis was 20,4% for schizophrenia; 27,3% for bipolar disorder; and 0,29% for suicidal behavior (self-harm). The lower and upper estimated number of people with mental disease associated with toxoplasmosis was 4'816.491 and 5'564.407 for schizophrenia; 6'348.946 and 7'510.118,82 for bipolar disorder; and 24.310 and 28.151 for self-harm; for a global total lower estimated number of 11'189.748 and global total upper estimated number of 13'102.678 people with mental disease associated with toxoplasmosis for the year 2019. According to the prediction through the Bayesian model of risk factors for toxoplasmosis associated with mental disease, these varied in importance geographically; thus, in Africa, the most important risk factor was water contamination and in the European region, the cooking conditions of meats. Toxoplasmosis and mental health should be a research priority given the enormous potential impact of reducing this parasite in the general population.
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Transtornos Mentais , Toxoplasma , Toxoplasmose , Humanos , Teorema de Bayes , Transtornos Mentais/epidemiologia , Transtornos Mentais/complicações , Toxoplasmose/complicações , Toxoplasmose/epidemiologia , Toxoplasmose/parasitologia , Fatores de RiscoRESUMO
INTRODUCTION: Capsulectomy is recommended in patients with cardiac implantable electronic device (CIED) infection after transvenous lead extraction (TLE) but is time-consuming and requires extensive tissue debridement. In this study, we describe the outcomes of chlorhexidine gluconate (CHG) lavage in lieu of capsulectomy for the treatment of CIED infections. METHODS: This retrospective study included patients who underwent TLE for CIED-related infections in two institutions in Colombia. In the capsulectomy group, complete capsulectomy was performed after hardware removal. In the CHG group, exhaustive lavage of the generator pocket with 20 cc of CHG at 2% followed by irrigation with approximately 500 cc of normal saline (0.9% sodium chloride) was performed. The primary outcomes included reinfection and hematoma formation in the generator pocket. Secondary outcomes included the occurrence of any adverse reaction to chlorhexidine, the need for reintervention, infection-related mortality, and total procedural time. RESULTS: A total of 102 patients (mean age 67.2 ± 13 years, 32.4% female) underwent CIED extraction with either total capsulectomy (n = 54) or CHG (n = 48) lavage. Hematoma formation was significantly higher in the capsulectomy group versus the CHG group (13% vs. 0%, p = .014), with no significant differences in the reinfection rate. Capsulectomy was associated with longer procedural time (133.7 ± 78.5 vs. 89.9 ± 51.8 min, p = .002). No adverse reactions to CHG were found. Four patients (4.3%) died from worsening sepsis: three in the capsulectomy group and one in the CHG group (p = .346). CONCLUSIONS: In patients with CIED infections, the use of CHG without capsulectomy resulted in a lower risk of hematoma formation and shorter procedural times without an increased risk of reinfection or adverse events associated with CHG use.
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Cardiopatias , Marca-Passo Artificial , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Masculino , Clorexidina , Marca-Passo Artificial/efeitos adversos , Estudos Retrospectivos , Irrigação Terapêutica , Reinfecção/etiologia , Cardiopatias/etiologiaRESUMO
Toxoplasma gondii, as other apicomplexa, employs adhesins transmembrane proteins for binding and invasion to host cells. Search and characterization of adhesins is pivotal in understanding Apicomplexa invasion mechanisms and targeting new druggable candidates. This work developed a machine learning software called ApiPredictor UniQE V2.0, based on two approaches: support vector machines and multilayer perceptron, to predict adhesins proteins from amino acid sequences. By using ApiPredictor UniQE V2.0, five SAG-Related Sequences (SRSs) were identified within the Toxoplasma gondii proteome. One of those candidates, TgSRS12B, was cloned in plasmid pEXP5-CT/TOPO and expressed in E. coli BL21 DE3. The resulting recombinant protein was purified via affinity chromatography. Co-precipitation assays in CaCo and Muller cells showed interactions between TgSRS12B-His-tagged and the membrane fractions from both human cell lines. In conclusion, we demonstrated that ApiPredictor UniQE V2.0, a bioinformatic free software, was able to identify TgSRS12B as a new adhesin protein.
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Toxoplasma , Escherichia coli/metabolismo , Humanos , Aprendizado de Máquina , Plasmídeos/genética , Proteínas de Protozoários/genética , Proteínas de Protozoários/metabolismo , Toxoplasma/genética , Toxoplasma/metabolismoRESUMO
AIMS: To evaluate the biological activity of extracts from cultures of marine bacteria against Toxoplasma gondii and Mycobacterium tuberculosis. METHODS AND RESULTS: Ethyl acetate extracts obtained from seven marine bacteria were tested against T. gondii GFP-RH and M. tuberculosis H37Rv. The cytotoxicity on HFF-1 cells was measured by a microplate resazurin fluorescent approach, and the haemolytic activity was determined photometrically. The extracts from Bacillus sp. (INV FIR35 and INV FIR48) affected the tachyzoite viability. The extracts from Bacillus, Pseudoalteromonas, Streptomyces and Micromonospora exhibited effects on infection and proliferation processes of parasite. Bacillus sp. INV FIR48 extract showed an minimum inhibitory concentration value of 50 µg ml-1 against M. tuberculosis H37Rv. All the extracts exhibited relatively low toxicity to HFF-1 cells and the primary culture of erythrocytes, except Bacillus sp. INV FIR35, which decreased cell viability under 20%. Liquid chromatography coupled to mass spectrometry analysis of the most active bacterial extract Bacillus sp. INV FIR48 showed the presence of peptide metabolites related to surfactin. CONCLUSIONS: The extract from culture of deep-sea Bacillus sp. INV FIR48 showed anti-T. gondii and anti-tuberculosis (TB) biological activity with low cytotoxicity. In addition, peptide metabolites were detected in the extract. SIGNIFICANCE AND IMPACT OF THE STUDY: Toxoplasmosis and TB are among the most prevalent diseases worldwide, and the current treatment drugs exhibit side effects. This study confirm that marine bacteria are on hand sources of anti-infective natural products.
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Mycobacterium tuberculosis , Toxoplasma , Tuberculose , Humanos , Testes de Sensibilidade Microbiana , Extratos Vegetais/farmacologia , Tuberculose/tratamento farmacológicoRESUMO
La pandemia por COVID-19 ha obligado a los gobiernos de todo el mundo a la toma de decisiones con información preliminar, insuficiente o discutible en argumentos científicos, algo que como académicos debemos entender y acompañar y se convierte en un reto mayor: ¿cómo dar recomendaciones con información limitada y reducir las incertidumbres? Para ello, primero que todo, se debe reconocer que estos procesos están sometidos a cambios según la evolución del conocimiento y la comunicación de la información se vuelve crucial para evitar minar la confianza pública ante los cambios. Es así como muchas recomendaciones para el manejo de COVID 19 han venido evolucionando a medida que se conoce mejor la patogénesis, sus mecanismos de transmisión y las particularidades en la respuesta inmune y, por ejemplo, pasamos de una recomendación inicial de medidas de prevención que incluía limpieza de superficies a una en la cual el énfasis es la limitación en número de personas en reunión. La Asociación Colombiana de infectología junto con otras 27 sociedades científicas lleva tres diferentes actualizaciones de recomendaciones basadas en evidencia en los primeros 12 meses de pandemia, es decir cada tres meses se han venido revisando las más de 250 recomendaciones, lo cual ha significado un trabajo enorme de revisión, discusión y presentación final las cuales, afortunadamente, han sido acogidas y tomadas como base de las decisiones gubernamentales.
The COVID-19 pandemic has forced governments around the world to take decisions on preliminary, insufficient The COVID-19 pandemic has forced governments around the world to make decisions with preliminary, insufficient or debatable information on scientific grounds, something that as academics we must understand and accompany and which becomes a major challenge: how to give recommendations with limited information and reduce uncertainties? To do this, first of all, it must be recognised that these processes are subject to change as knowledge evolves and the communication of information becomes crucial to avoid undermining public confidence in the face of change. Thus, many recommendations for the management of COVID 19 have evolved as the pathogenesis, transmission mechanisms and particularities of the immune response have become better understood and, for example, we have gone from an initial recommendation of measures to be taken in response to COVID 19 to a recommendation of measures to be taken in response to COVID 19, we have moved from an initial recommendation for prevention measures that included surface cleaning to one in which the emphasis is on limiting the number of people at a meeting. The Colombian Association of Infectious Diseases, together with 27 other scientific societies, has scientific societies has three different updates of evidence-based evidence-based recommendations in the first 12 months of a pandemic, i.e. every months of the pandemic, i.e. every three months, the more than 250 recommendations have been This has meant an enormous work of review, discussion and final presentation which, fortunately, have been accepted and taken as a basis for governmental decisions. and taken as a basis for governmental decisions.
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Humanos , Masculino , Feminino , Comunicação , Ciência , Sociedades Científicas , Tomada de Decisões , Pandemias , GovernoRESUMO
Frente al escepticismo de encontrar una vacuna para COVID19, los resultados de los ensayos clínicos de Fase III dieron la sentencia: se lograron vacunas con alto grado de eficacia que llega al 70% a 95%. Al momento de escribir esta editorial, dos de ellas ya tienen autorización para uso de emergencia por el FDA. La OMS realiza un seguimiento cotidiano a los avances de candidatos vacunales, el reporte para el 22 de Diciembre encontraba 57 en fases de evaluación clínica (entre estas 11 en fase III) y 166 en fase preclínica.
In the face of skepticism about finding a vaccine for COVID19 , the results of the Phase III clinical trials were conclusive: vaccines with a high degree of efficacy of 70% to 95% were achieved. At the time of writing this editorial, two of them have already been authorized for emergency use by the FDA. The WHO monitors the progress of vaccine candidates on a daily basis; the report as of December 22nd found 57 in clinical evaluation phases (including 11 in Phase III) and 166 in preclinical phase.
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Humanos , Vacinas , COVID-19 , Ciência , Bioensaio , EficáciaRESUMO
BACKGROUND: Transvenous lead extraction (TLE) is standard of care for the management of patients with cardiac implantable electronic device infection or lead-related complications. Currently, objective data on TLE in Latin America is lacking. OBJECTIVE: To describe the current practice standards in Latin American centers performing TLE. METHODS: An online survey was sent through the mailing list of the Latin American Heart Rhythm Society. Online reminders were sent through the mailing list; duplicate answers were discarded. The survey was available for 1 month, after which no more answers were accepted. RESULTS: A total of 48 answers were received, from 44 different institutions (39.6% from Colombia, 27.1% from Brazil), with most respondents (82%) being electrophysiologists. Twenty-nine institutions (66%) performed <10 lead extractions/year, with 7 (16%) institutions not performing lead extraction. Although most institutions in which lead extraction is performed reported using several tools, mechanical rotating sheaths were cited as the main tool (66%) and only 13% reported the use of laser sheaths. Management of infected leads was performed according to current guidelines. CONCLUSION: This survey is the first attempt to provide information on TLE procedures in Latin America and could provide useful information for future prospective registries. According to our results, the number of centers performing high volume lead extraction in Latin America is smaller than that reported in other continents, with most interventions performed using mechanical tools. Future prospective registries assessing acute and long-term success are needed.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Remoção de Dispositivo , Humanos , América Latina/epidemiologia , Inquéritos e Questionários , Resultado do TratamentoRESUMO
RESUMEN Objetivos: determinar la utilidad de la prueba de avidez en el seguimiento de los pacientes diagnosticados con toxoplasmosis congénita a través de la evaluación de su comportamiento en el tiempo. Metodología: estudio retrospectivo a partir de los datos en historias clínicas de niños que tuvieron confirmación diagnóstica y tratamiento para toxoplasmosis congénita, realizado en consulta de toxoplasmosis, tercer nivel de referencia en el centro de salud de la Universidad del Quindío. Se estudiaron 21 niños que fueron seleccionados de una cohorte inicial de 168 pacientes, reclutados en los programas de tamizaje prenatal y los programas de prevención o niños que acudieron para el diagnóstico neonatal. Resultados: no se encontró relación estadísticamente significativa entre el porcentaje de avidez baja en el primer mes y haber recibido tratamiento prenatal (p = 0,47). Tampoco entre la primera y los niveles de IgG o los meses de vida, a pesar de haber recibido tratamiento posnatal. Sin embargo, al estudiar específicamente el grupo de niños de 5 meses de edad, se encontró una correlación significativa con los niveles de IgG anti-Toxoplasma (p = 0,01). Conclusión: en esta cohorte de niños colombianos con toxoplasmosis congénita se encontraron los mismos resultados reportados en series previas con un mayor número de casos en Italia. La avidez no mostró ser útil para el seguimiento de los niños con toxoplasmosis congénita.
SUMMARY Objectives: To determine the use of avidity testing in the follow up of patients diagnosed with congenital toxoplasmosis, through the observation of its behavior in time. Methods: Retrospective study from clinical records of children with confirmed diagnosis and treatment for congenital toxoplasmosis, which took place on atoxoplasmosis consultation in the third reference level University of Quindío clinic. A total of 21 children were selected among an initial cohort of 168 patients, recruited during prenatal screening, neonatal screening or children that attended for neonatal diagnosis. Results: There was no statistical significance found between low avidity during the first month and having received prenatal treatment (p=0,47). There was no statistical relationship either between the percentage of avidity and the levels of IgG or the months of age, despite having received postnatal treatment. Nevertheless, when studying specifically the group of children > 5 months of age a significant correlation was found with levels of IgG (p=0,01). Conclusion: In this cohort of Colombian children with congenital toxoplasmosis, the same results were found comparing with those reported in series with greater number of cases. Avidity testing did not prove to be useful for the follow up of children with congenital toxoplasmosis.
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Humanos , Recém-Nascido , Toxoplasmose , Diagnóstico Pré-NatalRESUMO
La pandemia de COVID 19, ha puesto de presente la necesidad de contar con políticas de autonomía farmacéutica y biotecnológica para cada país. Esta autonomía es necesaria porque en eventos ocasionados por agentes de riesgo biológico, la afectación masiva de la población mundial hace imposible que se cubran las necesidades para todos los países. Muchos medicamentos de interés en salud pública no son producidos por la industria farmacéutica privada dado que los márgenes de ganancia no son importantes para ellos y se encuentran situaciones de desabastecimiento ante brotes de infecciones inusitados.
The COVID 19 pandemic has highlighted the need for pharmaceutical and biotechnology autonomy policies for each country. This autonomy is necessary because in events caused by biological risk agents, the massive involvement of the world population makes it impossible to cover the needs of all countries. Many drugs of public health interest are not produced by the private pharmaceutical industry because the profit margins are not important for them and there are situations of shortages in the event of outbreaks of unusual infections.
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Humanos , Biotecnologia , Surtos de Doenças , Indústria Farmacêutica , Produtos Biológicos , Biofarmácia , Preparações Farmacêuticas , Saúde Pública/tendências , Necessidades e Demandas de Serviços de SaúdeRESUMO
Esta pandemia ha dejado grandes lecciones sobre la literatura científica y la evaluación crítica del conocimiento. Aunque grandes revistas, egidas del rigor para validar conocimiento, tuvieron errores estrepitosos, la lección final es que la revisión por pares es el mejor sistema, y hasta ahora el único, que puede garantizar que un trabajo de investigación se ha realizado dentro de las exigencias de la ciencia formal y como se escribe habitualmente, es el menos malo de todos los otros sistemas de evaluación del trabajo científico. En medicina esto es crítico por su implicación en vidas humanas, pero nunca se debe esperar que este proceso esté exento de equivocaciones, la revista JAMA al respecto tuvo una editorial con un título muy diciente: "errar es humano y corregirlo es divino"
This pandemic has left us great lessons regarding scientific literature and the critical evaluation of knowledge. Although important journals that are rigorous when validating knowledge, had resounding errors, the ultimate lesson is that peer review is the best system, and until now the only one, that can ensure that a research work has been carried following scientific requirements, and as it is usually stated, it is the least worse scientific work evaluation systems when compared to others35. In medicine, this is critical given the way it affects human lives, but one should never expect this process to be error-free; JAMA journal had an editorial with a very telling title in this regard: "To err is human and to correct it is divine".
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Humanos , Masculino , Feminino , Revisão por Pares , Publicações Periódicas como Assunto , Ciência , Conhecimento , LiteraturaRESUMO
Se formulan recomendaciones de un grupo de consenso de expertos sobre los criterios para evaluar el desempeño diagnóstico (tamaño y selección de muestras para sensibilidad y especificidad analíticas, criterios para establecer límites de detección, criterios para establecer el estándar de oro para las serologías) que deberían ser tenidos en cuenta al evaluar y validar las pruebas diagnósticas para SARS CoV-2. Con el propósito de asegurar la calidad de las pruebas serológicas a utilizar en el país, se recomienda la participación en un programa de control de calidad externo, que garantice la idoneidad y desempeño en la realización de las pruebas diagnósticas serológicas y moleculares durante esta pandemia, ya que su uso tiene profundas implicaciones para las medidas de intervención clínicas individuales y de seguimiento y control en salud pública.
We formulate recommendations from a consensus working group on the criteria to evaluate the diagnostic performance (size and criteria of selection of samples to determine sensitivity, analytical specificity, criteria for limit of detection, criteria for gold standard to evaluate serological assays) that should be taken into account during the evaluation and validation/verification of diagnostic tests for SARS CoV-2 infection. A national external quality control program should be established to guarantee the suitability and performance of these diagnostic serological and molecular tests during this pandemic, that will have deep implications for decisions on clinical and public health.
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Humanos , Masculino , Feminino , Controle de Qualidade , Pandemias , Consenso , Testes Diagnósticos de Rotina , Testes Laboratoriais , Teste para COVID-19 , SARS-CoV-2 , InfecçõesRESUMO
La Organización Mundial de la Salud finalmente declaró al brote por el coronavirus SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) como una pandemia el 11 de marzo de 2020 . Al momento de escribir este editorial (Abril 4 de 2020) el mundo sobrepasó el millón de infectados y el número de muertes registraba cerca de 70 mil, con múltiples países sufriendo más de mil muertes diarias . Las características propias de este coronavirus, a pesar de ser similar a otros, como el SARS y el MERS, hace que existan interrogantes sobre su impacto en países de regiones y condiciones socioeconómicas y culturales diferentes.
The World Health Organization finally declared the SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) outbreak a pandemic on March 11, 2020 . At the time of writing this editorial (April 4, 2020) the world surpassed one million infected and the number of deaths was close to 70,000, with multiple countries suffering more than one thousand deaths per day. The specific characteristics of this coronavirus, despite being similar to others, such as SARS and MERS, raise questions about its impact in countries of different regions and socioeconomic and cultural conditions.