Autosomal dominant polycystic kidney disease in Colombia.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common genetic cause of chronic kidney disease (CKD) that requires dialysis. Knowing geographical clusters can be critical for early diagnosis, progression control, and genetic counseling. The objective was to establish the prevalence, geographic location, and ethnic groups of patients with ADPKD who underwent dialysis or kidney transplant in Colombia between 2015 and 2019. METHODS: We did a cross-sectional study with data from the National Registry of Chronic Kidney Disease (NRCKD) managed by the High-Cost Diseases Fund (Cuenta de Alto Costo [CAC] in Spanish) between July 1, 2015, and June 30, 2019. We included Colombian population with CKD with or without renal replacement therapy (RRT) due to ADPKD. Crude and adjusted prevalence rates were estimated by state and city. RESULTS: 3,339 patients with ADPKD were included, period prevalence was 9.81 per 100,000 population; there were 4.35 cases of RRT per 100,000 population, mean age of 52.58 years (± 13.21), and 52.78% women. Seventy-six patients were Afro-Colombians, six were indigenous, and one Roma people. A total of 46.07% began scheduled dialysis. The highest adjusted prevalence rate was in Valle del Cauca (6.55 cases per 100,000 population), followed by Risaralda, and La Guajira. Regarding cities, Cali had the highest prevalence rate (9.38 cases per 100,000 population), followed by Pasto, Medellin, and Bucaramanga. CONCLUSIONS: ADPKD prevalence is lower compared to Europe and US; some states with higher prevalence could be objective to genetic prevalence study.

Prevention and control of COVID-19 outbreak in a hemodialysis center.

BACKGROUND: The prevention and control of SARS-CoV-2 infection in hemodialysis (HD) units is challenging. AIM: To describe the clinical characteristics and outcome of patients with chronic kidney disease (CKD) on HD with COVID-19, between March 2020 and January 28, 2021, attending a single HD unit in Bogotá, Colombia. MATERIAL AND METHODS: In this prospective observational study, incidence, prevalence, and case-fatality rate were estimated, including screening results with RT-PCR and anti-SARS-CoV-2 IgG and IgM antibodies in all patients and health personnel in the HD unit. RESULTS: Among patients and health workers, 55 and 9 cases of COVID-19 were identified, respectively. The median age of patients was 63 years (84% males). Fifty five percent of patients were symptomatic, with fever, cough and/or myalgia. The most common comorbidities were hypertension, type 2 diabetes mellitus, and coronary heart disease. The cumulative incidence of infection was 30.2%, population seroprevalence was 24.9%, and fatality was 9.1%. CONCLUSIONS: The incidence of SARS-CoV-2 infection in this HD unit was high. Strict biosafety protocols are required to prevent outbreaks.

Early versus delayed erythropoietin for the anaemia of end-stage kidney disease.

BACKGROUND: Anaemia is a common complication in people with chronic kidney disease (CKD) and mainly develops as a consequence of relative erythropoietin (EPO) deficiency. Anaemia develops early in the course of disease and peaks among people with end-stage kidney disease (ESKD). Many types of EPO - also called erythropoiesis-stimulating agents (ESAs) - are used to treat anaemia in people with ESKD.ESAs have changed treatment of severe anaemia among people with CKD by relieving symptoms and avoiding complications associated with blood transfusion. However, no benefits have been found in relation to mortality rates and non-cardiac fatal events, except quality of life. Moreover, a relationship between ESA use and increased cardiovascular morbidity and mortality in patients with CKD has been reported in studies with fully correcting anaemia comparing with partial anaemia correction. Until 2012, guidelines recommended commencing ESA treatment when haemoglobin was less than 11 g/dL; the current recommendation is EPO commencement when haemoglobin is between 9 and 10 g/dL. However, advantages in commencing therapy when haemoglobin levels are greater than 10 g/dL but less than 11 g/dL remain unknown, especially among older people whose life expectancy is limited, but in whom EPO therapy may improve quality of life. OBJECTIVES: To assess the clinical benefits and harms of early versus delayed EPO for anaemia in patients with ESKD undergoing haemodialysis or peritoneal dialysis SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 8 July 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs) and quasi-RCTs evaluating at the clinical benefits and harms of early versus delayed EPO for anaemia in patients with ESKD undergoing haemodialysis or peritoneal dialysis. Studies comparing EPO with another EPO, placebo or no treatment were eligible for inclusion. DATA COLLECTION AND ANALYSIS: It was planned that two authors would independently extract data from included studies and assess risk of bias using the Cochrane risk of bias tool. For dichotomous outcomes (all-cause mortality, cardiovascular mortality, overall myocardial infarction, overall stroke, vascular access thrombosis, adverse effects of treatment, transfusion), we planned to use the risk ratio (RR) with 95% confidence intervals (CI). We planned to calculate the mean difference (MD) and CI 95% for continuous data (haemoglobin level) and the standardised mean difference (SMD) with CI 95% for quality of life if different scales had been used. MAIN RESULTS: Literature searches yielded 1910 records, of these 1534 were screened after duplicates removed, of which 1376 were excluded following title and abstract assessment. We assessed 158 full text records and identified 18 studies (66 records) that were potentially eligible for inclusion. However, none matched our inclusion criteria and were excluded. AUTHORS' CONCLUSIONS: We found no evidence to assess the benefits and harms of early versus delayed EPO for the anaemia of ESKD.

[Mental Health Care of Health Workers During Covid-19: Recommendations Based on Evidence and Expert Consensus]. / Cuidado de la salud mental del personal de salud durante COVID-19: recomendaciones basadas en evidencia y consenso de expertos.

INTRODUCTION: The crisis situation generated by COVID-19 and the measures adopted have generated social changes in the normal dynamics of the general population and especially for health workers, who find themselves caring for patients with suspected or confirmed infection. Recent studies have detected in them depression and anxiety symptoms and burnout syndrome, with personal and social conditions impacting their response capacity during the health emergency. Our aim was to generate recommendations for the promotion and protection of the mental health of health workers and teams in the first line of care in the health emergency due to COVID-19. METHODS: A rapid literature search was carried out in PubMed and Google Scholar, and an iterative expert consensus and through electronic consultation, with 13 participants from the areas of psychology, psychiatry and medicine; the grading of its strength and directionality was carried out according to the international standards of the Joanna Briggs Institute. RESULTS: Thirty-one recommendations were generated on self-care of health workers, community care among health teams, screening for alarm signs in mental health and for health institutions. CONCLUSIONS: The promotion and protection activities in mental health to face the health emergency generated by COVID-19 worldwide can include coordinated actions between workers, health teams and health institutions as part of a comprehensive, community care, co-responsible and sustained over time.

Mental health care of health workers during Covid-19: Recommendations based on evidence and expert consensus.

INTRODUCTION: The crisis situation generated by COVID-19 and the measures adopted have generated social changes in the normal dynamics of the general population and especially for health workers, who find themselves caring for patients with suspected or confirmed infection. Recent studies have detected in them depression and anxiety symptoms and burnout syndrome, with personal and social conditions impacting their response capacity during the health emergency. Our aim was to generate recommendations for the promotion and protection of the mental health of health workers and teams in the first line of care in the health emergency due to COVID-19. METHODS: A rapid literature search was carried out in PubMed and Google Scholar, and an iterative expert consensus and through electronic consultation, with 13 participants from the areas of psychology, psychiatry and medicine; the grading of its strength and directionality was carried out according to the international standards of the Joanna Briggs Institute. RESULTS: Thirty-one recommendations were generated on self-care of health workers, community care among health teams, screening for alarm signs in mental health and for health institutions. CONCLUSIONS: The promotion and protection activities in mental health to face the health emergency generated by COVID-19 worldwide can include coordinated actions between workers, health teams and health institutions as part of a comprehensive, community care, co-responsible and sustained over time.

Uso de técnicas no farmacológicas para favorecer el estado emocional durante la aplicación del método Ponseti en pacientes pediátricos con pie equino varo congénito en Bogotá, Colombia / Non-pharmacological techniques to improve emotional state while using the Ponseti method in pediatric patients with congenital talipes equinovarus in Bogotá, Colombia

Introducción. Durante la aplicación del método Ponseti (MP), el niño puede mostrar incomodidad, tensión muscular o movimientos corporales que hacen del procedimiento una experiencia desagradable y estresante para pacientes, familiares y personal de salud.Objetivos. Describir los desenlaces de la aplicación de técnicas no farmacológicas (TNF) para el favorecer el estado emocional durante la atención estándar de pacientes con pie equino varo congénito (PEVC) tratados con el MP, el nivel de satisfacción del paciente y su familia con la atención recibida y la calidad de la atención en salud, y evaluar los posibles factores asociados al éxito de la aplicación de las TNF. Metodología. Estudio observacional descriptivo realizado en una cohorte de 21 niños atendidos en una clínica Ponseti de Bogotá (Colombia) entre febrero y noviembre de 2021. Las TNF se aplicaron en dos esquemas diferenciados por los sentidos estimulados. Los datos se describen usando medidas de tendencia central y de dispersión (prueba de Shapiro-Wilk), y la asociación exploratoria entre tener éxito en los esquemas de TNF y las variables se determinó con la prueba de chi-cuadrado (p≥0,05).Resultados. La mediana de edad fue 4,5 meses y el primer esquema de TNF fue exitoso en el 66,67% de los pacientes (97 consultas). El nivel de satisfacción de los cuidadores fue alto (86,07%). El equipo sanitario reportó que el procedimiento fue "extremadamente fácil" o "muy fácil" (86,07%-88,52%). Se identificaron como posibles factores asociados explor-atoriamente al éxito del primer esquema de TNF el sexo, antecedente de tratamiento con MP, y nivel de satisfacción del cuidador con la atención recibida.Conclusión. Las TNF mejoran el estado psicoemocional del niño, facilitando la aplicación del MP y aumentando la satisfacción del cuidador y del equipo sanitario con las sesiones de tratamiento

Introduction: Children may show discomfort, muscle tension or body movements while using the Ponseti method (PM), making the procedure an unpleasant and stressful experience for patients, family members, and health care personnel. Objectives: To describe the outcomes achieved following the use of non-pharmacological techniques (NPT) for emotional support when providing standard care to patients with congenital talipes equinovarus (CTEV) treated with the PM, as well as the level of patient and family satisfaction with the care received and the quality of health care, and to evaluate the possible factors associated with the success of the use of NPT.Methodology: Descriptive observational study conducted in a cohort of 21 children treated in a Ponseti clinic in Bogotá (Colombia) between February and November 2021. NPT were implemented in two schemes differentiated by the senses stimulated. Data are described using measures of central tendency and dispersion (Shapiro-Wilk test), and the exploratory association between having success with the NPT schemes and the variables was determined using the chi-square test (p≥0.05). Results: The median age was 4.5 months, and the first NPT scheme was successful in 66.67% of patients (97 consultations). The level of caregiver satisfaction was high (86.07%). The healthcare team reported that the procedure was "extremely easy" or "very easy" (86.07%-88.52%). Possible factors exploratorily associated with the success of the first NPT scheme were identified as gender, history of treatment with the PM, and level of caregiver satisfaction with the care received.Conclusion: NPT improve the psychoemotional state of the child, facilitating PM implementation, and increasing caregiver and healthcare team satisfaction with the treatment sessions

Prevention and control of COVID-19 outbreak in a hemodialysis center / Prevención y control de un brote de COVID-19 en una unidad de hemodiálisis

BACKGROUND: The prevention and control of SARS-CoV-2 infection in hemodialysis (HD) units is challenging. AIM: To describe the clinical characteristics and outcome of patients with chronic kidney disease (CKD) on HD with COVID-19, between March 2020 and January 28, 2021, attending a single HD unit in Bogotá, Colombia. MATERIAL AND METHODS: In this prospective observational study, incidence, prevalence, and case-fatality rate were estimated, including screening results with RT-PCR and anti-SARS-CoV-2 IgG and IgM antibodies in all patients and health personnel in the HD unit. RESULTS: Among patients and health workers, 55 and 9 cases of COVID-19 were identified, respectively. The median age of patients was 63 years (84% males). Fifty five percent of patients were symptomatic, with fever, cough and/or myalgia. The most common comorbidities were hypertension, type 2 diabetes mellitus, and coronary heart disease. The cumulative incidence of infection was 30.2%, population seroprevalence was 24.9%, and fatality was 9.1%. CONCLUSIONS: The incidence of SARS-CoV-2 infection in this HD unit was high. Strict biosafety protocols are required to prevent outbreaks.

INTRODUCCIÓN: La prevención y el control de la infección por SARS-CoV-2 en las unidades de hemodiálisis (HD) es un desafío. OBJETIVO: Describir las características clínicas y la evolución de los pacientes con enfermedad renal crónica (ERC) en HD con COVID-19, entre marzo de 2020 y el 28 de enero de 2021, que acudieron a una unidad de HD en Bogotá, Colombia. MATERIAL Y MÉTODOS: Estudio observacional prospectivo con estimación de incidencia, prevalencia y letalidad, incluyendo los resultados del cribado con RT-PCR y anticuerpos IgG e IgM anti-SARS-CoV-2 en todos los pacientes y personal sanitario de la unidad de HD. RESULTADOS: Se identificaron 55 casos de pacientes en HD y 9 casos de trabajadores de salud con COVID-19. La mediana de edad de los pacientes fue de 63 años y 84% eran hombres. Cincuenta y cinco por ciento de los pacientes eran sintomáticos, con fiebre, tos y/o mialgia. Las comorbilidades más frecuentes fueron hipertensión arterial, diabetes mellitus tipo 2 y enfermedad coronaria. La incidencia acumulada de infección fue del 30,2%, la seroprevalencia poblacional del 24,9% y la letalidad del 9,1%. CONCLUSIONES: La incidencia de infección por SARS-CoV-2 en esta unidad de HD fue alta. Se requieren de protocolos estrictos de bioseguridad para evitar brotes.

Clinical course, biomarkers, management and outcomes of patients hospitalised due to COVID-19 in Colombia / Curso clínico, biomarcadores, manejo y desenlaces de pacientes hospitalizados por COVID-19 en Colombia

Abstract Objective: To analyse the clinic characteristics, risk factors and evolution of the first cohort of hospitalised patients with confirmed infection by COVID-19 in 5 Colombian institutions. Materials and methods: Is a retrospective observational study of consecutive hospitalized patients with a diagnosis of COVID-19 confirmed from March 01 to May 30, 2020 in Colombia. Results: A total of 44 patients were included. The median age was 62 years. 43.2% had a history of smoking, while 69.8% were overweight or obese. 88.6% had at least one comorbidity and 52.3% had three or more comorbidities. Hypertension and dyslipidaemia were the most frequent comorbidities (40.9% and 34.1%, respectively). The 30-day mortality rate was 47.7% with a median of 11 days. The composite outcome occurred in the 36.4%. The biomarkers associated with mor tality risk included troponin higher than 14 ng/L (RR: 5.25; 95% CI 1.37-20.1, p = 0.004) and D-dimer higher than 1000 ng/ml (RR: 3.0; 95% CI 1.4-6.3, p = 0.008). Conclusions: The clinical course of SARS-CoV-2 infection in hospitalized Colombian was characterised by a more advanced stage of the infection.

Resumen Objetivo: Analizar las características, clínicas, factores de riesgo, y la evolución de pacientes hospitalizados con infección confirmada por COVID-19 en 5 Institu ciones de Colombia. Material y método: Es un estudio observacional retrospectivo de pacientes consecutivos hospitalizados con diagnóstico de COVID-19 confirmado entre 01 de Febrero de 2020 y 30 de Mayo de 2020 en Colombia. Resultados: Un total de 44 pacientes fueron incluidos. La mediana de edad fue de 62 años y la mayoría del sexo masculino. El 43.2% tenían historia de tabaquismo, mientras que el 69.8% tenían sobrepeso u obesidad. El 88.6% tenían al menos una comorbilidad y el 52.3% tenían tres o más comorbilidades. La hipertensión arterial fue la comorbilidad más frecuente (40.9%), seguido de la dislipidemia (34.1%). La tasa de letalidad a 30 días fue de 47.7% y ocurrió con una mediana de 11 días. El 36.4% presentó el desenlace compuesto. Los biomarcadores asociados con el riesgo de muerte fue troponina > 14 ng/mL (RR:5.25, IC95% 1.37-20.1, p=0.004) y dímero D mayor a 1000 mg/dL (RR: 3.0, IC95% 1.4-6.3, p=0.008). Conclusiones: El curso clínico de la infección por SARS-CoV-2 en colombianos hospitalizados fue un estadio más avanzado de la infección.

Toxicodermia as an adverse event in a covid-19 patient: case report

ABSTRACT: Introduction: SARS-COV2 infection, which was initially associated with respiratory manifestations only, can also cause gastrointestinal, kidney, neurological and cardiovascular symptoms according to some reports. Case presentation: A 36-year-old female patient attended the emergency department due to dyspnea, asthenia, adynamia, mild odynophagia. and headache. The patient's medical history included obesity, smoking, and working as a health care worker. Considering the symptoms, antimalarial and antiretroviral treatment was indicated to treat COVID-19, a diagnosis that was confirmed three days after admission. However, on the fourth day of treatment, the patient presented with polydipsia and macular, pruritic, and generalized rash. Due to suspicion of toxicoderma, the treatment was suspended, and the skin condition improved. After 8 days of hospitalization, the patient was discharged with biosecurity recommendations and mandatory isolation for 28 days. Conclusion: The described case is a report of toxicoderma in a patient with COVID-19 under treatment with antiretroviral and antimalarial drugs. Based on the findings, a thorough examination of skin and mucosa of patients with suspected or confirmed COVID-19 will undoubtedly contribute to the correct characterization of this new disease.

RESUMEN Introducción. La infección por SARS-COV2, que en principio se pensó solo causaba manifestaciones respiratorias, también puede ocasionar síntomas gastrointestinales, renales, neurológicos, cardiovasculares e incluso cutáneos según algunos reportes. Presentación del caso. Paciente femenina de 36 años quien asistió al servicio de urgencias por cuadró clínico consistente en disnea, astenia, adinamia, odinofagia leve y cefalea. Como antecedentes de relevancia se registró obesidad, tabaquismo y ocupación como trabajadora de la salud. Dados los síntomas, se indicó tratamiento antimalárico y antirretroviral para tratar COVID-19, diagnóstico que fue confirmado a los tres días de ingreso, pero al cuarto día de instaurado este manejo la mujer presentó polidipsia y rash macular, pruriginoso y generalizado. Por sospecha de toxicodermia, el tratamiento fue suspendido y con esto el cuadro cutáneo mejoró. Luego de 8 días de hospitalización, la paciente recibió el alta, junto con recomendaciones de bioseguridad y confinamiento durante 28 días. Conclusiones. El caso descrito corresponde a un evento de toxicodermia en una paciente con COVID-19 en manejo con antirretroviral y antimalárico. A partir de los hallazgos, se establece que la exploración minuciosa de piel y mucosas en los pacientes con sospecha o diagnóstico confirmado de COVID-19 puede ser de gran ayuda para la correcta caracterización de esta nueva enfermedad.

Cuidado de la salud mental del personal de salud durante COVID-19: recomendaciones basadas en evidencia y consenso de expertos / Mental Health Care of Health Workers During Covid-19: Recommendations Based on Evidence and Expert Consensus

RESUMEN Introducción: La situación de crisis generada por la COVID-19 y las medidas adoptadas han generado cambios sociales en las dinámicas normales de la población general y en especial para los trabajadores de la salud, que se encuentran en atención del paciente con infección sospechada o confirmada. Estudios recientes han detectado en ellos síntomas depresivos y ansiosos y síndrome de burnout, afecciones personales y sociales que alteran su capacidad de respuesta durante la emergencia sanitaria. El objetivo es generar recomendaciones de promoción y protección de la salud mental de los trabajadores y equipos de salud dispuestos como primera línea de atención en la emergencia sanitaria por COVID-19. Métodos: Se realizó una búsqueda rápida de literatura en PubMed y Google Scholar, y un consenso de expertos iterativo y mediante consulta electrónica, con 13 participantes de las áreas de psicología, psiquiatría y medicina; la gradación de su fuerza y direccionalidad se realizó según las normas internacionales del Joanna Briggs Institute. Resultados: Se generaron 31 recomendaciones sobre el autocuidado del trabajador de la salud, el cuidado comunitario entre los equipos de salud, el cribado de signos de alarma en salud mental y para las instituciones sanitarias. Conclusiones: Las actividades de promoción y protección en salud mental para el afrontamiento de la emergencia sanitaria generada por la COVID-19 en todo el mundo pueden abarcar acciones articuladas entre el trabajador, los equipos de salud y las instituciones sanitarias como parte de un cuidado integral, comunitario, corresponsable y sostenidas en el tiempo.

ABSTRACT Introduction: The crisis situation generated by COVID-19 and the measures adopted have generated social changes in the normal dynamics of the general population and especially for health workers, who find themselves caring for patients with suspected or confirmed infection. Recent studies have detected in them depression and anxiety symptoms and burnout syndrome, with personal and social conditions impacting their response capacity during the health emergency. Our aim was to generate recommendations for the promotion and protection of the mental health of health workers and teams in the first line of care in the health emergency due to COVID-19. Methods: A rapid literature search was carried out in PubMed and Google Scholar, and an iterative expert consensus and through electronic consultation, with 13 participants from the areas of psychology, psychiatry and medicine; the grading of its strength and directionality was carried out according to the international standards of the Joanna Briggs Institute. Results:Thirty-one recommendations were generated on self-care of health workers, community care among health teams, screening for alarm signs in mental health and for health institutions. Conclusions: The promotion and protection activities in mental health to face the health emergency generated by COVID-19 worldwide can include coordinated actions between workers, health teams and health institutions as part of a comprehensive, community care, co-responsible and sustained over time.

Eficacia y seguridad del rituximab en el tratamiento de la esclerosis múltiple: una postura racional en el contexto colombiano / Efficacy and safety of rituximab in the treatment of multiple sclerosis: a rational position in the Colombian context

RESUMEN INTRODUCCIÓN: La esclerosis múltiple es una enfermedad neuroinflamatoria, crónica, degenerativa e incurable, asociada a pérdida neuronal, grados crecientes de discapacidad y deterioro cognoscitivo. Su manejo conlleva grandes costos para los sistemas de salud y la sociedad en general. OBJETIVO: Evaluar la eficacia y la seguridad del uso del rituximab en el manejo de la esclerosis múltiple. MATERIALES Y MÉTODOS: Revisión de la literatura y evaluación de la tecnología en salud tipo mini-HTA en red colaborativa con el Comité de Esclerosis Múltiple de la Asociación Colombiana de Neurología y el Instituto Global de Excelencia Clínica. RESULTADOS: Se identificaron 27 referencias de texto completo para el análisis de la seguridad y la eficacia del rituximab en el manejo de la esclerosis múltiple. Se utilizaron análisis de costos, indicadores epidemiológicos y estudios pivótales de rituximab. CONCLUSIÓN: La evidencia analizada confirma que la terapia con rituximab es efectiva y segura en el manejo de las formas de esclerosis múltiple remitente-recurrente (EMRR) y esclerosis múltiple primaria-progresiva (EMPP), con menor tasa de eventos adversos y tasas de interrupción o abandono del tratamiento más bajas que otras terapias modificadoras de la enfermedad (TME).

SUMMARY INTRODUCTION: Multiple sclerosis is a neuroinflammatory, chronic, degenerative, and incurable disease, associated with neuronal loss, increasing degrees of disability, and cognitive control. Its treatment causes great costs for health systems and society in general. OBJECTIVE: To evaluate the efficacy and safety of the use of rituximab in the management of multiple sclerosis. MATERIALS AND METHODS: Literature review and evaluation of mini-HTA type health technology in a collaborative network with the Multiple Sclerosis Committee of the Colombian Association of Neurology and the Global Institute of Clinical Excellence. RESULTS: 27 full-text references were identified for the safety and efficacy analysis of rituximab in the management of multiple sclerosis. Cost analysis, epidemiological indicators, and pivotal studies of rituximab were incorporated into the analysis. CONCLUSION: The evidence analyzed confirms that rituximab therapy is effective and safe in the management of the forms of Recurrent-Remittent Multiple Sclerosis (RRMS) and Primary-Progressive Multiple Sclerosis (PPMS), with a lower rate of adverse events and discontinuation or withdrawal rates of treatment lower than other disease-modifying therapies.

Consenso Colombiano para la prevención, diagnóstico y manejo de condiciones trombóticas en pacientes adultos con COVID-19: aplicando el Marco de la Evidencia a la Decisión (EtD) GRADE / Colombian consensus for the prevention, diagnosis and treatment of thrombotic conditions in adult patients with COVID-19: applying GRADE Evidence to Decision (EtD) Frameworks

resumen está disponible en el texto completo

Abstract Recent studies have reported the occurrence of thrombotic phenomena or coagulopathy in patients with COVID-19. There are divergent positions regarding the prevention, diagnosis, and treatment of these phenomena, and current clinical practice is based solely on deductions by extension from retrospective studies, case series, observational studies, and international guidelines developed prior to the pandemic. In this context, the aim was to generate a group of recommendations on the prevention, diagnosis and management of thrombotic complications associated with COVID-19. Methods: A rapid guidance was carried out applying the GRADE Evidence to Decision (EtD) frameworks and an iterative participation system, with statistical and qualitative analysis. Results: 31 clinical recommendations were generated focused on: a) Coagulation tests in symptomatic adults with suspected infection or confirmed SARS CoV-2 infection; b) Thromboprophylaxis in adults diagnosed with COVID-19 (Risk scales, thromboprophylaxis for outpatient, in-hospital management, and duration of thromboprophylaxis after discharge from hospitalization), c) Diagnosis and treatment of thrombotic complications, and d) Management of people with previous indication of anticoagulant agents. Conclusions: Recommendations of this consensus guide clinical decision-making regarding the prevention, diagnosis, and treatment of thrombotic phenomena in patients with COVID-19, and represent an agreement that will help decrease the dispersion in clinical practices according to the challenge imposed by the pandemic.

Eficacia y seguridad de la cloroquina, la hidroxicloroquina y la azitromicina en pacientes con COVID-19. Resumen de evidencia / Efficacy and safety of chloroquine, hydroxychloroquine and azithromycin in patients with COVID-19: Summary of evidence

Resumen Introducción: hasta el momento, no se ha demostrado la efectividad de ningún tratamiento para afrontar la emergencia sanitaria por COVID-19. Objetivo: presentar la evidencia disponible respecto a la eficacia y seguridad del uso de cloroquina, hidroxicloroquina y azitromicina en la profilaxis y el manejo de pacientes con COVID-19. Materiales y métodos: se realizó una revisión de la literatura en las bases de datos MEDLINE, Scopus y PubMed sobre publica- ciones que registraran el uso de cloroquina, hidroxicloroquina y azitromicina en pacientes con COVID-19. Resultados: se seleccionaron 12 publicaciones que incluyeron revisiones rápidas de literatura, estudios observacionales y ensayos clínicos. No se encontró información sobre la profilaxis con cloroquina, hidroxicloroquina ni azitromicina para SARS-CoV-2. Los eventos adversos reportados incluyeron emesis, dolor abdominal, náuseas, diarrea, erupción cutánea y picazón. Conclusiones: según la evidencia recopilada el uso de hidroxicloroquina o de cloroquina sola o en combinación con azitromicina en pacientes con COVID-19 no ha mostrado beneficio. Además, cada uno de estos esquemas de tratamiento se asocia con un mayor riesgo de muerte y de episodios de arritmias. En síntesis, la efectividad de estos medicamentos sigue sin estar esclarecida, por lo cual se sugiere evitar su uso en el tratamiento de personas con infección por SARS-CoV-2/COVID-19.

Abstract Introduction: The COVID-19 disease is a health emergency; treatment has not yet been proven. Objective: To present the available evidence of efficacy and safety of the use of hydroxychloroquine and azithromycin in the prophylaxis and management of patients with COVID-19. Methods: A rapid literature review was performed; we consulted Medline, scopus and pubmed databases. Results: Eleven publications were included including rapid literature reviews, observational studies, and clinical trials. No data were found studying prophylaxis with hydroxychloroquine and azithromycin for SARS-CoV-2. Reports of adverse events include episodes of emesis, abdominal pain, nausea, diarrhea, rash, and itching. Conclusions: The evidence collected suggests that the use of hydroxychloroquine and azithromycin in patients with COVID-19, could abnormal electrocardiogram and increased risk of mortality in-hospital. The effectiveness remains unclear.

Consenso colombiano para la prevención, el diagnóstico y el tratamiento de condiciones trombóticas en adultos con COVID-19: aplicando el Marco de la Evidencia a la Decisión (EtD) GRADE / Colombian consensus for the prevention, diagnosis and treatment of thrombotic conditions in adults with COVID-19: applying GRADE Evidence to Decision (EtD) Frameworks

Introducción estudios recientes han reportado fenómenos trombóticos o coagulopatía en pacientes con COVID-19. Hay posiciones divergentes en cuanto a la prevención, el diagnóstico y el tratamiento de estos fenómenos, y la práctica clínica actual está basada únicamente en deducciones por extensión a partir de estudios retrospectivos, series de casos, estudios observacionales y guías internacionales desarrolladas previas a la pandemia. Objetivo establecer una serie de recomendaciones sobre prevención, diagnóstico y manejo de las complicaciones trombóticas asociadas a COVID-19. Métodos se desarrolló una guía rápida en la que se aplicó el marco de la evidencia a la decisión (EtD) de GRADE y un sistema de participación iterativo, con análisis estadísticos y cualitativos de sus resultados. Resultados se generaron 31 recomendaciones clínicas enfocadas a: a) Pruebas de coagulación en adultos sintomáticos con sospecha de infección o infección confirmada por SARS-CoV-2; b) Tromboprofilaxis en personas adultas con diagnóstico de COVID-19 (escalas de riesgo, tromboprofilaxis de manejo ambulatorio, intrahospitalario y duración de tromboprofilaxis después del egreso de hospitalización), c) Diagnóstico y tratamiento de las complicaciones trombóticas y d) Manejo de personas con indicación previa a usar agentes anticoagulantes. Conclusiones las recomendaciones clínicas de este consenso orientan la toma de decisiones clínicas respecto a prevención, diagnóstico y tratamiento de fenómenos trombóticos en pacientes con COVID-19, y representan un acuerdo que ayudará a disminuir la dispersión en las prácticas clínicas acorde con el desafío que impone la pandemia.

Abstract Introduction: recent studies have reported the occurrence of thrombotic phenomena or coagulopathy in patients with COVID-19. There are divergent positions regarding the prevention, diagnosis, and treatment of these phenomena, and current clinical practice is based solely on deductions by extension from retrospective studies, case series, observational studies, and international guidelines developed prior to the pandemic. Objective: to generate a group of recommendations on the prevention, diagnosis and management of thrombotic complications associated with COVID-19. Methods: a rapid guidance was carried out applying the GRADE Evidence to Decision (EtD) frameworks and an iterative participation system, with statistical and qualitative analysis. Results: 31 clinical recommendations were generated focused on: a) Coagulation tests in symptomatic adults with suspected infection or confirmed SARS CoV-2 infection; b) Thromboprophylaxis in adults diagnosed with COVID-19 (Risk scales, thromboprophylaxis for outpatient, in-hospital management, and duration of thromboprophylaxis after discharge from hospitalization), c) Diagnosis and treatment of thrombotic complications, and d) Management of people with previous indication of anticoagulant agents. Conclusions: recommendations of this consensus guide clinical decision-making regarding the prevention, diagnosis, and treatment of thrombotic phenomena in patients with COVID-19, and represent an agreement that will help decrease the dispersion in clinical practices according to the challenge imposed by the pandemic.

Uso de resúmenes de evidencia para informar el tratamiento farmacológico de personas con sospecha o diagnóstico de infección respiratoria por SARS-CoV-2/COVID-19 / Use of evidence summaries to inform pharmacological treatment of people with suspected or diagnosedSARS-CoV-2/COVID-19 respiratory infection

Resumen Introducción: debido a la emergencia del coronavirus SARS-CoV-2 desde diciembre del 2019, se ha generado un gran volumen de producción científica, en algún caso incierta o controvertida especialmente en el manejo farmacológico de los pacientes con esta infección; por lo tanto, se considera relevante buscar alternativas metodológicas para realizar su síntesis rigurosa, sistemática y de calidad, pero con menor tiempo de ejecución y menor costo. Objetivo: presentar la evidencia disponible respecto al manejo farmacológico de personas con sospecha o diagnóstico de infección respiratoria por SARS-CoV-2 (COVID-19) utilizando el método de revisiones sistemáticas rápidas (RS-R) en medicamentos poten- cialmente eficaces para su manejo. Metodología: se realizó una búsqueda sistemática y estructurada en Medline, Embase, Scopus, Cochrane Library, Clinical trials y Google Scholar en inglés. Los estudios incluidos fueron guías de práctica clínica, consensos, revisiones sistemáticas, metaanálisis, ensayos clínicos y otros estudios primarios. La búsqueda y extracción de datos se realizó por múltiples revisores, pero ninguna fue pareada. Resultados: dieciseis preguntas de interés clínico fueron resueltas, relacionadas con el uso en COVID-19 de lopinavir/ ritonavir, nelfinavir, oseltamivir, remdesivir, ribavirina, teicoplanina, umifenovir, favipiravir, tocilizumab, ivermectina y plasma convaleciente; también se evaluó el uso de medicamentos de soporte e incluidos en el manejo como la dexametasona, así como el uso concomitante de medicamentos que generaron dudas como son los AINES, los IECA y los ARA II. Conclusiones: los resúmenes de evidencia se muestran dentro del escenario de la pandemia como una buena alternativa metodológica para ofrecer información de calidad a corto plazo para los tomadores de decisiones.

Abstract Introduction: Due to the emergence of the SARS-CoV-2 coronavirus since December 2019, a large volume of scientific production has been generated, in some cases uncertain or controversial, especially in the pharmacological management of patients with this infection; therefore, it is considered a relevant search for methodological alternatives to carry out its rigorous, systematic and quality synthesis, but with less execution time and lower cost. Objective: To present the available evidence regarding the pharmacological management of people with suspected or diagnosed respiratory SARS-CoV-2 (COVID-19) using the method of rapid systematic reviews (RS-R) in potentially effective drugs for their management. Methodology: A systematic and structured search was conducted in Medline, Embase, Scopus, Cochrane Library, Clinical trials and Google Scholar in English. Studies included clinical practice guidelines, consensus, systematic reviews, meta-analyses, clinical trials, and other primary studies. Data search and extraction were performed by multiple reviewers, but none were paired. Results: Sixteen questions of clinical interest were resolved, related to the use in COVID-19 of lopinavir/ritonavir, nelfinavir, oseltamivir, remdesivir, ribavirin, teicoplanin, umifenovir, favipiravir, tocilizumab, ivermectin, convalescent plasma; the use of support management drugs such as dexamethasone were also evaluated, as well as the concomitant use of drugs that generated doubts, such as NSAIDs, ACEis, and ARA IIs. Conclusions: Summaries of evidence are within the pandemic scenario as a good methodological alternative to offer quality information in the short term for decision-makers.

Consenso colombiano de expertos sobre recomendaciones informadas en la evidencia para la prevención, el diagnóstico y el manejo de la infección por SARS-CoV-2/COVID-19 en pacientes con Enfermedad Renal Crónica en diálisis / Colombian Expert Consensus on Evidence-Informed Recommendations for the Prevention, Diagnosis, and Management of SARS-CoV-2 / COVID-19 Infection in Patients with Chronic Kidney Disease on Dialysis

Resumen Introducción: Las personas con diálisis de mantenimiento se consideran una población en alto riesgo de infección por SARS-CoV-2, complicaciones y muerte. La periodicidad de la diálisis, la organización y la demanda en las unidades de diálisis y las limitaciones de alfabetización en salud poblacional limitan el cumplimiento del aislamiento y el distanciamiento social. Objetivo: Desarrollar, mediante un consenso de expertos, recomendaciones informadas en evidencia para la prevención, el diagnóstico y el manejo de la infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Materiales y métodos: Se realizó una revisión rápida de literatura en Pubmed, Embase y sociedades científicas. La calidad de evidencia fue evaluada según el tipo de estudio incluido. El acuerdo se definió para cada recomendación con umbral de al menos 70% de aprobación. La fuerza de las recomendaciones fue graduada como fuerte o débil. Resultados: El colectivo fue consultado entre el 17 y 19 de mayo de 2020. Se obtuvo respuesta de 44 expertos clínicos que declararon conflicto de interés previo a la consulta. El acuerdo de las recomendaciones estuvo entre 70,5 y 100%. Se presentan las recomendaciones de un colectivo experto para la prevención, el diagnóstico y el manejo de infección por SARS-CoV-2/COVID-19 en pacientes con enfermedad renal crónica. Conclusión: Debido a la reciente aparición de la infección por SARS-CoV-2 y las incertidumbres respecto a la prevención, el diagnóstico y el manejo, las recomendaciones presentadas se conciben como un estándar colombiano que permita garantizar un cuidado centrado en las personas con enfermedad renal crónica y la protección de los profesionales de la salud.

Abstract Introduction: People with chronic dialysis are considered a population at high risk of SARS CoV2 infection and its derived complications and death. The need to go to strict dialysis schedules, the high demand in the kidney facilities and the difficulties derived from the time and space organization in the rooms in the face to the pandemic added to the difficult learning, teaching and adapting new protocols manifest the needed of standard recommendation according to this problem in people who couldn't have an ideal isolation. Objective: Develop through an expert consensus, evidence-informed recommendations for the prevention, diagnosis, and management of SARS-CoV-2/COVID-19 infection in patients with chronic kidney disease on Dialysis. Materials and methods: We carried out a quick literature review, PubMed, Embase and scientific societies were consulted. The quality of the evidence was considered according to the type of study included. The agreement threshold defined for each recommendation was > 70% approval among experts. The strength of the recommendations was rated as strong or weak. Results: Between May 17 and 19, 2020, was conformed a team of 44 clinical experts who declared their interest conflict prior to the consultation. The agreement of the recommendations was between 70.5% and 100%. The recommendations were separated in prevention, early identification, and diagnostic, isolation in hemodialysis facilities and peritoneal dialysis, and team protection. Ethical considerations also were included. Conclusion: Due to the recent appearance of SARS-CoV-2 infection and the uncertainties regarding prevention, diagnosis and management, the recommendations presented are conceived as a Colombian standard that allows guaranteeing focused care for people with chronic kidney disease and the protection of health team.

Hallazgos histológicos en biopsia por protocolo asociados con reducción en función renal 12 meses postrasplante, en receptores de trasplante renal con bajo riesgo inmunológico, recibiendo inducción con basiliximab / Histological findings in protocol biopsy associated with reduction in renal function 12 months post transplant in renal transplant recipients with low immunological risk

Resumen Introducción: identificar los factores asociados con pérdida de la función del injerto puede ser un paso importante hacia la prolongación de la sobrevida del injerto renal. Objetivo: determinar la asociación entre los cambios histológicos presentes en las biopsias por protocolo, en el primer año postrasplante en receptores de bajo riesgo inmunológico, recibiendo inducción con basiliximab y pérdida en la función del injerto 12 meses postrasplante. Métodos: se incluyeron pacientes receptores de riñones de donante cadavérico (95 %) o donante vivo (5 %) trasplantados entre agosto de 2007 y julio de 2012. El desenlace primario fue pérdida en la tasa de filtración glomerular calculada (Cockroft & Gault) mayor a 5ml/min 12 meses postrasplante, en comparación con la función renal previa a la biopsia por protocolo. Resultados: la cohorte de estudio estuvo conformada por 114 pacientes, de los cuales 25 presentaron el desenlace principal. Los hallazgos asociados con pérdida de función fueron glomerulitis (p=0,024), inflamación intersticial (p=0,001), tubulitis (p=0,001), capilaritis (p=0,001), glomerulitis + capilaritis (p=0,001), nefropatía por polioma virus (p=0,04) y la presencia de rechazo subclínico (p=0,015). Por análisis de regresión logística la presencia de inflamación intersticial (OR = 2,11; IC 95 %: 1,13-3,95) y capilaritis (0R=7,12; IC 95 %:1,57-32,27) fueron las variables asociadas con pérdida de función del injerto renal 12 meses postrasplante renal. Conclusión: la inflamación intersticial y capilaritis son variables histológicas asociadas con pérdida de función del injerto renal, 12 meses postrasplante, independiente de otras variables.

Abstract Introduction: Identifying factors that are associated of allograft function loss might be an important step toward prolonging kidney allograft survival. Purpose: In this study we found to determine the association between histologic changes on 1-year surveillance biopsies and changes in graft function. Methods: Recipients of kidneys from deceased donors (95%) or living donors (5%) trasplanted between 2007 and 2012. The primary end point was reduction in calculated glomerular filtration rate (Cockroft anf Gault) higher 5ml/min 12 months post transplant vs calculated glomerular filtration rate previous surveillance biopsie. Results: This analysis included 114 adults, recipients of kidneys with low immunological risk receiving basiliximab induction from deceased donors (95%) or living donors (5%), transplanted between august 2007 and july 2012. The primary end point was reduction in calculated glomerular filtration rate (Cockroft & Gault) higher 5ml/min 12 months post trasplant. 25 of 114 patientes showing reduction; The histologic changes associated with renal function reduction were glomerulitis (p=0,024), interstitial inflamation (p=0,001), tubulitis (p=0,001), capilaritis (p=0,001), glomerulitis + capilaritis (p=0,001), polyoma virus nephropathy (p=0,04) and subclinical rejection (p=0,015). By regression analyses, interstitial inflamation (OR = 2,11; IC 95%: 1,13-3,95) and capilaritis (0R=7,12; IC 95%: 1,57-32,27) were associated with renal function reduction 12 month post-transplant. Conclusion: inflammation and capilaritis in protocol biopsies in first year post-transplant predict loss of graft function and independently of other variables.