A differential therapeutic consideration for use of corticosteroids according to established COVID-19 clinical phenotypes in critically ill patients / Una consideración terapéutica diferencial para el uso de corticoesteroides en COVID-19 según los diferentes fenotipos clínicos establecidos en pacientes críticos

bjective To determine if the use of corticosteroids was associated with Intensive Care Unit (ICU) mortality among whole population and pre-specified clinical phenotypes. Design A secondary analysis derived from multicenter, observational study. Setting Critical Care Units. Patients Adult critically ill patients with confirmed COVID-19 disease admitted to 63 ICUs in Spain. Interventions Corticosteroids vs. no corticosteroids. Main variables of interest Three phenotypes were derived by non-supervised clustering analysis from whole population and classified as (A: severe, B: critical and C: life-threatening). We performed a multivariate analysis after propensity optimal full matching (PS) for whole population and weighted Cox regression (HR) and Fine-Gray analysis (sHR) to assess the impact of corticosteroids on ICU mortality according to the whole population and distinctive patient clinical phenotypes. Results A total of 2017 patients were analyzed, 1171 (58%) with corticosteroids. After PS, corticosteroids were shown not to be associated with ICU mortality (OR: 1.0; 95% CI: 0.98–1.15). Corticosteroids were administered in 298/537 (55.5%) patients of “A” phenotype and their use was not associated with ICU mortality (HR=0.85 [0.55–1.33]). A total of 338/623 (54.2%) patients in “B” phenotype received corticosteroids. No effect of corticosteroids on ICU mortality was observed when HR was performed (0.72 [0.49–1.05]). Finally, 535/857 (62.4%) patients in “C” phenotype received corticosteroids. In this phenotype HR (0.75 [0.58–0.98]) and sHR (0.79 [0.63–0.98]) suggest a protective effect of corticosteroids on ICU mortality. Conclusion Our finding warns against the widespread use of corticosteroids in all critically ill patients with COVID-19 at moderate dose. Only patients with the highest inflammatory levels could benefit from steroid treatment (AU)

Objetivo Evaluar si el uso de corticoesteroides (CC) se asocia con la mortalidad en la unidad de cuidados intensivos (UCI) en la población global y dentro de los fenotipos clínicos predeterminados. Diseño Análisis secundario de estudio multicéntrico observacional. Ámbito UCI. Pacientes Pacientes adultos con COVID-19 confirmado ingresados en 63 UCI de España. Intervención Corticoides vs. no corticoides. Variables de interés principales A partir del análisis no supervisado de grupos, 3 fenotipos clínicos fueron derivados y clasificados como: A grave, B crítico y C potencialmente mortal. Se efectuó un análisis multivariado después de un propensity optimal full matching (PS) y una regresión ponderada de Cox (HR) y análisis de Fine-Gray (sHR) para evaluar el impacto del tratamiento con CC sobre la mortalidad en la población general y en cada fenotipo clínico. Resultados Un total de 2.017 pacientes fueron analizados, 1.171 (58%) con CC. Después del PS, el uso de CC no se relacionó significativamente con la mortalidad en UCI (OR: 1,0; IC 95%: 0,98-1,15). Los CC fueron administrados en 298/537 (55,5%) pacientes del fenotipo A y no se observó asociación significativa con la mortalidad (HR=0,85; 0,55-1,33). Un total de 338/623 (54,2%) pacientes del fenotipo B recibieron CC sin efecto significativo sobre la mortalidad (HR=0,72; 0,49-1,05). Por último, 535/857 (62,4%) pacientes del fenotipo C recibieron CC. En este fenotipo, se evidenció un efecto protector de los CC sobre la mortalidad HR (0,75; 0,58-0,98). Conclusión Nuestros hallazgos alertan sobre el uso indiscriminado de CC a dosis moderadas en todos los pacientes críticos con COVID-19. Solamente pacientes con elevado estado de inflamación podrían beneficiarse con el tratamiento con CC (AU)

A differential therapeutic consideration for use of corticosteroids according to established COVID-19 clinical phenotypes in critically ill patients.

Objective: To determine if the use of corticosteroids was associated with Intensive Care Unit (ICU) mortality among whole population and pre-specified clinical phenotypes. Design: A secondary analysis derived from multicenter, observational study. Setting: Critical Care Units. Patients: Adult critically ill patients with confirmed COVID-19 disease admitted to 63 ICUs in Spain. Interventions: Corticosteroids vs. no corticosteroids. Main variables of interest: Three phenotypes were derived by non-supervised clustering analysis from whole population and classified as (A: severe, B: critical and C: life-threatening). We performed a multivariate analysis after propensity optimal full matching (PS) for whole population and weighted Cox regression (HR) and Fine-Gray analysis (sHR) to assess the impact of corticosteroids on ICU mortality according to the whole population and distinctive patient clinical phenotypes. Results: A total of 2017 patients were analyzed, 1171 (58%) with corticosteroids. After PS, corticosteroids were shown not to be associated with ICU mortality (OR: 1.0; 95% CI: 0.98-1.15). Corticosteroids were administered in 298/537 (55.5%) patients of "A" phenotype and their use was not associated with ICU mortality (HR = 0.85 [0.55-1.33]). A total of 338/623 (54.2%) patients in "B" phenotype received corticosteroids. No effect of corticosteroids on ICU mortality was observed when HR was performed (0.72 [0.49-1.05]). Finally, 535/857 (62.4%) patients in "C" phenotype received corticosteroids. In this phenotype HR (0.75 [0.58-0.98]) and sHR (0.79 [0.63-0.98]) suggest a protective effect of corticosteroids on ICU mortality. Conclusion: Our finding warns against the widespread use of corticosteroids in all critically ill patients with COVID-19 at moderate dose. Only patients with the highest inflammatory levels could benefit from steroid treatment.

Objetivo: Evaluar si el uso de corticoesteroides (CC) se asocia con la mortalidad en la unidad de cuidados intensivos (UCI) en la población global y dentro de los fenotipos clínicos predeterminados. Diseño: Análisis secundario de estudio multicéntrico observacional. Ámbito: UCI. Pacientes: Pacientes adultos con COVID-19 confirmado ingresados en 63 UCI de España. Intervención: Corticoides vs. no corticoides. Variables de interés principales: A partir del análisis no supervisado de grupos, 3 fenotipos clínicos fueron derivados y clasificados como: A grave, B crítico y C potencialmente mortal. Se efectuó un análisis multivariado después de un propensity optimal full matching (PS) y una regresión ponderada de Cox (HR) y análisis de Fine-Gray (sHR) para evaluar el impacto del tratamiento con CC sobre la mortalidad en la población general y en cada fenotipo clínico. Resultados: Un total de 2.017 pacientes fueron analizados, 1.171 (58%) con CC. Después del PS, el uso de CC no se relacionó significativamente con la mortalidad en UCI (OR: 1,0; IC 95%: 0,98-1,15). Los CC fueron administrados en 298/537 (55,5%) pacientes del fenotipo A y no se observó asociación significativa con la mortalidad (HR = 0,85; 0,55-1,33). Un total de 338/623 (54,2%) pacientes del fenotipo B recibieron CC sin efecto significativo sobre la mortalidad (HR = 0,72; 0,49-1,05). Por último, 535/857 (62,4%) pacientes del fenotipo C recibieron CC. En este fenotipo, se evidenció un efecto protector de los CC sobre la mortalidad HR (0,75; 0,58-0,98). Conclusión: Nuestros hallazgos alertan sobre el uso indiscriminado de CC a dosis moderadas en todos los pacientes críticos con COVID-19. Solamente pacientes con elevado estado de inflamación podrían beneficiarse con el tratamiento con CC.

A differential therapeutic consideration for use of corticosteroids according to established COVID-19 clinical phenotypes in critically ill patients.

OBJECTIVE: To determine if the use of corticosteroids was associated with Intensive Care Unit (ICU) mortality among whole population and pre-specified clinical phenotypes. DESIGN: A secondary analysis derived from multicenter, observational study. SETTING: Critical Care Units. PATIENTS: Adult critically ill patients with confirmed COVID-19 disease admitted to 63 ICUs in Spain. INTERVENTIONS: Corticosteroids vs. no corticosteroids. MAIN VARIABLES OF INTEREST: Three phenotypes were derived by non-supervised clustering analysis from whole population and classified as (A: severe, B: critical and C: life-threatening). We performed a multivariate analysis after propensity optimal full matching (PS) for whole population and weighted Cox regression (HR) and Fine-Gray analysis (sHR) to assess the impact of corticosteroids on ICU mortality according to the whole population and distinctive patient clinical phenotypes. RESULTS: A total of 2017 patients were analyzed, 1171 (58%) with corticosteroids. After PS, corticosteroids were shown not to be associated with ICU mortality (OR: 1.0; 95% CI: 0.98-1.15). Corticosteroids were administered in 298/537 (55.5%) patients of "A" phenotype and their use was not associated with ICU mortality (HR=0.85 [0.55-1.33]). A total of 338/623 (54.2%) patients in "B" phenotype received corticosteroids. No effect of corticosteroids on ICU mortality was observed when HR was performed (0.72 [0.49-1.05]). Finally, 535/857 (62.4%) patients in "C" phenotype received corticosteroids. In this phenotype HR (0.75 [0.58-0.98]) and sHR (0.79 [0.63-0.98]) suggest a protective effect of corticosteroids on ICU mortality. CONCLUSION: Our finding warns against the widespread use of corticosteroids in all critically ill patients with COVID-19 at moderate dose. Only patients with the highest inflammatory levels could benefit from steroid treatment.

Secondary use of data extracted from a clinical information system to assess the adherence of tidal volume and its impact on outcomes.

OBJECTIVES: To extract data from clinical information systems to automatically calculate high-resolution quality indicators to assess adherence to recommendations for low tidal volume. DESIGN: We devised two indicators: the percentage of time under mechanical ventilation with excessive tidal volume (>8mL/kg predicted body weight) and the percentage of patients who received appropriate tidal volume (≤8mL/kg PBW) at least 80% of the time under mechanical ventilation. We developed an algorithm to automatically calculate these indicators from clinical information system data and analyzed associations between them and patients' characteristics and outcomes. SETTINGS: This study has been carried out in our 30-bed polyvalent intensive care unit between January 1, 2014 and November 30, 2019. PATIENTS: All patients admitted to intensive care unit ventilated >72h were included. INTERVENTION: Use data collected automatically from the clinical information systems to assess adherence to tidal volume recommendations and its outcomes. MAIN VARIABLES OF INTEREST: Mechanical ventilation days, ICU length of stay and mortality. RESULTS: Of all admitted patients, 340 met the inclusion criteria. Median percentage of time under mechanical ventilation with excessive tidal volume was 70% (23%-93%); only 22.3% of patients received appropriate tidal volume at least 80% of the time. Receiving appropriate tidal volume was associated with shorter duration of mechanical ventilation and intensive care unit stay. Patients receiving appropriate tidal volume were mostly male, younger, taller, and less severely ill. Adjusted intensive care unit mortality did not differ according to percentage of time with excessive tidal volume or to receiving appropriate tidal volume at least 80% of the time. CONCLUSIONS: Automatic calculation of process-of-care indicators from clinical information systems high-resolution data can provide an accurate and continuous measure of adherence to recommendations. Adherence to tidal volume recommendations was associated with shorter duration of mechanical ventilation and intensive care unit stay.

Secondary use of data extracted from a clinical information system to assess the adherence of tidal volume and its impact on outcomes / Uso secundario de los datos del Sistema de Información Clínica para evaluar la adherencia a las guías de práctica clínica respecto al volumen tidal y su impacto en los resultados

Objectives To extract data from clinical information systems to automatically calculate high-resolution quality indicators to assess adherence to recommendations for low tidal volume. Design We devised two indicators: the percentage of time under mechanical ventilation with excessive tidal volume (>8mL/kg predicted body weight) and the percentage of patients who received appropriate tidal volume (≤8mL/kg PBW) at least 80% of the time under mechanical ventilation. We developed an algorithm to automatically calculate these indicators from clinical information system data and analyzed associations between them and patients’ characteristics and outcomes. Settings This study has been carried out in our 30-bed polyvalent intensive care unit between January 1, 2014 and November 30, 2019. Patients All patients admitted to intensive care unit ventilated >72h were included. Intervention Use data collected automatically from the clinical information systems to assess adherence to tidal volume recommendations and its outcomes. Main variables of interest Mechanical ventilation days, ICU length of stay and mortality. Results Of all admitted patients, 340 met the inclusion criteria. Median percentage of time under mechanical ventilation with excessive tidal volume was 70% (23%–93%); only 22.3% of patients received appropriate tidal volume at least 80% of the time. Receiving appropriate tidal volume was associated with shorter duration of mechanical ventilation and intensive care unit stay. Patients receiving appropriate tidal volume were mostly male, younger, taller, and less severely ill. Adjusted intensive care unit mortality did not differ according to percentage of time with excessive tidal volume or to receiving appropriate tidal volume at least 80% of the time (AU)

Objetivos Extraer los datos del Sistema de Información Clínica para calcular automáticamente indicadores de calidad de alta resolución para evaluar la adherencia a las recomendaciones sobre el volumen tidal. Diseño Ideamos 2 indicadores: el porcentaje de tiempo en ventilación mecánica con volumen tidal excesivo (>8mL/kg peso ideal) y el porcentaje de pacientes con volumen tidal apropiado (≤8mL/kg peso ideal) al menos el 80% del tiempo en ventilación mecánica. Desarrollamos un algoritmo para calcular automáticamente dichos indicadores con los datos del Sistema de Información Clínica y analizamos su asociación con las características de los pacientes y su evolución. Ambiente El estudio se llevó a cabo en una unidad de cuidados intensivos polivalente de 30 camas desde el 1 enero 2014 hasta el 20 noviembre 2019. Pacientes Se incluyeron en el estudio todos los pacientes ingresados en la unidad de cuidados intensivos conectados a ventilación mecánica>72h. Intervención Usar los datos recogidos automáticamente desde el Sistema de Información Clínica para evaluar la adherencia a las recomendaciones del volumen tidal y sus resultados. Principales variables de interés Días de ventilación mecánica, días de estancia en la unidad de cuidados intensivos y mortalidad. Resultados De todos los pacientes ingresados, 340 cumplieron los criterios de inclusión. El tiempo medio de ventilación mecánica con volumen tidal excesivo fue 70% (23-93%); solo el 22,3% de los pacientes recibió un volumen tidal apropiado al menos el 80% del tiempo. Recibir un volumen tidal apropiado se asoció con menos días de ventilación mecánica y de estancia en la unidad de cuidados intensivos. Los pacientes que recibieron un volumen tidal apropiado fueron más frecuentemente hombres, más jóvenes, más altos y menos graves (AU)