Algoritmo de tratamiento con omalizumab en urticaria crónica espontánea / Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab

Antecedentes y objetivo: Los ensayos pivotales de omalizumab en urticaria crónica espontánea (UCE) tienen un periodo de tratamiento de entre 12 y 24 semanas. Sin embargo, muchos pacientes en práctica clínica requieren periodos de tratamiento más prolongados. Por ello el objetivo es presentar un algoritmo de manejo del fármaco. Materiales y métodos: El documento de consenso que detallamos nace de la puesta en común, aceptación, revisión y confrontación de la literatura reciente del grupo de trabajo de UCE "Xarxa d'Urticària Catalana i Balear" (XUrCB). Resultados: Se inicia el tratamiento a dosis autorizada y se ajusta la dosis en intervalos trimestrales en función del Urticaria Activity Score de los últimos 7 días (UAS7) y/o el Urticarial Control Test (UCT). Conclusiones: El algoritmo propuesto pretende servir de guía respecto a cómo ajustar dosis, cómo y cuándo parar el fármaco y el modo de reintroducirlo en casos de recaída

Background and objective: Pivotal trials with omalizumab for treatment of chronic spontaneous urticaria (CSU) are generally run over 12 to 24weeks. However, in clinical practice, many patients need longer treatment. In this article, we present an algorithm for treatment with omalizumab. Material and methods: The consensus document we present is the result of a series of meetings by the CSU working group of "Xarxa d'Urticària Catalana i Balear" (XUrCB) at which data from the recent literature were presented, discussed, compared, and agreed upon. Results: Treatment with omalizumab should be initiated at the authorized dose, and is adjusted at 3-monthly intervals according to the Urticaria Activity Score Over 7 days, the Urticaria Control Test, or both. Conclusions: The algorithm proposed is designed to provide guidance on how to adjust omalizumab doses, how and when to discontinue the drug, and how to reintroduce it in cases of relapse

Algorithm for Treatment of Chronic Spontaneous Urticaria with Omalizumab. / Algoritmo de tratamiento con omalizumab en urticaria crónica espontánea.

BACKGROUND AND OBJECTIVE: Pivotal trials with omalizumab for treatment of chronic spontaneous urticaria (CSU) are generally run over 12 to 24weeks. However, in clinical practice, many patients need longer treatment. In this article, we present an algorithm for treatment with omalizumab. MATERIAL AND METHODS: The consensus document we present is the result of a series of meetings by the CSU working group of "Xarxa d'Urticària Catalana i Balear" (XUrCB) at which data from the recent literature were presented, discussed, compared, and agreed upon. RESULTS: Treatment with omalizumab should be initiated at the authorized dose, and is adjusted at 3-monthly intervals according to the Urticaria Activity Score Over 7days, the Urticaria Control Test, or both. CONCLUSIONS: The algorithm proposed is designed to provide guidance on how to adjust omalizumab doses, how and when to discontinue the drug, and how to reintroduce it in cases of relapse.

Rapid Response Teams: a great opportunity / Equipos de Respuesta Rápida: Una gran oportunidad

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Efecto del momento de ingreso sobre el pronóstico de los pacientes en la UCI (on-hours vs. off-hours) y el ritmo circardiano / Effect of the timing of admission upon patient prognosis in the Intensive Care Unit: (On-hours versus off-hours) and diurnal variation

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Efecto sobre la mortalidad de la ampliación a los festivos y fines de semana del proyecto «UCI sin paredes». Estudio before-after / Effect upon mortality of the extension to holidays and weekends of the «ICU without walls» project. A before-after study

OBJETIVO: Estudiar si la ampliación, a festivos y fines de semana, del protocolo de detección proactiva precoz de gravedad en el hospital y actuación de intensivistas en planta convencional y urgencias (actividad «UCI sin paredes») se asocia a una reducción en la mortalidad de los pacientes ingresados en UCI en esos días. DISEÑO: Estudio cuasi experimental before-after. ÁMBITO: Hospital de nivel 2 con 210 camas en funcionamiento y UCI polivalente con 8 camas. PACIENTES O PARTICIPANTES: En el grupo control, donde no se realiza la actividad «UCI sin paredes» los fines de semana ni festivos, se incluyeron los pacientes ingresados en la UCI esos días del 1 de enero de 2010 al 30 de abril de 2013. En el grupo intervención se amplió la actividad «UCI sin paredes» a los fines de semana y festivos y se incluyeron los pacientes ingresados esos días del 1 de mayo de 2013 al 31 de octubre de 2014. Se excluyeron los pacientes procedentes de quirófano tras una cirugía programada. Variables de interés: Se analizaron las variables demográficas (edad, sexo), la procedencia (urgencias, planta de hospitalización, quirófano), el tipo de paciente (médico, quirúrgico), el motivo de ingreso, las comorbilidades y el SAPS 3 como puntuación de gravedad al ingreso, estancia en UCI y hospitalaria, además de la mortalidad en la UCI y en el hospital. RESULTADOS: Se incluyeron en el grupo control 389 pacientes, y 161 en el grupo intervención. No se encontraron diferencias entre ambos grupos, salvo en la comorbilidad cardiovascular (un 49% en el grupo control frente a un 33% en el grupo intervención; p < 0,001), en la gravedad al ingreso medida mediante el SAPS 3 (mediana de 52 [percentiles 25-75: 42-63] en el grupo control frente a 48 [percentiles 25-75: 40-56] en el grupo intervención; p= 0,008) y en la mortalidad en UCI, que fue de un 11% en el grupo control (IC 95% 8 a 14) frente al 3% (IC 95% 1 a 7) en el grupo intervención (p = 0,003). En el análisis multivariable, los 2 únicos factores asociados con la mortalidad en UCI fueron: SAPS 3 (OR 1,08; IC 95% 1,06-1,11) y el pertenecer al grupo intervención (OR 0,33; IC 95% 0,12-0,89). CONCLUSIONES: La ampliación de la actividad «UCI sin paredes» a los fines de semana y festivos conlleva un descenso en la mortalidad en la UCI

OBJECTIVE: To determine whether extension to holidays and weekends of the protocol for the early proactive detection of severity in hospital («ICU without walls» project) results in decreased mortality among patients admitted to the ICU during those days. DESIGN: A quasi-experimental before-after study was carried out. SETTING: A level 2 hospital with 210 beds and a polyvalent ICU with 8 beds. PATIENTS OR PARTICIPANTS: The control group involved no «ICU without walls» activity on holidays or weekends and included those patients admitted to the ICU on those days between 1 January 2010 and 30 April 2013. The intervention group in turn extended the «ICU without walls» activity to holidays and weekends, and included those patients admitted on those days between 1 May 2013 and 31 October 2014. Patients arriving from the operating room after scheduled surgery were excluded. Variables of interest: An analysis was made of the demographic variables (age, gender), origin (emergency room, hospital ward, operating room), type of patient (medical, surgical), reason for admission, comorbidities and SAPS 3 score as a measure of severity upon admission, stay in the ICU and in hospital, and mortality in the ICU and in hospital. RESULTS: A total of 389 and 161 patients were included in the control group and intervention group, respectively. There were no differences between the 2 groups except as regards cardiovascular comorbidity (49% in the control group versus 33% in the intervention group; P < .001), severity upon admission (median SAPS 3 score 52 [percentiles 25-75: 42-63) in the control group versus 48 [percentiles 25-75: 40-56] in the intervention group; P = .008) and mortality in the ICU (11% in the control group [95% CI 8-14] versus 3% [95% CI 1-7] in the intervention group; P = .003). In the multivariate analysis, the only 2 factors associated to mortality in the ICU were the SAPS 3 score (OR 1.08; 95% CI 1.06-1.11) and inclusion in the intervention group (OR 0.33; 95% CI 0.12-0.89). CONCLUSIONS: Extension of the «ICU without walls» activity to holidays and weekends results in a decrease in mortality in the ICU

Efecto del momento de ingreso sobre el pronóstico de los pacientes en la Unidad de Cuidados Intensivos: on-hours vs. off-hours / Effect of the timing of admission upon patient prognosis in the Intensive Care Unit: On-hours versus off-hours

OBJETIVO: Evaluar la repercusión del momento de ingreso en UCI sobre el pronóstico de los pacientes. DISEÑO: Estudio de cohorte prospectivo, observacional y no intervencionista. Se consideró on-hours el turno de mañana y tarde de los días laborables y off-hours el resto de los turnos. ÁMBITO: Hospital de nivel 2 con 210 camas en funcionamiento y UCI polivalente con 8 camas. PACIENTES O PARTICIPANTES: Todos los pacientes que ingresaron en la UCI durante 3 años, de enero de 2010 a diciembre de 2012, excluyendo aquellos pacientes procedentes de quirófano tras una cirugía programada. Los pacientes se estratificaron en 2 grupos en función de que el momento de ingreso fuera on-hours u off-hours. Intervenciones: Estudio no intervencionista. VARIABLES DE INTERÉS: Se analizaron las variables demográficas (edad, sexo), la procedencia (urgencias, planta de hospitalización, quirófano), el tipo de paciente (médico, quirúrgico), las comorbilidades y el SAPS 3 como puntuación de gravedad al ingreso, estancia en UCI y hospitalaria, además de mortalidad en la UCI y en el hospital. RESULTADOS: Se incluyeron 504 pacientes en el grupo on-hours y 602 en el grupo off-hours. En el análisis multivariable los factores asociados de forma independiente con la mortalidad hospitalaria fueron SAPS 3 (OR 1,10; IC 95% 1,08-1,12) y grupo off-hours (OR 2,00; IC 95% 1,20-3,33). En un análisis de subgrupos del grupo off-hours el ingreso de los pacientes en fin de semana o festivo frente a las noches de los días de diario se asoció de forma independiente con la mortalidad hospitalaria (OR 2,30; IC 95% 1,23-4,30). CONCLUSIONES: Ingresar en el grupo off-hours se asocia de forma independiente con la mortalidad. El ingreso en festivo se asocia de forma independiente con la mortalidad, independientemente del turno en que se produzca el ingreso los días de diario

OBJECTIVE: To assess the repercussion of the timing of admission to the ICU upon patient prognosis. DESIGN: A prospective, observational, non-interventional cohort study was carried out. Scope: A second level hospital with 210 operational beds and a general ICU with 8 operational beds. PATIENTS OR PARTICIPANTS: The study comprised all patients admitted to the ICU during 3 years (January 2010 to December 2012), excluding those subjects admitted from the operating room after scheduled surgery. The patients were divided into 2 groups according to the timing of admission (on-hours or off-hours). INTERVENTIONS: Non-interventional study. VARIABLES OF INTEREST: An analysis was made of demographic variables (age, sex), origin (emergency room, hospital ward, operating room), comorbidities and SAPS 3 as severity score upon admission, length of stay in the ICU and hospital ward, and ICU and hospital mortality. RESULTS: A total of 504 patients were included in the on-hours group, versus 602 in the off-hours group. Multivariate analysis showed the factors independently associated to hospital mortality to be SAPS 3 (OR 1.10; 95% CI 1.08-1.12), and off-hours admission (OR 2.00; 95% CI 1.20-3.33). In a subgroup analysis of the off-hours group, the admission of patients on weekends or non-working days compared to daily night shifts was found to be independently associated to hospital mortality (OR 2.30; 95% CI 1.23-4.30). CONCLUSIONS: Admission to the ICU in off-hours is independently associated to patient mortality, which is also higher in patients admitted on weekends and non-working days compared to the daily night shifts

Effect upon mortality of the extension to holidays and weekends of the "ICU without walls" project. A before-after study. / Efecto sobre la mortalidad de la ampliación a los festivos y fines de semana del proyecto «UCI sin paredes¼. Estudio before-after.

OBJECTIVE: To determine whether extension to holidays and weekends of the protocol for the early proactive detection of severity in hospital ("ICU without walls" project) results in decreased mortality among patients admitted to the ICU during those days. DESIGN: A quasi-experimental before-after study was carried out. SETTING: A level 2 hospital with 210 beds and a polyvalent ICU with 8 beds. PATIENTS OR PARTICIPANTS: The control group involved no "ICU without walls" activity on holidays or weekends and included those patients admitted to the ICU on those days between 1 January 2010 and 30 April 2013. The intervention group in turn extended the "ICU without walls" activity to holidays and weekends, and included those patients admitted on those days between 1 May 2013 and 31 October 2014. Patients arriving from the operating room after scheduled surgery were excluded. VARIABLES OF INTEREST: An analysis was made of the demographic variables (age, gender), origin (emergency room, hospital ward, operating room), type of patient (medical, surgical), reason for admission, comorbidities and SAPS 3 score as a measure of severity upon admission, stay in the ICU and in hospital, and mortality in the ICU and in hospital. RESULTS: A total of 389 and 161 patients were included in the control group and intervention group, respectively. There were no differences between the 2 groups except as regards cardiovascular comorbidity (49% in the control group versus 33% in the intervention group; P<.001), severity upon admission (median SAPS 3 score 52 [percentiles 25-75: 42-63) in the control group versus 48 [percentiles 25-75: 40-56] in the intervention group; P=.008) and mortality in the ICU (11% in the control group [95% CI 8-14] versus 3% [95% CI 1-7] in the intervention group; P=.003). In the multivariate analysis, the only 2 factors associated to mortality in the ICU were the SAPS 3 score (OR 1.08; 95% CI 1.06-1.11) and inclusion in the intervention group (OR 0.33; 95% CI 0.12-0.89). CONCLUSIONS: Extension of the "ICU without walls" activity to holidays and weekends results in a decrease in mortality in the ICU.

Effect of the timing of admission upon patient prognosis in the Intensive Care Unit: On-hours versus off-hours.

OBJECTIVE: To assess the repercussion of the timing of admission to the ICU upon patient prognosis. DESIGN: A prospective, observational, non-interventional cohort study was carried out. SCOPE: A second level hospital with 210 operational beds and a general ICU with 8 operational beds. PATIENTS OR PARTICIPANTS: The study comprised all patients admitted to the ICU during 3 years (January 2010 to December 2012), excluding those subjects admitted from the operating room after scheduled surgery. The patients were divided into 2 groups according to the timing of admission (on-hours or off-hours). INTERVENTIONS: Non-interventional study. VARIABLES OF INTEREST: An analysis was made of demographic variables (age, sex), origin (emergency room, hospital ward, operating room), comorbidities and SAPS 3 as severity score upon admission, length of stay in the ICU and hospital ward, and ICU and hospital mortality. RESULTS: A total of 504 patients were included in the on-hours group, versus 602 in the off-hours group. Multivariate analysis showed the factors independently associated to hospital mortality to be SAPS 3 (OR 1.10; 95% CI 1.08-1.12), and off-hours admission (OR 2.00; 95% CI 1.20-3.33). In a subgroup analysis of the off-hours group, the admission of patients on weekends or non-working days compared to daily night shifts was found to be independently associated to hospital mortality (OR 2.30; 95% CI 1.23-4.30). CONCLUSIONS: Admission to the ICU in off-hours is independently associated to patient mortality, which is also higher in patients admitted on weekends and non-working days compared to the daily night shifts.

Evaluación de las técnicas de fisioterapia mediante tomografía de impedancia / Evaluation of physiotherapy techniques using impedance tomography

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Intensive Care Unit without walls: Seeking patient safety by improving the efficiency of the system

The term «ICU without walls» refers to innovative management in Intensive Care, based on two key elements: (1) collaboration of all medical and nursing staff involved in patient care during hospitalization and (2) technological support for severity early detection protocols by identifying patients at risk of deterioration throughout the hospital, based on the assessment of vital signs and/or laboratory test values, with the clear aim of improving critical patient safety in the hospitalization process. At present, it can be affirmed that there is important work to be done in the detection of severity and early intervention in patients at risk of organ dysfunction. Such work must be adapted to the circumstances of each center and should include training in the detection of severity, multidisciplinary work in the complete patient clinical process, and the use of technological systems allowing intervention on the basis of monitored laboratory and physiological parameters, with effective and efficient use of the information generated. Not only must information be generated, but also efficient management of such information must also be achieved. It is necessary to improve our activity through innovation in management procedures that facilitate the work of the intensivist, in collaboration with other specialists, throughout the hospital environment. Innovation is furthermore required in the efficient management of the information generated in hospitals, through intelligent and directed usage of the new available technology

El término «UCI sin paredes» se refiere a una innovadora estrategia de tratamiento en cuidados intensivos que se basa en 2 elementos fundamentales: (1) colaboración de todo el personal médico y de enfermería implicado en la atención del paciente durante la hospitalización, y (2) apoyo tecnológico para protocolos de detección temprana de la gravedad identificando a los pacientes en situación de riesgo de deterioro en el hospital a partir de la evaluación de las constantes vitales y/o los resultados de las pruebas analíticas, con el claro objetivo de mejorar la seguridad de los pacientes críticos durante el proceso de hospitalización. En la actualidad puede decirse que todavía queda un importante trabajo por hacer en cuanto a la detección de la gravedad y la detección precoz en pacientes en situación de riesgo de disfunción orgánica. Este trabajo deberá adaptarse a las circunstancias de cada centro e incluir formación para la detección de la gravedad, el trabajo multidisciplinario en el conjunto del proceso clínico del paciente y el uso de sistemas tecnológicos que permitan la intervención a partir de la monitorización de parámetros fisiológicos y analíticos, con un uso eficiente y eficaz de la información generada. No solo debe generarse información sino que también es necesario que esta se gestione de manera eficaz. Es necesario mejorar nuestra actividad mediante la innovación en los procedimientos de gestión que facilitan la labor del intensivista, en colaboración con otros especialistas, en el entorno hospitalario. Además, se requiere innovación para gestionar de forma eficiente la información generada en los hospitales a partir del uso inteligente y eficiente de las nuevas tecnologías disponibles

Intensive care unit without walls: seeking patient safety by improving the efficiency of the system.

The term "ICU without walls" refers to innovative management in Intensive Care, based on two key elements: (1) collaboration of all medical and nursing staff involved in patient care during hospitalization and (2) technological support for severity early detection protocols by identifying patients at risk of deterioration throughout the hospital, based on the assessment of vital signs and/or laboratory test values, with the clear aim of improving critical patient safety in the hospitalization process. At present, it can be affirmed that there is important work to be done in the detection of severity and early intervention in patients at risk of organ dysfunction. Such work must be adapted to the circumstances of each center and should include training in the detection of severity, multidisciplinary work in the complete patient clinical process, and the use of technological systems allowing intervention on the basis of monitored laboratory and physiological parameters, with effective and efficient use of the information generated. Not only must information be generated, but also efficient management of such information must also be achieved. It is necessary to improve our activity through innovation in management procedures that facilitate the work of the intensivist, in collaboration with other specialists, throughout the hospital environment. Innovation is furthermore required in the efficient management of the information generated in hospitals, through intelligent and directed usage of the new available technology.

A medium-term, stochastic forecast model to support sustainable, mixed fisheries management in the Mediterranean Sea.

A medium-term (10 year) stochastic forecast model is developed and presented for mixed fisheries that can provide estimations of age-specific parameters for a maximum of 10 stocks and 10 fisheries. Designed to support fishery managers dealing with complex, multi-annual management plans, the model can be used to quantitatively test the consequences of various stock-specific and fishery-specific decisions, using non-equilibrium stock dynamics. Such decisions include fishing restrictions and other strategies aimed at achieving sustainable mixed fisheries consistent with the concept of maximum sustainable yield (MSY). In order to test the model, recently gathered data on seven stocks and four fisheries operating in the Ligurian and North Tyrrhenian Seas are used to generate quantitative, 10 year predictions of biomass and catch trends under four different management scenarios. The results show that using the fishing mortality at MSY as the biological reference point for the management of all stocks would be a strong incentive to reduce the technical interactions among concurrent fishing strategies. This would optimize the stock-specific exploitation and be consistent with sustainability criteria.

[Selective digestive decontamination. Why don't we apply the evidence in the clinical practice?]. / Descontaminación digestiva selectiva. 'Por qué no aplicamos la evidencia en la práctica clínica?

Selective digestive decontamination (SDD) is a prophylactic strategy whose objective is to reduce the incidence of infections, mainly mechanical ventilation associated pneumonia in patients who require intensive cares, preventing or eradicating the oropharyngeal and gastrointestinal carrier state of potentially pathogenic microorganisms. Fifty-four randomized clinical trials (RCTs) and 9 meta-analysis have evaluated SDD. Thirty eight RCTs show a significant reduction of the infections and 4 of mortality. All the meta-analyses show a significant reduction of the infections and 5 out of the 9 meta-analyses report a significant reduction in mortality. Thus, 5 patients from the ICU with SDD must be treated to prevent pneumonia and 12 patients from the ICU should be treated to prevent one death. The data that show benefit of the SDD on mortality have an evidence grade 1 or recommendation grade A (supported by at least two level 1 investigations). The aim of this review is to explain the pathogeny of infections in critical patients, describe selective digestive decontamination, analyze the evidence available on it efficacy and the potential adverse effects and discuss the reasons published by the experts who advise against the use of SDD, even though it is recognized as the best intervention evaluated in intensive cares to reduce morbidity and mortality of the infections.

Descontaminación digestiva selectiva. ¿Por qué no aplicamos la evidencia en la práctica clínica? / Selective digestive decontamination. Why don’t we apply the evidence in the clinical practice?

La descontaminación digestiva selectiva (DDS) es una estrategia profiláctica cuyo objetivo es reducir la incidencia de infecciones, principalmente la neumonía asociada a la ventilación mecánica, en los pacientes que requieren cuidados intensivos, previniendo o erradicando el estado de portador orofaríngeo y gastrointestinal de microorganismos potencialmente patógenos. Cincuenta y cuatro ensayos clínicos randomizados (ECR) y nueve metaanálisis han evaluado la DDS. Treinta y ocho ECR muestran una reducción significativa de las infecciones y cuatro de la mortalidad. Todos los metaanálisis muestran una reducción significativa de las infecciones y 5 de los 9 metaanálisis de la mortalidad. Se necesita tratar 5 pacientes de Unidad de Cuidados Intensivos (UCI) con DDS para prevenir una neumonía y 12 pacientes de UCI deben ser tratados para prevenir una muerte. Los datos que muestran un beneficio de la DDS sobre la mortalidad tienen un grado de evidencia 1 o un grado de recomendación A (soportada por al menos dos investigaciones de nivel 1). El objetivo de esta revisión es exponer la patogenia de las infecciones en los enfermos críticos, describir la DDS, analizar la evidencia disponible sobre su eficacia y los potenciales efectos adversos, y discutir las razones publicadas por los expertos que desaconsejan el uso de la DDS, a pesar de ser reconocida como la intervención mejor evaluada en cuidados intensivos para reducir la morbilidad y mortalidad de las infecciones

Selective digestive decontamination (SDD) is a prophylactic strategy whose objective is to reduce the incidence of infections, mainly mechanical ventilation associated pneumonia in patients who require intensive cares, preventing or eradicating the oropharyngeal and gastrointestinal carrier state of potentially pathogenic microorganisms. Fifty-four randomized clinical trials (RCTs) and 9 meta-analysis have evaluated SDD. Thirty eight RCTs show a significant reduction of the infections and 4 of mortality. All the meta-analyses show a significant reduction of the infections and 5 out of the 9 meta-analyses report a significant reduction in mortality. Thus, 5 patients from the ICU with SDD must be treated to prevent pneumonia and 12 patients from the ICU should be treated to prevent one death. The data that show benefit of the SDD on mortality have an evidence grade 1 or recommendation grade A (supported by at least two level 1 investigations). The aim of this review is to explain the pathogeny of infections in critical patients, describe selective digestive decontamination, analyze the evidence available on it efficacy and the potential adverse effects and discuss the reasons published by the experts who advise against the use of SDD, even though it is recognized as the best intervention evaluated in intensive cares to reduce morbidity and mortality of the infections