Competency assessment of residents of Intensive Care Medicine through a simulation-based objective structured clinical evaluation (OSCE). A multicenter observational study.

OBJECTIVES: The current official model of training in Intensive Care Medicine (ICM) in Spain is based on exposure to experiences through clinical rotations. The main objective was to determine the level of competency (I novice to V independent practitioner) achieved by the residents at the end of the 3rd year of training (R3) in ICM through a simulation-based OSCE. Secondary objectives were: (1) To identify gaps in performance, and (2) To investigate the reliability and feasibility of conducting simulation-based assessment at multiple sites. DESIGN: Observational multicenter study. SETTING: Thirteen Spanish ICU Departments. PARTICIPANTS: Thirty six R3. INTERVENTION: The participants performed on five, 15-min, high-fidelity crisis scenarios in four simulation centers. The performances were video recorded for later scoring by trained raters. MAIN VARIABLES OF INTEREST: Via a Delphi technique, an independent panel of expert intensivists identified critical essential performance elements (CEPE) for each scenario to define the levels of competency. RESULTS: A total of 176 performances were analyzed. The internal consistency of the check-lists were adequate (KR-20 range 0.64-0.79). Inter-rater reliability was strong [median Intraclass Correlation Coefficient across scenarios: 0.89 (0.65-0.97)]. Competency levels achieved by R3 were: Level I (18.8%), II (35.2%), III (42.6%), IV/V (3.4%). Overall, a great heterogeneity in performance was observed. CONCLUSION: The expected level of competency after one year in the ICU was achieved only in half of the performances. A more evidence-based educational approach is needed. Multiple center simulation-based assessment showed feasibility and reliability as an evaluation method of competency. TRIAL REGISTRATION: COBALIDATION. NCT04278976. (https://register. CLINICALTRIALS: gov).

Competency assessment of residents of Intensive Care Medicine through a simulation-based objective structured clinical evaluation (OSCE). A multicenter observational study / Evaluación del nivel de competencia de residentes de Medicina Intensiva mediante una evaluación clínica, objetiva y estructurada basada en simulación (ECOE). Estudio multicéntrico observacional

Objectives The current official model of training in Intensive Care Medicine (ICM) in Spain is based on exposure to experiences through clinical rotations. The main objective was to determine the level of competency (I novice to V independent practitioner) achieved by the residents at the end of the 3rd year of training (R3) in ICM through a simulation-based OSCE. Secondary objectives were: (1) To identify gaps in performance, and (2) To investigate the reliability and feasibility of conducting simulation-based assessment at multiple sites. Design Observational multicenter study. Setting Thirteen Spanish ICU Departments. Participants Thirty six R3. Intervention The participants performed on five, 15-min, high-fidelity crisis scenarios in four simulation centers. The performances were video recorded for later scoring by trained raters. Main variables of interes Via a Delphi technique, an independent panel of expert intensivists identified critical essential performance elements (CEPE) for each scenario to define the levels of competency. Results A total of 176 performances were analyzed. The internal consistency of the check-lists were adequate (KR-20 range 0.64–0.79). Inter-rater reliability was strong [median Intraclass Correlation Coefficient across scenarios: 0.89 (0.65–0.97)]. Competency levels achieved by R3 were: Level I (18.8%), II (35.2%), III (42.6%), IV/V (3.4%). Overall, a great heterogeneity in performance was observed. Conclusio The expected level of competency after one year in the ICU was achieved only in half of the performances. A more evidence-based educational approach is needed. Multiple center simulation-based assessment showed feasibility and reliability as an evaluation method of competency (AU)

Objetivos El modelo de formación en medicina intensiva (MI) en España se basa en la experiencia adquirida durante una serie de rotaciones programadas por diferentes áreas clínicas. El objetivo principal del estudio fue determinar el nivel de competencia (I principiante – V autónomo) de los residentes de MI al finalizar el tercer año de residencia (R3) mediante una ECOE basada en simulación. Objetivos secundarios: 1) identificar brechas en el desempeño; 2) investigar la fiabilidad y validez de una ECOE simulada multicéntrica como método de evaluación. Diseño Estudio multicéntrico observacional. Ámbito Trece servicios españoles de Medicina Intensiva. Participantes Treinta y seis R3. Intervención Los 36 R3 participaron en cinco escenarios clínicos simulados de 15 minutos de duración en cuatro centros de simulación. Las actuaciones se grabaron en video y posteriormente se calificaron por pares de expertos. Variables de interés principales Un panel de intensivistas expertos seleccionó mediante el método Delphi los elementos críticos esenciales de cada escenario para definir los niveles de competencia. Resultados La consistencia interna de los listados de verificación fue adecuada (KR-20:0,64-0,79). La fiabilidad interjueces fue elevada (coeficiente de correlación intraclase [mediana]: 0,89 [0,65-0,97]). Los niveles de competencia conseguidos fueron: nivel I (18,8%), II (35,2%), III (42,6%), IV/V (3,4%). Globalmente, se observó una gran heterogeneidad en el desempeño. Conclusión El nivel de competencia esperado se logró únicamente en la mitad de las actuaciones. Se necesita un modelo de formación más basado en objetivos y evidencias. La evaluación mediante escenarios simulados en múltiples centros demostró ser factible y fiable (AU)

Manejo postoperatorio en UCI de cirugía de cabeza y cuello / Postoperative management in the Intensive Care Unit of head and neck surgery patients

El cuidado del paciente tras cirugía mayor de cabeza y cuello ha cambiado en los últimos años. La patología que acapara este tipo de intervenciones es la tumoral; aunque también se utiliza para resolución de patologías benignas. Recientes avances en el equipamiento y en las técnicas quirúrgicas han mejorado el postoperatorio en este campo, permitiendo una recuperación precoz, un menor grado de dolor y tasa de infección, una menor estancia hospitalaria e incluso unos mejores resultados estéticos. Esto se debe al uso de técnicas mínimamente invasivas, que están cobrando protagonismo en los últimos años. Estas permiten realizar procedimientos complejos en la región de cabeza y cuello, a través de orificios naturales o pequeñas incisiones, con mínimo daño y mínimas secuelas para los pacientes. A pesar de estos avances, dada la complejidad de la intervención, el manejo de estos pacientes requerirá un enfoque multidisciplinar, fundamentalmente en las unidades de cuidados intensivos para vigilar la posible aparición de complicaciones. Entre los factores de riesgo potenciales destacan: comorbilidad previa, el tipo de intervención, como el vaciamiento cervical bilateral, la necesidad de politransfusión y la aparición de complicaciones precoces que requieren una reintervención. A pesar de diversos estudios realizados, no existen protocolos estandarizados para el período postoperatorio de este tipo de intervenciones, lo que hace que muchos trasladen protocolos de recuperación precoz (ERAS: «Enhanced Recovery After Surgery») ya instaurados en otras especialidades quirúrgicas

Patient care after major head and neck surgery has changed in recent years. Tumors are the most common reasons for this type of surgery, though it is also used to treat benign conditions. Recent advances in equipment and surgical techniques have improved the postoperative course in this field, allowing early recovery, less pain and infection, a shorter hospital stay, and even better aesthetic results. This is due to the use of minimally invasive techniques, which are gaining relevance. Such techniques allow complex procedures in the head and neck region, through natural orifices or small incisions, with minimal damage and sequelae for the patients. Despite these advances, however, the complexity of the treatment intervention requires multidisciplinary patient management, mostly in the Intensive Care Unit, in order to monitor the possible occurrence of complications. Potential risk factors include previous comorbidity, the type of surgery involved (e.g., bilateral cervical lymphadenectomy), multiple transfusions, and the appearance of early complications requiring repeat surgery. Despite the existence of several studies, there are no standardized protocols for the postoperative period in surgeries of this kind. This causes many specialists to resort to accelerated recovery protocols (ERAS: "Enhanced Recovery After Surgery") that have already been established in other surgical specialties

Postoperative management in the Intensive Care Unit of head and neck surgery patients. / Manejo postoperatorio en UCI de cirugía de cabeza y cuello.

Patient care after major head and neck surgery has changed in recent years. Tumors are the most common reasons for this type of surgery, though it is also used to treat benign conditions. Recent advances in equipment and surgical techniques have improved the postoperative course in this field, allowing early recovery, less pain and infection, a shorter hospital stay, and even better aesthetic results. This is due to the use of minimally invasive techniques, which are gaining relevance. Such techniques allow complex procedures in the head and neck region, through natural orifices or small incisions, with minimal damage and sequelae for the patients. Despite these advances, however, the complexity of the treatment intervention requires multidisciplinary patient management, mostly in the Intensive Care Unit, in order to monitor the possible occurrence of complications. Potential risk factors include previous comorbidity, the type of surgery involved (e.g., bilateral cervical lymphadenectomy), multiple transfusions, and the appearance of early complications requiring repeat surgery. Despite the existence of several studies, there are no standardized protocols for the postoperative period in surgeries of this kind. This causes many specialists to resort to accelerated recovery protocols (ERAS: "Enhanced Recovery After Surgery") that have already been established in other surgical specialties.

Estimación de las necesidades de profesionales médicos en los servicios de medicina intensiva / Physician staffing needs in critical care departments

Los servicios de medicina intensiva se asocian a una alta complejidad asistencial y un alto coste monetario. Las recomendaciones sobre el cálculo de las necesidades de intensivistas adolecen de baja evidencia y favorecen un criterio estructural y asistencial (proporción médico/camas), lo que origina modelos reduccionistas. La Sociedad Española de Medicina Intensiva y Unidades Coronarias constituyó una comisión técnica para redactar unas recomendaciones sobre la necesidad de intensivistas en los servicios de medicina intensiva. La comisión técnica definió 5 actividades: 1) asistencial; 2) actividades extra-UCI; 3) seguridad del paciente y gestión clínica; 4) docencia; y 5) investigación. Para cada actividad o categoría se crearon subcomités específicos que definieron criterios para cuantificar el porcentaje que supone cada tarea para los intensivistas por rango profesional. Para las actividades asistenciales dentro y fuera de la UCI, y también para las actividades docentes e investigadoras, se siguió un sistema cuantitativo del número de procedimientos o tareas por tiempos estimados. En relación con las actividades no instrumentales, más difíciles de evaluar en tiempo real, se siguió una matriz de ámbito/productividad, definiendo los porcentajes aproximados de tiempo dedicado por categoría profesional. Se elaboró una hoja de cálculo, modificando un modelo previo, atendiendo la suma de horas estipuladas por contrato. Las competencias exigidas van más allá de la asistencia intra-UCI, y no pueden calcularse bajo criterios estructurales. La metodología sobre 5 actividades, la cuantificación de sus tareas específicas y tiempos y la construcción de una hoja de cálculo generan un instrumento adecuado de gestión (AU)

Departments of Critical Care Medicine are characterized by high medical assistance costs and great complexity. Published recommendations on determining the needs of medical staff in the DCCM are based on low levels of evidence and attribute excessive significance to the structural/welfare approach (physician-to-beds ratio), thus generating incomplete and minimalistic information. The Spanish Society of Intensive Care Medicine and Coronary Units established a Technical Committee of experts, the purpose of which was to draft recommendations regarding requirements for medical professionals in the ICU. The Technical Committee defined the following categories: 1) Patient care-related aspects; 2) Activities outside the ICU; 3) Patient safety and clinical management aspects; 4) Teaching; and 5) Research. A subcommittee was established with experts pertaining to each activity category, defining criteria for quantifying the percentage time of the intensivists dedicated to each task, and taking into account occupational category. A quantitative method was applied, the parameters of which were the number of procedures or tasks and the respective estimated indicative times for patient care-related activities within or outside the context of the DCCM, as well as for teaching and research activities. Regarding non-instrumental activities, which are more difficult to evaluate in real time, a matrix of range versus productivity was applied, defining approximate percentages according to occupational category. All activities and indicative times were tabulated, and a spreadsheet was created that modified a previously designed model in order to perform calculations according to the total sum of hours worked and the hours stipulated in the respective work contract. The competencies needed and the tasks which a Department of Critical Care Medicine professional must perform far exceed those of a purely patient care-related character, and cannot be quantified using structural criteria. The method for describing the 5 types of activity, the quantification of specific tasks, the respective times needed for each task, and the generation of a spreadsheet led to the creation of a management instrument (AU)

Physician staffing needs in critical care departments. / Estimación de las necesidades de profesionales médicos en los servicios de medicina intensiva.

Departments of Critical Care Medicine are characterized by high medical assistance costs and great complexity. Published recommendations on determining the needs of medical staff in the DCCM are based on low levels of evidence and attribute excessive significance to the structural/welfare approach (physician-to-beds ratio), thus generating incomplete and minimalistic information. The Spanish Society of Intensive Care Medicine and Coronary Units established a Technical Committee of experts, the purpose of which was to draft recommendations regarding requirements for medical professionals in the ICU. The Technical Committee defined the following categories: 1) Patient care-related aspects; 2) Activities outside the ICU; 3) Patient safety and clinical management aspects; 4) Teaching; and 5) Research. A subcommittee was established with experts pertaining to each activity category, defining criteria for quantifying the percentage time of the intensivists dedicated to each task, and taking into account occupational category. A quantitative method was applied, the parameters of which were the number of procedures or tasks and the respective estimated indicative times for patient care-related activities within or outside the context of the DCCM, as well as for teaching and research activities. Regarding non-instrumental activities, which are more difficult to evaluate in real time, a matrix of range versus productivity was applied, defining approximate percentages according to occupational category. All activities and indicative times were tabulated, and a spreadsheet was created that modified a previously designed model in order to perform calculations according to the total sum of hours worked and the hours stipulated in the respective work contract. The competencies needed and the tasks which a Department of Critical Care Medicine professional must perform far exceed those of a purely patient care-related character, and cannot be quantified using structural criteria. The method for describing the 5 types of activity, the quantification of specific tasks, the respective times needed for each task, and the generation of a spreadsheet led to the creation of a management instrument.

Infraestructura humanizada en las UCI. Un reto a nuestro alcance / Humanised infrastructure in the ICU. A challenge within our reach

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Estrategia invasiva de rutina en el síndrome coronario agudo sin elevación del segmento ST con disfunción renal. Resultados del registro ARIAM-SEMICYUC / Routine invasive strategy in acute coronary syndrome patients with renal dysfunction. Results of the ARIAM-SEMICYUC registry

OBJETIVO: Evaluar la utilización y efectividad de la estrategia invasiva de rutina (EIR) en pacientes con síndrome coronario agudo sin elevación de ST con disfunción renal en el mundo real. MÉTODOS: Estudio de cohortes retrospectivo basado en el registro ARIAM-SEMICYUC (años 2011-2014). Se consideró que había disfunción renal cuando el GFR (Cockroft-Gault) era menor de 60 ml/min (disfunción moderada) o de 30 ml/min (disfunción grave). Se excluyeron los pacientes en los que la coronariografía precoz (< 72 h) se debió a shock cardiogénico o isquemia recurrente. El desenlace primario fue la mortalidad hospitalaria. El control del confounding se realizó mediante un análisis de propensión. RESULTADOS: Se analizan 4.279 pacientes, de los cuales un 26% tenía disfunción renal moderada y un 5% disfunción grave. Los pacientes con disfunción renal presentaron una mayor gravedad y comorbilidad, una mayor mortalidad hospitalaria (8,6 frente a 1,8%) y una menor utilización de la EIR (40 frente a 52%). Las OR ajustadas mediante emparejamiento para pacientes sin/con disfunción renal fueron de 0,38 (intervalo de confianza al 95% [IC 95%] de 0,17 a 0,81) y 0,52 (IC 95% de 0,32 a 0,87), respectivamente (p de interacción 0,4779). El impacto de la EIR (diferencia de riesgos ajustada) fue mayor en el grupo con disfunción renal (-5,1%, IC 95% entre -8,1 y -2,1, frente a --1,6%, IC 95% entre -2,6 y -0,6, p de interacción = 0,0335). Tampoco se detectó interacción significativa respecto a los demás enlaces considerados (mortalidad en UCI o a los 30 días, riesgo combinado de muerte o infarto, fracaso renal agudo o hemorragias moderadas/graves) . CONCLUSIONES: Los resultados evidencian que la efectividad de la EIR es similar en pacientes con función renal normal o reducida y alertan sobre una infrautilización de esta estrategia en estos últimos

OBJECTIVE: To evaluate the use and effectiveness of a routine invasive strategy (RIS) in patients with acute coronary syndrome without persistent ST-segment elevation with renal dysfunction in the real world scenario. METHODS: A retrospective cohort study based on the ARIAM-SEMICYUC Registry (2011-2014) was carried out. Renal dysfunction was defined as GFR (Cockroft-Gault) < 60 ml/min (moderate dysfunction) or < 30 ml/min (severe dysfunction). Patients in which early angiography (< 72h) was performed due to cardiogenic shock or recurrent myocardial ischemia were excluded. The primary endpoint was hospital mortality. Confounding factors were controlled using propensity score analysis. RESULTS: A total of 4,279 patients were analyzed, of which 26% had moderate renal dysfunction and 5% severe dysfunction. Patients with renal dysfunction had greater severity and comorbidity, higher hospital mortality (8.6 vs. 1.8%), and lesser use of the RIS (40 vs. 52%). The adjusted OR for mortality in patients without/with renal dysfunction were 0.38 (95% confidence interval [95% CI] 0.17 to 0.81) and 0.52 (95% CI 0.32 to 0.87), respectively (interaction P-value = .4779). The impact (adjusted risk difference) of RIS was higher in the group with renal dysfunction (-5.1%, 95% CI -8.1 to -2.1 vs. -1.6%, 95% CI -2.6 to -0.6; interaction P-value = .0335). No significant interaction was detected for the other endpoints considered (ICU mortality, 30-day mortality, myocardial infarction, acute renal failure or moderate/severe bleeding). CONCLUSIONS: The results suggest that the effectiveness of IRS is similar in patients with normal or abnormal renal function, and alert to the under-utilization of this strategy in such patients

Escalas pronósticas en la disfunción multiorgánica: estudio de cohortes / Predictive scoring systems in multiorgan failure: A cohort study

OBJETIVO: Valorar el grado en que las escalas pronósticas son capaces de predecir la mortalidad hospitalaria. DISEÑO: Estudio de cohortes retrospectivo de 2 años. ÁMBITO: UCI médico-quirúrgica de un hospital de tercer nivel. PACIENTES: Todos los pacientes con síndrome de disfunción multiorgánica en el primer día de ingreso. Variables de interés: APACHE II y IV, SAPS II y III, MPM II y muerte hospitalaria. RESULTADOS: Se incluyeron 568 pacientes. Mortalidad hospitalaria: 39,8% (226 pacientes). Discriminación (área bajo la curva; IC 95%): APACHE IV (0,805; 0,751-0,858), SAPS II (0,755; 0,697-0,814), MPM II (0,748; 0,688-0,809), SAPS III (0,737; 0,675-0,799) y APACHE II (0,699; 0,633-0,765). El MPM II es el que mejor calibra, seguido por el SAPS III. APACHE II, SAPS II y APACHE IV presentan una muy mala calibración. Razón estandarizada de mortalidad (IC 95%): APACHE IV 1,9 (1,78-2,02); APACHE II 1,1 (1,07-1,13); SAPS III 1,1 (1,06-1,14); SAPS II 1,03 (1,01-1,05); MPM 0,9 (0,86-0,94). CONCLUSIONES: APACHE IV tiene la mejor capacidad discriminativa y mala calibración. MPM II tiene una buena discriminación y la mejor calibración. En cuanto al SAPS II, mantiene la segunda mejor discriminación y una mala calibración. El APACHE II muestra unos valores de calibración y discriminación que desaconsejarían su utilización en la actualidad, y el SAPS III mantiene una adecuada calibración y una discriminación moderada. La valoración de estos resultados podría marcar el inicio de nuevos estudios a nivel regional/nacional en determinadas poblaciones de pacientes críticos

OBJECTIVE: An evaluation is made of the hospital mortality predicting capacity of the main predictive scoring systems. DESIGN: A 2-year retrospective cohort study was carried out. SETTING: A third level ICU with surgical and medical patients. PATIENTS: All patients with multiorgan failure during the first day in the ICU. Main variables: APACHE II and IV, SAPS II and III, MPM II and hospital mortality. RESULTS: A total of 568 patients were included. Mortality rate: 39.8% (226 patients). Discrimination (area under the ROC curve; 95% CI): APACHE IV (0.805; 0.751-0.858), SAPS II (0.755; 0.697-0.814), MPM II (0.748; 0.688-0.809), SAPS III (0.737; 0.675-0.799) and APACHE II (0.699; 0.633-0.765). MPM II showed the best calibration, followed by SAPS III. APACHE II, SAPS II and APACHE IV showed very poor calibration. Standard mortality ratio (95% CI): APACHE IV 1.9 (1.78-2.02); APACHE II 1.1 (1.07-1.13); SAPS III 1.1 (1.06-1.14); SAPS II 1.03 (1.01-1.05); MPM 0.9 (0.86-0.94). CONCLUSIONS: APACHE IV showed the best discrimination, with poor calibration. MPM II showed good discrimination and the best calibration. SAPS II, in turn, showed the second best discrimination, with poor calibration. The APACHE II calibration and discrimination values currently disadvise its use. SAPS III showed good calibration with modest discrimination. Future studies at regional or national level and in certain critically ill populations are needed

Routine invasive strategy in acute coronary syndrome patients with renal dysfunction. Results of the ARIAM-SEMICYUC registry. / Estrategia invasiva de rutina en el síndrome coronario agudo sin elevación del segmento ST con disfunción renal. Resultados del registro ARIAM-SEMICYUC.

OBJECTIVE: To evaluate the use and effectiveness of a routine invasive strategy (RIS) in patients with acute coronary syndrome without persistent ST-segment elevation with renal dysfunction in the real world scenario. METHODS: A retrospective cohort study based on the ARIAM-SEMICYUC Registry (2011-2014) was carried out. Renal dysfunction was defined as GFR (Cockroft-Gault)<60ml/min (moderate dysfunction) or<30ml/min (severe dysfunction). Patients in which early angiography (<72h) was performed due to cardiogenic shock or recurrent myocardial ischemia were excluded. The primary endpoint was hospital mortality. Confounding factors were controlled using propensity score analysis. RESULTS: A total of 4,279 patients were analyzed, of which 26% had moderate renal dysfunction and 5% severe dysfunction. Patients with renal dysfunction had greater severity and comorbidity, higher hospital mortality (8.6 vs. 1.8%), and lesser use of the RIS (40 vs. 52%). The adjusted OR for mortality in patients without/with renal dysfunction were 0.38 (95% confidence interval [95%CI] 0.17 to 0.81) and 0.52 (95%CI 0.32 to 0.87), respectively (interaction P-value=.4779). The impact (adjusted risk difference) of RIS was higher in the group with renal dysfunction (-5.1%, 95%CI -8.1 to -2.1 vs. -1.6%, 95%CI -2.6 to -0.6; interaction P-value=.0335). No significant interaction was detected for the other endpoints considered (ICU mortality, 30-day mortality, myocardial infarction, acute renal failure or moderate/severe bleeding). CONCLUSIONS: The results suggest that the effectiveness of IRS is similar in patients with normal or abnormal renal function, and alert to the under-utilization of this strategy in such patients.

Predictive scoring systems in multiorgan failure: A cohort study.

OBJECTIVE: An evaluation is made of the hospital mortality predicting capacity of the main predictive scoring systems. DESIGN: A 2-year retrospective cohort study was carried out. SETTING: A third level ICU with surgical and medical patients. PATIENTS: All patients with multiorgan failure during the first day in the ICU. MAIN VARIABLES: APACHE II and IV, SAPS II and III, MPM II and hospital mortality. RESULTS: A total of 568 patients were included. Mortality rate: 39.8% (226 patients). Discrimination (area under the ROC curve; 95% CI): APACHE IV (0.805; 0.751-0.858), SAPS II (0.755; 0.697-0.814), MPM II (0.748; 0.688-0.809), SAPS III (0.737; 0.675-0.799) and APACHE II (0.699; 0.633-0.765). MPM II showed the best calibration, followed by SAPS III. APACHE II, SAPS II and APACHE IV showed very poor calibration. Standard mortality ratio (95% CI): APACHE IV 1.9 (1.78-2.02); APACHE II 1.1 (1.07-1.13); SAPS III 1.1 (1.06-1.14); SAPS II 1.03 (1.01-1.05); MPM 0.9 (0.86-0.94). CONCLUSIONS: APACHE IV showed the best discrimination, with poor calibration. MPM II showed good discrimination and the best calibration. SAPS II, in turn, showed the second best discrimination, with poor calibration. The APACHE II calibration and discrimination values currently disadvise its use. SAPS III showed good calibration with modest discrimination. Future studies at regional or national level and in certain critically ill populations are needed.

Información de eventos adversos a pacientes y familiares / Adverse events open disclosure to patients and relatives

Objetivo: Realizar un revisión bibliográfica sobre la información de incidentes y eventos adversos a pacientes y familiares, así como revisar las principales políticas, guías institucionales y aspectos legales relacionados con dicho proceso. Material y método: Se consultaron diferentes fuentes electrónicas y en papel y se utilizó Pub-med como motor de búsqueda principal. Resultados: El sistema sanitario debe buscar la manera de cubrir las necesidades y expectativas de los pacientes cuando ocurre un evento adverso a través del cuidado, soporte emocional e información relativa al evento. Las guías éticas y profesionales establecen la responsabilidad de los profesionales y de las instituciones de desvelar los errores cometidos durante la atención sanitaria. Existen muchas barreras que dificultan llevar a cabo este complejo proceso. La formación de los profesionales y el desarrollo de guías institucionales pueden favorecer el cumplimiento. Los aspectos legales deben ser abordados a nivel local y evaluar el impacto real de un desarrollo legislativo específico sobre la efectividad del proceso. Conclusión: En nuestro ámbito no existen recomendaciones específicas en relación a la información a pacientes y familiares sobre eventos adversos. Se requieren propuestas consensuadas que den respuesta de forma científica y multidisciplinar a esta cuestión con importantes connotaciones tanto éticas como legales (AU)

Objective: Perform a literature review on incidents and adverse events open disclosure to patients and relatives, as well as to review major policies, institutional guides and legal aspects related to this process. Material and method: Different electronic and paper sources were consulted; Pub-med was used as main search engine. Results: The health system must find a way of meeting the needs and expectations of patients, emotional support and information on the event when an adverse event occurs through care. Ethical and professional guidelines set out the professionals and institutions responsibility of revealing the mistakes made during the health care. There are many barriers that make it difficult to carry out this complex process. The training of professionals and the development of institutional guides can encourage compliance. The legal aspects should be dealt with at local level and to assess the real impact of a specific legislative development on the effectiveness of the process. Conclusion: In our area, there are no specific recommendations in relation to the adverse event information to patients and relatives. Required consensus proposals that respond in a scientific and multidisciplinary manner to this question with important connotations both ethical and legal (AU)

Exacerbación de fibrosis pulmonar idiopática tras cirugía de tórax. Presentación de dos casos / Exacerbation of idiopathic pulmonary fibrosis after thoracic surgery

La fibrosis pulmonar idiopática (FPI) constituye el 50-60% de las neumonías intersticiales idiopáticas. Su rasgo histológico distintivo es la fibrosis y la inflamación difusa del parénquima pulmonar, predominantemente en septos alveolares. El diagnóstico se realiza habitualmente mediante criterios clínicos y radiológicos (tomografía computerizada de alta resolución -TACAR- como técnica más sensible), que permiten realizar el diagnóstico sin biopsia pulmonar con una sensibilidad del 90%. Si la TACAR no es concluyente se recomienda realizar una biopsia pulmonar. Un problema relacionado con ésta y otras técnicas quirúrgicas torácicas es la aparición de una exacerbación de la FPI de consecuencias fatales. Presentamos dos pacientes con fibrosis pulmonar que fueron sometidos a cirugía torácica presentando en el postoperatorio inmediato agudización grave con posterior fallecimiento. Por ello concluimos que la realización de biopsia pulmonar y otras técnicas quirúrgicas torácicas en pacientes con sospecha de FPI, debe ser evaluada cuidadosamente al no ser un procedimiento inocuo (AU)

Idiopathic Pulmonary Fibrosis (IFP) represents 50-60 % of idiopathic interstitial pneumonia. Key histological features of IFP include interstitial fibrosis in a “patchwork pattern”, interstitial scarring, honeycomb changes and fibroblast foci. Diagnosis requires clinical findings compatible with interstitial lung disease in combination with either characteristic radiologic finding (the high-resolution CT scans - HRTC - is a more sensitive technique). They allow realize the diagnosis without lung biopsy with asensibility of 90 %. If the HRTC is not conclusive a lung biopsy is recommended. A problem related to lung biopsy and other surgical thoracic technologies is the appearance of a fatal acute exacerbation of the FPI. Lung biopsy and other surgical thoracic technologies for diagnosis and treatment of IPF is not an entirely benign procedure. This information may be used in weighing the risk-benefit ratio in individual patients (AU)

Pronóstico de los ancianos ventilados mecánicamente en la UCI / Prognosis of elderly patients subjected to mechanical ventilation in the ICU

Objetivo Analizar el pronóstico de los pacientes ancianos ventilados mecánicamente en la Unidad de Cuidados Intensivos (UCI).Diseño y ámbito Análisis secundario de un estudio observacional prospectivo y multicéntrico llevado a cabo durante un periodo de 2 años en 13 UCI españolas. Pacientes Pacientes adultos que precisaron ventilación mecánica (VM) invasiva durante más de 24 horas. Intervencione Ninguna. Variables de interés Datos demográficos, APACHE II, SOFA, motivo de VM, comorbilidad, situación funcional, reintubación, duración de la VM, traqueotomía, mortalidad en la UCI, mortalidad hospitalaria. Resultados Se incluyeron 1.661 pacientes. De ellos 1.127 (67,9%) eran hombres. Edad: 62,1±16,2 años. APACHE II: 20,3±7,5. SOFA total: 8,4±3,5. Cuatrocientos veintitrés pacientes (25,4%) tenían 75 años o más. Los índices de comorbilidad y capacidad funcional fueron peor en este grupo de pacientes (p<0,001 para ambas variables). La mortalidad en la UCI fue superior en este grupo (33,6%) que en los más jóvenes (25,9%) (p=0,002), al igual que la mortalidad hospitalaria (41,8 vs 31,8%; p<0,0001). No hubo diferencias en cuanto a tiempo de VM, incidencia de traqueotomías o índice de reintubaciones. Por causas de VM solo los pacientes ≥ 75 años ventilados por neumonía, sepsis o trauma presentaron una mortalidad en UCI más alta que los menores de esa edad (46,3 vs 33,1% p=0,006; 55 vs 25,8% p=0,002; 63,6 vs 4,5% p<0,001 respectivamente).Conclusiones Los ancianos (≥ 75 años) tienen una mayor mortalidad en UCI y hospitalaria que los más jóvenes sin diferencias en la duración de la VM. Las diferencias son a expensas de patologías como neumonía, sepsis y trauma (AU)

Objective To analyze the prognosis of mechanically ventilated elderly patients in the Intensive Care Unit (ICU).Design and scope Sub-analysis of a prospective multicenter observational cohort study conducted over a period of two years in 13 medical-surgical ICUs in Spain. Patients Adult patients who required mechanical ventilation (MV) for longer than 24hours.InterventionsNone.Study variables Demographic data, APACHE II, SOFA, reason for MV, comorbidity, functional condition, reintubation, duration of MV, tracheotomy, ICU mortality, in-hospital mortality. Results A total of 1661 patients were recruited. Males accounted for 67.9% (n=1127), with a mean age of 62.1±16.2 years. APACHE II: 20.3±7.5. Total SOFA: 8.4±3.5. Four hundred and twenty-three patients (25.4%) were ≥ 75 years of age. Comorbidity and functional condition rates were poorer in these patients (p<0.001 for both variables). Mortality in the ICU was higher in the elderly patients (33.6%) than in the younger subjects (25.9%) (p=0.002). Also, in-hospital mortality was higher in those ≥ 75 years of age. No differences in duration of MV, prevalence of tracheostomy or reintubation incidence were found. Regarding the indication for MV, only the patient ≥ 75 years of age with pneumonia, sepsis or trauma had a higher in-ICU mortality than the younger patients (46.3% vs 33.1%, p=0.006; 55% vs 25.8%, p=0.002; 63.6% vs 4.5%, p<0,001, respectively). No differences were found referred to other reasons for MV. Conclusion Older patients (≥ 75 years) have significantly higher in-ICU and in-hospital mortality than younger patients without differences in the duration of mechanical ventilation. Differences in mortality were at the expense of pneumonia, sepsis and trauma (AU)

Prognosis of elderly patients subjected to mechanical ventilation in the ICU.

OBJECTIVE: To analyze the prognosis of mechanically ventilated elderly patients in the Intensive Care Unit (ICU). DESIGN AND SCOPE: Sub-analysis of a prospective multicenter observational cohort study conducted over a period of two years in 13 medical-surgical ICUs in Spain. PATIENTS: Adult patients who required mechanical ventilation (MV) for longer than 24 hours. INTERVENTIONS: None. STUDY VARIABLES: Demographic data, APACHE II, SOFA, reason for MV, comorbidity, functional condition, reintubation, duration of MV, tracheotomy, ICU mortality, in-hospital mortality. RESULTS: A total of 1661 patients were recruited. Males accounted for 67.9% (n=1127), with a mean age of 62.1 ± 16.2 years. APACHE II: 20.3 ± 7.5. Total SOFA: 8.4 ± 3.5. Four hundred and twenty-three patients (25.4%) were ≥ 75 years of age. Comorbidity and functional condition rates were poorer in these patients (p<0.001 for both variables). Mortality in the ICU was higher in the elderly patients (33.6%) than in the younger subjects (25.9%) (p=0.002). Also, in-hospital mortality was higher in those ≥ 75 years of age. No differences in duration of MV, prevalence of tracheostomy or reintubation incidence were found. Regarding the indication for MV, only the patient ≥ 75 years of age with pneumonia, sepsis or trauma had a higher in-ICU mortality than the younger patients (46.3% vs 33.1%, p=0.006; 55% vs 25.8%, p=0.002; 63.6% vs 4.5%, p<0,001, respectively). No differences were found referred to other reasons for MV. CONCLUSION: Older patients (≥ 75 years) have significantly higher in-ICU and in-hospital mortality than younger patients without differences in the duration of mechanical ventilation. Differences in mortality were at the expense of pneumonia, sepsis and trauma.

Modelo de probabilidad de ventilación mecánica prolongada / Prolonged mechanical ventilation probability model

Objetivo: Diseñar un modelo de probabilidad de ventilación mecánica prolongada (VMP) con variables clínicas obtenidas durante las primeras 24 horas de su instauración. Diseño: Estudio de cohorte, observacional, prospectivo, multicéntrico. Ámbito: Trece UCI españolas polivalentes. Pacientes: Adultos ventilados durante más de 24 horas. Intervenciones: Ninguna. Variables de interés: APACHE II, SOFA, variables clínicas y demográficas, motivo de VM, comorbilidad y estado funcional. Se construyó un modelo de riesgo multivariante en el que la variable dependiente tenía tres posibles estados: 1.- Muerte precoz. 2.- Retirada precoz de la VM. 3.- VMP. Resultados: Se incluyeron 1.661 pacientes. El 67,9% (n=1.127) fueron hombres. Edad: 62,1±16,2 años. APACHE II: 20,3±7,5. SOFA: 8,4±3,5. Las puntuaciones APACHE II y SOFA fueron mayores en pacientes ventilados > 7 días (p=0,04 y p=0,0001 respectivamente). El fracaso de la ventilación no invasiva (VNI) se asoció a VMP (p=0,005). Se generó un modelo de riesgo multivariante con las siguientes variables: APACHE II, SOFA, fracaso de VNI, ubicación hospitalaria antes del ingreso en UCI y motivo de ventilación mecánica. La exactitud del modelo global (..) (AU)

Objective: To design a probability model for prolonged mechanical ventilation (PMV) using variables obtained during the first 24hours of the start of MV. Design: An observational, prospective, multicenter cohort study. Scope: Thirteen Spanish medical-surgical intensive care units. Patients: Adult patients requiring mechanical ventilation for more than 24hours. Interventions: None. Study variables: APACHE II, SOFA, demographic data, clinical data, reason for mechanical ventilation, comorbidity, and functional condition. A multivariate risk model was constructed. The model contemplated a dependent variable with three possible conditions: 1. Early mortality; 2. Early extubation; and 3. PMV. Results: Of the 1661 included patients, 67.9% (n=1127) were men. Age: 62.1±16.2 years. APACHE II: 20.3±7.5. Total SOFA: 8.4±3.5. The APACHE II and SOFA scores were higher in patients ventilated for 7 or more days (p=0.04 and p=0.0001, respectively). Noninvasive ventilation failure was related to PMV (p=0.005). A multivariate model for the three above exposed outcomes was generated. The overall accuracy of the model in the training and validation sample was 0.763 (95%IC: 0.729-0.804) and 0.751 (95%IC: 0.672-0.816), respectively. The likelihood ratios (LRs) for early extubation, involving a cutoff point of 0.65, in the training sample were LR (+): 2.37 (95%CI: 1.77-3.19) and LR (-): 0.47 (95%CI: 0.41-0.55). The LRs for the early mortality model, for a cutoff point of 0.73, in the training sample, were LR (+): 2.64 (95%CI: 2.01-3.4) and LR (-): 0.39 (95%CI: 0.30-0.51). Conclusions: The proposed model could be a helpful tool in decision making. However, because of its moderate accuracy, it should be considered as a first approach, and the results should be corroborated by further studies involving larger samples and the use of standardized criteria (AU)

[Prolonged mechanical ventilation probability model]. / Modelo de probabilidad de ventilación mecánica prolongada.

OBJECTIVE: To design a probability model for prolonged mechanical ventilation (PMV) using variables obtained during the first 24 hours of the start of MV. DESIGN: An observational, prospective, multicenter cohort study. SCOPE: Thirteen Spanish medical-surgical intensive care units. PATIENTS: Adult patients requiring mechanical ventilation for more than 24 hours. INTERVENTIONS: None. STUDY VARIABLES: APACHE II, SOFA, demographic data, clinical data, reason for mechanical ventilation, comorbidity, and functional condition. A multivariate risk model was constructed. The model contemplated a dependent variable with three possible conditions: 1. Early mortality; 2. Early extubation; and 3. PMV. RESULTS: Of the 1661 included patients, 67.9% (n=1127) were men. Age: 62.1±16.2 years. APACHE II: 20.3±7.5. Total SOFA: 8.4±3.5. The APACHE II and SOFA scores were higher in patients ventilated for 7 or more days (p=0.04 and p=0.0001, respectively). Noninvasive ventilation failure was related to PMV (p=0.005). A multivariate model for the three above exposed outcomes was generated. The overall accuracy of the model in the training and validation sample was 0.763 (95%IC: 0.729-0.804) and 0.751 (95%IC: 0.672-0.816), respectively. The likelihood ratios (LRs) for early extubation, involving a cutoff point of 0.65, in the training sample were LR (+): 2.37 (95%CI: 1.77-3.19) and LR (-): 0.47 (95%CI: 0.41-0.55). The LRs for the early mortality model, for a cutoff point of 0.73, in the training sample, were LR (+): 2.64 (95%CI: 2.01-3.4) and LR (-): 0.39 (95%CI: 0.30-0.51). CONCLUSIONS: The proposed model could be a helpful tool in decision making. However, because of its moderate accuracy, it should be considered as a first approach, and the results should be corroborated by further studies involving larger samples and the use of standardized criteria.

[Technical and functional standards and implementation of a clinical information system in intensive care units]. / Estándares técnicos y funcionales, y proceso de implantación, de un sistema de información clínica en unidades de cuidados intensivos.

INTRODUCTION: Clinical Information Systems (CIS) are becoming a useful tool for managing patients and data in the ICU. However, the existing CIS differ in their capabilities and technical requirements. It is therefore essential for intensivists, as the end clients of these applications, to define the suitable minimum specifications required in order to be operative and helpful. OBJECTIVES: The Spanish Society of Intensive Care Medicine and Coronary Units, through its Organization and Management Workgroup, has designated a group of clinical and software experts to draft a document with the recommendable technical and operating requirements of these systems. METHODS: The group was formed by ten people supported by managers or engineers from the five principal industries producing CIS in Spain. The project involved the following phases: a) Completion of a check list. This step was considered necessary in order to establish the precise current situation of CIS applications. b) Discussion of the results by the group of experts in a meeting and in online format. RESULTS: The requirements were grouped into four sections: technical, functional, safety and data management. All requirements were classified as basic and optional in order to allow the end user to choose among different options according to the existing budget, though ensuring a minimal set of useful characteristics. A chronogram for the installation process was also proposed.

Intensity of continuous renal replacement therapies in patients with severe sepsis and septic shock: a systematic review and meta-analysis.

The purpose of this study was to assess the efficacy of continuous renal replacement therapies in patients with severe sepsis or septic shock, with or without acute kidney injury. We performed a systematic search in Medline, Embase, Web of Knowledge, Cochrane Library and Clinicaltrials.gov and a hand search of the retrieved studies. We included both randomised controlled clinical trials and subgroups of randomised trials that assessed the effect of continuous renal replacement therapies (at traditional or high doses) and reported clinical outcomes in adult patients with severe sepsis or septic shock. The study selection and data extraction were performed by duplicate. Analysis of heterogeneity and meta-analysis was performed according to the Cochrane Collaboration guidelines for conducting systematic reviews of interventions. Twelve studies (1895 patients) met the inclusion criteria. Pooling of all studies resulted in a mortality risk ratio of 0.96 (95% confidence interval 0.83 to 1.12). The studies showed moderate statistical heterogeneity (I2 statistic 52%, P = 0.02). The effect on mortality was not modified (interaction P values non significant) by the dose of continuous renal replacement therapies, the severity of illness or the risk of bias. The available evidence suggests that these therapies in patients with severe sepsis or septic shock are not associated with an improvement in other outcomes such as haemodynamics, pulmonary gas exchange, multiple organ dysfunction syndrome or length of stay. The best available evidence does not support the routine use of continuous renal replacement therapies (at traditional or high doses) in patients with severe sepsis or septic shock.