The use of mechanical restraint in critical care units: Characterisation, application standards and related factors. Results of a multicentre study.

OBJECTIVES: To describe and characterise the use of mechanical restraint (MR) in critical care units (CCU) in terms of frequency and quality of application and to study its relationship with pain/agitation-sedation/delirium, nurse:patient ratio and institutional involvement. METHOD: Multicentre observational study conducted in 17 CCUs between February and May 2016. The observation time per CCU was 96 h. The main variables were the prevalence of restraint, the degree of adherence to MR recommendations, pain/agitation-sedation/delirium monitoring and institutional involvement (protocols and training of professionals). RESULTS: A total of 1070 patients were included. The overall prevalence of restraint was 19.11%, in patients with endotracheal tube (ETT) 42.10% and in patients without ETT or artificial airway it was 13.92%. Adherence rates between 0% and 40% were obtained for recommendations related to non-pharmacological management and between 0% and 100% for those related to monitoring of ethical-legal aspects. The lower prevalence of restraint was correlated with adequate pain monitoring in non-communicative patients (P < .001) and with the provision of training for professionals (P = .020). An inverse correlation was found between the quality of the use of MR and its prevalence, both in the general group of patients admitted to CCU (r = -.431) and in the subgroup of patients with ETT (r = -.521). CONCLUSIONS: Restraint is especially frequently used in patients with ETT/artificial airway, but is also used in other patients who may not meet the use profile. There is wide room for improvement in non-pharmacological alternatives to the use of MC, ethical and legal vigilance, and institutional involvement. Better interpretation of patient behaviour with validated tools may help limit use of MR.

Uso de contenciones mecánicas en unidades de cuidados críticos: caracterización, estándares de aplicación y factores relacionados. Resultados de un estudio multicéntrico / The use of mechanical restraint in critical care units: Characterisation, application standards and related factors. Results of a multicentre study

Objetivos: Describir y caracterizar el uso de contenciones mecánicas (CM) en unidades de cuidados críticos (UCC) en términos de frecuencia y calidad de aplicación y analizar su relación con la monitorización del dolor/agitación-sedación/delirio, la ratio enfermera:paciente y la implicación institucional. Método: Estudio observacional multicéntrico realizado en 17 UCC entre febrero y mayo del año 2016. El tiempo de observación por UCC fue de 96h. Las principales variables fueron la prevalencia de contenciones, el grado de adherencia a las recomendaciones de uso de CM, la monitorización del dolor/agitación-sedación/delirio y la implicación institucional (protocolos y formación de los profesionales). Resultados: Se incluyeron 1.070 pacientes. La prevalencia general de contenciones fue del 19,11%, en pacientes con tubo endotraqueal (TET) del 42,10% y en pacientes sin TET ni vía aérea artificial del 13,92%. Se obtuvieron valores de adherencia entre el 0 y el 40% para las recomendaciones relacionadas con manejo no farmacológico y entre el 0 y el 100% para las relacionadas con la vigilancia de aspectos ético-legales. La menor prevalencia de contenciones se correlacionó con una adecuada monitorización del dolor en pacientes no comunicativos (p<0,001) y con la impartición de formación a los profesionales (p=0,020). Se halló correlación inversa entre la calidad de aplicación de CM y su prevalencia, tanto en el grupo general de pacientes ingresados en las UCC (r=−0,431) como en el subgrupo de pacientes con TET (r=−0,521). Conclusiones: Las contenciones son especialmente frecuentes en pacientes con TET/vía aérea artificial, pero también están presentes en otros pacientes que a priori no responden al perfil de uso atribuido. Las alternativas no farmacológicas al uso de CM, la vigilancia de aspectos éticos y legales y la implicación institucional presentan un amplio margen de mejora.(AU)

Objectives: To describe and characterise the use of mechanical restraint (MR) in critical care units (CCU) in terms of frequency and quality of application and to study its relationship with pain/agitation-sedation/delirium, nurse:patient ratio and institutional involvement. Method: Multicentre observational study conducted in 17 CCUs between February and May 2016. The observation time per CCU was 96h. The main variables were the prevalence of restraint, the degree of adherence to MR recommendations, pain/agitation-sedation/delirium monitoring and institutional involvement (protocols and training of professionals). Results: A total of 1070 patients were included. The overall prevalence of restraint was 19.11%, in patients with endotracheal tube (ETT) 42.10% and in patients without ETT or artificial airway it was 13.92%. Adherence rates between 0% and 40% were obtained for recommendations related to non-pharmacological management and between 0% and 100% for those related to monitoring of ethical-legal aspects. The lower prevalence of restraint was correlated with adequate pain monitoring in non-communicative patients (P<.001) and with the provision of training for professionals (P=.020). An inverse correlation was found between the quality of the use of MR and its prevalence, both in the general group of patients admitted to CCU (r=−.431) and in the subgroup of patients with ETT (r=−.521). Conclusions: Restraint is especially frequently used in patients with ETT/artificial airway, but is also used in other patients who may not meet the use profile. There is wide room for improvement in non-pharmacological alternatives to the use of MC, ethical and legal vigilance, and institutional involvement. Better interpretation of patient behaviour with validated tools may help limit use of MR.(AU)

Estudio observacional del uso de etanercept biosimilar en el tratamiento de enfermedades reumáticas / Etanercept in rheumatic diseases: observational study

Objetivos: 1.- Conocer la respuesta a etanercept biosimilar (E-BS) en pacientes naive y en pacientes a los que se realizó cambio desde el de referencia (E-R), diagnosticados de enfermedades reumáticas. 2.- Evaluar el impacto económico de estas actuaciones.Métodos: Estudio observacional retrospectivo de 110 pacientes en tratamiento con etanercept (referencia y/o biosimilar). Se analizaron dos grupos de pacientes: 62 pacientes que iniciaron tratamiento con E-BS y 48 pacientes a los que se les realizó cambio desde E-R (switch), y se compararon con grupos control. Variables analizadas: edad, sexo, diagnóstico, tratamiento, unidades dispensadas, modificaciones del tratamiento, motivo de suspensión o cambio, fecha de suspensión y tiempo de seguimiento. Se comparó el coste de la utilización del biosimilar y del que hubiera supuesto el de referencia.Resultados: Las tasas de retención observadas fueron: 65% en los naive (p=0,002) y 90% en los switch. En pacientes naive, el principal motivo de cambio fue respuesta parcial o insuficiente (90%) y en switch posible efecto nocebo (60%). No se observaron reacciones adversas. Al comparar estos grupos con poblaciones control, la principal diferencia fue la proporción de pacientes en los que se mantuvo tratamiento con E-BS frente a E-R, en pacientes naive (65% vs 34%; p=0,003) y switch (90% vs 27%; p<0,0001). La utilización de E-BS supuso un ahorro de 653.668 €.Conclusiones: La utilización de E-BS no fue diferente del E-R en cuanto a resultados clínicos y, desde el punto de vista económico, supone un ahorro sustancial que se debe considerar como medida que ayude a la sostenibilidad del sistema. (AU)

Objetive: 1.- To know the response to biosimilar etanercept (E-BS) in naive patients and in patients who change from the reference (E-R), diagnosed with rheumatic diseases. 2.- To evaluate the economic impact of these actions.Methods: Retrospective observational study of 110 patients in treatment with etanercept (reference and/or biosimilar). Two groups of patients were analyzed: 62 patients who started with E-BS and 48 patients who change from E-R (switch), and they were compared with control groups. Variables analyzed: age, sex, diagnosis, treatment, units dispensed, treatment modifications, reason for suspension or change, date of suspension and follow-up time. The cost of using the biosimilar was compared with that of the reference one.Results: The retention rates observed were: 65% in the naive (p=0.002) and 90% in switch. In naive patients, the main reason for change was partial or insufficient response (90%) and a possible nocebo effect in switch (60%). No adverse reactions were observed. When comparing these groups with control populations, the main difference was the proportion of patients in whom treatment with E-BS was maintained versus ER, in naive patients (65% vs 34%; p=0.003) and in switch (90% vs 27%; p<0.0001). The use of E-BS meant a saving of € 653,668.Conclusions: The use of E-BS was not different from the E-R in terms of clinical results and, from the economic point of view, represents a substantial saving that should be considered as a measure that helps the sustainability of the system. (AU)

[CD64 index as a marker of infection in patients with postoperative fever]. / El índice CD64 como marcador de infección en pacientes con fiebre postoperatoria.

OBJECTIVE: To evaluate the utility of the granulocyte CD64 index as a marker of infection in patients with postoperative fever. METHODS: Prospective observational study of a cohort of patients with postoperative fever (2nd-21st day after the intervention) collected during 14 months. Obtaining blood samples during the first 24 hours after the febrile peak to determine the CD64 index (ratio of fluorescence intensity, measured, in the granulocytes of the patient with respect to healthy controls), procalcitonin and C-reactive protein (CRP). RESULTS: During the study period, 50 patients were included, 28 patients (56%) with infection and 22 patients (44%) without evidence of infection. The PCR, procalcitonin and the CD64 index showed significantly higher values in the group of patients who suffered infection. The CD64 index showed a sensitivity of 88.9%, with a specificity of 65.2%. The positive predictive value (PPV) was 75% and the negative predictive value (NPV) was 83.3%, with an area under the curve (AUC) of 0.805 (95% CI 0.68-0.93). Procalcitonin presented a sensitivity of 53.9% and specificity of 86.4%, with NPV and PPV of 82.4% and 61.3% respectively, with AUC of 0.752 (95% CI 0.61-0.89). Regarding the PCR, it showed a sensitivity of 100%, with specificity of 4.4% with an area under the curve of 0.676 (95% CI 0.52-0.83). CONCLUSIONS: The quantification of the CD64 index in patients who develop fever in the early postoperative period is useful to distinguish post-surgical inflammatory phenomena from episodes of established infection.

Elastografía tipo ARFI: modificación tras tratamiento antiviral en el trasplante hepático con recidiva por VHC / ARFI elastography: changes after direct-acting antiviral treatment in transplanted livers with relapse of hepatitis C virus infection

Objetivo. Evaluar la modificación de los valores en la elastografía hepática tipo ARFI tras el tratamiento antiviral en pacientes con trasplante hepático e infección por el virus de la hepatitis C (VHC) con recidiva durante el postrasplante. Material y métodos. Se han estudiado 15 pacientes receptores de trasplante hepático con infección por el VHC y recidiva sobre el injerto durante el primer año tras el trasplante que fueron tratados con antivirales de acción directa. A todos ellos se les realizó ecografía basal, Doppler y elastografía hepática tipo ARFI en los 3 meses anteriores al inicio del tratamiento y durante los 3 meses posteriores a su finalización. En la misma semana de la elastografía se realizó analítica con perfil hepático y determinación de la carga viral (ARN-VHC) en sangre periférica mediante técnica de reacción en cadena de la polimerasa. Se ha estudiado el cambio en las velocidades de cizallamiento de la elastografía antes y después del tratamiento. El análisis estadístico se ha efectuado mediante el test de Wilcoxon para datos apareados. Resultados. Todos los pacientes alcanzaron una respuesta viral mantenida a los 3 meses de finalizar el tratamiento. Se han encontrado diferencias estadísticamente significativas en las velocidades de la elastografía, con disminución de estas tras finalizar el tratamiento (la mediana de los valores de la onda de cizallamiento previos al tratamiento fue de 1,97m/s, y tras finalizarlo fue de 1,58m/s; p=0,001). Conclusión. La velocidad de la onda de cizallamiento disminuye de manera significativa tras el tratamiento antiviral en los pacientes receptores de trasplante hepático con recidiva de la infección por VHC (AU)

Objective. To evaluate the changes in the values obtained in acoustic radiation force impulse (ARFI) elastography of the liver after antiviral treatment in patients with liver transplants and hepatitis C virus (HVC) infection recurring after transplantation. Material and methods. We studied 15 patients infected with HVC who had received liver transplants where an HVC infection recurring in the graft within one year after the transplant was treated with direct-acting antivirals. All patients underwent ultrasonography including Doppler and ARFI elastography in the three months before starting treatment with direct-acting antivirals (baseline study) and again in the three months after finishing the treatment. In the same week when the elastography study was done, liver function tests were done and the viral load (HCV RNA) was determined in peripheral blood with the polymerase chain reaction method. We used the Wilcoxon test for paired samples to compare the changes in the shear wave velocities before and after treatment. Results. All patients achieved a virologic response that was sustained at 3 months after the end of treatment. On elastography, median shear wave velocities decreased after treatment (1.97m/s before treatment vs. 1.58m/s after treatment; p=0.001). Conclusion. The shear wave velocity decreased significantly after antiviral treatment in patients who had relapsed HVC infection after liver transplantation (AU)

ARFI elastography: changes after direct-acting antiviral treatment in transplanted livers with relapse of hepatitis C virus infection. / Elastografía tipo ARFI: modificación tras tratamiento antiviral en el trasplante hepático con recidiva por VHC.

OBJECTIVE: To evaluate the changes in the values obtained in acoustic radiation force impulse (ARFI) elastography of the liver after antiviral treatment in patients with liver transplants and hepatitis C virus (HVC) infection recurring after transplantation. MATERIAL AND METHODS: We studied 15 patients infected with HVC who had received liver transplants where an HVC infection recurring in the graft within one year after the transplant was treated with direct-acting antivirals. All patients underwent ultrasonography including Doppler and ARFI elastography in the three months before starting treatment with direct-acting antivirals (baseline study) and again in the three months after finishing the treatment. In the same week when the elastography study was done, liver function tests were done and the viral load (HCV RNA) was determined in peripheral blood with the polymerase chain reaction method. We used the Wilcoxon test for paired samples to compare the changes in the shear wave velocities before and after treatment. RESULTS: All patients achieved a virologic response that was sustained at 3 months after the end of treatment. On elastography, median shear wave velocities decreased after treatment (1.97m/s before treatment vs. 1.58m/s after treatment; p=0.001). CONCLUSION: The shear wave velocity decreased significantly after antiviral treatment in patients who had relapsed HVC infection after liver transplantation.

[Patient satisfaction with anesthetic care monitored during phacoemulsification]. / Satisfacción del paciente con el cuidado anestésico monitorizado durante la facoemulsificación.

OBJECTIVES: To assess satisfaction with anesthesia during cataract surgery, as a quality indicator for such surgery. MATERIAL AND METHODS: Patients undergoing cataract surgery with topical and intracameral anesthesia were studied prospectively. We analyzed patient characteristics, physical status, postoperative pain, duration of surgery, administration of an intraoperative sedative, systemic complications, and satisfaction on the Iowa Satisfaction with Anesthesia Scale (ISAS). For patients operated on both eyes, the ISAS score in the first (ISAS1) and second (ISAS2) interventions were compared. RESULTS: A total of 233 patients were included in the study; 36 of them (15.5%) had ISAS scores of less than 5.4. The median ISAS score was 6.0 (interquartile range [IQR], 5.6-6.0). In the 71 patients operated on both eyes, the ISAS1 score was significantly lower than the ISAS2 score. Ten patients (4.3%) had visual analog scores of 3 or more in the postoperative period. Complications developed in 2.9% of the procedures (9/304). The median duration of surgery was 9 minutes (IQR, 8-10 minutes). Postoperative pain was the only factor that predicted a lower level of satisfaction. CONCLUSIONS: Pain is common during phacoemulsification and is the main cause of patient dissatisfaction with anesthetic care.

Satisfacción del paciente con el cuidado anestésico monitorizado durante la facoemulsificación / Patient satisfaction with anesthetic care monitored during phacoemulsification

OBJETIVOS: Evaluar la satisfacción con el cuidadoanestésico monitorizado como indicador de calidad en lacirugía de cataratas.MATERIALES Y MÉTODOS: Se realizó un estudio prospectivoen pacientes intervenidos de cataratas con anestesiatópica e intracamerular. Se analizaron las variablesdemográficas, el estado físico del paciente, dolorpostoperatorio, el tiempo quirúrgico, la administraciónde sedación intraoperatoria, las complicaciones sistémicasy la satisfacción según la escala de Iowa de satisfaccióncon la anestesia (EISA). Se comparó la EISA en laprimera y segunda intervención (EISA1 y EISA2 respectivamente)en los pacientes que se operaron de los dosojos durante el estudio.RESULTADOS: 233 pacientes fueron incluidos en el estudio,de los que un 15,5% (n = 36) tuvo un bajo grado desatisfacción (EISA < 5,4). La mediana muestral de laEISA fue de 6,0 (recorrido intercuartílico 5,6-6,0). En lospacientes operados de los 2 ojos (n = 71) la EISA1 fuesignificativamente menor que la EISA2. El 4,3% (n = 10)de los pacientes tuvo una escala visual analógica (EVA)≥ 3 en el postoperatorio. La frecuencia de complicacionesfue del 2,9 % (n = 9/304). La mediana del tiempoquirúrgico fue de 9 (recorrido intercuartílico 8-10) min.El dolor postoperatorio fue el único factor predictivo delos estudiados de un menor grado de satisfacción.CONCLUSIONES: El dolor perioperatorio es frecuente yes la causa principal de insatisfacción del paciente con elcuidado anestésico durante la facoemulsificaciónOBJETIVOS: Evaluar la satisfacción con el cuidadoanestésico monitorizado como indicador de calidad en lacirugía de cataratas.MATERIALES Y MÉTODOS: Se realizó un estudio prospectivoen pacientes intervenidos de cataratas con anestesiatópica e intracamerular. Se analizaron las variablesdemográficas, el estado físico del paciente, dolorpostoperatorio, el tiempo quirúrgico, la administraciónde sedación intraoperatoria, las complicaciones sistémicasy la satisfacción según la escala de Iowa de satisfaccióncon la anestesia (EISA). Se comparó la EISA en laprimera y segunda intervención (EISA1 y EISA2 respectivamente)en los pacientes que se operaron de los dosojos durante el estudio.RESULTADOS: 233 pacientes fueron incluidos en el estudio,de los que un 15,5% (n = 36) tuvo un bajo grado desatisfacción (EISA < 5,4). La mediana muestral de laEISA fue de 6,0 (recorrido intercuartílico 5,6-6,0). En lospacientes operados de los 2 ojos (n = 71) la EISA1 fuesignificativamente menor que la EISA2. El 4,3% (n = 10)de los pacientes tuvo una escala visual analógica (EVA)≥ 3 en el postoperatorio. La frecuencia de complicacionesfue del 2,9 % (n = 9/304). La mediana del tiempoquirúrgico fue de 9 (recorrido intercuartílico 8-10) min.El dolor postoperatorio fue el único factor predictivo delos estudiados de un menor grado de satisfacción.CONCLUSIONES: El dolor perioperatorio es frecuente yes la causa principal de insatisfacción del paciente con el cuidado anestésico durante la facoemulsificación

OBJECTIVES: To assess satisfaction with anesthesia during cataract surgery, as a quality indicator for such surgery. MATERIAL AND METHODS: Patients undergoing cataract surgery with topical and intracameral anesthesia were studied prospectively. We analyzed patient characteristics, physical status, postoperative pain, duration of surgery, administration of an intraoperative sedative, systemic complications, and satisfaction on the Iowa Satisfaction with Anesthesia Scale (ISAS). For patients operated on both eyes, the ISAS score in the first (ISAS1) and second (ISAS2) interventions were compared. RESULTS: A total of 233 patients were included in the study; 36 of them (15.5%) had ISAS scores of less than 5.4. The median ISAS score was 6.0 (interquartile range [IQR], 5.6-6.0). In the 71 patients operated on both eyes, the ISAS1 score was significantly lower than the ISAS2 score. Ten patients (4.3%) had visual analog scores of 3 or more in the postoperative period. Complications developed in 2.9% of the procedures (9/304). The median duration of surgery was 9 minutes (IQR, 8-10 minutes). Postoperative pain was the only factor that predicted a lower level of satisfaction. CONCLUSIONS: Pain is common during phacoemulsification and is the main cause of patient dissatisfaction with anesthetic care