Evaluación de las coberturas de vacunación antineumocócica y antigripal en pacientes reumatológicos con terapia biológica de un hospital autonómico de referencia / Evaluation of pneumococcal and influenza vaccination coverage in rheumatology patients receiving biological therapy in a regional referral hospital

OBJETIVO: Conocer las coberturas de vacunación frente a gripe estacional y neumococo en pacientes reumatológicos con terapia biológica. Identificar las variables que predicen adherencia a la vacunación. MATERIAL Y MÉTODO: Estudio transversal. Se incluyeron los pacientes reumatológicos que iniciaron terapia biológica entre el 01/01/2016 y el 31/12/2016 en un hospital autonómico de referencia. Se recogieron variables sociodemográficas, relacionadas con el diagnóstico, médico prescriptor, derivación a la Unidad de Vacunas y vacunación frente a neumococo con vacuna conjugada de 13 serotipos (VNC13) y polisacárida de 23 serotipos (VNP23), así como gripe estacional (2016/17). Se realizó análisis univariante, bivariante (Chi-cuadrado) y multivariante (regresión logística). Se consideró significativa una p < 0,05 y se utilizó el programa PASW V.18. RESULTADOS: Se incluyeron 222 pacientes. Las coberturas de vacunación fueron: VNC13, 80,2%; VNP23v, 77,9%; gripe 2016/17, 78,8%; VNC13 + VNP23, 75,2%; VNC13 + VNP23 + gripe 2016/17, 68,9%. La espondilitis axial registró las coberturas más altas (>80%) para la vacunación antineumocócica y en combinación con la antigripal. El 27% de los pacientes no fueron derivados a la Unidad. El médico prescriptor se asoció de manera estadísticamente significativa con cada una de las vacunas y sus combinaciones, pero fue la derivación a la Unidad de Vacunas la que se asoció de manera independiente con las mayores coberturas de vacunación (p < 0,001) en todos los casos. CONCLUSIONES: Comparando con la literatura científica, consideramos que las coberturas frente a neumococo y gripe en estos pacientes son elevadas. La derivación de estos pacientes a la Unidad de Vacunas resulta clave para garantizar una correcta inmunización y minimizar así algunos de los posibles efectos adversos infecciosos de las terapias biológicas

OBJECTIVE: Vaccination coverage for seasonal influenza and pneumococcus in rheumatology patients receiving biological treatment. To identify variables that predict vaccination adherence. MATERIAL AND METHOD: Descriptive cross-sectional study. The study involved rheumatology patients who initiated biological therapy between 01/01/2016 and 12/31/2016 in a regional referral hospital. Variables included sociodemographic information, diagnostic data, treating physician, referral to the vaccine unit and vaccination against pneumococcus with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23), as well as seasonal influenza (2016/17). Univariate, bivariate (Chi-square) and multivariate analysis (logistic regression) were performed. The differences were considered significant (P<.05) and the PASW V.18 software package was used. RESULTS: In all, 222 patients were included. Vaccination coverage was: PCV13, 80.2%; PPSV23, 77.9%; influenza 2016/17, 78.8%; PCV13 + PPSV23, 75.2%; PCV13 + PPSV23 + influenza 2016/17, 68.9%. Axial spondylitis had the highest coverage (>80%) for pneumococcal vaccination and combination of pneumococcal with influenza. Overall, 27% of the patients were not referred to the unit. The treating physician was associated with statistical significance in each vaccine alone or combined, but referral to the vaccine unit was independently associated with the highest vaccination coverage (P<.001) in all cases. CONCLUSIONS: Compared to the scientific literature, we consider that the coverage of our patients against pneumococcus and influenza is high. Referral of these patients to the vaccine unit is the key to guarantee a correct immunization and to minimize some of the possible infectious adverse effects of biological therapies

Evaluation of pneumococcal and influenza vaccination coverage in rheumatology patients receiving biological therapy in a regional referral hospital. / Evaluación de las coberturas de vacunación antineumocócica y antigripal en pacientes reumatológicos con terapia biológica de un hospital autonómico de referencia.

OBJECTIVE: Vaccination coverage for seasonal influenza and pneumococcus in rheumatology patients receiving biological treatment. To identify variables that predict vaccination adherence. MATERIAL AND METHOD: Descriptive cross-sectional study. The study involved rheumatology patients who initiated biological therapy between 01/01/2016 and 12/31/2016 in a regional referral hospital. Variables included sociodemographic information, diagnostic data, treating physician, referral to the vaccine unit and vaccination against pneumococcus with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23), as well as seasonal influenza (2016/17). Univariate, bivariate (Chi-square) and multivariate analysis (logistic regression) were performed. The differences were considered significant (P<.05) and the PASW v.18 software package was used. RESULTS: In all, 222 patients were included. Vaccination coverage was: PCV13, 80.2%; PPSV23, 77.9%; influenza 2016/17, 78.8%; PCV13+PPSV23, 75.2%; PCV13+PPSV23+influenza 2016/17, 68.9%. Axial spondylitis had the highest coverage (>80%) for pneumococcal vaccination and combination of pneumococcal with influenza. Overall, 27% of the patients were not referred to the unit. The treating physician was associated with statistical significance in each vaccine alone or combined, but referral to the vaccine unit was independently associated with the highest vaccination coverage (P<.001) in all cases. CONCLUSIONS: Compared to the scientific literature, we consider that the coverage of our patients against pneumococcus and influenza is high. Referral of these patients to the vaccine unit is the key to guarantee a correct immunization and to minimize some of the possible infectious adverse effects of biological therapies.

Evaluación de las coberturas de vacunación en pacientes con implante coclear de un hospital de referencia del norte de España / Evaluation of vaccination coverage in cochlear implant patients at a referral hospital in Northern Spain

Antecedentes y objetivo: El riesgo de meningitis bacteriana aumenta en los pacientes con implante coclear. Por ello, se indica la vacunación antineumocócica, antigripal y frente a Haemophilus influenzae tipo b en este grupo. El objetivo del presente estudio es conocer el cumplimiento del calendario vacunal en los pacientes implantados en un hospital de referencia. Materiales y métodos: Se incluyeron los pacientes con implante coclear intervenidos entre 2005 y 2015. Se evaluaron las coberturas vacunales frente a gripe estacional, Haemophilus influenzae tipo b, neumococo conjugada de 13 serotipos y neumococo polisacárida de 23 serotipos. Se dividió la muestra en 2 grupos por edad (< 14 años y ≥ 14 años). Se realizó un análisis univariante y bivariante. Resultados: De los 153 pacientes estudiados (28,01% 0-13 años y 71,9% ≥ 14), solo 2 (5,71%) tuvieron un 100% de adherencia al calendario vacunal, mientras que el 65,71% registró un cumplimiento del 50% o menor. Globalmente, la cobertura de vacunación frente a la pauta secuencial de neumococo fue del 48,57%. La población pediátrica superó el 90% de cobertura para la vacuna frente a Haemophilus influenzae tipo b y neumococo conjugada de 13 serotipos, mientras que en los mayores de 14 años apenas superó el 50%. La cobertura frente a gripe estacional fue inferior al 40%. Se obtuvo una correlación inversa entre la edad y el cumplimiento, aunque no estadísticamente significativa. Conclusiones. Las coberturas de vacunación en los pacientes con implante coclear evaluados son más bajas de lo esperado. Se propone la colaboración estrecha entre los servicios de Otorrinolaringología y las Unidades de Vacunas como principal estrategia para la mejora

Background and objective: The risk of bacterial meningitis increases in cochlear implant patients. Therefore, pneumococcal, influenza and Haemophilus influenzae type b vaccination is indicated in this group. The aim of this study was to determine compliance with the vaccination calendar in patients implanted in a referral hospital. Materials and methods: Patients with cochlear implant operated between 2005 and 2015 were included. Vaccine coverage for seasonal influenza, Haemophilus influenzae type b and pneumococcal conjugate 13-serotypes and pneumococcal polysaccharide 23-serotypes was evaluated. The sample was divided into 2 age groups (< 14 years and ≥ 14 years). A univariate and bivariate analysis was performed. Results: Of the 153 patients studied (28.01% 0-13 years old and 71.9% ≥ 14), only 2 (5.71%) had 100% adherence to the vaccination schedule, while 65.71% had compliance of 50% or less. Overall, vaccination coverage against the sequential pneumococcal pattern was 48.57%. The paediatric population exceeded 90% coverage for the vaccine against Haemophilus influenzae type b and pneumococcal conjugate 13-serotypes while in those over 14 years of age it barely exceeded 50%. Influenza coverage was less than 40%. An inverse correlation was obtained between age and compliance, although not statistically significant. Conclusions: Vaccination coverage in patients with cochlear implant is lower than expected. Close collaboration between Otolaryngology departments and the Vaccination Units is proposed as the main strategy for improvement

The Value of Adding Surveillance Cultures to Fluoroquinolone Prophylaxis in the Management of Multiresistant Gram Negative Bacterial Infections in Acute Myeloid Leukemia.

Multidrug resistant Gram-Negative Bacterial Infections (MR-GNBI) are an increasing cause of mortality in acute myeloid leukemia (AML), compromising the success of antineoplastic therapy. We prospectively explored a novel strategy, including mandatory fluoroquinolone prophylaxis, weekly surveillance cultures (SC) and targeted antimicrobial therapy for febrile neutropenia, aimed to reduce infectious mortality due to MR-GNBI. Over 146 cycles of chemotherapy, cumulative incidence of colonization was 50%. Half of the colonizations occurred in the consolidation phase of treatment. Application of this strategy led to a significant reduction in the incidence of GNB and carbapenemase-producing Klebisella pneumoniae (cpKp) species, resulting in a reduction of infectious mortality (HR 0.35 [95%, CI 0.13-0.96], p = 0.042). In multivariate analysis, fluroquinolone prophylaxis in addition to SC was associated with improved survival (OR 0.55 [95% CI 0.38-0.79], p = 0.001). Targeted therapy for colonized patients did not overcome the risk of death once cpKp or XDR Pseudomonas aeruginosa infections were developed. Mortality rate after transplant was similar between colonized and not colonized patients. However only 9% of transplanted patients were colonized by cpkp. In conclusion, colonization is a common phenomenon, not limited to the induction phase. This strategy reduces infectious mortality by lowering the global incidence of GN infections and the spread of resistant species.

Reacciones adversas asociadas a la vacunación en pacientes inmunodeprimidos y en situaciones especiales de una Unidad de Vacunas hospitalaria / Vaccine-related adverse reactions in immunocompromised patients and in special situations of a hospital Vaccine Unit

OBJETIVOS: Describir el tipo de vacunas administradas en la Unidad de Vacunas de un hospital de referencia y calcular la tasa de notificación global y específica de las reacciones adversas asociadas. MÉTODOS: Estudio observacional retrospectivo, realizado en el periodo entre noviembre de 2014 y noviembre de 2017, de los pacientes que desarrollaron una reacción adversa a medicamento (RAM) tras la administración de una vacuna y que fue notificada al Sistema Español de Farmacovigilancia. Las variables analizadas fueron edad, sexo, grupo de riesgo, tipo de vacuna, coadministración y tipo de RAM. Se llevó a cabo un análisis univariante y bivariante. Se calculó la tasa de notificación de RAM global y específica para cada vacuna. RESULTADOS: Se administraron un total de 18.123 vacunas de las que el 20,7% correspondían a la vacuna frente al virus de la hepatitis B. Se notificaron 53 sospechas de RAM. En el 64,2% de las ocasiones se había administrado solamente una vacuna. El 88,7% de las notificaciones correspondieron a vacunas inactivadas. La vacuna frente neumococo polisacárida de 23 serotipos fue la que generó el mayor número de notificaciones. La tasa de notificación global de RAM fue de 0,42%. La vacuna hexavalente fue la que registró la tasa de notificación más elevada (2,81%). El 49,1% de las RAM fueron de tipo sistémico. CONCLUSIONES: La tasa de notificación global fue baja aunque superior a la registrada por otros autores. La correcta notificación de posibles reacciones adversas postvacunales es imprescindible para contribuir a la seguridad vacunal y para aumentar la confianza de la población en las vacunas

OBJECTIVES: The aim of the study was to describe the type of vaccines administered in the Vaccine Unit at a reference hospital. Calculate the overall and specific reporting rate of adverse reactions. METHODS: Retrospective observational study for the period between November 2014 and November 2017, on patients who developed an adverse drug reaction (ADR) after the administration of a vaccine and who were notified to the Spanish Pharmacovigilance System. The variables analyzed were age, sex, risk group, vaccine class, co-administration and type of ADR. A univariate and bivariate analysis was performed. The global and vaccine specific rate of ADR notification was calculated. RESULTS: A total of 18,123 vaccines were administered, of which 20.7% corresponded to hepatitis B virus vaccine. Fifty-three RAM suspects were reported. In 64.2% of cases only one vaccine was administered. Inactivated vaccines accounted for 88.7% of notifications. The highest number of notifications was generated by the 23 serotypes pneumococcal polysaccharide vaccine. The overall reporting rate was 0.42%. The hexavalent vaccine had the highest reporting rate (2.81%).49.1% of the ADR were systemic. CONCLUSIONS: The overall reporting rate was low but higher than that of other authors. Proper reporting of possible adverse post-vaccine reactions is essential to contribute to vaccine safety and to increase public confidence in vaccines

Reactivación del síndrome periódico asociado a criopirinas tras la vacunación en una paciente candidata a inmunosupresión / Reactivation of the cryopyrin-associated periodic syndrome after vaccination in a patient who is a candidate for immunosuppression

No disponible

[Outbreak of extended-spectrum beta-lactamase-producing Klebsiella pneumoniae in a neonatal intensive care unit: Risk factors and key preventive measures for eradication in record time]. / Brote de Klebsiella pneumoniae productora de betalactamasas de espectro extendido en una unidad de cuidados intensivos neonatales: factores de riesgo y medidas de prevención clave para su erradicación en tiempo récord.

INTRODUCTION: In November 2014, an extended-spectrum beta-lactamase producing Klebsiella pneumoniae outbreak was detected in the neonatal intensive care unit of a tertiary care hospital. OBJECTIVE: Our aim was to determine the clinical, epidemiological and microbiological characteristics of the outbreak, to analyse the identified risk factors and to describe the preventive and control measures implemented for its eradication. METHODS: We conducted a case-control study. We performed Univariate and bivariate analyses, defining statistical significance as a p-value of less than 0.05. The implemented preventive and control measures were aimed at establishing the magnitude of the outbreak, effective communication, the evaluation of health care processes and education on patient safety. Clinical samples were collected for molecular and phenotypic characterization. FINDINGS: The sample consisted of 51 newborns, of who 17 were cases and the remaining 34 controls. The distribution of cases by birth weight was: 2 cases (11.8%) greater than 2500g, 4 cases (23.5%) between 1500 and 2500g, 5 cases (29.4%) between 1000 and 1500g, and 5 cases (29.4%) less than 1000g. In one case, the birth weight was not documented in the health record. The following risk factors for colonization or infection were statistically significant in our study: presence of a central venous catheter (OR, 5.0 [95% CI, 1.4-17.8]; P=.016); parenteral nutrition (OR, 6.8 [95% CI, 1.8-25.7]; P=.006); urinary catheterization (OR, 5.9 [95% CI, 1.2-30.0]; P=.028) and birth weight (P=.035). We found statistically significant differences in the mean total length of stay in hospital (P=.004) and length of stay in the NICU (P=.002). All 17 cases presented antimicrobial resistance with presence of extended-spectrum beta-lactamase type CTX-M-14. CONCLUSION: Workplace interventions focused on patient safety need to be reinforced, especially those concerning practices with the potential to increase the extrinsic risk of colonization or infection by extended-spectrum beta-lactamase -producing K. pneumoniae in the NICU, such as the insertion, care and maintenance of central venous catheter, parenteral nutrition and urinary catheterization.

Brote de Klebsiella pneumoniae productora de betalactamasas de espectro extendido en una unidad de cuidados intensivos neonatales: factores de riesgo y medidas de prevención clave para su erradicación en tiempo récord / Outbreak of extended-spectrum beta-lactamase-producing Klebsiella pneumoniae in a neonatal intensive care unit: Risk factors and key preventive measures for eradication in record time

Introducción: En noviembre de 2014, se detectó un brote de Klebsiella pneumoniae productora de betalactamasas de espectro extendido en la unidad de cuidados intensivos neonatales de un hospital terciario. Objetivo: El objetivo fue describir las características clínicas, epidemiológicas y microbiológicas del brote, analizar los factores de riesgo asociados y presentar las medidas preventivas y de control implementadas para su erradicación. Métodos: Estudio de casos y controles. Se realizaron análisis univariantes y bivariantes, considerándose estadísticamente significativo un valor de p < 0,05. Las medidas preventivas y de control se centraron en la necesidad de determinar la magnitud del problema, en la comunicación efectiva, la evaluación de los procedimientos sanitarios y la educación sobre la seguridad del paciente. Se realizó caracterización molecular y fenotípica de muestras clínicas. Resultados: La muestra de estudio consistió en 51 neonatos, de los que 17 fueron casos y los 34 restantes controles. La distribución de casos por peso al nacer fue: 2 con peso > 2.500 g (11,8%), 4 con peso de 1.500-2.500g (23,5%), 5 con peso de 1.000-1.500g (29,4%) y 5 con peso < 1.000g (29,4%). En un caso no se había registrado el peso al nacer en la historia clínica. Los factores de riesgo estadísticamente significativos para la colonización/infección fueron: presencia de catéter venoso (OR = 5,0 [IC 95% 1,4-17,8]; p = 0,016); nutrición parenteral (OR = 6,8 [IC 95%: 1,8-25,7]; p = 0,006); sondaje vesical (OR = 5,9 [IC 95% 1,2-30,0]; p = 0,028) y peso al nacer (p = 0,035). Encontramos diferencias estadísticamente significativas en la estancia hospitalaria media (p = 0,004) y los días de estancia en la unidad de cuidados intensivos neonatales (p=0,002). Se encontró resistencia a antimicrobianos tipo betalactamasas de espectro extendido CTX-M-14 en los 17 casos. Conclusión: Han de reforzarse las iniciativas de trabajo sobre la seguridad de los pacientes, especialmente aquellas aplicables a intervenciones con el potencial de aumentar el riesgo de colonización/infección por K. pneumoniae productora de betalactamasas de espectro extendido en la unidad de cuidados intensivos neonatales, como las asociadas a la inserción, cuidado y mantenimiento de catéter venoso, la nutrición parenteral y el sondaje vesical

Introduction: In November 2014, an extended-spectrum beta-lactamase producing Klebsiella pneumoniae outbreak was detected in the neonatal intensive care unit of a tertiary care hospital. Objective: Our aim was to determine the clinical, epidemiological and microbiological characteristics of the outbreak, to analyse the identified risk factors and to describe the preventive and control measures implemented for its eradication. Methods: We conducted a case-control study. We performed Univariate and bivariate analyses, defining statistical significance as a p-value of less than 0.05. The implemented preventive and control measures were aimed at establishing the magnitude of the outbreak, effective communication, the evaluation of health care processes and education on patient safety. Clinical samples were collected for molecular and phenotypic characterization. Findings: The sample consisted of 51 newborns, of who 17 were cases and the remaining 34 controls. The distribution of cases by birth weight was: 2 cases (11.8%) greater than 2500 g, 4 cases (23.5%) between 1500 and 2500g, 5 cases (29.4%) between 1000 and 1500 g, and 5 cases (29.4%) less than 1000g. In one case, the birth weight was not documented in the health record. The following risk factors for colonization or infection were statistically significant in our study: presence of a central venous catheter (OR, 5.0 [95% CI, 1.4-17.8]; P = .016); parenteral nutrition (OR, 6.8 [95% CI, 1.8-25.7]; P = .006); urinary catheterization (OR, 5.9 [95% CI, 1.2-30.0]; P = .028) and birth weight (P = .035). We found statistically significant differences in the mean total length of stay in hospital (P = .004) and length of stay in the NICU (P = .002). All 17 cases presented antimicrobial resistance with presence of extended-spectrum beta-lactamase type CTX-M-14. Conclusion: Workplace interventions focused on patient safety need to be reinforced, especially those concerning practices with the potential to increase the extrinsic risk of colonization or infection by extended-spectrum beta-lactamase -producing K. pneumoniae in the NICU, such as the insertion, care and maintenance of central venous catheter, parenteral nutrition and urinary catheterization

Broncoespasmo y flushing tras la vacunación con neumococo polisacárida de 23 serotipos en pacientes crónicos / Bronchospasm and flushing after vaccination with 23 serotype pneumococcal polysaccharide in chronic patients

Objetivos: Describir las características clínico-epidemiológicas en una serie de casos de sospecha de reacciones adversas sistémicas registradas tras la administración de la vacuna frente a neumococo polisacárida de 23 serotipos (PNEUMOVAX23(R)). Calcular la incidencia acumulada de dicha reacción y conocer si se han descrito casos similares y/o compatibles en la literatura científica o en Farmacovigilancia. Métodos: Estudio observacional retrospectivo realizado entre 01/12/2015 y 30/09/2017 en la Unidad de Vacunas de un hospital autonómico de referencia. Se calculó la incidencia acumulada de la reacción adversa sistémica para esa vacuna. Se consultó la base de datos del Sistema Español de Farmacovigilancia (FEDRA). Resultados: Se registraron 9 sospechas de reacciones adversas sistémicas inmediatas (flushing + broncoespasmo + SatO2<95%). La incidencia acumulada fue 1,036%. El desenlace fue recuperado/resuelto para todos. No se encontraron casos similares y/o compatibles. Conclusiones: Las reacciones descritas no constan en la ficha técnica de PNEUMOVAX23(R). Epidemiológicamente no se puede establecer ninguna relación causal entre la aparición de los síntomas y las variables estudiadas. Esta información podría ser la base de investigaciones más amplias que supusieran la posible modificación de la ficha técnica

Objectives: To describe the clinical-epidemiological characteristics of a series of suspected systemic adverse reactions registered with the 23 serotype pneumococcal polysaccharide vaccine (PNEUMOVAX23(R)). Calculate the cumulative incidence of the reaction and know if similar and/or compatible cases have been described in the scientific literature or in pharmacovigilance. Methods: Observational and retrospective study realized between 01/12/2015 and 30/09/2017 in the Vaccines Unit of an autonomic reference hospital. We calculated the cumulative incidence of the adverse reaction for that vaccine. The common pharmacovigilance database (FEDRA) was consulted. Results: Nine systemic adverse reactions were recorded (flushing + bronchospasm + SatO2<95%). The cumulative incidence was 1.036%. The outcome was recovered/resolved for everyone. No similar and/or compatible cases were found. Conclusions: The reactions described do not appear in the PNEUMOVAX23(R) data sheet. Epidemiologically, no causal relationship can be established between the symptoms and the variables studied. This study could be the basis for more detailed research that could modify the vaccine data sheet

Evaluation of vaccination coverage in cochlear implant patients at a referral hospital in Northern Spain. / Evaluación de las coberturas de vacunación en pacientes con implante coclear de un hospital de referencia del norte de España.

BACKGROUND AND OBJECTIVE: The risk of bacterial meningitis increases in cochlear implant patients. Therefore, pneumococcal, influenza and Haemophilus influenzae type b vaccination is indicated in this group. The aim of this study was to determine compliance with the vaccination calendar in patients implanted in a referral hospital. MATERIALS AND METHODS: Patients with cochlear implant operated between 2005 and 2015 were included. Vaccine coverage for seasonal influenza, Haemophilus influenzae type b and pneumococcal conjugate 13-serotypes and pneumococcal polysaccharide 23-serotypes was evaluated. The sample was divided into 2 age groups (<14 years and≥14 years). A univariate and bivariate analysis was performed. RESULTS: Of the 153 patients studied (28.01% 0-13 years old and 71.9%≥14), only 2 (5.71%) had 100% adherence to the vaccination schedule, while 65.71% had compliance of 50% or less. Overall, vaccination coverage against the sequential pneumococcal pattern was 48.57%. The paediatric population exceeded 90% coverage for the vaccine against Haemophilus influenzae type b and pneumococcal conjugate 13-serotypes while in those over 14 years of age it barely exceeded 50%. Influenza coverage was less than 40%. An inverse correlation was obtained between age and compliance, although not statistically significant. CONCLUSIONS: Vaccination coverage in patients with cochlear implant is lower than expected. Close collaboration between Otolaryngology departments and the Vaccination Units is proposed as the main strategy for improvement.

Reacciones adversas asociadas a la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales / Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations

Objetivo: Conocer el perfil de seguridad de la vacuna del meningococo B (4CMenB) en adultos en situaciones especiales. Método: Estudio prospectivo de seguridad de fase IV. Se aplicaron criterios de inclusión y ciertas condiciones de vacunación. Se recogieron las reacciones adversas descritas en la ficha técnica. La evaluación de las reaccio nes adversas se realizó a las 24 horas de la vacunación ("solicitadas") y durante los siete primeros días ("no solicitadas"). Resultados: Se incluyeron 72 pacientes (54,2% hombres; media de edad 52,5 años; 81,9% asplenia anatómica). La frecuencia de fiebre > 38 ºC en las primeras 24 horas fue mayor de la observada en la ficha técnica para el grupo de adultos (12,5% versus no conocida). Más del 75% de los pacientes refirió dolor local en las primeras horas [media de la puntuación de la Escala Visual Analógica 3,22 (IC95%: 2,67-3,76) en la primera dosis y 3,23 (IC95%: 2,69-3,78) en la segunda dosis]. No hubo diferencias estadísticamente significativas. El 97,22% registró síntomas hasta los siete días postvacunación. Conclusiones: 4CMenB muestra un buen perfil de seguridad en adultos en situaciones especiales. La frecuencia de fiebre > 38 ºC es mayor que la esperada. El dolor local es la reacción adversa más frecuentemente registrada, pero la intensidad es baja. Estos resultados invitan a una revisión de la situación de cara a sugerir una posible modificación de la ficha técnica

Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied. The adverse reactions described in the data sheet were collected. The adverse reactions evaluation was performed 24 hours after vaccination ("requested") and during the first seven days ("not requested"). Results: 72 patients were included (54.2% men, mean age 52.5 years, 81.9% anatomic asplenia). The frequency of fever > 38 ºC in the first 24 hours of vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours [average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the 1st dose and 3.23 (95% CI: 2.69-3.78) in the 2nd dose]. There were no statistically significant differences. 97.22% registered symptoms until 7 days after vaccination. Conclusions: 4CMenB shows a good safety profile in adults in special situations. The frequency of fever > 38 ºC is higher than expected. Local pain is the most frequently recorded adverse reactions, but the intensity is low. These results suggest a review of the situation in order to suggest a possible modification of the summary of product characteristics of the vaccine

Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations.

OBJECTIVE: To know the safety profile of the 4CMenB vaccine in adults in special situations. METHOD: Security prospective study of phase IV. Inclusion criteria and some  vaccination conditions were applied. The adverse reactions described in the data  sheet were collected. The adverse reactions evaluation was performed 24 hours  after vaccination ("requested") and during the first seven days ("not  requested"). RESULTS: 72 patients were included (54.2% men, mean age 52.5 years, 81.9%  anatomic asplenia). The frequency of fever > 38 ºC in the first 24 hours of  vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours [average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the first dose and 3.23 (95% CI: 2.69-3.78) in the second dose]. There were no statistically significant differences. 97.22% registered symptoms until 7 days  after vaccination. CONCLUSIONS: 4CMenB® shows a good safety profile in adults in special situations. The frequency of fever > 38 ºC is higher than expected. Local  pain is the most frequently recorded adverse reactions, but the intensity is low.  These results suggest a review of the situation in order to suggest a possible  modification of the summary of product characteristics of the vaccine.

Objetivo: Conocer el perfil de seguridad de la vacuna del meningococo B  (4CMenB) en adultos en situaciones especiales.Método: Estudio prospectivo de seguridad de fase IV. Se aplicaron criterios de  inclusión y ciertas condiciones de vacunación. Se recogieron las reacciones adversas descritas en la ficha técnica. La evaluación de las reacciones adversas se realizó a las 24 horas de la vacunación ("solicitadas") y  durante los siete primeros días ("no solicitadas").Resultados: Se incluyeron 72 pacientes (54,2% hombres; media de edad 52,5  años; 81,9% asplenia anatómica). La frecuencia de fiebre > 38 ºC en las  primeras 24 horas fue mayor de la observada en la ficha técnica para el grupo  de adultos (12,5% versus no conocida). Más del 75% de los pacientes refirió  dolor local en las primeras horas [media de la puntuación de la Escala Visual  Analógica 3,22 (IC95%: 2,67-3,76) en la primera dosis y 3,23 (IC95%: 2,69- 3,78) en la segunda dosis]. No hubo diferencias estadísticamente significativas.  El 97,22% registró síntomas hasta los siete días postvacunación.Conclusiones: 4CMenB® muestra un buen perfil de seguridad en adultos en  situaciones especiales. La frecuencia de fiebre > 38 ºC es mayor que la  esperada. El dolor local es la reacción adversa más frecuentemente registrada,  pero la intensidad es baja. Estos resultados invitan a una revisión de la situación  de cara a sugerir una posible modificación de la ficha técnica.

Adaptación de los calendarios de vacunación en población pediátrica que ha recibido quimioterapia / Adapting immunisation schedules for children undergoing chemotherapy

Introducción: Los niños que son sometidos a quimioterapia en el contexto de un cáncer presentan necesidades especiales de vacunación una vez finalizado el tratamiento. El objetivo de este trabajo es evaluar la adaptación de los calendarios de vacunación posquimioterapia en una población pediátrica. Método: Estudio observacional de una cohorte retrospectiva. Se incluyeron todos los niños entre 0 y 14 años que recibieron quimioterapia en un hospital de tercer nivel entre 2009 y 2015. Se aplicaron criterios de inclusión/exclusión. Se siguieron las indicaciones oficiales del Comité Asesor de Vacunas de la Asociación Española de Pediatría para estas situaciones. Se consultó el registro de vacunación de Atención Primaria y el de la Unidad de Vacunas del Servicio de Medicina Preventiva y Salud Pública del centro sanitario. Resultados: De los 99 niños que recibieron quimioterapia, se incluyeron en el estudio 51. El 70,6% fueron varones. El 54,9% padecían un tumor de órgano sólido y el 45,1% un tumor hematológico. El 70,6% tenía registrada alguna vacuna tras el tratamiento. Las vacunas administradas con mayor frecuencia fueron: difteria-tétanos-tosferina o difteria-tétanos (54,9%), meningococo C(41,2%) y la gripe estacional (39,2%). La tasa de adaptación de calendario posquimioterapia fue del 9,8%. La vacuna frente a neumococo conjugada 7v o 13v fue administrada en el 21,6% de los niños evaluados, sin embargo, solo se completó con polisacárida 23v en el 17,6% de los casos. Ninguno recibió vacunación frente a hepatitis A. No se encontraron diferencias estadísticamente significativas entre el cumplimiento del calendario y el tipo de tumor (p=0,066), el sexo (p=0,304) o la edad (p=0,342). Conclusión: Existe un importante margen de mejora en la adaptación de la vacunación posquimioterapia en niños con cáncer. La participación de los profesionales en programas de formación y la derivación de estos pacientes a las Unidades de Vacunas podría mejorar la tasa de adaptación garantizando una correcta inmunización en estos niños (AU)

Introduction: Children undergoing chemotherapy for cancer have special vaccination needs after completion of the treatment. The aim of this study was to evaluate the adaptation of post-chemotherapy vaccination schedules. Method: An observational study was performed on a retrospective cohort that included all children aged from 0 to 14 years, who completed chemotherapy in a tertiary hospital between 2009 and 2015. Inclusion and exclusion criteria were applied. Immunisation was administered in accordance with the guidelines of the Vaccine Advisory Committee of the Spanish Association of Paediatrics. Primary Care immunisation and clinical records of the Preventive Medicine and Public Health Department were reviewed. Results: Of the 99 children who had received chemotherapy, 51 (70.6% males) were included in the study. As regards the type of tumour, 54.9% had a solid organ tumour, and 45.1% had a haematological tumour. Post-chemotherapy immunisation was administered to 70.6%. The most common vaccines received were: diphtheria-tetanus-pertussis or diphtheria-tetanus (54.9%), meningococcus C (41.2%), and seasonal influenza (39.2%). The rate of adaptation of the immunisation schedule after chemotherapy was 9.8%. The pneumococcal conjugate vaccine against 7v or 13v was administered to 21.6% of study subjects. However, only 17.6% received polysaccharide 23v. None received vaccination against hepatitis A. No statistically significant differences were observed between adherence to immunisation schedules and type of tumour (P=.066), gender (P=.304), or age (P=.342). Conclusion: Post-chemotherapy immunisation of children with cancer is poor. The participation of health professionals in training programs and referral of paediatric cancer patients to Vaccine Units could improve the rate of schedule adaptation and proper immunisation of this population (AU)

Adapting immunisation schedules for children undergoing chemotherapy. / Adaptación de los calendarios de vacunación en población pediátrica que ha recibido quimioterapia.

INTRODUCTION: Children undergoing chemotherapy for cancer have special vaccination needs after completion of the treatment. The aim of this study was to evaluate the adaptation of post-chemotherapy vaccination schedules. METHOD: An observational study was performed on a retrospective cohort that included all children aged from 0 to 14 years, who completed chemotherapy in a tertiary hospital between 2009 and 2015. Inclusion and exclusion criteria were applied. Immunisation was administered in accordance with the guidelines of the Vaccine Advisory Committee of the Spanish Association of Paediatrics. Primary Care immunisation and clinical records of the Preventive Medicine and Public Health Department were reviewed. RESULTS: Of the 99 children who had received chemotherapy, 51 (70.6% males) were included in the study. As regards the type of tumour, 54.9% had a solid organ tumour, and 45.1% had a haematological tumour. Post-chemotherapy immunisation was administered to 70.6%. The most common vaccines received were: diphtheria-tetanus-pertussis or diphtheria-tetanus (54.9%), meningococcus C (41.2%), and seasonal influenza (39.2%). The rate of adaptation of the immunisation schedule after chemotherapy was 9.8%. The pneumococcal conjugate vaccine against 7v or 13v was administered to 21.6% of study subjects. However, only 17.6% received polysaccharide 23v. None received vaccination against hepatitis A. No statistically significant differences were observed between adherence to immunisation schedules and type of tumour (P=.066), gender (P=.304), or age (P=.342). CONCLUSION: Post-chemotherapy immunisation of children with cancer is poor. The participation of health professionals in training programs and referral of paediatric cancer patients to Vaccine Units could improve the rate of schedule adaptation and proper immunisation of this population.

Evaluation of the Bundle "Zero Surgical Site Infection" to Prevent Surgical Site Infection in Vascular Surgery.

BACKGROUND: To compare the incidence of surgical site infections (SSIs) before and after the implementation of a bundle of care called "Zero Surgical Site Infection." Secondary goals included estimating measures of association and their potential impact, determining care management indicators in vascular surgery, and evaluating the level of compliance with the bundle. METHODS: This is a prospective observational study with a historic control group. The bundle included (1) removal of body hair with clippers; (2) preoperative showering with chlorhexidine soap; (3) preparation of the surgical field with alcoholic chlorhexidine 2%; (4) adequacy of antimicrobial prophylaxis; (5) intraoperative and (6) postoperative glycemic and central temperature control. Student's t-test and chi-squared test were performed. Relative risk, attributable risk, number needed to treat, and preventable fraction were used as association and impact measures. RESULTS: In total, 192 patients were included. The overall incidence of SSI was 8.85%; the preventive fraction was 59.1%. The rate of incidence of SSI for clean surgery was reduced from 4.9% to 0% (P = 0.127), whereas the average hospital stay decreased from 22.38 to 13.70 days (P = 0.002). Concerning contaminated surgery, significant differences were found in the rate of incidence of SSI (33.3% vs. 13.9%, P = 0.035). Compliance with the bundle of preoperative and intraoperative measures exceeded 95% and almost reached 50%, respectively. Compliance with the bundle of postoperative measures reached 25%. CONCLUSIONS: This bundle has demonstrated to be effective in reducing the incidence of SSI in vascular surgery. The publication of these initial results should encourage the implementation of this bundle at national level.

[Design and Validation of a Questionnaire on Vaccination in Students of Health Sciences, Spain]. / Diseño y validación de un cuestionario sobre vacunación en estudiantes de ciencias de la salud.

OBJECTIVE: Immunization rates among medicine and nursing students -and among health professional in general- during hospital training are low. It is necessary to investigate the causes for these low immunization rates. The objective of this study was to design and validate a questionnaire for exploring the attitudes and behaviours of medicine and nursing students toward immunization of vaccine-preventable diseases. METHODS: An instrument validation study. The sample included 646 nursing and medicine students at University of Oviedo, Spain. It was a non-ramdom sampling. After the content validation process, a 24-item questionnaire was designed to assess attitudes and behaviours/behavioural intentions. Reliability (ordinal alpha), internal validity (exploratory factor analysis by parellel analysis), ANOVA and mediational model tests were performed. RESULTS: Exploratory factor analysis yielded two factors which accounted for 48.8% of total variance. Ordinal alpha for the total score was 0.92. Differences were observed across academic years in the dimensions of attitudes (F5.447=3.728) and knowledge (F5.448=65.59), but not in behaviours/behavioural intentions (F5.461=1.680). Attitudes demonstrated to be a moderating variable of knowledge and attitudes/behavioural attitudes (Indirect effect B=0.15; SD=0.3; 95% CI:0.09-0.19). CONCLUSIONS: We developed a questionnaie based on sufficient evidence of reliability and internal validity. Scores on attitudes and knowledge increase with the academic year. Attitudes act as a moderating variable between knowledge and behaviours/behavioural intentions.

Diseño y validación de un cuestionartio sobre vacunación en estudiantes de ciencias de la salud / Design and validation of a questionnaire on vaccination in students of health sciences, Spain

Fundamentos: Las tasas de vacunación en estudiantes de Ciencias de la Salud que realizan prácticas en los contextos hospitalarios son bajas, al igual que en el colectivo sanitario en general, y es necesario explorar sus causas. El objetivo principal fue diseñar y validar un cuestionario para conocer las actitudes y las conductas de los estudiantes de medicina y enfermería sobre la vacunación de enfermedades inmunoprevenibles. Métodos: La muestra se compuso de 646 alumnos/as de medicina y enfermería de la Universidad de Oviedo, Asturias. El muestreo fue de tipo incidental. Tras un proceso de validación de contenido, se diseñó un cuestionario con 24 ítems que englobaba actitudes y conductas/intenciones de conductas. Se realizaron análisis de fiabilidad (alfa ordinal) y validez interna (análisis factorial exploratorio mediante el método de análisis paralelo), además de ANOVAS y un modelo mediacional. Resultados: El análisis factorial exploratorio arrojó una solución de 2 factores que explicó el 48,8% de la varianza total. El alfa ordinal para la puntuación total fue 0,92. Hubo diferencias según el curso en las dimensiones de actitudes (F5,447=3,728;p<0,003) y de conocimientos (F5,448=65,59;p<0,001) pero no en las conductas/intenciones de conductas (F5,461=1,680;p<0,138). Las actitudes fueron una variable moduladora entre los conocimientos y las conductas/intenciones de conductas (B efecto indirecto=0,15; SE=0,3; IC95% :0,09-0,19). Conclusiones: Se dispone de un cuestionario con suficiente fiabilidad y validez interna. Las puntuaciones en actitudes y conocimientos son mayores según el curso. Las actitudes actúan como variable moduladora entre los conocimientos y las conductas/intenciones de conductas (AU)

Background: Immunization rates among medicine and nursing students -and among health professional in general- during hospital training are low. It is necessary to investigate the causes for these low immunization rates. The objective of this study was to design and validate a questionnaire for exploring the attitudes and behaviours of medicine and nursing students toward immunization of vaccine-preventable diseases. Methods: An instrument validation study. The sample included 646 nursing and medicine students at University of Oviedo, Spain. It was a non-ramdom sampling. After the content validation process, a 24-item questionnaire was designed to assess attitudes and behaviours/behavioural intentions. Reliability (ordinal alpha), internal validity (exploratory factor analysis by parellel analysis), ANOVA and mediational model tests were performed. Results: Exploratory factor analysis yielded two factors which accounted for 48.8% of total variance. Ordinal alpha for the total score was 0.92. Differences were observed across academic years in the dimensions of attitudes (F5.447=3.728;p<0.003) and knowledge (F5.448=65.59;p<0.001), but not in behaviours/behavioural intentions (F5.461=1.680;p<0.138). Attitudes demonstrated to be a moderating variable of knowledge and attitudes/ behavioural attitudes (Indirect effect B=0.15; SD=0.3; 95% CI:0.09-0.19). Conclusions: We developed a questionnaie based on sufficient evidence of reliability and internal validity. Scores on attitudes and knowledge increase with the academic year. Attitudes act as a moderating variable between knowledge and behaviours/behavioural intentions (AU)