Waning protection of influenza vaccination during four influenza seasons, 2011/2012 to 2014/2015.

BACKGROUND: Concerns have been raised about intraseasonal waning of the protection conferred by influenza vaccination. METHODS: During four influenza seasons, we consecutively recruited individuals aged 18years or older who had received seasonal influenza vaccine and were subsequently admitted to the hospital for influenza infection, asassessed by reverse transcription polymerase chain reaction. We estimated the adjusted odds ratio (aOR) of influenza infection by date of vaccination, defined by tertiles, as early, intermediate or late vaccination. We used a test-negative approach with early vaccination as reference to estimate the aOR of hospital admission with influenza among late vaccinees. We conducted sensitivity analyses by means of conditional logistic regression, Cox proportional hazards regression, and using days between vaccination and hospital admission rather than vaccination date. RESULTS: Among 3615 admitted vaccinees, 822 (23%) were positive for influenza. We observed a lower risk of influenza among late vaccinees during the 2011/2012 and 2014/2015A(H3N2)-dominant seasons: aOR=0.68 (95% CI: 0.47-1.00) and 0.69 (95% CI: 0.50-0.95). We found no differences in the risk of admission with influenza among late versus early vaccinees in the 2012/2013A(H1N1)pdm09-dominant or 2013/2014B/Yamagata lineage-dominant seasons: aOR=1.18 (95% CI: 0.58-2.41) and 0.98 (95% CI: 0.56-1.72). When we restricted our analysis to individuals aged 65years or older, we found a statistically significant lower risk of admission with influenza among late vaccinees during the 2011/2012 and 2014/2015A(H3N2)-dominant seasons: aOR=0.61 (95% CI: 0.41-0.91) and 0.69 (95% CI: 0.49-0.96). We observed 39% (95% CI: 9-59%) and 31% (95% CI: 5-50%) waning of vaccine effectiveness among participants aged 65years or older during the two A(H3N2)-dominant seasons. Similar results were obtained in the sensitivity analyses. CONCLUSION: Waning of vaccine protection was observed among individuals aged 65years old or over in two A(H3N2)-dominant influenza seasons.

Effectiveness of influenza vaccination programme in preventing hospital admissions, Valencia, 2014/15 early results.

Preliminary results for the 2014/15 season indicate low to null effect of vaccination against influenza A(H3N2)-related disease. As of week 5 2015, there have been 1,136 hospital admissions, 210 were due to influenza and 98% of subtype A strains were H3. Adjusted influenza vaccine effectiveness was 33% (range: 6-53%) overall and 40% (range: 13% to 59%) in those 65 years and older. Vaccination reduced by 44% (28-68%) the probability of admission with influenza.

Plan de seguridad clínica del Complejo Hospitalario Universitario de Albacete (CHUA). Diagnóstico inicial: estudio de eventos adversos / Clinical safety plan in a university hospital complex. Initial diagnosis: Study of adverse events

Objetivos. Determinar la incidencia de eventos adversos (EA) y de pacientes con EA en el Complejo Hospitalario Universitario de Albacete (CHUA). Identificar y definir los EA ligados a la asistencia; analizar los EA evitables y conocer su impacto; planificar las acciones de mejora. Método. Diseño. Estudio retrospectivo de cohortes. Ámbito de estudio. Pacientes dados de alta del 5 al 19 de noviembre de 2007. Definición de caso Todo accidente o incidente recogido en la historia clínica que ha causado daño al paciente o lo ha podido causar. Instrumentalización. Guía de cribado de efectos adversos, adaptada del estudio de Harvard. Versión española del formulario modular para revisión retrospectiva de casos, MRF2. Análisis estadístico. Análisis univariante, bivariante y modelo de regresión logística. Resultados. La incidencia de pacientes con EA relacionados con la asistencia hospitalaria fue de 6,8%. La incidencia fue diferente significativamente según: edad, presencia de factores de riesgo intrínseco y extrínseco (excluyendo el catéter venoso periférico). El 8,2% de los EA se relacionaron con cuidados, el 14,3% con medicación, el 26,5% con infecciones nosocomiales, el 35,7% con problemas técnicos en procedimientos, el 11,2% con diagnóstico y el 4,1% restante con otros tipos de EA. El 12,2% se consideraron leves, 78,6% moderados y 8,2% graves. El 50% de EA aumentaron la estancia, y en un 34,7% condicionó el ingreso. El 63,3% de los EA se consideraron evitables. Conclusiones. El estudio de EA en el CHUA constituye un aspecto de mejora dentro del programa de calidad del hospital. Las incidencias de pacientes con EA y con la asistencia sanitaria se encuentran entre las alcanzadas en el conjunto de estudios cuyo objetivo es la mejora de la calidad(AU)

Objectives. To establish the incidence of adverse events (AEs) and incidence of patients with AEs in the University Hospital Complex of Albacete (CHUA); to identify and define the AEs which are linked to health care; to analyse avoidable AE and determine their impact; to plan improvement actions. Method. Design. Retrospective cohort study. Sample. Patients registered from 5 November to 19 November, 2007. Case definition. Any accident or incident reported in the medical record which injured or may have injured the patient. Material. Adverse Events Screening Guide, adapted from the Harvard study. Spanish version of the Modular Review Form (MRF2) for retrospective case record review. Statistical Analysis. Univariate and bivariate analysis and logistic regression model. Results. The incidence of patients with AEs linked to hospital care was 6.8%. The incidence was significantly different depending on: age, presence of intrinsic or extrinsic risk factors (excluding peripheral venous catheter); 8.2% of AE was linked to care; 14.3% to medication; 26.5% to nosocomial infections; 35.7% to technical problems in procedures; 11.2% to diagnosis, and the remaining 4.1% to other types of AEs. In these incidences, 12.2% were considered mild, 78.6% moderate and 8.2% serious. Half (50%) of AEs caused an increase in hospital stay, and in 34.7% cases determined hospitalisation. A total of 63.3% of AEs were considered avoidable. Conclusions. The study of AEs in the CHUA represents an improvement within the hospital quality program. Incidences of patients with AEs and those related to health care fall within the range of those found in the studies where the objective was quality improvement(AU)

Estudio de eventos adversos en sanidad privada. Proyecto Confianza de seguridad del paciente / Study of adverse events in private healthcare. Confidence project for patient safety

Objetivos. Investigar e identificar áreas y problemas prioritarios de la seguridad del paciente y analizar las características de los pacientes y de la asistencia que se asocian a la aparición de eventos adversos (EA). Método. Estudio de cohortes retrospectivo en el que para identificar los EA se revisó la historia clínica (HC) de los pacientes hospitalizados en ocho centros comprometidos con el proyecto. Se recogió información de todos los pacientes atendidos entre el 15 y el 30 de noviembre de 2009. Resultados. De los 927 pacientes, en 40 pacientes se detectó alguna lesión, y en 23 de ellos la asistencia sanitaria estaba relacionada. Así, el porcentaje de pacientes con algún EA relacionado con la asistencia sanitaria fue del 2,48% (intervalo de confianza del 95%, 1,43%-3,54%). La edad, la comorbilidad y los dispositivos invasivos explican la aparición de EA. Se consideró leves al 33,3% (8 EA), moderados al 33,3% (8) y graves al 33,3% (8). Se consideró evitable al 50% de los EA. Conclusiones. La frecuencia hallada de EA es menor, posiblemente debido al diseño del estudio y la idiosincrasia de los pacientes atendidos: edad, comorbilidad y uso de dispositivos invasivos. Los EA encontrados presentan impacto y evitabilidad parecidos a los detectados en el sector público(AU)

Objectives. To investigate and identify priority areas and issues of patient safety and analyse which patient and health care characteristics are related to Adverse Events (AE). Methods. Retrospective cohort study to identify AE reviewing medical records of in-patients. Information was obtained from all patients attended between 15 and 30 November 2009 in eight facilities committed to the project. Results. Of the 927 patients, 40 patients had any injury, of which 23 were related to healthcare. Thus, the percentage of patients with any AE associated with health care was 2.48% (95%CI, 1.43%-3.54%). Age, comorbidity and use of invasive devices explained the occurrence of an AE. Of these, 33.3% (8 AE) were considered slight, 33.3% (8) moderate and 33.3% (8) severe. Half (50%) of AE were considered preventable. Conclusions. The frequency of AE found was low, possibly due to study design and the idiosyncrasy of the patients: age, comorbidity and use of invasive devices. The AE found have a similar impact and preventability as those identified in public sector(AU)

[Study of adverse events in private healthcare. Confidence project for patient safety]. / Estudio de eventos adversos en sanidad privada. Proyecto Confianza de seguridad del paciente.

OBJECTIVES: To investigate and identify priority areas and issues of patient safety and analyse which patient and health care characteristics are related to Adverse Events (AE). METHODS: Retrospective cohort study to identify AE reviewing medical records of in-patients. Information was obtained from all patients attended between 15 and 30 November 2009 in eight facilities committed to the project. RESULTS: Of the 927 patients, 40 patients had any injury, of which 23 were related to healthcare. Thus, the percentage of patients with any AE associated with health care was 2.48% (95%CI, 1.43%-3.54%). Age, comorbidity and use of invasive devices explained the occurrence of an AE. Of these, 33.3% (8 AE) were considered slight, 33.3% (8) moderate and 33.3% (8) severe. Half (50%) of AE were considered preventable. CONCLUSIONS: The frequency of AE found was low, possibly due to study design and the idiosyncrasy of the patients: age, comorbidity and use of invasive devices. The AE found have a similar impact and preventability as those identified in public sector.

[Clinical safety plan in a university hospital complex. Initial diagnosis: study of adverse events]. / Plan de seguridad clínica del Complejo Hospitalario Universitario de Albacete (CHUA). Diagnóstico inicial: estudio de eventos adversos.

OBJECTIVES: To establish the incidence of adverse events (AEs) and incidence of patients with AEs in the University Hospital Complex of Albacete (CHUA); to identify and define the AEs which are linked to health care; to analyse avoidable AE and determine their impact; to plan improvement actions. METHOD: . DESIGN: Retrospective cohort study. SAMPLE: Patients registered from 5 November to 19 November, 2007. CASE DEFINITION: Any accident or incident reported in the medical record which injured or may have injured the patient. MATERIAL: Adverse Events Screening Guide, adapted from the Harvard study. Spanish version of the Modular Review Form (MRF2) for retrospective case record review. STATISTICAL ANALYSIS: Univariate and bivariate analysis and logistic regression model. RESULTS: The incidence of patients with AEs linked to hospital care was 6.8%. The incidence was significantly different depending on: age, presence of intrinsic or extrinsic risk factors (excluding peripheral venous catheter); 8.2% of AE was linked to care; 14.3% to medication; 26.5% to nosocomial infections; 35.7% to technical problems in procedures; 11.2% to diagnosis, and the remaining 4.1% to other types of AEs. In these incidences, 12.2% were considered mild, 78.6% moderate and 8.2% serious. Half (50%) of AEs caused an increase in hospital stay, and in 34.7% cases determined hospitalisation. A total of 63.3% of AEs were considered avoidable. CONCLUSIONS: The study of AEs in the CHUA represents an improvement within the hospital quality program. Incidences of patients with AEs and those related to health care fall within the range of those found in the studies where the objective was quality improvement.

Factores que contribuyen a la infección relacionada con la asistencia sanitaria: cómo evitarlos / Factors that contribute to health care associated infections: how to prevent them

Objetivo. Identificar las características de los pacientes y de la asistencia asociadas con la infección relacionada con la atención sanitaria (IRAS) y determinar si existen diferencias entre las evitables (IRASE) y las que no lo son. Método. Estudio de cohortes retrospectivo basado en tres estudios españoles de eventos adversos ligados a la hospitalización. Se revisaron las historias clínicas valorando si la asistencia era la causante de IRAS e IRASE. Resultados. El 2,3% de los pacientes del estudio presentó una o más IRAS. El 60,2% fueron IRASE. Los que presentaron IRAS eran mayores que el resto, y presentaron mayor número de factores de riesgo intrínseco y extrínseco. Se observaron diferencias entre los pacientes que presentaron IRAS o IRASE en la presencia de algún factor de riesgo intrínseco. Los factores que mejor explicaron IRAS fueron distintos para cada una de las localizaciones más frecuentes. En el caso de las IRAS: catéter urinario (OR=2,4), catéter venoso central (OR=1,8) y sonda nasogástrica (OR=1,9); servicio de ingreso quirúrgico (OR=1,6) y estancia hospitalaria >1 semana (OR=7,5). Las estrategias identificadas para evitar IRAS fueron: técnica aséptica adecuada (25,5%), correcto seguimiento de los protocolos de sondaje vesical (20%) y de los cuidados y la valoración de vulnerabilidad de los pacientes (16,5%). Conclusiones. Entre los pacientes que presentaron IRAS y los que no presentaron se encontraron características diferenciadas. La evitabilidad es un juicio de valor independiente del de causalidad y se relaciona con si se han aplicado de forma correcta o no los protocolos. Identificar estos puntos en la asistencia permite establecer estrategias de mejora de la asistencia(AU)

Objective. To determine the patient and medical care characteristics of Health Care-Associated Infections (HCAI) and to determine whether or not there are any differences between those that may be avoidable. Method. A retrospective cohort study, based on three Spanish cohort studies of Adverse Events associated with hospitalization. The medical records were reviewed to assess whether or not the health care was the causing factor of the HCAI. We carried out the analyses using the same methodology as the National Study on the Adverse Effects associated with hospitalization (ENEAS). After reviewing the patient medical records to identify the HCAI associated factors, the reviewers gave a valued judgment on how likely the health care was the cause of the infection (HCAI) and whether there was evidence that they could have been avoided. Results. A total of 2.3% the patients in the study had one or more HCAI, with 60.2% of them being avoidable. The patients who had an HCAI were older and had a greater number of intrinsic and extrinsic risk factors. There was a significant difference in the presence of some intrinsic risk factor between patients who had an HCAI and those with an avoidable HCAI, but there were no differences as regards medical care extrinsic risk factors. The factors that best explained the HCAI were different for each one of the most common infection locations. Generally, the factors which best explained the HCAI were: urinary catheter (OR=2.4), nasogastric tube (OR=1.9) or central venous catheter (OR=1.8). Similarly, hospital admissions through a surgery department or a hospital stay longer than a week were identified as main factors, (OR=1.6), (OR=7.5), respectively. The best strategies to avoid an HCAI were: proper management of any aseptic technique and use of catheter (25.5%), a proper follow-up of the bladder catheterisation protocols (20%) and a proper health care follow-up of vulnerable patients (16.5%). Conclusion. Patients with an HCAI showed significant different characteristics from those who did not have an HCAI. The preventability is an independent valued judgment from the causality, and is associated to whether the proper protocol has been implemented or not. To identify these weaknesses enables us to establish strategies to improve the quality of medical care(AU)

[Factors that contribute to health care associated infections: how to prevent them]. / Factores que contribuyen a la infección relacionada con la asistencia sanitaria: cómo evitarlos.

OBJECTIVE: To determine the patient and medical care characteristics of Health Care-Associated Infections (HCAI) and to determine whether or not there are any differences between those that may be avoidable. METHOD: A retrospective cohort study, based on three Spanish cohort studies of Adverse Events associated with hospitalization. The medical records were reviewed to assess whether or not the health care was the causing factor of the HCAI. We carried out the analyses using the same methodology as the National Study on the Adverse Effects associated with hospitalization (ENEAS). After reviewing the patient medical records to identify the HCAI associated factors, the reviewers gave a valued judgment on how likely the health care was the cause of the infection (HCAI) and whether there was evidence that they could have been avoided. RESULTS: A total of 2.3% the patients in the study had one or more HCAI, with 60.2% of them being avoidable. The patients who had an HCAI were older and had a greater number of intrinsic and extrinsic risk factors. There was a significant difference in the presence of some intrinsic risk factor between patients who had an HCAI and those with an avoidable HCAI, but there were no differences as regards medical care extrinsic risk factors. The factors that best explained the HCAI were different for each one of the most common infection locations. Generally, the factors which best explained the HCAI were: urinary catheter (OR=2.4), nasogastric tube (OR=1.9) or central venous catheter (OR=1.8). Similarly, hospital admissions through a surgery department or a hospital stay longer than a week were identified as main factors, (OR=1.6), (OR=7.5), respectively. The best strategies to avoid an HCAI were: proper management of any aseptic technique and use of catheter (25.5%), a proper follow-up of the bladder catheterisation protocols (20%) and a proper health care follow-up of vulnerable patients (16.5%). CONCLUSION: Patients with an HCAI showed significant different characteristics from those who did not have an HCAI. The preventability is an independent valued judgment from the causality, and is associated to whether the proper protocol has been implemented or not. To identify these weaknesses enables us to establish strategies to improve the quality of medical care.

Prevalence of adverse events in the hospitals of five Latin American countries: results of the 'Iberoamerican Study of Adverse Events' (IBEAS).

BACKGROUND: Interest in patient safety (PS) is growing exponentially, fuelled by epidemiological research unveiling the extent of unsafe care. However, there is little information about the frequency of harm in developing and transitional countries. To address this issue, the authors performed a study known as the Iberoamerican Adverse Event Study, through a collaborative between the governments of Argentina, Colombia, Costa Rica, Mexico and Peru, the Spanish Ministry of Health, Social Policy and Equality, the Pan American Health Organization and the WHO Patient Safety. METHODS: The study used a cross-sectional design, involving 58 hospitals in the five Latin American countries, to measure the point prevalence of patients presenting an adverse event (AE) on the day of observation. All inpatients at the time of the study were included. RESULTS: A total of 11 379 inpatients were surveyed. Of these, 1191 had at least one AE that the reviewer judged to be related to the care received rather than to the underlying conditions. The estimated point prevalence rate was 10.5% (95% CI 9.91 to 11.04), with more than 28% of AE causing disability and another 6% associated with the death of the patient. Almost 60% of AE were considered preventable. CONCLUSIONS: The high rate of prevalent AE found suggests that PS may represent an important public-health issue in the participating hospitals. While new studies may be needed to confirm these results, these may already be useful to inspire new PS-improvement policies in those settings.

Diseño del estudio IBEAS: prevalencia de efectos adversos en hospitales de Latinoamérica / IBEAS design: adverse events prevalence in Latin American hospitals

Objetivos. Describir las características y metodología del estudio IBEAS: prevalencia de efectos adversos en hospitales de Latinoamérica, que persigue realizar una aproximación a la magnitud, trascendencia e impacto de los eventos adversos (EA); identificar áreas y problemas prioritarios de la seguridad del paciente; incrementar la masa crítica de profesionales involucrados en la seguridad del paciente e incorporar a la agenda de los países objetivos y actividades para mejorar la seguridad del paciente. Método. Estudio sobre la seguridad de los pacientes. Ámbito: 35 hospitales de 5 países: Argentina, Colombia, Costa Rica, México y Perú, a través del análisis de los efectos adversos identificados. Diseño de prevalencia utilizando la revisión de la historia clínica. Resultados. Se describen las implicaciones en el uso del diseño transversal en el estudio de EA, tanto en los recursos necesarios como en la validez interna y en la utilidad para la gestión de riesgos sanitarios. Conclusiones. El diseño transversal es eficiente en tiempo y recursos y fácil de realizar, y aunque no permite estudiar la totalidad del episodio de hospitalización, ha demostrado ser capaz para sostener un sistema de vigilancia. Debido a un posible sesgo de supervivencia, los EA que ocasionen un ingreso se verán sobrerrepresentados, y también aquellos relacionados con la infección nosocomial o los que sean difícilmente identificables si no se ve al paciente. La comunicación con el personal de planta (mientras el paciente está hospitalizado) favorece el juicio de la causalidad del efecto adverso y de su evitabilidad(AU)

Objectives. To describe the methodological characteristics of the IBEAS study: adverse events prevalence in Latin American hospitals, with the aim of analysing the magnitude, significance and impact of adverse events (AE); to identify the main problems associated with patient safety AE; to increase the capacity of professionals involved in patient safety; and the setting up of patient safety agendas in the participating countries. Methods. A patient safety study launched in 35 Latin American hospitals through the analysis of AE in 5 countries: Argentina, Colombia, Costa Rica, Mexico and Peru, using a cross-sectional study using a review of clinical records as the main method. Results. The implications of using a cross-sectional design when studying AE are described, in terms of resources required, internal validity and usefulness related to risk management. Conclusions. The cross-sectional design seems an efficient methodology in terms of time and resources spent, as well as being easy to carry out. Although the cross-sectional design does not review the all hospital episodes, it is able to provide a reliable estimate of prevalence and to support a surveillance system. Because of a possible survival bias, it is likely that the AE which led to hospital admissions will be overestimated, as well as the health related infections or those adverse events which are difficult to identify if the patient is not examined (e.g. contusions). Communication with the ward staff (if the patient is still hospitalised) help in finding the causality and their prevention(AU)

[IBEAS design: adverse events prevalence in Latin American hospitals]. / Diseño del estudio IBEAS: prevalencia de efectos adversos en hospitales de Latinoamérica.

OBJECTIVES: To describe the methodological characteristics of the IBEAS study: adverse events prevalence in Latin American hospitals, with the aim of analysing the magnitude, significance and impact of adverse events (AE); to identify the main problems associated with patient safety AE; to increase the capacity of professionals involved in patient safety; and the setting up of patient safety agendas in the participating countries. METHODS: A patient safety study launched in 35 Latin American hospitals through the analysis of AE in 5 countries: Argentina, Colombia, Costa Rica, Mexico and Peru, using a cross-sectional study using a review of clinical records as the main method. RESULTS: The implications of using a cross-sectional design when studying AE are described, in terms of resources required, internal validity and usefulness related to risk management. CONCLUSIONS: The cross-sectional design seems an efficient methodology in terms of time and resources spent, as well as being easy to carry out. Although the cross-sectional design does not review the all hospital episodes, it is able to provide a reliable estimate of prevalence and to support a surveillance system. Because of a possible survival bias, it is likely that the AE which led to hospital admissions will be overestimated, as well as the health related infections or those adverse events which are difficult to identify if the patient is not examined (e.g. contusions). Communication with the ward staff (if the patient is still hospitalised) help in finding the causality and their prevention.

Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events.

OBJECTIVE: To determine the incidence and incidence density of adverse events (AEs) in Spanish hospitals (including the pre-hospitalisation period). METHOD: Retrospective cohort study. RESULTS: The incidence of patients with AEs relating directly to hospital care was 8.4% (95% CI 7.7% to 9.1%) and rose 9.3% (95% CI 8.6% to 10.1%), including those from the pre-hospitalisation period. The incidence density was 1.2 AEs per 100 patient-days (95% CI 1.1 to 1.3). The incidence of moderate and serious AEs was 5.6 AEs per 1000 patient-days (95% CI 4.9% to 6.3%). In 66.3% of AEs, additional procedures were required and in 69.9% additional treatments were required. In total 42.8% of AEs were considered as avoidable. Of the subjects with some intrinsic risk factors, 13.2% developed AEs compared with 5.2% of the subjects who had no risk factors (p<0.001), and 9.5% of the subjects who had some extrinsic risk factors developed AEs compared with 3.4% of the subjects who had not (p<0.001). Patients older than 65 years of age showed a higher frequency of AEs than those under this age (12.4% vs 5.4%, p<0.001, RR 2.5). The most frequent AEs were those associated with medication (37.4%), hospital infections of any type (25.3%) and those relating to technical problems during a procedure (25.0%). A total of 31.4% of the AEs involved an increase in the length of stay. The AEs associated with medical assistance caused 6.1 additional hospital stays by patient. CONCLUSIONS: The incidence of patients with AE related to medical assistance in Spanish hospitals was relevant and similar to those found in the studies from Canada and New Zealand that had been conducted with comparable methodology. Patient vulnerability has been identified therein as playing a major role in generating healthcare-related AEs. These and other recent results indicate the need for AEs to be considered a public health priority in Europe.