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Objetivos Las intoxicaciones siguen siendo un problema de salud pública importante. En el presente estudio evaluamos la epidemiología de las intoxicaciones en la tercera edad. Métodos Estudio de cohorte retrospectivo realizado entre 2011 y 2019 en un hospital universitario. Analizamos variables demográficas, tipo de tóxico involucrado, naturaleza suicida o accidental de la intoxicación y la probabilidad de ingreso o muerte en el hospital. Resultados Un total de 880 (6,1%) de las 14.300 intoxicaciones atendidas en el mismo período sucedieron en mayores de 65 años. El grupo más numeroso fueron individuos entre 65-69 años (39%), seguidos por el grupo de 70-75 años (20%), siendo varones el 57%. En el 88% de los casos participó un único tóxico, por orden de frecuencia alcohol (51,6%), fármacos (29,5%) y productos domésticos o industriales (12,8%). Las intoxicaciones por alcohol predominaron en hombres hasta los 75 años y por encima de esta edad predominó la intoxicación farmacológica o suicida, principalmente en mujeres. Ingresaron un total de 145 (16%) sujetos, siendo los fármacos más frecuentemente implicados digoxina y benzodiacepinas. La probabilidad de ingreso se asoció con la intoxicación por metformina, digoxina, litio o la edad del paciente (OR por año = 1,03; IC 95%: 1,0-1,06). Fallecieron 19 pacientes (2,16%), principalmente por ingestas cáusticas suicidas (OR = 5,7: IC 95%: 1,4-23,6) o por fármacos, relacionados directamente con la metformina (OR = 10,1; IC 95%: 2,4-42,4). Conclusiones La prevalencia de intoxicaciones en la tercera edad no es despreciable, y los médicos deben sospecharlas ante situaciones clínicas complejas (AU)

Objectives Poisonings continue to be an important public health problem. Herein, we analyzed the epidemiology of poisonings in elderly individuals. Methods Retrospective cohort study conducted between 2011 and 2019 in a university hospital. We analyzed demographic variables, type of poison involved, suicidal or accidental nature of the poisoning, and the probability of admission, or death to the hospital. Results A total of 880 (6.1%) of the 14,300 poisonings treated in the same period occurred in people over 65 years of age. The most numerous group were individuals between 65-69 years-old (39%), followed by the group of 70-75 years-old (20%), being men 57%. In 88% of the cases a single poison participated, being by frequency alcohol (51.6%), drugs (29.5%), and household or industrial products (12.8%). Alcohol intoxication predominated in men up to 75 years of age, and above this age drug or suicidal intoxication predominated, mainly in women. A total of 145 (16%) subjects were hospitalized, the drugs most frequently implicated being digoxin and benzodiazepines. The probability of hospital admission was associated with intoxication by metformin, digoxin, lithium or with the age of the patient (OR per year = 1.03; 95% CI: 1.0-1.06). A total of 19 patients died (2.16%), mainly due to suicidal caustic ingestion (OR = 5.7: 95% CI: 1.4-23.6) or by drugs, directly related to metformin (OR = 10.1; 95% CI: 2.4-42.4). Conclusions The prevalence of poisoning in the elderly is not negligible, and physicians should have a high index of suspicion in a complex situation (AU)

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OBJECTIVES: Poisonings continue to be an important public health problem. Herein, we analyzed the epidemiology of poisonings in elderly individuals. METHODS: Retrospective cohort study conducted between 2011 and 2019 in a university hospital. We analyzed demographic variables, type of poison involved, suicidal or accidental nature of the poisoning, and the probability of admission, or death to the hospital. RESULTS: A total of 880 (6.1%) of the 14,300 poisonings treated in the same period occurred in people over 65 years of age. The most numerous group were individuals between 65-69 years-old (39%), followed by the group of 70-75 years-old (20%), being men 57%. In 88% of the cases a single poison participated, being by frequency alcohol (51.6%), drugs (29.5%), and household or industrial products (12.8%). Alcohol intoxication predominated in men up to 75 years of age, and above this age drug or suicidal intoxication predominated, mainly in women. A total of 145 (16%) subjects were hospitalized, the drugs most frequently implicated being digoxin and benzodiazepines. The probability of hospital admission was associated with intoxication by metformin, digoxin, lithium or with the age of the patient (OR per year = 1.03; 95% CI: 1.0-1.06). A total of 19 patients died (2.16%), mainly due to suicidal caustic ingestion (OR = 5.7: 95% CI: 1.4-23.6) or by drugs, directly related to metformin (OR = 10.1; 95% CI: 2.4-42.4). CONCLUSIONS: The prevalence of poisoning in the elderly is not negligible, and physicians should have a high index of suspicion in a complex situation.

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OBJECTIVES: Poisonings continue to be an important public health problem. Herein, we analyzed the epidemiology of poisonings in elderly individuals. METHODS: Retrospective cohort study conducted between 2011 and 2019 in a university hospital. We analyzed demographic variables, type of poison involved, suicidal or accidental nature of the poisoning, and the probability of admission, or death to the hospital. RESULTS: A total of 880 (6.1%) of the 14,300 poisonings treated in the same period occurred in people over 65 years of age. The most numerous group were individuals between 65-69 years-old (39%), followed by the group of 70-75 years-old (20%), being men 57%. In 88% of the cases a single poison participated, being by frequency alcohol (51.6%), drugs (29.5%), and household or industrial products (12.8%). Alcohol intoxication predominated in men up to 75 years of age, and above this age drug or suicidal intoxication predominated, mainly in women. A total of 145 (16%) subjects were hospitalized, the drugs most frequently implicated being digoxin and benzodiazepines. The probability of hospital admission was associated with intoxication by metformin, digoxin, lithium or with the age of the patient (OR per year = 1.03; 95% CI: 1.0-1.06). A total of 19 patients died (2.16%), mainly due to suicidal caustic ingestion (OR = 5.7: 95% CI: 1.4-23.6) or by drugs, directly related to metformin (OR = 10.1; 95% CI: 2.4-42.4). CONCLUSIONS: The prevalence of poisoning in the elderly is not negligible, and physicians should have a high index of suspicion in a complex situation.

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AIM OF THE STUDY: Endocrine-disrupting chemicals (EDCs) are exogenous agents that are capable of altering the endocrine system functions, including the regulation of developmental processes. The aim of this study was to investigate the association between EDC exposure and other parental factors in the etiology of hypospadias and cryptorchidism. METHODS: A case-control study was conducted. Cases (n = 210) were infants aged between 6 months and 14 years diagnosed with hypospadias or cryptorchidism who attended the authors' hospital over a period of 18 months, and controls (n = 210) were infants within the same range of age and without any urological disorders who attended the outpatient clinic of the same hospital during the same time period. Their selection was independent of exposures. Data on parental occupational exposure to EDCs and other sociodemographic variables were collected through face-to-face interviews and systematically for both cases and controls. Crude and adjusted odds ratios (ORs) were estimated to control for confounding with their 95% confidence interval (CI) by means of logistic regressions. Specifically, three final models of a dichotomous outcome were constructed: one for cryptorchidism, one for hypospadias, and the third considering both malformations together. The Hosmer-Lemeshow test was used to assess the goodness of fit of the models. Their discriminatory accuracy (DA) was ascertained by estimating their areas under the receiver operating characteristic curves area under the curve (AUC) along with their 95% CI. RESULTS: Associations were found between advanced maternal age (OR adjusted = 1.82; 95% CI: 1.14-2.92), mother's consumption of anti-abortives (OR = 5.40; 95% CI: 1.40-38.5) and other drugs (OR = 2.02; 95% CI: 1.31-3.16) during pregnancy, maternal and paternal occupational exposure to EDCs (OR = 4.08; 95% CI: 2.03-8.96 and OR = 3.90; 95% CI: 2.41-6.48, respectively), fathers smoking (OR = 2.0; 95% CI: 1.33-2.99), and fathers with urological disorders (OR = 2.31; 95% CI: 1.15-4.90). Maternal and paternal high educational level could be protective of cryptorchidism (OR = 0.47; 95% CI: 0.28-0.76 and OR = 0.63; 95% CI: 0.42-0.93, respectively). The DA of the models for the whole sample (AUC = 0.75; 95% CI: 0.70-0.79) for cryptorchidism (AUC = 0.76; 95% CI: 0.71-0.82) and for hypospadias (AUC = 0.75; 95% CI: 0.69-0.81) was moderately high. CONCLUSIONS: Advanced age, some parental occupational exposure to EDCs, some drug consumption, smoking, and the father's history of urological disorders may increase risk and predict the developments of these malformations. Studies with higher samples sizes are needed to assess associations between individual EDC occupational exposures and drugs and these malformations.

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Glucocorticoid (GC) therapy is the most common cause of adrenal insufficiency (AI). The real prevalence of AI after GC is unknown but it could involve more than 30% of patients. Some gene variation has been associated with the variability of hypothalamic-pituitary-adrenal (HPA) axis and this issue could contribute to the individual variation of adrenal function after GC treatment. Symptoms and signs of AI are nonspecific and frequently the diagnosis is delayed. Dosage, duration of treatment, administration route and serum cortisol value are not completely useful to predict AI. Clinical estimation of HPA suppression is difficult and biochemical testing is needed to confirm the diagnosis of AI. The different tapering regimens are based on a very low quality of evidence and considering the sizable individual variation, it is improbable that future research will find a secure GC tapering schedule for all patients. The aim of this review is to address the most important aspects in management of GC withdrawal in light of current knowledge.

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Objetivo. Este estudio analiza la frecuencia de las complicaciones postoperatorias tras la cirugía cardiaca, la incidencia del fracaso en el rescate (FR) y su relación con la supervivencia. Métodos. Desde enero del 2003 hasta diciembre del 2009, se intervinieron 2.750 pacientes adultos de cirugía cardiaca. Se analizaron 9 complicaciones postoperatorias. Para conocer las variables asociadas con alguna de estas complicaciones, se realizó análisis de regresión logística múltiple. La supervivencia se estimó mediante curvas de Kaplan-Meier y las complicaciones asociadas con la mortalidad se estimaron mediante regresión de Cox. Resultados. La mortalidad hospitalaria fue 1,4% (IC del 95%, 1,01%-1,9%). La frecuencia de complicaciones postoperatorias fue del 38,5% (36,7%-40,4%) y el FR, 3,6% (2,5%-4,9%). La cirugía urgente (OR = 2,03, IC del 95%, 1,52-2,72), la insuficiencia renal crónica (OR = 1,50, IC del 95%, 1,25-1,80) y la edad ≥70 años (OR = 1,42, IC del 95%, 1,20-1,68) fueron las variables que se asociaron con más fuerza con las complicaciones seleccionadas. La supervivencia a los 5 años fue del 93% en los pacientes sin complicaciones y el 83% en los pacientes con alguna de las complicaciones (p < 0,0001). Las complicaciones asociadas con la supervivencia a medio plazo fueron la neumonía (HR 2,6, IC del 95%, 1,275,50), el infarto agudo de miocardio (HR 1,9, IC del 95%, 1,10-2,30) y la insuficiencia renal aguda (HR 1,7, IC del 95%, 1,30-2,26). Conclusiones. La incidencia de complicaciones postoperatorias en cirugía cardiaca oscila alrededor del 40% y aumenta la mortalidad hospitalaria aunque el FR fue muy bajo (3,6%; IC del 95%, 2,5-4,9) (AU)

Objective. This study analyses the rate of post-operative complications after cardiac surgery, the incidence of the failure to rescue (FR), and the relationship between complications and survival. Methods. The study included a total of 2,750 adult patients operated of cardiac surgery between January 2003 and December 2009. An analysis was made of 9 post-operative complications. Multiple logistic regression analysis was used to find independent variables associated with any of the selected complications. Survival was analysed with Kaplan-Meyer survival estimates. A risk-adjusted Cox proportional regression model was used to find out which complications were associated with mid-term survival. Results. Hospital mortality rate was 1.4% (95% CI: 1.0%-1.9%). Postoperative complications rate was 38.5% (36.7%-40.4%), and FR 3.6% (2.5%-4.9%). Urgent surgery (OR = 2.03; 1.52-2.72), chronic renal failure (OR = 1.50, 95%.CI: 1.25-1.80), and age ≥70 years (OR = 1.42; 1.20-1.68) were the variables that showed the highest strength of association with the selected complications. Survival at 5 years in the group of patients without complications was 93%, and in the group of patients with complications it was 83% (P<.0001). Postoperative complications associated with mid-term survival were pneumonia (HR = 2.6, 95% CI; 1.27-5.50), acute myocardial infarction (HR = 1.9; 1.10-2.30), and acute renal failure (HR = 1.7; 1.30-2.26). Conclusions. The incidence of complications after cardiac surgery is around 40%, and was associated with an increase in hospital mortality, although FR was very low (3.6%; 95% CI: 2.5-4.9) (AU)

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OBJECTIVE: This study analyses the rate of post-operative complications after cardiac surgery, the incidence of the failure to rescue (FR), and the relationship between complications and survival. METHODS: The study included a total of 2,750 adult patients operated of cardiac surgery between January 2003 and December 2009. An analysis was made of 9 post-operative complications. Multiple logistic regression analysis was used to find independent variables associated with any of the selected complications. Survival was analysed with Kaplan-Meyer survival estimates. A risk-adjusted Cox proportional regression model was used to find out which complications were associated with mid-term survival. RESULTS: Hospital mortality rate was 1.4% (95% CI: 1.0%-1.9%). Postoperative complications rate was 38.5% (36.7%-40.4%), and FR 3.6% (2.5%-4.9%). Urgent surgery (OR = 2.03; 1.52-2.72), chronic renal failure (OR = 1.50, 95%.CI: 1.25-1.80), and age ≥70 years (OR = 1.42; 1.20-1.68) were the variables that showed the highest strength of association with the selected complications. Survival at 5 years in the group of patients without complications was 93%, and in the group of patients with complications it was 83% (P<.0001). Postoperative complications associated with mid-term survival were pneumonia (HR = 2.6, 95% CI; 1.27-5.50), acute myocardial infarction (HR = 1.9; 1.10-2.30), and acute renal failure (HR = 1.7; 1.30-2.26). CONCLUSIONS: The incidence of complications after cardiac surgery is around 40%, and was associated with an increase in hospital mortality, although FR was very low (3.6%; 95% CI: 2.5-4.9).

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BACKGROUND: The role that intensive care unit (ICU)-acquired pneumonia plays in the long-term outcomes of cardiac surgery patients is not well known. This study examined the association of pneumonia with in-hospital mortality and long-term mortality after adult cardiac surgery. METHODS: A total of 2750 patients admitted to our ICU after cardiac surgery from January 2003 to December 2009 are the basis for this observational study. Patients who developed ICU-acquired pneumonia were matched with patients without it in a 1:2 ratio. The matching criteria were age, urgent or scheduled surgery, surgical procedure, and the propensity score for pneumonia. Multiple regression analysis was used to find predictors of hospital mortality. The relationship between pneumonia and long-term survival was analyzed with Kaplan-Meier survival estimates and a risk-adjusted Cox proportional regression model for patients discharged alive from hospital. RESULTS: Pneumonia was diagnosed in 32 (1.2%) patients and there were 19 cases per 1000 days of mechanical ventilation. Patients with pneumonia had a significantly higher hospital mortality rate (28% vs 6.2%, P = .003) and a higher mortality at the end of follow-up (53% vs 19%, P < .0001) than those without it. Regression analysis showed that pneumonia was a strong predictor of hospital mortality. Five-year survival was as follows: pneumonia, 62%; control, 81%; and cohort patients, 91%. The Cox model showed that, after adjusting for confounding factors, patients with pneumonia (hazard ratio = 3.96, 95% confidence interval [CI]: 1.41-11.14) had poorer long-term survival. CONCLUSION: Pneumonia remains a serious complication in patients operated for cardiac surgery and is associated with increased hospital mortality and reduced long-term survival.

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OBJETIVO: Averiguar si existe asociación entre la transfusión perioperatoria de 1-2 unidades de hematíes y la morbilidad hospitalaria, la mortalidad a 30 días y la supervivencia a largo plazo en los pacientes operados en cirugía cardíaca. DISEÑO: Estudio de cohorte prospectivo. Ámbito: UCI de un hospital universitario. PACIENTES: Se valoró a todos los pacientes mayores de 17 años operados de cirugía cardíaca e ingresados en la UCI desde noviembre del 2002 hasta diciembre del 2009. Se analizó a los pacientes que no recibieron transfusión de hematíes (n = 703) y a los que recibieron transfusión perioperatoria de 1-2 unidades de hematíes (n = 959). Variables de interés: Se analizó el efecto de la transfusión sobre la morbilidad hospitalaria y la mortalidad a 30 días. El seguimiento de los enfermos dados de alta vivos del hospital finalizó el 31 de diciembre del 2011. La asociación de la transfusión con la supervivencia a largo plazo se evaluó con el método de Kaplan-Meier. La evaluación de los posibles factores predictivos de mortalidad a largo plazo se realizó mediante la construcción de modelos de regresión de Cox. RESULTADOS: La frecuencia de complicaciones postoperatorias cardíacas y no cardíacas fue mayor en los pacientes que recibieron transfusión. La mortalidad a 30 días de estos últimos fue mayor que en los pacientes no transfundidos (1% vs. 0,1%, p = 0,02). La presencia de anemia preoperatoria se asoció a un mayor uso de transfusión. La transfusión de hematíes no fue un factor de riesgo de mortalidad a largo plazo (Hazard ratio = 1,4; intervalo de confianza del 95%, 0,9-2,1). CONCLUSIONES: La transfusión perioperatoria de 1-2 unidades de hematíes en los pacientes operados de cirugía cardíaca se asocia a un incremento de la morbilidad hospitalaria y la mortalidad a 30 días, y no tiene efecto en la mortalidad a largo plazo

OBJECTIVE: A study was made to explore the possible association between the perioperative transfusion of 1 - 2 red blood cell units and in-hospital morbidity, 30-day mortality, and long-term survival in patients undergoing heart surgery. DESIGN: A prospective observational study was carried out. SETTING: The ICU of a university hospital. PATIENTS: All patients over 17 years of age that underwent heart surgery and were admitted to the ICU between November 2002 and December 2009 were included. Those patients who did not (n = 703) and those who did (n = 959) receive the perioperative transfusion of 1 - 2 red blood cell units were assessed. Study endpoints: The endpoints were the effect of transfusion on both hospital morbidity and on 30-day mortality. In addition, all patients discharged alive from hospital until 31 December 2011 were subjected to follow-up. The association between transfusion and survival was assessed by means of the Kaplan-Meier method. Cox proportional hazards models were used to assess factors associated with long-term survival. RESULTS: The frequency of both cardiac and non-cardiac perioperative complications was higher in patients receiving transfusion. The 30-day mortality rate was higher in those who received transfusion (1% vs 0.1%, P = .02). Preoperative anemia was associated with a more intensive use of transfusion. Red blood cell transfusion was not found to be a risk factor for long-term mortality (hazar ratio = 1.4, 95% CI 0.9-2.1). CONCLUSIONS: The perioperative transfusion of 1 - 2 red blood cell units in patients undergoing heart surgery increases both hospital morbidity and the 30-day mortality rate, but does not increase long-term mortality

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Para asegurar que el riesgo asistencial se gestiona de manera efectiva es necesario utilizar métodos sistemáticos y estructurados. La Norma española UNE 179003:2013 ofrece a las organizaciones sanitarias un marco y una forma sistemática de abordar la gestión de la seguridad del paciente desde una perspectiva clínica y organizativa, que contribuye a alcanzar un balance eficiente entre riesgo, resultados en salud y costes. Obtener la certificación con UNE 179003:2013 demuestra el cumplimiento de unas normas y unos procedimientos de trabajo dirigidos a disminuir la incidencia de eventos adversos, y obliga a realizar intervenciones de mejora continua, porque la Norma exige realizar un seguimiento periódico del sistema de gestión de riesgos mediante auditorias regulares. El objetivo de este trabajo es presentar el proceso realizado para obtener la certificación por la Norma UNE 179003:2013 en nuestro Servicio de Medicina Intensiva, proponer un programa de gestión de riesgos del paciente crítico y hacer algunas recomendaciones sobre su implantación

Systematic and structured methods must be used to ensure that healthcare risks are effectively managed. Spanish standard UNE 179003:2013 provides healthcare organizations with a framework and a systematic protocol for managing patient safety from a clinical and organizational perspective. Furthermore, it is useful in securing an efficient balance among health risk, health outcomes and costs. The UNE 179003:2013 certifies that a clinical service complies with rules and operating procedures aimed at reducing the incidence of adverse events. It also requires mandatory continuous improvement, given that the standard entails frequent monitoring of the risk management system through periodic audits. The aims of this paper are to describe the UNE 179003:2013 certification process in an Intensive Care Unit, propose a risk management program for critical patients, and offer some recommendations regarding its implementation

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OBJECTIVE: A study was made to explore the possible association between the perioperative transfusion of 1 - 2 red blood cell units and in-hospital morbidity, 30-day mortality, and long-term survival in patients undergoing heart surgery. DESIGN: A prospective observational study was carried out. SETTING: The ICU of a university hospital. PATIENTS: All patients over 17 years of age that underwent heart surgery and were admitted to the ICU between November 2002 and December 2009 were included. Those patients who did not (n=703) and those who did (n=959) receive the perioperative transfusion of 1 - 2 red blood cell units were assessed. STUDY ENDPOINTS: The endpoints were the effect of transfusion on both hospital morbidity and on 30-day mortality. In addition, all patients discharged alive from hospital until 31 December 2011 were subjected to follow-up. The association between transfusion and survival was assessed by means of the Kaplan-Meier method. Cox proportional hazards models were used to assess factors associated with long-term survival. RESULTS: The frequency of both cardiac and non-cardiac perioperative complications was higher in patients receiving transfusion. The 30-day mortality rate was higher in those who received transfusion (1% vs 0.1%, P=.02). Preoperative anemia was associated with a more intensive use of transfusion. Red blood cell transfusion was not found to be a risk factor for long-term mortality (hazar ratio=1.4, 95%CI 0.9-2.1). CONCLUSIONS: The perioperative transfusion of 1 - 2 red blood cell units in patients undergoing heart surgery increases both hospital morbidity and the 30-day mortality rate, but does not increase long-term mortality.

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Systematic and structured methods must be used to ensure that healthcare risks are effectively managed. Spanish standard UNE 179003:2013 provides healthcare organizations with a framework and a systematic protocol for managing patient safety from a clinical and organizational perspective. Furthermore, it is useful in securing an efficient balance among health risk, health outcomes and costs. The UNE 179003:2013 certifies that a clinical service complies with rules and operating procedures aimed at reducing the incidence of adverse events. It also requires mandatory continuous improvement, given that the standard entails frequent monitoring of the risk management system through periodic audits. The aims of this paper are to describe the UNE 179003:2013 certification process in an Intensive Care Unit, propose a risk management program for critical patients, and offer some recommendations regarding its implementation.

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Objetivo. Elaborar unas recomendaciones sobre «Información de eventos adversos a pacientes y familiares», mediante la realización de una conferencia de consenso. Material y métodos. Se realizó una revisión bibliográfica de la evidencia disponible, de las principales publicaciones de políticas y guías internacionales y la legislación específica desarrollada en algunos países sobre dicho proceso. La revisión bibliográfica constituyó la base para dar respuesta a una serie de preguntas planteadas en una sesión pública. Un grupo de expertos presentaron la mejor evidencia disponible interaccionando con las partes interesadas. Al término de la sesión un jurado, interdisciplinario y multiprofesional, estableció las recomendaciones finales de la conferencia de consenso. Resultados. Las principales recomendaciones abogan por el interés de elaborar políticas y guías institucionales en nuestro ámbito que favorezcan el proceso de información sobre eventos adversos a los pacientes. Se destaca la necesidad de formación de los profesionales en habilidades de comunicación y en seguridad del paciente, así como el desarrollo de estrategias de soporte a los profesionales que se ven implicados en un evento adverso. Se considera evaluar el interés e impacto de legislación específica que ayudará a la implantación de dichas políticas. Conclusiones. Es necesario un cambio cultural a todos los niveles, matizado y adaptado a las circunstancias específicas sociales y culturales de nuestro ámbito social y sanitario, e implicar a todos los actores del sistema para crear un marco de confianza y credibilidad en el que pueda hacerse efectivo el proceso de información sobre eventos adversos (AU)

Objective: To develop recommendations regarding «Information about adverse events to patients and their families», through the implementation of a consensus conference. Material and methods: A literature review was conducted to identify all relevant articles, the major policies and international guidelines, and the specific legislation developed in some countries on this process. The literature review was the basis for responding to a series of questions posed in a public session. A group of experts presented the best available evidence, interacting with stakeholders. At the end of the session, an interdisciplinary and multi-professional jury established the final recommendations of the consensus conference. Results: The main recommendations advocate the need to develop policies and institutional guidelines in our field, favouring the patient adverse events disclosure process. The recommendations emphasize the need for the training of professionals in communication skills and patient safety, as well as the development of strategies for supporting professionals who are involved in an adverse event. The assessment of the interest and impact of specific legislation that would help the implementation of these policies was also considered. Conclusions: A cultural change is needed at all levels, nuanced and adapted to the specific social and cultural aspects of our social and health spheres, and involves all stakeholders in the system to create a framework of trust and credibility in which the processing of information about adverse events may become effective (AU)

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OBJECTIVE: To develop recommendations regarding «Information about adverse events to patients and their families¼, through the implementation of a consensus conference. MATERIAL AND METHODS: A literature review was conducted to identify all relevant articles, the major policies and international guidelines, and the specific legislation developed in some countries on this process. The literature review was the basis for responding to a series of questions posed in a public session. A group of experts presented the best available evidence, interacting with stakeholders. At the end of the session, an interdisciplinary and multi-professional jury established the final recommendations of the consensus conference. RESULTS: The main recommendations advocate the need to develop policies and institutional guidelines in our field, favouring the patient adverse events disclosure process. The recommendations emphasize the need for the training of professionals in communication skills and patient safety, as well as the development of strategies for supporting professionals who are involved in an adverse event. The assessment of the interest and impact of specific legislation that would help the implementation of these policies was also considered. CONCLUSIONS: A cultural change is needed at all levels, nuanced and adapted to the specific social and cultural aspects of our social and health spheres, and involves all stakeholders in the system to create a framework of trust and credibility in which the processing of information about adverse events may become effective.

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Objetivo: Sintetizar la información disponible sobre contratos de riesgo compartido (CRC) con medicamentos huérfanos (MH). Métodos: Se realizó una búsqueda en MEDLINE, EMBASE e INHATA y se revisaron trabajos publicados con formato de artículo original, revisión narrativa y sistemática, editorial, comentario, carta al editor, artículo especial, informe y documento institucional con 19 palabras clave y combinaciones de ellas, y en Google con estos términos para encontrar cualquier tipo de documento, comunicado de prensa, declaración institucional pública o privada de cualquier fuente que aportara información relevante. Resultados: La experiencia acumulada con CRC para MH es escasa. No se han encontrado evaluaciones rigurosas de sus resultados, aunque los MH son adecuados para introducirse en clínica mediante ellos. Sus principales tipos son basados en resultados financieros y en rendimiento o resultados clínicos. Presentan ventajas teóricas, pero hay numerosos obstáculos en su diseño, implantación y seguimiento que amenazan sus difusión. Pocos han sido claramente exitosos. Conclusiones: Rigurosamente gestionados, los CRC pueden contribuir a fijar precios razonables, ajustados a la efectividad clínica de los MH, mejorar su farmacovigilancia y el conocimiento de su efectividad comparada, y reducir la incertidumbre y sus variadas consecuencias en pacientes, industria, financiadores y clínicos. En España existen grupos técnicos que puede aportar el conocimiento esencial para usar CRC. Su reto estriba en que se articulen los mecanismos necesarios para mitigar los obstáculos encontrados, armonicen sus evaluaciones y reciban el respaldo político e institucional necesarios (AU)

Objective: To summarize available information on share risk agreements (RSA) with orphan drugs (OD). Methods: A bibliographic search was carried out in MEDLINE, EMBASE and INAHTA using 19 keywords and combinations thereof. Papers published as original, narrative and systematic reviews, editorials, commentaries, letters to the Editor, and special articles were included and reviewed. Public or private institutional reports or documents found in Google that contained relevant information were also reviewed. Results: experience gained so far with RSA is scant. No published rigorous evaluations of outcomes of these agreements were found. It seems, however, that OD are suitable for introduction in clinical practice by means of RSA. There are two main types of RSA: financially based, and performance-outcome based. A number of theoretical advantages of SRA are described, as well as hurdles that hinder their design, implementation, and followup, and thus endangering their success. Very few RSA have clearly succeed so far. Conclusions: If thoroughly managed, RSA may reasonably contribute to value-based pricing of OD, improve their pharmacovigilance, knowledge about their comparative effectiveness, and to reducing uncertainty and its consequences on patients, industry, payers and clinicians. There are technical groups that can bring the essential knowledge to manage RSA in Spain. The challenge now is to be able to harmonize their assessments and appraisals, to put in motion the mechanisms needed to overcome those hurdles, and to provide them adequate political and institutional support (AU)

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OBJECTIVE: To analyse the relationship between the presence of malnutrition (MN), as measured by the NRS-2002 nutritional evaluation, and the rate of morbidity and mortality. DESIGN: Cross-sectional study. SETTING: Patients admitted to Mateu Orfila Hospital, the regional hospital for the island of Menorca, Spain. SUBJECTS: 1,075 patients who were admitted to Mateu Orfila Hospital (Menorca) who had laboratory studies and a nutritional risk (NR) evaluation available were studied. Those who had a clinical suspicion of MN or those at risk were studied. INTERVENTION: Demographic (age, gender) and clinical (current weight, normal weight, body mass index, weight loss, oral intake, presence of intestinal failure, fistula, renal failure, respiratory infection, urinary infection, hyperglycaemia, admission to the ICU, hospital stay, days of parenteral nutrition treatment and reason for admission) were collected during hospitalisation, as well as hospital mortality and mortality at 6 months following discharge. All underwent the NRS-2002 test. RESULTS: The mean patient age was 67.9 years and 58.3% were men. 62% of patients met the criteria for manutrition according to the NRS-2002 test. A statistically significant association was seen between malnutrition according to the NRS-2002 and intestinal failure, fistula, renal failure, respiratory infection, hyperglycemia, hospital mortality and mortality at 6 months. CONCLUSION: Malnutrition affects more than half of the patients who are admitted to a medium-long admission hospital and it is associated with increased morbidity and mortality. The results underscore the need to establish an update plan and preventative and therapeutic nutritional follow-up. These measures reduce the rate of avoidable complications and save the costs associated with them.

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La seguridad del paciente está adquiriendo carta de naturaleza en los contratos de gestión de los servicios de salud. Como la experiencia acumulada en seguridad es menor que en otras áreas asistenciales, conviene revisar algunas de sus vertientes para mejorar su inclusión en los contratos. En este artículo se ofrecen opiniones y recomendaciones sobre diseño y revisión del apartado de seguridad de los contratos de gestión, y reflexiones extraídas de trabajos metodológicos publicados y de opiniones recabadas informalmente de clínicos, quienes mejor conocen los entresijos de las prácticas seguras e inseguras. Tras repasar ciertas particularidades de estos contratos, se describen criterios para priorizar en ellos objetivos y acciones en seguridad, claves de su evaluación y se subraya la necesidad de sustituir intervenciones aisladas por actuaciones sistémicas y multifacéticas. Por último, se analizan errores, limitaciones y oportunidades de mejora que se observan al vincular los contratos con indicadores, sistemas de información y de notificación de eventos adversos, y se destaca la influencia que ejercen en su cumplimiento las reglas de juego y factores conductuales de los profesionales(AU)

Patient safety is becoming commonplace in management contracts. Since our experience in patient safety still falls short of other clinical areas, it is advisable to review some of its characteristics in order to improve its inclusion in these contracts. In this paper opinions and recommendations concerning the design and review of contractual clauses on safety are given, as well as reflections drawn from methodological papers and informal opinions of clinicians, who are most familiar with the nuances of safe and unsafe practices. After reviewing some features of these contracts, criteria for prioritizing and including safety objectives and activities in them, and key points for their evaluation are described. The need to replace isolated activities by systemic and multifaceted ones is emphasized. Errors, limitations and improvement opportunities observed when contracts are linked to indicators, information and adverse event reporting systems are analysed. Finally, the influence of the rules of the game, and clinicians behaviour are emphasised(AU)

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Objective: To analyse the relationship between the presence of malnutrition (MN), as measured by the NRS-2002 nutritional evaluation, and the rate of morbidity and mortality. Design: Cross-sectional study. Setting: Patients admitted to Mateu Orfila Hospital, the regional hospital for the island of Menorca, Spain. Subjects: 1,075 patients who were admitted to Mateu Orfila Hospital (Menorca) who had laboratory studies and a nutritional risk (NR) evaluation available were studied. Those who had a clinical suspicion of MN or those at risk were studied. Intervention: Demographic (age, gender) and clinical (current weight, normal weight, body mass index, weight loss, oral intake, presence of intestinal failure, fistula, renal failure, respiratory infection, urinary infection, hyperglycaemia, admission to the ICU, hospital stay, days of parenteral nutrition treatment and reason for admission) were collected during hospitalisation, as well as hospital mortality and mortality at 6 months following discharge. All underwent the NRS-2002 test. Results: The mean patient age was 67.9 years and 58.3% were men. 62% of patients met the criteria for manutrition according to the NRS-2002 test. A statistically significant association was seen between malnutrition according to the NRS-2002 and intestinal failure, fistula, renal failure, respiratory infection, hyperglycemia, hospital mortality and mortality at 6 months. Conclusion: Malnutrition affects more than half of the patients who are admitted to a medium-long admission hospital and it is associated with increased morbidity and mortality. The results underscore the need to establish an update plan and preventative and therapeutic nutritional follow-up. These measures reduce the rate of avoidable complications and save the costs associated with them (AU)

Objetivo: Determinar la relación entre el grado de Desnutrición (DN), detectada según el test de valoración nutricional NRS-2002, y la tasa de morbimortalidad. Métodos: Estudio transversal de 1075 pacientes que ingresaron en el Hospital Mateu Orfila (Menorca) de los que se disponía una analítica de ingreso y valoración del riesgo nutricional (RN) mediante el test NRS-2002. Se recogieron datos demográficos (edad, sexo) y clínicos (peso actual, peso habitual, Índice Masa Corporal, pérdida peso, ingesta oral, presencia de fracaso intestinal, fístula, fracaso renal, infección respiratoria, infección urinaria, hiperglucemia, estancia en la UCI, estancia hospitalaria, días de tratamiento de nutrición parenteral y enfermedad motivo de ingreso) durante su hospitalización así como la mortalidad hospitalaria y a los 6 meses posteriores al alta. Resultados: La edad media de los pacientes fue de 67,9 años y el 58,3% eran hombres. El 62%de los pacientes presentaron criterios de DN según el test NRS-2002. Se halló asociación estadísticamente significativa entre DN según el test NRS-2002 y fracaso intestinal, fístula, fracaso renal, infección respiratoria, hiperglucemia, mortalidad hospitalaria, mortalidad 6 meses y estancia hospitalaria. Conclusiones: La DN afecta a más de la mitad de los pacientes que ingresan en un hospital de media-larga estancia y se asocia con mayor morbi-mortalidad. Los resultados nos permiten establecer un plan de actuación y seguimiento nutricional de prevención y tratamiento (AU)

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Patient safety is becoming commonplace in management contracts. Since our experience in patient safety still falls short of other clinical areas, it is advisable to review some of its characteristics in order to improve its inclusion in these contracts. In this paper opinions and recommendations concerning the design and review of contractual clauses on safety are given, as well as reflections drawn from methodological papers and informal opinions of clinicians, who are most familiar with the nuances of safe and unsafe practices. After reviewing some features of these contracts, criteria for prioritizing and including safety objectives and activities in them, and key points for their evaluation are described. The need to replace isolated activities by systemic and multifaceted ones is emphasized. Errors, limitations and improvement opportunities observed when contracts are linked to indicators, information and adverse event reporting systems are analysed. Finally, the influence of the rules of the game, and clinicians behaviour are emphasised.

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