Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease.

BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.

Clinical evaluation of antifungal de-escalation in Candida infections: A systematic review and meta-analysis.

OBJECTIVES: De-escalation (DES) from echinocandins to azoles is recommended by several medical societies in Candida infections. We summarise the evidence of DES on clinical and microbiological cure and 30-day survival and compare it with continuing the treatment with echinocandins (non-DES). METHODS: We searched MEDLINE, Embase, Web of Science and Scopus. Studies describing DES in inpatients and reporting any of the outcomes evaluated were included. Pooled estimates of the tree outcomes were calculated with a fixed or random-effects model. Heterogeneity was explored stratifying by subgroups and via meta-regression. This systematic review is registered with PROSPERO (CRD42023475486). RESULTS: Of 1853 records identified, 9 studies were included, totalling 1575 patients. Five studies stepped-down to fluconazole; one to voriconazole and three to any of azoles. The mean day of DES was 5.2 (4.6-6.5) days. The clinical cure OR was 1.29 (95% CI: 0.88-1.88); the microbiological cure 1.62 (95% CI: 0.71-3.71); and 30-day survival 2.17 (95% CI: 1.09-4.32). The 30-day survival data into subgroups showed higher effect on critically ill patients and serious-risk bias studies. Meta-regression did not identify significant effect modifiers. CONCLUSIONS: DES is a safe strategy; it showed no higher 30-day mortality and a trend towards greater clinical and microbiological cure.

[Evolution of the incidence and survival of bronchogenic carcinoma in the province of Castellón (Spain) from 2004 to 2017.] / Evolución de la incidencia y supervivencia del carcinoma broncogénico en la provincia de Castellón en el periodo de tiempo 2004-2017.

OBJECTIVE: Bronchogenic carcinoma (BC) is the second most frequent worldwide and the most lethal tumour in both sexes. Its incidence varies not only among countries but also among different areas of the same country. So, the aim of this work was to analyse the evolution of its incidence and survival in the province of Castellón from 2004 to 2017 and to compare them with those of de rest of the country. METHODS: A retrospective observational study was carried out from patients diagnosed with BC and registered in the Castellón Tumour Register from 2004 to 2017. Survival was estimated using the Kaplan-Meier method whereas to estimate the relationship among different variables both the chi-square and ANOVA test were used. RESULTS: 4,346 cases were diagnosed, whose mean age was 67.5±11.3 years, 85.2% men, the most frequent histological types were adenocarcinoma (28.3%) and epidermoid carcinoma (25.1%). The gross global incidence was 53.4 cases/105 inhabitants, 90.9 cases/105 men and 15.7 cases/105 women. Median global survival at five years was 12.7%, 12% in men and 18.4% in women. CONCLUSIONS: The global incidence of BC in Castellón is lower than the national one, having remained stable in men while it is double in women. Global survival at five years is less than 15%, being higher in women than in men, nevertheless it increases compared to that of previous studies.

OBJETIVO: El carcinoma broncogénico (CB) es el segundo tumor más frecuente a nivel mundial y el más letal en ambos sexos. Su incidencia varía, no sólo entre países, sino también entre diferentes zonas de un mismo país. Por tanto, el objetivo de este trabajo fue analizar la evolución de su incidencia y la supervivencia en la provincia de Castellón desde 2004 hasta 2017, y compararlas con las del resto del país. METODOS: Se realizó un estudio observacional retrospectivo en pacientes diagnosticados de CB e inscritos en el Registro de Tumores de Castellón desde 2004 hasta 2017. La supervivencia se estimó mediante el método de Kaplan-Meier, mientras que para estimar la relación entre distintas variables se utilizaron los test Chi-cuadrado y ANOVA. RESULTADOS: Se diagnosticaron 4.346 casos, con una edad media de 67,5±11,3 años, el 85,2% eran hombres, los tipos histológicos más frecuentes fueron adenocarcinoma (28,3%) y carcinoma epidermoide (25,1%). La incidencia global bruta fue de 53,4 casos/105 habitantes, con 90,9 casos/105 de hombres y 15,7 casos/105 de mujeres. La mediana de supervivencia global a los cinco años fue del 12,7%, siendo del 12% en hombres y del 18,4% en mujeres. CONCLUSIONES: La incidencia global de CB en Castellón es inferior a la nacional, habiéndose mantenido estable en hombres mientras que se duplica en mujeres. La supervivencia global a los cinco años es inferior al 15%, siendo mayor en mujeres que en hombres; no obstante, aumenta respecto a la reportada en estudios previos.

Evolución de la incidencia y supervivencia del carcinoma broncogénico en la provincia de Castellón en el periodo de tiempo 2004-2017 / Evolution of the incidence and survival of bronchogenic carcinoma in the province of Castellón (Spain) from 2004 to 2017

FUNDAMENTOS: El carcinoma broncogénico (CB) es el segundo tumor más frecuente a nivel mundial y el más letal en ambossexos. Su incidencia varía, no sólo entre países, sino también entre diferentes zonas de un mismo país. Por tanto, el objetivo de estetrabajo fue analizar la evolución de su incidencia y la supervivencia en la provincia de Castellón desde 2004 hasta 2017, y compararlascon las del resto del país. MÉTODOS: Se realizó un estudio observacional retrospectivo en pacientes diagnosticados de CB e inscritos en el Registro deTumores de Castellón desde 2004 hasta 2017. La supervivencia se estimó mediante el método de Kaplan-Meier, mientras que paraestimar la relación entre distintas variables se utilizaron los test Chi-cuadrado y ANOVA.RESULTADOS: Se diagnosticaron 4.346 casos, con una edad media de 67,5±11,3 años, el 85,2% eran hombres, los tipos histológicosmás frecuentes fueron adenocarcinoma (28,3%) y carcinoma epidermoide (25,1%). La incidencia global bruta fue de 53,4 casos/10 5habitantes, con 90,9 casos/10 5 de hombres y 15,7 casos/10 5 de mujeres. La mediana de supervivencia global a los cinco años fue del12,7%, siendo del 12% en hombres y del 18,4% en mujeres. CONCLUSIONES: La incidencia global de CB en Castellón es inferior a la nacional, habiéndose mantenido estable en hombresmientras que se duplica en mujeres. La supervivencia global a los cinco años es inferior al 15%, siendo mayor en mujeres que enhombres; no obstante, aumenta respecto a la reportada en estudios previos.(AU)

BACKGROUND: Bronchogenic carcinoma (BC) is the second most frequent worldwide and the most lethal tumour in both sexes. Its incidence varies not only among countries but also among different areas of the same country. So, the aim of this work was toanalyse the evolution of its incidence and survival in the province of Castellón from 2004 to 2017 and to compare them with thoseof de rest of the country. METHODS: A retrospective observational study was carried out from patients diagnosed with BC and registered in the CastellónTumour Register from 2004 to 2017. Survival was estimated using the Kaplan-Meier method whereas to estimate the relationship amongdifferent variables both the chi-square and ANOVA test were used. RESULTS // 4,346 cases were diagnosed, whose mean age was 67.5±11.3 years, 85.2% men, the most frequent histological types wereadenocarcinoma (28.3%) and epidermoid carcinoma (25.1%). The gross global incidence was 53.4 cases/105 inhabitants, 90.9 cases/105men and 15.7 cases/105 women. Median global survival at five years was 12.7%, 12% in men and 18.4% in women. CONCLUSIONS: The global incidence of BC in Castellón is lower than the national one, having remained stable in men while itis double in women. Global survival at five years is less than 15%, being higher in women than in men, nevertheless it increasescompared to that of previous studies.(AU)

Use of Tocilizumab in hospitalized patients during the first wave of the COVID-19 pandemic

Introduction: The aim of this study was to characterize the use of tocilizumab in a hospital. Method: Retrospective cohort study including adult SARS-CoV-2 infected inpatients with moderately severe infection (PaO2/FiO2 < 300). ORs for mortality and treatment success were calculated. Results: The tocilizumab group (n=18), presented 5 days of symptoms vs 7 days in the untreated group (n=71). Minimum PaO2/FiO2 was 147.5 (95%CI: 116.7 to 194.0) vs 255.6 (95%CI: 320.7 to 452.4) (p=0.01).No significant differences were found between the two groups concerning survival (OR=1.22; 95%CI: 0.38 to 3.92), nor treatment success (OR=0.46; 95%CI: 0.16 to 1.33). After adjusting for age, sex and total corticosteroid dose, OR for success was 0.18 (95%CI: 0.03 to 0.96), while mortality was not significant. Conclusions: The use of tocilizumab in moderately severe hospitalized patients could decrease the hyperinflammatory state preventing disease progression (AU)

Introducción: El objetivo del estudio fue estudiar la utilización de tocilizumab en un centro hospitalarioMétodo:Estudio de cohortes retrospectivo que incluyó pacientes ingresados adultos infectados por SARS-CoV-2, con una infección de gravedad moderada (PaO2/FiO2 < 300). Se calcularon las OR de mortalidad y éxito del tratamiento. Resultados: El grupo tocilizumab (n=18), tuvo 5 vs 7 días con síntomas en el grupo no tratado (n=71). El PaO2/FiO2 mínimo fue de 147,5 (IC95%: 116,7 a 194,0) versus 255,6 (IC95%: 320,7 a 452,4) (p=0,01).No se encontraron diferencias significativas entre ambos grupos en supervivencia (OR=1,22; IC95%: 0,38 a 3,92); ni en el éxito del tratamiento (OR=0,46; IC95%: 0,16 a 1,33). Tras ajustar por edad, sexo y dosis total de corticoide, OR de éxitos fue 0,18 (IC95%: 0,03 a 0,96), mientras que mortalidad no fue significativa. Conclusiones: El uso de tocilizumab en pacientes hospitalizados moderadamente graves podría disminuir su estado hiperinflamatorio (AU)

Características de pacientes con enfermedades inflamatorias inmunomediadas hospitalizados por infección por SARS-CoV-2 / Characteristics of Patients With Immune-Mediated Inflammatory Diseases Hospitalized for SARS-CoV-2 Infection

Fundamentos: Las enfermedades inflamatorias inmunomediadas (IMID) predisponen a un aumento del riesgo infeccioso al modificar la respuesta inmune del huésped, que resulta crucial para la resolución de la infección por SARS-CoV-2. Las últimas publicaciones indican que los pacientes con IMID y sus tratamientos de base no empeoran el pronóstico de la infección por SARS-CoV-2. Objetivos: Describir las características clínicas y la evolución de pacientes con IMID que requirieron ingreso hospitalario por infección por SARS-CoV-2. En segundo lugar, comparar las características clínicas y la evolución entre pacientes que requirieron ingreso hospitalario por infección por SARS-CoV-2 con IMID y aquellos que no la presentaban. Métodos: Estudio observacional de cohortes retrospectivo, que incluyó pacientes ingresados por sospecha de SARS-CoV-2, tratados según el criterio médico y los protocolos basados en la evidencia científica. La recogida de datos clínicos se realizó por descarga directa o mediante revisión manual de la historia clínica electrónica. El análisis estadístico determinó las diferencias de características y evolución clínica de la infección en pacientes con IMID. Resultados: De los 612 pacientes revisados, 23 padecían IMID y 9 de ellos fueron diagnosticados de infección por SARS-CoV-2. No se observó correlación entre infección por SARS-CoV-2 e IMID. Los pacientes con IMID presentaban mayor prevalencia de enfermedad cardiovascular y obesidad, aunque no significativamente. Asimismo, los pacientes con IMID no presentaron una evolución clínica durante el ingreso hospitalario diferente respecto al resto de pacientes. Conclusión: Las IMID y los tratamientos de las mismas no determinan el pronóstico del ingreso hospitalario de la infección por SARS-CoV-2.(AU)

Background: Immune-mediated inflammatory diseases (IMID) predispose to a higher infection risk by modifying the host's immune response, which acts as a key factor in SARS-CoV-2 infection resolution. Recent publications show that IMID patients and its treatments do not worsen the outcome of SARS-CoV-2 infection. Objectives: To describe the clinical characteristics and outcomes of patients with IMID who required hospital admission due to SARS-CoV-2 infection. Secondly, to compare clinical characteristics and outcomes between patients who required hospital admission due to SARS-CoV-2 infection with IMID and those who were not affected. Methods: We performed an observational retrospective cohort study, including admitted patients with suspected SARS-CoV-2 infection, treated according to medical criteria and local protocols based on the best available scientific evidence. Clinical data were collected from their electronical clinical history. Statistical analysis determined the differences in the characteristics and clinical outcome of the infection in IMID patients. Results: Of a total number of 612 revised patients, 23 had an IMID and 9 of them were positive for the SARS-CoV-2 infection. We did not observe a correlation between these two disorders. There was a higher frequency of obesity and cardiovascular disease among IMID patients, but without statistical significance. The clinical outcomes were no different between hospitalized IMID and non IMID patients. Conclusion: IMID and its treatments do not determine the outcome of patients admitted with SARS-CoV-2 infection.(AU)

Characteristics of patients with immune-mediated inflammatory diseases hospitalized for SARS-CoV-2 infection.

BACKGROUND: Immune-mediated inflammatory diseases (IMID) predispose to a higher infection risk by modifying the host's immune response, which acts as a key factor in SARS-CoV-2 infection resolution. Recent publications show that IMID patients and its treatments do not worsen the outcome of SARS-CoV-2 infection. OBJECTIVES: To describe the clinical characteristics and outcomes of patients with IMID who required hospital admission due to SARS-CoV-2 infection. Secondly, to compare clinical characteristics and outcomes between patients who required hospital admission due to SARS-CoV-2 infection with IMID and those who were not affected. METHODS: We performed an observational retrospective cohort study, including admitted patients with suspected SARS-CoV-2 infection, treated according to medical criteria and local protocols based on the best available scientific evidence. Clinical data were collected from their electronical clinical history. Statistical analysis determined the differences in the characteristics and clinical outcome of the infection in IMID patients. RESULTS: Of a total number of 612 revised patients, 23 had an IMID and 9 of them were positive for the SARS-CoV-2 infection. We did not observe a correlation between these two disorders. There was a higher frequency of obesity and cardiovascular disease among IMID patients, but without statistical significance. The clinical outcomes were no different between hospitalized IMID and non IMID patients. CONCLUSION: IMID and its treatments do not determine the outcome of patients admitted with SARS-CoV-2 infection.

Two possible cases of erenumab-induced xerostomia.

WHAT IS KNOWN AND OBJECTIVE: Erenumab is a monoclonal antibody for the prophylactic treatment of migraine. We describe the first cases of xerostomia probably induced by this drug. CASE SUMMARY: We present two patients diagnosed with chronic migraine who started treatment with erenumab and presented with dry mouth after the first and second dose. WHAT IS NEW AND CONCLUSION: Xerostomia is not described as an adverse reaction in the drug's technical datasheet. A search was made in PubMed including 'erenumab', 'fremanezumab', 'galcanezumab', 'xerostomia', and no results were found. It is necessary to identify this potential adverse reaction in order to estimate its prevalence and possible impact on patients' quality of life.

Pharmacometabolomics by NMR in Oncology: A Systematic Review.

Pharmacometabolomics (PMx) studies aim to predict individual differences in treatment response and in the development of adverse effects associated with specific drug treatments. Overall, these studies inform us about how individuals will respond to a drug treatment based on their metabolic profiles obtained before, during, or after the therapeutic intervention. In the era of precision medicine, metabolic profiles hold great potential to guide patient selection and stratification in clinical trials, with a focus on improving drug efficacy and safety. Metabolomics is closely related to the phenotype as alterations in metabolism reflect changes in the preceding cascade of genomics, transcriptomics, and proteomics changes, thus providing a significant advance over other omics approaches. Nuclear Magnetic Resonance (NMR) is one of the most widely used analytical platforms in metabolomics studies. In fact, since the introduction of PMx studies in 2006, the number of NMR-based PMx studies has been continuously growing and has provided novel insights into the specific metabolic changes associated with different mechanisms of action and/or toxic effects. This review presents an up-to-date summary of NMR-based PMx studies performed over the last 10 years. Our main objective is to discuss the experimental approaches used for the characterization of the metabolic changes associated with specific therapeutic interventions, the most relevant results obtained so far, and some of the remaining challenges in this area.

Characteristics of Patients With Immune-Mediated Inflammatory Diseases Hospitalized for SARS-CoV-2 Infection. / Características de pacientes con enfermedades inflamatorias inmunomediadas hospitalizados por infección por SARS-CoV-2.

BACKGROUND: Immune-mediated inflammatory diseases (IMID) predispose to a higher infection risk by modifying the host's immune response, which acts as a key factor in SARS-CoV-2 infection resolution. Recent publications show that IMID patients and its treatments do not worsen the outcome of SARS-CoV-2 infection. OBJECTIVES: To describe the clinical characteristics and outcomes of patients with IMID who required hospital admission due to SARS-CoV-2 infection. Secondly, to compare clinical characteristics and outcomes between patients who required hospital admission due to SARS-CoV-2 infection with IMID and those who were not affected. METHODS: We performed an observational retrospective cohort study, including admitted patients with suspected SARS-CoV-2 infection, treated according to medical criteria and local protocols based on the best available scientific evidence. Clinical data were collected from their electronical clinical history. Statistical analysis determined the differences in the characteristics and clinical outcome of the infection in IMID patients. RESULTS: Of a total number of 612 revised patients, 23 had an IMID and 9 of them were positive for the SARS-CoV-2 infection. We did not observe a correlation between these two disorders. There was a higher frequency of obesity and cardiovascular disease among IMID patients, but without statistical significance. The clinical outcomes were no different between hospitalized IMID and non IMID patients. CONCLUSION: IMID and its treatments do not determine the outcome of patients admitted with SARS-CoV-2 infection.

Trascendencia de la detección precoz del riesgo nutricional en nuestros pacientes. Experiencia en un hospital de media-larga estancia / Transcendence of the early detection of nutritional risk in our patients. Experience at a half-long stay hospital

FUNDAMENTO: El cribado de riesgo nutricional permite detectar el riesgo de desnutrición desde su inicio y antes de su manifestación clínica. OBJETIVO: Evidenciar la utilidad del CONUT en el cribado nutricional al ingreso en un hospital de media-larga estancia. MÉTODOS: Se realizaron dos estudios longitudinales (2014n=121-2018n=155), utilizando CONUT para detectar precozmente el riesgo de desnutrición y evaluar la eficacia de la intervención nutricional. Las variables respuesta fueron el tipo y grado de desnutrición al ingreso y al alta. RESULTADOS: La prevalencia de desnutrición/riesgo nutricional detectada con CONUT al ingreso fue de 85,9%. Con la Valoración Nutricional Completa (VNC), la prevalencia de desnutrición al ingreso fue del 81,0% (5% desnutrición calórica, 17,4% mixta y 58,7% proteica). Un 5% de los pacientes en riesgo detectados mediante CONUT, todavía no podían ser diagnosticados mediante la VNC. Los valores al alta fueron 5% desnutrición calórica, 7,7% mixta y 36,4% proteica. CONUT permitió identificar y seguir la evolución del paciente desnutrido con mayor sensibilidad que los parámetros antropométricos. La intervención nutricional redujo la prevalencia y severidad de la desnutrición, mejorando fundamentalmente a expensas de corregir la desnutrición proteica. Los pacientes desnutridos presentaron mayor número de categorías diagnósticas. Se observaron diferencias significativas entre los perfiles nutricionales de las patologías más prevalentes. CONCLUSIONES: CONUT permitió automatizar eficientemente el cribado nutricional. La aplicación de un protocolo estructurado para la detección, monitorización y tratamiento de la desnutrición permitió identificar pacientes subsidiarios de beneficiarse del soporte nutricional, lo que se reflejó en una mejora del estado nutricional al alta

BACKGROUND: Nutritional risk screening enables the risk of malnutrition to be detected from its beginning and before its clinical expression. OBJECTIVE: To demonstrate the usefulness of CONUT in nutritional screening at admission to a medium-to-long stay hospital. METHODS: Two longitudinal studies (2014n=121-2018n=155) were conducted using CONUT for the early detection of the risk of malnutrition and to evaluate the efficacy of the nutritional intervention. The response variables were the type and degree of malnutrition at admission and discharge. RESULTS: The prevalence of malnutrition/nutritional risk detected with CONUT at admission was 85.9%. With the Comprehensive Nutritional Assessment (CNA), the prevalence of malnutrition at admission was 81.0% (caloric malnutrition 5%, mixed malnutrition 17.4%, and protein malnutrition 58.7%). 5% of the patients at risk detected by CONUT still could not be diagnosed by the CNA. The values at discharge were caloric malnutrition 5%, mixed malnutrition 7.7%, and protein malnutrition 36.4%. CONUT enabled the evolution of the malnourished patient to be identified and followed up with greater sensitivity when compared to the anthropometric parameters. Nutritional intervention reduced the prevalence and severity of malnutrition, essentially improving it upon protein malnutrition correction. Malnourished patients showed a greater number of diagnostic categories. Significant differences were observed among the nutritional profiles of the most prevalent diseases. CONCLUSIONS: CONUT enabled nutritional screening to be efficiently automated. The application of a structured protocol for the detection, monitoring and treatment of malnutrition made it possible to identify subsidiary patients to benefit from nutritional support, which was reflected in an improvement in nutritional status at discharge

Proposed model to determine satisfaction with computerised provider order entry systems in a long-stay hospital.

OBJECTIVES: Computerised provider order entry (CPOE) systems reduce medication errors, but are not without dangers. Knowing satisfaction with the CPOE helps to improve its implementation. Our objective was to determine the satisfaction of healthcare professionals with the CPOE in a long-stay hospital and to propose a single model. METHODS: A cross-sectional study in a long-stay hospital. Two questionnaires were distributed to determine satisfaction with CPOE, one for medical personnel (MP) and another for nursing personnel (NP). Data collected were: sex, age and work aspects. A strategy for item refinement and creation of a single scale was designed. RESULTS: The overall participation rate was 63.6%, with 68 responses from the target population of 107. Overall, 72.2% (13 of 18) of MP and 40% (20 of 50) of NP were satisfied with CPOE. Regarding the specific questions on satisfaction in the questionnaires, 88.9% (n=16) of MP were very satisfied but only 56.0% (n=28) of NP. The median of each question was 4, with the exception of those for NP referring to a faster process and improved coordination, which were 3 and 3.5, respectively. The items weighing more in the second component were eliminated and the questions merged. After refining the items, a final six-item model was obtained with a single component of high reliability (Cronbach's α=0.896), which accounts for 67% of total variance. CONCLUSION: The degree of satisfaction with CPOE in a long-stay hospital was high, though lower in NP than MP. Obtaining a single questionnaire can facilitate this process.

Evaluation of formaldehyde as an ocular irritant: a systematic review and Meta-analysis.

OBJECTIVE: The aim of this study was to use meta-regression to evaluate the safety of the maximum allowable dose of formaldehyde in terms of eye irritation symptoms. METHODS: We performed a systematic review of literature published in the PubMed, Embase, Lilacs, Web of Science, and Cochrane Library databases. We selected clinical trials, cohort studies, and case-control studies that compared eye irritation between patients exposed and not exposed to formaldehyde. Eighteen of the 2561 studies retrieved met the inclusion criteria. Data were extracted using structured forms and study quality was analyzed using the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) checklist. Odds ratios (ORs) were calculated using a random effects model with stratification by airborne dose and subsequent meta-regression analysis. RESULTS: The random effects model yielded an OR of 8.11 (95% CI: 5.85-10.37), with an I2 statistic of 99.8% and p < 0.00001. In the meta-regression analysis, we observed an I2 of 87.29% with an R2 of 23.96; the regression line for exposure had a slope of 1.466 (95% CI: 0.096-2.836) in relation to the Napierian log of the OR. Considering a safety level based on an OR of 2 relative to the unexposed group, an airborne concentration of formaldehyde of less than 0.001 mg/m3 can be considered safe. CONCLUSION: Although current formaldehyde exposure concentrations are relatively safe in terms of cancer risk, they continue to cause eye irritation.

[Staff burnout and psychosocial risk factors in a long-stay hospital in Spain]. / Burnout y factores de riesgo psicosocial en el personal de un hospital de larga estancia.

The aim of this study was to assess the relationship between psychosocial risks and burnout syndrome in a long-stay hospital in Spain. A cross-sectional study was conducted in 2017, applying the Spanish version of the MBI-HSS and the F-Psico 3.1 questionnaire of Spain's National Institute of Work Safety and Health. The predictive variables were sociodemographic characteristics, modulators, and psychosocial risk factors. The outcome variables were prevalence of burnout and the effects on his subscales. Associations between variables were measured by odds ratio. Burnout was directly associated with psychosocial risks related to workload, psychological demands, participation/supervision, role performance and social support, and consumption of anxiolytics. Meanwhile, protective factors were having children, feeling valued by patients and coworkers, satisfaction at work, optimism, and social support. The associations found on depersonalization were similar but weaker. Low personal fulfillment was directly associated with the psychosocial risks related to length of workweek, limited autonomy and variety/content of work, and role performance and social support. Low personal fulfillment was the subscale with the most modulating and protective sociodemographic variables included marital status, children, night shift, feeling valued by patients and family members, social support, self-efficacy, and optimism. According to our results, there is an association between psychosocial risks and burnout syndrome. Individuals with greater work satisfaction, self-efficacy, and optimism cope better with stress and are less vulnerable to psychosocial risks and burnout.

Nuestro objetivo fue evaluar la relación entre los riesgos psicosociales y el burnout en un hospital español de media-larga estancia. Se realizó un estudio transversal en 2017, aplicando la versión española del MBI-HSS y el cuestionario F-Psico 3.1 del Instituto Nacional de Seguridad e Higiene en el Trabajo. Variables predictoras: características sociodemográficas, moduladoras y factores de riesgo psicosocial. Variables resultado: prevalencia de burnout y afectación de sus subescalas. La asociación entre variables se cuantificó con odds ratio. El cansancio emocional se asoció positivamente a los riesgos psicosociales vinculados a carga de trabajo, demandas psicológicas, participación/supervisión, desempeño de rol, relaciones/apoyo social y al consumo de ansiolíticos; fueron factores protectores los hijos, sentirse valorado por pacientes y compañeros, satisfacción laboral, optimismo y apoyo social. Las asociaciones halladas para la despersonalización fueron similares, pero más débiles. La baja realización personal se asoció positivamente a los riesgos psicosociales vinculados al tiempo trabajado, autonomía, variedad/contenido del trabajo, desempeño de rol y apoyo social; fue la subescala que mostró mayor número de variables sociodemográficas/moduladoras protectoras: estado civil, tener hijos, trabajar de noche, sentirse valorado por pacientes y familiares, ilusión por el trabajo, apoyo social, autoeficacia y optimismo. Según nuestros resultados, existe asociación entre los riesgos psicosociales y el burnout. Los individuos con mayor satisfacción laboral, autoeficacia y optimismo, afrontan mejor el estrés y son menos vulnerables a los riesgos psicosociales y al burnout.

Nosso objetivo foi avaliar a relação entre os riscos psicossociais e a síndrome de burnout em um hospital espanhol de meia-longa permanência. Foi realizado um estudo transversal em 2017, aplicando a versão espanhola do MBI-HSS e o questionário F-Psico 3.1 do Instituto Nacional de Segurança e Higiene no Trabalho. Variáveis preditoras: características sociodemográficas, moduladoras e fatores de risco psicossocial. Variáveis de resultado: prevalência de burnout e afetação das subfaixas. A associação entre variáveis foi quantificada com odds ratio. A fatiga emocional foi associada positivamente aos riscos psicossociais vinculados a uma carga de trabalho, demandas psicológicas, participação/supervisão, desempenho de funções, relações/apoio social e consumo de ansiolíticos; por outro lado, foram fatores protetores: os filhos, se sentir valorados por pacientes e companheiros de trabalho, satisfação laboral, otimismo e apoio social. As associações encontradas para a despersonalização foram similares, entretanto mais débeis. A baixa realização pessoal foi associada positivamente aos riscos psicossociais vinculados ao tempo trabalhado, autonomia, variedade/conteúdo do trabalho, desempenho de funções e apoio social; foi a subfaixa que mostrou maior número de variáveis sociodemográficas/moduladoras protetoras: estado civil, ter filhos, trabalhar de noite, sentir-se valorizado por pacientes e membros da família, ilusão pelo trabalho, apoio social, auto-eficácia e otimismo. Segundo nossos resultados, existe uma associação entre os riscos psicossociais e a síndrome de burnout. Os indivíduos com maior satisfação laboral, auto-eficácia e otimismo afrontam melhor o stress e são menos vulneráveis aos riscos psicossociais e ao burnout.

[How to increase the health staff adherence to the hands hygiene protocol?] / ¿Cómo incrementar la adhesión del personal sanitario al protocolo de higiene de manos?

OBJECTIVE: Nosocomial infection is a frequent adverse event in health care. Hand hygiene (HH) reduces cross-transmission, but staff adherence is not always adequate. The objectives of this work were evaluating the effectiveness of the HH technique applied in the workplace and monitoring the adherence of the healthcare staff of a Hospital of Medium-Long Stay to the HH protocol. METHODS: Two cross sectional studies were carried out (2010-2012), to determine the prevalence of colonization of the hands of the staff by pathogenic microorganisms, a cross-sectional study (2015), to evaluate their knowledge of the HH technique and two cross-sectional studies (2015-2016), to evaluate the compliance of the protocol in the healthcare practice. The WHO Self-Assessment Framework was applied annually. The hydroalcoholic solution consumption was monitored as a process indicator. RESULTS: The prevalence of colonization of the staff hands went from 28.3% to 21.2%. Compliance with hand hygiene went from 39.5% to 72% and the results of the WHO Self-Assessment Framework went from an intermediate level with 287.5 points to an advanced level with 432.5 points. The consumption of hydroalcoholic solution went from 3.9 to 19.3 liters/1000 stays. CONCLUSIONS: Staff adherence to the HH protocol has increased, having significantly improved the compliance with the recommendations, the hydroalcoholic solution consumption and the HH level assigned to the hospital. The most effective measures to improve the results have been the development of specific improvement plans, having been decisive, the involvement of managers and the use of direct observation as a regular method of work.

OBJETIVO: La infección nosocomial es un evento adverso frecuente en la atención sanitaria. La higiene de manos (HM) reduce la transmisión cruzada, pero la adhesión del personal no siempre es adecuada. Los objetivos de este trabajo fueron evaluar la efectividad de la técnica de HM aplicada en el lugar de trabajo y monitorizar la adhesión del personal sanitario de un Hospital de Media-Larga Estancia al protocolo de HM. METODOS: Se realizaron dos cortes transversales (2010-2012), para conocer la prevalencia de colonización de las manos del personal por microorganismos patógenos, un estudio transversal (2015), para evaluar sus conocimientos sobre la técnica de HM y dos estudios observacionales (2015-2016) para evaluar el cumplimiento del protocolo en la práctica asistencial. Se aplicó anualmente el Marco de Autoevaluación de la OMS. Como indicador de proceso se monitorizó el consumo de solución hidroalcohólica. El análisis estadístico se realizó con el programa SPSS, versión 19.0. RESULTADOS: La prevalencia de colonización pasó del 28,3% al 21,2%. El cumplimiento de la HM pasó del 39,5% al 72%. Aplicando el Marco de Autoevaluación de la OMS se pasó de un nivel intermedio con 287,5 puntos a un nivel avanzado con 432,5 puntos. El consumo de solución hidroalcohólica pasó de 3,9 a 19,3 litros/1000 estancias. CONCLUSIONES: La adhesión al protocolo ha aumentado, habiendo mejorado significativamente el cumplimiento de las recomendaciones, el consumo de solución hidroalcohólica y el Nivel de HM asignado al hospital. Las medidas más eficaces para mejorar los resultados han sido la elaboración de planes de mejora específicos, habiendo sido decisiva la implicación de los directivos y el uso de la observación directa como método habitual de trabajo.

Relación entre la satisfacción laboral y la cultura de seguridad del paciente / Relationship between job satisfaction and patient safety culture

Objetivo: Evaluar la relación existente entre la cultura de seguridad y la satisfacción laboral en un hospital de media-larga estancia, evidenciar las relaciones existentes entre las dimensiones que definen ambos constructos e identificar las dimensiones con mayor impacto sobre las dos variables. Métodos: Estudio transversal realizado en 2015, utilizando la Encuesta de Satisfacción Laboral del Servicio Vasco de Salud y la versión española del cuestionario Hospital Survey on Patient Safety (Agency for Healthcare Research and Quality). Variables resultado: alta satisfacción laboral y alta seguridad percibida (puntuación igual o superior al percentil 75). Variables predictoras: características sociodemográficas y percepción de las dimensiones evaluadas. La asociación entre variables se cuantificó mediante odds ratio (OR) ajustada y su intervalo de confianza del 95%. Resultados: La satisfacción laboral media fue de 7,21 (desviación estándar [DE]: 2,01) y la seguridad percibida fue de 7,48 (DE: 1,98). El percentil 75 de la distribución en ambos casos fue 9. Las variables sociodemográficas presentaron escasa significación, mientras que una buena percepción de muchas de las dimensiones consideradas sí se asoció a las variables resultado. En el análisis de datos se obtuvieron múltiples correlaciones significativas y relaciones cruzadas entre las dimensiones que definen ambos constructos, así como entre el grado de satisfacción de las dimensiones consideradas y las variables resultado. Conclusión: Los resultados evidencian que existe relación entre la satisfacción laboral y la cultura de seguridad, y cuantifican el grado de asociación entre las variables estudiadas. La OR ajustada identifica las variables más fuertemente asociadas con el efecto y ayuda a seleccionar áreas de mejora

Objective: To evaluate the relationship between safety culture and job satisfaction in a medium-stay hospital, showing the relationships between the dimensions that define both constructs and identifying the dimensions with the greatest impact on both variables. Methods: Cross-sectional study conducted in 2015, using the Basque Health Service Job Satisfaction Survey and the Spanish version of the «Hospital Survey on Patient Safety» questionnaire (Agency for Healthcare Research and Quality). Result Variables: high job satisfaction and high degree of perceived security (score ≥75th percentile). Predictor variables: socio-demographic characteristics and perception of the evaluated dimensions. The association between variables was quantified by adjusted odds ratio (OR) and the 95% confidence interval. Results: The mean job satisfaction was 7.21 (standard deviation [SD]: 2.01) and the mean of perceived safety was 7.48 (SD=1.98). The 75th percentile of the distribution in both cases was 9. The socio-demographic variables had little significance, while a positive perception of many of the considered dimensions, was associated with high perception of the result variables. In the data analysis were obtained multiple significant correlations and cross-relations between the dimensions that define both constructs, as well as between the degree of satisfaction of the dimensions considered and the outcome variables. Conclusion: The results obtained evidenced the relationship between job satisfaction and safety culture and quantify the association degree between the studied variables. The adjusted OR identifies the variables most strongly associated with the effect and helps to select improvement areas

Burnout in the staff of a chronic care hospital.

OBJECTIVE To estimate the prevalence of Burnout in a medium or long-stay hospital, to monitor its evolution and to highlight the importance of cut-off points used to avoid distortions in the interpretation of the results. METHODS Two cross-sectional studies (2013-2016) were carried out, applying the Spanish version of the Maslach Burnout Inventory to the staff of a chronic care hospital (n = 323). Result variables were: Burnout prevalence and a high degree of affectation of the subscales and predictor variables: sociodemographic characteristics and factors that trigger and modulate the syndrome. The association between variables was quantified using odds ratio. RESULTS The participation rate went from 31.5% to 39.3%. The professionals presented a mean level of Burnout in both moments, observing a lower degree of affectation of the depersonalization subscales and personal accomplishment in the 2016 cut-off. The average score of the subscales in 2016 was 21.5 for emotional fatigue, 4.7 for depersonalization and 41.7 for personal fulfillment, compared to the values of emotional fatigue = 21.6, depersonalization = 6.9 and personal fulfillment = 36.3 obtained in 2013. The emotional fatigue score was slightly higher than the mean value of the national studies (19.9), while the rest of the values were similar to the mean values of the studies considered. The prevalence of Burnout and the interpretation of the results varied significantly according to the cut-off points considered. In both studies, sociodemographic variables showed little significance, while social support and interpersonal relationships were associated with the degree of burnout among professionals. CONCLUSIONS Our prevalence of Burnout was similar to that of other studies consulted, although the emotional component is more marked in our environment. The interpretation of the results varied significantly according to the cut-off points applied, due to the cross-cultural differences.

[Relationship between job satisfaction and patient safety culture]. / Relación entre la satisfacción laboral y la cultura de seguridad del paciente.

OBJECTIVE: To evaluate the relationship between safety culture and job satisfaction in a medium-stay hospital, showing the relationships between the dimensions that define both constructs and identifying the dimensions with the greatest impact on both variables. METHODS: Cross-sectional study conducted in 2015, using the Basque Health Service Job Satisfaction Survey and the Spanish version of the «Hospital Survey on Patient Safety¼ questionnaire (Agency for Healthcare Research and Quality). Result Variables: high job satisfaction and high degree of perceived security (score ≥75th percentile). Predictor variables: socio-demographic characteristics and perception of the evaluated dimensions. The association between variables was quantified by adjusted odds ratio (OR) and the 95% confidence interval. RESULTS: The mean job satisfaction was 7.21 (standard deviation [SD]: 2.01) and the mean of perceived safety was 7.48 (SD=1.98). The 75th percentile of the distribution in both cases was 9. The socio-demographic variables had little significance, while a positive perception of many of the considered dimensions, was associated with high perception of the result variables. In the data analysis were obtained multiple significant correlations and cross-relations between the dimensions that define both constructs, as well as between the degree of satisfaction of the dimensions considered and the outcome variables. CONCLUSION: The results obtained evidenced the relationship between job satisfaction and safety culture and quantify the association degree between the studied variables. The adjusted OR identifies the variables most strongly associated with the effect and helps to select improvement areas.

¿Cómo incrementar la adhesión del personal sanitario al protocolo de higiene de manos? / How to increase the health staff adherence to the hands hygiene protocol?

Fundamentos: La infección nosocomial es un evento adverso frecuente en la atención sanitaria. La higiene de manos (HM) reduce la transmisión cruzada, pero la adhesión del personal no siempre es adecuada. Los objetivos de este trabajo fueron evaluar la efectividad de la técnica de HM aplicada en el lugar de trabajo y monitorizar la adhesión del personal sanitario de un Hospital de Media-Larga Estancia al protocolo de HM. Métodos: Se realizaron dos cortes transversales (2010-2012), para conocer la prevalencia de colonización de las manos del personal por microorganismos patógenos, un estudio transversal (2015), para evaluar sus conocimientos sobre la técnica de HM y dos estudios observacionales (2015-2016) para evaluar el cumplimiento del protocolo en la práctica asistencial. Se aplicó anualmente el Marco de Autoevaluación de la OMS. Como indicador de proceso se monitorizó el consumo de solución hidroalcohólica. El análisis estadístico se realizó con el programa SPSS, versión 19.0. Resultados: La prevalencia de colonización pasó del 28,3% al 21,2%. El cumplimiento de la HM pasó del 39,5% al 72%. Aplicando el Marco de Autoevaluación de la OMS se pasó de un nivel intermedio con 287,5 puntos a un nivel avanzado con 432,5 puntos. El consumo de solución hidroalcohólica pasó de 3,9 a 19,3 litros/1000 estancias. Conclusiones: La adhesión al protocolo ha aumentado, habiendo mejorado significativamente el cumplimiento de las recomendaciones, el consumo de solución hidroalcohólica y el Nivel de HM asignado al hospital. Las medidas más eficaces para mejorar los resultados han sido la elaboración de planes de mejora específicos, habiendo sido decisiva la implicación de los directivos y el uso de la observación directa como método habitual de trabajo

Background: Nosocomial infection is a frequent adverse event in health care. Hand hygiene (HH) reduces cross-transmission, but staff adhe-rence is not always adequate. The objectives of this work were evaluating the effectiveness of the HH technique applied in the workplace and monitoring the adherence of the healthcare staff of a Hospital of Medium-Long Stay to the HH protocol. Methods: Two cross sectional studies were carried out (2010-2012), to determine the prevalence of colonization of the hands of the staff by pathogenic microorganisms, a cross-sectional study (2015), to evaluate their knowledge of the HH technique and two cross-sectional studies (2015-2016), to evaluate the compliance of the protocol in the healthcare practice. The WHO Self-Assessment Framework was applied annually. The hydroalcoholic solution consumption was monitored as a process indicator. Results: The prevalence of colonization of the staff hands went from 28.3% to 21.2%. Compliance with hand hygiene went from 39.5% to 72% and the results of the WHO Self-Assessment Framework went from an intermediate level with 287.5 points to an advanced level with 432.5 points. The consumption of hydroalcoholic solution went from 3.9 to 19.3 liters/1000 stays. Conclusions: Staff adherence to the HH protocol has increased, ha-ving significantly improved the compliance with the recommendations, the hydroalcoholic solution consumption and the HH level assigned to the hospital. The most effective measures to improve the results have been the development of specific improvement plans, having been decisive, the involvement of managers and the use of direct observation as a regular method of work

Burnout in the staff of a chronic care hospital / Burnout en el personal de un hospital de crónicos

ABSTRACT OBJECTIVE To estimate the prevalence of Burnout in a medium or long-stay hospital, to monitor its evolution and to highlight the importance of cut-off points used to avoid distortions in the interpretation of the results. METHODS Two cross-sectional studies (2013-2016) were carried out, applying the Spanish version of the Maslach Burnout Inventory to the staff of a chronic care hospital (n = 323). Result variables were: Burnout prevalence and a high degree of affectation of the subscales and predictor variables: sociodemographic characteristics and factors that trigger and modulate the syndrome. The association between variables was quantified using odds ratio. RESULTS The participation rate went from 31.5% to 39.3%. The professionals presented a mean level of Burnout in both moments, observing a lower degree of affectation of the depersonalization subscales and personal accomplishment in the 2016 cut-off. The average score of the subscales in 2016 was 21.5 for emotional fatigue, 4.7 for depersonalization and 41.7 for personal fulfillment, compared to the values of emotional fatigue = 21.6, depersonalization = 6.9 and personal fulfillment = 36.3 obtained in 2013. The emotional fatigue score was slightly higher than the mean value of the national studies (19.9), while the rest of the values were similar to the mean values of the studies considered. The prevalence of Burnout and the interpretation of the results varied significantly according to the cut-off points considered. In both studies, sociodemographic variables showed little significance, while social support and interpersonal relationships were associated with the degree of burnout among professionals. CONCLUSIONS Our prevalence of Burnout was similar to that of other studies consulted, although the emotional component is more marked in our environment. The interpretation of the results varied significantly according to the cut-off points applied, due to the cross-cultural differences.

RESUMEN OBJETIVO Estimar la prevalencia de Burnout en un hospital de media-larga estancia, monitorizar su evolución y evidenciar la importancia de los puntos de corte utilizados para evitar sesgos en la interpretación de los resultados. MÉTODOS Se realizaron dos estudios transversales (2013-2016), aplicando la versión española del cuestionario Maslach Burnout Inventory al personal de un hospital de crónicos (n = 323). Fueron variables resultado: prevalencia de Burnout y alto grado de afectación de las subescalas y variables predictoras: características sociodemográficas y factores desencadenantes y moduladores del síndrome. La asociación entre variables se cuantificó mediante odds ratio. RESULTADOS El índice de participación pasó del 31,5% al 39,3%. Los profesionales presentaron un nivel medio de Burnout en ambos momentos, observándose menor grado de afectación de las subescalas de despersonalización y realización personal en el corte realizado en 2016. La puntuación media de las subescalas en 2016 fue 21,5 para el cansancio emocional, 4,7 para la despersonalización y 41,7 para la realización personal, frente a los valores de cansancio emocional = 21,6, despersonalización = 6,9 y realización personal = 36,3 obtenidos en 2013. La puntuación de la escala de cansancio emocional fue ligeramente superior al valor promedio de los estudios nacionales (19,9), mientras que el resto de valores fueron similares a los valores promedio de los estudios considerados. La prevalencia de Burnout y la interpretación de los resultados variaron significativamente en función de los puntos de corte considerados. En ambos estudios, las variables sociodemográficas mostraron escasa significación, mientras que el apoyo social y las relaciones interpersonales se asociaron al grado de Burnout de los profesionales. CONCLUSIONES Nuestra prevalencia de Burnout fue similar a la de otros estudios consultados, aunque el componente emocional es más marcado en nuestro medio. La interpretación de los resultados varió significativamente en función de los puntos de corte aplicados, debido a las diferencias transculturales.