Updated antimicrobial dosing recommendations for obese patients.

The prevalence of obesity has increased considerably in the last few decades. Pathophysiological changes in obese patients lead to pharmacokinetic (PK) and pharmacodynamic (PD) alterations that can condition the correct exposure to antimicrobials if standard dosages are used. Inadequate dosing in obese patients can lead to toxicity or therapeutic failure. In recent years, additional antimicrobial PK/PD data, extended infusion strategies, and studies in critically ill patients have made it possible to obtain data to provide a better dosage in obese patients. Despite this, it is usually difficult to find information on drug dosing in this population, which is sometimes contradictory. This is a comprehensive review of the dosing of different types of antimicrobials (antibiotics, antifungals, antivirals, and antituberculosis drugs) in obese patients, where the literature on PK and possible dosing strategies in obese adults was critically assessed.

Agreement between pharmacists and physicians on the assessment of appropriateness of antimicrobial prescribing.

INTRODUCTION: Audits for monitoring the quality of antimicrobial prescribing are a main tool in antimicrobial stewardship programs; however, interobserver reliability has not been conclusively assessed. Our objective was to measure the level of agreement between pharmacists and physicians on the appropriateness of antimicrobials prescribing in hospitals. METHODS: A national multicenter, cross-sectional study was conducted of patients who were receiving antimicrobials one day of April 2021. Hospital participation was voluntary, and the study population was randomly selected. Pharmacists and physicians performed a simultaneous, independent assessment of the quality of antimicrobial prescriptions. The observers used an assessment method by which all indicators of the quality of antimicrobial use were considered. Finally, an algorithm was used to rate overall antimicrobial prescribing as appropriate, suboptimal, inappropriate, or not assessable. Gwet's AC1 coefficient was used to assess interobserver agreement. RESULTS: In total, 101 hospitals participated, and 411 hospital antimicrobial prescriptions were reviewed. The strength of agreement was moderate regarding the overall quality of prescribing (AC1=0.51; 95%CI=[0.44-0.58]). A very good level of agreement (AC1>0.80) was observed between pharmacists and physicians in all indicators of the quality, except for duration of treatment, rated as good (AC1=0.79; 95%CI=[0.75-0.83]), and registration on the medical record, rated as fair (AC1=0.34; 95%CI=[0.26-0.43]). The agreement was greater in critical care, onco-hematology, and pediatric units than in medical and surgery units. CONCLUSIONS: In this point prevalence study, a moderate level of agreement was observed between pharmacists and physicians in the evaluation of the appropriateness of antimicrobials prescribing in hospitals.

[Translated article] Analysis of the appropriateness of antibiotic prophylaxis in surgical procedures in Spain. Protocol for the "ProA-Q" study.

Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. OBJECTIVE: The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. METHOD: For this purpose, an observational, retrospective, cross-sectional, and multicentre study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines, and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing, and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analysed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analysed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalised linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. DISCUSSION: The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action and guide future strategies for antimicrobial stewardship programs in the area of antibiotic prophylaxis.

Análisis de la adecuación de la profilaxis antibiótica en procedimientos quirúrgicos en España. Protocolo del estudio ProA-Q / Analysis of the appropriateness of antibiotic prophylaxis in surgical procedures in Spain. Protocol for the "ProA-Q" study

La profilaxis antibiótica quirúrgica es una de las medidas más útiles para la prevención de la infección de la herida quirúrgica.Objetivoel objetivo de este proyecto es evaluar la adecuación del uso de profilaxis antibiótica en procedimientos quirúrgicos realizados en centros hospitalarios españoles, tanto de forma global como en función del tipo de cirugía realizada. Metodología para ello, se ha diseñado un estudio observacional, retrospectivo, transversal y multicéntrico, donde se recopilarán todas aquellas variables que permitan evaluar la adecuación de la profilaxis antibiótica quirúrgica mediante la comparación del tratamiento prescrito, las recomendaciones recogidas en las guías locales y el documento de consenso de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica y la Asociación Española de Cirujanos. Se tendrán en cuenta la indicación, elección del antimicrobiano, dosis, vía de administración y tiempo de infusión, momento de la administración de la primera dosis, redosificación y la duración de la profilaxis. La muestra estará constituida por pacientes que hayan sido intervenidos de forma programada o urgente, en régimen de hospitalización o ambulatorio, en centros hospitalarios de España. Se ha establecido un tamaño muestral de 2.335 pacientes para estimar con una confianza del 95% y una potencia del 80%, un porcentaje de adecuación que se espera esté en torno al 70%. Las diferencias entre las variables se analizarán mediante la prueba t-Student, U de Mann-Whitney, el test Chi2 o test de Fisher, según proceda. El grado de concordancia entre la profilaxis antibiótica recomendada por las guías de los distintos hospitales y la recomendada en la literatura se analizará mediante el cálculo del indicador Kappa de Cohen... (AU)

Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. Objective The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. Method For this purpose, an observational, retrospective, cross-sectional and multicenter study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2,335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analyzed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalized linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis... (AU)

Analysis of the appropriateness of antibiotic prophylaxis in surgical procedures in Spain. Protocol for the "ProA-Q" study. / Análisis de la adecuación de la profilaxis antibiótica en procedimientos quirúrgicos en España. Protocolo del estudio ProA-Q.

Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. OBJECTIVE: The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. METHOD: For this purpose, an observational, retrospective, cross-sectional and multicenter study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2,335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analyzed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalized linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. DISCUSSION: The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action and guide future strategies for antimicrobial stewardship programs in the area of antibiotic prophylaxis.

Leprosy in the twenty-first century: a microbiological, clinical, and epidemiological study in northwestern Spain.

Leprosy, or Hansen's disease, is a chronic granulomatous disease caused by Mycobacterium leprae and the recently discovered Mycobacterium lepromatosis. In Spain and other countries, where leprosy has been eliminated, an increasing number of imported cases have been documented, especially from South Africa and South America. The diagnosis of leprosy is mainly clinical, based on the signs established by the World Health Organization (WHO), although laboratory tools can be useful for diagnostic confirmation. The treatment is based on the administration of multi-drug therapy, and involves the multidisciplinary work of experts in ophthalmology, orthopedics, and physiotherapy. We studied the confirmed cases by microbiological and /or histopathological diagnosis in the health area of Santiago de Compostela (456,874 inhabitants in Galicia, in the Northwest of Spain), analyzing their clinical, microbiological, and epidemiological characteristics (2006-2015). In our study, we describe five cases of leprosy, four of them imported and one that, in the absence of more data, is native. Although we have only documented five cases during the 10 years of the study, our experience highlights the importance of considering the country of origin, travel history, and contacts in patients or staff working with leprosy patients. Despite the decrease of leprosy in our environment, it is important to enhance suspicion of the disease among health personnel, especially in those patients from countries where leprosy is endemic and those in close contact with the diagnosed patients.

Seroprevalencia de anticuerpos frente al virus del sarampión en Galicia: tendencias durante los últimos diez años en función de la edad y sexo / Seroprevalence of antibodies against measles virus in Galicia: trends during the last ten years depending on age and sex

OBJETIVOS: En 1998 la Región de Europa de la Organización Mundial de la Salud fijó el objetivo de eliminar el sarampión. En este estudio se analizó la prevalencia de la inmunidad frente al virus del sarampión en la población del área sanitaria de Santiago de Compostela a partir de los datos obtenidos entre 2008-2018. PACIENTES Y MÉTODOS: Se estudiaron 7.150 pacientes diferentes que se dividieron en grupos según su año de nacimiento: 2010-2017, 2000-2009, 1990-1999, 1980-1989, 1953-1979 y <1953. La determinación en suero de IgG frente al virus del sarampión se realizó mediante un inmunoensayo quimioluminiscente comercializado. RESULTADOS: Se observó un mínimo (76%) para las tasas de protección frente al virus del sarampión en los nacidos entre 1990-1999. Por grupo de edad se vio que en todos los grupos las mujeres presentaron un porcentaje superior de anticuerpos frente al sarampión. En un modelo de regresión logística con año de nacimiento y sexo se obtuvo una odds ratio para el año de nacimiento (p < 0,001) de 1,06 y para el sexo (p = 0,0013) de 0,82. CONCLUSIONES: Se observaron seroprevalencias inferiores a partir de la implantación de la vacuna, un cambio más acusado durante el periodo de implantación y desde el plan de vacunación para el sarampión del año 2000 en Galicia, las tasas de protección frente al virus del sarampión han ido aumentado en nuestra área. Aunque se observó una mayor proporción de mujeres protegidas frente a la de hombres, estas diferencias fueron escasas

OBJECTIVES: In 1998, the Europe Region of the World Health Organization set the goal of eliminating measles. In this study, the prevalence of immunity against measles virus in the population of the health area of Santiago de Compostela was analyzed based on data obtained between 2008-2018. METHODS: A total of 7,150 different patients were studied and divided into groups according to their year of birth: 2010-2017, 2000-2009, 1990-1999, 1980-1989, 1953-1979 and <1953. The serum determination of IgG against measles virus was performed using a commercialized chemiluminescent immunoassay. RESULTS: A minimum (76%) was observed for measles virus protection rates in those born between 1990-1999. By age group it was seen that in all groups the women presented a higher percentage of antibodies against measles. In a logistic regression model with year of birth and sex, an odds ratio of 1.06 (p < 0.001) was obtained for the year of birth and of 0.82 (p = 0.0013) for sex. CONCLUSIONS: It was observed lower seroprevalences from the implantation of the vaccine and a more pronounced change during the implantation period. From the vaccination plan for measles of the year 2000 in Galicia, the rates of protection against the virus of the measles have been increasing in our area. Although there is a greater proportion of women protected against men, these differences are small

Assessment of the efficacy and safety of fampridin / Evaluación de la efectividad y seguridad de fampridina

Objective: Assessment of the efficacy and safety of fampridine for walking improvement in adult patients with multiple sclerosis. Method: A descriptive retrospective study of all patients who initiated treatment with fampridine between March, 2014 and February, 2015. Efficacy was assessed through the 25- foot walk test and the 12-item walking scale for multiple sclerosis. It was reviewed whether patients had suffered any of the most frequent adverse effects described in the pivotal clinical trial. Results: Six patients were included, with a 66.7% response rate. At 3-6 months, the mean change in walking speed (compared to baseline) was 39.32% and there was a mean improvement of 15 points in the walking scale. Only one patient presented adverse effects. Conclusions: The results obtained are encouraging, particularly when fampridine is the only drug currently approved to control such a disabling symptom as instability while walking (AU)

Objetivo: Evaluación de la efectividad y seguridad de la fampridina en la mejoría de la marcha de pacientes adultos con esclerosis múltiple. Método: Estudio descriptivo retrospectivo de todos los pacientes que iniciaron tratamiento con fampridina entre marzo de 2014 y febrero de 2015. Se evaluó la efectividad utilizando el test de marcha de los 25 pies y la escala de movilidad de 12 ítems de la esclerosis múltiple. Se revisó si los pacientes habían sufrido alguno de los efectos adversos más frecuentes descritos en el ensayo pivotal. Resultados: Se incluyeron 6 pacientes, con una tasa de respuesta del 66,7%. A los 3-6 meses, el cambio medio en la velocidad de la marcha (comparado con el basal) fue del 39,32% y hubo una mejora media de 15 puntos en la escala de movilidad. Solo uno de los pacientes presentó efectos adversos. Conclusiones: Los resultados obtenidos son esperanzadores, sobre todo cuando la fampridina es el único fármaco autorizado actualmente para controlar un síntoma tan discapacitante como es la inestabilidad de la marcha (AU)

Assessment of the efficacy and safety of fampridine.

OBJECTIVE: Assessment of the efficacy and safety of fampridine for walking improvement in adult patients with multiple sclerosis. METHOD: A descriptive retrospective study of all patients who initiated treatment with fampridine between March, 2014 and February, 2015. Efficacy was assessed through the 25-foot walk test and the 12-item walking scale for multiple sclerosis. It was reviewed whether patients had suffered any of the most frequent adverse effects described in the pivotal clinical trial. RESULTS: Six patients were included, with a 66.7% response rate. At 3-6 months, the mean change in walking speed (compared to baseline) was 39.32% and there was a mean improvement of 15 points in the walking scale. Only one patient presented adverse effects. CONCLUSIONS: The results obtained are encouraging, particularly when fampridine is the only drug currently approved to control such a disabling symptom as instability while walking.

Objetivo: Evaluación de la efectividad y seguridad de la fampridina en la mejoría de la marcha de pacientes adultos con esclerosis múltiple.Método: Estudio descriptivo retrospectivo de todos los pacientes que iniciaron tratamiento con fampridina entre marzo de 2014 y febrero de 2015. Se evaluó la efectividad utilizando el test de marcha de los 25 pies y la escala de movilidad de 12 ítems de la esclerosis múltiple. Se revisó si los pacientes habían sufrido alguno de los efectos adversos más frecuentes descritos en el ensayo pivotal.Resultados: Se incluyeron 6 pacientes, con una tasa de respuesta del 66,7%. A los 3-6 meses, el cambio medio en la velocidad de la marcha (comparado con el basal) fue del 39,32% y hubo una mejora media de 15 puntos en la escala de movilidad. Solo uno de los pacientes presentó efectos adversos. Conclusiones: Los resultados obtenidos son esperanzadores, sobre todo cuando la fampridina es el único fármaco autorizado actualmente para controlar un síntoma tan discapacitante como es la inestabilidad de la marcha.

Characterization and evaluation of the directly observed treatment for tuberculosis in Santiago de Compostela (1996-2006).

OBJECTIVE: To realize a retrospective study of the characterization, results, and effectiveness of directly observed therapy, short course (DOTS) in the regional health area of Santiago de Compostela (population 453 068) between 1996 and 2006. DESIGN: Tuberculosis (TB) patient cases involved in DOTS treatment were reviewed. The studied variables included: age, sex, type of TB, TB location, microbiological studies, chest radiology, pattern and treatment duration, final status of case, and TB recurrence. RESULTS: There were 2456 diagnosed TB cases in the time period studied and 259 received DOTS. The reasons for inclusion in this treatment strategy were social dystocia in 33.2% of cases, retreatment in 30.8% of cases, alcoholism in 29.3% of cases, drug use in 17.4% of cases, HIV coinfection in 11.6% of cases, multidrug-resistant strains of TB (MDR-TB) in 3.1%, and being an immigrant in 1.9% of cases. Primary TB represented 3.5% of the instances and pulmonary TB represented 87.6%. Bacteriological confirmation was performed in 76.8% of this population. Cavitated forms in chest radiology were shown in 46.7% of patients. Standard treatment guidelines were used in 71.4% of patients. Treatment adherence was achieved in 96.1% of the cases and 86.9% cases had a successful final status. Recurrence of TB was 1.5%. CONCLUSION: Although it is not possible to determine the exact influence of the DOTS strategy, its introduction under the conditions of the Galician Program for Prevention and Control of Tuberculosis (GPPCT)5 has worked to improve the control of tuberculosis in our health area.