Efficacy and safety of proactive drug monitoring in inflammatory bowel disease treated with anti-TNF agents: A systematic review and meta-analysis.

BACKGROUND AND AIMS: A systematic review and a meta-analysis of the literature was conducted to assess efficacy and safety of proactive therapeutic drug monitoring (TDM) versus conventional management during maintenance treatment with anti-tumour necrosis factor (anti-TNFα) in patients with inflammatory bowel disease (IBD). METHODS: A search was conducted up to January 2022 (MEDLINE, EMBASE, and the Cochrane Library). The primary outcome was the ability to maintain clinical remission at 12 months. The certainty of evidence was determined using the GRADE approach. RESULTS: Nine studies were identified: one systematic review, six randomised clinical trials, and two cohort studies. No superior efficacy of proactive TDM [relative risk 1.16; 95% confidence interval (CI): 0.98-1.37, n=528; I2=55%] was shown. Proactive TDM could improve the durability of anti-TNFα treatment [odds ratio (OR) 0.12; 95%CI: 0.05-0.27; n=390; I2=45%), prevent acute infusion reactions (OR 0.21; 95%CI: 0.05-0.82; n=390; I2=0%), decrease adverse events (OR 0.38; 95%CI: 0.15-0.98; n=390; I2=14%), and reduce the probability of surgery, at lower economical expenditure. CONCLUSIONS: The analysed evidence did not confirm the superiority of proactive TDM of anti-TNFα treatment over conventional management in patients with IBD, so proactive TDM should not currently be recommended.

Sustained-release isosorbide mononitrate as adjuvant treatment in isolated systolic hypertension in the elderly.

Hypertension is one of the main cardiovascular risk factors. In the elderly, the most common form is isolated systolic hypertension, a consequence of the increase in arterial stiffness. None of the antihypertensives currently used affects arterial stiffness, whereas nitrates seem to have an effect. The aim of this work was to assess their effect on elderly patients with uncontrolled isolated systolic hypertension, defined as systolic blood pressure over 140 mmHg and diastolic blood pressure under 90 mmHg. The present study is a phase III, randomized, multicenter, double-blind, placebo-controlled clinical trial, conducted at the University Hospital La Princesa in Madrid. Patients of both sexes, aged 65 years or older, with poorly controlled isolated systolic hypertension, were treated with 40-60 mg of sustained-release isosorbide mononitrate or matching placebo for 12 weeks. The main objective was to assess the effect on clinical pulse pressure (PP); in addition, its effect on vascular function was evaluated. Analysis was performed by intention to treat. The study was registered at the European Union Clinical Trials Register (EUDRACT 2012-002988-10) and was funded by the Spanish Ministry of Health. A total of 58 patients with an average age of 77 years were enrolled, 32 were treated with nitrate, and 26 with placebo. No significant differences were found either in PP decline (5.28 vs 7.49 mmHg, p = 0.79) or in other variables, including parameters of vascular function. There were no differences in adverse events. The results of this study have not confirmed the benefit of nitrate treatment in isolated systolic hypertension or the improvement of vascular function.

Correction: Inflammation biomarkers in blood as mortality predictors in community-acquired pneumonia admitted patients: Importance of comparison with neutrophil count percentage or neutrophil-lymphocyte ratio.

[This corrects the article DOI: 10.1371/journal.pone.0173947.].

Development and validation of a risk stratification model for prediction of disability and hospitalisation in patients with heart failure: a study protocol.

BACKGROUND: Chronic heart failure (CHF) reduces quality of life and causes hospitalisation and death. Identifying predictive factors of such events may help change the natural history of this condition. AIM: To develop and validate a stratification system for classifying patients with CHF, according to their degree of disability and need for hospitalisation due to any unscheduled cause, over a period of 1 year. METHODS AND ANALYSIS: Prospective, concurrent, cohort-type study in two towns in the Madrid autonomous region having a combined population of 1 32 851. The study will include patients aged over 18 years who meet the following diagnostic criteria: symptoms and typical signs of CHF (Framingham criteria) and left ventricular ejection fraction (EF)<50% or structural cardiac lesion and/or diastolic dysfunction in the presence of preserved EF (EF>50%).Outcome variables will be(a) Disability, as measured by the WHO Disability Assessment Schedule V.2.0 Questionnaire, and (b) unscheduled hospitalisations. The estimated sample size is 557 patients, 371 for predictive model development (development cohort) and 186 for validation purposes (validation cohort). Predictive models of disability or hospitalisation will be constructed using logistic regression techniques. The resulting model(s) will be validated by estimating the probability of outcomes of interest for each individual included in the validation cohort. ETHICS AND DISSEMINATION: The study protocol has been approved by the Clinical Research Ethics Committee of La Princesa University Teaching Hospital (PI-705). All results will be published in a peer-reviewed journal and shared with the medical community at conferences and scientific meetings.

Inflammation biomarkers in blood as mortality predictors in community-acquired pneumonia admitted patients: Importance of comparison with neutrophil count percentage or neutrophil-lymphocyte ratio.

INTRODUCTION: The increase and persistence of inflammation in community-acquired pneumonia (CAP) patients can lead to higher mortality. Biomarkers capable of measuring this inadequate inflammatory response are likely candidates to be related with a bad outcome. We investigated the association between concentrations of several inflammatory markers and mortality of CAP patients. MATERIAL AND METHODS: This was a prospective study of hospitalised CAP patients in a Spanish university hospital. Blood tests upon admittance and in the early-stage evolution (72-120 hours) were carried out, where C-reactive protein, procalcitonin, proadrenomedullin, copeptin, white blood cell, Lymphocyte Count Percentage (LCP), Neutrophil Count Percentage (NCP) and Neutrophil/Lymphocyte Ratio (NLR) were measured. The outcome variable was mortality at 30 and 90 days. Statistical analysis included logistic regression, ROC analysis and area-under-curve test. RESULTS: 154 hospitalised CAP patients were included. Patients who died during follow-up had higher levels of procalcitonin, copeptin, proadrenomedullin, lower levels of LCP, and higher of NCP and NLR. Remarkably, multivariate analysis showed a relationship between NCP and mortality, regardless of age, severity of CAP and comorbidities. AUC analysis showed that NLR and NCP at admittance and during early-stage evolution achieved a good diagnostic power. ROC test for NCP and NLR were similar to those of the novel serum biomarkers analysed. CONCLUSIONS: NLR and NCP, are promising candidate predictors of mortality for hospitalised CAP patients, and both are cheaper, easier to perform, and at least as reliable as the new serum biomarkers. Future implementation of new biomarkers would require comparison not only with classic inflammatory parameters like White Blood Cell count but also with NLR and NCP.

Prevalencia y características de los pacientes con infección por virus de la inmunodeficiencia humana (VIH) diagnosticados de novo en un servicio de urgencias / Prevalence of undiagnosed human immunodeficiency virus infection in an emergency department and the characteristics of newly diagnosed patients

Objetivo: Estimar la prevalencia de la infección por el virus de la inmunodeficiencia humana (VIH) no diagnosticada entre la población que acude al servicio de urgencias hospitalario (SUH) mediante la realización rutinaria del test para VIH, y describir los factores asociados al diagnóstico. Método: Estudio descriptivo transversal que incluyó a los pacientes entre 15 y 75 años valorados en la zona de pacientes ambulantes del SUH y a los que se les realizó una analítica sanguínea por su motivo de consulta, en la que se obtuvo una muestra para realizar la prueba del VIH de manera rutinaria mediante test de enzimoinmunoanálisis (EIA) de 4ª generación. Los pacientes con resultado positivo fueron remitidos al servicio de infecciosas para seguimiento y tratamiento. Resultados: Se obtuvieron muestras de sangre de 1.722 pacientes. De estos, 21 (1,2%) rechazaron la realización de la serología y 19 (1,1%) no fueron finalmente analizados. La prevalencia de infección VIH no diagnosticada entre los 1.682 pacientes analizados fue del 0,6% [IC 95%: 0,23-0,96%]. Fue, sin significación estadística, mayor en los pacientes nacidos en otros países 0,97% [IC 95%: 0,3-2,20] y en los pacientes de 36 a 50 años 1,46% [IC 95%: 0,4-2,5]. Los factores que se asociaron con infección no conocida por VIH fueron ser hombre [OR: 5,78 (IC 95%: 1,0-31,4)], tener un motivo de consulta sugerente de infección [OR: 8,14 (IC 95%: 1,6-41,4)] y tener antecedentes de hepatitis [OR: 5,53 (IC 95%: 1,1-27,7)]. Conclusión: Hubo una alta prevalencia (0,6%) de infección por VIH no diagnosticada entre los pacientes atendidos en urgencias, los cuales mostraron una alta aceptación para realizar una serología VIH de manera rutinaria y universal. Estos resultados aconsejan mejorar las estrategias de detección de infección oculta por VIH (AU)

Objective: To estimate the prevalence of undiagnosed human immunodeficiency virus (HIV) infection detected by routine testing of patients seeking care in an emergency department and to describe the characteristics associated with new HIV-infection diagnosis. Methods: Walk-in patients between the ages of 15 and 75 years who required a blood test were included. Routine fourth-generation enzyme-linked immunoassays were performed to detect HIV infection in all samples extracted. Patients with positive results were referred to the infectious diseases department for monitoring and treatment. Results: Blood samples for 1722 patients were analyzed. Twenty-one patients (1.2%) refused to allow their samples to be tested; 19 more samples (1.1%) could not be tested. The prevalence of undiagnosed HIV infection among the remaining 1682 remaining patients was 0.6% (95% CI, 0.23%–0.96%). The prevalence tended to be nonsignificantly higher among patients born outside Spain (0.97% [95% CI, 0.3%–2.20%]) and in 36–50-year-olds (1.46% [95% CI, 0.4%–2.5%]). Characteristics associated with undiagnosed HIV infection were male sex (odds ratio [OR], 5.78 [95% CI, 1.0–31.4]), presenting with a chief complaint that suggested infection (OR, 8.14 [95% CI, 1.6–41.4]), and a history of hepatitis (OR, 5.53 [95% CI, 1.1–27.7]). Conclusions: The prevalence of undiagnosed HIV infection in our emergency department was high at 0.6%. The rate of patient acceptance of routine HIV testing was high. Strategies that target improving the detection of undiagnosed HIV infection are advisable (AU)

[ESTIMATE OF THE INTRINSIC ERROR OF THE MEASURING INSTRUMENT OF THE LABORATORY FOR ANALYTICAL DETERMINATIONS OF THE CRITICAL PATIENT]. / Estimación del error intrínseco del instrumento de medida del laboratorio. PARA LAS DETERMINACIONES ANALÍTICAS DEL PACIENTE CRÍTICO.

Decrease blood loss associated with the analytical laboratory is a determinant of safety and quality in the preanalytical phase, in order to achieve an optimal level of care, where nurses have leading role to be responsible for the care of the critically ill patient.

Estimación del error intrínsico del instrumento de medida del laboratorio para las determinaciones analíticas del paciente crítico / Estimate of the intrinsic error of the measuring instrument of the laboratory for analytical determinations of the critical patient

Disminuir las pérdidas sanguíneas asociadas a las analíticas de laboratorio constituye un determinante de seguridad y calidad en la fase preanalítica, para llegar a alcanzar un óptimo nivel asistencial donde las enfermeras poseen gran protagonismo, al ser responsables del cuidado del paciente críticamente enfermo (AU)

Decrease blood loss associated with the analytical laboratory is a determinant of safety and quality in the preanalytical phase, in order to achieve an optimal level of care, where nurses have leading role to be responsible for the care of the critically ill patient (AU)

[Prevalence of undiagnosed human immunodeficiency virus infection in an emergency department and the characteristics of newly diagnosed patients]. / Prevalencia y características de los pacientes con infección por virus de la inmunodeficiencia humana (VIH) diagnosticados de novo en un servicio de urgencias.

OBJECTIVES: To estimate the prevalence of undiagnosed human immunodeficiency virus (HIV) infection detected by routine testing of patients seeking care in an emergency department and to describe the characteristics associated with new HIV-infection diagnosis. MATERIAL AND METHODS: Walk-in patients between the ages of 15 and 75 years who required a blood test were included. Routine fourth-generation enzyme-linked immunoassays were performed to detect HIV infection in all samples extracted. Patients with positive results were referred to the infectious diseases department for monitoring and treatment. RESULTS: Blood samples for 1722 patients were analyzed. Twenty-one patients (1.2%) refused to allow their samples to be tested; 19 more samples (1.1%) could not be tested. The prevalence of undiagnosed HIV infection among the remaining 1682 remaining patients was 0.6% (95% CI, 0.23%-0.96%). The prevalence tended to be nonsignificantly higher among patients born outside Spain (0.97% [95% CI, 0.3%-2.20%]) and in 36-50-year-olds (1.46% [95% CI, 0.4%-2.5%]). Characteristics associated with undiagnosed HIV infection were male sex (odds ratio [OR], 5.78 [95% CI, 1.0-31.4]), presenting with a chief complaint that suggested infection (OR, 8.14 [95% CI, 1.6-41.4]), and a history of hepatitis (OR, 5.53 [95% CI, 1.1-27.7]). CONCLUSION: The prevalence of undiagnosed HIV infection in our emergency department was high at 0.6%. The rate of patient acceptance of routine HIV testing was high. Strategies that target improving the detection of undiagnosed HIV infection are advisable.

OBJETIVO: Estimar la prevalencia de la infección por el virus de la inmunodeficiencia humana (VIH) no diagnosticada entre la población que acude al servicio de urgencias hospitalario (SUH) mediante la realización rutinaria del test para VIH, y describir los factores asociados al diagnóstico. METODO: Estudio descriptivo transversal que incluyó a los pacientes entre 15 y 75 años valorados en la zona de pacientes ambulantes del SUH y a los que se les realizó una analítica sanguínea por su motivo de consulta, en la que se obtuvo una muestra para realizar la prueba del VIH de manera rutinaria mediante test de enzimoinmunoanálisis (EIA) de 4ª generación. Los pacientes con resultado positivo fueron remitidos al servicio de infecciosas para seguimiento y tratamiento. RESULTADOS: Se obtuvieron muestras de sangre de 1.722 pacientes. De estos, 21 (1,2%) rechazaron la realización de la serología y 19 (1,1%) no fueron finalmente analizados. La prevalencia de infección VIH no diagnosticada entre los 1.682 pacientes analizados fue del 0,6% [IC 95%: 0,23-0,96%]. Fue, sin significación estadística, mayor en los pacientes nacidos en otros países 0,97% [IC 95%: 0,3-2,20] y en los pacientes de 36 a 50 años 1,46% [IC 95%: 0,4-2,5]. Los factores que se asociaron con infección no conocida por VIH fueron ser hombre [OR: 5,78 (IC 95%: 1,0-31,4)], tener un motivo de consulta sugerente de infección [OR: 8,14 (IC 95%: 1,6-41,4)] y tener antecedentes de hepatitis [OR: 5,53 (IC 95%: 1,1-27,7)]. CONCLUSIONES: Hubo una alta prevalencia (0,6%) de infección por VIH no diagnosticada entre los pacientes atendidos en urgencias, los cuales mostraron una alta aceptación para realizar una serología VIH de manera rutinaria y universal. Estos resultados aconsejan mejorar las estrategias de detección de infección oculta por VIH.

The incidence of cardiovascular events after hospitalization due to CAP and their association with different inflammatory markers.

BACKGROUND: Late prognosis of Community-Acquired Pneumonia (CAP) patients is related to cardiovascular events. Persistence of inflammation-related markers, defined by high circulatory levels of interleukin 6 and 10 (IL-6/IL-10), is associated with a higher post-event mortality rate for CAP patients. However, association between these markers and other components of the immune response, and the risk of cardiovascular events, has not been adequately explored. The main objectives of this study are: 1) to quantify the incidence of cardiovascular disease, in the year post-dating their hospital admittance due to CAP and, 2) to describe the distribution patterns of a wide spectrum of inflammatory markers upon admittance to and release from hospital, and to determine their relationship with the incidence of cardiovascular disease. METHODS/DESIGN: A cohort prospective study. All patients diagnosed and hospitalized with CAP will be candidates for inclusion. The study will take place in the Universitary Hospital La Princesa, Spain, during two years. Two samples of blood will be taken from each patient: the first upon admittance and the second one prior to release, in order to analyse various immune agents. The main determinants are: pro-adrenomedullin, copeptin, IL-1, IL-6, TNF-α, IL-17, IFN-γ, IL-10 and TGF-ß, E-Selectin, ICAM-1, VCAM-1 and subpopulations of peripheral T lymphocytes (T regulator, Th1 and Th17), together with other clinical and analytical variables. Follow up will start at admittance and finish a year after discharge, registering incidence of death and cardiovascular events. The main objective is to establish the predictive power of different inflammatory markers in the prognosis of CAP, in the short and long term, and their relationship with cardiovascular disease. DISCUSSION: The level of some inflammatory markers (IL-6/IL-10) has been proposed as a means to differentiate the degree of severity of CAP, but their association with cardiovascular risk is not well established. In this study we aim to define new inflammatory markers associated with cardiovascular disease that could be helpful for the prognosis of CAP patients, by describing the distribution of a wide spectrum of inflammatory mediators and analyzing their association with the incidence of cardiovascular disease and mortality one year after release from hospital.

Nutritional screening; control of clinical undernutrition with analytical parameters.

OBJECTIVE: To update the system for nutritional screening. The high prevalence of nutritional unstability that causes the Clinical Undernutrition (CU), especially within the hospitals and assisted residencies, makes it necessary to use screening tools for the constant control of undernutrition to combat it during its development. CU is not so much due to a nutritional deficiency but to the illness and its treatments. However, the screening systems currently used are aimed at detecting an already established undernutrition rather than at detecting any nutritional risk that may be present. The metabolic changes of the nutritional status that have a trophopathic effect, can be easily and automatically detected in plasma, which allows to make the necessary changes in treatments that might be too aggressive, as well as to apply nutritional support according to each case. The manual screening systems can detect those somatic changes typical of undernutrition only after many days or weeks, which might be too late. Plasma albumin is a very reliable parameter for nutritional control. A lowered amount of it, due to whatever reason, is a clear sign of a possible deficit as well as of a nutritional risk suffered by the cell way before the somatic signs of undernutrition will become apparent. A fast detection of nutritional risk, anticipating undernutrition, offers prognostic abilities, which makes screening tools based on analytic parameters the most useful, ergonomic, reliable and efficient system for nutritional screening and prognosis in the clinical practice. CONCLUSION: It is necessary to update some concepts, to leave behind old myths and to choose modern screening systems that have proven to be efficient. This is the only way achieving the dream of controlling CU among ill and vulnerable patients.

Objetivo: Actualizar el cribado nutricional. La alta prevalencia del desequilibrio nutricional que genera la Desnutrición Clínica (DC), especialmente en hospitales y residencias asistidas, obliga al uso de herramientas de cribado y a controlar su evolución para combatirla sobre la marcha. La DC deriva menos de la carencia nutricional que de los efectos de la enfermedad y sus tratamientos, pero los actuales sistemas de cribado buscan más la desnutrición ya establecida que el riesgo nutricional existente. Las alteraciones metabólicas del equilibrio nutricional que constituyen la trofopatía se pueden captar en el plasma sin demoras, automáticamente, permitiendo rectificar actitudes terapéuticas demasiado agresivas o complementarlas con el adecuado soporte nutricional. Con los sistemas manuales de cribado, solo pasados días o semanas se evidenciarán, tardíamente, los cambios somáticos expresivos de esa desnutrición. La concentración de la albúmina plasmática es un parámetro muy valioso en el control nutricional. Su disminución, cualquiera que sea la causa, expresa un posible déficit pero también el riesgo nutricional a que se ve sometida la célula, antes de que la desnutrición se manifieste somáticamente. La precocidad de la detección del riesgo nutricional, anticipándose a la desnutrición y su gran capacidad pronóstica hacen de las herramientas basadas en parámetros analíticos, el procedimiento más útil, ergonómico, seguro y eficiente para el cribado y pronóstico nutricional en el entorno clínico. Conclusión: es hora de actualizar conceptos, deshacer mitos y optar por sistemas modernos de cribado eficientes, única manera de alcanzar el sueño de controlar la DC en nuestras poblaciones enfermas y frágiles.

Cribado nutricional; control de la desnutrición clínica con parámetros analíticos / Nutritional screening; control of clinical undernutrition with analytical parameters

Objetivo: Actualizar el cribado nutricional. La alta prevalencia del desequilibrio nutricional que genera la Desnutrición Clínica (DC), especialmente en hospitales y residencias asistidas, obliga al uso de herramientas de cribado y a controlar su evolución para combatirla sobre la marcha. La DC deriva menos de la carencia nutricional que de los efectos de la enfermedad y sus tratamientos, pero los actuales sistemas de cribado buscan más la desnutrición ya establecida que el riesgo nutricional existente. Las alteraciones metabólicas del equilibrio nutricional que constituyen la trofopatía se pueden captar en el plasma sin demoras, automáticamente, permitiendo rectificar actitudes terapéuticas demasiado agresivas o complementarlas con el adecuado soporte nutricional. Con los sistemas manuales de cribado, solo pasados días o semanas se evidenciarán, tardíamente, los cambios somáticos expresivos de esa desnutrición. La concentración de la albúmina plasmática es un parámetro muy valioso en el control nutricional. Su disminución, cualquiera que sea la causa, expresa un posible déficit pero también el riesgo nutricional a que se ve sometida la célula, antes de que la desnutrición se manifieste somáticamente. La precocidad de la detección del riesgo nutricional, anticipándose a la desnutrición y su gran capacidad pronóstica hacen de las herramientas basadas en parámetros analíticos, el procedimiento más útil, ergonómico, seguro y eficiente para el cribado y pronóstico nutricional en el entorno clínico. Conclusión: es hora de actualizar conceptos, deshacer mitos y optar por sistemas modernos de cribado eficientes, única manera de alcanzar el sueño de controlar la DC en nuestras poblaciones enfermas y frágiles (AU)

Objective: To update the system for nutritional screening. The high prevalence of nutritional unstability that causes the Clinical Undernutrition (CU), especially within the hospitals and assisted residencies, makes it necessary to use screening tools for the constant control of undernutrition to combat it during its development. CU is not so much due to a nutritional deficiency but to the illness and its treatments. However, the screening systems currently used are aimed at detecting an already established undernutrition rather than at detecting any nutritional risk that may be present. The metabolic changes of the nutritional status that have a trophopathic effect, can be easily and automatically detected in plasma, which allows to make the necessary changes in treatments that might be too aggressive, as well as to apply nutritional support according to each case. The manual screening systems can detect those somatic changes typical of undernutrition only after many days or weeks, which might be too late. Plasma albumin is a very reliable parameter for nutritional control. A lowered amount of it, due to whatever reason, is a clear sign of a possible deficit as well as of a nutritional risk suffered by the cell way before the somatic signs of undernutrition will become apparent. A fast detection of nutritional risk, anticipating undernutrition, offers prognostic abilities, which makes screening tools based on analytic parameters the most useful, ergonomic, reliable and efficient system for nutritional screening and prognosis in the clinical practice. Conclusion: It is necessary to update some concepts, to leave behind old myths and to choose modern screening systems that have proven to be efficient. This is the only way achieving the dream of controlling CU among ill and vulnerable patients (AU)

Fiabilidad de los resultados analíticos de muestra sanguínea desechando el doble del espacio muerto del catéter / Reliability of laboratory findings from blood samples when only the double dead space in catheter is discarded

OOBJETIVO: determinar la fiabilidad de dos métodos de extracción desangre a través de catéter arterial en los pacientes ingresados en una unidad de reanimación postquirúrgica. MATERIAL Y MÉTODO: estudio cuasi experimental realizado en el Hospital de la Princesa de Madrid, de febrero a mayo de 2010, en el que se compararon dos métodos de extracción de muestra de sangre para análisis a través de catéter arterial periférico, realizados secuencialmente: primero la intervención= 2 cc sangre desechada + 13,5 muestra a analizar, y segundo el control= inmediatamente después de la extracción previa= 15,5 cc + 13,5 muestra a analizar, en relación a los resultados de parámetros analíticos bioquímicos, hematológicos y de coagulación. RESULTADOS: la diferencia de las medias es muy pequeña en todos los parámetros estudiados; en todos los casos el "0" se encuentra incluido en los respectivos intervalos de confianza, no siendo estadísticamente significativos (p> 0,05). Las correlaciones son superiores a 0,93 en todos los parámetros estudiados en el caso de la bioquímica, superiores a0,84 en el caso de la hematimetría y superiores a 0,90 en el caso de la coagulación, obteniendo en todos los casos unos valores de p< de 0,05.CONCLUSIONES: para garantizar la calidad de los resultados de laboratorio es suficiente desechar el volumen correspondiente al doble del espacio muerto del sistema (en el presente estudio 2 cc)

PURPOSE: to assess reliability of two blood sample drawing methods though an arterial catheter in patients admitted to a postoperative resuscitation unit. MATERIAL AND METHODS: a quasi-experimental study was carried out at Hospital de la Princesa, Madrid, Spain, from February to May 2010.Two sequentially used methods for drawing blood samples for laboratory tests through a peripheral arterial catheter were compared: firstly the intervention procedure = 2 cc of blood discarded + a 13.5 sample for laboratory testing; and secondly the control procedure = immediately after previous sample drawing = 15.5 cc + a 13.5 sample for laboratory testing. Biochemistry, hematology and coagulation laboratory parameters were compared. RESULTS: differences in mean values were very low for all assessed parameters. Zero value is always included in confidence intervals; therefore, differences were not statistically significant (p > 0.05). Correlation is higher than 0.93 for all assessed biochemistry parameters, higher than 0.84 for hematology parameters, and higher than 0.90 for coagulation parameters (p < 0.05 for all comparisons).CONCLUSIONS: discarding the volume corresponding to the doubledead space in the system (2 cc in our study) is adequate to ensure quality in laboratory testing results

Comparison between microcomputed tomography and cone-beam computed tomography radiologic bone to assess atrophic posterior maxilla density and microarchitecture.

PURPOSE: The aim of this study was to analyze the relationship between bone density obtained by cone-beam computed tomography (CBCT) and morphometric parameters of bone analyzed by microcomputed tomography (µ-CT). MATERIAL AND METHODS: An overall of 32 subjects ≤8 mm of bone height were included in the study. One site per patient was randomly selected to obtain bone core. Totally, 27 biopsies were available for µ-CT analysis. In addition, CBCT was taken after positioning a previously fabricated acrylic resin template with a 2-mm-diameter metal rod at the randomly selected implant site to study radiographic bone density (RBD). The relationship between µ-CT and CBCT quantitative variable and RBD was analyzed using Spearman correlation. RESULTS: Positive correlations between BV/TV (r = 0.769, P < 0.001), BS/TV (r = 0.563, P = 0.002), Tb.Th (r = 0.491, P = 0.009), Tb.N (r = 0.518, P = 0.005) and vBMD (r = 0.699, P < 0.001) with RBD were identified. On the contrary, BS/BV (r = -0.509, P = 0.006), Tb.Sp (r = -0.539, P = 0.003) and Tb.Pf (r = -0.636, P < 0.001) were negatively correlated with RBD. Moreover, SMI (r = -0.380, P = 0.050) and DA (-0.245, P = 0.217) were negatively correlated but not statistically significant. CONCLUSION: This study demonstrated the correlation between radiographic bone density (RBD) and bone density assessed by µ-CT. Therefore, our data supported the use of CBCT as pre-operative tool for implant treatment planning because it is shown to be reliable to assess atrophic posterior maxilla density and microarchitecture.

Effect of oral nitrates on pulse pressure and arterial elasticity in patients aged over 65 years with refractory isolated systolic hypertension: study protocol for a randomized controlled trial.

BACKGROUND: Isolated systolic hypertension is a highly prevalent disease among the elderly. The little available evidence on the efficacy of nitrates for treating the disease is based on small experimental studies. METHODS/DESIGN: We performed a multicenter, randomized, double-blind, phase III, placebo-controlled trial in 154 patients aged over 65 years with refractory isolated systolic hypertension. Patients were randomized to placebo or 40 mg/day of extended-release isosorbide mononitrate added to standard therapy and titrated to 60 mg/day at week 6 if blood pressure exceeded 140/90 mmHg.The primary objective was to assess the effect on clinical pulse pressure of extended-release isosorbide mononitrate added to standard therapy in patients aged over 65 years with refractory isolated systolic hypertension after 3 months of treatment.The secondary objectives were as follows: to quantify the effect of adding the study drug on central blood pressure and vascular compliance using the augmentation index and pulse wave velocity; to evaluate the safety profile by recording adverse effects (frequency, type, severity) and the percentage of patients who had to withdraw from the trial because of adverse events; to quantify the percentage of patients who reach a clinical systolic blood pressure <140 mmHg or <130 mmHg measured by ambulatory blood pressure monitoring; and to quantify the change in pulse pressure measured by ambulatory blood pressure monitoring. DISCUSSION: Few clinical trials have been carried out to test the effect of oral nitrates on isolated systolic hypertension, even though these agents seem to be effective. Treatment with extended-release isosorbide mononitrate could improve control of systolic blood pressure without severe side effects, thus helping to reduce the morbidity and mortality of the disease. TRIAL REGISTRATION: EUDRACT Number: 2012-002988-10.

Disminución de la hemoglobina en pacientes postquirúrgicos y muestras sanguíneas diagnósticas / Decrease of hemoglobin in post-surgical patients and diagnostic blood testing

La anemia es un problema frecuente en los pacientes ingresados en cuidados intensivos. Su etiología es multifactorial, aumentando los requerimientos transfusionales y la morbimortalidad. Objetivo: conocer la prevalencia de anemia y transfusión de los pacientes postquirúrgicos durante los cinco primeros días de ingreso en la unidad e reanimación y si existe relación con las pérdidas sanguíneas por la obtención de muestras analíticas .Material y métodos: estudio descriptivo, observacional y retrospectivo, de los pacientes ingresados en la unidad de reanimación postquirúrgica, desde enero a diciembre de 2008, del Hospital Universitario de "La Princesa" (Madrid). Se incluyeron en el estudio los pacientes postquirúrgicos ingresados en la unidad de reanimación durante un tiempo igual o superior a cinco días. Se excluyeron del estudio a los fallecidos durante ese periodo, sometidos a cirugía cardiaca, los politraumatizados y aquéllos con una tendencia hemorrágica mayor a la habitual. Se analizaron datos relativos a la anemia, las transfusiones y las pérdidas de masa eritrocitaria y volumen sanguíneo de las extracciones de muestras para análisis. Resultados: se han revisado las historias clínicas de los 65 pacientes ingresados que cumplían los criterios de inclusión. La prevalencia de (..) (AU)

Anemia is a common problem in patients admitted to the Intensive Care Unit. It has a multifactorial etiology, with increased transfusion requirements and higher morbimortality. Objective: to ascertain the prevalence of anemia and the transfusion of post-surgical patients during the first five days of admission to the recovery room, and if there is blood loss related to the collection of blood samples for laboratory work. Material and methods: a descriptive, observational and retrospective study of patients admitted to the postoperative recovery unit, from January to december 2008, at the "The Princess" University Hospital (Madrid). Post-surgical patients admitted to the recovery room for a period of no less than five days were included in the study. Those patients who had died during the study period, those who had undergone cardiac surgery, those with multiple trauma injuries and those with a tendency higher than usual to bleed were excluded from analysis. Data relative to anemia, transfusions and loss of blood volume and red cell (..) (AU)

A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.

BACKGROUND: This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7-8 years. METHODS/DESIGN: This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7-8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a ß of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. DISCUSSION: The intervention providing the best results could be recommended as part of health education for young schoolchildren. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01418872.

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BACKGROUND: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency. METHODS/DESIGN: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses. DISCUSSION: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Efficacy of a strategy for implementing a guideline for the control of cardiovascular risk in a primary healthcare setting: the SIRVA2 study a controlled, blinded community intervention trial randomised by clusters.

UNLABELLED: This work describes the methodology used to assess a strategy for implementing clinical practice guidelines (CPG) for cardiovascular risk control in a health area of Madrid. BACKGROUND: The results on clinical practice of introducing CPGs have been little studied in Spain. The strategy used to implement a CPG is known to influence its final use. Strategies based on the involvement of opinion leaders and that are easily executed appear to be among the most successful. AIM: The main aim of the present work was to compare the effectiveness of two strategies for implementing a CPG designed to reduce cardiovascular risk in the primary healthcare setting, measured in terms of improvements in the recording of calculated cardiovascular risk or specific risk factors in patients' medical records, the control of cardiovascular risk factors, and the incidence of cardiovascular events. METHODS: This study involved a controlled, blinded community intervention in which the 21 health centres of the Number 2 Health Area of Madrid were randomly assigned by clusters to be involved in either a proposed CPG implementation strategy to reduce cardiovascular risk, or the normal dissemination strategy. The study subjects were patients ≥ 45 years of age whose health cards showed them to belong to the studied health area. The main variable examined was the proportion of patients whose medical histories included the calculation of their cardiovascular risk or that explicitly mentioned the presence of variables necessary for its calculation. The sample size was calculated for a comparison of proportions with alpha = 0.05 and beta = 0.20, and assuming that the intervention would lead to a 15% increase in the measured variables. Corrections were made for the design effect, assigning a sample size to each cluster proportional to the size of the population served by the corresponding health centre, and assuming losses of 20%. This demanded a final sample size of 620 patients. Data were analysed using summary measures for each cluster, both in making estimates and for hypothesis testing. Analysis of the variables was made on an intention-to-treat basis. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01270022.

Impacto de un tratamiento integral e intensivo de factores de riesgo sobre la mortalidad cardiovascular en prevención secundaria: estudio MIRVAS / Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study

Introducción y objetivos. Evaluamos si un tratamiento integral e intensivo de factores de riesgo cardiovascular logra reducir el número de eventos cardiovasculares y la tasa de mortalidad cardiovascular en pacientes en prevención secundaria a 3 años de seguimiento. Métodos. Se diseñó un ensayo clínico aleatorizado, controlado, no enmascarado y en condiciones de práctica clínica. Se seleccionó a 247 pacientes que habían tenido un síndrome coronario agudo o un ictus y se los aleatorizó a un tratamiento integral e intensivo de los factores de riesgo cardiovascular (n=121) o al seguimiento según la práctica clínica habitual (n=126). Las variables principales fueron: el número de episodios cardiovasculares ocurridos y la mortalidad cardiovascular tras 3 años de seguimiento. La variable secundaria fue el porcentaje de pacientes que alcanzaban control de cada factor de riesgo. Resultados. El 88,8% de los pacientes asignados al grupo de tratamiento intensivo tenía las lipoproteínas de baja densidad en < 100 mg/dl frente al 56,4% (riesgo relativo [RR]=1,57; intervalo de confianza [IC]del 95%, 1,28-1,93) del grupo de tratamiento habitual; un 75,7% de los diabéticos tenían valores de HbA1c < 7% frente a un 28,6% (RR=2,65; IC del 95%, 1,13-6,19) del grupo de tratamiento habitual. Ocurrieron 4 muertes de causa cardiovascular y 26 eventos no mortales en el grupo de tratamiento intensivo frente a 17 muertes y 54 eventos no mortales en el grupo de tratamiento habitual. La tasa de supervivencia a 3 años fue del 97,4% en el grupo intervención y el 85,5% en el grupo control (p=0,003). Conclusiones. Un tratamiento integral e intensivo de los factores de riesgo cardiovascular en pacientes en prevención secundaria reduce la morbimortalidad tras 3 años de seguimiento(AU)

The aim was to determine whether secondary prevention involving the comprehensive and intensive treatment of cardiovascular risk factors reduces cardiovascular events and cardiovascular mortality at 3-year follow up. Methods: The study design comprised a randomized, controlled, open trial in a routine clinical practice setting. In total, 247 patients who presented with acute coronary syndrome or stroke were selected. They were randomized to comprehensive and intensive treatment of cardiovascular risk factors (n=121) or to follow-up based on usual care (n=126). The main study outcomes were the number of cardiovascular events and cardiovascular mortality at 3-year follow-up. The percentage of patients in whom each risk factor was successfully controlled was a secondary outcome. Results: Overall, 88.8% of patients assigned to the intensive treatment group had a low-density lipoprotein cholesterol level <100 mg/dl compared with 56.4% of the usual-care group (relative risk [RR]=1.57; 95% confidence interval [CI], 1.28-1.93), and 75.7% of diabetics had a hemoglobin A1c <7% compared with 28.6% of the usual-care group (RR=2.65; 95% CI, 1.13-6.19). There were four deaths due to cardiovascular causes and 26 nonfatal events in the intensive treatment group versus 17 deaths and 54 nonfatal events in the usual-care group. The cumulative survival rate at 3 years was 97.4% in the intervention group and 85.5% in the control group (p=.003). Conclusions: Secondary prevention involving comprehensive and intensive treatment of cardiovascular risk factors reduced both morbidity and mortality at 3-year follow up(AU)