Ultrarapid Insulin Use Can Reduce Postprandial Hyperglycemia and Late Hypoglycemia, Even in Delayed Insulin Injections: A Connected Insulin Cap-Based Real-World Study.

Objectives: Reaching optimal postprandial glucose dynamics is a daily challenge for people with type 1 diabetes (T1D). This study aimed to analyze the postprandial hyperglycemic excursion (PHEs) and late postprandial hypoglycemia (LPH) risk according to prandial insulin time and type. Research Design and Methods: Real-world, retrospective study in T1D using multiple daily injections (MDI) analyzing 5 h of paired continuous glucose monitoring and insulin injections data collected from the connected cap Insulclock®. Meal events were identified using the rate of change detection methodology. Postprandial glucometrics and LPH (glucose <70 mg/dL 2-5 h after a meal) were evaluated according to insulin injection time and rapid (RI) or ultrarapid analog, Fiasp® (URI), use. Results: Meal glycemic excursions (n = 2488), RI: 1211, 48.7%; UR: 1277, 51.3%, in 82 people were analyzed according to injection time around the PHE: -45 to -15 min; -15 to 0 min; and 0 to +45 min. In 63% of the meals, insulin was injected after the PHE started. Lower PHE was observed with URI versus RI (glucose peak-baseline; mg/dL; mean ± standard deviation): 106.7 ± 35.2 versus 111.2 ± 40.3 (P = 0.003), particularly in 0/+45 injections: 111.6 ± 40.2 versus 118.1 ± 43.3; (P = 0.002). One third (29.1%) of participants added a second (correction) injection. The use of URI and avoiding a second injection were independently associated with less LPH risk, even in delayed injections (0/+45), (-36%, odds ratio [OR] 0.641; confidence interval [CI]: 0.462-0.909; P = 0.012) and -56% (OR 0.641; CI: 0.462-0.909 P = 0.038), respectively. Conclusions: URI analog use as prandial insulin reduces postprandial hyper- and hypoglycemia, even in delayed injections.

Analysis of the estimation of bleeding using several proposed haematometric equations.

PURPOSE: Among various methods for estimating blood loss, the gravimetric method is the most accurate; however, its use in routine practice is complicated. Although several equations have been proposed for this purpose, there is no consensus on the most suitable. METHODS: A cross-sectional study was conducted in seven secondary and tertiary hospitals between March and July 2018 including all patients undergoing total hip arthroplasty or hip prosthesis replacement under general or regional anaesthesia. We compared blood loss estimates obtained using the gravimetric method (weighing gauzes and pads and measuring volumes of blood collected by suction during surgery) and using three different equations, two of which considered intravenous fluids (CRYS 3.5 and 1.5) and a third which did not (the traditional equation). Additionally, intraclass correlation coefficients (ICCs) and Bland-Altman plots were used. RESULTS: The mean blood loss estimated using the gravimetric method was 513.7 ± 421.7 mL, while estimates calculated using the CRYS 3.5, CRYS 1.5 and traditional equations were 737.2 ± 627.4, 420.8 ± 636.2 and 603.4 ± 386.3 mL, respectively. Comparing these results, we found low levels of agreement (based on ICCs), except when using the traditional equation (ICC: 0.517). The limits of agreement comparing external blood loss with the estimates from the equations ranged from - 1655.6 to 1459.2 in the case of the CRYS 1.5 equation to - 839.6 to 1008.4 in the case of the traditional equation. CONCLUSIONS: For use in clinical practice, haematological index-based equations, regardless of whether they consider fluids administered, do not show sufficiently strong correlations with gravimetric estimates of intraoperative blood loss.

Perfil psicológico prequirúrgico de las mujeres con riesgo aumentado de cáncer de mama / Preoperative psychological profile of women with increased risk of breast cancer

Objetivo: analizar los niveles de sintomatología ansiosa y depresiva, imagen corporal y calidad de vida en un grupo de mujeres con vulnerabilidad genética de cáncer de mama que se iban a someter a una mastectomía reductora de riesgo. Método: 184 mujeres participaron en este estudio, todas ellas tenían riesgo aumentado de cáncer de mama, bien por ser portadoras de una mutación BRCA1/2 o por agregación familiar. Los instrumentos utilizados fueron: Escala de Ansiedad y Depresión Hospitalaria, Escala de Imagen Corporal, European Organisation for Research and Treatment of Cancer calidad de vida oncológica C30y BR23. Resultados: Los resultados de este estudio mostraron que las participantes presentaban niveles clínicos en sintomatología ansiosa y subclínicos en sintomatología depresiva. Sin embargo, se encontraban en niveles normativos en imagen corporal y calidad de vida. Las participantes con antecedentes oncológicos manifestaban, mayor insatisfacción con la imagen corporal, niveles inferiores en las escalas de funcionamiento físico, cognitivo y global de la calidad de vida, así como mayor fatiga, dolor general, en el brazo y en la mama en comparación con las mujeres sin diagnósticos previos. Conclusiones: Las mujeres sin mutación poseían mayor sintomatología en la mama y en el brazo que las mujeres con mutación, las cuales presentaban más dificultades económicas que las mujeres no portadoras. Evidenciando la necesidad de realizar una intervención psicológica antes de la cirugía especialmente en este colectivo (AU)

Aim: analyze depressive and anxiety symptomatology, body image and quality of life in a group of women with genetic vulnerability to breast cancer who were going to undergo a risk-reducing mastectomy. Method:184 women participated in this study, all of whom had an increased risk of breast cancer, either because they were BRCA1/2 mutation carriers or because they had several affected relatives. The psychological instruments used were: Hospital Anxiety and Depression Scale, Body Image Scale, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and BR23. Results: The results of this study showed that the participants presented clinical anxiety symptomatology and subclinical depressive symptomatology. However, all the sample were at normative levels in body image and quality of life. Participants with previous diagnosis of cancer showed, higher dissatisfaction with their body image, lower levels on the scales of physical, and cognitive and global functioning on quality of life, as well as higher fatigue, more general pain also in the breast and in the arm compared to women without diagnosis. Conclusions: BRCA1/2 non-mutation carriers showed more symptomatology in the breast and in the arm fatigue than BRCA1/2 mutation carriers. BRCA1/2 mutation carriers had more economic difficulties than non-carriers. It is highly recommended a psychological intervention before a risk-reducing surgery. (AU)

Procalcitonina es superior a recuento linfocitario, índice neutrófilo/linfocito y proteína C reactiva para la predicción de mortalidad a 30 días de pacientes con COVID-19 en el servicio de urgencias / Procalcitonin concentration in the emergency department predicts 30-day mortality in COVID-19 better than the lymphocyte count, the neutrophil-to- lymphocyte ratio, or the C-reactive protein level

Introducción. Existen múltiples variables demográficas y clínicas predictivas de mortalidad en pacientes con COVID-19. Sin embargo, hay menos información sobre el valor pronóstico de los biomarcadores inflamatorios. Métodos. Estudio de cohorte retrospectivo. Se incluyeron de forma consecutiva todos los pacientes con COVID-19, confirmado por laboratorio, atendidos en un servicio de urgencias hospitalario (SUH) y con valor basal de los siguientes biomarcadores: recuento linfocitario, índice neutrófilo/linfocito (INL), proteína C reactiva (PCR) y procalcitonina (PCT). La relación entre los biomarcadores y la mortalidad total a 30 días se analizó mediante una regresión de Cox y gráficos de dosis-respuesta. Resultados. Se incluyeron 896 pacientes, 151 (17%) fallecieron en los primeros 30 días. La mediana de edad fue de 63 años (51-78) y 494 (55%) eran hombres. El valor de INL, PCR y PCT fue mayor, mientras que el recuento linfocitario fue menor, en los pacientes que fallecieron respecto a los que sobrevivieron (p < 0,001). La PCT fue superior al recuento linfocitario, INL y PCR en la predicción de mortalidad a 30 días (ABC 0,79 [IC 95%: 0,75-0,83] vs 0,70 [IC 95%: 0,65-0,74], p < 0,001; 0,74 [IC 95%: 0,69-0,78], p = 0,03; y 0,72 [IC 95%: 0,68-0,76], p < 0,001). Los puntos de decisión de PCT propuestos, 0,06 ng/l para exclusión y 0,72 ng/l para inclusión de muerte a 30 días, podrían facilitar la toma de decisiones en urgencias. Hubo 357 pacientes (40%) con valores de PCT en estas categorías. El análisis multivariable mostró una mayor asociación con la mortalidad para PCT que en los otros biomarcadores estudiados. Conclusión. PCT es el biomarcador con mejor capacidad para predecir mortalidad a 30 días por cualquier causa en pacientes con COVID-19 valorados en un SUH.

Background. Although many demographic and clinical predictors of mortality have been studied in relation to COVID-19, little has been reported about the prognostic utility of inflammatory biomarkers. Methods. Retrospective cohort study. All patients with laboratory-confirmed COVID-19 treated in a hospital emergency department were included consecutively if baseline measurements of the following biomarkers were on record: lymphocyte counts, neutrophil-to-lymphocyte ratio NRL, and C-reactive protein (CRP) and procalcitonin (PCT) levels. We analyzed associations between the biomarkers and all-cause 30-day mortality using Cox regression models and dose–response curves. Results. We included 896 patients, 151 (17%) of whom died within 30 days. The median (interquartile range) age was 63 (51-78) years, and 494 (55%) were men. NLR, CRP and PCT levels at ED presentation were higher, while lymphocyte counts were lower, in patients who died compared to those who survived (P < .001). The areas under the receiver operating characteristic curves revealed the PCT concentration (0.79; 95% CI, 0.75-0.83) to be a better predictor of 30-day mortality than the lymphocyte count (0.70; 95% CI, 0.65-0.74; P < .001), the NLR (0.74; 95% CI, 0.69-0.78; P = .03), or the CRP level (0.72; 95% CI, 0.68-0.76; P < .001). The proposed PCT concentration decision points for use in emergency department case management were 0.06 ng/L (negative) and 0.72 ng/L (positive). These cutoffs helped classify risk in 357 patients (40%). Multivariable analysis demonstrated that the PCT concentration had the strongest association with mortality. Conclusion. PCT concentration in the emergency department predicts all-cause 30-day mortality in patients with COVID-19 better than other inflammatory biomarkers.

Procalcitonin concentration in the emergency department predicts 30-day mortality in COVID-19 better than the lymphocyte count, the neutrophil-tolymphocyte ratio, or the C-reactive protein level. / Procalcitonina es superior a recuento linfocitario, índice neutrófilo/linfocito y proteína C reactiva para la predicción de mortalidad a 30 días de pacientes con COVID-19 en el servicio de urgencias.

OBJECTIVES: Although many demographic and clinical predictors of mortality have been studied in relation to COVID-19, little has been reported about the prognostic utility of inflammatory biomarkers. MATERIAL AND METHODS: Retrospective cohort study. All patients with laboratory-confirmed COVID-19 treated in a hospital emergency department were included consecutively if baseline measurements of the following biomarkers were on record: lymphocyte counts, neutrophil-to-lymphocyte ratio NRL, and C-reactive protein (CRP) and procalcitonin (PCT) levels. We analyzed associations between the biomarkers and all-cause 30-day mortality using Cox regression models and dose-response curves. RESULTS: We included 896 patients, 151 (17%) of whom died within 30 days. The median (interquartile range) age was 63 (51-78) years, and 494 (55%) were men. NLR, CRP and PCT levels at ED presentation were higher, while lymphocyte counts were lower, in patients who died compared to those who survived (P .001). The areas under the receiver operating characteristic curves revealed the PCT concentration (0.79; 95% CI, 0.75-0.83) to be a better predictor of 30-day mortality than the lymphocyte count (0.70; 95% CI, 0.65-0.74; P .001), the NLR (0.74; 95% CI, 0.69-0.78; P = .03), or the CRP level (0.72; 95% CI, 0.68-0.76; P .001). The proposed PCT concentration decision points for use in emergency department case management were 0.06 ng/L (negative) and 0.72 ng/L (positive). These cutoffs helped classify risk in 357 patients (40%). Multivariable analysis demonstrated that the PCT concentration had the strongest association with mortality. CONCLUSION: PCT concentration in the emergency department predicts all-cause 30-day mortality in patients with COVID-19 better than other inflammatory biomarkers.

OBJETIVO: Existen múltiples variables demográficas y clínicas predictivas de mortalidad en pacientes con COVID-19. Sin embargo, hay menos información sobre el valor pronóstico de los biomarcadores inflamatorios. METODO: Estudio de cohorte retrospectivo. Se incluyeron de forma consecutiva todos los pacientes con COVID-19, confirmado por laboratorio, atendidos en un servicio de urgencias hospitalario (SUH) y con valor basal de los siguientes biomarcadores: recuento linfocitario, índice neutrófilo/linfocito (INL), proteína C reactiva (PCR) y procalcitonina (PCT). La relación entre los biomarcadores y la mortalidad total a 30 días se analizó mediante una regresión de Cox y gráficos de dosis-respuesta. RESULTADOS: Se incluyeron 896 pacientes, 151 (17%) fallecieron en los primeros 30 días. La mediana de edad fue de 63 años (51-78) y 494 (55%) eran hombres. El valor de INL, PCR y PCT fue mayor, mientras que el recuento linfocitario fue menor, en los pacientes que fallecieron respecto a los que sobrevivieron (p 0,001). La PCT fue superior al recuento linfocitario, INL y PCR en la predicción de mortalidad a 30 días (ABC 0,79 [IC 95%: 0,75-0,83] vs 0,70 [IC 95%: 0,65-0,74], p 0,001; 0,74 [IC 95%: 0,69-0,78], p = 0,03; y 0,72 [IC 95%: 0,68-0,76], p 0,001). Los puntos de decisión de PCT propuestos, 0,06 ng/l para exclusión y 0,72 ng/l para inclusión de muerte a 30 días, podrían facilitar la toma de decisiones en urgencias. Hubo 357 pacientes (40%) con valores de PCT en estas categorías. El análisis multivariable mostró una mayor asociación con la mortalidad para PCT que en los otros biomarcadores estudiados. CONCLUSIONES: PCT es el biomarcador con mejor capacidad para predecir mortalidad a 30 días por cualquier causa en pacientes con COVID-19 valorados en un SUH.

A comparative study of climacteric symptoms among two populations of mid-aged women.

The purpose of this study was to compare climacteric symptoms associated with health-related quality of life (HRQOL) among women from Madrid (Spain) and Belgrade (Serbia). A cross-sectional study included 461 women from Madrid and 513 women from Belgrade aged 40-65 years. Climacteric symptoms and HRQOL were examined using the Menopause Rating Scale (MRS). There were no differences in MRS total score (p = 0.873), somato-vegetative and urogenital domain scores regarding country groups. However, women from Belgrade had poorer psychological domain score than women from Madrid (p = 0.027). Madrilenian women were more likely to have worse MRS score if they were coupled, had gynaecological complaints and longer duration of amenorrhoea. In Belgradian women, having higher level of education and using hormone-replacement therapy was associated with worse MRS score. Midlife women from Madrid and Belgrade had similar perception of intensity of urogenital and somato-vegetative climacteric symptoms. Belgradian women, however, perceived psychological symptoms as more severe.IMPACT STATEMENTWhat is already known on this subject? Social and cultural meanings of menopause vary across countries. It is quite delicate to strike a balance between two or more populations of women that can be compared, but also have specific features that are unique to their area. Similarities such as position of women in the society, access to education, contraception and safe induced abortion can facilitate this comparison.What do the results of this study add? Spanish and Serbian women rated similarly somato-vegetative and urogenital complaints, but Serbian women had worse psychological symptoms compared to Spanish women. Spanish women were more likely to endure climacteric symptoms until they withdraw spontaneously. Serbian women of higher education were more likely to use hormone-replacement therapy to manage climacteric complaints.What are the implications of these findings for clinical practice and/or further research? This study is the first to compare climacteric symptoms between women in Spain and Serbia. Despite the universality of menopause, culture seems to play a major role in differences in the perception of specific climacteric symptoms. Examination of quality of life in menopausal transition is an important measure of health status and should become a part of the routine health care in midlife.

Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study.

INTRODUCTION: Non-infectious uveitis include a heterogeneous group of sight-threatening and incapacitating conditions. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), prescribed in monotherapy or in combination. Several observational studies showed that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet. METHODS AND ANALYSIS: The Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicentre, prospective, randomised, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis. We aim to recruit 192 subjects. The duration of the treatment and follow-up will last up to 52 weeks, plus 70 days follow-up with no treatment. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secondary measurements of efficacy (quality of life, visual acuity and costs) and safety, we will identify subjects' subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers. ETHICS AND DISSEMINATION: The protocol, annexes and informed consent forms were approved by the Reference Clinical Research Ethic Committee at the Hospital Clínico San Carlos (Madrid, Spain) and the Spanish Agency for Medicines and Health Products. We will elaborate a dissemination plan including production of materials adapted to several formats to communicate the clinical trial progress and findings to a broad group of stakeholders. The promoter will be the only access to the participant-level data, although it can be shared within the legal situation. TRIAL REGISTRATION NUMBER: 2020-000130-18; NCT04798755.

Effect of Obesity and Roux-En-Y Gastric Surgery on Omeprazole Pharmacokinetics.

INTRODUCTION: The prevalence of obesity is increasing globally. The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability and pharmacokinetic (PK) parameters of omeprazole. METHODS: Controlled, open-label, bioavailability clinical trial in patients undergoing Roux-en-Y gastric bypass (RYGB). Healthy patients with obesity (body mass index >35) were included and assessed for omeprazole PKs before and after RYGB (1 and 6 months). PK sampling was done at baseline and several times up to 12 h after drug dosing. Pre- and post-surgery parameters were compared using paired ANOVA or Wilcoxon tests, and control versus cases using ANOVA or Mann-Whitney tests. Given the post-surgery change in body weight, parameters were corrected by dose/body weight. RESULTS: Fourteen case and 24 control subjects were recruited; 92% were women (N = 35/38). In patients who underwent RYGB, maximum plasma concentration (Cmax) was significantly reduced at 1 and 6 months after surgery compared with presurgery values (p = 0.001). Regarding the AUC, the values are lower at 1 and 6 months after surgery than at baseline (p < 0.001). The drug clearance was also increased in the first month after surgery. No differences were found between patients 6 months after surgery and controls. Cmax and AUC corrected by dose/body weight were significantly different between the baseline surgery subjects and controls. Discusion/Conclusions: Omeprazole bioavailability is reduced in patients with obesity at 1 and 6 months after RYGB. However, omeprazole PK parameters 6 months after RYGB are similar to control subjects, and thus no dose correction is required after RYGB for a given indication.

Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial.

OBJECTIVES: The aim of this study was to assess whether the use of topical pharyngeal anesthesia improves endoscopist- and patient-reported tolerance and satisfaction, the total dose of propofol used and the rate of adverse effects associated with this procedure. METHODS: This double-blind randomized clinical trial was conducted in patients undergoing elective oesophagogastroduodenoscopy, who met the inclusion criteria. Patients were randomly assigned to receive five squirts of lidocaine 10% spray (50 mg, n = 268) or placebo (n = 271) 3 min before starting the procedure or sedation. The main outcome measures were patient- and endoscopist-reported tolerance, and additionally, satisfaction with the procedure, adverse events and supplementary propofol used. RESULTS: In the lidocaine group, it was twice (odds ratio [OR] 2.136, 95% confidence interval [CI] 1.228-3.715) or three times (OR 3.311, 95% CI 1.623-6.757) more likely that the endoscopist rated the procedure as well tolerated and easy to intubate than as well tolerated but the patient difficult to intubate or as poorly tolerated, respectively. Further, in these patients, less propofol was used (80 vs. 100 mg, P = 0.001). Controls were more likely to cough during the intubation (OR 2.172, 95% CI 1.378-3.423) and the procedure (OR 1.989, 95% CI 1.325-2.984), as well as more likely to retch (OR 3.582, 95% CI 1.667-7.7). CONCLUSIONS: Topical lidocaine may improve the procedure as rated by the endoscopist, as well as reduce the requirement for propofol and rate of adverse events such as retching and coughing. No adverse events associated with lidocaine administration were observed. ClinicalTrials registration no. NCT02733471.

Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery.

INTRODUCTION: Anxiety in children triggered by a scheduled surgical intervention is a major issue due to its frequency and consequences. Preoperative anxiety is associated with increased patient fear and agitation on anesthetic induction. The aim of this study is to compare three preoperative anxiety scales for children undergoing elective outpatient surgery, and to correlate each of these tools with the degree of patient compliance on induction, as assessed by the Induction Compliance Checklist (ICC). METHODS: An observational prospective study was performed on a cohort of children with ages between 2 and 16 years old, scheduled for outpatient surgery. Anxiety was assessed upon arrival to the hospital (M0), during transfer to the surgical unit (M1), and in the operating room during anesthetic induction (M2). Anxiety in the parents (measured with the State-Trait Anxiety Inventory, STAI) and in the children (measured with the Spence Anxiety Scale-Pediatric, SCAS-P, the State-Trait Anxiety Inventory Children, STAIC, and Modified Yale Preoperative Anxiety Scale, m-YPAS) was assessed. Compliance with anesthetic induction was assessed with ICC. RESULTS: The study included 76 patients (72.4% male, median age 7.9 years). Anxiety scores (m-YPAS) increased as the moment of surgery approached, being greater at the entrance to the surgical unit (M0 = 26.1 ± 9.5; M1 = 31.8 ± 18.1; M2 = 33.5 ± 21.1). A strong correlation was found between ICC scale and m-YPAS at M1 (0.738) and M2 timepoints (0.794), but not with the rest of scales at M0. CONCLUSIONS: Standard anxiety assessment scales do not predict the quality of anesthetic induction. m-YPAS scale can detect increasing anxiety in children as they approach the surgical procedure and this correlates strongly with a worse anesthetic induction, defined by higher score on ICC scale.

Socio-Demographic Health Determinants Are Associated with Poor Prognosis in Spanish Patients Hospitalized with COVID-19.

INTRODUCTION: Social vulnerability is a known determinant of health in respiratory diseases. Our aim was to identify whether there are socio-demographic factors among COVID-19 patients hospitalized in Spain and their potential impact on health outcomes during the hospitalization. METHODS: A multicentric retrospective case series study based on administrative databases that included all COVID-19 cases admitted in 19 Spanish hospitals from 1 March to 15 April 2020. Socio-demographic data were collected. Outcomes were critical care admission and in-hospital mortality. RESULTS: We included 10,110 COVID-19 patients admitted to 18 Spanish hospitals (median age 68 (IQR 54-80) years old; 44.5% female; 14.8% were not born in Spain). Among these, 779 (7.7%) cases were admitted to critical care units and 1678 (16.6%) patients died during the hospitalization. Age, male gender, being immigrant, and low hospital saturation were independently associated with being admitted to an intensive care unit. Age, male gender, being immigrant, percentile of average per capita income, and hospital experience were independently associated with in-hospital mortality. CONCLUSIONS: Social determinants such as residence in low-income areas and being born in Latin American countries were associated with increased odds of being admitted to an intensive care unit and of in-hospital mortality. There was considerable variation in outcomes between different Spanish centers.

Thirty-day outcomes in frail older patients discharged home from the emergency department with acute heart failure: effects of high-risk criteria identified by the DEED FRAIL-AHF trial. / Resultados a 30 días en los pacientes mayores frágiles con insuficiencia cardiaca aguda dados de alta desde urgencias o sus unidades vinculadas que cumplen los criterios de alto riesgo del estudio DEED FRAIL-AHF.

OBJECTIVES: To study the effect of high-risk criteria on 30-day outcomes in frail older patients with acute heart failure (AHF) discharged from an emergency department (ED) or an ED's observation and short-stay areas. MATERIAL AND METHODS: Secondary analysis of discharge records in the Older AHF Key Data registry. We selected frail patients (aged > 70 years) discharged with AHF from EDs. Risk factors were categorized as modifiable or nonmodifiable. The outcomes were a composite endpoint for a cardiovascular event (revisits for AHF, hospitalization for AHF, or cardiovascular death) and the number of days alive out-of-hospital (DAOH) within 30 days of discharge. RESULTS: We included 380 patients with a mean (SD) age of 86 (5.5) years (61.2% women). Modifiable risk factors were identified in 65.1%, nonmodifiable ones in 47.8%, and both types in 81.6%. The 30-day cardiovascular composite endpoint occurred in 83 patients (21.8%). The mean 30-day DAOH observed was 27.6 (6.1) days. Highrisk factors were present more often in patients who developed the cardiovascular event composite endpoint: the rates for patients with modifiable, nonmodifiable, or both types of risk were, respectively, as follows in comparison with patients not at high risk: 25.0% vs 17.2%, P = .092; 27.6% vs 16.7%, P = .010; and 24.7% vs 15.2%, P = .098). The 30-day DAOH outcome was also lower for at-risk patients, according to type of risk factor present: modifiable, 26.9 (7.0) vs 28.4 (4.4) days, P = .011; nonmodifiable, 27.1 (7.0) vs 28.0 (5.0) days, P = .127; and both, 27.1 (6.7) vs 28.8 (3.4) days, P = .005). After multivariate analysis, modifiable risk remained independently associated with fewer days alive (adjusted absolute difference in 30-day DAOH, -1.3 days (95% CI, -2.7 to -0.1 days). Nonmodifiable factors were associated with increased risk for the 30-day cardiovascular composite endpoint (adjusted absolute difference, 10.4%; 95% CI, -2.1% to 18.7%). CONCLUSION: Risk factors are common in frail elderly patients with AHF discharged home from hospital ED areas. Their presence is associated with a worse 30-day prognosis.

OBJETIVO: Estudiar el efecto a 30 días de los criterios de alto riesgo (CAR) en los mayores frágiles con insuficiencia cardiaca aguda (ICA) dados de alta desde urgencias o unidades vinculadas (URG_UV). METODO: Análisis secundario del registro OAK-Discharge. Se seleccionaron pacientes frágiles 70 años con ICA dados de alta desde URG_UV. Los CAR se clasificaron en modificables (CAR_M) y no modificables (CAR_NM). Las variables de resultado fueron la compuesta cardiovascular (VC_CV) (revisita u hospitalización por ICA o mortalidad cardiovascular) y días vivos fuera del hospital (DVFH) a 30 días del alta. RESULTADOS: Se incluyeron 380 pacientes con una edad media de 86 (DE 5,5) años, 61,2% mujeres. Un 65,1% tuvo CAR_M, 47,8% CAR_NM y 81,6% ambos. Ochenta y tres pacientes (21,8%) presentaron la VC_CV a 30 días. La media de DVFH a 30 días fue de 27,6 (DE 6,1) días. La presencia de CAR modificable, no modificable o ambos, se asoció más frecuentemente a la VC_CV a 30 días (25,0% vs 17,2%, p = 0,092; 27,6% vs 16,7%, p = 0,010; 24,7% vs 15,2%, p = 0,098) y a menos DVFH a 30 días [26,9 (7,0) vs 28,4 (4,4), p = 0,011; 27,1 (7,0) vs 28,0 (5,0), p = 0,127; 27,1 (6,7) vs 28,8 (3,4), p = 0,005], respectivamente. Tras el análisis multivariante, los CAR_M se asociaron de forma independiente con menos DVFH a 30 días (diferencia absoluta ajustada ­1,3 días; IC 95% ­2,7 a ­0,1) y los CAR_NM con más eventos en la VC_CV a 30 días (diferencia absoluta ajustada 10,4%; IC 95% 2,1% a 18,7%). CONCLUSIONES: Los CAR son frecuentes en los mayores frágiles con ICA dados de alta desde URG_UV y su presencia se asocia a peores resultados a 30 días tras alta.

Categorías diagnósticas y resultados a corto plazo en los pacientes con sospecha de COVID-19 atendidos en un servicio de urgencias / Diagnostic groups and short-term outcomes in suspected COVID-19 cases treated in an emergency department

OBJETIVO: EL objetivo principal fue describir el perfil clínico y la mortalidad a los 30 días de diferentes categorías diagnósticas en los casos de COVID-19 atendidos en un servicio de urgencias (SU). MÉTODO: Análisis secundario del registro COVID-19_URG-HCSC. Se seleccionaron los casos sospechosos de COVID-19 atendidos en un SU de Madrid desde el 28 de febrero hasta el 31 de marzo de 2020. La muestra se dividió: 1) sospecha con PCR no realizada (S/PCR NR); 2) sospecha con PCR negativa (S/PCR-); 3) sospecha con PCR positiva (S/PCR+); 4) alta sospecha con PCR negativa o no realizada (AS/PCR- o NR); y 5) alta sospecha con PCR positiva (AS/PCR+). Se recogieron variables clínicas, radiológicas y microbiológicas del episodio de urgencias. La variable de resultado principal fue la mortalidad por cualquier causa a los 30 días. Las variables secundarias fueron el ingreso y la gravedad del episodio. RESULTADOS: Se incluyeron 1.993 pacientes; 17,2% S/PCR NR, 11,4% S/PCR-, 22,1% S/PCR+, 11,7% AS/PCR- o NR y 37,6% AS/PCR+. Se hallaron diferencias estadísticamente significativas respecto a las variables demográficas, comorbilidad, clínicas, radiográficas, analíticas y terapéuticas y de resultados a corto plazo en función las categorías diagnósticas. La mortalidad global a los 30 días fue de un 11,5%, 56,5% casos fueron hospitalizados y 19,6% casos sufrieron un episodio grave. Las categorías de AS y de S/PCR+ tuvieron un incremento del riesgo ajustado de mortalidad a los 30 días y de sufrir un episodio grave durante el ingreso hospitalario respecto a S/PCR-. En relación al ingreso, solo las categorías de AS tuvieron un incremento del riesgo ajustado de hospitalización respecto a la categoría de S/PCR-. CONCLUSIONES: Existen diferentes categorías diagnósticas de la enfermedad COVID-19 en función del perfil clínico y microbiológico que tienen correlato con el pronóstico a 30 días

OBJECTIVE: The primary objective was to describe the clinical characteristics and 30-day mortality rates in emergency department patients with coronavirus disease 2019 (COVID-19) in different diagnostic groupings. METHODS: Secondary analysis of the COVID-19 registry compiled by the emergency department of Hospital Clínico San Carlos in Madrid, Spain. We selected suspected COVID-19 cases treated in the emergency department between February 28 and March 31, 2020. The cases were grouped as follows: 1) suspected, no polymerase chain reaction (PCR) test (S/no-PCR); 2) suspected, negative PCR (S/PCR-); 3) suspected, positive PCR (S/PCR+); 4) highly suspected, no PCR, or negative PCR (HS/no or PCR-); and 5) highly suspected, positive PCR (HS/PCR+). We collected clinical, radiologic, and microbiologic data related to the emergency visit. The main outcome was 30-day all-cause mortality. Secondary outcomes were hospitalization and clinical severity of the episode. RESULTS: A total of 1993 cases (90.9%) were included as follows: S/no-PCR, 17.2%; S/PCR-, 11.4%; S/PCR+, 22.1%; HS/no PCR or PCR-, 11.7%; and HS/PCR+, 37.6%. Short-term outcomes differed significantly in the different groups according to demographic characteristics; comorbidity and clinical, radiographic, analytical, and therapeutic variables. Thirty-day mortality was 11.5% (56.5% in hospitalized cases and 19.6% in cases classified as severe). The 2 HS categories and the S/PCR+ category had a greater adjusted risk for 30-day mortality and for having a clinically severe episode during hospitalization in comparison with S/PCR- cases. Only the 2 HS categories showed greater risk for hospitalization than the S/PCR- cases

Impact of Spanish Public Health Measures on Emergency Visits and COVID- 19 diagnosed cases during the pandemic in Madrid / Impacto de las medidas de Salud Pública españolas en las visitas a Urgencias y en los casos diagnosticados de COVID- 19 durante la pandemia en Madrid

INTRODUCTION: Changes in Public Health recommendations may have changed the number of emergency visits and COVID-19 diagnosed cases in an Emergency Department in Madrid. MATERIAL AND METHODS: This retrospective case series study included all consecutive patients in a tertiary and urban ED in Madrid from 1st to 31st March. The sample was divided: NonCOVID-19, Non-investigated COVID-19, Possible COVID-19, Probable COVID-19, Confirmed COVID-19. Differences between public health periods were tested by ANOVA for each cohort, and by ANCOVA including the number of PCR tests (%) as covariate. RESULTS: A total of 7,163 (4,071 Non-COVID-19, 563 Non-investigated COVID-19, 870 Possible, 648 Probable and 1,011 Confirmed COVID-19) cases were included. Public Health measurements applied during each period showed a clear effect on the case proportion for the five cohorts. CONCLUSION: The variability of case definitions and diagnostic test criteria may have impact on the number of emergency visits and COVID-19 diagnosed cases in Emergency Department

INTRODUCCIÓN: Los cambios en las recomendaciones de Salud Pública pueden haber modificado la cantidad de visitas y los casos diagnosticados por COVID-19 en un servicio de urgencias de Madrid. MATERIAL Y MÉTODOS: Estudio retrospectivo de series de casos que incluyó a todos los pacientes atendidos de manera consecutiva en un servicio de urgencias terciario y urbano en Madrid, del 1 al 31 de marzo. La muestra se dividió: no COVID-19, COVID-19 no investigado, COVID-19 posible, COVID-19 probable, COVID-19 confirmado. Las diferencias entre los diferentes periodos establecidos por Salud Pública se evaluaron por el test de ANOVA para cada cohorte, incluyendo el número porcentual de test de PCR como covariable. RESULTADOS: Se incluyeron un total de 7.163 casos (4.071 no COVID-19, 563 COVID-19 no investigados, 870 posibles, 648 probables y 1.011 confirmados COVID-19). Las medidas de Salud Pública aplicadas durante cada período mostraron un claro efecto en la proporción de casos para las cinco cohortes. CONCLUSIÓN: La variabilidad de las definiciones de casos y los criterios de las pruebas de diagnóstico pueden tener un impacto en la cantidad de visitas a urgencias y en los casos diagnosticados de COVID-19 en el servicio de Urgencias

Clinical presentation and outcome across age categories among patients with COVID-19 admitted to a Spanish Emergency Department.

PURPOSE: To determine the differences by age-dependent categories in the clinical profile, presentation, management, and short-term outcomes of patients with laboratory-confirmed COVID-19 admitted to a Spanish Emergency Department (ED). METHODS: Secondary analysis of COVID-19_URG-HCSC registry. We included all consecutive patients with laboratory-confirmed COVID-19 admitted to the ED of the University Hospital Clinico San Carlos (Madrid, Spain). The population was divided into six age groups. Demographic, baseline and acute clinical data, and in-hospital and 30-day outcomes were collected. RESULTS: 1379 confirmed COVID-19 cases (mean age 62 (SD 18) years old; 53.5% male) were included (18.1% < 45 years; 17.8% 45-54 years; 17.9% 55-64 years; 17.2% 65-74 years; 17.0% 75-84 years; and 11.9% ≥ 85 years). A statistically significant association was found between demographic, comorbidity, clinical, radiographic, analytical, and therapeutic variables and short-term results according to age-dependent categories. There were less COVID-specific symptoms and more atypical symptoms among older people. Age was a prognostic factor for hospital admission (aOR = 1.04; 95% CI 1.02-1.05) and in-hospital (aOR = 1.08; 95% CI 1.05-1.10) and 30-day mortality (aOR = 1.07; 95% CI 1.04-1.09), and was associated with not being admitted to intensive care (aOR = 0.95; 95% CI 0.93-0.98). CONCLUSIONS: Older age is associated with less COVID-specific symptoms and more atypical symptoms, and poor short-term outcomes. Age has independent prognostic value and may help in shared decision-making in patients with confirmed COVID-19 infection.

Diagnostic groups and short-term outcomes in suspected COVID-19 cases treated in an emergency department. / Categorías diagnósticas y resultados a corto plazo en los pacientes con sospecha de COVID-19 atendidos en un servicio de urgencias.

OBJECTIVES: The primary objective was to describe the clinical characteristics and 30-day mortality rates in emergency department patients with coronavirus disease 2019 (COVID-19) in different diagnostic groupings. MATERIAL AND METHODS: Secondary analysis of the COVID-19 registry compiled by the emergency department of Hospital Clínico San Carlos in Madrid, Spain. We selected suspected COVID-19 cases treated in the emergency department between February 28 and March 31, 2020. The cases were grouped as follows: 1) suspected, no polymerase chain reaction (PCR) test (S/no-PCR); 2) suspected, negative PCR (S/PCR-); 3) suspected, positive PCR (S/PCR+); 4) highly suspected, no PCR, or negative PCR (HS/no or PCR-); and 5) highly suspected, positive PCR (HS/PCR+). We collected clinical, radiologic, and microbiologic data related to the emergency visit. The main outcome was 30-day all-cause mortality. Secondary outcomes were hospitalization and clinical severity of the episode. RESULTS: A total of 1993 cases (90.9%) were included as follows: S/no-PCR, 17.2%; S/PCR-, 11.4%; S/PCR+, 22.1%; HS/no PCR or PCR-, 11.7%; and HS/PCR+, 37.6%. Short-term outcomes differed significantly in the different groups according to demographic characteristics; comorbidity and clinical, radiographic, analytical, and therapeutic variables. Thirty-day mortality was 11.5% (56.5% in hospitalized cases and 19.6% in cases classified as severe). The 2 HS categories and the S/PCR+ category had a greater adjusted risk for 30-day mortality and for having a clinically severe episode during hospitalization in comparison with S/PCR- cases. Only the 2 HS categories showed greater risk for hospitalization than the S/PCR- cases. CONCLUSION: COVID-19 diagnostic groups differ according to clinical and laboratory characteristics, and the differences are associated with the 30-day prognosis.

OBJETIVO: El objetivo principal fue describir el perfil clínico y la mortalidad a los 30 días de diferentes categorías diagnósticas en los casos de COVID-19 atendidos en un servicio de urgencias (SU). METODO: Análisis secundario del registro COVID-19_URG-HCSC. Se seleccionaron los casos sospechosos de COVID-19 atendidos en un SU de Madrid desde el 28 de febrero hasta el 31 de marzo de 2020. La muestra se dividió: 1) sospecha con PCR no realizada (S/PCR NR); 2) sospecha con PCR negativa (S/PCR­); 3) sospecha con PCR positiva (S/ PCR+); 4) alta sospecha con PCR negativa o no realizada (AS/PCR­ o NR); y 5) alta sospecha con PCR positiva (AS/ PCR+). Se recogieron variables clínicas, radiológicas y microbiológicas del episodio de urgencias. La variable de resultado principal fue la mortalidad por cualquier causa a los 30 días. Las variables secundarias fueron el ingreso y la gravedad del episodio. RESULTADOS: Se incluyeron 1.993 pacientes; 17,2% S/PCR NR, 11,4% S/PCR­, 22,1% S/PCR+, 11,7% AS/PCR­ o NR y 37,6% AS/PCR+. Se hallaron diferencias estadísticamente significativas respecto a las variables demográficas, comorbilidad, clínicas, radiográficas, analíticas y terapéuticas y de resultados a corto plazo en función las categorías diagnósticas. La mortalidad global a los 30 días fue de un 11,5%, 56,5% casos fueron hospitalizados y 19,6% casos sufrieron un episodio grave. Las categorías de AS y de S/PCR+ tuvieron un incremento del riesgo ajustado de mortalidad a los 30 días y de sufrir un episodio grave durante el ingreso hospitalario respecto a S/PCR­. En relación al ingreso, solo las categorías de AS tuvieron un incremento del riesgo ajustado de hospitalización respecto a la categoría de S/PCR­. CONCLUSIONES: Existen diferentes categorías diagnósticas de la enfermedad COVID-19 en función del perfil clínico y microbiológico que tienen correlato con el pronóstico a 30 días.

Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).

BACKGROUND: Most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen. METHODS: Multicenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4-6 weeks). SAMPLE: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. INTERVENTION: Control group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared. CONCLUSIONS: SATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4-6 weeks). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT 2019-003358-10.

Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial.

BACKGROUND: Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies. METHODS: We propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2-16 years undergoing outpatient surgery (n = 188). Subjects will be randomised into two groups - (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient's surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey. CONCLUSIONS: This study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.

Accuracy of the Menopause Rating Scale and the Menopause Quality of Life Questionnaire to discriminate menopausal women with anxiety and depression.

OBJECTIVE: The aim of the study was to evaluate the accuracy of the Menopause Rating Scale (MRS) and the Menopause Quality of Life Questionnaire (MENQOL) to discriminate women suffering from anxiety (AD) and depression disorder (DD). METHODS: A cohort of 416 women aged 45 to 65 years (51.7 ±â€Š3.8) completed the MRS, MENQOL and Hospital Anxiety and Depression Scale, plotting receiver operator curves to assess the diagnostic accuracy of the MRS and MENQOL items related to anxiety and depression. RESULTS: Both the MRS6 (area under the ROC curve [AUC] 0.773, 95% confidence interval [CI] 0.721-0.824) and MENQOL5 (AUC: 0.772, 95% CI 0.723-0.822) proved to be accurate tools to identify individuals with anxiety or with a likelihood to develop AD. Likewise, the items MRS4 (AUC: 0.771, 95% CI 0.625-0.797) and MENQOL8 (AUC: 0.744, 95% CI 0.668-0.821) appeared to be suitable to discriminate individuals with DD. Two cut-off points were established for each item in the different scales to optimize their capacity to detect and discriminate problems of anxiety and depression. Lower cut-off values (MRS ≥ 1; MENQOL ≥ 2) were established to detect AD and DD, the sensitivity of which varied between 76.0% and 84.6%% and a negative predictive value varying between 86.7% and 95.3%. A more specific cut-off was established for the discrimination of AD and DD (MRS ≥ 2; MENQOL ≥ 7), with a specificity ranging from 86.2% to 99.4% and a positive predictive value varying between 68.6% and 92.6%. CONCLUSIONS: The MRS and MENQOL display moderate accuracy in discriminating menopausal women with symptoms of anxiety and depression. The intensity of the symptoms appears to be related to the probability of detecting a probable or definitive disorder.