Real-world study on the use of pegylated interferon alpha-2a for treatment of mycosis fungoides/Sézary syndrome using Time to Next Treatment as a measure of clinical benefit: An EORTC CLTG study.

INTRODUCTION: Mycosis fungoides (MF) and Sézary syndrome (SS) are chronic malignant diseases that typically necessitate diverse strategies to achieve remission. Systemic interferon alpha (IFN-α, subtypes 2a and 2b) has been used for MF/SS since 1984, however its production was recently stopped and so the recombinant pegylated (PEG) form of IFN α-2a remains as single IFN alternative treatment, even though not approved for MF/SS. OBJECTIVE: To assess effectiveness and safety of PEG IFN α-2a in monotherapy and in combination with other treatments using time to next treatment (TTNT) as a measure of clinical therapeutic benefit in real world setting. METHODS: We conducted an international and multicenter retrospective study of patients with MF and SS at any stage, treated with PEG IFN α-2a, from July 2012 to February 2022. Patients were included across 11 centers in 10 countries. Primary endpoints were to determine TTNT of PEG IFN α-2a and the adverse events (AE) in MF/SS. RESULTS: In total 105 patients were included, mean age was 61 (22-86 years); 42 (40%) with disease stage IA-IIA, 63 (60%) with stage IIB-IVB. PEG IFN α-2a was combined with other therapies in 67 (64%) patients, usually with extracorporeal photopheresis (36%) and bexarotene (22%). Fifty-seven percent of stage I-IIA patients achieved ORR, whereas 51% of stage IIB-IVB. Combination therapy showed a TTNT of 10.4 months, while 7 months in monotherapy (p=0.0099). Overall, TTNT was 9.2 months, ORR was 53% (56/105), CR and PR were 13% and 40%, respectively.AE were described in 69% (72) of the patients. Flu-like symptoms (27%), lymphopenia (23%) and elevated liver function (10%) were the most frequently reported. Grade 3-4 adverse events were reported in 23 (21%) patients, which were mostly related to myelosuppression. LIMITATIONS: retrospective data analysis and unrestricted number of combination therapies. CONCLUSIONS: PEG IFN α-2a for MF/SS showed ORR of 53%, TTNT of 9.2 months, superiority of combination regimens in comparison to monotherapy and doses of 180 mcg/weekly related to higher ORR.

Extremely missing numerical data in Electronic Health Records for machine learning can be managed through simple imputation methods considering informative missingness: A comparative of solutions in a COVID-19 mortality case study.

BACKGROUND AND OBJECTIVE: Reusing Electronic Health Records (EHRs) for Machine Learning (ML) leads on many occasions to extremely incomplete and sparse tabular datasets, which can hinder the model development processes and limit their performance and generalization. In this study, we aimed to characterize the most effective data imputation techniques and ML models for dealing with highly missing numerical data in EHRs, in the case where only a very limited number of data are complete, as opposed to the usual case of having a reduced number of missing values. METHODS: We used a case study including full blood count laboratory data, demographic and survival data in the context of COVID-19 hospital admissions and evaluated 30 processing pipelines combining imputation methods with ML classifiers. The imputation methods included missing mask, translation and encoding, mean imputation, k-nearest neighbors' imputation, Bayesian ridge regression imputation and generative adversarial imputation networks. The classifiers included k-nearest neighbors, logistic regression, random forest, gradient boosting and deep multilayer perceptron. RESULTS: Our results suggest that in the presence of highly missing data, combining translation and encoding imputation-which considers informative missingness-with tree ensemble classifiers-random forest and gradient boosting-is a sensible choice when aiming to maximize performance, in terms of area under curve. CONCLUSIONS: Based on our findings, we recommend the consideration of this imputer-classifier configuration when constructing models in the presence of extremely incomplete numerical data in EHR.

Mammographic density in the environs of multiple industrial sources.

BACKGROUND: Mammographic density (MD), defined as the percentage of dense fibroglandular tissue in the breast, is a modifiable marker of the risk of developing breast cancer. Our objective was to evaluate the effect of residential proximity to an increasing number of industrial sources in MD. METHODS: A cross-sectional study was conducted on 1225 premenopausal women participating in the DDM-Madrid study. We calculated distances between women's houses and industries. The association between MD and proximity to an increasing number of industrial facilities and industrial clusters was explored using multiple linear regression models. RESULTS: We found a positive linear trend between MD and proximity to an increasing number of industrial sources for all industries, at distances of 1.5 km (p-trend = 0.055) and 2 km (p-trend = 0.083). Moreover, 62 specific industrial clusters were analyzed, highlighting the significant associations found between MD and proximity to the following 6 industrial clusters: cluster 10 and women living at ≤1.5 km (ß = 10.78, 95 % confidence interval (95%CI) = 1.59; 19.97) and at ≤2 km (ß = 7.96, 95%CI = 0.21; 15.70); cluster 18 and women residing at ≤3 km (ß = 8.48, 95%CI = 0.01; 16.96); cluster 19 and women living at ≤3 km (ß = 15.72, 95%CI = 1.96; 29.49); cluster 20 and women living at ≤3 km (ß = 16.95, 95%CI = 2.90; 31.00); cluster 48 and women residing at ≤3 km (ß = 15.86, 95%CI = 3.95; 27.77); and cluster 52 and women living at ≤2.5 km (ß = 11.09, 95%CI = 0.12; 22.05). These clusters include the following industrial activities: surface treatment of metals/plastic, surface treatment using organic solvents, production/processing of metals, recycling of animal waste, hazardous waste, urban waste-water treatment plants, inorganic chemical industry, cement and lime, galvanization, and food/beverage sector. CONCLUSIONS: Our results suggest that women living in the proximity to an increasing number of industrial sources and those near certain types of industrial clusters have higher MD.

Geographical and Temporal Variability of Ultra-Processed Food Consumption in the Spanish Population: Findings from the DRECE Study.

The consumption of ultra-processed foods (UPFs) has increased in recent decades, worldwide. Evidence on the negative impacts of food processing on health outcomes has also been steadily increasing. The aim of this study is to describe changes in consumption patterns of ultra-processed foods in the Spanish population over time and their geographical variability. Data from four representative cohorts of the Spanish population were used (1991−1996−2004−2008). Dietary information was collected using a validated frequency questionnaire and categorized using the NOVA classification. A total increase of 10.8% in UPF consumption between 1991 and 2008 was found in Spain (p-value < 0.001). The products contributing most to UPF consumption were sugar-sweetened beverages, processed meats, dairy products, and sweets. Those who consumed more ultra-processed foods were younger (p-value < 0.001) and female (p-value = 0.01). Significant differences between the different geographical areas of Spain were found. The eastern part of Spain was the area with the lowest UPF consumption, whereas the north-western part was the area with the highest increase in UPF consumption. Given the negative effect that the consumption of ultra-processed foods has on health, it is necessary to implement public health policies to curb this increase in UPF consumption.

Neuropsychological Symptom Identification and Classification in the Hospitalized COVID-19 Patients During the First Wave of the Pandemic in a Front-Line Spanish Tertiary Hospital.

Studies specifically designed to determine the profile of psychiatric symptoms among COVID-19 patients are limited and based on case series, self-report questionnaires, and surveys. The objective of the study was to identify and classify the neuropsychological symptoms of hospitalized COVID-19 patients during the first wave of the pandemic in one of the most important front-line tertiary hospitals from Spain, and to analyze its correlation with diagnosed mental disorders, as well as to explore potential risk factors associated with mental health problems. This observational, cohort study involved data from COVID-19 patients at the University Hospital 12 de Octubre (Madrid, Spain) from February to May 2020. First, patients underwent a semistructured phone interview (screening phase), based on the Mini International Neuropsychiatric Interview (MINI). Then the confirmation of the diagnosis (confirmation phase) was performed in patients who reported a mental disorder development or worsening. A factorial analysis was performed to identify groups of symptoms. A tetrachoric matrix was created, and factorial analysis, by a principal component analysis, was employed upon it. Factors showing values >1.0 were selected, and a varimax rotation was applied to these factors. Symptoms most frequently identified in patients were anosmia/ageusia (54.6%), cognitive complaints (50.3%), worry/nervousness (43.8%), slowing down (36.2%), and sadness (35.4%). Four factors were identified after the screening phase. The first ("anxiety/depression") and second ("executive dysfunction") factors explained 45.4 and 11.5% of the variance, respectively. Women, age between 50 and 60 years, duration in the hospital (more than 13 days), and psychiatric history showed significant higher levels (number of symptoms) in the factors. This study reports the factor structure of the psychiatric symptoms developed by patients with a confirmed diagnosis of SARS-CoV2 during the first wave of the COVID-19. Three item domains (anxiety, depression, and posttraumatic stress disorder symptoms) were loaded together on one factor, whereas sleep disturbance stood up as a separate factor. Interestingly, the item anosmia/ageusia was not captured by any factor. In conclusion, an increase in neuropsychiatric morbidity is expected in the upcoming months and years. Therefore, screening for early symptoms is the first step to prevent mental health problems associated with this pandemic.

Serum potassium dynamics during acute heart failure hospitalization.

BACKGROUND: Available information about prognostic implications of potassium levels alteration in the setting of acute heart failure (AHF) is scarce. OBJECTIVES: We aim to describe the prevalence of dyskalemia (hypo or hyperkalemia), its dynamic changes during AHF-hospitalization, and its long-term clinical impact after hospitalization. METHODS: We analyzed 1779 patients hospitalized with AHF who were included in the REDINSCOR II registry. Patients were classified in three groups, according to potassium levels both on admission and discharge: hypokalemia (potassium < 3.5 mEq/L), normokalemia (potassium = 3.5-5.0 mEq/L and, hyperkalemia (potassium > 5 mEq/L). RESULTS: The prevalence of hypokalemia and hyperkalemia on admission was 8.2 and 4.6%, respectively, and 6.4 and 2.7% at discharge. Hyperkalemia on admission was associated with higher in-hospital mortality (OR = 2.32 [95% CI: 1.04-5.21] p = 0.045). Among patients with hypokalemia on admission, 79% had normalized potassium levels at discharge. In the case of patients with hyperkalemia on admission, 89% normalized kalemia before discharge. In multivariate Cox regression, dyskalemia was associated with higher 12-month mortality, (HR = 1.48 [95% CI, 1.12-1.96], p = 0.005). Among all patterns of dyskalemia persistent hypokalemia (HR = 3.17 [95% CI: 1.71-5.88]; p < 0.001), and transient hyperkalemia (HR = 1.75 [95% CI: 1.07-2.86]; p = 0.023) were related to reduced 12-month survival. CONCLUSIONS: Potassium levels alterations are frequent and show a dynamic behavior during AHF admission. Hyperkalemia on admission is an independent predictor of higher in-hospital mortality. Furthermore, persistent hypokalemia and transient hyperkalemia on admission are independent predictors of 12-month mortality.

Efficacy of continuous glucose monitoring on maternal and neonatal outcomes in gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials.

AIMS: This systematic review aims to evaluate the effect of continuous glucose monitoring (CGM) on maternal and neonatal outcomes in gestational diabetes mellitus (GDM). METHODS: Two authors conducted a systematic search using PubMed, Embase, CENTRAL, CINAHL, Scopus, Web of Science, ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The inclusion criteria for the systematic review were randomized clinical trials that compared the effects of CGM and blood glucose monitoring (BGM) in women with GDM. A restricted maximum likelihood random-effects model was used for the meta-analysis. The measures of effect were risk ratios for categorical data and mean differences for continuous data. RESULTS: Of the 457 studies reviewed, six randomized clinical trials met the inclusion criteria. A total of 482 patients were included in the meta-analysis. The use of CGM was associated with lower HbA1c levels at the end of pregnancy (mean difference: -0.22; 95%CI -0.42 to -0.03) compared to BGM. Women using CGM also had less gestational weight gain (mean difference: -1.17, 95%CI -2.15 to -0.19), and their children had lower birth weight (mean difference: -116.26, 95%CI -224.70 to -7.81). No differences were observed in the other outcomes evaluated. CONCLUSION: Women with GDM using CGM may achieve lower average blood glucose levels, lower maternal weight gain and infant birth weight than women using BGM. Nevertheless, current evidence is limited by the low number of studies and the small sample sizes of these studies. Larger clinical trials are needed to better understand the effects of CGM in GDM. REGISTRATION: PROSPERO registration ID CRD42021225651.

Growth patterns of normo-nourished Afghan, Haitian and Congolese children aged 6-59 months: A comparative study.

OBJECTIVES: International growth charts have been used in the past decades to identify atypical growth and diagnose the nutritional status of individuals. The aim of this study was to construct and compare growth patterns of normo-nourished children between 6-59 months from Afghanistan, Haiti, and the Democratic Republic of the Congo, to assess if it would be worth developing growth charts at a national level. METHODS: We used an international sample of 46 466 subjects (53.7% female; 46.3% male) from the aforementioned regions. To create the growth charts, we used different statistical methodologies: the Lambda-Mu-Sigma (LMS), LMSP, and LMST models, and regression models based on fractional polynomials. The LMSP models were the ones that fitted our data best and were therefore the ones used to make comparisons between countries using percentiles (3rd, 50th, and 97th). RESULTS: We found that Haitian children were both, taller and heavier than their Afghan and Congolese equals of the same ages. Moreover, differences were bigger in the highest percentiles (i.e., 97th percentile). These differences might be the result of the influence that genetics and diverse social and environmental contexts have on growth rates. CONCLUSIONS: Using the same international reference standards for all populations could result in the overestimation or underestimation of the proportion of malnourished children. In light of our results, we recommend the future development of national and regional growth charts to provide health workers with more precise tools to evaluate the nutritional status in the child population.

Two Dimensions of Nutritional Value: Nutri-Score and NOVA.

Front-of-pack labels can improve the ability of consumers to identify which foods are healthier, making them a useful public health tool. Nutri-Score is a front-of-pack labelling system adopted by several European countries. This system ranks foods according to their nutritional quality, but does not consider other dimensions such as the degree of food processing. The aim of this study is to compare the nutritional quality (as assessed by Nutri-Score) and the ultra-processing (as assessed by the NOVA classification) of foods in the Open Food Facts database. A simple correspondence analysis was carried out to study the relationship between the two systems. Ultra-processed foods (NOVA 4) were found in all Nutri-Score categories, ranging from 26.08% in nutritional category A, 51.48% in category B, 59.09% in category C, 67.39% in category D to up to 83.69% in nutritional category E. Given the negative effect that the consumption of ultra-processed foods has on different aspects of health, front-of-pack labelling with Nutri-Score should at least be accompanied by complementary labelling indicating the level of processing, such as the NOVA classification.

Ultra-processed food intake and all-cause mortality: DRECE cohort study.

OBJECTIVE: To determine the association between ultra-processed food (UPF) intake and all-cause mortality in a representative sample of Spanish population. DESIGN: Prospective cohort design in which follow-up lasted from baseline (1991) to mortality date or 31 December 2017, whichever was first. Dietary information was collected using a validated frequency questionnaire and categorised following the NOVA classification according to the extent of food processing. The association between consumption of UPF and mortality was analysed using Cox models. Isoenergetic substitution models were constructed to compare the health effects of the NOVA groups. SETTING: Cohort from the Diet and Risk of Cardiovascular Diseases (CVD) in Spain (DRECE) study, representative of the Spanish population. PARTICIPANTS: Totally, 4679 subjects between 5 and 59 years old. RESULTS: Average consumption of UPF was 370·8 g/d (24·4 % of energy intake). After a median follow-up of 27 years, 450 deaths occurred. Those who consumed the highest amount of UPF had higher risk of mortality. For every 10 % of the energy intake from UPF consumption, an increase of 15 % in the hazard of all-cause mortality was observed (HR 1·15; (95 % CI 1·03, 1·27); P-value = 0·012). Substitution of UPF with minimally processed foods was significantly associated with a decreased risk of mortality. CONCLUSIONS: An increase in UPF consumption was associated with higher risk of all-cause mortality in a representative sample of the Spanish population. Moreover, the theoretical substitution of UPF with unprocessed or minimally processed foods leads to a decrease in mortality. These results support the need to promote diets based on unprocessed or minimally processed foods.

Trabecular bone score and bone mineral density in patients with long-term controlled acromegaly.

OBJECTIVE: Acromegaly is associated with increased vertebral fracture (VFs) risk not correlated to bone mineral density (BMD). Trabecular bone score (TBS), related to bone microarchitecture, provides information on bone strength. This cross-sectional study considered the usefulness of TBS and BMD to assess bone status in long-term controlled acromegalic patients. DESIGN, PATIENTS, MEASUREMENTS: 26 acromegaly patients (14 female and 12 males) were included in the study. A further 117 subjects were recruited as controls (58 females and 57 males). BMD was measured using dual-energy X-ray absorptiometry (DXA), TBS was obtained applying Medimaps software 2.0. Biochemical parameters were determined by standardized techniques. RESULTS: 73% of patients with acromegaly exhibited normal lumbar spine (LS) BMD. TBS was normal in 38% of acromegalic patients and partially degraded or degraded in 31% of patients, respectively. No differences were found in LS BMD between acromegalic patients and controls. TBS values were significantly lower in patients with acromegaly (1.27 ± 0.13 vs. 1.35 ± 0.17, p = .01). Postsurgical remission was associated with higher TBS values (1.35 ± 0.10 vs. 1.23 ± 0.13, p = .02) and pituitary radiotherapy treatment with lower TBS values (1.18 ± 0.12 vs. 1.31 ± 0.12, p = .004). On multivariate analysis, age, BMI and LS BMD were predictors of TBS changes in patients with acromegaly (p < .05). CONCLUSIONS: Patients with long-term controlled acromegaly can exhibit deterioration of bone microstructure measured with TBS, despite BMD measurement not showing bone loss. Our study suggests that TBS is useful for monitoring the bone status changes in acromegalic patients.

Impact of late-onset cytomegalovirus infection in the development of cardiac allograft vasculopathy in heart transplant recipients.

BACKGROUND: The impact of late-onset cytomegalovirus (CMV) infection (LOCI) on cardiac allograft vasculopathy (CAV) has yet to be established. METHODS: A retrospective study was performed for patients who had undergone heart transplantation (HT) between January 1995 and October 2017 to analyze epidemiology of LOCI (any positive level of CMV pp65 antigenemia or DNAemia after 100 days, without previous CMV replication) and its association with CAV. Our main hypothesis was that LOCI causes less direct and indirect effects compared to early onset infection (EOCI). RESULTS: Late-onset cytomegalovirus infection developed in 57 of 410 patients (13.9%) in a median time of 4.7 months post-transplant. CAV at 10 years was diagnosed in 31.6% of patients with LOCI, 34.6% with EOCI, and in 19.3% of CMV-uninfected patients. In the multivariate analysis, EOCI was an independent variable for developing CAV (HR 1.8, 95% CI 1.13-2.82, P = .01). Patients with LOCI showed a trend toward a higher risk of CAV, but the difference was not statistically significant (HR 1.7, 95% CI 0.95-3.08, P = .07). In the complementary log-log model, LOCI and EOCI had a similar CAV-free survival, and a higher probability of developing CAV than CMV-uninfected patients (P = .02). CONCLUSIONS: Cytomegalovirus infection after HT may result in the same long-term events regardless of its onset, with a higher risk of developing CAV at 10 years than patients without CMV.

Validation of self-reported perception of proximity to industrial facilities: MCC-Spain study.

BACKGROUND: Self-reported data about environmental exposures can lead to measurement error. OBJECTIVES: To validate the self-reported perception of proximity to industrial facilities. METHODS: MCC-Spain is a population-based multicase-control study of cancer in Spain that recruited incident cases of breast, colorectal, prostate, and stomach cancer. The participant's current residence and the location of the industries were geocoded, and the linear distance between them was calculated (gold standard). The epidemiological questionnaire included a question to determine whether the participants perceived the presence of any industry at ≤1 km from their residences. Sensitivity and specificity of individuals' perception of proximity to industries were estimated as measures of classification accuracy, and the area under the curve (AUC) and adjusted odds ratios (aORs) of misclassification were calculated as measures of discrimination. Analyses were performed for all cases and controls, and by tumor location, educational level, sex, industrial sector, and length of residence. Finally, aORs of cancer associated with real and self-reported distances were calculated to explore differences in the estimation of risk between these measures. RESULTS: Sensitivity of the questionnaire was limited (0.48) whereas specificity was excellent (0.89). AUC was sufficient (0.68). Participants with breast (aOR(95%CI) = 2.03 (1.67;2.46)), colorectal (aOR(95%CI) = 1.41 (1.20;1.64)) and stomach (aOR(95%CI) = 1.59 (1.20;2.10)) cancer showed higher risk of misclassification than controls. This risk was higher for lower educational levels (aOR15 years (95%CI) = 0.56 (0.36;0.85)). The use of self-reported proximity vs. real distance to industrial facilities biased the effect on cancer risk towards the nullity. CONCLUSIONS: Self-reported distance to industrial facilities can be a useful tool for hypothesis generation, but hypothesis-testing studies should use real distance to report valid conclusions. The sensitivity of the question might be improved with a more specific formulation.

The prognosis of patients hospitalized with a first episode of heart failure, validation of two scores: PREDICE and AHEAD.

PURPOSE: Heart failure (HF) is a chronic, frequent and disabling condition but with a modifiable course and a large potential for improving. The aim of this study was to validate the two available clinical prediction rules for mortality at one year in patients with primo-hospitalization for decompensated HF: PREDICE and AHEAD. The secondary aim was to evaluate in our setting the changes in the clinical pattern of HF in the last decade in patients hospitalized for a first episode of the disease. PATIENTS AND METHODS: A prospective multicenter cohort study, which included 180 patients hospitalized with "de novo" HF was conducted to validate the PREDICE score. Calibration and discrimination measurements were calculated for the PREDICE model and the PREDICE score (using the validation cohort of the PREDICE) and the AHEAD score (using both the development and the validation cohort of the PREDICE). RESULTS: For the PREDICE models, the area under the curve (AUC) was 0.68 (95% confidence interval [CI]: 0.57-0.79) and the calibration slope 0.65 (95% CI: 0.21-1.20). For the PREDICE score AUC was 0.59 (95% CI: 0.47-0.71) and slope 0.42 (95% CI: -0.20-1.17). For the AHEAD score the AUC was 0.68 (95% CI: 0.62-0.73) and slope 1.38 (95% CI: 0.62-0.73) when used the development cohort of PREDICE and the AUC was 0.58 (95% CI: 0.49-0.67), and slope 0.68 (95% CI: -0.06 to 1.47) when used its validation cohort. CONCLUSION: The present study shows that the two risk scores available for patients with primo-hospitalization for decompensated HF (PREDICE and AHEAD) are not currently valid for predicting mortality at one-year. In our setting the clinical spectrum of hospitalized patients with new-onset HF has been modified over time. The study underscores the need to validate the prognostic models before clinical implementation.

Evaluation of a nurse-led intervention program in heart failure: A randomized trial / Evaluación de un programa de intervención de enfermería en insuficiencia cardiaca: un ensayo aleatorizado

Background and objective: Several trials have evaluated the effect of disease management programs in heart failure (HF) with diverse results. The aim of this study was to develop a simple nurse-led clinic intervention program for patients with HF and assess whether this intervention positively affects the prognosis of patients, their care costs and perceived quality of life (QoL). Methods: Between 2011 and 2013, 127 patients with reduced ejection fraction were prospectively randomly allocated (1:2) to standard care or intervention program. Primary composite endpoint was all-cause mortality and hospital readmissions. Secondary endpoints were all-cause mortality, all-cause hospital readmissions, readmissions for HF, time to first readmission and QoL improvements assessed by "Minnesota Living with Heart Failure Questionnaire" (MLHFQ). An intention-to-treat analysis was performed. Results: After a median follow-up of 2-years, no differences were found in the primary composite endpoint. Likewise, there were no differences between groups in the predefined secondary endpoints of mortality and readmissions from any cause. However, in the intervention group, readmissions for HF were significantly reduced (35% vs. 18%; p=0.04) and QoL significantly improved (MLHFQ±SD: 2.29±14 vs. 10.9±14.75; p=0.04). Conclusions: In patients with HF, the use of a nurse-led intervention program significantly improves perceived QoL and reduce HF hospital readmissions

Introducción y objetivos: Se han publicado múltiples ensayos sobre programas de gestión de enfermedades en la insuficiencia cardiaca (IC) con resultados muy heterogéneos. El objetivo de este estudio fue desarrollar un sencillo programa de intervención clínica dirigido por enfermería en pacientes con IC y evaluar si dicha intervención afecta positivamente sobre el pronóstico de los pacientes, sus costes de atención y la calidad de vida percibida. Métodos: Entre 2011 y 2013, 127 pacientes con fracción de eyección reducida fueron aleatorizados (1:2) a manejo estándar o al programa de intervención. El objetivo primario compuesto fue mortalidad y reingresos hospitalarios por cualquier causa. Los criterios de valoración secundarios fueron mortalidad por cualquier causa, reingresos hospitalarios por cualquier causa, reingresos hospitalarios por IC, tiempo hasta el primer ingreso y mejoría de la calidad de vida evaluado por el Minnesota Living with Heart Failure Questionnaire (MLHFQ). Resultados: Tras un seguimiento medio de 2 años, no se encontraron diferencias en el criterio de valoración compuesto primario. Igualmente, no hubo diferencias en la mortalidad o los reingresos por cualquier causa. Sin embargo, en el grupo de intervención, los reingresos por IC se redujeron (35 vs. 18%; p=0,04) y la calidad de vida percibida mejoró de forma significativa (MLHFQ±DE: 2,29±14 vs. 10,9±14,75; p=0,04). Conclusiones: En los pacientes con IC, el empleo de un programa de intervención dirigido por enfermería mejora significativamente la calidad de vida percibida y reduce los reingresos hospitalarios por IC

Evaluation of a nurse-led intervention program in heart failure: A randomized trial.

BACKGROUND AND OBJECTIVE: Several trials have evaluated the effect of disease management programs in heart failure (HF) with diverse results. The aim of this study was to develop a simple nurse-led clinic intervention program for patients with HF and assess whether this intervention positively affects the prognosis of patients, their care costs and perceived quality of life (QoL). METHODS: Between 2011 and 2013, 127 patients with reduced ejection fraction were prospectively randomly allocated (1:2) to standard care or intervention program. Primary composite endpoint was all-cause mortality and hospital readmissions. Secondary endpoints were all-cause mortality, all-cause hospital readmissions, readmissions for HF, time to first readmission and QoL improvements assessed by "Minnesota Living with Heart Failure Questionnaire" (MLHFQ). An intention-to-treat analysis was performed. RESULTS: After a median follow-up of 2-years, no differences were found in the primary composite endpoint. Likewise, there were no differences between groups in the predefined secondary endpoints of mortality and readmissions from any cause. However, in the intervention group, readmissions for HF were significantly reduced (35% vs. 18%; p=0.04) and QoL significantly improved (MLHFQ±SD: 2.29±14 vs. 10.9±14.75; p=0.04). CONCLUSIONS: In patients with HF, the use of a nurse-led intervention program significantly improves perceived QoL and reduce HF hospital readmissions.

Switching from endoscopic submucosal dissection to salvage piecemeal knife-assisted snare resection to remove a lesion: a preoperative risk score from the beginning

Background and aims: endoscopic submucosal dissection (ESD) in the Western setting remains a challenge. Therefore, other simplified techniques such as knife-assisted snare resection (KAR) have been reported to overcome this issue. Methods: patients who underwent an ESD for the treatment of gastrointestinal neoplasms were included in a retrospective cross-sectional observational study. Factors associated with the end of ESD as a salvage p-KAR were identified and a logistic regression model was developed. Results: a total of 136 lesions in 133 patients were analyzed. Operator experience of under 50 cases and the combination of lesion size > 30 mm and colorectal location were independent predictive factors for switching to a salvage p-KAR according to the multivariate logistic regression analysis. We developed a risk scoring system based on these four variables (experience, size, location and the combination of size and location) with a receiver operating characteristic curve of 0.81 (95% CI: 0.74-0.89). The diagnostic accuracy of the score for a cut-off point ≥ 5 had a sensitivity of 0.79 (95% CI: 0.66-0.93) and a specificity of 0.71 (95% CI: 0.61-0.80). Conclusion: a simple predictive score system that includes four preoperative factors accurately predicts ESD to finish as a p-KAR. A careful selection of cases considering these variables could be useful to achieve better outcomes in the Western setting

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Switching from endoscopic submucosal dissection to salvage piecemeal knife-assisted snare resection to remove a lesion: A preoperative risk score from the beginning.

BACKGROUND AND AIMS: endoscopic submucosal dissection (ESD) in the Western setting remains a challenge. Therefore, other simplified techniques such as knife-assisted snare resection (KAR) have been reported to overcome this issue. METHODS: patients who underwent an ESD for the treatment of gastrointestinal neoplasms were included in a retrospective cross-sectional observational study. Factors associated with the end of ESD as a salvage p-KAR were identified and a logistic regression model was developed. RESULTS: a total of 136 lesions in 133 patients were analyzed. Operator experience of under 50 cases and the combination of lesion size > 30 mm and colorectal location were independent predictive factors for switching to a salvage p-KAR according to the multivariate logistic regression analysis. We developed a risk scoring system based on these four variables (experience, size, location and the combination of size and location) with a receiver operating characteristic curve of 0.81 (95% CI: 0.74-0.89). The diagnostic accuracy of the score for a cut-off point ≥ 5 had a sensitivity of 0.79 (95% CI: 0.66-0.93) and a specificity of 0.71 (95% CI: 0.61-0.80). CONCLUSION: a simple predictive score system that includes four preoperative factors accurately predicts ESD to finish as a p-KAR. A careful selection of cases considering these variables could be useful to achieve better outcomes in the Western setting.

Esophageal motor disorders are frequent during pre and post lung transplantation. Can they influence lung rejection?

Background: lung transplantation (LTx) is a viable option for most patients with end-stage lung diseases. Esophageal motor disorders (EMD) are frequent in candidates for LTx, but there is very little data about changes in esophageal motility post-LTx. Aim: the aim of our study was to assess esophageal motor disorders by high resolution manometry (HRM) both pre-LTx and six months post-LTx in patients with and without organ rejection. Study: HRM (Manoscan(r)) was performed in 57 patients both pre-LTx and six months post-LTx. HRM plots were analyzed according to the Chicago classification 3.0. Results: EMD were found in 33.3% and in 49.1% of patients pre-LTx and post-LTx, respectively, and abnormal peristalsis was more frequently found post-LTx (p = 0.018). Hypercontractile esophagus was frequently found post-LTx (1.8% and 19.3% pre-LTx and post-LTx, respectively). Esophagogastric junction (EGJ) morphology changed significantly pre-LTx and post-LTx; type I (normal) was more frequent post-LTx (63-2% and 82.5% respectively, p = 0.007). EMD were more frequent post-LTx in both the non-rejection and rejection group, although particularly in the rejection group (43.2% and 69.2% respectively, p = 0.09). EMD such as distal spasm, hypercontractile esophagus and EGJ outflow obstruction were also observed more frequently post-LTx in the rejection group. Conclusion: significant changes in esophageal motility were observed pre-LTx and particularly post-LTx; hypercontractile esophagus was a frequent EMD found post-LTx. EMD were more frequent in the group of patients that experienced organ rejection compared to the non-rejection group. EMD leading to an impaired esophageal clearance should be considered as an additional factor that contributes to LTx failure

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Usefulness of the ARCHITECT Chagas® assay as a single test for the diagnosis of chronic Chagas disease.

OBJECTIVES: Imported Chagas disease (CD) is an emerging health problem in Europe due to immigration from endemic countries. Although WHO currently recommends two different serological methods to establish diagnosis, new tools like the ARCHITECT Chagas assay have potential for use as a single diagnostic test. Our objective was to determine an optimal signal-to-cut-off (S/CO) value for the ARCHITECT Chagas assay to diagnose CD with a single test. METHODS: A retrospective study conducted at the 12 de Octubre University Hospital (Madrid, Spain). All patients with requests for Chagas screening between January 2014 and August 2017 were consecutively included. All samples were routinely tested with the ARCHITECT assay. Negative samples (S/CO < 0.8) required no further testing. Immunochromatographic testing (ICT) and/or indirect immunofluorescence (IFI) was used to confirm samples with S/CO ≥ 0.8. Receiver operator characteristic (ROC) curve analysis determined the ARCHITECT S/CO value that yielded 100% specificity and positive predictive value. SPSS software, version 22.0 was used for data analysis. RESULTS: A total of 4153 samples were analysed; 361 (8.69%) gave a reactive ARCHITECT Chagas result. 261/361 (72.3%) were women; median age was 38 years old (2-79). 92.8% were Bolivian. A total of 307 (85.0%) were confirmed as cases of Chagas; 52 (14.4%) were not infected; two (0.6%) were not evaluable. Seroprevalence was 7.39%. An S/CO ≥ 3.80 yielded 100% specificity (95% confidence interval [CI], 0.93-1.00) and 100% positive predictive value (95% CI, 0.99-1.00). CONCLUSIONS: Using S/CO ≥ 3.80, the ARCHITECT Chagas could be used as a single test for diagnosis of chronic CD in Bolivian immigrants. Patients with S/CO between 0.80 and 3.80 would require additional testing.