Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study.

BACKGROUND: The use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. METHODS: Multicenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024. DISCUSSION: The scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript. TRIAL REGISTRATION: NCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.

Validity and Applicability of the Global Leadership Initiative on Malnutrition (GLIM) Criteria in Patients Hospitalized for Acute Medical Conditions.

(1) Background: The objectives of this study were to evaluate the concurrent and predictive validity and the applicability of the global leadership initiative on malnutrition (GLIM) criteria in patients hospitalized for acute medical conditions. (2) Methods: prospective cohort study with patients hospitalized for acute medical conditions. For validation, the methodology proposed by the GLIM group of experts was used. Sensitivity and specificity values greater than 80% with respect to those for the subjective global assessment (SGA) were necessary for concurrent validation. The time necessary to complete each nutritional assessment test was determined. (3) Results: A total of 119 patients were evaluated. The SGA was applied to the entire cohort, but the GLIM criteria could not be applied to 3.4% of the patients. The sensitivity and specificity of the GLIM criteria with respect to those for the SGA to detect malnutrition were 78.0 and 86.2%, respectively. The GLIM predictive validity criterion was fulfilled because patients with malnutrition more frequently had a hospital stay >10 days (odds ratio of 2.98 (1.21-7.60)). The GLIM criteria required significantly more time for completion than did the SGA (p = 0.006). (4) Conclusion: The results of this study do not support the use of the GLIM criteria over the SGA for the diagnosis of malnutrition in patients hospitalized for acute medical conditions.

Impacts of Saharan Dust Intrusions on Bacterial Communities of the Low Troposphere.

We have analyzed the bacterial community of a large Saharan dust event in the Iberian Peninsula and, for the first time, we offer new insights regarding the bacterial distribution at different altitudes of the lower troposphere and the replacement of the microbial airborne structure as the dust event receeds. Samples from different open-air altitudes (surface, 100 m and 3 km), were obtained onboard the National Institute for Aerospace Technology (INTA) C-212 aircrafts. Samples were collected during dust and dust-free air masses as well two weeks after the dust event. Samples related in height or time scale seems to show more similar community composition patterns compared with unrelated samples. The most abundant bacterial species during the dust event, grouped in three different phyla: (a) Proteobacteria: Rhizobiales, Sphingomonadales, Rhodobacterales, (b) Actinobacteria: Geodermatophilaceae; (c) Firmicutes: Bacillaceae. Most of these taxa are well known for being extremely stress-resistant. After the dust intrusion, Rhizobium was the most abundant genus, (40-90% total sequences). Samples taken during the flights carried out 15 days after the dust event were much more similar to the dust event samples compared with the remaining samples. In this case, Brevundimonas, and Methylobacterium as well as Cupriavidus and Mesorizobium were the most abundant genera.

Nutritional deficiencies and bone metabolism after endobarrier in obese type 2 patients with diabetes.

Endobarrier® is a minimally invasive, reversible endoscopic treatment for obesity. It provokes malabsorption along 60 cm of the small intestine, which can contribute to the development of vitamin deficiencies and to changes in bone mineral density (BMD). To determine the prevalence of nutrient deficiencies, changes in body composition and BMD during the first year after Endobarrier® placement. Twenty-one patients with type 2 diabetes met inclusion criteria. Levels of vitamins, micro and macronutrients were assessed prior and at 1, 3 and 12 months post-operatively. DEXA was performed before and 12 months after implant. Nineteen patients completed the 12 months follow-up. Vitamin D deficiency was the most prevalent finding before Endobarrier® implant. The percentage of patients with severe deficiency decreased from 19 to 5% at 12 months after supplementation. Microcytic anaemia was initially present in 9.5% of patients and increased to 26.3% at 12 months. Low ferritin and vitamin B12 levels were observed in 14.2 and 4.8% of patients before the implant and worsened to 42 and 10.5%. Low concentrations of magnesium and phosphorus were also common but improved along the study. A significant but not clinically relevant decrease in BMD of 4.14 ± 4.0% at the femoral neck was observed at 12 months without changes in osteocalcin levels. Vitamin deficiencies are common after Endobarrier® implant. It is therefore important to screen patients prior to and at regular intervals after the implant, and to encourage adherence to diet counselling and supplementation.

Endobarrier® in Grade I Obese Patients with Long-Standing Type 2 Diabetes: Role of Gastrointestinal Hormones in Glucose Metabolism.

BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of Endobarrier® in grade 1 obese T2DM patients with poor metabolic control and the role of gastro-intestinal hormone changes on the metabolic outcomes. METHODS: Twenty-one patients aged 54.1 ± 9.5 years, diabetes duration 14.8 ± 8.5 years, BMI 33.4 ± 1.9 kg/m2, and HbA1c 9.1 ± 1.3 %, under insulin therapy, were implanted with Endobarrier®. Fasting concentrations of PYY, ghrelin and glucagon, and AUC for GLP-1 after a standard meal test were determined prior to and at months 1 and 12 after implantation. RESULTS: Patients lost 14.9 ± 5.7 % of their total body weight. HbA1c decreased 1.3 % in the first month, but at the end of the study, the reduction was 0.6 %. HbA1c ≤ 7 % was achieved in 26.3 % of patients. No differences in GLP-1 AUC values were found before and after implant. Fasting plasma ghrelin and PYY concentrations increased from month 1 to 12. Conversely, fasting plasma glucagon concentrations decreased at month 1 and increased thereafter. Weight (ß 0.152) and HbA1c decrease at month 1 (ß 0.176) were the only variables predictive of HbA1c values at 12 months (adjusted R 2 for the model 0.693, p = 0.001). Minor adverse events occurred in 14 % of patients and major events in 9.5 %. CONCLUSIONS: Endobarrier® in T2DM patients with grade I obesity and poor metabolic control is associated with significant weight decrease and moderate reduction in HbA1c at month 12. Our data do not support a role for GLP-1 in the metabolic improvement in this subset of patients.

Effect of bariatric surgery on bone mineral density: comparison of gastric bypass and sleeve gastrectomy.

The aim of our study was to compare bone mineral density (BMD) a year after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in age- and body mass index-matched women. In 33 morbidly obese women undergoing RYGB and 33 undergoing SG, plasma determinations of calcium, parathyroid hormone (PTH), 25-hydroxyvitamin D (25(OH) D3), and insulin-like growth factor-I (IGF-I) were made prior to and at 12 months after surgery. Dual-energy X-ray absorptiometry was performed in all patients 1 year after surgery. BMD at the femoral neck and the lumbar spine 1 year after surgery was similar in women undergoing RYGB and SG (1.01 ± 0.116 vs. 1.01 ± 0.122 g/cm(2), p = 0.993; 1.05 ± 0.116 vs. 1.08 ± 0.123 g/cm(2), p = 0.384). The percentage of patients with osteopenia and osteoporosis was not different between groups. In the linear regression analysis, age (ß = -0.628, p = 0.034) and lean mass 12 months after surgery (ß = 0.424, p = 0.021) were found to be the main determinants of femoral neck BMD. Age (ß = -0.765, p = 0.025), menopause (ß = -0.898, p = 0.033), and lean mass (ß = 0.615, p = 0.023) were determinants of BMD at the lumbar spine. No influence was found between low bone mass and type of surgery, plasma PTH, 25(OH) D3, or IGF-I. The effect of RYGB and SG on BMD was comparable a year after surgery. Menopausal women were at a higher risk of having low bone mass, but the presence of osteoporosis was uncommon.

Urinary levels of arsenic and heavy metals in children and adolescents living in the industrialised area of Ria of Huelva (SW Spain).

The Ria of Huelva (south-west Spain) is a highly polluted estuary as a consequence of long-term mining and industrial activities. Between 2003 and 2004, we conducted a biomonitoring study of exposure to arsenic and some heavy metals (cadmium, chromium, copper and nickel) in urine samples of a representative sample (n=227) of children and adolescents residing in this area, and of a reference group of 196 children and adolescents living in other less industrialised areas of Andalusia (south Spain). We also assessed the determinants of the variability in urinary metals within the population of the Ria of Huelva. There were no significant differences in the concentration of metal compounds between the two groups with the exception of Cd levels, which were significantly higher in the reference group. Levels of the five metal ions in both groups were generally within the range of values reported by other biomonitoring studies for general children population, although mean Cd levels tended to be higher as compared to other European studies. Among the population of the Ria of Huelva, the main determinants of the interindividual variation in urinary metals were age, sex, area of residence, and frequency of intake of certain food items (mainly fish and shellfish). Overall, results suggest that living in the Ria of Huelva is not increasing current levels of exposure to certain metals among children and adolescents above those found in other urban areas of Andalusia.

[Methods to smooth mortality indicators: application to analysis of inequalities in mortality in Spanish cities [the MEDEA Project]]. / Métodos para la suavización de indicadores de mortalidad: aplicación al análisis de desigualdades en mortalidad en ciudades del Estado español (Proyecto MEDEA).

Although there is some experience in the study of mortality inequalities in Spanish cities, there are large urban centers that have not yet been investigated using the census tract as the unit of territorial analysis. The coordinated project <> was designed to fill this gap, with the participation of 10 groups of researchers in Andalusia, Aragon, Catalonia, Galicia, Madrid, Valencia, and the Basque Country. The MEDEA project has four distinguishing features: a) the census tract is used as the basic geographical area; b) statistical methods that include the geographical structure of the region under study are employed for risk estimation; c) data are drawn from three complementary data sources (information on air pollution, information on industrial pollution, and the records of mortality registrars), and d) a coordinated, large-scale analysis, favored by the implantation of coordinated research networks, is carried out. The main objective of the present study was to explain the methods for smoothing mortality indicators in the context of the MEDEA project. This study focusses on the methodology and the results of the Besag, York and Mollié model (BYM) in disease mapping. In the MEDEA project, standardized mortality ratios (SMR), corresponding to 17 large groups of causes of death and 28 specific causes, were smoothed by means of the BYM model; however, in the present study this methodology was applied to mortality due to cancer of the trachea, bronchi and lung in men and women in the city of Barcelona from 1996 to 2003. As a result of smoothing, a different geographical pattern for SMR in both genders was observed. In men, a SMR higher than unity was found in highly deprived areas. In contrast, in women, this pattern was observed in more affluent areas.

Métodos para la suavización de indicadores de mortalidad: aplicación al análisis de desigualdades en mortalidad en ciudades del Estado español (Proyecto MEDEA) / Methods to smooth mortality indicators: application to analysis of inequalities in mortality in Spanish cities [the MEDEA Project]

Aunque la experiencia en el estudio de las desigualdadesen la mortalidad en las ciudades españolas es amplia, quedangrandes núcleos urbanos que no han sido investigadosutilizando la sección censal como unidad de análisis territorial.En este contexto se sitúa el proyecto coordinado ®Desigualdadessocioeconómicas y medioambientales en la mortalidaden ciudades de España. Proyecto MEDEA», en el cualparticipan 10 grupos de investigadores de Andalucía, Aragón,Cataluña, Galicia, Madrid, Comunitat Valenciana y PaísVasco. Cabe señalar cuatro particularidades: a) se utiliza comoárea geográfica básica la sección censal; b) se emplean métodosestadísticos que tienen en cuenta la estructura geográficade la región de estudio para la estimación de riesgos; c) seaprovechan las oportunidades que ofrecen 3 fuentes de datoscomplementarias (información sobre contaminación atmosférica,información sobre contaminación industrial y registrosde mortalidad), y d) se emprende un análisis coordinado degran alcance, favorecido por la implantación de la redes temáticasde investigación. El objetivo de este trabajo es explicarlos métodos para la suavización de indicadores de mortalidaden el proyecto MEDEA. El artículo se centra en lametodología y los resultados del modelo de mapa de enfermedadesde Besag, York y Mollié (BYM). Aunque en el proyectose han suavizado, mediante el modelo BYM, las razonesde mortalidad estandarizadas (RME) correspondientesa 17 grandes grupos de causas de defunción y 28 causasespecíficas, aquí se aplica esta metodología a la mortalidadpor cáncer de tráquea, de bronquios y de pulmón en ambossexos en la ciudad de Barcelona durante el período 1996-2003(AU)

Como resultado se aprecia un diferente patrón geográfico enlas RME suavizadas en ambos sexos. En los hombres se observanunas RME mayores que la unidad en los barrios conmayor privación socioeconómica. En las mujeres este patrónse observa en las zonas con un mayor nivel socioeconómico(AU)

Although there is some experience in the study of mortalityinequalities in Spanish cities, there are large urban centersthat have not yet been investigated using the census tract asthe unit of territorial analysis. The coordinated project ®Socioeconomicand environmental inequalities in mortality in Spanishcities. The MEDEA project» was designed to fill this gap,with the participation of 10 groups of researchers in Andalusia,Aragon, Catalonia, Galicia, Madrid, Valencia, and the BasqueCountry. The MEDEA project has four distinguishing features:a) the census tract is used as the basic geographicalarea; b) statistical methods that include the geographical structureof the region under study are employed for risk estimation;c) data are drawn from three complementary data sources(information on air pollution, information on industrialpollution, and the records of mortality registrars), and d) a coordinated,large-scale analysis, favored by the implantation ofcoordinated research networks, is carried out. The main objective of the present study was to explain the methods for smoothingmortality indicators in the context of the MEDEA project.This study focusses on the methodology and the resultsof the Besag, York and Mollié model (BYM) in disease mapping.In the MEDEA project, standardized mortality ratios(SMR), corresponding to 17 large groups of causes of deathand 28 specific causes, were smoothed by means of the BYMmodel; however, in the present study this methodology wasapplied to mortality due to cancer of the trachea, bronchi andlung in men and women in the city of Barcelona from 1996 to2003. As a result of smoothing, a different geographical patternfor SMR in both genders was observed. In men, a SMRhigher than unity was found in highly deprived areas. In contrast,in women, this pattern was observed in more affluentareas(AU)