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5. Validity of the Espiro Mobile Application in the Interpretation of Spirometric Patterns: An App Accuracy Study

Author

Universitat Rovira i Virgili, Savic-Pesic, D; Chamorro, N; Lopez-Rodriguez, V; Daniel-Diez, J; Creixenti, AT; El Mesnaoui, MI; Navas, VKB; Cotte, JDC; Cano, IA; Azevedo, FAD; Penas, MT; Voelcker-Sala, I; Villalobos, F; Satue-Gracia, EM; Martin-Lujan, F; Hung, IFN, Universitat Rovira i Virgili, and Savic-Pesic, D; Chamorro, N; Lopez-Rodriguez, V; Daniel-Diez, J; Creixenti, AT; El Mesnaoui, MI; Navas, VKB; Cotte, JDC; Cano, IA; Azevedo, FAD; Penas, MT; Voelcker-Sala, I; Villalobos, F; Satue-Gracia, EM; Martin-Lujan, F; Hung, IFN

Abstract

Spirometry is a pulmonary function test where correct interpretation of the results is crucial for accurate diagnosis of disease. There are online tools to assist in the interpretation of spirometry results; however, as yet none are validated. We evaluated the interpretation accuracy of the Espiro app using pulmonologist interpretations as the gold standard. This is an observational descriptive study in which 118 spirometry results were interpreted by the Espiro app, two pulmonologists, two primary care physicians, and two residents of a primary care training program. We determined the interpretation accuracy of the Espiro app and the concordance of the pattern and severity interpretation between the Espiro app and each of the observers using Cohen's kappa coefficient (k). We obtained a sensitivity and specificity for the Espiro app of 97.5% (95% confidence interval (CI): 86.8-99.9%) and 94.9% (95%CI: 87.4-98.6%) with pulmonologist 1 and 100% (95%CI: 91.6-100%) and 98.7% (95%CI: 92.9-99.9%) with pulmonologist 2. The concordance for the pattern interpretation was greater than k 0.907, representing almost perfect agreement. The concordance of the severity interpretation was greater than k 0.807, representing substantial to almost perfect agreement. We concluded that the Espiro app is a valid tool for spirometry interpretation.

Published
2024

9. Reproduction and larval biology of North Atlantic asteroids related to the invasion of the deep sea

Author

Benitez Villalobos, F.

Subjects
593.951, QH301 Biology
Abstract

A very important objective of ecological research is to explain the evolution of life histories, more specifically how natural selection modifies reproduction and development in order to generate the patterns that are observed in nature. With few exceptions, the reproductive mechanisms and patterns found in deep-water echinoderms are entirely similar to those found in shallow-water species. The aims of this study were 1) to examine the reproductive biology of the many deep-sea asteroids found on the continental slope to the west of Europe in order to determine if the reproductive adaptations are a function of depth, distribution or are phylogenetically controlled, and 2) to conduct experiments on the effects of pressure and temperature on larval development of Atlantic asteroids, to investigate the physiological potential for deep sea invasion by shallow-water species. Eggs of the shallow-water asteroids Asterias rubens Linnaeus and Marthasterias glacialis (Linnaeus) were fertilized in vitro and incubated through the early embryonic cleavages until the larval stage. They were subjected to different temperature/pressure regimes. Early embryos were able to tolerate pressures up to 150 atm at 15oC and 100 atm at 10oC. Survivorship of A. rubens swimming bipinnaria remained high (> 70%) after incubation at all the pressure/temperature combinations. In M. glacialis the highest survival of swimming larvae was 100% at 1 atm/5, 15 and 20oC and 50 atm/15 and 20oC. Data for the temperature and pressure effects on the later stages of development suggest that all the larval stages are more temperature/pressure tolerant than the early embryos and survivorship becomes greater with larval age. Therefore, the larvae of these two species could survive transport to deeper waters and these species may be capable of sending colonists to the deep sea. In the deep NE Atlantic the habitat has selected for species with specific reproductive traits, which provide them with successful and advantageous life history strategies. This can be clearly observed in the upper bathyal zone between 700 and 1100 m, where the environmental conditions have selected for small species with low fecundity and large eggs, plus habits related directly or indirectly with suspension feeding. These species exhibit reproductive features with trends to the opportunistic strategy and are distinctive of unpredictable environments, although their large egg size probably follows the general trend observed in species from cold waters in order to provide the larvae with energy sufficient for a high survival possibility. Conversely, phylogenetic and evolutionary factors are also important and seem to be decisive at the deepest waters where basically mainly species belonging to the strict deep-sea family Porcellanasteridae are found. All these species possess a mixture of features typical of classical K strategists and equilibrium strategists, which enable them to persist in a relatively stable environment with low energy availability. A comprehensive knowledge of the reproductive processes of the deep-sea fauna is essential in order to evaluate the level of variability caused in the environment principally by human activity and the possible effects on life-history of the species.

Published
2005

11. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

13. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Author

Willame, C, Dodd, C, Durán, C E, Elbers, Rjhj, Gini, R, Bartolini, C, Paoletti, O, Wang, L, Ehrenstein, V, Kahlert, J, Haug, U, Schink, T, Diez-Domingo, J, Mira-Iglesias, A, Carreras, J J, Vergara-Hernández, C, Giaquinto, C, Barbieri, E, Stona, L, Huerta, C, Martín-Pérez, M, García-Poza, P, de Burgos, A, Martínez-González, M, Bryant, V, Villalobos, F, Pallejà-Millán, M, Aragón, M, Souverein, P, Thurin, N H, Weibel, D, Klungel, O H, Sturkenboom, McJm, Willame, C, Dodd, C, Durán, C E, Elbers, Rjhj, Gini, R, Bartolini, C, Paoletti, O, Wang, L, Ehrenstein, V, Kahlert, J, Haug, U, Schink, T, Diez-Domingo, J, Mira-Iglesias, A, Carreras, J J, Vergara-Hernández, C, Giaquinto, C, Barbieri, E, Stona, L, Huerta, C, Martín-Pérez, M, García-Poza, P, de Burgos, A, Martínez-González, M, Bryant, V, Villalobos, F, Pallejà-Millán, M, Aragón, M, Souverein, P, Thurin, N H, Weibel, D, Klungel, O H, and Sturkenboom, McJm

Abstract

BACKGROUND: In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines.METHODS: A dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events.FINDINGS: A total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively.INTERPRETATION: Given the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates.FUNDING: The projec

Published
2023

14. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Willame, C, Dodd, C, Durán, C E, Elbers, Rjhj, Gini, R, Bartolini, C, Paoletti, O, Wang, L, Ehrenstein, V, Kahlert, J, Haug, U, Schink, T, Diez-Domingo, J, Mira-Iglesias, A, Carreras, J J, Vergara-Hernández, C, Giaquinto, C, Barbieri, E, Stona, L, Huerta, C, Martín-Pérez, M, García-Poza, P, de Burgos, A, Martínez-González, M, Bryant, V, Villalobos, F, Pallejà-Millán, M, Aragón, M, Souverein, P, Thurin, N H, Weibel, D, Klungel, O H, Sturkenboom, McJm, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Willame, C, Dodd, C, Durán, C E, Elbers, Rjhj, Gini, R, Bartolini, C, Paoletti, O, Wang, L, Ehrenstein, V, Kahlert, J, Haug, U, Schink, T, Diez-Domingo, J, Mira-Iglesias, A, Carreras, J J, Vergara-Hernández, C, Giaquinto, C, Barbieri, E, Stona, L, Huerta, C, Martín-Pérez, M, García-Poza, P, de Burgos, A, Martínez-González, M, Bryant, V, Villalobos, F, Pallejà-Millán, M, Aragón, M, Souverein, P, Thurin, N H, Weibel, D, Klungel, O H, and Sturkenboom, McJm

Published
2023

15. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Global Health, Circulatory Health, JC onderzoeksprogramma Methodology, Data Science & Biostatistiek, Child Health, Willame, C., Dodd, C., Durán, C. E., Elbers, R.J.H.J., Gini, R., Bartolini, C., Paoletti, O., Wang, L., Ehrenstein, V., Kahlert, J., Haug, U., Schink, T., Diez-Domingo, J., Mira-Iglesias, A., Carreras, J. J., Vergara-Hernández, C., Giaquinto, C., Barbieri, E., Stona, L., Huerta, C., Martín-Pérez, M., García-Poza, P., de Burgos, A., Martínez-González, M., Bryant, V., Villalobos, F., Pallejà-Millán, M., Aragón, M., Souverein, P., Thurin, N. H., Weibel, D., Klungel, O. H., Sturkenboom, M. C.J.M., RWE/Causal inference, Epi Infectieziekten Team 2, Global Health, Circulatory Health, JC onderzoeksprogramma Methodology, Data Science & Biostatistiek, Child Health, Willame, C., Dodd, C., Durán, C. E., Elbers, R.J.H.J., Gini, R., Bartolini, C., Paoletti, O., Wang, L., Ehrenstein, V., Kahlert, J., Haug, U., Schink, T., Diez-Domingo, J., Mira-Iglesias, A., Carreras, J. J., Vergara-Hernández, C., Giaquinto, C., Barbieri, E., Stona, L., Huerta, C., Martín-Pérez, M., García-Poza, P., de Burgos, A., Martínez-González, M., Bryant, V., Villalobos, F., Pallejà-Millán, M., Aragón, M., Souverein, P., Thurin, N. H., Weibel, D., Klungel, O. H., and Sturkenboom, M. C.J.M.

Published
2023

16. Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial

Author

Universitat Rovira i Virgili, Martín-Luján, F; Santigosa-Ayala, A; Pallejà-Millán, M; Rey-Reñones, C; Villalobos, F; Solà, R; RESET Study, Universitat Rovira i Virgili, and Martín-Luján, F; Santigosa-Ayala, A; Pallejà-Millán, M; Rey-Reñones, C; Villalobos, F; Solà, R; RESET Study

Abstract

The effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence.To assess the effectiveness of a motivational intervention based on spirometry results in achieving prolonged smoking abstinence (12 months post-intervention).A randomised, controlled, observer-blinded, multicentre clinical trial was conducted (from January 2012 to December 2015) in 20 primary healthcare centres in the Tarragona province, Spain.Participants, active smokers aged 35-70 without known respiratory disease, were recruited from primary healthcare centres by family doctors and nurses. They were randomly assigned to either the intervention group (IG = 308) or the control group (CG = 306). Both groups received brief smoking cessation counselling. Additionally, the IG underwent spirometry and received detailed information about the results, including lung age. The primary outcome was prolonged abstinence, defined as lasting at least 12 months and validated through cotinine measurement in urine.The prolonged abstinence rate was 7.8% in the IG, compared to 2.6% in the CG (p = 0.004). At 12 months, in the multivariate analysis, the intervention was identified as an independent factor for smoking cessation (OR 2.8; 95%CI 1.2 to 7.7), a trend maintained throughout the follow-up (HR 2.74; 95%CI 1.13 to 6.62). Moreover, according to the Prochaska and DiClemente model, the preparation or action phase to quit was also associated with smoking cessation (HR 2.55, 95%CI 1.07 to 6.09).A primary care-delivered intervention involving brief counselling and detailed spirometry information proves effective in increasing abstinence rates among active smokers without known respiratory disease. Additionally, smoking cessation is also influenced by

Published
2023

17. Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project

Author

Universitat Rovira i Virgili, Catalin, RE; Martin-Lujan, F; Salamanca-Gonzalez, P; Palleja-Millan, M; Villalobos, F; Santigosa-Ayala, A; Pedret, A; Valls-Zamora, RM; Sola, R, Universitat Rovira i Virgili, and Catalin, RE; Martin-Lujan, F; Salamanca-Gonzalez, P; Palleja-Millan, M; Villalobos, F; Santigosa-Ayala, A; Pedret, A; Valls-Zamora, RM; Sola, R

Abstract

Background: Previous studies have shown that adherence to the Mediterranean Diet (MeDi) has a positive impact on lung function in subjects with lung disease. In subjects free of respiratory diseases, but at risk, this association is not yet well established. Methods: Based on the reference data from the MEDISTAR clinical trial (Mediterranean Diet and Smoking in Tarragona and Reus; ISRCTN 03.362.372), an observational study was conducted with 403 middle-aged smokers without lung disease, treated at 20 centres of primary care in Tarragona (Catalonia, Spain). The degree of MeDi adherence was evaluated according to a 14-item questionnaire, and adherence was defined in three groups (low, medium, and high). Lung function were assessed by forced spirometry. Logistic regression and linear regression models were used to analyse the association between adherence to the MeDi and the presence of ventilatory defects. Results: Globally, the pulmonary alteration prevalence (impaired FEV1 and/or FVC) was 28.8%, although it was lower in participants with medium and high adherence to the MeDi, compared to those with a low score (24.2% and 27.4% vs. 38.5%, p = 0.004). Logistic regression models showed a significant and independent association between medium and high adherence to the MeDi and the presence of altered lung patterns (OR 0.467 [95%CI 0.266, 0.820] and 0.552 [95%CI 0.313, 0.973], respectively). Conclusions: MeDi adherence is inversely associated with the risk impaired lung function. These results indicate that healthy diet behaviours can be modifiable risk factors to protect lung function and reinforce the possibility of a nutritional intervention to increase adherence to MeDi, in addition to promoting smoking cessation.

Published
2023

18. Latin America Echinoderm Biodiversity and Biogeography: Patterns and Affinities

Author

Pérez-Ruzafa, A., Alvarado, J. J., Solís-Marín, F. A., Hernández, J. C., Morata, A., Marcos, C., Abreu-Pérez, M., Aguilera, O., Alió, J., Bacallado-Aránega, J. J., Barraza, E., Benavides-Serrato, M., Benítez-Villalobos, F., Betancourt-Fernández, L., Borges, M., Brandt, M., Brogger, M. I., Borrero-Pérez, G. H., Buitrón-Sánchez, B. E., Campos, L. S., Cantera, J. R., Clemente, S., Cohen-Renfijo, M., Coppard, S. E., Costa-Lotufo, L. V., del Valle-García, R., Díaz de Vivar, M. E., Díaz-Martínez, J. P., Díaz, Y., Durán-González, A., Epherra, L., Escolar, M., Francisco, V., Freire, C. A., García-Arrarás, J. E., Gil, D. G., Guarderas, P., Hadel, V. F., Hearn, A., Hernández-Delgado, E. A., Herrera-Moreno, A., Herrero-Pérezrul, M. D., Hooker, Y., Honey-Escandón, M. B. I., Lodeiros, C., Luzuriaga, M., Manso, C. L. C., Martín, A., Martínez, M. I., Martínez, S., Moro-Abad, L., Mutschke, E., Navarro, J. C., Neira, R., Noriega, N., Palleiro-Nayar, J. S., Pérez, A. F., Prieto-Ríos, E., Reyes, J., Rodríguez-Barreras, R., Rubilar, T., Sancho-Mejías, T. I., Sangil, C., Silva, J. R. M. C., Sonnenholzner, J. I., Ventura, C. R. R., Tablado, A., Tavares, Y., Tiago, C. G., Tuya, F., Williams, S. M., Alvarado, Juan José, editor, and Solis-Marin, Francisco Alonso, editor

Published
2013
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19. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Author

Willame, C, primary, Dodd, C, additional, Durán, CE, additional, Elbers, RJHJ, additional, Gini, R, additional, Bartolini, C, additional, Paoletti, O, additional, Wang, L, additional, Ehrenstein, V, additional, Kahlert, J, additional, Haug, U, additional, Schink, T, additional, Diez-Domingo, J, additional, Mira-Iglesias, A, additional, Carreras, JJ, additional, Vergara-Hernández, C, additional, Giaquinto, C, additional, Barbieri, E, additional, Stona, L, additional, Huerta, C, additional, Martín-Pérez, M, additional, García-Poza, P, additional, de Burgos, A, additional, Martínez-González, M, additional, Bryant, V, additional, Villalobos, F, additional, Pallejà-Millán, M, additional, Aragón, M, additional, Souverein, P, additional, Thurin, NH, additional, Weibel, D, additional, Klungel, OH, additional, and Sturkenboom, MCJM, additional

Published
2023
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22. Association between SARS-CoV-2 Vaccines and Myo- and Pericarditis; a Large Observational Study Using Electronic Healthcare Data from Four European Countries

Author

Riera-Arnau, J., Bots, S., Belitser, S., Messina, D., Schultze, A., Douglas, I., Duran, C., Poza, P. G., Gini, R., Herings, R. M. C., Sisay, M. M., Martin, I., Villalobos, F., Klungel, O. H., Sturkenboom, M., Gastroenterology and hepatology, Epidemiology and Data Science, Clinical pharmacology and pharmacy, APH - Quality of Care, and APH - Methodology

Published
2022

25. RELACIÓN ENTRE LOS NIVELES DE ÁCIDO TODO TRANS-RETINOICO EN SANGRE DE CORDÓN UMBILICAL Y MEDIDAS ANTROPOMÉTRICAS DEL RECIÉN NACIDO

Author

Victoria Espinosa F, Vanesa Boldoy S, Alejandro Villalobos F, and Silvia Sepúlveda B

Subjects
Vitamina A, ácido trans-retinoico, nutrición materna, nutrición fetal, Vitamin A, trans-retinoic acid, maternal nutrition, fetal nutrition, Gynecology and obstetrics, RG1-991
Abstract

Antecedentes: La vitamina A, principalmente en su forma de ácido todo trans-retinoico, desempeña una función de vital importancia durante el desarrollo gestacional en todos los tejidos y órganos del cuerpo. Objetivo: Determinar los niveles de ácido retinoico en el suero de sangre de cordón umbilical y relacionarlos con el peso/edad gestacional del recién nacido y el consumo materno de vitamina A, conjuntamente con variables socio-económicas y nutricionales. Método: Estudio descriptivo de corte transversal, analizando un total de 62 neonatos y sus madres, provenientes de las maternidades de los Hospitales San José y Barros Luco-Trudeau, Santiago de Chile. Resultados: En la población en estudio se observó una relación directa entre el peso/edad gestacional del neonato y el consumo materno de vitamina A, pero no con los niveles de esa vitamina en el suero de sangre de cordón umbilical. Se encontró que el consumo medio de vitamina A en las embarazadas fue sólo de 2298 ± 1416,8 Ul, siendo la dosis recomendada por OMS de 8000 Ul. Conclusión: Existe asociación entre la ingesta de vitamina A y el estado nutricional materno en relación con el peso/edad gestacional del neonato. Debido a que los requerimientos nutricionales del feto están privilegiados por sobre los maternos, no se observaron diferencias en las características antropométricas del neonato asociadas a la ingesta materna de vitamina ABackground: Vitamin A, mainly in their form of retinoic acid, it carries out a function of vital importance during the gestational development, in all the tissues and organs of the body. Objective: To evaluate the levels of retinoic acid in the serum of blood from umbilical cord and to relate them with the weight/gestational age ratio of the newborns and the maternal intake of vitamin A, jointly with socioeconomic and nutritional variables. Method: A descriptive study of traverse court, in the maternities of the Hospitals San José and Barros Luco-Trudeau of Santiago, Chile, studying a total of 62 cases. Results: In the population in study a direct relationship was observed between the newborn ratio weight/gestational age and the maternal consumption of vitamin A, but no relationship was found among the same weight/gestational age ratio and the levels of this vitamin in the serum of blood of umbilical cord. On the other hand, it was found that the average consumption of vitamin A in the maternities it was of 2298 ± 1416.8 IU, being the dose recommended by WHO for pregnant of 8000 IU, therefore, the whole population in study had a faulty consumption of vitamin A. Conclusion: Exists association among the intake of vitamin A and the maternal nutritional state with the weight/gestational age ratio of the newborn and the concentration of trans-retinoic acid in the umbilical cord. Because the nutritional requirements of the fetus are privileged over the maternal ones, differences were not observed in the newborn anthropometries features associated to the maternal vitamin A intake

Published
2007

27. Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines

Author

Willame, C, Dodd, C, Gini, R, Durán, CE, Thomsen, RM, Wang, L, Gedebjerg, A, Kahlert, J, Ehrenstein, V, Bartolini, C, Droz, C, Moore, N, Haug, U, Schink, T, Diez-Domingo, J, Mira-Iglesias, A, Vergara-Hernández, C, Carreras, JJ, Villalobos, F, Pallejà, M, Aragón, M, Perez-Gutthann, S, Arana, A, Giaquinto, C, Barbieri, E, Stona, L, Huerta, C, García Poza, P, de Burgos, A, Martínez-González, M, Souverein, P, Gardarsdottir, H, Siiskonen, SJ, Weibel, D, Mahy, P, Klungel, O, and Sturkenboom, MCJM

Subjects
background rates, AESI, Covid-19 vaccine, incidence
Abstract

Rationale and background: The global rapid spread of COVID-19 caused by the SARS-CoV-2 triggered the need for developing vaccines to control for this pandemic. This study aimed to generate background incidence rates of adverse events of special interest (AESI) that may be used to monitor benefit-risk profile of COVID-19 vaccines. Data sources: This study included 10 data sources from 7 European countries (Denmark, Germany, France, Italy, Netherlands, Spain, United Kingdom). Data sources contain health insurance data (GePaRD, SNDS), hospitalisation record linkage data (PHARMO, Danish registries (DCE-AU), SIDIAP, ARS) or data from general practitioners (CPRD, PEDIANET, BIFAP, FISABIO). For this final report data from 9 data sources were included. Study size: The study population for the total study comprised approximately 141.6 million individuals. In this final report, a total number of 45 million individuals were included. An update including French data is expected later this year Results This report comprises background rate data on AESI from 6 countries (UK, ES, IT, DK, NL, DE) and 9 data sources(BIFAP, Pedianet (children only), CPRD, ARS, Danish registries, FISABIO, SIDIAP, PHARMO, GeParD). Data from France (SNDS) could not be generated in a timely manner due to administrative constraints in data release. Data sources included different subpopulations based on the availability of numerator data of the observed persontime (Hosp= hospital based, PC= primary care, HOSP-PC= overlap between hospitalization and primary care). This entry also includes the results in excel format and also the links to the codes and event definitions, This protocol has been accepted by EMA as a deliverable of the framework contract No EMA/2018/28/PE. The protocol expresses the expertise of the authors and the ACCESS consortium as well as feedback received from EMA. It may not be understood or quoted as being made on beh behalf, or reflecting the position of the European Medicines Agency or one of its Committees or Working Parties. For questions please contact: m.c.j.sturkenboom@umcutrecht.nl

Published
2021
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35. The evolution of critical thermal limits of life on Earth

Author

Bennett, J.M., Sunday, J., Calosi, P., Villalobos, F., Martínez, B., Molina-Venegas, R., Araújo, M.B., Algar, A.C., Clusella-Trullas, S., Hawkins, B.A., Keith, S.A., Kühn, I., Rahbek, C., Rodríguez, L., Singer, A., Morales-Castilla, I., Olalla-Tárraga, M.Á., Bennett, J.M., Sunday, J., Calosi, P., Villalobos, F., Martínez, B., Molina-Venegas, R., Araújo, M.B., Algar, A.C., Clusella-Trullas, S., Hawkins, B.A., Keith, S.A., Kühn, I., Rahbek, C., Rodríguez, L., Singer, A., Morales-Castilla, I., and Olalla-Tárraga, M.Á.

Abstract

Understanding how species’ thermal limits have evolved across the tree of life is central to predicting species’ responses to climate change. Here, using experimentally-derived estimates of thermal tolerance limits for over 2000 terrestrial and aquatic species, we show that most of the variation in thermal tolerance can be attributed to a combination of adaptation to current climatic extremes, and the existence of evolutionary ‘attractors’ that reflect either boundaries or optima in thermal tolerance limits. Our results also reveal deep-time climate legacies in ectotherms, whereby orders that originated in cold paleoclimates have presently lower cold tolerance limits than those with warm thermal ancestry. Conversely, heat tolerance appears unrelated to climate ancestry. Cold tolerance has evolved more quickly than heat tolerance in endotherms and ectotherms. If the past tempo of evolution for upper thermal limits continues, adaptive responses in thermal limits will have limited potential to rescue the large majority of species given the unprecedented rate of contemporary climate change.

Published
2021

36. Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study

Author

Universitat Rovira i Virgili, Martin-Lujan F; Basora-Gallisa J; Villalobos F; Martin-Vergara N; Aparicio-Llopis E; Pascual-Palacios I; Santigosa-Ayala A; Catalin RE; Rey-Reñones C; Solà R; ESPITAP Study Group Investigators, Universitat Rovira i Virgili, and Martin-Lujan F; Basora-Gallisa J; Villalobos F; Martin-Vergara N; Aparicio-Llopis E; Pascual-Palacios I; Santigosa-Ayala A; Catalin RE; Rey-Reñones C; Solà R; ESPITAP Study Group Investigators

Abstract

Objective This 12-month study in a primary healthcare network aimed to assess the effectiveness of usual smoking cessation advice compared with personalised information about the spirometry results.Design Randomised, parallel, controlled, multicentre clinical trial.Setting This study involved 12 primary healthcare centres (Tarragona, Spain).Participants Active smokers aged 35-70 years, without known respiratory disease. Each participant received brief smoking cessation advice along with a spirometry assessment. Participants with normal results were randomised to the intervention group (IG), including detailed spirometry information at baseline and 6-month follow-up or control group (CG), which was simply informed that their spirometry values were within normal parameters.Main outcome Prolonged abstinence (12 months) validated by expired-CO testing.Results Spirometry was normal in 571 patients in 571 patients (45.9% male), 286 allocated to IG and 285 to CG. Baseline characteristics were comparable between the groups. Mean age was 49.8 (SD +/- 7.78) years and mean cumulative smoking exposure was 29.2 (+/- 18.7) pack-years. Prolonged abstinence was 5.6% (16/286) in the IG, compared with 2.1% (6/285) in the CG (p=0.03); the cumulative abstinence curve was favourable in the IG (HR 1.98; 95% CI 1.29 to 3.04).Conclusions In active smokers without known respiratory disease, brief advice plus detailed spirometry information doubled prolonged abstinence rates, compared with brief advice alone, in 12-month follow-up, suggesting a more effective intervention to achieve smoking cessation in primary healthcare.

Published
2021

37. Deprivation index and lifestyle: Baseline cross-sectional analysis of the predimed-plus catalonia study

Author

Universitat Rovira i Virgili, Basora J; Villalobos F; Pallejà-Millán M; Babio N; Goday A; Zomeño MD; Pintó X; Sacanella E; Salas-Salvadó J, Universitat Rovira i Virgili, and Basora J; Villalobos F; Pallejà-Millán M; Babio N; Goday A; Zomeño MD; Pintó X; Sacanella E; Salas-Salvadó J

Abstract

This baseline cross-sectional analysis from data acquired in a sub-sample of the PREDIMED-Plus study participants aimed to evaluate the relation between the Composite Socioeconomic Index (CSI) and lifestyle (diet and physical activity). This study involved 1512 participants (759 (52.2%) women) between 55 and 80 years with overweight/obesity and metabolic syndrome assigned to 137 primary healthcare centers in Catalonia, Spain. CSI and lifestyle (diet and physical activity) were assessed. Multiple linear regression or multinomial regression were applied to the data. Cluster analysis was performed to identify dietary patterns. The multiple linear regression model showed that a high deprivation index was related to a higher consumption of refined cereals (11.98 g/d, p-value = 0.001) and potatoes (6.68 g/d, p-value = 0.001), and to a lower consumption of fruits (−17.52 g/d, p-value = 0.036), and coffee and tea (−8.03 g/d, p-value = 0.013). Two a posteriori dietary patterns were identified by cluster analysis and labeled as “healthy” and “unhealthy”. In addition, the multinomial regression model showed that a high deprivation index was related to an unhealthy dietary pattern and low physical activity (OR 1.42 [95% CI 1.06–1.89]; p-value < 0.05). In conclusion, a high deprivation index was related to an unhealthy lifestyle (diet and physical activity) in PREDIMED-Plus study participants.

Published
2021

40. Latin America Echinoderm Biodiversity and Biogeography: Patterns and Affinities

Author

Pérez-Ruzafa, A., primary, Alvarado, J. J., additional, Solís-Marín, F. A., additional, Hernández, J. C., additional, Morata, A., additional, Marcos, C., additional, Abreu-Pérez, M., additional, Aguilera, O., additional, Alió, J., additional, Bacallado-Aránega, J. J., additional, Barraza, E., additional, Benavides-Serrato, M., additional, Benítez-Villalobos, F., additional, Betancourt-Fernández, L., additional, Borges, M., additional, Brandt, M., additional, Brogger, M. I., additional, Borrero-Pérez, G. H., additional, Buitrón-Sánchez, B. E., additional, Campos, L. S., additional, Cantera, J. R., additional, Clemente, S., additional, Cohen-Renfijo, M., additional, Coppard, S. E., additional, Costa-Lotufo, L. V., additional, del Valle-García, R., additional, Díaz de Vivar, M. E., additional, Díaz-Martínez, J. P., additional, Díaz, Y., additional, Durán-González, A., additional, Epherra, L., additional, Escolar, M., additional, Francisco, V., additional, Freire, C. A., additional, García-Arrarás, J. E., additional, Gil, D. G., additional, Guarderas, P., additional, Hadel, V. F., additional, Hearn, A., additional, Hernández-Delgado, E. A., additional, Herrera-Moreno, A., additional, Herrero-Pérezrul, M. D., additional, Hooker, Y., additional, Honey-Escandón, M. B. I., additional, Lodeiros, C., additional, Luzuriaga, M., additional, Manso, C. L. C., additional, Martín, A., additional, Martínez, M. I., additional, Martínez, S., additional, Moro-Abad, L., additional, Mutschke, E., additional, Navarro, J. C., additional, Neira, R., additional, Noriega, N., additional, Palleiro-Nayar, J. S., additional, Pérez, A. F., additional, Prieto-Ríos, E., additional, Reyes, J., additional, Rodríguez-Barreras, R., additional, Rubilar, T., additional, Sancho-Mejías, T. I., additional, Sangil, C., additional, Silva, J. R. M. C., additional, Sonnenholzner, J. I., additional, Ventura, C. R. R., additional, Tablado, A., additional, Tavares, Y., additional, Tiago, C. G., additional, Tuya, F., additional, and Williams, S. M., additional

Published
2012
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46. Detección de parásitos gastrointestinales en hurones (Mustela putorius furo) mediante análisis coprológico

Author

Troncoso, I., Fischer, C., Valenzuela, S., Fernández, I., Robles, A., Villalobos, F., and González-Acuña, D.

Subjects
prevalencia, hurones, endoparásitos, heces, coproparasitario, prevalence, ferrets, endoparasites, feces, coprological
Abstract

The aim of this study was to determine the presence of zoonotic gastrointestinal parasites by coprological examination in ferrets (Mustela putorius furo) reared as pets and the role of sex and age. The faeces of 30 ferrets were analysed, 16 [53.3%] from pet stores and 14 [46.7%] from homes in the city of Santiago and Concepción, Chile. Burrows' coprological technique was used for the diagnosis, which allows detecting eggs of protozoan helminths, cysts and trophozoites Three samples (10%) tested positive for protozoa, one for Entamoeba coli, in a 6 month old male from a pet store, and two for Endolimax nana in a 3-month-old female and a 2-year-old male from private homes. This would be the first record for the two species of protozoa commensals in ferrets in Chile, which were probably acquired by the close contact of mustelids with humans., El objetivo del estudio fue determinar la presencia de parásitos gastrointestinales zoonóticos mediante examen coproparasitológico en hurones (Mustela putorius furo) criados como mascotas y el rol de las variables sexo y edad. Se analizaron las heces de 30 hurones, 16 [53.3%] de tiendas de mascotas y 14 [46.7%] de hogares de la ciudad de Santiago y Concepción, Chile. Para el diagnóstico se utilizó la técnica coproparasitaria de Burrows, que permite detectar huevos de helmintos, quistes y trofozoítos de protozoos. Tres muestras (10%) resultaron positivas a protozoos, una a Entamoeba coli, en un macho de 6 meses de una tienda de mascotas, y dos a Endolimax nana en una hembra de 3 meses y un macho se 2 años, ambos de hogares. Este sería el primer registro para las dos especies de protozoos comensales en hurones en Chile, los que probablemente fueron adquiridos por el estrecho contacto de los mustélidos con los humanos. &nbsp

Published
2019

48. Association between the potential influence of a lifestyle intervention in older individuals with excess weight and metabolic syndrome on untreated household cohabitants and their family support: The predimed-plus study

Author

Universitat Rovira i Virgili, Basora, J; Villalobos, F; Pallejà-Millán, M; Babio, N; Goday, A; Castañer, O; Fitó, M; Zomeño, MD; Pintó, X; Sacanella, E; Paz-Graniel, I; Salas-Salvadó, J, Universitat Rovira i Virgili, and Basora, J; Villalobos, F; Pallejà-Millán, M; Babio, N; Goday, A; Castañer, O; Fitó, M; Zomeño, MD; Pintó, X; Sacanella, E; Paz-Graniel, I; Salas-Salvadó, J

Abstract

© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This cross-sectional study aims to evaluate the association between the PREDIMED-Plus study lifestyle intervention and (i) adherence to the Mediterranean diet (MedDiet) and (ii) physical activity of cohabiting study participants, and to define the related social characteristics of the household members. Participants were a subsample of 541 cohabitants of the PREDIMED-Plus study. Adherence to the MedDiet, physical activity, anthropometric measurements, family function, and social support were assessed. Multiple linear regressions were applied to the data. Partners of the PREDIMED-Plus participants had higher adherence to the MedDiet compared to their sons/daughters (9.0 vs. 6.9 points). In comparison to partners with low adherence to the MedDiet, partners with high adherence were older, practiced more physical activity, ate more frequently with the PREDIMED-Plus participants, and had better family function (adaptability item). Compared to physically active partners, very active ones were older, more likely to be women, and had lower BMI and higher adherence to the MedDiet. In addition, they ate more frequently with the PREDIMED-Plus participants and had better family function. Using multiple lineal regressions, an increase in the adherence to the MedDiet of the PREDIMED-Plus participant, and better family function, were positively associated with their partner’s adherence to the MedDiet. The PREDIMED-Plus intervention showed a positive association with adherence to the MedDiet of the study participants’ partners. In addition, this association was influenced by the social characteristics of the household members.

Published
2020

50. Women's knowledge about the genitourinary syndrome of menopause: adherence to its treatments in the COVID-19 era in a sample of them: COMEM-GSM study.

Author

Baquedano Mainar, Laura, Sánchez Méndez, Sonia, Dieste Pérez, Peña, Hernández Aragón, Mónica, Mendoza Ladrón de Guevara, Nicolás, the COMEM Study Spanish investigators, Baquedano, L., Espiau, A., Ortega, S., Ruiz, L., Lamarca, M., José, Y., Rubio, P., Villalobos, F., Borque, A., Dieste, P., Gabasa, L., Roy, V., Puente, M. J., and Chóliz, M.

Subjects
GENITOURINARY diseases, COVID-19 treatment, PATIENT compliance, COVID-19 pandemic, CORONAVIRUS disease treatment, VAGINAL dryness
Abstract

Objective: To study knowledge regarding genitourinary syndrome of menopause (GSM) and the treatments for it and to analyze treatment adherence during the COVID-19 confinement.Methods: Multi-center observational study including women between 35 and 75 years. An extension study of treatment adherence was conducted during the coronavirus pandemic between March and April 2020.Results: A sample of 2355 women were included. Vaginal dryness was the most frequently identified symptom (74.3%). Lubricants were the best-known treatments (69.6%), followed by local estrogens (25.7%); 66% of the women did not speak to their gynecologist about sexuality. Comparative analyses were conducted according to age, menopausal status, type of menopause, place of residence, type of health care received and level of education. During the coronavirus confinement period, adherence to treatments for vulvovaginal atrophy was poor in 72.5% asked (n = 204). Reduced sexual activity (p > 0.001) and coronavirus diagnosis (p = 0.003) were significantly associated with poorer treatment compliance.Conclusions: There is great lack of knowledge of the treatments used for GSM. Most women do not talk to their gynecologist about sexuality. Adherence to treatments during the coronavirus confinement has been worryingly low. [ABSTRACT FROM AUTHOR]

Published
2021
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