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Economic evaluations of eHealth interventions targeting mental health problems in the workplace: a systematic review
(Taylor & Francis Group, 2025) Peeters, Stijn B.; Hilgersom, Merel; Krugten, Frédérique C.W. van; Olaya Guzmán, Beatriz; Haro Abad, Josep Maria; Feltz-Cornelis, Christina M. van der; Hakkaart-van Roijen, Leona
Background: Work-related mental health problems impose significant economic and personal burdens. eHealth interventions may offer low-cost, practical solutions, but guidance on their cost-effectiveness in workplace mental health is limited. Objective: The objective of this study was to systematically review economic evaluations of workplace eHealth interventions for mental health, offering insights into methodologies and cost-effectiveness outcomes. Methods: Adhering to PRISMA guidelines, searches were conducted in Embase, MEDLINE, Web of Science, Google Scholar, Cochrane library, PsycInfo and EconLit databases in May 2022, selecting peer-reviewed papers that performed economic evaluations on workplace eHealth interventions for adult mental health. Quality was assessed using the Drummond checklist.Results: From 3213 references, eight met the inclusion criteria. These studies varied in economic perspective, types of economic analysis type, primary outcome measures, intervention focus (e.g. stress, alcohol, insomnia & return-to-work) and direct non-medical costs. Five eHealth interventions were found to be cost-effective and/or have a positive return on investment, with seven studies rated as high quality according to the Drummond checklist. Conclusions: The study outcomes unveiled the potential cost-effectiveness of eHealth interventions targeting mental health issues, particularly these focusing on workplace stress. However, generalization is challenging due to variations in the methodologies across studies.
Interactions of cognitive reserve with regional brain anatomy and brain function during a working memory task in healthy elders
(Elsevier B.V., 2009-02) Bartrés Faz, David; Solé Padullés, Cristina; Junqué i Plaja, Carme, 1955-; Rami González, Lorena; Bosch Capdevila, Beatriz; Bargalló Alabart, Núria; Falcón Falcón, Carles Maria; Sánchez del Valle Díaz, Raquel; Molinuevo, José Luis
Cognitive reserve (CR) defines the capacity of the adult brain to cope with pathology in order to minimize symptomatology. Relevant lifetime social, cognitive and leisure activities represent measurable proxies of cognitive CR but its underlying structural and functional brain mechanisms remain poorly understood. We investigated the relationship between CR and regional gray matter volumes and brain activity (fMRI) during a working memory task in a sample of healthy elders. Participants with higher CR had larger gray matter volumes in frontal and parietal regions. Conversely, a negative correlation was observed between CR and fMRI signal in the right inferior frontal cortex, suggesting increased neural efficiency for higher CR individuals. This latter association however disappeared after adjusting for gray matter images in a voxel-based manner. Altogether, present results may reflect both general and specific anatomofunctional correlates of CR in the healthy elders. Thus, whereas heteromodal anterior and posterior gray matter regions correspond to passive (i.e. morphological) correlates of CR unrelated to functional brain activation during this particular cognitive task, the right inferior frontal area reveals interactions between active and passive components of CR related to the cognitive functions tested in the fMRI study.
Effects of androgenization on the white matter microstructure of female-to-male transsexuals. A diffusion tensor imaging study
(Elsevier Ltd., 2012-08-01) Rametti, Giuseppina; Carrillo, Beatriz; Gómez Gil, Esther; Junqué i Plaja, Carme, 1955-; Zubiaurre Elorza, Leire; Segovia, Santiago; Gómez Jiménez, Ángel; Karadi, Kazmer; Guillamon Fernández, Antonio
Diffusion tensor imaging (DTI) can sensitively detect white matter sex differences and the effects of pharmacological treatments. Before cross-sex hormone treatment, the white matter microstructure of several brain bundles in female-to-male transsexuals (FtMs) differs from those in females but not from that in males. The purpose of this study was to investigate whether cross-sex hormone treatment (androgenization) affects the brain white matter microstructure. Using a Siemens 3 T Trio Tim Magneton, DTI was performed twice, before and during cross-sex hormonal treatment with testosterone in 15 FtMs scanned. Fractional anisotropy (FA) was analyzed on white matter of the whole brain, and the latter was spatially analyzed using Tract-Based Spatial Statistics. Before each scan the subjects were assessed for serum testosterone, sex hormone binding globulin level (SHBG), and their free testosterone index. After at least seven months of cross-gender hormonal treatment, FA values increased in the right superior longitudinal fasciculus (SLF) and the right corticospinal tract (CST) in FtMs compared to their pre-treatment values. Hierarchical regression analyses showed that the increments in the FA values in the SLF and CST are predicted by the free testosterone index before hormonal treatment. All these observations suggest that testosterone treatment changes white matter microstructure in FtMs.
El síndrome clínico judicial: el impacto de los procedimiento judiciales en los médicos
(Elsevier España, 2018-08-22) Arimany-Manso, Josep; Vizcaíno, Marta; Gómez-Duran, Esperanza L
Las reclamaciones por presunto defecto de praxis resultan una preocupación relevante para los facultativos, sin embargo, el impacto que las mismas tienen sobre estos recibe escasa atención. Se presenta una revisión sistemática de la literatura científica mediante la búsqueda en la base de datos MEDLINE, sin límite temporal, de manuscritos en castellano, inglés o francés, sobre la reacción de los facultativos ante una reclamación por negligencia. Se evaluó su calidad metodológica y analizaron sus resultados. La búsqueda identificó un total de 18 artículos, en su mayoría sin análisis de muestra empírica, que describían la sintomatología, el constructo de síndrome clínico judicial, su prevalencia, etiopatogenia y aspectos de prevención y abordaje. La literatura médica al respecto resulta muy escasa y con una pobre fundamentación empírica. Sin embargo, los datos disponibles subrayan la relevancia del impacto de las reclamaciones sobre los facultativos y urgen a instaurar medidas de prevención y abordaje del denominado síndrome clínico judicial.
Presencia de encefalopatía después de shunt porto-cava
(Sociedad Española de Patología Digestiva, 1985-06-01) Balanzó, Joaquim; Morales, M.; García Galera J.; Leal, J.R.; Porta, F.; Aymami, A.; Junqué i Plaja, Carme, 1955-; Trias, R.
Es varen examinar 33 pacients amb cirrosi hepàtica i es va valorar la presencia d'encefalopatia. Es varen valorar cognitivament i presentaven rendiment anormal en memòria en pràcticament la meitat dels casos
Cortical thinning is associated with disease stages and dementia in Parkinson's Disease
(British Medical Journal, 2013-03-05) Zarei, Mohammad; Ibarretxe Bilbao, Naroa; Compta, Yaroslau; Hough, Morgan; Junqué i Plaja, Carme, 1955-; Bargalló Alabart, Núria; Tolosa, Eduardo; Martí Domènech, Ma. Josep
Objective: To investigate the pattern of cortical thinning in Parkinson's disease (PD) across different disease stages and to elucidate to what extent cortical thinning is related to cognitive impairment. Design: Ninety-six subjects including 39 controls and 57 PD patients participated in this study. PD subjects were divided into three groups (early, n=24; moderate, n=18; with dementia, n=15). High field structural brain MRI images were acquired in a 3T scanner and analyses of cortical thickness and surface were carried out. Vertex-wise group comparisons were performed and cortical thickness was correlated with motor and cognitive measures. Results: We found a positive correlation between Mini-Mental State Examination scores and cortical thickness in the anterior temporal, dorsolateral prefrontal, posterior cingulate, temporal fusiform and occipitotemporal cortex. Unified Parkinson's Disease Rating Scale-III (motor subsection) scores showed a robust negative correlation with caudate volumes. We found that disease stage in PD was associated with thinning of the medial frontal (premotor and supplementary motor cortex), posterior cingulate, precuneus, lateral occipital, temporal and dorsolateral prefrontal cortex. Discriminant analysis and a receiver operating characteristics approach showed that mean cortical thickness and hippocampus volume have 80% accuracy in identifying PD patients with dementia. PD stage and PD dementia can be characterised by a specific pattern of cortical thinning. Conclusions: We conclude that measuring cortical thickness can be useful in assessing disease stage and cognitive impairment in patients with PD. In addition, cortical thickness may be useful in identifying dementia in PD.
Patterns of subregional cerebellar atrophy across epilepsy syndromes: An ENIGMA-Epilepsy study
(John Wiley & Sons, 2024-02-27) Rummel C; Scheffler F; Severino, Mariasavina; Silva LS; Staba RJ; Stein DJ; Striano, Pasquale; Taylor PN; Thomopoulos SI; Thompson PM; Bender B; Tortora, Domenico; Brioschi R; Vaudano AE; Bürkle E; Weber B; Caligiuri ME; Wiest R; Cendes, Fernando; Winston, Gavin P; de Tisi J; Yasuda CL; Duncan, John S; Engel JP Jr; Foley S; Fortunato F; Kerestes R; Perry A; Vivash, Lucy; O'Brien TJ; Alvim MKM; Arienzo D; Aventurato ÍK; Ballerini A; Baltazar GF; Bargalló Alabart, Núria; Zheng H; McDonald CR; Sisodiya SM; Harding IH; Gambardella, Antonio; Giacomini T; Guerrini, Renzo; Hall G; Hamandi, Khalid; Ives-Deliperi V; João RB; Keller SS; Kleiser B; Labate, Angelo; Lenge, Matteo; Marotta C; Martin P; Mascalchi M; Meletti S; Owens-Walton C; Parodi CB; Pascual-Diaz, Saül; Powell D; Rao J; Rebsamen M; Reiter J; Riva A; Rüber T
Objective: The intricate neuroanatomical structure of the cerebellum is of longstanding interest in epilepsy, but has been poorly characterized within the current corticocentric models of this disease. We quantified cross-sectional regional cerebellar lobule volumes using structural magnetic resonance imaging in 1602 adults with epilepsy and 1022 healthy controls across 22 sites from the global ENIGMA-Epilepsy working group. Methods: A state-of-the-art deep learning-based approach was employed that parcellates the cerebellum into 28 neuroanatomical subregions. Linear mixed models compared total and regional cerebellar volume in (1) all epilepsies, (2) temporal lobe epilepsy with hippocampal sclerosis (TLE-HS), (3) nonlesional temporal lobe epilepsy, (4) genetic generalized epilepsy, and (5) extratemporal focal epilepsy (ETLE). Relationships were examined for cerebellar volume versus age at seizure onset, duration of epilepsy, phenytoin treatment, and cerebral cortical thickness. Results: Across all epilepsies, reduced total cerebellar volume was observed (d = .42). Maximum volume loss was observed in the corpus medullare (dmax = .49) and posterior lobe gray matter regions, including bilateral lobules VIIB (dmax = .47), crus I/II (dmax = .39), VIIIA (dmax = .45), and VIIIB (dmax = .40). Earlier age at seizure onset ( ηρ2max = .05) and longer epilepsy duration ( ηρ2max = .06) correlated with reduced volume in these regions. Findings were most pronounced in TLE-HS and ETLE, with distinct neuroanatomical profiles observed in the posterior lobe. Phenytoin treatment was associated with reduced posterior lobe volume. Cerebellum volume correlated with cerebral cortical thinning more strongly in the epilepsy cohort than in controls. Significance: We provide robust evidence of deep cerebellar and posterior lobe subregional gray matter volume loss in patients with chronic epilepsy. Volume loss was maximal for posterior subregions implicated in nonmotor functions, relative to motor regions of both the anterior and posterior lobe. Associations between cerebral and cerebellar changes, and variability of neuroanatomical profiles across epilepsy syndromes argue for more precise incorporation of cerebellar subregional damage into neurobiological models of epilepsy.
Psychoeducation in bipolar disorder with a SIMPLe smartphone application: Feasibility, acceptability and satisfaction
(Elsevier B.V., 2016-08-01) Hidalgo Mazzei, Diego; Mateu, Ainoa; Reinares, María; Murru, Andrea; del Mar Bonnín Roig, Caterina; Varo, Cristina; Valentí Ribas, Marc; Undurraga, Juan; Strejilevich, Sergio; Sánchez Moreno, José; Vieta i Pascual, Eduard, 1963-; Colom, Francesc
Background: During the last fifteen years, the possibility of delivering psychoeducation programs through Internet-based platforms have been explored. Studies evaluating those programs have shown good to acceptable retention rates. In this context, we developed a smartphone application (SIMPLe) collecting information about mood symptoms and offering personalized psychoeducation messages. The main aims of this study were to evaluate the feasibility, acceptability and satisfaction of the smartphone application. Methods: The study was conducted from March to August 2015. Participation in the study was proposed to a consecutive sample of adult patients attending an outpatient mental health clinic. Sociodemographic data, clinical and functional assessments alongside smartphone ownership and uses were collected at baseline and at 3 months' follow-up. A 5 item Likert-scale satisfaction questionnaire was also employed. Results: 51 participants were initially enrolled in the study, 36 (74%) remained actively using the application after 3 months. The whole sample interacted with the application a mean of 77 days (SD=26.2). During these days they completed 88% of the daily tests. Over 86% of the participants agreed that the experience using the application was satisfactory. Limitations: The diversity of smartphones operating systems led to a moderate, although representative, sample number. Additionally, the subjective data reporting, narrow time frame of use and stability of the patients could have affected the results. Conclusions: The results confirm that this particular intervention is feasible and represent a satisfactory and acceptable instrument for the self-management of bipolar disorder as an add-on to the usual treatment but future clinical trials must still probe its efficacy.
Treatment of neurocognitive symptoms in unipolar depression: A systematic review and future perspectives
(Elsevier B.V., 2017-10-15) Salagre Muñoz, Estela; Solé Cabezuelo, Brisa; Tomioka, Yoko; Fernandes, Brisa; Hidalgo Mazzei, Diego; Garriga, Marina; Jiménez Martínez, Ester; Sánchez Moreno, José; Vieta i Pascual, Eduard, 1963-; Grande i Fullana, Iria
Background: Cognitive symptoms in Major Depressive Disorder (MDD) are persistent and commonly entail neurocognitive impairment and a decline in quality of life. This systematic review gathers the current scientific evidence on therapeutic strategies for neuropsychological impairment in MDD. Method: A systematic search on PubMed, PsycINFO and Clinicaltrials.gov was carried out on December 2016 according to PRISMA using Boolean terms to identify interventions for the treatment of cognitive dysfunction in MDD. Only English-written articles providing original data and focusing in adults with MDD were included with no time restrictions. Results: A total of 95 studies reporting data on 40 pharmacological and non-pharmacological interventions were included. Interventions were grouped into the following categories: 1) Pharmacological Therapies (antidepressants, stimulants, compounds acting on NMDA receptors, compounds acting on the cholinergic system, compounds showing anti-inflammatory or antioxidant properties, other mechanisms of action), 2) Physical Therapies and 3) Psychological Therapies, 4) Exercise. There are some promising compounds showing a positive impact on cognitive symptoms including vortioxetine, lisdexamfetamine or erythropoietin. Limitations: The studies included showed significant methodological differences in heterogeneous samples. The lack of a standardized neuropsychological battery makes comparisons between studies difficult. Conclusion: Current evidence is not sufficient to widely recommend the use of procognitive treatments in MDD although promising results are coming to light.
La selección de estudiantes de Medicina con competencias enhumanidades: resultados de una prueba piloto
(Elsevier, 2024-02-16) Roma Millan, Josep; March‐Llanes Jaume; Peguero, Eva; Segura i Fàbregas, Bàrbara; Castro, Antoni; Grupo de trabajo para el estudio del acceso al grado de medicina
[spa] Las características de los alumnos que inician el Grado de Medicina en España están determinadas por elresultado de las pruebas de acceso (EBAU). Con elfin de seleccionar un perfil de alumno más alineado a lascompetencias que deberá adquirir para ejercer la profesión, las facultades de medicina de Cataluña, con losdepartamentos de salud y de universidades de la Generalitat, realizaron una prueba piloto, inspirada en losprocesos de selección que se realizan en otros países de nuestro entorno.Objetivo:elaborar una prueba para la detección de habilitades no técnicas en los alumnos que acceden al grado.Metodología:la prueba consistía en responder 3 tipos de test, para medir la comunicación y relación con elentorno profesional (CREP), el juicio ético ante situaciones concretas (JUESC) y, por último, la capacidad derazonamiento crítico (CRAC). Fueron un total 134 preguntas de elección múltiple que previamente habían sidovalidadas por miembros de los equipos decanales. Contestaron la prueba 511 estudiantes de primercurso (49%del total) en septiembre del 2022.Resultados:las medias y las desviaciones típicas de los 3 test fueron: CREP (7,18; 0,99), JUESC (4,68; 0,81), CRAC(5,43; 1,02), y el total de la prueba (5,67; 0,62). Las pruebas defiabilidad (Cronbach) fueron: CREP (0,56), JUESC(0,54), CRAC (0,49), total (0,65).Conclusión:una prueba que seleccione mejor a los estudiantes de Medicina con base en un perfil más acorde convalores humanísticos es perfectamente factible, aunque sobre la base de esta experiencia, se precisa mejorar elinstrumento para hacerlo más confiable.© 2024 The Authors. Publicado por Elsevier España, S.L.U. Este es un artículo Open Access bajo la licencia CC BY-NC-
Sharing brain imaging data in the Open Science era: how and why?
(Elsevier, 2024-07) Giehl, Kathrin; Mutsaerts, Henk-Jan; Aarts, Kristien; Barkhof, Frederik; Caspers. Svenja; Chetelat, Gaël; Colin, Marie-Elisabeth; Düzel, Emrah; Frisoni, Giovanni B.; Ikram, M. Arfan; Jovicich, Jorge; Morbelli, Silvia; Oertel, Wolfgang; Paret, Christian; Perani, Daniela; Ritter, Petra; Segura i Fàbregas, Bàrbara; Wisse, Laura E.M.; De Witte, Elke; Cappa, Stefano F.; van Eimeren, Thilo
The sharing of human neuroimaging data has great potential to accelerate the development of imaging biomarkers in neurological and psychiatric disorders; however, major obstacles remain in terms of how and why to share data in the Open Science context. In this Health Policy by the European Cluster for Imaging Biomarkers, we outline the current main opportunities and challenges based on the results of an online survey disseminated among senior scientists in the field. Although the scientific community fully recognises the importance of data sharing, technical, legal, and motivational aspects often prevent active adoption. Therefore, we provide practical advice on how to overcome the technical barriers. We also call for a harmonised application of the General Data Protection Regulation across EU countries. Finally, we suggest the development of a system that makes data count by recognising the generation and sharing of data as a highly valuable contribution to the community
Study Protocol for a Prospective, Unicentric, Double-Blind, Randomized, and Placebo-Controlled Trial on the Efficacy of a Low-Histamine Diet and DAO Enzyme Supplementation in Patients with Histamine Intolerance
(MDPI, 2025-01-01) Combalia, Andrea; Comas Basté, Oriol; Casas Rodríguez, Rosa M.; Latorre Moratalla, Mariluz; Estruch Riba, Ramon; Vidal Carou, Ma. Carmen; Duelo, Adriana; Sánchez Pérez, Sònia; Ruiz León, Ana María; Casanovas Garriga, Francesc; Pellicer Roca, Salvador; Iduriaga-Platero, Irache; Costa-Catala, Judit; Veciana Nogués, María Teresa; Fernández-Solà, J. (Joaquim); Muñoz Cano, Rosa Maria; Bartra Tomàs, Joan
Background/Objectives: Histamine intolerance is primarily caused by a deficiency in the diamine oxidase (DAO) enzyme at the intestinal level. The reduced histamine degradation in the gut leads to its accumulation in plasma, thereby causing multiple clinical manifestations, such as urticaria, diarrhea, headache, dyspnea, or tachycardia, among others. The dietary management of this food intolerance consists of the follow-up of a low-histamine diet, often combined with DAO supplementation. To date, around twenty studies have investigated the effectiveness of these dietary strategies in reducing the frequency and/or intensity of symptoms, with promising results. However, the limitations of these studies (small patient cohort, lack of control group, and short dietary intervention periods) highlight the need for more ambitiously designed research. Therefore, the main objective of this prospective, unicentric, double-blind, randomized, and placebo-controlled trial is to evaluate the efficacy of a low-histamine diet and/or DAO supplementation over a three-month period in improving symptoms of histamine intolerance. Additionally, the impacts of these dietary strategies on the intestinal microbiota composition, urinary profile of histamine metabolites, serum DAO activity, and plasma histamine levels will be assessed throughout the intervention. Methods: The trial will enroll 400 patients who will be randomly assigned to one of two groups: the intervention group, which will follow a low-histamine diet, or the control group, which will maintain their habitual dietary habits. Within each of these groups, participants will be further divided into four subgroups to receive either exogenous DAO enzyme supplementation (from porcine or plant sources, with the latter administered at two different dosages) or a placebo. Therefore, a total of eight distinct intervention groups will be considered. The comparison of these groups will allow the evaluation of the individual effects of the low-histamine diet or DAO enzyme supplementation, as well as their possible synergistic effect. Results: The results of this study should help to improve dietary recommendations for histamine-intolerant patients and ultimately enhance their quality of life.
Manual motor speed dysfunction as a neurocognitive endophenotype in euthymic bipolar disorder patients and their healthy relatives. Evidence from a 5-year follow-up study
(Elsevier B.V., 2017-03-16) Vieta i Pascual, Eduard, 1963-; Tabarés-Seisdedos, Rafael; Correa-Ghisays, Patricia; Balanzá-Martínez, V.; Selva-Verag, , Gabriel; Vila-Francés, Juan; Soria-Olivas, Emilio; Vivas-Lalinde, Juliana; San Martín, Constanza; Borrás, A.M.; Ayesa Arriola, Rosa; Sánchez-Moreno, José; Sánchez Ort, J.; Crespo Facorro, Benedicto
Background Few studies have examined Manual Motor Speed (MMS) in bipolar disorder (BD). The aim of this longitudinal, family study was to explore whether dysfunctional MMS represents a neurocognitive endophenotype of BD. Methods A sample of 291 subjects, including 131 BD patients, 77 healthy first-degree relatives (BD-Rel), and 83 genetically-unrelated healthy controls (HC), was assessed with the Finger-Tapping Test (FTT) on three occasions over a 5-year period. Dependence of FTT on participants´ age was removed by means of a lineal model of HC samples, while correcting simultaneously the time and learning effect. Differences between groups were evaluated with an ANOVA test. Results The patients' performance was significantly worse than that of HC over time (p≤0.006), and these deficits remained when non-euthymic BD patients (n=9) were excluded from analysis. Some significant differences between BD patients and BD-Rel (p≤0.037) and between BD-Rel and HC (p≤0.033) were found, but they tended to disappear as time progressed (p≥0.057). Performance of the BD-Rel group was intermediate to that of BD and HC. Most sociodemographic and clinical variables did not affect these results in patients. (p≥0.1). However, treatment with carbamazepine and benzodiazepines may exert a iatrogenic effect on MMS performance (p≤0.006). Limitations Only right-handed subjects were included in this study. Substantial attrition over time was detected. Conclusions There were significant differences between the patients´ MMS performance and that of healthy relatives and controls, regardless of most clinical and sociodemographic variables. Dysfunctional MMS could be considered an endophenotype of BD. Further studies are needed to rule out possible iatrogenic effects of some psychopharmacological treatments.
Sociodemographic, clinical, and immunological factors associated with SARS-CoV-2 diagnosis and severe COVID-19 outcomes in people living with HIV: a retrospective cohort study.
(Elsevier B.V., 2021-10-13) Cortés, C.; Force, L.; Letang, Emilio; Vilaró, I.; Casabona, J.; Miró Meda, José M. (José María), 1956-; PISCIS study group.; Nomah, D.K.; Reyes-Urueña, J.; Díaz, Y.; Moreno, Silvia; Aceiton, J.; Bruguera, A.; Vivanco-Hidalgo, R.M.; Llibre, J.M.; Domingo, Pere (Domingo Pedrol); Falcó, V.; Imaz, Arkaitz
Background: Factors affecting outcomes of SARS-CoV-2 infection in people living with HIV are unclear. We assessed the factors associated with SARS-CoV-2 diagnosis and severe outcomes among people living with HIV. Methods: We did a retrospective cohort study using data from the PISCIS cohort of people with HIV in Catalonia (Spain) between March 1 and Dec 15, 2020. We linked PISCIS data with integrated health-care, clinical, and surveillance registries through the Public Data Analysis for Health Research and Innovation Program of Catalonia (PADRIS) to obtain data on SARS-CoV-2 diagnosis, chronic comorbidities, as well as clinical and mortality outcomes. Participants were aged at least 16 years in care at 16 hospitals in Catalonia. Factors associated with SARS-CoV-2 diagnoses and severe outcomes were assessed using univariable and multivariable Cox regression models. We estimated the effect of immunosuppression on severe outcomes (hospital admission for >24 h with dyspnoea, tachypnoea, hypoxaemia, asphyxia, or hyperventilation; or death) using Kaplan-Meier survival analysis. Findings: We linked 20 847 (72·8%) of 28 666 participants in the PISCIS cohort with PADRIS data; 13 142 people had HIV. 749 (5·7%) people with HIV were diagnosed with SARS-CoV-2: their median age was 43·5 years (IQR 37·0-52·7), 131 (17·5%) were female, and 618 (82·5%) were male. 103 people with HIV (13·8%) were hospitalised, seven (0·9%) admitted to intensive care, and 13 (1·7%) died. SARS-CoV-2 diagnosis was more common among migrants (adjusted hazard ratio 1·55, 95% CI 1·31-1·83), men who have sex with men (1·42, 1·09-1·86), and those with four or more chronic comorbidities (1·46, 1·09-1·97). Age at least 75 years (5·2, 1·8-15·3), non-Spanish origin (2·1, 1·3-3·4), and neuropsychiatric (1·69, 1·07-2·69), autoimmune disease (1·92, 1·14-3·23), respiratory disease (1·84, 1·09-3·09), and metabolic disease (2·59, 1·59-4·23) chronic comorbidities were associated with increased risk of severe outcomes. A Kaplan-Meier estimator showed differences in the risk of severe outcomes according to CD4 cell count in patients with detectable HIV RNA (p=0·039) but no differences were observed in patients with undetectable HIV RNA (p=0·15). Interpretation: People living with HIV with detectable HIV viraemia, chronic comorbidities, and some subpopulations could be at increased risk of severe outcomes from COVID-19. These groups should be prioritised in clinical management and SARS-CoV-2 vaccination programmes. Funding: Fundació "la Caixa". Translations: For the Catalan, Spanish and Russian translations of the Summary see Supplementary Materials section.
Early Antiretroviral Therapy Not Associated With Higher Cryptococcal Meningitis Mortality in People With Human Immunodeficiency Virus in High-Income Countries: An International Collaborative Cohort Study
(Oxford University Press, 2023-03-08) Teira, Ramon; Saag, Michael S.; Crane, Heidi M.; Moore, Richard D.; Jacobson, Jeffrey M.; Mathews, W. Chris; Geng, Elvin; Eron, Joseph J.; Althoff, Keri N.; Kroch, Abigail; Brandes, Vanessa; Lang, Raynell; Bucher, Heiner C.; Gill, M. John; Sabin, Caroline; Sterne, Jonathan A. C.; Vidal Marsal, Francisco; Obel, Niels; Mocroft, Amanda; Wittkop, Linda; D'Arminio Monforte, Antonella; Torti, Carlo; Mussini, Cristina; Ingle, Suzanne M.; Miró Meda, José M. (José María), 1956-; May, Margaret T.; Cain, Lauren E.; Schwimmer, Christine; Zangerle, Robert; Sambatakou, Helen; Cazanave, Charles; Reiss, Peter; Furrer, Hansjakob; Konopnicki, Deborah
Background Randomized controlled trials (RCTs) from low- and middle-income settings suggested that early initiation of antiretroviral therapy (ART) leads to higher mortality rates among people with HIV (PWH) who present with cryptococcal meningitis (CM). There is limited information about the impact of ART timing on mortality rates in similar people in high-income settings. Methods Data on ART-naive PWH with CM diagnosed from 1994 to 2012 from Europe/North America were pooled from the COHERE, NA-ACCORD, and CNICS HIV cohort collaborations. Follow-up was considered to span from the date of CM diagnosis to earliest of the following: death, last follow-up, or 6 months. We used marginal structural models to mimic an RCT comparing the effects of early (within 14 days of CM) and late (14–56 days after CM) ART on all-cause mortality, adjusting for potential confounders. Results Of 190 participants identified, 33 (17%) died within 6 months. At CM diagnosis, their median age (interquartile range) was 38 (33–44) years; the median CD4+ T-cell count, 19/μL (10–56/μL); and median HIV viral load, 5.3 (4.9–5.6) log10 copies/mL. Most participants (n = 157 [83%]) were male, and 145 (76%) started ART. Mimicking an RCT, with 190 people in each group, there were 13 deaths among participants with an early ART regimen and 20 deaths among those with a late ART regimen. The crude and adjusted hazard ratios comparing late with early ART were 1.28 (95% confidence interval, .64–2.56) and 1.40 (.66–2.95), respectively. Conclusions We found little evidence that early ART was associated with higher mortality rates among PWH presenting with CM in high-income settings, although confidence intervals were wide.
The 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis: Updating the Modified Duke Criteria.
(Oxford University Press, 2023-08) Meer, Jan T. M. van der; Vaart, Thomas W. van der; Miró Meda, José M. (José María), 1956-; Querido Fortes, Claudio; Fosbøl, Emil; Hannan, Margaret M.; Hasse, Barbara; Hoen, Bruno; Karchmer, Adolf W.; Mestres Lucio, Carlos-Alberto; Petti, Cathy A,; Pizzi, María Nazarena; Preston, Stephen D.; Fowler, Vance G.; Durack, David T.; Selton Suty, Christine; Athan, Eugene; Bayer, Arnold S.; Chamis, Anna Lisa; Dahl, Anders; DiBernardo, Louis; Durante Mangoni, E.; Duval, Xavier; Roque, Albert; Vandenesch, Francois
The microbiology, epidemiology, diagnostics, and treatment of infective endocarditis (IE) have changed significantly since the Duke Criteria were published in 1994 and modified in 2000. The International Society for Cardiovascular Infectious Diseases (ISCVID) convened a multidisciplinary Working Group to update the diagnostic criteria for IE. The resulting 2023 Duke-ISCVID IE Criteria propose significant changes, including new microbiology diagnostics (enzyme immunoassay for Bartonella species, polymerase chain reaction, amplicon/metagenomic sequencing, in situ hybridization), imaging (positron emission computed tomography with 18F-fluorodeoxyglucose, cardiac computed tomography), and inclusion of intraoperative inspection as a new Major Clinical Criterion. The list of “typical” microorganisms causing IE was expanded and includes pathogens to be considered as typical only in the presence of intracardiac prostheses. The requirements for timing and separate venipunctures for blood cultures were removed. Last, additional predisposing conditions (transcatheter valve implants, endovascular cardiac implantable electronic devices, prior IE) were clarified. These diagnostic criteria should be updated periodically by making the Duke-ISCVID Criteria available online as a “Living Document.”
Prognostic impact of circulating plasma cells in patients with multiple myeloma: implications for plasma cell leukemia definition
(Ferrata Storti Foundation, 2017-06-01) Granell, Miquel; Calvo, Xavier; Garcia Guinon, Antoni; Escoda, Lourdes; Abella, Eugènia; Martinez, Clara Mª; Teixido, Montserrat; Gimenez, Mª Teresa; Senín, Alicia; Sanz, Patricia; Campoy, Desirée; Vicent, Ana; Arenillas, Leonor; Rosiñol Dachs, Laura; Sierra, Jorge; Bladé, J. (Joan) ; Fernández de Larrea Rodríguez, Carlos José ; GEMMAC (Grup per l'estudi del mieloma i l'amiloïdosi de Catalunya)
The presence of circulating plasma cells in patients with multiple myeloma is considered a marker for highly proliferative disease. In the study herein, the impact of circulating plasma cells assessed by cytology on survival of patients with multiple myeloma was analyzed. Wright-Giemsa stained peripheral blood smears of 482 patients with newly diagnosed myeloma or plasma cell leukemia were reviewed and patients were classified into 4 categories according to the percentage of circulating plasma cells: 0%, 1-4%, 5-20%, and plasma cell leukemia with the following frequencies: 382 (79.2%), 83 (17.2%), 12 (2.5%) and 5 (1.0%), respectively. Median overall survival according to the circulating plasma cells group was 47, 50, 6 and 14 months, respectively. At multivariate analysis, the presence of 5 to 20% circulating plasma cells was associated with a worse overall survival (relative risk 4.9, 95% CI 2.6-9.3) independently of age, creatinine, the Durie-Salmon system stage and the International Staging System (ISS) stage. Patients with ≥5% circulating plasma cells had lower platelet counts (median 86×109/L vs 214×109/L, P<0.0001) and higher bone marrow plasma cells (median 53% vs 36%, P=0.004). The presence of ≥5% circulating plasma cells in patients with multiple myeloma has a similar adverse prognostic impact as plasma cell leukemia.
IL-15 Enhances the Persistence and Function of BCMA-Targeting CAR-T Cells Compared to IL-2 or IL-15/IL-7 by Limiting CAR-T Cell Dysfunction and Differentiation
(MDPI, 2021-07-14) Battram, Anthony M.; Bachiller, Mireia; López Díaz, Víctor; Fernández de Larrea Rodríguez, Carlos José ; Urbano Ispizua, Álvaro; Martin-Antonio, Beatriz
Simple Summary T cells modified with a chimeric antigen receptor (CAR) that targets BCMA, a protein expressed on malignant plasma cells, represent a novel treatment option for multiple myeloma. Despite initially eliminating the disease, the function of BCMA-directed CAR-T cells diminishes within a year of administration, leading to disease relapse. The aim of this research was to alter the cytokines used in the ex vivo expansion of anti-BCMA CAR-T cells, to avoid the development of an unfavorable phenotype that would impair in vivo function. We discovered that CAR-T cells expanded with IL-15 had reduced dysfunction and enhanced persistence compared to those grown with IL-2 or a combination of IL-15 and IL-7, which resulted in longer and improved anti-tumor responses in a mouse model. Therefore, the use of IL-15 alone in place of IL-2 or IL-15/IL-7 should be considered when designing CAR-T cell production protocols, to improve the duration of patient responses. Chimeric antigen receptor (CAR)-T cell immunotherapy has revolutionized the treatment of B-lymphoid malignancies. For multiple myeloma (MM), B-cell maturation antigen (BCMA)-targeted CAR-T cells have achieved outstanding complete response rates, but unfortunately, patients often relapse within a year of receiving the therapy. Increased persistence and reduced dysfunction are crucial features that enhance the durability of CAR-T cell responses. One of the factors that influence CAR-T cell in vivo longevity and loss of function, but which has not yet been extensively studied for BCMA-directed CAR-T cells, are the cytokines used during their production. We here compared the impact of IL-2, IL-15 and a combination of IL-15/IL-7 on the phenotype and function of ARI2h, an academic BCMA-directed CAR-T cell that is currently being administered to MM patients. For this study, flow cytometry, in vitro cytotoxicity assays and analysis of cytokine release were performed. In addition, ARI2h cells expanded with IL-2, IL-15, or IL-15/IL-7 were injected into MM tumor-bearing mice to assess their in vivo efficacy. We demonstrated that each of the cytokine conditions was suitable for the expansion of ARI2h cells, with clear in vitro activity. Strikingly, however, IL-15-produced ARI2h cells had improved in vivo efficacy and persistence. When explored further, it was found that IL-15 drove a less-differentiated ARI2h phenotype, ameliorated parameters related to CAR-T cell dysfunction, and lowered the release of cytokines potentially involved in cytokine release syndrome and MM progression. Moreover, we observed that IL-15 was less potent in inducing T cell senescence and DNA damage accumulation, both of which may contribute to an unfavorable CAR-T cell phenotype. These findings show the superiority of IL-15 to IL-2 and IL-15/IL-7 in the quality of anti-BCMA CAR-T cells, particularly their efficacy and persistence, and as such, could improve the duration of responses if applied to the clinical production of CAR-T cells for patients.
Development and Validation of a Prediction Model of Outcome After B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Multiple Myeloma
(American Society of Clinical Oncology, 2024-02-15) Gagelmann, Nico; Dima, Danai; Merz, Maximilian; Hashmi, Hamza; Ahmed, Nausheen; Tovar, Natalia; Oliver-Caldés, Aina; Stölzel, Friedrich; Rathje, Kristin; Fischer, Luise; Born, Patrick; Schäfer, Lisa; Albici, Anca-Maria; Schub, Natalie; Kfir-Erenfeld, Shlomit; Assayag, Miri; Asherie, Nathalie; Wulf, Gerald Georg; Kharboutli, Soraya; Müller, Fabian; Shune, Leyla; Davis, James A; Anwer, Faiz; Vucinic, Vladan; Platzbecker, Uwe; Ayuk, Francis; Kröger, Nicolaus; Khouri, Jack; Gurnari, Carmelo; McGuirk, Joseph; Stepensky, Polina; Abdallah, Al-Ola; Fernández de Larrea Rodríguez, Carlos José
Purpose: Although chimeric antigen receptor T therapy (CAR-T) cells are an established therapy for relapsed/refractory multiple myeloma (RRMM), there are no established models predicting outcome to identify patients who may benefit the most from CAR-T. Patients and methods: This is an international retrospective observational study including patients with RRMM infused with currently available commercial or academically produced anti-B-cell maturation antigen (BCMA) CAR-T. We describe characteristics and outcomes in Europe (n = 136) and the United States (n = 133). Independent predictors of relapse/progression built a simple prediction model (Myeloma CAR-T Relapse [MyCARe] model) in the training cohort (Europe), which was externally validated (US cohort) and tested within patient- and treatment-specific subgroups. Results: The overall response rate was 87% and comparable between both cohorts, and complete responses were seen in 48% (Europe) and 49% (the United States). The median time to relapse was 5 months, and early relapse <5 months from infusion showed poor survival across cohorts, with the 12-month overall survival of 30% (Europe) and 14% (the United States). The presence of extramedullary disease or plasma cell leukemia, lenalidomide-refractoriness, high-risk cytogenetics, and increased ferritin at the time of lymphodepletion were independent predictors of early relapse or progression. Each factor received one point, forming the three-tiered MyCARe model: scores 0-1 (low risk), scores 2-3 (intermediate risk), and a score of 4 (high risk). The MyCARe model was significantly associated with distinct 5-month incidence of relapse/progression (P < .001): 7% for low-risk, 27% for intermediate-risk, and 53% for high-risk groups. The model was validated in the US cohort and maintained prognostic utility for response, survival, and outcomes across subgroups. Conclusion: Outcomes of patients with RRMM after CAR-T are comparable between Europe and the United States. The MyCARe model may facilitate optimal timing of CAR-T cells in patient-specific subgroups.
Primary plasma cell leukemia: consensus definition by the International Myeloma Working Group according to peripheral blood plasma cell percentage
(Springer Nature, 2021-12-02) Fernández de Larrea Rodríguez, Carlos José ; Kyle, Robert; Rosiñol Dachs, Laura; Paiva, Bruno; Engelhardt, Monika; Usmani, Saad; Caers, Jo; Gonsalves, Wilson; Schjesvold, Fredrik; Merlini, Giampaolo; Lentzch, Suzanne; Ocio, Enrique; Garderet, Laurent; Moreau, Philippe; Sonneveld, Pieter; Badros, Ashraf; Gahrton, Gosta; Goldschmidt, Hartmut; Tuchman, Sascha; Einsele, Hermann; Durie, Brian; Wirk, Baldeep; Musto, Pellegrino; Hayden, Patrick; Kaiser, Martin; San Miguel, Jesus; Bladé, J. (Joan); Rajkumar, S. Vincent; Victoria Mateos, Maria
Primary plasma cell leukemia (PCL) has a consistently ominous prognosis, even after progress in the last decades. PCL deserves a prompt identification to start the most effective treatment for this ultra-high-risk disease. The aim of this position paper is to revisit the diagnosis of PCL according to the presence of circulating plasma cells in patients otherwise meeting diagnostic criteria of multiple myeloma. We could identify two retrospective series where the question about what number of circulating plasma cells in peripheral blood should be used for defining PCL. The presence of ≥5% circulating plasma cells in patients with MM had a similar adverse prognostic impact as the previously defined PCL. Therefore, PCL should be defined by the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma.

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