Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial.

BACKGROUND: To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of BNT162b2 (Comirnaty, BioNTech, Mainz, Germany) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria, AstraZeneca, Oxford, UK). METHODS: We did a phase 2, open-label, randomised, controlled trial on adults aged 18-60 years, vaccinated with a single dose of ChAdOx1-S 8-12 weeks before screening, and no history of SARS-CoV-2 infection. Participants were randomly assigned (2:1) to receive either BNT162b2 (0·3 mL) via a single intramuscular injection (intervention group) or continue observation (control group). The primary outcome was 14-day immunogenicity, measured by immunoassays for SARS-CoV-2 trimeric spike protein and receptor binding domain (RBD). Antibody functionality was assessed using a pseudovirus neutralisation assay, and cellular immune response using an interferon-γ immunoassay. The safety outcome was 7-day reactogenicity, measured as solicited local and systemic adverse events. The primary analysis included all participants who received at least one dose of BNT162b2 and who had at least one efficacy evaluation after baseline. The safety analysis included all participants who received BNT162b2. This study is registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739), and is ongoing. FINDINGS: Between April 24 and 30, 2021, 676 individuals were enrolled and randomly assigned to either the intervention group (n=450) or control group (n=226) at five university hospitals in Spain (mean age 44 years [SD 9]; 382 [57%] women and 294 [43%] men). 663 (98%) participants (n=441 intervention, n=222 control) completed the study up to day 14. In the intervention group, geometric mean titres of RBD antibodies increased from 71·46 BAU/mL (95% CI 59·84-85·33) at baseline to 7756·68 BAU/mL (7371·53-8161·96) at day 14 (p<0·0001). IgG against trimeric spike protein increased from 98·40 BAU/mL (95% CI 85·69-112·99) to 3684·87 BAU/mL (3429·87-3958·83). The interventional:control ratio was 77·69 (95% CI 59·57-101·32) for RBD protein and 36·41 (29·31-45·23) for trimeric spike protein IgG. Reactions were mild (n=1210 [68%]) or moderate (n=530 [30%]), with injection site pain (n=395 [88%]), induration (n=159 [35%]), headache (n=199 [44%]), and myalgia (n=194 [43%]) the most commonly reported adverse events. No serious adverse events were reported. INTERPRETATION: BNT162b2 given as a second dose in individuals prime vaccinated with ChAdOx1-S induced a robust immune response, with an acceptable and manageable reactogenicity profile. FUNDING: Instituto de Salud Carlos III. TRANSLATIONS: For the French and Spanish translations of the abstract see Supplementary Materials section.

Multirefractory primary immune thrombocytopenia; targeting the decreased sialic acid content.

Patients with multirefractory immune thrombocytopenia (ITP) have limited treatment options. Recent data suggest that specific anti-platelet antibodies may cause destruction of platelets by favoring platelet loss of sialic acid. In this multicenter study 35 patients with ITP, including 16 with multirefractory disease, were analyzed for antiplatelet-antibodies, thrombopoietin (TPO) levels, and platelet desialylation. In selected cases, responses to a novel treatment strategy using oseltamivir were tested. We found that antibodies against GPIbα were overrepresented in multirefractory patients compared to responders (n = 19). In contrast to conventional ITP patients, multirefractory patients exhibited a significant increased platelet activation state (granule secretion) and desialylation (RCA-1 binding) (p < 0.05), and a trend toward higher plasma TPO concentrations. The decreased sialic acid content seemed to be restricted to platelet glycoproteins, since other plasma proteins were not hypoglycosylated. A total of 10 patients with multirefractory ITP having remarkable loss of platelet terminal sialic acids were given oseltamivir phosphate. When the antiviral drug was combined with TPO receptor agonists (TPO-RAs) or with immunosuppressant drugs, platelet responses were observed in 66.7% of patients. All responding patients presented with antibodies reactive only against GPIbα. These findings suggest that desialylation may play a key pathogenic role in some multirefractory ITP patients, and provide diagnostic tools for the identification of such patients. Furthermore, we show that sialidase inhibitor treatment in combination with therapies that help to increase platelet production can induce sustained platelet responses in some patients with anti-GPIbα -mediated thrombocytopenia that have failed previous therapies.

Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study.

Background: The CombiVacS study was designed to assess immunogenicity and reactogenicity of the heterologous ChAdOx1-S/BNT162b2 combination, and 14-day results showed a strong immune response. The present secondary analysis addresses the evolution of humoral and cellular response up to day 180. Methods: Between April 24 and 30, 2021, 676 adults primed with ChAdOx1-S were enrolled in five hospitals in Spain, and randomised to receive BNT162b2 as second dose (interventional group [IG]) or no vaccine (control group [CG]). Individuals from CG received BNT162b2 as second dose and also on day 28, as planned based on favourable results on day 14. Humoral immunogenicity, measured by immunoassay for SARS-CoV-2 receptor binding domain (RBD), antibody functionality using pseudovirus neutralisation assays for the reference (G614), Alpha, Beta, Delta, and Omicron variants, as well as cellular immune response using interferon-γ and IL-2 immunoassays were assessed at day 28 after BNT162b2 in both groups, at day 90 (planned only in the interventional group) and at day 180 (laboratory data cut-off on Nov 19, 2021). This study was registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739). Findings: In this secondary analysis, 664 individuals (441 from IG and 223 from CG) were included. At day 28 post vaccine, geometric mean titres (GMT) of RBD antibodies were 5616·91 BAU/mL (95% CI 5296·49-5956·71) in the IG and 7298·22 BAU/mL (6739·41-7903·37) in the CG (p < 0·0001). RBD antibodies titres decreased at day 180 (1142·0 BAU/mL [1048·69-1243·62] and 1836·4 BAU/mL [1621·62-2079·62] in the IG and CG, respectively; p < 0·0001). Neutralising antibodies also waned from day 28 to day 180 in both the IG (1429·01 [1220·37-1673·33] and 198·72 [161·54-244·47], respectively) and the CG (1503·28 [1210·71-1866·54] and 295·57 [209·84-416·33], respectively). The lowest variant-specific response was observed against Omicron-and Beta variants, with low proportion of individuals exhibiting specific neutralising antibody titres (NT50) >1:100 at day 180 (19% and 22%, respectively). Interpretation: Titres of RBD antibodies decay over time, similar to homologous regimes. Our findings suggested that delaying administration of the second dose did not have a detrimental effect after vaccination and may have improved the response obtained. Lower neutralisation was observed against Omicron and Beta variants at day 180. Funding: Funded by Instituto de Salud Carlos III (ISCIII).

Vaccination of larvae of the bony fish gilthead seabream reveals a lack of correlation between lymphocyte development and adaptive immunocompetence.

Fish eggs are released and embryos hatch into a pathogenically hostile environment, at a time when their immunological capacity is severely limited. Although the eggs are initially protected by the envelope as well as by several innate and adaptive immune substances, which are transferred to eggs during fish vitellogenesis, it seems that young specimens depend fundamentally on their innate defence mechanisms. Here we show in the gilthead seabream, an immunologically tractable teleost fish model, that the first lymphocyte marker genes, those coding for the two subunits for the recombination activating gene, were detected by RT-PCR around 21-27 days post-hatching (dph). In addition, the transcripts coding for the alpha and beta subunits of the T-cell receptor and the light and heavy chains of immunoglobulin M were detected at 27-48 dph. However, most innate immune genes analyzed were already expressed at hatching, including those coding for the toll-like receptors, pro- and anti-inflammatory molecules, antiviral and antibacterial factors, and phagocyte markers. Using the information from the gene expression study, we also examined the achievement of immunocompetence by analyzing the protection induced by a bacterin against the pathogenic bacterium Photobacterium damselae subsp. piscicida. The results show that vaccination of young larvae of this species by either immersion or oral routes resulted in increased susceptibility to infection of the specimens, and point to the lack of correlation between the achievement of immunocompetence and detection of the adaptive immunity markers.

Zebrafish modeling reveals that SPINT1 regulates the aggressiveness of skin cutaneous melanoma and its crosstalk with tumor immune microenvironment.

BACKGROUND: Skin cutaneous melanoma (SKCM) is the most lethal form of skin cancer and while incidence rates are declining for most cancers, they have been steadily rising for SKCM. Serine protease inhibitor, kunitz-type, 1 (SPINT1) is a type II transmembrane serine protease inhibitor that has been shown to be involved in the development of several types of cancer, such as squamous cell carcinoma and colorectal cancer. METHODS: We used the unique advantages of the zebrafish to model the impact of Spint1a deficiency in early transformation, progression and metastatic invasion of SKCM together with in silico analysis of the occurrence and relevance of SPINT1 genetic alterations of the SKCM TCGA cohort. RESULTS: We report here a high prevalence of SPINT1 genetic alterations in SKCM patients and their association with altered tumor immune microenvironment and poor patient survival. The zebrafish model reveals that Spint1a deficiency facilitates oncogenic transformation, regulates the tumor immune microenvironment crosstalk, accelerates the onset of SKCM and promotes metastatic invasion. Notably, Spint1a deficiency is required at both cell autonomous and non-autonomous levels to enhance invasiveness of SKCM. CONCLUSIONS: These results reveal a novel therapeutic target for SKCM.

A comparison of implicit memory tests in schizophrenic patients and normal controls.

The objective of the current study was to compare the performance of schizophrenic patients and normal controls on implicit memory tests. Two neuropsychological tasks were administered to 29 patients and normal participant samples. The implicit tests were: Word fragment completion and Word production from semantic categories. The priming score was the variable of interest. Priming effects are obtained in normal subjects and schizophrenia patients, regardless of the implicit test used. However, a dissociation in priming between normal and patient groups was observed, depending on the test used. For word fragment test, priming was identical between the two groups. However, for word production, priming obtained in schizophrenics was lower than priming in normal controls. Results confirm a dissociation effect in implicit memory tests. These results could be explained in the context of the Roediger and Blaxton (1987) distinction between data-driven and conceptually-driven processing. This evidence suggests that a complete neuropsychological assessment of memory in schizophrenia should include different kinds of implicit memory tests (procedural, perceptual, and conceptual tasks).

SipA, a novel type of protein from Synechococcus sp. PCC 7942, binds to the kinase domain of NblS.

Cyanobacteria respond to nutrient stress conditions by degrading their light-harvesting complexes for photosynthesis, a process regulated in Synechococcus sp. PCC 7942 by the sensor histidine kinase non-bleaching sensor (NblS). In yeast two-hybrid screenings for proteins interacting with NblS we have identified a novel type of protein, named SipA for NblS interacting protein A. Specific binding between NblS and SipA is observed with both yeast and bacterial two-hybrid systems. Additional yeast two-hybrid screenings with SipA as bait further confirmed the specificity of the interaction and allowed us to map their determinants to the ATP-binding domain of NblS. Strong conservation and coevolution of both NblS and SipA in cyanobacteria further suggests the importance of SipA in the context of the NblS signal transduction network.

Urokinase versus VATS for treatment of empyema: a randomized multicenter clinical trial.

BACKGROUND AND OBJECTIVE: Parapneumonic empyema (PPE) is a frequent complication of acute bacterial pneumonia in children. There is limited evidence regarding the optimal treatment of this condition. The aim of this study was to compare the efficacy of drainage plus urokinase versus video-assisted thoracoscopic surgery in the treatment of PPE in childhood. METHODS: This prospective, randomized, multicenter clinical trial enrolled patients aged <15 years and hospitalized with septated PPE. Study patients were randomized to receive urokinase or thoracoscopy. The main outcome variable was the length of hospital stay after treatment. The secondary outcomes were total length of hospital stay, number of days with the chest drain, number of days with fever, and treatment failures. The trial was approved by the ethics committees of all the participating hospitals. RESULTS: A total of 103 patients were randomized to treatment and analyzed; 53 were treated with thoracoscopy and 50 with urokinase. There were no differences in demographic characteristics or in the main baseline characteristics between the 2 groups. No statistically significant differences were found between thoracoscopy and urokinase in the median postoperative stay (10 vs 9 days), median hospital stay (14 vs 13 days), or days febrile after treatment (4 vs 6 days). A second intervention was required in 15% of children in the thoracoscopy group versus 10% in the urokinase group (P = .47). CONCLUSIONS: Drainage plus urokinase instillation is as effective as video-assisted thoracoscopic surgery as first-line treatment of septated PPE in children.

Procedimiento para la interpretación de un cambio entre dos valores consecutivos de una magnitud biológica / Procedure for the interpretation of a change between two consecutive values of a biological quantity

Los intervalos de referencia biológicos no proporcionan información suficiente para la interpretación de un cambio entre dos valores medidos consecutivos debido a que, para la gran mayoría de las magnitudes, la variabilidad biológica intraindividual es menor que la variabilidad biológica interindividual. Teniendo en cuenta esta situación, el laboratorio podría proporcionar, conjuntamente con los intervalos de referencia, información adicional que permita estimar de manera objetiva la significación de un cambio en los valores de una magnitud biológica para un mismo individuo. En este sentido, la manera más adecuada para interpretar un cambio debe realizarse en función del concepto de incertidumbre, ya que permite considerar todas las posibles fuentes de variación a las que están sometidos los valores medidos. Este documento, basado en guías de ámbito nacional e internacional se describe un procedimiento para la interpretación de un cambio entre dos valores consecutivos de una magnitud biológica, basado en el estudio de las diversas fuentes de incertidumbre que le afectan

Biological reference intervals do not provide sufficient information for the interpretation of a change between two consecutive measured values of a biological quantity because, for the vast majority of quantities, the intra-individual biological variability is smaller than the inter-individual biological variability. Taking into account this situation, the laboratory could provide, in conjunction with the reference intervals, additional information to objectively estimate the significance of a change in the values of a biological quantity. In this sense, the most adequate way to interpret the change must be made on the basis of the uncertainty concept, since it allows taking into account all the possible sources of variation to which the measured values are subjected. This document, based on national and international guidelines, describes a procedure for the interpretation of a change between two consecutive values of a biological quantity, based on the study of the various sources of uncertainty that affect it

Impact of glucose-lowering agents on the risk of cancer in type 2 diabetic patients. The Barcelona case-control study.

BACKGROUND: The aim of the present study is to evaluate the impact of glucose-lowering agents in the risk of cancer in a large type 2 diabetic population. METHODS: A nested case-control study was conducted within a defined cohort (275,164 type 2 diabetic patients attending 16 Primary Health Care Centers of Barcelona). Cases (n = 1,040) comprised those subjects with any cancer diagnosed between 2008 and 2010, registered at the Cancer Registry of Hospital Vall d'Hebron (Barcelona). Three control subjects for each case (n = 3,120) were matched by age, sex, diabetes duration, and geographical area. The treatments analyzed (within 3 years prior to cancer diagnosis) were: insulin glargine, insulin detemir, human insulin, fast-acting insulin and analogues, metformin, sulfonylureas, repaglinide, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, and alpha glucosidase inhibitors. Conditional logistic regressions were used to calculate the risk of cancer associated with the use of each drug adjusted by age, BMI, dose and duration of treatment, alcohol use, smoking habit, and diabetes duration. RESULTS: No differences were observed between case and control subjects for the proportion, dose or duration of exposure to each treatment. None of the types of insulin and oral agents analyzed showed a significant increase in the risk of cancer. Moreover, no cancer risk was observed when glargine was used alone or in combination with metformin. CONCLUSIONS: Our results suggest that diabetes treatment does not influence the risk of cancer associated with type 2 diabetes. Therefore, an eventual increase of cancer should not be a reason for biasing the selection of any glucose-lowering treatment in type 2 diabetic population.

Procedimiento para el estudio de interferencias exógenas en la medición de magnitudes biológicas. Documento técnico (2017) / Procedure for the study of exogenous interferences in the measurement of biological quantities. Technical document (2017)

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Forma abreviada de la WAIS: IV estudio piloto en pacientes con esquizofrenia / WAIS-IV short form: a pilot study with schizophrenia patients

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The aim of this study is to develop a WAIS-IV short form of the Spanish version for its use with schizophrenia patients, which would allow estimating their intellectual capacity in a short period of time (approximately 30 minutes). The sample was composed by a clinical group consisting of 35 schizophrenia patients and a control group consisting of 35 people with no known history of mental illness. Data demonstrated that the best combination of tests was: Similarities (Verbal comprehension), Visual puzzles (Perceptual reasoning), Arithmetic (Working memory) and Coding (Processing speed). With this short form, it was possible to obtain a linear correlation between the IQ of the full scale and that of the abridged form of 0.941 in the clinical and 0.940 in the control group. For both groups, the differences between the real IQ averages and the estimated ones were not significant. Moreover, the short form is capable of classifying a substantial number of people in the same IQ category than the full scale does (AU)

Viral nervous necrosis virus persistently replicates in the central nervous system of asymptomatic gilthead seabream and promotes a transient inflammatory response followed by the infiltration of IgM+ B lymphocytes.

The viral nervous necrosis virus (VNNV) is the causal agent of viral encephalopathy and retinopathy (VER), a worldwide fish disease that is responsible for high mortality in both marine and freshwater species. Infected fish suffer from encephalitis, which leads to abnormal swimming behavior and extensive cellular vacuolation and neuronal degeneration in the central nervous system (CNS) and retina. The marine fish gilthead seabream (Sparus aurata) does not develop VER but it is an asymptomatic carrier of VNNV. In this study, we report that VNNV was able to replicate and persist for up to 3 months in the CNS of the gilthead seabream without causing any neural damage. In addition, we found an early inflammatory response in the CNS that was characterized by the induction of genes encoding pro-inflammatory cytokines, a delayed but persistent induction of anti-inflammatory cytokines, and the infiltration of IgM(+) B lymphocytes, suggesting that local adaptive immunity played a major role in the control of VNNV in the CNS of this species.

Interactions between the nitrogen signal transduction protein PII and N-acetyl glutamate kinase in organisms that perform oxygenic photosynthesis.

PII, one of the most conserved signal transduction proteins, is believed to be a key player in the coordination of nitrogen assimilation and carbon metabolism in bacteria, archaea, and plants. However, the identity of PII receptors remains elusive, particularly in photosynthetic organisms. Here we used yeast two-hybrid approaches to identify new PII receptors and to explore the extent of conservation of PII signaling mechanisms between eubacteria and photosynthetic eukaryotes. Screening of Synechococcus sp. strain PCC 7942 libraries with PII as bait resulted in identification of N-acetyl glutamate kinase (NAGK), a key enzyme in the biosynthesis of arginine. The integrity of Ser49, a residue conserved in PII proteins from organisms that perform oxygenic photosynthesis, appears to be essential for NAGK binding. The effect of glnB mutations on NAGK activity is consistent with positive regulation of NAGK by PII. Phylogenetic and yeast two-hybrid analyses strongly suggest that there was conservation of the NAGK-PII regulatory interaction in the evolution of cyanobacteria and chloroplasts, providing insight into the function of eukaryotic PII-like proteins.

Satisfacción de pacientes y familiares con una Unidad de Hospitalización Psiquiátrica / Satisfaction levels of patients and their families with a Psychiatric Hospital Unit

Durante las últimas décadas se ha desarrollado un interés creciente por el estudio de la satisfacción de los pacientes psiquiátricos con los servicios de salud mental dado que puede influir de forma importante en la adherencia al tratamiento y la evolución clínica. La satisfacción de los pacientes psiquiátricos constituye un indicador de la calidad de dichos servicios y es un importante predictor de la futura utilización que los pacientes harán de los servicios y de su cooperación con el tratamiento. En nuestro país existen pocos estudios de satisfacción con las unidades de hospitalización psiquiátrica. En este trabajo se analiza la satisfacción de pacientes ingresados en una unidad de hospitalización psiquiátrica y de sus familiares. Los resultados ponen de manifiesto una satisfacción general elevada con el servicio recibido en la unidad, siendo particularmente alta con el comportamiento y la competencia percibida en los profesionales, y más moderada con la información recibida y la posibilidad de implicación en el plan de tratamiento. Se analiza además la influencia que ejercen determinadas variables (sociodemográficas, relacionadas con el ingreso, relacionadas con la enfermedad mental y el funcionamiento social) sobre la satisfacción de los pacientes psiquiátricos y de sus familiares (AU)

In recent decades there has been growing interest in examining patient satisfaction since it can have great influence on the patients’ adherence to treatment and their clinical evolution. Similarly, it has been demonstrated that the satisfaction of psychiatric patients is an indicator of the quality of mental health services. It has also been demonstrated that it is a strong predictor of the future use that psychiatric patients will make of these services and their willingness to cooperate with treatment. In Spain, there have been few studies conducted on patient satisfaction in Spanish psychiatric hospital units. This study analyzes the satisfaction levels of in-patients in a psychiatric hospital unit and those of their family members. The results show high levels of overall satisfaction with the services received in the unit. They show particularly high levels of satisfaction with regard to the perceived behavior and competence of the professionals involved and more moderate levels of satisfaction with regard to the information received and opportunities to become involved in the treatment plan. The study also analyzes the influence of social demographic variables and other variables (related to admission, the type of mental illness, and the social functioning of the patient) on the satisfaction levels of psychiatric patients and their family members (AU)

A comparison of implicit memory tests in schizophrenic patients and normal controls

The objective of the current study was to compare the performance of schizophrenic patients and normal controls on implicit memory tests. Two neuropsychological tasks were administered to 29 patients and normal participant samples. The implicit tests were: Word fragment completion and Word production from semantic categories. The priming score was the variable of interest. Priming effects are obtained in normal subjects and schizophrenia patients, regardless of the implicit test used. However, a dissociation in priming between normal and patient groups was observed, depending on the test used. For word fragment test, priming was identical between the two groups. However, for word production, priming obtained in schizophrenics was lower than priming in normal controls. Results confirm a dissociation effect in implicit memory tests. These results could be explained in the context of the Roediger and Blaxton (1987) distinction between data-driven and conceptually-driven processing. This evidence suggests that a complete neuropsychological assessment of memory in schizophrenia should include different kinds of implicit memory tests (procedural, perceptual, and conceptual tasks) (AU)

El objetivo de este estudio fue comparar la ejecución de pacientes esquizofrénicos y controles no clínicos en tests de memoria implícita. Se administraron dos pruebas neuropsicológicas a una muestra de 29 pacientes y a dos muestras de participantes no clínicos. Los tests implícitos fueron: Completar fragmentos de palabras y Generación de ejemplares de categorías semánticas.La variable de interés fue la facilitación. Los efectos de facilitación se obtienen en sujetos no clínicos y en pacientes esquizofrénicos, independientemente del test implícito que se utilice. Sin embargo, se ha observado una disociación en la facilitación entre grupos de controles y pacientes, dependiendo del test utilizado. En tests de fragmentos de palabras la facilitación es idéntica en los dos grupos. Sin embargo, en producción de palabras, la facilitación obtenida en esquizofrénicos es menor que la facilitación en controles. Los resultados confirman la existencia de un efecto disociativo en tests de memoria implícita. Estos resultados podrían explicarse en el contexto dela distinción de Roediger y Blaxton (1987) entre procesamiento guiado por los datos y procesamiento guiado conceptualmente. Esta evidencia sugiere que la evaluación neuropsicológica de la memoria en la esquizofrenia debería incluir distintos tipos de pruebas de memoria implícita (procedimentales, perceptuales, y conceptuales) (AU)

Social perception training in schizophrenia: a pilot study

Uno de los factores cognitivos deteriorados en esquizofrénicos es la cognición social. Elobjetivo de este estudio ha sido investigar la mejora de la percepción social, uno de loscomponentes clave de la cognición social, en pacientes crónicos. Dieciocho pacientes externoscon diagnóstico de esquizofrenia fueron aleatoriamente asignados al grupo controly al grupo que recibía la intervención. Los pacientes en el grupo de tratamiento recibieronentrenamiento en el subprograma de percepción social de la IPT. El desempeño de lospacientes en percepción social fue evaluado antes de la intervención, después de la intervencióny tras un periodo de seis meses de seguimiento, utilizando una escala que habíasido desarrollada específicamente para evaluar percepción social (Social Perception Scale-SPS). Los resultados indican que la escala puede diferenciar entre el grupo que ha recibidola intervención y el grupo control. También fueron evaluadas la atención, la psicopatologíay el funcionamiento social. A pesar del pequeño número de pacientes los resultados sonprometedores y sugieren mejoras en las habilidades de percepción social (identificación deestímulos, interpretación y resumen de la información de una fotografía) en los pacientesentrenados con el programa de la IPT respecto a los pacientes del grupo control(AU)

Social cognition has been recognized as one of the key cognitive factors that is impairedin schizophrenia. The aim of this study was to investigate the possibility of improvementsin social perception, which is a key component of social cognition, in chronically ill patients.Eighteen schizophrenic outpatients were randomly assigned to therapy and control groups.The patients in the therapy group followed the social perception subprogram of IPT. Thepatients‘ performance in social perception was assessed before the intervention, after theintervention and at the end of a six-month follow-up period, using a scale that was specificallydeveloped to assess social perception (Social Perception Scale –SPS). The results indicatethat it can differentiate between the group that followed the therapy program and the controlgroup. Attention, psychopathology and social functioning were also evaluated. Althoughonly a small group of patients participated in the study, the results are promising. Theysuggest improvements in the social perception abilities that were trained using the IPTprogram in the therapy group in comparison with the control group. The patients in thetherapy group improved their ability to identify stimuli and to interpret and summariseinformation in a picture(AU)

Regulación del proceso de evaluaciónde ensayos clínicos multicéntricosen España / Regulation of the evaluation process of multicentric clinical trials in Spain

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