La valoració del coneixement de la llengua pròpia i del dret propi de Catalunya en la provisió de places del personal al servei de l’administració de justícia

La recerca proposa l’estudi del contingut i abast de les principals disposicions normatives que ordenen la valoració del coneixement de la llengua i el dret propis de Catalunya en la provisió de les places judicials. L’anàlisi de la tramitació parlamentària de les disposicions ha permès posar en context decisions del legislador, oferint instruments d’hermenèutica útils per resoldre debats interpretatius que avui es plantegen en seu doctrinal. La recerca inclou l’estudi dels efectes d’aquests textos normatius, en tant que permeten mesurar-ne la seva eficàcia i s’han de tenir en compte en el debat de les reformes que, eventualment, puguin desplegar-se. Des de la perspectiva d’anàlisi de les polítiques públiques, la recerca descriu les principals mesures formulades i implementades per les diferents Administracions Públiques, i molt especialment per la Generalitat de Catalunya, amb l’objectiu de corregir disfuncions que presenta aquest marc legal i reglamentari. La recerca ha posat en evidència que el règim jurídic que ordena l’aptitud lingüística i el coneixement del dret propi de Catalunya per part del personal judicial es caracteritza per la seva complexitat i falta de coherència. La valoració del coneixement de la llengua i el dret propis de la Comunitat Autònoma s’ha regulat molt tardament. Com a regla general, es valora com un mèrit en la provisió de la plaça, sotmès a més a intenses controvèrsies pel que fa a la determinació dels barems de puntuació concedits. En certs casos, com és el cos de Fiscals substituts, la valoració de la llengua i el dret propis de la Comunitat Autònoma ni tan sols es valora com un mèrit. Simplement no es té en compte. Pel que fa referència als secretaris judicials, la darrera reforma de la L.O. 6/1985 d’1 de juliol, del Poder Judicial, aprovada per L.O. 19/2003 de 23 de desembre, ha introduït el requisit de la capacitació lingüística per cobrir determinades places, per bé que el criteri general és el de la meritació puntuable. Altrament, en el cas del personal judicial depenent de la Generalitat s’ha garantit el requisit d’aptitud lingüística. D’aquesta manera, s’ha optat per assegurar un coneixement adequat i suficient de les dues llengües oficials, tant en l’expressió oral com en l’escrita, per a desenvolupar eficaçment les funcions pròpies del seu lloc de treball.

Avaluació de programes formatius de seguretat viària i la reincidència posterior

Els programes formatius d’educació viària són una mesura penal alternativa que s’imposa habitualment als autors dels delictes relacionats amb el trànsit (articles 379 i següents del Codi Penal) per suspendre o substituir la pena de presó. Aquests programes tenen un doble objectiu: aconseguir reduir a curt termini la sinistralitat viària i propiciar un canvi cultural permanent en la conducció. L’objectiu principal d’aquesta recerca va ser identificar les característiques comunes dels infractors de trànsit que fan aquest tipus d’intervenció, conèixer els factors de risc associats a aquests infractors i en quina mesura l’estat psicològic és un factor de risc en l’estil de conducció. També es volia determinar si hi havia diferències entre les entitats que impartien la formació, avaluar l’efectivitat d’aquests programes en l’estil de conducció dels participants en finalitzar el curs i conèixer la reincidència dels seus participants i la seva relació amb l’estat i el canvi de les variables de l’estudi. La mostra va comptar amb 278 participants voluntaris del total de 354 infractors de trànsit que van realitzar un programa formatiu entre l’1 d’abril de 2009 i el 13 de febrer de 2010. D’aquests, un total de 100 participants van autoritzar a ser contactats novament entre el desembre del 2011 i el gener del 2012, per mirar la reincidència. Les fonts d’informació van ser els qüestionaris passats als infractors i el buidatge de la base de dades d’execució penal del Departament de Justícia, amb informació judicial i personal i el seguiment dels usuaris fins a dos anys després d’haver finalitzat el curs formatiu, per saber si havien tornat a reincidir en el mateix delicte.

Evaluación de programas formativos de seguridad vial y su reincidencia posterior

Los programas formativos de educación vial son una medida penal alternativa que se impone habitualmente a los autores de delitos relacionados con el tráfico (artículos 379 y siguientes del Código Penal) para suspender o sustituir la pena de prisión. Estos programas tienen un doble objetivo: conseguir reducir a corto plazo la siniestralidad vial y propiciar un cambio cultural permanente en la conducción. El objetivo principal de esta investigación fue identificar las características comunes de los infractores de tráfico que han de hacer este tipo de intervención y conocer sus factores de riesgo. También se estudiaron las diferencias entre las entidades que imparten los cursos formativos, se evaluó su efectividad y se estudió la reincidencia de los conductores. En total participaron 278 infractores que realizaron un programa formativo entre el 1 de abril de 2009 y el 13 de febrero de 2010 y se les siguió hasta enero de 2012.

Long-term efficacy and safety of atazanavir/ritonavir treatment in a cohort of treatment-naïve HIV patients: An interim analysis of the REMAIN study.

Purpose: Combined antiretroviral therapy has dramatically improved HIV-infected individuals survival. Long-term strategies are currently needed to achieve the goal of durable virologic suppression. However, long-term available data for specific antiretrovirals (ARV) are limited. In clinical trials, boosted atazanavir (ATV/r) regimens has shown good efficacy and tolerability in ARV-naïve patients for up to 4 years. The REMAIN study aimed to evaluate the long-term outcomes of ATV/r regimens in ARV-naïve patients in a real life setting. Methods: Non-comparative, observational study conducted in Germany, Portugal and Spain. Historical and longitudinal follow-up data was extracted six monthly from the medical record of HIV-infected, treatment-naïve patients, who initiated an ATV/r-regimen between 2008 and 2010. The primary endpoint was the proportion of patients remaining on ATV treatment over time. Secondary endpoints included virologic response (HIV-1 RNA <50 c/mL and <500 c/mL), reasons for discontinuation and long-term safety. The duration of treatment and time to virologic failure (VF) were analyzed using the Kaplan- Meier method. Data from an interim analysis including patients with at least one year of follow-up are reported here. Results: A total of 411 patients were included in this interim analysis [median (Q1, Q3) follow-up: 23.42 (16.25, 32.24) months≥: 77% male; median age 40 years [min, max: 19, 78≥; 16% IDUs; 18% CDC C; 18% hepatitis C. TDF/FTC was the most common backbone (85%). At baseline, median (Q1, Q3) HIV-RNA and CD4 cell count were 4.91 (4.34, 5.34) log10 c/mL and 256 (139, 353) cells/mm3, respectively. The probability of remaining on treatment was 0.84 (95% CI: 0.80, 0.87) and 0.72 (95% CI: 0.67, 0.76) for the first and second year, respectively. After 2 years of follow-up, 84% (95% CI: 0.79, 0.88) of patients were virologically suppressed (<50 c/mL). No major protease inhibitors mutations were observed at VF. Overall, 125 patients (30%) discontinued ATV therapy [median (Q1, Q3) time to discontinuation: 11.14 (6.24, 19.35) months]. Adverse events (AEs) were the main reason for discontinuation (n =47, 11%). Hyperbilirubinaemia was the most common AE leading to discontinuation (14 patients). No unexpected AEs were reported. Conclusions: In a real life clinical setting, ATV/r regimens showed durable virologic efficacy with good tolerability in an ARV-naïve population. Data from longer follow-up will provide additional valuable information.

Safety and immunomodulatory effects of three probiotic strains isolated from the feces of breast-fed infants in healthy adults: SETOPROB study.

We previously described the isolation and characterization of three probiotic strains from the feces of exclusively breast-fed newborn infants: Lactobacillus paracasei CNCM I-4034, Bifidobacterium breve CNCM I-4035 and Lactobacillus rhamnosus CNCM I-4036. These strains were shown to adhere to intestinal mucus in vitro, to be sensitive to antibiotics and to resist biliary salts and low pH. In the present study, a multicenter, randomized, double-blind, placebo-controlled trial with 100 healthy volunteers in three Spanish cities was carried out to evaluate the tolerance, safety, gut colonization and immunomodulatory effects of these three probiotics. Volunteers underwent a 15-day washout period, after which they were randomly divided into 5 groups that received daily a placebo, a capsule containing one of the 3 strains or a capsule containing a mixture of two strains for 30 days. The intervention was followed by another 15-day washout period. Patients did not consume fermented milk for the entire duration of the study. Gastrointestinal symptoms, defecation frequency and stool consistency were not altered by probiotic intake. No relevant changes in blood and serum, as well as no adverse events occurred during or after treatment. Probiotic administration slightly modified bacterial populations in the volunteers' feces. Intestinal persistence occurred in volunteers who received L. rhamnosus CNCM I-4036. Administration of B. breve CNCM I-4035 resulted in a significant increase in fecal secretory IgA content. IL-4 and IL-10 increased, whereas IL-12 decreased in the serum of volunteers treated with any of the three strains. These results demonstrate that the consumption of these three bacterial strains was safe and exerted varying degrees of immunomodulatory effects.

Integració i gestió dels marcatges laborals del personal d'empresa al sistema SAP R/3

L'objectiu d'aquest projecte és realitzar l'estudi i el disseny per a la corresponent implantació d'un sistema de control dels marcatges per fer el traspàs i poder-los gestionar amb SAP R/3 en un grup d'empreses.

Conocimiento de la ley y preparación del personal sanitario sobre el proceso asistencial de la muerte.

The aims of this study were to ascertain the perception that health professionals (doctors, nurses and nursing assistants) have about their preparation for the care of terminally ill patients and to determine their knowledge about palliative care legislation. This cross sectional study was performed at a hospital in Granada (Spain); we administered an ad hoc questionnaire. The results indicated that although most of the staff had worked with terminally ill patients, only half believed that they have been trained to care for them. A significant proportion stated that they did not know about the current palliative care legislation. Most professionals would question the withdrawal of therapies for the maintenance of life; most of them are also unaware of the mechanism for reporting on the completion of a Living Will, as well as a Plan for Palliative Care in Andalusia (Spain).

Adaptación y validación al español del cuestionario 4CornerSAT para la medida de la satisfacción profesional del personal médico de atención especializada.

BACKGROUND Satisfaction of physicians is a concern in the healthcare sector, and it requires a multi-dimensional questionnaire in Spanish which studies their high-order needs. The objectives of this study are to adapt the 4CornerSAT Questionnaire to measure career satisfaction of physicians and to evaluate its validity in our context. METHOD The 4CornerSAT Questionnaire was adapted into Spanish, validating it among physicians of hospitals in Andalusia, Spain. A confirmatory factor analysis (CFA) was performed to corroborate the a priori model, and it was evaluated the internal consistency and the construct validity through the Cronbach's alpha and the correlation between the scale and the global item, respectively. RESULTS The adapted questionnaire was administrated to 121 specialist physicians. The CFA corroborated the four dimensions of the questionnaire (χ2=114.64, df=94, p<0.07; χ2/df=1.22; RMSEA=0.04). The internal consistency obtained an α=0.92 and the correlation between the summed scale and the global item verified the construct validity (r=0.77; p<0.001). CONCLUSIONS The 4CornerSAT questionnaire was adapted to Spanish, identifying an adequate construct validity and internal consistency.

The combination of social and personal contexts affects dominance hierarchy development in shore crabs, Carcinus maenas

Many animals that live in groups maintain competitive relationships, yet avoid continual fighting, by forming dominance hierarchies. We compare predictions of stochastic, individual-based models with empirical experimental evidence using shore crabs to test competing hypotheses regarding hierarchy development. The models test (1) what information individuals use when deciding to fight or retreat, (2) how past experience affects current resource-holding potential, and (3) how individuals deal with changes to the social environment. First, we conclude that crabs assess only their own state and not their opponent's when deciding to fight or retreat. Second, willingness to enter, and performance in, aggressive contests are influenced by previous contest outcomes. Winning increases the likelihood of both fighting and winning future interactions, while losing has the opposite effect. Third, when groups with established dominance hierarchies dissolve and new groups form, individuals reassess their ranks, showing no memory of previous rank or group affiliation. With every change in group composition, individuals fight for their new ranks. This iterative process carries over as groups dissolve and form, which has important implications for the relationship between ability and hierarchy rank. We conclude that dominance hierarchies emerge through an interaction of individual and social factors, and discuss these findings in terms of an underlying mechanism. Overall, our results are consistent with crabs using a cumulative assessment strategy iterated across changes in group composition, in which aggression is constrained by an absolute threshold in energy spent and damage received while fighting.

Safety in vicinity of industrials plants: risk assessment and land use planning

The aim of this book is to survey on different Land Use Planning and safety approaches in vicinity of industrial plants. As this research is associated with three broad fields of Land Use Planning, safety and security, the set principle is to avoid unnecessary and over detailed information, but including the useful ones to provide a comprehensive resource which can be applicable for several purposes. Besides, the proposed method, which is explained in Chapter 7, can initiate a new field for future of Land Use Planning in vicinity of industrial plants.

CNS safety at 48-week of switching to ATV/r plus 3TC or two nucleos(t)ides in HIV-suppressed patients on stable ART: the SALT neurocognitive sub-study.

INTRODUCTION Due to their low CNS penetrance, there are concerns about the capacity of non-conventional PI-based ART (monotherapy and dual therapies) to preserve neurocognitive performance (NP). METHODS We evaluated the NP change of aviremic participants of the SALT clinical trial (1) switching therapy to dual therapy (DT: ATV/r+3TC) or triple therapy (TT: ATV/r+2NRTI) who agreed to perform an NP assessment (NPZ-5) at baseline and W48. Neurocognitive impairment and NP were assessed using AAN-2007 criteria (2) and global deficit scores (GDS) (3). Neurocognitive change (GDS change: W48 - baseline) and the effect of DT on NP evolution crude and adjusted by significant confounders were determined using ANCOVA. RESULTS A total of 158 patients were included (Table 1). They had shorter times because HIV diagnosis, ART initiation and HIV-suppression and their virologic outcome at W48 by snapshot was higher (79.1% vs 72.7%; p=0.04) compared to the 128 patients not included in the sub-study. By AAN-2007 criteria, 51 patients in each ART group (68% vs 63%) were neurocognitively impaired at baseline (p=0.61). Forty-seven patients were not reassessed at W48: 30 lost of follow-up (16 DT-14 TT) and 17 had non-evaluable data (6 DT-11 TT). Patients retested were more likely to be men (78.9% vs 61.4%) and had neurological cofounders (9.6% vs 0%) than patients non-retested. At W48, 3 out of 16 (5.7%) patients on DT and 6 out of 21 (10.5%) on TT who were non-impaired at baseline became impaired (p=0.49) while 10 out of 37 (18.9%) on DT and 7 out of 36 (12.3%) on TT who were neurocognitively impaired at baseline became non-impaired (p=0.44). Mean GDS changes (95% CI) were: Overall -0.2 (-0.3 to -0.04): DT -0.26 (-0.4 to -0.07) and TT -0.08 (-0.2 to 0.07). NP was similar between DT and TT (0.15). This absence of differences was also observed in all cognitive tests. Effect of DT: -0.16 [-0.38 to 0.06]) (r(2)=0.16) on NP evolution was similar to TT (reference), even after adjusting (DT: -0.11 [-0.33 to 0.1], TT: reference) by significant confounders (geographical origin, previous ATV use and CD4 cell count) (r(2)=0.25). CONCLUSIONS NP stability was observed after 48 weeks of follow up in the majority of patients whether DT or TT was used to maintain HIV-suppression. Incidence rates of NP impairment or NP impairment recovery were also similar between DT and TT.

Lipid changes in HIV-patients switching to the coformulated single tablet FTC/RPV/TDF (Eviplera®). Efficacy and safety analysis. GeSida Study 8114.

INTRODUCTION Rilpivirine (RPV) has a better lipid profile than efavirenz (EFV) in naïve patients (1). Switching to RPV may be convenient for many patients, while maintaining a good immunovirological control (2). The aim of this study was to analyze lipid changes in HIV-patients at 24 weeks after switching to Eviplera® (emtricitabine/RPV/tenofovir disoproxil fumarate [FTC/RPV/TDF]). MATERIALS AND METHODS Retrospective, multicentre study of a cohort of asymptomatic HIV-patients who switched from a regimen based on 2 nucleoside reverse transcriptase inhibitors (NRTI)+protease inhibitor (PI)/non nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir boosted PI monotherapy to Eviplera® during February-December, 2013; all had undetectable HIV viral load for ≥3 months prior to switching. Patients with previous failures on antiretroviral therapy (ART) including TDF and/or FTC/3TC, with genotype tests showing resistance to components of Eviplera®, or who had changed the third drug of the ART during the study period were excluded. Changes in lipid profile and cardiovascular risk (CVR), and efficacy and safety at 24 weeks were analyzed. RESULTS Among 305 patients included in the study, 298 were analyzed (7 cases were excluded due to lack of data). Men 81.2%, mean age 44.5 years, 75.8% of HIV sexually transmitted. 233 (78.2%) patients switched from a regimen based on 2 NRTI+NNRTI (90.5% EFV/FTC/TDF). The most frequent reasons for switching were central nervous system (CNS) adverse events (31.0%), convenience (27.6%) and metabolic disorders (23.2%). At this time, 293 patients have reached 24 weeks: 281 (95.9%) have continued Eviplera®, 6 stopped it (3 adverse events, 2 virologic failures, 1 discontinuation) and 6 have been lost to follow up. Lipid profiles of 283 cases were available at 24 weeks and mean (mg/dL) baseline vs 24 weeks are: total cholesterol (193 vs 169; p=0.0001), HDL-c (49 vs 45; p=0.0001), LDL-c (114 vs 103; p=0.001), tryglycerides (158 vs 115; p=0.0001), total cholesterol to HDL-c ratio (4.2 vs 4.1; p=0.3). CVR decreased (8.7 vs 7.5%; p= 0.0001). CD4 counts were similar to baseline (653 vs 674 cells/µL; p=0.08), and 274 (96.8%) patients maintained viral suppression. CONCLUSIONS At 24 weeks after switching to Eviplera®, lipid profile and CVR improved while maintaining a good immunovirological control. Most subjects switched to Eviplera® from a regimen based on NNRTI, mainly EFV/FTC/TDF. CNS adverse events, convenience and metabolic disorders were the most frequent reasons for switching.

Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

Truncated robust distance for clinical laboratory safety data monitoring and assessment.

Laboratory safety data are routinely collected in clinical studies for safety monitoring and assessment. We have developed a truncated robust multivariate outlier detection method for identifying subjects with clinically relevant abnormal laboratory measurements. The proposed method can be applied to historical clinical data to establish a multivariate decision boundary that can then be used for future clinical trial laboratory safety data monitoring and assessment. Simulations demonstrate that the proposed method has the ability to detect relevant outliers while automatically excluding irrelevant outliers. Two examples from actual clinical studies are used to illustrate the use of this method for identifying clinically relevant outliers.