Influencia del sistema de producci?n en la calidad de la canal de cerdos de raza b?sara

La utilizaci?n de razas locales en sistemas de producci?n alternativos presenta una serie de ventajas, como la gesti?n medioambiental, la biodiversidad y la producci?n agr?cola sostenible orientada hacia un mercado de productos de calidad diferenciada, especialmente en ?reas desfavorecidas. En este trabajo se estudi? la influencia de dos sistemas de producci?n en la calidad de la canal de cerdos de raza B?sara. La alimentaci?n recibida fue igual en ambos casos. En la fase de crecimiento (98 d?as) se alimentaron con pienso compuesto comercial, mientras que durante el acabado se les administr? pienso compuesto y harina de ma?z. Se recogieron datos de peso vivo y canal despu?s de 24h a 4?C y se calcul? el rendimiento de la canal. Se realizaron medidas morfom?tricas lineales de la media canal derecha, tras 24h post-mortem. El espesor de la grasa dorsal se midi? a nivel de la 1? costilla, la ?ltima costilla, en el m?sculo gluteus medius en el ?rea m?s espesa de grasa (extremo craneal) y en la de inferior espesura. Teniendo en cuenta los resultados obtenidos, no se observan diferencias significativas en ninguno de los par?metros analizados. El peso de la canal fr?a (94,23?7,55 kg) y el rendimiento (75,51?1,48%) as? como las medidas morfom?tricas mostraron valores pr?cticamente coincidentes entre ambos tipos de sistemas de producci?n. Tampoco se observaron diferencias en el espesor de la grasa dorsal. Las cuatro medidas indican un grado elevado y homog?neo de grasa dorsal, caracter?stica frecuentemente constatada en razas de cerdos no mejoradas (razas locales) existentes en todo el mundo.FE1B-06B2-126F | Jos? Pedro Pinto de Ara?joN/

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection

Background and Objective: Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data source

Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection

Background Electronic reporting and processing of suspected adverse drug reactions (ADRs) is increasing and has facilitated automated screening procedures. It is crucial for healthcare professionals to understand the nature and proper use of data available in pharmacovigilance practice. Objectives To (a) compare performance of EU-ADR [electronic healthcare record (EHR) exemplar] and FAERS [spontaneous reporting system (SRS) exemplar] databases in detecting signals using "positive" and "negative" drug-event reference sets; and (b) evaluate the impact of timing bias on sensitivity thresholds by comparing all data to data restricted to the time before a warning/regulatory action. Methods Ten events with known positive and negative reference sets were selected. Signals were identified when respective statistics exceeded defined thresholds. Main outcome measure Performance metrics, including sensitivity, specificity, positive predictive value and accuracy were calculated. In addition, the effect of regulatory action on the performance of signal detection in each data source was evaluated. Results The sensitivity for detecting signals in EHR data varied depending on the nature of the adverse events and increased substantially if the analyses were restricted to the period preceding the first regulatory action. Across all events, using data from all years, a sensitivity of 45-73 % was observed for EU-ADR and 77 % for FAERS. The specificity was high and similar for EU-ADR (82-96 %) and FAERS (98 %). EU-ADR data showed range of PPV (78-91 %) and accuracy (78-72 %) and FAERS data yielded a PPV of 97 % with 88 % accuracy. Conclusion Using all cumulative data, signal detection in SRS data achieved higher specificity and sensitivity than EHR data. However, when data were restricted to time prior to a regulatory action, performance characteristics changed in a manner consistent with both the type of data and nature of the ADR. Further research focusing on prospective validation of is necessary to learn more about the performance and utility of these databases in modern pharmacovigilance practice

Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project

A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice

Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

Purpose In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. Methods Aggregated demographic, clinical, and prescription data from eight databases in four countries (Denmark, Italy, Netherlands, the UK) were pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa (c). Comparison of incidence rates of upper gastrointestinal bleeding (UGIB) and nonsteroidal anti-inflammatory drug (NSAID) utilization patterns were used to evaluate data harmonization and quality across databases. The known association of NSAIDs and UGIB was employed to demonstrate sensitivity of the system by comparing incidence rate ratios (IRRs) of UGIB during NSAID use to UGIB during all other person-time. Results The study population for this analysis comprised 19 647 445 individuals corresponding to 59 929 690 person-years of follow-up. 39 967 incident cases of UGIB were identified during the study period. Crude incidence rates varied between 38.8 and 109.5/100 000 person-years, depending on country and type of database, while age-standardized rates ranged from 25.1 to 65.4/100 000 person-years. NSAID use patterns were similar for databases within the same country but heterogeneous among different countries. A statistically significant age-and gender-adjusted association between use of any NSAID and increased risk for UGIB was confirmed in all databases, IRR from 2.0 (95%CI:1.7-2.2) to 4.3 (95%CI: 4.1-4.5). Conclusions Combining data from EHR databases of different countries to identify drug-adverse event associations is feasible and can set the stage for changing and enlarging the scale for drug safety monitoring. Copyright (C) 2010 John Wiley & Sons, Ltd