Del case report a la evidencia epidemiológica de causalidad en investigación biomédica

Not availableA lo largo de los últimos años la investigación clínica se ha desarrollado de manera significativa y ha contribuido a que actualmente las ciencias biosanitarias estén más fundamentadas en pruebas y evidencias científicas. La investigación en biomedicina se realiza a dos niveles, básico y epidemiológico. El enfoque epidemiológico presenta unos objetivos muy variados: desde la simple descripción de una realidad (caso clínico o case report) hasta la verificación de una hipótesis en relación con unos factores causales. En todo el espectro posible se pueden aplicar diferentes diseños epidemiológicos, para lograr la finalidad última que se persigue, aunque la validez de la elección determina el rigor científico de las conclusiones del estudio. Un elemento importante de cara a la inferencia de causalidad, sin posible participación de errores o sesgos, es la existencia de un grupo de comparación sobre el que el investigador no interviene (grupo no tratado o control) y, especialmente, la aleatorización del proceso, es decir, cuando la inclusión de los individuos en uno u otro grupo (tratado o control) depende exclusivamente del azar. El establecimiento de causalidad se realiza en base a las características cualitativas y cuantitativas de la asociación existente entre el proceso morboso y los factores de riesgo estudiados

Hatchery production of the greater amberjack (Seriola dumerili)

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PROF-XXI: Teaching and Learning Centers to Support the 21st Century Professor

PROF-XXI is a European-funded project whose aim is the creation of Teaching and Learning Centers (TLCs) for Latin American Higher Institutions in an effort to promote the development of competences for university professors and foster teaching innovation in onsite, but also in online and hybrid education. PROF-XXI includes a partnership of seven higher education institutions, three from European countries (Spain, France, and Portugal), and four from Latin American countries (two from Guatemala, and two from Colombia). This article presents the main results of the first part of the project, including the diagnosis of institutional practices, the state of the art of TLCs around the world, the framework on 21st century professors in Latin America, and the PROF-XXI framework

Guidance on aneugenicity assessment

The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment

Re-evaluation of the existing health-based guidance values for copper and exposure assessment from all sources

Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health-based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non-dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow-on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non-oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth

Propuestas en las ruinas del Convento de San Antón. Castrojeriz

Propuestas de intervención en las ruinas del Convento de San Antón de Castrojeriz.Departamento de Teoría de la Arquitectura y Proyectos ArquitectónicosDepartamento de Teoría de la Arquitectura y Proyectos ArquitectónicosAsociación Hospital de Peregrinos San AntónDemarcación de Burgos del COACYL

Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment

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