La investigación biomédica, el mercado, los clínicos, la seguridad y la responsabilidad social corporativa posfase III: retener la confianza / Biomedical research, the market, clinicians, safety and corporate social responsibility post-phase III: maintaining confidence

Introducción: Los ensayos controlados aleatorios son el gold standar occidental respecto a la toma de decisiones, tanto para los clínicos como para los gestores o responsables de políticas comunitarias. En este poderoso despliegue de esfuerzo investigador existen grados variables de conflictos de intereses y los clínicos, que no somos ajenos a eso, estamos entrando en un mar de dudas acerca de la seguridad, dimensión que emerge como un elemento diacrítico, irrenunciable. El objeto del estudio fue toda evaluación crítica y la selección sobre editoriales, ensayos clínicos o metaanálisis publicados en soporte físico o vía web, acreditados internacionalmente, que resultaran más relevantes y que abordaran como objetivo primario la seguridad de los pacientes. Pacientes y métodos: Investigación evaluativa que se llevó a cabo en el Complejo Hospitalario Torrecárdenas, perteneciente al Servicio Andaluz de Salud. Sistema Sanitario Público de Andalucía, en el contexto de una unidad formativa acreditada (Mejora_F) en 2008, denominada «transferencia del conocimiento biomédico desde la bibliografía». Resultados: Los artículos analizados fueron 170 (el 75% en inglés, con predominio de New England Journal of Medicine [>50%], seguida de Journal Of the American Medical Association, The Lancet, British Medical Journal, Journal of American Geriatrics, Medicina Clínica, Revista Clínica Española e Infectología). De los 170 artículos elegibles, seleccionamos 5 tópicos clave por su impacto como los más representativos por su frecuencia de citación. Representaron, a nuestro juicio, «una bandera roja» de seguridad los siguientes: betaestimulantes de acción larga y aumento de mortalidad en asma; neurolépticos en ancianos y prolongación del intervalo QT asociado a muerte súbita; tiazolidindiona en diabetes de tipo ii y efectos negativos cardiovasculares; potenciación de estatinas-ezetimiba y discutible asociación con mayor mortalidad por cáncer, y tratamiento intensivo en diabetes y probable aumento de mortalidad. Conclusiones: Lo que realmente importa en biomedicina es qué efectos provoca una estrategia dada en los pacientes reales, no en los puntos intermedios. Los clínicos no deberíamos apoyar resultados parciales de diseños basados en datos intermedios -indudablemente menos costosos y más rápidos- sin conocer adecuadamente la seguridad de la estrategia erigida para alcanzarlos. Sólo así nos constituimos en verdaderos garantes de la seguridad, sólo así, y en ausencia de conflictos de intereses, podremos mantener la confianza dada (AU)

Introduction: Randomised controlled trials (RCTs) are the gold standard in the western world for decision making, as much for the clinicians as for the agencies or managers for community policies. In this powerful deployment of investigative effort there are variable degrees of conflict of interests, and the clinicians, not foreign to this, are entering a sea of doubts on safety, a dimension that emerges like a diacritical, inalienable element. The aim of the study was to select and ctically evaluate editorials, clinical trials and/or meta-analyses published on physical support, or the more important internationally credited websites, which has patient safety as their primary objective. Patients and Methods: Evaluative study performed in the Torrecardenas Hospital, of the Andalucian Public Health Service (SSPA), in the context of an accredited training unit (Mejora_F), so called "transference of the biomedical knowledge from the bibliography" from 2008 to 2009. Results: Analyzed articles: 170 (75 % in English, with predominance of N Eng J Med >50 %; followed by Journal Of the American Medical Association, The Lancet, British Medical Journal, Journal of American Geriatrics; Med Clin, Rev Clin Esp.; and Infectología). From 170 eligible articles we selected 5 key topoi due to their impact as the most representative owing to their citation frequency. They represented, in our judgment, "a red flag" of safety: long-acting beta-stimulators or LABS and increase in mortality in asthma; neuroleptics in the elderly and extension of the QT interval associated with sudden death; thiazolidinediones in type II diabetes and negative cardiovascular effects; promotion of statins-ezetimibe and the debatable association with major mortality for cancer, and intensive treatment in diabetes and probable increase in mortality. Conclusions: What really maters in biomedicine is that it leads to a given strategy in real patients, not the intermediate points. Clinicians should not support partial results of designs based on intermediate information -undoubtedly less costly and more rapid- without adequately knowing the safety of the strategy built to reach them. Only in this way we can be real guarantors of safety, and only in this way, and in absence of conflicts of interests we will be able to support the given confidence (AU)

[Biomedical research, the market, clinicians, safety and corporate social responsibility post-phase III: maintaining confidence]. / La investigación biomédica, el mercado, los clínicos, la seguridad y la responsabilidad social corporativa posfase III: retener la confianza.

INTRODUCTION: Randomised controlled trials (RCTs) are the gold standard in the western world for decision making, as much for the clinicians as for the agencies or managers for community policies. In this powerful deployment of investigative effort there are variable degrees of conflict of interests, and the clinicians, not foreign to this, are entering a sea of doubts on safety, a dimension that emerges like a diacritical, inalienable element. The aim of the study was to select and ctically evaluate editorials, clinical trials and/or meta-analyses published on physical support, or the more important internationally credited websites, which has patient safety as their primary objective. PATIENTS AND METHODS: Evaluative study performed in the Torrecardenas Hospital, of the Andalucian Public Health Service (SSPA), in the context of an accredited training unit (Mejora_F), so called "transference of the biomedical knowledge from the bibliography" from 2008 to 2009. RESULTS: Analyzed articles: 170 (75 % in English, with predominance of N Eng J Med >50 %; followed by Journal Of the American Medical Association, The Lancet, British Medical Journal, Journal of American Geriatrics; Med Clin, Rev Clin Esp.; and Infectología). From 170 eligible articles we selected 5 key topoi due to their impact as the most representative owing to their citation frequency. They represented, in our judgment, "a red flag" of safety: long-acting beta-stimulators or LABS and increase in mortality in asthma; neuroleptics in the elderly and extension of the QT interval associated with sudden death; thiazolidinediones in type II diabetes and negative cardiovascular effects; promotion of statins-ezetimibe and the debatable association with major mortality for cancer, and intensive treatment in diabetes and probable increase in mortality. CONCLUSIONS: What really maters in biomedicine is that it leads to a given strategy in real patients, not the intermediate points. Clinicians should not support partial results of designs based on intermediate information - undoubtedly less costly and more rapid - without adequately knowing the safety of the strategy built to reach them. Only in this way we can be real guarantors of safety, and only in this way, and in absence of conflicts of interests we will be able to support the given confidence.

[Virus and systemic vasculitis]. / Virus y vasculitis sistémicas.

The participation of genetic and environmental factors has always been invoked in the pathogenesis of the autoimmune systemic diseases, including the primary vasculitides. Among the environmental factors, infections, fundamentally those having a viral nature, have always been focused on, especially after the discovery of the close existing relationship between the polyarteritis nodosa and the hepatitis B virus, on the one hand, and mixed cryoglobulinemia and the hepatitis C virus, on the other. The present review summarizes data from the most recent literature related to associations between virus infections and primary vasculitides, following the Chapel-Hill vasculitis classification.

Virus y vasculitis sistémicas / Virus and systemic vasculitis

En la patogenia de las enfermedades autoinmunes sistémicas, incluyendo las vasculitis, siempre se ha invocado la participación de factores genéticos y factores ambientales. Entre los ambientales, las infecciones, fundamentalmente de naturaleza vírica, han sido siempre un foco de atención, máxime tras el descubrimiento de la estrecha relación existente entre la poliarteritis nudosa y el virus de la hepatitis B, por una parte, y la crioglobulinemia mixta esencial y el virus de la hepatitis C, por otra. La presente revisión pretende actualizar los conocimientos recogidos en la literatura más reciente sobre el binomio virus y vasculitis sistémicas, siguiendo la clasificación de vasculitis de Chapel-Hill

The participation of genetic and environmental factors has always been invoked in the pathogenesis of the autoimmune systemic diseases, including the primary vasculitides. Among the environmental factors, infections, fundamentally those having a viral nature, have always been focused on, especially after the discovery of the close existing relationship between the polyarteritis nodosa and the hepatitis B virus, on the one hand, and mixed cryoglobulinemia and the hepatitis C virus, on the other. The present review summarizes data from the most recent literature related to associations between virus infections and primary vasculitides, following the Chapel-Hill vasculitis classification

Sobre la muerte real de pacientes ancianos terminales no oncológicos en un hospital general / Dying of non neoplasic palliative old patients in a general hospital

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