The transfer knowledge for the development of clinical guidelines informed on evidences

Este artículo comparte la experiencia del proceso de transferencia tecnológica (TT) realizada por el Instituto Nacional de Salud (INS) hacia los grupos clínicos multidisciplinarios de las diversas IPRESS y direcciones del Ministerio de Salud (MINSA), dentro del marco de desarrollo de guías de práctica clínica informadas en evidencia (GPC-IE). Presenta el contexto evolutivo de las GPC junto al rol que desarrolló el INS, tanto en el desarrollo de la normativa vigente como en su implementación. Expresa las situaciones propias de la operacionalización del proceso que no fueron contempladas inicialmente en la norma y los aportes realizados para su abordaje; como la variabilidad de las estrategias de priorización de temas a desarrollar, las características adicionales del grupo elaborador (GE) y grupo metodólogo (GM), la relevancia del grupo gestor, las estrategias pedagógicas empleadas para el manejo de los grupos clínicos, las precisiones adicionales que se realizaron en relación a la declaración de conflicto de interés (DCI) en pro de contribuir en la transparencia, y de fortalecer la TT asumida. Manifiesta las estrategias empleadas para la valoración de las perspectivas y preferencias de los pacientes. Finalmente expresa los resultados y los desafíos en la TT continua en el marco de GPC-IE.This article shares the experience of the technology transfer (TT) developed by the Peruvian National Institute of Health (INS) towards the multidisciplinary clinical groups of different IPRESS and managers of the Ministry of Health (MINSA), inside the framework of the development of guidelines for Clinical Practice-Informed in Evidence (GPC-IE). It presents the evolutionary context of the CPG together with the role assumed by the INS, in their development of current regulations and in their implementation. It expresses the inherent situation to operationalization of the process that were not initially contemplated in the guideline and the contributions made to afford it; as the variability of the prioritization strategies of topics to be developed, the additional characteristics of the development group (GE) and methodology group (GM), the relevance of the management group, the pedagogical strategies used for the management of the clinical groups, the additional precisions that were carried out in relation to the declaration of conflict of interest (DCI) in order to contribute to transparency, and to strengthen the assumed TT. It shows the strategies used to assess the perspectives and preferences of patients. Finally it expresses the results and the challenges in the continuous TT in the framework of GPC-IE

Histological assessment of nanostructured fibrin-agarose skin substitutes grafted in burnt patients. A time-course study

A previously developed fibrin-agarose skin model—UGRSKIN—showed promising clinical results in severely burnt patients. To determine the histological parameters associated to the biocompatibility and therapeutic effects of this model, we carried out a comprehensive structural and ultrastructural study of UGRSKIN grafted in severely burnt patients after 3 months of follow-up. The grafted epidermis was analogue to native human skin from day 30th onward, revealing well-structured strata with well-differentiated keratinocytes expressing CK5, CK8, CK10, claudin, plakoglobin, filaggrin, and involucrin in a similar way to controls, suggesting that the epidermis was able to mature and differentiate very early. Melanocytes and Langerhans cells were found from day 30th onward, together with a basement membrane, abundant hemidesmosomes and lack of rete ridges. At the dermal layer, we found an interface between the grafted skin and the host tissue at day 30th, which tended to disappear with time. The grafted superficial dermis showed a progressive increase in properly-oriented collagen fibers, elastic fibers and proteoglycans, including decorin, similarly to control dermis at day 60-90th of in vivo follow-up. Blood vessels determined by CD31 and SMA expression were more abundant in grafted skin than controls, whereas lymphatic vessels were more abundant at day 90th. These results contribute to shed light on the histological parameters associated to biocompatibility and therapeutic effect of the UGRSKIN model grafted in patients and demonstrate that the bioengineered skin grafted in patients is able to mature and differentiate very early at the epithelial level and after 60–90 days at the dermal level.Consejería de Salud y Familias, Junta de AndalucíaGrant/Award Numbers: PE- 0395-2019, PI-0458-2016Consejería de Transformación Económica, Industria,Conocimiento y Universidades, Grant/Award Number: B-CTS-450-UGR20Instituto de Salud Carlos III, Grant/Award Number: AC17/0001

Policies and interventions to reduce injuries due to traffic accidents: From evidence to practice

Este artículo presenta intervenciones para prevenir la mortalidad y lesiones por accidentes de tránsito (AT), desde la evidencia científica y perspectiva de los actores involucrados. Para ello se realizó una búsqueda sistemática, se organizó un resumen de políticas con participación de actores clave para finalmente realizar un dialogo deliberativo con representantes técnicos de las diversas instituciones relacionadas con el abordaje del problema propuesto. Describe las intervenciones relacionadas a educación, infraestructura vial, asistencia pre-hospitalaria, normatividad y fiscalización que fueron insumo para la contextualización a nuestro medio local. Los representantes técnicos multisectoriales aportaron consideraciones para su implementación, los potenciales beneficios o daños, el uso de recursos, adaptaciones necesarias, posibles barreras y facilitadores para su abordaje. Presenta el rol canalizador que desarrolló el Instituto Nacional de Salud para colaborar en la transferencia de la evidencia a la práctica. Asimismo, plantea necesidades de investigación, que requieren ser abordados en las intervenciones integrales de seguridad vial.This article presents interventions to prevent mortality and injuries from traffic accidents (TA), from the scientific evidence and perspective of the actors involved. For this purpose, a systematic search was carried out, a policy summary was organized with the participation of key actors to finally carry out a deliberative dialogue with technical representatives of the various institutions related to the approach of the proposed problem. Describe evidence-based interventions related to education, integral infrastructure, pre-hospital assistance, regulations and control that were deliberate and contextualized to our local environment. The multi-sector technical representatives contributed considerations for its implementation, the potential benefits or damages, the use of resources, necessary adaptations, possible barriers and facilitators for its approach. It presents the channeling role that National Institute of Health developed to collaborate in the transfer of evidence to practice. It also raises research needs, which need to be addressed in comprehensive road safety intervention

Successful development and clinical translation of a novel anterior lamellar artificial cornea

We thank the Andalusian Public Foundation Progress and Health, through the Andalusian Initiative for Advanced Therapies, for assuming the roles and responsibilities of sponsoring this clinical trial. We thank Dr. Manuel de la Rosa and Dr. Salvador Arias Santiago for providing insight and expertise that assisted the research.The datasets generated and/or analyzed during the current study are available in the Gene Expression Omnibus (GEO) public repository, ref. GSE86584 https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE86584Blindness due to corneal diseases is a common pathology affecting up to 23 million individuals worldwide. The tissue‐engineered anterior human cornea, which is currently being tested in a Phase I/II clinical trial to treat severe corneal trophic ulcers with preliminary good feasibility and safety results. This bioartificial cornea is based on a nanostructured fibrin–agarose biomaterial containing human allogeneic stromal keratocytes and cornea epithelial cells, mimicking the human native anterior cornea in terms of optical, mechanical, and biological behavior. This product is manufactured as a clinical‐grade tissue engineering product, fulfilling European requirements and regulations. The clinical translation process included several phases: an initial in vitro and in vivo preclinical research plan, including preclinical advice from the Spanish Medicines Agency followed by additional preclinical development, the adaptation of the biofabrication protocols to a good manufacturing practice manufacturing process, including all quality controls required, and the design of an advanced therapy clinical trial. The experimental development and successful translation of advanced therapy medicinal products for clinical application has to overcome many obstacles, especially when undertaken by academia or SMEs. We expect that our experience and research strategy may help future researchers to efficiently transfer their preclinical results into the clinical settings.This study was supported by the Spanish National Plan for Scientific and Technical Research and Innovation (I + D + I) from the Spanish Ministry of Economy and Competitiveness (Carlos III Institute of Health), grants FIS PI14/0955 and FIS PI17/0391 (both cofinanced by ERDF‐FEDER, European Union); by the Spanish Ministry of Health, Social Policy and Equity, grant EC10‐285; and by preclinical research funds from the Regional Ministry of Health through the Andalusian Initiative for Advanced Therapies

La mentoría en la Escuela Universitaria Politécnica de la Universidad de Sevilla

XVIII Congreso Universitario de Innovación Educativa en las Enseñanzas Técnicas. Escuela Técnica Superior de Ingenieros Industriales y de Telecomunicación. Universidad de Cantabria : Santander, 6 a 9 de julio de 2010Con el fin de integrar a los alumnos de nuevo ingreso, la Escuela Universitaria Politécnica de la Universidad de Sevilla ha puesto en marcha en el curso 2008-09 un Plan de Acción Tutorial (EUPAT) basado en una red en la que participan el profesorado tutor, alumnado mentor y alumnado tutorizado. En el presente trabajo se resumirá el proceso de formación del alumnado mentor y el trabajo desarrollado por el mismo dentro del Plan de Acción Tutorial. Así mismo, se analizarán las dificultades encontradas durante el transcurso de su formación y realización de la labor de mentoría y el nivel de satisfacción alcanzado. Finalmente, se hará una reflexión sobre las debilidades y los puntos de mejora que se pueden deducir del desarrollo hasta el momento de esta acción tutorialIn order to integrate new students, the Polytechnic School of the University of Seville has launched in the year 2008-09 an Tutorial Action Plan (EUPAT) based on a network involving teachers, mentor students and tutored students. In this paper we resume the formation of mentor students and work developed by the same within the Tutorial Action Plan. Also, analyzing the difficulties encountered during the course of their training and carrying out the work of mentoring and the satisfaction level achieved. Finally, we will reflect on the weaknesses and areas for improvement that can be deducted from the development until the time of this action tutorial

Protagonismo del mentor en una actividad tutorial de carácter multidisciplinar en Ingeniería

XIX Congreso Universitario de Innovación Educativa en las Enseñanzas Técnicas : Barcelona, 6 a 8 de julio de 2011En la Escuela Politécnica Superior (EPS) de la Universidad de Sevilla se ha trabajado, por tercer curso consecutivo, en un Plan de Acción Tutorial desarrollado por 16 profesores tutores y 20 alumnos mentores de 5 titulaciones de Ingeniería Técnica. El objetivo perseguido en este curso ha sido potenciar actividades que han surgido del propio albedrío de los alumnos mentores, lo que ha dado como resultado la realización de una serie de actividades de mentoría motivadas y dirigidas desde el principio por los alumnos mentores. La actividad conjunta de todos ellos ha llevado a organizar unos subgrupos de mentorías en función de determinadas características del alumnado de primer curso (deportistas, trabajadores, becarios de otras universidades…), a realizar reuniones presenciales de mentores para puesta a punto de estas actividades así como de puesta al día de los resultados que se iban consiguiendo, además de organizar una segunda captación de mentorizados tras las notas del primer cuatrimestre, y la protagonización de una Jornada de Mentoría al final del curso.A third edition with 16 tutorial lecturers and 20 tutorial students from five different degrees (Technical Engineering of the Polytechnical School, EPS, at University of Seville) in a Tutorial Plan development, has been prepared. During the present year, the main characteristic has been a serial of mentoring actions motivated and directed by these mentors. This activity has been organized considering several subgroups of mentoring depending on special characteristics in first year students (sportsplayers, workers, grant holders from other universities…), moreover the organization of a second recruiting of new students after the first term marks, updating meetings for mentors only, and to be main figures in a Congress on Mentoring at the end of the academic year

El abordaje temprano y tratamiento mixto en el manejo de la esquizofrenia

Introduction: Schizophrenia is a psychotic disorder characterized by substantive alteration of mental functioning and effects on the social functionality of affected individuals. Objective: Provide recommendations based on the best available evidence for early approach, pharmacological and psychosocial treatment. Methods: An Evidence-based Clinical Practice Guide (GPC-BE) was developed, adapted through a systematic, rigorous, transparent process, by a working group composed of methodologists and psychiatrists who are experts in the management of schizophrenia. The guide includes four clinical questions and recommendations, we searched for guides that respond to the prioritized topic, guides were pre-selected and evaluated using the “Appraisal of Guidelines for Research and Evaluation II” (AGREE-II) instrument, the one with the best methodological quality was chosen for adaptation. The systematic search for evidence for each clinical question was performed in multiple databases: MEDLINE / Ovid, EMBASE / Ovid, EMB reviews / Ovid. The selection and analysis of evidence was carried out using clinical pairs and methodologists, the recommendations were prepared using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Results: With the participation of the panel of clinical experts from institutes and hospitals in Peru in the management of schizophrenia, four recommendations were established for the early intervention, pharmacological and mixed treatment of adult patients with schizophrenia. Conclusions: The early approach of the first psychotic episode through community mental health centers (CSMC) and specialized hospitals and pharmacological treatment together with standardized psychosocial therapy is recommended. This article summarizes the evidence-based clinical practice guideline developed by a Peruvian public hospital specializing in mental health disorders.Introducción: La esquizofrenia es un trastorno psicótico caracterizado por alteración sustantiva del funcionamiento mental y efectos sobre la funcionalidad social de la persona afectada. Objetivo: Brindar recomendaciones basadas en la mejor evidencia disponible para abordaje temprano, tratamiento farmacológico y psicosocial. Métodos: Se elaboró una guía de práctica clínica basada en evidencias (GPC-BE), adaptada mediante proceso sistemático, riguroso, transparente, desarrollado por un grupo elaborador integrado por metodólogos y psiquiatras expertos en el manejo de esquizofrenia. La guía comprende cuatro preguntas clínicas y recomendaciones, se realizó búsqueda de guías que respondan al tema priorizado, se preseleccionaron y evaluaron guías mediante el instrumento “Appraisal of Guidelines for Research and Evaluation II” (AGREE-II), la de mejor calidad metodológica fue elegida para adaptación. La búsqueda sistemática de evidencias para cada pregunta clínica fue realizada en múltiples bases de datos: MEDLINE/Ovid, EMBASE/Ovid, EMB reviews/Ovid. La selección y análisis de evidencias se realizó mediante pares clínicos y metodológos, las recomendaciones fueron elaboradas aplicando metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Resultados: Con participación del panel de expertos clínicos de institutos y hospitales del Perú referentes en el manejo de esquizofrenia, se elaboraron cuatro recomendaciones para la intervención temprana, tratamiento farmacológico y mixto de pacientes adultos con esquizofrenia. Conclusiones: Se recomienda el abordaje temprano del primer episodio psicótico a través de centros de salud mental comunitarios (CSMC) y hospitales especializados y tratamiento farmacológico junto a terapia psicosocial estandarizada. El presente artículo resume la guía de práctica clínica basada en evidencias elaborada por un hospital público peruano especializado en salud mental

Markers of endothelial damage in patients with chronic kidney disease on hemodialysis

Patients with Stage 5 chronic kidney disease who are on hemodialysis (HD) remain in a chronic inflammatory state, characterized by the accumulation of uremic toxins that induce endothelial damage and cardiovascular disease (CVD). Our aim was to examine microvesicles (MVs), monocyte subpopulations, and angiopoietins (Ang) to identify prognostic markers in HD patients with or without diabetes mellitus (DM). A total of 160 prevalent HD patients from 10 centers across Spain were obtained from the Biobank of the Nephrology Renal Network (Madrid, Spain): 80 patients with DM and 80 patients without DM who were matched for clinical and demographic criteria. MVs from plasma and several monocyte subpopulations (CD142+/CD16+, CD14+/CD162+) were analyzed by flow cytometry, and the plasma concentrations of Ang1 and Ang2 were quantified by ELISA. Data on CVD were gathered over the 5.5 yr after these samples were obtained. MV level, monocyte subpopulations (CD14+/CD162+ and CD142+/CD16+), and Ang2-to-Ang1 ratios increased in HD patients with DM compared with non-DM patients. Moreover, MV level above the median (264 MVs/µl) was associated independently with greater mortality. MVs, monocyte subpopulations, and Ang2-to-Ang1 ratio can be used as predictors for CVD. In addition, MV level has a potential predictive value in the prevention of CVD in HD patients. These parameters undergo more extensive changes in patients with DM.Support for this work was provided by Plan Nacional de IDi Proyectos de Investigación en Salud of Instituto de Salud Carlos III (ISCIII)–Subdirección General de Evaluación, Fondos de desarrollo regional (FEDER; PI11/01536, PI12/01489, PI14/00806, PI15/01785); Junta de Andalucía grants (P010-CTS-6337, P11-CTS-7352); and Fundación Nefrológica. P. Buendía, A. Carmona, and C. Luna-Ruiz are fellows from Consejería de Innovacion, Ciencia y Empresa, Junta de Andalucía

Prevention and clinical management of pre-eclampsia and eclampsia: Evidence-based clinical practice guidelines from the national reference institute in maternal health of Peru

Introducción. En Perú, los trastornos hipertensivos del embarazo son la segunda causa de mortalidad materna. Objetivo. La presente guía de práctica clínica basada en evidencias (GPC-BE) brinda recomendaciones para la prevención y tratamiento de la pre-eclampsia y eclampsia. Métodos. Se elaboró una GPC-BE adaptada mediante un proceso sistemático, riguroso y transparente con un grupo elaborador conformado por metodólogos y profesionales de la salud expertos en el manejo de la enfermedad. La guía cuenta con dieciséis preguntas clínicas y dieciséis recomendaciones. Se realizó la búsqueda y preselección de GPC, las mismas que fueron evaluadas mediante el instrumento “Appraisal of Guidelines for Research and Evaluation II” (AGREEII), para su adaptación. La búsqueda sistemática de evidencias para responder las preguntas clínicas se realizó en múltiples bases de datos: MEDLINE/PubMed, EMBASE/Ovid, Cochrane Library, LILACS y SciELO. Las evidencias fueron seleccionadas y analizadas críticamente por pares clínicos y metodológicos; las recomendaciones fueron elaboradas mediante la metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Resultados. Con la participación de un panel de expertos clínicos del Instituto Nacional Materno Perinatal, redes de salud y otras instituciones de referencia, se elaboraron 16 recomendaciones dirigidas a la prevención y tratamiento de mujeres gestantes en riesgo de pre-eclampsia, gestantes con pre-eclampsia, eclampsia o enfermedad hipertensiva. Conclusiones. Este artículo resume la guía de práctica clínica basada en evidencias para la prevención y tratamiento de pre-eclampsia y eclampsia en gestantes en el instituto de referencia nacional en salud materna y neonatal del Perú.Introduction. In Peru, hypertensive disorders of pregnancy are the second cause of maternal mortality. Objective. This evidence-based clinical practice guideline (EB-CPG) provides recommendations for the prevention and treatment of pre-eclampsia and eclampsia. Methods. An adapted EB-CPG was elaborated through a systematic, rigorous and transparent process with a group consisting of methodologists and health professionals who are experts in the management of the disease. The guide has sixteen clinical questions and sixteen recommendations. The search and pre-selection of EB-CPGs were performed, which were evaluated through the “Appraisal of Guidelines for Research and Evaluation II” tool (AGREE-II), for its adaptation. The systematic search for evidence to answer the 16 clinical questions were made in multiple databases: MEDLINE / PubMed, EMBASE / Ovid, Cochrane Library, LILACS and SciELO. Evidences were selected and analyzed critically by clinicians and methodologists in pairs, recommendations were elaborated through the Grading of Recommendations Assessment, Development, and Evaluation methodology (GRADE). Results. With the participation of a panel of clinical experts from the National Perinatal Maternal Institute, representatives from health care networks and other reference institutions, 16 recommendations were established for the prevention and treatment of pregnant women at risk of pre-eclampsia, for pregnant women with pre-eclampsia, eclampsia or hypertensive disease. Conclusions. This article summarizes the evidence-based clinical practice guidelines for the prevention and treatment of preeclampsia and eclampsia in peruvian pregnant women for the national reference institute for maternal and neonatal health of Peru

Practical guideline for Benign paroxismal positional vertigo

Introduction and objective: Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vertigo, characterized by brief attacks of rotatory vertigo associated with nystagmus, which are elicited by specific changes in head position relative to gravity. The observation of positional nystagmus is essential for the diagnosis of BPPV. The treatment consists in maneuvers of canalith repositioning procedure to move otoconial debris from the affected semicircular canal to the utricle. These guidelines are intended for all who treat the BPPV in their work, with an intention to assist in the diagnosis and application of an appropriate therapeutic method. Method: The experience and analysis of different national and international consensus on BPPV, has allowed to a large group of ENT specialists of the Communities of Castilla y León, Cantabria and La Rioja (Spain), carry out this guide. Results: The different clinical entities are reviewed. BPPV of the posterior semicircular canal, horizontal canal and anterior canal, BPPV affecting several canals, atypical and central BPPV, subjective BPPV and the characteristics of this process in the elderly. Canalith repositioning procedures have been illustrated with explanatory drawings. Discussion and conclusions: Although the pathophysiology of BPPV is canalolithiasis comprising free-floating otoconial debris within the endolymph of a semicircular canal, or cupulolithiasis comprising otoconial debris adherent to the cupula, there are still many issues to be resolved. We think that the best way to find answers is part of using a common methodology in the diagnosis and treatment of these patients.Introducción y Objetivo: El vértigo periférico más frecuente es el Vértigo Posicional Paroxístico Benigno (VPPB), caracterizado por bruscos ataques de sensación rotatoria, que aparecen como consecuencia de determinados cambios en la posición de la cabeza con relación a la gravedad. La observación del nistagmo posicional es fundamental para el diagnóstico de VPPB. El tratamiento consiste en aplicar maniobras de reposición, para intentar trasladar los restos otoconiales libres, desde el conducto semicircular (CS) afectado hasta el utrículo. Esta guía, está orientada para quienes tratan el VPPB, con la intención práctica de ayudarles en el diagnóstico y tratamiento de esta enfermedad. Método: La experiencia y el análisis de diferentes acuerdos nacionales e internacionales sobre el VPPB, han permitido a un amplio grupo de especialistas ORL de las Comunidades de Castilla y León, Cantabria y La Rioja (España), llevar a cabo esta guía. Resultados: Se revisan las diferentes entidades clínicas. VPPB del conducto semicircular posterior (CSP), horizontal (CSA) y anterior (CSA), incluyéndose también el VPPB multicanal, VPPB atípico y central, VPPB subjetivo y las características de este proceso en el anciano. Las maniobras de reposición se han ilustrado con dibujos explicativos. Discusión y conclusiones: Aunque la fisiopatología del VPPB se explica por la presencia de restos otoconiales libres en la endolinfa de uno o varios conductos semicirculares (canalitiasis) y en algunos casos por su adherencia a la cúpula del CS (cupulolitiasis), aún quedan muchas cuestiones por resolver. Pero creemos que la mejor manera de encontrar respuestas parte de utilizar una metodología común en el diagnóstico y tratamiento de estos pacientes