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CoordinadoresSantiago Prieto Menchero

Daniel Pineda Tenor

Asociación Española de Biopatología MédicaMedicina de Laboratorio

Comité de Calidad, Gestión, Seguridad y Evidencia

Edición

2018



Índice

Autores 9

Comité de Calidad, Gestión, Seguridad y Evidencia 11

Información del Proyecto 23 Pares 13

Relación de Documentos del Proyecto 23 Pares 15

Par 1. Metrología y CalidadPar 2. Homeostasis (AB/Hidroelectrolítico)/renal Par 3. EndocrinoPar 4. ObstetriciaPar 5. FertilidadPar 6. PediatríaPar 7. CardiologíaPar 8. DigestivoPar 9. Hematimetría y Patología HematológicaPar 10. HemostasiaPar 11. Genética y Medicina PersonalizadaPar 12. Inmunología/Reumatología/AlergiaPar 13. Serología y Test Rápidos MicrobiológicosPar 14. POCTPar 15. OncologíaPar 16. TrasplantePar 17. UrgenciasPar 18. TDM/ToxicologíaPar 19. Informe Clínico del LaboratorioPar 20. Consultoría, Preanalítica y Pruebas FuncionalesPar 21. Atención Primaria y ProgramasPar 22. Estadística e InvestigaciónPar 23. Gestión

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CoordinadoresDr. Santiago Prieto Menchero

Dr. Daniel Pineda TenorAutores

Dr. Daniel Pineda TenorDr. Santiago Prieto MencheroDra. Carmen Lorenzo Lozano

Dra. María Elena Redín SarasolaDr. Félix Gascón Luna

Dr. Enrique Prada de Medio Dra. Ana Cosmen SánchezDra. Laura Criado Gómez

Dr. Alfonso Luís Blázquez ManzaneraDr. Daniel Al Kassam Martínez

Dra. María Mercedes Calero RuízDr. Francisco Cañizares Hernández



Panel de Expertos


PresidenteDr. Daniel Pineda Tenor

VicepresidenteDr. Santiago Prieto Menchero

VocalesDr. Félix Gascón Luna

Dra. Ana Cosmen SánchezDra. Carmen Lorenzo Lozano

Dra. Mª Ángeles Cuadrado CenzualDr. Pedro María Belinchón Torres

Dr. Enrique Prada de MedioDra. Raquel Blazquez Sánchez

Dr. Alfonso Luís Blázquez ManzaneraDra. María Elena Redín Sarasola

Dra. Laura Criado Gómez


Es una iniciativa surgida en el seno del

cuyos integrantes se relacionan a continuación:



InformaciónEl conocimiento que se integra en el laboratorio clínico es muyextenso y se halla en continua evolución, por lo que elaprendizaje y actualización continua constituye una necesidad.

Son pares porque para cada tema se plantea que se elija un Documento de referencia,que representa evidencia contrastada, y un Documento específico, que representa unenfoque particular, innovador o novedoso sobre el mismo tema.

¿Quién lidera el proyecto? El Comité de Calidad, Gestión, Seguridad y Evidencia de laAEBM-MLhttps://aebm.org/comites-main/comite-de-calidad-gestion-seguridad-y-evidencia.html

¿Quién elige los documentos? Pueden ser propuestos por cualquier miembro desociedad científica adscrito al protocolo de actuación conjunta (https://aebm.org/noticias/de-la-asociacion/618-protocolo-de-actuacion-conjunta-aebm-ml-y-aefa.html), en el momentoactual AEBM-ML y AEFA

¿Cómo participar? A través del enlace que se habilitará en la página web de la AEBM-MLen el momento en el que se oferta el proyecto.

Necesitamos tus datos, un breve comentario de porqué propones el documento y un link alartículo en cuestión. Tu aportación y comentario se incluirán en el documento final.

¿Para qué sirve? Representa una valoración global del conocimiento en Medicina deLaboratorio en el momento actual, tanto desde la evidencia como desde nuevasperspectivasRepresenta una guía para los nuevos residentes, para aquellos que están preparando unaoposición o simplemente para profesionales que quieren explorar áreas del laboratorio quehabitualmente no trabajan.

La AEBM-ML propone un proyecto con vocación anual en el que se recojan 23 pares deartículos, que cubran las necesidades de conocimiento del profesional desde unaperspectiva completa: el ADN del especialista del laboratorio

https://aebm.org/comites-main/comite-de-calidad-gestion-seguridad-y-evidencia.html

https://aebm.org/noticias/de-la-asociacion/618-protocolo-de-actuacion-conjunta-aebm-ml-y-aefa.html

Clin Chem Lab Med 2015; 53(6): 833–835

Defining analytical performance specifications: ConsensusStatement from the 1st Strategic Conference of the European

Federation of Clinical Chemistry and Laboratory Medicine

En Noviembre de 2014, se celebró en Milán la primera Conferencia Estratégica de laEuropean Federation of Clinical Chemistry and Laboratory Medicine (EFLM) sobre“Definición de Objetivos de Rendimiento Analítico, 15 años después de la Conferenciade Estocolmo sobre Especificaciones de Calidad en el Laboratorio Clínico”.En esta trascendental reunión se realizó una profunda revisión y reclasificación de lostradicionales niveles de especificaciones de la calidad analítica consensuados desde1999 tras la Conferencia de Estocolmo. La jerarquía original compuesta de 5 niveles:• Nivel 1. Basado en la evaluación de los efectos de las prestaciones analíticas en

los resultados clínicos obtenidos bajo situaciones clínicas concretas.

• Nivel 2. Basado en las prestaciones basadas en decisiones clínicas generales.

• Nivel 3. Recomendaciones de grupos profesionales.• Nivel 4. Recomendaciones de entidades legislativas o organizadores de

programas de evaluación externa de la calidad• Nivel 5. Basado en el estado del arte.

Se simplificó por un modelo más adaptado a la situación real de los laboratoriosclínicos donde los niveles 1 y 2 se mantenían prácticamente intactos y el tercer nivelagrupaba los antiguos tercer, cuarto y quinto:• Nivel 1. Basado en la evaluación de los efectos de las prestaciones analíticas en

los resultados clínicos obtenidos bajo situaciones clínicas concretas.

• Nivel 2. Basado en los componentes de la variabilidad biológica del mensurando.

• Nivel 3. Basado en el estado del arte..

Resumen

ComentarioSe presenta esta referencia que desarrolla en profundidad y aclara el porqué de estecambio en la tradicional pirámide jerárquica de establecimiento de especificaciones decalidad analítica

Enlacehttps://www.eflm.eu/files/efcc/3.5%20CCLM-Consensus%20Statement.pdf

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Metrología y Calidad



1ParReferenciaAcceso: libre

https://www.eflm.eu/files/efcc/3.5%20CCLM-Consensus%20Statement.pdf

Clinical Chemistry 62:7 (2016) 959–965

Selecting Statistical Procedures for Quality Control Planning Based on Risk Management

Background: According to the traditional approach to statistical QC planning, the performanceof QC procedures is assessed in terms of its probability of rejecting an analytical run thatcontains critical size errors (PEDC).Recently, the maximum expected increase in the number of unacceptable patient resultsreported during the presence of an undetected out-of-control error condition[Max E(NUF)], has been proposed as an alternative QC performance measure because it ismore related to the current introduction of risk management concepts for QC planning in theclinical laboratory.Methods: We used a statistical model to investigate the relationship between PEDC and MaxE(NUF) for simple QCprocedures widely used in clinical laboratories and to construct chartsrelating Max E(NUF) with the capability of the analytical process that allow for QC planningbased on the risk of harm to a patient due to the report of erroneous results.Results: A QC procedure shows nearly the same Max E(NUF) value when used for controllinganalytical processes with the same capability, and there is a close relationship between PEDCand Max E(NUF) for simple QC procedures; therefore, the value of PEDC can be estimatedfrom the value of Max E(NUF) and vice versa. QC procedures selected by their high PEDCvalue are also characterized by a low value for Max E(NUF).Conclusions: The PEDC value can be used for estimating the probability of patient harm,allowing for the selection of appropriate QC procedures in QC planning based on riskmanagement.

Abstract

Este documento enlaza la planificación del control de calidad interno con la gestión de riesgomediante una metodología novedosa.Investigan la relación entre PEDC (Probabilidad de detección de errores críticos) y Max E(NUF) (máximo aumento esperado en el número de resultados inaceptables de pacientesinformados durante la presencia de una condición fuera de control no detectada). Cadaprocedimiento de CC tiene sus propios valores de Máx E (NUF) y PEDC cuando se usa paracontrolar un proceso analítico con un valor sigma dado y existe una estrecha relación entrePEDC y Max E (NUF) para procedimientos de control de calidad simples aplicados enlaboratorios clínicos, lo que permite el uso de PEDC para estimar la probabilidad de daño alpaciente.

Enlacehttps://www.ncbi.nlm.nih.gov/pubmed/27197677



1Par

Comentario

Metrología y Calidad

EspecíficoAcceso: suscripción

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https://www.ncbi.nlm.nih.gov/pubmed/27197677

Laboratory Hematology 9(2):58-63

ISLH recommended reference procedure for theenumeration of particles in urine

Abstract

Comentario

Enlacehttps://www.researchgate.net/publication/10689879_ISLH_recommended_reference_procedure_for_the_enumeration_of_particles_in_urine

Homeostasis (AB/HidroelectrolíMco)/renal




Automated systems for counting urine particles are now being developed and marketed. Areference measurement procedure must be developed to determine the accuracy and validity ofthese systems and to provide means for instrument calibration. A task force of the InternationalSociety of Laboratory Hematology (ISLH) has proposed such a procedure for the enumerationof erythrocytes, leukocytes, hyaline casts, and squamous epithelial cells in urine. The proposedstandard can be extended to include other urine particles such as the smaller epithelial cellsand granular or cellular casts when there is consensus on the morphological description ofthese entities. The ISLH Task Force standard is based on ISO/DIS (International Organizationfor Standardization) draft international standard 78-2, with special consideration given to therequirements for biological materials and for reference measurement procedures, the currentmodel being based on the structures being developed by CEN/TC (European StandardisationCommittee, Technical Committee on Health Care Informatics) 140 prEN 12286 and ISO/CD(ISO committee draft) 15193, with reference to ISO/CD 15195. Where relevant the terms anddefinitions are those provided in the International Vocabulary of Basic and General Terms inMetrology (VIM) [1].The proposed standard draws heavily on previously published guidelines such as the FinnishRecommendations from the Working Group on Clean Midstream Specimens [2], the NCCLSUrinalysis and Collection, Transportation and Preservation of Urine Specimens (NCCLSDocument GP16-A) [3], JCCLS (Japanese Committee for Clinical Laboratory StandardsGuideline) GP1-P2 [4], and the ECLM (European Confederation of Laboratory Medicine)European Urinalysis Guidelines [5]. The importance of preanalytical specimen information isusually underestimated, and this information is generally not documented. This information isrelevant and must be included in the procedure

Este documento es referencia en urianálisis en cuanto a recomendaciones y estandarizacióndel recuento de elementos formes al microscopio. Debe utilizarse como método de referenciacuando validamos cualquier procedimiento de medida en el estudio del sedimento urinario ennuestros laboratorios, para garantizar exactitud y reproducibilidad de los resultados informadosen nuestra actividad diaria. En él se describen los errores a tener en cuenta y requerimientosen el procedimiento de medida. Como especial relevancia cabe destacar que en susrecomendaciones, no sólo se centra en el procedimiento analítico, si no que abordaespecificaciones de la fase preanalítica en la muestra de orina a estudiar.

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https://www.researchgate.net/publication/10689879_ISLH_recommended_reference_procedure_for_the_enumeration_of_particles_in_urine

J Clin Pathol. 2017 Feb;70(2):94-101

Validation and verification of automated urine particle analysers

There is often uncertainty on how validation and verification of newly introduced testsshould be conducted, and there is a real risk of verification becoming a meaninglessritual, rather than a useful exercise. This article reviews the literature and makesrecommendations regarding the validation and verification of automated urine particlesanalysers. A generic practical approach to verification is also recommended. For manyanalysers, the accuracy of white blood cells, epithelial cells and bacterial counts iscorroborated by a number of independent evaluations; thus, any verification laboratorywork could be significantly scaled down. Conversely, in the scenario that automatedurine microscopy is used as a screening test to reduce the number of urines cultured,the extremely variable performance reported in the literature requires a full-scaleverification to define the optimal cut-off values that give a sensitivity of >98% with thelocal settings and circumstances. With some analysers, the risk of carry-over alsoneeds to be assessed, as part of the verification process, and exclusion criteria (urinesrequiring culture regardless of the microscopy results) need to be well defined, as thereare patients or specimen types for which the performance of microscopy as a screeningtest may not be adequate

Abstract

Enlacehttps://jcp.bmj.com/content/70/2/94.long



2Par

Comentario


Homeostasis (AB/Hidroelectrolítico)/renal

En este artículo de revisión se repasan los requerimientos de verificación que se deben llevara cabo al incorporar en el laboratorio analizadores que realizan el recuento de elementosformes en orina. Tiene en cuenta aspectos como qué muestras procesar en función delprotocolo a implementar, puntos de corte establecidos y los requerimientos de la norma ISO15189 y cómo llevarlo a la práctica real. También presenta resultados de validaciónmetodológica publicados por los diferentes fabricantes de analizadores automáticos delsedimento urinario.La verificación de un método debe contemplar la comparación con el método utilizadoanteriormente en el laboratorio para identificar diferencias y resultados dispares a resolver,pero no debe ser un trabajo tedioso. En general la validación metodológica la realiza elfabricante al incorporar esa tecnología en el mercado y en los laboratorios clínicos haremosuna verificación para incorporarlo en nuestra práctica asistencial. En esta revisión se presentaun algoritmo para orientar sobre el procedimiento de verificación a llevar a cabo en función dela información que tengamos disponible.

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https://jcp.bmj.com/content/70/2/94.long

Diabetes Care 2019 Jan; 42(Supplement 1): S13-S28.

Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2019. American Diabetes Association

The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes”includes ADA's current clinical practice recommendations and is intended to provide thecomponents of diabetes care, general treatment goals and guidelines, and tools toevaluate quality of care. Members of the ADA Professional Practice Committee, amultidisciplinary expert committee, are responsible for updating the Standards of Careannually, or more frequently as warranted. For a detailed description of ADA standards,statements, and reports, as well as the evidence-grading system for ADA's clinicalpractice recommendations, please refer to the Standards of Care Introduction. Readerswho wish to comment on the Standards of Care are invited to do so atprofessional.diabetes.org/SOC.

Abstract

ComentarioLa Asociación Americana de Diabetes publica anualmente en Enero un númeromonográfico donde recopila el conocimiento en la materia actualizado.Su lectura se hace casi obligada a todos los profesionales que trabajen en este áreapara mantenerse al día del conocimiento y de los cambios.Todo el monográfico es de acceso libre y cubre diversas áreas. Se ha seleccionado el capítulo 2 de clasificación de la diabetes como más representativo.

Enlacehttp://care.diabetesjournals.org/content/42/Supplement_1/S13

Medicina de Laboratorio y Endocrinología




20

http://care.diabetesjournals.org/lookup/doi/10.2337/dc19-sppc01

http://care.diabetesjournals.org/lookup/doi/10.2337/dc19-sint01

http://professional.diabetes.org/SOC

http://care.diabetesjournals.org/content/42/Supplement_1/S13

Lancet Diabetes Endocrinol. 2018 May;6(5):361-369.

Novel subgroups of adult-onset diabetes and their association with outcomes: a data-driven cluster analysis of six variables

Diabetes is presently classified into two main forms, type 1 and type 2 diabetes, buttype 2 diabetes in particular is highly heterogeneous. A refined classification couldprovide a powerful tool to individualise treatment regimens and identify individuals withincreased risk of complications at diagnosis.Methods: We did data-driven cluster analysis (k-means and hierarchical clustering) inpatients with newly diagnosed diabetes (n=8980) from the Swedish All New Diabetics inScania cohort. Clusters were based on six variables (glutamate decarboxylaseantibodies, age at diagnosis, BMI, HbA1c, and homoeostatic model assessment 2estimates of β-cell function and insulin resistance), and were related to prospective datafrom patient records on development of complications and prescription of medication.Findings: We identified five replicable clusters of patients with diabetes, which hadsignificantly different patient characteristics and risk of diabetic complications. Inparticular, individuals in cluster 3 (most resistant to insulin) had significantly higher riskof diabetic kidney disease than individuals in clusters 4 and 5, but had been prescribedsimilar diabetes treatment. Cluster 2 (insulin deficient) had the highest risk ofretinopathy. In support of the clustering, genetic associations in the clusters differedfrom those seen in traditional type 2 diabetes.Interpretation: We stratified patients into five subgroups with differing diseaseprogression and risk of diabetic complications. This new substratification mighteventually help to tailor and target early treatment to patients who would benefit most,thereby representing a first step towards precision medicine in diabetes

Abstract

Se trata de una revisión de un amplio grupo de pacientes que a través de seisvariables pueden ser reclasificados y asignados a grupos con distintas característicasde riesgo de progresión y complicaciones. ¿Un nuevo enfoque para personalizar ladiabetes?. Es un enfoque novedoso que merece la pena conocer y sobre el quedeberíamos reflexionar.

Enlacehttps://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext

Medicina de Laboratorio y Endocrinología



3Par

Comentario


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https://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30051-2/fulltext

Obstet Gynecol Clin North Am. 2017 June ; 44(2): 245–256. doi:10.1016/j.ogc.2017.02.004.

Prenatal Diagnosis: Screening and Diagnostic Tools

Approximately 3% to 5% of pregnancies are complicated by birth defects or geneticdisorders.Chromosomal abnormalities are present in approximately 1 in 150 livebirths, and congenital malformations remain the leading cause of infant death and aleading cause of childhood death. These chromosomal abnormalities include aneuploidy(defined as having one or more extra or missing chromosomes), translocations,duplications, and deletions.The most common chromosomal disorder is trisomy 21 (Down syndrome), with anincidence of 1 per 800 live births. Trisomy 13 and 18 can also result in live births,though with a significantly lower incidence.2,4Sex chromosome aneuploidies are lesscommon than autosomal aneuploidies. The only known viable monosomy is monosomyX (Turner syndrome).Other factors also influence patients’ risk in any given pregnancy, including thepresence of birth defects or soft markers on ultrasound and past obstetric history,particularly if it is notable for a prior pregnancy affected by aneuploidy or anothergenetic disorder. A past family history of aneuploidy increases current pregnancy risk ofaneuploidy, especially if a parent is a balanced robertsonian translocation carrier,though most cases are sporadic and secondary to chromosomal nondisjunction.

Abstract

Comentario

EnlacehGps://www.ncbi.nlm.nih.gov/pmc/arLcles/PMC5548328/pdf/nihms889485.pdf

Obstetricia




Se realiza una descripción actualizada de las diferentes estrategias de cribado y lasherramientas disponibles para realizar el diagnóstico prenatal, incluyendo lasestrategias bioquímicas empleadas en primer y segundo trimestre, así como técnicasinvasivas, evaluación de DNA fetal y análisis citogenéticos.

22

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548328/


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548328/pdf/nihms889485.pdf

Obstet Med. 2016 Dec; 9(4): 148–152

Noninvasive prenatal testing for aneuploidy using cell-free DNA – New implications for maternal health

The rapid global uptake of noninvasive prenatal testing for Down syndrome based onmaternal plasma cell-free DNA has provided new data on the interrelationship betweencell-free DNA and maternal health. Specific maternal conditions that can affect theperformance of noninvasive prenatal testing include obesity, active autoimmune diseaseand low molecular weight heparin treatment. There is also a growing appreciation of theimplications of discordant noninvasive prenatal testing results for maternal health,including unexpected diagnoses of maternal chromosomal conditions, or rarely, occultcancer. The interrelatedness of noninvasive prenatal testing and maternal health meanthat the longstanding principles underpinning prenatal screening – voluntary testing,informed decision making, availability of specialist genetic counselling and well-definedclinical pathways – are more important than ever before

Abstract

La reproducción asistida es una práctica ampliamente extendida en nuestro ámbitoprofesional, con un gran auge desde sus inicios hasta nuestros días.La etiología es multifactorial, adquiriendo una relevancia importante los factoresinmunológicos y genéticos asociados. Debido a la falta de homogeneidad de criteriosen estas materias, se creó un grupo de expertos pertenecientes a diferentessociedades científicas reconocidas y con experiencia en el campo de la reproducciónasistida, para establecer unas recomendaciones sobre una base científica sólida.Es un artículo muy interesante y descriptivo de la situación actual sobre las pruebasinmunológicas y genéticas disponibles para parejas que acuden a estas técnicasreproductivas.




4Par

Comentario

EspecíficoAcceso: libre

Obstetricia

23



Hum Reprod Update. 2010 May-Jun;16(3):231-45

World Health Organization reference values for human semen characteristics

Semen quality is taken as a surrogate measure of male fecundity in clinical andrology, malefertility, reproductive toxicology, epidemiology and pregnancy risk assessments. Referenceintervals for values of semen parameters from a fertile population could provide data from whichprognosis of fertility or diagnosis of infertility can be extrapolated. Semen samples from over4500 men in 14 countries on four continents were obtained from retrospective and prospectiveanalyses on fertile men, men of unknown fertility status and men selected as normozoospermic.Men whose partners had a time-topregnancy (TTP) of 12 months were chosen as individuals toprovide reference distributions for semen parameters. Distributions were also generated for apopulation assumed to represent the general population. The following one-sided lowerreference limits, the fifth centiles (with 95th percent confidence intervals), were generated frommen whose partners had TTP 12 months: semen volume, 1.5 ml (1.4–1.7); total sperm number,39 million per ejaculate (33–46); sperm concentration, 15 million per ml (12 –16); vitality, 58%live (55 –63); progressive motility, 32% (31 –34); total (progressive þ nonprogressive) motility,40% (38 –42); morphologically normal forms, 4.0% (3.0 –4.0). Semen quality of the referencepopulation was superior to that of the men from the general population and normozoospermicmen. conclusions: The data represent sound reference distributions of semen characteristics offertile men in a number of countries. They provide an appropriate tool in conjunction with clinicaldata to evaluate a patient’s semen quality and prospects for fertility.

Abstract

Comentario


Fertilidad




La necesidad de estandarizar o sistematizar los procedimientos asociados al análisis delsemen para el estudio de fertilidad, ha llevado a la Organización Mundial de la Salud (OMS) ala publicación de sucesivas ediciones del manual: Manual para el Examen del Semen Humanoy la Interacción Moco Semen, los cuales han servido de guía para los laboratorios deandrología. En el año 2010 la OMS presentó la última edición y la que continúa vigente “WorldHealth Organization reference values for human semen characteristics”. La principaldiferencia con las ediciones anteriores es que los valores han sido obtenidos de varones cuyapareja ha logrado embarazo en los últimos 12 meses, por lo que son considerados fértiles. Secambia el concepto “valor de referencia” por el de “límite de referencia inferior”. Documento dereferencia para todos los laboratorios clínicos que realicen estudios de fertilidad.

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Medicina Clínica. 2018 Aug; 151: e19–e24

Recomendaciones para el estudio genético e inmunológico en la disfunción reproductiva

Varios miembros de diferentes asociaciones científicas y expertos de la reproducciónhan actualizado las recomendaciones de estudio genético e inmunológico en lasparejas con disfunción en la reproducción con el fin de mejorar la asistencia sanitaria.El estudio se ha considerado altamente recomendable cuando la prueba diagnóstica esrelevante para la toma de decisiones, moderada cuando esta ha mostrado un resultadopoco consistente y baja, cuando el beneficio de la prueba es incierto. Con la indicaciónde estas recomendaciones obtendremos una información relevante para el diagnóstico,pronóstico y tratamiento de la pareja con disfunción en la reproducción.

Resumen

La reproducción asistida es una práctica ampliamente extendida en nuestro ámbitoprofesional, con un gran auge desde sus inicios hasta nuestros días.La etiología es multifactorial, adquiriendo una relevancia importante los factoresinmunológicos y genéticos asociados. Debido a la falta de homogeneidad de criteriosen estas materias, se creó un grupo de expertos pertenecientes a diferentessociedades científicas reconocidas y con experiencia en el campo de la reproducciónasistida, para establecer unas recomendaciones sobre una base científica sólida.Es un artículo muy interesante y descriptivo de la situación actual sobre las pruebasinmunológicas y genéticas disponibles para parejas que acuden a estas técnicasreproductivas.

Enlacehttp://www.elsevier.es/es-revista-medicina-clinica-2-avance-resumen-recomendaciones-el-estudio-genetico-e-S0025775318301477



5Par

Comentario


FerIlidad

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http://www.elsevier.es/es-revista-medicina-clinica-2-avance-resumen-recomendaciones-el-estudio-genetico-e-S0025775318301477

J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):136-60

European Society for Pediatric Gastroenterology, Hepatology, and Nutrition Guidelines for the Diagnosis of Coeliac Disease

Objective: Diagnostic criteria for coeliac disease (CD) from the European Society for PaediatricGastroenterology, Hepatology, and Nutrition (ESPGHAN) were published in 1990. Since then,the autoantigen in CD, tissue transglutaminase, has been identified; the perception of CD haschanged from that of a rather uncommon enteropathy to a common multiorgan disease stronglydependent on the haplotypes human leukocyte antigen (HLA)-DQ2 and HLA-DQ8; and CD-specific antibody tests have improved.Methods: A panel of 17 experts defined CD and developed new diagnostic criteria based onthe Delphi process. Two groups of patients were defined with different diagnostic approaches todiagnose CD: children with symptoms suggestive of CD (group 1) and asymptomatic children atincreased risk for CD (group 2). The 2004 National Institutes of Health/Agency for HealthcareResearch and Quality report and a systematic literature search on antibody tests for CD inpaediatric patients covering the years 2004 to 2009 was the basis for the evidence-basedrecommendations on CD-specific antibody testing.Results: In group 1, the diagnosis of CD is based on symptoms, positive serology, andhistology that is consistent with CD. If immunoglobulin A anti-tissue transglutaminase type 2antibody titers are high (>10 times the upper limit of normal), then the option is to diagnose CDwithout duodenal biopsies by applying a strict protocol with further laboratory tests. In group 2,the diagnosis of CD is based on positive serology and histology. HLA-DQ2 and HLA-DQ8testing is valuable because CD is unlikely if both haplotypes are negative.Conclusions: The aim of the new guidelines was to achieve a high diagnostic accuracy and toreduce the burden for patients and their families. The performance of these guidelines in clinicalpractice should be evaluated prospectively.

Abstract

Comentario

Enlaceh?ps://journals.lww.com/jpgn/Fulltext/2012/01000/European_Society_for_Pediatric_Gastroenterology,.28.aspx

Pediatría




El grupo de trabajo responsable de la elaboración de las “Guidelines from the EuropeanSociety for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN)” ha realizadouna revisión y actualización de los criterios diagnósticos de la enfermedad celiaca, incluyendolos nuevos test de anticuerpos específicos (especial relevancia para anti transglutaminasa tipo2, antiendomisio y antigliadina deaminada) y susceptibilidad basada en haplotipos HLA (DQ2 yDQ8)

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https://journals.lww.com/jpgn/Fulltext/2012/01000/European_Society_for_Pediatric_Gastroenterology,.28.aspx

Nucleic Acids Research, 2018, Vol. 46, Database issue

PedAM: a database for Pediatric Disease Annotationand Medicine

There is a significant number of children around the world suffering from theconsequence of the misdiagnosis and ineffective treatment for various diseases.To facilitate the precision medicine in pediatrics, a database namely the PediatricDisease Annotations & Medicines (PedAM) has been built to standardize and classifypediatric diseases. The PedAM integrates both biomedical resources and clinical datafrom Electronic Medical Records to support the development of computational tools, bywhich enables robust data analysis and integration. It also uses disease-manifestation(D-M) integrated from existing biomedical ontologies as prior knowledge toautomatically recognize text-mined, D-M-specific syntactic patterns from 774 514 full-text articles and 8 848 796 abstracts in MEDLINE. Additionally, disease connectionsbased on phenotypes or genes can be visualized on the web page of PedAM. Currently,the PedAM contains standardized 8528 pediatric disease terms (4542 unique diseaseconcepts and 3986 synonyms) with eight annotation fields for each disease, includingdefinition synonyms, gene, symptom, cross-reference (Xref), human phenotypes and itscorresponding phenotypes in the mouse. The database PedAM is freely accessible athttp://www.unimd.org/pedam/.

Abstract

La medicina de precisión permite implementar nuevas estrategias en el diagnóstico deenfermedades, siendo necesaria la combinación de criterios fisiopatológicos, perfilesmoleculares y el uso de recursos bibliográficos y bases de datos de informaciónindividual. El presente trabajo evalúa información procedente de literatura médica,incluyendo datos clínicos y moleculares, para la mayoría de las enfermedadespediátricas. La información se estandariza y clasifica a través de diferentes enfoques ypatrones para generar un sistema de notación de enfermedades, denominado“Pediatric Disease Annotations and Medicines (PedAM)”

Enlacehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753298/pdf/gkx1049.pdf



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Pediatría

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753298/pdf/gkx1049.pdf

Crit Rev Clin Lab Sci. 2017 Nov - Dec;54(7-8):551-571

Cardiac troponins: 25 years on the stage and still improvingtheir clinical value

Twenty-five years ago, non-isotopic immunoassays for measuring the cardiac specific isoformsof troponin I (cTnI) and T (cTnT) were developed. Both biomarkers radically changed thediagnosis, prognosis, and therapy indication of acute coronary syndromes (ACS) and,particularly, of myocardial infarction (MI). However, cardiac troponins (cTn) rapidlydemonstrated their usefulness in other cardiac and non-cardiac conditions, a part of theischemic coronary diseases. Consequently, the number of patients to be tested for cTn and thenumber of tests requested to clinical laboratories sharply increased. Though the manufacturerscontinuously improved the analytical characteristics of the first cTn assays and produceddifferent cTn assay "generations", the universal definition of myocardial infarction required less-than-available analytical imprecision at the cTn concentration used to assess MI (i.e. the 99threference percentile). To address the clinical requirements, manufacturers developed the high-sensitivity cTn (hs-cTn) assays that allow to measure the 99th reference percentile withadequate precision, to detect cTn in many healthy subjects and, hence, to calculate the hs-cTnbiological variation and especially to observe in very short time intervals serial differences in hs-cTn attributable to cardiac ischemia. Since the number of patients attending the emergencydepartments (ED) for a suspected ACS or MI is increasing, the improved properties of hs-cTnassays, allowing faster and safer patient assessment, will help to alleviate the sometimesovercrowded EDs. However, there are many biological, analytical, and clinical factors that caninfluence the true hs-cTn values of a patient. Clinicians and laboratory professionals shouldknow about them for the best interpretation of the otherwise largely useful hs-cTnmeasurements. In conclusion, 25 years after their introduction for clinical use, "cTn are still onthe stage and improving their clinical value".

Abstract

Comentario

Enlacehttps://www.tandfonline.com/doi/abs/10.1080/10408363.2017.1410777?journalCode=ilab20&

Cardiología



7ParReferenciaAcceso: suscripción

El presente estudio realiza una revisión sobre la utilización de los diferentes marcadoresempleados en el diagnóstico de síndromes coronarios agudos a lo largo del tiempo, conespecial énfasis en la Troponina. Se describen aspectos tales como los factores biológicos queafectan a los niveles de troponina, sus características analíticas, errores de medida, definiciónde intervalos de referencia, factores clínicos y su utilidad e interpretación en el contexto de lapatología cardiaca.

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https://www.tandfonline.com/doi/abs/10.1080/10408363.2017.1410777?journalCode=ilab20&

JACC en prensa

Fourth Universal Definition ofMyocardial Infarction (2018)

In the late 19th century, post-mortem examinations demonstrated a possiblerelationship between thrombotic occlusion of a coronary artery and myocardial infarction(MI). However, it was not until the beginning of the 20th century that the first clinicaldescriptions appeared describing a connection between the formation of a thrombus ina coronary artery and its associated clinical features. The clinical entity was referred toas coronary thrombosis, although use of the term ‘MI’ ultimately prevailed. Over theyears, several different definitions of MI have been used, leading to controversy andconfusion. Hence, a general and worldwide definition for MI was needed. This occurredfor the first time in the 1950–70s, when working groups from the World HealthOrganization (WHO) established a primarily electrocardiographic (ECG)-baseddefinition of MI intended for epidemiological use. With the introduction of more sensitivecardiac biomarkers, the European Society of Cardiology (ESC) and the AmericanCollege of Cardiology (ACC) collaborated to redefine MI using a biochemical andclinical approach, and reported that myocardial injury detected by abnormal biomarkersin the setting of acute myocardial ischaemia should be labelled as MI. The principle wasfurther refined by the Global MI Task Force, leading to the Universal Definition ofMyocardial Infarction Consensus Document in 2007, introducing a novel MIclassification system with five subcategories. The development of even more sensitiveassays for markers of myocardial injury made further revision of the documentnecessary, particularly for patients who undergo coronary procedures or cardiacsurgery. As a result, the Joint ESC/ACC/ AHA/ WHF Task Force produced the ThirdUniversal Definition of Myocardial Infarction Consensus Document in 2012

Abstract

El presente documento muestra el consenso de la Task Force para la actual CuartaDefinición Universal del Infarto de Miocárdio.

Enlacehttp://www.onlinejacc.org/content/accj/early/2018/08/22/j.jacc.2018.08.1038.full.pdf



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Cardiología

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http://www.onlinejacc.org/content/accj/early/2018/08/22/j.jacc.2018.08.1038.full.pdf

HEPATOLOGY, Vol. 50, No. 1, 2009

Primary Biliary Cirrhosis. AASLD PRACTICE GUIDELINES

These recommendations provide a data-supported approach to the management of

primary biliary cirrhosis (PBC). They are based on the following: (1) formal review and

analysis of the recently published world literature on the topic (Medline search); (2)

American College of Physicians Manual for Assessing Health Practices and Designing

Practice Guidelines 1; (3) guideline policies, including the AASLD Policy on the

Development and Use of Practice Guidelines and the American Gastroenterological

Association Policy Statement on Guidelines2; and (4) the experience of the authors in

the specified topic. Intended for use by physicians, these recommendations suggest

preferred approaches to the diagnostic, therapeutic, and preventive aspects of care.

They are intended to be flexible, in contrast to standards of care, which are inflexible

policies to be followed in every case. Specific recommendations are based on relevant

published information. To more fully characterize the quality of evidence supporting

recommendations, the Practice Guideline Committee of the AASLD requires a Class

(reflecting benefit versus risk) and Level (assessing strength or certainty) of Evidence to

be assigned and reported with each recommendation (Table 1, adapted from the

American College of Cardiology and the American Heart Association Practice

Guidelines).

Abstract

Comentario

Enlaceh7ps://www.aasld.org/sites/default/files/guideline_documents/PrimaryBillaryCirrhosis2009.pdf

Digestivo




La cirrosis biliar primaria constituye una enfermedad colestásica crónica,

considerándose un modelo de enfermedad autoinmune debido a su firma serológica

distintiva, el anticuerpo antimitocondrial (AMA), hallado en el 95% de los casos, y a la patología

específica del conducto biliar, caracterizada por una colangitis no supurativa que afecta a los

ductos biliares. El trabajo presentado constituye una guía de diagnóstico y manejo de esta

patología.

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https://www.aasld.org/sites/default/files/guideline_documents/PrimaryBillaryCirrhosis2009.pdf

Hepatology. 2018 Nov;68(5):1786-1803.

Ubiquitin-Specific Peptidase 10 (USP10) Inhibits HepaticSteatosis, Insulin Resistance, and Inflammation Through Sirt6

Nonalcoholic fatty liver disease (NAFLD) is characterizedby hepatic steatosis, insulin resistance and inflammation, and the pathogenic mechanism ofNAFLD is poorly understood. Ubiquitin-specific peptidase 10 (USP10), a member ofthe ubiquitin-specific protease family, is involved in environmental stress responses, tumorgrowth, inflammation, and cellular metabolism. However, the roleof USP10 in hepaticsteatosis, insulin resistance, and inflammation remains largelyunexplored. USP10 expression was detected in livers of patients with NAFLD, mice with high-fat diet (HFD)-induced obesity, and genetically obese (ob/ob) mice, as well as in palmitate-induced hepatocytes. The function of USP10 in hepatic steatosis, insulin resistance,and inflammation was investigated using hepatocyte-specific USP10 deficiency oroverexpression in mice induced by HFD treatment or genetic defect. The molecularmechanisms underlying USP10-regulated hepaticsteatosis were further investigated in HFD-treated mice. USP10 expression was significantly decreased in the fatty livers of NAFLDpatients and obese mice and in palmitate-treated hepatocytes. USP10 deficiency exacerbatedthe metabolic dysfunction induced by HFD treatment for 12 weeks.Conversely, USP10 overexpression significantly suppressed metabolic dysfunction in mice afterHFD treatment and inhibited the development of NAFLD in ob/ob mice. Further investigationindicated that USP10 regulates hepatic steatosis by interacting with Sirt6 and inhibiting itsubiquitination and degradation. Sirt6 overexpression markedly ameliorated the effectsof USP10 deficiency in hepatic steatosis, insulin resistance, and inflammation.Conversely, Sirt6 deficiency decreased the ameliorative effects of USP10 overexpression inresponse to HFD treatment. Conclusion: USP10 inhibits hepatic steatosis, insulin resistance,and inflammation through Sirt6.

Abstract

La enfermedad del hígado graso no alcohólico (Nonalcoholic fatty liver disease - NAFLD) secaracteriza por un metabolismo lípídico anormal, que induce el desarrollo de esteatosishepática, resistencia a la insulina e inflamación. El presente estudio describe como laUbiquitin-specific peptidase 10 (USP10) participa en la regulación de estas afeccionesmediante la vía de Sirt6.

Enlacehttps://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30062



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Digestivo

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https://aasldpubs.onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30062

Anaesthesia. 2017 Feb;72(2):233-247.

Interna'onal consensus statement on the peri-opera'vemanagement of anaemia and iron deficiency.

Despite current recommendations on the management of pre-operative anaemia, thereis no pragmatic guidance for the diagnosis and management of anaemia and irondeficiency in surgical patients. A number of experienced researchers and clinicians tookpart in an expert workshop and developed the following consensus statement. Afterpresentation of our own research data and local policies and procedures, appropriaterelevant literature was reviewed and discussed. We developed a series of best-practiceand evidence-based statements to advise on patient care with respect to anaemia andiron deficiency in the peri-operative period. These statements include: a diagnosticapproach for anaemia and iron deficiency in surgical patients; identification of patientsappropriate for treatment; and advice on practical management and follow-up. We urgeanaesthetists and peri-operative physicians to embrace these recommendations, andhospital administrators to enable implementation of these concepts by allocatingadequate resources.

Abstract

Comentario


Hematimetría y Patología Hematológica




El manejo de la anemia y el déficit de hierro en los pacientes quirúrgicos siempre estema de debate que requiere consenso. Las dudas que se generan a la hora deestablecer los puntos de corte adecuados para valorar la anemia y el déficit de hierroen un paciente quirúrgico, implican un papel destacado del Laboratorio Clínico ya que,con su informe, asume el protagonismo de la decisión asistencial a tomar en elprocedimiento quirúrgico.En este documento se plasma un consenso internacional que establece unasrecomendaciones concretas para la definición del estado anémico o de deficiencia dehierro en pacientes peri-quirúrgicos. Dichas recomendaciones deben ser conocidas porlos profesionales del laboratorio para poder participar en la toma de decisiones en elproceso asistencial de estos pacientes.

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Am J Hematol. 2018 Sep;93(9):1183-1191.

Management of anemia in patients who decline blood transfusion

Declining a treatment modality should not be considered the same as refusal of medicalcare as illustrated by the management of Jehovah's Witness patients who do not accepttransfusions. Over the years, a comprehensive set of strategies have been developedto meet the specific needs of these patients and these strategies are collectively called"Bloodless Medicine and Surgery" (BMS). The focus in BMS is to optimize the patients'hematopoietic capacity to increase hemoglobin (Hgb) level, minimize blood loss,improve hemostasis, and provide supportive strategies to minimize oxygen consumptionand maximize oxygen utilization. We present 3 case reports that illustrate some of thechallenges faced and measures available to effectively treat these patients. Under BMSprograms, patients with extremely low hemoglobin levels, not conducive to survivalunder ordinary conditions, have survived and recovered without receiving allogeneictransfusions. Additionally, the valuable experience gained from caring for these patientshas paved the way to develop the concept of Patient Blood Management as a standardcare to benefit all patients, and not only those for whom blood is not an option.

Abstract

Revertir el estado anémico de un paciente como preparación a la cirugía o durante lamisma, es un tema que debe requerir de un planteamiento específico cuando se tratade pacientes que, por cualquier motivo, rechazan el uso de las transfusionessanguíneas. Si el documento de referencia nos permite definir el estado anémico, eneste documento se plantean opciones para su tratamiento en el caso de no poder usartransfusiones, aunque clínicamente estén indicadas.Los profesionales de laboratorio que participen en el manejo de hemoderivados debenconocer estas alternativas terapéuticas que permiten, no solo atender a este tipo depacientes, sino también disminuir el uso de hemoderivados en general.




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HemaGmetría y Patología Hematológica

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ReferenciaAcceso: suscripción

Semin Thromb Hemost. 2016 Jul,42(5):471-7

Diagnostics of Inherited Bleeding Disorders of Secondary Hemostasis: An Easy Guide for Routine Clinical Laboratories

The investigation of inherited bleeding disorders of secondary hemostasis remains achallenge for most clinical laboratories, especially those that lack experience orspecialized personnel. Bleeding can be essentially caused by a variety of acquired orcongenital conditions, which impair either primary or secondary hemostasis. Since auniversally agreed approach for the diagnostics of hemorrhagic disorders is stillunavailable, this article aims to provide an easy guidance for routine clinicallaboratories.This pragmatic approach to identifying and diagnosing inherited bleeding disorders ofsecondary hemostasis entails a multifaceted strategy, based on a collection of personaland family history, the results of first-line tests, which can then be followed by second-or third-line analyses to definitely establish the specific nature and the severity of thebleeding phenotype. Briefly, the presence of profound hemorrhages rather thanmucocutaneous bleeding is suggestive of a disorder of secondary hemostasis. Althougha positive family history is frequently reported in patients with congenital conditions, thelack of clinically meaningful symptoms in patient’s relatives is not absolutely indicative ofan acquired disorder. The next step encompasses the assessment of first-linecoagulation tests (i.e., prothrombin time, activated partial thromboplastin time, andfibrinogen) if family history is not suggestive of a specific factor deficiency.The emergence of abnormal data of these assays and the variable combination of theirresults is then helpful to guide the performance of second-line tests, in particularspecific factor assays, which will then provide a reasonable basis for a preliminarydiagnosis. Third-line tests (namely, immunological assays of clotting factors andmolecular biology) are then supportive for a final diagnosis and for identifying the natureof the factor deficiency (i.e., quantitative or functional)..

Abstract

ComentarioComo el título indica, es una guía fácil y actual sobre las pruebas diagnósticas encoagulación y su metodología, muy útil para aquellos profesionales que no tengan unaformación profunda en dichas pruebas. Contempla tanto las pruebas de coagulación derutina como las especiales para el diagnóstico de Trombosis y Hemorragia.

Enlacehttps://www.thieme-connect.com/DOI/DOI?10.1055/s-0036-1571311

Hemostasia



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https://www.thieme-connect.com/DOI/DOI?10.1055/s-0036-1571311


International Journal of Laboratory Hematology, 37 : 6, 729-738

Internal Quality Control Practices in Coagulation Laboratories:recommendations based on a patterns-of-practice survey

Introduction: Internal quality control (IQC) procedures are crucial for ensuring accurate

patient test results. The IQMH Centre for Proficiency Testing conducted a web-based

survey to gather information on the current IQC practices in coagulation testing.

Methods: A questionnaire was distributed to 174 Ontario laboratories licensed to

perform prothrombin time (PT) and activated partial thromboplastin time (APTT).

Results: All laboratories reported using two levels of commercial QC (CQC); 12%

incorporate pooled patient plasma into their IQC program; >68% run CQC at the

beginning of each shift; 56% following maintenance, with reagent changes, during a

shift, or with every repeat sample; 6% only run CQC at the beginning of the day and

25% when the instruments have been idle for a defined period of time. IQC run

frequency was determined by manufacturer recommendations (71%) but also

influenced by the stability of test (27%), clinical impact of an incorrect test result (25%),

and sample’s batch number (10%). IQC was monitored using preset limits based on

standard deviation (66%), precision goals (46%), or allowable performance limits (36%).

95% use multirules. Failure actions include repeating the IQC (90%) and reporting

patient results; if repeat passes, 42% perform repeat analysis of all patient samples

from last acceptable IQC.

Conclusion: Variability exists in coagulation IQC practices among Ontario clinical

laboratories. The recommendations presented here would be useful in encouraging

standardized IQC practices.

Abstract

ComentarioAunque la publicación de este documento es anterior a su par, refleja la variabilidad del

comportamiento de los laboratorios clínicos en el control de calidad de las pruebas de

coagulación y lo más importante, realiza recomendaciones para la gestión del control

de calidad y gestión de riesgo.

Enlaceh>ps://onlinelibrary.wiley.com/doi/abs/10.1111/ijlh.12397

Hemostasia



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https://onlinelibrary.wiley.com/doi/abs/10.1111/ijlh.12397


Rev Lab Clin. 2018 Dec,4:177-238

El papel del laboratorio clínico en la medicina personalizada: situación actual y retos futuros

La medicina personalizada, medicina de precisión o medicina individualizada ha sido

definida como una manera de abordar el tratamiento y la prevención de las

enfermedades en base a la variabilidad genética, ambiental y al estilo de vida de cada

persona. Clasifica a los individuos en subpoblaciones que difieren en la susceptibilidad

a desarrollar una enfermedad determinada o en la respuesta a un tratamiento

específico, con el fin de aplicar el seguimiento y tratamiento más adecuado a cada

paciente. La implementación de los procesos asociados a la Medicina Personalizada

implica que los profesionales de laboratorio se enfrenten a una tecnología muy

avanzada y poco conocida y a la dificultad de interpretación de los hallazgos,

especialmente la valoración de su significación clínica. En este artículo se revisa la

situación actual de la Medicina Personalizada, la función del laboratorio dentro de la

misma y los retos que se deben afrontar.

Resumen

ComentarioLa medicina de laboratorio constituye parte esencial en el proceso de toma de

decisiones clínicas, interviniendo en aspectos tales como el cribado, diagnóstico,

pronostico y monitorización de resultados de gran parte de las patologías médicas. La

medicina personalizada emplea características tales como la variabilidad genética

individual, ambiente y estilo de vida con el objetivo de mejorar la efectividad en el

diagnóstico y prevención de la enfermedad. El Comité de Medicina Personalizada de

la Asociación Española de Biopatología Médica- Medicina de Laboratorio plantea una

exhaustiva revisión del estado actual y la proyección de la medicina personalizada,

Enlacehttp://www.elsevier.es/es-revista-revista-del-laboratorio-clinico-282-avance-resumen-el-papel-del-laboratorio-clinico-S1888400817301241

Genética y Medicina Personalizada



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http://www.elsevier.es/es-revista-revista-del-laboratorio-clinico-282-avance-resumen-el-papel-del-laboratorio-clinico-S1888400817301241


Nat Genet. 2011 Jul 10; 43(8): 761–767.

Interaction between ERAP1 and HLA-B27 in ankylosing spondylitis implicates peptide handling in the mechanism for

HLA-B27 in disease susceptibility

Ankylosing spondylitis is a common form of inflammatory arthritis predominantlyaffecting the spine and pelvis that occurs in approximately 5 out of 1,000 adults ofEuropean descent. Here we report the identification of three variants in the RUNX3,LTBRTNFRSF1A and IL12B regions convincingly associated with ankylosing spondylitis(P < 5 × 10−8 in the combined discovery and replication datasets) and a further four lociat PTGER4, TBKBP1, ANTXR2 and CARD9 that show strong association across all ourdatasets (P < 5 × 10−6 overall, with support in each of the three datasets studied). Wealso show that polymorphisms of ERAP1, which encodes an endoplasmic reticulumaminopeptidase involved in peptide trimming before HLA class I presentation, onlyaffect ankylosing spondylitis risk in HLA-B27–positive individuals. These findingsprovide strong evidence that HLA-B27 operates in ankylosing spondylitis through amechanism involving aberrant processing of antigenic peptides.

Abstract

ComentarioLa espondilitis anquilosante constituye una enfermedad tipo de espondiloartropatía, ungrupo de patologías que incluye psoriasis artrítica, artritis reactiva y enfermedadinflamatoria de los vasos. Si bien la asociación entre la espondilitis anquilosiante y elalelo HLA 27B ha sido ampliamente descrita, el presente estudio amplia a 9 los locigenéticos significativamente asociados a esta condición, incluyendo IL23R, RUNX3,KIF21B, 2p15, IL12B, ERAP1, HLA-B, LTBRTNFRSF1A y 21q22, identifica otroscuatro loci que muestran una fuerte evidencia de asociación y es probable queparticipen en la patogénesis de la enfermedad (ANTXR2, PTGER4, CARD9 yTBKBP1) y amplía considerablemente nuestra comprensión de la etiopatogenia de lacondición, incluyendo el mecanismo probable por el cual HLA-B27 opera en laenfermedad.

Enlacehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3640413/



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ReferenciaAcceso: libre

Methodical Aspects and Diagnostic Strategies

The international consensus on standardized nomenclature of antinuclear antibody HEp-2 Cell patterns (ICAP) initiative -

Current state andperspectives

The determination of antinuclear antibodies (ANA) is frequently used for the screeningof autoantibodies in systemic autoimmune diseases and indirect immunofluorescence(IIF) has been the main methodology for ANA determination.The establishment and distribution of autoantibody reference reagents was acornerstone in the development of autoantibody standardization. Over the past 35years, the Autoantibody Standardization Committee (www.AutoAb.org), a subcommitteeof the International Union of Immunological Societies (IUIS) Quality Assessment andStandardization Committee, has coordinated a joint initiative with the Centers forDisease Control and Prevention (CDC) and other agencies to provide autoantibodyreference standards (also known as CDC ANA reference standards, or IUIS ANAreference standards).The ICAP agenda was focused on the discussion of ANA patterns regarding four cellcompartments: nucleus, nucleolus, cytoplasm, and mitotic apparatus. Each session wascoordinated by two experts, who presented a preliminary proposal that wassubsequently discussed by the assembly that counted with 63 participants from severalcountries. The report on the first ICAP has been recently published in Frontiers inImmunology16 and is available online at the IWAA 2014 website with a link to the ICAPwebsite: (www.ANApatterns.org).

Abstract

ComentarioEl Comité de Normalización de Autoanticuerpos (www.AutoAb.org), un subcomité delComité de Evaluación y Normalización de la Calidad de la Unión Internacional deSociedades Inmunológicas (IUIS), ha coordinado una iniciativa conjunta con losCentros para el Control y Prevención de Enfermedades (CDC) y otras agencias paraproporcionar estándares de referencia de autoanticuerpos (también conocidos comoestándares de referencia ANA de CDC, o estándares de referencia ANA de IUIS). Eltexto propuesto muestra el consenso internacional de nomenclatura estandarizada depatrones de anticuerpos antinucleares en células Hep-2, el cual puede ser consultadoen la web www.anapatterns.org.

Enlacehttps://anapatterns.org/publications/icap_dresden_chapter.pdf

Inmunología/Reuma/Alergia



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https://anapatterns.org/publications/icap_dresden_chapter.pdf


PLoS One. 2017; 12(8): e0183420.

Relationship between serum calprotectin (S100A8/9) and clinical, laboratory and ultrasound parameters of disease

activity in rheumatoid arthritis: A large cohort study

Background: Calprotectin may be a sensitive biomarker of rheumatoid arthritis (RA)disease activity.Objectives: In the current study, we investigated whether calprotectin is a betterbiomarker than CRP for predicting clinical activity and ultrasound parameters in patientswith RA.Methods: A total of 160 patients with RA underwent clinical (swollen joint count—SJC,tender joint count—TJC, Disease Activity Score—DAS28, Clinical Disease ActivityIndex—CDAI, and simplified Disease Activity Index—SDAI) and ultrasound (GermanUS7) examination. Clinical and laboratory measures were correlated with ultrasoundfindings using Spearman´s correlation coefficient. Differences in serum calprotectinlevels in patients with variable disease activity according to the DAS28-ESR and CDAIscores were assessed using ANOVA. Multivariate regression analysis was used todetermine the predictive values of calprotectin, CRP and SJC for CDAI and PD USsynovitis scores.Results: Serum calprotectin was significantly associated with DAS28-ESR (r = 0.321,p<0.001), DAS28-CRP (r = 0.346, p<0.001), SDAI (r = 0.305, p<0.001), CDAI (r =0.279, p<0.001) scores and CRP levels (r = 0.556, p<0.001). Moreover, calprotectinwas significantly correlated with GS (r = 0.379, p<0.001) and PD synovitis scores (r =0.419, p<0.001). The multivariate regression analysis showed that calprotectin is abetter predictor of the CDAI score and PD US synovitis than CRP.Conclusions: The results of this study support an additional role of calprotectin inassessing inflammatory activity in patients with RA.

Abstract

ComentarioLa artritis reumatoide (AR) constituye la enfermedad inflamatoria crónica más común,afectando aproximadamente al 1% de la población. La calprotectina es la principalproteína citosólica presente en leucocitos durante procesos inflamatorios, y ha sidoidentificada en numerosos trabajos como marcador de la actividad de AR. El presentetrabajo profundiza en la comprensión de esta relación, proponiendo además rolesadicionales en el establecimiento de la actividad inflamatoria.

Enlaceh6ps://www.ncbi.nlm.nih.gov/pmc/arDcles/PMC5568227/



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Procedimientos en Microbiología Clinica. Sociedad Española de Enfermedades Infecciosas y Microbiologia Clínica (SEIMC). 2014.

Diagnós(co Microbiológico de las Hepa((s Víricas

La inflamación hepática o hepatitis tiene causas diversas tanto infecciosas como noinfecciosas. Entre estas últimas, se encuentran el alcoholismo, el consumo de drogas,la intoxicación química o por fármacos y las enfermedades autoinmunes. Entre lasprimeras, cabe destacar la etiología viral que es la causa de, al menos, la mitad detodas las hepatitis mundiales.Se han descrito distintos virus con tropismo primario por el tejido hepático. Estosmicroorganismos se han ido nombrando sucesivamente con las letras del abecedario:A, B, C, D, E y G. El objetivo de este documento es revisar este grupo heterogéneo devirus en sus aspectos más básicos, sus implicaciones clínicas, su diagnóstico, sutratamiento y sus principales medidas profilácticas.Existen otros virus causantes de hepatitis como el Citomegalovirus, el virus de EpsteinBarr, virus del herpes simple, virus de la fiebre amarilla y el Parvovirus B19. Estos virus,sin embargo, no afectan al hígado de manera exclusiva y específica, sino que puedenafectar también a otros órganos o sistemas, por lo que no serán incluidos en esteprocedimiento.

Resumen

ComentarioSe propone el texto recogido en los procedimientos en microbiología clínica refrendadopor la SEIMC en relación al diagnóstico microbiológico de las hepatitis víricas,incluyendo los virus A, B, C, D, E y G. Se incluye una descripción completa de cadauno de los virus y de su historia natural, así como las recomendaciones a seguir parasu diagnóstico, tratamiento y profilaxis.

Enlacehttps://seimc.org/contenidos/documentoscientificos/procedimientosmicrobiologia/seimc-procedimientomicrobiologia50.pdf

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https://seimc.org/contenidos/documentoscientificos/procedimientosmicrobiologia/seimc-procedimientomicrobiologia50.pdf


| JNCI J Natl Cancer Inst, 2019, Vol. 111, No. 2: 129-136

Antibodies Against Chlamydia trachomatis and Ovarian Cancer Risk in Two Independent Populations

Background: Pelvic inflammatory disease (PID) has been associated with ovariancancer risk. To clarify the role of Chlamydia trachomatis and other infectious agents inthe development of ovarian cancer, we evaluated the association of serologic markerswith incident ovarian cancer using a staged approach in two independent populations.Methods: Studies included: 1) a case–control study in Poland (244 ovariancancers/556 control subjects) and 2) a prospective nested case–control study in thePLCO Cancer Screening Trial (160 ovarian cancers/159 control subjects). Associationsof serologic marker levels with ovarian cancer risk at diagnostic as well as higherthresholds, identified in Poland and independently evaluated in PLCO, were estimatedusing multivariable adjusted logistic regression.Results: In the Polish study, antibodies (based on laboratory cut-point) against thechlamydia plasmid-encoded Pgp3 protein (serological gold standard) were associatedwith increased ovarian cancer risk (adjusted odds ratio [OR] = 1.63, 95% confidenceinterval [CI] = 1.20 to 2.22); when a positive result was redefined at higher levels,ovarian cancer risk was increased (cut-point 2: OR = 2.00, 95% CI = 1.38 to 2.89; cut-point 3 [max OR]: OR = 2.19, 95% CI = 1.29 to 3.73). In the prospective PLCO study,Pgp3 antibodies were associated with elevated risk at the laboratory cut-point (OR =1.43, 95% CI = 0.78 to 2.63) and more stringent cut-points (cut-point 2: OR = 2.25, 95%CI = 1.07 to 4.71); cut-point 3: OR = 2.53, 95% CI = 0.63 to 10.08). In both studies,antibodies against other infectious agents measured were not associated with risk.Conclusions: In two independent populations, antibodies against prior/current C.trachomatis (Pgp3) were associated with a doubling in ovarian cancer risk, whereasmarkers of other infectious agents were unrelated. These findings lend support for anassociation between PID and ovarian cancer.

Abstract

ComentarioLa Chlamydia trachomatis es una bacteria de transmisión sexual y la principal causa deenfermedad inflamatoria pélvica en paises desarrollados. El presente estudio evalúa larelación existente entre la presencia de anticuerpos frente esta y otras bacterias(incluyendo Micoplasma genitalium) y el desarrollo de cáncer de ovario.

Enlacehttps://academic.oup.com/jnci/article/111/2/129/5001107



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https://academic.oup.com/jnci/article/111/2/129/5001107


Crit Rev Clin Lab Sci. 2017 Nov - Dec;54(7-8):471-494

Point-of-care testing (POCT) is the analysis of patient specimens outside the clinical laboratory,near or at the site of patient care, usually performed by clinical staff without laboratory training,although it also encompasses patient self-monitoring. It is able to provide a rapid result near thepatient and which can be acted upon immediately. The key driver is the conceptthat clinical decision making may be delayed when samples are sent to the clinical laboratory.Balanced against this are considerations of increased costs for purchase and maintenance ofequipment, staff training, connectivity to the laboratory information system (LIS), quality control(QC) and external quality assurance (EQA) procedures, all required for accreditation under ISO22870. The justification for POCT depends upon being able to demonstrate that a more timelyresult (shorter turnaround times (TATs)) is able to leverage a clinicallyimportant advantage in decision making compared with the central laboratory (CL). In the fourdecades since POCT was adapted for the self-monitoring of blood glucose levels by subjectswith diabetes, numerous new POCT methodologies have become available, enabling theclinician to receive results and initiate treatment more rapidly. However, these instruments areoften operated by staff not trained in laboratory medicine and hence are prone to errors in theanalytical phase (as opposed to laboratory testing where the analytical phase has the leasterrors). In some environments, particularly remote rural settings, the CL may be at aconsiderable distance and timely availability of cardiac troponins and other analytes can triagereferrals to the main centers, thus avoiding expensive unnecessary patient transportation costs.However, in the Emergency Department, availability of more rapid results with POCT does notalways translate into shorter stays due to other barriers to implementation of care. In thisreview, we apply the principles of evidence-based laboratory medicine (EBLM) looking for highquality systematic reviews and meta-analyses, ideally underpinned by randomized controlledtrials (RCTs), looking for evidence of whether POCT confersany advantage in clinical decision makingin different scenarios..

Abstract

ComentarioEl presente trabajo constituye una completa revisión que pretende asignar el valor y lasventajas que presentan la utilización de pruebas Point of Care en situaciones clínicasconcretas y diferentes escenarios de aplicación, incluyendo entornos rurales,automonitorización o unidades críticas entre otros.

Enlacehttps://www.tandfonline.com/doi/abs/10.1080/10408363.2017.1399336?journalCode=ilab20

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Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) – does it leverage any

advantage in clinical decision making?

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https://www.tandfonline.com/doi/abs/10.1080/10408363.2017.1399336?journalCode=ilab20


Clin Chem Lab Med. 2018 Nov 9. En prensa

Development of the Point-of-Care Key Evidence Tool (POCKET): a checklist for multi-dimensional evidence

generation in point-of-care tests

Background: This study aimed to develop the Point-of-Care Key Evidence Tool(POCKET); a multi-dimensional checklist to guide the evaluation of point-of-care tests(POCTs) incorporating validity, utility, usability, cost-effectiveness and patientexperience. The motivation for this was to improve the efficiency of evidence generationin POCTs and reduce the lead-time for the adoption of novel POCTs.Methods: A mixed qualitative and quantitative approach was applied. Following aliterature search, a three round Delphi process was undertaken incorporating a semi-structured interview study and two questionnaire rounds. Participants includedclinicians, laboratory personnel, commissioners, regulators (including members ofNational Institute for Health and Care Excellence [NICE] committees), patients, industryrepresentatives and methodologists. Qualitative data were analysed based on groundedtheory. The final tool was revised at an expert stakeholder workshop.Results: Forty-three participants were interviewed within the semi-structured interviewstudy, 32 participated in the questionnaire rounds and nine stakeholders attended theexpert workshop. The final version of the POCKET checklist contains 65 differentevidence requirements grouped into seven themes. Face validity, content validity andusability has been demonstrated. There exists a shortfall in the evidence that industryand research methodologists believe should be generated regarding POCTs and what isactually required by policy and decision makers to promote implementation into currenthealthcare pathways.Conclusions: This study has led to the development of POCKET, a checklist forevidence generation and synthesis in POCTs. This aims to guide industry andresearchers to the evidence that is required by decision makers to facilitate POCTadoption so that the benefits they can bring to patients can be effectively realised.

Abstract

ComentarioLa principal ventaja del empleo de técnicas POCT es la obtención de resultadosinmediatos a la cabecera del paciente, acelerando la toma de decisiones clínicas. Eltexto propuesto desarrolla un sistema de evaluación para sistemas POCT,considerando aspectos tales como la validez, utilidad, usabilidad, coste-efectividad yexperiencia del paciente.

Enlaceh;ps://www.degruyter.com/doi/10.1515/cclm-2018-1089



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Point of Care Testing

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https://www.degruyter.com/doi/10.1515/cclm-2018-1089


Clin Chem. 2002 Aug;48(8):1151-9

Prac%ce Guidelines for Tumor Marker Use in the Clinic

Background: Increasing interest in implementing the practice of evidence-basedmedicine in oncology has encouraged the development of clinical guidelines, many ofwhich include recommendations about the appropriate use of serum tumor markers.Methods: Recent national and international guidelines relating to the use of tumormarkers in germ cell, colorectal, breast, ovarian, prostate, lung, neuroendocrine, andthyroid cancers were identified from the scientific literature and other sources andtabulated.Results: Guideline recommendations developed by national and international groupsand relating to the use of tumor markers for specific cancers are reviewed andcompared, considering the recommendations made for their use in screening,diagnosis, prognosis, and monitoring of therapy. Potential advantages anddisadvantages of clinical guidelines, how best to implement them, and means ofauditing their effectiveness are also considered.Conclusions: Excellent clinical guidelines, including recommendations for the mostappropriate use of tumor markers, are already available for many cancers. Manyquestions relating to optimal use of these important tests remain to be answered, butcurrent guidelines already contain much valuable information and advice. Furtherdissemination and implementation of the guidelines should encourage better use oftumor markers in clinical practice. Careful audit studies are also required to establishthe impact of these guidelines on the practice of evidence-based medicine..

Abstract

ComentarioExisten diferentes recomendaciones de las sociedades científicas americanas yeuropeas sobre el manejo de marcadores tumorales en la práctica clínica. La lecturade este artículo permite al profesional del Laboratorio conocer cuáles son lassimilitudes y las diferencias en su manejo.Además el artículo engloba una completa bibliografía que permite acceder rápidamentea las particularidades de cada Sociedad Científica.


Oncología



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Am J Respir Crit Care Med. 2016 Feb 15;193(4):427-37.

Assessment of a Combined Panel ofSix Serum Tumor Markers for Lung Cancer

Rationale: We have previously identified six serum tumor markers (TMs) (carcinoembryonicantigen, carbohydrate antigen 15.3, squamous cell carcinoma-associated antigen, cytokeratin-19 fragment, neuron-specific enolase, and pro-gastrin-releasing peptide) related to thepresence of lung cancer (LC).Objectives: To validate their individual performance in an independent cohort, and to explore iftheir combined assessment (≥1 abnormal TM value) is a more accurate marker for LCpresence.Methods: We determined these six TMs in 3,144 consecutive individuals referred to ourinstitution by their primary care physician because of the clinical suspicion of LC.Measurements and main results: LC was excluded in 1,316 individuals and confirmed in1,828 patients (1,563 with non-small cell LC and 265 with small cell LC). This study validatedthe previously reported performance of each individual TM. We also showed thattheir combined assessment (≥1 abnormal TM) had a better sensitivity, specificity, negativepredictive value, and positive predictive value (88.5, 82, 83.7, and 87.3%, respectively) thaneach TM considered individually and that it increased the diagnostic performance (area underthe curve) of a clinical model that included tumor size, age, and smoking status. In patients withradiographic nodules less than 3 cm, the negative predictive value of the TM panel was 71.8%,hence providing some support for a more conservative diagnostic approach. Finally weidentified two TMs (neuron-specific enolase and pro-gastrin-releasing peptide) that differentiatethe risk of non-small cell LC from that of small cell LC.Conclusions: The combined assessment of a panel of six serum TMs is a more accuratemarker for LC presence than these same TMs considered individually. The potential of theseTMs in the diagnostic and screening settings deserves further research.

Abstract

ComentarioEste artículo plantea la utilidad de un panel múltiple de marcadores tumorales en elmanejo del cáncer de pulmón. Sobre todo es de utilidad para mostrar como losmarcadores tumorales bien empleados, pueden ser de gran utilidad para seleccionarpacientes con un mayor riesgo, ayudar al diagnóstico histológico, e incluso mejorar elrendimiento diagnóstico global.

Enlacehttps://www.ncbi.nlm.nih.gov/pubmed/?term=Assessment+of+a+Combined+Panel+of+Six+Serum+Tumor+Markers+for+Lung+Cancer

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https://www.ncbi.nlm.nih.gov/pubmed/?term=Assessment+of+a+Combined+Panel+of+Six+Serum+Tumor+Markers+for+Lung+Cancer


Transplantation Journal. 2013 Jan,95(1):19-47

Background: The introduction of solid-phase immunoassay (SPI) technology for the detection and characterizationof human leukocyte antigen (HLA) antibodies in transplantation while providing greater sensitivity than wasobtainable by complement-dependent lymphocytotoxicity (CDC) assays has resulted in a new paradigm with respectto the interpretation of donor-specific antibodies (DSA). Although the SPI assay performed on the Luminexinstrument (hereafter referred to as the Luminex assay), in particular, has permitted the detection of antibodies notdetectable by CDC, the clinical significance of these antibodies is incompletely understood.Methods: With this background, The Transplantation Society convened a group of laboratory and clinical experts inthe field of transplantation to prepare a consensus report and make recommendations on the use of this newtechnology based on both published evidence and expert opinion. Three working groups were formed to address (a)the technical issues with respect to the use of this technology, (b) the interpretation of pretransplantation antibodytesting in the context of various clinical settings and organ transplant types (kidney, heart, lung, liver, pancreas,intestinal, and islet cells), and (c) the application of antibody testing in the posttransplantation setting.Results: A comprehensive list of recommendations was prepared by each group. A summary of the keyrecommendations follows. Technical Group: (a) SPI must be used for the detection of pretransplantation HLAantibodies in solid organ transplant recipients and, in particular, the use of the single-antigen bead assay to detectantibodies to HLA loci, such as Cw, DQA, DPA, and DPB, which are not readily detected by other methods. (b) Theuse of SPI for antibody detection should be supplemented with cell-based assays to examine the correlationsbetween the two types of assays and to establish the likelihood of a positive crossmatch (XM). (c) There must be anawareness of the technical factors that can influence the results and their clinical interpretation when using theLuminex bead technology, such as variation in antigen density and the presence of denatured antigen on the beads.Pretransplantation Group: (a) Risk categories should be established based on the antibody and the XM resultsobtained. (b) DSA detected by CDC and a positive XM should be avoided due to their strong association withantibody-mediated rejection and graft loss. (c) A renal transplantation can be performed in the absence of aprospective XM if single-antigen bead screening for antibodies to all class I and II HLA loci is negative. This decision,however, needs to be taken in agreement with local clinical programs and the relevant regulatory bodies. (d) Thepresence of DSA HLA antibodies should be avoided in heart and lung transplantation and considered a risk factor forliver, intestinal, and islet cell transplantation. Posttransplantation Group: (a) High-risk patients (i.e., desensitized orDSA positive/XM negative) should be monitored by measurement of DSA and protocol biopsies in the first 3 monthsafter transplantation. (b) Intermediate-risk patients (history of DSA but currently negative) should be monitored forDSA within the first month. If DSA is present, a biopsy should be performed. (c) Low-risk patients (nonsensitized firsttransplantation) should be screened for DSA at least once 3 to 12 months after transplantation. If DSA is detected, abiopsy should be performed. In all three categories, the recommendations for subsequent treatment are based on thebiopsy results.Conclusions: A comprehensive list of recommendations is provided covering the technical and pretransplantationand posttransplantation monitoring of HLA antibodies in solid organ transplantation. The recommendations areintended to provide state-of-the-art guidance in the use and clinical application of recently developed methods forHLA antibody detection when used in conjunction with traditional methods..

Abstract

ComentarioSe presenta un guía consenso y recomendaciones de manejo en el uso clínico de anticuerpos HLA

Enlacehttps://insights.ovid.com/pubmed?pmid=23238534

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Consensus guidelines on the testing and clinical management issues associated with HLA and non-HLA antibodies in transplantation

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https://insights.ovid.com/pubmed?pmid=23238534


Transpl Infect Dis. 2017 Dec;19(6)

Cytomegalovirus infection management in solid organ transplant recipients across European centers in the

time of molecular diagnostics: An ESGICH survey.

Background: Scant information is available about how transplant centers are managing theiruse of quantitative molecular testing (QNAT) assays for active cytomegalovirus (CMV) infectionmonitoring in solid organ transplant (SOT) recipients. The current study was aimed at gatheringinformation on current practices in the management of CMV infection across European centersin the era of molecular testing assays.Methods: A questionnaire-based cross-sectional survey study was conducted by the EuropeanStudy Group of Infections in Immunocompromised Hosts (ESGICH) of the Society of ClinicalMicrobiology and Infectious Diseases (ESCMID). The invitation and a weekly reminder with apersonal link to an Internet service provider (https://es.surveymonkey.com/) was sent totransplant physicians, transplant infectious diseases specialists, and clinical virologists workingat 340 European transplant centers.Results: Of the 1181 specialists surveyed, a total of 173 responded (14.8%): 73 transplantphysicians, 57 transplant infectious diseases specialists, and 43 virologists from 173 institutionslocated at 23 different countries. The majority of centers used QNAT assays for active CMVinfection monitoring. Most centers preferred commercially available real-time polymerase chainreaction (RT-PCR) assays over laboratory-developed procedures for quantifying CMV DNAload in whole blood or plasma. Use of a wide variety of DNA extraction platforms and RT-PCRassays was reported. All programs used antiviral prophylaxis, preemptive therapy, or both,according to current guidelines. However, the centers used different criteria for startingpreemptive antiviral treatment, for monitoring systemic CMV DNA load, and for requestinggenotypic assays to detect emerging CMV-resistant variants.Conclusions: Significant variation in CMV infection management in SOT recipients stillremains across European centers in the era of molecular testing. International multicenterstudies are required to achieve commutability of CMV testing and antiviral managementprocedures.

Abstract

ComentarioLa infección por citomegalovirus (CMV) sigue siendo una causa importante de morbilidad ymortalidad en receptores de trasplante de órgano sólido (SOT). Se presentan en el textopropuesto las recomendaciones de manejo elaboradas por el Grupo de estudio europeo deinfecciones en huéspedes inmunocomprometidos (ESGICH) y avalado por la Sociedad deMicrobiología Clínica y Enfermedades infecciosas (ESCMID).

Enlaceh;ps://www.ncbi.nlm.nih.gov/pubmed/28859257

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Revista del Laboratorio Clínico. En prensa

Magnitudes Biológicas que Tiene Interés Medirde Modo Urgente

El objeto de esta revisión es actualizar la relación de las magnitudes biológicas quetiene interés medir de modo urgente. Este concepto es aplicable a aquellas magnitudescuyo resultado es de utilidad para llevar a cabo una actuación médica inmediata ya seacon fines diagnósticos o terapéuticos. Aunque los modelos organizativos actualesasignan al laboratorio de urgencias la determinación de ciertas magnitudes adicionales,éstas no deben de ser incluidas en este documento ya que responden a motivosorganizativos. Esta relación puede servir de guía a la hora de elaborar un catálogo demagnitudes urgentes, de manera que cada laboratorio seleccione las que mejor seadapten a sus características y necesidades, teniendo también en cuenta el tiempo derespuesta deseable. En el apartado 3 se justifica brevemente la inclusión de cadamagnitud en la relación recomendada. No se pretende efectuar una revisión exhaustivadel valor semiológico de las magnitudes propuestas, ni recomendar algoritmosdiagnósticos, aspectos que pueden ser objeto de otros documentos.Una de las cuestiones que nos planteamos en esta revisión, atendiendo a la realidadde numerosos laboratorios de urgencias en nuestro país, fue la inclusión en la mismade magnitudes microbiológicas, generalmente las pruebas de detección rápida basadasen la reacción antígeno-anticuerpo y las tinciones. Sin embargo, dada la disponibilidadde documentos relativos a dichas técnicas publicados por otras sociedades (5) hemosconsiderado adecuado no incluir dichas magnitudes en este documento.Del mismo modo, no se incluyen las magnitudes relacionadas con la medicinatransfusional. El Real Decreto 1088/2005, de 16 de septiembre, por el que seestablecen los requisitos técnicos y condiciones mínimas de la hemodonación y de loscentros y servicios de transfusión establece que la responsabilidad de los centros yservicios de transfusión será ejercida por un médico especialista en Hematología yHemoterapia..

Resumen (extracto introducción del documento)

ComentarioSe recomienda la lectura del documento de la Comisión Magnitudes Biológicasrelacionadas con la Urgencia Médica de la Sociedad Española de Medicina deLaboratorio (SEQCML), en la que se actualizan las magnitudes cuya medición es deinterés en situaciones de urgencia.Enlacehttp://www.elsevier.es/es-revista-revista-del-laboratorio-clinico-282-epub-S1888400817300016

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http://www.elsevier.es/es-revista-revista-del-laboratorio-clinico-282-epub-S1888400817300016


Revista Clínica Española. 2016 Sep. 216:6, 293-344

Documento de consenso y recomendaciones sobre el uso de los péptidos natriuréticos en la práctica clínica

Los péptidos natriuréticos son una herramienta de laboratorio útil en el diagnóstico,pronóstico y tratamiento de los pacientes con insuficiencia cardiaca. Su uso involucra adiferentes ámbitos sanitarios (consultas, urgencias, hospitalización, laboratorio) y a muydiferentes profesionales de la Atención Primaria o especializada. Sin embargo, suincorporación a la práctica asistencial aún es escasa y desigual. Para un correcto uso einterpretación en la práctica clínica se necesita un mínimo de conocimientospreanalíticos (fisiopatología), analíticos (métodos) y postanalíticos (interpretación eintegración con los datos clínicos). Este documento de consenso elaborado por variassociedades científicas tiene como objetivo actualizar los conceptos y conocimientosnecesarios sobre los péptidos natriuréticos que permitan su aplicación para eldiagnóstico, pronóstico y tratamiento de la insuficiencia cardiaca, en los diferentesámbitos sanitarios.

Resumen

ComentarioEl documento que se presenta surge del consenso de la Sociedad Española deCardiología (SEC), Sociedad Española de Medicina Interna (SEMI), SociedadEspañola de Medicina Familiar y Comunitaria (SEMFyC) y la Sociedad Española deMedicina de Urgencias (SEMES) acerca del uso de los péptidos natriuréticos en lainsuficiencia cardiaca, con especial énfasis en el péptido natriurético tipo B y susmetabolitos. Se evalúan aspectos tales como los métodos de medida, su utilidaddiagnóstica bajo situaciones clínicas concretas, su evaluación pronóstica y su manejoen seguimiento y tratamiento.

Enlaceh?p://www.revclinesp.es/es-documento-consenso-recomendaciones-sobre-el-arGculo-S0014256516000485

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http://www.revclinesp.es/es-documento-consenso-recomendaciones-sobre-el-articulo-S0014256516000485


Ther Drug Monit 2018;40:389–393

Mass Spectrometry for Research and Applica6on in Therapeu6c Drug Monitoring or Clinical and Forensic Toxicology

This article reviews current applications of various hyphenated low- and high-resolutionmass spectrometry techniques in the field of therapeutic drug monitoring andclinical/forensic toxicology in both research and practice. They cover gaschromatography, liquid chromatography, matrix-assisted laser desorption ionization, orpaper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap massanalyzers.

Abstract

ComentarioEste artículo de revisión, cubre metodológicamente uno de los campos analíticosemergentes actuales de la toxicología clínica y forense. Se discuten diferentesequipamientos, incluido la preparación de muestras, centrándose en cómo enfocar laextracción en línea, siendo su automatización un avance importante, y los ajustesespectrales de masas.Se revisan y discuten las limitaciones y los desafíos asociados al uso de matricesalternativas, tales como manchas de sangre seca, así como diversos fluidos y tejidoscorporales (cabello, saliva, jugo digestivo, etc.), en el contexto de diversosprocedimientos, como por ejemplo los delitos facilitados por drogas. El número deaplicaciones para estas matrices será creciente, una vez que nuestra comprensiónpara el tratamiento previo de la muestra, almacenamiento y la farmacocinética vayamejorando.Se exploran las ventajas y limitaciones de la cromatografía de acoplada en tándem(LCMS/MS) de alta resolución (HR), para la cuantificación de fármacos y drogas deabuso, así como la demanda de una cierta resolución o una precisión de masaespecífica.Esperamos que el lector obtendrá nuevos conocimientos en este campo dellaboratorio, descubriendo información nueva y relevante, para su trabajo diario yproyectos de investigación.


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Journal of Analy,cal Toxicology. 2017;41:181–195

Simultaneous Screening and Quantification of Basic, Neutral and Acidic Drugs in Blood Using UPLC-QTOF-MS

An analytical method using ultra performance liquid chromatography (UPLC) quadrupole time-of-flight

mass spectrometry (QTOF-MS) was developed and validated for the targeted toxicological screening and

quantification of commonly used pharmaceuticals and drugs of abuse in postmortem blood using 100 µL

sample. It screens for more than 185 drugs and metabolites and quantifies more than 90 drugs. The

selected compounds include classes of pharmaceuticals and drugs of abuse such as: antidepressants,

antipsychotics, analgesics (including narcotic analgesics), anti-inflammatory drugs, benzodiazepines,

beta-blockers, amphetamines, new psychoactive substances (NPS), cocaine and metabolites.

Compounds were extracted into acetonitrile using a salting-out assisted liquid-liquid extraction (SALLE)

procedure. The extracts were analyzed using a Waters ACQUITY UPLC coupled with a XEVO QTOF

mass spectrometer. Separation of the analytes was achieved by gradient elution using Waters ACQUITY

HSS C18 column (2.1 mm x 150 mm, 1.8 μm). The mass spectrometer was operated in both positive and

negative electrospray ionization modes. The high-resolution mass spectrometry (HRMS) data was

acquired using a patented Waters MSE acquisition mode which collected low and high energy spectra

alternatively during the same acquisition. Positive identification of target analytes was based on accurate

mass measurements of the molecular ion, product ion, peak area ratio and retention times. Calibration

curves were linear over the concentration range 0.05-2 mg/L for basic and neutral analytes and 0.1-6

mg/L for acidic analytes with the correlation coefficients (r2) > 0.96 for most analytes. The limits of

detection (LOD) were between 0.001-0.05 mg/L for all analytes. Good recoveries were achieved ranging

from 80% to 100% for most analytes using the SALLE method. The method was validated for sensitivity,

selectivity, accuracy, precision, stability, carryover and matrix effects. The developed method was tested

on a number of authentic forensic samples producing consistent results that correlated with results

obtained from other validated methods.

Abstract

ComentarioEn los últimos años, la progresiva implantación de la espectroscopia de masas en los laboratorios

clínicos de rutina ha supuesto la identificación simultánea de múltiples metabolitos con una alta

sensibilidad y especificidad. El potencial analítico del acoplamiento instrumental de la cromatografía

líquida y la espectrometría de masas en tándem (LCMS/MS), con analizadores de triple cuádruplo (QqQ)

e híbrido cuádruplo-tiempo de vuelo (QTOF), para la cuantificación de metabolitos en diversas matrices,

ha permitido la rápida expansión de esta tecnología. Si bien las aplicaciones de la LCMS/MS se utilizan

en muchas áreas clínicas, el control terapéutico de los medicamentos, drogas de abuso y la toxicología

clínica sigue siendo el principal enfoque. Estas incluyen drogas legales e ilegales pertenecientes a

diferentes categorías, incluyendo múltiples fármacos, así como cannabinoides, opioides, Z-drogas,

anfetaminas y nuevas sustancias psicoactivas como las catinonas. El diseño y validación de métodos,

usando el simple concepto de diluir con un estándar interno, como el único procedimiento base de

preparación de las muestras, antes del análisis instrumental interno e inyección directa, hacen que la

naturaleza no discriminatoria del proceso, sea aún más atractiva la LCMS/MS (HR) de alta resolución

para determinaciones de multicomponente desconocidos.

Enlaceh?ps://www.ncbi.nlm.nih.gov/pubmed/27881618

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Actualizaciones en el Laboratorio Clínico.Editor: Asociación Española de Biopatología Médica. Fecha de Distribución: Mayo de 2010

El Informe Fisiopatológico del Laboratorio

El informe fisiopatológico diferencia al laboratorio clínico de otros tipos de laboratorios.

A través de él, ya sea de manera implícita o explícita (definiendo una prueba

llamada así: informe de laboratorio), los datos medidos se trasforman en información

de utilidad para mejorar la salud de los pacientes. El proceso de generación de

dicho informe es amplio y puede abarcar desde decidir antes de la extracción de la

muestra si la prueba es procedente, hasta incluir recomendaciones de

interpretación o sugerencias de seguimientos futuros, pasando por la ampliación

y/o anulación de pruebas durante el proceso de análisis a la vista de los resultados

que van obteniéndose.Las nuevas tecnologías añaden importantes desafíos y

oportunidades en la gestión de la información desde el laboratorio.La apuesta por la

inclusión de comentarios interpretativos y la opción de integrarlo, no sólo como una

parte sino como la base del informe, en el laboratorio, es la llamada

capacitación clínica. Es en estos momentos el mayor desafío al que se

enfrentan los facultativos de los laboratorios clínicos y se trata de un criterio

decisivo a incluir en la formación de nuevos especialistas.

Resumen

ComentarioEl presente texto, incluido en el curso de formación continuada a distancia de la

Asociación Española de Biopatología Médica– Medicina de Laboratorio (AEBM-ML) se

expone de forma clara la definición y requisitos que debe cumplir un informe de

laboratorio, reflexionando sobre su importancia y el valor que aporta al Servicio de

Laboratorio Clínico.

Enlacehttps://www.researchgate.net/publication/265412294_El_informe_fisiopatologico_del_laboratorioDr_Santiago_Prieto_MencheroDra_Maria_Santiaga_Pacheco_DelgadoDra_Adela_Castaneda_de_la_Mata_Servicio_de_Laboratorio_Clinico_Hospital_Universitario_de_Fuenlabr

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Clin Chem Lab Med. 2017 Nov 27;56(1):e1-e4.

Handling the altered test results of hemolyzed samples. Recommendations of the Quality, Management, Safety and Evidence Committee (CCGSE) of the Spanish Association of Medical Biopathology and Laboratory Medicine (AEBM-ML)

Hemolysis is one of the major sources of error of the clinical laboratory, being the maincause of unsuitable samples for analysis. Several authors have proposed mathematicalequations that correct concentrations of several analytes affected, with particularrelevance for potassium. This document presents recommendations for management ofthose correction equations, which have been proposed by the quality committee,management, security and evidence of AEBM-ML: (1) It is recommended to prioritizethe preventive actions against corrective actions; (2) Each laboratory should estimate orverify the used correction equation according to its particular characteristics; (3) Thevalues stimated by the equation should not be informed. However, these data may bean useful clinical tool.

Abstract

ComentarioLa hemólisis, entendida como la rotura de eritrocitos y liberación de hemoglobina yotros constituyentes intracelulares al plasma circulante, constituye una de lasincidencias más frecuentes en el laboratorio, erigiéndose como una de las causas máshabituales de rechazo de muestras. El Comité de Calidad, Gestión, Seguridad yEvidencia (CCGSE) de la Asociación Española de Biopatología Médica– Medicina deLaboratorio (AEBM-ML) propone en el presente trabajo una serie recomendaciones demanejo ante los resultados alterados por muestras hemolizadas, incluyendo la actitudante la aplicación de ecuaciones de corrección de resultados.

Enlaceh>ps://www.degruyter.com/view/j/cclm.2018.56.issue-1/cclm-2017-0354/cclm-2017-0354.xml

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Clin Chem Lab Med. 2018 Nov 27;56(12):2015-2038

EFLM Paper Joint EFLM-COLABIOCLI Recommenda:on for venous blood sampling

This document provides a joint recommendation for venous blood sampling of the

European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working

Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for

Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical

Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that

blood collection is a safe and patient-centered procedure and provides practical

guidance on how to successfully overcome potential barriers and obstacles to its

widespread implementation. The target audience for this recommendation are

healthcare staff members directly involved in blood collection. This recommendation

applies to the use of a closed blood collection system and does not provide guidance for

the blood collection with an open needle and syringe and catheter collections.

Moreover, this document neither addresses patient consent, test ordering, sample

handling and transport nor collection from children and unconscious patients. The

recommended procedure is based on the best available evidence. Each step was

graded using a system that scores the quality of the evidence and the strength of the

recommendation. The process of grading was done at several face-to-face meetings

involving the same mixture of stakeholders stated previously. The main parts of this

recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Post-

sampling procedures and 4) Implementation. A first draft of the recommendation was

circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited

to comment the document. A revised version has been sent for voting on to all EFLM

and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21

COLABIOCLI members. We encourage professionals throughout Europe and Latin

America to adopt and implement this recommendation to improve the quality of blood

collection practices and increase patient and workers safety.

Abstract

ComentarioEl objetivo de este documento es proporcionar un conjunto de recomendaciones de

fácil comprensión, condensadas y basadas en la evidencia para el muestreo de sangre

venosa

Enlacehttps://www.researchgate.net/publication/326378790_EFLM_Paper_Joint_EFLM-COLABIOCLI_Recommendation_for_venous_blood_sampling

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Ann Clin Biochem. 2017 Jul;54(4):448-462

Effects of time and temperature on 48 routine chemistry, haematology and coagulation analytes in whole blood samples

Background: Phlebotomy for the purpose of blood analysis is often performed atremote locations, and samples are usually temporarily stored before transport to acentral laboratory for analysis. The circumstances during storage and shipment may notmeet the necessary requirements. If analysed anyway, false results may be generated.We therefore examined the influence of precentrifugation time and temperature of themost frequently requested tests in whole blood.Methods: Healthy volunteers donated blood in which 48 analytes were tested. Routinechemistry was performed in lithium heparin tubes, haematology inethylenediaminetetraacetic acid tubes, coagulation in citrate tubes and glucose insodium fluoride tubes. One tube was measured directly. The others were kept atdifferent temperatures (4, 8, 20 or 30℃) and stored for 4, 6, 8 or 24 h before analysis.Additionally, some analytes were examined at 12, 16, 24 and 28℃. The meanpercentage deviation was compared with different decision levels, including the totalallowable error.Results: When using the total allowable error as an acceptable limit, most of theinvestigated analytes remained stable. However, bicarbonate is unstable at almost alltested time-points and temperatures. Calcium, lactate dehydrogenase, potassium andsodium are particularly affected at low temperatures, while phosphate is mainly affectedat and above room temperature after 8 h.Conclusion: We established the influence of time and temperature on a broad range ofanalytes, which may be applied to set the limits in transportation and storage of wholeblood samples.

Abstract

ComentarioEn el presente estudio se evalúan un amplio rango de tiempos y temperaturas duranteel transporte de tubos de sangre en un conjunto de analítos de interés para ellaboratorio clínico, utilizando como criterio evaluador la desviación en base al error totaladmisible.

Enlaceh=ps://journals.sagepub.com/doi/abs/10.1177/0004563216665868?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed



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BMJ Qual Saf. 2017 Jun;26(6):484-494

The global burden of diagnos1c errors in primary care

Diagnosis is one of the most important tasks performed by primary care physicians. TheWorld Health Organization (WHO) recently prioritized patient safety areas in primarycare, and included diagnostic errors as a high-priority problem. In addition, a recentreport from the Institute of Medicine in the USA, ‘Improving Diagnosis in Health Care’,concluded that most people will likely experience a diagnostic error in their lifetime. Inthis narrative review, we discuss the global significance, burden and contributory factorsrelated to diagnostic errors in primary care. We synthesize available literature to discussthe types of presenting symptoms and conditions most commonly affected. We thensummarize interventions based on available data and suggest next steps to reduce theglobal burden of diagnostic errors. Research suggests that we are unlikely to find a‘magic bullet’ and confirms the need for a multifaceted approach to understand andaddress the many systems and cognitive issues involved in diagnostic error. Becauseerrors involve many common conditions and are prevalent across all countries, theWHO’s leadership at a global level will be instrumental to address the problem. Basedon our review, we recommend that the WHO consider bringing together primary careleaders, practicing frontline clinicians, safety experts, policymakers, the health ITcommunity, medical education and accreditation organizations, researchers frommultiple disciplines, patient advocates, and funding bodies among others, to addressthe many common challenges and opportunities to reduce diagnostic error. This couldlead to prioritization of practice changes needed to improve primary care as well assetting research priorities for intervention development to reduce diagnostic error.

Abstract

ComentarioLa presencia de un error de diagnóstico tiene lugar cuando el diagnóstico de unpaciente se omite por completo, se retrasa y/o es en definitiva incorrecto. En lapresente revisión se definen los distintos tipos de errores diagnósticos presentes en lapráctica clínica, así como su epidemiología, situaciones de riesgo y estrategias paraminimizar que estos tengan lugar.

Enlacehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502242/

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Clin Chem Lab Med 2018; 56(9): 1469–1475

Computer-assisted interventions in the clinical laboratory process improve the diagnosis and treatment of severe

vitamin B12 deficiency

Severe vitamin B12 deficiency can result in serious complications if undiagnosed or untreated. Ouraim was to test the efficacy of interventions in the laboratory process to improve the detection andthe treatment of severe vitamin B12 deficiency.Quasi-experimental investigation with a retrospective 7-year pre-intervention period and 29-monthpost-intervention follow-up in a university hospital. Two interventions were designed to improve thedetection and treatment of subjects with vitamin B12 deficiency: the laboratory information system(LIS) automatically added seru vitamin B12 (s-vitamin B12) based on certain conditions; andcreated a comment in the report and scheduled an appointment with the general practitioner (GP).We calculated the number of new diagnoses of severe vitamin deficiency (s-vitamin B12 <73.8pmol/L) and the proportion of identified patients that were correctly treated in the pre- and post-intervention periods. We compared the number of tests needed to detect a new case when orderedby GPs vs. added by the strategy. Finally, we investigated the economic cost of each new case.The strategy added 699 s-vitamin B12 and detected 66 new cases of severe vitamin deficiency. Thenumber of tests needed to identify a new case when s-vitamin B12 was ordered by GPs was 187,as opposed to 10 when added through the intervention (p<0.001). The intervention reagent costwas €26.7 per new case. In the post-intervention cohort, 88% of patients were correctly treated, asopposed to 52% in the pre-intervention (p<0.001). Interventions in the clinical laboratory processimproved the diagnosis and treatment of severe vitamin B12 deficiency.

Abstract

ComentarioEste trabajo describe una estrategia del laboratorio clínico para mejorar en la prevención ytratamiento del déficit severo de Vitamina B12. El avance de tecnologías y el desarrollo dealgoritmos informáticos deben servir para ayudar al laboratorio a contribuir en la mejora de laatención sanitaria prestada al paciente en la detección precoz de numerosas patologías.La necesidad de evitar errores en atención primaria y de desarrollar técnicas que mejoren laatención ya fue descrita, entre otros, por Hardeep Singh et al (Singh, H., Schiff, G. D., Graber, M.L., Onakpoya, I., y Thompson, M. J. (2017). The global burden of diagnostic errors in primary care.BMJ Qual Saf, 26(6), 484-494). En España, la atención primaria está limitada por diversos factorescomo el tiempo por paciente, petitorio de algunas pruebas diagnósticas, etc.Como demuestra este trabajo, el laboratorio clínico puede ejercer un papel fundamental dentro dela medicina de atención primaria. Por un lado, se ha visto que una colaboración entre ambasespecialidades puede ayudar a anticipar la detección de patologías e instaurar el correctotratamiento. Se trata de intervenciones que no llevan consigo un elevado gasto sanitario, sino todolo contrario.

EnlacehFps://www.degruyter.com/view/j/cclm.2018.56.issue-9/cclm-2017-1116/cclm-2017-1116.xml

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JAMA. 1982;247(18):2543-2546

Evalua&ng the Yield of Medical Tests

A method is presented for evaluating the amount of information a medical test providesabout individual patients. Emphasis is placed on the role of a test in the evaluation ofpatients with a chronic disease. In this context, the yield of a test is best interpreted byanalyzing the prognostic information it furnishes. Information from the history, physicalexamination, and routine procedures should be used in assessing the yield of a newtest. As an example, the method is applied to the use of the treadmill exercise test inevaluating the prognosis of patients with suspected coronary artery disease. Thetreadmill test is shown to provide surprisingly little prognostic information beyond thatobtained from basic clinical measurements..

Abstract

ComentarioEn este artículo clásico se reflexiona sobre la importancia de integrar la informaciónclínica del paciente en la interpretación de la información aportada por los testdiagnósticos. Se propone un método de evaluación, que comprende el establecimientode la información previa del paciente, la codificación de resultados, la cuantificación dela información adicional y significativa proporcionada por nuevos test y la cuantificaciónde información adicional, todo ello bajo una propuesta de análisis estadístico deregresión.

Enlacehttps://jamanetwork.com/journals/jama/article-abstract/372568

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PLoS Med. 2005 Aug;2(8):e124

Why Most Published Research Findings Are False

There is increasing concern that most current published research findings are false. Theprobability that a research claim is true may depend on study power and bias, thenumber of other studies on the same question, and, importantly, the ratio of true to norelationships among the relationships probed in each scientific field. In this framework, aresearch finding is less likely to be true when the studies conducted in a field aresmaller; when effect sizes are smaller; when there is a greater number and lesserpreselection of tested relationships; where there is greater flexibility in designs,definitions, outcomes, and analytical modes; when there is greater financial and otherinterest and prejudice; and when more teams are involved in a scientific field in chase ofstatistical significance. Simulations show that for most study designs and settings, it ismore likely for a research claim to be false than true. Moreover, for many currentscientific fields, claimed research findings may often be simply accurate measures ofthe prevailing bias. In this essay, I discuss the implications of these problems for theconduct and interpretation of research.

Abstract

ComentarioSe realiza en el trabajo propuesto una interesante reflexión sobre la naturalezaesencialmente incorrecta de gran parte de los resultados aportados por la literaturacientífica en la actualidad, sobre sus causas y posible repercusión. Se muestranejemplos y análisis estadísticos para corroborar sus propuestas, al tiempo que seproponen diferentes medidas para minimizar los efectos descritos.

Enlaceh8ps://journals.plos.org/plosmedicine/arDcle?id=10.1371/journal.pmed.0020124



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BMJ Qual Saf. 2013 Oct;22 Suppl 2:ii6-ii10

When diagnos,c tes,ng leads to harm: a new outcomes-based approach for laboratory medicine

Many diagnostic errors are associated with laboratory testing, and many of these arepreventable. However, a reduction in testing-related diagnostic errors (TDE) is hinderedby the absence of a well-defined relationship between diagnostic harm and the testingprocess (whether from laboratory or non-laboratory sources) as well as by a lack ofrelevant measures for evaluation. The goal of this paper is to review current models thatdescribe the testing process, and then propose a different approach to facilitate thereduction of diagnostic errors and harm related to diagnostic testing. We thendemonstrate how this approach can be used to develop measures that may improvepatient outcomes and guide future research to reduce TDE. Finally, we highlight theneed for collaboration between clinicians and laboratory physicians and scientists toachieve these goals.

Abstract

ComentarioLos errores en las solicitudes al laboratorio clínico y la interpretación incorrecta de losresultados obtenidos contribuyen de manera muy importante a los erroresdiagnósticos. En el presente estudio se evalúan las principales causas de los erroresdiagnósticos con su base en los resultados de laboratorio, y se aborda una estrategiasegún la cual los clínicos y los profesionales de laboratorio han de trabajar de formaconjunta para proporcionar ya no resultados, sino diagnósticos certeros de manerarápida y eficiente, favoreciendo además la elección de tratamientos adecuados y unaefectiva monitorización.

Enlacehttps://qualitysafety.bmj.com/content/22/Suppl_2/ii6

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Clin Chem Lab Med. 2018; 56:403-412

Reaching consensus on communication of critical laboratory results using a collective intelligence method

Background: There is no consensus in the literature about what analytes or valuesshould be informed as critical results and how they should be communicated. The mainaim of this project is to establish consensual standards of critical results for thelaboratories participating in the study. Among the project's secondary objectives,establishing consensual procedures for communication can be highlighted.Methods: Consensus was reached among all participating laboratories establishing thebasis for the construction of the initial model put forward for consensus in conjunctionwith the clinicians. A real-time Delphi, methodology "health consensus" (HC), withmotivating and participative questions was applied. The physician was expected tochoose a numeric value within a scale designed for each analyte.Results: The medians of critical results obtained represent the consensus on criticalresults for outpatient and inpatient care. Both in primary care and in hospital care a highdegree of consensus was observed for critical values proposed in the analysis ofcreatinine, digoxin, phosphorus, glucose, international normalized ratio (INR),leukocytes, magnesium, neutrophils, chloride, sodium, calcium and lithium. For the restof critical results the degree of consensus obtained was "medium high". The resultsobtained showed that in 72% of cases the consensual critical value coincided with themedians initially proposed by the laboratories.Conclusions: The real-time Delphi has allowed obtaining consensual standards forcommunication of critical results among the laboratories participating in the study, whichcan serve as a basis for other organizations.

Abstract

ComentarioLa gestión de los valores críticos por parte del laboratorio clínico y su rápidacomunicación al clínico contribuye de forma importante a la seguridad del paciente. Lacooperación entre el clínico y el laboratorio es esencial, siendo responsabilidad de esteúltimo evaluar como el clínico interpreta estos valores y prioriza la atención al paciente.Se muestra en el texto propuesto el empleo de métodos basados en la inteligenciacolectiva basados en metodología Delphi como herramienta de evaluación y consenso.

Enlaceh:ps://www.ncbi.nlm.nih.gov/pubmed/29055937

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