Association between cardiometabolic comorbidities and Parkinson's disease in a Mexican population.

BACKGROUND: The prevalence of Parkinson's disease (PD) increases as the population ages. Studies have shown that some cardiometabolic comorbidities could be associated with risk or protection against developing PD. A retrospective case-control study was carried out to analyze the relationship between PD and cardiometabolic comorbidities. MATERIAL AND METHODS: Subjects with PD and controls without PD were consecutively recruited. Data on type 2 diabetes mellitus, systemic arterial hypertension (SAH), dyslipidemia and body mass index were collected. Logistic regression analyses were carried out. RESULTS: A total of 781 subjects with PD (56.5% males) and 1,000 controls (44.4% males) were included. After adjusting for age and gender, SAH was found as an independent risk factor (OR: 1.32; 95% CI: 1.05-1.67; p = 0.02), and obesity as a protective factor (OR: 0.72; 95% CI: 0.56-0.93; p = 0.01). CONCLUSIONS: Subjects with SAH had a higher risk of having PD, while obese subjects had a lower risk of having PD. The relationship between cardiometabolic disease, its treatment, and PD etiopathogenesis appears to be extremely complex given the amount of contradictory data.

ANTECEDENTES: La prevalencia de la enfermedad de Parkinson (EP) aumenta a medida que la población envejece. Los estudios han demostrado que algunas comorbilidades cardiometabólicas pudieran estar asociadas con el riesgo o la protección de desarrollar la EP. Se realizó un estudio retrospectivo de casos y controles para analizar la relación entre la EP y las comorbilidades cardiometabólicas. MATERIAL Y MÉTODOS: Se reclutaron sujetos con EP y controles sin EP de forma consecutiva. Se recolectaron datos sobre diabetes mellitus tipo 2, hipertensión arterial sistémica (HTA), dislipidemia e índice de masa corporal. Se llevó a cabo análisis de regresión logística. RESULTADOS: Se incluyeron un total de 781 personas con EP (56,5% hombres) y 1,000 controles (44,4% hombres). Después de ajustar por edad y sexo, la HTA se encontró como factor de riesgo independiente (OR 1.32, IC 95% 1.05-1.67, p = 0.02) y la obesidad como factor protector (OR 0.72, IC 95% 0.56-0.93, p = 0.01). CONCLUSIONES: Los sujetos con HTA tienen un mayor riesgo de tener EP; mientras que los sujetos obesos tienen un menor riesgo de tener EP. La relación entre la enfermedad cardiometabólica, su tratamiento y etiopatogenia de la EP parece ser extremadamente compleja dada la cantidad de datos contradictorios.

Association Between Somatization and Nonmotor Symptoms Severity in People With Parkinson Disease.

OBJECTIVE: To assess the frequency of somatization and its association with motor, nonmotor symptoms, and quality of life in persons with Parkinson disease (PD). METHODS: A cross-sectional case-control study was carried out. Assessments included the List of 90 Symptoms somatic factor (SCL-90-R SOM), Movement Disorder Society Unified Parkinson's Ratings Scale (MDS-UPDRS), Non-Motor Symptom Scale (NMSS), Montreal Cognitive Assessment (MoCA), and Parkinson Questionnaire-8 (PDQ-8). RESULTS: A total 93 persons with PD and 93 controls were included. Somatization within the PD group was 2 times more frequent compared to the control group (43% vs 21.5%, P = .003). Persons with PD had higher NMSS total scores (48.6 ± 42.6 vs 28.3 ± 30.4, P = .001). Patients with PD with somatization had worst MDS-UPDRS, NMSS, MoCA, and PDQ-8 (all P < .05). CONCLUSION: Somatization is more frequent in persons with PD compared to healthy controls. Somatization in PD is associated with nonmotor symptoms and worst quality of life.

(Sobre)vivir la COVID-19. Experiencias de encierro en centros penitenciarios de la Ciudad de México / Survive the COVID-19. Experiences of confinement in penitentiary centers in Mexico City / (Sobre)viure la COVID-19. Experiències del tancament en centres penitenciaris de la Ciutat de Mèxic

Se presenta una reflexión de la valía e importancia de los talleres de filosofía, inscritos en el Proyecto Boecio, que se han llevado a cabo en el Reclusorio Femenil de Santa Martha Acatitla y Reclusorio Varonil Oriente, ambos en Ciudad de México. Se mencionarán los contenidos y aprendizajes de dichos talleres, los cuales han sido significativos para las personas privadas de su libertad, para sobrellevar su proceso judicial, y el sobrevivir su "encierro", así como también, la manera en que sus familiares y amistades han sido beneficiados con dichos aprendizajes de sus seres queridos en reclusión, al brindarles herramientas para sobrellevar el estar "encerrados en casa" por la cuarentena de la COVID-19

This is a reflection about the value and importance of the philosophy workshops, registered in the Boethius Project, which have been carried out at the Santa Martha Acatitla's Womens Prison and East Men's Prison both of them in Mexico City. The contents and learning from these workshops will be mentioned, which have been signicant for the people in prison, to survive their judicial process and "confinement", as well as the way in which their family and friends have been benefitied with these learnings from their loved ones in jail, by providing then with tools to support "Stay in home" by the COVID-19 quarantine

Es presenta una reflexió de la importància dels tallers de filosofia, inscrits en el Projecte Boeci, que s'han dut a terme en el Reclusorio Femenil de Santa Martha Acatitla y Reclusorio Varonil Oriente, tots dos a Ciutat de Mèxic. Es parlarà dels continguts I aprenentatges d'aquests tallers, els quals han estat significatius per a les persones privades de la seva llibertat, per suportar el seu procés judicial, I sobreviure el seu "tancament", així com també, la manera en què els seus familiars I amistats s'han beneficiat d'aquests aprenentatges dels seus éssers estimats en reclusió, en poder brindar-los eines per a suportar l'estar "tancats a casa" per la quarantena de la COVID-19

Malnutrition and Associated Motor and Non-motor Factors in People with Parkinson's Disease.

BACKGROUND: People with Parkinson's disease (PwP) are at higher risk of developing malnutrition. Several factors have been suggested to be involved including motor symptoms, non-motor symptoms, and treatment-related complications. OBJECTIVE: The objective of the study was to analyze the combined effect of motor, non-motor, and pharmacological factors in the risk of malnutrition in PwP. METHODS: Eighty-seven consecutive PwP were included in the study. Clinical data and pharmacological treatment were collected. Nutritional status was assessed using the Mini-Nutritional Assessment (MNA) questionnaire. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Non-motor Symptoms Scale (NMSS), Hamilton Depression Rating Scale HAM-D, and Montreal Cognitive Assessment were applied. RESULTS: Thirty (34.4%) PwP were at risk of malnutrition and seven had malnutrition (8%). Abnormal nutritional status was associated with lower education, higher MDSUPDRS Parts I, II, and III and total scores, and higher scores in the NMSS domain of sleep disorders and fatigue. MDS-UPDRS motor score remained as a determinant of abnormal nutritional status, defined as MNA < 23.5, with an odds ratio 1.1 (95% confidence interval 1.01-1.10, p = 0.02). CONCLUSION: The main factor associated with nutritional status was severity of the motor symptoms as assessed by the MDS-UPDRS Part III. Non-motor symptoms and treatment-related complications were not associated with malnutrition.

Mexican Concensus of Multiple Myeloma.

To identify this increasingly common pathology, known as multiple myeloma (MM), it is necessary to refer to the specific factors that characterize it; to this end, the classic criteria known as CRAB (hyperkalemia, renal failure, anemia, and lytic lesions) are available, in which renal failure is one of the most frequent complications. Recently, three indisputable biomarkers have been described for the diagnostic support for MM, which are: more than 10% of clonal plasma cells in bone marrow or, a biopsy that corroborates the presence of a plasmacytoma, light chain ratio ≥ 100 mg/dL and more than one focal lesion on magnetic resonance imaging. A differential diagnosis for plasma cell leukemia, solitary bone plasmacytoma, and extramedullary plasmacytoma should always be considered. Being this an incurable disease, a lot of research has been done regarding its therapeutic management, whose main objective is the disappearance of plasma cells and the patient clinical improvement. Melphalan was the first drug that showed a benefit in 1958 and afterward, with the addition of a steroid as a second drug, it was possible to improve response rates. Subsequently, different molecules were studied, forming multiple combinations, and achieving better rates of overall survival and progression-free survival. Years later, with the arrival of proteasome inhibitors such as bortezomib, and immunomodulators such as thalidomide and lenalidomide, an important turnaround in the disease has been seen, as deeper responses, more prolonged remissions, and improvement in the quality of life of patients have been achieved. This consensus has the purpose of integrating a group of Mexican specialists and promoting the updating of this pathology.

Para identificar una patología cada vez más común, conocida como mieloma múltiple, es necesario hacer alusión de los factores específicos que la caracterizan. Para ello existen los clásicos criterios conocidos como CRAB (hipercalcemia, insuficiencia renal, anemia y lesiones líticas), siendo la insuficiencia renal una de sus complicaciones más frecuentes. Recientemente se han descrito tres biomarcadores indiscutibles para el apoyo diagnóstico del mieloma múltiple, que son: más del 10% de células plasmáticas clonales en medula ósea o biopsia que corrobora la presencia de un plasmocitoma, relación de cadenas ligeras ≥ 100 mg/dl y más de una lesión focal en resonancia magnética. Se debe tomar siempre en cuenta el diagnóstico diferencial con leucemia de células plasmáticas, plasmocitoma óseo solitario y plasmocitoma extramedular. Al ser una enfermedad incurable, se ha investigado mucho en cuanto al manejo terapéutico, el cual tiene como objetivo principal la desaparición de las células plasmáticas y la mejoría clínica del paciente. El primer fármaco que demostró algún beneficio fue el melfalán en el año 1958 y posteriormente al adicionar un esteroide como segundo fármaco se logró mejorar las tasas de respuesta. Después se fueron estudiando diferentes moléculas, con las que se han realizado múltiples combinaciones, alcanzando mejores tasas de supervivencia global y supervivencia libre de progresión. Años más tarde, con la llegada de los inhibidores de proteosoma como el bortezomib, así como de los agentes inmunomoduladores como la talidomida y la lenalidomida, se presenta un giro importante en la enfermedad, ya que se logran respuestas más profundas, periodo de remisiones más prolongadas y mejoría en la calidad de vida de los pacientes. Este consenso tiene la finalidad de integrar a un grupo de especialistas mexicanos y promover la actualización de esta patología.

Malnutrition and Associated Motor and Non-motor Factors in People with Parkinson's Disease

Background: People with Parkinson’s disease (PwP) are at higher risk of developing malnutrition. Several factors have been suggested to be involved including motor symptoms, non-motor symptoms, and treatment-related complications. Objective: The objective of the study was to analyze the combined effect of motor, non-motor, and pharmacological factors in the risk of malnutrition in PwP. Methods: Eighty-seven consecutive PwP were included in the study. Clinical data and pharmacological treatment were collected. Nutritional status was assessed using the Mini-Nutritional Assessment (MNA) questionnaire. Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Non-motor Symptoms Scale (NMSS), Hamilton Depression Rating Scale HAM-D, and Montreal Cognitive Assessment were applied. Results: Thirty (34.4%) PwP were at risk of malnutrition and seven had malnutrition (8%). Abnormal nutritional status was associated with lower education, higher MDS-UPDRS Parts I, II, and III and total scores, and higher scores in the NMSS domain of sleep disorders and fatigue. MDS-UPDRS motor score remained as a determinant of abnormal nutritional status, defined as MNA <23.5, with an odds ratio 1.1 (95% confidence interval 1.01-1.10, p = 0.02). Conclusion: The main factor associated with nutritional status was severity of the motor symptoms as assessed by the MDS-UPDRS Part III. Non-motor symptoms and treatment-related complications were not associated with malnutrition. (REV INVEST CLIN. 2020;72(5):293-9)

Impact of implementing a category 1 external quality assurance scheme for monitoring harmonization of clinical laboratories in Spain.

Background: The objective of the present study was to examine the evolution of the analytical performance specifications (APS) used in External Quality Assurance (EQA) schemes, as well as the efficacy of a category 1 EQA scheme in monitoring the harmonization of clinical laboratory results in Spain. Methods: A review of the literature on the types of quality specifications used in schemes in other countries and their evolution was performed. In addition, a comparative analysis of the potential impact that different APS from eight countries had on clinical decision-making was made based on three measurands: sodium, thyroid-stimulating hormone (TSH), and activated partial thromboplastin time (aPTT). Results: Harmonization of analytical methods was demonstrated by assessing whether average results deviated from the certified reference value of control materials within the APS derived from biological variation (BV). The APS used in EQA have evolved from state-of-the-art models to BV. Poor clinical decision-making would occur if the results accepted by some APS were applied. Conclusions: In Spain, only 2 of the 18 measurands studied are considered to be well harmonized. Closer collaboration between laboratories and analytical system providers would be required to resolve discrepancies.

Spanish society of laboratory medicine external quality assurance programmes: evolution of the analytical performance of clinical laboratories over 30 years and comparison with other programmes.

The purpose of this study is to understand the evolution of the analytical performance of the laboratories participating in the Spanish society of laboratory medicine (SEQCML) external quality assurance (EQA) programmes during its 30 years of operation and to compare it with the performance of other EQA programmes to establish whether the results are similar. The results obtained during this period are evaluated by applying the biological variability (BV) and state of the art-derived quality specifications. In addition, the results are compared with those obtained by other EQA programme organisations. It is noted that the laboratories participating in the EQA-SEQCML programmes have improved their performance over 30 years of experience and that the specifications derived from biological variation are achievable. It is difficult to compare EQA programmes, due to lack of accessibility and the differences in the design of these programmes (control materials, calculations used and analytical specifications established). The data from this study show that for some biological magnitudes the results obtained by the programmes are not yet harmonised, although efforts are being made to achieve this. Organisers of EQA programmes should also join the harmonisation effort by providing information on their results to enable comparison.

Pruebas Terapéuticas Con Fines Diagnósticos En Trastornos Del Movimiento / Therapeutic Tests For The Diagnosis Of Movement Disorders

Resumen El diagnóstico en medicina tiene su piedra angular en la obtención de la historia clínica y la exploración física; sin embargo, en algunas de las patologías el uso de pruebas diagnósticas es de gran utilidad como apoyo para confirmar o descartar una enfermedad. Las pruebas diagnósticas incluyen una amplia variedad de procedimientos y dentro de estas se incluyen las pruebas terapéuticas, también llamadas desafíos o retos, en los que se administra una sustancia activa para evaluar la respuesta y apoyar la impresión diagnóstica. En el contexto de los trastornos del movimiento las pruebas terapéuticas más frecuentemente utilizadas son la de levodopa, apomorfina y etanol. En esta revisión se presenta, describe y discute el alcance y utilidad de estas.

Abstract The diagnosis in medicine has its cornerstone in obtaining the clinical history and in the physical examination. However, in some of the pathologies the use of diagnostic tests is very useful as a support to confirm or rule out a disease. Diagnostic tests include a wide variety of procedures and these include therapeutic tests, also called challenges, in which an active substance is administered to evaluate the response and support the presumptive diagnosis. In the context of movement disorders, the most frequently used therapeutic tests are those with levodopa, apomorphine and ethanol. In this review we present, describe and discuss the scope and usefulness of these challenges.

State-of-the-art Approach to Goal Setting.

Four external quality assurance programs combined their data to calculate the minimum acceptable quality specifications for laboratory testing. Other sources of quality specifications may be too stringent for the current market, or too lenient given the clinical demands on the test result, but these state-of-the-art goals may be practical and useful. Two main approaches were used: (1) defining the 95% percentile and comparing with other quality specifications, and (2) using an iterative approach to increase the quality specification until 90% of laboratories could achieve 75% of their results within the specification. 72 out of 82 analytes followed procedure 2.

Respuesta de los autores «Ventajas del control de calidad interno de gestión externa» / Reply for author «Advantages of externally managed internal quality control»

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Control interno de la calidad vs control externo de la calidad / Internal quality control vs external quality control

El control interno de la calidad es el procedimiento que monitoriza la calidad de los resultados y permite aceptar o rechazar las series analíticas. Existen 2 variedades, el modelo de gestión interna, donde el tratamiento estadístico de los resultados control se realiza únicamente con los datos obtenidos por el propio laboratorio, y el control interno con gestión externa, donde el procesamiento estadístico se realiza con los datos obtenidos por el propio laboratorio y por otros laboratorios. Ambos sirven para calcular la imprecisión analítica y no son adecuados para evaluar el error total ni el sesgo. El control externo de la calidad es la determinación del desempeño de cada laboratorio mediante la comparación con otros laboratorios. Existen 3 modelos, los 2 primeros: evaluación externa de la calidad y ensayo de aptitud son muy similares, y se centran en las prestaciones analíticas, mientras que el tercero, denominado garantía externa de la calidad, tiene en cuenta todas las fases del laboratorio. Con el control externo de la calidad, en cualquiera de sus modelos, se mide el error total de cada mensurando, porque la muestra de control, que es ciega para el participante, se analiza una única vez. A largo plazo, cuando se dispone de todos los resultados del programa, se puede medir el error sistemático o sesgo. A la luz de los requisitos legales vigentes, las buenas prácticas del laboratorio y los artículos de referencia internacionales, el control interno de la calidad no es ni sustituye al control de la calidad externo (AU)

Internal quality control is the procedure used for monitoring the analytical process and to accept or reject the analytical run. There are two models: internal quality control that exclusively uses the control results from the own laboratory, and internal control externally managed, that also uses control data from other laboratories reported to an external organization. Both of them measure the analytical imprecision but are not adequate to estimate neither bias nor inaccuracy (total error). External quality control evaluates the laboratory performance by comparing with other laboratories, through an external organization. There are three models, external quality assessment and proficiency testing which are almost the same and are focused on the analytical process and external quality assurance that applies to all laboratory processes. The three models of external control measure total error, because the control sample (blind for the laboratory) is tested in singleton. At long-term, when all results for one cycle are available, laboratory bias may also been calculated. From the light of legal requirements, good laboraotry practices and papers from widely accepted authors, internal quality control is not and do not substitute external quality control (AU)

Adenoma quístico de paratiroides: a propósito de un caso / Cystic parathyroid adenoma: report of a case

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Grado de implantación de especificaciones de la calidad analítica en España / Level of implementation of analytical quality specifications in Spain

Objetivos: Este trabajo pretende conocer el grado de implantación de las especificaciones de la calidad en los laboratorios clínicos de España y concretamente de las especificaciones mínimas de la calidad analítica consensuadas por el Comité de Expertos Interdisciplinar sobre Especificaciones de la Calidad (CEIEC) en el Laboratorio Clínico, así como la opinión del sector respecto a la necesidad del establecimiento de valores preceptivos de requisitos de la calidad analítica: Material y método: Se diseñó una encuesta que constaba de 22 preguntas, 4 de ellas de tipo descriptivo, 16 retrospectivas y 2 prospectivas. El periodo de recogida de respuestas fue de septiembre a noviembre de 2012. Como requisito de los encuestados solo se consideró que participasen en algún programa de intercomparación de las sociedades científicas españolas representadas en el citado comité. El número de encuestas remitidas fue de 1.738. Resultados: Se recibieron 340 respuestas (19,6% del total). El 59% de los que respondieron tiene implantado un sistema de reconocimiento formal de la calidad. El 83% comprueba si cumplen o no con las especificaciones, el 68% dispone de un compromiso documental de cumplirlas y el 64% ha elaborado el listado con los valores concretos de especificaciones. El 55% conoce la existencia de unas especificaciones mínimas de la calidad consensuadas por el CEIEC. El 49% estaría de acuerdo en que estas especificaciones fueran preceptivas, mientras que el 33% no se define (AU)

Objectives: This work aims to determine the level of implementation of analytical quality specifications in Spanish clinical laboratories and, in particular, the minimum analytical quality specifications obtained by consensus of the Interdisciplinary Expert Committee on Quality Specifications (CEIEC) in the Clinical Laboratory, as well as to determine the opinions of the professionals as regards establishing mandatory analytical quality specifications.. Material and method: A questionnaire was designed including 4 descriptive, 16 retrospective, and 2 prospective questions. The responses were collected during September to November 2012. The requirement for participating was to be involved in an intercomparison program of any of the 4 Spanish scientific societies represented on the abovementioned committee. A total of 1,738 questionnaires were sent. Results: A total of 340 responses (19.6% over the total) were received. The results showed that 59% of respondents have a formally recognized quality system. The attainment of predefined specifications was checked by 83%, with 68% having a commitment for documented quality specifications, and 64% had made a list with specification values. A majority (55%) is aware of the existence of the consensus minimum quality specifications of the CEIEC, and 49% would agree that these specifications should become mandatory, while 33% did not declare a clear position on this subject (AU)

New surgical approach of retrorectal cystic hamartoma using transanal minimally invasive surgery (TAMIS) / Nova abordagem cirúrgica do hamartoma cístico retrorretal usando cirurgia transanal minimamente invasiva (TAMIS)

Introduction: Tailgut cysts or cystic hamartomas are rare developmental tumors of the pre-sacral space. Their true incidence is not well known but we must think on it when we have a patient with a multicystic uncapsulated tumor at presacral space. Tailgut cysts are often asymptomatic, and in other cases present with chronic perineal pain, constipation or rectal tenesmus. They must be treated to avoid complications such as infections (perianal fistula or abscess) and malignant degenerations (usually adenocarcinoma). Case report: One patient with anal pain was diagnosed with a perianal abscess. He was operated but at the second month review a MRI revealed a multilocular lesion in the presacral suggesting the presence of a retrorectal cystic hamartoma. An elective operation was performed by endoanal surgical approach using TAMIS. En bloc resection of the cyst was achieved with safe margins. The pathology result reported retrorectal cystic hamartoma. The patient was asymptomatic with no signs of recurrence in subsequent controls. Our experience, despite being based on one case, is evidence that TAMIS (Transanal Minimally Invasive Surgery) allows a minimally invasive dissection with similar benefits as the use of TEM/TEO devices. (AU)

Introdução: Tail gut cysts ou hamartomas císticos são tumores raros de desenvolvimento do espaço pré-sacral. Sua verdadeira incidência não é bem conhecida, mas devemos pensarnele quando temos um paciente com um tumor uncapsulated multicística no espaço présacral. Hamartomas císticos são muitas vezes assintomáticas, em outros casos, apresentase com dor perineal crônica, constipação ou tenesmo retal. Eles devem ser tratados para evitar complicações, como infecções (fístula perianal ou abscesso) e degenerações malignas (geralmente adenocarcinoma). Relato de Caso: Um paciente com dor anal foi diagnosticado com um abscesso perianal. Ele foi operado, mas na revisão do segundo mês uma ressonância magnética revelou uma lesão multilocular no pré-sacral, sugerindo a presença de um hamartoma cístico retrorretal. Uma operação eletiva foi realizada por abordagem cirúrgica endoanal usando TAMIS. A resseção em bloco do cisto foi conseguido com margens seguras. O resultado do exame patológico relatou hamartoma cístico retrorretal. O paciente encontrava-se assintomático, sem sinais de recidiva em controles posteriores. A nossa experiência, apesar de ser baseado em um dos casos, as provas que TAMIS (cirurgia transanal minimamente invasiva) permite um esvaziamento minimamente invasivo com benefícios similares como o uso de dispositivos de MET/TEO. (AU)

Actualización de las especificaciones de la calidad analítica 2014. Consenso de las Sociedades Científicas nacionales / Updates of analytical quality specifications 2014. Consensus of national scientific societies

El objetivo de este estudio es calcular las especificaciones mínimas de la calidad (EMC) en bioquímica de orina, hemoglobina glucosilada en sangre y diversas determinaciones hematológicas, comparar estas especificaciones con las publicadas por organizaciones de diversos países y actualizar el listado con las 80 magnitudes estudiadas. Los materiales empleados en este estudio son todos los resultados de las EMC incluidas en los programas de garantía externa de la calidad organizadas por 4 sociedades científicas españolas, obtenidos desde 2007 hasta 2010. El número total de resultados obtenidos para hemoglobina glucosilada es de 13.054, para orina según cada magnitud va desde 14.180 (albúmina) hasta 20.594 (creatinina), y en hematología desde 1.839 (hemoglobina fetal) a 6.961 (antitrombina). Se concluye que cumplir la EMC de hemoglobina glucosilada no es suficiente para asegurar la calidad analítica según criterios clínicos, mientras que sí lo garantizan las EMC de orina; las magnitudes de hematología estudiadas en esta fase no pudieron compararse con especificaciones de obligado cumplimiento en otros países (no se encuentran publicadas), y algunas de ellas podrían requerir el cálculo de especificaciones diferentes para distintos niveles de concentración (AU)

The aim of this study is to calculate minimum quality specifications (MQS) in urine biochemistry, blood glycosylated hemoglobin and several hematological analytes, and to compare these specifications with those from other countries, as well as to update the values for the 80 analytes studied. Materials used in this work are the results from laboratories participating in the external quality assurance programs organized by four Spanish scientific societies, and obtained in the time period 2007-2010. A total of 13,054 results were obtained for glycosy-lated hemoglobin, and from 14,180 (albumin) to 20,594 (creatinine) for urine biochemistry, andfor hematology, from 1,839 (fetal hemoglobin) to 6,961 (antithrombin).The conclusions found were: to achieve the MQS for glycosylated hemoglobin does not ensure meeting clinical requirements, whereas MQS for urine biochemistry also meet the requirements based on biological variation. The MQS studied in this work could not be compared witht hose from other countries (there are no published values), and some of them could require calculations stratified according to several concentration levels (AU)

Aplicación práctica de las especificaciones mínimas de la calidad analítica obtenidas por consenso / Application of the minimum specifications for analytical quality obtained by consensus

Cuatro sociedades científicas españolas, organizadoras de programas de garantía externa de la calidad en el ámbito del laboratorio clínico, crearon un grupo de trabajo para definir y divulgar especificaciones mínimas de la calidad analítica obtenidas por consenso (EMC) elaboradas con base en los resultados de sus programas de garantía externa de la calidad durante el período 2005-2010. Se definieron EMC para 60 magnitudes. En este trabajo se dan unas directrices sobre cómo utilizar estas especificaciones en la práctica diaria del laboratorio clínico. Se concluye que ante un resultado de un programa de evaluación externa con un error total superior a la EMC el laboratorio realizará un análisis de causas y establecerá las acciones correctivas oportunas para evitar que esta circunstancia vuelva a ocurrir. El cumplimiento de las EMC es un requisito necesario pero no suficiente en el sistema de la calidad del laboratorio. Debido a su condición de mínimas no deberían utilizarse como un objetivo de la calidad (AU)

A working group was created to define and explain the minimum specifications for analytical quality obtained by consensus (MSC) by the four Spanish scientific societies that organise external quality assurance programs in laboratory medicine. The basis of these MSC were results obtained in the external programs of the 2005-2010 period, and were defined for 60 analytes. This paper gives guidelines on how the individual laboratory should use these specifications in its daily routine. It is concluded that laboratories should perform a cause analysis study and take the appropriate corrective action when a single result in an external program falls outside the MSC for an analyte. Fulfilling MSC is a necessary -but not sufficient- requirement in the laboratory quality system, but due to its condition of ‘minimum quality’ they should not be used as quality goals (AU)

Minimum analytical quality specifications of inter-laboratory comparisons: agreement among Spanish EQAP organizers.

BACKGROUND: Four Spanish scientific societies organizing external quality assessment programs (EQAP) formed a working group to promote the use of common minimum quality specifications for clinical tests. Laboratories that do not meet the minimum specifications are encouraged to make immediate review of the analytical procedure affected and to implement corrective actions if necessary. METHODS: The philosophy was to use the 95th percentile of results sent to EQAP (expressed in terms of percentage deviation from the target value) obtained for all results (except the outliers) during a cycle of 1 year. The target value for a number of analytes of the basic biochemistry program was established as the overall mean. However, because of the substantial discrepancies between routine methods for basic hematology, hormones, proteins, therapeutic drugs and tumor markers, the target in these cases was the peer group mean. RESULTS: The resulting specifications were quite similar to those established in the US (CLIA), and Germany (Richtlinie). CONCLUSIONS: The proposed specifications stand for the minimum level of quality to be attained for laboratories, to assure harmonized service performance. They have nothing to do with satisfying clinical requirements, which are the final level of quality to be reached, and that is strongly recommended in our organizations by means of documents, courses, symposiums and all types of educational activities.