[Critical reading of articles about diagnostic tests (part I): Are the results of the study valid?]. / Lectura crítica de artículos de pruebas diagnósticas I: ¿Son válidos los resultados del estudio?

In the era of evidence-based medicine, one of the most important skills a radiologist should have is the ability to analyze the diagnostic literature critically. This tutorial aims to present guidelines for determining whether primary diagnostic articles are valid for clinical practice. The following elements should be evaluated: whether the study can be applied to clinical practice, whether the technique was compared to the reference test, whether an appropriate spectrum of patients was included, whether expectation bias and verification bias were limited, the reproducibility of the study, the practical consequences of the study, the confidence intervals for the parameters analyzed, the normal range for continuous variables, and the placement of the test in the context of other diagnostic tests. We use elementary practical examples to illustrate how to select and interpret the literature on diagnostic imaging and specific references to provide more details.

Desarrollo de una propuesta para la implementación de un sistema de gestión de la calidad en un laboratorio clínico en caracas-venezuela / Development of a purpose for the implementation of a quality managment system in a clinical laboratory in caracas-venezuela

Los Laboratorios Clínicos requieren Sistemas de Gestión de la Calidad (SGC) para operar de manera óptima y eficiente. Actualmente pocos laboratorios en Venezuela, trabajan con SGC formales, por ello se planteó elaborar un diagnóstico para generar propuestas del SGC actual en un laboratorio clínico a través de una Lista de Verificación (LV) elaborada según la Norma COVENIN/ISO 15189-2007. La LV fue completada a través de entrevistas con el coordinador del laboratorio y la demostración de evidencias de cumplimiento de los requisitos del SGC descritos en la norma seleccionada. Se tabularon los resultados obtenidos y se elaboró un diagrama de causa-efecto y un diagrama de Pareto para jerarquizar y determinar las causas de las no conformidades en el SGC actual. Los resultados obtenidos reflejaron la carencia de un SGC adecuado, ya que se obtuvo que un 77% de los requisitos no están implementados ni documentados, un 11,4% están documentados pero no implementados y solo un 3,4% están implementados y documentados (8,2%) de las clausulas no aplican al laboratorio estudiado. De acuerdo a estos resultados se concluyó que existe un Sistema de Gestión de la Calidad adecuado en el Laboratorio y para favorecer su progreso se redactaron propuestas acordes al laboratorio para la implementación del mismo en este centro de salud.

The clinical laboratories require quality management systems (QMS) to operate in an optimal and efficient way. Actually only a few laboratories work with formal QMS, due this fact, we established to elaborate a diagnosis in order to create purposes over the present QMS through a verification list (VL) that was performed in accordance with the COVENIN/ISO: 15189-2007 normative. The VL was completed through interviews with laboratory coordinator and the demostration of the evidence of fulfillment for the requirements of the QMS described in the standard. The data was tabulated and a cause-effect diagram was elaborated, also a Pareto diagram to give hierarchy to the results obtained and to determine the causes of the non conformities in the actual QMS. The results reflected the lack an adequate QMS, cause 77% of the requirements are not implemented nor documented, a 11,4% are documented but not implemented, and only a 3,4% are implemented and documented (8,2% of the requirements do not apply for this lab). According to these results we conclude that it does not exist an adequate QMS in this laboratory, and in order to promote its progress we wrote purpose in agreement with the laboratory for the implementation in this health center.