Revisión sistemática sobre la efectividad de la Patología Digital como herramienta de diagnóstico asistencial en anatomía patológica y citopatología / Systematic review about effectiveness of Digital Pathology as a diagnostic tool for pathology and cytopathology

INTRODUCCIÓN La Anatomía Patológica (AP) se encarga del diagnóstico de las enfer medades, en base a la integración de las características morfológicas y mo leculares en muestras tisulares (biopsias) y citológicas, ayuda a dilucidar la patogenia de las enfermedades y a determinar su clasificación. Este informe se centra en la patología digital (PD) como el establecimiento de un diag nóstico anatomopatológico a través de imágenes digitales de preparaciones histológicas y citológicas. Los preparaciones histológicas y citológicas ("preparaciones" o "laminillas") son muestras de tejido o de citologías fijadas y teñidas en un portaobjetos de vidrio, con un sistema de cubreobjetos (vidrio, película o gel) que permite su examen microscópico y su conservación a largo plazo. Los sistemas de imagen de PD se basan en preparaciones digitales (PrD), que son imágenes microscópicas digitalizadas del total de la muestra (en inglés, "Whole Slide Images", WSI) disponible en las preparaciones. Estos sistemas constan de escáneres de alta resolución, servidores de al macenamiento y estaciones de trabajo para visualizar las PrD y emitir el diagnóstico. Actualmente, no hay muchos departamentos o servicios de anatomía patológica en los hospitales de España que hayan implementado la PD ínte gramente. Hay algunas experiencias destacables en patología quirúrgica y proyectos piloto en algunas Comunidades Autónomas. El objetivo de presente informe es conocer la efectividad de las herra mientas diagnósticas basadas en sistemas digitales de imagen microscópica, como práctica clínica en los servicios de anatomía patológica. Como objeti vos secundarios se plantean: • Analizar los grados de concordancia y discordancia de los diagnósticos realizados a través de PD en comparación con los realizados con mi croscopio convencional. • Conocer las características principales de los casos de discordancias ma yores en diagnóstico anatomopatológico digital. • Analizar la carga de trabajo en un servicio con patología digital respec to a un servicio sin ella. Se plantea como pregunta de investigación si el diagnóstico en anato mía patológica (incluyendo patología quirúrgica y citología) a través de sis temas de PD no es inferior en concordancia al diagnóstico con microscopio convencional. METODOLOGÍA Se ha realizado una revisión sistemática (RS) de la literatura científica disponible sobre eficacia y seguridad de la PD mediante digitalización com pleta de preparaciones histológicas y citológicas. Se realizó la búsqueda de la literatura científica sobre eficacia, seguri dad, y eficiencia en las siguientes bases de datos electrónicas: Medline, Em base, PROSPERO, DARE (Database of Abstracts of Reviews of Effects), Health Technology Assessment (HTA) Database y NHS-EED (National Health System Economic Evaluation Database) Centre for Reviews and Dissemination (CRD), INAHTA (The International Network of Agencies of Health Technology Assessment), CADTH (Canadian Agency for Drugs and Technologies in Health), AHRQ (Agency for Healthcare research and Quality), NICE (The National Institute for Health and Care excellence) y FDA (US Food and Drug Administration). Se seleccionaron aquellos estudios con metodología de ensayo clí nico aleatorizado (ECA) o RS que tuvieran resultados sobre eficacia y seguridad de la PD en el diagnóstico anatomopatológico en la práctica clínica. Se realizaron tablas de resumen de los resultados de todos los estudios incluidos, recogiendo los valores de concordancia, discordancias menores y discordancias mayores. Se añadieron los datos relativos a la eficiencia de la herramienta diagnóstica de aquellos estudios que los incorporaban. Cuan do fue posible, se realizó una estimación de la media ponderada con sus IC95% para las concordancias en el diagnóstico con ambas intervenciones (diagnóstico con microscopio convencional y diagnóstico digital). RESULTADOS La RS llevada a cabo arrojó un resultado de 1.544 referencias a es tudios, sin contar duplicados. De entre ellas, se seleccionó como fuente de partida una RS de 2020 que permitió restringir la búsqueda a aque llos estudios posteriores a la misma (Azam 2020). Cuando se aplicaron todos los criterios de cribado, se seleccionaron, 3 RS más y 5 estudios individuales. Las características heterogéneas de los estudios incluidos y el tipo de variable de resultado encontrada en la mayoría de ellos, la concordan cia del diagnóstico, no han permitido poder realizar un meta-análisis. No obstante, tal como realizan Azam y cols. en su RS, se ha llevado a cabo un cálculo de la media ponderada, teniendo en cuenta la cifra de concordan cia diagnóstica y el tamaño de la muestra de la que se ha obtenido. Este cálculo resulta en una media de concordancia entre PD y microscopio de 96,17% en un total de 53.535 muestras (preparaciones histológicas y citológicas). La seguridad de estos diagnósticos por PD es adecuada, al no encon trar discordancias diagnósticas mayores (implican diferencias en el trata miento) de relevancia clínica en el total de estudios incluidos. CONCLUSIONES • La patología digital es una técnica diagnóstica efectiva y segura en la práctica clínica. • La concordancia con el diagnóstico con microscopio convencional su pera el 95% • Las discordancias mayores observadas son mínimas. • La implantación de un sistema de PD en un servicio de anatomía pato lógica requiere de un entrenamiento y formación de los profesionales, patólogos y citotécnicos. • Su implementación requiere de la adquisición de equipos y software de calidad que cumplan con las normativas vigentes en la Unión Europea. • Cualquier sistema de PD debe integrarse con los sistemas de informa ción de los servicios de salud, incluida la historia clínica electrónica. • Se necesita un sistema de almacenamiento de imágenes integrado con los sistemas de información y que cumpla con la normativa vigente de protección de datos.

INTRODUCTION Anatomic pathology (AP) is the diagnosis of diseases, based on the integration of morphological and molecular features in tissue (biopsies) and cytological samples, helping to elucidate the pathogenesis of diseases and to determine their classification. In this report, digital pathology (DP) concept is focused on the establishment of a pathological diagnosis through digital imaging of histological and cytological slides. These slides are histological or cytological samples that are fixed and stained on a glass slide, using overslipping methods (glass, film or gels) that allow their microscopic examination and long-term storage. DP imaging systems are based on digital slides that are microscopic digitised images of the whole specimen on a slide (Whole Slide Ima ges: WSI). Digital Pathology systems include high-resolution scanners, storage servers and workstations to visualise the WSI and diagnosis elaboration. Currently, there are not many pathology departments with a full imple mentation of DP services in Spanish hospitals, at least in surgical patholo gy. However, there are some outstanding experiences and pilot projects in some Autonomous Communities. The aim of this report is to know the effectiveness of diagnostic tools based on digital systems of microscopic images as a routine practice in ana tomic pathology departments. Secondary objectives are as follows: • To analyse the degrees of concordance and discordance of diagnoses made using DP compared to those made using conventional microscopy. • To find out the main characteristics of cases of major discordance in digital pathology diagnosis. • To analyse the workload in a department with digital pathology compa red to a department without it. The research question is whether diagnosis in histopathology and cyto pathology using DP systems is not inferior to diagnosis using conventional microscopy. METHODOLOGY A systematic review of the available scientific literature on the efficacy and safety of DP by complete digitisation of histological and cytological slides was carried out. The scientific literature on efficacy, safety and efficiency was searched in the following electronic databases: Medline, Embase, PROSPERO, DARE (Database of Abstracts of Reviews of Effects), Health Technology Assess ment (HTA) Database and NHS-EED (National Health System Econo mic Evaluation Database) Centre for Reviews and Dissemination (CRD), INAHTA (The International Network of Agencies of Health Technology Assessment), CADTH (Canadian Agency for Drugs and Technologies in Health), AHRQ (Agency for Healthcare research and Quality), NICE (The National Institute for Health and Care excellence) and FDA (US Food and Drug Administration). We selected those studies with randomised clinical trial (RCT) or sys tematic reviews (SR) methodology that had results on the efficacy and safe ty of DP in pathology diagnosis in clinical practice. Summary tables were made of the results of all the included stu dies, containing concordance values, minor discordances and major dis cordances. Data on the efficiency of the diagnostic tool were added for those studies that included them. Where possible, an estimate of the wei ghted mean with its 95%CI was made for the diagnostic concordances with both interventions (conventional microscopic diagnosis and digital diagnosis). RESULTS The SR carried out produced a result of 1,544 references to studies, not counting duplicates. From these, a SR from 2020 was selected as the starting source, which allowed us to restrict the search to those studies sub- sequent to it (Azam 2020). When all screening criteria were applied, three more SRs and five individual studies were selected. The heterogeneous characteristics of the included studies and the type of outcome variable found in most of them, diagnostic concordance, did not allow us to perform a meta-analysis. However, as performed by Azam et al. in their SR, a weighted mean calculation has been carried out, taking into account the diagnostic concordance data and the size of the sample from which it was obtained. This calculation results in a mean concordance be tween DP and microscopy of 96.17% in a total of 53,535 samples (histology and cytology slides). The safety of these DP diagnoses is adequate as no major diagnostic discordances (implying differences in treatment) of clinical relevance were found in the total number of studies included. CONCLUSIONS • Digital pathology is an effective and safe diagnostic technique in clinical practice. • Concordance with conventional microscopic diagnosis exceeds 95%. • Major discordances observed are minimal. • The implementation of a DP system in an anatomical pathology depart ment requires training and education of professionals, pathologists and cytotechnicians. • Its implementation requires the acquisition of quality equipment and software that complies with current EU regulations. • Any DP system must be integrated with health service information sys tems, including the electronic medical record. • An image storage system that is integrated with information systems and complies with data protection regulations is needed.

Use of a low-cost telecytopathology method for remote assessment of thyroid FNAs.

BACKGROUND: Rapid on-site evaluation is a great tool for optimizing the adequacy and quality of cytologic samples. The objective of the current study was to analyze a low-cost telecytopathology method for the remote assessment of thyroid fine-needle aspiration biopsies (FNABs), with comparison of the primarily rendered adequacy and diagnosis with the final conventional analysis. METHODS: Material collected from thyroid FNABs was immediately smeared onto glass slides and stained with Diff-Quik. A conventional microscope attached to a smart device was operated on-site by either a medical student or a pathology resident for Wi-Fi transmission of the images by Skype. The cytopathologist would remotely guide the screening of the slides, zooming in and out of areas of interest. Remote assessment included an analysis of material adequacy and a preliminary diagnosis. The quality of the transmission and the number of slides also were recorded. After a washout period of 3 weeks, final diagnosis and adequacy were assigned by conventional microscopy. RESULTS: The final agreement rate for adequacy between remote and conventional analysis was 90.5%. For diagnosis, the final agreement rate was 83.3%. The diagnosis agreement rate varied, depending on the quality of transmission: there was 88% agreement when the quality was excellent, 77.8% agreement when it was good, and 62.5% agreement when it was poor. CONCLUSIONS: Low-cost telecytopathology is an efficient method for the remote assessment of thyroid FNAB adequacy and diagnosis. The wide use of such technology in low-resource or remote centers may have a positive impact on the number of adequate or satisfactory samples, optimizing the management of patients who have thyroid nodules.

Design and Validation of a Low-Cost Telepathology System.

OBJECTIVE: This work sought to evaluate the precision and repeatability of a telepathology prototype based on open software and hardware. MATERIALS AND METHODS: A prototype was designed with application in telepathology and telemicroscopy. Accuracy and prototype precision were evaluated by calculating the mean absolute error and the intraclass and repeatability correlation coefficients for a series of 190 displacements at 10, 25, 50, 75, and 100 µm. RESULTS AND CONCLUSIONS: This work developed a low-cost prototype that is accessible, easily reproducible, implementable, and scalable; based on the use of technology created under principles of open software and hardware. A pathologist reviewed the obtained images and found them to be of diagnostic quality. Its excellent repeatability, coupled with its good accuracy, allows for its application in telemicroscopy and static, dynamic, and whole-slide imaging pathology systems.

Los orígenes caribeños del Sistema Nacional de Salud Pública en los EEUU: una aproximación global a la historia de la medicina y de la salud pública en Latinoamérica / The Caribbean origins of the National Public Health System in the USA: a global approach to the history of medicine and public health in Latin America

Este artículo define la historia global en relación con historia de la medicina y la salud pública. Defiende que una aproximación global a la historia abre un espacio para reverberaciones transmitidas desde la periferia geográfica hacia regiones occidentales, las cuales, tradicionalmente, han dominado la historiografía moderna. Analiza dos intervenciones médicas, en el Caribe, a finales del siglo XIX y principios del XX, y señala que estos sucesos tuvieron profundas consecuencias en los EEUU. Los logros alcanzados en el Caribe, en lo relativo al control de la fiebre amarilla y del anquilostoma, además de servir de modelo para campañas sanitarias en el sur de los EEUU, impulsaron la centralización de la salud pública norteamericana bajo el control centralizador del gobierno federal.

This article defines global history in relation to the history of medicine and public health. It argues that a global approach to history opens up a space for examining the reverberations transmitted from the geographic periphery towards western regions, which have traditionally dominated modern historiography. It analyzes two medical interventions in the Caribbean in the late nineteenth and early twentieth century, showing how these events had profound consequences in the USA. The successes achieved in the Caribbean in terms of yellow fever and ancylostoma control, as well as providing a model for health campaigns in the southern USA, inspired the centralization of public health in North America under the centralizing control of the federal government.

Digital slides: present status of a tool for consultation, teaching, and quality control in pathology.

In the last few years, telepathology has benefited from the progress in the technology of image digitalization and transmission through the world web. The applications of telepathology and virtual imaging are more current in research and morphology teaching. In surgical pathology daily practice, this technology still has limits and is more often used for case consultation. In the present review, we intend to discuss its applications and challenges for pathologists and scientists. Much of the limitations of virtual imaging for the surgical pathologist reside in the capacity of storage of images, which so far has hindered the more widespread use of this technology. Overcoming this major drawback may revolutionize the surgical pathologist's activity and slide storing.