Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure

Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review. This manuscript presents the results of this search, which covered the period from January 1974 to October 2022. After careful independent screening, 21 reviews, mainly conducted in North America and Europe, were retained and included. Among the findings were that deep learning is the most commonly utilised method and that electronic health records and registries are among the most prevalent sources of data for AI/ML algorithms. Out of the 21 included reviews, 19 focused on risk prediction and/or the early diagnosis of HF. Furthermore, 10 reviews provided evidence of the impact on the incidence/progression of HF, and 13 on the length of stay. From an HTA perspective, the main areas requiring improvement are the quality assessment of studies on AI/ML (included in 11 out of 21 reviews) and their data sources, as well as the definition of the criteria used to assess the selection of the most appropriate AI/ML algorithm. © 2023 by the authors

A patient empowerment framework for integrated healthcare management programs of diabetes in the digital era

Diabetes mellitus is one of the most prevalent chronic diseases. Despite current cutting-edge research, in particular, type 1 diabetes (T1D) remains incurable and its only treatment consists of controlling blood sugar levels with insulin, as well as diet and lifestyle management to avoid long-term complications. Therefore, good education in this complex scenario is essential for patients with T1D, especially to achieve and maintain a good quality of life while managing the disease over the years. The digital transformation of diabetes care has the potential to empower health and social care systems to manage costs and engage their resources efficiently; to improve quality, transfer value and enhance the holistic care of people with diabetes. In particular, educating patients from the outset leads to their activation and empowerment in managing their health, increasing the effectiveness of clinical interventions combined with traditional techniques. The aim of this thesis lies in the definition and verification of a framework to empower type 1 diabetic patients through digital health strategies for integrated value-based care. The methodology of this work has been divided into four phases: 1) knowledge decomposition to find missed opportunities regarding digital technologies and their inclusion as part of diabetes care; 2) analysis of patients' needs and stakeholders related to the patient environment; 3) design of the proposed framework; 4) verification of the framework. During the implementation of the methodology, particular emphasis has been given to the concept of open innovation as a form of collaboration in which several actors participate in harmony: the public and private sector, health professionals and researchers, patients and citizens. In particular, based on the Living Lab approach, which is based on open innovation and the Quadruple Helix model, giving citizens a key role in defining and creating research and innovation processes. Firstly, a scoping review was conducted to find out which groups of digital technologies are most commonly used for self-management and digital education of type 1 diabetic patients. As a result of this phase, eight existing literature gaps on this topic have been identified. Among the most relevant are outlined briefly: The most used digital tool is the mobile health application. However, there is a lack of implementation of digital educational modules or features in them. Also, digital technologies do not consider adequately the role of healthcare professionals as facilitators and the concept of patient empowerment is not clearly focused on the development of digital tools. During the second phase, a series of interviews were conducted with professionals, patients and technology providers in the sector in order to corroborate the results of the first phase and to find out the current needs at that time, from which it was concluded that Hb1Ac is leading decisions on diabetes management and no secondary outcomes are measured in the daily clinical practices. On top of that, health literacy and digital literacy of patients and professionals are also key components. Then, during the third phase, the Platform Design Toolkit methodology was applied to design the conceptual framework of patient empowerment, extracting the main components and value relationships between the actors (i.e. between health professionals (endocrinologists and nurse educators), patients, hospital organisations and industry). As the main outcome of this phase, the conceptual framework was designed, populated by six main blocks that brought together the facilitators grouped into four levels (i.e. organisations at the macro-level, health professionals at the meso-level, patients at the micro-level and industry at the meta-level), the data flows that serve as input, the technology enabler, the output generated, the outcomes that are collected and finally the impact yielded by the intervention. Given these elements, the proposed framework was verified by means of a retrospective case study with the researcher as observer, this being the last phase. The case study was conducted through the European INCAP project, which implemented remote digital technology to address two very important needs that were not covered by the healthcare system at the time (1) the provision of adequate educational information and feedback to patients, and (2) the provision of comprehensive follow-up with the involvement of all stakeholders. The case study allowed to perform a retrospective analysis, contributing to (1) clear define the stakeholders involved in the scenario of the diabetic patient and its internal and external communication system through the Living Lab concept, (2) the inclusion of a value generation mechanism and its parameters, and (3) the establishment of the technological element and its relationships with the primary and secondary outcomes. Finally, the proposed framework allowed connecting critical elements in the care of a diabetic patient that are currently managed independently: integrated care, value-based care, the inclusion of digital technologies as part of their education and disease management and emphasizing the importance of measuring secondary outcomes (Patient reported outcomes) to improve the overall care of the patient living with diabetes. This dissertation contributes to the foundation of knowledge and understanding related to digital interventions, focuses on education, for diabetes self-management and patient empowerment in a value-based integrated care context. ----------RESUMEN---------- La diabetes mellitus es una de las enfermedades crónicas más prevalentes. A pesar de la investigación actual, en particular, la diabetes de tipo 1 (T1D) sigue sin tener cura y su único tratamiento consiste en el control de los niveles de azúcar en sangre con insulina, así como la gestión de la dieta y el estilo de vida para evitar complicaciones a largo plazo. Por lo tanto, una buena educación en este complejo escenario es esencial para los pacientes con T1D, especialmente para lograr y mantener una buena calidad de vida mientras se controla la enfermedad a lo largo de los años. La transformación digital de la atención a la diabetes tiene el potencial de capacitar a los sistemas para gestionar los costes y comprometer sus recursos de manera eficiente; para mejorar la calidad, transferir valor y mejorar la atención holística de las personas con diabetes. Concretamente, educar a los pacientes desde el principio conduce a su activación y empoderamiento en la gestión de su salud, aumentando la eficacia de las intervenciones clínicas combinadas con las técnicas tradicionales. El objetivo de esta tesis radica en la definición y verificación de un marco para empoderar a los pacientes diabéticos tipo 1 a través de estrategias de salud digital para una atención integrada basada en el valor. La metodología de este trabajo se divide en cuatro fases: 1) descomposición del conocimiento para encontrar oportunidades perdidas en relación con las tecnologías digitales y su inclusión como parte de la atención a la diabetes; 2) análisis de las necesidades de los pacientes y de las partes interesadas relacionadas con el entorno del paciente; 3) diseño del marco conceptual; 4) verificación del marco propuesto. Durante la aplicación de la metodología, se ha hecho especial hincapié en el concepto de innovación abierta como forma de colaboración en la que participan en armonía varios actores: el sector público y el privado, los profesionales sanitarios y los investigadores, los pacientes y los ciudadanos. En particular, utilizando el enfoque del Living Lab, que se basa en la innovación abierta y el modelo de la Cuádruple Hélice, otorgando los ciudadanos un papel clave en la definición y creación de procesos de investigación e innovación. En primer lugar, se llevó a cabo una revisión del alcance para averiguar qué grupos de tecnologías digitales son los más utilizados para la autogestión y la educación digital de los pacientes con diabetes tipo 1. Como resultado de esta fase, se han identificado ocho oportunidades no cubiertas existentes sobre este tema. Entre las más relevantes se exponen brevemente: La herramienta digital más utilizada es la aplicación de salud móvil. Sin embargo, existe una falta de implementación de módulos o funciones educativas digitales en ellas. Además, las tecnologías digitales no consideran adecuadamente el papel de los profesionales sanitarios como facilitadores y el concepto de empoderamiento del paciente no está bien enfocado al desarrollo de herramientas digitales. Durante la segunda fase, se realizaron una serie de entrevistas a profesionales, pacientes y proveedores de tecnología del sector para corroborar los resultados de la primera fase y conocer las necesidades actuales en ese momento, de las que se concluyó que la Hb1Ac lidera las decisiones de gestión de la diabetes y no se miden resultados secundarios (aquellos que no son puramente clínicos) en las prácticas clínicas diarias. Además, la alfabetización sanitaria y la alfabetización digital de los pacientes y los profesionales son también componentes clave. A continuación, durante la tercera fase, se aplicó la metodología del Platform Design Toolkit para diseñar el marco conceptual del empoderamiento del paciente, extrayendo los principales componentes y las relaciones de valor entre los actores (es decir, entre los profesionales de la salud (endocrinólogos y educadores de enfermería), los pacientes, las organizaciones hospitalarias y la industria). Como resultado principal de esta fase, se diseñó el marco conceptual, compuesto por seis bloques principales que reunían los facilitadores agrupados en cuatro niveles (es decir, las organizaciones en el macronivel, los profesionales sanitarios en el mesonivel, los pacientes en el micronivel y la industria en el metanivel), los flujos de datos que sirven de entrada al modelo, el componente tecnológico, la salida generada, los resultados que se recogen y, por último, el impacto producido por la intervención. Teniendo en cuenta estos elementos, el marco propuesto se verificó mediante un estudio de caso con el investigador como observador, siendo esta la última fase. El estudio de caso se llevó a cabo a través del proyecto europeo INCAP, que implementó la tecnología digital a distancia para abordar dos necesidades muy importantes que no estaban cubiertas por el sistema sanitario en ese momento (1) la provisión de información educativa adecuada y la retroalimentación a los pacientes, y (2) la provisión de un seguimiento exhaustivo con la participación de todas las partes interesadas. El estudio de caso permitió realizar un análisis retrospectivo, contribuyendo a (1) definir claramente los actores involucrados en el escenario del paciente diabético y su sistema de comunicación interna y externa a través del concepto de Living Lab, (2) la inclusión de un mecanismo de generación de valor y sus parámetros, y (3) el establecimiento del elemento tecnológico y sus relaciones con los resultados primarios y secundarios. Por último, el marco propuesto permitió conectar elementos críticos en el cuidado de un paciente diabético que actualmente se gestionan de forma independiente: la atención integrada, la atención basada en el valor, la inclusión de tecnologías digitales como parte de su educación y gestión de la enfermedad y el énfasis en la importancia de medir los resultados secundarios para mejorar la atención general del paciente que vive con diabetes. Esta tesis contribuye a la base del conocimiento y la comprensión relacionados con las intervenciones digitales, centradas en la educación, para la autogestión de la diabetes y el empoderamiento del paciente en un contexto de atención integrada basada en el valor

Propuesta y evaluación de un sistema de reconocimiento de iris basado en filtros de sobel

A pesar de la variedad de sistemas biométricos existentes, los métodos de reconocimiento de usuarios mediante iris son uno de los procedimientos más fiables a la hora de identificar a una persona. Estos implementan un procedimiento secuencial dividido en cuatro etapas: captura de la muestra, pre-procesado, extracción de características y comparación de patrones. Uno de los algoritmos más utilizados es el propuesto por John Daugman, cuyo sistema de reconocimiento de iris se basa en filtros de Gabor en la etapa de extracción de características. El objetivo de este trabajo es proponer y evaluar un sistema de reconocimiento de iris alternativo basado, en este caso, en filtros de Sobel. El sistema se implementa en Matlab, realizándose un estudio comparativo de las tasas de error de ambos sistemas, en la arquitectura de verificación. La base de datos utilizada para la evaluación de la tarea propuesta es la CASIA-IrisV1 formada por un total de 756 muestras tomadas de manera manual y con una iluminación uniforme

Evaluating IoT-Based Services to Support Patient Empowerment in Digital Home Hospitalization Services

Hospitals need to optimize patient care, as, among other factors, life expectancy has increased due to improvements in sanitation, nutrition, and medicines. Hospitalization-at-home (HaH) could increase admission efficiency, moderate costs, and reduce the demand for beds. This study aimed to provide data on the feasibility, acceptability, and effectiveness of the integration of IoT-based technology to support the remote monitoring and follow-up of patients admitted to HaH units, as well as the acceptability of IoT-based solutions in healthcare processes. The need for a reduction in the number of admission days, the percentage of admissions after discharge, and the actions of the emergency services during admission were the most relevant findings of this study. Furthermore, in terms of patient safety and trust perception, 98% of patients preferred this type of digitally-supported hospitalization model and up to 95% were very satisfied. On the professional side, the results showed a reduction in work overload and an increase in trust when the system was adopted

Evaluating IoT-Based Services to Support Patient Empowerment in Digital Home Hospitalization Services

Hospitals need to optimize patient care, as, among other factors, life expectancy has increased due to improvements in sanitation, nutrition, and medicines. Hospitalization-at-home (HaH) could increase admission efficiency, moderate costs, and reduce the demand for beds. This study aimed to provide data on the feasibility, acceptability, and effectiveness of the integration of IoT-based technology to support the remote monitoring and follow-up of patients admitted to HaH units, as well as the acceptability of IoT-based solutions in healthcare processes. The need for a reduction in the number of admission days, the percentage of admissions after discharge, and the actions of the emergency services during admission were the most relevant findings of this study. Furthermore, in terms of patient safety and trust perception, 98% of patients preferred this type of digitally-supported hospitalization model and up to 95% were very satisfied. On the professional side, the results showed a reduction in work overload and an increase in trust when the system was adopted

Feasibility study of a clinical decision support system for polymedicated patients in primary care

Abstract Age‐related changes in pharmacokinetics and pharmacodynamics, multimorbidity, frailty, and cognitive impairment represent challenges for drug treatments. Moreover, older adults are commonly exposed to polypharmacy, leading to increased risk of drug interactions and related adverse events, and higher costs for the healthcare systems. Thus, the complex task of prescribing medications to older polymedicated patients encourages the use of Clinical Decision Support Systems (CDSS). This paper evaluates the CDSS miniQ for identifying potentially inappropriate prescribing in poly‐medicated older adults and assesses the usability and acceptability of the system in health care professionals, patients, and caregivers. The results of the study demonstrate that the miniQ system was useful for Primary Care physicians in significantly improving prescription, thereby reducing potentially inappropriate medication prescriptions for elderly patients. Additionally, the system was found to be beneficial for patients and their caregivers in understanding their medications, as well as usable and acceptable among healthcare professionals, patients, and caregivers, highlighting the potential to improve the prescription process and reduce errors, and enhancing the quality of care for elderly patients with polypharmacy, reducing adverse drug events, and improving medication management