GATEKEEPER's Strategy for the Multinational Large-Scale Piloting of an eHealth Platform: Tutorial on How to Identify Relevant Settings and Use Cases.

BACKGROUND: The World Health Organization's strategy toward healthy aging fosters person-centered integrated care sustained by eHealth systems. However, there is a need for standardized frameworks or platforms accommodating and interconnecting multiple of these systems while ensuring secure, relevant, fair, trust-based data sharing and use. The H2020 project GATEKEEPER aims to implement and test an open-source, European, standard-based, interoperable, and secure framework serving broad populations of aging citizens with heterogeneous health needs. OBJECTIVE: We aim to describe the rationale for the selection of an optimal group of settings for the multinational large-scale piloting of the GATEKEEPER platform. METHODS: The selection of implementation sites and reference use cases (RUCs) was based on the adoption of a double stratification pyramid reflecting the overall health of target populations and the intensity of proposed interventions; the identification of a principles guiding implementation site selection; and the elaboration of guidelines for RUC selection, ensuring clinical relevance and scientific excellence while covering the whole spectrum of citizen complexities and intervention intensities. RESULTS: Seven European countries were selected, covering Europe's geographical and socioeconomic heterogeneity: Cyprus, Germany, Greece, Italy, Poland, Spain, and the United Kingdom. These were complemented by the following 3 Asian pilots: Hong Kong, Singapore, and Taiwan. Implementation sites consisted of local ecosystems, including health care organizations and partners from industry, civil society, academia, and government, prioritizing the highly rated European Innovation Partnership on Active and Healthy Aging reference sites. RUCs covered the whole spectrum of chronic diseases, citizen complexities, and intervention intensities while privileging clinical relevance and scientific rigor. These included lifestyle-related early detection and interventions, using artificial intelligence-based digital coaches to promote healthy lifestyle and delay the onset or worsening of chronic diseases in healthy citizens; chronic obstructive pulmonary disease and heart failure decompensations management, proposing integrated care management based on advanced wearable monitoring and machine learning (ML) to predict decompensations; management of glycemic status in diabetes mellitus, based on beat to beat monitoring and short-term ML-based prediction of glycemic dynamics; treatment decision support systems for Parkinson disease, continuously monitoring motor and nonmotor complications to trigger enhanced treatment strategies; primary and secondary stroke prevention, using a coaching app and educational simulations with virtual and augmented reality; management of multimorbid older patients or patients with cancer, exploring novel chronic care models based on digital coaching, and advanced monitoring and ML; high blood pressure management, with ML-based predictions based on different intensities of monitoring through self-managed apps; and COVID-19 management, with integrated management tools limiting physical contact among actors. CONCLUSIONS: This paper provides a methodology for selecting adequate settings for the large-scale piloting of eHealth frameworks and exemplifies with the decisions taken in GATEKEEPER the current views of the WHO and European Commission while moving forward toward a European Data Space.

Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Complex Perianal Fistulas Not Associated With Crohn's Disease: A Phase I Clinical Trial.

BACKGROUND: Anal fistula treatment aims to eradicate the fistula, preserve the sphincter, prevent recurrence, and allow an early return to daily activities for the patient. Because of the difficulty of achieving these goals, stem cell-based therapy has emerged for the treatment of complex perianal fistula with promising results. OBJECTIVE: The objective of this study was to evaluate the safety of allogeneic mesenchymal stem cells in the treatment of complex anal fistula in patients without Crohn's disease. DESIGN: This was a prospective nonrandomized phase I clinical trial. SETTINGS: This study was conducted at a second-level hospital. PATIENTS: Twenty consecutive patients diagnosed with a complex fistula were included. INTERVENTIONS: All patients received 40 × 106 allogeneic mesenchymal stem cells. In patients with 2 tracts, 20 × 106 stem cells were applied on each tract. MAIN OUTCOME MEASURES: The patients were discharged 24 hours after the procedure and were evaluated at 1, 2, 4, 8, 16, and 24 weeks after the application. The long-term follow-up was performed 1 year after the procedure. RESULTS: The procedure was performed in a total of 20 patients from October 1, 2016, to October 31, 2017; 1 patient was eliminated from the final data analysis. No adverse effects were reported within the first 24 hours, and all the patients were discharged asymptomatic. Three patients (15%) presented with perianal abscess. In 1 patient, the abscess appeared at the fourth week, and, in the other 2 patients, the abscess was diagnosed at week 8. Complete closure was achieved in 13 (69%) patients. LIMITATIONS: This was a nonrandomized controlled trial. CONCLUSION: The use of allogeneic mesenchymal stem cells as a treatment is a safe option for the management of complex perianal fistula not associated with Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B443. SEGURIDAD DE LAS CLULAS MADRE MESENQUIMALES ALOGNICAS DERIVADAS DEL TEJIDO ADIPOSO PARA EL TRATAMIENTO DE FSTULAS PERIANALES COMPLEJAS NO ASOCIADAS CON LA ENFERMEDAD DE CROHN ENSAYO CLNICO DE FASE I: ANTECEDENTES:El tratamiento de la fístula anal tiene como objetivo erradicar la fístula, preservar el esfínter, prevenir la recurrencia y permitir un retorno temprano a las actividades diarias del paciente. Debido a la dificultad de alcanzar estos objetivos, ha surgido una terapia basada en células madre para el tratamiento de la fístula perianal compleja con resultados prometedores.OBJETIVO:El objetivo de este estudio fue evaluar la seguridad de las células madre mesenquimales alogénicas en el tratamiento de la fístula anal compleja en pacientes sin enfermedad de Crohn.DISEÑO:Este fue un ensayo clínico prospectivo no aleatorizado de fase I.AMBIENTE:Este estudio se realizó en un hospital de segundo nivel.PACIENTES:Veinte pacientes consecutivos diagnosticados de fístula compleja.INTERVENCIONES:Todos los pacientes recibieron 40 x 106 células madre mesenquimales alogénicas, en pacientes con dos tractos, se aplicaron 20 x 106 células madre en cada tracto.PRINCIPALES MEDIDAS DE RESULTADO:Los pacientes fueron dados de alta 24 horas después del procedimiento y fueron evaluados 1, 2, 4, 8, 16, 24 semanas después de la aplicación. El seguimiento a largo plazo se realizó un año después del procedimiento.RESULTADOS:El procedimiento se realizó en un total de 20 pacientes desde el 1 de octubre de 2016 al 31 de octubre de 2017; un paciente fue eliminado del análisis de datos final. No se informaron efectos adversos en las primeras 24 horas, todos los pacientes fueron dados de alta asintomáticos. Tres pacientes (15%) presentaron absceso perianal. En un paciente, el absceso apareció a la cuarta semana y en los otros dos pacientes el absceso se diagnosticó en la octava semana. El cierre completo se logró en 13 (69%) de los pacientes.LIMITACIONES:Este fue un ensayo controlado no aleatorio.CONCLUSIÓN:El uso de células madre mesenquimales alogénicas como tratamiento es una opción segura para el manejo de la fístula perianal compleja no asociada con la enfermedad de Crohn. Consulte Video Resumen en http://links.lww.com/DCR/B443.

Ethical Decision Making in Iot Data Driven Research: A Case Study of a Large-Scale Pilot.

IoT technologies generate intelligence and connectivity and develop knowledge to be used in the decision-making process. However, research that uses big data through global interconnected infrastructures, such as the 'Internet of Things' (IoT) for Active and Healthy Ageing (AHA), is fraught with several ethical concerns. A large-scale application of IoT operating in diverse piloting contexts and case studies needs to be orchestrated by a robust framework to guide ethical and sustainable decision making in respect to data management of AHA and IoT based solutions. The main objective of the current article is to present the successful completion of a collaborative multiscale research work, which addressed the complicated exercise of ethical decision making in IoT smart ecosystems for older adults. Our results reveal that among the strong enablers of the proposed ethical decision support model were the participatory and deliberative procedures complemented by a set of regulatory and non-regulatory tools to operationalize core ethical values such as transparency, trust, and fairness in real care settings for older adults and their caregivers.

Use of the Learning Curve-Cumulative Summation Test for Leopold Maneuvers Assessment in a Simulator: A Pilot Study.

INTRODUCTION: Simulation enables medical students to practice clinical skills in a safe environment. Graduates in medicine must be able to correctly perform an examination on a pregnant woman using Leopold maneuvers. Learning curves-cumulative summation (LC-CUSUM) may help determine when the student has achieved a specific skill. Our objective was to perform the LC-CUSUM test regarding the ability of students to correctly carry out Leopold maneuvers; a pregnancy simulator was used, transferring the results to a clinical setting. METHODS: Five medical students were trained to carry out Leopold maneuvers using the simulator. Each student performed maneuvers for 50 cases of different fetus positions; a LC-CUSUM was plotted for each student. Afterward, the students performed the Leopold maneuvers on 5 pregnant women. RESULTS: Of the 5 students, 3 achieved a level of proficiency; the attempts needed for reaching this level were 13, 13, and 37, respectively. The other 2 students did not reach proficiency level. Of the students who became successfully proficient with the simulator, one of them attained a 100% success rate in pregnant patients, whereas the other two had success rates of 80%. The students who did not achieve a level of competency with the simulator had only a 60% success rate with patients. CONCLUSIONS: Because of the differences observed between students in the number of attempts needed for achieving proficiency in Leopold maneuvers, we believe that each student should build his/her own learning curve. Achieving competency in carrying out Leopold maneuvers using the simulator could be transferable to patients.

A novel device based on smart textile to control heart's activity during exercise.

In recent years, several systems have been developed to control cardiac function during exercise, and some are also capable of recording RR data to provide heart rate variability (HRV) analyses. In this study we compare time between heart beats and HRV parameters obtained with a smart textile system (GOW; Weartech sl., Spain) and an electrocardiogram machine commonly used in hospitals during continuous cycling tests. Twelve cardiology patients performed a 30-min cycling test at stable submaximal intensity. RR interval data were recorded during the test by both systems. 3-min RR segments were taken to compare the time intervals between beats and HRV variables using Bland-Altman analyses and intraclass correlation coefficients. Limits of agreement (LoAs) on RR intervals were stable at around 3 ms (widest LoAs -5.754 to 6.094 ms, tightest LoAs -2.557 to 3.105 ms, medium LoAs -3.638 ± 0.812 to 3.145 ± 0.539 ms). HRV parameters related to short-term change presented wide LoAs (RMSSD -0.17 to 18.41 %, HF -17.64 to 33.21 %, SD1 -0.50 to 17.54 %) as an effect of the error measurement of the GOW system. The GOW system is a valid tool for controlling HR during physical activity, although its use as a clinical tool for HRV cannot be supported.

universAAL: towards the assisting technologies market breakthrough.

The universAAL initiative aims at fulfilling EU objectives to promote open platforms in the Ambient Assisted Living domain by: (1) producing a platform providing the necessary technical support; (2) carrying out support activities promoting widespread acceptance and adoption of the platform. Coordinated exploitation models to ensure the sustainability of project results are being developed by a partnership of committed partners in order to deliver the evidence of usefulness, usability, and reliability of the universAAL platform while assuring its maintenance, thus making universAAL a unique candidate for re-use under real-life conditions.

METABO: a new paradigm towards diabetes disease management. An innovative business model.

Dealing with a chronic disease and, more specifically, with Diabetes Mellitus and other metabolic disorders, represents a great challenge for care givers, patients and the healthcare systems as their treatment requires continuous medical care and patient self management. The engagement of patients in the adoption of healthy lifestyles with a positive impact in the progression of their diseases is fundamental to avoid the appearance of chronic complications or co-morbidities. This paper presents the externalization of the health management of diabetic patients as an alternative to the current models of care for these patients that can help improve the quality of follow up and care delivery and contribute to the sustainability of the healthcare systems.

An integrated advanced communication and coaching platform for enabling personalized management of chronic cardiovascular diseases.

Chronic cardiovascular diseases directly account for millions of deaths, billions of Euros and a big number of disabilities affecting the world's population. Even though primary and secondary prevention factors are well known, the awareness and the concern of citizens and patients is not big enough to cause a significant change in lifestyle that modifies the increasing trends. Patients and families, professionals and healthcare systems are not prepared to fight against this burden in an effective and aligned way. Some disease management programmes based on ICT solutions have and are currently being tested around the world but their relative impaction has been very limited. This paper proposes a new turn into Personal Health Systems applied to chronic disease management by increasing the capabilities for personalization, providing the patients with motivation and coaching support and enabling the work of the professionals with intelligent tools for strategic and clinical decision making based on the newest medical evidence.

Accessing to electronic medical history using a mobility intra hospital system.

The aim of this paper is to describe the solution that has been developed in Valencia Region (Spain) to provide health professionals (physicians and nurses) access to all the functionalities of a Hospital Information System (HIS) already available at fixed clients workstations. These functionalities are adapted to the care process carried out at patient bedside. In this way, professionals will have access to treatment and administration, recording of vital signs, nursing assessment, scales, care plan, extractions, medical records, progress notes so that they have all necessary information at the bedside, and record swiftly changes that occur in-situ. In addition, clinical safety is reinforced, including RFID patient identification mechanisms and barcode readers for blood samples or unidosis medication.

Ambient Assisted Living spaces validation by services and devices simulation.

The design of Ambient Assisted Living (AAL) products is a very demanding challenge. AAL products creation is a complex iterative process which must accomplish exhaustive prerequisites about accessibility and usability. In this process the early detection of errors is crucial to create cost-effective systems. Computer-assisted tools can suppose a vital help to usability designers in order to avoid design errors. Specifically computer simulation of products in AAL environments can be used in all the design phases to support the validation. In this paper, a computer simulation tool for supporting usability designers in the creation of innovative AAL products is presented. This application will benefit their work saving time and improving the final system functionality.

Ambient Assisted Nutritional Advisor for elderly people living at home.

Nutrition is a critical aspect when getting older because bad nutrition habits can accelerate the process of degradation of the physical condition of the old person. In order to mitigate this problem, an Ambient Assisted Living service has been developed. Research with this service is focused on demonstrating that with an Ambient Intelligence systems it is possible to make the nutritional management much more effective by influencing the user, by automatically and seamlessly monitoring and by facilitating tools for nutritional management for people that want to be autonomous. In this paper both requirement acquisition and development processes are described as well.

Information and assistance bubbles to help elderly people in public environments.

Ambient Assisted Living (AAL) is an emerging bundle of technologies and services that has been specially conceived to support disabled and elderly people to be more autonomous in their daily life. Support for mobility is a key aspect in AAL, and makes elderly people feel very independent and socially integrated. This paper describes an AAL solution to support elderly people outside home: provides information and assistance at the street near public buildings, and inside public buildings. The concept of bubble is proposed in this paper as a physical space where it is possible to consume to a number of local services. Presented mobility-based AAL Services are integrated with an ambient assisted home, so users perceive mobility service as an extension of the care chain beyond the boundaries of their homes.

e_Disease Management. A system for the management of the chronic conditions.

Disease Management (DM) is a system of coordinated healthcare intervention and communications for populations with conditions in which patient self-care efforts are significant. e-DM makes reference to processes of DM based on clinical guidelines sustained in the scientific medical evidence and supported by the intervention of Information and Telecommunication Technology (ICT) in all levels where these plans are developed. This paper discusses the design and implementation of a e-DM system which meets the requirements for the integrated chronic disease management following the recommendations of the Disease Management Association and the American Heart Association.

New technologies for promoting a healthy diet and active living.

Information and communication technologies (ICT) offer innovative formats for promoting healthy lifestyles and reinforcing public health initiatives. They can be applied to large population segments without losing the functionality of being tailored to individual fluctuating needs. Advantages of ICT include real-time provision and adaptation of nutrition and health recommendations based on an individual's particular situation, the potential to combine assessment procedures with healthy lifestyle support and the ability to unify psychosocial and cultural dimensions to enhance adherence. Two pilot programs are presented that show the potential for applying ICT to the promotion of healthy eating and physical activity habits.

Innovative concepts for prevention and disease management of cardiovascular diseases.

Innovative concepts for prevention and disease management of cardio-vascular disease are being developed in the framework of MyHeart project. After a successful first phase where 16 different concepts were tested, four of them where selected on the basis of user acceptance, technical feasibility and foreseen impact. The present paper gives an overview of such product-concepts that are being implemented and will be extensively tested in the next phase of the project.

Communication platform for biosensor-based sleep management applications.

This paper presents the architecture of a complete communications platform for biosensor-based applications in the domain of sleep disorders. It covers from the direct communication with the sensors themselves to the most remote application modules. It has been divided into three levels: BAN (Body Area Network), LAN (Local Area Network) and WAN (Wide Area Network), and it uses wireless communications at all levels of the architecture.

Interactive Information Environment for the controlled practice of physical training to improve cardiovascular fitness.

Physical inactivity is one of the risk factors of Coronary heart disease. Physical activity protects against the development of CVD and also favorably modifies other risk factors, however a huge part of the population lead a relatively sedentary lifestyle. Virtual Trainer (VT) Concept is a technological platform for the controlled practice of physical training to achieve better cardiovascular fitness results that includes a motivational environment crated to support the long term compliance with the training program. VT consist of a technological platform, a method for the fitness condition assessment and the motivational multimedia environment. This paper describes the firsts results achieved in the project on the technological platform and the fitness condition assessment.